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1 G:\COMP\PHSA\PHSA-MERGED.XML PUBLIC HEALTH SERVICE ACT [As Amended Through P.L. 115–408, Enacted December 31, 2018] References in brackets ¿ ø¿ ø are to title 42, United States Code TITLE I—SHORT TITLE AND DEFINITIONS SHORT TITLE S ECTION ø 201 note ¿ This Act may be cited as the ‘‘Public 1. Health Service Act’’. DEFINITIONS . 2. ø 201 ¿ When used in this Act— EC S (a) The term ‘‘Service’’ means the Public Health Service; (b) The term ‘‘Surgeon General’’ means the Surgeon General of the Public Health Service; (c) Unless the context otherwise requires, the term ‘‘Secretary’’ means the Secretary of Health and Human Services; (d) The term ‘‘regulations’’, except when otherwise specified, means rules and regulations made by the Surgeon General with the approval of the Secretary; (e) The term ‘‘executive department’’ means any executive de- partment, agency, or independent establishment of the United States or any corporation wholly owned by the United States; (f) Except as provided in sections 314(g)(4)(B), 318(c)(1), 331(h)(3), 335(5), 361(d), 701(9), 1002(c), 1401(13), 1531(1), and 1633(1), the term ‘‘State’’ includes, in addition to the several States, only the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, American Samoa, and the Trust Territory of the Pacific Islands. (g) The term ‘‘possession’’ includes, among other possessions, Puerto Rico and the Virgin Islands; ø Repealed. ¿ (h) (i) The term ‘‘vessel’’ includes every description of watercraft or other artificial contrivance used, or capable of being used, as a means of transportation on water, exclusive of aircraft and amphib- ious contrivances; (j) The term ‘‘habit-forming narcotic drug’’ or ‘‘narcotic’’ means opium and coca leaves and the several alkaloids derived therefrom, the best known of these alkaloids being morphia, heroin, and co- deine, obtained from opium, and cocaine derived from the coca plant; all compounds, salts, preparations, or other derivatives ob- tained either from the raw material or from the various alkaloids; Indian hemp and its various derivatives, compounds, and prepara- tions, and peyote in its various forms; isonipecaine and its deriva- tives, compounds, salts and preparations; opiates (as defined in sec- tion 3228(f) of the Internal Revenue Code); 1 March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00001 Fmt 9001 Sfmt 9001 G:\COMP\PHSA\PHSA.BEL HOLCPC

2 G:\COMP\PHSA\PHSA-MERGED.XML 2 Sec. 201 PUBLIC HEALTH SERVICE ACT (k) The term ‘‘addict’’ means any person who habitually uses any habit-forming narcotic drugs so as to endanger the public mor- als, health, safety, or welfare, or who is or has been so far addicted to the use of such habit-forming narcotic drugs as to have lost the power of self-control with reference to his addiction; (l) The term ‘‘psychiatric disorders’’ includes diseases of the nervous system which affect mental health; (m) The term ‘‘State mental health authority’’ means the State health authority, except that, in the case of any State in which there is a single State agency, other than the State health author- ity, charged with responsibility for administering the mental health program of the State, it means such other State agency; (n) The term ‘‘heart diseases’’ means diseases of the heart and circulation; (o) The term ‘‘dental diseases and conditions’’ means diseases and conditions affecting teeth and their supporting structures, and other related diseases of the mouth; (p) The term ‘‘uniformed service’’ means the Army, Navy, Air Force, Marine Corps, Coast Guard, Public Health Service, or Coast and Geodetic Survey; and (q) The term ‘‘drug dependent person’’ means a person who is using a controlled substance (as defined in section 102 of the Con- trolled Substances Act) and who is in a state of psychic or physical dependence, or both, arising from the use of that substance on a continuous basis. Drug dependence is characterized by behavioral and other responses which include a strong compulsion to take the substance on a continuous basis in order to experience its psychic effects or to avoid the discomfort caused by its absence. TITLE II—ADMINISTRATION AND MISCELLANEOUS PROVISIONS P DMINISTRATION ART A—A PUBLIC HEALTH SERVICE S 202 The Public Health Service in the Department ¿ ø . 201. EC of Health and Human Services shall be administered by the Assist- ant Secretary for Health under the supervision and direction of the Secretary. ORGANIZATION 1 . 202. S ø 203 ¿ The Service shall consist of (1) the Office of EC the Surgeon General, (2) the National Institutes of Health, (3) the 1 The organizational units specified in this section, other than the Agency for Health Care Pol- icy and Research, were all abolished as statutory entities by Reorganization Plan No. 3 of 1966. Although the Reorganization Plan abolished the National Institutes of Health as an agency, it did not abolish the individual research institutes. In 1985, Public Law 99–158 added title IV of this Act, which provides that the National Insti- tutes of Health is an agency of the Public Health Service. See section 401(a). Other laws have established additional agencies within the Service. Section 501(a) of this Act provides that the Substance Abuse and Mental Health Services Administration is an agency of the Service. Section 901(a) establishes the Agency for Healthcare Research and Quality within the Service (formerly designated as the Agency for Health Care Policy and Research). Although not established in this Act, the Centers for Disease Control and Prevention, the Health Resources and Services Administration, and the Agency for Toxic Substances and Dis- ease Registry are agencies of the Service. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00002 Fmt 9001 Sfmt 5601 G:\COMP\PHSA\PHSA.BEL HOLCPC

3 G:\COMP\PHSA\PHSA-MERGED.XML 3 Sec. 203 PUBLIC HEALTH SERVICE ACT Bureau of Medical Services, and (4) the Bureau of State Services, 2 The Sec- and the Agency for Health Care Policy and Research. retary is authorized and directed to assign to the Office of the Sec- retary, to the National Institutes of Health, to the Bureau of Med- ical Services, and to the Bureau of State Services, respectively, the several functions of the Service, and to establish within them such divisions, sections and other units as he may find necessary; and from time to time, abolish, transfer, and consolidate divisions, sec- tions, and other units and assign their functions and personnel in such manner as he may find necessary for efficient operation of the Service. No division shall be established, abolished, or transferred, and no divisions shall be consolidated, except with the approval of the Secretary. The National Institutes of Health shall be adminis- tered as a part of the field service. The Secretary may delegate to any officer or employee of the Service such of his powers and duties under this Act, except the making of regulations, as he may deem necessary or expedient. SEC. 203. COMMISSIONED CORPS AND READY RESERVE CORPS. ¿ 204 ø .— STABLISHMENT (a) E (1) I N GENERAL .—There shall be in the Service a commis- sioned Regular Corps and a Ready Reserve Corps for service in time of national emergency. .—All commissioned officers shall be citi- EQUIREMENT (2) R zens of the United States and shall be appointed without re- gard to the civil-service laws and compensated without regard 3 as amended. to the Classification Act of 1923, (3) A .—Commissioned officers of the Ready Re- PPOINTMENT serve Corps shall be appointed by the President and commis- sioned officers of the Regular Corps shall be appointed by the President. .—Commissioned officers of the Ready Re- (4) A CTIVE DUTY serve Corps shall at all times be subject to call to active duty by the Surgeon General, including active duty for the purpose of training. .—Warrant officers may be ap- ARRANT OFFICERS (5) W pointed to the Service for the purpose of providing support to the health and delivery systems maintained by the Service and any warrant officer appointed to the Service shall be consid- ered for purposes of this Act and title 37, United States Code, to be a commissioned officer within the Commissioned Corps of the Service. (b) A ORP EGULAR R FFICERS SSIMILATING R ESERVE C NTO THE O I ORPS .—Effective on the date of enactment of the Patient Protec- C tion and Affordable Care Act, all individuals classified as officers in the Reserve Corps under this section (as such section existed on the day before the date of enactment of such Act) and serving on active duty shall be deemed to be commissioned officers of the Reg- ular Corps. The Food and Drug Administration is also an agency of the Service. 2 So in law. See section 2008(g)(2) of Public Law 103–43 (107 Stat. 212). The term ‘‘the Agen- cy’’ probably should be preceded by ‘‘(5)’’, and the ‘‘and’’ before ‘‘(4)’’ probably should be struck. Further, Public Law 106–129 redesignated the Agency for Health Care Policy and Research as the Agency for Healthcare Research and Quality (see 113 Stat. 1653). 3 Civil service and classification laws are now codified to title 5, United States Code. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00003 Fmt 9001 Sfmt 9001 G:\COMP\PHSA\PHSA.BEL HOLCPC

4 G:\COMP\PHSA\PHSA-MERGED.XML 4 Sec. 203A PUBLIC HEALTH SERVICE ACT U SE OF EADY R ESEARCH .— (c) P URPOSE AND R .—The purpose of the Ready Reserve Corps is (1) P URPOSE to fulfill the need to have additional Commissioned Corps per- sonnel available on short notice (similar to the uniformed serv- ice’s reserve program) to assist regular Commissioned Corps personnel to meet both routine public health and emergency response missions. .—The Ready Reserve Corps shall— SES (2) U (A) participate in routine training to meet the general and specific needs of the Commissioned Corps; (B) be available and ready for involuntary calls to ac- tive duty during national emergencies and public health crises, similar to the uniformed service reserve personnel; (C) be available for backfilling critical positions left va- cant during deployment of active duty Commissioned Corps members, as well as for deployment to respond to public health emergencies, both foreign and domestic; and (D) be available for service assignment in isolated, hardship, and medically underserved communities (as de- fined in section 799B) to improve access to health services. UNDING .—For the purpose of carrying out the duties and (d) F responsibilities of the Commissioned Corps under this section, there are authorized to be appropriated $5,000,000 for each of fis- cal years 2010 through 2014 for recruitment and training and $12,500,000 for each of fiscal years 2010 through 2014 for the Ready Reserve Corps. SEC. 203A. ø 204a ¿ DEPLOYMENT READINESS. EADINESS R EQUIREMENTS FOR C OMMISSIONED C ORPS O FFI - (a) R .— CERS .—The Secretary, with respect to members N GENERAL (1) I of the following Corps components, shall establish require- ments, including training and medical examinations, to ensure the readiness of such components to respond to urgent or emergency public health care needs that cannot otherwise be met at the Federal, State, and local levels: (A) Active duty Regular Corps. (B) Active Reserves. .—The Secretary NNUAL ASSESSMENT OF MEMBERS (2) A shall annually determine whether each member of the Corps meets the applicable readiness requirements established under paragraph (1). (3) F AILURE TO MEET REQUIREMENTS .—A member of the Corps who fails to meet or maintain the readiness require- ments established under paragraph (1) or who fails to comply with orders to respond to an urgent or emergency public health care need shall, except as provided in paragraph (4), in accord- ance with procedures established by the Secretary, be subject to disciplinary action as prescribed by the Secretary. (4) W AIVER OF REQUIREMENTS .— N GENERAL .—The Secretary may waive one or (A) I more of the requirements established under paragraph (1) for an individual who is not able to meet such require- ments because of— March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00004 Fmt 9001 Sfmt 9001 G:\COMP\PHSA\PHSA.BEL HOLCPC

5 G:\COMP\PHSA\PHSA-MERGED.XML 5 Sec. 204 PUBLIC HEALTH SERVICE ACT (i) a disability; (ii) a temporary medical condition; or (iii) any other extraordinary limitation as deter- mined by the Secretary. EGULATIONS .—The Secretary shall promulgate (B) R regulations under which a waiver described in subpara- graph (A) may be granted. RGENT OR EMERGENCY PUBLIC HEALTH CARE NEED .— (5) U For purposes of this section and section 214, the term ‘‘urgent or emergency public health care need’’ means a health care need, as determined by the Secretary, arising as the result of— (A) a national emergency declared by the President under the National Emergencies Act (50 U.S.C. 1601 et seq.); (B) an emergency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5121 et seq.); (C) a public health emergency declared by the Sec- retary under section 319 of this Act; or (D) any emergency that, in the judgment of the Sec- retary, is appropriate for the deployment of members of the Corps. .—The Secretary M ANAGEMENT FOR D EPLOYMENT ORPS (b) C shall— (1) organize members of the Corps into units for rapid de- ployment by the Secretary to respond to urgent or emergency public health care needs; (2) establish appropriate procedures for the command and control of units or individual members of the Corps that are deployed at the direction of the President or the Secretary in response to an urgent or emergency public health care need of national, State or local significance; (3) ensure that members of the Corps are trained, equipped and otherwise prepared to fulfill their public health and emergency response roles; and (4) ensure that deployment planning takes into account— (A) any deployment exemptions that may be granted by the Secretary based on the unique requirements of an agency and an individual’s functional role in such agency; and (B) the nature of the urgent or emergency public health care need. EPLOYMENT OF ETAILED OR A SSIGNED O FFICERS .—For D (c) D purposes of pay, allowances, and benefits of a Commissioned Corps officer who is detailed or assigned to a Federal entity, the deploy- ment of such officer by the Secretary in response to an urgent or emergency public health care need shall be deemed to be an au- thorized activity of the Federal entity to which the officer is de- tailed or assigned. SURGEON GENERAL EC . 204. ø 205 ¿ The Surgeon General shall be appointed from S the Regular Corps for a four-year term by the President by and March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00005 Fmt 9001 Sfmt 9001 G:\COMP\PHSA\PHSA.BEL HOLCPC

6 G:\COMP\PHSA\PHSA-MERGED.XML 6 Sec. 205 PUBLIC HEALTH SERVICE ACT with the advice and consent of the Senate. The Surgeon General shall be appointed from individuals who (1) are members of the Regular Corps, and (2) have specialized training or significant ex- perience in public health programs. Upon the expiration of such term, the Surgeon General, unless reappointed, shall revert to the grade and number in the Regular or Reserve Corps that he would have occupied had he not served as Surgeon General. DEPUTY SURGEON GENERAL AND ASSISTANT SURGEONS GENERAL ø S ¿ (a) The Surgeon General shall assign one com- EC . 205. 206 missioned officer from the Regular Corps to administer the Office of the Surgeon General, to act as Surgeon General during the ab- sence or disability of the Surgeon General or in the event of a va- cancy in that office, and to perform such other duties as the Sur- geon General may prescribe, and while so assigned he shall have the title of Deputy Surgeon General. (b) The Surgeon General shall assign eight commissioned offi- cers from the Regular Corps to be, respectively, the Director of the National Institutes of Health, the Chief of the Bureau of State Services, the Chief of the Bureau of Medical Services, the Chief Medical Officer of the United States Coast Guard, the Chief Dental Officer of the Service, the Chief Nurse Officer of the Service, the Chief Pharmacist Officer of the Service, and the Chief Sanitary En- gineering Officer of the Service, and while so serving they shall each have the title of Assistant Surgeon General. (c)(1) The Surgeon General, with the approval of the Secretary, is authorized to create special temporary positions in the grade of Assistant Surgeons General when necessary for the proper staffing of the Service. The Surgeon General may assign officers of either the Regular Corps or the Reserve Corps to any such temporary po- sition, and while so serving they shall each have the title of Assist- ant Surgeon General. (2) Except as provided in this paragraph, the number of special temporary positions created by the Surgeon General under para- graph (1) shall not on any day exceed 1 per centum of the highest number, during the ninety days preceding such day, of officers of the Regular Corps on active duty and officers of the Reserve Corps on active duty for more than thirty days. If on any day the number of such special temporary positions exceeds such 1 per centum limi- tations, for a period of not more than one year after such day, the number of such special temporary positions shall be reduced for purposes of complying with such 1 per centum limitation only by the resignation, retirement, death, or transfer to a position of a lower grade, of any officer holding any such temporary position. (d) The Surgeon General shall designate the Assistant Surgeon General who shall serve as Surgeon General in case of absence or disability, or vacancy in the offices, of both the Surgeon General and the Deputy Surgeon General. , RANKS , AND TITLES OF THE COMMISSIONED CORPS GRADES S EC ø 207 ¿ (a) The Surgeon General during the period of . 206. his appointment as such, shall be of the same grade as the Surgeon General of the army; the Deputy Surgeon General and the Chief March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00006 Fmt 9001 Sfmt 9001 G:\COMP\PHSA\PHSA.BEL HOLCPC

7 G:\COMP\PHSA\PHSA-MERGED.XML 7 Sec. 206 PUBLIC HEALTH SERVICE ACT Medical Officer of the United States Coast Guard, while assigned as such, shall have the grade corresponding with the grade of major general; and the Chief Dental Officer, while assigned as such, shall have the grade as is prescribed by law for the officer of the Dental Corps selected and appointed as Assistant Surgeon General of the Army. During the period of appointment to the posi- tion of Assistant Secretary for Health, a commissioned officer of the Public Health Service shall have the grade corresponding to the grade of General of the Army. Assistant Surgeons General, while assigned as such, shall have the grade corresponding with either the grade of brigadier general or the grade of major general, as may be determined by the Secretary after considering the impor- That the number of Provided, tance of the duties to be performed: Assistant Surgeons General having a grade higher than that cor- responding to the grade of brigadier general shall at no time exceed one-half of the number of positions created by subsection (b) of sec- tion 205 or pursuant to subsection (c) of such section. The grades of commissioned officers of the Service shall correspond with grades of officers of the Army as follows: (1) Officers of the director grade—colonel; (2) Officers of the senior grade—lieutenant colonel; (3) Officers of the full grade—major; (4) Officers of the senior assistant grade—captain; (5) Officers of the assistant grade—first lieutenant; (6) Officers of the junior assistant grade—second lieuten- ant; (7) Chief warrant officers of (W–4) grade—chief warrant of- ficer (W–4); (8) Chief warrant officers of (W–3) grade—chief warrant of- ficer (W–3); (9) Chief warrant officers of (W–2) grade—chief warrant of- ficer (W–2); and (10) Warrant officers of (W–1) grade—warrant officer (W– 1). (b) The titles of medical officers of the foregoing grades shall be respectively (1) medical director, (2) senior surgeon, (3) surgeon, (4) senior assistant surgeon, (5) assistant surgeon and (6) junior as- sistant surgeon. (c) The President is authorized to prescribe titles, appropriate to the several grades, for commissioned officers of the Service other than medical officers. All titles of the officers of the Reserve Corps shall have the suffix ‘‘Reserve’’. (d) Within the total number of officers of the Regular Corps au- thorized by the appropriation Act or Acts for each fiscal year to be on active duty, the Secretary shall by regulation prescribe the max- imum number of officers authorized to be in each of the grades from the warrant officer (W–1) grade to the director grade, inclu- sive. Such numbers shall be determined after considering the an- ticipated needs of the Service during the fiscal year, the funds available, the number of officers in each grade at the beginning of the fiscal year, and the anticipated appointments, the anticipated promotions based on years of service, and the anticipated retire- ments during the fiscal year. The number so determined for any grade for a fiscal year may not exceed the number limitation (if March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00007 Fmt 9001 Sfmt 9001 G:\COMP\PHSA\PHSA.BEL HOLCPC

8 G:\COMP\PHSA\PHSA-MERGED.XML 8 Sec. 207 PUBLIC HEALTH SERVICE ACT any) contained in the appropriation Act or Acts for such year. Such regulations for each fiscal year shall be prescribed as promptly as possible after the appropriation Act fixing the authorized strength of the corps for that year, and shall be subject to amendment only if such authorized strength or such number limitation is thereafter changed. The maxima established by such regulations shall not re- quire (apart from action pursuant to other provisions of this Act) any officer to be separated from the Service or reduced in grade. (e) In computing the maximum number of commissioned offi- cers of the Public Health Service authorized by law to hold a grade which corresponds to the grade of brigadier general or major gen- eral, there may be excluded from such computation not more than three officers who hold such a grade so long as such officers are as- signed to duty and are serving in a policymaking position in the Department of Defense. (f) In computing the maximum number of commissioned offi- cers of the Public Health Service authorized by law or administra- tive determination to serve on active duty, there may be excluded from such computation officers who are assigned to duty in the De- partment of Defense. APPOINTMENT OF PERSONNEL . 207. ø EC ¿ (a)(1) Except as provided in subsections (b) 209 S and (e) of this section, original appointments to the Regular Corps may be made only in the warrant officer (W–1), chief warrant offi- cer (W–2), chief warrant officer (W–3), chief warrant officer (W–4), junior assistant, assistant, and senior assistant grades and original appointments to a grade above junior assistant shall be made only after passage of an examination, given in accordance with regula- tions of the President, in one or more of the several branches of medicine, dentistry, hygiene, sanitary engineering, pharmacy, psy- chology, nursing, or related scientific specialties in the field of pub- lic health. (2) Original appointments to the Reserve Corps may be made to any grade up to and including the director grade but only after passage of an examination given in accordance with regulations of the President. Reserve commissions shall be for an indefinite pe- riod and may be terminated at any time, as the President may di- rect. (3) No individual who has attained the age of forty-four shall be appointed to the Regular Corps, or called to active duty in the Reserve Corps for a period in excess of one year, unless (A) he has had a number of years of active service (as defined in section 211(d)) equal to the number of years by which his age exceeds forty-four, or (B) the Surgeon General determines that he possesses exceptional qualifications, not readily available elsewhere in the Commissioned Corps of the Public Health Service, for the perform- ance of special duties with the Service, or (C) in the case of an offi- cer of the Reserve Corps, the Commissioned Corps of the Service has been declared by the President to be a military service. (b)(1) Not more than 10 per centum of the original appoint- ments to the Regular Corps authorized to be made during any fis- cal year may be made to grades above that of senior assistant, but March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00008 Fmt 9001 Sfmt 9001 G:\COMP\PHSA\PHSA.BEL HOLCPC

9 G:\COMP\PHSA\PHSA-MERGED.XML 9 Sec. 207 PUBLIC HEALTH SERVICE ACT no such appointment (other than an appointment under section 204) may be made to a grade above that of director. For the pur- pose of this subsection the number of original appointments au- thorized to be made during a fiscal year shall be (1) the excess of the number of officers of the Regular Corps authorized by the ap- propriation Act or Acts for such year over the number of officers on active duty in the Regular Corps on the first day of such year, plus (2) the number of such officers of the Regular Corps who, dur- ing such fiscal year, have been or will be retired upon attainment of age sixty-four or have for any other reason ceased to be on active duty. In determining the number of appointments authorized by this subsection an appointment shall be deemed to be made in the fiscal year in which the nomination is transmitted by the President to the Senate. (2) In addition to the number of original appointments to the Regular Corps authorized by paragraph (1) to be made to grades above that of senior assistant, original appointments authorized to be made to the Regular Corps in any year may be made to grades above that of senior assistant, but not above that of director, in the case of any individual who— (A)(i) was on active duty in the Regular Corps on July 1, 1960, (ii) was on such active duty continuously for not less than one year immediately prior to such date, and (iii) applies for appointment to the Regular Corps prior to July 1, 1962; or (B) does not come within clause (A)(i) and (ii) but was on active duty in the Reserve Corps continuously for not less than one year immediately prior to his appointment to the Regular Corps and has not served on active duty continuously for a pe- riod, occurring after June 30, 1960, of more than three and one-half years prior to applying for such appointment. (3) No person shall be appointed pursuant to this subsection unless he meets standards established in accordance with regula- tions of the President. (c) Commissions evidencing the appointment by the President of officers of the Regular or Reserve Corps shall be issued by the Secretary under the seal of the Department of Health, Education, and Welfare. (d)(1) For purposes of basic pay and for purposes of promotion, any person appointed under subsection (a) to the grade of senior assistant in the Regular Corps and any person appointed under subsection (b), shall, except as provided in paragraphs (2) and (3) of this subsection, be considered as having had on the date of ap- pointment the following length of service: Three years if appointed to the senior assistant grade, ten years if appointed to the full grade, seventeen years if appointed to the senior grade, and eight- een years if appointed to the director grade. (2) For purposes of basic pay, any person appointed under sub- section (a) to the grade of senior assistant in the Regular Corps, and any person appointed under subsection (b), shall, in lieu of the credit provided in paragraph (1), be credited with the service for which he is entitled to credit under any other provision of law if such service exceeds that to which he would be entitled under such paragraph. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00009 Fmt 9001 Sfmt 9001 G:\COMP\PHSA\PHSA.BEL HOLCPC

10 G:\COMP\PHSA\PHSA-MERGED.XML 10 Sec. 207 PUBLIC HEALTH SERVICE ACT (3) For purposes of promotion, any person originally appointed in the Regular Corps to the senior assistant grade or above who has had active service in the Reserve Corps shall be considered as having had on the date of appointment the length of service pro- vided for in paragraph (1), plus whichever of the following is great- er: (A) The excess of his total active service in the Reserve Corps (above the grade of junior assistant) over the length of service pro- vided in such paragraph, to the extent that such excess is on ac- count of service in the Reserve Corps in or above the grade to which he is appointed in the Regular Corps or (B) his active service in the same or any higher grade in the Reserve Corps after the first day on which, under regulations in effect on the date of his appointment to the Regular Corps, he would have had the training and experience necessary for such appointment. (4) For purposes of promotion, any person whose original ap- pointment is to the assistant grade in the Regular Corps shall be considered as having had on the date of appointment service equal to his total active service in the Reserve Corps in and above the assistant grade. (e)(1) A former officer of the Regular Corps may, if application for appointment is made within two years after the date of the ter- mination of his prior commission in the Regular Corps, be re- appointed to the Regular Corps without examination, except as the Surgeon General may otherwise prescribe, and without regard to the numerical limitations of subsection (b). (2) Reappointments pursuant to this subsection may be made to the permanent grade held by the former officer at the time of the termination of his prior commission, or to the next higher grade if such officer meets the eligibility requirements prescribed by regulation for original appointment to such higher grade. For purposes of pay, promotion, and seniority in grade, such re- appointed officer shall receive the credits for service to which he would be entitled if such appointment were an original appoint- ment, but in no event less than the credits he held at the time his prior commission was terminated, except that if such officer is re- appointed to the next higher grade he shall receive no credit for se- niority in grade. (3) No former officer shall be reappointed pursuant to this sub- section unless he shall meet such standards as the Secretary may prescribe. (f) In accordance with regulations, special consultants may be employed to assist and advise in the operations of the Service. Such consultants may be appointed without regard to the civil-service laws and their compensation may be fixed without regard to the 4 Classification Act of 1923, as amended. (g) In accordance with regulations, individual scientists, other than commissioned officers of the Service, may be designated by the Surgeon General to receive fellowships, appointed for duty with the Service without regard to the civil-service laws and com- pensated without regard to the Classification Act of 1923, as 4 amended, may hold their fellowships under conditions prescribed 4 See footnote for the second sentence of section 203. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00010 Fmt 9001 Sfmt 9001 G:\COMP\PHSA\PHSA.BEL HOLCPC

11 G:\COMP\PHSA\PHSA-MERGED.XML 11 Sec. 208 PUBLIC HEALTH SERVICE ACT therein, and may be assigned for studies or investigations either in this country or abroad during the terms of their fellowships. (h) Persons who are not citizens may be employed as consult- ants pursuant to subsection (e) and may be appointed to fellow- ships pursuant to subsection (f). Unless otherwise specifically pro- vided, any prohibition in any other Act against the employment of aliens, or against the payment of compensation to them, shall not be applicable in the case of persons employed or appointed pursu- ant to such subsections. (i) The appointment of any officer or employee of the Service made in accordance with the civil-service laws shall be made by the Secretary, and may be made effective as of the date on which such officer or employee enters upon duty. PAY AND ALLOWANCES S ø 210 ¿ (a)(1) Commissioned officers of the Regular EC . 208. and Reserve Corps shall be entitled to receive such pay and allow- ances as are now or may hereafter be authorized by law. (2) For provisions relating to the receipt of special pay by com- missioned officers of the Regular and Reserve Corps while on active duty, see section 303a(b) or 373 of title 37, United States Code. (b) Commissioned officers on active duty, and retired officers entitled to retired pay pursuant to section 210(g)(3), section 211 or section 221(a), shall be permitted to purchase supplies from the Army, Navy, Air Force, and Marine Corps at the same price as is charged officers thereof. (c) Members of the National Advisory Health Council and members of other national advisory or review councils or commit- tees established under this Act, including members of the Technical Electronic Product Radiation Safety Standards Committee and the Board of Regents of the National Library of Medicine, but exclud- ing ex officio members, while attending conferences or meetings of their respective councils or committees or while otherwise serving at the request of the Secretary shall be entitled to receive com- pensation at rates to be fixed by the Secretary, but at rates not ex- ceeding the daily equivalent of the rate specified at the time of such service for grade GS–18 of the General Schedule, including traveltime; and while away from their homes or regular places of business they may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 of the United States Code for persons in the Government service em- ployed intermittently. (d) Field employees of the Service, except those employed on a per diem or fee basis, who render part-time duty and are also sub- ject to call at any time for services not contemplated in their reg- ular part-time employment, may be paid annual compensation for such part-time duty and, in addition, such fees for such other serv- ices as the Surgeon General may determine; but in no case shall the total paid to any such employee for any fiscal year exceed the amount of the minimum annual salary rate of the classification grade of the employee. (e) Any civilian employee of the Service who is employed at the Gillis W. Long Hansen’s Disease Center on the date of the enact- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00011 Fmt 9001 Sfmt 9001 G:\COMP\PHSA\PHSA.BEL HOLCPC

12 G:\COMP\PHSA\PHSA-MERGED.XML 12 Sec. 209 PUBLIC HEALTH SERVICE ACT ment of the Consolidated Omnibus Budget Reconciliation Act of 1985 shall be entitled to receive, in addition to any compensation to which the employee may otherwise be entitled and for so long as the employee remains employed at the Center, an amount equal to one-fourth of such compensation. (f) Individuals appointed under subsection (g) shall have in- cluded in their fellowships such stipends or allowances, including travel and subsistence expenses, as the Surgeon General may deem necessary to procure qualified fellows. (g) The Secretary is authorized to establish and fix the com- pensation for, within the Public Health Service, not more than one hundred and seventy-nine positions, of which not less than one hundred and fifteen shall be for the National Institutes of Health, not less than five shall be for the National Institute on Alcohol Abuse and Alcoholism for individuals engaged in research on alco- hol and alcoholism, not less than ten shall be for the National Cen- ter for Health Services Research, not less than twelve shall be for the National Center for Health Statistics, and not less than seven shall be for the National Center for Health Care Technology, in the professional, scientific, and executive service, each such position being established to effectuate those research and development ac- tivities of the Public Health Service which require the services of specially qualified scientific, professional, and administrative per- sonnel: Provided, That the rates of compensation for positions es- tablished pursuant to the provisions of this subsection shall not be less than the minimum rate of grade 16 of the General Schedule 5 of the Classification Act of 1949, as amended, nor more than (1) the highest rate of grade 18 of the General Schedule of such Act, or (2) in the case of two such positions, the rate specified, at the time the service in the position is performed, for level II of the Ex- ecutive Schedule (5 U.S.C. 5313); and such rates of compensation for all positions included in this proviso shall be subject to the ap- proval of the Civil Service Commission. Positions created pursuant to this subsection shall be included in the classified civil service of the United States, but appointments to such positions shall be made without competitive examination upon approval of the pro- posed appointee’s qualifications by the Civil Service Commission or such officers or agents as it may designate for this purpose. PROFESSIONAL CATEGORIES ø EC . 209. ¿ 210b S (a) For the purpose of establishing eligibility of officers of the Regular Corps for promotions, the Surgeon Gen- eral shall by regulation divide the corps into professional cat- egories. Each category shall, as far as practicable, be based upon one of the subjects of examination set forth in section 207(a)(1) or upon a subdivision of such subject, and the categories shall be de- signed to group officers by fields of training in such manner that officers in any one grade in any one category will be available for similar duty in the discharge of the several functions of the Serv- ice. (b) Each officer of the Regular Corps on active duty shall, on the basis of his training and experience, be assigned by the Sur- 5 See footnote for the second sentence of section 203. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00012 Fmt 9001 Sfmt 9001 G:\COMP\PHSA\PHSA.BEL HOLCPC

13 G:\COMP\PHSA\PHSA-MERGED.XML 13 Sec. 210 PUBLIC HEALTH SERVICE ACT geon General to one of the categories established by regulations under subsection (a). Except upon amendment of such regulations, no assignment so made shall be changed unless the Surgeon Gen- eral finds (1) that the original assignment was erroneous, or (2) that the officer is equally well qualified to serve in another cat- egory to which he has requested to be transferred, and that such transfer is in the interests of the Service. (c) Within the limits fixed by the Secretary in regulations under section 206(d) for any fiscal year, the Surgeon General shall determine for each category in the Regular Corps the maximum number of officers authorized to be in each of the grades from the warrant officer (W–1) grade to the director grade, inclusive. (d) The excess of the number so fixed for any grade in any cat- egory over the number of officers of the Regular Corps on active duty in such grade in such category (including, in the case of the director grade, officers holding such grade in accordance with sec- tion 206(c)) shall for the purpose of promotions constitute vacancies in such grade in such category. For purposes of this subsection, an officer who has been temporarily promoted or who is temporarily holding the grade of director in accordance with section 206(c) shall be deemed to hold the grade to which so promoted or which he is temporarily holding; but while he holds such promotion or grade, and while any officer is temporarily assigned to a position pursuant to section 205(c), the number fixed under subsection (c) of this sec- tion for the grade of his permanent rank shall be reduced by one. (e) The absence of a vacancy in a grade in a category shall not prevent an appointment to such grade pursuant to section 207, a permanent length of service promotion, or the recall of a retired of- ficer to active duty; but the making of such an appointment, pro- motion, or recall shall be deemed to fill a vacancy if one exists. (f) Whenever a vacancy exists in any grade in a category the Surgeon General may increase by one the number fixed by him under subsection (c) for the next lower grade in the same category, without regard to the numbers fixed in regulations under section 206(d); and in that event the vacancy in the higher grade shall not be filled except by a permanent promotion, and upon the making of such promotion the number for the next lower grade shall be re- duced by one. PROMOTIONS AND SEPARATION OF COMMISSIONED OFFICERS IN THE REGULAR CORPS . 210. ø 211 ¿ (a) Promotions of officers of the Regular Corps S EC to any grade up to and including the director grade shall be either permanent promotions based on length of service, other permanent promotions to fill vacancies, or temporary promotions. Permanent promotions shall be made by the President, and temporary pro- motions shall be made by the President. Each permanent pro- motion shall be to the next higher grade, and shall be made only after examination given in accordance with regulations of the President. (b) The President may by regulation provide that in a specified professional category permanent promotions to the senior grade, or to both the full grade and the senior grade, shall be made only if March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00013 Fmt 9001 Sfmt 9001 G:\COMP\PHSA\PHSA.BEL HOLCPC

14 G:\COMP\PHSA\PHSA-MERGED.XML 14 Sec. 210 PUBLIC HEALTH SERVICE ACT there are vacancies in such grade. A grade in any category with re- spect to which such regulations have been issued is referred to in this section as a ‘‘restricted grade’’. (c) Examinations to determine qualification for permanent pro- motions may be either noncompetitive or competitive, as the Sur- geon General shall in each case determine; except that examina- tions for promotions to the assistant or senior assistant grade shall in all cases be noncompetitive. The officers to be examined shall be selected by the Surgeon General from the professional category, and in the order of seniority in the grade, from which promotion is to be recommended. In the case of a competitive examination the Surgeon General shall determine in advance of the examination the number (which may be one or more) of officers who, after pass- ing the examination, will be recommended to the President for pro- motion; but if the examination is one for promotions based on length of service, or is one for promotions to fill vacancies other than vacancies in the director grade or in a restricted grade, such number shall not be less than 80 per centum of the number of offi- cers to be examined. (d) Officers of the Regular Corps, found pursuant to subsection (c) to be qualified, shall be given permanent promotions based on length of service, as follows: (1) Officers in the warrant officer (W–1) grade, chief warrant officer (W–2) grade, chief warrant officer (W–3) grade, chief war- rant officer (W–4) grade, and junior assistant grade shall be pro- moted at such times as may be prescribed in regulations of the President. (2) Officers with permanent rank in the assistant grade, the senior assistant grade, and the full grade shall (except as provided in regulations under subsection (b)) be promoted after completion of three, ten, and seventeen years, respectively, of service in grades above the junior assistant grade; and such promotions, when made, shall be effective, for purposes of pay and seniority in grade, as of the day following the completion of such years of service. An officer with permanent rank in the assistant, senior assistant, or full grade who has not completed such years of service shall be pro- moted at the same time, and his promotion shall be effective as of the same day, as any officer junior to him in the same grade in the same professional category who is promoted under this paragraph. (e) Officers in a professional category of the Regular Corps, found pursuant to subsection (c) to be qualified may be given per- manent promotions to fill any or all vacancies in such category in the senior assistant grade, the full grade, the senior grade, or the director grade; but no officer who has not had one year of service with permanent or temporary rank in the next lower grade shall be promoted to any restricted grade or to the director grade. (f) If an officer who has completed the years of service required for promotion to a grade under paragraph (2) of subsection (d) fails to receive such promotion, he shall (unless he has already been twice examined for promotion to such grade) be once reexamined for promotion to such grade. If he is thereupon promoted (otherwise than under subsection (e)), the effective date of such promotion shall be one year later than it would have been but for such failure. Upon the effective date of any permanent promotion of such officer March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00014 Fmt 9001 Sfmt 9001 G:\COMP\PHSA\PHSA.BEL HOLCPC

15 G:\COMP\PHSA\PHSA-MERGED.XML 15 Sec. 210 PUBLIC HEALTH SERVICE ACT to such grade, he shall be considered as having had only the length of service required for such promotion which he previously failed to receive. (g) If, for reasons other than physical disability, an officer of the Regular Corps in the warrant officer (W–1) grade or junior as- sistant grade is found pursuant to subsection (c) not to be qualified for promotion he shall be separated from the Service. If, for reasons other than physical disability, an officer of the Regular Corps in the chief warrant officer (W–2), chief warrant officer (W–3), assist- ant, senior assistant, or full grade, after having been twice exam- ined for promotion (other than promotion to a restricted grade), fails to be promoted— (1) if in the chief warrant officer (W–2) or assistant grade he shall be separated from the Service and paid six months’ basic pay and allowances; (2) if in the chief warrant officer (W–3) or senior assistant grade he shall be separated from the Service and paid one year’s basic pay and allowances; (3) if in the full grade he shall be considered as not in line for promotion and shall, at such time thereafter as the Surgeon General may determine, be retired from the Service with re- tired pay (unless he is entitled to a greater amount by reason of another provision of law)— (A) in the case of an officer who first became a mem- ber of a uniformed service before September 8, 1980, at the 1 2 percent of the retired pay base determined ⁄ rate of 2 under section 1406(h) of title 10, United States Code, for each year, not in excess of 30, of his active commissioned service in the Service; or (B) in the case of an officer who first became a mem- ber of a uniformed service on or after September 8, 1980, at the rate determined by multiplying— (i) the retired pay base determined under section 1407 of title 10, United States Code; by (ii) the retired pay multiplier determined under section 1409 of such title for the number of years of his active commissioned service in the Service. (h) If an officer of the Regular Corps, eligible to take an exam- ination for promotion, refuses to take such examination, he may be separated from the Service in accordance with regulations of the President. (i) At the end of his first three years of service, the record of each officer of the Regular Corps, originally appointed to the senior assistant grade or above, shall be reviewed in accordance with reg- ulations of the President and, if found not qualified for further service, he shall be separated from the Service and paid six months’ pay and allowances. (j)(1) The order of seniority of officers in a grade in the Regular Corps shall be determined, subject to the provisions of paragraph (2), by the relative length of time spent in active service after the effective date of each such officer’s original appointment or perma- nent promotion in that grade. When permanent promotions of two or more officers to the same grade are effective on the same day, their relative seniority shall be the same as it was in the grade March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00015 Fmt 9001 Sfmt 9001 G:\COMP\PHSA\PHSA.BEL HOLCPC

16 G:\COMP\PHSA\PHSA-MERGED.XML 16 Sec. 210 PUBLIC HEALTH SERVICE ACT from which promoted. In all other cases of original appointments or permanent promotions (or both) to the same grade effective on the same day, relative seniority shall be determined in accordance with regulations of the President. (2) In the case of an officer originally appointed in the Regular Corps to the grade of assistant or above, his seniority in the grade to which appointed shall be determined after inclusion, as service in such grade, of any active service in such grade or in any higher grade in the Reserve Corps, but (if the appointment is to the grade of senior assistant or above) only to the extent of whichever of the following is greater: (A) His active service in such grade or any higher grade in the Reserve Corps after the first day on which, under regulations in effect on the date of his appointment to the Regular Corps, he had the training and experience necessary for such appointment, or (B) the excess of his total active service in the Reserve Corps (above the grade of junior assistant) over three years if his appointment in the Regular Corps is to the senior as- sistant grade, over ten years if the appointment is to the full grade, or over seventeen years if the appointment is to the senior grade. (k) Any commissioned officer of the Regular Corps in any grade in any professional category may be recommended to the President for temporary promotion to fill a vacancy in any higher grade in such category, up to and including the director grade. In time of war, or of national emergency proclaimed by the President, any commissioned officer of the Regular Corps in any grade in any pro- fessional category may be recommended to the President for pro- motion to any higher grade in such category, up to and including the director grade, whether or not a vacancy exists in such grade. The selection of officers to be recommended for temporary pro- motions shall be made in accordance with regulations of the Presi- dent. Promotion of an officer recommended pursuant to this sub- section may be made without regard to length of service, without examination, and without vacating his permanent appointment, and shall carry with it the pay and allowances of the grade to which promoted. Such promotions may be terminated at any time, as may be directed by the President. (l) Whenever the number of officers of the Regular Corps on ac- tive duty, plus the number of officers of the Reserve Corps who have been on active duty for thirty days or more, exceeds the au- thorized strength of the Regular Corps, the Secretary shall deter- mine the requirements of the Service in each grade in each cat- egory, based upon the total number of officers so serving on active duty and the tasks being performed by the Service; and the Sur- geon General shall thereupon assign each officer of the Reserve Corps on active duty to a professional category. If the Secretary finds that the number of officers fixed under section 209(c) for any grade and category (or the number of officers, including officers of the Reserve Corps, on active duty in such grade in such category, if such number is greater than the number fixed under section 209(c)) is insufficient to meet such requirements of the Service, offi- cers of either the Regular Corps or the Reserve Corps may be rec- ommended for temporary promotion to such grade in such category. Any such promotion may be terminated at any time, as may be di- rected by the President. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00016 Fmt 9001 Sfmt 9001 G:\COMP\PHSA\PHSA.BEL HOLCPC

17 G:\COMP\PHSA\PHSA-MERGED.XML 17 Sec. 211 PUBLIC HEALTH SERVICE ACT (m) Any officer of the Regular Corps, or any officer of the Re- serve Corps on active duty, who is promoted to a higher grade shall, unless he expressly declines such promotion, be deemed for all purposes to have accepted such promotion; and shall not be re- quired to renew his oath of office, or to execute a new affidavit as required by the Act of December 11, 1926, as amended (5 U.S.C. 6 21a). RETIREMENT OF COMMISSIONED OFFICERS S (a)(1) A commissioned officer of the Service ¿ EC . 211. ø 212 shall, if he applies for retirement, be retired on or after the first day of the month following the month in which he attains the age of sixty-four years. This paragraph does not permit or require the involuntary retirement of any individual because of the age of the individual. (2) A commissioned officer of the Service may be retired by the Secretary, and shall be retired if he applies for retirement, on the first day of any month after completion of thirty years of active service. (3) Any commissioned officer of the Service who has had less than thirty years of active service may be retired by the Secretary, with or without application by the officer, on the first day of any month after completion of twenty or more years of active service of which not less than ten are years of active commissioned service in any of the uniformed services. 7 (4) Except as provided in paragraph (6), a commissioned offi- cer retired pursuant to paragraph (1), (2), or (3) who was (in the case of an officer in the Reserve Corps) on active duty with the Service on the day preceding such retirement shall be entitled to 1 receive retired pay at the rate of 2 ⁄ 2 per centum of the basic pay of the highest grade held by him as such officer and in which, in the case of a temporary promotion to such grade, he has performed active duty for not less than six months, (A) for each year of active service, or (B) if it results in higher retired pay, for each of the fol- lowing years: (i) his years of active service (determined without regard to subsection (d)) as a member of a uniformed service; plus (ii) in the case of a medical or dental officer, four years and, in the case of a medical officer, who has completed one year of medical internship or the equivalent thereof, one addi- tional year, the four years and the one year to be reduced by the period of active service performed during such officer’s at- tendance at medical school or dental school or during his med- ical internship; plus (iii) the number of years of service with which he was enti- tled to be credited for purposes of basic pay on May 31, 1958, or (if higher) on any date prior thereto, reduced by any such year included under clause (i) and further reduced by any such year with which he was entitled to be credited under para- graphs (7) and (8) of section 205(a) of title 37, United States Code, on any date before June 1, 1958; 6 That Act has been codified to section 3332 of title 5, United States Code. 7 See amended version of paragraph (4) set out in a note below in effect on January 1, 2018. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00017 Fmt 9001 Sfmt 9001 G:\COMP\PHSA\PHSA.BEL HOLCPC

18 G:\COMP\PHSA\PHSA-MERGED.XML 18 Sec. 211 PUBLIC HEALTH SERVICE ACT except that (C) in the case of any officer whose retired pay, so com- puted, is less than 50 per centum of such basic pay, who retires pursuant to paragraph (1) of this subsection, who has not less than twelve whole years of active service (computed without the applica- tion of subsection (e)), and who does not use, for purposes of a re- 8 tirement annuity under the Civil Service Retirement Act, any service which is also creditable in computing his retired pay from the Service, it shall, instead, be 50 per centum of such pay, and (D) the retired pay of an officer shall in no case be more than 75 per centum of such basic pay. Note: Effective on January 1, 2018 (pursuant to section 635(a) of ø Public Law 114–92), section 631(c)(4) of such Public Law provides for amendments to paragraph (4). Upon such date, section 211(a)(4) (as amended) reads as follows: ¿ (4) Except as provided in paragraph (6), a commissioned officer retired pursuant to paragraph (1), (2), or (3) who was (in the case of an officer in the Reserve Corps) on active duty with the Service on the day preceding such retirement shall be entitled to receive re- tired pay calculated by multiplying the retired pay base determined under section 1406 of title 10, United States Code, by the retired pay multiplier determined under section 1409 of such title for the numbers of years of service credited to the officer under this para- graph and in which, in the case of a temporary promotion to such grade, he has performed active duty for not less than six months, (A) for each year of active service, or (B) if it results in higher re- tired pay, for each of the following years: (i) his years of active service (determined without regard to subsection (d)) as a member of a uniformed service; plus (ii) in the case of a medical or dental officer, four years and, in the case of a medical officer, who has completed one year of medical internship or the equivalent thereof, one addi- tional year, the four years and the one year to be reduced by the period of active service performed during such officer’s at- tendance at medical school or dental school or during his med- ical internship; plus (iii) the number of years of service with which he was enti- tled to be credited for purposes of basic pay on May 31, 1958, or (if higher) on any date prior thereto, reduced by any such year included under clause (i) and further reduced by any such year with which he was entitled to be credited under para- graphs (7) and (8) of section 205(a) of title 37, United States Code, on any date before June 1, 1958; except that (C) in the case of any officer whose retired pay, so com- puted, is less than 50 per centum of such basic pay, who retires pur- suant to paragraph (1) of this subsection, who has not less than twelve whole years of active service (computed without the applica- tion of subsection (e)), and who does not use, for purposes of a re- tirement annuity under the Civil Service Retirement Act, any service which is also creditable in computing his retired pay from the Serv- 8 The Civil Service Retirement Act has been codified to chapter 83 of title 5, United States Code. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00018 Fmt 9001 Sfmt 6603 G:\COMP\PHSA\PHSA.BEL HOLCPC

19 G:\COMP\PHSA\PHSA-MERGED.XML 19 Sec. 211 PUBLIC HEALTH SERVICE ACT ice, it shall, instead, be 50 per centum of such pay, (D) the retired pay of an officer shall in no case be more than 75 per centum of such basic pay, and (E) in the case of any officer who participates in the modernized retirement system by reason of section 1409(b) of title 10, United States Code (including pursuant to an election under subparagraph (B) of that section), subparagraph (C) shall be applied by substituting ‘‘40 per centum’’ for ‘‘50 per centum’’ each place the term appears. (5) With the approval of the President, a commissioned officer whose service as Surgeon General, Deputy Surgeon General, or As- sistant Surgeon General has totaled four years or more and who has had not less than twenty-five years of active service in the Service may retire voluntarily at any time; and except as provided in paragraph (6), his retired pay shall be at the rate of 75 per cen- tum of the basic pay of the highest grade held by him as such offi- cer. (6) The retired pay of a commissioned officer retired under this subsection who first became a member of a uniformed service after September 7, 1980, is determined by multiplying— (A) the retired pay base determined under section 1407 of title 10, United States Code; by (B) the retired pay multiplier determined under section 1409 of such title for the number of years of service credited to the officer under paragraph (4). (7) Retired pay computed under section 210(g)(3) or under paragraph (4) or (5) of this subsection, if not a multiple of $1, shall be rounded to the next lower multiple of $1. (b) For purposes of subsection (a), the basic pay of the highest grade to which a commissioned officer has received a temporary promotion means the basic pay to which he would be entitled if serving on active duty in such grade on the date of his retirement. (c) A commissioned officer, retired for reasons other than for failure of promotion to the senior grade, may (1) if an officer of the Regular Corps or an officer of the Reserve Corps entitled to retired pay under subsection (a), be involuntarily recalled to active duty during such times as the Commissioned Corps constitutes a branch of the land or naval forces of the United States, and (2) if an officer of either the Regular or Reserve Corps, be recalled to active duty at any time with his consent. (d) The term ‘‘active service’’, as used in subsection (a), in- cludes: (1) all active service in any of the uniformed services; (2) active service with the Public Health Service, other than as a commissioned officer, which the Surgeon General de- termines is comparable to service performed by commissioned officers of the Service, except that, if there are more than five years of such service only the last five years thereof may be in- cluded; (3) all active service (other than service included under the preceding provisions of this subsection) which is creditable for retirement purposes under laws governing the retirement of members of any of the uniformed services; and March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00019 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

20 G:\COMP\PHSA\PHSA-MERGED.XML 20 Sec. 212 PUBLIC HEALTH SERVICE ACT (4) service performed as a member of the Senior Bio- medical Research Service established by section 228, except that, if there are more than 5 years of such service, only the last 5 years thereof may be included. (e) For the purpose of determining the number of years by which a percentage of the basic pay of an officer is to be multiplied in computing the amount of his retired pay pursuant to section 210(g)(3) or paragraph (4) of subsection (a) of this section, each full month of service that is in addition to the number of full years of service credited to an officer is counted as one-twelfth of a year and any remaining fractional part of a month is disregarded. (f) For purposes of retirement or separation for physical dis- ability under chapter 61 of title 10, United States Code, a commis- sioned officer of the Service shall be credited, in addition to the service described in section 1208(a)(2) of that title, with active serv- ice with the Public Health Service, other than as a commissioned officer, which the Surgeon General determines is comparable to service performed by commissioned officers of the Service, except that, if there are more than five years of such service, only the last five years thereof may be so credited. For such purposes, such sec- tion 1208(a)(2) shall be applicable to officers of the Regular or Re- serve Corps of the Service. MILITARY BENEFITS EC . 212. ø 213 ¿ (a) Except as provided in subsection (b), com- S missioned officers of the Service and their surviving beneficiaries shall, with respect to active service performed by such officers— (1) in time of war; (2) on detail for duty with the Army, Navy, Air Force, Ma- rine Corps, or Coast Guard; or (3) while the Service is part of the military forces of the United States pursuant to Executive order of the President; be entitled to all rights, privileges, immunities, and benefits now or hereafter provided under any law of the United States in the case of commissioned officers of the Army or their surviving bene- ficiaries on account of active military service, except retired pay and uniform allowances. (b) The President may prescribe the conditions under which commissioned officers of the Service may be awarded military rib- bons, medals, and decorations. (c) The authority vested by law in the Department of the Army, the Secretary of the Army, or other officers of the Depart- ment of the Army with respect to rights, privileges, immunities, and benefits referred to in subsection (a) shall be exercised, with respect to commissioned officers of the Service, by the Surgeon General. (d) Active service of commissioned officers of the Service shall be deemed to be active military service in the Armed Forces of the United States for the purposes of all laws administered by the Sec- retary of Veterans Affairs (except the Servicemen’s Indemnity Act of 1951) and section 217 of the Social Security Act. (e) Active service of commissioned officers of the Service shall be deemed to be active military service in the Armed Forces of the March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00020 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

21 G:\COMP\PHSA\PHSA-MERGED.XML 21 Sec. 214 PUBLIC HEALTH SERVICE ACT United States for the purposes of all rights, privileges, immunities, and benefits now or hereafter provided under the Servicemembers Civil Relief Act (50 App. U.S.C. 501 et seq.). (f) Active service of commissioned officers of the Service shall be deemed to be active military service in the Armed Forces of the United States for purposes of all laws related to discrimination on the basis of race, color, sex, ethnicity, age, religion, and disability. PRESENTATION OF UNITED STATES FLAG UPON RETIREMENT S EC . 213. ø 214 ¿ (a) P RESENTATION OF F LAG .—Upon the release of an officer of the commissioned corps of the Service from active commissioned service for retirement, the Secretary of Health and Human Services shall present a United States flag to the officer. (b) M ULTIPLE P RESENTATIONS N OT A UTHORIZED .—An officer is not eligible for presentation of a flag under subsection (a) if the of- ficer has previously been presented a flag under this section or any other provision of law providing for the presentation of a United States flag incident to release from active service for retirement. (c) N ECIPIENT R .—The presentation of a flag under O C OST TO this section shall be at no cost to the recipient. DETAIL OF PERSONNEL 9 EC . 214. ¿ ø 215 S (a) The Secretary is authorized, upon the re- quest of the head of an executive department, to detail officers or employees of the Service to such department for duty as agreed upon by the Secretary and the head of such department in order to cooperate in, or conduct work related to, the functions of such department or of the Service. When officers or employees are so de- tailed their salaries and allowances may be paid from working funds established as provided by law or may be paid by the Service from applicable appropriation and reimbursement may be made as agreed upon by the Secretary and the head of the executive depart- ment concerned. Officers detailed for duty with the Army, Navy, or Coast Guard shall be subject to the laws for the government of the service to which detailed. (b) Upon the request of any State health authority or, in the case of work relating to mental health, any State mental health au- thority, personnel of the Service may be detailed by the Surgeon General for the purpose of assisting such State or political subdivi- sion thereof in work related to the functions of the Service. (c) The Surgeon General may detail personnel of the Service to any appropriate committee of the Congress or to nonprofit edu- cational research or other institutions engaged in health activities for special studies of scientific problems and for the dissemination of information relating to public health. (d) Personnel detailed under subsections (b) and (c) shall be paid from applicable appropriations of the Service except that, in accordance with regulations such personnel may be placed on leave without pay and paid by the State, subdivision, or institution to which they are detailed. In the case of detail of personnel under 9 Former section 213 was repealed by section 14 of Public Law 87–649 (76 Stat. 499). Section 415(c) of title 37, United States Code, now applies to the matter with which former section 213 was concerned. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00021 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

22 G:\COMP\PHSA\PHSA-MERGED.XML 22 Sec. 215 PUBLIC HEALTH SERVICE ACT subsections (b) or (c) to be paid from applicable Service appropria- tions, the Secretary may condition such detail on an agreement by the State, subdivision, or institution concerned that such State, subdivision, or institution concerned shall reimburse the United States for the amount of such payments made by the Service. The services of personnel while detailed pursuant to this section shall be considered as having been performed in the Service for purposes of the computation of basic pay, promotion, retirement, compensa- tion for injury or death, and the benefits provided by section 212. (e) Except with respect to the United States Coast Guard and the Department of Defense, and except as provided in agreements negotiated with officials at agencies where officers of the Commis- sioned Corps may be assigned, the Secretary shall have the sole authority to deploy any Commissioned Corps officer assigned under this section to an entity outside of the Department of Health and Human Services for service under the Secretary’s direction in re- sponse to an urgent or emergency public health care need (as de- fined in section 203A(a)(5)). REGULATIONS . 215. (a) The President shall from time to time pre- 216 ¿ S EC ø scribe regulations with respect to the appointment, promotion, re- tirement, termination of commission, title, pay, uniforms, allow- ances (including increased allowances for foreign service), and dis- cipline of the commissioned corps of the Service. (b) The Surgeon General, with the approval of the Secretary, unless specifically otherwise provided, shall promulgate all other regulations necessary to the administration of the Service, includ- ing regulations with respect to uniforms for employees, and regula- tions with respect to the custody, use, and preservation of the records, papers, and property of the Service. (c) No regulations relating to qualifications for appointment of medical officers or employees shall give preference to any school of medicine. USE OF SERVICE IN TIME OF WAR OR EMERGENCY S ø 217 ¿ In time of war, or of emergency proclaimed by EC . 216. the President, he may utilize the Service to such extent and in such manner as shall in his judgment promote the public interest. In time of war, or of emergency involving the national defense pro- claimed by the President, he may by Executive order declare the commissioned corps of the Service to be a military service. Upon such declaration, and during the period of such war or such emer- gency or such part thereof as the President shall prescribe, the commissioned corps (a) shall constitute a branch of the land and naval forces of the United States, (b) shall, to the extent prescribed by regulations of the President, be subject to the Uniform Code of Military Justice, and (c) shall continue to operate as part of the Service except to the extent that the President may direct as Com- mander in Chief. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00022 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

23 G:\COMP\PHSA\PHSA-MERGED.XML 23 Sec. 218 PUBLIC HEALTH SERVICE ACT NATIONAL ADVISORY COUNCILS 218 ø . 217. (a) Within 120 days of the date of the enact- ¿ S EC ment of this subsection, the Secretary shall appoint and organize a National Advisory Council on Migrant Health (hereinafter in this subsection referred to as the Council) which shall advise, consult with, and make recommendations to, the Secretary on matters con- cerning the organization, operation, selection, and funding of mi- grant health centers and other entities under grants and contracts 10 under section 329. (b) The Council shall consist of fifteen members, at least twelve of whom shall be members of the governing boards of migrant 10 Of health centers or other entities assisted under section 329. such twelve members who are members of such governing boards, at least nine shall be chosen from among those members of such governing boards who are being served by such centers or grantees and who are familiar with the delivery of health care to migratory agricultural workers and seasonal agricultural workers. The re- maining three Council members shall be individuals qualified by training and experience in the medical sciences or in the adminis- tration of health programs. (c) Each member of the Council shall hold office for a term of four years, except that (1) any member appointed to fill a vacancy occurring prior to the expiration of the term for which his prede- cessor was appointed shall be appointed for the remainder of such term; and (2) the terms of the members first taking office after the date of enactment of this subsection shall expire as follows: four shall expire four years after such date, four shall expire three years after such date, four shall expire two years after such date, and three shall expire one year after such date, as designated by the Secretary at the time of appointment. (d) Section 14(a) of the Federal Advisory Committee Act shall not apply to the Council. TRAINING OF OFFICERS S ¿ 218a . 218. (a) Appropriations available for the pay and ø EC allowances of commissioned officers of the Service shall also be available for the pay and allowances of any such officer on active duty while attending any Federal or non-Federal educational insti- tution or training program and, subject to regulations of the Presi- dent and to the limitation prescribed in such appropriations, for payment of his tuition, fees, and other necessary expenses incident to such attendance. (b) Any officer whose tuition, fees, and other necessary ex- penses are paid pursuant to subsection (a) while attending an edu- cational institution or training program for a period in excess of thirty days shall be obligated to pay to the Service an amount equal to two times the total amount of such tuition, fees, and other 10 As a result of the amendments made by Public Law 104–299 (110 Stat. 3626), the Public Health Service Act no longer contained a section 329, 340, or 340A, and section 330 of such Act was substantially revised. Section 330 now includes provisions that relate to medically under- served populations, to migratory and seasonal agricultural workers, to homeless individuals, and to residents of public housing. Section 402 of Public Law 107–251 (116 Stat. 1655) added a new section 340 that relates to a healthy communities access program. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00023 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

24 G:\COMP\PHSA\PHSA-MERGED.XML 24 Sec. 219 PUBLIC HEALTH SERVICE ACT necessary expenses received by such officer during such period, and two times the total amount of any compensation received by, and any allowance paid to, such officer during such period, if after re- turn to active service such officer voluntarily leaves the Service within (1) six months, or (2) twice the period of such attendance, whichever is greater. Such subsequent period of service shall com- mence upon the cessation of such attendance and of any further continuous period of training duty for which no tuition and fees are paid by the Service and which is part of the officer’s prescribed for- mal training program, whether such further training is at Service facility or otherwise. The Surgeon General may waive, in whole or in part, any payment which may be required by this subsection upon a determination that such payment would be inequitable or would not be in public interest. (c) A commissioned officer may be placed in leave without pay status while attending an educational institution or training pro- gram whenever the Secretary determines that such status is in the best interest of the Service. For purposes of computation of basic pay, promotion, retirement, compensation for injury or death, and the benefits provided by sections 212 and 224, an officer in such status pursuant to the preceding sentence shall be considered as performing service in the Service and shall have an active service obligation as set forth in subsection (b) of this section. ANNUAL AND SICK LEAVE ¿ (a) In accordance with regulations of the 210–1 S EC . 219. ø President, commissioned officers of the Regular Corps and officers of the Reserve Corps on active duty may be granted annual leave and sick leave without any deductions from their pay and allow- ances: Provided , That such regulations shall not authorize annual leave to be accumulated in excess of sixty days. 11 (d) For purposes of this section the term ‘‘accumulated an- nual leave’’ means unused accrued annual leave carried forward from one leave year into a succeeding leave year, and the term ‘‘ac- crued annual leave’’ means the annual leave accruing to an officer during one leave year. ASSISTANT GRADE PROMOTION CREDIT — Any medical officer of the Regular Corps of ¿ 211c EC . 220. ø S the Public Health Service who— (1)(A) was appointed to the assistant grade in the Regular Corps and whose service in such Corps has been continuous from the date of appointment or (B) may hereafter be ap- pointed to the assistant grade in the Regular Corps, and (2) had or will have completed a medical internship on the date of such appointment, shall be credited with one year for purposes of promotion and se- niority in grade, except that no such credit shall be authorized if the officer has received or will receive similar credit for his intern- 11 Former subsection (b) was repealed by section 14 of Public Law 87–649 (76 Stat. 499). Sec- tion 503(b) of title 37, United States Code, now applies to the matter with which former sub- section (b) was concerned. Former subsection (c) was repealed by section 311 of Public Law 96– 76 (93 Stat. 586). March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00024 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

25 G:\COMP\PHSA\PHSA-MERGED.XML 25 Sec. 221 PUBLIC HEALTH SERVICE ACT ship under other provisions of law. In the case of an officer on ac- tive duty on the effective date of this section who is entitled to the credit authorized herein, the one year shall be added to the pro- motion and seniority-in-grade credits with which he is credited on such date. ETC PRIVILEGES OF OFFICERS AND SURVIVING , RIGHTS , . BENEFICIARIES . 221. ø EC ¿ (a) Commissioned officers of the Service or 213a S their surviving beneficiaries are entitled to all the rights, benefits, privileges, and immunities now or hereafter provided for commis- sioned officers of the Army or their surviving beneficiaries under the following provisions of title 10, United States Code: (1) Section 1036, Escorts for dependents of members: transportation and travel allowances. (2) Chapter 61, Retirement or Separation for Physical Dis- ability, except that sections 1201, 1202, and 1203 do not apply to commissioned officers of the Public Health Service who have been ordered to active duty for training for a period of more than 30 days. (3) Chapter 69, Retired Grade, except sections 1370, 1374, 1375, and 1376(a). (4) Chapter 71, Computation of Retired Pay, except for- mula No. 3 of section 1401. (5) Chapter 73, Retired Serviceman’s Family Protection Plan, Survivor Benefit Plan. (6) Chapter 75, Death Benefits. (7) Section 2771, Final settlement of accounts: deceased members. (8) Chapter 163, Military Claims, but only when commis- sioned officers of the Service are entitled to military benefits under section 212 of this Act. (9) Section 2603, Acceptance of fellowships, scholarships, or grants. (10) Section 2634 Motor vehicles: for members on perma- nent change of station. (11) Section 1035, Deposit of savings. (12) Section 1552, Correction of military records: claims in- cident thereto. (13) Section 1553, Review of discharge or dismissal. (14) Section 1554, Review of retirement or separation with- out pay for physical disability. (15) Section 1124, Cash awards for suggestions, inventions, or scientific achievements. (16) Section 1052, Reimbursement for adoption expenses. (17) Section 1059, Transitional compensation and com- missary and exchange benefits for dependents of members sep- arated for dependent abuse. (18) Section 1034, Protected Communications; Prohibition of Retaliatory Personnel Actions. (b) The authority vested by title 10, United States Code, in the ‘‘military departments’’, ‘‘the Secretary concerned’’, or ‘‘the Sec- retary of Defense’’ with respect to the rights, privileges, immuni- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00025 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

26 G:\COMP\PHSA\PHSA-MERGED.XML 26 Sec. 222 PUBLIC HEALTH SERVICE ACT ties, and benefits referred to in subsection (a) shall be exercised, with respect to commissioned officers of the Service, by the Sec- retary of Health, Education, and Welfare or his designee. For pur- poses of paragraph (18) of subsection (a), the term ‘‘Inspector Gen- eral’’ in section 1034 of such title 10 shall mean the Inspector Gen- eral of the Department of Health and Human Services. ADVISORY COUNCILS OR COMMITTEES ø 217a ¿ S EC . 222. (a) The Secretary may, without regard to the provisions of title 5, United States Code, governing appointments in the competitive service, and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, from time to time, appoint such advisory councils or committees (in addition to those authorized to be established under other provisions of law), for such periods of time, as he deems desirable with such period com- mencing on a date specified by the Secretary for the purpose of ad- vising him in connection with any of his functions. (b) Members of any advisory council or committee appointed under this section who are not regular full-time employees of the United States shall, while attending meetings or conferences of such council or committee or otherwise engaged on business of such council or committee receive compensation and allowances as pro- vided in section 208(c) for members of national advisory councils established under this Act. (c) Upon appointment of any such council or committee, the Secretary may delegate to such council or committee such advisory functions relating to grants-in-aid for research or training projects or programs, in the areas or fields with which such council or com- mittee is concerned, as the Secretary determines to be appropriate. VOLUNTEER SERVICES EC S 217b ¿ Subject to regulations, volunteer and uncom- . 223. ø pensated services may be accepted by the Secretary, or by any other officer or employee of the Department of Health and Human Services designated by him, for use in the operation of any health care facility or in the provision of health care. DEFENSE OF CERTAIN MALPRACTICE AND NEGLIGENCE SUITS EC . 224. ø 233 ¿ (a) The remedy against the United States pro- S vided by sections 1346(b) and 2672 of title 28, or by alternative benefits provided by the United States where the availability of such benefits precludes a remedy under section 1346(b) of title 28, for damage for personal injury, including death, resulting from the performance of medical, surgical, dental, or related functions, in- cluding the conduct of clinical studies or investigation, by any com- missioned officer or employee of the Public Health Service while acting within the scope of his office or employment, shall be exclu- sive of any other civil action or proceeding by reason of the same subject-matter against the officer or employee (or his estate) whose act or omission gave rise to the claim. (b) The Attorney General shall defend any civil action or pro- ceeding brought in any court against any person referred to in sub- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00026 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

27 G:\COMP\PHSA\PHSA-MERGED.XML 27 Sec. 224 PUBLIC HEALTH SERVICE ACT section (a) of this section (or his estate) for any such damage or in- jury. Any such person against whom such civil action or proceeding is brought shall deliver within such time after date of service or knowledge of service as determined by the Attorney General, all process served upon him or an attested true copy thereof to his im- mediate superior or to whomever was designated by the Secretary to receive such papers and such persons shall promptly furnish copies of the pleading and process therein to the United States at- torney for the district embracing the place wherein the proceeding is brought, to the Attorney General, and to the Secretary. (c) Upon a certification by the Attorney General that the de- fendant was acting in the scope of his employment at the time of the incident out of which the suit arose, any such civil action or proceeding commenced in a State court shall be removed without bond at any time before trial by the Attorney General to the dis- trict court of the United States of the district and division embrac- ing the place wherein it is pending and the proceeding deemed a tort action brought against the United States under the provisions of title 28 and all references thereto. Should a United States dis- trict court determine on a hearing on a motion to remand held be- fore a trial on the merit that the case so removed is one in which a remedy by suit within the meaning of subsection (a) of this sec- tion is not available against the United States, the case shall be remanded to the State Court: , That where such a remedy Provided is precluded because of the availability of a remedy through pro- ceedings for compensation or other benefits from the United States as provided by any other law, the case shall be dismissed, but in the event the running of any limitation of time for commencing, or filing an application or claim in, such proceedings for compensation or other benefits shall be deemed to have been suspended during the pendency of the civil action or proceeding under this section. (d) The Attorney General may compromise or settle any claim asserted in such civil action or proceeding in the manner provided in section 2677 of title 28 and with the same effect. (e) For purposes of this section, the provisions of section 2680(h) of title 28 shall not apply to assault or battery arising out of negligence in the performance of medical, surgical, dental, or re- lated functions, including the conduct of clinical studies or inves- tigations. (f) The Secretary or his designee may, to the extent that he deems appropriate, hold harmless or provide liability insurance for any officer or employee of the Public Health Service for damage for personal injury, including death, negligently caused by such officer or employee while acting within the scope of his office or employ- ment and as a result of the performance of medical, surgical, den- tal, or related functions, including the conduct of clinical studies or investigations, if such employee is assigned to a foreign country or detailed to a State or political subdivision thereof or to a non-profit institution, and if the circumstances are such as are likely to pre- clude the remedies of third persons against the United States de- scribed in section 2679(b) of title 28, for such damage or injury. (g)(1)(A) For purposes of this section and subject to the ap- proval by the Secretary of an application under subparagraph (D), an entity described in paragraph (4), and any officer, governing March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00027 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

28 G:\COMP\PHSA\PHSA-MERGED.XML 28 Sec. 224 PUBLIC HEALTH SERVICE ACT board member, or employee of such an entity, and any contractor of such an entity who is a physician or other licensed or certified health care practitioner (subject to paragraph (5)), shall be deemed to be an employee of the Public Health Service for a calendar year that begins during a fiscal year for which a transfer was made under subsection (k)(3) (subject to paragraph (3)). The remedy against the United States for an entity described in paragraph (4) and any officer, governing board member, employee, or contractor (subject to paragraph (5)) of such an entity who is deemed to be an employee of the Public Health Service pursuant to this para- graph shall be exclusive of any other civil action or proceeding to the same extent as the remedy against the United States is exclu- sive pursuant to subsection (a). (B) The deeming of any entity or officer, governing board mem- ber, employee, or contractor of the entity to be an employee of the Public Health Service for purposes of this section shall apply with respect to services provided— (i) to all patients of the entity, and (ii) subject to subparagraph (C), to individuals who are not patients of the entity. (C) Subparagraph (B)(ii) applies to services provided to individ- uals who are not patients of an entity if the Secretary determines, after reviewing an application submitted under subparagraph (D), that the provision of the services to such individuals— (i) benefits patients of the entity and general populations that could be served by the entity through community-wide intervention efforts within the communities served by such en- tity; (ii) facilitates the provision of services to patients of the entity; or (iii) are otherwise required under an employment contract (or similar arrangement) between the entity and an officer, governing board member, employee, or contractor of the entity. (D) The Secretary may not under subparagraph (A) deem an entity or an officer, governing board member, employee, or con- tractor of the entity to be an employee of the Public Health Service for purposes of this section, and may not apply such deeming to services described in subparagraph (B)(ii), unless the entity has submitted an application for such deeming to the Secretary in such form and such manner as the Secretary shall prescribe. The appli- cation shall contain detailed information, along with supporting documentation, to verify that the entity, and the officer, governing board member, employee, or contractor of the entity, as the case may be, meets the requirements of subparagraphs (B) and (C) of this paragraph and that the entity meets the requirements of para- graphs (1) through (4) of subsection (h). (E) The Secretary shall make a determination of whether an entity or an officer, governing board member, employee, or con- tractor of the entity is deemed to be an employee of the Public Health Service for purposes of this section within 30 days after the receipt of an application under subparagraph (D). The determina- tion of the Secretary that an entity or an officer, governing board member, employee, or contractor of the entity is deemed to be an employee of the Public Health Service for purposes of this section March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00028 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

29 G:\COMP\PHSA\PHSA-MERGED.XML 29 Sec. 224 PUBLIC HEALTH SERVICE ACT shall apply for the period specified by the Secretary under subpara- graph (A). (F) Once the Secretary makes a determination that an entity or an officer, governing board member, employee, or contractor of an entity is deemed to be an employee of the Public Health Service for purposes of this section, the determination shall be final and binding upon the Secretary and the Attorney General and other parties to any civil action or proceeding. Except as provided in sub- section (i), the Secretary and the Attorney General may not deter- mine that the provision of services which are the subject of such a determination are not covered under this section. (G) In the case of an entity described in paragraph (4) that has not submitted an application under subparagraph (D): (i) The Secretary may not consider the entity in making es- timates under subsection (k)(1). (ii) This section does not affect any authority of the entity to purchase medical malpractice liability insurance coverage with Federal funds provided to the entity under section 329, 330, or 340A. (H) In the case of an entity described in paragraph (4) for which an application under subparagraph (D) is in effect, the entity may, through notifying the Secretary in writing, elect to terminate the applicability of this subsection to the entity. With respect to such election by the entity: (i) The election is effective upon the expiration of the 30- day period beginning on the date on which the entity submits such notification. (ii) Upon taking effect, the election terminates the applica- bility of this subsection to the entity and each officer, gov- erning board member, employee, and contractor of the entity. (iii) Upon the effective date for the election, clauses (i) and (ii) of subparagraph (G) apply to the entity to the same extent and in the same manner as such clauses apply to an entity that has not submitted an application under subparagraph (D). (iv) If after making the election the entity submits an ap- plication under subparagraph (D), the election does not pre- 12 clude the Secretary from approving the application (and thereby restoring the applicability of this subsection to the en- tity and each officer, governing board member, employee, and contractor of the entity, subject to the provisions of this sub- section and the subsequent provisions of this section. (2) If, with respect to an entity or person deemed to be an em- ployee for purposes of paragraph (1), a cause of action is instituted against the United States pursuant to this section, any claim of the entity or person for benefits under an insurance policy with respect to medical malpractice relating to such cause of action shall be sub- rogated to the United States. (3) This subsection shall apply with respect to a cause of action arising from an act or omission which occurs on or after January 1, 1993. 12 So in law. See section 5(a) of Public Law 104–73 (109 Stat. 779). There is no closing paren- thesis. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00029 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

30 G:\COMP\PHSA\PHSA-MERGED.XML 30 Sec. 224 PUBLIC HEALTH SERVICE ACT (4) An entity described in this paragraph is a public or non- profit private entity receiving Federal funds under section 330. (5) For purposes of paragraph (1), an individual may be consid- ered a contractor of an entity described in paragraph (4) only if— (A) the individual normally performs on average at least 1 32 ⁄ 2 hours of service per week for the entity for the period of the contract; or (B) in the case of an individual who normally performs an 1 average of less than 32 hours of services per week for the en- ⁄ 2 tity for the period of the contract, the individual is a licensed or certified provider of services in the fields of family practice, general internal medicine, general pediatrics, or obstetrics and gynecology. (h) The Secretary may not approve an application under sub- section (g)(1)(D) unless the Secretary determines that the entity— (1) has implemented appropriate policies and procedures to reduce the risk of malpractice and the risk of lawsuits arising out of any health or health-related functions performed by the entity; (2) has reviewed and verified the professional credentials, references, claims history, fitness, professional review organi- zation findings, and license status of its physicians and other licensed or certified health care practitioners, and, where nec- essary, has obtained the permission from these individuals to gain access to this information; (3) has no history of claims having been filed against the United States as a result of the application of this section to the entity or its officers, employees, or contractors as provided for under this section, or, if such a history exists, has fully co- operated with the Attorney General in defending against any such claims and either has taken, or will take, any necessary corrective steps to assure against such claims in the future; and (4) will fully cooperate with the Attorney General in pro- viding information relating to an estimate described under sub- section (k). (i)(1) Notwithstanding subsection (g)(1), the Attorney General, in consultation with the Secretary, may on the record determine, after notice and opportunity for a full and fair hearing, that an in- dividual physician or other licensed or certified health care practi- tioner who is an officer, employee, or contractor of an entity de- scribed in subsection (g)(4) shall not be deemed to be an employee of the Public Health Service for purposes of this section, if treating such individual as such an employee would expose the Government to an unreasonably high degree of risk of loss because such indi- vidual— (A) does not comply with the policies and procedures that the entity has implemented pursuant to subsection (h)(1); (B) has a history of claims filed against him or her as pro- vided for under this section that is outside the norm for li- censed or certified health care practitioners within the same specialty; (C) refused to reasonably cooperate with the Attorney Gen- eral in defending against any such claim; March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00030 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

31 G:\COMP\PHSA\PHSA-MERGED.XML 31 Sec. 224 PUBLIC HEALTH SERVICE ACT (D) provided false information relevant to the individual’s performance of his or her duties to the Secretary, the Attorney General, or an applicant for or recipient of funds under this Act; or (E) was the subject of disciplinary action taken by a State medical licensing authority or a State or national professional society. (2) A final determination by the Attorney General under this subsection that an individual physician or other licensed or cer- tified health care professional shall not be deemed to be an em- ployee of the Public Health Service shall be effective upon receipt by the entity employing such individual of notice of such deter- mination, and shall apply only to acts or omissions occurring after the date such notice is received. (j) In the case of a health care provider who is an officer, em- ployee, or contractor of an entity described in subsection (g)(4), sec- tion 335(e) shall apply with respect to the provider to the same ex- tent and in the same manner as such section applies to any mem- ber of the National Health Service Corps. (k)(1)(A) For each fiscal year, the Attorney General, in con- sultation with the Secretary, shall estimate by the beginning of the year the amount of all claims which are expected to arise under this section (together with related fees and expenses of witnesses) for which payment is expected to be made in accordance with sec- tion 1346 and chapter 171 of title 28, United States Code, from the acts or omissions, during the calendar year that begins during that fiscal year, of entities described in subsection (g)(4) and of officers, employees, or contractors (subject to subsection (g)(5)) of such enti- ties. (B) The estimate under subparagraph (A) shall take into ac- count— (i) the value and frequency of all claims for damage for personal injury, including death, resulting from the perform- ance of medical, surgical, dental, or related functions by enti- ties described in subsection (g)(4) or by officers, employees, or contractors (subject to subsection (g)(5)) of such entities who are deemed to be employees of the Public Health Service under subsection (g)(1) that, during the preceding 5-year period, are filed under this section or, with respect to years occurring be- fore this subsection takes effect, are filed against persons other than the United States, (ii) the amounts paid during that 5-year period on all claims described in clause (i), regardless of when such claims were filed, adjusted to reflect payments which would not be permitted under section 1346 and chapter 171 of title 28, United States Code, and (iii) amounts in the fund established under paragraph (2) but unspent from prior fiscal years. (2) Subject to appropriations, for each fiscal year, the Secretary shall establish a fund of an amount equal to the amount estimated under paragraph (1) that is attributable to entities receiving funds under each of the grant programs described in paragraph (4) of subsection (g), but not to exceed a total of $10,000,000 for each such fiscal year. Appropriations for purposes of this paragraph March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00031 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

32 G:\COMP\PHSA\PHSA-MERGED.XML 32 Sec. 224 PUBLIC HEALTH SERVICE ACT shall be made separate from appropriations made for purposes of sections 329, 330 and 340A. (3) In order for payments to be made for judgments against the United States (together with related fees and expenses of wit- nesses) pursuant to this section arising from the acts or omissions 13 of entities described in subsection (g)(4) and of officers, employ- ees, or contractors (subject to subsection (g)(5)) of such entities, the total amount contained within the fund established by the Sec- retary under paragraph (2) for a fiscal year shall be transferred not later than the December 31 that occurs during the fiscal year to the appropriate accounts in the Treasury. (l)(1) If a civil action or proceeding is filed in a State court against any entity described in subsection (g)(4) or any officer, gov- erning board member, employee, or any contractor of such an enti- ty for damages described in subsection (a), the Attorney General, within 15 days after being notified of such filing, shall make an ap- pearance in such court and advise such court as to whether the Secretary has determined under subsections (g) and (h), that such entity, officer, governing board member, employee, or contractor of the entity is deemed to be an employee of the Public Health Service for purposes of this section with respect to the actions or omissions that are the subject of such civil action or proceeding. Such advice shall be deemed to satisfy the provisions of subsection (c) that the Attorney General certify that an entity, officer, governing board member, employee, or contractor of the entity was acting within the scope of their employment or responsibility. (2) If the Attorney General fails to appear in State court within the time period prescribed under paragraph (1), upon petition of any entity or officer, governing board member, employee, or con- tractor of the entity named, the civil action or proceeding shall be removed to the appropriate United States district court. The civil action or proceeding shall be stayed in such court until such court conducts a hearing, and makes a determination, as to the appro- priate forum or procedure for the assertion of the claim for dam- ages described in subsection (a) and issues an order consistent with such determination. (m)(1) An entity or officer, governing board member, employee, or contractor of an entity described in subsection (g)(1) shall, for purposes of this section, be deemed to be an employee of the Public Health Service with respect to services provided to individuals who are enrollees of a managed care plan if the entity contracts with such managed care plan for the provision of services. (2) Each managed care plan which enters into a contract with an entity described in subsection (g)(4) shall deem the entity and any officer, governing board member, employee, or contractor of the entity as meeting whatever malpractice coverage requirements such plan may require of contracting providers for a calendar year if such entity or officer, governing board member, employee, or con- tractor of the entity has been deemed to be an employee of the Pub- lic Health Service for purposes of this section for such calendar year. Any plan which is found by the Secretary on the record, after 13 Section 3(2) of Public Law 104–73 (109 Stat. 778) provides that subsection (k)(3) is amended by inserting ‘‘governing board member,’’ after ‘‘officer,’’. The amendment cannot be executed be- cause the latter term does not appear. (Compare ‘‘officer,’’ and ‘‘officers,’’.) March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00032 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

33 G:\COMP\PHSA\PHSA-MERGED.XML 33 Sec. 224 PUBLIC HEALTH SERVICE ACT notice and an opportunity for a full and fair hearing, to have vio- lated this subsection shall upon such finding cease, for a period to be determined by the Secretary, to receive and to be eligible to re- ceive any Federal funds under titles XVIII or XIX of the Social Se- curity Act. (3) For purposes of this subsection, the term ‘‘managed care plan’’ shall mean health maintenance organizations and similar en- tities that contract at-risk with payors for the provision of health services or plan enrollees and which contract with providers (such as entities described in subsection (g)(4)) for the delivery of such services to plan enrollees. (n)(1) Not later than one year after the date of the enactment of the Federally Supported Health Centers Assistance Act of 1995, the Comptroller General of the United States shall submit to the Congress a report on the following: (A) The medical malpractice liability claims experience of entities that have been deemed to be employees for purposes of this section. (B) The risk exposure of such entities. (C) The value of private sector risk-management services, and the value of risk-management services and procedures re- quired as a condition of receiving a grant under section 329, 330, or 340A. (D) A comparison of the costs and the benefits to taxpayers of maintaining medical malpractice liability coverage for such entities pursuant to this section, taking into account— (i) a comparison of the costs of premiums paid by such entities for private medical malpractice liability insurance with the cost of coverage pursuant to this section; and (ii) an analysis of whether the cost of premiums for private medical malpractice liability insurance coverage is consistent with the liability claims experience of such enti- ties. (2) The report under paragraph (1) shall include the following: (A) A comparison of— (i) an estimate of the aggregate amounts that such en- tities (together with the officers, governing board mem- bers, employees, and contractors of such entities who have been deemed to be employees for purposes of this section) would have directly or indirectly paid in premiums to ob- tain medical malpractice liability insurance coverage if this section were not in effect; with (ii) the aggregate amounts by which the grants re- ceived by such entities under this Act were reduced pursu- ant to subsection (k)(2). (B) A comparison of— (i) an estimate of the amount of privately offered such insurance that such entities (together with the officers, governing board members, employees, and contractors of such entities who have been deemed to be employees for purposes of this section) purchased during the three-year period beginning on January 1, 1993; with (ii) an estimate of the amount of such insurance that such entities (together with the officers, governing board March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00033 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

34 G:\COMP\PHSA\PHSA-MERGED.XML 34 Sec. 224 PUBLIC HEALTH SERVICE ACT members, employees, and contractors of such entities who have been deemed to be employees for purposes of this sec- tion) will purchase after the date of the enactment of the Federally Supported Health Centers Assistance Act of 1995. (C) An estimate of the medical malpractice liability loss history of such entities for the 10-year period preceding Octo- ber 1, 1996, including but not limited to the following: (i) Claims that have been paid and that are estimated to be paid, and legal expenses to handle such claims that have been paid and that are estimated to be paid, by the Federal Government pursuant to deeming entities as em- ployees for purposes of this section. (ii) Claims that have been paid and that are estimated to be paid, and legal expenses to handle such claims that have been paid and that are estimated to be paid, by pri- vate medical malpractice liability insurance. (D) An analysis of whether the cost of premiums for pri- vate medical malpractice liability insurance coverage is con- sistent with the liability claims experience of entities that have been deemed as employees for purposes of this section. (3) In preparing the report under paragraph (1), the Comp- troller General of the United States shall consult with public and private entities with expertise on the matters with which the re- port is concerned. (o)(1) For purposes of this section, a free clinic health profes- sional shall in providing a qualifying health service to an indi- vidual, or an officer, governing board member, employee, or con- tractor of a free clinic shall in providing services for the free clinic, be deemed to be an employee of the Public Health Service for a cal- endar year that begins during a fiscal year for which a transfer was made under paragraph (6)(D). The preceding sentence is sub- ject to the provisions of this subsection. (2) In providing a health service to an individual, a health care practitioner shall for purposes of this subsection be considered to be a free clinic health professional if the following conditions are met: (A) The service is provided to the individual at a free clin- ic, or through offsite programs or events carried out by the free clinic. (B) The free clinic is sponsoring the health care practi- tioner pursuant to paragraph (5)(C). (C) The service is a qualifying health service (as defined in paragraph (4)). (D) Neither the health care practitioner nor the free clinic receives any compensation for the service from the individual or from any third-party payor (including reimbursement under any insurance policy or health plan, or under any Federal or State health benefits program). With respect to compliance with such condition: (i) The health care practitioner may receive repayment from the free clinic for reasonable expenses incurred by the health care practitioner in the provision of the service to the individual. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00034 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

35 G:\COMP\PHSA\PHSA-MERGED.XML 35 Sec. 224 PUBLIC HEALTH SERVICE ACT (ii) The free clinic may accept voluntary donations for the provision of the service by the health care practitioner to the individual. (E) Before the service is provided, the health care practi- tioner or the free clinic provides written notice to the indi- vidual of the extent to which the legal liability of the health care practitioner is limited pursuant to this subsection (or in the case of an emergency, the written notice is provided to the individual as soon after the emergency as is practicable). If the individual is a minor or is otherwise legally incompetent, the condition under this subparagraph is that the written notice be provided to a legal guardian or other person with legal respon- sibility for the care of the individual. (F) At the time the service is provided, the health care practitioner is licensed or certified in accordance with applica- ble law regarding the provision of the service. (3)(A) For purposes of this subsection, the term ‘‘free clinic’’ means a health care facility operated by a nonprofit private entity meeting the following requirements: (i) The entity does not, in providing health services through the facility, accept reimbursement from any third- party payor (including reimbursement under any insurance policy or health plan, or under any Federal or State health benefits program). (ii) The entity, in providing health services through the fa- cility, either does not impose charges on the individuals to whom the services are provided, or imposes a charge according to the ability of the individual involved to pay the charge. (iii) The entity is licensed or certified in accordance with applicable law regarding the provision of health services. (B) With respect to compliance with the conditions under sub- paragraph (A), the entity involved may accept voluntary donations for the provision of services. (4) For purposes of this subsection, the term ‘‘qualifying health service’’ means any medical assistance required or authorized to be provided in the program under title XIX of the Social Security Act, without regard to whether the medical assistance is included in the plan submitted under such program by the State in which the health care practitioner involved provides the medical assistance. References in the preceding sentence to such program shall as ap- plicable be considered to be references to any successor to such pro- gram. (5) Subsection (g) (other than paragraphs (3) through (5)) and subsections (h), (i), and (l) apply to a health care practitioner for purposes of this subsection to the same extent and in the same manner as such subsections apply to an officer, governing board member, employee, or contractor of an entity described in sub- section (g)(4), subject to paragraph (6) and subject to the following: (A) The first sentence of paragraph (1) applies in lieu of the first sentence of subsection (g)(1)(A). (B) This subsection may not be construed as deeming any free clinic to be an employee of the Public Health Service for purposes of this section. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00035 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

36 G:\COMP\PHSA\PHSA-MERGED.XML 36 Sec. 224 PUBLIC HEALTH SERVICE ACT (C) With respect to a free clinic, a health care practitioner is not a free clinic health professional unless the free clinic sponsors the health care practitioner. For purposes of this sub- section, the free clinic shall be considered to be sponsoring the health care practitioner if— (i) with respect to the health care practitioner, the free clinic submits to the Secretary an application meeting the requirements of subsection (g)(1)(D); and (ii) the Secretary, pursuant to subsection (g)(1)(E), de- termines that the health care practitioner is deemed to be an employee of the Public Health Service. (D) In the case of a health care practitioner who is deter- mined by the Secretary pursuant to subsection (g)(1)(E) to be a free clinic health professional, this subsection applies to the health care practitioner (with respect to the free clinic spon- soring the health care practitioner pursuant to subparagraph (C)) for any cause of action arising from an act or omission of the health care practitioner occurring on or after the date on which the Secretary makes such determination. (E) Subsection (g)(1)(F) applies to a health care practi- tioner for purposes of this subsection only to the extent that, in providing health services to an individual, each of the condi- tions specified in paragraph (2) is met. (6)(A) For purposes of making payments for judgments against the United States (together with related fees and expenses of wit- nesses) pursuant to this section arising from the acts or omissions of free clinic health professionals, there is authorized to be appro- priated $10,000,000 for each fiscal year. (B) The Secretary shall establish a fund for purposes of this subsection. Each fiscal year amounts appropriated under subpara- graph (A) shall be deposited in such fund. (C) Not later than May 1 of each fiscal year, the Attorney Gen- eral, in consultation with the Secretary, shall submit to the Con- gress a report providing an estimate of the amount of claims (to- gether with related fees and expenses of witnesses) that, by reason of the acts or omissions of free clinic health professionals, will be paid pursuant to this section during the calendar year that begins in the following fiscal year. Subsection (k)(1)(B) applies to the esti- mate under the preceding sentence regarding free clinic health pro- fessionals to the same extent and in the same manner as such sub- section applies to the estimate under such subsection regarding of- ficers, governing board members, employees, and contractors of en- tities described in subsection (g)(4). (D) Not later than December 31 of each fiscal year, the Sec- retary shall transfer from the fund under subparagraph (B) to the appropriate accounts in the Treasury an amount equal to the esti- mate made under subparagraph (C) for the calendar year begin- ning in such fiscal year, subject to the extent of amounts in the fund. (7)(A) This subsection takes effect on the date of the enactment of the first appropriations Act that makes an appropriation under paragraph (6)(A), except as provided in subparagraph (B)(i). (B)(i) Effective on the date of the enactment of the Health In- surance Portability and Accountability Act of 1996— March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00036 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

37 G:\COMP\PHSA\PHSA-MERGED.XML 37 Sec. 224 PUBLIC HEALTH SERVICE ACT (I) the Secretary may issue regulations for carrying out this subsection, and the Secretary may accept and consider ap- plications submitted pursuant to paragraph (5)(C); and (II) reports under paragraph (6)(C) may be submitted to the Congress. (ii) For the first fiscal year for which an appropriation is made under subparagraph (A) of paragraph (6), if an estimate under sub- paragraph (C) of such paragraph has not been made for the cal- endar year beginning in such fiscal year, the transfer under sub- paragraph (D) of such paragraph shall be made notwithstanding the lack of the estimate, and the transfer shall be made in an amount equal to the amount of such appropriation. (p) A MALLPOX C OUNTERMEASURES BY OF DMINISTRATION S H ROFESSIONALS .— EALTH P (1) I N GENERAL .—For purposes of this section, and subject to other provisions of this subsection, a covered person shall be deemed to be an employee of the Public Health Service with respect to liability arising out of administration of a covered countermeasure against smallpox to an individual during the effective period of a declaration by the Secretary under para- graph (2)(A). (2) D ECLARATION BY SECRETARY CONCERNING COUNTER - .— MEASURE AGAINST SMALLPOX (A) A UTHORITY TO ISSUE DECLARATION .— N GENERAL .—The Secretary may issue a dec- (i) I laration, pursuant to this paragraph, concluding that an actual or potential bioterrorist incident or other ac- tual or potential public health emergency makes ad- visable the administration of a covered counter- measure to a category or categories of individuals. OVERED COUNTERMEASURE .—The Secretary (ii) C shall specify in such declaration the substance or sub- stances that shall be considered covered counter- measures (as defined in paragraph (7)(A)) for purposes of administration to individuals during the effective period of the declaration. PERIOD .—The Secretary shall (iii) E FFECTIVE specify in such declaration the beginning and ending dates of the effective period of the declaration, and may subsequently amend such declaration to shorten or extend such effective period, provided that the new closing date is after the date when the declaration is amended. UBLICATION (iv) P .—The Secretary shall promptly publish each such declaration and amendment in the Federal Register. (B) L IABILITY OF UNITED STATES ONLY FOR ADMINISTRA - TIONS WITHIN SCOPE OF DECLARATION .—Except as provided in paragraph (5)(B)(ii), the United States shall be liable under this subsection with respect to a claim arising out of the administration of a covered countermeasure to an individual only if— (i) the countermeasure was administered by a qualified person, for a purpose stated in paragraph March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00037 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

38 G:\COMP\PHSA\PHSA-MERGED.XML 38 Sec. 224 PUBLIC HEALTH SERVICE ACT (7)(A)(i), and during the effective period of a declara- tion by the Secretary under subparagraph (A) with re- spect to such countermeasure; and (ii)(I) the individual was within a category of indi- viduals covered by the declaration; or (II) the qualified person administering the coun- termeasure had reasonable grounds to believe that such individual was within such category. (C) P RESUMPTION OF ADMINISTRATION WITHIN SCOPE OF - DECLARATION IN CASE OF ACCIDENTAL VACCINIA INOCULA TION .— N GENERAL .—If vaccinia vaccine is a covered (i) I countermeasure specified in a declaration under sub- paragraph (A), and an individual to whom the vaccinia vaccine is not administered contracts vaccinia, then, under the circumstances specified in clause (ii), the in- dividual— (I) shall be rebuttably presumed to have con- tracted vaccinia from an individual to whom such vaccine was administered as provided by clauses (i) and (ii) of subparagraph (B); and (II) shall (unless such presumption is rebut- ted) be deemed for purposes of this subsection to be an individual to whom a covered counter- measure was administered by a qualified person in accordance with the terms of such declaration and as described by subparagraph (B). (ii) C IRCUMSTANCES IN WHICH PRESUMPTION AP - .—The presumption and deeming stated in clause PLIES (i) shall apply if— (I) the individual contracts vaccinia during the effective period of a declaration under sub- paragraph (A) or by the date 30 days after the close of such period; or (II) the individual has resided with, or has had contact with, an individual to whom such vac- cine was administered as provided by clauses (i) and (ii) of subparagraph (B) and contracts vaccinia after such date. (D) A CTS AND OMISSIONS DEEMED TO BE WITHIN SCOPE .— OF EMPLOYMENT (i) I N GENERAL .—In the case of a claim arising out of alleged transmission of vaccinia from an individual described in clause (ii), acts or omissions by such indi- vidual shall be deemed to have been taken within the scope of such individual’s office or employment for pur- poses of— (I) subsection (a); and (II) section 1346(b) and chapter 171 of title 28, United States Code. (ii) I NDIVIDUALS TO WHOM DEEMING APPLIES .—An individual is described by this clause if— (I) vaccinia vaccine was administered to such individual as provided by subparagraph (B); and March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00038 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

39 G:\COMP\PHSA\PHSA-MERGED.XML 39 Sec. 224 PUBLIC HEALTH SERVICE ACT (II) such individual was within a category of individuals covered by a declaration under sub- paragraph (A)(i). (3) E ; .— XHAUSTION OFFSET ; EXCLUSIVITY (A) E XHAUSTION .— (i) I N GENERAL .—A person may not bring a claim under this subsection unless such person has ex- hausted such remedies as are available under part C of this title, except that if the Secretary fails to make a final determination on a request for benefits or com- pensation filed in accordance with the requirements of such part within 240 days after such request was filed, the individual may seek any remedy that may be available under this section. (ii) T OLLING OF STATUTE OF LIMITATIONS .—The time limit for filing a claim under this subsection, or for filing an action based on such claim, shall be tolled during the pendency of a request for benefits or com- pensation under part C of this title. (iii) C ONSTRUCTION .—This subsection shall not be construed as superseding or otherwise affecting the application of a requirement, under chapter 171 of title 28, United States Code, to exhaust administrative remedies. (B) E XCLUSIVITY .—The remedy provided by subsection (a) shall be exclusive of any other civil action or proceeding for any claim or suit this subsection encompasses, except for a proceeding under part C of this title. FFSET .—The value of all compensation and bene- (C) O fits provided under part C of this title for an incident or series of incidents shall be offset against the amount of an award, compromise, or settlement of money damages in a claim or suit under this subsection based on the same inci- dent or series of incidents. (4) C .— ERTIFICATION OF ACTION BY ATTORNEY GENERAL Subsection (c) applies to actions under this subsection, subject to the following provisions: ATURE OF CERTIFICATION .—The certification by (A) N the Attorney General that is the basis for deeming an ac- tion or proceeding to be against the United States, and for removing an action or proceeding from a State court, is a certification that the action or proceeding is against a cov- ered person and is based upon a claim alleging personal injury or death arising out of the administration of a cov- ered countermeasure. (B) C ERTIFICATION OF ATTORNEY GENERAL CONCLU - .—The certification of the Attorney General of the SIVE facts specified in subparagraph (A) shall conclusively es- tablish such facts for purposes of jurisdiction pursuant to this subsection. OVERED PERSON TO (5) C WITH UNITED COOPERATE .— STATES N GENERAL .—A covered person shall cooperate (A) I with the United States in the processing and defense of a March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00039 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

40 G:\COMP\PHSA\PHSA-MERGED.XML 40 Sec. 224 PUBLIC HEALTH SERVICE ACT claim or action under this subsection based upon alleged acts or omissions of such person. (B) C .—Upon ONSEQUENCES OF FAILURE TO COOPERATE the motion of the United States or any other party and upon finding that such person has failed to so cooperate— (i) the court shall substitute such person as the party defendant in place of the United States and, upon motion, shall remand any such suit to the court in which it was instituted if it appears that the court lacks subject matter jurisdiction; (ii) the United States shall not be liable based on the acts or omissions of such person; and (iii) the Attorney General shall not be obligated to defend such action. ECOURSE AGAINST COVERED PERSON IN CASE OF GROSS (6) R MISCONDUCT OR CONTRACT VIOLATION .— N GENERAL .—Should payment be made by the (A) I United States to any claimant bringing a claim under this subsection, either by way of administrative determination, settlement, or court judgment, the United States shall have, notwithstanding any provision of State law, the right to recover for that portion of the damages so awarded or paid, as well as interest and any costs of litigation, result- ing from the failure of any covered person to carry out any obligation or responsibility assumed by such person under a contract with the United States or from any grossly neg- ligent, reckless, or illegal conduct or willful misconduct on the part of such person. ENUE .—The United States may maintain an ac- (B) V tion under this paragraph against such person in the dis- trict court of the United States in which such person re- sides or has its principal place of business. .—As used in this subsection, terms have (7) D EFINITIONS the following meanings: .—The term ‘‘covered (A) C OVERED COUNTERMEASURE countermeasure’’ or ‘‘covered countermeasure against smallpox’’, means a substance that is— (i)(I) used to prevent or treat smallpox (including the vaccinia or another vaccine); or 14 used to control or treat the adverse ef- (II) fects of vaccinia inoculation or of administration of another covered countermeasure; and (ii) specified in a declaration under paragraph (2). (B) C OVERED PERSON .—The term ‘‘covered person’’, when used with respect to the administration of a covered countermeasure, means a person who is— (i) a manufacturer or distributor of such counter- measure; 15 (ii) a health care entity under whose auspices — 14 Indentation is so in law. See section 3(e) of Public Law 108–20 (117 Stat. 647). 15 Clause (ii) is shown according to the probable intent of the Congress. In amending the clause to create a subclause (I), section 3(f)(2)(B) of Public Law 108–20 (117 Stat. 647) provided that the clause is amended by redesignating certain words ‘‘as clause (I) and indenting accord- ingly’’. The reference in the amendatory instructions to ‘‘clause (I)’’ probably should be to ‘‘sub- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00040 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

41 G:\COMP\PHSA\PHSA-MERGED.XML 41 Sec. 224 PUBLIC HEALTH SERVICE ACT (I) such countermeasure was administered; (II) a determination was made as to whether, or under what circumstances, an individual should receive a covered countermeasure; (III) the immediate site of administration on the body of a covered countermeasure was mon- itored, managed, or cared for; or (IV) an evaluation was made of whether the administration of a countermeasure was effective; (iii) a qualified person who administered such countermeasure; (iv) a State, a political subdivision of a State, or an agency or official of a State or of such a political subdivision, if such State, subdivision, agency, or offi- cial has established requirements, provided policy guidance, supplied technical or scientific advice or as- sistance, or otherwise supervised or administered a program with respect to administration of such coun- termeasures; (v) in the case of a claim arising out of alleged transmission of vaccinia from an individual— (I) the individual who allegedly transmitted the vaccinia, if vaccinia vaccine was administered to such individual as provided by paragraph (2)(B) and such individual was within a category of indi- viduals covered by a declaration under paragraph (2)(A)(i); or (II) an entity that employs an individual de- scribed by clause (I) or where such individual has privileges or is otherwise authorized to provide health care; (vi) an official, agent, or employee of a person de- scribed in clause (i), (ii), (iii), or (iv); (vii) a contractor of, or a volunteer working for, a person described in clause (i), (ii), or (iv), if the con- tractor or volunteer performs a function for which a person described in clause (i), (ii), or (iv) is a covered person; or (viii) an individual who has privileges or is other- wise authorized to provide health care under the aus- pices of an entity described in clause (ii) or (v)(II). (C) Q .—The term ‘‘qualified person’’, UALIFIED PERSON when used with respect to the administration of a covered countermeasure, means a licensed health professional or 16 — other individual who (i) is authorized to administer such counter- measure under the law of the State in which the coun- termeasure was administered; or clause (I)’’, and the use in the instructions of the word ‘‘accordingly’’ requires the exercise of editorial judgment. 16 Subparagraph (C) is shown according to the probable intent of the Congress. In amending the subparagraph to create a clause (i), section 3(g) of Public Law 108–20 (117 Stat. 648) pro- vided that the subparagraph is amended by redesignating certain words ‘‘as clause (i) and in- denting accordingly’’. The use in the amendatory instructions of the word ‘‘accordingly’’ requires the exercise of editorial judgment. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00041 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

42 G:\COMP\PHSA\PHSA-MERGED.XML 42 Sec. 224 PUBLIC HEALTH SERVICE ACT (ii) is otherwise authorized by the Secretary to ad- minister such countermeasure. (D) A RISING OUT OF ADMINISTRATION OF A COVERED .—The term ‘‘arising out of administra- COUNTERMEASURE tion of a covered countermeasure’’, when used with respect to a claim or liability, includes a claim or liability arising out of— (i) determining whether, or under what conditions, an individual should receive a covered counter- measure; (ii) obtaining informed consent of an individual to the administration of a covered countermeasure; (iii) monitoring, management, or care of an imme- diate site of administration on the body of a covered countermeasure, or evaluation of whether the adminis- tration of the countermeasure has been effective; or (iv) transmission of vaccinia virus by an indi- vidual to whom vaccinia vaccine was administered as provided by paragraph (2)(B). (q)(1) For purposes of this section, a health professional volun- teer at a deemed entity described in subsection (g)(4) shall, in pro- viding a health professional service eligible for funding under sec- tion 330 to an individual, be deemed to be an employee of the Pub- lic Health Service for a calendar year that begins during a fiscal year for which a transfer was made under paragraph (4)(C). The preceding sentence is subject to the provisions of this subsection. (2) In providing a health service to an individual, a health care practitioner shall for purposes of this subsection be considered to be a health professional volunteer at an entity described in sub- section (g)(4) if the following conditions are met: (A) The service is provided to the individual at the facili- ties of an entity described in subsection (g)(4), or through off- site programs or events carried out by the entity. (B) The entity is sponsoring the health care practitioner pursuant to paragraph (3)(B). (C) The health care practitioner does not receive any com- pensation for the service from the individual, the entity de- scribed in subsection (g)(4), or any third-party payer (including reimbursement under any insurance policy or health plan, or under any Federal or State health benefits program), except that the health care practitioner may receive repayment from the entity described in subsection (g)(4) for reasonable ex- penses incurred by the health care practitioner in the provision of the service to the individual, which may include travel ex- penses to or from the site of services. (D) Before the service is provided, the health care practi- tioner or the entity described in subsection (g)(4) posts a clear and conspicuous notice at the site where the service is provided of the extent to which the legal liability of the health care practitioner is limited pursuant to this subsection. (E) At the time the service is provided, the health care practitioner is licensed or certified in accordance with applica- ble Federal and State laws regarding the provision of the serv- ice. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00042 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

43 G:\COMP\PHSA\PHSA-MERGED.XML 43 Sec. 224 PUBLIC HEALTH SERVICE ACT (F) At the time the service is provided, the entity described in subsection (g)(4) maintains relevant documentation certi- fying that the health care practitioner meets the requirements of this subsection. (3) Subsection (g) (other than paragraphs (3) and (5)) and sub- sections (h), (i), and (l) apply to a health care practitioner for pur- poses of this subsection to the same extent and in the same man- ner as such subsections apply to an officer, governing board mem- ber, employee, or contractor of an entity described in subsection (g)(4), subject to paragraph (4), and subject to the following: (A) The first sentence of paragraph (1) applies in lieu of the first sentence of subsection (g)(1)(A). (B) With respect to an entity described in subsection (g)(4), a health care practitioner is not a health professional volunteer at such entity unless the entity sponsors the health care prac- titioner. For purposes of this subsection, the entity shall be considered to be sponsoring the health care practitioner if— (i) with respect to the health care practitioner, the en- tity submits to the Secretary an application meeting the requirements of subsection (g)(1)(D); and (ii) the Secretary, pursuant to subsection (g)(1)(E), de- termines that the health care practitioner is deemed to be an employee of the Public Health Service. (C) In the case of a health care practitioner who is deter- mined by the Secretary pursuant to subsection (g)(1)(E) to be a health professional volunteer at such entity, this subsection applies to the health care practitioner (with respect to services performed on behalf of the entity sponsoring the health care practitioner pursuant to subparagraph (B)) for any cause of ac- tion arising from an act or omission of the health care practi- tioner occurring on or after the date on which the Secretary makes such determination. (D) Subsection (g)(1)(F) applies to a health care practi- tioner for purposes of this subsection only to the extent that, in providing health services to an individual, each of the condi- tions specified in paragraph (2) is met. (4)(A) Amounts in the fund established under subsection (k)(2) shall be available for transfer under subparagraph (C) for purposes of carrying out this subsection. (B)(i) Not later than May 1 of each fiscal year, the Attorney General, in consultation with the Secretary, shall submit to the Congress a report providing an estimate of the amount of claims (together with related fees and expenses of witnesses) that, by rea- son of the acts or omissions of health professional volunteers, will be paid pursuant to this section during the calendar year that be- gins in the following fiscal year. (ii) Subsection (k)(1)(B) applies to the estimate under clause (i) regarding health professional volunteers to the same extent and in the same manner as such subsection applies to the estimate under such subsection regarding officers, governing board members, em- ployees, and contractors of entities described in subsection (g)(4). (iii) The report shall include a summary of the data relied upon for the estimate in clause (i), including the number of claims filed and paid from the previous calendar year. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00043 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

44 G:\COMP\PHSA\PHSA-MERGED.XML 44 Sec. 226 PUBLIC HEALTH SERVICE ACT (C) Not later than December 31 of each fiscal year, the Sec- retary shall transfer from the fund under subsection (k)(2) to the appropriate accounts in the Treasury an amount equal to the esti- mate made under subparagraph (B) for the calendar year begin- ning in such fiscal year, subject to the extent of amounts in the fund. (5)(A) This subsection shall take effect on October 1, 2017, ex- cept as provided in subparagraph (B) and paragraph (6). (B) Effective on the date of the enactment of this subsection— (i) the Secretary may issue regulations for carrying out this subsection, and the Secretary may accept and consider ap- plications submitted pursuant to paragraph (3)(B); and (ii) reports under paragraph (4)(B) may be submitted to Congress. (6) Beginning on October 1, 2022, this subsection shall cease to have any force or effect. ADMINISTRATION OF GRANTS IN CERTAIN MULTIGRANT PROJECTS 17 S ¿ . 226. EC ø 235 For the purpose of facilitating the adminis- tration of, and expediting the carrying out of the purposes of, the programs established by titles VII, VIII, and IX, and sections 304, 314(a), 314(b), 314(c), 314(d), and 314(e) of this Act in situations in which grants are sought or made under two or more of such pro- grams with respect to a single project, the Secretary is authorized to promulgate regulations— (1) under which the administrative functions under such programs with respect to such project will be performed by a single administrative unit which is the administrative unit charged with the administration of any of such programs or is the administrative unit charged with the supervision of two or more of such programs; (2) designed to reduce the number of applications, reports, and other materials required under such programs to be sub- mitted with respect to such project, and otherwise to simplify, consolidate, and make uniform (to the extent feasible), the data and information required to be contained in such applications, reports, and other materials; and (3) under which inconsistent or duplicative requirements imposed by such programs will be revised and made uniform with respect to such project; except that nothing in this section shall be construed to authorize the Secretary to waive or suspend, with respect to any such project, any requirement with respect to any of such programs if such re- quirement is imposed by law or by any regulation required by law. ORPHAN PRODUCTS BOARD S EC . 227. ø 236 ¿ (a) There is established in the Department of Health and Human Services a board for the development of drugs (including biologics) and devices (including diagnostic products) for rare diseases or conditions to be known as the Orphan Products 17 Former section 225 was repealed by section 408(b)(1) of Public Law 94–484 (90 Stat. 2281). Subpart III of part D of title III now applies to the matter with which former section 225 was concerned. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00044 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

45 G:\COMP\PHSA\PHSA-MERGED.XML 45 Sec. 227 PUBLIC HEALTH SERVICE ACT Board. The Board shall be comprised of the Assistant Secretary for Health of the Department of Health and Human Services and rep- resentatives, selected by the Secretary, of the Food and Drug Ad- ministration, the National Institutes of Health, the Centers for Dis- ease Control and Prevention, and any other Federal department or agency which the Secretary determines has activities relating to drugs and devices for rare diseases or conditions. The Assistant Secretary for Health shall chair the Board. (b) The function of the Board shall be to promote the develop- ment of drugs and devices for rare diseases or conditions and the coordination among Federal, other public, and private agencies in carrying out their respective functions relating to the development of such articles, such diseases or conditions. (c) In the case of drugs for rare diseases or conditions the Board shall— (1) evaluate— (A) the effect of subchapter B of the Federal Food, Drug, and Cosmetic Act on the development of such drugs, and 18 (B) the implementation of such subchapter; (2) evaluate the activities of the National Institutes of Health for the development of drugs for such diseases or condi- tions, (3) assure appropriate coordination among the Food and Drug Administration, the National Institutes of Health and the Centers for Disease Control and Prevention in the carrying out of their respective functions relating to the development of drugs for such diseases or conditions to assure that the activi- ties of each agency are complementary. (4) assure appropriate coordination among all interested Federal agencies, manufacturers, and organizations rep- resenting patients, in their activities relating to such drugs, (5) with the consent of the sponsor of a drug for a rare dis- ease or condition exempt under section 505(i) of the Federal Food, Drug, and Cosmetic Act or regulations issued under such section, inform physicians and the public respecting the avail- ability of such drug for such disease or condition and inform physicians and the public respecting the availability of drugs approved under section 505(c) of such Act or licensed under section 351 of this Act for rare diseases or conditions, (6) seek business entities and others to undertake the sponsorship of drugs for rare diseases or conditions, seek inves- tigators to facilitate the development of such drugs, and seek business entities to participate in the distribution of such drugs, and (7) recognize the efforts of public and private entities and individuals in seeking the development of drugs for rare dis- eases or conditions and in developing such drugs. (d) The Board shall consult with interested persons respecting the activities of the Board under this section and as part of such consultation shall provide the opportunity for the submission of oral views. 18 So in law. The semicolon probably should be a comma. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00045 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

46 G:\COMP\PHSA\PHSA-MERGED.XML 46 Sec. 228 PUBLIC HEALTH SERVICE ACT (e) The Board shall submit to the Committee on Labor and Human Resources of the Senate and the Committee on Energy and Commerce of the House of Representatives an annual report— (1) identifying the drugs which have been designated under section 526 of the Federal Food, Drug, and Cosmetic Act for a rare disease or condition, (2) describing the activities of the Board, and (3) containing the results of the evaluations carried out by the Board. The Director of the National Institutes of Health shall submit to the Board for inclusion in the annual report a report on the rare disease and condition research activities of the Institutes of the Na- tional Institutes of Health; the Secretary of the Treasury shall sub- mit to the Board for inclusion in the annual report a report on the use of the credit against tax provided by section 44H of the Inter- nal Revenue Code of 1954; and the Secretary of Health and Human Services shall submit to the Board for inclusion in the annual re- port a report on the program of assistance under section 5 of the Orphan Drug Act for the development of drugs for rare diseases and conditions. Each annual report shall be submitted by June 1 of each year for the preceding calendar year. SILVIO O CONTE SENIOR BIOMEDICAL RESEARCH AND BIOMEDICAL . PRODUCT ASSESSMENT SERVICE EC . 228. ø 237 ¿ (a)(1) There shall be in the Public Health S Service a Silvio O. Conte Senior Biomedical Research and Bio- medical Product Assessment Service (in this section referred to as the ‘‘Service’’), not to exceed 2,000 members, the purpose of which is to recruit and retain outstanding and qualified scientific and technical experts in the fields of biomedical research, clinical re- search evaluation, and biomedical product assessment. (2) The authority established in paragraph (1) may not be con- strued to require the Secretary to reduce the number of employees serving under any other employment system in order to offset the number of members serving in the Service. (3) The Secretary shall assign experts under this section to agencies within the Department of Health and Human Services taking into account the need for the expertise of such expert. (b) The Service shall be appointed by the Secretary without re- gard to the provisions of title 5, United States Code, regarding ap- pointment, and shall consist of individuals outstanding in the field of biomedical research, clinical research evaluation, or biomedical product assessment. No individual may be appointed to the Service unless such individual (1) has earned a doctoral level degree in bio- medicine or a related field, or a doctoral or master’s level degree in engineering, bioinformatics, or a related or emerging field, and (2) meets the qualification standards prescribed by the Office of Personnel Management for appointment to a position at GS–15 of the General Schedule. Notwithstanding any previous applicability to an individual who is a member of the Service, the provisions of subchapter I of chapter 35 (relating to retention preference), chap- ter 43 (relating to performance appraisal and performance actions), chapter 51 (relating to classification), subchapter III of chapter 53 March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00046 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

47 G:\COMP\PHSA\PHSA-MERGED.XML 47 Sec. 229 PUBLIC HEALTH SERVICE ACT (relating to General Schedule pay rates), and chapter 75 (relating to adverse actions) of title 5, United States Code, shall not apply to any member of the Service. (c) The Secretary shall develop a performance appraisal system designed to— (1) provide for the systematic appraisal of the performance of members, and (2) encourage excellence in performance by members. (d)(1) The Secretary shall determine, subject to the provisions of this subsection, the pay of members of the Service. (2) The pay of a member of the Service shall not be less than the minimum rate payable for GS–15 of the General Schedule and shall not exceed the amount of annual compensation (excluding ex- penses) specified in section 102 of title 3, United States Code. (e) Subject to the following sentence, the Secretary may, not- withstanding the provisions of title 5, United States Code, regard- ing appointment, appoint an individual who is separated from the Service involuntarily and without cause to a position in the com- petitive civil service at GS–15 of the General Schedule, and such appointment shall be a career appointment. In the case of such an individual who immediately prior to his appointment to the Service was not a career appointee in the civil service or the Senior Execu- tive Service, such appointment shall be in the excepted civil service and may not exceed a period of 2 years. (f) The Secretary shall promulgate such rules and regulations, not inconsistent with this section, as may be necessary for the effi- cient administration of the Service. 19 ø SEC. 229. HEALTH AND HUMAN SERVICES OFFICE ON WOM- ¿ 237a EN’S HEALTH. STABLISHMENT OF (a) E .—There is established within O FFICE the Office of the Secretary, an Office on Women’s Health (referred to in this section as the ‘‘Office’’). The Office shall be headed by a Deputy Assistant Secretary for Women’s Health who may report to the Secretary. (b) D .—The Secretary, acting through the Office, with re- UTIES spect to the health concerns of women, shall— (1) establish short-range and long-range goals and objec- tives within the Department of Health and Human Services and, as relevant and appropriate, coordinate with other appro- priate offices on activities within the Department that relate to disease prevention, health promotion, service delivery, re- search, and public and health care professional education, for issues of particular concern to women throughout their life- span; (2) provide expert advice and consultation to the Secretary concerning scientific, legal, ethical, and policy issues relating to women’s health; 19 Section 3509 of the Patient Protection and Affordable Care Act (Public Law 111–148, en- acted March 23, 2010) established offices of womens health in the Office of the Secretary of HHS (this section), the Centers for Disease Control and Prevention (section 310A of this Act), the Agency for Healthcare Research and Quality (section 925 of this Act), the Health Resources and Services Administration (section 713 of the Social Security Act), and the Food and Drug Admin- istration (section 1011 of the Federal Food, Drug, and Cosmetic Act). March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00047 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

48 G:\COMP\PHSA\PHSA-MERGED.XML 48 Sec. 229 PUBLIC HEALTH SERVICE ACT (3) monitor the Department of Health and Human Serv- ices’ offices, agencies, and regional activities regarding wom- en’s health and identify needs regarding the coordination of ac- tivities, including intramural and extramural multidisciplinary activities; (4) establish a Department of Health and Human Services Coordinating Committee on Women’s Health, which shall be chaired by the Deputy Assistant Secretary for Women’s Health and composed of senior level representatives from each of the agencies and offices of the Department of Health and Human Services; (5) establish a National Women’s Health Information Cen- ter to— (A) facilitate the exchange of information regarding matters relating to health information, health promotion, preventive health services, research advances, and edu- cation in the appropriate use of health care; (B) facilitate access to such information; (C) assist in the analysis of issues and problems relat- ing to the matters described in this paragraph; and (D) provide technical assistance with respect to the ex- change of information (including facilitating the develop- ment of materials for such technical assistance); (6) coordinate efforts to promote women’s health programs and policies with the private sector; and (7) through publications and any other means appropriate, provide for the exchange of information between the Office and recipients of grants, contracts, and agreements under sub- section (c), and between the Office and health professionals and the general public. RANTS AND C ONTRACTS R EGARDING D UTIES .— (c) G (1) A .—In carrying out subsection (b), the Sec- UTHORITY retary may make grants to, and enter into cooperative agree- ments, contracts, and interagency agreements with, public and private entities, agencies, and organizations. (2) E VALUATION AND DISSEMINATION .—The Secretary shall directly or through contracts with public and private entities, agencies, and organizations, provide for evaluations of projects carried out with financial assistance provided under paragraph (1) and for the dissemination of information developed as a re- sult of such projects. (d) R EPORTS .—Not later than 1 year after the date of enact- ment of this section, and every second year thereafter, the Sec- retary shall prepare and submit to the appropriate committees of Congress a report describing the activities carried out under this section during the period for which the report is being prepared. UTHORIZATION OF A PPROPRIATIONS .—For the purpose of (e) A carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00048 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

49 G:\COMP\PHSA\PHSA-MERGED.XML 49 Sec. 231 PUBLIC HEALTH SERVICE ACT B—M ART ROVISIONS ISCELLANEOUS P P GIFTS (a) The Secretary is authorized to accept on 238 ¿ . 231. EC S ø behalf of the United States gifts made unconditionally by will or otherwise for the benefit of the Service or for the carrying out of any of its functions. Conditional gifts may be so accepted if rec- ommended by the Surgeon General, and the principal of and in- come from any such conditional gift shall be held, invested, rein- vested, and used in accordance with its conditions, but no gift shall be accepted which is conditioned upon any expenditure not to be met therefrom or from the income thereof unless such expenditure has been approved by Act of Congress. (b) Any unconditional gift of money accepted, pursuant to the authority granted in subsection (a) of this section, the net proceeds from the liquidation (pursuant to subsection (c) or subsection (d) of this section) of any other property so accepted, and the proceeds of insurance on any such gift property not used for its restoration, shall be deposited in the Treasury of the United States and are hereby appropriated and shall be held in trust by the Secretary of the Treasury for the benefit of the Service, and he may invest and reinvest such funds in interest-bearing obligations of the United States or in obligations guaranteed as to both principal and inter- est by the United States. Such gifts and the income from such in- vestments shall be available for expenditure in the operation of the Service and the performance of its functions, subject to the same examination and audit as is provided for appropriations made for the Service by Congress. (c) The evidences of any unconditional gift of intangible per- sonal property, other than money, accepted pursuant to the author- ity granted in subsection (a) of this section shall be deposited with the Secretary of the Treasury and he, in his discretion, may hold them, or liquidate them except that they shall be liquidated upon the request of the Secretary, whenever necessary to meet payments required in the operation of the Service or the performance of its functions. The proceeds and income from any such property held by the Secretary of the Treasury shall be available for expenditure as is provided in subsection (b) of this section. (d) The Secretary shall hold any real property or any tangible personal property accepted unconditionally pursuant to the author- ity granted in subsection (a) of this section and he shall permit such property to be used for the operation of the Service and the performance of its functions or he may lease or hire such property, and may insure such property, and deposit the income thereof with the Secretary of the Treasury to be available for expenditure as Provided, That the in- provided in subsection (b) of this section: come from any such real property or tangible personal property shall be available for expenditure in the discretion of the Secretary for the maintenance, preservation, or repair and insurance of such property and that any proceeds from insurance may be used to re- store the property insured. Any such property when not required for the operation of the Service or the performance of its functions may be liquidated by the Secretary, and the proceeds thereof de- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00049 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

50 G:\COMP\PHSA\PHSA-MERGED.XML 50 Sec. 232 PUBLIC HEALTH SERVICE ACT posited with the Secretary of the Treasury, whenever in his judg- ment the purposes of the gifts will be served thereby. USE OF IMMIGRATION STATION HOSPITALS S . 232. EC 238a ¿ The Immigration and Naturalization Service ø may, by agreement of the heads of the departments concerned, per- mit the Public Health Service to use hospitals at immigration sta- tions for the care of Public Health Service patients. The Surgeon General shall reimburse the Immigration and Naturalization Serv- ice for the actual cost of furnishing fuel, light, water, telephone, and similar supplies and services, which reimbursement shall be covered into the proper Immigration and Naturalization Service ap- propriation, or such costs may be paid from working funds estab- lished as provided by law, but no charge shall be made for the ex- pense of physical upkeep of the hospitals. The Immigration and Naturalization Service shall reimburse the Surgeon General for the care and treatment of persons detained in hospitals of the Public Health Service at the request of the Immigration and Naturaliza- tion Service unless such persons are entitled to care and treatment 20 under section 322(a). MONEY COLLECTED FOR CARE OF PATIENTS S ¿ 238b ø . 233. Money collected as provided by law for ex- EC penses incurred in the care and treatment of foreign seamen, and money received for the care and treatment of pay patients, includ- ing any amounts received from any executive department on ac- count of care and treatment of pay patients, shall be covered into the appropriation from which the expenses of such care and treat- ment were paid. TRANSPORTATION OF REMAINS OF OFFICERS S 238c Appropriations available for traveling ex- ¿ EC . 234. ø penses of the Service shall be available for meeting the cost of preparation for burial and of transportation to the place of burial of remains of commissioned officers, and of personnel specified in regulations, who die in line of duty. Appropriations available for carrying out the provisions of this Act shall also be available for the payment of such expenses relating to the recovery, care, and disposition of the remains of personnel or their dependents as may be authorized under other provisions of law. GRANTS TO FEDERAL INSTITUTIONS Appropriations to the Public Health Service EC ¿ 238d . 235. ø S available under this Act for research, training, or demonstration project grants or for grants to expand existing treatment and re- search programs and facilities for alcoholism, narcotic addiction, drug abuse, and drug dependence and appropriations under title VI of the Mental Health Systems Act shall also be available, on the 20 Subsection (a) of section 322 was repealed by section 986 of Public Law 97–35, and the Pub- lic Law redesignated former subsection (c) as subsection (a). Section 232 (above) was enacted before this repeal and redesignation. Current section 322(a) authorizes the treatment and care of certain persons. (Section 232 was originally enacted as section 502, and was subsequently re- designated by Public Laws 98–24, 99–660, 100–690, and 103–43.) March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00050 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

51 G:\COMP\PHSA\PHSA-MERGED.XML 51 Sec. 239 PUBLIC HEALTH SERVICE ACT same terms and conditions as apply to non-Federal institutions, for grants for the same purpose to Federal institutions, except that grants to such Federal institutions may be funded at 100 per cen- tum of the costs. TRANSFER OF FUNDS EC . 236. S 238e ¿ For the purpose of any reorganization under ø section 202, the Secretary, with the approval of the Director of the 21 Bureau of the Budget, is authorized to make such transfers of funds between appropriations as may be necessary for the continu- ance of transferred functions. AVAILABILITY OF APPROPRIATIONS S EC . 237. ø 238f ¿ Appropriations for carrying out the purposes of this Act shall be available for expenditure for personal services and rent at the seat of Government; books of reference, periodicals, and exhibits; printing and binding; transporting in Government- owned automotive equipment, to and from school, children of per- sonnel who have quarters for themselves and their families at sta- tions determined by the Surgeon General to be isolated stations; expenses incurred in pursuing, identifying, and returning prisoners who escape from any hospital, institution, or station of the Service or from the custody of any officer or employee of the Service, in- cluding rewards for the capture of such prisoners; furnishing, re- pairing, and cleaning such wearing apparel as may be prescribed by the Surgeon General for use by employees in the performance of their official duties; reimbursing officers and employees, subject to regulations of the Administrator, for the cost of repairing or re- placing their personal belongings damaged or destroyed by patients while such officers or employees are engaged in the performance of their official duties; and maintenance of buildings of the National Institutes of Health. UNAUTHORIZED WEARING OF UNIFORMS EC . 238. ø 238g ¿ Except as may be authorized by regulations S of the President, the insignia and uniform of commissioned officers of the Service, or any distinctive part of such insignia or uniform, or any insignia or uniform any part of which is similar to a distinc- tive part thereof, shall not be worn, after the promulgation of such regulations, by any person other than a commissioned officer of the Service. BIANNUAL REPORT The Surgeon General shall transmit to the EC . 239. ø 238h ¿ S Secretary, for submission to the Congress, on January 1, 1995, and on January 1, every 2 years thereafter, a full report of the adminis- tration of the functions of the Service under this Act, including a detailed statement of receipts and disbursements. 21 Now the Office of Management and Budget. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00051 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

52 G:\COMP\PHSA\PHSA-MERGED.XML 52 Sec. 240 PUBLIC HEALTH SERVICE ACT MEMORIALS AND OTHER ACKNOWLEDGMENTS ø 238i ¿ The Secretary may provide for suitably ac- EC . 240. S knowledging, within the Department (whether by memorials, des- ignations, or other suitable acknowledgments), (1) efforts of persons who have contributed substantially to the health of the Nation and (2) gifts for use in activities of the Department related to health. EVALUATION OF PROGRAMS . 241. ø 238j ¿ (a) I N S ENERAL .—Such portion as the Sec- EC G retary shall determine, but not less than 0.2 percent nor more than 1 percent, of any amounts appropriated for programs authorized under this Act shall be made available for the evaluation (directly, or by grants of contracts) of the implementation and effectiveness of such programs. EPORT ON E VALUATIONS .—Not later than February 1 of (b) R each year, the Secretary shall prepare and submit to the Com- mittee on Labor and Human Resources of the Senate and the Com- mittee on Energy and Commerce of the House of Representatives a report summarizing the findings of the evaluations conducted under subsection (a). CONTRACT AUTHORITY EC . 242. ø 238k ¿ The authority of the Secretary to enter into S contracts under this Act shall be effective for any fiscal year only to such extent or in such amounts as are provided in advance by appropriation Acts. RECOVERY EC . 243. ø 238l ¿ (a) If any facility with respect to which funds S have been paid under the Community Mental Health Centers Act (as such Act was in effect prior to October 1, 1981) is, at any time within twenty years after the completion of remodeling, construc- tion, or expansion or after the date of its acquisition— (1) sold or transferred to any entity (A) which would not have been qualified to file an application under section 222 of such Act (as such section was in effect prior to October 1, 1981) or (B) which is disapproved as a transferee by the State mental health agency or by another entity designated by the chief ex- ecutive officer of the State, or (2) ceases to be used by a community mental health center in the provision of comprehensive mental health services, the United States shall be entitled to recover from the transferor, transferee, or owner of the facility, the base amount prescribed by subsection (c)(1) plus the interest (if any) prescribed by subsection (c)(2). (b) The transferor and transferee of a facility that is sold or transferred as described in subsection (a)(1), or the owner of a facil- ity the use of which changes as described in subsection (a)(2), shall provide the Secretary written notice of such sale, transfer, or change within 10 days after the date on which such sale, transfer, or cessation of use occurs or within 30 days after the date of enact- ment of this subsection, whichever is later. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00052 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

53 G:\COMP\PHSA\PHSA-MERGED.XML 53 Sec. 244 PUBLIC HEALTH SERVICE ACT (c)(1) The base amount that the United States is entitled to re- cover under subsection (a) is the amount bearing the same ratio to the then value (as determined by the agreement of the parties or in an action brought in the district court of the United States for the district in which the facility is situated) of so much of the facil- ity as constituted an approved project or projects as the amount of the Federal participation bore to the cost of the remodeling, con- struction, expansion, or acquisition of the project or projects. (2)(A) The interest that the United States is entitled to recover under subsection (a) is the interest for the period (if any) described in subparagraph (B) at a rate (determined by the Secretary) based on the average of the bond equivalent rates of ninety-one-day Treasury bills auctioned during that period. (B) The period referred to in subparagraph (A) is the period be- ginning— (i) if notice is provided as prescribed by subsection (b), 191 days after the date on which such sale, transfer, or cessation of use occurs, or (ii) if notice is not provided as prescribed by subsection (b), 11 days after such sale, transfer, or cessation of use occurs, and ending on the date the amount the United States is entitled to recover is collected. (d) The Secretary may waive the recovery rights of the United States under subsection (a) with respect to a facility (under such conditions as the Secretary may establish by regulation) if the Sec- retary determines that there is good cause for waiving such rights. (e) The right of recovery of the United States under subsection (a) shall not, prior to judgment, constitute a lien on any facility. USE OF FISCAL AGENTS EC . 244. ø 238m ¿ (a) The Secretary may enter into contracts S with fiscal agents— (1)(A) to determine the amounts payable to persons who, on behalf of the Indian Health Service, furnish health services to eligible Indians, (B) to determine the amounts payable to persons who, on behalf of the Public Health Service, furnish health services to individuals pursuant to section 319 or 322, (2) to receive, disburse, and account for funds in making payments described in paragraph (1), (3) to make such audits of records as may be necessary to assure that these payments are proper, and (4) to perform such additional functions as may be nec- essary to carry out the functions described in paragraphs (1) through (3). (b)(1) Contracts under subsection (a) may be entered into with- out regard to section 3709 of the Revised Statutes (41 U.S.C. 5) or any other provision of law requiring competition. (2) No such contract shall be entered into with an entity unless the Secretary finds that the entity will perform its obligations under the contract efficiently and effectively and will meet such re- quirements as to financial responsibility, legal authority, and other matters as he finds pertinent. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00053 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

54 G:\COMP\PHSA\PHSA-MERGED.XML 54 Sec. 245 PUBLIC HEALTH SERVICE ACT (c) A contract under subsection (a) may provide for advances of funds to enable entities to make payments under the contract. (d) Subsections (d) and (e) of section 1842 of the Social Security Act shall apply to contracts with entities under subsection (a) in the same manner as they apply to contracts with carriers under that section. (e) In this section, the term ‘‘fiscal agent’’ means a carrier de- scribed in section 1842(f)(1) of the Social Security Act and includes, with respect to contracts under subsection (a)(1)(A), an Indian tribe or tribal organization acting under contract with the Secretary under the Indian Self-Determination Act (Public Law 93–638). ABORTION - RELATED DISCRIMINATION IN GOVERNMENTAL ACTIVITIES REGARDING TRAINING AND LICENSING OF PHYSICIANS S EC . 245. ø 238n ¿ (a) I N G ENERAL .—The Federal Government, and any State or local government that receives Federal financial assistance, may not subject any health care entity to discrimination on the basis that— (1) the entity refuses to undergo training in the perform- ance of induced abortions, to require or provide such training, to perform such abortions, or to provide referrals for such training or such abortions; (2) the entity refuses to make arrangements for any of the activities specified in paragraph (1); or (3) the entity attends (or attended) a post-graduate physi- cian training program, or any other program of training in the health professions, that does not (or did not) perform induced abortions or require, provide or refer for training in the per- formance of induced abortions, or make arrangements for the provision of such training. (b) A OSTGRADUATE P HYSICIAN T RAINING CCREDITATION OF P ROGRAMS .— P .—In determining whether to grant a legal (1) I N GENERAL status to a health care entity (including a license or certifi- cate), or to provide such entity with financial assistance, serv- ices or other benefits, the Federal Government, or any State or local government that receives Federal financial assistance, shall deem accredited any postgraduate physician training pro- gram that would be accredited but for the accrediting agency’s 22 reliance upon an accreditation standards that requires an entity to perform an induced abortion or require, provide, or refer for training in the performance of induced abortions, or make arrangements for such training, regardless of whether such standard provides exceptions or exemptions. The govern- ment involved shall formulate such regulations or other mecha- nisms, or enter into such agreements with accrediting agencies, as are necessary to comply with this subsection. .— ULES OF CONSTRUCTION (2) R (A) I N GENERAL .—With respect to subclauses (I) and (II) of section 705(a)(2)(B)(i) (relating to a program of in- sured loans for training in the health professions), the re- quirements in such subclauses regarding accredited intern- 22 So in law. Probably should read ‘‘standard’’. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00054 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

55 G:\COMP\PHSA\PHSA-MERGED.XML 55 Sec. 247 PUBLIC HEALTH SERVICE ACT ship or residency programs are subject to paragraph (1) of this subsection. (B) E XCEPTIONS .—This section shall not— (i) prevent any health care entity from voluntarily electing to be trained, to train, or to arrange for train- ing in the performance of, to perform, or to make re- ferrals for induced abortions; or (ii) prevent an accrediting agency or a Federal, State or local government from establishing standards of medical competency applicable only to those individ- uals who have voluntarily elected to perform abor- tions. (c) D EFINITIONS .—For purposes of this section: (1) The term ‘‘financial assistance’’, with respect to a gov- ernment program, includes governmental payments provided as reimbursement for carrying out health-related activities. (2) The term ‘‘health care entity’’ includes an individual physician, a postgraduate physician training program, and a participant in a program of training in the health professions. (3) The term ‘‘postgraduate physician training program’’ includes a residency training program. ø 238o ¿ RESTRICTION ON USE OF FUNDS FOR ASSISTED SUI- SEC. 246. CIDE, EUTHANASIA, AND MERCY KILLING. Appropriations for carrying out the purposes of this Act shall not be used in a manner inconsistent with the Assisted Suicide 23 Funding Restriction Act of 1997. RECOMMENDATIONS AND GUIDELINES REGARDING AUTOMATED EXTERNAL DEFIBRILLATORS FOR FEDERAL BUILDINGS .—The Sec- S ø 238p ¿ (a) G UIDELINES ON P LACEMENT . 247. EC retary shall establish guidelines with respect to placing automated external defibrillator devices in Federal buildings. Such guidelines shall take into account the extent to which such devices may be used by lay persons, the typical number of employees and visitors in the buildings, the extent of the need for security measures re- garding the buildings, buildings or portions of buildings in which there are special circumstances such as high electrical voltage or extreme heat or cold, and such other factors as the Secretary deter- mines to be appropriate. (b) R R ECOMMENDATIONS .—The Secretary shall publish ELATED in the Federal Register the recommendations of the Secretary on the appropriate implementation of the placement of automated ex- ternal defibrillator devices under subsection (a), including proce- dures for the following: (1) Implementing appropriate training courses in the use of such devices, including the role of cardiopulmonary resus- citation. (2) Proper maintenance and testing of the devices. (3) Ensuring coordination with appropriate licensed profes- sionals in the oversight of training of the devices. 23 Public Law 105–12 (111 Stat. 23). March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00055 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

56 G:\COMP\PHSA\PHSA-MERGED.XML 56 Sec. 248 PUBLIC HEALTH SERVICE ACT (4) Ensuring coordination with local emergency medical systems regarding the placement and incidents of use of the devices. ONSIDERATION OF ; C R ECOMMENDA - ERTAIN C ONSULTATIONS (c) C .—In carrying out this section, the Secretary shall— TIONS (1) consult with appropriate public and private entities; (2) consider the recommendations of national and local public-health organizations for improving the survival rates of individuals who experience cardiac arrest in nonhospital set- tings by minimizing the time elapsing between the onset of cardiac arrest and the initial medical response, including defibrillation as necessary; and (3) consult with and counsel other Federal agencies where such devices are to be used. C ERTAIN FOR E STABLISHING G UIDELINES AND R EC - ATE (d) D .—The Secretary shall comply with this section not OMMENDATIONS later than 180 days after the date of the enactment of the Cardiac Arrest Survival Act of 2000. EFINITIONS .—For purposes of this section: (e) D (1) The term ‘‘automated external defibrillator device’’ has the meaning given such term in section 248. (2) The term ‘‘Federal building’’ includes a building or por- tion of a building leased or rented by a Federal agency, and in- cludes buildings on military installations of the United States. LIABILITY REGARDING EMERGENCY USE OF AUTOMATED EXTERNAL DEFIBRILLATORS EGARD . 248. 238q ¿ (a) G OOD S AMARITAN P ROTECTIONS EC ø - S R AED S .—Except as provided in subsection (b), any person who ING uses or attempts to use an automated external defibrillator device on a victim of a perceived medical emergency is immune from civil liability for any harm resulting from the use or attempted use of such device; and in addition, any person who acquired the device is immune from such liability, if the harm was not due to the fail- ure of such acquirer of the device— (1) to notify local emergency response personnel or other appropriate entities of the most recent placement of the device within a reasonable period of time after the device was placed; (2) to properly maintain and test the device; or (3) to provide appropriate training in the use of the device to an employee or agent of the acquirer when the employee or agent was the person who used the device on the victim, except that such requirement of training does not apply if— (A) the employee or agent was not an employee or agent who would have been reasonably expected to use the device; or (B) the period of time elapsing between the engage- ment of the person as an employee or agent and the occur- rence of the harm (or between the acquisition of the device and the occurrence of the harm, in any case in which the device was acquired after such engagement of the person) was not a reasonably sufficient period in which to provide the training. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00056 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

57 G:\COMP\PHSA\PHSA-MERGED.XML 57 Sec. 248 PUBLIC HEALTH SERVICE ACT I MMUNITY NAPPLICABILITY OF (b) I .—Immunity under subsection (a) does not apply to a person if— (1) the harm involved was caused by willful or criminal misconduct, gross negligence, reckless misconduct, or a con- scious, flagrant indifference to the rights or safety of the victim who was harmed; (2) the person is a licensed or certified health professional who used the automated external defibrillator device while act- ing within the scope of the license or certification of the profes- sional and within the scope of the employment or agency of the professional; (3) the person is a hospital, clinic, or other entity whose purpose is providing health care directly to patients, and the harm was caused by an employee or agent of the entity who used the device while acting within the scope of the employ- ment or agency of the employee or agent; or (4) the person is an acquirer of the device who leased the device to a health care entity (or who otherwise provided the device to such entity for compensation without selling the de- vice to the entity), and the harm was caused by an employee or agent of the entity who used the device while acting within the scope of the employment or agency of the employee or agent. (c) R ONSTRUCTION ULES OF C .— N GENERAL .—The following applies with respect to this (1) I section: (A) This section does not establish any cause of action, or require that an automated external defibrillator device be placed at any building or other location. (B) With respect to a class of persons for which this section provides immunity from civil liability, this section supersedes the law of a State only to the extent that the State has no statute or regulations that provide persons in such class with immunity for civil liability arising from the use by such persons of automated external defibrillator de- vices in emergency situations (within the meaning of the State law or regulation involved). (C) This section does not waive any protection from li- ability for Federal officers or employees under— (i) section 224; or (ii) sections 1346(b), 2672, and 2679 of title 28, United States Code, or under alternative benefits pro- vided by the United States where the availability of such benefits precludes a remedy under section 1346(b) of title 28. IVIL ACTIONS UNDER FEDERAL LAW .— (2) C N GENERAL .—The applicability of subsections (a) (A) I and (b) includes applicability to any action for civil liability described in subsection (a) that arises under Federal law. (B) F EDERAL AREAS ADOPTING STATE LAW .—If a geo- graphic area is under Federal jurisdiction and is located within a State but out of the jurisdiction of the State, and if, pursuant to Federal law, the law of the State applies in such area regarding matters for which there is no applica- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00057 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

58 G:\COMP\PHSA\PHSA-MERGED.XML 58 Sec. 261 PUBLIC HEALTH SERVICE ACT ble Federal law, then an action for civil liability described in subsection (a) that in such area arises under the law of the State is subject to subsections (a) through (c) in lieu of any related State law that would apply in such area in the absence of this subparagraph. (d) F J .—In any civil action arising under URISDICTION EDERAL State law, the courts of the State involved have jurisdiction to apply the provisions of this section exclusive of the jurisdiction of the courts of the United States. (e) D .— EFINITIONS (1) P ERCEIVED MEDICAL EMERGENCY .—For purposes of this section, the term ‘‘perceived medical emergency’’ means cir- cumstances in which the behavior of an individual leads a rea- sonable person to believe that the individual is experiencing a life-threatening medical condition that requires an immediate medical response regarding the heart or other cardiopulmonary functioning of the individual. .—For purposes of this section: THER DEFINITIONS (2) O (A) The term ‘‘automated external defibrillator device’’ means a defibrillator device that— (i) is commercially distributed in accordance with the Federal Food, Drug, and Cosmetic Act; (ii) is capable of recognizing the presence or ab- sence of ventricular fibrillation, and is capable of de- termining without intervention by the user of the de- vice whether defibrillation should be performed; (iii) upon determining that defibrillation should be performed, is able to deliver an electrical shock to an individual; and (iv) in the case of a defibrillator device that may be operated in either an automated or a manual mode, is set to operate in the automated mode. (B)(i) The term ‘‘harm’’ includes physical, nonphysical, economic, and noneconomic losses. (ii) The term ‘‘economic loss’’ means any pecuniary loss resulting from harm (including the loss of earnings or other benefits related to employment, medical expense loss, replacement services loss, loss due to death, burial costs, and loss of business or employment opportunities) to the extent recovery for such loss is allowed under applica- ble State law. (iii) The term ‘‘noneconomic losses’’ means losses for physical and emotional pain, suffering, inconvenience, physical impairment, mental anguish, disfigurement, loss of enjoyment of life, loss of society and companionship, loss of consortium (other than loss of domestic service), hedonic damages, injury to reputation and all other nonpecuniary losses of any kind or nature. P C—S MALLPOX E MERGENCY P ERSONNEL P ROTECTION ART ø ¿ GENERAL PROVISIONS. 239 SEC. 261. EFINITIONS .—For purposes of this part: (a) D March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00058 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

59 G:\COMP\PHSA\PHSA-MERGED.XML 59 Sec. 261 PUBLIC HEALTH SERVICE ACT .—The term ‘‘covered coun- OVERED COUNTERMEASURE (1) C termeasure’’ means a covered countermeasure as specified in a Declaration made pursuant to section 224(p). (2) C .—The term ‘‘covered individual’’ OVERED INDIVIDUAL means an individual— (A) who is a health care worker, law enforcement offi- cer, firefighter, security personnel, emergency medical per- sonnel, other public safety personnel, or support personnel for such occupational specialities; (B) who is or will be functioning in a role identified in a State, local, or Department of Health and Human Serv- ices smallpox emergency response plan (as defined in para- graph (7)) approved by the Secretary; (C) who has volunteered and been selected to be a member of a smallpox emergency response plan described in subparagraph (B) prior to the time at which the Sec- retary publicly announces that an active case of smallpox has been identified either within or outside of the United States; and (D) to whom a smallpox vaccine is administered pur- suant to such approved plan during the effective period of the Declaration (including the portion of such period before the enactment of this part). (3) C OVERED INJURY .—The term ‘‘covered injury’’ means an injury, disability, illness, condition, or death (other than a minor injury such as minor scarring or minor local reaction) determined, pursuant to the procedures established under sec- tion 262, to have been sustained by an individual as the direct result of— (A) administration to the individual of a covered coun- termeasure during the effective period of the Declaration; or (B) accidental vaccinia inoculation of the individual in circumstances in which— (i) the vaccinia is contracted during the effective period of the Declaration or within 30 days after the end of such period; (ii) smallpox vaccine has not been administered to the individual; and (iii) the individual has been in contact with an in- dividual who is (or who was accidentally inoculated by) a covered individual. ECLARATION .—The term ‘‘Declaration’’ means the Dec- (4) D laration Regarding Administration of Smallpox Counter- measures issued by the Secretary on January 24, 2003, and published in the Federal Register on January 28, 2003. FFECTIVE PERIOD OF THE DECLARATION .—The term ‘‘ef- (5) E fective period of the Declaration’’ means the effective period specified in the Declaration, unless extended by the Secretary. (6) E LIGIBLE INDIVIDUAL .—The term ‘‘eligible individual’’ means an individual who is (as determined in accordance with section 262)— (A) a covered individual who sustains a covered injury in the manner described in paragraph (3)(A); or March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00059 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

60 G:\COMP\PHSA\PHSA-MERGED.XML 60 Sec. 262 PUBLIC HEALTH SERVICE ACT (B) an individual who sustains a covered injury in the manner described in paragraph (3)(B). (7) S MALLPOX EMERGENCY RESPONSE PLAN .—The term ‘‘smallpox emergency response plan’’ or ‘‘plan’’ means a re- sponse plan detailing actions to be taken in preparation for a possible smallpox-related emergency during the period prior to the identification of an active case of smallpox either within or outside the United States. ROGRAM .—The Secretary shall ensure that a OLUNTARY P (b) V State, local, or Department of Health and Human Services plan to vaccinate individuals that is approved by the Secretary establishes procedures to ensure, consistent with the Declaration and any ap- plicable guidelines of the Centers for Disease Control and Preven- tion, that— (1) potential participants are educated with respect to con- traindications, the voluntary nature of the program, and the availability of potential benefits and compensation under this part; (2) there is voluntary screening provided to potential par- ticipants that can identify health conditions relevant to contra- indications; and (3) there is appropriate post-inoculation medical surveil- lance that includes an evaluation of adverse health effects that may reasonably appear to be due to such vaccine and prompt referral of, or the provision of appropriate information to, any individual requiring health care as a result of such adverse health event. ø 239a ¿ DETERMINATION OF ELIGIBILITY AND BENEFITS. SEC. 262. N G ENERAL .—The Secretary shall establish procedures for (a) I determining, as applicable with respect to an individual— (1) whether the individual is an eligible individual; (2) whether an eligible individual has sustained a covered injury or injuries for which medical benefits or compensation may be available under sections 264 and 265, and the amount of such benefits or compensation; and (3) whether the covered injury or injuries of an eligible in- dividual caused the individual’s death for purposes of benefits under section 266. I OVERED .—The Secretary may accept a certifi- NDIVIDUALS (b) C cation, by a Federal, State, or local government entity or private health care entity participating in the administration of covered countermeasures under the Declaration, that an individual is a cov- ered individual. RITERIA FOR R EIMBURSEMENT .— (c) C NJURIES SPECIFIED IN INJURY TABLE .—In any case (1) I where an injury or other adverse effect specified in the injury table established under section 263 as a known effect of a vac- cine manifests in an individual within the time period specified in such table, such injury or other effect shall be presumed to have resulted from administration of such vaccine. THER DETERMINATIONS .—In making determinations (2) O other than those described in paragraph (1) as to the causation or severity of an injury, the Secretary shall employ a prepon- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00060 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

61 G:\COMP\PHSA\PHSA-MERGED.XML 61 Sec. 263 PUBLIC HEALTH SERVICE ACT derance of the evidence standard and take into consideration all relevant medical and scientific evidence presented for con- sideration, and may obtain and consider the views of qualified medical experts. .—The Secretary shall not (d) D EADLINE FOR F ILING R EQUEST consider any request for a benefit under this part with respect to an individual, unless— (1) in the case of a request based on the administration of the vaccine to the individual, the individual files with the Sec- retary an initial request for benefits or compensation under this part not later than one year after the date of administra- tion of the vaccine; or (2) in the case of a request based on accidental vaccinia in- oculation, the individual files with the Secretary an initial re- quest for benefits or compensation under this part not later than two years after the date of the first symptom or mani- festation of onset of the adverse effect. (e) S PTION TRUCTURED S ETTLEMENTS AT S ECRETARY ’ S O .—In any case in which there is a reasonable likelihood that compensa- tion or payment under section 264, 265, or 266(b) will be required for a period in excess of one year from the date an individual is determined eligible for such compensation or payment, the Sec- retary shall have the discretion to make a lump-sum payment, pur- chase an annuity or medical insurance policy, or execute an appro- priate structured settlement agreement, provided that such pay- ment, annuity, policy, or agreement is actuarially determined to have a value equal to the present value of the projected total amount of benefits or compensation that the individual is eligible to receive under such section or sections. ETERMINATION D .— EVIEW OF (f) R (1) S ’ S REVIEW AUTHORITY .—The Secretary may ECRETARY review a determination under this section at any time on the Secretary’s own motion or on application, and may affirm, va- cate, or modify such determination in any manner the Sec- retary deems appropriate. The Secretary shall develop a proc- ess by which an individual may file a request for reconsider- ation of any determination made by the Secretary under this section. (2) J UDICIAL AND ADMINISTRATIVE REVIEW .—No court of the United States, or of any State, District, territory or possession thereof, shall have subject matter jurisdiction to review, whether by mandamus or otherwise, any action by the Sec- retary under this section. No officer or employee of the United States shall review any action by the Secretary under this sec- tion (unless the President specifically directs otherwise). ø SMALLPOX VACCINE INJURY TABLE. SEC. 263. ¿ 239b 24 (a) S MALLPOX V ACCINE I NJURY T ABLE .— STABLISHMENT REQUIRED .—The Secretary shall estab- (1) E lish by interim final regulation a table identifying adverse ef- fects (including injuries, disabilities, illnesses, conditions, and 24 Subsection (a) designation so in law. Section 263 does not contain a subsection (b). See the amendment made by section 2 of Public Law 108–20 (117 Stat. 638, 641), which added a new part C to title II. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00061 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

62 G:\COMP\PHSA\PHSA-MERGED.XML 62 Sec. 264 PUBLIC HEALTH SERVICE ACT deaths) that shall be presumed to result from the administra- tion of (or exposure to) a smallpox vaccine, and the time period in which the first symptom or manifestation of onset of each such adverse effect must manifest in order for such presump- tion to apply. .—The Secretary may by regulation MENDMENTS (2) A amend the table established under paragraph (1). An amend- ment to the table takes effect on the date of the promulgation of the final rule that makes the amendment, and applies to all requests for benefits or compensation under this part that are filed on or after such date or are pending as of such date. In addition, the amendment applies retroactively to an individual who was not with respect to the injury involved an eligible in- dividual under the table as in effect before the amendment but who with respect to such injury is an eligible individual under the table as amended. With respect to a request for benefits or compensation under this part by an individual who becomes an eligible individual as described in the preceding sentence, the Secretary may not provide such benefits or compensation un- less the request (or amendment to a request, as applicable) is filed before the expiration of one year after the effective date of the amendment to the table in the case of an individual to whom the vaccine was administered and before the expiration of two years after such effective date in the case of a request based on accidental vaccinia inoculation. ø ¿ MEDICAL BENEFITS. 239c SEC. 264. G ENERAL .—Subject to the succeeding provisions of this (a) I N section, the Secretary shall make payment or reimbursement for medical items and services as reasonable and necessary to treat a covered injury of an eligible individual, including the services, ap- pliances, and supplies prescribed or recommended by a qualified physician, which the Secretary considers likely to cure, give relief, reduce the degree or the period of disability, or aid in lessening the amount of monthly compensation. (b) B S ECONDARY TO O THER C OVERAGE .—Payment or ENEFITS reimbursement for services or benefits under subsection (a) shall be secondary to any obligation of the United States or any third party (including any State or local governmental entity, private insur- ance carrier, or employer) under any other provision of law or con- tractual agreement, to pay for or provide such services or benefits. ø 239d ¿ COMPENSATION FOR LOST EMPLOYMENT INCOME. SEC. 265. G (a) I .—Subject to the succeeding provisions of this N ENERAL section, the Secretary shall provide compensation to an eligible in- dividual for loss of employment income (based on such income at the time of injury) incurred as a result of a covered injury, at the rate specified in subsection (b). (b) A C OMPENSATION .— MOUNT OF (1) I N GENERAL .—Compensation under subsection (a) shall 2 ⁄ 3 percent of the relevant pay period (week- be at the rate of 66 ly, monthly, or otherwise), except as provided in paragraph (2). (2) A .—If an el- UGMENTED COMPENSATION FOR DEPENDENTS igible individual has one or more dependents, the basic com- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00062 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

63 G:\COMP\PHSA\PHSA-MERGED.XML 63 Sec. 265 PUBLIC HEALTH SERVICE ACT pensation for loss of employment income as described in para- 1 percent. graph (1) shall be augmented at the rate of 8 ⁄ 3 .— ONSIDERATION OF OTHER PROGRAMS (3) C (A) I .—The Secretary may consider the pro- N GENERAL visions of sections 8114, 8115, and 8146a of title 5, United States Code, and any implementing regulations, in deter- mining the amount of payment under subsection (a) and the circumstances under which such payments are reason- able and necessary. INORS .—With respect to an eligible individual (B) M who is a minor, the Secretary may consider the provisions of section 8113 of title 5, United States Code, and any im- plementing regulations, in determining the amount of pay- ment under subsection (a) and the circumstances under which such payments are reasonable and necessary. - .—For pur- (4) T EMPLOYMENT INCOME REATMENT OF SELF poses of this section, the term ‘‘employment income’’ includes income from self-employment. (c) L IMITATIONS .— .— ENEFITS SECONDARY TO OTHER COVERAGE (1) B (A) I N GENERAL .—Any compensation under subsection (a) shall be secondary to the obligation of the United States or any third party (including any State or local gov- ernmental entity, private insurance carrier, or employer), under any other law or contractual agreement, to pay com- pensation for loss of employment income or to provide dis- ability or retirement benefits. (B) R .—Compensation ELATION TO OTHER OBLIGATIONS under subsection (a) shall not be made to an eligible indi- vidual to the extent that the total of amounts paid to the individual under such subsection and under the other obli- gations referred to in subparagraph (A) is an amount that exceeds the rate specified in subsection (b)(1). If under any such other obligation a lump-sum payment is made, such payment shall, for purposes of this paragraph, be deemed to be received over multiple years rather than received in a single year. The Secretary may, in the discretion of the Secretary, determine how to apportion such payment over multiple years. O BENEFITS IN CASE OF DEATH .—No payment shall be (2) N made under subsection (a) in compensation for loss of employ- ment income subsequent to the receipt, by the survivor or sur- vivors of an eligible individual, of benefits under section 266 for death. (3) L IMIT ON TOTAL BENEFITS .— (A) I N GENERAL .—Except as provided in subparagraph (B)— (i) total compensation paid to an individual under subsection (a) shall not exceed $50,000 for any year; and (ii) the lifetime total of such compensation for the individual may not exceed an amount equal to the amount authorized to be paid under section 266. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00063 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

64 G:\COMP\PHSA\PHSA-MERGED.XML 64 Sec. 266 PUBLIC HEALTH SERVICE ACT .—The limita- (B) P ERMANENT AND TOTAL DISABILITY tion under subparagraph (A)(ii) does not apply in the case of an eligible individual who is determined to have a cov- ered injury or injuries meeting the definition of disability in section 216(i) of the Social Security Act (42 U.S.C. 416(i)). (4) W .— AITING PERIOD (A) I .—Except as provided in subparagraph N GENERAL (B), an eligible individual shall not be provided compensa- tion under this section for the first 5 work days of loss of employment income. (B) E XCEPTION .—Subparagraph (A) does not apply if the period of loss of employment income of an eligible indi- vidual is 10 or more work days. (5) T ERMINATION OF BENEFITS .—No payment shall be made under subsection (a) in compensation for loss of employment income once the eligible individual involves reaches the age of 65. ENEFIT IN DDITION TO M EDICAL B ENEFITS .—A benefit A (d) B under subsection (a) shall be in addition to any amounts received by an eligible individual under section 264. SEC. 266. ø 239e ¿ PAYMENT FOR DEATH. EATH B ENEFIT .— (a) D N GENERAL .—The Secretary shall pay, in the case of an (1) I eligible individual whose death is determined to have resulted from a covered injury or injuries, a death benefit in the amount determined under paragraph (2) to the survivor or sur- vivors in the same manner as death benefits are paid pursuant to the Public Safety Officers’ Benefits Program under subpart 1 of part L of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.) with respect to an eligible deceased (except that in the case of an eligible indi- vidual who is a minor with no living parent, the legal guardian shall be considered the survivor in the place of the parent). ENEFIT AMOUNT .— (2) B (A) I N GENERAL .—The amount of the death benefit under paragraph (1) in a fiscal year shall equal the amount of the comparable benefit calculated under the Public Safety Officers’ Benefits Program under subpart 1 of part L of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.) in such fiscal year, without regard to any reduction attributable to a lim- itation on appropriations, but subject to subparagraph (B). (B) R EDUCTION FOR PAYMENTS FOR LOST EMPLOYMENT INCOME .—The amount of the benefit as determined under subparagraph (A) shall be reduced by the total amount of any benefits paid under section 265 with respect to lost employment income. (3) L .— IMITATIONS N GENERAL .—No benefit is payable under para- (A) I graph (1) with respect to the death of an eligible individual if— March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00064 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

65 G:\COMP\PHSA\PHSA-MERGED.XML 65 Sec. 266 PUBLIC HEALTH SERVICE ACT (i) a disability benefit is paid with respect to such individual under the Public Safety Officers’ Benefits Program under subpart 1 of part L of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.); or (ii) a death benefit is paid or payable with respect to such individual under the Public Safety Officers’ Benefits Program under subpart 1 of part L of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.). (B) E XCEPTION IN THE CASE OF A LIMITATION ON AP - PROPRIATIONS FOR DISABILITY BENEFITS UNDER PSOB .—In the event that disability benefits available to an eligible individual under the Public Safety Officers’ Benefits Pro- gram under subpart 1 of part L of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.) are reduced because of a limitation on appro- priations, and such reduction would affect the amount that would be payable under subparagraph (A) without regard to this subparagraph, benefits shall be available under paragraph (1) to the extent necessary to ensure that the survivor or survivors of such individual receives a total amount equal to the amount described in paragraph (2). (b) E ASE OF D EPENDENTS .— LECTION IN C .—In the case of an eligible individual N GENERAL (1) I whose death is determined to have resulted from a covered in- jury or injuries, if the individual had one or more dependents under the age of 18, the legal guardian of the dependents may, in lieu of the death benefit under subsection (a), elect to re- ceive on behalf of the aggregate of such dependents payments in accordance with this subsection. An election under the pre- ceding sentence is effective in lieu of a request under sub- section (a) by an individual who is not the legal guardian of such dependents. MOUNT OF PAYMENTS .—Payments under paragraph (1) (2) A with respect to an eligible individual described in such para- graph shall be made as if such individual were an eligible indi- vidual to whom compensation would be paid under subsection (a) of section 265, with the rate augmented in accordance with subsection (b)(2) of such section and with such individual con- sidered to be an eligible individual described in subsection (c)(3)(B) of such section. (3) L IMITATIONS .— GE OF DEPENDENTS .—No payments may be made (A) A under paragraph (1) once the youngest of the dependents involved reaches the age of 18. ENEFITS SECONDARY TO OTHER COVERAGE .— (B) B (i) I N GENERAL .—Any payment under paragraph (1) shall be secondary to the obligation of the United States or any third party (including any State or local governmental entity, private insurance carrier, or em- ployer), under any other law or contractual agreement, to pay compensation for loss of employment income or to provide disability benefits, retirement benefits, life March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00065 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

66 G:\COMP\PHSA\PHSA-MERGED.XML 66 Sec. 267 PUBLIC HEALTH SERVICE ACT insurance benefits on behalf of dependents under the age of 18, or death benefits. (ii) R ELATION TO OTHER OBLIGATIONS .—Payments under paragraph (1) shall not be made to with respect to an eligible individual to the extent that the total of amounts paid with respect to the individual under such paragraph and under the other obligations re- ferred to in clause (i) is an amount that exceeds the rate of payment that applies under paragraph (2). If under any such other obligation a lump-sum payment is made, such payment shall, for purposes of this sub- paragraph, be deemed to be received over multiple years rather than received in a single year. The Sec- retary may, in the discretion of the Secretary, deter- mine how to apportion such payment over multiple years. A DDITION TO M EDICAL B ENEFITS .—A benefit ENEFIT IN (c) B under subsection (a) or (b) shall be in addition to any amounts re- ceived by an eligible individual under section 264. 239f ADMINISTRATION. SEC. 267. ¿ ø A GREEMENT W ITH O THER A (a) A DMINISTRATION BY GENCY OR GENCIES .—The Secretary may administer any or all of the provi- A sions of this part through Memorandum of Agreement with the head of any appropriate Federal agency. (b) R EGULATIONS .—The head of the agency administering this part or provisions thereof (including any agency head admin- istering such Act or provisions through a Memorandum of Agree- ment under subsection (a)) may promulgate such implementing regulations as may be found necessary and appropriate. Initial im- plementing regulations may be interim final regulations. ¿ AUTHORIZATION OF APPROPRIATIONS. ø SEC. 268. 239g For the purpose of carrying out this part, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2003 through 2007, to remain available until expended, including administrative costs and costs of provision and payment of benefits. The Secretary’s payment of any benefit under section 264, 265, or 266 shall be subject to the availability of appropria- tions under this section. 239h SEC. 269. RELATIONSHIP TO OTHER LAWS. ø ¿ Except as explicitly provided herein, nothing in this part shall be construed to override or limit any rights an individual may have to seek compensation, benefits, or redress under any other provi- sion of Federal or State law. PART D—UNITED STATES PUBLIC HEALTH SCIENCES TRACK ø 239l ¿ ESTABLISHMENT. SEC. 271. .— NITED TATES P UBLIC H EALTH S ERVICES T RACK S (a) U N GENERAL .—There is hereby authorized to be estab- (1) I lished a United States Public Health Sciences Track (referred to in this part as the ‘‘Track’’), at sites to be selected by the March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00066 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

67 G:\COMP\PHSA\PHSA-MERGED.XML 67 Sec. 272 PUBLIC HEALTH SERVICE ACT Secretary, with authority to grant appropriate advanced de- grees in a manner that uniquely emphasizes team-based serv- ice, public health, epidemiology, and emergency preparedness and response. It shall be so organized as to graduate not less than— (A) 150 medical students annually, 10 of whom shall be awarded studentships to the Uniformed Services Uni- versity of Health Sciences; (B) 100 dental students annually; (C) 250 nursing students annually; (D) 100 public health students annually; (E) 100 behavioral and mental health professional stu- dents annually; (F) 100 physician assistant or nurse practitioner stu- dents annually; and (G) 50 pharmacy students annually. (2) L OCATIONS .—The Track shall be located at existing and accredited, affiliated health professions education training pro- grams at academic health centers located in regions of the United States determined appropriate by the Surgeon General, in consultation with the National Health Care Workforce Com- mission established in section 5101 of the Patient Protection and Affordable Care Act. G .—Except as provided in subsection UMBER OF RADUATES (b) N (a), the number of persons to be graduated from the Track shall be prescribed by the Secretary. In so prescribing the number of per- sons to be graduated from the Track, the Secretary shall institute actions necessary to ensure the maximum number of first-year en- rollments in the Track consistent with the academic capacity of the affiliated sites and the needs of the United States for medical, den- tal, and nursing personnel. EVELOPMENT .—The development of the Track may be by (c) D such phases as the Secretary may prescribe subject to the require- ments of subsection (a). (d) I NTEGRATED P LAN .—The Surgeon General L ONGITUDINAL shall develop an integrated longitudinal plan for health professions continuing education throughout the continuum of health-related education, training, and practice. Training under such plan shall emphasize patient-centered, interdisciplinary, and care coordina- tion skills. Experience with deployment of emergency response teams shall be included during the clinical experiences. D ACULTY .—The Surgeon General shall de- EVELOPMENT (e) F velop faculty development programs and curricula in decentralized venues of health care, to balance urban, tertiary, and inpatient venues. ø 239l–1 ¿ ADMINISTRATION. SEC. 272. N ENERAL .—The business of the Track shall be conducted G (a) I by the Surgeon General with funds appropriated for and provided by the Department of Health and Human Services. The National Health Care Workforce Commission shall assist the Surgeon Gen- eral in an advisory capacity. (b) F .— ACULTY March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00067 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

68 G:\COMP\PHSA\PHSA-MERGED.XML 68 Sec. 272 PUBLIC HEALTH SERVICE ACT .—The Surgeon General, after considering (1) I N GENERAL the recommendations of the National Health Care Workforce Commission, shall obtain the services of such professors, in- structors, and administrative and other employees as may be necessary to operate the Track, but utilize when possible, ex- isting affiliated health professions training institutions. Mem- bers of the faculty and staff shall be employed under salary schedules and granted retirement and other related benefits prescribed by the Secretary so as to place the employees of the Track faculty on a comparable basis with the employees of fully accredited schools of the health professions within the United States. .—The Surgeon General may confer academic ti- ITLES (2) T tles, as appropriate, upon the members of the faculty. (3) N ONAPPLICATION OF PROVISIONS .—The limitations in section 5373 of title 5, United States Code, shall not apply to the authority of the Surgeon General under paragraph (1) to prescribe salary schedules and other related benefits. (c) A .—The Surgeon General may negotiate agree- GREEMENTS ments with agencies of the Federal Government to utilize on a re- imbursable basis appropriate existing Federal medical resources lo- cated in the United States (or locations selected in accordance with section 271(a)(2)). Under such agreements the facilities concerned will retain their identities and basic missions. The Surgeon Gen- eral may negotiate affiliation agreements with accredited univer- sities and health professions training institutions in the United States. Such agreements may include provisions for payments for educational services provided students participating in Department of Health and Human Services educational programs. (d) P .—The Surgeon General may establish the fol- ROGRAMS lowing educational programs for Track students: (1) Postdoctoral, postgraduate, and technological programs. (2) A cooperative program for medical, dental, physician assistant, pharmacy, behavioral and mental health, public health, and nursing students. (3) Other programs that the Surgeon General determines necessary in order to operate the Track in a cost-effective man- ner. M EDICAL ONTINUING DUCATION .—The Surgeon General E (e) C shall establish programs in continuing medical education for mem- bers of the health professions to the end that high standards of health care may be maintained within the United States. (f) A S URGEON G ENERAL .— UTHORITY OF THE N GENERAL .—The Surgeon General is authorized— (1) I (A) to enter into contracts with, accept grants from, and make grants to any nonprofit entity for the purpose of carrying out cooperative enterprises in medical, dental, physician assistant, pharmacy, behavioral and mental health, public health, and nursing research, consultation, and education; (B) to enter into contracts with entities under which the Surgeon General may furnish the services of such pro- fessional, technical, or clerical personnel as may be nec- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00068 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

69 G:\COMP\PHSA\PHSA-MERGED.XML 69 Sec. 273 PUBLIC HEALTH SERVICE ACT essary to fulfill cooperative enterprises undertaken by the Track; (C) to accept, hold, administer, invest, and spend any gift, devise, or bequest of personal property made to the Track, including any gift, devise, or bequest for the sup- port of an academic chair, teaching, research, or dem- onstration project; (D) to enter into agreements with entities that may be utilized by the Track for the purpose of enhancing the ac- tivities of the Track in education, research, and techno- logical applications of knowledge; and (E) to accept the voluntary services of guest scholars and other persons. .—The Surgeon General may not enter into IMITATION (2) L any contract with an entity if the contract would obligate the Track to make outlays in advance of the enactment of budget authority for such outlays. .—Scientists or other medical, dental, or CIENTISTS (3) S nursing personnel utilized by the Track under an agreement described in paragraph (1) may be appointed to any position within the Track and may be permitted to perform such duties within the Track as the Surgeon General may approve. .—A person who provides vol- OLUNTEER SERVICES (4) V untary services under the authority of subparagraph (E) of paragraph (1) shall be considered to be an employee of the Fed- eral Government for the purposes of chapter 81 of title 5, relat- ing to compensation for work-related injuries, and to be an em- ployee of the Federal Government for the purposes of chapter 171 of title 28, relating to tort claims. Such a person who is not otherwise employed by the Federal Government shall not be considered to be a Federal employee for any other purpose by reason of the provision of such services. ø 239l–2 ¿ STUDENTS; SELECTION; OBLIGATION. SEC. 273. TUDENT (a) S .— S ELECTION .—Medical, dental, physician assistant, N GENERAL (1) I pharmacy, behavioral and mental health, public health, and nursing students at the Track shall be selected under proce- dures prescribed by the Surgeon General. In so prescribing, the Surgeon General shall consider the recommendations of the National Health Care Workforce Commission. RIORITY .—In developing admissions procedures under (2) P paragraph (1), the Surgeon General shall ensure that such pro- cedures give priority to applicant medical, dental, physician as- sistant, pharmacy, behavioral and mental health, public health, and nursing students from rural communities and underrepresented minorities. ONTRACT AND S ERVICE O BLIGATION .— (b) C ONTRACT .—Upon being admitted to the Track, a med- (1) C ical, dental, physician assistant, pharmacy, behavioral and mental health, public health, or nursing student shall enter into a written contract with the Surgeon General that shall contain— (A) an agreement under which— March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00069 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

70 G:\COMP\PHSA\PHSA-MERGED.XML 70 Sec. 273 PUBLIC HEALTH SERVICE ACT (i) subject to subparagraph (B), the Surgeon Gen- eral agrees to provide the student with tuition (or tui- tion remission) and a student stipend (described in paragraph (2)) in each school year for a period of years (not to exceed 4 school years) determined by the stu- dent, during which period the student is enrolled in the Track at an affiliated or other participating health professions institution pursuant to an agreement be- tween the Track and such institution; and (ii) subject to subparagraph (B), the student agrees— (I) to accept the provision of such tuition and student stipend to the student; (II) to maintain enrollment at the Track until the student completes the course of study in- volved; (III) while enrolled in such course of study, to maintain an acceptable level of academic standing (as determined by the Surgeon General); (IV) if pursuing a degree from a school of medicine or osteopathic medicine, dental, public health, or nursing school or a physician assistant, pharmacy, or behavioral and mental health pro- fessional program, to complete a residency or in- ternship in a specialty that the Surgeon General determines is appropriate; and (V) to serve for a period of time (referred to in this part as the ‘‘period of obligated service’’) with- in the Commissioned Corps of the Public Health Service equal to 2 years for each school year dur- ing which such individual was enrolled at the Col- lege, reduced as provided for in paragraph (3); (B) a provision that any financial obligation of the United States arising out of a contract entered into under this part and any obligation of the student which is condi- tioned thereon, is contingent upon funds being appro- priated to carry out this part; (C) a statement of the damages to which the United States is entitled for the student’s breach of the contract; and (D) such other statements of the rights and liabilities of the Secretary and of the individual, not inconsistent with the provisions of this part. UITION AND STUDENT STIPEND .— (2) T UITION REMISSION RATES .—The Surgeon General, (A) T based on the recommendations of the National Health Care Workforce Commission, shall establish Federal tui- tion remission rates to be used by the Track to provide re- imbursement to affiliated and other participating health professions institutions for the cost of educational services provided by such institutions to Track students. The agree- ment entered into by such participating institutions under paragraph (1)(A)(i) shall contain an agreement to accept as March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00070 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

71 G:\COMP\PHSA\PHSA-MERGED.XML 71 Sec. 273 PUBLIC HEALTH SERVICE ACT payment in full the established remission rate under this subparagraph. TIPEND (B) S .—The Surgeon General, based on the rec- ommendations of the National Health Care Workforce Commission, shall establish and update Federal stipend rates for payment to students under this part. (3) R .— EDUCTIONS IN THE PERIOD OF OBLIGATED SERVICE The period of obligated service under paragraph (1)(A)(ii)(V) shall be reduced— (A) in the case of a student who elects to participate in a high-needs speciality residency (as determined by the National Health Care Workforce Commission), by 3 months for each year of such participation (not to exceed a total of 12 months); and (B) in the case of a student who, upon completion of their residency, elects to practice in a Federal medical fa- cility (as defined in section 781(e)) that is located in a health professional shortage area (as defined in section 332), by 3 months for year of full-time practice in such a facility (not to exceed a total of 12 months). (c) S EARS OF S ERVICE .—During the third and fourth ECOND 2 Y years in which a medical, dental, physician assistant, pharmacy, behavioral and mental health, public health, or nursing student is enrolled in the Track, training should be designed to prioritize clin- ical rotations in Federal medical facilities in health professional shortage areas, and emphasize a balance of hospital and commu- nity-based experiences, and training within interdisciplinary teams. , P HYSICIAN A ENTIST , P HARMACIST , B EHAVIORAL SSISTANT (d) D M ENTAL H EALTH P ROFESSIONAL , P UBLIC H EALTH P ROFES - AND , SIONAL URSE T RAINING .—The Surgeon General shall estab- AND N lish provisions applicable with respect to dental, physician assist- ant, pharmacy, behavioral and mental health, public health, and nursing students that are comparable to those for medical students under this section, including service obligations, tuition support, and stipend support. The Surgeon General shall give priority to health professions training institutions that train medical, dental, physician assistant, pharmacy, behavioral and mental health, pub- lic health, and nursing students for some significant period of time together, but at a minimum have a discrete and shared core cur- riculum. T EDERAL D ISASTER (e) E EAMS .—The Surgeon General, in LITE F consultation with the Secretary, the Director of the Centers for Dis- ease Control and Prevention, and other appropriate military and Federal government agencies, shall develop criteria for the appoint- ment of highly qualified Track faculty, medical, dental, physician assistant, pharmacy, behavioral and mental health, public health, and nursing students, and graduates to elite Federal disaster pre- paredness teams to train and to respond to public health emer- gencies, natural disasters, bioterrorism events, and other emer- gencies. TUDENT D ROPPED F ROM T RACK IN A FFILIATE S CHOOL .—A (f) S medical, dental, physician assistant, pharmacy, behavioral and mental health, public health, or nursing student who, under regu- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00071 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

72 G:\COMP\PHSA\PHSA-MERGED.XML 72 Sec. 274 PUBLIC HEALTH SERVICE ACT lations prescribed by the Surgeon General, is dropped from the Track in an affiliated school for deficiency in conduct or studies, or for other reasons, shall be liable to the United States for all tuition and stipend support provided to the student. ¿ FUNDING. SEC. 274. 239l–3 ø Beginning with fiscal year 2010, the Secretary shall transfer from the Public Health and Social Services Emergency Fund such sums as may be necessary to carry out this part. TITLE III—GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE A—R ESEARCH AND I ART NVESTIGATION P IN GENERAL . 301. ¿ 241 EC (a) The Secretary shall conduct in the Service, ø S and encourage, cooperate with, and render assistance to other ap- propriate public authorities, scientific institutions, and scientists in the conduct of, and promote the coordination of, research, inves- tigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments of man, including water pu- rification, sewage treatment, and pollution of lakes and streams. In carrying out the foregoing the Secretary is authorized to— (1) collect and make available through publications and other appropriate means, information as to, and the practical application of, such research and other activities; (2) make available research facilities of the Service to ap- propriate public authorities, and to health officials and sci- entists engaged in special study; (3) make grants-in-aid to universities, hospitals, labora- tories, and other public or private institutions, and to individ- uals for such research projects as are recommended by the ad- visory council to the entity of the Department supporting such projects and make, upon recommendation of the advisory coun- cil to the appropriate entity of the Department, grants-in-aid to public or nonprofit universities, hospitals, laboratories, and other institutions for the general support of their research; (4) secure from time to time and for such periods as he deems advisable, the assistance and advice of experts, scholars, and consultants from the United States or abroad; (5) for purposes of study, admit and treat at institutions, hospitals, and stations of the Service, persons not otherwise el- igible for such treatment; (6) make available, to health officials, scientists, and ap- propriate public and other nonprofit institutions and organiza- tions, technical advice and assistance on the application of sta- tistical methods to experiments, studies, and surveys in health and medical fields; (7) enter into contracts, including contracts for research in accordance with and subject to the provisions of law applicable to contracts entered into by the military departments under title 10, United States Code, sections 2353 and 2354, except March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00072 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

73 G:\COMP\PHSA\PHSA-MERGED.XML 73 Sec. 301 PUBLIC HEALTH SERVICE ACT that determination, approval, and certification required there- by shall be by the Secretary of Health, Education, and Welfare; and (8) adopt, upon recommendations of the advisory councils to the appropriate entities of the Department or, with respect to mental health, the National Advisory Mental Health Coun- cil, such additional means as the Secretary considers necessary or appropriate to carry out the purposes of this section. (b)(1) The Secretary shall conduct and may support through grants and contracts studies and testing of substances for carcino- genicity, teratogenicity, mutagenicity, and other harmful biological effects. In carrying out this paragraph, the Secretary shall consult with entities of the Federal Government, outside of the Department of Health, Education, and Welfare, engaged in comparable activi- ties. The Secretary, upon request of such an entity and under ap- propriate arrangements for the payment of expenses, may conduct for such entity studies and testing of substances for carcinogenicity, teratogenicity, mutagenicity, and other harmful biological effects. (2)(A) The Secretary shall establish a comprehensive program of research into the biological effects of low-level ionizing radiation under which program the Secretary shall conduct such research and may support such research by others through grants and con- tracts. (B) The Secretary shall conduct a comprehensive review of Federal programs of research on the biological effects of ionizing radiation. (3) The Secretary shall conduct and may support through grants and contracts research and studies on human nutrition, with particular emphasis on the role of nutrition in the prevention and treatment of disease and on the maintenance and promotion of health, and programs for the dissemination of information re- specting human nutrition to health professionals and the public. In carrying out activities under this paragraph, the Secretary shall provide for the coordination of such of these activities as are per- formed by the different divisions within the Department of Health, Education, and Welfare and shall consult with entities of the Fed- eral Government, outside of the Department of Health, Education, and Welfare, engaged in comparable activities. The Secretary, upon request of such an entity and under appropriate arrangements for the payment of expenses, may conduct and support such activities for such entity. (4) The Secretary shall publish a biennial report which con- tains— (A) a list of all substances (i) which either are known to be carcinogens or may reasonably be anticipated to be carcino- gens and (ii) to which a significant number of persons residing in the United States are exposed; (B) information concerning the nature of such exposure and the estimated number of persons exposed to such sub- stances; (C) a statement identifying (i) each substance contained in the list under subparagraph (A) for which no effluent, ambient, or exposure standard has been established by a Federal agen- cy, and (ii) for each effluent, ambient, or exposure standard es- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00073 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

74 G:\COMP\PHSA\PHSA-MERGED.XML 74 Sec. 301 PUBLIC HEALTH SERVICE ACT tablished by a Federal agency with respect to a substance con- tained in the list under subparagraph (A), the extent to which, on the basis of available medical, scientific, or other data, such standard, and the implementation of such standard by the agency, decreases the risk to public health from exposure to the substance; and (D) a description of (i) each request received during the year involved— (I) from a Federal agency outside the Department of Health, Education, and Welfare for the Secretary, or (II) from an entity within the Department of Health, Education, and Welfare to any other entity within the De- partment, to conduct research into, or testing for, the carcinogenicity of substances or to provide information described in clause (ii) of subparagraph (C), and (ii) how the Secretary and each such other entity, respectively, have responded to each such request. (5) The authority of the Secretary to enter into any contract for the conduct of any study, testing, program, research, or review, or assessment under this subsection shall be effective for any fiscal year only to such extent or in such amounts as are provided in ad- vance in Appropriation Acts. (c) The Secretary may conduct biomedical research, directly or through grants or contracts, for the identification, control, treat- ment, and prevention of diseases (including tropical diseases) which do not occur to a significant extent in the United States. (d)(1)(A) If a person is engaged in biomedical, behavioral, clin- ical, or other research, in which identifiable, sensitive information is collected (including research on mental health and research on the use and effect of alcohol and other psychoactive drugs), the Sec- retary, in coordination with other agencies, as applicable— (i) shall issue to such person a certificate of confidentiality to protect the privacy of individuals who are the subjects of such research if the research is funded wholly or in part by the Federal Government; and (ii) may, upon application by a person engaged in research, issue to such person a certificate of confidentiality to protect the privacy of such individuals if the research is not so funded. (B) Except as provided in subparagraph (C), any person to whom a certificate is issued under subparagraph (A) to protect the privacy of individuals described in such subparagraph shall not dis- close or provide to any other person not connected with the re- search the name of such an individual or any information, docu- ment, or biospecimen that contains identifiable, sensitive informa- tion about such an individual and that was created or compiled for purposes of the research. (C) The disclosure prohibition in subparagraph (B) shall not apply to disclosure or use that is— (i) required by Federal, State, or local laws, excluding in- stances described in subparagraph (D); (ii) necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual; March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00074 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

75 G:\COMP\PHSA\PHSA-MERGED.XML 75 Sec. 301 PUBLIC HEALTH SERVICE ACT (iii) made with the consent of the individual to whom the information, document, or biospecimen pertains; or (iv) made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research. (D) Any person to whom a certificate is issued under subpara- graph (A) to protect the privacy of an individual described in such subparagraph shall not, in any Federal, State, or local civil, crimi- nal, administrative, legislative, or other proceeding, disclose or pro- vide the name of such individual or any such information, docu- ment, or biospecimen that contains identifiable, sensitive informa- tion about the individual and that was created or compiled for pur- poses of the research, except in the circumstance described in sub- paragraph (C)(iii). (E) Identifiable, sensitive information protected under subpara- graph (A), and all copies thereof, shall be immune from the legal process, and shall not, without the consent of the individual to whom the information pertains, be admissible as evidence or used for any purpose in any action, suit, or other judicial, legislative, or administrative proceeding. (F) Identifiable, sensitive information collected by a person to whom a certificate has been issued under subparagraph (A), and all copies thereof, shall be subject to the protections afforded by this section for perpetuity. (G) The Secretary shall take steps to minimize the burden to researchers, streamline the process, and reduce the time it takes to comply with the requirements of this subsection. (2) The Secretary shall coordinate with the heads of other ap- plicable Federal agencies to ensure that such departments have policies in place with respect to the issuance of a certificate of con- fidentiality pursuant to paragraph (1) and other requirements of this subsection. (3) Nothing in this subsection shall be construed to limit the access of an individual who is a subject of research to information about himself or herself collected during such individual’s partici- pation in the research. (4) For purposes of this subsection, the term ‘‘identifiable, sen- sitive information’’ means information that is about an individual and that is gathered or used during the course of research de- scribed in paragraph (1)(A) and— (A) through which an individual is identified; or (B) for which there is at least a very small risk, as deter- mined by current scientific practices or statistical methods, that some combination of the information, a request for the in- formation, and other available data sources could be used to deduce the identity of an individual. (e) The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall expand, intensify, and co- ordinate the activities of the Centers for Disease Control and Pre- vention with respect to preterm labor and delivery and infant mor- tality. (f)(1) The Secretary may exempt from disclosure under section 552(b)(3) of title 5, United States Code, biomedical information that March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00075 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

76 G:\COMP\PHSA\PHSA-MERGED.XML 76 Sec. 302 PUBLIC HEALTH SERVICE ACT is about an individual and that is gathered or used during the course of biomedical research if— (A) an individual is identified; or (B) there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, the request, and other avail- able data sources could be used to deduce the identity of an in- dividual. (2)(A) Each determination of the Secretary under paragraph (1) to exempt information from disclosure shall be made in writing and accompanied by a statement of the basis for the determination. (B) Each such determination and statement of basis shall be available to the public, upon request, through the Office of the Chief FOIA Officer of the Department of Health and Human Serv- ices. (3) Nothing in this subsection shall be construed to limit a re- search participant’s access to information about such participant collected during the participant’s participation in the research. (g) Subchapter I of chapter 35 of title 44, United States Code, shall not apply to the voluntary collection of information during the conduct of research by the National Institutes of Health. (h)(1) The Secretary may make available to individuals and en- tities, for biomedical and behavioral research, substances and liv- ing organisms. Such substances and organisms shall be made available under such terms and conditions (including payment for them) as the Secretary determines appropriate. (2) Where research substances and living organisms are made available under paragraph (1) through contractors, the Secretary may direct such contractors to collect payments on behalf of the Secretary for the costs incurred to make available such substances and organisms and to forward amounts so collected to the Sec- retary, in the time and manner specified by the Secretary. (3) Amounts collected under paragraph (2) shall be credited to the appropriations accounts that incurred the costs to make avail- able the research substances and living organisms involved, and shall remain available until expended for carrying out activities under such accounts. NARCOTICS . 302. S 242 ¿ (a) In carrying out the purposes of section 301 EC ø with respect to drugs the use or misuse of which might result in drug abuse or dependency, the studies and investigations author- ized therein shall include the use and misuse of narcotic drugs and other drugs. Such studies and investigations shall further include the quantities of crude opium, coca leaves, and their salts, deriva- tives, and preparations, and other drugs subject to control under the Controlled Substances Act and Controlled Substances Import and Export Act, together with reserves thereof, necessary to supply the normal and emergency medicinal and scientific requirements of the United States. The results of studies and investigations of the quantities of narcotic drugs or other drugs subject to control under such Acts, together with reserves of such drugs, that are necessary March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00076 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

77 G:\COMP\PHSA\PHSA-MERGED.XML 77 Sec. 304 PUBLIC HEALTH SERVICE ACT to supply the normal and emergency medicinal and scientific re- quirements of the United States, shall be reported not later than the first day of April of each year to the Attorney General, to be used at his discretion in determining manufacturing quotas or im- portation requirements under such Acts. (b) The Surgeon General shall cooperate with States for the purpose of aiding them to solve their narcotic drug problems and shall give authorized representatives of the States the benefit of his experience in the care, treatment, and rehabilitation of narcotic ad- dicts to the end that each State may be encouraged to provide ade- quate facilities and methods for the care and treatment of its nar- cotic addicts. GENERAL AUTHORITY RESPECTING RESEARCH , EVALUATIONS , AND DEMONSTRATIONS IN HEALTH STATISTICS , HEALTH SERVICES , AND HEALTH CARE TECHNOLOGY ASSESSMENT 1 ø (a) The Secretary may, through the Agency ¿ S EC . 304. 242b for Health Care Policy and Research or the National Center for Health Statistics or using National Research Service Awards or other appropriate authorities, undertake and support training pro- grams to provide for an expanded and continuing supply of individ- uals qualified to perform the research, evaluation, and demonstra- tion projects set forth in section 306 and in title IX. (b) To implement subsection (a) and section 306, the Secretary may, in addition to any other authority which under other provi- sions of this Act or any other law may be used by him to imple- ment such subsection, do the following: (1) Utilize personnel and equipment, facilities, and other physical resources of the Department of Health and Human Services, permit appropriate (as determined by the Secretary) entities and individuals to utilize the physical resources of such Department, provide technical assistance and advice, make grants to public and nonprofit private entities and indi- viduals, and, when appropriate, enter into contracts with pub- lic and private entities and individuals. (2) Admit and treat at hospitals and other facilities of the Service persons not otherwise eligible for admission and treat- ment at such facilities. (3) Secure, from time to time and for such periods as the Secretary deems advisable but in accordance with section 3109 of title 5, United States Code, the assistance and advice of con- sultants from the United States or abroad. The Secretary may for the purpose of carrying out the functions set forth in sec- 2 306, and 309, obtain (in accordance with section tions 305, 3109 of title 5 of the United States Code, but without regard to the limitation in such section on the number of days or the period of service) for each of the centers the services of not more than fifteen experts who have appropriate scientific or professional qualifications. 1 Former section 303 was repealed by section 3201(b)(1) of Public Law 106–310 (114 Stat. 1190). 2 See footnote for section 306. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00077 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

78 G:\COMP\PHSA\PHSA-MERGED.XML 78 Sec. 306 PUBLIC HEALTH SERVICE ACT (4) Acquire, construct, improve, repair, operate, and main- tain laboratory, research, and other necessary facilities and equipment, and such other real or personal property (including patents) as the Secretary deems necessary; and acquire, with- out regard to the Act of March 3, 1877 (40 U.S.C. 34), by lease or otherwise, through the Administrator of General Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to the District of Columbia. (c)(1) The Secretary shall coordinate all health services re- search, evaluations, and demonstrations, all health statistical and epidemiological activities, and all research, evaluations, and dem- onstrations respecting the assessment of health care technology un- dertaken and supported through units of the Department of Health and Human Services. To the maximum extent feasible such coordi- nation shall be carried out through the Agency for Health Care Pol- icy and Research and the National Center for Health Statistics. (2) The Secretary shall coordinate the health services research, evaluations, and demonstrations, the health statistical and (where appropriate) epidemiological activities, and the research, evalua- tions, and demonstrations respecting the assessment of health care technology authorized by this Act through the Agency for Health Care Policy and Research and the National Center for Health Sta- tistics. NATIONAL CENTER FOR HEALTH STATISTICS 3 . 306. EC ø 242k ¿ (a) There is established in the Department S of Health and Human Services the National Center for Health Sta- tistics (hereinafter in this section referred to as the ‘‘Center’’) which shall be under the direction of a Director who shall be appointed by the Secretary. The Secretary, acting through the Center, shall conduct and support statistical and epidemiological activities for the purpose of improving the effectiveness, efficiency, and quality of health services in the United States. (b) In carrying out subsection (a), the Secretary, acting through the Center— (1) shall collect statistics on— (A) the extent and nature of illness and disability of the population of the United States (or of any groupings of the people included in the population), including life ex- pectancy, the incidence of various acute and chronic ill- nesses, and infant and maternal morbidity and mortality, (B) the impact of illness and disability of the popu- lation on the economy of the United States and on other aspects of the well-being of its population (or of such groupings), (C) environmental, social, and other health hazards, (D) determinants of health, (E) health resources, including physicians, dentists, nurses, and other health professionals by specialty and type of practice and the supply of services by hospitals, ex- 3 Former section 305 was repealed by section 6103(d)(1)(A) of Public Law 101–239 (103 Stat. 2205). Title IX now applies to the matter with which former section 305 was concerned. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00078 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

79 G:\COMP\PHSA\PHSA-MERGED.XML 79 Sec. 306 PUBLIC HEALTH SERVICE ACT tended care facilities, home health agencies, and other health institutions, (F) utilization of health care, including utilization of (i) ambulatory health services by specialties and types of practice of the health professionals providing such serv- ices, and (ii) services of hospitals, extended care facilities, home health agencies, and other institutions, (G) health care costs and financing, including the trends in health care prices and cost, the sources of pay- ments for health care services, and Federal, State, and local governmental expenditures for health care services, and (H) family formation, growth, and dissolution; (2) shall undertake and support (by grant or contract) re- search, demonstrations, and evaluations respecting new or im- proved methods for obtaining current data on the matters re- ferred to in paragraph (1); (3) may undertake and support (by grant or contract) epi- demiological research, demonstrations, and evaluations on the matters referred to in paragraph (1); and (4) may collect, furnish, tabulate, and analyze statistics, and prepare studies, on matters referred to in paragraph (1) upon request of public and nonprofit private entities under ar- rangements under which the entities will pay the cost of the service provided. Amounts appropriated to the Secretary from payments made under arrangements made under paragraph (4) shall be available to the Secretary for obligation until expended. (c) The Center shall furnish such special statistical and epide- miological compilations and surveys as the Committee on Labor and Human Resources and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Com- mittee on Appropriations of the House of Representatives may re- quest. Such statistical and epidemiological compilations and sur- veys shall not be made subject to the payment of the actual or esti- mated cost of the preparation of such compilations and surveys. (d) To insure comparability and reliability of health statistics, the Secretary shall, through the Center, provide adequate technical assistance to assist State and local jurisdictions in the development of model laws dealing with issues of confidentiality and com- parability of data. (e) For the purpose of producing comparable and uniform health information and statistics, there is established the Coopera- tive Health Statistics System. The Secretary, acting through the Center, shall— (1) coordinate the activities of Federal agencies involved in the design and implementation of the System; (2) undertake and support (by grant or contract) research, development, demonstrations, and evaluations respecting the System; (3) make grants to and enter into contracts with State and local health agencies to assist them in meeting the costs of data collection and other activities carried out under the Sys- tem; and March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00079 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

80 G:\COMP\PHSA\PHSA-MERGED.XML 80 Sec. 306 PUBLIC HEALTH SERVICE ACT (4) review the statistical activities of the Department of Health and Human Services to assure that they are consistent with the System. States participating in the System shall designate a State agency to administer or be responsible for the administration of the statis- tical activities within the State under the System. The Secretary, acting through the Center, shall prescribe guidelines to assure that 4 statistical activities within States participating in the system produce uniform and timely data and assure appropriate access to such data. (f) To assist in carrying out this section, the Secretary, acting through the Center, shall cooperate and consult with the Depart- ments of Commerce and Labor and any other interested Federal departments or agencies and with State and local health depart- ments and agencies. For such purpose he shall utilize insofar as possible the services or facilities of any agency of the Federal Gov- ernment and, without regard to section 3709 of the Revised Stat- utes (41 U.S.C. 5), of any appropriate State or other public agency, and may, without regard to such section, utilize the services or fa- cilities of any private agency, organization, group, or individual, in accordance with written agreements between the head of such agency, organization, or group and the Secretary or between such individual and the Secretary. Payment, if any, for such services or facilities shall be made in such amounts as may be provided in such agreement. (g) To secure uniformity in the registration and collection of mortality, morbidity, and other health data, the Secretary shall prepare and distribute suitable and necessary forms for the collec- tion and compilation of such data. (h)(1) There shall be an annual collection of data from the records of births, deaths, marriages, and divorces in registration areas. The data shall be obtained only from and restricted to such records of the States and municipalities which the Secretary, in his discretion, determines possess records affording satisfactory data in necessary detail and form. The Secretary shall encourage States and registration areas to obtain detailed data on ethnic and racial populations, including subpopulations of Hispanics, Asian Ameri- cans, and Pacific Islanders with significant representation in the State or registration area. Each State or registration area shall be paid by the Secretary the Federal share of its reasonable costs (as determined by the Secretary) for collecting and transcribing (at the request of the Secretary and by whatever method authorized by him) its records for such data. (2) There shall be an annual collection of data from a statis- tically valid sample concerning the general health, illness, and dis- ability status of the civilian noninstitutionalized population. Spe- cific topics to be addressed under this paragraph, on an annual or periodic basis, shall include the incidence of illness and accidental injuries, prevalence of chronic diseases and impairments, disability, physician visits, hospitalizations, and the relationship between de- mographic and socioeconomic characteristics and health character- istics. 4 So in law. Probably should be capitalized. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00080 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

81 G:\COMP\PHSA\PHSA-MERGED.XML 81 Sec. 306 PUBLIC HEALTH SERVICE ACT (i) The Center may provide to public and nonprofit private en- tities technical assistance in the effective use in such activities of statistics collected or compiled by the Center. (j) In carrying out the requirements of section 304(c) and para- graph (1) of subsection (e) of this section, the Secretary shall co- ordinate health statistical and epidemiological activities of the De- partment of Health and Human Services by— (1) establishing standardized means for the collection of health information and statistics under laws administered by the Secretary; (2) developing, in consultation with the National Com- mittee on Vital and Health Statistics, and maintaining the minimum sets of data needed on a continuing basis to fulfill the collection requirements of subsection (b)(1); (3) after consultation with the National Committee on Vital and Health Statistics, establishing standards to assure the quality of health statistical and epidemiological data collec- tion, processing, and analysis; (4) in the case of proposed health data collections of the Department which are required to be reviewed by the Director of the Office of Management and Budget under section 3509 of title 44, United States Code, reviewing such proposed collec- tions to determine whether they conform with the minimum sets of data and the standards promulgated pursuant to para- graphs (2) and (3), and if any such proposed collection is found not to be in conformance, by taking such action as may be nec- essary to assure that it will conform to such sets of data and standards, and (5) periodically reviewing ongoing health data collections of the Department, subject to review under such section 3509, to determine if the collections are being conducted in accordance with the minimum sets of data and the standards promulgated pursuant to paragraphs (2) and (3) and, if any such collection is found not to be in conformance, by taking such action as may be necessary to assure that the collection will conform to such sets of data and standards not later than the nineteenth day after the date of the completion of the review of the collec- tion. (k)(1) There is established in the Office of the Secretary a com- mittee to be known as the National Committee on Vital and Health Statistics (hereinafter in this subsection, referred to as the ‘‘Com- mittee’’) which shall consist of 18 members. (2) The members of the Committee shall be appointed from among persons who have distinguished themselves in the fields of health statistics, electronic interchange of health care information, privacy and security of electronic information, population-based public health, purchasing or financing health care services, inte- grated computerized health information systems, health services research, consumer interests in health information, health data standards, epidemiology, and the provision of health services. Members of the Committee shall be appointed for terms of 4 years. (3) Of the members of the Committee— (A) 1 shall be appointed, not later than 60 days after the date of the enactment of the Health Insurance Portability and March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00081 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

82 G:\COMP\PHSA\PHSA-MERGED.XML 82 Sec. 306 PUBLIC HEALTH SERVICE ACT Accountability Act of 1996, by the Speaker of the House of Representatives after consultation with the Minority Leader of the House of Representatives; (B) 1 shall be appointed, not later than 60 days after the date of the enactment of the Health Insurance Portability and Accountability Act of 1996, by the President pro tempore of the Senate after consultation with the Minority Leader of the Sen- ate; and (C) 16 shall be appointed by the Secretary. (4) Members of the Committee shall be compensated in accord- ance with section 208(c). (5) The Committee— (A) shall assist and advise the Secretary— (i) to delineate statistical problems bearing on health and health services which are of national or international interest; (ii) to stimulate studies of such problems by other or- ganizations and agencies whenever possible or to make in- vestigations of such problems through subcommittees; (iii) to determine, approve, and revise the terms, defi- nitions, classifications, and guidelines for assessing health status and health services, their distribution and costs, for use (I) within the Department of Health and Human Serv- ices, (II) by all programs administered or funded by the Secretary, including the Federal-State-local cooperative health statistics system referred to in subsection (e), and (III) to the extent possible as determined by the head of the agency involved, by the Department of Veterans Af- fairs, the Department of Defense, and other Federal agen- cies concerned with health and health services; (iv) with respect to the design of and approval of health statistical and health information systems con- cerned with the collection, processing, and tabulation of health statistics within the Department of Health and Human Services, with respect to the Cooperative Health Statistics System established under subsection (e), and with respect to the standardized means for the collection of health information and statistics to be established by the Secretary under subsection (j)(1); (v) to review and comment on findings and proposals developed by other organizations and agencies and to make recommendations for their adoption or implementa- tion by local, State, national, or international agencies; (vi) to cooperate with national committees of other countries and with the World Health Organization and other national agencies in the studies of problems of mu- tual interest; (vii) to issue an annual report on the state of the Na- tion’s health, its health services, their costs and distribu- tions, and to make proposals for improvement of the Na- tion’s health statistics and health information systems; and March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00082 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

83 G:\COMP\PHSA\PHSA-MERGED.XML 83 Sec. 306 PUBLIC HEALTH SERVICE ACT (viii) in complying with the requirements imposed on the Secretary under part C of title XI of the Social Secu- rity Act; (B) shall study the issues related to the adoption of uni- form data standards for patient medical record information and the electronic exchange of such information; (C) shall report to the Secretary not later than 4 years after the date of the enactment of the Health Insurance Port- ability and Accountability Act of 1996 recommendations and legislative proposals for such standards and electronic ex- change; and (D) shall be responsible generally for advising the Sec- retary and the Congress on the status of the implementation of part C of title XI of the Social Security Act. (6) In carrying out health statistical activities under this part, the Secretary shall consult with, and seek the advice of, the Com- mittee and other appropriate professional advisory groups. (7) Not later than 1 year after the date of the enactment of the Health Insurance Portability and Accountability Act of 1996, and annually thereafter, the Committee shall submit to the Congress, and make public, a report regarding the implementation of part C of title XI of the Social Security Act. Such report shall address the following subjects, to the extent that the Committee determines ap- propriate: (A) The extent to which persons required to comply with part C of title XI of the Social Security Act are cooperating in implementing the standards adopted under such part. (B) The extent to which such entities are meeting the secu- rity standards adopted under such part and the types of pen- alties assessed for noncompliance with such standards. (C) Whether the Federal and State Governments are re- ceiving information of sufficient quality to meet their respon- sibilities under such part. (D) Any problems that exist with respect to implementa- tion of such part. (E) The extent to which timetables under such part are being met. (l) In carrying out this section, the Secretary, acting through the Center, shall collect and analyze adequate health data that is specific to particular ethnic and racial populations, including data collected under national health surveys. Activities carried out under this subsection shall be in addition to any activities carried out under subsection (m). (m)(1) The Secretary, acting through the Center, may make grants to public and nonprofit private entities for— (A) the conduct of special surveys or studies on the health of ethnic and racial populations or subpopulations; (B) analysis of data on ethnic and racial populations and subpopulations; and (C) research on improving methods for developing statis- tics on ethnic and racial populations and subpopulations. (2) The Secretary, acting through the Center, may provide technical assistance, standards, and methodologies to grantees sup- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00083 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

84 G:\COMP\PHSA\PHSA-MERGED.XML 84 Sec. 307 PUBLIC HEALTH SERVICE ACT ported by this subsection in order to maximize the data quality and comparability with other studies. (3) Provisions of section 308(d) do not apply to surveys or stud- ies conducted by grantees under this subsection unless the Sec- retary, in accordance with regulations the Secretary may issue, de- termines that such provisions are necessary for the conduct of the survey or study and receives adequate assurance that the grantee will enforce such provisions. (4)(A) Subject to subparagraph (B), the Secretary, acting through the Center, shall collect data on Hispanics and major His- panic subpopulation groups and American Indians, and for devel- oping special area population studies on major Asian American and Pacific Islander populations. (B) The provisions of subparagraph (A) shall be effective with respect to a fiscal year only to the extent that funds are appro- priated pursuant to paragraph (3) of subsection (n), and only if the amounts appropriated for such fiscal year pursuant to each of para- graphs (1) and (2) of subsection (n) equal or exceed the amounts so appropriated for fiscal year 1997. (n)(1) For health statistical and epidemiological activities un- dertaken or supported under subsections (a) through (l), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1991 through 2003. (2) For activities authorized in paragraphs (1) through (3) of subsection (m), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1999 through 2003. Of such amounts, the Secretary shall use not more than 10 percent for administration and for activities described in subsection (m)(2). (3) For activities authorized in subsection (m)(4), there are au- thorized to be appropriated $1,000,000 for fiscal year 1998, and such sums as may be necessary for each of the fiscal years 1999 through 2002. INTERNATIONAL COOPERATION . 307. 242 l ¿ (a) The Secretary may participate with other EC ø S countries in cooperative endeavors in— (1) biomedical research, health care technology, and the health services research and statistical analysis authorized under section 306 and title IX; and (2) biomedical research, health care services, health care research, or other related activities in furtherance of the activi- ties, objectives or goals authorized under the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/ AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008. (b) In connection with the cooperative endeavors authorized by subsection (a), the Secretary may— (1) make such use of resources offered by participating for- eign countries as he may find necessary and appropriate; (2) establish and maintain fellowships in the United States and in participating foreign countries; (3) make grants to public institutions or agencies and to nonprofit private institutions or agencies in the United States and in participating foreign countries for the purpose of estab- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00084 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

85 G:\COMP\PHSA\PHSA-MERGED.XML 85 Sec. 307 PUBLIC HEALTH SERVICE ACT lishing and maintaining the fellowships authorized by para- graph (2); (4) make grants or loans of equipment and materials, for use by public or nonprofit private institutions or agencies, or by individuals, in participating foreign countries; (5) participate and otherwise cooperate in any inter- national meetings, conferences, or other activities concerned with biomedical research, health services research, health sta- tistics, or health care technology; (6) facilitate the interchange between the United States and participating foreign countries, and among participating foreign countries, of research scientists and experts who are engaged in experiments or programs of biomedical research, health services research, health statistical activities, or health care technology activities, and in carrying out such purpose may pay per diem compensation, subsistence, and travel for such scientists and experts when away from their places of res- idence at rates not to exceed those provided in section 5703(b) of title 5, United States Code, for persons in the Government service employed intermittently; (7) procure, in accordance with section 3109 of title 5, United States Code, the temporary or intermittent services of experts or consultants; (8) enter into contracts with individuals for the provision of services (as defined in section 104 of part 37 of title 48, Code of Federal Regulations (48 CFR 37.104)) in participating for- eign countries, which individuals may not be deemed employ- ees of the United States for the purpose of any law adminis- tered by the Office of Personnel Management; (9) provide such funds by advance or reimbursement to the Secretary of State, as may be necessary, to pay the costs of ac- quisition, lease, construction, alteration, equipping, furnishing or management of facilities outside of the United States; and (10) in consultation with the Secretary of State, through grant or cooperative agreement, make funds available to public or nonprofit private institutions or agencies in foreign coun- tries in which the Secretary is participating in activities de- scribed under subsection (a) to acquire, lease, construct, alter, or renovate facilities in those countries. (c) The Secretary may provide to personnel appointed or as- signed by the Secretary to serve abroad, allowances and benefits similar to those provided under chapter 9 of title I of the Foreign Service Act of 1980 (22 U.S.C. 4081 et seq.). Leaves of absence for personnel under this subsection shall be on the same basis as that provided under subchapter I of chapter 63 of title 5, United States Code or section 903 of the Foreign Service Act of 1980 (22 U.S.C. 4083), to individuals serving in the Foreign Service. (d) In carrying out immunization programs and other programs in developing countries for the prevention, treatment, and control of infectious diseases, including HIV/AIDS, tuberculosis, and ma- laria, the Director of the Centers for Disease Control and Preven- tion, in coordination with the Coordinator of United States Govern- ment Activities to Combat HIV/AIDS Globally, the National Insti- tutes of Health, national and local government, and other organiza- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00085 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

86 G:\COMP\PHSA\PHSA-MERGED.XML 86 Sec. 308 PUBLIC HEALTH SERVICE ACT tions, such as the World Health Organization and the United Na- tions Children’s Fund, shall develop and implement effective strat- egies to improve injection safety, including eliminating unnecessary injections, promoting sterile injection practices and technologies, strengthening the procedures for proper needle and syringe dis- posal, and improving the education and information provided to the public and to health professionals. , AND GENERAL PROVISIONS RESPECTING EFFECTIVENESS , EFFICIENCY QUALITY OF HEALTH SERVICES . 308. S 242m ¿ (a)(1) Not later than March 15 of each year, EC ø the Secretary shall submit to the President and Congress the fol- lowing reports: (A) A report on health care costs and financing. Such re- port shall include a description and analysis of the statistics collected under section 306(b)(1)(G). (B) A report on health resources. Such report shall include a description and analysis, by geographical area, of the statis- tics collected under section 306(b)(1)(E). (C) A report on the utilization of health resources. Such re- port shall include a description and analysis, by age, sex, in- come, and geographic area, of the statistics collected under sec- tion 306(b)(1)(F). (D) A report on the health of the Nation’s people. Such re- port shall include a description and analysis, by age, sex, in- come, and geographic area, of the statistics collected under sec- tion 306(b)(1)(A). (2) The reports required in paragraph (1) shall be prepared through the National Center for Health Statistics. (3) The Office of Management and Budget may review any re- port required by paragraph (1) of this subsection before its submis- sion to Congress, but the Office may not revise any such report or delay its submission beyond the date prescribed for its submission, and may submit to Congress its comments respecting any such re- port. (b)(1) No grant or contract may be made under section 304, 306, or 307 unless an application therefor has been submitted to the Secretary in such form and manner, and containing such infor- mation, as the Secretary may by regulation prescribe and unless a peer review group referred to in paragraph (2) has recommended the application for approval. (2)(A) Each application submitted for a grant or contract under section 306 in an amount exceeding $50,000 of direct costs and for a health services research, evaluation, or demonstration project, or for a grant under section 306(m), shall be submitted to a peer re- view group for an evaluation of the technical and scientific merits of the proposals made in each such application. The Director of the National Center for Health Statistics shall establish such peer re- view groups as may be necessary to provide for such an evaluation of each such application. (B) A peer review group to which an application is submitted pursuant to subparagraph (A) shall report its finding and rec- ommendations respecting the application to the Secretary, acting March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00086 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

87 G:\COMP\PHSA\PHSA-MERGED.XML 87 Sec. 308 PUBLIC HEALTH SERVICE ACT through the Director of the National Center for Health Statistics, in such form and manner as the Secretary shall by regulation pre- scribe. The Secretary may not approve an application described in such subparagraph unless a peer review group has recommended the application for approval. (C) The Secretary, acting through the Director of the National Center for Health Statistics, shall make appointments to the peer review groups required in subparagraph (A) from among persons who are not officers or employees of the United States and who possess appropriate technical and scientific qualifications, except that peer review groups regarding grants under section 306(m) may include appropriately qualified such officers and employees. (c) The Secretary shall take such action as may be necessary to assure that statistics developed under sections 304 and 306 are of high quality, timely, comprehensive as well as specific, standard- ized, and adequately analyzed and indexed, and shall publish, make available, and disseminate such statistics on as wide a basis as is practicable. (d) No information, if an establishment or person supplying the information or described in it is identifiable, obtained in the course of activities undertaken or supported under section 304, 306, or 307 may be used for any purpose other than the purpose for which it was supplied unless such establishment or person has consented (as determined under regulations of the Secretary) to its use for such other purpose and in the case of information obtained in the course of health statistical or epidemiological activities under sec- tion 304 or 306, such information may not be published or released in other form if the particular establishment or person supplying the information or described in it is identifiable unless such estab- lishment or person has consented (as determined under regulations of the Secretary) to its publication or release in other form. (e)(1) Payments of any grant or under any contract under sec- tion 304, 306, or 307 may be made in advance or by way of reim- bursement, and in such installments and on such conditions, as the Secretary deems necessary to carry out the purposes of such sec- tion. (2) The amounts otherwise payable to any person under a grant or contract made under section 304, 306, or 307 shall be re- duced by— (A) amounts equal to the fair market value of any equip- ment or supplies furnished to such person by the Secretary for the purpose of carrying out the project with respect to which such grant or contract is made, and (B) amounts equal to the pay, allowances, traveling ex- penses, and related personnel expenses attributable to the per- formance of services by an officer or employee of the Govern- ment in connection with such project, if such officer or em- ployee was assigned or detailed by the Secretary to perform such services, but only if such person requested the Secretary to furnish such equipment or supplies, or such services, as the case may be. (f) Contracts may be entered into under section 304 or 306 without regard to section 3324 of title 31, United States Code, and section 3709 of the Revised Statutes (41 U.S.C. 5). March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00087 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

88 G:\COMP\PHSA\PHSA-MERGED.XML 88 Sec. 310 PUBLIC HEALTH SERVICE ACT HEALTH CONFERENCES AND HEALTH EDUCATION INFORMATION 5 . 310. EC ø S ¿ (a) A conference of the health authorities in 242o and among the several States shall be called annually by the Sec- retary. Whenever in his opinion the interests of the public health would be promoted by a conference, the Secretary may invite as many of such health authorities and officials of other State or local public or private agencies, institutions, or organizations to confer as he deems necessary or proper. Upon the application of health authorities of five or more States it shall be the duty of the Sec- retary to call a conference of all State health authorities joining in the request. Each State represented at any conference shall be en- titled to a single vote. Whenever at any such conference matters re- lating to mental health are to be discussed, the mental health au- thorities of the respective States shall be invited to attend. (b) From time to time the Secretary shall issue information re- lated to public health, in the form of publications or otherwise, for the use of the public, and shall publish weekly reports of health conditions in the United States and other countries and other perti- nent health information for the use of persons and institutions con- cerned with health services. CENTERS FOR DISEASE CONTROL AND PREVENTION ¿ SEC. 310A. ø 242s OFFICE OF WOMEN’S HEALTH. STABLISHMENT .—There is established within the Office of (a) E the Director of the Centers for Disease Control and Prevention, an office to be known as the Office of Women’s Health (referred to in this section as the ‘‘Office’’). The Office shall be headed by a direc- tor who shall be appointed by the Director of such Centers. (b) P URPOSE .—The Director of the Office shall— (1) report to the Director of the Centers for Disease Con- trol and Prevention on the current level of the Centers’ activity regarding women’s health conditions across, where appro- priate, age, biological, and sociocultural contexts, in all aspects of the Centers’ work, including prevention programs, public and professional education, services, and treatment; (2) establish short-range and long-range goals and objec- tives within the Centers for women’s health and, as relevant and appropriate, coordinate with other appropriate offices on activities within the Centers that relate to prevention, re- search, education and training, service delivery, and policy de- velopment, for issues of particular concern to women; (3) identify projects in women’s health that should be con- ducted or supported by the Centers; (4) consult with health professionals, nongovernmental or- ganizations, consumer organizations, women’s health profes- sionals, and other individuals and groups, as appropriate, on the policy of the Centers with regard to women; and (5) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s Health (established under section 229(b)(4)). 5 Former section 309 was repealed by section 6103(d)(1)(B) of Public Law 101–239 (103 Stat. 2205). March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00088 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

89 G:\COMP\PHSA\PHSA-MERGED.XML 89 Sec. 311 PUBLIC HEALTH SERVICE ACT .—As used in this section, the term ‘‘women’s EFINITION (c) D health conditions’’, with respect to women of all age, ethnic, and ra- cial groups, means diseases, disorders, and conditions— (1) unique to, significantly more serious for, or signifi- cantly more prevalent in women; and (2) for which the factors of medical risk or type of medical intervention are different for women, or for which there is rea- sonable evidence that indicates that such factors or types may be different for women. (d) A .—For the purpose of A UTHORIZATION OF PPROPRIATIONS carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014. P EDERAL B—F TATE C OOPERATION ART -S IN GENERAL S . 311. ø 243 ¿ (a) The Secretary is authorized to accept from EC State and local authorities any assistance in the enforcement of quarantine regulations made pursuant to this Act which such au- thorities may be able and willing to provide. The Secretary shall also assist States and their political subdivisions in the prevention and suppression of communicable diseases and with respect to other public health matters, shall cooperate with and aid State and local authorities in the enforcement of their quarantine and other health regulations, and shall advise the several States on matters relating to the preservation and improvement of the public health. (b) The Secretary shall encourage cooperative activities be- tween the States with respect to comprehensive and continuing planning as to their current and future health needs, the establish- ment and maintenance of adequate public health services, and oth- erwise carrying out the public health activities. The Secretary is also authorized to train personnel for State and local health work. The Secretary may charge only private entities reasonable fees for the training of their personnel under the preceding sentence. (c)(1) The Secretary is authorized to develop (and may take such action as may be necessary to implement) a plan under which personnel, equipment, medical supplies, and other resources of the Service and other agencies under the jurisdiction of the Secretary may be effectively used to control epidemics of any disease or con- dition and to meet other health emergencies or problems. The Sec- retary may enter into agreements providing for the cooperative planning between the Service and public and private community health programs and agencies to cope with health problems (includ- ing epidemics and health emergencies). (2) The Secretary may, at the request of the appropriate State or local authority, extend temporary (not in excess of six months) assistance to States or localities in meeting health emergencies of such a nature as to warrant Federal assistance. The Secretary may require such reimbursement of the United States for assistance provided under this paragraph as he may determine to be reason- able under the circumstances. Any reimbursement so paid shall be credited to the applicable appropriation for the Service for the year in which such reimbursement is received. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00089 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

90 G:\COMP\PHSA\PHSA-MERGED.XML 90 Sec. 312 PUBLIC HEALTH SERVICE ACT 244 ¿ SEC. 312. ø PUBLIC ACCESS DEFIBRILLATION PROGRAMS. ENERAL G (a) I N .—The Secretary shall award grants to States, political subdivisions of States, Indian tribes, and tribal organiza- tions to develop and implement public access defibrillation pro- grams— (1) by training and equipping local emergency medical services personnel, including firefighters, police officers, para- medics, emergency medical technicians, and other first re- sponders, to administer immediate care, including cardiopulmonary resuscitation and automated external defibrillation, to cardiac arrest victims; (2) by purchasing automated external defibrillators, plac- ing the defibrillators in public places where cardiac arrests are likely to occur, and training personnel in such places to admin- ister cardiopulmonary resuscitation and automated external defibrillation to cardiac arrest victims; (3) by setting procedures for proper maintenance and test- ing of such devices, according to the guidelines of the manufac- turers of the devices; (4) by providing training to members of the public in cardiopulmonary resuscitation and automated external defibrillation; (5) by integrating the emergency medical services system with the public access defibrillation programs so that emer- gency medical services personnel, including dispatchers, are in- formed about the location of automated external defibrillators in their community; and (6) by encouraging private companies, including small businesses, to purchase automated external defibrillators and provide training for their employees to administer cardiopulmonary resuscitation and external automated defibrillation to cardiac arrest victims in their community. REFERENCE .—In awarding grants under subsection (a), the (b) P Secretary shall give a preference to a State, political subdivision of a State, Indian tribe, or tribal organization that— (1) has a particularly low local survival rate for cardiac ar- rests, or a particularly low local response rate for cardiac ar- rest victims; or (2) demonstrates in its application the greatest commit- ment to establishing and maintaining a public access defibrillation program. (c) U F UNDS .—A State, political subdivision of a State, In- SE OF dian tribe, or tribal organization that receives a grant under sub- section (a) may use funds received through such grant to— (1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and Drug Administration; (2) provide automated external defibrillation and basic life support training in automated external defibrillator usage through nationally recognized courses; (3) provide information to community members about the public access defibrillation program to be funded with the grant; March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00090 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

91 G:\COMP\PHSA\PHSA-MERGED.XML 91 Sec. 312 PUBLIC HEALTH SERVICE ACT (4) provide information to the local emergency medical services system regarding the placement of automated external defibrillators in public places; (5) produce materials to encourage private companies, in- cluding small businesses, to purchase automated external defibrillators; (6) establish an information clearinghouse, that shall be administered by an organization that has substantial expertise in pediatric education, pediatric medicine, and electrophysiology and sudden death, that provides information to increase public access to defibrillation in schools; and (7) further develop strategies to improve access to auto- mated external defibrillators in public places. .— PPLICATION (d) A N GENERAL .—To be eligible to receive a grant under (1) I subsection (a), a State, political subdivision of a State, Indian tribe, or tribal organization shall prepare and submit an appli- cation to the Secretary at such time, in such manner, and con- taining such information as the Secretary may reasonably re- quire. ONTENTS .—An application submitted under paragraph (2) C (1) shall— (A) describe the comprehensive public access defibrillation program to be funded with the grant and demonstrate how such program would make automated ex- ternal defibrillation accessible and available to cardiac ar- rest victims in the community; (B) contain procedures for implementing appropriate nationally recognized training courses in performing cardiopulmonary resuscitation and the use of automated external defibrillators; (C) contain procedures for ensuring direct involvement of a licensed medical professional and coordination with the local emergency medical services system in the over- sight of training and notification of incidents of the use of the automated external defibrillators; (D) contain procedures for proper maintenance and testing of the automated external defibrillators, according to the labeling of the manufacturer; (E) contain procedures for ensuring notification of local emergency medical services system personnel, including dispatchers, of the location and type of devices used in the public access defibrillation program; and (F) provide for the collection of data regarding the ef- fectiveness of the public access defibrillation program to be funded with the grant in affecting the out-of-hospital car- diac arrest survival rate. .—For the purpose of UTHORIZATION OF A PPROPRIATIONS (e) A carrying out this section, there are authorized to be appropriated 6 each of fiscal years 2003 through 2014. Not $25,000,000 for for 6 The words ‘‘for for’’ so in law. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00091 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

92 G:\COMP\PHSA\PHSA-MERGED.XML 92 Sec. 313 PUBLIC HEALTH SERVICE ACT more than 10 percent of amounts received under a grant awarded under this section may be used for administrative expenses. SEC. 313. PUBLIC ACCESS DEFIBRILLATION DEMONSTRATION ø ¿ 245 PROJECTS. G N .—The Secretary shall award grants to political (a) I ENERAL subdivisions of States, Indian tribes, and tribal organizations to de- velop and implement innovative, comprehensive, community-based public access defibrillation demonstration projects that— (1) provide cardiopulmonary resuscitation and automated external defibrillation to cardiac arrest victims in unique set- tings; (2) provide training to community members in cardiopulmonary resuscitation and automated external defibrillation; and (3) maximize community access to automated external defibrillators. (b) U F UNDS .—A recipient of a grant under subsection (a) SE OF shall use the funds provided through the grant to— (1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and Drug Administration; (2) provide basic life training in automated external defibrillator usage through nationally recognized courses; (3) provide information to community members about the public access defibrillation demonstration project to be funded with the grant; (4) provide information to the local emergency medical services system regarding the placement of automated external defibrillators in the unique settings; and (5) further develop strategies to improve access to auto- mated external defibrillators in public places. (c) A PPLICATION .— (1) I N GENERAL .—To be eligible to receive a grant under subsection (a), a political subdivision of a State, Indian tribe, or tribal organization shall prepare and submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require. (2) C ONTENTS .—An application submitted under paragraph (1) may— (A) describe the innovative, comprehensive, commu- nity-based public access defibrillation demonstration project to be funded with the grant; (B) explain how such public access defibrillation dem- onstration project represents innovation in providing pub- lic access to automated external defibrillation; and (C) provide for the collection of data regarding the ef- fectiveness of the demonstration project to be funded with the grant in— (i) providing emergency cardiopulmonary resus- citation and automated external defibrillation to car- diac arrest victims in the setting served by the dem- onstration project; and (ii) affecting the cardiac arrest survival rate in the setting served by the demonstration project. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00092 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

93 G:\COMP\PHSA\PHSA-MERGED.XML 93 Sec. 314 PUBLIC HEALTH SERVICE ACT A PPROPRIATIONS (d) A UTHORIZATION OF .—There is authorized to be appropriated to carry out this section $5,000,000 for each of fiscal years 2002 through 2006. Not more than 10 percent of amounts received under a grant awarded under this section may be used for administrative expenses. GRANTS FOR COMPREHENSIVE HEALTH PLANNING AND PUBLIC HEALTH SERVICES Grants to States for Comprehensive State Health Planning . 314. ø 246 ¿ EC UTHORIZATION .—In order to assist the (a)(1) A S States in comprehensive and continuing planning for their current and future health needs, the Secretary is authorized during the pe- riod beginning July 1, 1966, and ending June 30, 1973, to make grants to States which have submitted, and had approved by the Secretary, State plans for comprehensive State health planning. For the purposes of carrying out this subsection, there are hereby authorized to be appropriated $2,500,000 for the fiscal year ending June 30, 1967, $7,000,000 for the fiscal year ending June 30, 1968, $10,000,000 for the fiscal year ending June 30, 1969, $15,000,000 for the fiscal year ending June 30, 1970, $15,000,000 for the fiscal year ending June 30, 1971, $17,000,000 for the fiscal year ending June 30, 1972, $20,000,000 for the fiscal year ending June 30, 1973, and $10,000,000 for the fiscal year ending June 30, 1974. TATE P LANS FOR C OMPREHENSIVE S TATE H EALTH P LAN - (2) S NING .—In order to be approved for purposes of this subsection, a State plan for comprehensive State health planning must— (A) designate, or provide for the establishment of, a single State agency, which may be an interdepartmental agency, as the sole agency for administering or supervising the adminis- tration of the State’s health planning functions under the plan; (B) provide for the establishment of a State health plan- ning council, which shall include representatives of Federal, State, and local agencies (including as an ex officio member, if there is located in such State one or more hospitals or other health care facilities of the Department of Veterans Affairs, the individual whom the Secretary of Veterans Affairs shall have designated to serve on such council as the representative of the hospitals or other health care facilities of such Department which are located in such State) and nongovernmental organi- zations and groups concerned with health (including represen- tation of the regional medical program or programs included in whole or in part within the State) and of consumers of health services, to advise such State agency in carrying out its func- tions under the plan, and a majority of the membership of such council shall consist of representatives of consumers of health services; (C) set forth policies and procedures for the expenditure of funds under the plan, which, in the judgment of the Secretary, are designed to provide for comprehensive State planning for health services (both public and private and including home health care), including the facilities and persons required for the provision of such services, to meet the health needs of the March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00093 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

94 G:\COMP\PHSA\PHSA-MERGED.XML 94 Sec. 314 PUBLIC HEALTH SERVICE ACT people of the State and including environmental considerations as they relate to public health; (D) provide for encouraging cooperative efforts among gov- ernmental or nongovernmental agencies, organizations and groups concerned with health services, facilities, or manpower, and for cooperative efforts between such agencies, organiza- tions, and groups and similar agencies, organizations, and groups in the fields of education, welfare, and rehabilitation; (E) contain or be supported by assurances satisfactory to the Secretary that the funds paid under this subsection will be used to supplement and, to the extent practicable, to increase the level of funds that would otherwise be made available by the State for the purpose of comprehensive health planning and not to supplant such non-Federal funds; 7 (F) provide such methods of administration (including methods relating to the establishment and maintenance of per- sonnel standards on a merit basis, except that the Secretary shall exercise no authority with respect to the selection, tenure of office, and compensation of any individual employed in ac- cordance with such methods) as are found by the Secretary to be necessary for the proper and efficient operation of the plan; (G) provide that the State agency will make such reports, in such form and containing such information, as the Secretary may from time to time reasonably require, and will keep such records and afford such access thereto as the Secretary finds necessary to assure the correctness and verification of such re- ports; (H) provide that the State agency will from time to time, but not less often than annually, review its State plan ap- proved under this subsection and submit to the Secretary ap- propriate modifications thereof; (I) effective July 1, 1968, (i) provide for assisting each health care facility in the State to develop a program for cap- ital expenditures for replacement, modernization, and expan- sion which is consistent with an overall State plan developed in accordance with criteria established by the Secretary after consultation with the State which will meet the needs of the State for health care facilities, equipment, and services without duplication and otherwise in the most efficient and economical manner, and (ii) provide that the State agency furnishing such assistance will periodically review the program (developed pur- suant to clause (i)) of each health care facility in the State and recommended appropriate modification thereof; (J) provide for such fiscal control and fund accounting pro- cedures as may be necessary to assure proper disbursement of and accounting for funds paid to the State under this sub- section; and 7 Section 208(a)(3) of Public Law 91–648 (42 U.S.C. 4728) transferred to the United States Civil Service Commission all functions, powers, and duties of the Secretary under any law appli- cable to a grant program which requires the establishment and maintenance of personnel stand- ards on a merit basis with respect to the program. Reorganization Plan No. 2 of 1978 (42 U.S.C. 1101 note) transferred to the Office of Personnel Management all functions of the United States Civil Service Commission. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00094 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

95 G:\COMP\PHSA\PHSA-MERGED.XML 95 Sec. 314 PUBLIC HEALTH SERVICE ACT (K) contain such additional information and assurances as the Secretary may find necessary to carry out the purposes of this subsection. LLOTMENTS TATE .—From the sums appropriated for A (3)(A) S such purpose for each fiscal year, the several States shall be enti- tled to allotments determined, in accordance with regulations, on the basis of the population and the per capita income of the respec- tive States; except that no such allotment to any State for any fis- cal year shall be less than 1 per centum of the sum appropriated for such fiscal year pursuant to paragraph (1). Any such allotment to a State for a fiscal year shall remain available for obligation by the State, in accordance with the provisions of this subsection and the State’s plan approved thereunder, until the close of the suc- ceeding fiscal year. (B) The amount of any allotment to a State under subpara- graph (A) for any fiscal year which the Secretary determines will not be required by the State, during the period for which it is avail- able, for the purposes for which allotted shall be available for real- lotment by the Secretary from time to time, on such date or dates as he may fix, to other States with respect to which such a deter- mination has not been made, in proportion to the original allot- ments to such States under subparagraph (A) for such fiscal year, but with such proportionate amount for any of such other States being reduced to the extent it exceeds the sum the Secretary esti- mates such State needs and will be able to use during such period; and the total of such reductions shall be similarly reallotted among the States whose proportionate amounts were not so reduced. Any amount so reallotted to a State from funds appropriated pursuant to this subsection for a fiscal year shall be deemed part of its allot- ment under subparagraph (A) for such fiscal year. S .—From each State’s allotment for a AYMENTS TO TATES (4) P fiscal year under this subsection, the State shall from time to time be paid the Federal share of the expenditures incurred during that year or the succeeding year pursuant to its State plan approved under this subsection. Such payments shall be made on the basis of estimates by the Secretary of the sums the State will need in order to perform the planning under its approved State plan under this subsection, but with such adjustments as may be necessary to take account of previously made underpayments or overpayments. The ‘‘Federal share’’ for any State for purposes of this subsection shall be all, or such part as the Secretary may determine, of the cost of such planning, except that in the case of the allotments for the fiscal year ending June 30, 1970, it shall not exceed 75 per cen- tum, of such cost. Project Grants for Areawide Health Planning (b)(1)(A) The Secretary is authorized, during the period begin- ning July 1, 1966, and ending June 30, 1974, to make, with the ap- proval of the State agency administering or supervising the admin- istration of the State plan approved under subsection (a), project grants to any other public or nonprofit private agency or organiza- tion (but with appropriate representation of the interests of local government where the recipient of the grant is not a local govern- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00095 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

96 G:\COMP\PHSA\PHSA-MERGED.XML 96 Sec. 314 PUBLIC HEALTH SERVICE ACT ment or combination thereof or an agency of such government or combination) to cover not to exceed 75 per centum of the costs of projects for developing (and from time to time revising) comprehen- sive regional, metropolitan area, or other local area plans for co- ordination of existing and planned health services, including the fa- cilities and persons required for provision of such services; and in- cluding the provision of such services through home health care; except that in the case of project grants made in any State prior to July 1, 1968, approval of such State agency shall be required only if such State has such a State plan in effect at the time of such grants. No grant may be made under this subsection after June 30, 1970, to any agency or organization to develop or revise health plans for an area unless the Secretary determines that such agency or organization provides means for appropriate representa- tion of the interests of the hospitals, other health care facilities, and practicing physicians serving such area, and the general pub- lic. For the purposes of carrying out this subsection, there are here- by authorized to be appropriated $5,000,000 for the fiscal year end- ing June 30, 1967, $7,500,000 for the fiscal year ending June 30, 1968, $10,000,000 for the fiscal year ending June 30, 1969, $15,000,000 for the fiscal year ending June 30, 1970, $20,000,000 for the fiscal year ending June 30, 1971, $30,000,000 for the fiscal year ending June 30, 1972, $40,000,000 for the fiscal year ending June 30, 1973, and $25,100,000 for the fiscal year ending June 30, 1974. (B) Project grants may be made by the Secretary under sub- paragraph (A) to the State agency administering or supervising the administration of the State plan approved under subsection (a) with respect to a particular region or area, but only if (i) no appli- cation for such a grant with respect to such region or area has been filed by any other agency or organization qualified to receive such a grant, and (ii) such State agency certifies, and the Secretary finds, that ample opportunity has been afforded to qualified agen- cies and organizations to file application for such a grant with re- spect to such region or area and that it is improbable that, in the foresee-able future, any agency or organization which is qualified for such a grant will file application therefor. (2)(A) In order to be approved under this subsection, an appli- cation for a grant under this subsection must contain or be sup- ported by reasonable assurances that there has been or will be es- tablished, in or for the area with respect to which such grant is sought, an areawide health planning council. The membership of such council shall include representatives of public, voluntary, and non-profit private agencies, institutions, and organizations con- cerned with health (including representatives of the interests of local government of the regional medical program for such area, and of consumers of health services). A majority of the members of such council shall consist of representatives of consumers of health services. (B) In addition, an application for a grant under this sub- section must contain or be supported by reasonable assurances that the areawide health planning agency has made provision for assist- ing health care facilities in its area to develop a program for capital expenditures for replacement, modernization, and expansion, which March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00096 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

97 G:\COMP\PHSA\PHSA-MERGED.XML 97 Sec. 315 PUBLIC HEALTH SERVICE ACT is consistent with an overall State plan which will meet the needs of the State and the area for health care facilities, equipment, and services without duplication and otherwise in the most efficient and economical manner. Project Grants for Training, Studies, and Demonstrations (c) The Secretary is also authorized, during the period begin- ning July 1, 1966, and ending June 30, 1974, to make grants to any public or nonprofit private agency, institution, or other organiza- tion to cover all or any part of the cost of projects for training, studies, or demonstrations looking toward the development of im- proved or more effective comprehensive health planning throughout the Nation. For the purposes of carrying out this subsection, there are hereby authorized to be appropriated $1,500,000 for the fiscal year ending June 30, 1967, $2,500,000 for the fiscal year ending June 30, 1968, $5,000,000 for the fiscal year ending June 30, 1969, $7,500,000 for the fiscal year ending June 30, 1970, $8,000,000 for the fiscal year ending June 30, 1971, $10,000,000 for the fiscal year ending June 30, 1972, $12,000,000 for the fiscal year ending June 30, 1973, and $4,700,000 for the fiscal year ending June 30, 1974. 42 U.S.C. 247 SEC. 315. ASSISTING VETERANS WITH MILITARY EMER- ø ¿ GENCY MEDICAL TRAINING TO MEET REQUIREMENTS FOR BECOMING CIVILIAN HEALTH CARE PROFES- SIONALS. .— ROGRAM (a) P .—The Secretary may establish a program, N GENERAL (1) I in consultation with the Secretary of Labor, consisting of awarding demonstration grants to States to streamline State requirements and procedures in order to assist veterans who held certain military occupational specialties related to medical care or who have completed certain medical training while serving in the Armed Forces of the United States to meet cer- tification, licensure, and other requirements applicable to civil- ian health care professions (such as emergency medical techni- cian, paramedic, licensed practical nurse, registered nurse, physical therapy assistant, or physician assistant professions) in the State. (2) C ONSULTATION AND COLLABORATION .—In determining the eligible military occupational specialties or training courses and the assistance required as described in paragraph (1), the Secretary shall consult with the Secretary of Defense, the Sec- retary of Veterans Affairs, and the Assistant Secretary of Labor for Veterans’ Employment and Training, and shall col- laborate with the initiatives carried out under section 4114 of title 38, United States Code, and sections 1142 through 1144 of title 10, United States Code. SE OF UNDS .—Amounts received as a demonstration F (b) U grant under this section shall be used to— (1) prepare and implement a plan to streamline State re- quirements and procedures as described in subsection (a), in- cluding by— (A) determining the extent to which the requirements for the education, training, and skill level of civilian health care professions (such as emergency medical technicians, March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00097 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

98 G:\COMP\PHSA\PHSA-MERGED.XML 98 Sec. 316 PUBLIC HEALTH SERVICE ACT paramedics, licensed practical nurses, registered nurses, physical therapy assistants, or physician assistants) in the State are equivalent to requirements for the education, training, and skill level of veterans who served in medical related fields while a member of the Armed Forces of the United States; and (B) identifying methods, such as waivers, for veterans who served in medical related fields while a member of the Armed Forces of the United States to forgo or meet any such equivalent State requirements; and (2) if necessary to meet workforce shortages or address gaps in education, training, or skill level to meet certification, licensure or other requirements applicable to becoming a civil- ian health care professional (such as an emergency medical technician, paramedic, licensed practical nurse, registered nurse, physical therapy assistant, or physician assistant pro- fessions) in the State, develop or expand career pathways at in- stitutions of higher education to support veterans in meeting such requirements. EPORT .—Upon the completion of the demonstration pro- (c) R gram under this section, the Secretary shall submit to Congress a report on the program. UNDING .—No additional funds are authorized to be appro- (d) F priated for the purpose of carrying out this section. This section shall be carried out using amounts otherwise available for such purpose. (e) S UNSET .—The demonstration program under this section shall not exceed 5 years. ’ S DISEASE PATIENTS FAMILY SUPPORT GROUPS FOR ALZHEIMER 8 S EC . 316. ø 247a ¿ (a) Subject to available appropriations, the Secretary, acting through the National Institute of Mental Health, the National Institutes of Health, and the Administration on Aging, shall promote the establishment of family support groups to provide, without charge, educational, emotional, and practical sup- port to assist individuals with Alzheimer’s disease or a related memory disorder and members of the families of such individuals. In promoting the establishment of such groups, the Secretary shall give priority to— (1) university medical centers and other appropriate health care facilities which receive Federal funds from the Secretary and which conduct research on Alzheimer’s disease or provide services to individuals with such disease; and (2) community-based programs which receive funds from the Secretary, acting through the Administration on Aging. (b) The Secretary shall promote the establishment of a national network to coordinate the family support groups described in sub- section (a). 8 With respect to section 315, subsection (d) of such section provided as follows: ‘‘This section shall cease to exist on March 31, 1989.’’. See section 1 of Public Law 100–471 (102 Stat. 2284). March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00098 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

99 G:\COMP\PHSA\PHSA-MERGED.XML 99 Sec. 317 PUBLIC HEALTH SERVICE ACT PROJECT GRANTS FOR PREVENTIVE HEALTH SERVICES ø 247b ¿ (a) The Secretary may make grants to States, EC S . 317. and in consultation with State health authorities, to political sub- divisions of States and to other public entities to assist them in meeting the costs of establishing and maintaining preventive health service programs. (b) No grant may be made under subsection (a) unless an ap- plication therefor has been submitted to, and approved by, the Sec- retary. Such an application shall be in such form and be submitted in such manner as the Secretary shall by regulation prescribe and shall provide— (1) a complete description of the type and extent of the program for which the applicant is seeking a grant under sub- section (a); (2) with respect to each such program (A) the amount of Federal, State, and other funds obligated by the applicant in its latest annual accounting period for the provision of such program, (B) a description of the services provided by the ap- plicant in such program in such period, (C) the amount of Fed- eral funds needed by the applicant to continue providing such services in such program, and (D) if the applicant proposes changes in the provision of the services in such program, the priorities of such proposed changes, reasons for such changes, and the amount of Federal funds needed by the applicant to make such changes; (3) assurances satisfactory to the Secretary that the pro- gram which will be provided with funds under a grant under subsection (a) will be provided in a manner consistent with the State health plan in effect under section 1524(c) and in those cases where the applicant is a State, that such program will be provided, where appropriate, in a manner consistent with any plans in effect under an application approved under sec- tion 315; (4) assurances satisfactory to the Secretary that the appli- cant will provide for such fiscal control and fund accounting procedures as the Secretary by regulation prescribes to assure the proper disbursement of and accounting for funds received under grants under subsection (a); (5) assurances satisfactory to the Secretary that the appli- cant will provide for periodic evaluation of its program or pro- grams; (6) assurances satisfactory to the Secretary that the appli- cant will make such reports (in such form and containing such information as the Secretary may by regulation prescribe) as the Secretary may reasonably require and keep such records and afford such access thereto as the Secretary may find nec- essary to assure the correctness of, and to verify, such reports; (7) assurances satisfactory to the Secretary that the appli- cant will comply with any other conditions imposed by this sec- tion with respect to grants; and (8) such other information as the Secretary may by regula- tion prescribe. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00099 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

100 G:\COMP\PHSA\PHSA-MERGED.XML 100 Sec. 317 PUBLIC HEALTH SERVICE ACT (c)(1) The Secretary shall not approve an application submitted under subsection (b) for a grant for a program for which a grant was previously made under subsection (a) unless the Secretary de- termines— (A) the program for which the application was submitted is operating effectively to achieve its stated purpose, (B) the applicant complied with the assurances provided the Secretary when applying for such previous grant, and (C) the applicant will comply with the assurances provided with the application. (2) The Secretary shall review annually the activities under- taken by each recipient of a grant under subsection (a) to deter- mine if the program assisted by such grant is operating effectively to achieve its stated purposes and if the recipient is in compliance with the assurances provided the Secretary when applying for such grant. (d) The amount of a grant under subsection (a) shall be deter- mined by the Secretary. Payments under such grants may be made in advance on the basis of estimates or by the way of reimburse- ment, with necessary adjustments on account of underpayments or overpayments, and in such installments and on such terms and conditions as the Secretary finds necessary to carry out the pur- poses of such grants. (e) The Secretary, at the request of a recipient of a grant under subsection (a), may reduce the amount of such grant by— (1) the fair market value of any supplies (including vac- cines and other preventive agents) or equipment furnished the grant recipient, and (2) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or employee. When the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the re- quest of such grant recipient and for the purpose of carrying out a program with respect to which the grant under subsection (a) is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in fur- nishing the supplies or equipment, or in detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of the grant and shall be deemed to have been paid to the grant recipient. (f)(1) Each recipient of a grant under subsection (a) shall keep such records as the Secretary shall by regulation prescribe, includ- ing records which fully disclose the amount and disposition by such recipient of the proceeds of such grant, the total cost of the under- taking in connection with which such grant was made, and the amount of that portion of the cost of the undertaking supplied by other sources, and such other records as will facilitate an effective audit. (2) The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, docu- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00100 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

101 G:\COMP\PHSA\PHSA-MERGED.XML 101 Sec. 317 PUBLIC HEALTH SERVICE ACT ments, papers, and records of the recipient of grants under sub- section (a) that are pertinent to such grants. (g)(1) Nothing in this section shall limit or otherwise restrict the use of funds which are granted to a State or to an agency or a political subdivision of a State under provisions of Federal law (other than this section) and which are available for the conduct of preventive health service programs from being used on connection with programs assisted through grants under subsection (a). (2) Nothing in this section shall be construed to require any State or any agency or political subdivision of a State to have a preventive health service program which would require any person, who objects to any treatment provided under such a program, to be treated or to have any child or ward treated under such program. (h) The Secretary shall include, as part of the report required by section 1705, a report on the extent of the problems presented by the diseases and conditions referred to in subsection (j) on the amount of funds obligated under grants under subsection (a) in the preceding fiscal year for each of the programs listed in subsection (j); and on the effectiveness of the activities assisted under grants under subsection (a) in controlling such diseases and conditions. (i) The Secretary may provide technical assistance to States, State health authorities, and other public entities in connection with the operation of their preventive health service programs. (j)(1) Except for grants for immunization programs the author- ization of appropriations for which are established in paragraph (2), for grants under subsections (a) and (k)(1) for preventive health service programs to immunize without charge children, adolescents, and adults against vaccine-preventable diseases, there are author- ized to be appropriated such sums as may be necessary. Not more than 10 percent ot the total amount appropriated under the pre- ceding sentence for any fiscal year shall be available for grants under subsection (k)(1) for such fiscal year. (2) For grants under subsection (a) for preventive health serv- ice programs for the provision without charge of immunizations with vaccines approved for use, and recommended for routine use, there are authorized to be appropriated such sums as may be nec- essary. (k)(1) The Secretary may make grants to States, political sub- divisions of States, and other public and nonprofit private entities for— (A) research into the prevention and control of diseases that may be prevented through vaccination; (B) demonstration projects for the prevention and control of such diseases; (C) public information and education programs for the pre- vention and control of such diseases; and (D) education, training, and clinical skills improvement ac- tivities in the prevention and control of such diseases for health professionals (including allied health personnel). (2) The Secretary may make grants to States, political subdivi- sions of States, and other public and nonprofit private entities for— (A) research into the prevention and control of diseases and conditions; March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00101 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

102 G:\COMP\PHSA\PHSA-MERGED.XML 102 Sec. 317 PUBLIC HEALTH SERVICE ACT (B) demonstration projects for the prevention and control of such diseases and conditions; (C) public information and education programs for the pre- vention and control of such diseases and conditions; and (D) education, training, and clinical skills improvement ac- tivities in the prevention and control of such diseases and con- ditions for health professionals (including allied health per- sonnel). (3) No grant may be made under this subsection unless an ap- plication therefor is submitted to the Secretary in such form, at such time, and containing such information as the Secretary may by regulation prescribe. (4) Subsections (d), (e), and (f) shall apply to grants under this subsection in the same manner as such subsections apply to grants under subsection (a). (l) A URCHASE R ECOMMENDED V UTHORITY TO P ACCINES FOR DULTS A .— (1) I .—The Secretary may negotiate and enter N GENERAL into contracts with manufacturers of vaccines for the purchase and delivery of vaccines for adults as provided for under sub- section (e). (2) S TATE PURCHASE .—A State may obtain additional quan- tities of such adult vaccines (subject to amounts specified to the Secretary by the State in advance of negotiations) through the purchase of vaccines from manufacturers at the applicable price negotiated by the Secretary under this subsection. EMONSTRATION P ROGRAM T O I MPROVE I MMUNIZATION (m) D C .— OVERAGE .—The Secretary, acting through the Direc- N GENERAL (1) I tor of the Centers for Disease Control and Prevention, shall es- tablish a demonstration program to award grants to States to improve the provision of recommended immunizations for chil- dren, adolescents, and adults through the use of evidence- based, population-based interventions for high-risk popu- lations. (2) S .—To be eligible for a grant under para- TATE PLAN graph (1), a State shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including a State plan that de- scribes the interventions to be implemented under the grant and how such interventions match with local needs and capa- bilities, as determined through consultation with local authori- ties. (3) U .—Funds received under a grant under SE OF FUNDS this subsection shall be used to implement interventions that are recommended by the Task Force on Community Preventive Services (as established by the Secretary, acting through the Director of the Centers for Disease Control and Prevention) or other evidence-based interventions, including— (A) providing immunization reminders or recalls for target populations of clients, patients, and consumers; (B) educating targeted populations and health care providers concerning immunizations in combination with one or more other interventions; March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00102 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

103 G:\COMP\PHSA\PHSA-MERGED.XML 103 Sec. 317A PUBLIC HEALTH SERVICE ACT (C) reducing out-of-pocket costs for families for vac- cines and their administration; (D) carrying out immunization-promoting strategies for participants or clients of public programs, including as- sessments of immunization status, referrals to health care providers, education, provision of on-site immunizations, or incentives for immunization; (E) providing for home visits that promote immuniza- tion through education, assessments of need, referrals, pro- vision of immunizations, or other services; (F) providing reminders or recalls for immunization providers; (G) conducting assessments of, and providing feedback to, immunization providers; (H) any combination of one or more interventions de- scribed in this paragraph; or (I) immunization information systems to allow all States to have electronic databases for immunization records. .—In awarding grants under this sub- ONSIDERATION (4) C section, the Secretary shall consider any reviews or rec- ommendations of the Task Force on Community Preventive Services. VALUATION .—Not later than 3 years after the date on (5) E which a State receives a grant under this subsection, the State shall submit to the Secretary an evaluation of progress made toward improving immunization coverage rates among high- risk populations within the State. .—Not later than 4 years after the EPORT TO CONGRESS (6) R date of enactment of the Affordable Health Choices Act, the Secretary shall submit to Congress a report concerning the ef- fectiveness of the demonstration program established under this subsection together with recommendations on whether to continue and expand such program. UTHORIZATION OF APPROPRIATIONS .—There is author- (7) A ized to be appropriated to carry out this subsection, such sums as may be necessary for each of fiscal years 2010 through 2014. , REFERRALS , AND EDUCATION REGARDING LEAD SCREENINGS POISONING EC . 317A. ø 247b–1 ¿ (a) A UTHORITY FOR G RANTS .— S N GENERAL .—Subject to paragraph (2), the Secretary, (1) I acting through the Director of the Centers for Disease Control and Prevention, may make grants to States and political sub- divisions of States for the initiation and expansion of commu- nity programs designed— (A) to provide, for infants and children— (i) screening for elevated blood lead levels; (ii) referral for treatment of such levels; and (iii) referral for environmental intervention associ- ated with such levels; and (B) to provide education about childhood lead poi- soning. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00103 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

104 G:\COMP\PHSA\PHSA-MERGED.XML 104 Sec. 317A PUBLIC HEALTH SERVICE ACT .—With re- UTHORITY REGARDING CERTAIN ENTITIES (2) A spect to a geographic area with a need for activities authorized in paragraph (1), in any case in which neither the State nor the political subdivision in which such area is located has ap- plied for a grant under paragraph (1), the Secretary may make a grant under such paragraph to any grantee under section 329, 330, or 340A for carrying out such activities in the area. ROVISION OF ALL SERVICES AND ACTIVITIES THROUGH (3) P .—In making grants under paragraph (1), the EACH GRANTEE Secretary shall ensure that each of the activities described in such paragraph is provided through each grantee under such paragraph. The Secretary may authorize such a grantee to pro- vide the services and activities directly, or through arrange- ments with other providers. M EDICAID TATUS AS ROVIDER .— P (b) S .—Subject to paragraph (2), the Secretary (1) I N GENERAL may not make a grant under subsection (a) unless, in the case of any service described in such subsection that is made avail- able pursuant to the State plan approved under title XIX of the Social Security Act for the State involved— (A) the applicant for the grant will provide the service directly, and the applicant has entered into a participation agreement under the State plan and is qualified to receive payments under such plan; or (B) the applicant will enter into an agreement with a provider under which the provider will provide the service, and the provider has entered into such a participation agreement and is qualified to receive such payments. (2) W REGARDING CERTAIN SECONDARY AGREE - AIVER .— MENTS (A) In the case of a provider making an agreement pursuant to paragraph (1)(B) regarding the provision of services, the requirement established in such paragraph regarding a participation agreement shall be waived by the Secretary if the provider does not, in providing health care services, impose a charge or accept reimbursement avail- able from any third-party payor, including reimbursement under any insurance policy or under any Federal or State health benefits plan. (B) A determination by the Secretary of whether a pro- vider referred to in subparagraph (A) meets the criteria for a waiver under such subparagraph shall be made without regard to whether the provider accepts voluntary dona- tions regarding the provision of services to the public. RIORITY IN M AKING G RANTS .—In making grants under sub- (c) P section (a), the Secretary shall give priority to applications for pro- grams that will serve areas with a high incidence of elevated blood lead levels in infants and children. (d) G RANT A PPLICATION .—No grant may be made under sub- section (a), unless an application therefor has been submitted to, and approved by, the Secretary. Such an application shall be in such form and shall be submitted in such manner as the Secretary shall prescribe and shall include each of the following: March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00104 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

105 G:\COMP\PHSA\PHSA-MERGED.XML 105 Sec. 317A PUBLIC HEALTH SERVICE ACT (1) A complete description of the program which is to be provided by or through the applicant. (2) Assurances satisfactory to the Secretary that the pro- gram to be provided under the grant applied for will include educational programs designed to— (A) communicate to parents, educators, and local health officials the significance and prevalence of lead poi- soning in infants and children (including the sources of lead exposure, the importance of screening young children for lead, and the preventive steps that parents can take in reducing the risk of lead poisoning) which the program is designed to detect and prevent; and (B) communicate to health professionals and para- professionals updated knowledge concerning lead poisoning and research (including the health consequences, if any, of low-level lead burden; the prevalence of lead poisoning among all socioeconomic groupings; the benefits of ex- panded lead screening; and the therapeutic and other interventions available to prevent and combat lead poi- soning in affected children and families). (3) Assurances satisfactory to the Secretary that the appli- cant will report on a quarterly basis the number of infants and children screened for elevated blood lead levels, the number of infants and children who were found to have elevated blood lead levels, the number and type of medical referrals made for such infants and children, the outcome of such referrals, and other information to measure program effectiveness. (4) Assurances satisfactory to the Secretary that the appli- cant will make such reports respecting the program involved as the Secretary may require. (5) Assurances satisfactory to the Secretary that the appli- cant will coordinate the activities carried out pursuant to sub- section (a) with related activities and services carried out in the State by grantees under title V or XIX of the Social Secu- rity Act. (6) Assurances satisfactory to the Secretary that Federal funds made available under such a grant for any period will be so used as to supplement and, to the extent practical, in- crease the level of State, local, and other non-Federal funds that would, in the absence of such Federal funds, be made available for the program for which the grant is to be made and will in no event supplant such State, local, and other non- Federal funds. (7) Assurances satisfactory to the Secretary that the appli- cant will ensure complete and consistent reporting of all blood lead test results from laboratories and health care providers to State and local health departments in accordance with guide- lines of the Centers for Disease Control and Prevention for standardized reporting as described in subsection (m). (8) Such other information as the Secretary may prescribe. (e) R S ERVICES AND A CTIVITIES U NDER O THER ELATIONSHIP TO ROGRAMS .— P (1) I N GENERAL .—A recipient of a grant under subsection (a) may not make payments from the grant for any service or March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00105 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

106 G:\COMP\PHSA\PHSA-MERGED.XML 106 Sec. 317A PUBLIC HEALTH SERVICE ACT activity to the extent that payment has been made, or can rea- sonably be expected to be made, with respect to such service or activity— (A) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; or (B) by an entity that provides health services on a pre- paid basis. PPLICABILITY TO CERTAIN SECONDARY AGREEMENTS (2) A .—Paragraph (1) shall not apply in FOR PROVISION OF SERVICES the case of a provider through which a grantee under sub- section (a) provides services under such subsection if the Sec- retary has provided a waiver under subsection (b)(2) regarding the provider. A ETHOD AND P AYMENT .—The Secretary shall (f) M MOUNT OF determine the amount of a grant made under subsection (a). Pay- ments under such grants may be made in advance on the basis of estimates or by way of reimbursement, with necessary adjustments on account of underpayments or overpayments, and in such install- ments and on such terms and conditions as the Secretary finds nec- essary to carry out the purposes of such grants. Not more than 10 percent of any grant may be obligated for administrative costs. (g) S , E QUIPMENT , AND E MPLOYEE D ETAIL .—The Sec- UPPLIES retary, at the request of a recipient of a grant under subsection (a), may reduce the amount of such grant by— (1) the fair market value of any supplies or equipment fur- nished the grant recipient; and (2) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or employee; when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the re- quest of such grant recipient and for the purpose of carrying out a program with respect to which the grant under subsection (a) is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in fur- nishing the supplies or equipment, or in detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of the grant and shall be deemed to have been paid to the grant recipient. ECORDS .—Each recipient of a grant under subsection (a) (h) R shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such re- cipient of the proceeds of such grant, the total cost of the under- taking in connection with which such grant was made, and the amount of that portion of the cost of the undertaking supplied by other sources, and such other records as will facilitate an effective audit. (i) A E XAMINATION OF R ECORDS .—The Secretary and UDIT AND the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00106 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

107 G:\COMP\PHSA\PHSA-MERGED.XML 107 Sec. 317B PUBLIC HEALTH SERVICE ACT records of the recipient of a grant under subsection (a), that are pertinent to such grant. EPORT .— NNUAL (j) A R .—Not later than May 1 of each year, the N GENERAL (1) I Secretary shall submit to the Congress a report on the effec- tiveness during the preceding fiscal year of programs carried out with grants under subsection (a) and of any programs that are carried out by the Secretary pursuant to subsection (l)(2). ERTAIN REQUIREMENTS .—Each report under para- (2) C graph (1) shall include, in addition to any other information that the Secretary may require, the following information: (A) The number of infants and children screened. (B) Demographic information on the population of in- fants and children screened, including the age and racial or ethnic status of such population. (C) The number of screening sites. (D) A description of the severity of the extent of the blood lead levels of the infants and children screened, ex- pressed in categories of severity. (E) The sources of payment for the screenings. (F) The number of grantees that have established sys- tems to ensure mandatory reporting of all blood lead tests from laboratories and health care providers to State and local health departments. (G) A comparison of the data provided pursuant to subparagraphs (A) through (F) with the equivalent data, if any, provided in the report under paragraph (1) preceding the report involved. T RIBES .—For purposes of this section, the term ‘‘po- NDIAN (k) I litical subdivision’’ includes Indian tribes. UNDING .— (l) F UTHORIZATION OF APPROPRIATIONS .—For the purpose (1) A of carrying out this section, there are authorized to be appro- priated $40,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 2005. LLOCATION FOR OTHER PROGRAMS .—Of the amounts (2) A appropriated under paragraph (1) for any fiscal year, the Sec- retary may reserve not more than 20 percent for carrying out programs regarding the activities described in subsection (a) in addition to the program of grants established in such sub- section. S UIDELINES FOR R EPORTING .—The Sec- TANDARDIZED (m) G retary, acting through the Director of the Centers for Disease Con- trol and Prevention, shall develop national guidelines for the uni- form reporting of all blood lead test results to State and local health departments. , TECHNOLOGY ASSESSMENT , AND EPIDEMIOLOGY EDUCATION REGARDING LEAD POISONING . 317B. ø 247b–3 EC (a) P REVENTION .— S ¿ UBLIC EDUCATION .—The Secretary, acting through the (1) P Director of the Centers for Disease Control and Prevention, shall carry out a program to educate health professionals and March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00107 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

108 G:\COMP\PHSA\PHSA-MERGED.XML 108 Sec. 317B PUBLIC HEALTH SERVICE ACT paraprofessionals and the general public on the prevention of lead poisoning in infants and children. In carrying out the pro- gram, the Secretary shall make available information con- cerning the health effects of low-level lead toxicity, the causes of lead poisoning, and the primary and secondary preventive measures that may be taken to prevent such poisoning. NTERAGENCY TASK FORCE .— (2) I (A) Not later than 6 months after the date of the en- 9 , actment of the Preventive Health Amendments of 1992 the Secretary shall establish a council to be known as the Interagency Task Force on the Prevention of Lead Poi- soning (in this paragraph referred to as the ‘‘Task Force’’). The Task Force shall coordinate the efforts of Federal agencies to prevent lead poisoning. (B) The Task Force shall be composed of— (i) the Secretary, who shall serve as the chair of the Task Force; (ii) the Secretary of Housing and Urban Develop- ment; (iii) the Administrator of the Environmental Pro- tection Agency; and (iv) senior staff of each of the officials specified in clauses (i) through (iii), as selected by the officials re- spectively. (C) The Task Force shall— (i) review, evaluate, and coordinate current strate- gies and plans formulated by the officials serving as members of the Task Force, including— (I) the plan of the Secretary of Health and Human Services entitled ‘‘Strategic Plan for the Elimination of Lead Poisoning’’, dated February 21, 1991; (II) the plan of the Secretary of Housing and Urban Development entitled ‘‘Comprehensive and Workable Plan for the Abatement of Lead-Based Paint in Privately Owned Housing’’, dated Decem- ber 7, 1990; and (III) the strategy of the Administrator of the Environmental Protection Agency entitled ‘‘Strat- egy for Reducing Lead Exposures’’, dated Feb- ruary 21, 1991; (ii) develop a unified implementation plan for pro- grams that receive Federal financial assistance for ac- tivities related to the prevention of lead poisoning; (iii) establish a mechanism for sharing and dis- seminating information among the agencies rep- resented on the Task Force; (iv) identify the most promising areas of research and education concerning lead poisoning; (v) identify the practical and technological con- straints to expanding lead poisoning prevention; 9 Enacted October 27, 1992. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00108 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

109 G:\COMP\PHSA\PHSA-MERGED.XML 109 Sec. 317C PUBLIC HEALTH SERVICE ACT (vi) annually carry out a comprehensive review of Federal programs providing assistance to prevent lead poisoning, and not later than May 1 of each year, sub- mit to the Committee on Labor and Human Resources of the Senate and the Committee on the Environment and Public Works of the Senate, and to the Committee on Energy and Commerce of the House of Representa- tives, a report that summarizes the findings made as a result of such review and that contains the rec- ommendations of the Task Force on the programs and policies with respect to which the Task Force is estab- lished, including related budgetary recommendations; and (vii) annually review and coordinate departmental and agency budgetary requests with respect to all lead poisoning prevention activities of the Federal Govern- ment. (b) T SSESSMENT AND ECHNOLOGY PIDEMIOLOGY .—The Sec- A E retary, acting through the Director of the Centers for Disease Con- trol and Prevention, shall, directly or through grants or contracts— (1) provide for the development of improved, more cost-ef- fective testing measures for detecting lead toxicity in children; (2) provide for the development of improved methods of as- sessing the prevalence of lead poisoning, including such meth- ods as may be necessary to conduct individual assessments for each State; (3) provide for the collection of data on the incidence and prevalence of lead poisoning of infants and children, on the de- mographic characteristics of infants and children with such poisoning (including racial and ethnic status), and on the source of payment for treatment for such poisoning (including the extent to which insurance has paid for such treatment); and (4) provide for any applied research necessary to improve the effectiveness of programs for the prevention of lead poi- soning in infants and children. NATIONAL CENTER ON BIRTH DEFECTS AND DEVELOPMENTAL DISABILITIES . 317C. ø 247b–4 S (a) I N G ENERAL .— EC ¿ ATIONAL CENTER .—There is established within the (1) N Centers for Disease Control and Prevention a center to be known as the National Center on Birth Defects and Develop- mental Disabilities (referred to in this section as the ‘‘Center’’), which shall be headed by a director appointed by the Director of the Centers for Disease Control and Prevention. ENERAL DUTIES .—The Secretary shall carry out pro- (2) G grams— (A) to collect, analyze, and make available data on birth defects, developmental disabilities, and disabilities and health (in a manner that facilitates compliance with subsection (c)(2)), including data on the causes of such de- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00109 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

110 G:\COMP\PHSA\PHSA-MERGED.XML 110 Sec. 317C PUBLIC HEALTH SERVICE ACT fects and disabilities and on the incidence and prevalence of such defects and disabilities; (B) to operate regional centers for the conduct of ap- plied epidemiological research on the prevention of such defects and disabilities; (C) to provide information and education to the public on the prevention of such defects and disabilities; (D) to conduct research on and to promote the preven- tion of such defects and disabilities, and secondary health conditions among individuals with disabilities; and (E) to support a National Spina Bifida Program to pre- vent and reduce suffering from the Nation’s most common permanently disabling birth defect. (3) F OLIC ACID .—The Secretary shall carry out section 317J through the Center. (4) C .— ERTAIN PROGRAMS (A) T RANSFERS .—All programs and functions described in subparagraph (B) are transferred to the Center, effec- tive upon the expiration of the 180-day period beginning on the date of the enactment of the Children’s Health Act 10 of 2000 . (B) R ELEVANT PROGRAMS .—The programs and func- tions described in this subparagraph are all programs and functions that— (i) relate to birth defects; folic acid; cerebral palsy; intellectual disabilities; child development; newborn screening; autism; fragile X syndrome; fetal alcohol syndrome; pediatric genetic disorders; disability pre- vention; or other relevant diseases, disorders, or condi- tions as determined the Secretary; and (ii) were carried out through the National Center for Environmental Health as of the day before the date of the enactment of the Act referred to in sub- paragraph (A). (C) R ELATED TRANSFERS .—Personnel employed in con- nection with the programs and functions specified in sub- paragraph (B), and amounts available for carrying out the programs and functions, are transferred to the Center, ef- fective upon the expiration of the 180-day period beginning on the date of the enactment of the Act referred to in sub- paragraph (A). Such transfer of amounts does not affect the period of availability of the amounts, or the avail- ability of the amounts with respect to the purposes for which the amounts may be expended. (b) G RANTS AND C ONTRACTS .— (1) I .—In carrying out subsection (a), the Sec- N GENERAL retary may make grants to and enter into contracts with public and nonprofit private entities. (2) S UPPLIES AND SERVICES IN LIEU OF AWARD FUNDS .— (A) Upon the request of a recipient of an award of a grant or contract under paragraph (1), the Secretary may, subject to subparagraph (B), provide supplies, equipment, 10 Public Law 106–310, enacted October 17, 2000. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00110 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

111 G:\COMP\PHSA\PHSA-MERGED.XML 111 Sec. 317C PUBLIC HEALTH SERVICE ACT and services for the purpose of aiding the recipient in car- rying out the purposes for which the award is made and, for such purposes, may detail to the recipient any officer or employee of the Department of Health and Human Services. (B) With respect to a request described in subpara- graph (A), the Secretary shall reduce the amount of pay- ments under the award involved by an amount equal to the costs of detailing personnel and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of ex- penses incurred in complying with such request, expend the amounts withheld. (3) A .—The Secretary may make an PPLICATION FOR AWARD award of a grant or contract under paragraph (1) only if an ap- plication for the award is submitted to the Secretary and the application is in such form, is made in such manner, and con- tains such agreements, assurances, and information as the Sec- retary determines to be necessary to carry out the purposes for which the award is to be made. (c) B IENNIAL EPORT .—Not later than February 1 of fiscal year R 1999 and of every second such year thereafter, the Secretary shall submit to the Committee on Commerce of the House of Representa- tives, and the Committee on Labor and Human Resources of the Senate, a report that, with respect to the preceding 2 fiscal years— (1) contains information regarding the incidence and prev- alence of birth defects, developmental disabilities, and the health status of individuals with disabilities and the extent to which these conditions have contributed to the incidence and prevalence of infant mortality and affected quality of life; (2) contains information under paragraph (1) that is spe- cific to various racial and ethnic groups (including Hispanics, non-Hispanic whites, Blacks, Native Americans, and Asian Americans); (3) contains an assessment of the extent to which various approaches of preventing birth defects, developmental disabil- ities, and secondary health conditions among individuals with disabilities have been effective; (4) describes the activities carried out under this section; (5) contains information on the incidence and prevalence of individuals living with birth defects and disabilities or develop- mental disabilities, information on the health status of individ- uals with disabilities, information on any health disparities ex- perienced by such individuals, and recommendations for im- proving the health and wellness and quality of life of such indi- viduals; (6) contains a summary of recommendations from all birth defects research conferences sponsored by the Centers for Dis- ease Control and Prevention, including conferences related to spina bifida; and (7) contains any recommendations of the Secretary regard- ing this section. PPLICABILITY OF P RIVACY L AWS .—The provisions of this (d) A section shall be subject to the requirements of section 552a of title March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00111 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

112 G:\COMP\PHSA\PHSA-MERGED.XML 112 Sec. 317D PUBLIC HEALTH SERVICE ACT 5, United States Code. All Federal laws relating to the privacy of information shall apply to the data and information that is col- lected under this section. C OMMITTEE .—Notwithstanding any other provi- DVISORY (e) A sion of law, the members of the advisory committee appointed by the Director of the National Center for Environmental Health that have expertise in birth defects, developmental disabilities, and dis- abilities and health shall be transferred to and shall advise the Na- tional Center on Birth Defects and Developmental Disabilities ef- fective on the date of enactment of the Birth Defects and Develop- mental Disabilities Prevention Act of 2003. A PPROPRIATIONS .—For the purpose of UTHORIZATION OF (f) A carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2003 through 2007. PREVENTIVE HEALTH MEASURES WITH RESPECT TO PROSTATE CANCER . 317D. ø 247b–5 ¿ EC N G ENERAL .—The Secretary, acting (a) I S through the Director of the Centers for Disease Control and Pre- vention, may make grants to States and local health departments for the purpose of enabling such States and departments to carry out programs that may include the following: (1) To identify factors that influence the attitudes or levels of awareness of men and health care practitioners regarding screening for prostate cancer. (2) To evaluate, in consultation with the Agency for Health Care Policy and Research and the National Institutes of Health, the effectiveness of screening strategies for prostate cancer. (3) To identify, in consultation with the Agency for Health Care Policy and Research, issues related to the quality of life for men after prostrate cancer screening and followup. (4) To develop and disseminate public information and education programs for prostate cancer, including appropriate messages about the risks and benefits of prostate cancer screening for the general public, health care providers, policy makers and other appropriate individuals. (5) To improve surveillance for prostate cancer. (6) To address the needs of underserved and minority pop- ulations regarding prostate cancer. (7) Upon a determination by the Secretary, who shall take into consideration recommendations by the United States Pre- ventive Services Task Force and shall seek input, where appro- priate, from professional societies and other private and public entities, that there is sufficient consensus on the effectiveness of prostate cancer screening— (A) to screen men for prostate cancer as a preventive health measure; (B) to provide appropriate referrals for the medical treatment of men who have been screened under subpara- graph (A) and to ensure, to the extent practicable, the pro- vision of appropriate followup services and support serv- ices such as case management; March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00112 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

113 G:\COMP\PHSA\PHSA-MERGED.XML 113 Sec. 317D PUBLIC HEALTH SERVICE ACT (C) to establish mechanisms through which State and local health departments can monitor the quality of screening procedures for prostate cancer, including the in- terpretation of such procedures; and (D) to improve, in consultation with the Health Re- sources and Services Administration, the education, train- ing, and skills of health practitioners (including appro- priate allied health professionals) in the detection and con- trol of prostate cancer. (8) To evaluate activities conducted under paragraphs (1) through (7) through appropriate surveillance or program moni- toring activities. ATCHING F UNDS .— EQUIREMENT OF M (b) R (1) I .—The Secretary may not make a grant N GENERAL under subsection (a) unless the applicant involved agrees, with respect to the costs to be incurred by the applicant in carrying out the purpose described in such section, to make available non-Federal contributions (in cash or in kind under paragraph (2)) toward such costs in an amount equal to not less than $1 for each $3 of Federal funds provided in the grant. Such con- tributions may be made directly or through donations from public or private entities. ETERMINATION OF AMOUNT OF NON FEDERAL CON - - (2) D TRIBUTION .— (A) Non-Federal contributions required in paragraph (1) may be in cash or in kind, fairly evaluated, including equipment or services (and excluding indirect or overhead costs). Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in deter- mining the amount of such non-Federal contributions. (B) In making a determination of the amount of non- Federal contributions for purposes of paragraph (1), the Secretary may include only non-Federal contributions in excess of the average amount of non-Federal contributions made by the applicant involved toward the purpose de- scribed in subsection (a) for the 2-year period preceding the fiscal year for which the applicant involved is applying to receive a grant under such subsection. (C) In making a determination of the amount of non- Federal contributions for purposes of paragraph (1), the Secretary shall, subject to subparagraphs (A) and (B) of this paragraph, include any non-Federal amounts ex- pended pursuant to title XIX of the Social Security Act by the applicant involved toward the purpose described in paragraphs (1) and (2) of subsection (a). (c) E S E ARLY D ETECTION .—The IGNIFICANCE OF DUCATION ON Secretary may not make a grant under subsection (a) unless the applicant involved agrees that, in carrying out subsection (a)(3), the applicant will carry out education programs to communicate to men, and to local health officials, the significance of the early de- tection of prostate cancer. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00113 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

114 G:\COMP\PHSA\PHSA-MERGED.XML 114 Sec. 317D PUBLIC HEALTH SERVICE ACT EQUIREMENT OF ROVISION OF A LL S ERVICES BY (d) R ATE P D C ERTAIN .—The Secretary may not make a grant under subsection (a) unless the applicant involved agrees— (1) to ensure that, initially and throughout the period dur- ing which amounts are received pursuant to the grant, not less than 60 percent of the grant is expended to provide each of the services or activities described in paragraphs (1) and (2) of such subsection; (2) to ensure that, by the end of any second fiscal year of payments pursuant to the grant, each of the services or activi- ties described in such subsection is provided; and (3) to ensure that not more than 40 percent of the grant is expended to provide the services or activities described in 11 paragraphs (3) through (6) of such section . (e) A DDITIONAL R EQUIRED A GREEMENTS .— (1) P RIORITY FOR LOW - INCOME MEN .—The Secretary may not make a grant under subsection (a) unless the applicant in- volved agrees that low-income men, and men at risk of pros- tate cancer, will be given priority in the provision of services and activities pursuant to paragraphs (1) and (2) of such sub- section. .—The IMITATION ON IMPOSITION OF FEES FOR SERVICES (2) L Secretary may not make a grant under subsection (a) unless the applicant involved agrees that, if a charge is imposed for the provision of services or activities under the grant, such charge— (A) will be made according to a schedule of charges that is made available to the public; (B) will be adjusted to reflect the income of the man involved; and (C) will not be imposed on any man with an income of less than 100 percent of the official poverty line, as es- tablished by the Director of the Office of Management and Budget and revised by the Secretary in accordance with section 673(2) of the Omnibus Budget Reconciliation Act of 1981. (3) R ELATIONSHIP TO ITEMS AND SERVICES UNDER OTHER PROGRAMS .—The Secretary may not make a grant under sub- section (a) unless the applicant involved agrees that the grant will not be expended to make payment for any item or service to the extent that payment has been made, or can reasonably be expected to be made, with respect to such item or service— (A) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; or (B) by an entity that provides health services on a pre- paid basis. (4) C OORDINATION WITH OTHER PROSTATE CANCER PRO - GRAMS .—The Secretary may not make a grant under sub- section (a) unless the applicant involved agrees that the serv- ices and activities funded through the grant will be coordinated with other Federal, State, and local prostate cancer programs. 11 So in law. Probably should be ‘‘subsection’’. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00114 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

115 G:\COMP\PHSA\PHSA-MERGED.XML 115 Sec. 317D PUBLIC HEALTH SERVICE ACT IMITATION ON ADMINISTRATIVE EXPENSES (5) L .—The Sec- retary may not make a grant under subsection (a) unless the applicant involved agrees that not more than 10 percent of the grant will be expended for administrative expenses with re- spect to the grant. ESTRICTIONS ON USE OF GRANT .—The Secretary may (6) R not make a grant under subsection (a) unless the applicant in- volved agrees that the grant will not be expended to provide inpatient hospital services for any individual. .—The Secretary may not make a ECORDS AND AUDITS (7) R grant under subsection (a) unless the applicant involved agrees that— (A) the applicant will establish such fiscal control and fund accounting procedures as may be necessary to ensure the proper disbursal of, and accounting for, amounts re- ceived by the applicant under such section; and (B) upon request, the applicant will provide records maintained pursuant to paragraph (1) to the Secretary or the Comptroller of the United States for purposes of audit- ing the expenditures by the applicant of the grant. (f) R EPORTS TO S ECRETARY .—The Secretary may not make a grant under subsection (a) unless the applicant involved agrees to submit to the Secretary such reports as the Secretary may require with respect to the grant. .—The Secretary RANT ESCRIPTION OF I NTENDED U SES OF G (g) D may not make a grant under subsection (a) unless— (1) the applicant involved submits to the Secretary a de- scription of the purposes for which the applicant intends to ex- pend the grant; (2) the description identifies the populations, areas, and lo- 12 with a need for the services or ac- calities in the applicant tivities described in subsection (a); (3) the description provides information relating to the services and activities to be provided, including a description of the manner in which the services and activities will be co- ordinated with any similar services or activities of public or nonprivate entities; and (4) the description provides assurances that the grant funds will be used in the most cost-effective manner. (h) R PPLICATION EQUIREMENT OF S UBMISSION OF A .—The Sec- retary may not make a grant under subsection (a) unless an appli- cation for the grant is submitted to the Secretary, the application contains the description of intended uses required in subsection (g), and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Sec- retary determines to be necessary to carry out this section. (i) M MOUNT OF A P ETHOD AND AYMENT .—The Secretary shall determine the amount of a grant made under subsection (a). Pay- ments under such grants may be made in advance on the basis of estimates or by way of reimbursement, with necessary adjustments on account of the underpayments or overpayments, and in such in- 12 So in law. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00115 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

116 G:\COMP\PHSA\PHSA-MERGED.XML 116 Sec. 317E PUBLIC HEALTH SERVICE ACT stallments and on such terms and conditions as the Secretary finds necessary to carry out the purposes of such grants. (j) T P ROVISION OF S UPPLIES AND ECHNICAL SSISTANCE AND A IEU OF RANT L F UNDS .— S G ERVICES IN (1) T .—The Secretary may provide ECHNICAL ASSISTANCE training and technical assistance with respect to the planning, development, and operation of any program or service carried out pursuant to subsection (a). The Secretary may provide such technical assistance directly or through grants to, or contracts with, public and private entities. (2) P ROVISION OF SUPPLIES AND SERVICES IN LIEU OF GRANT FUNDS .— (A) Upon the request of an applicant receiving a grant under subsection (a), the Secretary may, subject to sub- paragraph (B), provide supplies, equipment, and services for the purpose of aiding the applicant in carrying out such section and, for such purpose, may detail to the applicant any officer or employee of the Department of Health and Human Services. (B) With respect to a request described in subpara- graph (A), the Secretary shall reduce the amount of pay- ments under the grant under subsection (a) to the appli- cant involved by an amount equal to the costs of detailing personnel (including pay, allowances, and travel expenses) and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld. EFINITION .—For purposes of this section, the term ‘‘units (k) D of local government’’ includes Indian tribes. UTHORIZATION OF A PPROPRIATIONS .— (l) A N GENERAL .—For the purpose of carrying out this sec- (1) I tion, there are authorized to be appropriated $20,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 2004. (2) A TECHNICAL ASSISTANCE .—Of the LLOCATION FOR amounts appropriated under paragraph (1) for a fiscal year, the Secretary shall reserve not more than 20 percent for car- rying out subsection (j)(1). NATIONAL STRATEGY FOR COMBATING AND ELIMINATING TUBERCULOSIS EC . 317E. ø 247b–6 ¿ (a) I N G ENERAL .—The Secretary, acting S through the Director of the Centers for Disease Control and Pre- vention, may make grants to States, political subdivisions, and other public entities for preventive health service programs for the prevention, control, and elimination of tuberculosis. D EVELOPMENT ; D ESEARCH AND P ROJECTS ; EMONSTRATION (b) R E T .—With respect to the prevention, treat- RAINING DUCATION AND ment, control, and elimination of tuberculosis, the Secretary may, directly or through grants to public or nonprofit private entities, carry out the following: March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00116 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

117 G:\COMP\PHSA\PHSA-MERGED.XML 117 Sec. 317E PUBLIC HEALTH SERVICE ACT (1) Research, with priority given to research and develop- ment concerning latent tuberculosis infection, strains of tuber- culosis resistant to drugs, and research concerning cases of tu- berculosis that affect certain populations at risk for tuber- culosis. (2) Research and development and related activities to de- velop new tools for the elimination of tuberculosis, including drugs, diagnostics, vaccines, and public health interventions, such as directly observed therapy and non-pharmaceutical intervention, and methods to enhance detection and response to outbreaks of tuberculosis, including multidrug resistant tu- berculosis. The Secretary is encouraged to give priority to pro- grammatically relevant research so that new tools can be uti- lized in public health practice. (3) Demonstration projects for— (A) the development of regional capabilities to prevent, control, and eliminate tuberculosis and prevent multidrug resistant and extensively drug resistant strains of tuber- culosis; (B) the intensification of efforts to reduce health dis- parities in the incidence of tuberculosis; (C) the intensification of efforts to control tuberculosis along the United States-Mexico border and among United States-Mexico binational populations, including through expansion of the scope and number of programs that— (i) detect and treat binational cases of tuber- culosis; and (ii) treat high-risk cases of tuberculosis referred from Mexican health departments; (D) the intensification of efforts to prevent, detect, and treat tuberculosis among foreign-born persons who are in the United States; (E) the intensification of efforts to prevent, detect, and treat tuberculosis among populations and settings docu- mented as having a high risk for tuberculosis; and (F) tuberculosis detection, control, and prevention. (4) Public information and education activities. (5) Education, training, clinical skills improvement activi- ties, and workplace exposure prevention for health profes- sionals, including allied health personnel and emergency re- sponse employees. (6) Support of Centers to carry out activities under para- graphs (1) through (4). (7) Collaboration with international organizations and for- eign countries in carrying out such activities. (8) Develop, enhance, and expand information technologies that support tuberculosis control including surveillance and database management systems with cross-jurisdictional capa- bilities, which shall conform to the standards and implementa- tion specifications for such information technologies as rec- ommended by the Secretary. (c) C W ITH P ROVIDERS OF P RIMARY H EALTH S ERV - OOPERATION .—The Secretary may make a grant under subsection (a) or (b) ICES only if the applicant for the grant agrees that, in carrying out ac- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00117 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

118 G:\COMP\PHSA\PHSA-MERGED.XML 118 Sec. 317E PUBLIC HEALTH SERVICE ACT tivities under the grant, the applicant will cooperate with public and nonprofit private providers of primary health services or sub- stance abuse services, including entities receiving assistance under section 329, 330, or 340A or under title V or XIX. (d) A RANT PPLICATION FOR .— G (1) I N GENERAL .—The Secretary may make a grant under subsection (a) or (b) only if an application for the grant is sub- mitted to the Secretary and the application, subject to para- graph (2), is in such form, is made in such manner, and con- tains such agreements, assurances, and information as the Sec- retary determines to be necessary to carry out the subsection involved. (2) P CONTROL , AND ELIMINATION .— LAN FOR PREVENTION , The Secretary may make a grant under subsection (a) only if the application under paragraph (1) contains a plan regarding the prevention, control, and elimination of tuberculosis in the geographic area with respect to which the grant is sought. (3) D - ETERMINATION OF AMOUNT OF NONFEDERAL CONTRIBU TIONS .— (A) P RIORITY .—In awarding grants under subsection (a) or (b), the Secretary shall give highest priority to an applicant that provides assurances that the applicant will contribute non-Federal funds to carry out activities under this section, which may be provided directly or through do- nations from public or private entities and may be in cash or in kind, including equipment or services. EDERAL AMOUNTS NOT TO BE INCLUDED AS CON - (B) F TRIBUTIONS .—Amounts provided by the Federal Govern- ment, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of non-Federal contributions as described in subparagraph (A). UNDS S IEU OF G RANT F L .— ERVICES IN UPPLIES AND (e) S (1) I N GENERAL .—Upon the request of a grantee under sub- section (a) or (b), the Secretary may, subject to paragraph (2), provide supplies, equipment, and services for the purpose of aiding the grantee in carrying out the subsection involved and, for such purpose, may detail to the State any officer or em- ployee of the Department of Health and Human Services. (2) C ORRESPONDING REDUCTION IN PAYMENTS .—With re- spect to a request described in paragraph (1), the Secretary shall reduce the amount of payments under the grant involved by an amount equal to the costs of detailing personnel and the fair market value of any supplies, equipment, or services pro- vided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld. (f) A DVISORY C OUNCIL .— (1) I N GENERAL .—The Secretary shall establish an advisory council to be known as the Advisory Council for the Elimi- nation of Tuberculosis (in this subsection referred to as the ‘‘Council’’). (2) D UTIES .—The Council shall provide advice and rec- ommendations regarding the elimination of tuberculosis to the March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00118 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

119 G:\COMP\PHSA\PHSA-MERGED.XML 119 Sec. 317E PUBLIC HEALTH SERVICE ACT Secretary. In addition, the Council shall, with respect to elimi- nating such disease, provide to the Secretary and other appro- priate Federal officials advice on— (A) coordinating the activities of the Department of Health and Human Services and other Federal agencies that relate to the disease, including activities under sub- section (b); (B) responding rapidly and effectively to emerging issues in tuberculosis; and (C) efficiently utilizing the Federal resources involved. (3) C .— OMPREHENSIVE PLAN .—In carrying out paragraph (2), the N GENERAL (A) I Council shall make or update recommendations on the de- velopment, revision, and implementation of a comprehen- sive plan to eliminate tuberculosis in the United States. (B) C ONSULTATION .—In carrying out subparagraph (A), the Council may consult with appropriate public and private entities, which may, subject to the direction or dis- cretion of the Secretary, include— (i) individuals who are scientists, physicians, laboratorians, and other health professionals, who are not officers or employees of the Federal Government and who represent the disciplines relevant to tuber- culosis elimination; (ii) members of public-private partnerships or pri- vate entities established to address the elimination of tuberculosis; (iii) members of national and international non- governmental organizations whose purpose is to elimi- nate tuberculosis; (iv) members from the general public who are knowledgeable with respect to tuberculosis elimination including individuals who have or have had tuber- culosis; and (v) scientists, physicians, laboratorians, and other health professionals who reside in a foreign country with a substantial incidence or prevalence of tuber- culosis, and who represent the specialties and dis- ciplines relevant to the research under consideration. (C) C ERTAIN COMPONENTS OF PLAN .—In carrying out subparagraph (A), the Council shall, subject to the direc- tion or discretion of the Secretary— (i) consider recommendations for the involvement of the United States in continuing global and cross- border tuberculosis control activities in countries where a high incidence of tuberculosis directly affects the United States; and (ii) review the extent to which progress has been made toward eliminating tuberculosis. (4) B IENNIAL REPORT .— (A) I N GENERAL .—The Council shall submit a biennial report to the Secretary, as determined necessary by the Secretary, on the activities carried under this section. Each such report shall include the opinion of the Council March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00119 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

120 G:\COMP\PHSA\PHSA-MERGED.XML 120 Sec. 317E PUBLIC HEALTH SERVICE ACT on the extent to which its recommendations regarding the elimination of tuberculosis have been implemented, includ- ing with respect to— (i) activities under subsection (b); and (ii) the national plan referred to in paragraph (3). .—The Secretary shall make a report sub- UBLIC (B) P mitted under subparagraph (A) public. (5) C OMPOSITION .—The Council shall be composed of— (A) ex officio representatives from the Centers for Dis- ease Control and Prevention, the National Institutes of Health, the United States Agency for International Devel- opment, the Agency for Healthcare Research and Quality, the Health Resources and Services Administration, the United States-Mexico Border Health Commission, and other Federal departments and agencies that carry out sig- nificant activities related to tuberculosis; (B) State and local tuberculosis control and public health officials; (C) individuals who are scientists, physicians, laboratorians, and other health professionals who rep- resent disciplines relevant to tuberculosis elimination; and (D) members of national and international nongovern- mental organizations established to address the elimi- nation of tuberculosis. , INFORMATION , TAFF .—The AND OTHER ASSISTANCE (6) S Secretary shall provide to the Council such staff, information, and other assistance as may be necessary to carry out the du- ties of the Council. (g) F T UBERCULOSIS T ASK F ORCE .— EDERAL UTIES .—The Federal Tuberculosis Task Force (in this (1) D subsection referred to as the ‘‘Task Force’’) shall provide to the Secretary and other appropriate Federal officials advice on re- search into new tools under subsection (b)(2), including advice regarding the efficient utilization of the Federal resources in- volved. (2) C OMPREHENSIVE PLAN FOR NEW TOOLS DEVELOPMENT .— In carrying out paragraph (1), the Task Force shall make rec- ommendations on the development of a comprehensive plan for the creation of new tools for the elimination of tuberculosis, in- cluding drugs, diagnostics, and vaccines. ONSULTATION .—In developing the comprehensive plan (3) C under paragraph (1), the Task Force shall consult with exter- nal parties including representatives from groups such as— (A) scientists, physicians, laboratorians, and other health professionals who represent the specialties and dis- ciplines relevant to the research under consideration; (B) members from public-private partnerships, private entities, or foundations (or both) engaged in activities rel- evant to research under consideration; (C) members of national and international nongovern- mental organizations established to address tuberculosis elimination; March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00120 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

121 G:\COMP\PHSA\PHSA-MERGED.XML 121 Sec. 317E PUBLIC HEALTH SERVICE ACT (D) members from the general public who are knowl- edgeable with respect to tuberculosis including individuals who have or have had tuberculosis; and (E) scientists, physicians, laboratorians, and other health professionals who reside in a foreign country with a substantial incidence or prevalence of tuberculosis, and who represent the specialties and disciplines relevant to the research under consideration. PPROPRIATIONS .— UTHORIZATION OF A (h) A (1) G .— ENERAL PROGRAM (A) I N GENERAL .—For the purpose of carrying out this section, there are authorized to be appropriated $200,000,000 for fiscal year 2009, $210,000,000 for fiscal year 2010, $220,500,000 for fiscal year 2011, $231,525,000 for fiscal year 2012, and $243,101,250 for fiscal year 2013. (B) R .—Of the ESERVATION FOR EMERGENCY GRANTS amounts appropriated under subparagraph (A) for a fiscal year, the Secretary may reserve not more than 25 percent for emergency grants under subsection (a) for any geo- graphic area, State, political subdivision of a State, or other public entity in which there is, relative to other areas, a substantial number of cases of tuberculosis, multidrug resistant tuberculosis, or extensively drug re- sistant tuberculosis or a substantial rate of increase in such cases. RIORITY .—In allocating amounts appropriated (C) P under subparagraph (A), the Secretary shall give priority to allocating such amounts for grants under subsection (a). (D) A .— LLOCATION OF FUNDS (i) R .—Of the amounts EQUIREMENT OF FORMULA appropriated under subparagraph (A), not reserved under subparagraph (B), and allocated by the Sec- retary for grants under subsection (a), the Secretary shall distribute a portion of such amounts to grantees under subsection (a) on the basis of a formula. .—The formula developed ELEVANT FACTORS (ii) R by the Secretary under clause (i) shall take into ac- count the level of tuberculosis morbidity and case com- plexity in the respective geographic area and may con- sider other factors relevant to tuberculosis in such area. O CHANGE TO FORMULA REQUIRED .—This (iii) N subparagraph does not require the Secretary to modify the formula that was used by the Secretary to dis- tribute funds to grantees under subsection (a) for fis- cal year 2009. IMITATION .—The authorization of appropriations es- (2) L tablished in paragraph (1) for a fiscal year is effective only if the amount appropriated under such paragraph for such year equals or exceeds the amount appropriated to carry out this section for fiscal year 2009. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00121 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

122 G:\COMP\PHSA\PHSA-MERGED.XML 122 Sec. 317F PUBLIC HEALTH SERVICE ACT LOAN REPAYMENT PROGRAM .— 247b–7 ¿ (a) I N G ENERAL . 317F. S ø EC .—Subject to paragraph (2), the Secretary UTHORITY (1) A may carry out a program of entering into contracts with appro- priately qualified health professionals under which such health professionals agree to conduct prevention activities, as employ- ees of the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry, in consider- ation of the Federal Government agreeing to repay, for each year of such service, not more than $35,000 of the principal and interest of the educational loans of such health profes- sionals. (2) L IMITATION .—The Secretary may not enter into an agreement with a health professional pursuant to paragraph (1) unless such professional— (A) has a substantial amount of educational loans rel- ative to income; and (B) agrees to serve as an employee of the Centers for Disease Control and Prevention or the Agency for Toxic Substances and Disease Registry for purposes of para- graph (1) for a period of not less than 3 years. (b) A C ERTAIN P ROVISIONS .—With respect to PPLICABILITY OF the National Health Service Corps Loan Repayment Program es- tablished in subpart III of part D of title III of this Act, the provi- sions of such subpart shall, except as inconsistent with subsection (a), apply to the program established in this section in the same manner and to the same extent as such provisions apply to the Na- tional Health Service Corps Loan Repayment Program. (c) A A PPROPRIATIONS UTHORIZATION OF .—For the purpose of carrying out this section, there are authorized to be appropriated $500,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through 2002. (d) A A PPROPRIATIONS .—Amounts appropriated VAILABILITY OF for a fiscal year for contracts under subsection (a) shall remain available until the expiration of the second fiscal year beginning after the fiscal year for which the amounts were appropriated. ø 247b–8 ¿ FELLOWSHIP AND TRAINING PROGRAMS. SEC. 317G. The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish fellowship and training programs to be conducted by such Centers to train individ- uals to develop skills in epidemiology, surveillance, laboratory anal- ysis, and other disease detection and prevention methods. Such programs shall be designed to enable health professionals and health personnel trained under such programs to work, after re- ceiving such training, in local, State, national, and international ef- forts toward the prevention and control of diseases, injuries, and disabilities. Such fellowships and training may be administered through the use of either appointment or nonappointment proce- dures. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00122 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

123 G:\COMP\PHSA\PHSA-MERGED.XML 123 Sec. 317I PUBLIC HEALTH SERVICE ACT DIABETES IN CHILDREN AND YOUTH ø 247b–9 ¿ (a) S URVEILLANCE ON J UVENILE D IABE . 317H. EC S - .—The Secretary, acting through the Director of the Centers for TES Disease Control and Prevention, shall develop a sentinel system to collect data on juvenile diabetes, including with respect to inci- dence and prevalence, and shall establish a national database for such data. (b) T IABETES IN Y YPE .—The Secretary shall imple- 2 D OUTH ment a national public health effort to address type 2 diabetes in youth, including— (1) enhancing surveillance systems and expanding re- search to better assess the prevalence and incidence of type 2 diabetes in youth and determine the extent to which type 2 di- abetes is incorrectly diagnosed as type 1 diabetes among chil- dren; and (2) developing and improving laboratory methods to assist in diagnosis, treatment, and prevention of diabetes including, but not limited to, developing noninvasive ways to monitor blood glucose to prevent hypoglycemia and improving existing glucometers that measure blood glucose. (c) A A PPROPRIATIONS .—For the purpose of UTHORIZATION OF carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005. COMPILATION OF DATA ON ASTHMA S EC 247b–10 ¿ (a) I N G ENERAL .—The Secretary, acting . 317I. ø through the Director of the Centers for Disease Control and Pre- vention, shall— (1) conduct local asthma surveillance activities to collect data on the prevalence and severity of asthma and the quality of asthma management; (2) compile and annually publish data on the prevalence of children suffering from asthma in each State; and (3) to the extent practicable, compile and publish data on the childhood mortality rate associated with asthma nationally. (b) S URVEILLANCE A CTIVITIES .—The Director of the Centers for Disease Control and Prevention, acting through the representative of the Director on the National Asthma Education Prevention Pro- gram Coordinating Committee, shall, in carrying out subsection (a), provide an update on surveillance activities at each Committee meeting. OLLABORATIVE E .—The activities described in sub- FFORTS (c) C section (a)(1) may be conducted in collaboration with eligible enti- ties awarded a grant under section 399L. UTHORIZATION OF A PPROPRIATIONS .—For the purpose of (d) A carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00123 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

124 G:\COMP\PHSA\PHSA-MERGED.XML 124 Sec. 317J PUBLIC HEALTH SERVICE ACT EFFECTS OF FOLIC ACID IN PREVENTION OF BIRTH DEFECTS S 247b–11 ¿ (a) I N G ENERAL .—The Secretary, acting EC ø . 317J. through the Director of the Centers for Disease Control and Pre- vention, shall expand and intensify programs (directly or through grants or contracts) for the following purposes: (1) To provide education and training for health profes- sionals and the general public for purposes of explaining the effects of folic acid in preventing birth defects and for purposes of encouraging each woman of reproductive capacity (whether or not planning a pregnancy) to consume on a daily basis a die- tary supplement that provides an appropriate level of folic acid. (2) To conduct research with respect to such education and training, including identifying effective strategies for increas- ing the rate of consumption of folic acid by women of reproduc- tive capacity. (3) To conduct research to increase the understanding of the effects of folic acid in preventing birth defects, including understanding with respect to cleft lip, cleft palate, and heart defects. (4) To provide for appropriate epidemiological activities re- garding folic acid and birth defects, including epidemiological activities regarding neural tube defects. (b) C ITH S TATES AND ONSULTATIONS RIVATE E NTITIES .—In W P carrying out subsection (a), the Secretary shall consult with the States and with other appropriate public or private entities, includ- ing national nonprofit private organizations, health professionals, and providers of health insurance and health plans. ECHNICAL (c) T .—The Secretary may (directly or A SSISTANCE through grants or contracts) provide technical assistance to public and nonprofit private entities in carrying out the activities de- scribed in subsection (a). VALUATIONS .—The Secretary shall (directly or through (d) E grants or contracts) provide for the evaluation of activities under subsection (a) in order to determine the extent to which such activi- ties have been effective in carrying out the purposes of the program under such subsection, including the effects on various demo- graphic populations. Methods of evaluation under the preceding sentence may include surveys of knowledge and attitudes on the consumption of folic acid and on blood folate levels. Such methods may include complete and timely monitoring of infants who are born with neural tube defects. (e) A UTHORIZATION OF A PPROPRIATIONS .—For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005. SAFE MOTHERHOOD S . 317K. ø 247b–12 ¿ (a) S URVEILLANCE .— EC URPOSE .—The purposes of this subsection are to es- (1) P tablish or continue a Federal initiative to support State and tribal maternal mortality review committees, to improve data collection and reporting around maternal mortality, and to de- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00124 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

125 G:\COMP\PHSA\PHSA-MERGED.XML 125 Sec. 317K PUBLIC HEALTH SERVICE ACT velop or support surveillance systems at the local, State, and national level to better understand the burden of maternal complications and mortality and to decrease the disparities among populations at risk of death and severe complications from pregnancy. .—For the purpose described in paragraph CTIVITIES (2) A (1), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may carry out the fol- lowing activities: (A) The Secretary may continue and improve activities related to a national maternal mortality data collection and surveillance program to identify and support the re- view of pregnancy-associated deaths and pregnancy-related deaths that occur during, or within 1 year following, preg- nancy. (B) The Secretary may expand the Pregnancy Risk As- sessment Monitoring System to provide surveillance and collect data in each State. (C) The Secretary may expand the Maternal and Child Health Epidemiology Program to provide technical sup- port, financial assistance, or the time-limited assignment of senior epidemiologists to maternal and child health pro- grams in each State. (D) The Secretary may, in cooperation with States, In- dian tribes, and tribal organizations, develop a program to support States, Indian tribes, and tribal organizations in establishing or operating maternal mortality review com- mittees, in accordance with subsection (d). REVENTION R ESEARCH .— (b) P URPOSE .—The purpose of this subsection is to provide (1) P the Secretary with the authority to further expand research concerning risk factors, prevention strategies, and the roles of the family, health care providers and the community in safe motherhood. .—The Secretary may carry out activities to ESEARCH (2) R expand research relating to— (A) prepregnancy counseling, especially for at risk pop- ulations such as women with diabetes and women with substance use disorder; (B) the identification of critical components of prenatal delivery and postpartum care; (C) the identification of outreach and support services, such as folic acid education, that are available for preg- nant women; (D) the identification of women who are at high risk for complications; (E) preventing preterm delivery; (F) preventing urinary tract infections; (G) preventing unnecessary caesarean sections; (H) the identification of the determinants of disparities in maternal care, health risks, and health outcomes, in- cluding an examination of the higher rates of maternal mortality among African American women and other March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00125 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

126 G:\COMP\PHSA\PHSA-MERGED.XML 126 Sec. 317K PUBLIC HEALTH SERVICE ACT groups of women with disproportionately high rates of ma- ternal mortality; (I) activities to reduce disparities in maternity services and outcomes; (J) an examination of the relationship between inter- personal violence and maternal complications and mor- tality; (K) preventing and reducing adverse health con- sequences that may result from smokingand substance abuse and misuse before, during and after pregnancy; (L) preventing infections that cause maternal and in- fant complications; and (M) other areas determined appropriate by the Sec- retary. (c) P ROGRAMS P REVENTION .—The Secretary may carry out ac- tivities to promote safe motherhood, including— (1) public education campaigns on healthy pregnancies; (2) education programs for physicians, nurses and other health care providers; (3) activities to promote community support services for pregnant women; and (4) activities to promote physical, mental, and behavioral health during, and up to 1 year following, pregnancy, with an emphasis on prevention of, and treatment for, mental health disorders and substance use disorder. ATERNAL M ORTALITY R EVIEW C OMMITTEES .— (d) M (1) I N GENERAL .—In order to participate in the program under subsection (a)(2)(D), the applicable maternal mortality review committee of the State, Indian tribe, or tribal organiza- tion shall— (A) include multidisciplinary and diverse membership that represents a variety of clinical specialties, State, trib- al, or local public health officials, epidemiologists, statisti- cians, community organizations, geographic regions within the area covered by such committee, and individuals or or- ganizations that represent the populations in the area cov- ered by such committee that are most affected by preg- nancy-related deaths or pregnancy-associated deaths and lack of access to maternal health care services; and (B) demonstrate to the Centers for Disease Control and Prevention that such maternal mortality review com- mittee’s methods and processes for data collection and re- view, as required under paragraph (3), use best practices to reliably determine and include all pregnancy-associated deaths and pregnancy-related deaths, regardless of the outcome of the pregnancy. (2) P ROCESS FOR CONFIDENTIAL REPORTING .—States, Indian tribes, and tribal organizations that participate in the program described in this subsection shall, through the State maternal mortality review committee, develop a process that— (A) provides for confidential case reporting of preg- nancy-associated and pregnancy-related deaths to the ap- propriate State or tribal health agency, including such re- porting by— March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00126 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

127 G:\COMP\PHSA\PHSA-MERGED.XML 127 Sec. 317K PUBLIC HEALTH SERVICE ACT (i) health care professionals; (ii) health care facilities; (iii) any individual responsible for completing death records, including medical examiners and med- ical coroners; and (iv) other appropriate individuals or entities; and (B) provides for voluntary and confidential case report- ing of pregnancy-associated deaths and pregnancy-related deaths to the appropriate State or tribal health agency by family members of the deceased, and other appropriate in- dividuals, for purposes of review by the applicable mater- nal mortality review committee; and (C) shall include— (i) making publicly available contact information of the committee for use in such reporting; and (ii) conducting outreach to local professional orga- nizations, community organizations, and social serv- ices agencies regarding the availability of the review committee. (3) D .—States, Indian tribes, ATA COLLECTION AND REVIEW and tribal organizations that participate in the program de- scribed in this subsection shall— (A) annually identify pregnancy-associated deaths and pregnancy-related deaths— (i) through the appropriate vital statistics unit by— (I) matching each death record related to a pregnancy-associated death or pregnancy-related death in the State or tribal area in the applicable year to a birth certificate of an infant or fetal death record, as applicable; (II) to the extent practicable, identifying an underlying or contributing cause of each preg- nancy-associated death and each pregnancy-re- lated death in the State or tribal area in the ap- plicable year; and (III) collecting data from medical examiner and coroner reports, as appropriate; (ii) using other appropriate methods or informa- tion to identify pregnancy-associated deaths and preg- nancy-related deaths, including deaths from pregnancy outcomes not identified through clause (i)(I); (B) through the maternal mortality review committee, review data and information to identify adverse outcomes that may contribute to pregnancy-associated death and pregnancy-related death, and to identify trends, patterns, and disparities in such adverse outcomes to allow the State, Indian tribe, or tribal organization to make rec- ommendations to individuals and entities described in paragraph (2)(A), as appropriate, to improve maternal care and reduce pregnancy-associated death and pregnancy-re- lated death; (C) identify training available to the individuals and entities described in paragraph (2)(A) for accurate identi- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00127 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

128 G:\COMP\PHSA\PHSA-MERGED.XML 128 Sec. 317K PUBLIC HEALTH SERVICE ACT fication and reporting of pregnancy-associated and preg- nancy-related deaths; (D) ensure that, to the extent practicable, the data col- lected and reported under this paragraph is in a format that allows for analysis by the Centers for Disease Control and Prevention; and (E) publicly identify the methods used to identify preg- nancy-associated deaths and pregnancy-related deaths in accordance with this section. (4) C .—States, Indian tribes, and tribal or- ONFIDENTIALITY ganizations participating in the program described in this sub- section shall establish confidentiality protections to ensure, at a minimum, that— (A) there is no disclosure by the maternal mortality re- view committee, including any individual members of the committee, to any person, including any government offi- cial, of any identifying information about any specific ma- ternal mortality case; and (B) no information from committee proceedings, in- cluding deliberation or records, is made public unless spe- cifically authorized under State and Federal law. (5) R .—For fiscal year 2019, and each sub- EPORTS TO CDC sequent fiscal year, each maternal mortality review committee participating in the program described in this subsection shall submit to the Director of the Centers for Disease Control and Prevention a report that includes— (A) data, findings, and any recommendations of such committee; and (B) as applicable, information on the implementation during such year of any recommendations submitted by the committee in a previous year. TATE PARTNERSHIPS .—States may partner with one or (6) S more neighboring States to carry out the activities under this subparagraph. With respect to the States in such a partner- ship, any requirement under this subparagraph relating to the reporting of information related to such activities shall be deemed to be fulfilled by each such State if a single such report is submitted for the partnership. (7) A PPROPRIATE MECHANISMS FOR INDIAN TRIBES AND TRIB - AL ORGANIZATIONS .—The Secretary, in consultation with Indian tribes, shall identify and establish appropriate mechanisms for Indian tribes and tribal organizations to demonstrate, report data, and conduct the activities as required for participation in the program described in this subsection. Such mechanisms may include technical assistance with respect to grant applica- tion and submission procedures, and award management ac- tivities. (8) R .—The Secretary shall develop ESEARCH AVAILABILITY a process to ensure that data collected under paragraph (5) is made available, as appropriate and practicable, for research purposes, in a manner that protects individually identifiable or potentially identifiable information and that is consistent with State and Federal privacy law. EFINITIONS .—In this section— (e) D March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00128 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

129 G:\COMP\PHSA\PHSA-MERGED.XML 129 Sec. 317L PUBLIC HEALTH SERVICE ACT (1) the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given such terms in section 4 of the Indian Self- Determination and Education Assistance Act; (2) the term ‘‘pregnancy-associated death’’ means a death of a woman, by any cause, that occurs during, or within 1 year following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy; and (3) the term ‘‘pregnancy-related death’’ means a death of a woman that occurs during, or within 1 year following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy— (A) from any cause related to, or aggravated by, the pregnancy or its management; and (B) not from accidental or incidental causes. (f) A PPROPRIATIONS .—For the purpose of UTHORIZATION OF A carrying out this section, there are authorized to be appropriated $58,000,000 for each of fiscal years 2019 through 2023. PRENATAL AND POSTNATAL HEALTH N . 317L. 247b–13 EC (a) I ø G ENERAL .—The Secretary, acting ¿ S through the Director of the Centers for Disease Control and Pre- vention, shall carry out programs— (1) to collect, analyze, and make available data on prenatal smoking and alcohol and other substance abuse and misuse, including— (A) data on— (i) the incidence, prevalence, and implications of such activities; and (ii) the incidence and prevalence of implications and outcomes, including neonatal abstinence syndrome and other maternal and child health outcomes associ- ated with such activities; and (B) additional information or data, as appropriate, on family health history, medication exposures during preg- nancy, demographic information, such as race, ethnicity, geographic location, and family history, and other relevant information, to inform such analysis; (2) to conduct applied epidemiological research on the pre- vention and long-term outcomes associated with prenatal and postnatal smoking, alcohol and other substance abuse and mis- use; (3) to support, conduct, and evaluate the effectiveness of educational, treatment, and cessation programs; (4) to provide information and education to the public on the prevention and implications of prenatal and postnatal smoking, alcohol and other substance abuse and misuse; and (5) to issue public reports on the analysis of data described in paragraph (1), including analysis of— (A) long-term outcomes of children affected by neo- natal abstinence syndrome; (B) health outcomes associated with prenatal smoking, alcohol, and substance abuse and misuse; and March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00129 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

130 G:\COMP\PHSA\PHSA-MERGED.XML 130 Sec. 317L–1 PUBLIC HEALTH SERVICE ACT (C) relevant studies, evaluations, or information the Secretary determines to be appropriate. (b) G RANTS .—In carrying out subsection (a), the Secretary may award grants to and enter into contracts with States, local govern- ments, tribal entities, scientific and academic institutions, federally qualified health centers, and other public and nonprofit entities, and may provide technical and consultative assistance to such enti- ties. (c) C .—To carry out this section, the OORDINATING A CTIVITIES Secretary may— (1) provide technical and consultative assistance to entities receiving grants under subsection (b); (2) ensure a pathway for data sharing between States, tribal entities, and the Centers for Disease Control and Pre- vention; (3) ensure data collection under this section is consistent with applicable State, Federal, and Tribal privacy laws; and (4) coordinate with the National Coordinator for Health In- formation Technology, as appropriate, to assist States and Tribes in implementing systems that use standards recognized by such National Coordinator, as such recognized standards are available, in order to facilitate interoperability between such systems and health information technology systems, in- cluding certified health information technology. (d) A PPROPRIATIONS .—For the purpose of UTHORIZATION OF A carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2019 through 2023. ø 247b–13a ¿ SCREENING AND TREATMENT FOR MATERNAL SEC. 317L–1. DEPRESSION. (a) G RANTS .—The Secretary shall make grants to States to es- tablish, improve, or maintain programs for screening, assessment, and treatment services, including culturally and linguistically ap- propriate services, as appropriate, for women who are pregnant, or who have given birth within the preceding 12 months, for maternal depression. (b) A PPLICATION .—To seek a grant under this section, a State shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may re- quire. At a minimum, any such application shall include expla- nations of— (1) how a program, or programs, will increase the percent- age of women screened and treated, as appropriate, for mater- nal depression in 1 or more communities; and (2) how a program, or programs, if expanded, would in- crease access to screening and treatment services for maternal depression. (c) P .—In awarding grants under this section, the Sec- RIORITY retary may give priority to States proposing to improve or enhance access to screening services for maternal depression in primary care settings. SE OF F UNDS .—The activities eligible for funding through (d) U a grant under subsection (a)— (1) shall include— March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00130 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

131 G:\COMP\PHSA\PHSA-MERGED.XML 131 Sec. 317M PUBLIC HEALTH SERVICE ACT (A) providing appropriate training to health care pro- viders; and (B) providing information to health care providers, in- cluding information on maternal depression screening, treatment, and followup support services, and linkages to community-based resources; and (2) may include— (A) enabling health care providers (including obstetri- cian-gynecologists, pediatricians, psychiatrists, mental health care providers, and adult primary care clinicians) to provide or receive real-time psychiatric consultation (in- person or remotely) to aid in the treatment of pregnant and parenting women; (B) establishing linkages with and among community- based resources, including mental health resources, pri- mary care resources, and support groups; and (C) utilizing telehealth services for rural areas and medically underserved areas (as defined in section 330I(a)). A UTHORIZATION OF .—To carry out this sec- PPROPRIATIONS (e) A tion, there are authorized to be appropriated $5,000,000 for each of fiscal years 2018 through 2022. ORAL HEALTH PROMOTION AND DISEASE PREVENTION . 317M. ø 247b–14 ¿ (a) G EC I NCREASE R ESOURCES RANTS TO S C OMMUNITY W ATER F LUORIDATION .— FOR N GENERAL (1) I .—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention, may make grants to States and Indian tribes for the purpose of in- creasing the resources available for community water fluorida- tion. .—A State shall use amounts provided SE OF FUNDS (2) U under a grant under paragraph (1)— (A) to purchase fluoridation equipment; (B) to train fluoridation engineers; (C) to develop educational materials on the benefits of fluoridation; or (D) to support the infrastructure necessary to monitor and maintain the quality of water fluoridation. OMMUNITY W ATER F LUORIDATION .— (b) C N GENERAL .—The Secretary, acting through the Direc- (1) I tor of the Centers for Disease Control and Prevention and in collaboration with the Director of the Indian Health Service, shall establish a demonstration project that is designed to as- sist rural water systems in successfully implementing the water fluoridation guidelines of the Centers for Disease Control and Prevention that are entitled ‘‘Engineering and Administra- tive Recommendations for Water Fluoridation, 1995’’ (referred to in this subsection as the ‘‘EARWF’’). (2) R EQUIREMENTS .— OLLABORATION .—In collaborating under para- (A) C graph (1), the Directors referred to in such paragraph shall ensure that technical assistance and training are provided March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00131 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

132 G:\COMP\PHSA\PHSA-MERGED.XML 132 Sec. 317M PUBLIC HEALTH SERVICE ACT to tribal programs located in each of the 12 areas of the Indian Health Service. The Director of the Indian Health Service shall provide coordination and administrative sup- port to tribes under this section. (B) G ENERAL USE OF FUNDS .—Amounts made available under paragraph (1) shall be used to assist small water systems in improving the effectiveness of water fluorida- tion and to meet the recommendations of the EARWF. (C) F LUORIDATION SPECIALISTS .— N GENERAL (i) I .—In carrying out this subsection, the Secretary shall provide for the establishment of fluoridation specialist engineering positions in each of the Dental Clinical and Preventive Support Centers through which technical assistance and training will be provided to tribal water operators, tribal utility op- erators and other Indian Health Service personnel working directly with fluoridation projects. (ii) L IAISON .—A fluoridation specialist shall serve as the principal technical liaison between the Indian Health Service and the Centers for Disease Control and Prevention with respect to engineering and fluori- dation issues. (iii) CDC.—The Director of the Centers for Dis- ease Control and Prevention shall appoint individuals to serve as the fluoridation specialists. .—The project established under MPLEMENTATION (D) I this subsection shall be planned, implemented and evalu- ated over the 5-year period beginning on the date on which funds are appropriated under this section and shall be de- signed to serve as a model for improving the effectiveness of water fluoridation systems of small rural communities. VALUATION (3) E .—In conducting the ongoing evaluation as provided for in paragraph (2)(D), the Secretary shall ensure that such evaluation includes— (A) the measurement of changes in water fluoridation compliance levels resulting from assistance provided under this section; (B) the identification of the administrative, technical and operational challenges that are unique to the fluorida- tion of small water systems; (C) the development of a practical model that may be easily utilized by other tribal, State, county or local gov- ernments in improving the quality of water fluoridation with emphasis on small water systems; and (D) the measurement of any increased percentage of Native Americans or Alaskan Natives who receive the ben- efits of optimally fluoridated water. (c) S -B ASED D ENTAL S EALANT P ROGRAM .— CHOOL N GENERAL .—The Secretary, acting through the Direc- (1) I tor of the Centers for Disease Control and Prevention and in collaboration with the Administrator of the Health Resources and Services Administration, shall award a grant to each of the 50 States and territories and to Indians, Indian tribes, trib- al organizations and urban Indian organizations (as such March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00132 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

133 G:\COMP\PHSA\PHSA-MERGED.XML 133 Sec. 317M PUBLIC HEALTH SERVICE ACT terms are defined in section 4 of the Indian Health Care Im- provement Act) to provide for the development of school-based dental sealant programs to improve the access of children to sealants. .—A State shall use amounts received SE OF FUNDS (2) U under a grant under paragraph (1) to provide funds to eligible school-based entities or to public elementary or secondary schools to enable such entities or schools to provide children with access to dental care and dental sealant services. Such services shall be provided by licensed dental health profes- sionals in accordance with State practice licensing laws. (3) E .—To be eligible to receive funds under LIGIBILITY paragraph (1), an entity shall— (A) prepare and submit to the State an application at such time, in such manner and containing such informa- tion as the State may require; and (B) be a public elementary or secondary school— (i) that is located in an urban area in which and more than 50 percent of the student population is par- ticipating in Federal or State free or reduced meal pro- grams; or (ii) that is located in a rural area and, with re- spect to the school district in which the school is lo- cated, the district involved has a median income that is at or below 235 percent of the poverty line, as de- fined in section 673(2) of the Community Services Block Grant Act (42 U.S.C. 9902(2)). RAL H EALTH I NFRASTRUCTURE .— (d) O (1) C .—The Secretary, acting OOPERATIVE AGREEMENTS through the Director of the Centers for Disease Control and Prevention, shall enter into cooperative agreements with State, territorial, and Indian tribes or tribal organizations (as those terms are defined in section 4 of the Indian Health Care Im- provement Act) to establish oral health leadership and pro- gram guidance, oral health data collection and interpretation, (including determinants of poor oral health among vulnerable populations), a multi-dimensional delivery system for oral health, and to implement science-based programs (including dental sealants and community water fluoridation) to improve oral health. (2) A UTHORIZATION OF APPROPRIATIONS .—There is author- ized to be appropriated such sums as necessary to carry out this subsection for fiscal years 2010 through 2014. EFINITIONS .—For purposes of this section, the term ‘‘In- (e) D dian tribe’’ means an Indian tribe or tribal organization as defined in section 4(b) and section 4(c) of the Indian Self-Determination and Education Assistance Act. (f) A A PPROPRIATIONS .—For the purpose of UTHORIZATION OF carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00133 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

134 G:\COMP\PHSA\PHSA-MERGED.XML 134 Sec. 317N PUBLIC HEALTH SERVICE ACT 247b–15 ¿ SEC. 317N. ø SURVEILLANCE AND EDUCATION REGARDING IN- FECTIONS ASSOCIATED WITH ILLICIT DRUG USE AND OTHER RISK FACTORS. N ENERAL .—The Secretary, acting through the Director of (a) I G the Centers for Disease Control and Prevention, may (directly or through grants to public and nonprofit private entities) provide for programs for the following: (1) To cooperate with States and Indian tribes in imple- menting or maintaining a national system to determine the in- cidence of infections commonly associated with illicit drug use, such as viral hepatitis, human immunodeficiency virus, and in- fective endocarditis, and to assist the States in determining the prevalence of such infections, which may include the reporting of cases of such infections. (2) To identify, counsel, and offer testing to individuals who are at risk of infections described in paragraph (1) result- ing from illicit drug use, receiving blood transfusions prior to July 1992, or other risk factors. (3) To provide appropriate referrals for counseling, testing, and medical treatment of individuals identified under para- graph (2) and to ensure, to the extent practicable, the provision of appropriate follow-up services. (4) To develop and disseminate public information and education programs for the detection and control of infections described in paragraph (1), with priority given to high-risk populations as determined by the Secretary. (5) To improve the education, training, and skills of health professionals in the detection and control of infections de- scribed in paragraph (1), including to improve coordination of treatment of substance use disorders and infectious diseases, with priority given to substance use disorder treatment pro- viders, pediatricians and other primary care providers, obste- trician-gynecologists, and infectious disease clinicians, includ- ing HIV clinicians. ABORATORY P ROCEDURES .—The Secretary may (directly or (b) L through grants to public and nonprofit private entities) carry out programs to provide for improvements in the quality of clinical-lab- oratory procedures regarding infections described in subsection (a)(1). (c) D EFINITION .—In this section, the term ‘‘Indian tribe’’ has the meaning given that term in section 4 of the Indian Self-Deter- mination and Education Assistance Act. A UTHORIZATION OF .—For the purpose of PPROPRIATIONS (d) A carrying out this section, there are authorized to be appropriated $40,000,000 for each of the fiscal years 2019 through 2023. GRANTS FOR LEAD POISONING RELATED ACTIVITIES S . 317O. ø 247b–16 ¿ (a) A UTHORITY T O M AKE G RANTS .— EC N GENERAL .—The Secretary shall make grants to (1) I States to support public health activities in States and local- ities where data suggests that at least 5 percent of preschool- age children have an elevated blood lead level through— March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00134 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

135 G:\COMP\PHSA\PHSA-MERGED.XML 135 Sec. 317O PUBLIC HEALTH SERVICE ACT (A) effective, ongoing outreach and community edu- cation targeted to families most likely to be at risk for lead poisoning; (B) individual family education activities that are de- signed to reduce ongoing exposures to lead for children with elevated blood lead levels, including through home visits and coordination with other programs designed to identify and treat children at risk for lead poisoning; and (C) the development, coordination and implementation of community-based approaches for comprehensive lead poisoning prevention from surveillance to lead hazard con- trol. TATE MATCH .—A State is not eligible for a grant under (2) S this section unless the State agrees to expend (through State or local funds) $1 for every $2 provided under the grant to carry out the activities described in paragraph (1). .—To be eligible to receive a grant under (3) A PPLICATION this section, a State shall submit an application to the Sec- retary in such form and manner and containing such informa- tion as the Secretary may require. S W O THER C HILDREN OORDINATION ITH P ROGRAMS .—A ’ (b) C State shall identify in the application for a grant under this section how the State will coordinate operations and activities under the grant with— (1) other programs operated in the State that serve chil- dren with elevated blood lead levels, including any such pro- grams operated under title V, XIX, or XXI of the Social Secu- rity Act; and (2) one or more of the following— (A) the child welfare and foster care and adoption as- sistance programs under parts B and E of title IV of such Act; (B) the head start program established under the Head Start Act (42 U.S.C. 9831 et seq.); (C) the program of assistance under the special sup- plemental nutrition program for women, infants and chil- dren (WIC) under section 17 of the Child Nutrition Act of 1966 (42 U.S.C. 1786); (D) local public and private elementary or secondary schools; or (E) public housing agencies, as defined in section 3 of the United States Housing Act of 1937 (42 U.S.C. 1437a). (c) P M EASURES .—The Secretary shall establish ERFORMANCE needs indicators and performance measures to evaluate the activi- ties carried out under grants awarded under this section. Such in- dicators shall be commensurate with national measures of mater- nal and child health programs and shall be developed in consulta- tion with the Director of the Centers for Disease Control and Pre- vention. UTHORIZATION OF A PPROPRIATIONS .—There are authorized (d) A to be appropriated to carry out this section such sums as may be necessary for each of the fiscal years 2001 through 2005. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00135 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

136 G:\COMP\PHSA\PHSA-MERGED.XML 136 PUBLIC HEALTH SERVICE ACT Sec. 317P 13 JOHANNA ( S LAW ) HUMAN PAPILLOMAVIRUS ’ EC . 317P. ø 247b–17 ¿ (a) S URVEILLANCE .— S N GENERAL .—The Secretary, acting through the Cen- (1) I ters for Disease Control and Prevention, shall— (A) enter into cooperative agreements with States and other entities to conduct sentinel surveillance or other spe- cial studies that would determine the prevalence in var- ious age groups and populations of specific types of human papillomavirus (referred to in this section as ‘‘HPV’’) in dif- ferent sites in various regions of the United States, through collection of special specimens for HPV using a va- riety of laboratory-based testing and diagnostic tools; and (B) develop and analyze data from the HPV sentinel surveillance system described in subparagraph (A). (2) R EPORT .—The Secretary shall make a progress report to the Congress with respect to paragraph (1) no later than 1 year after the effective date of this section. (b) P .— ROGRAM P REVENTION A CTIVITIES ; E DUCATION (1) I .—The Secretary, acting through the Cen- N GENERAL ters for Disease Control and Prevention, shall conduct preven- tion research on HPV, including— (A) behavioral and other research on the impact of HPV-related diagnosis on individuals; (B) formative research to assist with the development of educational messages and information for the public, for patients, and for their partners about HPV; (C) surveys of physician and public knowledge, atti- tudes, and practices about genital HPV infection; and (D) upon the completion of and based on the findings under subparagraphs (A) through (C), develop and dis- seminate educational materials for the public and health care providers regarding HPV and its impact and preven- tion. (2) R FINAL PROPOSAL EPORT ; .—The Secretary shall make a progress report to the Congress with respect to paragraph (1) not later than 1 year after the effective date of this section, and shall develop a final report not later than 3 years after such effective date, including a detailed summary of the signifi- cant findings and problems and the best strategies to prevent future infections, based on available science. REVENTION .— DUCATION AND P (c) HPV E (1) I N GENERAL .—The Secretary shall prepare and dis- tribute educational materials for health care providers and the public that include information on HPV. Such materials shall address— (A) modes of transmission; (B) consequences of infection, including the link be- tween HPV and cervical cancer; 13 The typeface and casing of the parenthetical matter in the section heading appears in law with all letter cased in lowercase and in bold face type; however, it is reflect here as it should appear in light face and all small caps. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00136 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

137 G:\COMP\PHSA\PHSA-MERGED.XML 137 Sec. 317P PUBLIC HEALTH SERVICE ACT (C) the available scientific evidence on the effective- ness or lack of effectiveness of condoms in preventing in- fection with HPV; and (D) the importance of regular Pap smears, and other diagnostics for early intervention and prevention of cer- vical cancer purposes in preventing cervical cancer. (2) M EDICALLY ACCURATE INFORMATION .—Educational ma- terial under paragraph (1), and all other relevant educational and prevention materials prepared and printed from this date forward for the public and health care providers by the Sec- retary (including materials prepared through the Food and Drug Administration, the Centers for Disease Control and Pre- vention, and the Health Resources and Services Administra- tion), or by contractors, grantees, or subgrantees thereof, that are specifically designed to address STDs including HPV shall contain medically accurate information regarding the effective- ness or lack of effectiveness of condoms in preventing the STD the materials are designed to address. Such requirement only applies to materials mass produced for the public and health care providers, and not to routine communications. (d) J S AW .— OHANNA L ’ .— (1) N ATIONAL PUBLIC AWARENESS CAMPAIGN .—The Secretary shall carry out a na- N GENERAL (A) I tional campaign to increase the awareness and knowledge of health care providers and women with respect to gynecologic cancers. RITTEN MATERIALS .—Activities under the na- (B) W tional campaign under subparagraph (A) shall include— (i) maintaining a supply of written materials that provide information to the public on gynecologic can- cers; and (ii) distributing the materials to members of the public upon request. (C) P UBLIC SERVICE ANNOUNCEMENTS .—Activities under the national campaign under subparagraph (A) shall, in accordance with applicable law and regulations, include developing and placing, in telecommunications media, public service announcements intended to encour- age women to discuss with their physicians their risks of gynecologic cancers. Such announcements shall inform the public on the manner in which the written materials re- ferred to in subparagraph (B) can be obtained upon re- quest, and shall call attention to early warning signs and risk factors based on the best available medical informa- tion. (2) R .— EPORT AND STRATEGY (A) R EPORT .—Not later than 6 months after the date of the enactment of this subsection, the Secretary shall submit to the Congress a report including the following: (i) A description of the past and present activities of the Department of Health and Human Services to increase awareness and knowledge of the public with respect to different types of cancer, including gynecologic cancers. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00137 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

138 G:\COMP\PHSA\PHSA-MERGED.XML 138 Sec. 317P PUBLIC HEALTH SERVICE ACT (ii) A description of the past and present activities of the Department of Health and Human Services to increase awareness and knowledge of health care pro- viders with respect to different types of cancer, includ- ing gynecologic cancers. (iii) For each activity described pursuant to clause (i) or (ii), a description of the following: (I) The funding for such activity for fiscal year 2006 and the cumulative funding for such activity for previous fiscal years. (II) The background and history of such activ- ity, including— (aa) the goals of such activity; (bb) the communications objectives of such activity; (cc) the identity of each agency within the Department of Health and Human Services responsible for any aspect of the activity; and (dd) how such activity is or was expected to result in change. (III) How long the activity lasted or is ex- pected to last. (IV) The outcomes observed and the evalua- tion methods, if any, that have been, are being, or will be used with respect to such activity. (V) For each such outcome or evaluation method, a description of the associated results, analyses, and conclusions. TRATEGY .— (B) S EVELOPMENT ; SUBMISSION TO CONGRESS .—Not (i) D later than 3 months after submitting the report re- quired by subparagraph (A), the Secretary shall de- velop and submit to the Congress a strategy for im- proving efforts to increase awareness and knowledge of the public and health care providers with respect to different types of cancer, including gynecological can- cers. (ii) C ONSULTATION .—In developing the strategy under clause (i), the Secretary should consult with qualified private sector groups, including nonprofit or- ganizations. (3) F ULL COMPLIANCE .— N GENERAL .—Not later than March 1, 2008, the (A) I Secretary shall ensure that all provisions of this section, including activities directed to be carried out by the Cen- ters for Disease Control and Prevention and the Food and Drug Administration, are fully implemented and being complied with. Not later than April 30, 2008, the Secretary shall submit to Congress a report that certifies compliance with the preceding sentence and that contains a descrip- tion of all activities undertaken to achieve such compli- ance. (B) If the Secretary fails to submit the certification as provided for under subparagraph (A), the Secretary shall, March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00138 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

139 G:\COMP\PHSA\PHSA-MERGED.XML 139 Sec. 317Q PUBLIC HEALTH SERVICE ACT not later than 3 months after the date on which the report is to be submitted under subparagraph (A), and every 3 months thereafter, submit to Congress an explanation as to why the Secretary has not yet complied with the first sentence of subparagraph (A), a detailed description of all actions undertaken within the month for which the report is being submitted to bring the Secretary into compliance with such sentence, and the anticipated date the Secretary expects to be in full compliance with such sentence. (4) C ONSULTATION WITH NONPROFIT GYNECOLOGIC CANCER ORGANIZATIONS .—In carrying out the national campaign under this subsection, the Secretary shall consult with nonprofit gynecologic cancer organizations, with a mission both to con- quer ovarian or other gynecologic cancer and to provide out- reach to State and local governments and communities, for the purpose of determining the best practices for providing gynecologic cancer information and outreach services to varied populations. 14 (6) A UTHORIZATION OF APPROPRIATIONS .—For the pur- pose of carrying out this subsection, there is authorized to be appropriated $16,500,000 for the period of fiscal years 2007 through 2009 and $18,000,000 for the period of fiscal years 2012 through 2014. SEC. 317Q. ø 247b–18 ¿ SURVEILLANCE AND RESEARCH REGARDING MUSCULAR DYSTROPHY. (a) I N G ENERAL .—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants and cooperative agreements to public or nonprofit private entities (including health departments of States and political subdivisions of States, and including universities and other educational entities) for the collection, analysis, and reporting of data on Duchenne and other forms of muscular dystrophy. In making such awards, the Secretary may provide direct technical assistance in lieu of cash. (b) N M USCULAR D YSTROPHY E PIDEMIOLOGY P RO - ATIONAL .—The Secretary, acting through the Director of the Centers GRAM for Disease Control and Prevention, may award grants to public or nonprofit private entities (including health departments of States and political subdivisions of States, and including universities and other educational entities) for the purpose of carrying out epidemio- logical activities regarding Duchenne and other forms of muscular dystrophies, including collecting and analyzing information on the number, incidence, correlates, and symptoms of cases. In carrying out the preceding sentence, the Secretary shall provide for a na- tional surveillance program and, to the extent possible, ensure that data be representative of all affected populations and shared in a timely manner. In making awards under this subsection, the Sec- retary may provide direct technical assistance in lieu of cash. (c) C OORDINATION W ITH C ENTERS OF E XCELLENCE .—The Sec- retary shall ensure that epidemiological information under sub- sections (a) and (b) is made available to centers of excellence sup- ported under section 404E(b) by the Director of the National Insti- tutes of Health. 14 So in law. There is no paragraph (5). March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00139 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

140 G:\COMP\PHSA\PHSA-MERGED.XML 140 Sec. 317R PUBLIC HEALTH SERVICE ACT ATA .—In carrying out this section, the Secretary may en- (d) D sure that any data on patients that is collected as part of the Mus- cular Dystrophy STARnet (under a grant under this section) is reg- ularly updated to reflect changes in patient condition over time. (e) R EPORTS AND S TUDY .— .—Not later than 18 months after the (1) A NNUAL REPORT date of the enactment of the Paul D. Wellstone Muscular Dys- trophy Community Assistance, Research, and Education Amendments of 2008, and annually thereafter, the Director of the Centers for Disease Control and Prevention shall submit to the appropriate committees of the Congress a report— (A) concerning the activities carried out by MD 15 STARnet site funded under this section during the year for which the report is prepared; (B) containing the data collected and findings derived from the MD STARnet sites each fiscal year (as funded under a grant under this section during fiscal years 2008 through 2012); and (C) that every 2 years outlines prospective data collec- tion objectives and strategies. (2) T RACKING HEALTH OUTCOMES .—The Secretary may pro- vide health outcome data on the health and survival of people with muscular dystrophy. (f) A UTHORIZATION OF PPROPRIATIONS .—There are authorized A to be appropriated such sums as may be necessary to carry out this section. SEC. 317R. ø 247b–20 ¿ FOOD SAFETY GRANTS. ENERAL (a) I N G .—The Secretary may award grants to States and Indian tribes (as defined in section 4(e) of the Indian Self-De- termination and Education Assistance Act (25 U.S.C. 450b(e))) to expand participation in networks to enhance Federal, State, and local food safety efforts, including meeting the costs of establishing and maintaining the food safety surveillance, technical, and labora- tory capacity needed for such participation. (b) A UTHORIZATION OF PPROPRIATIONS .—For the purpose of A carrying out this section, there are authorized to be appropriated $19,500,000 for fiscal year 2010, and such sums as may be nec- essary for each of the fiscal years 2011 through 2015. SEC. 317S. ø 247b–21 ¿ MOSQUITO-BORNE DISEASES; COORDINATION GRANTS TO STATES; ASSESSMENT AND CONTROL GRANTS TO POLITICAL SUBDIVISIONS. RANTS TO OORDINATION G TATES S (a) C ; A SSESSMENT G RANTS TO P S UBDIVISIONS .— OLITICAL N GENERAL .—With respect to mosquito control pro- (1) I grams to prevent and control mosquito-borne diseases (referred to in this section as ‘‘control programs’’), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States for the purpose of— (A) coordinating control programs in the State in- volved; and (B) assisting such State in making grants to political subdivisions of the State to conduct assessments to deter- 15 So in law. The term ‘‘site’’ probably should be ‘‘sites’’. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00140 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

141 G:\COMP\PHSA\PHSA-MERGED.XML 141 Sec. 317S PUBLIC HEALTH SERVICE ACT mine the immediate needs in such subdivisions for control programs, and to develop, on the basis of such assess- ments, plans for carrying out control programs in the sub- divisions. REFERENCE IN MAKING GRANTS .—In making grants (2) P under paragraph (1), the Secretary shall give preference to States that have one or more political subdivisions with an in- cidence, prevalence, or high risk of mosquito-borne disease, or a population of infected mosquitoes, that is substantial relative to political subdivisions in other States. ERTAIN REQUIREMENTS .—A grant may be made under (3) C paragraph (1) only if— (A) the State involved has developed, or agrees to de- velop, a plan for coordinating control programs in the State, and the plan takes into account any assessments or plans described in subsection (b)(3) that have been con- ducted or developed, respectively, by political subdivisions in the State; (B) in developing such plan, the State consulted or will consult (as the case may be under subparagraph (A)) with political subdivisions in the State that are carrying out or planning to carry out control programs; (C) the State agrees to monitor control programs in the State in order to ensure that the programs are carried out in accordance with such plan, with priority given to co- ordination of control programs in political subdivisions de- scribed in paragraph (2) that are contiguous; (D) the State agrees that the State will make grants to political subdivisions as described in paragraph (1)(B), and that such a grant will not exceed $10,000; and (E) the State agrees that the grant will be used to sup- plement, and not supplant, State and local funds available for the purpose described in paragraph (1). (4) R .—A grant may be made under EPORTS TO SECRETARY paragraph (1) only if the State involved agrees that, promptly after the end of the fiscal year for which the grant is made, the State will submit to the Secretary a report that— (A) describes the activities of the State under the grant; and (B) contains an evaluation of whether the control pro- grams of political subdivisions in the State were effectively coordinated with each other, which evaluation takes into account any reports that the State received under sub- section (b)(5) from such subdivisions. .—A State may not receive more UMBER OF GRANTS (5) N than one grant under paragraph (1). (b) P C ONTROL G RANTS TO P OLITICAL S UBDIVI - REVENTION AND .— SIONS N GENERAL .—The Secretary, acting through the Direc- (1) I tor of the Centers for Disease Control and Prevention, may make grants to political subdivisions of States or consortia of political subdivisions of States, for the operation of control pro- grams. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00141 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

142 G:\COMP\PHSA\PHSA-MERGED.XML 142 Sec. 317S PUBLIC HEALTH SERVICE ACT .—In making grants (2) P REFERENCE IN MAKING GRANTS under paragraph (1), the Secretary shall give preference to a political subdivision or consortium of political subdivisions that— (A) has— (i) a history of elevated incidence or prevalence of mosquito-borne disease; (ii) a population of infected mosquitoes; or (iii) met criteria determined by the Secretary to suggest an increased risk of elevated incidence or prevalence of mosquito-borne disease in the pending fiscal year; (B) demonstrates to the Secretary that such political subdivision or consortium of political subdivisions will, if appropriate to the mosquito circumstances involved, effec- tively coordinate the activities of the control programs with contiguous political subdivisions; (C) demonstrates to the Secretary (directly or through State officials) that the State in which such a political sub- division or consortium of political subdivisions is located has identified or will identify geographic areas in such State that have a significant need for control programs and will effectively coordinate such programs in such areas; and (D) is located in a State that has received a grant under subsection (a). .—A grant may EQUIREMENT OF ASSESSMENT AND PLAN (3) R be made under paragraph (1) only if the political subdivision or consortium of political subdivisions involved— (A) has conducted an assessment to determine the im- mediate needs in such subdivision or consortium for a con- trol program, including an entomological survey of poten- tial mosquito breeding areas; and (B) has, on the basis of such assessment, developed a plan for carrying out such a program. .— EQUIREMENT OF MATCHING FUNDS (4) R N GENERAL .—With respect to the costs of a control (A) I program to be carried out under paragraph (1) by a polit- ical subdivision or consortium of political subdivisions, a grant under such paragraph may be made only if the sub- division or consortium agrees to make available (directly or through donations from public or private entities) non- Federal contributions toward such costs in an amount that 1 is not less than 3 of such costs ($1 for each $2 of Federal ⁄ funds provided in the grant). (B) D .—Non- ETERMINATION OF AMOUNT CONTRIBUTED Federal contributions required in subparagraph (A) may be in cash or in kind, fairly evaluated, including plant, equip- ment, or services. Amounts provided by the Federal Gov- ernment, or services assisted or subsidized to any signifi- cant extent by the Federal Government, may not be in- cluded in determining the amount of such non-Federal con- tributions. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00142 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

143 G:\COMP\PHSA\PHSA-MERGED.XML 143 Sec. 317S PUBLIC HEALTH SERVICE ACT .—The Secretary may waive the require- AIVER (C) W ment established in subparagraph (A) if the Secretary de- termines that extraordinary economic conditions in the po- litical subdivision or consortium of political subdivisions involved justify the waiver. (5) R .—A grant may be made under EPORTS TO SECRETARY paragraph (1) only if the political subdivision or consortium of political subdivisions involved agrees that, promptly after the end of the fiscal year for which the grant is made, the subdivi- sion or consortium will submit to the Secretary, and to the State within which the subdivision or consortium is located, a report that describes the control program and contains an eval- uation of whether the program was effective. (6) A MOUNT OF GRANT ; NUMBER OF GRANTS .— (A) A .— MOUNT OF GRANT .—A grant under (i) S INGLE POLITICAL SUBDIVISION paragraph (1) awarded to a political subdivision for a fiscal year may not exceed $100,000. (ii) C .—A grant under paragraph (1) ONSORTIUM awarded to a consortium of 2 or more political subdivi- sions may not exceed $110,000 for each political sub- division. A consortium is not required to provide matching funds under paragraph (4) for any amounts received by such consortium in excess of amounts each political subdivision would have received separately. AIVER OF REQUIREMENT .—A grant may ex- (iii) W ceed the maximum amount in clause (i) or (ii) if the Secretary determines that the geographical area cov- ered by a political subdivision or consortium awarded a grant under paragraph (1) has an extreme need due to the size or density of— (I) the human population in such geographical area; or (II) the mosquito population in such geo- graphical area. (B) N UMBER OF GRANTS .—A political subdivision or a consortium of political subdivisions may not receive more than one grant under paragraph (1). (c) A RANTS .—A grant may be made under PPLICATIONS FOR G subsection (a) or (b) only if an application for the grant is sub- mitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section. ECHNICAL A SSISTANCE .—Amounts appropriated under sub- (d) T section (f) may be used by the Secretary to provide training and technical assistance with respect to the planning, development, and operation of assessments and plans under subsection (a) and con- trol programs under subsection (b). The Secretary may provide such technical assistance directly or through awards of grants or contracts to public and private entities. EFINITION OF P OLITICAL S UBDIVISION .—In this section, the (e) D term ‘‘political subdivision’’ means the local political jurisdiction immediately below the level of State government, including coun- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00143 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

144 G:\COMP\PHSA\PHSA-MERGED.XML 144 Sec. 317T PUBLIC HEALTH SERVICE ACT ties, parishes, and boroughs. If State law recognizes an entity of general government that functions in lieu of, and is not within, a county, parish, or borough, the Secretary may recognize an area under the jurisdiction of such other entities of general government as a political subdivision for purposes of this section. (f) A A UTHORIZATION OF .— PPROPRIATIONS .—For the purpose of carrying out this sec- (1) I N GENERAL tion, there are authorized to be appropriated $100,000,000 for fiscal year 2003, and such sums as may be necessary for each of fiscal years 2004 through 2007. (2) P UBLIC HEALTH EMERGENCIES .—In the case of control programs carried out in response to a mosquito-borne disease that constitutes a public health emergency, the authorization of appropriations under paragraph (1) is in addition to applica- ble authorizations of appropriations under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. (3) F .—For fiscal year ISCAL YEAR 2004 APPROPRIATIONS 2004, 50 percent or more of the funds appropriated under para- graph (1) shall be used to award grants to political subdivi- sions or consortia of political subdivisions under subsection (b). ¿ 247b–22 ø SEC. 317T. MICROBICIDE RESEARCH. N .—The Director of the Centers for Disease Con- ENERAL (a) I G trol and Prevention is strongly encouraged to fully implement the Centers’ microbicide agenda to support research and development of microbicides for use to prevent the transmission of the human immunodeficiency virus. (b) A UTHORIZATION OF A PPROPRIATIONS .—There are authorized to be appropriated such sums as may be necessary for each of fiscal years 2009 through 2013 to carry out this section. PROJECTS AND PROGRAMS FOR THE PREVENTION AND CONTROL OF 16 SEXUALLY TRANSMITTED DISEASES ¿ 247c . 318. EC S ø (a) The Secretary may provide technical as- sistance to appropriate public and non-profit private entities and to scientific institutions for their research in, and training and public health programs for the prevention and control of sexually trans- mitted diseases. (b) The Secretary may make grants to States, political subdivi- sions of States, and any other public and nonprofit private entity for— (1) research into the prevention and control of sexually transmitted diseases; (2) demonstration projects for the prevention and control of sexually transmitted diseases; 16 Title II of Public Law 103–333, an appropriations Act, provides (under the heading relating to the Centers for Disease Control and Prevention; see 108 Stat. 2550) in part as follows: ‘‘That funds appropriated under this heading for fiscal year 1995 and subsequent fiscal years shall be available for payment of the costs of medical care, related expenses, and burial expenses here- after incurred by or on behalf of any person who had participated in the study of untreated syphilis initiated in Tuskegee, Alabama, in 1932, in such amounts and subject to such terms and conditions as prescribed by the Secretary of Health and Human Services and for payment, in such amounts and subject to such terms and conditions, of such costs and expenses hereafter incurred by or on behalf of such person’s wife or offspring determined by the Secretary to have suffered injury or disease from syphilis contracted from such person’’. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00144 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

145 G:\COMP\PHSA\PHSA-MERGED.XML 145 Sec. 318 PUBLIC HEALTH SERVICE ACT (3) public information and education programs for the pre- vention and control of such diseases; and (4) education, training, and clinical skills improvement ac- tivities in the prevention and control of such diseases for health professionals (including allied health personnel). (c) The Secretary is also authorized to make project grants to States and, in consultation with the State health authority, to po- litical subdivisions of States, for— (1) sexually transmitted diseases surveillance activities, in- cluding the reporting, screening, and followup of diagnostic tests for, and diagnosed cases of, sexually transmitted diseases; (2) casefinding and case followup activities respecting sex- ually transmitted diseases, including contact tracing of infec- tious cases of sexually transmitted diseases and routine test- ing, including laboratory tests and followup systems; (3) interstate epidemiologic referral and followup activities respecting sexually transmitted diseases; and (4) such special studies or demonstrations to evaluate or test sexually transmitted diseases prevention and control strat- egies and activities as may be prescribed by the Secretary. (d) The Secretary may make grants to States and political sub- divisions of States for the development, implementation, and eval- uation of innovative, interdisciplinary approaches to the prevention and control of sexually transmitted diseases. (e)(1) For the purpose of making grants under subsections (b) through (d), there are authorized to be appropriated $85,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through 1998. (2) Each recipient of a grant under this section shall keep such records as the Secretary shall prescribe including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant, the total cost of the project or undertaking in connection with which such grant was given or used and the amount of that portion of the cost of the project or undertaking supplied by other sources, and such other records as will facilitate an effective audit. (3) The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, docu- ments, papers, and records of the recipients of grants under this section that are pertinent to such grants. (4) The Secretary, at the request of a recipient of a grant under this section, may reduce such grant by the fair market value of any supplies or equipment furnished to such recipient and by the amount of pay, allowances, travel expenses, and any other costs in connection with the detail of an officer or employee of the United States to the recipient when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such recipient and for the pur- pose of carrying out the program with respect to which the grant under this section is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies, equipment, or personal services on which the reduction of such grant is based. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00145 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

146 G:\COMP\PHSA\PHSA-MERGED.XML 146 Sec. 318A PUBLIC HEALTH SERVICE ACT (5) All information obtained in connection with the examina- tion, care, or treatment of any individual under any program which is being carried out with a grant made under this section shall not, without such individual’s consent, be disclosed except as may be necessary to provide service to him or as may be required by a law of a State or political subdivision of a State. Information derived from any such program may be disclosed— (A) in summary, statistical, or other form; or (B) for clinical or research purposes; but only if the identity of the individuals diagnosed or provided care or treatment under such program is not disclosed. (f) Nothing in this section shall be construed to require any State or any political subdivision of a State to have a sexually transmitted diseases program which would require any person, who objects to any treatment provided under such a program, to be treated under such a program. INFERTILITY AND SEXUALLY TRANSMITTED DISEASES .—The Secretary, acting . 318A. 247c–1 ¿ (a) I N G ENERAL ø S EC through the Director of the Centers for Disease Control and Pre- vention, may make grants to States, political subdivisions of States, and other public or nonprofit private entities for the pur- pose of carrying out the activities described in subsection (c) re- garding any treatable sexually transmitted disease that can cause infertility in women if treatment is not received for the disease. UTHORITY R EGARDING I NDIVIDUAL D ISEASES .—With re- (b) A spect to diseases described in subsection (a), the Secretary shall, in making a grant under such subsection, specify the particular dis- ease or diseases with respect to which the grant is to be made. The Secretary may not make the grant unless the applicant involved agrees to carry out this section only with respect to the disease or diseases so specified. A CTIVITIES .—With respect to any sexually UTHORIZED (c) A transmitted disease described in subsection (a), the activities re- ferred to in such subsection are— (1) screening women for the disease and for secondary con- ditions resulting from the disease, subject to compliance with criteria issued under subsection (f); (2) providing treatment to women for the disease; (3) providing counseling to women on the prevention and control of the disease (including, in the case of a woman with the disease, counseling on the benefits of locating and pro- viding such counseling to any individual from whom the woman may have contracted the disease and any individual whom the woman may have exposed to the disease); (4) providing follow-up services; (5) referrals for necessary medical services for women screened pursuant to paragraph (1), including referrals for evaluation and treatment with respect to acquired immune de- ficiency syndrome and other sexually transmitted diseases; (6) in the case of any woman receiving services pursuant to any of paragraphs (1) through (5), providing to the partner March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00146 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

147 G:\COMP\PHSA\PHSA-MERGED.XML 147 Sec. 318A PUBLIC HEALTH SERVICE ACT of the woman the services described in such paragraphs, as ap- propriate; (7) providing outreach services to inform women of the availability of the services described in paragraphs (1) through (6); (8) providing to the public information and education on the prevention and control of the disease, including dissemi- nating such information; and (9) providing training to health care providers in carrying out the screenings and counseling described in paragraphs (1) and (3). VAILABILITY OF A LL S EQUIREMENT OF T HROUGH A ERVICES (d) R ACH G RANTEE .—The Secretary may make a grant under sub- E section (a) only if the applicant involved agrees that each activity authorized in subsection (c) will be available through the applicant. With respect to compliance with such agreement, the applicant may expend the grant to carry out any of the activities directly, and may expend the grant to enter into agreements with other public or nonprofit private entities under which the entities carry out the activities. (e) R ROVIDERS R EGARDING C ERTAIN S ERVICES EQUIRED P .—The Secretary may make a grant under subsection (a) only if the appli- cant involved agrees that, in expending the grant to carry out ac- tivities authorized in subsection (c), the services described in para- graphs (1) through (7) of such subsection will be provided only through entities that are State or local health departments, grant- ees under section 329, 330, 340A, or 1001, or are other public or nonprofit private entities that provide health services to a signifi- cant number of low-income women. (f) Q A SSURANCE EGARDING S CREENING FOR D IS - UALITY R .—For purposes of this section, the Secretary shall establish EASES criteria for ensuring the quality of screening procedures for dis- eases described in subsection (a). ONFIDENTIALITY .—The Secretary may make a grant under (g) C subsection (a) only if the applicant involved agrees, subject to appli- cable law, to maintain the confidentiality of information on individ- uals with respect to activities carried out under subsection (c). IMITATION ON I MPOSITION OF F EES FOR S ERVICES .—The (h) L Secretary may make a grant under subsection (a) only if the appli- cant involved agrees that, if a charge is imposed for the provision of services or activities under the grant, such charge— (1) will be made according to a schedule of charges that is made available to the public; (2) will be adjusted to reflect the income of the individual involved; and (3) will not be imposed on any individual with an income of less than 150 percent of the official poverty line, as estab- lished by the Director of the Office of Management and Budget and revised by the Secretary in accordance with section 673(2) of the Omnibus Budget Reconciliation Act of 1981. (i) L C ERTAIN E XPENDITURES .—The Secretary IMITATIONS ON may make a grant under subsection (a) only if the applicant in- volved agrees that not less than 80 percent of the grant will be ex- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00147 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

148 G:\COMP\PHSA\PHSA-MERGED.XML 148 Sec. 318A PUBLIC HEALTH SERVICE ACT pended for the purpose of carrying out paragraphs (1) through (7) of subsection (c). (j) R .— EPORTS TO ECRETARY S (1) C .—The Secretary may make a OLLECTION OF DATA grant under subsection (a) only if the applicant involved agrees, with respect to any disease selected under subsection (b) for the applicant, to submit to the Secretary, for each fiscal year for which the applicant receives such a grant, a report providing— (A) the incidence of the disease among the population of individuals served by the applicant; (B) the number and demographic characteristics of in- dividuals in such population; (C) the types of interventions and treatments provided by the applicant, and the health conditions with respect to which referrals have been made pursuant to subsection (c)(5); (D) an assessment of the extent to which the activities carried pursuant to subsection (a) have reduced the inci- dence of infertility in the geographic area involved; and (E) such other information as the Secretary may re- quire with respect to the project carried out with the grant. (2) U TILITY AND COMPARABILITY OF DATA .—The Secretary shall carry out activities for the purpose of ensuring the utility and comparability of data collected pursuant to paragraph (1). AINTENANCE OF E FFORT .—With respect to activities for (k) M which a grant under subsection (a) is authorized to be expended, the Secretary may make such a grant only if the applicant involved agrees to maintain expenditures of non-Federal amounts for such activities at a level that is not less than the average level of such expenditures maintained by the applicant for the 2-year period pre- ceding the fiscal year for which the applicant is applying to receive such a grant. (l) R EQUIREMENT OF A PPLICATION .— (1) I N GENERAL .—The Secretary may make a grant under subsection (a) only if an application for the grant is submitted to the Secretary, the application contains the plan required in paragraph (2), and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section. UBMISSION OF PLAN FOR PROGRAM OF GRANTEE .— (2) S N GENERAL .—The Secretary may make a grant (A) I under subsection (a) only if the applicant involved submits to the Secretary a plan describing the manner in which the applicant will comply with the agreements required as a condition of receiving such a grant, including a specifica- tion of the entities through which activities authorized in subsection (c) will be provided. ARTICIPATION OF CERTAIN ENTITIES .—The Sec- (B) P retary may make a grant under subsection (a) only if the applicant provides assurances satisfactory to the Secretary that the plan submitted under subparagraph (A) has been March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00148 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

149 G:\COMP\PHSA\PHSA-MERGED.XML 149 Sec. 318A PUBLIC HEALTH SERVICE ACT prepared in consultation with an appropriate number and variety of— (i) representatives of entities in the geographic area involved that provide services for the prevention and control of sexually transmitted diseases, including programs to provide to the public information and edu- cation regarding such diseases; and (ii) representatives of entities in such area that provide family planning services. (m) D G .—The period during which payments URATION OF RANT are made to an entity from a grant under subsection (a) may not exceed 3 years. The provision of such payments shall be subject to annual approval by the Secretary of the payments and subject to the availability of appropriations for the fiscal year involved to make the payments in such year. The preceding sentence may not be construed to establish a limitation on the number of grants under such subsection that may be made to an entity. (n) T SSISTANCE , AND S ECHNICAL S ERVICES IN A UPPLIES AND IEU OF RANT F UNDS .— L G (1) T .—The Secretary may provide ECHNICAL ASSISTANCE training and technical assistance to grantees under subsection (a) with respect to the planning, development, and operation of any program or service carried out under such subsection. The Secretary may provide such technical assistance directly or through grants or contracts. , EQUIPMENT , AND EMPLOYEE DETAIL .—The UPPLIES (2) S Secretary, at the request of a recipient of a grant under sub- section (a), may reduce the amount of such grant by— (A) the fair market value of any supplies or equipment furnished the grant recipient; and (B) the amount of the pay, allowances, and travel ex- penses of any officer or employee of the Government when detailed to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or employee; when the furnishing of such supplies or equipment or the de- tail of such an officer or employee is for the convenience of and at the request of such grant recipient and for the purpose of carrying out a program with respect to which the grant under subsection (a) is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment, or in detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of the grant and shall be deemed to have been paid to the grant re- cipient. (o) E R EPORTS BY S ECRETARY .— VALUATIONS AND VALUATIONS .—The Secretary shall, directly or through (1) E contracts with public or private entities, provide for annual evaluations of programs carried out pursuant to subsection (a) in order to determine the quality and effectiveness of the pro- grams. EPORT TO CONGRESS .—Not later than 1 year after the (2) R date on which amounts are first appropriated pursuant to sub- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00149 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

150 G:\COMP\PHSA\PHSA-MERGED.XML 150 Sec. 318B PUBLIC HEALTH SERVICE ACT section (q), and biennially thereafter, the Secretary shall sub- mit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report— (A) summarizing the information provided to the Sec- retary in reports made pursuant to subsection (j)(1), in- cluding information on the incidence of sexually trans- mitted diseases described in subsection (a); and (B) summarizing evaluations carried out pursuant to paragraph (1) during the preceding fiscal year. EDERAL P OORDINATION OF .—The Secretary F ROGRAMS (p) C shall coordinate the program carried out under this section with any similar programs administered by the Secretary (including co- ordination between the Director of the Centers for Disease Control and Prevention and the Director of the National Institutes of Health). (q) A PPROPRIATIONS .—For the purpose of UTHORIZATION OF A carrying out this section, other than subsections (o) and (r), there are authorized to be appropriated $25,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 1998. (r) S RANTS FOR R ESEARCH ON D ELIVERY OF EPARATE ERV - G S .— ICES (1) I .—The Secretary may make grants for the N GENERAL purpose of conducting research on the manner in which the de- livery of services under subsection (a) may be improved. The Secretary may make such grants only to grantees under such subsection and to public and nonprofit private entities that are carrying out programs substantially similar to programs car- ried out under such subsection. (2) A .—For the purpose UTHORIZATION OF APPROPRIATIONS of carrying out paragraph (1), there are authorized to be appro- priated such sums as may be necessary for each of the fiscal years 1993 through 1998. DATA COLLECTION REGARDING PROGRAMS UNDER TITLE XXVI . 318B. ø 247c–2 ¿ For the purpose of collecting and pro- S EC viding data for program planning and evaluation activities under title XXVI, there are authorized to be appropriated to the Secretary (acting through the Director of the Centers for Disease Control and Prevention) such sums as may be necessary for each of the fiscal years 2001 through 2005. Such authorization of appropriations is in addition to other authorizations of appropriations that are avail- able for such purpose. ø 247d ¿ SEC. 319. PUBLIC HEALTH EMERGENCIES. (a) E MERGENCIES .—If the Secretary determines, after consulta- tion with such public health officials as may be necessary, that— (1) a disease or disorder presents a public health emer- gency; or (2) a public health emergency, including significant out- breaks of infectious diseases or bioterrorist attacks, otherwise exists, March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00150 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

151 G:\COMP\PHSA\PHSA-MERGED.XML 151 Sec. 319 PUBLIC HEALTH SERVICE ACT the Secretary may take such action as may be appropriate to re- spond to the public health emergency, including making grants, providing awards for expenses, and entering into contracts and con- ducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder as described in paragraphs (1) and (2). Any such determination of a public health emergency ter- minates upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, which- ever occurs first. Determinations that terminate under the pre- ceding sentence may be renewed by the Secretary (on the basis of the same or additional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after making a de- termination under this subsection of a public health emergency (in- cluding a renewal), the Secretary shall submit to the Congress written notification of the determination. H EALTH E MERGENCY UBLIC UND .— F (b) P .—There is established in the Treasury a (1) I N GENERAL fund to be designated as the ‘‘Public Health Emergency Fund’’ to be made available to the Secretary without fiscal year limi- tation to carry out subsection (a) only if a public health emer- gency has been declared by the Secretary under such sub- section. There is authorized to be appropriated to the Fund such sums as may be necessary. (2) R EPORT .—Not later than 90 days after the end of each fiscal year, the Secretary shall prepare and submit to the Com- mittee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Commerce and the Committee on Appropriations of the House of Representatives a report describing— (A) the expenditures made from the Public Health Emergency Fund in such fiscal year; and (B) each public health emergency for which the ex- penditures were made and the activities undertaken with respect to each emergency which was conducted or sup- ported by expenditures from the Fund. N OT S UPPLEMENT .—Funds appropriated under UPPLANT (c) S this section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities under this section. (d) D S UBMITTAL AND R EPORTING D EADLINES .—In any case ATA in which the Secretary determines that, wholly or partially as a re- sult of a public health emergency that has been determined pursu- ant to subsection (a), individuals or public or private entities are unable to comply with deadlines for the submission to the Sec- retary of data or reports required under any law administered by the Secretary, the Secretary may, notwithstanding any other provi- sion of law, grant such extensions of such deadlines as the cir- cumstances reasonably require, and may waive, wholly or partially, any sanctions otherwise applicable to such failure to comply. Before or promptly after granting such an extension or waiver, the Sec- retary shall notify the Congress of such action and publish in the Federal Register a notice of the extension or waiver. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00151 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

152 G:\COMP\PHSA\PHSA-MERGED.XML 152 Sec. 319 PUBLIC HEALTH SERVICE ACT R (e) T TATE AND L OCAL P ER - EASSIGNMENT OF EMPORARY S P UBLIC H EALTH E MERGENCY .— D SONNEL URING A - MERGENCY REASSIGNMENT OF FEDERALLY FUNDED PER (1) E .—Notwithstanding any other provision of law, and SONNEL subject to paragraph (2), upon request by the Governor of a State or a tribal organization or such Governor or tribal orga- nization’s designee, the Secretary may authorize the requesting State or Indian tribe to temporarily reassign, for purposes of immediately addressing a public health emergency in the State or Indian tribe, State and local public health department or agency personnel funded in whole or in part through programs authorized under this Act, as appropriate. CTIVATION OF EMERGENCY REASSIGNMENT .— (2) A (A) P UBLIC HEALTH EMERGENCY .—The Secretary may authorize a temporary reassignment of personnel under paragraph (1) only during the period of a public health emergency determined pursuant to subsection (a). (B) C .—To seek authority for a ONTENTS OF REQUEST temporary reassignment of personnel under paragraph (1), the Governor of a State or a tribal organization shall sub- mit to the Secretary a request for such reassignment flexi- bility and shall include in the request each of the fol- lowing: (i) An assurance that the public health emergency in the geographic area of the requesting State or In- dian tribe cannot be adequately and appropriately ad- dressed by the public health workforce otherwise available. (ii) An assurance that the public health emergency would be addressed more efficiently and effectively through the requested temporary reassignment of State and local personnel described in paragraph (1). (iii) An assurance that the requested temporary reassignment of personnel is consistent with any ap- plicable All-Hazards Public Health Emergency Pre- paredness and Response Plan under section 319C–1. (iv) An identification of— (I) each Federal program from which per- sonnel would be temporarily reassigned pursuant to the requested authority; and (II) the number of personnel who would be so reassigned from each such program. (v) Such other information and assurances upon which the Secretary and Governor of a State or tribal organization agree. (C) C ONSIDERATION .—In reviewing a request for tem- porary reassignment under paragraph (1), the Secretary shall consider the degree to which the program or pro- grams funded in whole or in part by programs authorized under this Act would be adversely affected by the reassign- ment. ERMINATION AND EXTENSION .— (D) T March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00152 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

153 G:\COMP\PHSA\PHSA-MERGED.XML 153 Sec. 319 PUBLIC HEALTH SERVICE ACT .—A State or Indian tribe’s tem- ERMINATION (i) T porary reassignment of personnel under paragraph (1) shall terminate upon the earlier of the following: (I) The Secretary’s determination that the public health emergency no longer exists. (II) Subject to clause (ii), the expiration of the 30-day period following the date on which the Sec- retary approved the State or Indian tribe’s request for such reassignment flexibility. XTENSION OF REASSIGNMENT FLEXIBILITY .— (ii) E The Secretary may extend reassignment flexibility of personnel under paragraph (1) beyond the date other- wise applicable under clause (i)(II) if the public health emergency still exists as of such date, but only if— (I) the State or Indian tribe that submitted the initial request for a temporary reassignment of personnel submits a request for an extension of such temporary reassignment; and (II) the request for an extension contains the same information and assurances necessary for the approval of an initial request for such tem- porary reassignment pursuant to subparagraph (B). (3) V OLUNTARY NATURE OF TEMPORARY REASSIGNMENT OF .— STATE AND LOCAL PERSONNEL (A) I N GENERAL .—Unless otherwise provided under the law or regulation of the State or Indian tribe that receives authorization for temporary reassignment of personnel under paragraph (1), personnel eligible for reassignment pursuant to such authorization— (i) shall have the opportunity to volunteer for tem- porary reassignment; and (ii) shall not be required to agree to a temporary reassignment. ROHIBITION ON CONDITIONING FEDERAL AWARDS .— (B) P The Secretary may not condition the award of a grant, con- tract, or cooperative agreement under this Act on the re- quirement that a State or Indian tribe require that per- sonnel eligible for reassignment pursuant to an authoriza- tion under paragraph (1) agree to such reassignment. OTICE TO CONGRESS .—The Secretary shall give notice (4) N to the Congress in conjunction with the approval under this subsection of— (A) any initial request for temporary reassignment of personnel; and (B) any request for an extension of such temporary re- assignment. (5) G UIDANCE .—The Secretary shall— (A) not later than 6 months after the enactment of this subsection, issue proposed guidance on the temporary re- assignment of personnel under this subsection; and (B) after providing notice and a 60-day period for pub- lic comment, finalize such guidance. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00153 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

154 G:\COMP\PHSA\PHSA-MERGED.XML 154 Sec. 319 PUBLIC HEALTH SERVICE ACT .—Not later than 4 years after the (6) R EPORT TO CONGRESS date of enactment of the Pandemic and All-Hazards Prepared- ness Reauthorization Act of 2013, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the appropriate committees of the Congress a re- port, on temporary reassignment under this subsection, includ- ing— (A) a description of how, and under what cir- cumstances, such temporary reassignment has been used by States and Indian tribes; (B) an analysis of how such temporary reassignment has assisted States and Indian tribes in responding to pub- lic health emergencies; (C) an evaluation of how such temporary reassignment has improved operational efficiencies in responding to pub- lic health emergencies; (D) an analysis of the extent to which, if any, Federal programs from which personnel have been temporarily re- assigned have been adversely affected by the reassign- ment; and (E) recommendations on how medical surge capacity could be improved in responding to public health emer- gencies and the impact of the reassignment flexibility under this section on such surge capacity. (7) D .—In this subsection— EFINITIONS (A) the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given such terms in section 4 of the In- dian Self-Determination and Education Assistance Act; and (B) the term ‘‘State’’ includes, in addition to the enti- ties listed in the definition of such term in section 2, the Freely Associated States. UNSET .—This subsection shall terminate on Sep- (8) S tember 30, 2018. (f) D W ITH R ESPECT TO P APERWORK R EDUCTION ETERMINATION MERGENCY CT D URING A P UBLIC H EALTH E AIVER .— W A ETERMINATION .—If the Secretary determines, after (1) D consultation with such public health officials as may be nec- essary, that— (A)(i) the criteria set forth for a public health emer- gency under paragraph (1) or (2) of subsection (a) has been met; or (ii) a disease or disorder, including a novel and emerg- ing public health threat, is significantly likely to become a public health emergency; and (B) the circumstances of such public health emergency, or potential for such significantly likely public health emergency, including the specific preparation for and re- sponse to such public health emergency or threat, neces- sitate a waiver from the requirements of subchapter I of chapter 35 of title 44, United States Code (commonly re- ferred to as the Paperwork Reduction Act), then the requirements of such subchapter I with respect to vol- untary collection of information shall not be applicable during March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00154 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

155 G:\COMP\PHSA\PHSA-MERGED.XML 155 Sec. 319A PUBLIC HEALTH SERVICE ACT the immediate investigation of, and response to, such public health emergency during the period of such public health emergency or the period of time necessary to determine if a disease or disorder, including a novel and emerging public health threat, will become a public health emergency as pro- vided for in this paragraph. The requirements of such sub- chapter I with respect to voluntary collection of information shall not be applicable during the immediate postresponse re- view regarding such public health emergency if such imme- diate postresponse review does not exceed a reasonable length of time. RANSPARENCY .—If the Secretary determines that a (2) T waiver is necessary under paragraph (1), the Secretary shall promptly post on the Internet website of the Department of Health and Human Services a brief justification for such waiv- er, the anticipated period of time such waiver will be in effect, and the agencies and offices within the Department of Health and Human Services to which such waiver shall apply, and up- date such information posted on the Internet website of the Department of Health and Human Services, as applicable. .—Any waiver under this FFECTIVENESS OF WAIVER (3) E subsection shall take effect on the date on which the Secretary posts information on the Internet website as provided for in this subsection. ERMINATION OF WAIVER .—Upon determining that the (4) T circumstances necessitating a waiver under paragraph (1) no longer exist, the Secretary shall promptly update the Internet website of the Department of Health and Human Services to reflect the termination of such waiver. IMITATIONS .— (5) L ERIOD OF WAIVER .—The period of a waiver under (A) P paragraph (1) shall not exceed the period of time for the related public health emergency, including a public health emergency declared pursuant to subsection (a), and any immediate postresponse review regarding the public health emergency consistent with the requirements of this sub- section. .—An initiative subject to UBSEQUENT COMPLIANCE (B) S a waiver under paragraph (1) that is ongoing after the date on which the waiver expires, shall be subject to the requirements of subchapter I of chapter 35 of title 44, United States Code, and the Secretary shall ensure that compliance with such requirements occurs in as timely a manner as possible based on the applicable circumstances, but not to exceed 30 calendar days after the expiration of the applicable waiver. ø ¿ VACCINE TRACKING AND DISTRIBUTION. 247d–1 SEC. 319A. (a) T RACKING .—The Secretary, together with relevant manufac- turers, wholesalers, and distributors as may agree to cooperate, may track the initial distribution of federally purchased influenza vaccine in an influenza pandemic. Such tracking information shall be used to inform Federal, State, local, and tribal decision makers during an influenza pandemic. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00155 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

156 G:\COMP\PHSA\PHSA-MERGED.XML 156 Sec. 319C–1 PUBLIC HEALTH SERVICE ACT (b) D ISTRIBUTION .—The Secretary shall promote communica- tion between State, local, and tribal public health officials and such manufacturers, wholesalers, and distributors as agree to partici- pate, regarding the effective distribution of seasonal influenza vac- cine. Such communication shall include estimates of high priority populations, as determined by the Secretary, in State, local, and tribal jurisdictions in order to inform Federal, State, local, and trib- al decision makers during vaccine shortages and supply disrup- tions. (c) C ONFIDENTIALITY .—The information submitted to the Sec- retary or its contractors, if any, under this section or under any other section of this Act related to vaccine distribution information shall remain confidential in accordance with the exception from the public disclosure of trade secrets, commercial or financial informa- tion, and information obtained from an individual that is privileged and confidential, as provided for in section 552(b)(4) of title 5, United States Code, and subject to the penalties and exceptions under sections 1832 and 1833 of title 18, United States Code, relat- ing to the protection and theft of trade secrets, and subject to pri- vacy protections that are consistent with the regulations promul- gated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996. None of such information provided by a manufacturer, wholesaler, or distributor shall be disclosed with- out its consent to another manufacturer, wholesaler, or distributor, or shall be used in any manner to give a manufacturer, wholesaler, or distributor a proprietary advantage. UIDELINES .—The Secretary, in order to maintain the con- (d) G fidentiality of relevant information and ensure that none of the in- formation contained in the systems involved may be used to pro- vide proprietary advantage within the vaccine market, while allow- ing State, local, and tribal health officials access to such informa- tion to maximize the delivery and availability of vaccines to high priority populations, during times of influenza pandemics, vaccine shortages, and supply disruptions, in consultation with manufac- turers, distributors, wholesalers and State, local, and tribal health departments, shall develop guidelines for subsections (a) and (b). (e) A UTHORIZATION OF A PPROPRIATIONS .—There are authorized to be appropriated to carry out this section, $30,800,000 for each of fiscal years 2014 through 2018. (f) R EPORT TO C ONGRESS .—As part of the National Health Se- curity Strategy described in section 2802, the Secretary shall pro- vide an update on the implementation of subsections (a) through (d). 247d–3a SEC. 319C–1. ø IMPROVING STATE AND LOCAL PUBLIC HEALTH ¿ 17 SECURITY. (a) I N G ENERAL .—To enhance the security of the United States with respect to public health emergencies, the Secretary shall award cooperative agreements to eligible entities to enable such en- tities to conduct the activities described in subsection (d). LIGIBLE E NTITIES .—To be eligible to receive an award (b) E under subsection (a), an entity shall— 17 Former sections 319B and 319C were repealed by section 204(b)(1) of Public Law 109–417 (120 Stat. 2951). March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00156 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

157 G:\COMP\PHSA\PHSA-MERGED.XML 157 Sec. 319C–1 PUBLIC HEALTH SERVICE ACT (1)(A) be a State; (B) be a political subdivision determined by the Secretary to be eligible for an award under this section (based on criteria described in subsection (h)(4)); or (C) be a consortium of States; and (2) prepare and submit to the Secretary an application at such time, and in such manner, and containing such informa- tion as the Secretary may require, including— (A) an All-Hazards Public Health Emergency Pre- paredness and Response Plan which shall include— (i) a description of the activities such entity will carry out under the agreement to meet the goals iden- tified under section 2802, including with respect to chemical, biological, radiological, or nuclear threats, whether naturally occurring, unintentional, or delib- erate; (ii) a description of the activities such entity will carry out with respect to pandemic influenza, as a component of the activities carried out under clause (i), and consistent with the requirements of para- graphs (2) and (5) of subsection (g); (iii) preparedness and response strategies and ca- pabilities that take into account the medical and pub- lic health needs of at-risk individuals in the event of a public health emergency; (iv) a description of the mechanism the entity will implement to utilize the Emergency Management As- sistance Compact or other mutual aid agreements for medical and public health mutual aid; (v) a description of how the entity will include the State Unit on Aging in public health emergency pre- paredness; (vi) a description of how, as appropriate, the enti- ty may partner with relevant public and private stake- holders in public health emergency preparedness and response; (vii) a description of how the entity, as applicable and appropriate, will coordinate with State emergency preparedness and response plans in public health emergency preparedness, including State educational agencies (as defined in section 8101 of the Elementary and Secondary Education Act of 1965) and State child care lead agencies (designated under section 658D of the Child Care and Development Block Grant Act of 1990); (viii) in the case of entities that operate on the United States-Mexico border or the United States- Canada border, a description of the activities such en- tity will carry out under the agreement that are spe- cific to the border area including disease detection, identification, investigation, and preparedness and re- sponse activities related to emerging diseases and in- fectious disease outbreaks whether naturally occurring March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00157 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

158 G:\COMP\PHSA\PHSA-MERGED.XML 158 Sec. 319C–1 PUBLIC HEALTH SERVICE ACT or due to bioterrorism, consistent with the require- ments of this section; and (ix) a description of any activities that such entity will use to analyze real-time clinical specimens for pathogens of public health or bioterrorism significance, including any utilization of poison control centers; (B) an assurance that the entity will report to the Sec- retary on an annual basis (or more frequently as deter- mined by the Secretary) on the evidence-based bench- marks and objective standards established by the Sec- retary to evaluate the preparedness and response capabili- ties of such entity under subsection (g); (C) an assurance that the entity will conduct, on at least an annual basis, an exercise or drill that meets any criteria established by the Secretary to test the prepared- ness and response capabilities of such entity, including ad- 18 dressing the needs of at-risk individuals,, and that the entity will report back to the Secretary within the applica- tion of the following year on the strengths and weaknesses identified through such exercise or drill, and corrective ac- tions taken to address material weaknesses; (D) an assurance that the entity will provide to the Secretary the data described under section 319D(c)(3) as determined feasible by the Secretary; (E) an assurance that the entity will conduct activities to inform and educate the hospitals within the jurisdiction of such entity on the role of such hospitals in the plan re- quired under subparagraph (A); (F) an assurance that the entity, with respect to the plan described under subparagraph (A), has developed and will implement an accountability system to ensure that such entity make satisfactory annual improvement and de- scribe such system in the plan under subparagraph (A); (G) a description of the means by which to obtain pub- lic comment and input on the plan described in subpara- graph (A) and on the implementation of such plan, that shall include an advisory committee or other similar mech- anism for obtaining comment from the public and from other State, local, and tribal stakeholders; and (H) as relevant, a description of the process used by the entity to consult with local departments of public health to reach consensus, approval, or concurrence on the relative distribution of amounts received under this sec- tion. (c) L .—Beginning in fiscal year 2009, the Secretary IMITATION may not award a cooperative agreement to a State unless such State is a participant in the Emergency System for Advance Reg- istration of Volunteer Health Professionals described in section 319I. (d) U SE OF F UNDS .— (1) I N GENERAL .—An award under subsection (a) shall be expended for activities to achieve the preparedness goals de- 18 Two commas so in law. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00158 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

159 G:\COMP\PHSA\PHSA-MERGED.XML 159 Sec. 319C–1 PUBLIC HEALTH SERVICE ACT scribed under paragraphs (1), (2), (4), (5), and (6) of section 2802(b). FFECT OF SECTION (2) E .—Nothing in this subsection may be construed as establishing new regulatory authority or as modifying any existing regulatory authority. (e) C APABILITIES OCAL R OORDINATION C W .—An ITH L ESPONSE entity shall, to the extent practicable, ensure that activities carried out under an award under subsection (a) are coordinated with ac- tivities of relevant Metropolitan Medical Response Systems, local public health departments, the Cities Readiness Initiative, and local emergency plans. (f) C W H OMELAND S ECURITY .—In making ONSULTATION ITH awards under subsection (a), the Secretary shall consult with the Secretary of Homeland Security to— (1) ensure maximum coordination of public health and medical preparedness and response activities with the Metro- politan Medical Response System, and other relevant activities; (2) minimize duplicative funding of programs and activi- ties; and (3) analyze activities, including exercises and drills, con- ducted under this section to develop recommendations and guidance on best practices for such activities. (g) A M EASURABLE E VIDENCE -B ASED B ENCH - CHIEVEMENT OF O MARKS AND TANDARDS .— BJECTIVE S .—Not later than 180 days after the date of N GENERAL (1) I enactment of the Pandemic and All-Hazards Preparedness Act, the Secretary shall develop or where appropriate adopt, and re- quire the application of, measurable evidence-based bench- marks and objective standards that measure levels of pre- paredness with respect to the activities described in this sec- tion and with respect to activities described in section 319C– 2. In developing such benchmarks and standards, the Sec- retary shall consult with and seek comments from State, local, and tribal officials and private entities, as appropriate. Where appropriate, the Secretary shall incorporate existing objective standards. Such benchmarks and standards shall— (A) include outcome goals representing operational achievements of the National Preparedness Goals devel- oped under section 2802(b) with respect to all-hazards, in- cluding chemical, biological, radiological, or nuclear threats; and (B) at a minimum, require entities to— (i) measure progress toward achieving the out- come goals; and (ii) at least annually, test, exercise, and rigorously evaluate the public health and medical emergency pre- paredness and response capabilities of the entity, and report to the Secretary on such measured and tested capabilities and measured and tested progress toward achieving outcome goals, based on criteria established by the Secretary. RITERIA FOR PANDEMIC INFLUENZA PLANS .— (2) C N GENERAL .—Not later than 180 days after the (A) I date of enactment of the Pandemic and All-Hazards Pre- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00159 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

160 G:\COMP\PHSA\PHSA-MERGED.XML 160 Sec. 319C–1 PUBLIC HEALTH SERVICE ACT paredness Act, the Secretary shall develop and dissemi- nate to the chief executive officer of each State criteria for an effective State plan for responding to pandemic influ- enza. The Secretary shall periodically update, as necessary and appropriate, such pandemic influenza plan criteria and shall require the integration of such criteria into the benchmarks and standards described in paragraph (1). (B) R .—Nothing in this section ULE OF CONSTRUCTION shall be construed to require the duplication of Federal ef- forts with respect to the development of criteria or stand- ards, without regard to whether such efforts were carried out prior to or after the date of enactment of this section. (3) T ECHNICAL ASSISTANCE .—The Secretary shall, as deter- mined appropriate by the Secretary, provide to a State, upon request, technical assistance in meeting the requirements of this section, including the provision of advice by experts in the development of high-quality assessments, the setting of State objectives and assessment methods, the development of meas- ures of satisfactory annual improvement that are valid and re- liable, and other relevant areas. (4) N OTIFICATION OF FAILURES .—The Secretary shall de- velop and implement a process to notify entities that are deter- mined by the Secretary to have failed to meet the requirements of paragraph (1) or (2). Such process shall provide such entities with the opportunity to correct such noncompliance. An entity that fails to correct such noncompliance shall be subject to paragraph (5). ITHHOLDING OF AMOUNTS FROM ENTITIES THAT FAIL (5) W .—Begin- TO ACHIEVE BENCHMARKS OR SUBMIT INFLUENZA PLAN ning with fiscal year 2009, and in each succeeding fiscal year, the Secretary shall— (A) withhold from each entity that has failed substan- tially to meet the benchmarks and performance measures described in paragraph (1) for the immediately preceding fiscal year (beginning with fiscal year 2008), pursuant to the process developed under paragraph (4), the amount de- scribed in paragraph (6); and (B) withhold from each entity that has failed to submit to the Secretary a plan for responding to pandemic influ- enza that meets the criteria developed under paragraph (2), the amount described in paragraph (6). (6) A MOUNTS DESCRIBED .— N GENERAL .—The amounts described in this para- (A) I graph are the following amounts that are payable to an en- tity for activities described in section 319C–1 or 319C–2: (i) For the fiscal year immediately following a fis- cal year in which an entity experienced a failure de- scribed in subparagraph (A) or (B) of paragraph (5) by the entity, an amount equal to 10 percent of the amount the entity was eligible to receive for such fis- cal year. (ii) For the fiscal year immediately following two consecutive fiscal years in which an entity experienced such a failure, an amount equal to 15 percent of the March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00160 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

161 G:\COMP\PHSA\PHSA-MERGED.XML 161 Sec. 319C–1 PUBLIC HEALTH SERVICE ACT amount the entity was eligible to receive for such fis- cal year, taking into account the withholding of funds for the immediately preceding fiscal year under clause (i). (iii) For the fiscal year immediately following three consecutive fiscal years in which an entity expe- rienced such a failure, an amount equal to 20 percent of the amount the entity was eligible to receive for such fiscal year, taking into account the withholding of funds for the immediately preceding fiscal years under clauses (i) and (ii). (iv) For the fiscal year immediately following four consecutive fiscal years in which an entity experienced such a failure, an amount equal to 25 percent of the amount the entity was eligible to receive for such a fis- cal year, taking into account the withholding of funds for the immediately preceding fiscal years under clauses (i), (ii), and (iii). (B) S EPARATE ACCOUNTING .—Each failure described in subparagraph (A) or (B) of paragraph (5) shall be treated as a separate failure for purposes of calculating amounts withheld under subparagraph (A). (7) R EALLOCATION OF AMOUNTS WITHHELD .— (A) I N GENERAL .—The Secretary shall make amounts withheld under paragraph (6) available for making awards under section 319C–2 to entities described in subsection (b)(1) of such section. (B) P REFERENCE IN REALLOCATION .—In making awards under section 319C–2 with amounts described in subpara- graph (A), the Secretary shall give preference to eligible entities (as described in section 319C–2(b)(1)) that are lo- cated in whole or in part in States from which amounts have been withheld under paragraph (6). AIVE OR REDUCE WITHHOLDING (8) W .—The Secretary may waive or reduce the withholding described in paragraph (6), for a single entity or for all entities in a fiscal year, if the Sec- retary determines that mitigating conditions exist that justify the waiver or reduction. .— (h) F UNDING .— UTHORIZATION OF APPROPRIATIONS (1) A (A) I N GENERAL .—For the purpose of carrying out this section, there is authorized to be appropriated $641,900,000 for fiscal year 2014 for awards pursuant to paragraph (3) (subject to the authority of the Secretary to make awards pursuant to paragraphs (4) and (5)), and $641,900,000 for each of fiscal years 2015 through 2018. (B) R EQUIREMENT FOR STATE MATCHING FUNDS .—Be- ginning in fiscal year 2009, in the case of any State or con- sortium of two or more States, the Secretary may not award a cooperative agreement under this section unless the State or consortium of States agree that, with respect to the amount of the cooperative agreement awarded by the Secretary, the State or consortium of States will make available (directly or through donations from public or pri- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00161 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

162 G:\COMP\PHSA\PHSA-MERGED.XML 162 Sec. 319C–1 PUBLIC HEALTH SERVICE ACT vate entities) non-Federal contributions in an amount equal to— (i) for the first fiscal year of the cooperative agree- ment, not less than 5 percent of such costs ($1 for each $20 of Federal funds provided in the cooperative agreement); and (ii) for any second fiscal year of the cooperative agreement, and for any subsequent fiscal year of such cooperative agreement, not less than 10 percent of such costs ($1 for each $10 of Federal funds provided in the cooperative agreement). (C) D - - ETERMINATION OF AMOUNT OF NON FEDERAL CON .—As determined by the Secretary, non-Federal TRIBUTIONS contributions required in subparagraph (B) may be pro- vided directly or through donations from public or private entities and may be in cash or in kind, fairly evaluated, in- cluding plant, equipment or services. Amounts provided by the Federal government, or services assisted or subsidized to any significant extent by the Federal government, may not be included in determining the amount of such non- Federal contributions. (2) M AINTAINING STATE FUNDING .— (A) I N GENERAL .—An entity that receives an award under this section shall maintain expenditures for public health security at a level that is not less than the average level of such expenditures maintained by the entity for the preceding 2 year period. ULE OF CONSTRUCTION .—Nothing in this section (B) R shall be construed to prohibit the use of awards under this section to pay salary and related expenses of public health and other professionals employed by State, local, or tribal public health agencies who are carrying out activities sup- ported by such awards (regardless of whether the primary assignment of such personnel is to carry out such activi- ties). (3) D ETERMINATION OF AMOUNT .— (A) I N GENERAL .—The Secretary shall award coopera- tive agreements under subsection (a) to each State or con- sortium of 2 or more States that submits to the Secretary an application that meets the criteria of the Secretary for the receipt of such an award and that meets other imple- mentation conditions established by the Secretary for such awards ASE AMOUNT .—In determining the amount of an (B) B award pursuant to subparagraph (A) for a State, the Sec- retary shall first determine an amount the Secretary con- siders appropriate for the State (referred to in this para- graph as the ‘‘base amount’’), except that such amount may not be greater than the minimum amount determined under subparagraph (D). (C) I NCREASE ON BASIS OF POPULATION .—After deter- mining the base amount for a State under subparagraph (B), the Secretary shall increase the base amount by an amount equal to the product of— March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00162 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

163 G:\COMP\PHSA\PHSA-MERGED.XML 163 Sec. 319C–1 PUBLIC HEALTH SERVICE ACT (i) the amount appropriated under paragraph (1)(A) for the fiscal year, less an amount equal to the sum of all base amounts determined for the States under subparagraph (B), and less the amount, if any, reserved by the Secretary under paragraphs (4) and (5); and (ii) subject to paragraph (4)(C), the percentage constituted by the ratio of an amount equal to the pop- ulation of the State over an amount equal to the total population of the States (as indicated by the most re- cent data collected by the Bureau of the Census). (D) M INIMUM AMOUNT .—Subject to the amount appro- priated under paragraph (1)(A), an award pursuant to sub- paragraph (A) for a State shall be the greater of the base amount as increased under subparagraph (C), or the min- imum amount under this subparagraph. The minimum amount under this subparagraph is— (i) in the case of each of the several States, the District of Columbia, and the Commonwealth of Puer- to Rico, an amount equal to the lesser of— (I) $5,000,000; or (II) if the amount appropriated under para- graph (1)(A) is less than $667,000,000, an amount equal to 0.75 percent of the amount appropriated under such paragraph, less the amount, if any, re- served by the Secretary under paragraphs (4) and (5); or (ii) in the case of each of American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, and the Virgin Islands, an amount determined by the Secretary to be appropriate, except that such amount may not exceed the amount determined under clause (i). (4) C .— ERTAIN POLITICAL SUBDIVISIONS (A) I .—For fiscal year 2007, the Secretary N GENERAL may, before making awards pursuant to paragraph (3) for such year, reserve from the amount appropriated under paragraph (1) for the year an amount determined nec- essary by the Secretary to make awards under subsection (a) to political subdivisions that have a substantial number of residents, have a substantial local infrastructure for re- sponding to public health emergencies, and face a high de- gree of risk from bioterrorist attacks or other public health emergencies. Not more than three political subdivisions may receive awards pursuant to this subparagraph. OORDINATION WITH STATEWIDE PLANS .—An award (B) C pursuant to subparagraph (A) may not be made unless the application of the political subdivision involved is in co- ordination with, and consistent with, applicable Statewide plans described in subsection (b). (C) R ELATIONSHIP TO FORMULA GRANTS .—In the case of a State that will receive an award pursuant to paragraph (3), and in which there is located a political subdivision that will receive an award pursuant to subparagraph (A), March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00163 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

164 G:\COMP\PHSA\PHSA-MERGED.XML 164 Sec. 319C–1 PUBLIC HEALTH SERVICE ACT the Secretary shall, in determining the amount under paragraph (3)(C) for the State, subtract from the popu- lation of the State an amount equal to the population of such political subdivision. (D) C ONTINUITY OF FUNDING .—In determining whether to make an award pursuant to subparagraph (A) to a polit- ical subdivision, the Secretary may consider, as a factor in- dicating that the award should be made, that the political subdivision received public health funding from the Sec- retary for fiscal year 2006. (5) S DEGREE OF RISK .— ; IGNIFICANT UNMET NEEDS .—For fiscal year 2007, the Secretary (A) I N GENERAL may, before making awards pursuant to paragraph (3) for such year, reserve from the amount appropriated under paragraph (1) for the year an amount determined nec- essary by the Secretary to make awards under subsection (a) to eligible entities that— (i) have a significant need for funds to build ca- pacity to identify, detect, monitor, and respond to a bioterrorist or other threat to the public health, which need will not be met by awards pursuant to paragraph (3); and (ii) face a particularly high degree of risk of such a threat. (B) R .—Awards pursuant to sub- ECIPIENTS OF GRANTS paragraph (A) may be supplemental awards to States that receive awards pursuant to paragraph (3), or may be awards to eligible entities described in subsection (b)(1)(B) within such States. INDING WITH RESPECT TO DISTRICT OF COLUM - (C) F BIA .—The Secretary shall consider the District of Columbia to have a significant unmet need for purposes of subpara- graph (A), and to face a particularly high degree of risk for such purposes, on the basis of the concentration of entities of national significance located within the District. (6) F UNDING OF LOCAL ENTITIES .—The Secretary shall, in making awards under this section, ensure that with respect to the cooperative agreement awarded, the entity make available appropriate portions of such award to political subdivisions and local departments of public health through a process in- volving the consensus, approval or concurrence with such local entities. (7) A VAILABILITY OF COOPERATIVE AGREEMENT FUNDS .— N GENERAL .—Amounts provided to an eligible en- (A) I tity under a cooperative agreement under subsection (a) for a fiscal year and remaining unobligated at the end of such year shall remain available to such entity for the next fiscal year for the purposes for which such funds were provided. (B) F UNDS CONTINGENT ON ACHIEVING BENCHMARKS .— The continued availability of funds under subparagraph (A) with respect to an entity shall be contingent upon such entity achieving the benchmarks and submitting the pan- demic influenza plan as described in subsection (g). March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00164 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

165 G:\COMP\PHSA\PHSA-MERGED.XML 165 Sec. 319C–1 PUBLIC HEALTH SERVICE ACT F DMINISTRATIVE AND ESPONSIBILITY .— ISCAL (i) A R .—Each entity shall NNUAL REPORTING REQUIREMENTS (1) A prepare and submit to the Secretary annual reports on its ac- tivities under this section and section 319C–2. Each such re- port shall be prepared by, or in consultation with, the health department. In order to properly evaluate and compare the performance of different entities assisted under this section and section 319C–2 and to assure the proper expenditure of funds under this section and section 319C–2, such reports shall be in such standardized form and contain such information as the Secretary determines and describes within 180 days of the date of enactment of the Pandemic and All-Hazards Prepared- ness Act (after consultation with the States) to be necessary to— (A) secure an accurate description of those activities; (B) secure a complete record of the purposes for which funds were spent, and of the recipients of such funds; (C) describe the extent to which the entity has met the goals and objectives it set forth under this section or sec- tion 319C–2; (D) determine the extent to which funds were ex- pended consistent with the entity’s application transmitted under this section or section 319C–2; and (E) publish such information on a Federal Internet website consistent with subsection (j). UDITS ; IMPLEMENTATION .— (2) A (A) I N GENERAL .—Each entity receiving funds under this section or section 319C–2 shall, not less often than once every 2 years, audit its expenditures from amounts received under this section or section 319C–2. Such audits shall be conducted by an entity independent of the agency administering a program funded under this section or sec- tion 319C–2 in accordance with the Comptroller General’s standards for auditing governmental organizations, pro- grams, activities, and functions and generally accepted au- diting standards. Within 30 days following the completion of each audit report, the entity shall submit a copy of that audit report to the Secretary. EPAYMENT .—Each entity shall repay to the (B) R United States amounts found by the Secretary, after notice and opportunity for a hearing to the entity, not to have been expended in accordance with this section or section 319C–2 and, if such repayment is not made, the Secretary may offset such amounts against the amount of any allot- ment to which the entity is or may become entitled under this section or section 319C–2 or may otherwise recover such amounts. (C) W ITHHOLDING OF PAYMENT .—The Secretary may, after notice and opportunity for a hearing, withhold pay- ment of funds to any entity which is not using its allot- ment under this section or section 319C–2 in accordance with such section. The Secretary may withhold such funds until the Secretary finds that the reason for the with- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00165 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

166 G:\COMP\PHSA\PHSA-MERGED.XML 166 Sec. 319C–2 PUBLIC HEALTH SERVICE ACT holding has been removed and there is reasonable assur- ance that it will not recur. (j) C D ATA .—The Secretary OMPILATION AND VAILABILITY OF A shall compile the data submitted under this section and make such data available in a timely manner on an appropriate Internet website in a format that is useful to the public and to other entities and that provides information on what activities are best contrib- uting to the achievement of the outcome goals described in sub- section (g). ø ¿ PARTNERSHIPS FOR STATE AND REGIONAL SEC. 319C–2. 247d–3b HOSPITAL PREPAREDNESS TO IMPROVE SURGE CAPAC- ITY. N ENERAL .—The Secretary shall award competitive (a) I G grants or cooperative agreements to eligible entities to enable such entities to improve surge capacity and enhance community and hospital preparedness for public health emergencies, including, as appropriate, capacity and preparedness to address the needs of children and other at-risk individuals. (b) E .—To be eligible for an award under subsection LIGIBILITY (a), an entity shall— (1)(A) be a partnership consisting of— (i) one or more hospitals, at least one of which shall be a designated trauma center, consistent with section 1213(c); (ii) one or more other local health care facilities, in- cluding clinics, health centers, community health centers, primary care facilities, mental health centers, mobile med- ical assets, or nursing homes; and (iii)(I) one or more political subdivisions; (II) one or more States; or (III) one or more States and one or more political sub- divisions; and (B) prepare, in consultation with the Chief Executive Offi- cer and the lead health officials of the State, District, or terri- tory in which the hospital and health care facilities described in subparagraph (A) are located, and submit to the Secretary, an application at such time, in such manner, and containing such information as the Secretary may require; or (2)(A) be an entity described in section 319C–1(b)(1); and (B) submit an application at such time, in such manner, and containing such information as the Secretary may require, including the information or assurances required under section 319C–1(b)(2) and an assurance that the State will adhere to any applicable guidelines established by the Secretary. (c) U F UNDS .—An award under subsection (a) shall be ex- SE OF pended for activities to achieve the preparedness goals described under paragraphs (1), (3), (4), (5), and (6) of section 2802(b) with respect to all-hazards, including chemical, biological, radiological, or nuclear threats. (d) P REFERENCES .— EGIONAL COORDINATION .—In making awards under (1) R subsection (a), the Secretary shall give preference to eligible entities that submit applications that, in the determination of the Secretary— March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00166 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

167 G:\COMP\PHSA\PHSA-MERGED.XML 167 Sec. 319C–2 PUBLIC HEALTH SERVICE ACT (A) will enhance coordination— (i) among the entities described in subsection (b)(1)(A)(i); and (ii) between such entities and the entities de- scribed in subsection (b)(1)(A)(ii); and (B) include, in the partnership described in subsection (b)(1)(A), a significant percentage of the hospitals and health care facilities within the geographic area served by such partnership. (2) O THER PREFERENCES .—In making awards under sub- section (a), the Secretary shall give preference to eligible enti- ties that, in the determination of the Secretary— (A) include one or more hospitals that are participants in the National Disaster Medical System; (B) are located in a geographic area that faces a high degree of risk, as determined by the Secretary in consulta- tion with the Secretary of Homeland Security; or (C) have a significant need for funds to achieve the medical preparedness goals described in section 2802(b)(3). (e) C LANNED ONSISTENCY OF CTIVITIES .—The Secretary may P A not award a cooperative agreement to an eligible entity described in subsection (b)(1) unless the application submitted by the entity is coordinated and consistent with an applicable State All-Hazards Public Health Emergency Preparedness and Response Plan and rel- evant local plans, as determined by the Secretary in consultation with relevant State health officials. IMITATION ON WARDS .—A political subdivision shall not A (f) L participate in more than one partnership described in subsection (b)(1). OORDINATION .— (g) C (1) L OCAL RESPONSE CAPABILITIES .—An eligible entity shall, to the extent practicable, ensure that activities carried out under an award under subsection (a) are coordinated with activities of relevant local Metropolitan Medical Response Sys- tems, local Medical Reserve Corps, the local Cities Readiness Initiative, and local emergency plans. .—Partnerships consisting of (2) N ATIONAL COLLABORATION one or more eligible entities under this section may, to the ex- tent practicable, collaborate with other partnerships consisting of one or more eligible entities under this section for purposes of national coordination and collaboration with respect to ac- tivities to achieve the preparedness goals described under paragraphs (1), (3), (4), (5), and (6) of section 2802(b). AINTENANCE OF F UNDING .— (h) M N GENERAL .—An entity that receives an award under (1) I this section shall maintain expenditures for health care pre- paredness at a level that is not less than the average level of such expenditures maintained by the entity for the preceding 2 year period. (2) R ULE OF CONSTRUCTION .—Nothing in this section shall be construed to prohibit the use of awards under this section to pay salary and related expenses of public health and other professionals employed by State, local, or tribal agencies who are carrying out activities supported by such awards (regard- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00167 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

168 G:\COMP\PHSA\PHSA-MERGED.XML 168 Sec. 319D PUBLIC HEALTH SERVICE ACT less of whether the primary assignment of such personnel is to carry out such activities). (i) P .— ERFORMANCE AND CCOUNTABILITY A (1) I .—The requirements of section 319C–1(g), N GENERAL (i), and (j) shall apply to entities receiving awards under this section (regardless of whether such entities are described under subsection (b)(1)(A) or (b)(2)(A)) in the same manner as such requirements apply to entities under section 319C–1. An entity described in subsection (b)(1)(A) shall make such reports available to the lead health official of the State in which such partnership is located. (2) M - EETING GOALS OF NATIONAL HEALTH SECURITY STRAT EGY .—The Secretary shall implement objective, evidence-based metrics to ensure that entities receiving awards under this sec- tion are meeting, to the extent practicable, the applicable goals of the National Health Security Strategy under section 2802. (j) A PPROPRIATIONS .— UTHORIZATION OF A (1) I .—For purposes of carrying out this section, N GENERAL there is authorized to be appropriated $374,700,000 for each of fiscal years 2014 through 2018. (2) R ESERVATION OF AMOUNTS FOR PARTNERSHIPS .—Prior to making awards described in paragraph (3), the Secretary may reserve from the amount appropriated under paragraph (1) for a fiscal year, an amount determined appropriate by the Sec- retary for making awards to entities described in subsection (b)(1)(A). (3) A WARDS TO STATES AND POLITICAL SUBDIVISIONS .— (A) I .—From amounts appropriated for a N GENERAL fiscal year under paragraph (1) and not reserved under paragraph (2), the Secretary shall make awards to entities described in subsection (b)(2)(A) that have completed an application as described in subsection (b)(2)(B). (B) A .—The Secretary shall determine the MOUNT amount of an award to each entity described in subpara- graph (A) in the same manner as such amounts are deter- mined under section 319C–1(h). (4) A .— VAILABILITY OF COOPERATIVE AGREEMENT FUNDS (A) I N GENERAL .—Amounts provided to an eligible en- tity under a cooperative agreement under subsection (a) for a fiscal year and remaining unobligated at the end of such year shall remain available to such entity for the next fiscal year for the purposes for which such funds were provided. (B) F UNDS CONTINGENT ON ACHIEVING BENCHMARKS .— The continued availability of funds under subparagraph (A) with respect to an entity shall be contingent upon such entity achieving the benchmarks and submitting the pan- demic influenza plan as required under subsection (i). ø 247d–4 ¿ REVITALIZING THE CENTERS FOR DISEASE CON- SEC. 319D. TROL AND PREVENTION. ACILITIES ; C APACITIES .— (a) F (1) F INDINGS .—Congress finds that the Centers for Disease Control and Prevention has an essential role in defending against and combatting public health threats domestically and March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00168 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

169 G:\COMP\PHSA\PHSA-MERGED.XML 169 Sec. 319D PUBLIC HEALTH SERVICE ACT abroad and requires secure and modern facilities, and ex- panded and improved capabilities related to bioterrorism and other public health emergencies, sufficient to enable such Cen- ters to conduct this important mission. ACILITIES .— (2) F (A) I .—The Director of the Centers for Dis- N GENERAL ease Control and Prevention may design, construct, and equip new facilities, renovate existing facilities (including laboratories, laboratory support buildings, scientific com- munication facilities, transshipment complexes, secured and isolated parking structures, office buildings, and other facilities and infrastructure), and upgrade security of such facilities, in order to better conduct the capacities de- scribed in section 319A, and for supporting public health activities. ULTIYEAR CONTRACTING AUTHORITY .—For any (B) M project of designing, constructing, equipping, or renovating any facility under subparagraph (A), the Director of the Centers for Disease Control and Prevention may enter into a single contract or related contracts that collectively in- clude the full scope of the project, and the solicitation and contract shall contain the clause ‘‘availability of funds’’ found at section 52.232–18 of title 48, Code of Federal Reg- ulations. (3) I MPROVING THE CAPACITIES OF THE CENTERS FOR DIS - .—The Secretary shall expand, EASE CONTROL AND PREVENTION enhance, and improve the capabilities of the Centers for Dis- ease Control and Prevention relating to preparedness for and responding effectively to bioterrorism and other public health emergencies. Activities that may be carried out under the pre- ceding sentence include— (A) expanding or enhancing the training of personnel; (B) improving communications facilities and networks, including delivery of necessary information to rural areas; (C) improving capabilities for public health surveil- lance and reporting activities, taking into account the inte- grated system or systems of public health alert commu- nications and surveillance networks under subsection (b); and (D) improving laboratory facilities related to bioter- rorism and other public health emergencies, including in- creasing the security of such facilities. ATIONAL C OMMUNICATIONS AND S URVEILLANCE N ET - (b) N WORKS .— (1) I N GENERAL .—The Secretary, directly or through awards of grants, contracts, or cooperative agreements, shall provide for the establishment of an integrated system or sys- tems of public health alert communications and surveillance networks between and among— (A) Federal, State, and local public health officials; (B) public and private health-related laboratories, hos- pitals, poison control centers, and other health care facili- ties; and March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00169 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

170 G:\COMP\PHSA\PHSA-MERGED.XML 170 Sec. 319D PUBLIC HEALTH SERVICE ACT (C) any other entities determined appropriate by the Secretary. (2) R EQUIREMENTS .—The Secretary shall ensure that net- works under paragraph (1) allow for the timely sharing and discussion, in a secure manner, of essential information con- cerning bioterrorism or another public health emergency, or recommended methods for responding to such an attack or emergency, allowing for coordination to maximize all-hazards medical and public health preparedness and response and to minimize duplication of effort. (3) S TANDARDS .—Not later than one year after the date of the enactment of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Secretary, in co- operation with health care providers and State and local public health officials, shall establish any additional technical and re- porting standards (including standards for interoperability) for networks under paragraph (1) and update such standards as necessary. (c) M WARENESS H EALTH S ITUATIONAL P UBLIC ODERNIZING A B IOSURVEILLANCE .— AND N GENERAL .—Not later than 2 years after the date of (1) I enactment of the Pandemic and All-Hazards Preparedness Re- authorization Act of 2013, the Secretary, in collaboration with State, local, and tribal public health officials, shall establish a near real-time electronic nationwide public health situational awareness capability through an interoperable network of sys- tems to share data and information to enhance early detection of rapid response to, and management of, potentially cata- strophic infectious disease outbreaks, novel emerging threats, and other public health emergencies that originate domesti- cally or abroad. Such network shall be built on existing State situational awareness systems or enhanced systems that en- able such connectivity. .—Not later than (2) S TRATEGY AND IMPLEMENTATION PLAN 180 days after the date of enactment of the Pandemic and All- Hazards Preparedness Reauthorization Act of 2013, the Sec- retary shall submit to the appropriate committees of Congress a coordinated strategy and an accompanying implementation plan that identifies and demonstrates the measurable steps the Secretary will carry out to— (A) develop, implement, and evaluate the network de- scribed in paragraph (1), utilizing the elements described in paragraph (3); (B) modernize and enhance biosurveillance activities; and (C) improve information sharing, coordination, and communication among disparate biosurveillance systems supported by the Department of Health and Human Serv- ices. LEMENTS .—The network described in paragraph (1) (3) E shall include data and information transmitted in a standard- ized format from— (A) State, local, and tribal public health entities, in- cluding public health laboratories; March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00170 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

171 G:\COMP\PHSA\PHSA-MERGED.XML 171 Sec. 319D PUBLIC HEALTH SERVICE ACT (B) Federal health agencies; (C) zoonotic disease monitoring systems; (D) public and private sector health care entities, hos- pitals, pharmacies, poison control centers or professional organizations in the field of poison control, community health centers, health centers and clinical laboratories, to the extent practicable and provided that such data are vol- untarily provided simultaneously to the Secretary and ap- propriate State, local, and tribal public health agencies; and (E) such other sources as the Secretary may deem ap- propriate. (4) R .—Paragraph (3) shall not be ULE OF CONSTRUCTION construed as requiring separate reporting of data and informa- tion from each source listed. (5) R .—In establishing and operating EQUIRED ACTIVITIES the network described in paragraph (1), the Secretary shall— (A) utilize applicable interoperability standards as de- termined by the Secretary, and in consultation with the Office of the National Coordinator for Health Information Technology, through a joint public and private sector proc- ess; (B) define minimal data elements for such network; (C) in collaboration with State, local, and tribal public health officials, integrate and build upon existing State, local, and tribal capabilities, ensuring simultaneous shar- ing of data, information, and analyses from the network described in paragraph (1) with State, local, and tribal public health agencies; and (D) in collaboration with State, local, and tribal public health officials, develop procedures and standards for the collection, analysis, and interpretation of data that States, regions, or other entities collect and report to the network described in paragraph (1). (6) C ONSULTATION THE NATIONAL BIODEFENSE WITH SCIENCE BOARD .—In carrying out this section and consistent with section 319M, the National Biodefense Science Board shall provide expert advice and guidance, including rec- ommendations, regarding the measurable steps the Secretary should take to modernize and enhance biosurveillance activi- ties pursuant to the efforts of the Department of Health and Human Services to ensure comprehensive, real-time, all-haz- ards biosurveillance capabilities. In complying with the pre- ceding sentence, the National Biodefense Science Board shall— (A) identify the steps necessary to achieve a national biosurveillance system for human health, with inter- national connectivity, where appropriate, that is predi- cated on State, regional, and community level capabilities and creates a networked system to allow for two-way infor- mation flow between and among Federal, State, and local government public health authorities and clinical health care providers; (B) identify any duplicative surveillance programs under the authority of the Secretary, or changes that are March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00171 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

172 G:\COMP\PHSA\PHSA-MERGED.XML 172 Sec. 319D PUBLIC HEALTH SERVICE ACT necessary to existing programs, in order to enhance and modernize such activities, minimize duplication, strength- en and streamline such activities under the authority of the Secretary, and achieve real-time and appropriate data that relate to disease activity, both human and zoonotic; and (C) coordinate with applicable existing advisory com- mittees of the Director of the Centers for Disease Control and Prevention, including such advisory committees con- sisting of representatives from State, local, and tribal pub- lic health authorities and appropriate public and private sector health care entities and academic institutions, in order to provide guidance on public health surveillance ac- tivities. (d) S EGIONAL S YSTEMS T O TATE AND NHANCE S ITUATIONAL R E WARENESS IN UBLIC H EALTH E MERGENCIES P A .— N GENERAL .—To implement the network described in (1) I subsection (c), the Secretary may award grants to States or consortia of States to enhance the ability of such States or con- sortia of States to establish or operate a coordinated public health situational awareness system for regional or Statewide early detection of, rapid response to, and management of po- tentially catastrophic infectious disease outbreaks and public health emergencies, in collaboration with appropriate public health agencies, sentinel hospitals, clinical laboratories, phar- macies, poison control centers, other health care organizations, and animal health organizations within such States. (2) E LIGIBILITY .—To be eligible to receive a grant under paragraph (1), the State or consortium of States shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including an assurance that the State or consortium of States will submit to the Secretary— (A) reports of such data, information, and metrics as the Secretary may require; (B) a report on the effectiveness of the systems funded under the grant; and (C) a description of the manner in which grant funds will be used to enhance the timelines and comprehensive- ness of efforts to detect, respond to, and manage poten- tially catastrophic infectious disease outbreaks and public health emergencies. (3) U .—A State or consortium of States that SE OF FUNDS receives an award under this subsection— (A) shall establish, enhance, or operate a coordinated public health situational awareness system for regional or Statewide early detection of, rapid response to, and man- agement of potentially catastrophic infectious disease out- breaks and public health emergencies; (B) may award grants or contracts to entities de- scribed in paragraph (1) within or serving such State to as- sist such entities in improving the operation of information technology systems, facilitating the secure exchange of data and information, and training personnel to enhance March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00172 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

173 G:\COMP\PHSA\PHSA-MERGED.XML 173 Sec. 319D PUBLIC HEALTH SERVICE ACT the operation of the system described in subparagraph (A); and (C) may conduct a pilot program for the development of multi-State telehealth network test beds that build on, enhance, and securely link existing State and local tele- health programs to prepare for, monitor, respond to, and manage the events of public health emergencies, facilitate coordination and communication among medical, public health, and emergency response agencies, and provide medical services through telehealth initiatives within the States that are involved in such a multi-State telehealth network test bed. (4) L .—Information technology systems acquired IMITATION or implemented using grants awarded under this section must be compliant with— (A) interoperability and other technological standards, as determined by the Secretary; and (B) data collection and reporting requirements for the network described in subsection (c). (5) I .—Not later than 3 years NDEPENDENT EVALUATION after the date of enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, the Government Ac- countability Office shall conduct an independent evaluation, and submit to the Secretary and the appropriate committees of Congress a report concerning the activities conducted under this subsection and subsection (c). ELEHEALTH E NHANCEMENTS FOR E MERGENCY R ESPONSE .— (e) T (1) E .—The Secretary, in consultation with the VALUATION Federal Communications Commission and other relevant Fed- eral agencies, shall— (A) conduct an inventory of telehealth initiatives in ex- istence on the date of enactment of the Pandemic and All- Hazards Preparedness Act, including— (i) the specific location of network components; (ii) the medical, technological, and communica- tions capabilities of such components; (iii) the functionality of such components; and (iv) the capacity and ability of such components to handle increased volume during the response to a pub- lic health emergency; (B) identify methods to expand and interconnect the regional health information networks funded by the Sec- retary, the State and regional broadband networks funded through the rural health care support mechanism pilot program funded by the Federal Communications Commis- sion, and other telehealth networks; (C) evaluate ways to prepare for, monitor, respond rapidly to, or manage the events of, a public health emer- gency through the enhanced use of telehealth technologies, including mechanisms for payment or reimbursement for use of such technologies and personnel during public health emergencies; (D) identify methods for reducing legal barriers that deter health care professionals from providing telemedicine March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00173 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

174 G:\COMP\PHSA\PHSA-MERGED.XML 174 Sec. 319E PUBLIC HEALTH SERVICE ACT services, such as by utilizing State emergency health care professional credentialing verification systems, encour- aging States to establish and implement mechanisms to improve interstate medical licensure cooperation, facili- tating the exchange of information among States regarding investigations and adverse actions, and encouraging States to waive the application of licensing requirements during a public health emergency; (E) evaluate ways to integrate the practice of telemedi- cine within the National Disaster Medical System; and (F) promote greater coordination among existing Fed- eral interagency telemedicine and health information tech- nology initiatives. (2) R .—Not later than 12 months after the date of EPORT enactment of the Pandemic and All-Hazards Preparedness Act, the Secretary shall prepare and submit a report to the Com- mittee on Health, Education, Labor, and Pensions of the Sen- ate and the Committee on Energy and Commerce of the House of Representatives regarding the findings and recommenda- tions pursuant to subparagraphs (A) through (F) of paragraph (1). A .—There are authorized UTHORIZATION OF PPROPRIATIONS (f) A to be appropriated to carry out this section, $138,300,000 for each of fiscal years 2014 through 2018. .—For purposes of this section the term ‘‘bio- EFINITION (g) D surveillance’’ means the process of gathering near real-time biologi- cal data that relates to human and zoonotic disease activity and threats to human or animal health, in order to achieve early warn- ing and identification of such health threats, early detection and prompt ongoing tracking of health events, and overall situational awareness of disease activity. ø 247d–5 ¿ COMBATING ANTIMICROBIAL RESISTANCE. SEC. 319E. ASK (a) T .— F ORCE .—The Secretary shall establish an Anti- N GENERAL (1) I microbial Resistance Task Force to provide advice and rec- ommendations to the Secretary and coordinate Federal pro- grams relating to antimicrobial resistance. The Secretary may appoint or select a committee, or other organization in exist- ence as of the date of the enactment of this section, to serve as such a task force, if such committee, or other organization meets the requirements of this section. (2) M EMBERS OF TASK FORCE .—The task force described in paragraph (1) shall be composed of representatives from such Federal agencies, and shall seek input from public health con- stituencies, manufacturers, veterinary and medical professional societies and others, as determined to be necessary by the Sec- retary, to develop and implement a comprehensive plan to ad- dress the public health threat of antimicrobial resistance. GENDA .— (3) A N GENERAL .—The task force described in para- (A) I graph (1) shall consider factors the Secretary considers ap- propriate, including— March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00174 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

175 G:\COMP\PHSA\PHSA-MERGED.XML 175 Sec. 319E PUBLIC HEALTH SERVICE ACT (i) public health factors contributing to increasing antimicrobial resistance; (ii) public health needs to detect and monitor anti- microbial resistance; (iii) detection, prevention, and control strategies for resistant pathogens; (iv) the need for improved information and data collection; (v) the assessment of the risk imposed by patho- gens presenting a threat to the public health; and (vi) any other issues which the Secretary deter- mines are relevant to antimicrobial resistance. ETECTION AND CONTROL .—The Secretary, in con- (B) D sultation with the task force described in paragraph (1) and State and local public health officials, shall— (i) develop, improve, coordinate or enhance partici- pation in a surveillance plan to detect and monitor emerging antimicrobial resistance; and (ii) develop, improve, coordinate or enhance par- ticipation in an integrated information system to as- similate, analyze, and exchange antimicrobial resist- ance data between public health departments. (4) M EETINGS .—The task force described under paragraph (1) shall convene not less than twice a year, or more frequently as the Secretary determines to be appropriate. (b) R ESEARCH AND N EW A NTIMICROBIAL D EVELOPMENT OF RUGS AND D IAGNOSTICS .—The Secretary and the Director of Agri- D cultural Research Services, consistent with the recommendations of the task force established under subsection (a), shall directly or through awards of grants or cooperative agreements to public or private entities provide for the conduct of research, investigations, experiments, demonstrations, and studies in the health sciences that are related to— (1) the development of new therapeutics, including vac- cines and antimicrobials, against resistant pathogens; (2) the development or testing of medical diagnostics to de- tect pathogens resistant to antimicrobials; (3) the epidemiology, mechanisms, and pathogenesis of antimicrobial resistance; (4) the sequencing of the genomes, or other DNA analysis, or other comparative analysis, of priority pathogens (as deter- mined by the Director of the National Institutes of Health in consultation with the task force established under subsection (a)), in collaboration and coordination with the activities of the Department of Defense and the Joint Genome Institute of the Department of Energy; and (5) other relevant research areas. DUCATION OF M EDICAL AND P UBLIC H EALTH P ERSONNEL .— (c) E The Secretary, after consultation with the Assistant Secretary for Health, the Surgeon General, the Director of the Centers for Dis- ease Control and Prevention, the Administrator of the Health Re- sources and Services Administration, the Director of the Agency for Healthcare Research and Quality, members of the task force de- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00175 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

176 G:\COMP\PHSA\PHSA-MERGED.XML 176 Sec. 319E PUBLIC HEALTH SERVICE ACT scribed in subsection (a), professional organizations and societies, and such other public health officials as may be necessary, shall— (1) develop and implement educational programs to in- crease the awareness of the general public with respect to the public health threat of antimicrobial resistance and the appro- priate use of antibiotics; (2) develop and implement educational programs to in- struct health care professionals in the prudent use of anti- biotics; and (3) develop and implement programs to train laboratory personnel in the recognition or identification of resistance in pathogens. (d) G .— RANTS (1) I .—The Secretary shall award competitive N GENERAL grants to eligible entities to enable such entities to increase the capacity to detect, monitor, and combat antimicrobial resist- ance. (2) E .—Eligible entities for grants under LIGIBLE ENTITIES paragraph (1) shall be State or local public health agencies, In- dian tribes or tribal organizations, or other public or private nonprofit entities. (3) U .—An eligible entity receiving a grant SE OF FUNDS under paragraph (1) shall use funds from such grant for activi- ties that are consistent with the factors identified by the task force under subsection (a)(3), which may include activities that— (A) provide training to enable such entity to identify patterns of resistance rapidly and accurately; (B) develop, improve, coordinate or enhance participa- tion in information systems by which data on resistant in- fections can be shared rapidly among relevant national, State, and local health agencies and health care providers; and (C) develop and implement policies to control the spread of antimicrobial resistance. RANTS FOR D EMONSTRATION P ROGRAMS .— (e) G N GENERAL (1) I .—The Secretary shall award competitive grants to eligible entities to establish demonstration programs to promote judicious use of antimicrobial drugs or control the spread of antimicrobial-resistant pathogens. LIGIBLE ENTITIES .—Eligible entities for grants under (2) E paragraph (1) may include hospitals, clinics, institutions of long-term care, professional medical societies, schools or pro- grams that train medical laboratory personnel, or other public or private nonprofit entities. ECHNICAL ASSISTANCE .—The Secretary shall provide (3) T appropriate technical assistance to eligible entities that receive grants under paragraph (1). ONITORING AT F EDERAL H EALTH C ARE F ACILITIES .—The (f) M Secretary shall encourage reporting on aggregate antimicrobial drug use and antimicrobial resistance to antimicrobial drugs and the implementation of antimicrobial stewardship programs by health care facilities of the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service and shall pro- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00176 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

177 G:\COMP\PHSA\PHSA-MERGED.XML 177 Sec. 319E PUBLIC HEALTH SERVICE ACT vide technical assistance to the Secretary of Defense and the Sec- retary of Veterans Affairs, as appropriate and upon request. EPORT ON NTIMICROBIAL R ESISTANCE IN H UMANS AND A (g) R NTIMICROBIAL RUGS A .—Not later than 1 year after the U SE OF D date of enactment of the 21st Century Cures Act, and annually thereafter, the Secretary shall prepare and make publicly available data and information concerning— (1) aggregate national and regional trends of antimicrobial resistance in humans to antimicrobial drugs, including such drugs approved under section 506(h) of the Federal Food, Drug, and Cosmetic Act; (2) antimicrobial stewardship, which may include sum- maries of State efforts to address antimicrobial resistance in humans to antimicrobial drugs and antimicrobial stewardship; and (3) coordination between the Director of the Centers for Disease Control and Prevention and the Commissioner of Food and Drugs with respect to the monitoring of— (A) any applicable resistance under paragraph (1); and (B) drugs approved under section 506(h) of the Federal Food, Drug, and Cosmetic Act. R ELATED TO A NTIMICROBIAL S TEWARDSHIP NFORMATION (h) I P ROGRAMS .—The Secretary shall, as appropriate, disseminate guid- ance, educational materials, or other appropriate materials related to the development and implementation of evidence-based anti- microbial stewardship programs or practices at health care facili- ties, such as nursing homes and other long-term care facilities, am- bulatory surgical centers, dialysis centers, outpatient clinics, and hospitals, including community and rural hospitals. (i) S UPPORTING -B ASED A CTIVITIES TO C OMBAT A NTI - S TATE ESISTANCE R MICROBIAL .—The Secretary shall continue to work with State and local public health departments on statewide or regional programs related to antimicrobial resistance. Such efforts may in- clude activities to related to— (1) identifying patterns of bacterial and fungal resistance in humans to antimicrobial drugs; (2) preventing the spread of bacterial and fungal infections that are resistant to antimicrobial drugs; and (3) promoting antimicrobial stewardship. NTIMICROBIAL R ESISTANCE AND S TEWARDSHIP A CTIVITIES .— (j) A (1) I .—For the purposes of supporting steward- N GENERAL ship activities, examining changes in antimicrobial resistance, and evaluating the effectiveness of section 506(h) of the Fed- eral Food, Drug, and Cosmetic Act, the Secretary shall— (A) provide a mechanism for facilities to report data related to their antimicrobial stewardship activities (in- cluding analyzing the outcomes of such activities); and (B) evaluate— (i) antimicrobial resistance data using a standard- ized approach; and (ii) trends in the utilization of drugs approved under such section 506(h) with respect to patient pop- ulations. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00177 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

178 G:\COMP\PHSA\PHSA-MERGED.XML 178 Sec. 319F PUBLIC HEALTH SERVICE ACT .—The Secretary shall use available SE OF SYSTEMS (2) U systems, including the National Healthcare Safety Network or other systems identified by the Secretary, to fulfill the require- ments or conduct activities under this section. NTIMICROBIAL .—For purposes of subsections (f) through (j), (k) A the term ‘‘antimicrobial’’ includes any antibacterial or antifungal drugs, and may include drugs that eliminate or inhibit the growth of other microorganisms, as appropriate. N OT S UPPLANT .—Funds appropriated under UPPLEMENT (l) S this section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities under this section. UTHORIZATION OF PPROPRIATIONS .—There are authorized A (m) A to be appropriated to carry out this section, $40,000,000 for fiscal year 2001, $25,000,000 for each of the fiscal years 2002 and 2003, and such sums as may be necessary for each of the fiscal years 2004 through 2006. ø 247d–6 ¿ PUBLIC HEALTH COUNTERMEASURES TO A BIO- SEC. 319F. TERRORIST ATTACK. LL -H AZARDS P UBLIC H EALTH AND M EDICAL R ESPONSE (a) A URRICULA AND C .— T RAINING .—The Secretary, in collaboration with the N GENERAL (1) I Secretary of Defense, and in consultation with relevant public and private entities, shall develop core health and medical re- sponse curricula and trainings by adapting applicable existing curricula and training programs to improve responses to public health emergencies. .—The public health and medical response URRICULUM (2) C training program may include course work related to— (A) medical management of casualties, taking into ac- count the needs of at-risk individuals; (B) public health aspects of public health emergencies; (C) mental health aspects of public health emer- gencies; (D) national incident management, including coordina- tion among Federal, State, local, tribal, international agen- cies, and other entities; and (E) protecting health care workers and health care first responders from workplace exposures during a public health emergency. (3) P .—On a periodic basis, products prepared EER REVIEW as part of the program shall be rigorously tested and peer-re- viewed by experts in the relevant fields. .—The Secretary and the Secretary of Defense (4) C REDIT shall— (A) take into account continuing professional education requirements of public health and healthcare professions; and (B) cooperate with State, local, and tribal accrediting agencies and with professional associations in arranging for students enrolled in the program to obtain continuing professional education credit for program courses. (5) D ISSEMINATION AND TRAINING .— March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00178 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

179 G:\COMP\PHSA\PHSA-MERGED.XML 179 Sec. 319F PUBLIC HEALTH SERVICE ACT .—The Secretary may provide for the N GENERAL (A) I dissemination and teaching of the materials described in paragraphs (1) and (2) by appropriate means, as deter- mined by the Secretary. ERTAIN ENTITIES .—The education and training ac- (B) C tivities described in subparagraph (A) may be carried out by Federal public health, medical, or dental entities, ap- propriate educational entities, professional organizations and societies, private accrediting organizations, and other nonprofit institutions or entities meeting criteria estab- lished by the Secretary. RANTS AND CONTRACTS .—In carrying out this sub- (C) G section, the Secretary may carry out activities directly or through the award of grants and contracts, and may enter into interagency agreements with other Federal agencies. EDERAL F DVICE TO THE .— OVERNMENT G (b) A EQUIRED ADVISORY COMMITTEES .—In coordination (1) R with the working group under subsection (a), the Secretary shall establish advisory committees in accordance with para- graphs (2) and (3) to provide expert recommendations to assist such working groups in carrying out their respective respon- 19 . sibilities under subsections (a) and (b) (2) N - ATIONAL ADVISORY COMMITTEE ON CHILDREN AND TER 20 .— RORISM .—For purposes of paragraph (1), the N GENERAL (A) I Secretary shall establish an advisory committee to be known as the National Advisory Committee on At-Risk In- dividuals and Public Health Emergencies (referred to in this paragraph as the ‘‘Advisory Committee’’). .—The Advisory Committee shall provide UTIES (B) D recommendations regarding— (i) the preparedness of the health care (including mental health care) system to respond to public health emergencies as they relate to at-risk individuals; (ii) needed changes to the health care and emer- gency medical service systems and emergency medical services protocols to meet the special needs of at-risk individuals; and (iii) changes, if necessary, to the national stockpile under section 121 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 to meet the emergency health security of at-risk indi- viduals. OMPOSITION .—The Advisory Committee shall be (C) C composed of such Federal officials as may be appropriate 19 Probably should be ‘‘to assist such working group in carrying out its responsibilities under subsection (a)’’. Formerly there were two working groups, one under subsection (a) and one under subsection (b). Now there is only the working group under subsection (a). See the amend- ments made by sections 104(a) and 108 of Public Law 107–188 (116 Stat. 605, 609). 20 The heading for subsection (b)(2) probably should read ‘‘N ATIONAL ADVISORY COMMITTEE ON ’’. The amendment made by section RISK INDIVIDUALS AND PUBLIC HEALTH EMERGENCIES - AT 301(d)(1) of Public Law 109–417 (120 Stat. 2854) to strike ‘‘C HILDREN AND TERRORISM ’’ and in- RISK INDIVIDUALS AND PUBLIC HEALTH EMERGENCIES sert ‘‘A T - ’’ could not be executed due to incor- rect capitalization of the word ‘‘Children’’ in the matter to be struck. Also the letter ‘‘A’’ in the word ‘‘At-risk’’ in the inserted text probably should be lowercase type. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00179 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

180 G:\COMP\PHSA\PHSA-MERGED.XML 180 Sec. 319F PUBLIC HEALTH SERVICE ACT to address the special needs of the diverse population groups of at-risk populations. (D) T ERMINATION .—The Advisory Committee termi- nates six years after the date of the enactment of the Pub- lic Health Security and Bioterrorism Preparedness and Re- sponse Act of 2002. (3) E - MERGENCY PUBLIC INFORMATION AND COMMUNICA TIONS ADVISORY COMMITTEE .— (A) I .—For purposes of paragraph (1), the N GENERAL Secretary shall establish an advisory committee to be known as the Emergency Public Information and Commu- nications Advisory Committee (referred to in this para- graph as the ‘‘EPIC Advisory Committee’’). (B) D UTIES .—The EPIC Advisory Committee shall make recommendations to the Secretary and report on ap- propriate ways to communicate public health information regarding bioterrorism and other public health emer- gencies to the public. (C) C .—The EPIC Advisory Committee OMPOSITION shall be composed of individuals representing a diverse group of experts in public health, medicine, communica- tions, behavioral psychology, and other areas determined appropriate by the Secretary. (D) D ISSEMINATION .—The Secretary shall review the recommendations of the EPIC Advisory Committee and en- sure that appropriate information is disseminated to the public. (E) T ERMINATION .—The EPIC Advisory Committee ter- minates one year after the date of the enactment of Public Health Security and Bioterrorism Preparedness and Re- sponse Act of 2002. XPANSION OF E PIDEMIC I NTELLIGENCE S ERVICE P RO - (c) E GRAM .—The Secretary may establish 20 officer positions in the Epi- demic Intelligence Service Program, in addition to the number of the officer positions offered under such Program in 2006, for indi- viduals who agree to participate, for a period of not less than 2 years, in the Career Epidemiology Field Officer program in a State, local, or tribal health department that serves a health professional shortage area (as defined under section 332(a)), a medically under- served population (as defined under section 330(b)(3)), or a medi- cally underserved area or area at high risk of a public health emer- gency as designated by the Secretary. (d) C UBLIC ENTERS FOR EALTH P REPAREDNESS ; C ORE C UR - P H T RAINING .— RICULA AND N GENERAL (1) I .—The Secretary may establish at accred- ited schools of public health, Centers for Public Health Pre- paredness (hereafter referred to in this section as the ‘‘Cen- ters’’). (2) E .—To be eligible to receive an award under LIGIBILITY this subsection to establish a Center, an accredited school of public health shall agree to conduct activities consistent with the requirements of this subsection. ORE CURRICULA .—The Secretary, in collaboration with (3) C the Centers and other public or private entities shall establish March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00180 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

181 G:\COMP\PHSA\PHSA-MERGED.XML 181 Sec. 319F PUBLIC HEALTH SERVICE ACT core curricula based on established competencies leading to a 4-year bachelor’s degree, a graduate degree, a combined bach- elor and master’s degree, or a certificate program, for use by each Center. The Secretary shall disseminate such curricula to other accredited schools of public health and other health pro- fessions schools determined appropriate by the Secretary, for voluntary use by such schools. (4) C - BASED TRAINING PROGRAM .—The ORE COMPETENCY Secretary, in collaboration with the Centers and other public or private entities shall facilitate the development of a com- petency-based training program to train public health practi- tioners. The Centers shall use such training program to train public health practitioners. The Secretary shall disseminate such training program to other accredited schools of public health, health professions schools, and other public or private entities as determined by the Secretary, for voluntary use by such entities. (5) C - ONTENT OF CORE CURRICULA AND TRAINING PRO GRAM .—The Secretary shall ensure that the core curricula and training program established pursuant to this subsection re- spond to the needs of State, local, and tribal public health au- thorities and integrate and emphasize essential public health security capabilities consistent with section 2802(b)(2). (6) A WORKFORCE COMMUNICATION .—As a condi- CADEMIC - tion of receiving funding from the Secretary under this sub- section, a Center shall collaborate with a State, local, or tribal public health department to— (A) define the public health preparedness and re- sponse needs of the community involved; (B) assess the extent to which such needs are fulfilled by existing preparedness and response activities of such school or health department, and how such activities may be improved; (C) prior to developing new materials or trainings, evaluate and utilize relevant materials and trainings de- veloped by others Centers; and (D) evaluate community impact and the effectiveness of any newly developed materials or trainings. (7) P UBLIC HEALTH SYSTEMS RESEARCH .—In consultation with relevant public and private entities, the Secretary shall define the existing knowledge base for public health prepared- ness and response systems, and establish a research agenda based on Federal, State, local, and tribal public health pre- paredness priorities. As a condition of receiving funding from the Secretary under this subsection, a Center shall conduct public health systems research that is consistent with the agenda described under this paragraph. CCELERATED R ESEARCH AND D EVELOPMENT ON P RIORITY (e) A ATHOGENS AND OUNTERMEASURES .— C P (1) I N GENERAL .—With respect to pathogens of potential use in a bioterrorist attack, and other agents that may cause a public health emergency, the Secretary, taking into consider- ation any recommendations of the working group under sub- section (a), shall conduct, and award grants, contracts, or coop- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00181 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

182 G:\COMP\PHSA\PHSA-MERGED.XML 182 Sec. 319F PUBLIC HEALTH SERVICE ACT erative agreements for, research, investigations, experiments, demonstrations, and studies in the health sciences relating to— (A) the epidemiology and pathogenesis of such patho- gens; (B) the sequencing of the genomes, or other DNA anal- ysis, or other comparative analysis, of priority pathogens (as determined by the Director of the National Institutes of Health in consultation with the working group estab- lished in subsection (a)), in collaboration and coordination with the activities of the Department of Defense and the Joint Genome Institute of the Department of Energy; (C) the development of priority countermeasures; and (D) other relevant areas of research; with consideration given to the needs of children and other vul- nerable populations. .—The Secretary shall give priority under this RIORITY (2) P section to the funding of research and other studies related to priority countermeasures. (3) R .—In car- OLE OF DEPARTMENT OF VETERANS AFFAIRS rying out paragraph (1), the Secretary shall consider using the biomedical research and development capabilities of the De- partment of Veterans Affairs, in conjunction with that Depart- ment’s affiliations with health-professions universities. When advantageous to the Government in furtherance of the pur- poses of such paragraph, the Secretary may enter into coopera- tive agreements with the Secretary of Veterans Affairs to achieve such purposes. (4) P .—For purposes of this sec- RIORITY COUNTERMEASURES tion, the term ‘‘priority countermeasure’’ means a drug, biologi- cal product, device, vaccine, vaccine adjuvant, antiviral, or di- agnostic test that the Secretary determines to be— (A) a priority to treat, identify, or prevent infection by a biological agent or toxin listed pursuant to section 351A(a)(1), or harm from any other agent that may cause a public health emergency; or (B) a priority to treat, identify, or prevent conditions that may result in adverse health consequences or death and may be caused by the administering of a drug, biologi- cal product, device, vaccine, vaccine adjuvant, antiviral, or diagnostic test that is a priority under subparagraph (A). UTHORIZATION OF A PPROPRIATIONS .— (f) A ISCAL YEAR 2007 .—There are authorized to be appro- (1) F priated to carry out this section for fiscal year 2007— (A) to carry out subsection (a)— (i) $5,000,000 to carry out paragraphs (1) through (4); and (ii) $7,000,000 to carry out paragraph (5); (B) to carry out subsection (c), $3,000,000; and (C) to carry out subsection (d), $31,000,000, of which $5,000,000 shall be used to carry out paragraphs (3) through (5) of such subsection. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00182 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

183 G:\COMP\PHSA\PHSA-MERGED.XML 183 Sec. 319F–1 PUBLIC HEALTH SERVICE ACT UBSEQUENT FISCAL YEARS (2) S .—There are authorized to be appropriated such sums as may be necessary to carry out this section for fiscal year 2008 and each subsequent fiscal year. ø 247d–6a SEC. 319F–1. AUTHORITY FOR USE OF CERTAIN PROCE- ¿ DURES REGARDING QUALIFIED COUNTERMEASURE RE- 21 SEARCH AND DEVELOPMENT ACTIVITIES. .— (a) I N G ENERAL (1) A .—In conducting and supporting research UTHORITY and development activities regarding countermeasures under section 319F(h), the Secretary may conduct and support such activities in accordance with this section and, in consultation with the Director of the National Institutes of Health, as part of the program under section 446, if the activities concern qualified countermeasures. (2) D EFINITIONS .—In this section: (A) Q UALIFIED COUNTERMEASURE .—The term ‘‘quali- fied countermeasure’’ means a drug (as that term is de- fined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as that term is defined by section 351(i) of this Act (42 U.S.C. 262(i))), or device (as that term is defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))), that the Secretary determines to be a priority (consistent with sections 302(2) and 304(a) of the Home- land Security Act of 2002)— (i) to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease) or toxin, chemical, radio- logical, or nuclear agent that may cause a public health emergency affecting national security; (ii) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by admin- istering a drug, biological product, or device that is used as described in this subparagraph; or (iii) is a product or technology intended to en- hance the use or effect of a drug, biological product, or device described in clause (i) or (ii). (B) I NFECTIOUS DISEASE .—The term ‘‘infectious dis- ease’’ means a disease potentially caused by a pathogenic organism (including a bacteria, virus, fungus, or parasite) that is acquired by a person and that reproduces in that person. .— NTERAGENCY COOPERATION (3) I N GENERAL .—In carrying out activities under this (A) I section, the Secretary is authorized, subject to subpara- graph (B), to enter into interagency agreements and other collaborative undertakings with other agencies of the United States Government. 21 Section 5 of Public Law 108–276 (118 Stat. 860) requires various reports regarding section 319F–1 and related provisions of law. Section 5 is included in the appendix to this compilation. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00183 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

184 G:\COMP\PHSA\PHSA-MERGED.XML 184 Sec. 319F–1 PUBLIC HEALTH SERVICE ACT .—An agreement or undertaking under (B) L IMITATION this paragraph shall not authorize another agency to exer- cise the authorities provided by this section. (4) A VAILABILITY OF FACILITIES TO THE SECRETARY .—In any grant, contract, or cooperative agreement entered into under the authority provided in this section with respect to a bio- containment laboratory or other related or ancillary specialized research facility that the Secretary determines necessary for the purpose of performing, administering, or supporting quali- fied countermeasure research and development, the Secretary may provide that the facility that is the object of such grant, contract, or cooperative agreement shall be available as needed to the Secretary to respond to public health emergencies affect- ing national security. .—Each RANSFERS OF QUALIFIED COUNTERMEASURES (5) T agreement for an award of a grant, contract, or cooperative agreement under section 319F(h) for the development of a qualified countermeasure shall provide that the recipient of the award will comply with all applicable export-related controls with respect to such countermeasure. P ROCUREMENT A XPEDITED .— UTHORITY (b) E (1) I NCREASED SIMPLIFIED ACQUISITION THRESHOLD FOR .— QUALIFIED COUNTERMEASURE PROCUREMENTS N GENERAL (A) I .—For any procurement by the Sec- retary of property or services for use (as determined by the Secretary) in performing, administering, or supporting qualified countermeasure research or development activi- ties under this section that the Secretary determines nec- essary to respond to pressing research and development needs under this section, the amount specified in section 4(11) of the Office of Federal Procurement Policy Act (41 U.S.C. 403(11)), as applicable pursuant to section 302A(a) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 252a(a)), shall be deemed to be $25,000,000 in the administration, with respect to such procurement, of— (i) section 303(g)(1)(A) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 253(g)(1)(A)) and its implementing regulations; and (ii) section 302A(b) of such Act (41 U.S.C. 252a(b)) and its implementing regulations. (B) A PPLICATION OF CERTAIN PROVISIONS .—Notwith- standing subparagraph (A) and the provision of law and regulations referred to in such subparagraph, each of the following provisions shall apply to procurements described in this paragraph to the same extent that such provisions would apply to such procurements in the absence of sub- paragraph (A): (i) Chapter 37 of title 40, United States Code (re- lating to contract work hours and safety standards). (ii) Subsections (a) and (b) of section 7 of the Anti- Kickback Act of 1986 (41 U.S.C. 57(a) and (b)). March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00184 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

185 G:\COMP\PHSA\PHSA-MERGED.XML 185 Sec. 319F–1 PUBLIC HEALTH SERVICE ACT (iii) Section 304C of the Federal Property and Ad- ministrative Services Act of 1949 (41 U.S.C. 254d) (re- lating to the examination of contractor records). (iv) Section 3131 of title 40, United States Code (relating to bonds of contractors of public buildings or works). (v) Subsection (a) of section 304 of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 254(a)) (relating to contingent fees to middle- men). (vi) Section 6002 of the Solid Waste Disposal Act (42 U.S.C. 6962). (vii) Section 1354 of title 31, United States Code (relating to the limitation on the use of appropriated funds for contracts with entities not meeting veterans employment reporting requirements). (C) I NTERNAL CONTROLS TO BE INSTITUTED .—The Sec- retary shall institute appropriate internal controls for pro- curements that are under this paragraph, including re- quirements with regard to documenting the justification for use of the authority in this paragraph with respect to the procurement involved. (D) A .—In conducting UTHORITY TO LIMIT COMPETITION a procurement under this paragraph, the Secretary may not use the authority provided for under subparagraph (A) to conduct a procurement on a basis other than full and open competition unless the Secretary determines that the mission of the BioShield Program under the Project Bio- Shield Act of 2004 would be seriously impaired without such a limitation. ROCEDURES OTHER THAN FULL AND OPEN COMPETI - (2) P .— TION .—In using the authority provided in N GENERAL (A) I section 303(c)(1) of title III of the Federal Property and Ad- ministrative Services Act of 1949 (41 U.S.C. 253(c)(1)) to use procedures other than competitive procedures in the case of a procurement described in paragraph (1) of this subsection, the phrase ‘‘available from only one responsible source’’ in such section 303(c)(1) shall be deemed to mean ‘‘available from only one responsible source or only from a limited number of responsible sources’’. (B) R ELATION TO OTHER AUTHORITIES .—The authority under subparagraph (A) is in addition to any other author- ity to use procedures other than competitive procedures. PPLICABLE GOVERNMENT - WIDE REGULATIONS .— (C) A The Secretary shall implement this paragraph in accord- ance with government-wide regulations implementing such section 303(c)(1) (including requirements that offers be so- licited from as many potential sources as is practicable under the circumstances, that required notices be pub- lished, and that submitted offers be considered), as such regulations apply to procurements for which an agency has authority to use procedures other than competitive proce- dures when the property or services needed by the agency March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00185 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

186 G:\COMP\PHSA\PHSA-MERGED.XML 186 Sec. 319F–1 PUBLIC HEALTH SERVICE ACT are available from only one responsible source or only from a limited number of responsible sources and no other type of property or services will satisfy the needs of the agency. NCREASED MICROPURCHASE THRESHOLD .— (3) I .—For a procurement described by N GENERAL (A) I paragraph (1), the amount specified in subsections (c), (d), and (f) of section 32 of the Office of Federal Procurement Policy Act (41 U.S.C. 428) shall be deemed to be $15,000 in the administration of that section with respect to such procurement. .—The Sec- NTERNAL CONTROLS TO BE INSTITUTED (B) I retary shall institute appropriate internal controls for pur- chases that are under this paragraph and that are greater than $2,500. (C) E XCEPTION TO PREFERENCE FOR PURCHASE CARD .—No provision of law establishing a preference MECHANISM for using a Government purchase card method for pur- chases shall apply to purchases that are under this para- graph and that are greater than $2,500. (4) R EVIEW .— .—Notwithstanding subsection (f), (A) R EVIEW ALLOWED section 1491 of title 28, United States Code, and section 3556 of title 31 of such Code, review of a contracting agen- cy decision relating to a procurement described in para- graph (1) may be had only by filing a protest— (i) with a contracting agency; or (ii) with the Comptroller General under sub- chapter V of chapter 35 of title 31, United States Code. (B) O VERRIDE OF STAY OF CONTRACT AWARD OR PER - .—Notwith- FORMANCE COMMITTED TO AGENCY DISCRETION standing section 1491 of title 28, United States Code, and section 3553 of title 31 of such Code, the following author- izations by the head of a procuring activity are committed to agency discretion: (i) An authorization under section 3553(c)(2) of title 31, United States Code, to award a contract for a procurement described in paragraph (1) of this sub- section. (ii) An authorization under section 3553(d)(3)(C) of such title to perform a contract for a procurement de- scribed in paragraph (1) of this subsection. UTHORITY TO E XPEDITE P EER R EVIEW .— (c) A (1) I .—The Secretary may, as the Secretary de- N GENERAL termines necessary to respond to pressing qualified counter- measure research and development needs under this section, employ such expedited peer review procedures (including con- sultation with appropriate scientific experts) as the Secretary, in consultation with the Director of NIH, deems appropriate to obtain assessment of scientific and technical merit and likely contribution to the field of qualified countermeasure research, in place of the peer review and advisory council review proce- dures that would be required under sections 301(a)(3), March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00186 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

187 G:\COMP\PHSA\PHSA-MERGED.XML 187 Sec. 319F–1 PUBLIC HEALTH SERVICE ACT 405(b)(1)(B), 405(b)(2), 406(a)(3)(A), 492, and 494, as applicable to a grant, contract, or cooperative agreement— (A) that is for performing, administering, or sup- porting qualified countermeasure research and develop- ment activities; and (B) the amount of which is not greater than $1,500,000. (2) S UBSEQUENT PHASES OF RESEARCH .—The Secretary’s determination of whether to employ expedited peer review with respect to any subsequent phases of a research grant, contract, or cooperative agreement under this section shall be deter- mined without regard to the peer review procedures used for any prior peer review of that same grant, contract, or coopera- tive agreement. Nothing in the preceding sentence may be con- strued to impose any requirement with respect to peer review not otherwise required under any other law or regulation. (d) A ERSONAL UTHORITY FOR ERVICES C ONTRACTS .— P S (1) I N GENERAL .—For the purpose of performing, admin- istering, or supporting qualified countermeasure research and development activities, the Secretary may, as the Secretary de- termines necessary to respond to pressing qualified counter- measure research and development needs under this section, obtain by contract (in accordance with section 3109 of title 5, United States Code, but without regard to the limitations in such section on the period of service and on pay) the personal services of experts or consultants who have scientific or other professional qualifications, except that in no case shall the compensation provided to any such expert or consultant exceed the daily equivalent of the annual rate of compensation for the President. (2) F .— EDERAL TORT CLAIMS ACT COVERAGE .—A person carrying out a contract N GENERAL (A) I under paragraph (1), and an officer, employee, or gov- erning board member of such person, shall, subject to a de- termination by the Secretary, be deemed to be an em- ployee of the Department of Health and Human Services for purposes of claims under sections 1346(b) and 2672 of title 28, United States Code, for money damages for per- sonal injury, including death, resulting from performance of functions under such contract. (B) E XCLUSIVITY OF REMEDY .—The remedy provided by subparagraph (A) shall be exclusive of any other civil ac- tion or proceeding by reason of the same subject matter against the entity involved (person, officer, employee, or governing board member) for any act or omission within the scope of the Federal Tort Claims Act. (C) R - ECOURSE IN CASE OF GROSS MISCONDUCT OR CON TRACT VIOLATION .— (i) I N GENERAL .—Should payment be made by the United States to any claimant bringing a claim under this paragraph, either by way of administrative deter- mination, settlement, or court judgment, the United States shall have, notwithstanding any provision of State law, the right to recover against any entity iden- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00187 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

188 G:\COMP\PHSA\PHSA-MERGED.XML 188 Sec. 319F–1 PUBLIC HEALTH SERVICE ACT tified in subparagraph (B) for that portion of the dam- ages so awarded or paid, as well as interest and any costs of litigation, resulting from the failure of any such entity to carry out any obligation or responsi- bility assumed by such entity under a contract with the United States or from any grossly negligent or reckless conduct or intentional or willful misconduct on the part of such entity. ENUE .—The United States may maintain an (ii) V action under this subparagraph against such entity in the district court of the United States in which such entity resides or has its principal place of business. .— NTERNAL CONTROLS TO BE INSTITUTED (3) I (A) I N GENERAL .—The Secretary shall institute appro- priate internal controls for contracts under this subsection, including procedures for the Secretary to make a deter- mination of whether a person, or an officer, employee, or governing board member of a person, is deemed to be an employee of the Department of Health and Human Serv- ices pursuant to paragraph (2). (B) D EMPLOYEE STATUS TO BE ETERMINATION OF .—A determination by the Secretary under subpara- FINAL graph (A) that a person, or an officer, employee, or gov- erning board member of a person, is or is not deemed to be an employee of the Department of Health and Human Services shall be final and binding on the Secretary and the Attorney General and other parties to any civil action or proceeding. (4) N UMBER OF PERSONAL SERVICES CONTRACTS LIMITED .— The number of experts and consultants whose personal serv- ices are obtained under paragraph (1) shall not exceed 30 at any time. P ERSONNEL A UTHORITY .— TREAMLINED (e) S N GENERAL .—In addition to any other personnel au- (1) I thorities, the Secretary may, as the Secretary determines nec- essary to respond to pressing qualified countermeasure re- search and development needs under this section, without re- gard to those provisions of title 5, United States Code, gov- erning appointments in the competitive service, and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, appoint professional and technical employ- ees, not to exceed 30 such employees at any time, to positions in the National Institutes of Health to perform, administer, or support qualified countermeasure research and development activities in carrying out this section. IMITATIONS .—The authority provided for under para- (2) L graph (1) shall be exercised in a manner that— (A) recruits and appoints individuals based solely on their abilities, knowledge, and skills; (B) does not discriminate for or against any applicant for employment on any basis described in section 2302(b)(1) of title 5, United States Code; March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00188 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

189 G:\COMP\PHSA\PHSA-MERGED.XML 189 Sec. 319F–2 PUBLIC HEALTH SERVICE ACT (C) does not allow an official to appoint an individual who is a relative (as defined in section 3110(a)(3) of such title) of such official; (D) does not discriminate for or against an individual because of the exercise of any activity described in para- graph (9) or (10) of section 2302(b) of such title; and (E) accords a preference, among equally qualified per- sons, to persons who are preference eligibles (as defined in section 2108(3) of such title). (3) I NTERNAL CONTROLS TO BE INSTITUTED .—The Secretary shall institute appropriate internal controls for appointments under this subsection. (f) A CTIONS C OMMITTED TO A GENCY D ISCRETION .—Actions by the Secretary under the authority of this section are committed to agency discretion. SEC. 319F–2. ø 247d–6b ¿ STRATEGIC NATIONAL STOCKPILE AND SECU- 22 RITY COUNTERMEASURE PROCUREMENTS. TOCKPILE .— (a) S TRATEGIC N ATIONAL S N GENERAL (1) I .—The Secretary, in collaboration with the Director of the Centers for Disease Control and Prevention, and in coordination with the Secretary of Homeland Security (referred to in this section as the ‘‘Homeland Security Sec- retary’’), shall maintain a stockpile or stockpiles of drugs, vac- cines and other biological products, medical devices, and other supplies in such numbers, types, and amounts as are deter- mined consistent with section 2811 by the Secretary to be ap- propriate and practicable, taking into account other available sources, to provide for the emergency health security of the United States, including the emergency health security of chil- dren and other vulnerable populations, in the event of a bioter- rorist attack or other public health emergency. The Secretary shall conduct an annual review (taking into account at-risk in- dividuals) of the contents of the stockpile, including non-phar- maceutical supplies, and make necessary additions or modifica- tions to the contents based on such review and shall submit such review annually to the appropriate congressional commit- tees of jurisdiction to the extent that disclosure of such infor- mation does not compromise national security. (2) P ROCEDURES .—The Secretary, in managing the stock- pile under paragraph (1), shall— (A) consult with the working group under section 319F(a); (B) ensure that adequate procedures are followed with respect to such stockpile for inventory management and accounting, and for the physical security of the stockpile; (C) in consultation with Federal, State, and local offi- cials, take into consideration the timing and location of special events; (D) review and revise, as appropriate, the contents of the stockpile on a regular basis to ensure that emerging threats, advanced technologies, and new countermeasures 22 Section 5 of Public Law 108–276 (118 Stat. 860) requires various reports regarding section 319F–2 and related provisions of law. Section 5 is included in the appendix to this compilation. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00189 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

190 G:\COMP\PHSA\PHSA-MERGED.XML 190 Sec. 319F–2 PUBLIC HEALTH SERVICE ACT are adequately considered and that the potential depletion of countermeasures currently in the stockpile is identified and appropriately addressed, including through necessary replenishment; (E) devise plans for the effective and timely supply- chain management of the stockpile, in consultation with appropriate Federal, State and local agencies, and the pub- lic and private health care infrastructure; (F) deploy the stockpile as required by the Secretary of Homeland Security to respond to an actual or potential emergency; (G) deploy the stockpile at the discretion of the Sec- retary to respond to an actual or potential public health emergency or other situation in which deployment is nec- essary to protect the public health or safety; and (H) ensure the adequate physical security of the stock- pile. (3) U .—The Secretary shall ensure TILIZATION GUIDELINES timely and accurate recommended utilization guidelines for qualified countermeasures (as defined in section 319F–1), qualified pandemic and epidemic products (as defined in sec- tion 319F–3), and security countermeasures (as defined in sub- section (c)), including for such products in the stockpile. (b) S V D EVELOPMENT .— MALLPOX ACCINE .—The Secretary shall award contracts, N GENERAL (1) I enter into cooperative agreements, or carry out such other ac- tivities as may reasonably be required in order to ensure that the stockpile under subsection (a) includes an amount of vac- cine against smallpox as determined by such Secretary to be sufficient to meet the health security needs of the United States. .—Nothing in this section shall ULE OF CONSTRUCTION (2) R be construed to limit the private distribution, purchase, or sale of vaccines from sources other than the stockpile described in subsection (a). (c) A A UTHORITY R EGARDING P ROCUREMENT OF C ER - DDITIONAL C TAIN VAILABILITY OF S PECIAL R ESERVE OUNTERMEASURES ; A .— F UND (1) I N GENERAL .— (A) U SE OF FUND .—A security countermeasure may, in accordance with this subsection, be procured with amounts in the special reserve fund as defined in subsection (h). ECURITY COUNTERMEASURE .—For purposes of this (B) S subsection, the term ‘‘security countermeasure’’ means a drug (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as that term is defined by section 351(i) of this Act (42 U.S.C. 262(i))), or device (as that term is defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))) that— (i)(I) the Secretary determines to be a priority (consistent with sections 302(2) and 304(a) of the Homeland Security Act of 2002) to diagnose, mitigate, prevent, or treat harm from any biological, chemical, March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00190 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

191 G:\COMP\PHSA\PHSA-MERGED.XML 191 Sec. 319F–2 PUBLIC HEALTH SERVICE ACT radiological, or nuclear agent identified as a material threat under paragraph (2)(A)(ii), or to diagnose, miti- gate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device against such an agent; (II) the Secretary determines under paragraph (2)(B)(ii) to be a necessary countermeasure; and (III)(aa) is approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act; or (bb) is a countermeasure for which the Secretary determines that sufficient and satisfactory clinical ex- perience or research data (including data, if available, from pre-clinical and clinical trials) support a reason- able conclusion that the countermeasure will qualify for approval or licensing within 10 years after the date of a determination under paragraph (5); or (ii) is authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act. .— ETERMINATION OF MATERIAL THREATS (2) D .—The Homeland Security Sec- ATERIAL THREAT (A) M retary, in consultation with the Secretary and the heads of other agencies as appropriate, shall on an ongoing basis— (i) assess current and emerging threats of chem- ical, biological, radiological, and nuclear agents; and (ii) determine which of such agents present a ma- terial threat against the United States population suf- ficient to affect national security. (B) P ; NECESSARY COUNTER - UBLIC HEALTH IMPACT .—The Secretary shall on an ongoing basis— MEASURES (i) assess the potential public health consequences for the United States population of exposure to agents identified under subparagraph (A)(ii); and (ii) determine, on the basis of such assessment, the agents identified under subparagraph (A)(ii) for which countermeasures are necessary to protect the public health. .—The Secretary and the OTICE TO CONGRESS (C) N Homeland Security Secretary shall promptly notify the ap- propriate committees of Congress that a determination has been made pursuant to subparagraph (A) or (B). (D) A SSURING ACCESS TO THREAT INFORMATION .—In making the assessment and determination required under subparagraph (A), the Homeland Security Secretary shall use all relevant information to which such Secretary is en- titled under section 202 of the Homeland Security Act of 2002, including but not limited to information, regardless of its level of classification, relating to current and emerg- ing threats of chemical, biological, radiological, and nu- clear agents. (3) A SSESSMENT OF AVAILABILITY AND APPROPRIATENESS OF .— COUNTERMEASURES March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00191 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

192 G:\COMP\PHSA\PHSA-MERGED.XML 192 Sec. 319F–2 PUBLIC HEALTH SERVICE ACT .—The Secretary, in consultation with (A) I N GENERAL the Homeland Security Secretary, shall assess on an ongo- ing basis the availability and appropriateness of specific countermeasures to address specific threats identified under paragraph (2). (B) I .—The Secretary shall institute a NFORMATION process for making publicly available the results of assess- ments under subparagraph (A) while withholding such in- formation as— (i) would, in the judgment of the Secretary, tend to reveal public health vulnerabilities; or (ii) would otherwise be exempt from disclosure under section 552 of title 5, United States Code. (4) C COM ; ALL FOR DEVELOPMENT OF COUNTERMEASURES - .— MITMENT FOR RECOMMENDATION FOR PROCUREMENT (A) P .—If, pursuant to an ROPOSAL TO THE PRESIDENT assessment under paragraph (3), the Homeland Security Secretary and the Secretary make a determination that a countermeasure would be appropriate but is either currently not developed or unavailable for procurement as a security countermeasure or is approved, licensed, or cleared only for alternative uses, such Secretaries may jointly submit to the President a proposal to— (i) issue a call for the development of such coun- termeasure; and (ii) make a commitment that, upon the first devel- opment of such countermeasure that meets the condi- tions for procurement under paragraph (5), the Secre- taries will, based in part on information obtained pur- suant to such call, and subject to the availability of ap- propriations, make available the special reserve fund as defined in subsection (h) for procurement of such countermeasure, as applicable. (B) C OUNTERMEASURE SPECIFICATIONS .—The Home- land Security Secretary and the Secretary shall, to the ex- tent practicable, include in the proposal under subpara- graph (A)— (i) estimated quantity of purchase (in the form of number of doses or number of effective courses of treatments regardless of dosage form); (ii) necessary measures of minimum safety and ef- fectiveness; (iii) estimated price for each dose or effective course of treatment regardless of dosage form; and (iv) other information that may be necessary to encourage and facilitate research, development, and manufacture of the countermeasure or to provide spec- ifications for the countermeasure. (C) P RESIDENTIAL APPROVAL .—If the President ap- proves a proposal under subparagraph (A), the Homeland Security Secretary and the Secretary shall make known to persons who may respond to a call for the countermeasure involved— (i) the call for the countermeasure; March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00192 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

193 G:\COMP\PHSA\PHSA-MERGED.XML 193 Sec. 319F–2 PUBLIC HEALTH SERVICE ACT (ii) specifications for the countermeasure under subparagraph (B); and (iii) the commitment described in subparagraph (A)(ii). (5) S ’ - S DETERMINATION OF COUNTERMEASURES AP ECRETARY PROPRIATE FOR FUNDING FROM SPECIAL RESERVE FUND .— N GENERAL (A) I .—The Secretary, in accordance with the provisions of this paragraph, shall identify specific se- curity countermeasures that the Secretary determines, in consultation with the Homeland Security Secretary, to be appropriate for inclusion in the stockpile under subsection (a) pursuant to procurements made with amounts in the special reserve fund as defined in subsection (h) (referred to in this subsection individually as a ‘‘procurement under this subsection’’). (B) R .—In making a determination under EQUIREMENTS subparagraph (A) with respect to a security counter- measure, the Secretary shall determine and consider the following: (i) The quantities of the product that will be need- ed to meet the stockpile needs. (ii) The feasibility of production and delivery with- in 10 years of sufficient quantities of the product. (iii) Whether there is a lack of a significant com- mercial market for the product at the time of procure- ment, other than as a security countermeasure. ECOMMENDATIONS FOR PROCUREMENT .— (6) R (A) N - OTICE TO APPROPRIATE CONGRESSIONAL COMMIT TEES .—The Secretary shall notify the Committee on Appro- priations and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appro- priations and the Committee on Energy and Commerce of the House of Representatives of each decision to make available the special reserve fund as defined in subsection (h) for procurement of a security countermeasure, includ- ing, where available, the number of, the nature of, and other information concerning potential suppliers of such countermeasure, and whether other potential suppliers of the same or similar countermeasures were considered and rejected for procurement under this section and the rea- sons for each such rejection. (B) S .—Pro- UBSEQUENT SPECIFIC COUNTERMEASURES curement under this subsection of a security counter- measure for a particular purpose does not preclude the subsequent procurement under this subsection of any other security countermeasure for such purpose if the Sec- retary has determined under paragraph (5)(A) that such countermeasure is appropriate for inclusion in the stock- pile and if, as determined by the Secretary, such counter- measure provides improved safety or effectiveness, or for other reasons enhances preparedness to respond to threats of use of a biological, chemical, radiological, or nuclear agent. Such a determination by the Secretary is committed to agency discretion. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00193 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

194 G:\COMP\PHSA\PHSA-MERGED.XML 194 Sec. 319F–2 PUBLIC HEALTH SERVICE ACT .— (7) P ROCUREMENT (A) P .—The spe- AYMENTS FROM SPECIAL RESERVE FUND cial reserve fund as defined in subsection (h) shall be available for payments made by the Secretary to a vendor for procurement of a security countermeasure in accord- ance with the provisions of this paragraph. .— ROCUREMENT (B) P N GENERAL .—The Secretary shall be respon- (i) I sible for— (I) arranging for procurement of a security countermeasure, including negotiating terms (in- cluding quantity, production schedule, and price) of, and entering into, contracts and cooperative agreements, and for carrying out such other ac- tivities as may reasonably be required, including advanced research and development, in accord- ance with the provisions of this subparagraph; and (II) promulgating such regulations as the Sec- retary determines necessary to implement the pro- visions of this subsection. ONTRACT TERMS .—A contract for procure- (ii) C ments under this subsection shall (or, as specified below, may) include the following terms: (I) P AYMENT CONDITIONED ON DELIVERY .—The contract shall provide that no payment may be made until delivery of a portion, acceptable to the Secretary, of the total number of units contracted for, except that, notwithstanding any other provi- sion of law, the contract may provide that, if the Secretary determines (in the Secretary’s discre- tion) that an advance payment, partial payment for significant milestones, or payment to increase manufacturing capacity is necessary to ensure success of a project, the Secretary shall pay an amount, not to exceed 10 percent of the contract amount, in advance of delivery. The Secretary shall, to the extent practicable, make the deter- mination of advance payment at the same time as the issuance of a solicitation. The contract shall provide that such advance payment is required to be repaid if there is a failure to perform by the vendor under the contract. The contract may also provide for additional advance payments of 5 per- cent each for meeting the milestones specified in such contract, except that such payments shall not exceed 50 percent of the total contract amount. If the specified milestones are reached, the advanced payments of 5 percent shall not be required to be repaid. Nothing in this subclause shall be con- strued as affecting the rights of vendors under provisions of law or regulation (including the Fed- eral Acquisition Regulation) relating to the termi- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00194 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

195 G:\COMP\PHSA\PHSA-MERGED.XML 195 Sec. 319F–2 PUBLIC HEALTH SERVICE ACT nation of contracts for the convenience of the Gov- ernment. (II) D ISCOUNTED PAYMENT .—The contract may provide for a discounted price per unit of a prod- uct that is not licensed, cleared, or approved as described in paragraph (1)(B)(i)(III)(aa) at the time of delivery, and may provide for payment of an additional amount per unit if the product be- comes so licensed, cleared, or approved before the expiration date of the contract (including an addi- tional amount per unit of product delivered before the effective date of such licensing, clearance, or approval). (III) C ONTRACT DURATION .—The contract shall be for a period not to exceed five years, except that, in first awarding the contract, the Secretary may provide for a longer duration, not exceeding 10 years, if the Secretary determines that com- plexities or other difficulties in performance under the contract justify such a period. The contract shall be renewable for additional periods, none of which shall exceed five years. (IV) S TORAGE BY VENDOR .—The contract may provide that the vendor will provide storage for stocks of a product delivered to the ownership of the Federal Government under the contract, for such period and under such terms and conditions as the Secretary may specify, and in such case amounts from the special reserve fund as defined in subsection (h) shall be available for costs of shipping, handling, storage, and related costs for such product. RODUCT APPROVAL .—The contract shall (V) P provide that the vendor seek approval, clearance, or licensing of the product from the Secretary; for a timetable for the development of data and other information to support such approval, clearance, or licensing; and that the Secretary may waive part or all of this contract term on request of the vendor or on the initiative of the Secretary. (VI) N STOCKPILE TRANSFERS OF SECURITY ON - COUNTERMEASURES .—The contract shall provide that the vendor will comply with all applicable ex- port-related controls with respect to such counter- measure. (VII) S .—The contract may ALES EXCLUSIVITY provide that the vendor is the exclusive supplier of the product to the Federal Government for a specified period of time, not to exceed the term of the contract, on the condition that the vendor is able to satisfy the needs of the Government. Dur- ing the agreed period of sales exclusivity, the ven- dor shall not assign its rights of sales exclusivity to another entity or entities without approval by March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00195 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

196 G:\COMP\PHSA\PHSA-MERGED.XML 196 Sec. 319F–2 PUBLIC HEALTH SERVICE ACT the Secretary. Such a sales exclusivity provision in such a contract shall constitute a valid basis for a sole source procurement under section 303(c)(1) of the Federal Property and Administrative Serv- ices Act of 1949 (41 U.S.C. 253(c)(1)). .—The ARM BASED SURGE CAPACITY (VIII) W contract may provide that the vendor establish do- mestic manufacturing capacity of the product to ensure that additional production of the product is available in the event that the Secretary deter- mines that there is a need to quickly purchase ad- ditional quantities of the product. Such contract may provide a fee to the vendor for establishing and maintaining such capacity in excess of the ini- tial requirement for the purchase of the product. Additionally, the cost of maintaining the domestic manufacturing capacity shall be an allowable and allocable direct cost of the contract. (IX) C ONTRACT TERMS .—The Secretary, in any contract for procurement under this section— (aa) may specify— (AA) the dosing and administration requirements for the countermeasure to be developed and procured; (BB) the amount of funding that will be dedicated by the Secretary for ad- vanced research, development, and pro- curement of the countermeasure; and (CC) the specifications the counter- measure must meet to qualify for pro- curement under a contract under this sec- tion; and (bb) shall provide a clear statement of de- fined Government purpose limited to uses re- lated to a security countermeasure, as defined in paragraph (1)(B). - VAILABILITY OF SIMPLIFIED ACQUISITION PRO (iii) A .— CEDURES N GENERAL .—If the Secretary determines (I) I that there is a pressing need for a procurement of a specific countermeasure, the amount of the pro- curement under this subsection shall be deemed to be below the threshold amount specified in sec- tion 4(11) of the Office of Federal Procurement Policy Act (41 U.S.C. 403(11)), for purposes of ap- plication to such procurement, pursuant to section 302A(a) of the Federal Property and Administra- tive Services Act of 1949 (41 U.S.C. 252a(a)), of— (aa) section 303(g)(1)(A) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 253(g)(1)(A)) and its imple- menting regulations; and March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00196 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

197 G:\COMP\PHSA\PHSA-MERGED.XML 197 Sec. 319F–2 PUBLIC HEALTH SERVICE ACT (bb) section 302A(b) of such Act (41 U.S.C. 252a(b)) and its implementing regula- tions. (II) A PPLICATION OF CERTAIN PROVISIONS .— Notwithstanding subclause (I) and the provision of law and regulations referred to in such clause, each of the following provisions shall apply to pro- curements described in this clause to the same ex- tent that such provisions would apply to such pro- curements in the absence of subclause (I): (aa) Chapter 37 of title 40, United States Code (relating to contract work hours and safety standards). (bb) Subsections (a) and (b) of section 7 of the Anti-Kickback Act of 1986 (41 U.S.C. 57(a) and (b)). (cc) Section 304C of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 254d) (relating to the examination of contractor records). (dd) Section 3131 of title 40, United States Code (relating to bonds of contractors of public buildings or works). (ee) Subsection (a) of section 304 of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 254(a)) (relating to con- tingent fees to middlemen). (ff) Section 6002 of the Solid Waste Dis- posal Act (42 U.S.C. 6962). (gg) Section 1354 of title 31, United States Code (relating to the limitation on the use of appropriated funds for contracts with entities not meeting veterans employment re- porting requirements). (III) I CONTROLS NTERNAL ESTAB - TO BE .—The Secretary shall establish appro- LISHED priate internal controls for procurements made under this clause, including requirements with re- spect to documentation of the justification for the use of the authority provided under this para- graph with respect to the procurement involved. (IV) A .—In UTHORITY TO LIMIT COMPETITION conducting a procurement under this subpara- graph, the Secretary may not use the authority provided for under subclause (I) to conduct a pro- curement on a basis other than full and open com- petition unless the Secretary determines that the mission of the BioShield Program under the Project BioShield Act of 2004 would be seriously impaired without such a limitation. (iv) P ROCEDURES OTHER THAN FULL AND OPEN COMPETITION .— N GENERAL .—In using the authority pro- (I) I vided in section 303(c)(1) of title III of the Federal March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00197 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

198 G:\COMP\PHSA\PHSA-MERGED.XML 198 Sec. 319F–2 PUBLIC HEALTH SERVICE ACT Property and Administrative Services Act of 1949 (41 U.S.C. 253(c)(1)) to use procedures other than competitive procedures in the case of a procure- ment under this subsection, the phrase ‘‘available from only one responsible source’’ in such section 303(c)(1) shall be deemed to mean ‘‘available from only one responsible source or only from a limited number of responsible sources’’. (II) R ELATION TO OTHER AUTHORITIES .—The authority under subclause (I) is in addition to any other authority to use procedures other than com- petitive procedures. - WIDE REGULA - PPLICABLE GOVERNMENT (III) A TIONS .—The Secretary shall implement this clause in accordance with government-wide regulations implementing such section 303(c)(1) (including re- quirements that offers be solicited from as many potential sources as is practicable under the cir- cumstances, that required notices be published, and that submitted offers be considered), as such regulations apply to procurements for which an agency has authority to use procedures other than competitive procedures when the property or serv- ices needed by the agency are available from only one responsible source or only from a limited number of responsible sources and no other type of property or services will satisfy the needs of the agency. REMIUM PROVISION IN MULTIPLE AWARD CON - (v) P .— TRACTS (I) I N GENERAL .—If, under this subsection, the Secretary enters into contracts with more than one vendor to procure a security countermeasure, such Secretary may, notwithstanding any other provision of law, include in each of such contracts a provision that— (aa) identifies an increment of the total quantity of security countermeasure required, whether by percentage or by numbers of units; and (bb) promises to pay one or more specified premiums based on the priority of such ven- dors’ production and delivery of the increment identified under item (aa), in accordance with the terms and conditions of the contract. ETERMINATION OF GOVERNMENT ’ SRE - (II) D .—If the Secretary in- QUIREMENT NOT REVIEWABLE cludes in each of a set of contracts a provision as described in subclause (I), such Secretary’s deter- mination of the total quantity of security counter- measure required, and any amendment of such determination, is committed to agency discretion. XTENSION OF CLOSING DATE FOR RECEIPT OF (vi) E .—A decision by the Sec- PROPOSALS NOT REVIEWABLE March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00198 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

199 G:\COMP\PHSA\PHSA-MERGED.XML 199 Sec. 319F–2 PUBLIC HEALTH SERVICE ACT retary to extend the closing date for receipt of pro- posals for a procurement under this subsection is com- mitted to agency discretion. (vii) L IMITING COMPETITION TO SOURCES RESPOND - .—In conducting a ING TO REQUEST FOR INFORMATION procurement under this subsection, the Secretary may exclude a source that has not responded to a request for information under section 303A(a)(1)(B) of the Fed- eral Property and Administrative Services Act of 1949 (41 U.S.C. 253a(a)(1)(B)) if such request has given no- tice that the Secretary may so exclude such a source. (viii) F .—In carrying out this section, LEXIBILITY the Secretary may, consistent with the applicable pro- visions of this section, enter into contracts and other agreements that are in the best interest of the Govern- ment in meeting identified security countermeasure needs, including with respect to reimbursement of the cost of advanced research and development as a rea- sonable, allowable, and allocable direct cost of the con- tract involved. (8) I .— NTERAGENCY COOPERATION (A) I N GENERAL .—In carrying out activities under this section, the Homeland Security Secretary and the Sec- retary are authorized, subject to subparagraph (B), to enter into interagency agreements and other collaborative undertakings with other agencies of the United States Government. Such agreements may allow other executive agencies to order qualified and security countermeasures under procurement contracts or other agreements estab- lished by the Secretary. Such ordering process (including transfers of appropriated funds between an agency and the Department of Health and Human Services as reimburse- ments for such orders for countermeasures) may be con- ducted under the authority of section 1535 of title 31, United States Code, except that all such orders shall be processed under the terms established under this sub- section for the procurement of countermeasures. (B) L IMITATION .—An agreement or undertaking under this paragraph shall not authorize another agency to exer- cise the authorities provided by this section to the Home- land Security Secretary or to the Secretary. ISCLOSURES .—No Federal agency shall disclose under sec- (d) D tion 552 of title 5, United States Code, any information identifying the location at which materials in the stockpile under subsection (a) are stored. EFINITION .—For purposes of subsection (a), the term (e) D ‘‘stockpile’’ includes— (1) a physical accumulation (at one or more locations) of the supplies described in subsection (a); or (2) a contractual agreement between the Secretary and a vendor or vendors under which such vendor or vendors agree to provide to such Secretary supplies described in subsection (a). UTHORIZATION OF A PPROPRIATIONS .— (f) A March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00199 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

200 G:\COMP\PHSA\PHSA-MERGED.XML 200 Sec. 319F–2 PUBLIC HEALTH SERVICE ACT .—For the purpose of (1) S TRATEGIC NATIONAL STOCKPILE carrying out subsection (a), there are authorized to be appro- priated $533,800,000 for each of fiscal years 2014 through 2018. Such authorization is in addition to amounts in the spe- cial reserve fund referred to in subsection (h). (2) S MALLPOX VACCINE DEVELOPMENT .—For the purpose of carrying out subsection (b), there are authorized to be appro- priated $509,000,000 for fiscal year 2002, and such sums as may be necessary for each of fiscal years 2003 through 2006. (g) S F UND .— ESERVE R PECIAL (1) A UTHORIZATION OF APPROPRIATIONS .—In addition to amounts appropriated to the special reserve fund prior to the date of the enactment of this subsection, there is authorized to be appropriated, for the procurement of security counter- measures under subsection (c) and for carrying out section 319L (relating to the Biomedical Advanced Research and De- velopment Authority), $2,800,000,000 for the period of fiscal years 2014 through 2018. Amounts appropriated pursuant to the preceding sentence are authorized to remain available until September 30, 2019. (2) U SE OF SPECIAL RESERVE FUND FOR ADVANCED RE - .—The Secretary may utilize not SEARCH AND DEVELOPMENT more than 50 percent of the amounts authorized to be appro- priated under paragraph (1) to carry out section 319L (related to the Biomedical Advanced Research and Development Au- thority). Amounts authorized to be appropriated under this subsection to carry out section 319L are in addition to amounts otherwise authorized to be appropriated to carry out such sec- tion. .—Amounts in the spe- ESTRICTIONS ON USE OF FUNDS (3) R cial reserve fund shall not be used to pay costs other than pay- ments made by the Secretary to a vendor for advanced develop- ment (under section 319L) or for procurement of a security countermeasure under subsection (c)(7). (4) R SECURITY COUNTERMEASURE EPORT - ON PROCURE .—Not later than March 1 of each year in which the Sec- MENT retary determines that the amount of funds available for pro- curement of security countermeasures is less than $1,500,000,000, the Secretary shall submit to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Ap- propriations and the Committee on Energy and Commerce of the House of Representatives a report detailing the amount of such funds available for procurement and the impact such amount of funding will have— (A) in meeting the security countermeasure needs identified under this section; and (B) on the annual Public Health Emergency Medical Countermeasures Enterprise and Strategy Implementation Plan (pursuant to section 2811(d)). LARIFICATION ON CONTRACTING AUTHORITY .—The Sec- (5) C retary, acting through the Director of the Biomedical Advanced Research and Development Authority, shall carry out the pro- grams funded by the special reserve fund (for the procurement March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00200 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

201 G:\COMP\PHSA\PHSA-MERGED.XML 201 Sec. 319F–3 PUBLIC HEALTH SERVICE ACT of security countermeasures under subsection (c) and for car- rying out section 319L), including the execution of procurement contracts, grants, and cooperative agreements pursuant to this section and section 319L. .—In this section: EFINITIONS (h) D (1) The term ‘‘advanced research and development’’ has the meaning given such term in section 319L(a). (2) The term ‘‘special reserve fund’’ means the ‘‘Biodefense Countermeasures’’ appropriations account, any appropriation made available pursuant to section 521(a) of the Homeland Se- curity Act of 2002, and any appropriation made available pur- suant to subsection (g)(1). 247d–6d ¿ TARGETED LIABILITY PROTECTIONS FOR PAN- SEC. 319F–3. ø DEMIC AND EPIDEMIC PRODUCTS AND SECURITY COUN- TERMEASURES. P ROTECTIONS .— (a) L IABILITY .—Subject to the other provisions of this N GENERAL (1) I section, a covered person shall be immune from suit and liabil- ity under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure. COPE OF CLAIMS FOR LOSS .— (2) S (A) L .—For purposes of this section, the term ‘‘loss’’ OSS means any type of loss, including— (i) death; (ii) physical, mental, or emotional injury, illness, disability, or condition; (iii) fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and (iv) loss of or damage to property, including busi- ness interruption loss. Each of clauses (i) through (iv) applies without regard to the date of the occurrence, presentation, or discovery of the loss described in the clause. (B) S COPE .—The immunity under paragraph (1) ap- plies to any claim for loss that has a causal relationship with the administration to or use by an individual of a cov- ered countermeasure, including a causal relationship with the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, pack- aging, marketing, promotion, sale, purchase, donation, dis- pensing, prescribing, administration, licensing, or use of such countermeasure. ERTAIN CONDITIONS .—Subject to the other provisions (3) C of this section, immunity under paragraph (1) with respect to a covered countermeasure applies only if— (A) the countermeasure was administered or used dur- ing the effective period of the declaration that was issued under subsection (b) with respect to the countermeasure; March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00201 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

202 G:\COMP\PHSA\PHSA-MERGED.XML 202 Sec. 319F–3 PUBLIC HEALTH SERVICE ACT (B) the countermeasure was administered or used for the category or categories of diseases, health conditions, or threats to health specified in the declaration; and (C) in addition, in the case of a covered person who is a program planner or qualified person with respect to the administration or use of the countermeasure, the counter- measure was administered to or used by an individual who— (i) was in a population specified by the declara- tion; and (ii) was at the time of administration physically present in a geographic area specified by the declara- tion or had a connection to such area specified in the declaration. (4) A .—With respect PPLICABILITY OF CERTAIN CONDITIONS to immunity under paragraph (1) and subject to the other pro- visions of this section: (A) In the case of a covered person who is a manufac- turer or distributor of the covered countermeasure in- volved, the immunity applies without regard to whether such countermeasure was administered to or used by an individual in accordance with the conditions described in paragraph (3)(C). (B) In the case of a covered person who is a program planner or qualified person with respect to the administra- tion or use of the covered countermeasure, the scope of im- munity includes circumstances in which the counter- measure was administered to or used by an individual in circumstances in which the covered person reasonably could have believed that the countermeasure was adminis- tered or used in accordance with the conditions described in paragraph (3)(C). FFECT OF DISTRIBUTION METHOD .—The provisions of (5) E this section apply to a covered countermeasure regardless of whether such countermeasure is obtained by donation, com- mercial sale, or any other means of distribution, except to the extent that, under paragraph (2)(E) of subsection (b), the dec- laration under such subsection provides that subsection (a) ap- plies only to covered countermeasures obtained through a par- ticular means of distribution. (6) R EBUTTABLE PRESUMPTION .—For purposes of paragraph (1), there shall be a rebuttable presumption that any adminis- tration or use, during the effective period of the emergency dec- laration by the Secretary under subsection (b), of a covered countermeasure shall have been for the category or categories of diseases, health conditions, or threats to health with respect to which such declaration was issued. ECLARATION BY S ECRETARY .— (b) D UTHORITY TO ISSUE DECLARATION .—Subject to para- (1) A graph (2), if the Secretary makes a determination that a dis- ease or other health condition or other threat to health con- stitutes a public health emergency, or that there is a credible risk that the disease, condition, or threat may in the future constitute such an emergency, the Secretary may make a dec- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00202 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

203 G:\COMP\PHSA\PHSA-MERGED.XML 203 Sec. 319F–3 PUBLIC HEALTH SERVICE ACT laration, through publication in the Federal Register, recom- mending, under conditions as the Secretary may specify, the manufacture, testing, development, distribution, administra- tion, or use of one or more covered countermeasures, and stat- ing that subsection (a) is in effect with respect to the activities so recommended. ONTENTS .—In issuing a declaration under paragraph (2) C (1), the Secretary shall identify, for each covered counter- measure specified in the declaration— (A) the category or categories of diseases, health condi- tions, or threats to health for which the Secretary rec- ommends the administration or use of the countermeasure; (B) the period or periods during which, including as modified by paragraph (3), subsection (a) is in effect, which period or periods may be designated by dates, or by mile- stones or other description of events, including factors specified in paragraph (6); (C) the population or populations of individuals for which subsection (a) is in effect with respect to the admin- istration or use of the countermeasure (which may be a specification that such subsection applies without geo- graphic limitation to all individuals); (D) the geographic area or areas for which subsection (a) is in effect with respect to the administration or use of the countermeasure (which may be a specification that such subsection applies without geographic limitation), in- cluding, with respect to individuals in the populations identified under subparagraph (C), a specification, as de- termined appropriate by the Secretary, of whether the dec- laration applies only to individuals physically present in such areas or whether in addition the declaration applies to individuals who have a connection to such areas, which connection is described in the declaration; and (E) whether subsection (a) is effective only to a par- ticular means of distribution as provided in subsection (a)(5) for obtaining the countermeasure, and if so, the par- ticular means to which such subsection is effective. FFECTIVE PERIOD OF DECLARATION .— (3) E (A) F LEXIBILITY OF PERIOD .—The Secretary may, in de- scribing periods under paragraph (2)(B), have different pe- riods for different covered persons to address different logistical, practical or other differences in responsibilities. (B) A .—In each dec- DDITIONAL TIME TO BE SPECIFIED laration under paragraph (1), the Secretary, after con- sulting, to the extent the Secretary deems appropriate, with the manufacturer of the covered countermeasure, shall also specify a date that is after the ending date speci- fied under paragraph (2)(B) and that allows what the Sec- retary determines is— (i) a reasonable period for the manufacturer to ar- range for disposition of the covered countermeasure, including the return of such product to the manufac- turer; and March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00203 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

204 G:\COMP\PHSA\PHSA-MERGED.XML 204 Sec. 319F–3 PUBLIC HEALTH SERVICE ACT (ii) a reasonable period for covered persons to take such other actions as may be appropriate to limit ad- ministration or use of the covered countermeasure. (C) A DDITIONAL PERIOD FOR CERTAIN STRATEGIC NA - .—With respect to a TIONAL STOCKPILE COUNTERMEASURES covered countermeasure that is in the stockpile under sec- tion 319F-2, if such countermeasure was the subject of a declaration under paragraph (1) at the time that it was ob- tained for the stockpile, the effective period of such dec- laration shall include a period when the countermeasure is administered or used pursuant to a distribution or release from the stockpile. (4) A MENDMENTS TO DECLARATION .—The Secretary may through publication in the Federal Register amend any portion of a declaration under paragraph (1). Such an amendment shall not retroactively limit the applicability of subsection (a) with respect to the administration or use of the covered coun- termeasure involved. (5) C .—In publishing a declaration ERTAIN DISCLOSURES under paragraph (1) in the Federal Register, the Secretary is not required to disclose any matter described in section 552(b) of title 5, United States Code. (6) F .—In deciding whether and ACTORS TO BE CONSIDERED under what circumstances or conditions to issue a declaration under paragraph (1) with respect to a covered countermeasure, the Secretary shall consider the desirability of encouraging the design, development, clinical testing or investigation, manufac- ture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of such countermeasure. UDICIAL REVIEW (7) J .—No court of the United States, or of any State, shall have subject matter jurisdiction to review, whether by mandamus or otherwise, any action by the Sec- retary under this subsection. .—During the effective pe- (8) P REEMPTION OF STATE LAW riod of a declaration under subsection (b), or at any time with respect to conduct undertaken in accordance with such declara- tion, no State or political subdivision of a State may establish, enforce, or continue in effect with respect to a covered counter- measure any provision of law or legal requirement that— (A) is different from, or is in conflict with, any require- ment applicable under this section; and (B) relates to the design, development, clinical testing or investigation, formulation, manufacture, distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other aspect of safety or effi- cacy, or the prescribing, dispensing, or administration by qualified persons of the covered countermeasure, or to any matter included in a requirement applicable to the covered countermeasure under this section or any other provision of this Act, or under the Federal Food, Drug, and Cosmetic Act. EPORT TO CONGRESS .—Within 30 days after making a (9) R declaration under paragraph (1), the Secretary shall submit to March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00204 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

205 G:\COMP\PHSA\PHSA-MERGED.XML 205 Sec. 319F–3 PUBLIC HEALTH SERVICE ACT the appropriate committees of the Congress a report that pro- vides an explanation of the reasons for issuing the declaration and the reasons underlying the determinations of the Sec- retary with respect to paragraph (2). Within 30 days after making an amendment under paragraph (4), the Secretary shall submit to such committees a report that provides the rea- sons underlying the determination of the Secretary to make the amendment. (c) D M ISCONDUCT .— EFINITION OF W ILLFUL .— EFINITION (1) D (A) I N GENERAL .—Except as the meaning of such term is further restricted pursuant to paragraph (2), the term ‘‘willful misconduct’’ shall, for purposes of subsection (d), denote an act or omission that is taken— (i) intentionally to achieve a wrongful purpose; (ii) knowingly without legal or factual justifica- tion; and (iii) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit. (B) R ULE OF CONSTRUCTION .—The criterion stated in subparagraph (A) shall be construed as establishing a standard for liability that is more stringent than a stand- ard of negligence in any form or recklessness. .— UTHORITY TO PROMULGATE REGULATORY DEFINITION (2) A N GENERAL .—The Secretary, in consultation with (A) I the Attorney General, shall promulgate regulations, which may be promulgated through interim final rules, that fur- ther restrict the scope of actions or omissions by a covered person that may qualify as ‘‘willful misconduct’’ for pur- poses of subsection (d). ACTORS TO BE CONSIDERED (B) F .—In promulgating the regulations under this paragraph, the Secretary, in con- sultation with the Attorney General, shall consider the need to define the scope of permissible civil actions under subsection (d) in a way that will not adversely affect the public health. (C) T EMPORAL SCOPE OF REGULATIONS .—The regula- tions under this paragraph may specify the temporal effect that they shall be given for purposes of subsection (d). (D) I NITIAL RULEMAKING .—Within 180 days after the enactment of the Public Readiness and Emergency Pre- paredness Act, the Secretary, in consultation with the At- torney General, shall commence and complete an initial rulemaking process under this paragraph. ROOF OF WILLFUL MISCONDUCT .—In an action under (3) P subsection (d), the plaintiff shall have the burden of proving by clear and convincing evidence willful misconduct by each cov- ered person sued and that such willful misconduct caused death or serious physical injury. (4) D EFENSE FOR ACTS OR OMISSIONS TAKEN PURSUANT TO ’ S DECLARATION .—Notwithstanding any other provi- SECRETARY sion of law, a program planner or qualified person shall not have engaged in ‘‘willful misconduct’’ as a matter of law where March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00205 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

206 G:\COMP\PHSA\PHSA-MERGED.XML 206 Sec. 319F–3 PUBLIC HEALTH SERVICE ACT such program planner or qualified person acted consistent with applicable directions, guidelines, or recommendations by the Secretary regarding the administration or use of a covered countermeasure that is specified in the declaration under sub- section (b), provided either the Secretary, or a State or local health authority, was provided with notice of information re- garding serious physical injury or death from the administra- tion or use of a covered countermeasure that is material to the plaintiff’s alleged loss within 7 days of the actual discovery of such information by such program planner or qualified person. (5) E XCLUSION FOR REGULATED ACTIVITY OF MANUFACTURER .— OR DISTRIBUTOR .—If an act or omission by a manufac- (A) I N GENERAL turer or distributor with respect to a covered counter- measure, which act or omission is alleged under subsection (e)(3)(A) to constitute willful misconduct, is subject to regu- lation by this Act or by the Federal Food, Drug, and Cos- metic Act, such act or omission shall not constitute ‘‘willful misconduct’’ for purposes of subsection (d) if— (i) neither the Secretary nor the Attorney General has initiated an enforcement action with respect to such act or omission; or (ii) such an enforcement action has been initiated and the action has been terminated or finally resolved without a covered remedy. Any action or proceeding under subsection (d) shall be stayed during the pendency of such an enforcement action. (B) D .—For purposes of this paragraph, the EFINITIONS following terms have the following meanings: NFORCEMENT ACTION .—The term ‘‘enforcement (i) E action’’ means a criminal prosecution, an action seek- ing an injunction, a seizure action, a civil monetary proceeding based on willful misconduct, a mandatory recall of a product because voluntary recall was re- fused, a proceeding to compel repair or replacement of a product, a termination of an exemption under sec- tion 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, a debarment proceeding, an investigator disqualification proceeding where an investigator is an employee or agent of the manufacturer, a revocation, based on willful misconduct, of an authorization under section 564 of such Act, or a suspension or withdrawal, based on willful misconduct, of an approval or clear- ance under chapter V of such Act or of a licensure under section 351 of this Act. (ii) C OVERED REMEDY .—The term ‘‘covered rem- edy’’ means an outcome— (I) that is a criminal conviction, an injunction, or a condemnation, a civil monetary payment, a product recall, a repair or replacement of a prod- uct, a termination of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, a debarment, an investigator dis- qualification, a revocation of an authorization March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00206 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

207 G:\COMP\PHSA\PHSA-MERGED.XML 207 Sec. 319F–3 PUBLIC HEALTH SERVICE ACT under section 564 of such Act, or a suspension or withdrawal of an approval or clearance under chapter 5 of such Act or of a licensure under sec- tion 351 of this Act; and (II) that results from a final determination by a court or from a final agency action. (iii) F INAL .—The terms ‘‘final’’ and ‘‘finally’’— (I) with respect to a court determination, or to a final resolution of an enforcement action that is a court determination, mean a judgment from which an appeal of right cannot be taken or a vol- untary or stipulated dismissal; and (II) with respect to an agency action, or to a final resolution of an enforcement action that is an agency action, mean an order that is not sub- ject to further review within the agency and that has not been reversed, vacated, enjoined, or other- wise nullified by a final court determination or a voluntary or stipulated dismissal. (C) R .— ULES OF CONSTRUCTION .—Nothing in this paragraph shall (i) I N GENERAL be construed— (I) to affect the interpretation of any provision of the Federal Food, Drug, and Cosmetic Act, of this Act, or of any other applicable statute or reg- ulation; or (II) to impair, delay, alter, or affect the au- thority, including the enforcement discretion, of the United States, of the Secretary, of the Attor- ney General, or of any other official with respect to any administrative or court proceeding under this Act, under the Federal Food, Drug, and Cos- metic Act, under title 18 of the United States Code, or under any other applicable statute or regulation. ANDATORY RECALLS (ii) M .—A mandatory recall called for in the declaration is not a Food and Drug Administration enforcement action. (d) E MMUNITY OF C OVERED P ERSONS .— XCEPTION TO I .—Subject to subsection (f), the sole excep- N GENERAL (1) I tion to the immunity from suit and liability of covered persons set forth in subsection (a) shall be for an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct, as defined pursuant to subsection (c), by such covered person. For purposes of section 2679(b)(2)(B) of title 28, United States Code, such a cause of action is not an action brought for viola- tion of a statute of the United States under which an action against an individual is otherwise authorized. (2) P ERSONS WHO CAN SUE .—An action under this sub- section may be brought for wrongful death or serious physical injury by any person who suffers such injury or by any rep- resentative of such a person. ROCEDURES FOR S UIT .— (e) P March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00207 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

208 G:\COMP\PHSA\PHSA-MERGED.XML 208 Sec. 319F–3 PUBLIC HEALTH SERVICE ACT .—Any action under (1) E XCLUSIVE FEDERAL JURISDICTION subsection (d) shall be filed and maintained only in the United States District Court for the District of Columbia. (2) G .—The substantive law for decision in OVERNING LAW an action under subsection (d) shall be derived from the law, including choice of law principles, of the State in which the al- leged willful misconduct occurred, unless such law is incon- sistent with or preempted by Federal law, including provisions of this section. (3) P .—In an action under LEADING WITH PARTICULARITY subsection (d), the complaint shall plead with particularity each element of the plaintiff’s claim, including— (A) each act or omission, by each covered person sued, that is alleged to constitute willful misconduct relating to the covered countermeasure administered to or used by the person on whose behalf the complaint was filed; (B) facts supporting the allegation that such alleged willful misconduct proximately caused the injury claimed; and (C) facts supporting the allegation that the person on whose behalf the complaint was filed suffered death or se- rious physical injury. (4) V CERTIFICATION , ERIFICATION .— , AND MEDICAL RECORDS N GENERAL .—In an action under subsection (d), (A) I the plaintiff shall verify the complaint in the manner stat- ed in subparagraph (B) and shall file with the complaint the materials described in subparagraph (C). A complaint that does not substantially comply with subparagraphs (B) and (C) shall not be accepted for filing and shall not stop the running of the statute of limitations. (B) V .— ERIFICATION REQUIREMENT N GENERAL .—The complaint shall include a (i) I verification, made by affidavit of the plaintiff under oath, stating that the pleading is true to the knowl- edge of the deponent, except as to matters specifically identified as being alleged on information and belief, and that as to those matters the plaintiff believes it to be true. (ii) I DENTIFICATION OF MATTERS ALLEGED UPON IN - FORMATION AND BELIEF .—Any matter that is not spe- cifically identified as being alleged upon the informa- tion and belief of the plaintiff, shall be regarded for all purposes, including a criminal prosecution, as having been made upon the knowledge of the plaintiff. (C) M ATERIALS REQUIRED .—In an action under sub- section (d), the plaintiff shall file with the complaint— (i) an affidavit, by a physician who did not treat the person on whose behalf the complaint was filed, certifying, and explaining the basis for such physi- cian’s belief, that such person suffered the serious physical injury or death alleged in the complaint and that such injury or death was proximately caused by the administration or use of a covered counter- measure; and March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00208 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

209 G:\COMP\PHSA\PHSA-MERGED.XML 209 Sec. 319F–3 PUBLIC HEALTH SERVICE ACT (ii) certified medical records documenting such in- jury or death and such proximate causal connection. (5) T .—Any action under subsection (d) HREE JUDGE COURT - shall be assigned initially to a panel of three judges. Such panel shall have jurisdiction over such action for purposes of considering motions to dismiss, motions for summary judg- ment, and matters related thereto. If such panel has denied such motions, or if the time for filing such motions has expired, such panel shall refer the action to the chief judge for assign- ment for further proceedings, including any trial. Section 1253 of title 28, United States Code, and paragraph (3) of subsection (b) of section 2284 of title 28, United States Code, shall not apply to actions under subsection (d). (6) C IVIL DISCOVERY .— (A) T .—In an action under subsection (d), no dis- IMING covery shall be allowed— (i) before each covered person sued has had a rea- sonable opportunity to file a motion to dismiss; (ii) in the event such a motion is filed, before the court has ruled on such motion; and (iii) in the event a covered person files an inter- locutory appeal from the denial of such a motion, be- fore the court of appeals has ruled on such appeal. (B) S .—Notwithstanding any other provision TANDARD of law, the court in an action under subsection (d) shall permit discovery only with respect to matters directly re- lated to material issues contested in such action, and the court shall compel a response to a discovery request (in- cluding a request for admission, an interrogatory, a re- quest for production of documents, or any other form of discovery request) under Rule 37, Federal Rules of Civil Procedure, only if the court finds that the requesting party needs the information sought to prove or defend as to a material issue contested in such action and that the likely benefits of a response to such request equal or exceed the burden or cost for the responding party of providing such response. (7) R EDUCTION IN AWARD OF DAMAGES FOR COLLATERAL SOURCE BENEFITS .— N GENERAL .—In an action under subsection (d), (A) I the amount of an award of damages that would otherwise be made to a plaintiff shall be reduced by the amount of collateral source benefits to such plaintiff. ROVIDER OF COLLATERAL SOURCE BENEFITS NOT (B) P .—No provider of collateral TO HAVE LIEN OR SUBROGATION source benefits shall recover any amount against the plain- tiff or receive any lien or credit against the plaintiff’s re- covery or be equitably or legally subrogated to the right of the plaintiff in an action under subsection (d). (C) C OLLATERAL SOURCE BENEFIT DEFINED .—For pur- poses of this paragraph, the term ‘‘collateral source ben- efit’’ means any amount paid or to be paid in the future to or on behalf of the plaintiff, or any service, product, or other benefit provided or to be provided in the future to or March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00209 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

210 G:\COMP\PHSA\PHSA-MERGED.XML 210 Sec. 319F–3 PUBLIC HEALTH SERVICE ACT on behalf of the plaintiff, as a result of the injury or wrongful death, pursuant to— (i) any State or Federal health, sickness, income- disability, accident, or workers’ compensation law; (ii) any health, sickness, income-disability, or acci- dent insurance that provides health benefits or in- come-disability coverage; (iii) any contract or agreement of any group, orga- nization, partnership, or corporation to provide, pay for, or reimburse the cost of medical, hospital, dental, or income disability benefits; or (iv) any other publicly or privately funded pro- gram. (8) N .—In an action under sub- ONECONOMIC DAMAGES section (d), any noneconomic damages may be awarded only in an amount directly proportional to the percentage of responsi- bility of a defendant for the harm to the plaintiff. For purposes of this paragraph, the term ‘‘noneconomic damages’’ means damages for losses for physical and emotional pain, suffering, inconvenience, physical impairment, mental anguish, disfigure- ment, loss of enjoyment of life, loss of society and companion- ship, loss of consortium, hedonic damages, injury to reputation, and any other nonpecuniary losses. (9) R ULE 11 SANCTIONS .—Whenever a district court of the United States determines that there has been a violation of Rule 11 of the Federal Rules of Civil Procedure in an action under subsection (d), the court shall impose upon the attorney, law firm, or parties that have violated Rule 11 or are respon- sible for the violation, an appropriate sanction, which may in- clude an order to pay the other party or parties for the reason- able expenses incurred as a direct result of the filing of the pleading, motion, or other paper that is the subject of the viola- tion, including a reasonable attorney’s fee. Such sanction shall be sufficient to deter repetition of such conduct or comparable conduct by others similarly situated, and to compensate the party or parties injured by such conduct. NTERLOCUTORY APPEAL .—The United States Court of (10) I Appeals for the District of Columbia Circuit shall have jurisdic- tion of an interlocutory appeal by a covered person taken with- in 30 days of an order denying a motion to dismiss or a motion for summary judgment based on an assertion of the immunity from suit conferred by subsection (a) or based on an assertion of the exclusion under subsection (c)(5). CTIONS BY AND A GAINST THE U NITED S TATES .—Nothing in (f) A this section shall be construed to abrogate or limit any right, rem- edy, or authority that the United States or any agency thereof may possess under any other provision of law or to waive sovereign im- munity or to abrogate or limit any defense or protection available to the United States or its agencies, instrumentalities, officers, or employees under any other law, including any provision of chapter 171 of title 28, United States Code (relating to tort claims proce- dure). EVERABILITY .—If any provision of this section, or the appli- (g) S cation of such provision to any person or circumstance, is held to March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00210 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

211 G:\COMP\PHSA\PHSA-MERGED.XML 211 Sec. 319F–3 PUBLIC HEALTH SERVICE ACT be unconstitutional, the remainder of this section and the applica- tion of such remainder to any person or circumstance shall not be affected thereby. ONSTRUCTION C ONCERNING N ATIONAL V ACCINE ULE OF C (h) R C OMPENSATION P ROGRAM .—Nothing in this section, or any NJURY I amendment made by the Public Readiness and Emergency Pre- paredness Act, shall be construed to affect the National Vaccine In- jury Compensation Program under title XXI of this Act. .—In this section: EFINITIONS (i) D .—The term ‘‘covered coun- OVERED COUNTERMEASURE (1) C termeasure’’ means— (A) a qualified pandemic or epidemic product (as de- fined in paragraph (7)); (B) a security countermeasure (as defined in section 319F–2(c)(1)(B)); or (C) a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)), biological product (as such term is defined by section 351(i) of this Act), or device (as such term is de- fined by section 201(h) of the Federal Food, Drug and Cos- metic Act (21 U.S.C. 321(h)) that is authorized for emer- gency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act. (2) C OVERED PERSON .—The term ‘‘covered person’’, when used with respect to the administration or use of a covered countermeasure, means— (A) the United States; or (B) a person or entity that is— (i) a manufacturer of such countermeasure; (ii) a distributor of such countermeasure; (iii) a program planner of such countermeasure; (iv) a qualified person who prescribed, adminis- tered, or dispensed such countermeasure; or (v) an official, agent, or employee of a person or entity described in clause (i), (ii), (iii), or (iv). .—The term ‘‘distributor’’ means a person ISTRIBUTOR (3) D or entity engaged in the distribution of drugs, biologics, or de- vices, including but not limited to manufacturers; repackers; common carriers; contract carriers; air carriers; own-label dis- tributors; private-label distributors; jobbers; brokers; ware- houses, and wholesale drug warehouses; independent whole- sale drug traders; and retail pharmacies. ANUFACTURER .—The term ‘‘manufacturer’’ includes— (4) M (A) a contractor or subcontractor of a manufacturer; (B) a supplier or licenser of any product, intellectual property, service, research tool, or component or other arti- cle used in the design, development, clinical testing, inves- tigation, or manufacturing of a covered countermeasure; and (C) any or all of the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer. (5) P ERSON .—The term ‘‘person’’ includes an individual, partnership, corporation, association, entity, or public or pri- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00211 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

212 G:\COMP\PHSA\PHSA-MERGED.XML 212 Sec. 319F–3 PUBLIC HEALTH SERVICE ACT vate corporation, including a Federal, State, or local govern- ment agency or department. ROGRAM PLANNER .—The term ‘‘program planner’’ (6) P means a State or local government, including an Indian tribe, a person employed by the State or local government, or other person who supervised or administered a program with respect to the administration, dispensing, distribution, provision, or use of a security countermeasure or a qualified pandemic or epidemic product, including a person who has established re- quirements, provided policy guidance, or supplied technical or scientific advice or assistance or provides a facility to admin- ister or use a covered countermeasure in accordance with a declaration under subsection (b). UALIFIED PANDEMIC OR EPIDEMIC PRODUCT .—The term (7) Q ‘‘qualified pandemic or epidemic product’’ means a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)), biological prod- uct (as such term is defined by section 351(i) of this Act), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h)) that is— (A)(i) a product manufactured, used, designed, devel- oped, modified, licensed, or procured— (I) to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic; or (II) to limit the harm such pandemic or epidemic might otherwise cause; (ii) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, pre- vent, treat, or cure a serious or life-threatening disease or condition caused by a product described in clause (i); or 23 a product or technology intended to enhance (iii) the use or effect of a drug, biological product, or device described in clause (i) or (ii); and (B)(i) approved or cleared under chapter V of the Fed- eral Food, Drug, and Cosmetic Act or licensed under sec- tion 351 of this Act; (ii) the object of research for possible use as described by subparagraph (A) and is the subject of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act; or (iii) authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act. (8) Q UALIFIED PERSON .—The term ‘‘qualified person’’, when used with respect to the administration or use of a covered countermeasure, means— (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dis- pensed; or 23 Margin of clause (iii) so in law. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00212 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

213 G:\COMP\PHSA\PHSA-MERGED.XML 213 Sec. 319F–4 PUBLIC HEALTH SERVICE ACT (B) a person within a category of persons so identified in a declaration by the Secretary under subsection (b). ECURITY COUNTERMEASURE (9) S .—The term ‘‘security coun- termeasure’’ has the meaning given such term in section 319F– 2(c)(1)(B). ERIOUS PHYSICAL INJURY .—The term ‘‘serious phys- (10) S ical injury’’ means an injury that— (A) is life threatening; (B) results in permanent impairment of a body func- tion or permanent damage to a body structure; or (C) necessitates medical or surgical intervention to preclude permanent impairment of a body function or per- manent damage to a body structure. 247d–6e SEC. 319F–4. COVERED COUNTERMEASURE PROCESS. ø ¿ STABLISHMENT OF UND .—Upon the issuance by the Sec- (a) E F retary of a declaration under section 319F–3(b), there is hereby es- tablished in the Treasury an emergency fund designated as the ‘‘Covered Countermeasure Process Fund’’ for purposes of providing timely, uniform, and adequate compensation to eligible individuals for covered injuries directly caused by the administration or use of a covered countermeasure pursuant to such declaration, which Fund shall consist of such amounts designated as emergency ap- propriations under section 402 of H. Con. Res. 95 of the 109th Con- gress, this emergency designation shall remain in effect through October 1, 2006. AYMENT OF C OMPENSATION .— (b) P (1) I N GENERAL .—If the Secretary issues a declaration under 319F–3(b), the Secretary shall, after amounts have by law been provided for the Fund under subsection (a), provide compensation to an eligible individual for a covered injury di- rectly caused by the administration or use of a covered coun- termeasure pursuant to such declaration. LEMENTS OF COMPENSATION .—The compensation that (2) E shall be provided pursuant to paragraph (1) shall have the same elements, and be in the same amount, as is prescribed by sections 264, 265, and 266 in the case of certain individuals injured as a result of administration of certain counter- measures against smallpox, except that section 266(a)(2)(B) shall not apply. ULE OF CONSTRUCTION .—Neither reasonable and nec- (3) R essary medical benefits nor lifetime total benefits for lost em- ployment income due to permanent and total disability shall be limited by section 266. ETERMINATION OF ELIGIBILITY AND COMPENSATION .— (4) D Except as provided in this section, the procedures for deter- mining, and for reviewing a determination of, whether an indi- vidual is an eligible individual, whether such individual has sustained a covered injury, whether compensation may be available under this section, and the amount of such com- pensation shall be those stated in section 262 (other than in subsection (d)(2) of such section), in regulations issued pursu- ant to that section, and in such additional or alternate regula- tions as the Secretary may promulgate for purposes of this sec- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00213 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

214 G:\COMP\PHSA\PHSA-MERGED.XML 214 Sec. 319F–4 PUBLIC HEALTH SERVICE ACT tion. In making determinations under this section, other than those described in paragraph (5)(A) as to the direct causation of a covered injury, the Secretary may only make such deter- mination based on compelling, reliable, valid, medical and sci- entific evidence. .— OVERED COUNTERMEASURE INJURY TABLE (5) C N GENERAL .—The Secretary shall by regulation (A) I establish a table identifying covered injuries that shall be presumed to be directly caused by the administration or use of a covered countermeasure and the time period in which the first symptom or manifestation of onset of each such adverse effect must manifest in order for such pre- sumption to apply. The Secretary may only identify such covered injuries, for purpose of inclusion on the table, where the Secretary determines, based on compelling, reli- able, valid, medical and scientific evidence that adminis- tration or use of the covered countermeasure directly caused such covered injury. .—The provisions of section 263 MENDMENTS (B) A (other than a provision of subsection (a)(2) of such section that relates to accidental vaccinia inoculation) shall apply to the table established under this section. UDICIAL REVIEW .—No court of the United States, (C) J or of any State, shall have subject matter jurisdiction to review, whether by mandamus or otherwise, any action by the Secretary under this paragraph. (6) M EANINGS OF TERMS .—In applying sections 262, 263, 264, 265, and 266 for purposes of this section— (A) the terms ‘‘vaccine’’ and ‘‘smallpox vaccine’’ shall be deemed to mean a covered countermeasure; (B) the terms ‘‘smallpox vaccine injury table’’ and ‘‘table established under section 263’’ shall be deemed to refer to the table established under paragraph (4); and (C) other terms used in those sections shall have the meanings given to such terms by this section. OLUNTARY P ROGRAM .—The Secretary shall ensure that a (c) V State, local, or Department of Health and Human Services plan to administer or use a covered countermeasure is consistent with any declaration under 319F–3 and any applicable guidelines of the Cen- ters for Disease Control and Prevention and that potential partici- pants are educated with respect to contraindications, the voluntary nature of the program, and the availability of potential benefits and compensation under this part. XHAUSTION ; E XCLUSIVITY ; E LECTION .— (d) E (1) E .—Subject to paragraph (5), a covered indi- XHAUSTION vidual may not bring a civil action under section 319F–3(d) against a covered person (as such term is defined in section 319F–3(i)(2)) unless such individual has exhausted such rem- edies as are available under subsection (a), except that if amounts have not by law been provided for the Fund under subsection (a), or if the Secretary fails to make a final deter- mination on a request for benefits or compensation filed in ac- cordance with the requirements of this section within 240 days March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00214 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

215 G:\COMP\PHSA\PHSA-MERGED.XML 215 Sec. 319G PUBLIC HEALTH SERVICE ACT after such request was filed, the individual may seek any rem- edy that may be available under section 319F–3(d). OLLING OF STATUTE OF LIMITATIONS .—The time limit (2) T for filing a civil action under section 319F–3(d) for an injury or death shall be tolled during the pendency of a claim for com- pensation under subsection (a). .—This section shall not be con- ULE OF CONSTRUCTION (3) R strued as superseding or otherwise affecting the application of a requirement, under chapter 171 of title 28, United States Code, to exhaust administrative remedies. .—The remedy provided by subsection (a) XCLUSIVITY (4) E shall be exclusive of any other civil action or proceeding for any claim or suit this section encompasses, except for a pro- ceeding under section 319F–3. .—If under subsection (a) the Secretary deter- LECTION (5) E mines that a covered individual qualifies for compensation, the individual has an election to accept the compensation or to bring an action under section 319F–3(d). If such individual elects to accept the compensation, the individual may not bring such an action. EFINITIONS .—For purposes of this section, the following (e) D terms shall have the following meanings: .—The term ‘‘covered coun- OVERED COUNTERMEASURE (1) C termeasure’’ has the meaning given such term in section 319F– 3. OVERED INDIVIDUAL .—The term ‘‘covered individual’’, (2) C with respect to administration or use of a covered counter- measure pursuant to a declaration, means an individual— (A) who is in a population specified in such declara- tion, and with respect to whom the administration or use of the covered countermeasure satisfies the other specifica- tions of such declaration; or (B) who uses the covered countermeasure, or to whom the covered countermeasure is administered, in a good faith belief that the individual is in the category described by subparagraph (A). OVERED INJURY .—The term ‘‘covered injury’’ means se- (3) C rious physical injury or death. (4) D ECLARATION .—The term ‘‘declaration’’ means a dec- laration under section 319F–3(b). (5) E LIGIBLE INDIVIDUAL .—The term ‘‘eligible individual’’ means an individual who is determined, in accordance with subsection (b), to be a covered individual who sustains a cov- ered injury. ø 247d–7 ¿ DEMONSTRATION PROGRAM TO ENHANCE BIO- SEC. 319G. TERRORISM TRAINING, COORDINATION, AND READINESS. (a) I G ENERAL .—The Secretary shall make grants to not more N than three eligible entities to carry out demonstration programs to improve the detection of pathogens likely to be used in a bioter- rorist attack, the development of plans and measures to respond to bioterrorist attacks, and the training of personnel involved with the various responsibilities and capabilities needed to respond to acts of bioterrorism upon the civilian population. Such awards shall be March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00215 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

216 G:\COMP\PHSA\PHSA-MERGED.XML 216 Sec. 319G PUBLIC HEALTH SERVICE ACT made on a competitive basis and pursuant to scientific and tech- nical review. (b) E LIGIBLE E NTITIES .—Eligible entities for grants under sub- section (a) are States, political subdivisions of States, and public or private non-profit organizations. PECIFIC C RITERIA .—In making grants under subsection (a), (c) S the Secretary shall take into account the following factors: (1) Whether the eligible entity involved is proximate to, and collaborates with, a major research university with exper- tise in scientific training, identification of biological agents, medicine, and life sciences. (2) Whether the entity is proximate to, and collaborates with, a laboratory that has expertise in the identification of bi- ological agents. (3) Whether the entity demonstrates, in the application for the program, support and participation of State and local gov- ernments and research institutions in the conduct of the pro- gram. (4) Whether the entity is proximate to, and collaborates with, or is, an academic medical center that has the capacity to serve an uninsured or underserved population, and is equipped to educate medical personnel. (5) Such other factors as the Secretary determines to be appropriate. URATION OF A WARD .—The period during which payments (d) D are made under a grant under subsection (a) may not exceed 5 years. The provision of such payments shall be subject to annual approval by the Secretary of the payments and subject to the avail- ability of appropriations for the fiscal year involved to make the payments. (e) S UPPLEMENT N OT S UPPLANT .—Grants under subsection (a) shall be used to supplement, and not supplant, other Federal, State, or local public funds provided for the activities described in such subsection. 24 (f) G ENERAL A CCOUNTING O FFICE R EPORT .—Not later than 180 days after the conclusion of the demonstration programs car- ried out under subsection (a), the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate, and the Committee on Commerce and the Committee on Appropriations of the House of Representatives, a report that de- scribes the ability of grantees under such subsection to detect pathogens likely to be used in a bioterrorist attack, develop plans and measures for dealing with such threats, and train personnel involved with the various responsibilities and capabilities needed to deal with bioterrorist threats. UTHORIZATION OF A PPROPRIATIONS .—There is authorized (g) A to be appropriated to carry out this section $6,000,000 for fiscal year 2001, and such sums as may be necessary through fiscal year 2006. 24 Now the Government Accountability Office. See section 8 of Public Law 108–271 (118 Stat. 814). March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00216 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

217 G:\COMP\PHSA\PHSA-MERGED.XML 217 Sec. 319I PUBLIC HEALTH SERVICE ACT 247d–7a ø ¿ SEC. 319H. GRANTS REGARDING TRAINING AND EDUCATION OF CERTAIN HEALTH PROFESSIONALS. G .—The Secretary may make awards of grants N ENERAL (a) I and cooperative agreements to appropriate public and nonprofit private health or educational entities, including health professions schools and programs as defined in section 799B, for the purpose of providing low-interest loans, partial scholarships, partial fellow- ships, revolving loan funds, or other cost-sharing forms of assist- ance for the education and training of individuals in any category of health professions for which there is a shortage that the Sec- retary determines should be alleviated in order to prepare for or re- spond effectively to bioterrorism and other public health emer- gencies. (b) A EGARDING N UTHORITY -F EDERAL C ONTRIBUTIONS .— R ON The Secretary may require as a condition of an award under sub- section (a) that a grantee under such subsection provide non-Fed- eral contributions toward the purpose described in such subsection. UTHORIZATION OF PPROPRIATIONS .—For the purpose of (c) A A carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2002 through 2006. ø 247d–7b ¿ EMERGENCY SYSTEM FOR ADVANCE REGISTRA- SEC. 319I. TION OF HEALTH PROFESSIONS VOLUNTEERS. N (a) I .—Not later than 12 months after the date of G ENERAL enactment of the Pandemic and All-Hazards Preparedness Act, the Secretary shall link existing State verification systems to maintain a single national interoperable network of systems, each system being maintained by a State or group of States, for the purpose of verifying the credentials and licenses of health care professionals who volunteer to provide health services during a public health emergency. .—The interoperable network of systems es- (b) R EQUIREMENTS tablished under subsection (a) (referred to in this section as the ‘‘verification network’’) shall include— (1) with respect to each volunteer health professional in- cluded in the verification network— (A) information necessary for the rapid identification of, and communication with, such professionals; and (B) the credentials, certifications, licenses, and rel- evant training of such individuals; and (2) the name of each member of the Medical Reserve Corps, the National Disaster Medical System, and any other relevant federally-sponsored or administered programs deter- mined necessary by the Secretary. (c) O SSISTANCE .—The Secretary may make grants and A THER provide technical assistance to States and other public or nonprofit private entities for activities relating to the verification network de- veloped under subsection (a). (d) A CCESSIBILITY .—The Secretary shall ensure that the verification network is electronically accessible by State, local, and tribal health departments and can be linked with the identification cards under section 2813. (e) C ONFIDENTIALITY .—The Secretary shall establish and re- quire the application of and compliance with measures to ensure March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00217 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

218 G:\COMP\PHSA\PHSA-MERGED.XML 218 Sec. 319J PUBLIC HEALTH SERVICE ACT the effective security of, integrity of, and access to the data in- cluded in the verification network. OORDINATION .—The Secretary shall coordinate with the (f) C Secretary of Veterans Affairs and the Secretary of Homeland Secu- rity to assess the feasibility of integrating the verification network under this section with the VetPro system of the Department of Veterans Affairs and the National Emergency Responder Credentialing System of the Department of Homeland Security. The Secretary shall, if feasible, integrate the verification network under this section with such VetPro system and the National Emergency Responder Credentialing System. (g) U .—The States that are partici- I PDATING OF NFORMATION pants in the verification network shall, on at least a quarterly basis, work with the Director to provide for the updating of the in- formation contained in the verification network. .—Inclusion of a health professional in the LARIFICATION (h) C verification network shall not constitute appointment of such indi- vidual as a Federal employee for any purpose, either under section 2812(c) or otherwise. Such appointment may only be made under section 2812 or 2813. .—The Secretary shall en- C ARE P ROVIDER L ICENSES EALTH (i) H courage States to establish and implement mechanisms to waive the application of licensing requirements applicable to health pro- fessionals, who are seeking to provide medical services (within their scope of practice), during a national, State, local, or tribal public health emergency upon verification that such health profes- sionals are licensed and in good standing in another State and have not been disciplined by any State health licensing or discipli- nary board. ULE OF C ONSTRUCTION .—This section may not be con- (j) R strued as authorizing the Secretary to issue requirements regard- ing the provision by the States of credentials, licenses, accredita- tions, or hospital privileges. A PPROPRIATIONS .—For the purpose of UTHORIZATION OF (k) A carrying out this section, there are authorized to be appropriated $5,000,000 for each of fiscal years 2014 through 2018. 247d–7c SEC. 319J. SUPPLIES AND SERVICES IN LIEU OF AWARD ø ¿ FUNDS. (a) I N G ENERAL .—Upon the request of a recipient of an award under any of sections 319 through 319I or section 319K, the Sec- retary may, subject to subsection (b), provide supplies, equipment, and services for the purpose of aiding the recipient in carrying out the purposes for which the award is made and, for such purposes, may detail to the recipient any officer or employee of the Depart- ment of Health and Human Services. (b) C ORRESPONDING R P AYMENTS .—With respect to EDUCTION IN a request described in subsection (a), the Secretary shall reduce the amount of payments under the award involved by an amount equal to the costs of detailing personnel and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00218 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

219 G:\COMP\PHSA\PHSA-MERGED.XML 219 Sec. 319L PUBLIC HEALTH SERVICE ACT 247d–7d ø ¿ SEC. 319K. SECURITY FOR COUNTERMEASURE DEVELOP- MENT AND PRODUCTION. G .—The Secretary, in consultation with the At- N ENERAL (a) I torney General and the Secretary of Defense, may provide technical or other assistance to provide security to persons or facilities that conduct development, production, distribution, or storage of priority countermeasures (as defined in section 319F(h)(4)). .—The Secretary may develop guidelines to en- UIDELINES (b) G able entities eligible to receive assistance under subsection (a) to secure their facilities against potential terrorist attack. 247d–7e SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DEVEL- ø ¿ OPMENT AUTHORITY. .—In this section: (a) D EFINITIONS (1) BARDA.—The term ‘‘BARDA’’ means the Biomedical Advanced Research and Development Authority. (2) F .—The term ‘‘Fund’’ means the Biodefense Med- UND ical Countermeasure Development Fund established under subsection (d). (3) O THER TRANSACTIONS .—The term ‘‘other transactions’’ means transactions, other than procurement contracts, grants, and cooperative agreements, such as the Secretary of Defense may enter into under section 2371 of title 10, United States Code. (4) Q .—The term ‘‘qualified UALIFIED COUNTERMEASURE countermeasure’’ has the meaning given such term in section 319F–1. (5) Q .—The term UALIFIED PANDEMIC OR EPIDEMIC PRODUCT ‘‘qualified pandemic or epidemic product’’ has the meaning given the term in section 319F–3. (6) A DVANCED RESEARCH AND DEVELOPMENT .— (A) I N GENERAL .—The term ‘‘advanced research and development’’ means, with respect to a product that is or may become a qualified countermeasure or a qualified pan- demic or epidemic product, activities that predominantly— (i) are conducted after basic research and pre- clinical development of the product; and (ii) are related to manufacturing the product on a commercial scale and in a form that satisfies the regu- latory requirements under the Federal Food, Drug, and Cosmetic Act or under section 351 of this Act. (B) A .—The term under subpara- CTIVITIES INCLUDED graph (A) includes— (i) testing of the product to determine whether the product may be approved, cleared, or licensed under the Federal Food, Drug, and Cosmetic Act or under section 351 of this Act for a use that is or may be the basis for such product becoming a qualified counter- measure or qualified pandemic or epidemic product, or to help obtain such approval, clearance, or license; (ii) design and development of tests or models, in- cluding animal models, for such testing; (iii) activities to facilitate manufacture of the product on a commercial scale with consistently high March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00219 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

220 G:\COMP\PHSA\PHSA-MERGED.XML 220 Sec. 319L PUBLIC HEALTH SERVICE ACT quality, as well as to improve and make available new technologies to increase manufacturing surge capacity; (iv) activities to improve the shelf-life of the prod- uct or technologies for administering the product; and (v) such other activities as are part of the ad- vanced stages of testing, refinement, improvement, or preparation of the product for such use and as are specified by the Secretary. ECURITY COUNTERMEASURE .—The term ‘‘security coun- (7) S termeasure’’ has the meaning given such term in section 319F– 2. .—The term ‘‘research tool’’ means a de- ESEARCH TOOL (8) R vice, technology, biological material (including a cell line or an antibody), reagent, animal model, computer system, computer software, or analytical technique that is developed to assist in the discovery, development, or manufacture of qualified coun- termeasures or qualified pandemic or epidemic products. .—The term ‘‘program manager’’ (9) P ROGRAM MANAGER means an individual appointed to carry out functions under this section and authorized to provide project oversight and management of strategic initiatives. (10) P ERSON .—The term ‘‘person’’ includes an individual, partnership, corporation, association, entity, or public or pri- vate corporation, and a Federal, State, or local government agency or department. (b) S P LAN FOR C OUNTERMEASURE R ESEARCH , D EVEL - TRATEGIC , OPMENT ROCUREMENT .— AND P .—Not later than 6 months after the date N GENERAL (1) I of enactment of the Pandemic and All-Hazards Preparedness Act, the Secretary shall develop and make public a strategic plan to integrate biodefense and emerging infectious disease requirements with the advanced research and development, strategic initiatives for innovation, and the procurement of qualified countermeasures and qualified pandemic or epidemic products. The Secretary shall carry out such activities as may be practicable to disseminate the information contained in such plan to persons who may have the capacity to substantially contribute to the activities described in such strategic plan. The Secretary shall update and incorporate such plan as part of the National Health Security Strategy described in section 2802. ONTENT .—The strategic plan under paragraph (1) (2) C shall guide— (A) research and development, conducted or supported by the Department of Health and Human Services, of qualified countermeasures and qualified pandemic or epi- demic products against possible biological, chemical, radio- logical, and nuclear agents and to emerging infectious dis- eases; (B) innovation in technologies that may assist ad- vanced research and development of qualified counter- measures and qualified pandemic or epidemic products (such research and development referred to in this section March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00220 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

221 G:\COMP\PHSA\PHSA-MERGED.XML 221 Sec. 319L PUBLIC HEALTH SERVICE ACT as ‘‘countermeasure and product advanced research and development’’); and (C) procurement of such qualified countermeasures and qualified pandemic or epidemic products by such De- partment. (c) B A ESEARCH AND D IOMEDICAL A U - DVANCED R EVELOPMENT .— THORITY .—There is established within the De- (1) E STABLISHMENT partment of Health and Human Services the Biomedical Ad- vanced Research and Development Authority. (2) I N GENERAL .—Based upon the strategic plan described in subsection (b), the Secretary shall coordinate the accelera- tion of countermeasure and product advanced research and de- velopment by— (A) facilitating collaboration between the Department of Health and Human Services and other Federal agencies, relevant industries, academia, and other persons, with re- spect to such advanced research and development; (B) promoting countermeasure and product advanced research and development; (C) facilitating contacts between interested persons and the offices or employees authorized by the Secretary to advise such persons regarding requirements under the Federal Food, Drug, and Cosmetic Act and under section 351 of this Act; and (D) promoting innovation to reduce the time and cost of countermeasure and product advanced research and de- velopment. IRECTOR .—The BARDA shall be headed by a Director (3) D (referred to in this section as the ‘‘Director’’) who shall be ap- pointed by the Secretary and to whom the Secretary shall dele- gate such functions and authorities as necessary to implement this section, including the execution of procurement contracts, grants, and cooperative agreements pursuant to this section. (4) D UTIES .— OLLABORATION .—To carry out the purpose de- (A) C scribed in paragraph (2)(A), the Secretary shall— (i) facilitate and increase the expeditious and di- rect communication between the Department of Health and Human Services and relevant persons with respect to countermeasure and product advanced research and development, including by— (I) facilitating such communication regarding the processes for procuring such advanced re- search and development with respect to qualified countermeasures and qualified pandemic or epi- demic products of interest; and (II) soliciting information about and data from research on potential qualified countermeasures and qualified pandemic or epidemic products and related technologies; (ii) at least annually— (I) convene meetings with representatives from relevant industries, academia, other Federal March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00221 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

222 G:\COMP\PHSA\PHSA-MERGED.XML 222 Sec. 319L PUBLIC HEALTH SERVICE ACT agencies, international agencies as appropriate, and other interested persons; (II) sponsor opportunities to demonstrate the operation and effectiveness of relevant biodefense countermeasure technologies; and (III) convene such working groups on counter- measure and product advanced research and de- velopment as the Secretary may determine are necessary to carry out this section; and (iii) carry out the activities described in section 405 of the Pandemic and All-Hazards Preparedness Act. (B) S RESEARCH AND DEVELOP UPPORT ADVANCED - .—To carry out the purpose described in paragraph MENT (2)(B), the Secretary shall— (i) conduct ongoing searches for, and support calls for, potential qualified countermeasures and qualified pandemic or epidemic products; (ii) direct and coordinate the countermeasure and product advanced research and development activities of the Department of Health and Human Services; (iii) establish strategic initiatives to accelerate countermeasure and product advanced research and development (which may include advanced research and development for purposes of fulfilling require- ments under the Federal Food, Drug, and Cosmetic Act or section 351 of this Act) and innovation in such areas as the Secretary may identify as priority unmet need areas; and (iv) award contracts, grants, cooperative agree- ments, and enter into other transactions, for counter- measure and product advanced research and develop- ment. (C) F ACILITATING ADVICE .—To carry out the purpose described in paragraph (2)(C) the Secretary shall— (i) connect interested persons with the offices or employees authorized by the Secretary to advise such persons regarding the regulatory requirements under the Federal Food, Drug, and Cosmetic Act and under section 351 of this Act related to the approval, clear- ance, or licensure of qualified countermeasures or qualified pandemic or epidemic products; and (ii) with respect to persons performing counter- measure and product advanced research and develop- ment funded under this section, enable such offices or employees to provide to the extent practicable such ad- vice in a manner that is ongoing and that is otherwise designed to facilitate expeditious development of quali- fied countermeasures and qualified pandemic or epi- demic products that may achieve such approval, clear- ance, or licensure. UPPORTING INNOVATION .—To carry out the pur- (D) S pose described in paragraph (2)(D), the Secretary may award contracts, grants, and cooperative agreements, or March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00222 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

223 G:\COMP\PHSA\PHSA-MERGED.XML 223 Sec. 319L PUBLIC HEALTH SERVICE ACT enter into other transactions, such as prize payments, to promote— (i) innovation in technologies that may assist countermeasure and product advanced research and development; (ii) research on and development of research tools and other devices and technologies; and (iii) research to promote strategic initiatives, such as rapid diagnostics, broad spectrum antimicrobials, vaccine-manufacturing technologies, dose-sparing tech- nologies, efficacy-increasing technologies, and platform technologies. (E) M - EDICAL COUNTERMEASURES INNOVATION PART NER .— (i) I N GENERAL .—To support the purposes de- scribed in paragraph (2), the Secretary, acting through the Director of BARDA, may enter into an agreement (including through the use of grants, contracts, cooper- ative agreements, or other transactions as described in paragraph (5)) with an independent, nonprofit entity to— (I) foster and accelerate the development and innovation of medical countermeasures and tech- nologies that may assist advanced research and the development of qualified countermeasures and qualified pandemic or epidemic products, includ- ing through the use of strategic venture capital practices and methods; (II) promote the development of new and promising technologies that address urgent med- ical countermeasure needs, as identified by the Secretary; (III) address unmet public health needs that are directly related to medical countermeasure re- quirements, such as novel antimicrobials for multidrug resistant organisms and multiuse plat- form technologies for diagnostics, prophylaxis, vac- cines, and therapeutics; and (IV) provide expert consultation and advice to foster viable medical countermeasure innovators, including helping qualified countermeasure innovators navigate unique industry challenges with respect to developing chemical, biological, ra- diological, and nuclear countermeasure products. (ii) E .— LIGIBILITY N GENERAL .—To be eligible to enter into (I) I an agreement under clause (i) an entity shall— (aa) be an independent, nonprofit entity; (bb) have a demonstrated record of being able to create linkages between innovators and investors and leverage such partnerships and resources for the purpose of addressing identified strategic needs of the Federal Gov- ernment; March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00223 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

224 G:\COMP\PHSA\PHSA-MERGED.XML 224 Sec. 319L PUBLIC HEALTH SERVICE ACT (cc) have experience in promoting novel technology innovation; (dd) be problem-driven and solution-fo- cused based on the needs, requirements, and problems identified by the Secretary under clause (iv); (ee) demonstrate the ability, or the poten- tial ability, to promote the development of medical countermeasure products; (ff) demonstrate expertise, or the capacity to develop or acquire expertise, related to technical and regulatory considerations with respect to medical countermeasures; and (gg) not be within the Department of Health and Human Services. (II) P .—In selecting an ARTNERING EXPERIENCE entity with which to enter into an agreement under clause (i), the Secretary shall place a high value on the demonstrated experience of the enti- ty in partnering with the Federal Government to meet identified strategic needs. (iii) N OT AGENCY .—An entity that enters into an agreement under clause (i) shall not be deemed to be a Federal agency for any purpose, including for any purpose under title 5, United States Code. IRECTION .—Pursuant to an agreement en- (iv) D tered into under this subparagraph, the Secretary, act- ing through the Director of BARDA, shall provide di- rection to the entity that enters into an agreement under clause (i). As part of this agreement the Direc- tor of BARDA shall— (I) communicate the medical countermeasure needs, requirements, and problems to be ad- dressed by the entity under the agreement; (II) develop a description of work to be per- formed by the entity under the agreement; (III) provide technical feedback and appro- priate oversight over work carried out by the enti- ty under the agreement, including subsequent de- velopment and partnerships consistent with the needs and requirements set forth in this subpara- graph; (IV) ensure fair consideration of products de- veloped under the agreement in order to maintain competition to the maximum practical extent, as applicable and appropriate under applicable provi- sions of this section; and (V) ensure, as a condition of the agreement that the entity— (aa) has in place a comprehensive set of policies that demonstrate a commitment to transparency and accountability; (bb) protects against conflicts of interest through a comprehensive set of policies that March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00224 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

225 G:\COMP\PHSA\PHSA-MERGED.XML 225 Sec. 319L PUBLIC HEALTH SERVICE ACT address potential conflicts of interest, ethics, disclosure, and reporting requirements; (cc) provides monthly accounting on the use of funds provided under such agreement; and (dd) provides on a quarterly basis, reports regarding the progress made toward meeting the identified needs set forth in the agree- ment. (v) S UPPLEMENT NOT SUPPLANT .—Activities carried out under this subparagraph shall supplement, and not supplant, other activities carried out under this section. (vi) N .—To prevent O ESTABLISHMENT OF ENTITY unnecessary duplication and target resources effec- tively, nothing in this subparagraph shall be construed to authorize the Secretary to establish within the De- partment of Health and Human Services an entity for the purposes of carrying out this subparagraph. (vii) T RANSPARENCY AND OVERSIGHT .—Upon re- quest, the Secretary shall provide to Congress the in- formation provided to the Secretary under clause (iv)(V)(dd). (viii) I NDEPENDENT EVALUATION .—Not later than 4 years after the date of enactment of the 21st Century Cures Act, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the Secretary and the appropriate commit- tees of Congress a report, concerning the activities conducted under this subparagraph. Such report shall include recommendations with respect to any agree- ment or activities carried out pursuant to this sub- paragraph. (ix) S UNSET .—This subparagraph shall have no force or effect after September 30, 2022. RANSACTION AUTHORITIES (5) T .— (A) O THER TRANSACTIONS .— .—The Secretary shall have the au- (i) I N GENERAL thority to enter into other transactions under this sub- section in the same manner as the Secretary of De- fense enters into such transactions under section 2371 of title 10, United States Code. (ii) L IMITATIONS ON AUTHORITY .— N GENERAL .—Subsections (b), (c), and (h) (I) I of section 845 of the National Defense Authoriza- tion Act for Fiscal Year 1994 (10 U.S.C. 2371 note) shall apply to other transactions under this subparagraph as if such transactions were for pro- totype projects described by subsection (a) of such section 845. (II) W RITTEN DETERMINATIONS REQUIRED .— The authority of this subparagraph may be exer- cised for a project that is expected to cost the De- partment of Health and Human Services in excess March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00225 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

226 G:\COMP\PHSA\PHSA-MERGED.XML 226 Sec. 319L PUBLIC HEALTH SERVICE ACT of $20,000,000 only upon a written determination by the senior procurement executive for the De- partment (as designated for purpose of section 16(c) of the Office of Federal Procurement Policy Act (41 U.S.C. 414(c))), that the use of such au- thority is essential to promoting the success of the project. The authority of the senior procurement executive under this subclause may not be dele- gated. (iii) G UIDELINES .—The Secretary shall establish guidelines regarding the use of the authority under clause (i). Such guidelines shall include auditing re- quirements. (B) E XPEDITED AUTHORITIES .— (i) I .—In awarding contracts, grants, N GENERAL and cooperative agreements, and in entering into other transactions under subparagraph (B) or (D) of paragraph (4), the Secretary shall have the expedited procurement authorities, the authority to expedite peer review, and the authority for personal services contracts, supplied by subsections (b), (c), and (d) of section 319F–1. (ii) A PPLICATION OF PROVISIONS .—Provisions in such section 319F–1 that apply to such authorities and that require institution of internal controls, limit re- view, provide for Federal Tort Claims Act coverage of personal services contractors, and commit decisions to the discretion of the Secretary shall apply to the au- thorities as exercised pursuant to this paragraph. UTHORITY TO LIMIT COMPETITION .—For pur- (iii) A poses of applying section 319F–1(b)(1)(D) to this para- graph, the phrase ‘‘BioShield Program under the Project BioShield Act of 2004’’ shall be deemed to mean the countermeasure and product advanced re- search and development program under this section. (iv) A VAILABILITY OF DATA .—The Secretary shall require that, as a condition of being awarded a con- tract, grant, cooperative agreement, or other trans- action under subparagraph (B) or (D) of paragraph (4), a person make available to the Secretary on an ongo- ing basis, and submit upon request to the Secretary, all data related to or resulting from countermeasure and product advanced research and development car- ried out pursuant to this section. DVANCE PAYMENTS ; ADVERTISING .—The Secretary (C) A may waive the requirements of section 3324(a) of title 31, United States Code, or section 3709 of the Revised Stat- utes of the United States (41 U.S.C. 5) upon the deter- mination by the Secretary that such waiver is necessary to obtain countermeasures or products under this section. ILESTONE - BASED PAYMENTS ALLOWED .—In award- (D) M ing contracts, grants, and cooperative agreements, and in entering into other transactions, under this section, the Secretary may use milestone-based awards and payments. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00226 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

227 G:\COMP\PHSA\PHSA-MERGED.XML 227 Sec. 319L PUBLIC HEALTH SERVICE ACT .—The Secretary may OREIGN NATIONALS ELIGIBLE (E) F under this section award contracts, grants, and cooperative agreements to, and may enter into other transactions with, highly qualified foreign national persons outside the United States, alone or in collaboration with American participants, when such transactions may inure to the ben- efit of the American people. (F) E STABLISHMENT OF RESEARCH CENTERS .—The Sec- retary may assess the feasibility and appropriateness of establishing, through contract, grant, cooperative agree- ment, or other transaction, an arrangement with an exist- ing research center in order to achieve the goals of this section. If such an agreement is not feasible and appro- priate, the Secretary may establish one or more federally- funded research and development centers, or university-af- filiated research centers, in accordance with section 303(c)(3) of the Federal Property and Administrative Serv- ices Act of 1949 (41 U.S.C. 253(c)(3)). (G) G OVERNMENT PURPOSE .—In awarding contracts, grants, and cooperative agreements under this section, the Secretary shall provide a clear statement of defined Gov- ernment purpose related to activities included in sub- section (a)(6)(B) for a qualified countermeasure or qualified pandemic or epidemic product. (6) A RISK INDIVIDUALS T - .—In carrying out the functions under this section, the Secretary may give priority to the ad- vanced research and development of qualified countermeasures and qualified pandemic or epidemic products that are likely to be safe and effective with respect to children, pregnant women, elderly, and other at-risk individuals. ERSONNEL AUTHORITIES (7) P .— - PECIALLY QUALIFIED SCIENTIFIC AND PROFES (A) S .— SIONAL PERSONNEL (i) I N GENERAL .—In addition to any other per- sonnel authorities, the Secretary may— (I) without regard to those provisions of title 5, United States Code, governing appointments in the competitive service, appoint highly qualified individuals to scientific or professional positions in BARDA, such as program managers, to carry out this section; and (II) compensate them in the same manner and subject to the same terms and conditions in which individuals appointed under section 9903 of such title are compensated, without regard to the provi- sions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and Gen- eral Schedule pay rates. (ii) M ANNER OF EXERCISE OF AUTHORITY .—The au- thority provided for in this subparagraph shall be ex- ercised subject to the same limitations described in section 319F–1(e)(2). ERM OF APPOINTMENT .—The term limitations (iii) T described in section 9903(c) of title 5, United States March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00227 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

228 G:\COMP\PHSA\PHSA-MERGED.XML 228 Sec. 319L PUBLIC HEALTH SERVICE ACT Code, shall apply to appointments under this subpara- graph, except that the references to the ‘‘Secretary’’ and to the ‘‘Department of Defense’s national security missions’’ shall be deemed to be to the Secretary of Health and Human Services and to the mission of the Department of Health and Human Services under this section. (B) S .—In carrying out this sec- PECIAL CONSULTANTS tion, the Secretary may appoint special consultants pursu- ant to section 207(f). (C) L .— IMITATION .—The Secretary may hire up to N GENERAL (i) I 100 highly qualified individuals, or up to 50 percent of the total number of employees, whichever is less, under the authorities provided for in subparagraphs (A) and (B). (ii) R .—The Secretary shall report to Con- EPORT gress on a biennial basis on the implementation of this subparagraph. (d) F .— UND (1) E STABLISHMENT .—There is established the Biodefense Medical Countermeasure Development Fund, which shall be available to carry out this section in addition to such amounts as are otherwise available for this purpose. UNDING .—To carry out the purposes of this section, (2) F there is authorized to be appropriated to the Fund $415,000,000 for each of fiscal years 2014 through 2018, such amounts to remain available until expended. NAPPLICABILITY OF C ERTAIN P ROVISIONS .— (e) I (1) D ISCLOSURE .— (A) I .—The Secretary shall withhold from N GENERAL disclosure under section 552 of title 5, United States Code, specific technical data or scientific information that is cre- ated or obtained during the countermeasure and product advanced research and development carried out under sub- section (c) that reveals significant and not otherwise pub- licly known vulnerabilities of existing medical or public health defenses against biological, chemical, nuclear, or ra- diological threats. Such information shall be deemed to be information described in section 552(b)(3) of title 5, United States Code. (B) R EVIEW .—Information subject to nondisclosure under subparagraph (A) shall be reviewed by the Secretary every 5 years, or more frequently as determined necessary by the Secretary, to determine the relevance or necessity of continued nondisclosure. UNSET .—This paragraph shall cease to have force (C) S or effect on the date that is 12 years after the date of en- actment of the Pandemic and All-Hazards Preparedness Act. EVIEW .—Notwithstanding section 14 of the Federal (2) R Advisory Committee Act, a working group of BARDA under this section and the National Biodefense Science Board under section 319M shall each terminate on the date that is 5 years March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00228 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

229 G:\COMP\PHSA\PHSA-MERGED.XML 229 Sec. 319M PUBLIC HEALTH SERVICE ACT after the date on which each such group or Board, as applica- ble, was established. Such 5-year period may be extended by the Secretary for one or more additional 5-year periods if the Secretary determines that any such extension is appropriate. (f) I VALUATION NDEPENDENT .— E (1) I N GENERAL .—Not later than 180 days after the date of enactment of this subsection, the Comptroller General of the United States shall conduct an independent evaluation of the activities carried out to facilitate flexible manufacturing capac- ity pursuant to this section. (2) R EPORT .—Not later than 1 year after the date of enact- ment of this subsection, the Comptroller General of the United States shall submit to the appropriate committees of Congress a report concerning the results of the evaluation conducted under paragraph (1). Such report shall review and assess— (A) the extent to which flexible manufacturing capac- ity under this section is dedicated to chemical, biological, radiological, and nuclear threats; (B) the activities supported by flexible manufacturing initiatives; and (C) the ability of flexible manufacturing activities car- ried out under this section to— (i) secure and leverage leading technical expertise with respect to countermeasure advanced research, de- velopment, and manufacturing processes; and (ii) meet the surge manufacturing capacity needs presented by novel and emerging threats, including chemical, biological, radiological, and nuclear agents. ø 247d–f ¿ NATIONAL BIODEFENSE SCIENCE BOARD AND SEC. 319M. WORKING GROUPS. (a) I ENERAL .— N G .—The Secretary shall STABLISHMENT AND FUNCTION (1) E establish the National Biodefense Science Board (referred to in this section as the ‘‘Board’’) to provide expert advice and guid- ance to the Secretary on scientific, technical and other matters of special interest to the Department of Health and Human Services regarding current and future chemical, biological, nu- clear, and radiological agents, whether naturally occurring, ac- cidental, or deliberate. (2) M EMBERSHIP .—The membership of the Board shall be comprised of individuals who represent the Nation’s pre- eminent scientific, public health, and medical experts, as fol- lows— (A) such Federal officials as the Secretary may deter- mine are necessary to support the functions of the Board; (B) four individuals representing the pharmaceutical, biotechnology, and device industries; (C) four individuals representing academia; and (D) five other members as determined appropriate by the Secretary, of whom— (i) one such member shall be a practicing healthcare professional; (ii) one such member shall be an individual from an organization representing healthcare consumers; March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00229 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

230 G:\COMP\PHSA\PHSA-MERGED.XML 230 Sec. 319M PUBLIC HEALTH SERVICE ACT (iii) one such member shall be an individual with pediatric subject matter expertise; and (iv) one such member shall be a State, tribal, ter- ritorial, or local public health official. Nothing in this paragraph shall preclude a member of the Board from satisfying two or more of the requirements de- scribed in subparagraph (D). (3) T .—A member of the Board de- ERM OF APPOINTMENT scribed in subparagraph (B), (C), or (D) of paragraph (2) shall serve for a term of 3 years, except that the Secretary may ad- just the terms of the initial Board appointees in order to pro- vide for a staggered term of appointment for all members. (4) C ; MAXIMUM TERMS .—A ONSECUTIVE APPOINTMENTS member may be appointed to serve not more than 3 terms on the Board and may serve not more than 2 consecutive terms. (5) D UTIES .—The Board shall— (A) advise the Secretary on current and future trends, challenges, and opportunities presented by advances in bi- ological and life sciences, biotechnology, and genetic engi- neering with respect to threats posed by naturally occur- ring infectious diseases and chemical, biological, radio- logical, and nuclear agents; (B) at the request of the Secretary, review and con- sider any information and findings received from the work- ing groups established under subsection (b); (C) at the request of the Secretary, provide rec- ommendations and findings for expanded, intensified, and coordinated biodefense research and development activi- ties; and (D) provide any recommendation, finding, or report provided to the Secretary under this paragraph to the ap- propriate committees of Congress. EETINGS .— (6) M (A) I .—Not later than one year after NITIAL MEETING the date of enactment of the Pandemic and All-Hazards Preparedness Act, the Secretary shall hold the first meet- ing of the Board. (B) S UBSEQUENT MEETINGS .—The Board shall meet at the call of the Secretary, but in no case less than twice an- nually. .—Any vacancy in the Board shall not affect ACANCIES (7) V its powers, but shall be filled in the same manner as the origi- nal appointment. (8) C HAIRPERSON .—The Secretary shall appoint a chair- person from among the members of the Board. OWERS .— (9) P (A) H EARINGS .—The Board may hold such hearings, sit and act at such times and places, take such testimony, and receive such evidence as the Board considers advisable to carry out this subsection. OSTAL SERVICES .—The Board may use the United (B) P States mails in the same manner and under the same con- ditions as other departments and agencies of the Federal Government. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00230 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

231 G:\COMP\PHSA\PHSA-MERGED.XML 231 Sec. 320 PUBLIC HEALTH SERVICE ACT .— ERSONNEL (10) P .—A (A) E MPLOYEES OF THE FEDERAL GOVERNMENT member of the Board that is an employee of the Federal Government may not receive additional pay, allowances, or benefits by reason of the member’s service on the Board. .—A member of the Board that is THER MEMBERS (B) O not an employee of the Federal Government may be com- pensated at a rate not to exceed the daily equivalent of the annual rate of basic pay prescribed for level IV of the Ex- ecutive Schedule under section 5315 of title 5, United States Code, for each day (including travel time) during which the member is engaged in the actual performance of duties as a member of the Board. RAVEL EXPENSES .—Each member of the Board (C) T shall receive travel expenses, including per diem in lieu of subsistence, in accordance with applicable provisions under subchapter I of chapter 57 of title 5, United States Code. .—Any Federal ETAIL OF GOVERNMENT EMPLOYEES (D) D Government employee may be detailed to the Board with the approval for the contributing agency without reim- bursement, and such detail shall be without interruption or loss of civil service status or privilege. W THER G ROUPS .—The Secretary may establish a ORKING (b) O working group of experts, or may use an existing working group or advisory committee, to— (1) identify innovative research with the potential to be de- veloped as a qualified countermeasure or a qualified pandemic or epidemic product; (2) identify accepted animal models for particular diseases and conditions associated with any biological, chemical, radio- logical, or nuclear agent, any toxin, or any potential pandemic infectious disease, and identify strategies to accelerate animal model and research tool development and validation; and (3) obtain advice regarding supporting and facilitating ad- vanced research and development related to qualified counter- measures and qualified pandemic or epidemic products that are likely to be safe and effective with respect to children, pregnant women, and other vulnerable populations, and other issues regarding activities under this section that affect such populations. EFINITIONS .—Any term that is defined in section 319L and (c) D that is used in this section shall have the same meaning in this section as such term is given in section 319L. UTHORIZATION OF A PPROPRIATIONS .—There are authorized (d) A to be appropriated $1,000,000 to carry out this section for fiscal year 2007 and each fiscal year thereafter. ’ S DISEASE PROGRAM HANSEN EC . 320. ø 247e ¿ (a)(1) At or through the National Hansen’s S Disease Programs Center (located in the State of Louisiana), the Secretary shall without charge provide short-term care and treat- ment, including outpatient care, for Hansen’s disease and related March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00231 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

232 G:\COMP\PHSA\PHSA-MERGED.XML 232 Sec. 320A PUBLIC HEALTH SERVICE ACT complications to any person determined by the Secretary to be in need of such care and treatment. The Secretary may not at or through such Center provide long-term care for any such disease or complication. (2) The Center referred to in paragraph (1) shall conduct train- ing in the diagnosis and management of Hansen’s disease and re- lated complications, and shall conduct and promote the coordina- tion of research (including clinical research), investigations, dem- onstrations, and studies relating to the causes, diagnosis, treat- ment, control, and prevention of Hansen’s disease and other mycobacterial diseases and complications related to such diseases. (3) Paragraph (1) is subject to section 211 of the Department 25 of Health and Human Services Appropriations Act, 1998. (b) In addition to the Center referred to in subsection (a), the Secretary may establish sites regarding persons with Hansen’s dis- ease. Each such site shall provide for the outpatient care and treat- ment for Hansen’s disease and related complications to any person determined by the Secretary to be in need of such care and treat- ment. (c) The Secretary shall carry out subsections (a) and (b) acting through an agency of the Service. For purposes of the preceding sentence, the agency designated by the Secretary shall carry out both activities relating to the provision of health services and ac- tivities relating to the conduct of research. (d) The Secretary shall make payments to the Board of Health of the State of Hawaii for the care and treatment (including out- patient care) in its facilities of persons suffering from Hansen’s dis- ease at a rate determined by the Secretary. The rate shall be ap- proximately equal to the operating cost per patient of such facili- ties, except that the rate may not exceed the comparable costs per patient with Hansen’s disease for care and treatment provided by the Center referred to in subsection (a). Payments under this sub- section are subject to the availability of appropriations for such purpose. COORDINATED PROGRAM TO IMPROVE PEDIATRIC ORAL HEALTH 26 (a) I .—The Secretary, acting ENERAL G S EC . 320A. N ø 247d–8 ¿ through the Administrator of the Health Resources and Services Administration, shall establish a program to fund innovative oral health activities that improve the oral health of children under 6 years of age who are eligible for services provided under a Federal health program, to increase the utilization of dental services by such children, and to decrease the incidence of early childhood and baby bottle tooth decay. (b) G RANTS .—The Secretary shall award grants to or enter into contracts with public or private nonprofit schools of dentistry or ac- credited dental training institutions or programs, community den- tal programs, and programs operated by the Indian Health Service (including federally recognized Indian tribes that receive medical 25 Title II of Public Law 105–78. See 111 Stat. 1477, 1489. 26 The placement of this section in title III was carried out to reflect the probable intent of Congress. Section 1603 of Public Law 106–310 (114 Stat. 1151) provided for an amendment to ‘‘Part B of the Public Health Service Act’’, without specifying which title of this Act was the subject of the amendment. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00232 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

233 G:\COMP\PHSA\PHSA-MERGED.XML 233 Sec. 321 PUBLIC HEALTH SERVICE ACT services from the Indian Health Service, urban Indian health pro- grams funded under title V of the Indian Health Care Improve- ment Act, and tribes that contract with the Indian Health Service pursuant to the Indian Self-Determination and Education Assist- ance Act) to enable such schools, institutions, and programs to de- velop programs of oral health promotion, to increase training of oral health services providers in accordance with State practice laws, or to increase the utilization of dental services by eligible children. .—In awarding grants under this section, the ISTRIBUTION (c) D Secretary shall, to the extent practicable, ensure an equitable na- tional geographic distribution of the grants, including areas of the United States where the incidence of early childhood caries is high- est. (d) A A PPROPRIATIONS .—There is authorized UTHORIZATION OF to be appropriated to carry out this section $10,000,000 for each the fiscal years 2001 through 2005. C—H OSPITALS , M EDICAL E XAMINATIONS , AND M EDICAL C ARE ART P HOSPITALS EC . 321. ø 248 ¿ The Surgeon General, pursuant to regulations, S shall— (a) Control, manage, and operate all institutions, hospitals, and stations of the Service, including minor repairs and main- tenance, and provide for the care, treatment, and hospitaliza- tion of patients, including the furnishing of prosthetic and or- thopedic devices; and from time to time with the approval of the President, select suitable sites for and establish such addi- tional institutions, hospitals, and stations in the States and possessions of the United States as in his judgment are nec- essary to enable the Service to discharge its functions and du- ties; (b) Provide for the transfer of Public Health Service pa- tients, in the care of attendants where necessary, between hos- pitals and stations operated by the Service or between such hospitals and stations and other hospitals and stations in which Public Health Service patients may be received, and the payment of expenses of such transfer; (c) Provide for the disposal of articles produced by patients in the course of their curative treatment, either by allowing the patient to retain such articles or by selling them and depos- iting the money received therefor to the credit of the appropria- tion from which the materials for making the articles were purchased; (d) Provide for the disposal of money and effects, in the custody of the hospitals or stations, of deceased patients; and (e) Provide, to the extent the Surgeon General determines that other public or private funds are not available therefor, for the payment of expenses of preparing and transporting the remains of, or the payment of reasonable burial expenses for, any patient dying in a hospital or station. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00233 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

234 G:\COMP\PHSA\PHSA-MERGED.XML 234 Sec. 322 PUBLIC HEALTH SERVICE ACT CARE AND TREATMENT OF PERSONS UNDER QUARANTINE AND CERTAIN OTHER PERSONS . 322. EC S (a) Any person when detained in accordance ¿ 249 ø with quarantine laws, or, at the request of the Immigration and Naturalization Service, any person detained by that Service, may be treated and cared for by the Public Health Service. (b) Persons not entitled to treatment and care at institutions, hospitals, and stations of the Service may, in accordance with regu- lations of the Surgeon General, be admitted thereto for temporary treatment and care in case of emergency. (c) Persons whose care and treatment is authorized by sub- section (a) may, in accordance with regulations, receive such care and treatment at the expense of the Service from public or private medical or hospital facilities other than those of the Service, when authorized by the officer in charge of the station at which the ap- plication is made. 27 CARE AND TREATMENT OF FEDERAL PRISONERS S . 323. EC The Service shall supervise and furnish med- ¿ 250 ø ical treatment and other necessary medical, psychiatric, and re- lated technical and scientific services, authorized by the Act of May 13, 1930, as amended (U.S.C., 1940 edition, title 18, secs. 751, 28 752), in penal and correctional institutions of the United States. EXAMINATION AND TREATMENT OF FEDERAL EMPLOYEES 251 ø . 324. EC S (a) The Surgeon General is authorized to pro- ¿ vide at institutions, hospitals, and stations of the Service medical, surgical, and hospital services and supplies for persons entitled to 29 treatment under the United States Employees’ Compensation Act and extensions thereof. The Surgeon General may also provide for making medical examinations of— (1) employees of the Federal Government for retirement purposes; (2) employees in Federal classified service, and applicants for appointment, as requested by the Civil Service Commission for the purpose of promoting health and efficiency; (3) seamen for purposes of qualifying for certificates of service; and (4) employees eligible for benefits under the Longshore- men’s and Harbor Workers’ Compensation Act, as amended 30 (U.S.C. 1940 edition, title 33, chapter 18), as requested by any deputy commissioner thereunder. (b) The Secretary is authorized to provide medical, surgical, and dental treatment and hospitalization and optometric care for 27 Title I of the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 2005 (as contained in division B of Public Law 108–447) provided that of the amounts appropriated for salaries and expenses regarding the Federal Prison System ‘‘the Attorney General may transfer to the Health Resources and Services Administration such amounts as may be necessary for direct expenditures by that Administration for medical relief for inmates of Federal penal and correctional institutions’’. (See 118 Stat. 2860.) Similar provi- sions have appeared in the analogous appropriations Act of many prior years. See section 250a of title 42, United States Code, and the notes following such section. 28 Now codified to section 4005 of title 18, United States Code. 29 Codified to chapter 81 of title 5, United States Code. 30 Codification remains chapter 18 of title 33, United States Code. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00234 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

235 G:\COMP\PHSA\PHSA-MERGED.XML 235 Sec. 326 PUBLIC HEALTH SERVICE ACT Federal employees (as defined in section 8901(1) of title 5 of the United States Code) and their dependents at remote medical facili- ties of the Public Health Service where such care and treatment are not otherwise available. Such employees and their dependents who are not entitled to this care and treatment under any other provision of law shall be charged for it at rates established by the Secretary to reflect the reasonable cost of providing the care and treatment. Any payments pursuant to the preceding sentence shall be credited to the applicable appropriation to the Public Health Service for the year in which such payments are received. EXAMINATION OF ALIENS . 325. ø 252 ¿ S EC The Surgeon General shall provide for mak- ing, at places within the United States or in other countries, such physical and mental examinations of aliens as are required by the immigration laws, subject to administrative regulations prescribed by the Attorney General and medical regulations prescribed by the Surgeon General with the approval of the Secretary. COAST AND GEODETIC SURVEY , SERVICES TO COAST GUARD , AND PUBLIC HEALTH SERVICE EC . 326. ø 253 ¿ (a) Subject to regulations of the President— S (1) commissioned officers, chief warrant officers, warrant officers, cadets, and enlisted personnel of the Regular Coast Guard on active duty, including those on shore duty and those on detached duty; and Regular and temporary members of the United States Coast Guard Reserve when on active duty; (2) commissioned officers, ships’ officers, and members of the crews of vessels of the United States Coast and Geodetic Survey on active duty including those on shore duty and those on detached duty; and (3) commissioned officers of the Regular or Reserve Corps of the Public Health Service on active duty; shall be entitled to medical, surgical, and dental treatment and hospitalization by the Service. The Surgeon General may detail commissioned officers for duty aboard vessels of the Coast Guard or the Coast and Geodetic Survey. (b)(1) The Secretary may provide health care for an officer of the Regular or Reserve Corps involuntarily separated from the Service, and for any dependent of such officer, if— (A) the officer or dependent was receiving health care at the expense of the Service at the time of the separation; and (B) the Secretary finds that the officer or dependent is un- able to obtain appropriate insurance for the conditions for which the officer or dependent was receiving health care. (2) Health care may be provided under paragraph (1) for a pe- riod of not more than one year from the date of separation of the officer from the Service. (c) The Service shall provide all services referred to in sub- section (a) required by the Coast Guard or Coast and Geodetic Sur- vey and shall perform all duties prescribed by statute in connection with the examinations to determine physical or mental condition for purposes of appointment, enlistment, and reenlistment, pro- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00235 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

236 G:\COMP\PHSA\PHSA-MERGED.XML 236 Sec. 327 PUBLIC HEALTH SERVICE ACT motion and retirement, and officers of the Service assigned to duty on Coast Guard or Coast and Geodetic Survey vessels may extend aid to the crews of American vessels engaged in deep-sea fishing. INTERDEPARTMENTAL WORK ø 254 . 327. Nothing contained in this part shall affect the EC S ¿ authority of the Service to furnish any materials, supplies, or equipment, or perform any work or services, requested in accord- ance with section 7 of the Act of May 21, 1920, as amended (U.S.C., 1940 edition, title 31, sec. 686), or the authority of any other execu- tive department to furnish any materials, supplies, or equipment, or perform any work or services, requested by the Department of Health, Education, and Welfare for the Service in accordance with that section. SHARING OF MEDICAL CARE FACILITIES AND RESOURCES . 327A. ø 254a EC (a) For purposes of this section— ¿ S (1) the term ‘‘specialized health resources’’ means health care resources (whether equipment, space, or personnel) which, because of cost, limited availability, or unusual nature, are ei- ther unique in the health care community or are subject to maximum utilization only through mutual use; (2) the term ‘‘hospital’’, unless otherwise specified, includes (in addition to other hospitals) any Federal hospital. (b) For the purpose of maintaining or improving the quality of care in Public Health Service facilities and to provide a professional environment therein which will help to attract and retain highly qualified and talented health personnel, to encourage mutually beneficial relationships between Public Health Service facilities and hospitals and other health facilities in the health care commu- nity, and to promote the full utilization of hospitals and other health facilities and resources, the Secretary may— (1) enter into agreements or arrangements with schools of medicine, schools of osteopathic medicine, and with other health professions schools, agencies, or institutions, for such interchange or cooperative use of facilities and services on a re- ciprocal or reimbursable basis, as will be of benefit to the training or research programs of the participating agencies; and (2) enter into agreement or arrangements with hospitals and other health care facilities for the mutual use or the ex- change of use of specialized health resources, and providing for reciprocal reimbursement. Any reimbursement pursuant to any such agreement or arrange- ment shall be based on charges covering the reasonable cost of such utilization, including normal depreciation and amortization costs of equipment. Any proceeds to the Government under this subsection shall be credited to the applicable appropriation of the Public Health Service for the year in which such proceeds are received. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00236 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

237 G:\COMP\PHSA\PHSA-MERGED.XML 237 Sec. 330 PUBLIC HEALTH SERVICE ACT D—P ART EALTH C ARE RIMARY H P Subpart I—Health Centers 254b ¿ HEALTH CENTERS. ø SEC. 330. H EALTH C ENTER .— (a) D EFINITION OF (1) I .—For purposes of this section, the term N GENERAL ‘‘health center’’ means an entity that serves a population that is medically underserved, or a special medically underserved population comprised of migratory and seasonal agricultural workers, the homeless, and residents of public housing, by pro- viding, either through the staff and supporting resources of the center or through contracts or cooperative arrangements— (A) required primary health services (as defined in subsection (b)(1)); and (B) as may be appropriate for particular centers, addi- tional health services (as defined in subsection (b)(2)) nec- essary for the adequate support of the primary health services required under subparagraph (A); for all residents of the area served by the center (hereafter re- ferred to in this section as the ‘‘catchment area’’). (2) L .—The requirement in paragraph (1) to pro- IMITATION vide services for all residents within a catchment area shall not apply in the case of a health center receiving a grant only under subsection (g), (h), or (i). EFINITIONS .—For purposes of this section: (b) D (1) R EQUIRED PRIMARY HEALTH SERVICES .— (A) I N GENERAL .—The term ‘‘required primary health services’’ means— (i) basic health services which, for purposes of this section, shall consist of— (I) health services related to family medicine, internal medicine, pediatrics, obstetrics, or gyne- cology that are furnished by physicians and where appropriate, physician assistants, nurse practi- tioners, and nurse midwives; (II) diagnostic laboratory and radiologic serv- ices; (III) preventive health services, including— (aa) prenatal and perinatal services; (bb) appropriate cancer screening; (cc) well-child services; (dd) immunizations against vaccine-pre- ventable diseases; (ee) screenings for elevated blood lead lev- els, communicable diseases, and cholesterol; (ff) pediatric eye, ear, and dental screenings to determine the need for vision and hearing correction and dental care; (gg) voluntary family planning services; and (hh) preventive dental services; (IV) emergency medical services; and March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00237 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

238 G:\COMP\PHSA\PHSA-MERGED.XML 238 Sec. 330 PUBLIC HEALTH SERVICE ACT (V) pharmaceutical services as may be appro- priate for particular centers; (ii) referrals to providers of medical services (in- cluding specialty referral when medically indicated) and other health-related services (including substance use disorder and mental health services); (iii) patient case management services (including counseling, referral, and follow-up services) and other services designed to assist health center patients in establishing eligibility for and gaining access to Fed- eral, State, and local programs that provide or finan- cially support the provision of medical, social, housing, educational, or other related services; (iv) services that enable individuals to use the services of the health center (including outreach and transportation services and, if a substantial number of the individuals in the population served by a center are of limited English-speaking ability, the services of appropriate personnel fluent in the language spoken by a predominant number of such individuals); and (v) education of patients and the general popu- lation served by the health center regarding the avail- ability and proper use of health services. (B) E XCEPTION .—With respect to a health center that receives a grant only under subsection (g), the Secretary, upon a showing of good cause, shall— (i) waive the requirement that the center provide all required primary health services under this para- graph; and (ii) approve, as appropriate, the provision of cer- tain required primary health services only during cer- tain periods of the year. DDITIONAL HEALTH SERVICES .—The term ‘‘additional (2) A health services’’ means services that are not included as re- quired primary health services and that are appropriate to meet the health needs of the population served by the health center involved. Such term may include— (A) behavioral and mental health and substance use disorder services; (B) recuperative care services; (C) environmental health services, including— (i) the detection and alleviation of unhealthful conditions associated with— (I) water supply; (II) chemical and pesticide exposures; (III) air quality; or (IV) exposure to lead; (ii) sewage treatment; (iii) solid waste disposal; (iv) rodent and parasitic infestation; (v) field sanitation; (vi) housing; and (vii) other environmental factors related to health; and March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00238 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

239 G:\COMP\PHSA\PHSA-MERGED.XML 239 Sec. 330 PUBLIC HEALTH SERVICE ACT (D) in the case of health centers receiving grants under subsection (g), special occupation-related health services for migratory and seasonal agricultural workers, including— (i) screening for and control of infectious diseases, including parasitic diseases; and (ii) injury prevention programs, including preven- tion of exposure to unsafe levels of agricultural chemi- cals including pesticides. (3) M EDICALLY UNDERSERVED POPULATIONS .— (A) I .—The term ‘‘medically underserved N GENERAL population’’ means the population of an urban or rural area designated by the Secretary as an area with a short- age of personal health services or a population group des- ignated by the Secretary as having a shortage of such serv- ices. (B) C RITERIA .—In carrying out subparagraph (A), the Secretary shall prescribe criteria for determining the spe- cific shortages of personal health services of an area or population group. Such criteria shall— (i) take into account comments received by the Secretary from the chief executive officer of a State and local officials in a State; and (ii) include factors indicative of the health status of a population group or residents of an area, the abil- ity of the residents of an area or of a population group to pay for health services and their accessibility to them, and the availability of health professionals to residents of an area or to a population group. IMITATION .—The Secretary may not designate a (C) L medically underserved population in a State or terminate the designation of such a population unless, prior to such designation or termination, the Secretary provides reason- able notice and opportunity for comment and consults with— (i) the chief executive officer of such State; (ii) local officials in such State; and (iii) the organization, if any, which represents a majority of health centers in such State. (D) P ERMISSIBLE DESIGNATION .—The Secretary may designate a medically underserved population that does not meet the criteria established under subparagraph (B) if the chief executive officer of the State in which such pop- ulation is located and local officials of such State rec- ommend the designation of such population based on un- usual local conditions which are a barrier to access to or the availability of personal health services. LANNING RANTS .— G (c) P (1) C ENTERS .—The Secretary may make grants to public and nonprofit private entities for projects to plan and develop health centers which will serve medically underserved popu- lations. A project for which a grant may be made under this subsection may include the cost of the acquisition and lease of buildings and equipment (including the costs of amortizing the March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00239 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

240 G:\COMP\PHSA\PHSA-MERGED.XML 240 Sec. 330 PUBLIC HEALTH SERVICE ACT principal of, and paying the interest on, loans) and shall in- clude— (A) an assessment of the need that the population pro- posed to be served by the health center for which the project is undertaken has for required primary health services and additional health services; (B) the design of a health center program for such pop- ulation based on such assessment; (C) efforts to secure, within the proposed catchment area of such center, financial and professional assistance and support for the project; (D) initiation and encouragement of continuing com- munity involvement in the development and operation of the project; and (E) proposed linkages between the center and other appropriate provider entities, such as health departments, local hospitals, and rural health clinics, to provide better coordinated, higher quality, and more cost-effective health care services. (2) L .—Not more than two grants may be made IMITATION under this subsection for the same project, except that upon a showing of good cause, the Secretary may make additional grant awards. ECOGNITION OF HIGH POVERTY .— (3) R .—In making grants under this sub- (A) I N GENERAL section, the Secretary may recognize the unique needs of high poverty areas. (B) H IGH POVERTY AREA DEFINED .—For purposes of subparagraph (A), the term ‘‘high poverty area’’ means a catchment area which is established in a manner that is consistent with the factors in subsection (k)(3)(J), and the poverty rate of which is greater than the national average poverty rate as determined by the Bureau of the Census. MPROVING UALITY OF C ARE .— (d) I Q .—The Secretary may award (1) S UPPLEMENTAL AWARDS supplemental grant funds to health centers funded under this section to implement evidence-based models for increasing ac- cess to high-quality primary care services, which may include models related to— (A) improving the delivery of care for individuals with multiple chronic conditions; (B) workforce configuration; (C) reducing the cost of care; (D) enhancing care coordination; (E) expanding the use of telehealth and technology-en- abled collaborative learning and capacity building models; (F) care integration, including integration of behav- ioral health, mental health, or substance use disorder serv- ices; and (G) addressing emerging public health or substance use disorder issues to meet the health needs of the popu- lation served by the health center. USTAINABILITY .—In making supplemental awards (2) S under this subsection, the Secretary may consider whether the March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00240 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

241 G:\COMP\PHSA\PHSA-MERGED.XML 241 Sec. 330 PUBLIC HEALTH SERVICE ACT health center involved has submitted a plan for continuing the activities funded under this subsection after supplemental funding is expended. PECIAL CONSIDERATION .—The Secretary may give spe- (3) S cial consideration to applications for supplemental funding under this subsection that seek to address significant barriers to access to care in areas with a greater shortage of health care providers and health services relative to the national average. PERATING .— G RANTS (e) O UTHORITY .— (1) A .—The Secretary may make grants for (A) I N GENERAL the costs of the operation of public and nonprofit private health centers that provide health services to medically underserved populations. NTITIES THAT FAIL TO MEET CERTAIN REQUIRE (B) E - MENTS .—The Secretary may make grants, for a period of not to exceed 1 year, for the costs of the operation of public and nonprofit private entities which provide health serv- ices to medically underserved populations but with respect to which the Secretary is unable to make each of the deter- minations required by subsection (k)(3). The Secretary shall not make a grant under this paragraph unless the applicant provides assurances to the Secretary that within 120 days of receiving grant funding for the operation of the health center, the applicant will submit, for approval by the Secretary, an implementation plan to meet the re- quirements of subsection (k)(3). The Secretary may extend such 120-day period for achieving compliance upon a dem- onstration of good cause by the health center. (C) O PERATION OF NETWORKS .—The Secretary may make grants to health centers that receive assistance under this section, or at the request of the health centers, directly to a network that is at least majority controlled and, as applicable, at least majority owned by such health centers receiving assistance under this section, for the costs associated with the operation of such network includ- ing— (i) the purchase or lease of equipment, which may include data and information systems (including the costs of amortizing the principal of, and paying the in- terest on, loans for equipment); (ii) the provision of training and technical assist- ance; and (iii) other activities that— (I) reduce costs associated with the provision of health services; (II) improve access to, and availability of, health services provided to individuals served by the centers; (III) enhance the quality and coordination of health services; or (IV) improve the health status of commu- nities. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00241 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

242 G:\COMP\PHSA\PHSA-MERGED.XML 242 Sec. 330 PUBLIC HEALTH SERVICE ACT .—The costs for which a grant may be (2) U SE OF FUNDS made under subparagraph (A) or (B) of paragraph (1) may in- clude the costs of acquiring and leasing buildings and equip- ment (including the costs of amortizing the principal of, and paying interest on, loans), and the costs of providing training related to the provision of required primary health services and additional health services and to the management of health center programs. (3) C .—The Secretary may award grants ONSTRUCTION which may be used to pay the costs associated with expanding and modernizing existing buildings or constructing new build- ings (including the costs of amortizing the principal of, and paying the interest on, loans) for projects approved prior to Oc- tober 1, 1996. (4) L IMITATION .—Not more than two grants may be made under subparagraph (B) of paragraph (1) for the same entity. MOUNT (5) A .— (A) I .—The amount of any grant made in N GENERAL any fiscal year under subparagraphs (A) and (B) of para- graph (1) to a health center shall be determined by the Secretary, but may not exceed the amount by which the costs of operation of the center in such fiscal year exceed the total of— (i) State, local, and other operational funding pro- vided to the center; and (ii) the fees, premiums, and third-party reimburse- ments, which the center may reasonably be expected to receive for its operations in such fiscal year. ETWORKS .—The total amount of grant funds (B) N made available for any fiscal year under paragraph (1)(C) to a health center or to a network shall be determined by the Secretary, but may not exceed 2 percent of the total amount appropriated under this section for such fiscal year. (C) P .—Payments under grants under sub- AYMENTS paragraph (A) or (B) of paragraph (1) shall be made in ad- vance or by way of reimbursement and in such install- ments as the Secretary finds necessary and adjustments may be made for overpayments or underpayments. .—Nongrant funds de- (D) U SE OF NONGRANT FUNDS scribed in clauses (i) and (ii) of subparagraph (A), includ- ing any such funds in excess of those originally expected, shall be used as permitted under this section, and may be used for such other purposes as are not specifically prohib- ited under this section if such use furthers the objectives of the project. EW ACCESS POINTS AND EXPANDED SERVICES .— (6) N PPROVAL OF NEW ACCESS POINTS .— (A) A (i) I N GENERAL .—The Secretary may approve ap- plications for grants under subparagraph (A) or (B) of paragraph (1) to establish new delivery sites. PECIAL CONSIDERATION .—In carrying out (ii) S clause (i), the Secretary may give special consideration to applicants that have demonstrated the new delivery March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00242 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

243 G:\COMP\PHSA\PHSA-MERGED.XML 243 Sec. 330 PUBLIC HEALTH SERVICE ACT site will be located within a sparsely populated area, or an area which has a level of unmet need that is higher relative to other applicants. .—In car- ONSIDERATION OF APPLICATIONS (iii) C rying out clause (i), the Secretary shall approve appli- cations for grants in such a manner that the ratio of the medically underserved populations in rural areas which may be expected to use the services provided by the applicants involved to the medically underserved populations in urban areas which may be expected to use the services provided by the applicants is not less than two to three or greater than three to two. .—If in carrying out ERVICE AREA OVERLAP (iv) S clause (i) the applicant proposes to serve an area that is currently served by another health center funded under this section, the Secretary may consider wheth- er the award of funding to an additional health center in the area can be justified based on the unmet need for additional services within the catchment area. (B) A .— PPROVAL OF EXPANDED SERVICE APPLICATIONS N GENERAL .—The Secretary may approve ap- (i) I plications for grants under subparagraph (A) or (B) of paragraph (1) to expand the capacity of the applicant to provide required primary health services described in subsection (b)(1) or additional health services de- scribed in subsection (b)(2). (ii) P RIORITY EXPANSION PROJECTS .—In carrying out clause (i), the Secretary may give special consider- ation to expanded service applications that seek to ad- dress emerging public health or behavioral health, mental health, or substance abuse issues through in- creasing the availability of additional health services described in subsection (b)(2) in an area in which there are significant barriers to accessing care. .—In car- ONSIDERATION OF APPLICATIONS (iii) C rying out clause (i), the Secretary shall approve appli- cations for grants in such a manner that the ratio of the medically underserved populations in rural areas which may be expected to use the services provided by the applicants involved to the medically underserved populations in urban areas which may be expected to use the services provided by such applicants is not less than two to three or greater than three to two. NFANT M ORTALITY G RANTS .— (f) I (1) I .—The Secretary may make grants to N GENERAL health centers for the purpose of assisting such centers in— (A) providing comprehensive health care and support services for the reduction of— (i) the incidence of infant mortality; and (ii) morbidity among children who are less than 3 years of age; and (B) developing and coordinating service and referral arrangements between health centers and other entities March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00243 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

244 G:\COMP\PHSA\PHSA-MERGED.XML 244 Sec. 330 PUBLIC HEALTH SERVICE ACT for the health management of pregnant women and chil- dren described in subparagraph (A). (2) P RIORITY .—In making grants under this subsection the Secretary shall give priority to health centers providing serv- ices to any medically underserved population among which there is a substantial incidence of infant mortality or among which there is a significant increase in the incidence of infant mortality. (3) R EQUIREMENTS .—The Secretary may make a grant under this subsection only if the health center involved agrees that— (A) the center will coordinate the provision of services under the grant to each of the recipients of the services; (B) such services will be continuous for each such re- cipient; (C) the center will provide follow-up services for indi- viduals who are referred by the center for services de- scribed in paragraph (1); (D) the grant will be expended to supplement, and not supplant, the expenditures of the center for primary health services (including prenatal care) with respect to the pur- pose described in this subsection; and (E) the center will coordinate the provision of services with other maternal and child health providers operating in the catchment area. IGRATORY AND S EASONAL A GRICULTURAL W ORKERS .— (g) M (1) I N GENERAL .—The Secretary may award grants for the purposes described in subsections (c), (e), and (f) for the plan- ning and delivery of services to a special medically under- served population comprised of— (A) migratory agricultural workers, seasonal agricul- tural workers, and members of the families of such migra- tory and seasonal agricultural workers who are within a designated catchment area; and (B) individuals who have previously been migratory agricultural workers but who no longer meet the require- ments of subparagraph (A) of paragraph (3) because of age or disability and members of the families of such individ- uals who are within such catchment area. (2) E NVIRONMENTAL CONCERNS .—The Secretary may enter into grants or contracts under this subsection with public and private entities to— (A) assist the States in the implementation and en- forcement of acceptable environmental health standards, including enforcement of standards for sanitation in mi- gratory agricultural worker and seasonal agricultural worker labor camps, and applicable Federal and State pes- ticide control standards; and (B) conduct projects and studies to assist the several States and entities which have received grants or contracts under this section in the assessment of problems related to camp and field sanitation, exposure to unsafe levels of ag- ricultural chemicals including pesticides, and other envi- ronmental health hazards to which migratory agricultural March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00244 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

245 G:\COMP\PHSA\PHSA-MERGED.XML 245 Sec. 330 PUBLIC HEALTH SERVICE ACT workers and seasonal agricultural workers, and members of their families, are exposed. EFINITIONS (3) D .—For purposes of this subsection: (A) M .—The term IGRATORY AGRICULTURAL WORKER ‘‘migratory agricultural worker’’ means an individual whose principal employment is in agriculture, who has been so employed within the last 24 months, and who es- tablishes for the purposes of such employment a temporary abode. (B) S EASONAL AGRICULTURAL WORKER .—The term ‘‘sea- sonal agricultural worker’’ means an individual whose principal employment is in agriculture on a seasonal basis and who is not a migratory agricultural worker. (C) A GRICULTURE .—The term ‘‘agriculture’’ means farming in all its branches, including— (i) cultivation and tillage of the soil; (ii) the production, cultivation, growing, and har- vesting of any commodity grown on, in, or as an ad- junct to or part of a commodity grown in or on, the land; and (iii) any practice (including preparation and proc- essing for market and delivery to storage or to market or to carriers for transportation to market) performed by a farmer or on a farm incident to or in conjunction with an activity described in clause (ii). P OPULATION .— OMELESS (h) H N GENERAL .—The Secretary may award grants for the (1) I purposes described in subsections (c), (e), and (f) for the plan- ning and delivery of services to a special medically under- served population comprised of homeless individuals, including grants for innovative programs that provide outreach and com- prehensive primary health services to homeless children and youth, children and youth at risk of homelessness, homeless veterans, and veterans at risk of homelessness. (2) R EQUIRED SERVICES .—In addition to required primary health services (as defined in subsection (b)(1)), an entity that receives a grant under this subsection shall be required to pro- vide substance abuse services as a condition of such grant. .—A grant UPPLEMENT NOT SUPPLANT REQUIREMENT (3) S awarded under this subsection shall be expended to supple- ment, and not supplant, the expenditures of the health center and the value of in kind contributions for the delivery of serv- ices to the population described in paragraph (1). EMPORARY CONTINUED PROVISION OF SERVICES TO CER - (4) T .—If any grantee under TAIN FORMER HOMELESS INDIVIDUALS this subsection has provided services described in this section under the grant to a homeless individual, such grantee may, notwithstanding that the individual is no longer homeless as a result of becoming a resident in permanent housing, expend the grant to continue to provide such services to the individual for not more than 12 months. EFINITIONS .—For purposes of this section: (5) D OMELESS INDIVIDUAL .—The term ‘‘homeless indi- (A) H vidual’’ means an individual who lacks housing (without March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00245 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

246 G:\COMP\PHSA\PHSA-MERGED.XML 246 Sec. 330 PUBLIC HEALTH SERVICE ACT regard to whether the individual is a member of a family), including an individual whose primary residence during the night is a supervised public or private facility that pro- vides temporary living accommodations and an individual who is a resident in transitional housing. (B) S UBSTANCE USE DISORDER SERVICES .—The term 31 ‘‘substance abuse services’’ includes detoxification, risk reduction, outpatient treatment, residential treatment, and 31 rehabilitation for substance abuse provided in settings other than hospitals. ESIDENTS OF P UBLIC H OUSING .— (i) R N GENERAL (1) I .—The Secretary may award grants for the purposes described in subsections (c), (e), and (f) for the plan- ning and delivery of services to a special medically under- served population comprised of residents of public housing (such term, for purposes of this subsection, shall have the same meaning given such term in section 3(b)(1) of the United States Housing Act of 1937) and individuals living in areas imme- diately accessible to such public housing. (2) S .—A grant awarded under UPPLEMENT NOT SUPPLANT this subsection shall be expended to supplement, and not sup- plant, the expenditures of the health center and the value of in kind contributions for the delivery of services to the popu- lation described in paragraph (1). (3) C ONSULTATION WITH RESIDENTS .—The Secretary may not make a grant under paragraph (1) unless, with respect to the residents of the public housing involved, the applicant for the grant— (A) has consulted with the residents in the prepara- tion of the application for the grant; and (B) agrees to provide for ongoing consultation with the residents regarding the planning and administration of the program carried out with the grant. (j) A CCESS G RANTS .— (1) I .—The Secretary may award grants to eligi- N GENERAL ble health centers with a substantial number of clients with limited English speaking proficiency to provide translation, in- terpretation, and other such services for such clients with lim- ited English speaking proficiency. (2) E LIGIBLE HEALTH CENTER .—In this subsection, the term ‘‘eligible health center’’ means an entity that— (A) is a health center as defined under subsection (a); (B) provides health care services for clients for whom English is a second language; and (C) has exceptional needs with respect to linguistic ac- cess or faces exceptional challenges with respect to lin- guistic access. RANT AMOUNT .—The amount of a grant awarded to a (3) G center under this subsection shall be determined by the Ad- ministrator. Such determination of such amount shall be based on the number of clients for whom English is a second lan- 31 Section 50901(b)(8)(B)(iii)(II) of division E of Public Law 115–123 provides for an amend- ment to strike ‘‘abuse’’ and insert ‘‘use disorder’’. The term ‘‘abuse’’ appears twice and, as such, the amendment has not been carried out above. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00246 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

247 G:\COMP\PHSA\PHSA-MERGED.XML 247 Sec. 330 PUBLIC HEALTH SERVICE ACT guage that is served by such center, and larger grant amounts shall be awarded to centers serving larger numbers of such cli- ents. (4) U SE OF FUNDS .—An eligible health center that receives a grant under this subsection may use funds received through such grant to— (A) provide translation, interpretation, and other such services for clients for whom English is a second language, including hiring professional translation and interpreta- tion services; and (B) compensate bilingual or multilingual staff for lan- guage assistance services provided by the staff for such cli- ents. (5) A PPLICATION .—An eligible health center desiring a grant under this subsection shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require, includ- ing— (A) an estimate of the number of clients that the cen- ter serves for whom English is a second language; (B) the ratio of the number of clients for whom English is a second language to the total number of clients served by the center; (C) a description of any language assistance services that the center proposes to provide to aid clients for whom English is a second language; and (D) a description of the exceptional needs of such cen- ter with respect to linguistic access or a description of the exceptional challenges faced by such center with respect to linguistic access. (6) A .—There are author- UTHORIZATION OF APPROPRIATIONS ized to be appropriated to carry out this subsection, in addition to any funds authorized to be appropriated or appropriated for health centers under any other subsection of this section, such sums as may be necessary for each of fiscal years 2002 through 2006. (k) A PPLICATIONS .— .—No grant may be made under this sec- (1) S UBMISSION tion unless an application therefore is submitted to, and ap- proved by, the Secretary. Such an application shall be sub- mitted in such form and manner and shall contain such infor- mation as the Secretary shall prescribe. ESCRIPTION OF UNMET NEED .—An application for a (2) D grant under subparagraph (A) or (B) of subsection (e)(1) or sub- section (e)(6) for a health center shall include— (A) a description of the unmet need for health services in the catchment area of the center; (B) a demonstration by the applicant that the area or the population group to be served by the applicant has a shortage of personal health services; (C) a demonstration that the center will be located so that it will provide services to the greatest number of indi- viduals residing in the catchment area or included in such population group; and March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00247 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

248 G:\COMP\PHSA\PHSA-MERGED.XML 248 Sec. 330 PUBLIC HEALTH SERVICE ACT (D) in the case of an application for a grant pursuant to subsection (e)(6), a demonstration that the applicant has consulted with appropriate State and local government agencies, and health care providers regarding the need for the health services to be provided at the proposed delivery site. Such a demonstration shall be made on the basis of the criteria prescribed by the Secretary under subsection (b)(3) or on any other criteria which the Secretary may prescribe to determine if the area or population group to be served by the applicant has a shortage of personal health services. In considering an application for a grant under subparagraph (A) or (B) of sub- section (e)(1), the Secretary may require as a condition to the approval of such application an assurance that the applicant will provide any health service defined under paragraphs (1) and (2) of subsection (b) that the Secretary finds is needed to meet specific health needs of the area to be served by the ap- plicant. Such a finding shall be made in writing and a copy shall be provided to the applicant. (3) R EQUIREMENTS .—Except as provided in subsection (e)(1)(B) or subsection (e)(6), the Secretary may not approve an application for a grant under subparagraph (A) or (B) of sub- section (e)(1) unless the Secretary determines that the entity for which the application is submitted is a health center (with- in the meaning of subsection (a)) and that— (A) the required primary health services of the center will be available and accessible in the catchment area of the center promptly, as appropriate, and in a manner which assures continuity; (B) the center has made and will continue to make every reasonable effort to establish and maintain collabo- rative relationships with other health care providers, in- cluding other health care providers that provide care with- in the catchment area, local hospitals, and specialty pro- viders in the catchment area of the center, to provide ac- cess to services not available through the health center and to reduce the non-urgent use of hospital emergency departments; (C) the center will have an ongoing quality improve- ment system that includes clinical services and manage- ment, and that maintains the confidentiality of patient records; (D) the center will demonstrate its financial responsi- bility by the use of such accounting procedures and other requirements as may be prescribed by the Secretary; (E) the center— (i)(I) has or will have a contractual or other ar- rangement with the agency of the State, in which it provides services, which administers or supervises the administration of a State plan approved under title XIX of the Social Security Act for the payment of all or a part of the center’s costs in providing health serv- ices to persons who are eligible for medical assistance under such a State plan; and March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00248 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

249 G:\COMP\PHSA\PHSA-MERGED.XML 249 Sec. 330 PUBLIC HEALTH SERVICE ACT 32 (II) has or will have a contractual or other arrangement with the State agency administering the program under title XXI of such Act (42 U.S.C. 1397aa et seq.) with respect to individuals who are State children’s health insurance program beneficiaries; or (ii) has made or will make every reasonable effort to enter into arrangements described in subclauses (I) and (II) of clause (i); (F) the center has made or will make and will con- tinue to make every reasonable effort to collect appropriate reimbursement for its costs in providing health services to persons who are entitled to insurance benefits under title XVIII of the Social Security Act, to medical assistance under a State plan approved under title XIX of such Act, or to assistance for medical expenses under any other pub- lic assistance program or private health insurance pro- gram; (G) the center— (i) has prepared a schedule of fees or payments for the provision of its services consistent with locally pre- vailing rates or charges and designed to cover its rea- sonable costs of operation and has prepared a cor- responding schedule of discounts to be applied to the payment of such fees or payments, which discounts are adjusted on the basis of the patient’s ability to pay; (ii) has made and will continue to make every rea- sonable effort— (I) to secure from patients payment for serv- ices in accordance with such schedules; and (II) to collect reimbursement for health serv- ices to persons described in subparagraph (F) on the basis of the full amount of fees and payments for such services without application of any dis- count; (iii)(I) will assure that no patient will be denied health care services due to an individual’s inability to pay for such services; and (II) will assure that any fees or payments required by the center for such services will be reduced or waived to enable the center to fulfill the assurance de- scribed in subclause (I); and (iv) has submitted to the Secretary such reports as the Secretary may require to determine compliance with this subparagraph; (H) the center has established a governing board which except in the case of an entity operated by an In- dian tribe or tribal or Indian organization under the In- dian Self-Determination Act or an urban Indian organiza- tion under the Indian Health Care Improvement Act (25 U.S.C. 1651 et seq.)— 32 Indentation is so in law. See section 101(7)(A)(i)(III) of Public Law 107–251 (116 Stat. 225). March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00249 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

250 G:\COMP\PHSA\PHSA-MERGED.XML 250 Sec. 330 PUBLIC HEALTH SERVICE ACT (i) is composed of individuals, a majority of whom are being served by the center and who, as a group, represent the individuals being served by the center; (ii) meets at least once a month, selects the serv- ices to be provided by the center, schedules the hours during which such services will be provided, approves the center’s annual budget, approves the selection of a director for the center who shall be directly employed by the center, and, except in the case of a governing board of a public center (as defined in the second sen- tence of this paragraph), establishes general policies for the center; and (iii) in the case of an application for a second or subsequent grant for a public center, has approved the application or if the governing body has not approved the application, the failure of the governing body to approve the application was unreasonable; except that, upon a showing of good cause the Secretary shall waive, for the length of the project period, all or part of the requirements of this subparagraph in the case of a health center that receives a grant pursuant to subsection (g), (h), (i), or (p); (I) the center has developed— (i) an overall plan and budget that meets the re- quirements of the Secretary; and (ii) an effective procedure for compiling and re- porting to the Secretary such statistics and other in- formation as the Secretary may require relating to— (I) the costs of its operations; (II) the patterns of use of its services; (III) the availability, accessibility, and accept- ability of its services; and (IV) such other matters relating to operations of the applicant as the Secretary may require; (J) the center will review periodically its catchment area to— (i) ensure that the size of such area is such that the services to be provided through the center (includ- ing any satellite) are available and accessible to the residents of the area promptly and as appropriate; (ii) ensure that the boundaries of such area con- form, to the extent practicable, to relevant boundaries of political subdivisions, school districts, and Federal and State health and social service programs; and (iii) ensure that the boundaries of such area elimi- nate, to the extent possible, barriers to access to the services of the center, including barriers resulting from the area’s physical characteristics, its residential patterns, its economic and social grouping, and avail- able transportation; (K) in the case of a center which serves a population including a substantial proportion of individuals of limited English-speaking ability, the center has— March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00250 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

251 G:\COMP\PHSA\PHSA-MERGED.XML 251 Sec. 330 PUBLIC HEALTH SERVICE ACT (i) developed a plan and made arrangements re- sponsive to the needs of such population for providing services to the extent practicable in the language and cultural context most appropriate to such individuals; and (ii) identified an individual on its staff who is flu- ent in both that language and in English and whose responsibilities shall include providing guidance to such individuals and to appropriate staff members with respect to cultural sensitivities and bridging lin- guistic and cultural differences; (L) the center, has developed an ongoing referral rela- tionship with one or more hospitals; (M) the center encourages persons receiving or seeking health services from the center to participate in any public or private (including employer-offered) health programs or plans for which the persons are eligible, so long as the cen- ter, in complying with this subparagraph, does not violate the requirements of subparagraph (G)(iii)(I); and (N) the center has written policies and procedures in place to ensure the appropriate use of Federal funds in compliance with applicable Federal statutes, regulations, and the terms and conditions of the Federal award. For purposes of subparagraph (H), the term ‘‘public center’’ means a health center funded (or to be funded) through a grant under this section to a public agency. A SSISTANCE .—The Secretary shall establish a ECHNICAL (l) T program through which the Secretary shall provide (either through the Department of Health and Human Services or by grant or con- tract) technical and other assistance to eligible entities to assist such entities to meet the requirements of subsection (k)(3). Services provided through the program may include necessary technical and nonfinancial assistance, including fiscal and program management assistance, training in fiscal and program management, operational and administrative support, and the provision of information to the entities of the variety of resources available under this title and how those resources can be best used to meet the health needs of the communities served by the entities. Funds expended to carry out activities under this subsection and operational support activi- ties under subsection (m) shall not exceed 3 percent of the amount appropriated for this section for the fiscal year involved. (m) M EMORANDUM OF A GREEMENT .—In carrying out this sec- tion, the Secretary may enter into a memorandum of agreement with a State. Such memorandum may include, where appropriate, provisions permitting such State to— (1) analyze the need for primary health services for medi- cally underserved populations within such State; (2) assist in the planning and development of new health centers; (3) review and comment upon annual program plans and budgets of health centers, including comments upon allocations of health care resources in the State; (4) assist health centers in the development of clinical practices and fiscal and administrative systems through a tech- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00251 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

252 G:\COMP\PHSA\PHSA-MERGED.XML 252 Sec. 330 PUBLIC HEALTH SERVICE ACT nical assistance plan which is responsive to the requests of health centers; and (5) share information and data relevant to the operation of new and existing health centers. ECORDS .— (n) R (1) I .—Each entity which receives a grant under N GENERAL subsection (e) shall establish and maintain such records as the Secretary shall require. .—Each entity which is required to estab- VAILABILITY (2) A lish and maintain records under this subsection shall make such books, documents, papers, and records available to the Secretary or the Comptroller General of the United States, or any of their duly authorized representatives, for examination, copying or mechanical reproduction on or off the premises of such entity upon a reasonable request therefore. The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have the authority to conduct such examination, copying, and reproduction. A UTHORITY .—The Secretary may delegate ELEGATION OF (o) D the authority to administer the programs authorized by this section to any office, except that the authority to enter into, modify, or issue approvals with respect to grants or contracts may be dele- gated only within the central office of the Health Resources and Services Administration. (p) S C ONSIDERATION .—In making grants under this sec- PECIAL tion, the Secretary shall give special consideration to the unique needs of sparsely populated rural areas, including giving priority in the awarding of grants for new health centers under subsections (c) and (e), and the granting of waivers as appropriate and permitted under subsections (b)(1)(B)(i) and (k)(3)(G). UDITS .— (q) A N GENERAL .—Each entity which receives a grant under (1) I this section shall provide for an independent annual financial audit of any books, accounts, financial records, files, and other papers and property which relate to the disposition or use of the funds received under such grant and such other funds re- ceived by or allocated to the project for which such grant was made. For purposes of assuring accurate, current, and complete disclosure of the disposition or use of the funds received, each such audit shall be conducted in accordance with generally ac- cepted accounting principles. Each audit shall evaluate— (A) the entity’s implementation of the guidelines es- tablished by the Secretary respecting cost accounting, (B) the processes used by the entity to meet the finan- cial and program reporting requirements of the Secretary, and (C) the billing and collection procedures of the entity and the relation of the procedures to its fee schedule and schedule of discounts and to the availability of health in- surance and public programs to pay for the health services it provides. A report of each such audit shall be filed with the Secretary at such time and in such manner as the Secretary may require. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00252 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

253 G:\COMP\PHSA\PHSA-MERGED.XML 253 Sec. 330 PUBLIC HEALTH SERVICE ACT .—Each entity which receives a grant under ECORDS (2) R this section shall establish and maintain such records as the Secretary shall by regulation require to facilitate the audit re- quired by paragraph (1). The Secretary may specify by regula- tion the form and manner in which such records shall be estab- lished and maintained. VAILABILITY OF RECORDS .—Each entity which is re- (3) A quired to establish and maintain records or to provide for and audit under this subsection shall make such books, documents, papers, and records available to the Secretary or the Comp- troller General of the United States, or any of their duly au- thorized representatives, for examination, copying or mechan- ical reproduction on or off the premises of such entity upon a reasonable request therefore. The Secretary and the Comp- troller General of the United States, or any of their duly au- thorized representatives, shall have the authority to conduct such examination, copying, and reproduction. .—The Secretary may, under appropriate cir- AIVER (4) W cumstances, waive the application of all or part of the require- ments of this subsection with respect to an entity. A waiver provided by the Secretary under this paragraph may not re- main in effect for more than 1 year and may not be extended after such period. An entity may not receive more than one waiver under this paragraph in consecutive years. (r) A A PPROPRIATIONS .— UTHORIZATION OF ENERAL AMOUNTS FOR GRANTS .—For the purpose of (1) G carrying out this section, in addition to the amounts authorized to be appropriated under subsection (d), there is authorized to be appropriated the following: (A) For fiscal year 2010, $2,988,821,592. (B) For fiscal year 2011, $3,862,107,440. (C) For fiscal year 2012, $4,990,553,440. (D) For fiscal year 2013, $6,448,713,307. (E) For fiscal year 2014, $7,332,924,155. (F) For fiscal year 2015, $8,332,924,155. (G) For fiscal year 2016, and each subsequent fiscal year, the amount appropriated for the preceding fiscal year adjusted by the product of— (i) one plus the average percentage increase in costs incurred per patient served; and (ii) one plus the average percentage increase in the total number of patients served. PECIAL PROVISIONS .— (2) S (A) P .—The Secretary may not expend UBLIC CENTERS in any fiscal year, for grants under this section to public centers (as defined in the second sentence of subsection (k)(3)) the governing boards of which (as described in sub- section (k)(3)(H)) do not establish general policies for such centers, an amount which exceeds 5 percent of the amounts appropriated under this section for that fiscal year. For purposes of applying the preceding sentence, the term ‘‘public centers’’ shall not include health centers that receive grants pursuant to subsection (h) or (i). March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00253 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

254 G:\COMP\PHSA\PHSA-MERGED.XML 254 Sec. 330 PUBLIC HEALTH SERVICE ACT .—For fiscal year 2002 (B) D ISTRIBUTION OF GRANTS and each of the following fiscal years, the Secretary, in awarding grants under this section, shall ensure that the proportion of the amount made available under each of subsections (g), (h), and (i), relative to the total amount ap- propriated to carry out this section for that fiscal year, is equal to the proportion of the amount made available under that subsection for fiscal year 2001, relative to the total amount appropriated to carry out this section for fis- cal year 2001. (3) F .—The Secretary shall annually pre- UNDING REPORT pare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on En- ergy and Commerce of the House of Representatives, a report including, at a minimum— (A) the distribution of funds for carrying out this sec- tion that are provided to meet the health care needs of medically underserved populations, including the home- less, residents of public housing, and migratory and sea- sonal agricultural workers, and the appropriateness of the delivery systems involved in responding to the needs of the particular populations; (B) an assessment of the relative health care access needs of the targeted populations; (C) the distribution of awards and funding for new or expanded services in each of rural areas and urban areas; (D) the distribution of awards and funding for estab- lishing new access points, and the number of new access points created; (E) the amount of unexpended funding for loan guar- antees and loan guarantee authority under title XVI; (F) the rationale for any substantial changes in the distribution of funds; (G) the rate of closures for health centers and access points; (H) the number and reason for any grants awarded pursuant to subsection (e)(1)(B); and (I) the number and reason for any waivers provided pursuant to subsection (q)(4). (4) R ULE OF CONSTRUCTION WITH RESPECT TO RURAL .— HEALTH CLINICS (A) I N GENERAL .—Nothing in this section shall be con- strued to prevent a community health center from con- tracting with a Federally certified rural health clinic (as defined in section 1861(aa)(2) of the Social Security Act), a low-volume hospital (as defined for purposes of section 1886 of such Act), a critical access hospital, a sole commu- nity hospital (as defined for purposes of section 1886(d)(5)(D)(iii) of such Act), or a medicare-dependent share hospital (as defined for purposes of section 1886(d)(5)(G)(iv) of such Act) for the delivery of primary health care services that are available at the clinic or hos- pital to individuals who would otherwise be eligible for free or reduced cost care if that individual were able to ob- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00254 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

255 G:\COMP\PHSA\PHSA-MERGED.XML 255 Sec. 330A PUBLIC HEALTH SERVICE ACT tain that care at the community health center. Such serv- ices may be limited in scope to those primary health care services available in that clinic or hospitals. (B) A .—In order for a clinic or hospital to SSURANCES receive funds under this section through a contract with a community health center under subparagraph (A), such clinic or hospital shall establish policies to ensure— (i) nondiscrimination based on the ability of a pa- tient to pay; and (ii) the establishment of a sliding fee scale for low- income patients. (5) F UNDING FOR PARTICIPATION OF HEALTH CENTERS IN ALL OF US RESEARCH PROGRAM .—In addition to any amounts made available pursuant to paragraph (1) of this subsection, section 402A of this Act, or section 10503 of the Patient Protec- tion and Affordable Care Act, there is authorized to be appro- priated, and there is appropriated, out of any monies in the Treasury not otherwise appropriated, to the Secretary $25,000,000 for fiscal year 2018 to support the participation of health centers in the All of Us Research Program under the Precision Medicine Initiative under section 498E of this Act. 254c RURAL HEALTH CARE SERVICES OUTREACH, RURAL SEC. 330A. ¿ ø HEALTH NETWORK DEVELOPMENT, AND SMALL HEALTH CARE PROVIDER QUALITY IMPROVEMENT GRANT PRO- GRAMS. .—The purpose of this section is to provide grants (a) P URPOSE for expanded delivery of health care services in rural areas, for the planning and implementation of integrated health care networks in rural areas, and for the planning and implementation of small health care provider quality improvement activities. (b) D EFINITIONS .— IRECTOR .—The term ‘‘Director’’ means the Director (1) D specified in subsection (d). (2) F RURAL HEALTH EDERALLY QUALIFIED HEALTH CENTER ; CLINIC .—The terms ‘‘Federally qualified health center’’ and ‘‘rural health clinic’’ have the meanings given the terms in sec- tion 1861(aa) of the Social Security Act (42 U.S.C. 1395x(aa)). (3) H EALTH PROFESSIONAL SHORTAGE AREA .—The term ‘‘health professional shortage area’’ means a health profes- sional shortage area designated under section 332. (4) M UNDERSERVED COMMUNITY .—The term EDICALLY ‘‘medically underserved community’’ has the meaning given the term in section 799B(6). EDICALLY UNDERSERVED POPULATION .—The term (5) M ‘‘medically underserved population’’ has the meaning given the term in section 330(b)(3). ROGRAM .—The Secretary shall establish, under section (c) P 301, a small health care provider quality improvement grant pro- gram. (d) A DMINISTRATION .— ROGRAMS .—The rural health care services outreach, (1) P rural health network development, and small health care pro- vider quality improvement grant programs established under section 301 shall be administered by the Director of the Office March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00255 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

256 G:\COMP\PHSA\PHSA-MERGED.XML 256 Sec. 330A PUBLIC HEALTH SERVICE ACT of Rural Health Policy of the Health Resources and Services Administration, in consultation with State offices of rural health or other appropriate State government entities. (2) G RANTS .— N GENERAL .—In carrying out the programs de- (A) I scribed in paragraph (1), the Director may award grants under subsections (e), (f), and (g) to expand access to, co- ordinate, and improve the quality of essential health care services, and enhance the delivery of health care, in rural areas. (B) T .—The Director may award the YPES OF GRANTS grants— (i) to promote expanded delivery of health care services in rural areas under subsection (e); (ii) to provide for the planning and implementa- tion of integrated health care networks in rural areas under subsection (f); and (iii) to provide for the planning and implementa- tion of small health care provider quality improvement activities under subsection (g). H EALTH C ARE S URAL O UTREACH G RANTS .— ERVICES (e) R (1) G .—The Director may award grants to eligible RANTS entities to promote rural health care services outreach by ex- panding the delivery of health care services to include new and enhanced services in rural areas. The Director may award the grants for periods of not more than 3 years. (2) E LIGIBILITY .—To be eligible to receive a grant under this subsection for a project, an entity— (A) shall be a rural public or rural nonprofit private entity; (B) shall represent a consortium composed of mem- bers— (i) that include 3 or more health care providers; and (ii) that may be nonprofit or for-profit entities; and (C) shall not previously have received a grant under this subsection for the same or a similar project, unless the entity is proposing to expand the scope of the project or the area that will be served through the project. (3) A PPLICATIONS .—To be eligible to receive a grant under this subsection, an eligible entity, in consultation with the ap- propriate State office of rural health or another appropriate State entity, shall prepare and submit to the Secretary an ap- plication, at such time, in such manner, and containing such information as the Secretary may require, including— (A) a description of the project that the eligible entity will carry out using the funds provided under the grant; (B) a description of the manner in which the project funded under the grant will meet the health care needs of rural underserved populations in the local community or region to be served; March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00256 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

257 G:\COMP\PHSA\PHSA-MERGED.XML 257 Sec. 330A PUBLIC HEALTH SERVICE ACT (C) a description of how the local community or region to be served will be involved in the development and ongo- ing operations of the project; (D) a plan for sustaining the project after Federal sup- port for the project has ended; (E) a description of how the project will be evaluated; and (F) other such information as the Secretary deter- mines to be appropriate. (f) R EALTH N ETWORK D EVELOPMENT G RANTS .— URAL H .— (1) G RANTS .—The Director may award rural (A) I N GENERAL health network development grants to eligible entities to promote, through planning and implementation, the devel- opment of integrated health care networks that have com- bined the functions of the entities participating in the net- works in order to— (i) achieve efficiencies; (ii) expand access to, coordinate, and improve the quality of essential health care services; and (iii) strengthen the rural health care system as a whole. (B) G .—The Director may award such a RANT PERIODS rural health network development grant for implementa- tion activities for a period of 3 years. The Director may also award such a rural health network development grant for planning activities for a period of 1 year, to assist in the development of an integrated health care network, if the proposed participants in the network do not have a history of collaborative efforts and a 3-year grant would be inappropriate. LIGIBILITY .—To be eligible to receive a grant under (2) E this subsection, an entity— (A) shall be a rural public or rural nonprofit private entity; (B) shall represent a network composed of partici- pants— (i) that include 3 or more health care providers; and (ii) that may be nonprofit or for-profit entities; and (C) shall not previously have received a grant under this subsection (other than a grant for planning activities) for the same or a similar project. (3) A PPLICATIONS .—To be eligible to receive a grant under this subsection, an eligible entity, in consultation with the ap- propriate State office of rural health or another appropriate State entity, shall prepare and submit to the Secretary an ap- plication, at such time, in such manner, and containing such information as the Secretary may require, including— (A) a description of the project that the eligible entity will carry out using the funds provided under the grant; (B) an explanation of the reasons why Federal assist- ance is required to carry out the project; March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00257 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

258 G:\COMP\PHSA\PHSA-MERGED.XML 258 Sec. 330A PUBLIC HEALTH SERVICE ACT (C) a description of— (i) the history of collaborative activities carried out by the participants in the network; (ii) the degree to which the participants are ready to integrate their functions; and (iii) how the local community or region to be served will benefit from and be involved in the activi- ties carried out by the network; (D) a description of how the local community or region to be served will experience increased access to quality health care services across the continuum of care as a re- sult of the integration activities carried out by the net- work; (E) a plan for sustaining the project after Federal sup- port for the project has ended; (F) a description of how the project will be evaluated; and (G) other such information as the Secretary deter- mines to be appropriate. UALITY EALTH C ARE P ROVIDER Q H I MPROVEMENT MALL (g) S RANTS .— G RANTS .—The Director may award grants to provide (1) G for the planning and implementation of small health care pro- vider quality improvement activities. The Director may award the grants for periods of 1 to 3 years. (2) E LIGIBILITY .—To be eligible for a grant under this sub- section, an entity— (A)(i) shall be a rural public or rural nonprofit private health care provider or provider of health care services, such as a critical access hospital or a rural health clinic; or (ii) shall be another rural provider or network of small rural providers identified by the Secretary as a key source of local care; and (B) shall not previously have received a grant under this subsection for the same or a similar project. PPLICATIONS .—To be eligible to receive a grant under (3) A this subsection, an eligible entity, in consultation with the ap- propriate State office of rural health or another appropriate State entity shall prepare and submit to the Secretary an ap- plication, at such time, in such manner, and containing such information as the Secretary may require, including— (A) a description of the project that the eligible entity will carry out using the funds provided under the grant; (B) an explanation of the reasons why Federal assist- ance is required to carry out the project; (C) a description of the manner in which the project funded under the grant will assure continuous quality im- provement in the provision of services by the entity; (D) a description of how the local community or region to be served will experience increased access to quality health care services across the continuum of care as a re- sult of the activities carried out by the entity; March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00258 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

259 G:\COMP\PHSA\PHSA-MERGED.XML 259 Sec. 330A–1 PUBLIC HEALTH SERVICE ACT (E) a plan for sustaining the project after Federal sup- port for the project has ended; (F) a description of how the project will be evaluated; and (G) other such information as the Secretary deter- mines to be appropriate. (4) E XPENDITURES FOR SMALL HEALTH CARE PROVIDER QUALITY IMPROVEMENT GRANTS .—In awarding a grant under this subsection, the Director shall ensure that the funds made available through the grant will be used to provide services to residents of rural areas. The Director shall award not less than 50 percent of the funds made available under this subsection to providers located in and serving rural areas. (h) G ENERAL R EQUIREMENTS .— (1) P ROHIBITED USES OF FUNDS .—An entity that receives a grant under this section may not use funds provided through the grant— (A) to build or acquire real property; or (B) for construction. .—The Secretary OORDINATION WITH OTHER AGENCIES (2) C shall coordinate activities carried out under grant programs described in this section, to the extent practicable, with Fed- eral and State agencies and nonprofit organizations that are operating similar grant programs, to maximize the effect of public dollars in funding meritorious proposals. .—In awarding grants under this section, REFERENCE (3) P the Secretary shall give preference to entities that— (A) are located in health professional shortage areas or medically underserved communities, or serve medically un- derserved populations; or (B) propose to develop projects with a focus on primary care, and wellness and prevention strategies. EPORT (i) R .—Not later than September 30, 2005, the Secretary shall prepare and submit to the appropriate committees of Con- gress a report on the progress and accomplishments of the grant programs described in subsections (e), (f), and (g). UTHORIZATION OF A PPROPRIATIONS .—There are authorized (j) A to be appropriated to carry out this section $45,000,000 for each of fiscal years 2008 through 2012. 254c–1a ¿ GRANTS TO NURSE–MANAGED HEALTH CLINICS. ø SEC. 330A–1. (a) D EFINITIONS .— (1) C .—In OMPREHENSIVE PRIMARY HEALTH CARE SERVICES this section, the term ‘‘comprehensive primary health care services’’ means the primary health services described in sec- tion 330(b)(1). URSE MANAGED HEALTH CLINIC .—The term ‘‘nurse- - (2) N managed health clinic’’ means a nurse-practice arrangement, managed by advanced practice nurses, that provides primary care or wellness services to underserved or vulnerable popu- lations and that is associated with a school, college, university or department of nursing, federally qualified health center, or independent nonprofit health or social services agency. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00259 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

260 G:\COMP\PHSA\PHSA-MERGED.XML 260 Sec. 330B PUBLIC HEALTH SERVICE ACT .—The Secretary shall award RANTS G (b) A UTHORITY TO A WARD grants for the cost of the operation of nurse-managed health clinics that meet the requirements of this section. (c) A PPLICATIONS .—To be eligible to receive a grant under this section, an entity shall— (1) be an NMHC; and (2) submit to the Secretary an application at such time, in such manner, and containing— (A) assurances that nurses are the major providers of services at the NMHC and that at least 1 advanced prac- tice nurse holds an executive management position within the organizational structure of the NMHC; (B) an assurance that the NMHC will continue pro- viding comprehensive primary health care services or wellness services without regard to income or insurance status of the patient for the duration of the grant period; and (C) an assurance that, not later than 90 days of receiv- ing a grant under this section, the NMHC will establish a community advisory committee, for which a majority of the members shall be individuals who are served by the NMHC. MOUNT .—The amount of any grant made under RANT A (d) G this section for any fiscal year shall be determined by the Sec- retary, taking into account— (1) the financial need of the NMHC, considering State, local, and other operational funding provided to the NMHC; and (2) other factors, as the Secretary determines appropriate. (e) A UTHORIZATION OF A PPROPRIATIONS .—For the purposes of carrying out this section, there are authorized to be appropriated $50,000,000 for the fiscal year 2010 and such sums as may be nec- essary for each of the fiscal years 2011 through 2014. SEC. 330B. ø 254c–2 ¿ SPECIAL DIABETES PROGRAMS FOR TYPE I DIABE- 33 TES. (a) I .—The Secretary, directly or through grants, ENERAL N G shall provide for research into the prevention and cure of Type I diabetes. UNDING .— (b) F (1) T RANSFERRED FUNDS .—Notwithstanding section 2104(a) of the Social Security Act, from the amounts appropriated in such section for each of fiscal years 1998 through 2002, $30,000,000 is hereby transferred and made available in such fiscal year for grants under this section. .—For the purpose of making grants PPROPRIATIONS (2) A under this section, there is appropriated, out of any funds in the Treasury not otherwise appropriated— 33 Section 4923 of Public Law 105–33 (111 Stat. 574, as amended by section 1(c) of Public Law 107–360 (116 Stat. 3019),) requires the Secretary of Health and Human Services to conduct evaluations regarding programs under sections 330B and 330C. An interim report is required to be submitted to the appropriate committees of Congress not later than January 1, 2000, and a final report is required to be submitted not later than January 1, 2007. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00260 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

261 G:\COMP\PHSA\PHSA-MERGED.XML 261 Sec. 330D PUBLIC HEALTH SERVICE ACT (A) $70,000,000 for each of fiscal years 2001 and 2002 (which shall be combined with amounts transferred under paragraph (1) for each such fiscal years); (B) $100,000,000 for fiscal year 2003; (C) $150,000,000 for each of fiscal years 2004 through 2017; and (D) $150,000,000 for each of fiscal years 2018 and 2019, to remain available until expended. 34 254c–3 SEC. 330C. SPECIAL DIABETES PROGRAMS FOR INDIANS. ø ¿ (a) I N G ENERAL .—The Secretary shall make grants for pro- viding services for the prevention and treatment of diabetes in ac- cordance with subsection (b). (b) S ERVICES T HROUGH I NDIAN H EALTH F ACILITIES .—For pur- poses of subsection (a), services under such subsection are provided in accordance with this subsection if the services are provided through any of the following entities: (1) The Indian Health Service. (2) An Indian health program operated by an Indian tribe or tribal organization pursuant to a contract, grant, cooperative agreement, or compact with the Indian Health Service pursu- ant to the Indian Self-Determination Act. (3) An urban Indian health program operated by an urban Indian organization pursuant to a grant or contract with the Indian Health Service pursuant to title V of the Indian Health Care Improvement Act. (c) F .— UNDING (1) T RANSFERRED FUNDS .—Notwithstanding section 2104(a) of the Social Security Act, from the amounts appropriated in such section for each of fiscal years 1998 through 2002, $30,000,000, to remain available until expended, is hereby transferred and made available in such fiscal year for grants under this section. (2) A .—For the purpose of making grants PPROPRIATIONS under this section, there is appropriated, out of any money in the Treasury not otherwise appropriated— (A) $70,000,000 for each of fiscal years 2001 and 2002 (which shall be combined with amounts transferred under paragraph (1) for each such fiscal years); (B) $100,000,000 for fiscal year 2003; (C) $150,000,000 for each of fiscal years 2004 through 2017; and (D) $150,000,000 for each of fiscal years 2018 and 2019, to remain available until expended. ø 254c–4 ¿ CENTERS FOR STRATEGIES ON FACILITATING UTI- SEC. 330D. LIZATION OF PREVENTIVE HEALTH SERVICES AMONG VARIOUS POPULATIONS. (a) I N G ENERAL .—The Secretary, acting through the appro- priate agencies of the Public Health Service, shall make grants to public or nonprofit private entities for the establishment and oper- ation of regional centers whose purpose is to develop, evaluate, and disseminate effective strategies, which utilize quality management measures, to assist public and private health care programs and 34 See footnote to section 330B. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00261 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

262 G:\COMP\PHSA\PHSA-MERGED.XML 262 Sec. 330E PUBLIC HEALTH SERVICE ACT providers in the appropriate utilization of preventive health care services by specific populations. (b) R .—The activities carried out by a T RAINING ESEARCH AND center under subsection (a) may include establishing programs of research and training with respect to the purpose described in such subsection, including the development of curricula for training indi- viduals in implementing the strategies developed under such sub- section. (c) P EGARDING I NFANTS AND C HILDREN RIORITY R .—In carrying out the purpose described in subsection (a), the Secretary shall give priority to various populations of infants, young children, and their mothers. (d) A UTHORIZATION OF PPROPRIATIONS .—For the purpose of A carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2000 through 2004. ø 254c–5 ¿ EPILEPSY; SEIZURE DISORDER. SEC. 330E. ATIONAL P UBLIC H EALTH C AMPAIGN .— (a) N N GENERAL .—The Secretary shall develop and imple- (1) I ment public health surveillance, education, research, and inter- vention strategies to improve the lives of persons with epilepsy, with a particular emphasis on children. Such projects may be carried out by the Secretary directly and through awards of grants or contracts to public or nonprofit private entities. The Secretary may directly or through such awards provide tech- nical assistance with respect to the planning, development, and operation of such projects. .—Activities under paragraph (1) ERTAIN ACTIVITIES (2) C shall include— (A) expanding current surveillance activities through existing monitoring systems and improving registries that maintain data on individuals with epilepsy, including chil- dren; (B) enhancing research activities on the diagnosis, treatment, and management of epilepsy; (C) implementing public and professional information and education programs regarding epilepsy, including ini- tiatives which promote effective management of the dis- ease through children’s programs which are targeted to parents, schools, daycare providers, patients; (D) undertaking educational efforts with the media, providers of health care, schools and others regarding stig- mas and secondary disabilities related to epilepsy and sei- zures, and its effects on youth; (E) utilizing and expanding partnerships with organi- zations with experience addressing the health and related needs of people with disabilities; and (F) other activities the Secretary deems appropriate. OORDINATION OF ACTIVITIES .—The Secretary shall en- (3) C sure that activities under this subsection are coordinated as appropriate with other agencies of the Public Health Service that carry out activities regarding epilepsy and seizure. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00262 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

263 G:\COMP\PHSA\PHSA-MERGED.XML 263 Sec. 330F PUBLIC HEALTH SERVICE ACT D EIZURE EMONSTRATION P ROJECTS IN M EDI - ISORDER (b) S ; D A .— NDERSERVED CALLY U REAS (1) I .—The Secretary, acting through the Ad- N GENERAL ministrator of the Health Resources and Services Administra- tion, may make grants for the purpose of carrying out dem- onstration projects to improve access to health and other serv- ices regarding seizures to encourage early detection and treat- ment in children and others residing in medically underserved areas. (2) A PPLICATION FOR GRANT .—A grant may not be awarded under paragraph (1) unless an application therefore is sub- mitted to the Secretary and the Secretary approves such appli- cation. Such application shall be submitted in such form and manner and shall contain such information as the Secretary may prescribe. .—For purposes of this section: (c) D EFINITIONS (1) The term ‘‘epilepsy’’ refers to a chronic and serious neu- rological condition characterized by excessive electrical dis- charges in the brain causing recurring seizures affecting all life activities. The Secretary may revise the definition of such term to the extent the Secretary determines necessary. (2) The term ‘‘medically underserved’’ has the meaning ap- plicable under section 799B(6). UTHORIZATION OF A PPROPRIATIONS .—For the purpose of (d) A carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005. ø SEC. 330F. CERTAIN SERVICES FOR PREGNANT WOMEN. 254c–6 ¿ A A WARENESS .— NFANT (a) I DOPTION (1) I N GENERAL .—The Secretary shall make grants to na- tional, regional, or local adoption organizations for the purpose of developing and implementing programs to train the des- ignated staff of eligible health centers in providing adoption in- formation and referrals to pregnant women on an equal basis with all other courses of action included in nondirective coun- seling to pregnant women. EST - PRACTICES GUIDELINES .— (2) B (A) I .—A condition for the receipt of a grant N GENERAL under paragraph (1) is that the adoption organization in- volved agree that, in providing training under such para- graph, the organization will follow the guidelines devel- oped under subparagraph (B). (B) P ROCESS FOR DEVELOPMENT OF GUIDELINES .— .—The Secretary shall establish N GENERAL (i) I and supervise a process described in clause (ii) in which the participants are— (I) an appropriate number and variety of adoption organizations that, as a group, have ex- pertise in all models of adoption practice and that represent all members of the adoption triad (birth mother, infant, and adoptive parent); and (II) affected public health entities. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00263 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

264 G:\COMP\PHSA\PHSA-MERGED.XML 264 Sec. 330F PUBLIC HEALTH SERVICE ACT ESCRIPTION OF PROCESS (ii) D .—The process re- ferred to in clause (i) is a process in which the partici- pants described in such clause collaborate to develop best-practices guidelines on the provision of adoption information and referrals to pregnant women on an equal basis with all other courses of action included in nondirective counseling to pregnant women. (iii) D ATE CERTAIN FOR DEVELOPMENT .—The Sec- retary shall ensure that the guidelines described in clause (ii) are developed not later than 180 days after the date of the enactment of the Children’s Health Act 35 of 2000 . (C) R ELATION TO AUTHORITY FOR GRANTS .—The Sec- retary may not make any grant under paragraph (1) before the date on which the guidelines under subparagraph (B) are developed. (3) U SE OF GRANT .— (A) I N GENERAL .—With respect to a grant under para- graph (1)— (i) an adoption organization may expend the grant to carry out the programs directly or through grants to or contracts with other adoption organizations; (ii) the purposes for which the adoption organiza- tion expends the grant may include the development of a training curriculum, consistent with the guide- lines developed under paragraph (2)(B); and (iii) a condition for the receipt of the grant is that the adoption organization agree that, in providing training for the designated staff of eligible health cen- ters, such organization will make reasonable efforts to ensure that the individuals who provide the training are individuals who are knowledgeable in all elements of the adoption process and are experienced in pro- viding adoption information and referrals in the geo- graphic areas in which the eligible health centers are located, and that the designated staff receive the training in such areas. (B) R ULE OF CONSTRUCTION REGARDING TRAINING OF TRAINERS .—With respect to individuals who under a grant under paragraph (1) provide training for the designated staff of eligible health centers (referred to in this subpara- graph as ‘‘trainers’’), subparagraph (A)(iii) may not be con- strued as establishing any limitation regarding the geo- graphic area in which the trainers receive instruction in being such trainers. A trainer may receive such instruction in a different geographic area than the area in which the trainer trains (or will train) the designated staff of eligible health centers. (4) A DOPTION ORGANIZATIONS ; ELIGIBLE HEALTH CENTERS ; OTHER DEFINITIONS .—For purposes of this section: (A) The term ‘‘adoption organization’’ means a na- tional, regional, or local organization— 35 Public Law 106–310, enacted October 17, 2000. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00264 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

265 G:\COMP\PHSA\PHSA-MERGED.XML 265 Sec. 330F PUBLIC HEALTH SERVICE ACT (i) among whose primary purposes are adoption; (ii) that is knowledgeable in all elements of the adoption process and on providing adoption informa- tion and referrals to pregnant women; and (iii) that is a nonprofit private entity. (B) The term ‘‘designated staff’’, with respect to an eli- gible health center, means staff of the center who provide pregnancy or adoption information and referrals (or will provide such information and referrals after receiving training under a grant under paragraph (1)). (C) The term ‘‘eligible health centers’’ means public and nonprofit private entities that provide health services to pregnant women. (5) T RAINING FOR CERTAIN ELIGIBLE HEALTH CENTERS .—A condition for the receipt of a grant under paragraph (1) is that the adoption organization involved agree to make reasonable efforts to ensure that the eligible health centers with respect to which training under the grant is provided include— (A) eligible health centers that receive grants under section 1001 (relating to voluntary family planning projects); (B) eligible health centers that receive grants under section 330 (relating to community health centers, migrant health centers, and centers regarding homeless individuals and residents of public housing); and (C) eligible health centers that receive grants under this Act for the provision of services in schools. .— ARTICIPATION OF CERTAIN ELIGIBLE HEALTH CLINICS (6) P In the case of eligible health centers that receive grants under section 330 or 1001: (A) Within a reasonable period after the Secretary be- gins making grants under paragraph (1), the Secretary shall provide eligible health centers with complete infor- mation about the training available from organizations re- ceiving grants under such paragraph. The Secretary shall make reasonable efforts to encourage eligible health cen- ters to arrange for designated staff to participate in such training. Such efforts shall affirm Federal requirements, if any, that the eligible health center provide nondirective counseling to pregnant women. (B) All costs of such centers in obtaining the training shall be reimbursed by the organization that provides the training, using grants under paragraph (1). (C) Not later than 1 year after the date of the enact- 36 ment of the Children’s Health Act of 2000 , the Secretary shall submit to the appropriate committees of the Congress a report evaluating the extent to which adoption informa- tion and referral, upon request, are provided by eligible health centers. Within a reasonable time after training under this section is initiated, the Secretary shall submit to the appropriate committees of the Congress a report evaluating the extent to which adoption information and 36 Public Law 106–310, enacted October 17, 2000. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00265 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

266 G:\COMP\PHSA\PHSA-MERGED.XML 266 Sec. 330G PUBLIC HEALTH SERVICE ACT referral, upon request, are provided by eligible health cen- ters in order to determine the effectiveness of such train- ing and the extent to which such training complies with subsection (a)(1). In preparing the reports required by this subparagraph, the Secretary shall in no respect interpret the provisions of this section to allow any interference in the provider-patient relationship, any breach of patient confidentiality, or any monitoring or auditing of the coun- seling process or patient records which breaches patient confidentiality or reveals patient identity. The reports re- quired by this subparagraph shall be conducted by the Sec- retary acting through the Administrator of the Health Re- sources and Services Administration and in collaboration with the Director of the Agency for Healthcare Research and Quality. (b) A RANT .—The Secretary may make a grant PPLICATION FOR G under subsection (a) only if an application for the grant is sub- mitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section. (c) A A PPROPRIATIONS .—For the purpose of UTHORIZATION OF carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005. ø 254c–7 ¿ SPECIAL NEEDS ADOPTION PROGRAMS; PUBLIC SEC. 330G. AWARENESS CAMPAIGN AND OTHER ACTIVITIES. PECIAL N EEDS A DOPTION A WARENESS C AMPAIGN .— (a) S N GENERAL (1) I .—The Secretary shall, through making grants to nonprofit private entities, provide for the planning, development, and carrying out of a national campaign to pro- vide information to the public regarding the adoption of chil- dren with special needs. (2) I NPUT ON PLANNING AND DEVELOPMENT .—In providing for the planning and development of the national campaign under paragraph (1), the Secretary shall provide for input from a number and variety of adoption organizations throughout the States in order that the full national diversity of interests among adoption organizations is represented in the planning and development of the campaign. (3) C ERTAIN FEATURES .—With respect to the national cam- paign under paragraph (1): (A) The campaign shall be directed at various popu- lations, taking into account as appropriate differences among geographic regions, and shall be carried out in the language and cultural context that is most appropriate to the population involved. (B) The means through which the campaign may be carried out include— (i) placing public service announcements on tele- vision, radio, and billboards; and (ii) providing information through means that the Secretary determines will reach individuals who are most likely to adopt children with special needs. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00266 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

267 G:\COMP\PHSA\PHSA-MERGED.XML 267 Sec. 330G PUBLIC HEALTH SERVICE ACT (C) The campaign shall provide information on the subsidies and supports that are available to individuals re- garding the adoption of children with special needs. (D) The Secretary may provide that the placement of public service announcements, and the dissemination of brochures and other materials, is subject to review by the Secretary. R EQUIREMENT .— ATCHING (4) M N GENERAL (A) I .—With respect to the costs of the ac- tivities to be carried out by an entity pursuant to para- graph (1), a condition for the receipt of a grant under such paragraph is that the entity agree to make available (di- rectly or through donations from public or private entities) non-Federal contributions toward such costs in an amount that is not less than 25 percent of such costs. (B) D ETERMINATION OF AMOUNT CONTRIBUTED .—Non- Federal contributions under subparagraph (A) may be in cash or in kind, fairly evaluated, including plant, equip- ment, or services. Amounts provided by the Federal Gov- ernment, or services assisted or subsidized to any signifi- cant extent by the Federal Government, may not be in- cluded in determining the amount of such contributions. R ATIONAL P ROGRAM .—The Secretary shall (di- ESOURCES (b) N rectly or through grant or contract) carry out a program that, through toll-free telecommunications, makes available to the public information regarding the adoption of children with special needs. Such information shall include the following: (1) A list of national, State, and regional organizations that provide services regarding such adoptions, including ex- changes and other information on communicating with the or- ganizations. The list shall represent the full national diversity of adoption organizations. (2) Information beneficial to individuals who adopt such children, including lists of support groups for adoptive parents and other postadoptive services. (c) O THER .—With respect to the adoption of children P ROGRAMS with special needs, the Secretary shall make grants— (1) to provide assistance to support groups for adoptive parents, adopted children, and siblings of adopted children; and (2) to carry out studies to identify— (A) the barriers to completion of the adoption process; and (B) those components that lead to favorable long-term outcomes for families that adopt children with special needs. PPLICATION FOR G RANT .—The Secretary may make an (d) A award of a grant or contract under this section only if an applica- tion for the award is submitted to the Secretary and the applica- tion is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary deter- mines to be necessary to carry out this section. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00267 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

268 G:\COMP\PHSA\PHSA-MERGED.XML 268 Sec. 330H PUBLIC HEALTH SERVICE ACT .—For the purpose of carrying out this section, (e) F UNDING there are authorized to be appropriated such sums as may be nec- essary for each of the fiscal years 2001 through 2005. 254c–8 HEALTHY START FOR INFANTS. ¿ SEC. 330H. ø ENERAL .— (a) I N G .—The Sec- ONTINUATION AND EXPANSION OF PROGRAM (1) C retary, acting through the Administrator of the Health Re- sources and Services Administration, Maternal and Child Health Bureau, shall under authority of this section continue in effect the Healthy Start Initiative and may, during fiscal year 2001 and subsequent years, carry out such program on a national basis. .—For purposes of paragraph (1), the term EFINITION (2) D ‘‘Healthy Start Initiative’’ is a reference to the program that, as an initiative to reduce the rate of infant mortality and im- prove perinatal outcomes, makes grants for project areas with high annual rates of infant mortality and that, prior to the ef- fective date of this section, was a demonstration program car- ried out under section 301. M AKING G RANTS .— ONSIDERATIONS IN (b) C EQUIREMENTS .—In making grants under subsection (1) R (a), the Secretary shall require that applicants (in addition to meeting all eligibility criteria established by the Secretary) es- tablish, for project areas under such subsection, community- based consortia of individuals and organizations (including agencies responsible for administering block grant programs under title V of the Social Security Act, consumers of project services, public health departments, hospitals, health centers under section 330, and other significant sources of health care services) that are appropriate for participation in projects under subsection (a). THER CONSIDERATIONS .—In making grants under sub- (2) O section (a), the Secretary shall take into consideration the fol- lowing: (A) Factors that contribute to infant mortality, such as low birthweight. (B) The extent to which applicants for such grants fa- cilitate— (i) a community-based approach to the delivery of services; and (ii) a comprehensive approach to women’s health care to improve perinatal outcomes. PECIAL PROJECTS .—Nothing in paragraph (2) shall be (3) S construed to prevent the Secretary from awarding grants under subsection (a) for special projects that are intended to address significant disparities in perinatal health indicators in communities along the United States-Mexico border or in Alas- ka or Hawaii. OORDINATION .—Recipients of grants under subsection (a) (c) C shall coordinate their services and activities with the State agency or agencies that administer block grant programs under title V of the Social Security Act in order to promote cooperation, integration, and dissemination of information with Statewide systems and with March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00268 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

269 G:\COMP\PHSA\PHSA-MERGED.XML 269 Sec. 330I PUBLIC HEALTH SERVICE ACT other community services funded under the Maternal and Child Health Block Grant. (d) R .—Except to the extent inconsistent ULE OF ONSTRUCTION C with this section, this section may not be construed as affecting the authority of the Secretary to make modifications in the program carried out under subsection (a). (e) F .— UNDING (1) A UTHORIZATION OF APPROPRIATIONS .—For the purpose of carrying out this section, there are authorized to be appro- priated— (A) $120,000,000 for fiscal year 2008; and (B) for each of fiscal years 2009 through 2013, the amount authorized for the preceding fiscal year increased by the percentage increase in the Consumer Price Index for all urban consumers for such year. (2) A .— LLOCATION .—Of the amounts ap- (A) P ROGRAM ADMINISTRATION propriated under paragraph (1) for a fiscal year, the Sec- retary may reserve up to 5 percent for coordination, dis- semination, technical assistance, and data activities that are determined by the Secretary to be appropriate for car- rying out the program under this section. (B) E VALUATION .—Of the amounts appropriated under paragraph (1) for a fiscal year, the Secretary may reserve up to 1 percent for evaluations of projects carried out under subsection (a). Each such evaluation shall include a determination of whether such projects have been effective in reducing the disparity in health status between the gen- eral population and individuals who are members of racial or ethnic minority groups. ø 254c–14 ¿ TELEHEALTH NETWORK AND TELEHEALTH RE- SEC. 330I. SOURCE CENTERS GRANT PROGRAMS. (a) D EFINITIONS .—In this section: ; .—The terms ‘‘Director’’ and ‘‘Office’’ IRECTOR OFFICE (1) D mean the Director and Office specified in subsection (c). (2) F EDERALLY QUALIFIED HEALTH CENTER AND RURAL HEALTH CLINIC .—The term ‘‘Federally qualified health center’’ and ‘‘rural health clinic’’ have the meanings given the terms in section 1861(aa) of the Social Security Act (42 U.S.C. 1395x(aa)). (3) F RONTIER COMMUNITY .—The term ‘‘frontier community’’ shall have the meaning given the term in regulations issued under subsection (r). EDICALLY UNDERSERVED AREA .—The term ‘‘medically (4) M underserved area’’ has the meaning given the term ‘‘medically underserved community’’ in section 799B(6). UNDERSERVED POPULATION .—The term EDICALLY (5) M ‘‘medically underserved population’’ has the meaning given the term in section 330(b)(3). (6) T ELEHEALTH SERVICES .—The term ‘‘telehealth services’’ means services provided through telehealth technologies. ELEHEALTH TECHNOLOGIES .—The term ‘‘telehealth (7) T technologies’’ means technologies relating to the use of elec- tronic information, and telecommunications technologies, to March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00269 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

270 G:\COMP\PHSA\PHSA-MERGED.XML 270 Sec. 330I PUBLIC HEALTH SERVICE ACT support and promote, at a distance, health care, patient and professional health-related education, health administration, and public health. .—The Secretary shall establish, under section ROGRAMS (b) P 301, telehealth network and telehealth resource centers grant pro- grams. DMINISTRATION .— (c) A STABLISHMENT .—There is established in the Health (1) E Resources and Services Administration an Office for the Ad- vancement of Telehealth. The Office shall be headed by a Di- rector. UTIES .—The telehealth network and telehealth re- (2) D source centers grant programs established under section 301 shall be administered by the Director, in consultation with the State offices of rural health, State offices concerning primary care, or other appropriate State government entities. .— (d) G RANTS .—The Director may, in ELEHEALTH NETWORK GRANTS (1) T carrying out the telehealth network grant program referred to in subsection (b), award grants to eligible entities for projects to demonstrate how telehealth technologies can be used through telehealth networks in rural areas, frontier commu- nities, and medically underserved areas, and for medically un- derserved populations, to— (A) expand access to, coordinate, and improve the quality of health care services; (B) improve and expand the training of health care providers; and (C) expand and improve the quality of health informa- tion available to health care providers, and patients and their families, for decisionmaking. (2) T .—The Director ELEHEALTH RESOURCE CENTERS GRANTS may, in carrying out the telehealth resource centers grant pro- gram referred to in subsection (b), award grants to eligible en- tities for projects to demonstrate how telehealth technologies can be used in the areas and communities, and for the popu- lations, described in paragraph (1), to establish telehealth re- source centers. RANT ERIODS .—The Director may award grants under P (e) G this section for periods of not more than 4 years. (f) E E NTITIES .— LIGIBLE (1) T ELEHEALTH NETWORK GRANTS .— RANT RECIPIENT .—To be eligible to receive a (A) G grant under subsection (d)(1), an entity shall be a non- profit entity. (B) T .— ELEHEALTH NETWORKS (i) I N GENERAL .—To be eligible to receive a grant under subsection (d)(1), an entity shall demonstrate that the entity will provide services through a tele- health network. (ii) N .—Each entity partici- ATURE OF ENTITIES pating in the telehealth network may be a nonprofit or for-profit entity. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00270 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

271 G:\COMP\PHSA\PHSA-MERGED.XML 271 Sec. 330I PUBLIC HEALTH SERVICE ACT .—The telehealth OMPOSITION OF NETWORK (iii) C network shall include at least 2 of the following enti- ties (at least 1 of which shall be a community-based health care provider): (I) Community or migrant health centers or other Federally qualified health centers. (II) Health care providers, including phar- macists, in private practice. (III) Entities operating clinics, including rural health clinics. (IV) Local health departments. (V) Nonprofit hospitals, including community access hospitals. (VI) Other publicly funded health or social service agencies. (VII) Long-term care providers. (VIII) Providers of health care services in the home. (IX) Providers of outpatient mental health services and entities operating outpatient mental health facilities. (X) Local or regional emergency health care providers. (XI) Institutions of higher education. (XII) Entities operating dental clinics. .—To be eligi- ELEHEALTH RESOURCE CENTERS GRANTS (2) T ble to receive a grant under subsection (d)(2), an entity shall be a nonprofit entity. PPLICATIONS (g) A .—To be eligible to receive a grant under sub- section (d), an eligible entity, in consultation with the appropriate State office of rural health or another appropriate State entity, shall prepare and submit to the Secretary an application, at such time, in such manner, and containing such information as the Sec- retary may require, including— (1) a description of the project that the eligible entity will carry out using the funds provided under the grant; (2) a description of the manner in which the project funded under the grant will meet the health care needs of rural or other populations to be served through the project, or improve the access to services of, and the quality of the services re- ceived by, those populations; (3) evidence of local support for the project, and a descrip- tion of how the areas, communities, or populations to be served will be involved in the development and ongoing operations of the project; (4) a plan for sustaining the project after Federal support for the project has ended; (5) information on the source and amount of non-Federal funds that the entity will provide for the project; (6) information demonstrating the long-term viability of the project, and other evidence of institutional commitment of the entity to the project; (7) in the case of an application for a project involving a telehealth network, information demonstrating how the project March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00271 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

272 G:\COMP\PHSA\PHSA-MERGED.XML 272 Sec. 330I PUBLIC HEALTH SERVICE ACT will promote the integration of telehealth technologies into the operations of health care providers, to avoid redundancy, and improve access to and the quality of care; and (8) other such information as the Secretary determines to be appropriate. (h) T .— AXIMUM A MOUNT OF ; C SSISTANCE ONDITIONS ; M ERMS A The Secretary shall establish the terms and conditions of each grant program described in subsection (b) and the maximum amount of a grant to be awarded to an individual recipient for each fiscal year under this section. The Secretary shall publish, in a publication of the Health Resources and Services Administration, notice of the application requirements for each grant program de- scribed in subsection (b) for each fiscal year. (i) P REFERENCES .— (1) T .—In awarding grants under ELEHEALTH NETWORKS subsection (d)(1) for projects involving telehealth networks, the Secretary shall give preference to an eligible entity that meets at least 1 of the following requirements: (A) O RGANIZATION .—The eligible entity is a rural com- munity-based organization or another community-based or- ganization. (B) S ERVICES .—The eligible entity proposes to use Fed- eral funds made available through such a grant to develop plans for, or to establish, telehealth networks that provide mental health, public health, long-term care, home care, preventive, case management services, or prenatal care for high-risk pregnancies. (C) C OORDINATION .—The eligible entity demonstrates how the project to be carried out under the grant will be coordinated with other relevant federally funded projects in the areas, communities, and populations to be served through the grant. ETWORK .—The eligible entity demonstrates that (D) N the project involves a telehealth network that includes an entity that— (i) provides clinical health care services, or edu- cational services for health care providers and for pa- tients or their families; and (ii) is— (I) a public library; (II) an institution of higher education; or (III) a local government entity. (E) C ONNECTIVITY .—The eligible entity proposes a project that promotes local connectivity within areas, com- munities, or populations to be served through the project. (F) I NTEGRATION .—The eligible entity demonstrates that health care information has been integrated into the project. (2) T .—In awarding grants ELEHEALTH RESOURCE CENTERS under subsection (d)(2) for projects involving telehealth re- source centers, the Secretary shall give preference to an eligi- ble entity that meets at least 1 of the following requirements: ROVISION OF SERVICES .—The eligible entity has a (A) P record of success in the provision of telehealth services to March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00272 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

273 G:\COMP\PHSA\PHSA-MERGED.XML 273 Sec. 330I PUBLIC HEALTH SERVICE ACT medically underserved areas or medically underserved populations. OLLABORATION AND SHARING OF EXPERTISE (B) C .—The eligible entity has a demonstrated record of collaborating and sharing expertise with providers of telehealth services at the national, regional, State, and local levels. (C) B .—The eli- ROAD RANGE OF TELEHEALTH SERVICES gible entity has a record of providing a broad range of tele- health services, which may include— (i) a variety of clinical specialty services; (ii) patient or family education; (iii) health care professional education; and (iv) rural residency support programs. (j) D ISTRIBUTION OF .— F UNDS (1) I N GENERAL .—In awarding grants under this section, the Director shall ensure, to the greatest extent possible, that such grants are equitably distributed among the geographical regions of the United States. (2) T ELEHEALTH NETWORKS .—In awarding grants under subsection (d)(1) for a fiscal year, the Director shall ensure that— (A) not less than 50 percent of the funds awarded shall be awarded for projects in rural areas; and (B) the total amount of funds awarded for such projects for that fiscal year shall be not less than the total amount of funds awarded for such projects for fiscal year 2001 under section 330A (as in effect on the day before the date of enactment of the Health Care Safety Net Amend- ments of 2002). SE OF UNDS .— F (k) U (1) T ELEHEALTH NETWORK PROGRAM .—The recipient of a grant under subsection (d)(1) may use funds received through such grant for salaries, equipment, and operating or other costs, including the cost of— (A) developing and delivering clinical telehealth serv- ices that enhance access to community-based health care services in rural areas, frontier communities, or medically underserved areas, or for medically underserved popu- lations; (B) developing and acquiring, through lease or pur- chase, computer hardware and software, audio and video equipment, computer network equipment, interactive equipment, data terminal equipment, and other equipment that furthers the objectives of the telehealth network grant program; (C)(i) developing and providing distance education, in a manner that enhances access to care in rural areas, fron- tier communities, or medically underserved areas, or for medically underserved populations; or (ii) mentoring, precepting, or supervising health care providers and students seeking to become health care pro- viders, in a manner that enhances access to care in the areas and communities, or for the populations, described in clause (i); March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00273 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

274 G:\COMP\PHSA\PHSA-MERGED.XML 274 Sec. 330I PUBLIC HEALTH SERVICE ACT (D) developing and acquiring instructional program- ming; (E)(i) providing for transmission of medical data, and maintenance of equipment; and (ii) providing for compensation (including travel ex- penses) of specialists, and referring health care providers, who are providing telehealth services through the tele- health network, if no third party payment is available for the telehealth services delivered through the telehealth network; (F) developing projects to use telehealth technology to facilitate collaboration between health care providers; (G) collecting and analyzing usage statistics and data to document the cost-effectiveness of the telehealth serv- ices; and (H) carrying out such other activities as are consistent with achieving the objectives of this section, as determined by the Secretary. (2) T ELEHEALTH RESOURCE CENTERS .—The recipient of a grant under subsection (d)(2) may use funds received through such grant for salaries, equipment, and operating or other costs for— (A) providing technical assistance, training, and sup- port, and providing for travel expenses, for health care pro- viders and a range of health care entities that provide or will provide telehealth services; (B) disseminating information and research findings related to telehealth services; (C) promoting effective collaboration among telehealth resource centers and the Office; (D) conducting evaluations to determine the best utili- zation of telehealth technologies to meet health care needs; (E) promoting the integration of the technologies used in clinical information systems with other telehealth tech- nologies; (F) fostering the use of telehealth technologies to pro- vide health care information and education for health care providers and consumers in a more effective manner; and (G) implementing special projects or studies under the direction of the Office. (l) P SES OF F UNDS .—An entity that receives a ROHIBITED U grant under this section may not use funds made available through the grant— (1) to acquire real property; (2) for expenditures to purchase or lease equipment, to the extent that the expenditures would exceed 40 percent of the total grant funds; (3) in the case of a project involving a telehealth network, to purchase or install transmission equipment (such as laying cable or telephone lines, or purchasing or installing microwave towers, satellite dishes, amplifiers, or digital switching equip- ment); (4) to pay for any equipment or transmission costs not di- rectly related to the purposes for which the grant is awarded; March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00274 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

275 G:\COMP\PHSA\PHSA-MERGED.XML 275 Sec. 330I PUBLIC HEALTH SERVICE ACT (5) to purchase or install general purpose voice telephone systems; (6) for construction; or (7) for expenditures for indirect costs (as determined by the Secretary), to the extent that the expenditures would ex- ceed 15 percent of the total grant funds. (m) C .—In providing services under this section, OLLABORATION an eligible entity shall collaborate, if feasible, with entities that— (1)(A) are private or public organizations, that receive Fed- eral or State assistance; or (B) are public or private entities that operate centers, or carry out programs, that receive Federal or State assistance; and (2) provide telehealth services or related activities. (n) C ITH O THER A OORDINATION .—The Secretary W GENCIES shall coordinate activities carried out under grant programs de- scribed in subsection (b), to the extent practicable, with Federal and State agencies and nonprofit organizations that are operating similar programs, to maximize the effect of public dollars in fund- ing meritorious proposals. (o) O UTREACH A CTIVITIES .—The Secretary shall establish and implement procedures to carry out outreach activities to advise po- tential end users of telehealth services in rural areas, frontier com- munities, medically underserved areas, and medically underserved populations in each State about the grant programs described in subsection (b). ELEHEALTH .—It is the sense of Congress that, for purposes (p) T of this section, States should develop reciprocity agreements so that a provider of services under this section who is a licensed or other- wise authorized health care provider under the law of 1 or more States, and who, through telehealth technology, consults with a li- censed or otherwise authorized health care provider in another State, is exempt, with respect to such consultation, from any State law of the other State that prohibits such consultation on the basis that the first health care provider is not a licensed or authorized health care provider under the law of that State. (q) R EPORT .—Not later than September 30, 2005, the Secretary shall prepare and submit to the appropriate committees of Con- gress a report on the progress and accomplishments of the grant programs described in subsection (b). (r) R EGULATIONS .—The Secretary shall issue regulations speci- fying, for purposes of this section, a definition of the term ‘‘frontier area’’. The definition shall be based on factors that include popu- lation density, travel distance in miles to the nearest medical facil- ity, travel time in minutes to the nearest medical facility, and such other factors as the Secretary determines to be appropriate. The Secretary shall develop the definition in consultation with the Di- rector of the Bureau of the Census and the Administrator of the Economic Research Service of the Department of Agriculture. (s) A UTHORIZATION OF A PPROPRIATIONS .—There are authorized to be appropriated to carry out this section— (1) for grants under subsection (d)(1), $40,000,000 for fiscal year 2002, and such sums as may be necessary for each of fis- cal years 2003 through 2006; and March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00275 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

276 G:\COMP\PHSA\PHSA-MERGED.XML 276 Sec. 330J PUBLIC HEALTH SERVICE ACT (2) for grants under subsection (d)(2), $20,000,000 for fiscal year 2002, and such sums as may be necessary for each of fis- cal years 2003 through 2006. ¿ ø SEC. 330J. RURAL EMERGENCY MEDICAL SERVICE TRAINING 254c–15 AND EQUIPMENT ASSISTANCE PROGRAM. (a) G RANTS .—The Secretary, acting through the Administrator of the Health Resources and Services Administration (referred to in this section as the ‘‘Secretary’’) shall award grants to eligible enti- ties to enable such entities to provide for improved emergency med- ical services in rural areas or to residents of rural areas. (b) E PPLICATION .—To be eligible to receive grant LIGIBILITY ; A under this section, an entity shall— (1) be— (A) an emergency medical services agency operated by a local or tribal government (including fire-based and non- fire based); or (B) an emergency medical services agency that is de- scribed in section 501(c) of the Internal Revenue Code of 1986 and exempt from tax under section 501(a) of such Code; and (2) submit an application to the Secretary at such time, in such manner, and containing such information as the Sec- retary may require. (c) U SE OF F UNDS .—An entity— (1) shall use amounts received through a grant under sub- section (a) to— (A) train emergency medical services personnel as ap- propriate to obtain and maintain licenses and certifications relevant to service in an emergency medical services agen- cy described in subsection (b)(1); (B) conduct courses that qualify graduates to serve in an emergency medical services agency described in sub- section (b)(1) in accordance with State and local require- ments; (C) fund specific training to meet Federal or State li- censing or certification requirements; and (D) acquire emergency medical services equipment; and (2) may use amounts received through a grant under sub- section (a) to— (A) recruit and retain emergency medical services per- sonnel, which may include volunteer personnel; (B) develop new ways to educate emergency health care providers through the use of technology-enhanced educational methods; or (C) acquire personal protective equipment for emer- gency medical services personnel as required by the Occu- pational Safety and Health Administration. (d) G RANT A MOUNTS .—Each grant awarded under this section shall be in an amount not to exceed $200,000. EFINITIONS .—In this section: (e) D (1) The term ‘‘emergency medical services’’— (A) means resources used by a public or private non- profit licensed entity to deliver medical care outside of a March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00276 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

277 G:\COMP\PHSA\PHSA-MERGED.XML 277 Sec. 330K PUBLIC HEALTH SERVICE ACT medical facility under emergency conditions that occur as a result of the condition of the patient; and (B) includes services delivered (either on a com- pensated or volunteer basis) by an emergency medical services provider or other provider that is licensed or cer- tified by the State involved as an emergency medical tech- nician, a paramedic, or an equivalent professional (as de- termined by the State). (2) The term ‘‘rural area’’ means— (A) a nonmetropolitan statistical area; (B) an area designated as a rural area by any law or regulation of a State; or (C) a rural census tract of a metropolitan statistical area (as determined under the most recent rural urban commuting area code as set forth by the Office of Manage- ment and Budget). (f) M ATCHING R EQUIREMENT .—The Secretary may not award a grant under this section to an entity unless the entity agrees that the entity will make available (directly or through contributions from other public or private entities) non-Federal contributions to- ward the activities to be carried out under the grant in an amount equal to 10 percent of the amount received under the grant. (g) A UTHORIZATION OF PPROPRIATIONS .— A .—There are authorized to be appropriated (1) I N GENERAL to carry out this section such sums as may be necessary for each of fiscal years 2019 through 2023. (2) A DMINISTRATIVE COSTS .—The Secretary may use not more than 10 percent of the amount appropriated under para- graph (1) for a fiscal year for the administrative expenses of carrying out this section. ø SEC. 330K. MENTAL HEALTH SERVICES DELIVERED VIA 254c–16 ¿ TELEHEALTH. EFINITIONS (a) D .—In this section: (1) E LIGIBLE ENTITY .—The term ‘‘eligible entity’’ means a public or nonprofit private telehealth provider network that of- fers services that include mental health services provided by qualified mental health providers. (2) Q UALIFIED MENTAL HEALTH PROFESSIONALS .—The term ‘‘qualified mental health professionals’’ refers to providers of mental health services reimbursed under the medicare pro- gram carried out under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) who have additional training in the treatment of mental illness in children and adolescents or who have additional training in the treatment of mental illness in the elderly. PECIAL POPULATIONS .—The term ‘‘special populations’’ (3) S refers to the following 2 distinct groups: (A) Children and adolescents in mental health under- served rural areas or in mental health underserved urban areas. (B) Elderly individuals located in long-term care facili- ties in mental health underserved rural or urban areas. ELEHEALTH .—The term ‘‘telehealth’’ means the use of (4) T electronic information and telecommunications technologies to March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00277 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

278 G:\COMP\PHSA\PHSA-MERGED.XML 278 Sec. 330K PUBLIC HEALTH SERVICE ACT support long distance clinical health care, patient and profes- sional health-related education, public health, and health ad- ministration. UTHORIZED ROGRAM .— A (b) P N GENERAL .—The Secretary, acting through the Direc- (1) I tor of the Office for the Advancement of Telehealth of the Health Resources and Services Administration, shall award grants to eligible entities to establish demonstration projects for the provision of mental health services to special popu- lations as delivered remotely by qualified mental health profes- sionals using telehealth and for the provision of education re- garding mental illness as delivered remotely by qualified men- tal health professionals using telehealth. .—The Secretary shall award the OPULATIONS SERVED (2) P grants under paragraph (1) in a manner that distributes the grants so as to serve equitably the populations described in subparagraphs (A) and (B) of subsection (a)(3). SE OF UNDS .— F (c) U (1) I N GENERAL .—An eligible entity that receives a grant under this section shall use the grant funds— (A) for the populations described in subsection (a)(3)(A)— (i) to provide mental health services, including di- agnosis and treatment of mental illness, as delivered remotely by qualified mental health professionals using telehealth; and (ii) to collaborate with local public health entities to provide the mental health services; and (B) for the populations described in subsection (a)(3)(B)— (i) to provide mental health services, including di- agnosis and treatment of mental illness, in long-term care facilities as delivered remotely by qualified men- tal health professionals using telehealth; and (ii) to collaborate with local public health entities to provide the mental health services. THER USES .—An eligible entity that receives a grant (2) O under this section may also use the grant funds to— (A) pay telecommunications costs; and (B) pay qualified mental health professionals on a rea- sonable cost basis as determined by the Secretary for serv- ices rendered. (3) P .—An eligible entity that receives a ROHIBITED USES grant under this section shall not use the grant funds to— (A) purchase or install transmission equipment (other than such equipment used by qualified mental health pro- fessionals to deliver mental health services using tele- health under the project involved); or (B) build upon or acquire real property. (d) E D ISTRIBUTION .—In awarding grants under this QUITABLE section, the Secretary shall ensure, to the greatest extent possible, that such grants are equitably distributed among geographical re- gions of the United States. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00278 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

279 G:\COMP\PHSA\PHSA-MERGED.XML 279 Sec. 330M PUBLIC HEALTH SERVICE ACT .—An entity that desires a grant under this PPLICATION (e) A section shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary determines to be reasonable. (f) R EPORT .—Not later than 4 years after the date of enactment of the Health Care Safety Net Amendments of 2002, the Secretary shall prepare and submit to the appropriate committees of Con- gress a report that shall evaluate activities funded with grants under this section. (g) A UTHORIZATION OF A PPROPRIATIONS .—There are authorized to be appropriated to carry out this section, $20,000,000 for fiscal year 2002 and such sums as may be necessary for fiscal years 2003 through 2006. ø 254c–18 ¿ TELEMEDICINE; INCENTIVE GRANTS REGARDING SEC. 330L. COORDINATION AMONG STATES. (a) I G ENERAL .—The Secretary may make grants to State pro- N fessional licensing boards to carry out programs under which such licensing boards of various States cooperate to develop and imple- ment State policies that will reduce statutory and regulatory bar- riers to telemedicine. (b) A A PPROPRIATIONS .—For the purpose of UTHORIZATION OF carrying out subsection (a), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2002 through 2006. 37 SEC. 330M PEDIATRIC MENTAL HEALTH CARE ACCESS ø 254c–19 ¿ GRANTS. G ENERAL .—The Secretary, acting through the Adminis- N (a) I trator of the Health Resources and Services Administration and in coordination with other relevant Federal agencies, shall award grants to States, political subdivisions of States, and Indian tribes and tribal organizations (for purposes of this section, as such terms are defined in section 4 of the Indian Self-Determination and Edu- cation Assistance Act (25 U.S.C. 450b)) to promote behavioral health integration in pediatric primary care by— (1) supporting the development of statewide or regional pe- diatric mental health care telehealth access programs; and (2) supporting the improvement of existing statewide or re- gional pediatric mental health care telehealth access programs. (b) P R EQUIREMENTS ROGRAM .— (1) I .—A pediatric mental health care telehealth N GENERAL access program referred to in subsection (a), with respect to which a grant under such subsection may be used, shall— (A) be a statewide or regional network of pediatric mental health teams that provide support to pediatric pri- mary care sites as an integrated team; (B) support and further develop organized State or re- gional networks of pediatric mental health teams to pro- vide consultative support to pediatric primary care sites; (C) conduct an assessment of critical behavioral con- sultation needs among pediatric providers and such pro- viders’ preferred mechanisms for receiving consultation, training, and technical assistance; 37 So in original. There probably should be a period after ‘‘330M’’. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00279 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

280 G:\COMP\PHSA\PHSA-MERGED.XML 280 Sec. 330M PUBLIC HEALTH SERVICE ACT (D) develop an online database and communication mechanisms, including telehealth, to facilitate consultation support to pediatric practices; (E) provide rapid statewide or regional clinical tele- phone or telehealth consultations when requested between the pediatric mental health teams and pediatric primary care providers; (F) conduct training and provide technical assistance to pediatric primary care providers to support the early identification, diagnosis, treatment, and referral of chil- dren with behavioral health conditions; (G) provide information to pediatric providers about, and assist pediatric providers in accessing, pediatric men- tal health care providers, including child and adolescent psychiatrists, and licensed mental health professionals, such as psychologists, social workers, or mental health counselors and in scheduling and conducting technical as- sistance; (H) assist with referrals to specialty care and commu- nity or behavioral health resources; and (I) establish mechanisms for measuring and moni- toring increased access to pediatric mental health care services by pediatric primary care providers and expanded capacity of pediatric primary care providers to identify, treat, and refer children with mental health problems. EDIATRIC MENTAL HEALTH TEAMS .—In this subsection, (2) P the term ‘‘pediatric mental health team’’ means a team con- sisting of at least one case coordinator, at least one child and adolescent psychiatrist, and at least one licensed clinical men- tal health professional, such as a psychologist, social worker, or mental health counselor. Such a team may be regionally based. PPLICATION .—A State, political subdivision of a State, In- (c) A dian tribe, or tribal organization seeking a grant under this section shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may re- quire, including a plan for the comprehensive evaluation of activi- ties that are carried out with funds received under such grant. (d) E VALUATION .—A State, political subdivision of a State, In- dian tribe, or tribal organization that receives a grant under this section shall prepare and submit an evaluation of activities that are carried out with funds received under such grant to the Sec- retary at such time, in such manner, and containing such informa- tion as the Secretary may reasonably require, including a process and outcome evaluation. CCESS TO B ROADBAND .—In administering grants under (e) A this section, the Secretary may coordinate with other agencies to ensure that funding opportunities are available to support access to reliable, high-speed Internet for providers. (f) M ATCHING R EQUIREMENT .—The Secretary may not award a grant under this section unless the State, political subdivision of a State, Indian tribe, or tribal organization involved agrees, with re- spect to the costs to be incurred by the State, political subdivision of a State, Indian tribe, or tribal organization in carrying out the March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00280 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

281 G:\COMP\PHSA\PHSA-MERGED.XML 281 Sec. 331 PUBLIC HEALTH SERVICE ACT purpose described in this section, to make available non-Federal contributions (in cash or in kind) toward such costs in an amount that is not less than 20 percent of Federal funds provided in the grant. UTHORIZATION OF A .—To carry out this sec- PPROPRIATIONS (g) A tion, there are authorized to be appropriated, $9,000,000 for the pe- riod of fiscal years 2018 through 2022. Subpart II—National Health Service Corps Program NATIONAL HEALTH SERVICE CORPS . 331. ø 254d ¿ (a)(1) For the purpose of eliminating health EC S 38 manpower shortages in health professional shortage areas, there is established, within the Service, the National Health Service Corps, which shall consist of— (A) such officers of the Regular and Reserve Corps of the Service as the Secretary may designate, (B) such civilian employees of the United States as the Secretary may appoint, and (C) such other individuals who are not employees of the United States. (2) The Corps shall be utilized by the Secretary to provide pri- mary health services in health professional shortage areas. (3) For purposes of this subpart and subpart III: (A) The term ‘‘Corps’’ means the National Health Service Corps. (B) The term ‘‘Corps member’’ means each of the officers, employees, and individuals of which the Corps consists pursu- ant to paragraph (1). (C) The term ‘‘health professional shortage area’’ has the meaning given such term in section 332(a). (D) The term ‘‘primary health services’’ means health serv- ices regarding family medicine, internal medicine, pediatrics, obstetrics and gynecology, dentistry, or mental health, that are provided by physicians or other health professionals. (E)(i) The term ‘‘behavioral and mental health profes- sionals’’ means health service psychologists, licensed clinical social workers, licensed professional counselors, marriage and family therapists, psychiatric nurse specialists, and psychia- trists. (ii) The term ‘‘graduate program of behavioral and mental health’’ means a program that trains behavioral and mental health professionals. (b)(1) The Secretary may conduct at schools of medicine, osteo- pathic medicine, dentistry, and, as appropriate, nursing and other schools of the health professions, including schools at which grad- uate programs of behavioral and mental health are offered, and at entities which train allied health personnel, recruiting programs for the Corps, the Scholarship Program, and the Loan Repayment Program. Such recruiting programs shall include efforts to recruit 38 So in law. Probably should be ‘‘health professional shortages’’. See section 401 of Public Law 101–597 (104 Stat. 3035). March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00281 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

282 G:\COMP\PHSA\PHSA-MERGED.XML 282 Sec. 331 PUBLIC HEALTH SERVICE ACT individuals who will serve in the Corps other than pursuant to obli- gated service under the Scholarship or Loan Repayment Program. (2) In the case of physicians, dentists, behavioral and mental health professionals, certified nurse midwives, certified nurse prac- titioners, and physician assistants who have an interest and a com- mitment to providing primary health care, the Secretary may es- tablish fellowship programs to enable such health professionals to gain exposure to and expertise in the delivery of primary health services in health professional shortage areas. To the maximum ex- tent practicable, the Secretary shall ensure that any such programs are established in conjunction with accredited residency programs, and other training programs, regarding such health professions. (c)(1) The Secretary may reimburse an applicant for a position in the Corps (including an individual considering entering into a written agreement pursuant to section 338D) for the actual and reasonable expenses incurred in traveling to and from the appli- cant’s place of residence to an eligible site to which the applicant may be assigned under section 333 for the purpose of evaluating such site with regard to being assigned at such site. The Secretary may establish a maximum total amount that may be paid to an in- dividual as reimbursement for such expenses. (2) The Secretary may also reimburse the applicant for the ac- tual and reasonable expenses incurred for the travel of 1 family member to accompany the applicant to such site. The Secretary may establish a maximum total amount that may be paid to an in- dividual as reimbursement for such expenses. (3) In the case of an individual who has entered into a contract for obligated service under the Scholarship Program or under the Loan Repayment Program, the Secretary may reimburse such indi- vidual for all or part of the actual and reasonable expenses in- curred in transporting the individual, the individual’s family, and the family’s possessions to the site of the individual’s assignment under section 333. The Secretary may establish a maximum total amount that may be paid to an individual as reimbursement for such expenses. (d)(1) The Secretary may, under regulations promulgated by the Secretary, adjust the monthly pay of each member of the Corps (other than a member described in subsection (a)(1)(C)) who is di- rectly engaged in the delivery of health services in a health profes- sional shortage area as follows: (A) During the first 36 months in which such a member is so engaged in the delivery of health services, his monthly pay may be increased by an amount which when added to the member’s monthly pay and allowances will provide a monthly income competitive with the average monthly income from a practice of an individual who is a member of the profession of the Corps member, who has equivalent training, and who has been in practice for a period equivalent to the period during which the Corps member has been in practice. (B) During the period beginning upon the expiration of the 36 months referred to in subparagraph (A) and ending with the month in which the member’s monthly pay and allowances are equal to or exceed the monthly income he received for the last of such 36 months, the member may receive in addition to his March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00282 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

283 G:\COMP\PHSA\PHSA-MERGED.XML 283 Sec. 331 PUBLIC HEALTH SERVICE ACT monthly pay and allowances an amount which when added to such monthly pay and allowances equals the monthly income he received for such last month. (C) For each month in which a member is directly engaged in the delivery of health services in a health professional short- age area in accordance with an agreement with the Secretary entered into under section 741(f)(1)(C), under which the Sec- retary is obligated to make payments in accordance with sec- tion 741(f)(2), the amount of any monthly increase under sub- paragraph (A) or (B) with respect to such member shall be de- creased by an amount equal to one-twelfth of the amount which the Secretary is obligated to pay upon the completion of the year of practice in which such month occurs. For purposes of subparagraphs (A) and (B), the term ‘‘monthly pay’’ includes special pay received under chapter 5 of title 37 of the United States Code. (2) In the case of a member of the Corps who is directly en- gaged in the delivery of health services in a health professional shortage area in accordance with a service obligation incurred under the Scholarship Program or the Loan Repayment Program, the adjustment in pay authorized by paragraph (1) may be made for such a member only upon satisfactory completion of such serv- ice obligation, and the first 36 months of such member’s being so engaged in the delivery of health services shall, for purposes of paragraph (1)(A), be deemed to begin upon such satisfactory com- pletion. (3) A member of the Corps described in subparagraph (C) of subsection (a)(1) shall when assigned to an entity under section 333 be subject to the personnel system of such entity, except that such member shall receive during the period of assignment the income that the member would receive if the member was a member of the Corps described in subparagraph (B) of such subsection. (e) Corps members assigned under section 333 to provide health services in health professional shortage areas shall not be counted against any employment ceiling affecting the Department. (f) Sections 214 and 216 shall not apply to members of the Na- tional Health Service Corps during their period of obligated service under the Scholarship Program or the Loan Repayment Program, except when such members are Commissioned Corps officers who entered into a contract with Secretary under section 338A or 338B after December 31, 2006 and when the Secretary determines that exercising the authority provided under section 214 or 216 with re- spect to any such officer to would not cause unreasonable disrup- tion to health care services provided in the community in which such officer is providing health care services. (g)(1) The Secretary shall, by rule, prescribe conversion provi- sions applicable to any individual who, within a year after comple- tion of service as a member of the Corps described in subsection (a)(1)(C), becomes a commissioned officer in the Regular or Reserve Corps of the Service. (2) The rules prescribed under paragraph (1) shall provide that in applying the appropriate provisions of this Act which relate to retirement, any individual who becomes such an officer shall be en- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00283 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

284 G:\COMP\PHSA\PHSA-MERGED.XML 284 Sec. 331 PUBLIC HEALTH SERVICE ACT titled to have credit for any period of service as a member of the Corps described in subsection (a)(1)(C). (h) The Secretary shall ensure that adequate staff is provided to the Service with respect to effectively administering the program for the Corps. (i)(1) In carrying out subpart III, the Secretary may, in accord- ance with this subsection, issue waivers to individuals who have entered into a contract for obligated service under the Scholarship Program or the Loan Repayment Program under which the individ- uals are authorized to satisfy the requirement of obligated service through providing clinical practice that is half time. (2) A waiver described in paragraph (1) may be provided by the Secretary only if— (A) the entity for which the service is to be performed— (i) has been approved under section 333A for assign- ment of a Corps member; and (ii) has requested in writing assignment of a health professional who would serve half time; (B) the Secretary has determined that assignment of a health professional who would serve half time would be appro- priate for the area where the entity is located; (C) a Corps member who is required to perform obligated service has agreed in writing to be assigned for half-time serv- ice to an entity described in subparagraph (A); (D) the entity and the Corps member agree in writing that the Corps member will perform half-time clinical practice; (E) the Corps member agrees in writing to fulfill all of the service obligations under section 338C through half-time clin- ical practice and either— (i) double the period of obligated service that would otherwise be required; or (ii) in the case of contracts entered into under section 338B, accept a minimum service obligation of 2 years with an award amount equal to 50 percent of the amount that would otherwise be payable for full-time service; and (F) the Corps member agrees in writing that if the Corps member begins providing half-time service but fails to begin or complete the period of obligated service, the method stated in 338E(c) for determining the damages for breach of the individ- ual’s written contract will be used after converting periods of obligated service or of service performed into their full-time equivalents. (3) In evaluating waivers issued under paragraph (1), the Sec- retary shall examine the effect of multidisciplinary teams. (j) For the purposes of this subpart and subpart III: (1) The term ‘‘Department’’ means the Department of Health and Human Services. (2) The term ‘‘Loan Repayment Program’’ means the Na- tional Health Service Corps Loan Repayment Program estab- lished under section 338B. (3) The term ‘‘Scholarship Program’’ means the National Health Service Corps Scholarship Program established under section 338A. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00284 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

285 G:\COMP\PHSA\PHSA-MERGED.XML 285 Sec. 332 PUBLIC HEALTH SERVICE ACT (4) The term ‘‘State’’ includes, in addition to the several States, only the District of Columbia, the Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Is- lands, the Virgin Islands, Guam, American Samoa, and the Trust Territory of the Pacific Islands. (5) The terms ‘‘full time’’ and ‘‘full-time’’ mean a minimum of 40 hours per week in a clinical practice, for a minimum of 45 weeks per year. (6) The terms ‘‘half time’’ and ‘‘half-time’’ mean a min- imum of 20 hours per week (not to exceed 39 hours per week) in a clinical practice, for a minimum of 45 weeks per year. DESIGNATION OF HEALTH PROFESSIONAL SHORTAGE AREAS . 332. ø EC ¿ (a)(1) For purposes of this subpart the term 254e S ‘‘health professional shortage area’’ means (A) an area in an urban or rural area (which need not conform to the geographic boundaries of a political subdivision and which is a rational area for the deliv- ery of health services) which the Secretary determines has a health manpower shortage, (B) a population group which the Secretary de- termines has such a shortage, or (C) a public or nonprofit private medical facility or other public facility which the Secretary deter- mines has such a shortage. All Federally qualified health centers and rural health clinics, as defined in section 1861(aa) of the Social Security Act (42 U.S.C. 1395x(aa)), that meet the requirements of section 334 shall be automatically designated as having such a shortage. The Secretary shall not remove an area from the areas determined to be health professional shortage areas under subpara- graph (A) of the preceding sentence until the Secretary has af- forded interested persons and groups in such area an opportunity to provide data and information in support of the designation as a health professional shortage area or a population group described in subparagraph (B) of such sentence or a facility described in sub- paragraph (C) of such sentence, and has made a determination on the basis of the data and information submitted by such persons and groups and other data and information available to the Sec- retary. (2) For purposes of this subsection, the term ‘‘medical facility’’ means a facility for the delivery of health services and includes— (A) a hospital, State mental hospital, public health center, outpatient medical facility, rehabilitation facility, facility for long-term care, community mental health center, migrant health center, facility operated by a city or county health de- partment, and community health center and which is not rea- sonably accessible to an adequately served area; (B) such a facility of a State correctional institution or of the Indian Health Service, and a health program or facility op- erated by a tribe or tribal organization under the Indian Self- Determination Act; (C) such a facility used in connection with the delivery of health services under section 321 (relating to hospitals), 322 (relating to care and treatment of persons under quarantine and others), 323 (relating to care and treatment of Federal prisoners), 324 (relating to examination and treatment of cer- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00285 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

286 G:\COMP\PHSA\PHSA-MERGED.XML 286 Sec. 332 PUBLIC HEALTH SERVICE ACT tain Federal employees), 325 (relating to examination of aliens), 326 (relating to services to certain Federal employees), 320 (relating to services for persons with Hansen’s disease), or 330(h) (relating to the provision of health services to homeless individuals); and (D) a Federal medical facility. (3) Homeless individuals (as defined in section 330(h)(5)), sea- sonal agricultural workers (as defined in section 330(g)(3)) and mi- gratory agricultural workers (as so defined)), and residents of pub- lic housing (as defined in section 3(b)(1) of the United States Hous- ing Act of 1937 (42 U.S.C. 1437a(b)(1))) may be population groups under paragraph (1). (b) The Secretary shall establish by regulation criteria for the designation of areas, population groups, medical facilities, and other public facilities, in the States, as health professional shortage areas. In establishing such criteria, the Secretary shall take into consideration the following: (1) The ratio of available health manpower to the number of individuals in an area or population group, or served by a medical facility or other public facility under consideration for designation. (2) Indicators of a need, notwithstanding the supply of health manpower, for health services for the individuals in an area or population group or served by a medical facility or other public facility under consideration for designation. (3) The percentage of physicians serving an area, popu- lation group, medical facility, or other public facility under con- sideration for designation who are employed by hospitals and who are graduates of foreign medical schools. (c) In determining whether to make a designation, the Sec- retary shall take into consideration the following: (1) The recommendations of the Governor of each State in which the area, population group, medical facility, or other public facility under consideration for designation is in whole or part located. (2) The extent to which individuals who are (A) residents of the area, members of the population group, or patients in the medical facility or other public facility under consideration for designation, and (B) entitled to have payment made for medical services under title XVIII, XIX, or XXI of the Social Security Act, cannot obtain such services because of suspension of physicians from the programs under such titles. (d)(1) In accordance with the criteria established under sub- section (b) and the considerations listed in subsection (c), the Sec- retary shall designate health professional shortage areas in the States, publish a descriptive list of the areas, population groups, medical facilities, and other public facilities so designated, and at least annually review and, as necessary, revise such designations. (2) For purposes of paragraph (1), a complete descriptive list shall be published in the Federal Register not later than July 1 of 1991 and each subsequent year. (e)(1) Prior to the designation of a public facility, including a Federal medical facility, as a health professional shortage area, the Secretary shall give written notice of such proposed designation to March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00286 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

287 G:\COMP\PHSA\PHSA-MERGED.XML 287 Sec. 332 PUBLIC HEALTH SERVICE ACT the chief administrative officer of such facility and request com- ments within 30 days with respect to such designation. (2) Prior to the designation of a health professional shortage area under this section, the Secretary shall, to the extent prac- ticable, give written notice of the proposed designation of such area to appropriate public or private nonprofit entities which are located or have a demonstrated interest in such area and request com- ments from such entities with respect to the proposed designation of such area. (f) The Secretary shall give written notice of the designation of a health professional shortage area, not later than 60 days from the date of such designation, to— (1) the Governor of each State in which the area, popu- lation group, medical facility, or other public facility so des- ignated is in whole or part located; and (2) appropriate public or nonprofit private entities which are located or which have a demonstrated interest in the area so designated. (g) Any person may recommend to the Secretary the designa- tion of an area, population group, medical facility, or other public facility as a health professional shortage area. (h) The Secretary may conduct such information programs in areas, among population groups, and in medical facilities and other public facilities designated under this section as health professional shortage areas as may be necessary to inform public and nonprofit private entities which are located or have a demonstrated interest in such areas of the assistance available under this title by virtue of the designation of such areas. ISSEMINATION .—The Administrator of the Health Re- (i) D sources and Services Administration shall disseminate information concerning the designation criteria described in subsection (b) to— (1) the Governor of each State; (2) the representative of any area, population group, or fa- cility selected by any such Governor to receive such informa- tion; (3) the representative of any area, population group, or fa- cility that requests such information; and (4) the representative of any area, population group, or fa- cility determined by the Administrator to be likely to meet the criteria described in subsection (b). (j)(1) The Secretary shall submit the report described in para- graph (2) if the Secretary, acting through the Administrator of the Health Resources and Services Administration, issues— (A) a regulation that revises the definition of a health pro- fessional shortage area for purposes of this section; or (B) a regulation that revises the standards concerning pri- ority of such an area under section 333A. (2) On issuing a regulation described in paragraph (1), the Sec- retary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report that describes the regulation. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00287 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

288 G:\COMP\PHSA\PHSA-MERGED.XML 288 Sec. 333 PUBLIC HEALTH SERVICE ACT (3) Each regulation described in paragraph (1) shall take effect 180 days after the committees described in paragraph (2) receive a report referred to in such paragraph describing the regulation. (k)(1) The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall identify, based on the data collected under paragraph (3), maternity care health professional target areas that satisfy the criteria described in paragraph (2) for purposes of, in connection with receipt of as- sistance under this title, assigning to such identified areas mater- nity care health professionals who, without application of this sub- section, would otherwise be eligible for such assistance. The Sec- retary shall distribute maternity care health professionals within health professional shortage areas using the maternity care health professional target areas so identified. (2) For purposes of paragraph (1), the Secretary shall establish criteria for maternity care health professional target areas that identify geographic areas within health professional shortage areas that have a shortage of maternity care health professionals. (3) For purposes of this subsection, the Secretary shall collect and publish in the Federal Register data comparing the availability and need of maternity care health services in health professional shortage areas and in areas within such health professional short- age areas. (4) In carrying out paragraph (1), the Secretary shall seek input from relevant provider organizations, including medical soci- eties, organizations representing medical facilities, and other orga- nizations with expertise in maternity care. (5) For purposes of this subsection, the term ‘‘full scope mater- nity care health services’’ includes during labor care, birthing, pre- natal care, and postpartum care. (6) Nothing in this subsection shall be construed as— (A) requiring the identification of a maternity care health professional target area in an area not otherwise already des- ignated as a health professional shortage area; or (B) affecting the types of health professionals, without ap- plication of this subsection, otherwise eligible for assistance, including a loan repayment or scholarship, pursuant to the ap- plication of this section. ASSIGNMENT OF CORPS PERSONNEL S ø 254f ¿ (a)(1) The Secretary may assign members of EC . 333. the Corps to provide, under regulations promulgated by the Sec- retary, health services in or to a health professional shortage area during the assignment period only if— (A) a public or private entity, which is located or has a demonstrated interest in such area, makes application to the Secretary for such assignment; (B) such application has been approved by the Secretary; (C) the entity agrees to comply with the requirements of section 334; and (D) the Secretary has (i) conducted an evaluation of the need and demand for health professional shortage area, the in- tended use of Corps members to be assigned to the area, com- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00288 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

289 G:\COMP\PHSA\PHSA-MERGED.XML 289 Sec. 333 PUBLIC HEALTH SERVICE ACT munity support for the assignment of Corps members to the area, the area’s efforts to secure health professional shortage area, and the fiscal management capability of the entity to which Corps members would be assigned and (ii) on the basis of such evaluation has determined that— (I) there is a need and demand for health manpower for the area; (II) there has been appropriate and efficient use of any Corps members previously assigned to the entity for the area; (III) there is general community support for the as- signment of Corps members to the entity; (IV) the area has made unsuccessful efforts to secure health manpower for the area; (V) there is a reasonable prospect of sound fiscal man- agement, including efficient collection of fee-for-service, third-party, and other appropriate funds, by the entity with respect to Corps members assigned to such entity; and 39 (VI) the entity demonstrates willingness to support or facilitate mentorship, professional de- velopment, and training opportunities for Corps members. An application for assignment of a Corps member to a health pro- fessional shortage area shall include a demonstration by the appli- cant that the area or population group to be served by the appli- cant has a shortage of personal health services and that the Corps member will be located so that the member will provide services to the greatest number of persons residing in such area or included in such population group. Such a demonstration shall be made on the basis of the criteria prescribed by the Secretary under section 332(b) and on additional criteria which the Secretary shall pre- scribe to determine if the area or population group to be served by the applicant has a shortage of personal health services. (2) Corps members may be assigned to a Federal health care facility, but only upon the request of the head of the department or agency of which such facility is a part. (3) In approving applications for assignment of members of the Corps the Secretary shall not discriminate against applications from entities which are not receiving Federal financial assistance under this Act. In approving such applications, the Secretary shall give preference to applications in which a nonprofit entity or public entity shall provide a site to which Corps members may be as- signed. (b)(1) The Secretary may not approve an application for the as- signment of a member of the Corps described in subparagraph (C) of section 331(a)(1) to an entity unless the application of the entity contains assurances satisfactory to the Secretary that the entity (A) has sufficient financial resources to provide the member of the Corps with an income of not less than the income to which the member would be entitled if the member was a member described 39 Margin so in law. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00289 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

290 G:\COMP\PHSA\PHSA-MERGED.XML 290 Sec. 333 PUBLIC HEALTH SERVICE ACT in subparagraph (B) of section 331(a)(1), or (B) would have such fi- nancial resources if a grant was made to the entity under para- graph (2). (2)(A) If in approving an application of an entity for the assign- ment of a member of the Corps described in subparagraph (C) of section 331(a)(1) the Secretary determines that the entity does not have sufficient financial resources to provide the member of the Corps with an income of not less than the income to which the member would be entitled if the member was a member described in subparagraph (B) of section 331(a)(1), the Secretary may make a grant to the entity to assure that the member of the Corps as- signed to it will receive during the period of assignment to the enti- ty such an income. (B) The amount of any grant under subparagraph (A) shall be determined by the Secretary. Payments under such a grant may be made in advance or by way of reimbursement, and at such inter- vals and on such conditions, as the Secretary finds necessary. No grant may be made unless an application therefor is submitted to and approved by the Secretary. Such an application shall be in such form, submitted in such manner, and contain such informa- tion, as the Secretary shall by regulation prescribe. (c) The Secretary shall assign Corps members to entities in health professional shortage areas without regard to the ability of the individuals in such areas, population groups, medical facilities, or other public facilities to pay for such services. (d)(1) The Secretary may provide technical assistance to a pub- lic or private entity which is located in a health professional short- age area and which desires to make an application under this sec- tion for assignment of a Corps member to such area. Assistance provided under this paragraph may include assistance to an entity in (A) analyzing the potential use of health professions personnel in defined health services delivery areas by the residents of such areas, (B) determining the need for such personnel in such areas, (C) determining the extent to which such areas will have a finan- cial base to support the practice of such personnel and the extent to which additional financial resources are needed to adequately support the practice, (D) determining the types of inpatient and other health services that should be provided by such personnel in such areas, and (E) developing long-term plans for addressing health professional shortages and improving access to health care. The Secretary shall encourage entities that receive technical assist- ance under this paragraph to communicate with other commu- nities, State Offices of Rural Health, State Primary Care Associa- tions and Offices, and other entities concerned with site develop- ment and community needs assessment. (2) The Secretary may provide, to public and private entities which are located in a health professional shortage area to which area a Corps member has been assigned, technical assistance to as- sist in the retention of such member in such area after the comple- tion of such member’s assignment to the area. (3) The Secretary may provide, to health professional shortage areas to which no Corps member has been assigned, (A) technical assistance to assist in the recruitment of health manpower for such March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00290 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

291 G:\COMP\PHSA\PHSA-MERGED.XML 291 Sec. 333 PUBLIC HEALTH SERVICE ACT areas, and (B) current information on public and private programs which provide assistance in the securing of health manpower. (4)(A) The Secretary shall undertake to demonstrate the im- provements that can be made in the assignment of members of the Corps to health professional shortage areas and in the delivery of health care by Corps members in such areas through coordination with States, political subdivisions of States, agencies of States and political subdivisions, and other public and private entities which have expertise in the planning, development, and operation of cen- ters for the delivery of primary health care. In carrying out this subparagraph, the Secretary shall enter into agreements with qualified entities which provide that if— (i) the entity places in effect a program for the planning, development, and operation of centers for the delivery of pri- mary health care in health professional shortage areas which reasonably addresses the need for such care in such areas, and (ii) under the program the entity will perform the func- tions described in subparagraph (B), the Secretary will assign under this section members of the Corps in accordance with the program. (B) For purposes of subparagraph (A), the term ‘‘qualified enti- ty’’ means a State, political subdivision of a State, an agency of a State or political subdivision, or other public or private entity oper- ating solely within one State, which the Secretary determines is able— (i) to analyze the potential use of health professions per- sonnel in defined health services delivery areas by the resi- dents of such areas; (ii) to determine the need for such personnel in such areas and to recruit, select, and retain health professions personnel (including members of the National Health Service Corps) to meet such need; (iii) to determine the extent to which such areas will have a financial base to support the practice of such personnel and the extent to which additional financial resources are needed to adequately support the practice; (iv) to determine the types of inpatient and other health services that should be provided by such personnel in such areas; (v) to assist such personnel in the development of their clinical practice and fee schedules and in the management of their practice; (vi) to assist in the planning and development of facilities for the delivery of primary health care; and (vii) to assist in establishing the governing bodies of cen- ters for the delivery of such care and to assist such bodies in defining and carrying out their responsibilities. (e) Notwithstanding any other law, any member of the Corps licensed to practice medicine, osteopathic medicine, dentistry, or any other health profession in any State shall, while serving in the Corps, be allowed to practice such profession in any State. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00291 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

292 G:\COMP\PHSA\PHSA-MERGED.XML 292 Sec. 333A PUBLIC HEALTH SERVICE ACT 254f–1 ¿ SEC. 333A. ø PRIORITIES IN ASSIGNMENT OF CORPS PER- SONNEL. G .—In approving applications made under sec- N ENERAL (a) I tion 333 for the assignment of Corps members, the Secretary shall— (1) give priority to any such application that— (A) is made regarding the provision of primary health services to a health professional shortage area with the greatest such shortage; and (B) is made by an entity that— (i) serves a health professional shortage area de- scribed in subparagraph (A); (ii) coordinates the delivery of primary health services with related health and social services; (iii) has a documented record of sound fiscal man- agement; and (iv) will experience a negative impact on its capac- ity to provide primary health services if a Corps mem- ber is not assigned to the entity; (2) with respect to the geographic area in which the health professional shortage area is located, take into consideration the willingness of individuals in the geographic area, and of the appropriate governmental agencies or health entities in the area, to assist and cooperate with the Corps in providing effec- tive primary health services; and (3) take into consideration comments of medical, osteo- pathic, dental, or other health professional societies whose members deliver services to the health professional shortage area, or if no such societies exist, comments of physicians, den- tists, or other health professionals delivering services to the area. (b) E C RITERIA FOR D ETERMINING P RIOR - STABLISHMENT OF .— ITIES .—The Secretary shall establish criteria N GENERAL (1) I specifying the manner in which the Secretary makes a deter- mination under subsection (a)(1)(A) of the health professional shortage areas with the greatest such shortages. (2) P UBLICATION OF CRITERIA .—The criteria required in paragraph (1) shall be published in the Federal Register not later than July 1, 1991. Any revisions made in the criteria by the Secretary shall be effective upon publication in the Federal Register. (c) N R EGARDING P RIORITIES .— OTIFICATIONS ROPOSED LIST .—The Secretary shall prepare and pub- (1) P lish a proposed list of health professional shortage areas and entities that would receive priority under subsection (a)(1) in the assignment of Corps members. The list shall contain the information described in paragraph (2), and the relative scores and relative priorities of the entities submitting applications under section 333, in a proposed format. All such entities shall have 30 days after the date of publication of the list to provide additional data and information in support of inclusion on the list or in support of a higher priority determination and the March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00292 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

293 G:\COMP\PHSA\PHSA-MERGED.XML 293 Sec. 333A PUBLIC HEALTH SERVICE ACT Secretary shall reasonably consider such data and information in preparing the final list under paragraph (2). REPARATION OF LIST FOR APPLICABLE PERIOD .—For the (2) P purpose of carrying out paragraph (3), the Secretary shall pre- pare and, as appropriate, update a list of health professional shortage areas and entities that are receiving priority under subsection (a)(1) in the assignment of Corps members. Such list— (A) shall include a specification, for each such health professional shortage area, of the entities for which the Secretary has provided an authorization to receive assign- ments of Corps members in the event that Corps members are available for the assignments; and (B) shall, of the entities for which an authorization de- scribed in subparagraph (A) has been provided, specify— (i) the entities provided such an authorization for the assignment of Corps members who are partici- pating in the Scholarship Program; (ii) the entities provided such an authorization for the assignment of Corps members who are partici- pating in the Loan Repayment Program; and (iii) the entities provided such an authorization for the assignment of Corps members who have become Corps members other than pursuant to contractual ob- ligations under the Scholarship or Loan Repayment Programs. The Secretary may set forth such specifications by medical specialty. .— OTIFICATION OF AFFECTED PARTIES (3) N NTITIES .—Not later than 30 days after the Sec- (A) E retary has added to a list under paragraph (2) an entity specified as described in subparagraph (A) of such para- graph, the Secretary shall notify such entity that the enti- ty has been provided an authorization to receive assign- ments of Corps members in the event that Corps members are available for the assignments. NDIVIDUALS .—In the case of an individual obli- (B) I gated to provide service under the Scholarship Program, not later than 3 months before the date described in sec- tion 338C(b)(5), the Secretary shall provide to such indi- vidual the names of each of the entities specified as de- scribed in paragraph (2)(B)(i) that is appropriate for the individual’s medical specialty and discipline. (4) R .—If the Secretary proposes to make a revi- EVISIONS sion in the list under paragraph (2), and the revision would ad- versely alter the status of an entity with respect to the list, the Secretary shall notify the entity of the revision. Any entity ad- versely affected by such a revision shall be notified in writing by the Secretary of the reasons for the revision and shall have 30 days from such notification to file a written appeal of the determination involved which shall be reasonably considered by the Secretary before the revision to the list becomes final. The revision to the list shall be effective with respect to assign- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00293 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

294 G:\COMP\PHSA\PHSA-MERGED.XML 294 Sec. 334 PUBLIC HEALTH SERVICE ACT ment of Corps members beginning on the date that the revi- sion becomes final. UMBER OF E NTITIES O FFERED AS A SSIGN - N IMITATION ON (d) L S CHOLARSHIP P ROGRAM .— HOICES IN C MENT .—By (1) D ETERMINATION OF AVAILABLE CORPS MEMBERS April 1 of each calendar year, the Secretary shall determine the number of participants in the Scholarship Program who will be available for assignments under section 333 during the program year beginning on July 1 of that calendar year. (2) D ETERMINATION OF NUMBER OF ENTITIES .—At all times during a program year, the number of entities specified under subsection (c)(2)(B)(i) shall be— (A) not less than the number of participants deter- mined with respect to that program year under paragraph (1); and (B) not greater than twice the number of participants determined with respect to that program year under para- graph (1). SEC. 334. ø 254g ¿ CHARGES FOR SERVICES BY ENTITIES USING CORPS MEMBERS. VAILABILITY OF S ERVICES R EGARDLESS OF A BILITY T O P AY (a) A P OR OURCE .—An entity to which a Corps member is as- AYMENT S signed shall not deny requested health care services, and shall not discriminate in the provision of services to an individual— (1) because the individual is unable to pay for the services; or (2) because payment for the services would be made under— (A) the medicare program under title XVIII of the So- cial Security Act (42 U.S.C. 1395 et seq.); (B) the medicaid program under title XIX of such Act (42 U.S.C. 1396 et seq.); or (C) the State children’s health insurance program under title XXI of such Act (42 U.S.C. 1397aa et seq.). (b) C HARGES FOR .—The following rules shall apply to S ERVICES charges for health care services provided by an entity to which a Corps member is assigned: (1) I .— N GENERAL CHEDULE OF FEES OR PAYMENTS .—Except as pro- (A) S vided in paragraph (2), the entity shall prepare a schedule of fees or payments for the entity’s services, consistent with locally prevailing rates or charges and designed to cover the entity’s reasonable cost of operation. (B) S CHEDULE OF DISCOUNTS .—Except as provided in paragraph (2), the entity shall prepare a corresponding schedule of discounts (including, in appropriate cases, waivers) to be applied to the payment of such fees or pay- ments. In preparing the schedule, the entity shall adjust the discounts on the basis of a patient’s ability to pay. SE OF SCHEDULES .—The entity shall make every (C) U reasonable effort to secure from patients fees and pay- ments for services in accordance with such schedules, and fees or payments shall be sufficiently discounted in accord- ance with the schedule described in subparagraph (B). March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00294 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

295 G:\COMP\PHSA\PHSA-MERGED.XML 295 Sec. 335 PUBLIC HEALTH SERVICE ACT - ERVICES TO BENEFICIARIES OF FEDERAL AND FEDER (2) S .—In the case of health care services ALLY ASSISTED PROGRAMS furnished to an individual who is a beneficiary of a program listed in subsection (a)(2), the entity— (A) shall accept an assignment pursuant to section 1842(b)(3)(B)(ii) of the Social Security Act (42 U.S.C. 1395u(b)(3)(B)(ii)) with respect to an individual who is a beneficiary under the medicare program; and (B) shall enter into an appropriate agreement with— (i) the State agency administering the program under title XIX of such Act with respect to an indi- vidual who is a beneficiary under the medicaid pro- gram; and (ii) the State agency administering the program under title XXI of such Act with respect to an indi- vidual who is a beneficiary under the State children’s health insurance program. .—The entity shall take rea- OLLECTION OF PAYMENTS (3) C sonable and appropriate steps to collect all payments due for health care services provided by the entity, including payments from any third party (including a Federal, State, or local gov- ernment agency and any other third party) that is responsible for part or all of the charge for such services. PROVISION OF HEALTH SERVICES BY CORPS MEMBERS S . 335. ø 254h ¿ (a) In providing health services in a health EC professional shortage area, Corps members shall utilize the tech- niques, facilities, and organizational forms most appropriate for the area, population group, medical facility, or other public facility, and shall, to the maximum extent feasible, provide such services (1) to all individuals in, or served by, such health professional shortage area regardless of their ability to pay for the services, and (2) in a manner which is cooperative with other health care providers serving such health professional shortage area. (b)(1) Notwithstanding any other provision of law, the Sec- retary may (A) to the maximum extent feasible make such arrange- ments as he determines necessary to enable Corps members to uti- lize the health facilities in or serving the health professional short- age area in providing health services; (B) make such arrangements as he determines are necessary for the use of equipment and sup- plies of the Service and for the lease or acquisition of other equip- ment and supplies; and (C) secure the permanent or temporary services of physicians, dentists, nurses, administrators, and other health personnel. If there are no health facilities in or serving such area, the Secretary may arrange to have Corps members provide health services in the nearest health facilities of the Service or may lease or otherwise provide facilities in or serving such area for the provision of health services. (2) If the individuals in or served by a health professional shortage area are being served (as determined under regulations of the Secretary) by a hospital or other health care delivery facility of the Service, the Secretary may, in addition to such other ar- rangements as he may make under paragraph (1), arrange for the March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00295 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

296 G:\COMP\PHSA\PHSA-MERGED.XML 296 Sec. 336 PUBLIC HEALTH SERVICE ACT utilization of such hospital or facility by Corps members in pro- viding health services, but only to the extent that such utilization will not impair the delivery of health services and treatment through such hospital or facility to individuals who are entitled to health services and treatment through such hospital or facility. (c) The Secretary may make one loan to any entity with an ap- proved application under section 333 to assist such entity in meet- ing the costs of (1) establishing medical, dental, or other health profession practices, including the development of medical practice management systems; (2) acquiring equipment for use in providing health services; and (3) renovating buildings to establish health fa- cilities. No loan may be made under this subsection unless an ap- plication therefor is submitted to, and approved by, the Secretary. The amount of any such loan shall be determined by the Secretary, except that no such loan may exceed $50,000. (d) Upon the expiration of the assignment of all Corps mem- bers to a health professional shortage area, the Secretary may (not- withstanding any other provision of law) sell, to any appropriate local entity, equipment and other property of the United States uti- lized by such members in providing health services. Sales made under this subsection shall be made at the fair market value (as determined by the Secretary) of the equipment or such other prop- erty; except that the Secretary may make such sales for a lesser value to an appropriate local entity, if he determines that the enti- ty is financially unable to pay the full market value. (e)(1)(A) It shall be unlawful for any hospital to deny an au- thorized Corps member admitting privileges when such Corps member otherwise meets the professional qualifications established by the hospital for granting such privileges and agrees to abide by the published bylaws of the hospital and the published bylaws, rules, and regulations of its medical staff. (B) Any hospital which is found by the Secretary, after notice and an opportunity for a hearing on the record, to have violated this subsection shall upon such finding cease, for a period to be de- termined by the Secretary, to receive and to be eligible to receive any Federal funds under this Act or under titles XVIII, XIX, or XXI of the Social Security Act. (2) For purposes of this subsection, the term ‘‘hospital’’ includes a State or local public hospital, a private profit hospital, a private nonprofit hospital, a general or special hospital, and any other type of hospital (excluding a hospital owned or operated by an agency of the Federal Government), and any related facilities. 254h–1 FACILITATION OF EFFECTIVE PROVISION OF CORPS ø ¿ SEC. 336. SERVICES. I (a) C C HARACTERISTICS OF M EM - ONSIDERATION OF NDIVIDUAL M AKING A SSIGNMENTS .—In making an assignment of a BERS IN Corps member to an entity that has had an application approved under section 333, the Secretary shall, subject to making the as- signment in accordance with section 333A, seek to assign to the en- tity a Corps member who has (and whose spouse, if any, has) char- acteristics that increase the probability that the member will re- main in the health professional shortage area involved after the completion of the period of service in the Corps. OUNSELING ON S ERVICE IN C ORPS .— (b) C March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00296 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

297 G:\COMP\PHSA\PHSA-MERGED.XML 297 Sec. 336 PUBLIC HEALTH SERVICE ACT .—The Secretary shall, subject to paragraph N GENERAL (1) I (3), offer appropriate counseling on service in the Corps to indi- viduals during the period of membership in the Corps, particu- larly during the initial period of each assignment. (2) C AREER ADVISOR REGARDING OBLIGATED SERVICE .— (A) In the case of individuals who have entered into contracts for obligated service under the Scholarship or Loan Repayment Program, counseling under paragraph (1) shall include appropriate counseling on matters particular to such obligated service. The Secretary shall ensure that career advisors for providing such counseling are available to such individuals throughout the period of participation in the Scholarship or Loan Repayment Program. (B) With respect to the Scholarship Program, coun- seling under paragraph (1) shall include counseling indi- viduals during the period in which the individuals are pur- suing an educational degree in the health profession in- volved, including counseling to prepare the individual for service in the Corps. (3) E .—With respect to in- XTENT OF COUNSELING SERVICES dividuals who have entered into contracts for obligated service under the Scholarship or Loan Repayment Program, this sub- section shall be carried out regarding such individuals throughout the period of obligated service (and, additionally, throughout the period specified in paragraph (2)(B), in the case of the Scholarship Program). With respect to Corps members generally, this subsection shall be carried out to the extent practicable. RANTS R EGARDING P REPARATION OF S TUDENTS FOR P RAC - (c) G TICE .—With respect to individuals who have entered into contracts for obligated service under the Scholarship or Loan Repayment Program, the Secretary may make grants to, and enter into con- tracts with, public and nonprofit private entities (including health professions schools) for the conduct of programs designed to pre- pare such individuals for the effective provision of primary health services in the health professional shortage areas to which the indi- viduals are assigned. (d) P ROFESSIONAL T RAINING .— D EVELOPMENT AND N GENERAL .—The Secretary shall assist Corps mem- (1) I bers in establishing and maintaining professional relationships and development opportunities, including by— (A) establishing appropriate professional relationships between the Corps member involved and the health profes- sions community of the geographic area with respect to which the member is assigned; (B) establishing professional development, training, and mentorship linkages between the Corps member in- volved and the larger health professions community, in- cluding through distance learning, direct mentorship, and development and implementation of training modules de- signed to meet the educational needs of offsite Corps mem- bers; (C) establishing professional networks among Corps members; or March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00297 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

298 G:\COMP\PHSA\PHSA-MERGED.XML 298 Sec. 336 PUBLIC HEALTH SERVICE ACT (D) engaging in other professional development, mentorship, and training activities for Corps members, at the discretion of the Secretary. SSISTANCE IN ESTABLISHING PROFESSIONAL RELATION - (2) A SHIPS .—In providing such assistance under paragraph (1), the Secretary shall focus on establishing relationships with hos- pitals, with academic medical centers and health professions schools, with area health education centers under section 751, with health education and training centers under section 752, and with border health education and training centers under such section 752. Such assistance shall include assistance in obtaining faculty appointments at health professions schools. UPPLEMENT NOT SUPPLANT .—Such efforts under this (3) S subsection shall supplement, not supplant, non-government ef- forts by professional health provider societies to establish and maintain professional relationships and development opportu- nities. R UTIES EMPORARY ELIEF F ROM C ORPS D .— (e) T .—The Secretary shall, subject to paragraph N GENERAL (1) I (4), provide assistance to Corps members in establishing ar- rangements through which Corps members may, as appro- priate, be provided temporary relief from duties in the Corps in order to pursue continuing education in the health profes- sions, to participate in exchange programs with teaching cen- ters, to attend professional conferences, or to pursue other in- terests, including vacations. SSUMPTION OF DUTIES OF MEMBER .— (2) A (A) Temporary relief under paragraph (1) may be pro- vided only if the duties of the Corps member involved are assumed by another health professional. With respect to such temporary relief, the duties may be assumed by Corps members or by health professionals who are not Corps members, if the Secretary approves the profes- sionals for such purpose. Any health professional so ap- proved by the Secretary shall, during the period of pro- viding such temporary relief, be deemed to be a Corps member for purposes of section 224 (including for purposes 40 , of the remedy described in such section), section 333(f) and section 335(e). (B) In carrying out paragraph (1), the Secretary shall provide for the formation and continued existence of a group of health professionals to provide temporary relief under such paragraph. ECRUITMENT FROM GENERAL HEALTH PROFESSIONS (3) R COMMUNITY .—In carrying out paragraph (1), the Secretary shall— (A) encourage health professionals who are not Corps members to enter into arrangements under which the health professionals temporarily assume the duties of Corps members for purposes of paragraph (1); and 40 So in law. As a result of the amendments made by section 103(b) of Public Law 101–597 (104 Stat. 3015), there is no subsection (f) in section 333. (Subsection (e) of section 333, like sections 224 and 335(e), establishes a right for Corps members.) March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00298 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

299 G:\COMP\PHSA\PHSA-MERGED.XML 299 Sec. 336A PUBLIC HEALTH SERVICE ACT (B) with respect to the entities to which Corps mem- bers have been assigned under section 333, encourage the entities to facilitate the development of arrangements de- scribed in subparagraph (A). (4) L IMITATION .—In carrying out paragraph (1), the Sec- retary may not, except as provided in paragraph (5), obligate any amounts (other than for incidental expenses) for the pur- pose of— (A) compensating a health professional who is not a Corps member for assuming the duties of a Corps member; or (B) paying the costs of a vacation, or other interests that a Corps member may pursue during the period of temporary relief under such paragraph. (5) S .—In the case of OLE PROVIDERS OF HEALTH SERVICES any Corps member who is the sole provider of health services in the geographic area involved, the Secretary may, from amounts appropriated under section 338, obligate on behalf of the member such sums as the Secretary determines to be nec- essary for purposes of providing temporary relief under para- graph (1). (f) D ETERMINATIONS R EGARDING E FFECTIVE S ERVICE .—In car- rying out subsection (a) and sections 338A(d) and 338B(d), the Sec- retary shall carry out activities to determine— (1) the characteristics of physicians, dentists, and other health professionals who are more likely to remain in practice in health professional shortage areas after the completion of the period of service in the Corps; (2) the characteristics of health manpower shortage 41 areas , and of entities seeking assignments of Corps mem- bers, that are more likely to retain Corps members after the members have completed the period of service in the Corps; and (3) the appropriate conditions for the assignment and utili- 41 zation in health manpower shortage areas of certified nurse practitioners, certified nurse midwives, and physician assist- ants. ANNUAL REPORTS S EC The Secretary shall submit an annual report . 336A. ø 254i ¿ to Congress, and shall include in such report with respect to the previous calendar year— (1) the number, identity, and priority of all health profes- sional shortage areas designated in such year and the number of health professional shortage areas which the Secretary esti- mates will be designated in the subsequent year; (2) the number of applications filed under section 333 in such year for assignment of Corps members and the action taken on each such application; (3) the number and types of Corps members assigned in such year to health professional shortage areas, the number 41 So in law. Probably should be ‘‘health professional shortage areas’’. See section 401 of Public Law 101–597 (104 Stat. 3035). March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00299 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

300 G:\COMP\PHSA\PHSA-MERGED.XML 300 Sec. 337 PUBLIC HEALTH SERVICE ACT and types of additional Corps members which the Secretary es- timates will be assigned to such areas in the subsequent year, and the need for additional members for the Corps; (4) the recruitment efforts engaged in for the Corps in such year and the number of qualified individuals who applied for service in the Corps in such year; (5) the number of patients seen and the number of patient visits recorded during such year with respect to each health professional shortage area to which a Corps member was as- signed during such year; (6) the number of Corps members who elected, and the number of Corps members who did not elect, to continue to provide health services in health professional shortage areas after termination of their service in the Corps and the reasons (as reported to the Secretary) of members who did not elect for not making such election; (7) the results of evaluations and determinations made under section 333(a)(1)(D) during such year; and (8) the amount charged during such year for health serv- ices provided by Corps members, the amount which was col- lected in such year by entities in accordance with section 334, and the amount which was paid to the Secretary in such year 42 . under such agreements NATIONAL ADVISORY COUNCIL 254j ø S (a) There is established a council to be known ¿ EC . 337. as the National Advisory Council on the National Health Service Corps (hereinafter in this section referred to as the ‘‘Council’’). The Council shall be composed of fifteen members appointed by the Sec- retary. The Council shall consult with, advise, and make rec- ommendations to, the Secretary with respect to his responsibilities in carrying out this subpart (other than section 338G), and shall review and comment upon regulations promulgated by the Sec- retary under this subpart. (b)(1) Members of the Council shall be appointed for a term of three years, except that any member appointed to fill a vacancy oc- curring prior to the expiration of the term for which the member’s predecessor was appointed shall be appointed for the remainder of such term. No member shall be removed, except for cause. (2) Members of the Council (other than members who are offi- cers or employees of the United States), while attending meetings or conferences thereof or otherwise serving on the business of the Council, shall be entitled to receive for each day (including travel- time) in which they are so serving compensation at a rate fixed by the Secretary (but not to exceed the daily equivalent of the annual rate of basic pay in effect for grade GS–18 of the General Sched- ule); and while so serving away from their homes or regular places of business all members may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of 42 There is no antecedent reference to ‘‘agreements’’. Formerly, paragraph (8) contained the clause ‘‘, the amount which was collected in such year by entities in accordance with agreements under section 334,’’. Section 307(b) of Public Law 107–251 (116 Stat. 1649) struck ‘‘agreements under’’ in that clause. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00300 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

301 G:\COMP\PHSA\PHSA-MERGED.XML 301 Sec. 338A PUBLIC HEALTH SERVICE ACT title 5 of the United States Code for persons in the Government service employed intermittently. (c) Section 14 of the Federal Advisory Committee Act shall not apply with respect to the Council. AUTHORIZATION OF APPROPRIATION ¿ S EC (a) For the purpose of carrying out this sub- . 338. ø 254k part, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2008 through 2012. (b) An appropriation under an authorization under subsection (a) for any fiscal year may be made at any time before that fiscal year and may be included in an Act making an appropriation under an authorization under subsection (a) for another fiscal year; but no funds may be made available from any appropriation under such authorization for obligation under sections 331 through 335, section 336A, and section 337 before the fiscal year for which such appropriation is authorized. Subpart III—Scholarship Program and Loan Repayment Program NATIONAL HEALTH SERVICE CORPS SCHOLARSHIP PROGRAM EC . 338A. ø 254 l ¿ (a) The Secretary shall establish the Na- S tional Health Service Corps Scholarship Program to assure, with respect to the provision of primary health services pursuant to sec- tion 331(a)(2)— (1) an adequate supply of physicians, dentists, behavioral and mental health professionals, certified nurse midwives, cer- tified nurse practitioners, and physician assistants; and (2) if needed by the Corps, an adequate supply of other health professionals. (b) To be eligible to participate in the Scholarship Program, an individual must— (1) be accepted for enrollment, or be enrolled, as a full-time student (A) in an accredited (as determined by the Secretary) educational institution in a State and (B) in a course of study or program, offered by such institution and approved by the Secretary, leading to a degree in medicine, osteopathic medi- cine, dentistry, or other health profession, or an appropriate degree from a graduate program of behavioral and mental health; (2) be eligible for, or hold, an appointment as a commis- sioned officer in the Regular or Reserve Corps of the Service or be eligible for selection for civilian service in the Corps; (3) submit an application to participate in the Scholarship Program; and (4) sign and submit to the Secretary, at the time of sub- mittal of such application, a written contract (described in sub- section (f)) to accept payment of a scholarship and to serve (in accordance with this subpart) for the applicable period of obli- gated service in a health professional shortage area. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00301 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

302 G:\COMP\PHSA\PHSA-MERGED.XML 302 Sec. 338A PUBLIC HEALTH SERVICE ACT (c)(1) In disseminating application forms and contract forms to individuals desiring to participate in the Scholarship Program, the Secretary shall include with such forms— (A) a fair summary of the rights and liabilities of an indi- vidual whose application is approved (and whose contract is ac- cepted) by the Secretary, including in the summary a clear ex- planation of the damages to which the United States is entitled under section 338E in the case of the individual’s breach of the contract; and (B) information respecting meeting a service obligation through private practice under an agreement under section 338D and such other information as may be necessary for the individual to understand the individual’s prospective participa- tion in the Scholarship Program and service in the Corps, in- cluding a statement of all factors considered in approving ap- plications for participation in the Program and in making as- signments for participants in the Program. (2) The application form, contract form, and all other informa- tion furnished by the Secretary under this subpart shall be written in a manner calculated to be understood by the average individual applying to participate in the Scholarship Program. The Secretary shall make such application forms, contract forms, and other infor- mation available to individuals desiring to participate in the Schol- arship Program on a date sufficiently early to insure that such in- dividuals have adequate time to carefully review and evaluate such forms and information. (3)(A) The Secretary shall distribute to health professions schools materials providing information on the Scholarship Pro- gram and shall encourage the schools to disseminate the materials to the students of the schools. (B)(i) In the case of any health professional whose period of ob- ligated service under the Scholarship Program is nearing comple- tion, the Secretary shall encourage the individual to remain in a health professional shortage area and to continue providing pri- mary health services. (ii) During the period in which a health professional is plan- ning and making the transition to private practice from obligated service under the Scholarship Program, the Secretary may provide assistance to the professional regarding such transition if the pro- fessional is remaining in a health professional shortage area and is continuing to provide primary health services. (C) In the case of entities to which participants in the Scholar- ship Program are assigned under section 333, the Secretary shall encourage the entities to provide options with respect to assisting the participants in remaining in the health professional shortage areas involved, and in continuing to provide primary health serv- ices, after the period of obligated service under the Scholarship Program is completed. The options with respect to which the Sec- retary provides such encouragement may include options regarding the sharing of a single employment position in the health profes- sions by 2 or more health professionals, and options regarding the recruitment of couples where both of the individuals are health professionals. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00302 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

303 G:\COMP\PHSA\PHSA-MERGED.XML 303 Sec. 338A PUBLIC HEALTH SERVICE ACT (d)(1) Subject to section 333A, in providing contracts under the Scholarship Program— (A) the Secretary shall consider the extent of the dem- onstrated interest of the applicants for the contracts in pro- viding primary health services; (B) the Secretary, in considering applications from individ- uals accepted for enrollment or enrolled in dental school, shall consider applications from all individuals accepted for enroll- ment or enrolled in any accredited dental school in a State; and (C) may consider such other factors regarding the appli- cants as the Secretary determines to be relevant to selecting qualified individuals to participate in such Program. (2) In providing contracts under the Scholarship Program, the Secretary shall give priority— (A) first, to any application for such a contract submitted by an individual who has previously received a scholarship under this section or under section 758; (B) second, to any application for such a contract sub- mitted by an individual who has characteristics that increase the probability that the individual will continue to serve in a health professional shortage area after the period of obligated service pursuant to subsection (f) is completed; and (C) third, subject to subparagraph (B), to any application for such a contract submitted by an individual who is from a disadvantaged background. (e)(1) An individual becomes a participant in the Scholarship Program only upon the Secretary’s approval of the individual’s ap- plication submitted under subsection (b)(3) and the Secretary’s ac- ceptance of the contract submitted by the individual under sub- section (b)(4). (2) The Secretary shall provide written notice to an individual promptly upon the Secretary’s approving, under paragraph (1), of the individual’s participation in the Scholarship Program. (f) The written contract (referred to in this subpart) between the Secretary and an individual shall contain— (1) an agreement that— (A) subject to paragraph (2), the Secretary agrees (i) to provide the individual with a scholarship (described in subsection (g)) in each such school year or years for a pe- riod of years (not to exceed four school years) determined by the individual, during which period the individual is pursuing a course of study described in subsection (b)(1)(B), and (ii) to accept (subject to the availability of ap- propriated funds for carrying out sections 331 through 335 and section 337) the individual into the Corps (or for equivalent service as otherwise provided in this subpart); and (B) subject to paragraph (2), the individual agrees— (i) to accept provision of such a scholarship to the individual; (ii) to maintain enrollment in a course of study de- scribed in subsection (b)(1)(B) until the individual completes the course of study; March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00303 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

304 G:\COMP\PHSA\PHSA-MERGED.XML 304 Sec. 338A PUBLIC HEALTH SERVICE ACT (iii) while enrolled in such course of study, to maintain an acceptable level of academic standing (as determined under regulations of the Secretary by the educational institution offering such course of study); (iv) if pursuing a degree from a school of medicine or osteopathic medicine, to complete a residency in a specialty that the Secretary determines is consistent with the needs of the Corps; and (v) to serve for a time period (hereinafter in the subpart referred to as the ‘‘period of obligated service’’) equal to— (I) one year for each school year for which the individual was provided a scholarship under the Scholarship Program, or (II) two years, whichever is greater, as a provider of primary health services in a health professional shortage area (des- ignated under section 332) to which he is assigned by the Secretary as a member of the Corps, or as other- wise provided in this subpart; (2) a provision that any financial obligation of the United States arising out of a contract entered into under this subpart and any obligation of the individual which is conditioned there- on, is contingent upon funds being appropriated for scholar- ships under this subpart and to carry out the purposes of sec- tions 331 through 335 and sections 337 and 338; (3) a statement of the damages to which the United States is entitled, under section 338E for the individual’s breach of the contract; and (4) such other statements of the rights and liabilities of the Secretary and of the individual, not inconsistent with the pro- visions of this subpart. (g)(1) A scholarship provided to a student for a school year under a written contract under the Scholarship Program shall con- sist of— (A) payment to, or (in accordance with paragraph (2)) on behalf of, the student of the amount (except as provided in sec- tion 711) of— (i) the tuition of the student in such school year; and (ii) all other reasonable educational expenses, includ- ing fees, books, and laboratory expenses, incurred by the student in such school year; and (B) payment to the student of a stipend of $400 per month (adjusted in accordance with paragraph (3)) for each of the 12 consecutive months beginning with the first month of such school year. (2) The Secretary may contract with an educational institution, in which a participant in the Scholarship Program is enrolled, for the payment to the educational institution of the amounts of tui- tion and other reasonable educational expenses described in para- graph (1)(A). Payment to such an educational institution may be made without regard to section 3648 of the Revised Statutes (31 U.S.C. 529). March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00304 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

305 G:\COMP\PHSA\PHSA-MERGED.XML 305 Sec. 338B PUBLIC HEALTH SERVICE ACT (3) The amount of the monthly stipend, specified in paragraph (1)(B) and as previously adjusted (if at all) in accordance with this paragraph, shall be increased by the Secretary for each school year ending in a fiscal year beginning after September 30, 1978, by an amount (rounded to the next highest multiple of $1) equal to the amount of such stipend multiplied by the overall percentage (under section 5303 of title 5, United States Code) of the adjustment (if such adjustment is an increase) in the rates of pay under the Gen- eral Schedule made effective in the fiscal year in which such school year ends. (h) Notwithstanding any other provision of law, individuals who have entered into written contracts with the Secretary under this section, while undergoing academic training, shall not be counted against any employment ceiling affecting the Department. 254l–1 ¿ NATIONAL HEALTH SERVICE CORPS LOAN REPAY- ø SEC. 338B. MENT PROGRAM. .—The Secretary shall establish a program STABLISHMENT (a) E to be known as the National Health Service Corps Loan Repayment Program to assure, with respect to the provision of primary health services pursuant to section 331(a)(2)— (1) an adequate supply of physicians, dentists, behavioral and mental health professionals, certified nurse midwives, cer- tified nurse practitioners, and physician assistants; and (2) if needed by the Corps, an adequate supply of other health professionals. .—To be eligible to participate in the Loan Re- LIGIBILITY (b) E payment Program, an individual must— (1)(A) have a degree in medicine, osteopathic medicine, dentistry, or another health profession, or an appropriate de- gree from a graduate program of behavioral and mental health, or be certified as a nurse midwife, nurse practitioner, or physi- cian assistant; (B) be enrolled in an approved graduate training program in medicine, osteopathic medicine, dentistry, behavioral and mental health, or other health profession; or (C) be enrolled as a full-time student— (i) in an accredited (as determined by the Secretary) educational institution in a State; and (ii) in the final year of a course of a study or program, offered by such institution and approved by the Secretary, leading to a degree in medicine, osteopathic medicine, den- tistry, or other health profession; (2) be eligible for, or hold, an appointment as a commis- sioned officer in the Regular or Reserve Corps of the Service or be eligible for selection for civilian service in the Corps; and (3) submit to the Secretary an application for a contract described in subsection (f) (relating to the payment by the Sec- retary of the educational loans of the individual in consider- ation of the individual serving for a period of obligated service). (c) A , C ONTRACT , AND I NFORMATION R EQUIRE - PPLICATION .— MENTS (1) S UMMARY AND INFORMATION .—In disseminating appli- cation forms and contract forms to individuals desiring to par- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00305 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

306 G:\COMP\PHSA\PHSA-MERGED.XML 306 Sec. 338B PUBLIC HEALTH SERVICE ACT ticipate in the Loan Repayment Program, the Secretary shall include with such forms— (A) a fair summary of the rights and liabilities of an individual whose application is approved (and whose con- tract is accepted) by the Secretary, including in the sum- mary a clear explanation of the damages to which the United States is entitled under section 338E in the case of the individual’s breach of the contract; and (B) information respecting meeting a service obligation through private practice under an agreement under section 338D and such other information as may be necessary for the individual to understand the individual’s prospective participation in the Loan Repayment Program and service in the Corps. .—The application form, contract NDERSTANDABILITY (2) U form, and all other information furnished by the Secretary under this subpart shall be written in a manner calculated to be understood by the average individual applying to participate in the Loan Repayment Program. (3) A .—The Secretary shall make such applica- VAILABILITY tion forms, contract forms, and other information available to individuals desiring to participate in the Loan Repayment Pro- gram on a date sufficiently early to ensure that such individ- uals have adequate time to carefully review and evaluate such forms and information. (4) R .— ECRUITMENT AND RETENTION (A) The Secretary shall distribute to health professions schools materials providing information on the Loan Re- payment Program and shall encourage the schools to dis- seminate the materials to the students of the schools. (B)(i) In the case of any health professional whose pe- riod of obligated service under the Loan Repayment Pro- gram is nearing completion, the Secretary shall encourage the individual to remain in a health professional shortage area and to continue providing primary health services. (ii) During the period in which a health professional is planning and making the transition to private practice from obligated service under the Loan Repayment Pro- gram, the Secretary may provide assistance to the profes- sional regarding such transition if the professional is re- maining in a health professional shortage area and is continuing to provide primary health services. (C) In the case of entities to which participants in the Loan Repayment Program are assigned under section 333, the Secretary shall encourage the entities to provide op- tions with respect to assisting the participants in remain- ing in the health professional shortage areas involved, and in continuing to provide primary health services, after the period of obligated service under the Loan Repayment Pro- gram is completed. The options with respect to which the Secretary provides such encouragement may include op- tions regarding the sharing of a single employment posi- tion in the health professions by 2 or more health profes- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00306 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

307 G:\COMP\PHSA\PHSA-MERGED.XML 307 Sec. 338B PUBLIC HEALTH SERVICE ACT sionals, and options regarding the recruitment of couples where both of the individuals are health professionals. (d)(1) Subject to section 333A, in providing contracts under the Loan Repayment Program— (A) the Secretary shall consider the extent of the dem- onstrated interest of the applicants for the contracts in pro- viding primary health services; and (B) may consider such other factors regarding the appli- cants as the Secretary determines to be relevant to selecting qualified individuals to participate in such Program. (2) In providing contracts under the Loan Repayment Program, the Secretary shall give priority— (A) to any application for such a contract submitted by an individual whose training is in a health profession or specialty determined by the Secretary to be needed by the Corps; (B) to any application for such a contract submitted by an individual who has (and whose spouse, if any, has) characteris- tics that increase the probability that the individual will con- tinue to serve in a health professional shortage area after the period of obligated service pursuant to subsection (f) is com- pleted; and (C) subject to subparagraph (B), to any application for such a contract submitted by an individual who is from a disadvan- taged background. (e) A EQUIRED FOR P PPROVAL .—An individual be- R ARTICIPATION comes a participant in the Loan Repayment Program only upon the Secretary and the individual entering into a written contract de- scribed in subsection (f). ONTENTS OF .—The written contract (referred to C ONTRACTS (f) C in this subpart) between the Secretary and an individual shall con- tain— (1) an agreement that— (A) subject to paragraph (3), the Secretary agrees— (i) to pay on behalf of the individual loans in ac- cordance with subsection (g); and (ii) to accept (subject to the availability of appro- priated funds for carrying out sections 331 through 335 and section 337) the individual into the Corps (or for equivalent service as otherwise provided in this subpart); and (B) subject to paragraph (3), the individual agrees— (i) to accept loan payments on behalf of the indi- vidual; (ii) in the case of an individual described in sub- section (b)(1)(C), to maintain enrollment in a course of study or training described in such subsection until the individual completes the course of study or train- ing; (iii) in the case of an individual described in sub- section (b)(1)(C), while enrolled in such course of study or training, to maintain an acceptable level of aca- demic standing (as determined under regulations of the Secretary by the educational institution offering such course of study or training); and March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00307 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

308 G:\COMP\PHSA\PHSA-MERGED.XML 308 Sec. 338B PUBLIC HEALTH SERVICE ACT (iv) to serve for a time period (hereinafter in this subpart referred to as the ‘‘period of obligated service’’) equal to 2 years or such longer period as the indi- vidual may agree to, as a provider of primary health services in a health professional shortage area (des- ignated under section 332) to which such individual is assigned by the Secretary as a member of the Corps or released under section 338D; (2) a provision permitting the Secretary to extend for such longer additional periods, as the individual may agree to, the period of obligated service agreed to by the individual under paragraph (1)(B)(iv), including extensions resulting in an ag- gregate period of obligated service in excess of 4 years; (3) a provision that any financial obligation of the United States arising out of a contract entered into under this subpart and any obligation of the individual that is conditioned there- on, is contingent on funds being appropriated for loan repay- ments under this subpart and to carry out the purposes of sec- tions 331 through 335 and sections 337 and 338; (4) a statement of the damages to which the United States is entitled, under section 338E for the individual’s breach of the contract; and (5) such other statements of the rights and liabilities of the Secretary and of the individual, not inconsistent with this sub- part. .— AYMENTS (g) P N GENERAL .—A loan repayment provided for an indi- (1) I vidual under a written contract under the Loan Repayment Program shall consist of payment, in accordance with para- graph (2), on behalf of the individual of the principal, interest, and related expenses on government and commercial loans re- ceived by the individual regarding the undergraduate or grad- uate education of the individual (or both), which loans were made for— (A) tuition expenses; (B) all other reasonable educational expenses, includ- ing fees, books, and laboratory expenses, incurred by the individual; or (C) reasonable living expenses as determined by the Secretary. (2) P .— AYMENTS FOR YEARS SERVED (A) I N GENERAL .—For each year of obligated service that an individual contracts to serve under subsection (f) the Secretary may pay up to $50,000, plus, beginning with fiscal year 2012, an amount determined by the Secretary on an annual basis to reflect inflation, on behalf of the in- dividual for loans described in paragraph (1). In making a determination of the amount to pay for a year of such serv- ice by an individual, the Secretary shall consider the ex- tent to which each such determination— (i) affects the ability of the Secretary to maximize the number of contracts that can be provided under the Loan Repayment Program from the amounts ap- propriated for such contracts; March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00308 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

309 G:\COMP\PHSA\PHSA-MERGED.XML 309 Sec. 338C PUBLIC HEALTH SERVICE ACT (ii) provides an incentive to serve in health profes- sional shortage areas with the greatest such short- ages; and (iii) provides an incentive with respect to the health professional involved remaining in a health professional shortage area, and continuing to provide primary health services, after the completion of the period of obligated service under the Loan Repayment Program. EPAYMENT SCHEDULE .—Any arrangement made (B) R by the Secretary for the making of loan repayments in ac- cordance with this subsection shall provide that any repay- ments for a year of obligated service shall be made no later than the end of the fiscal year in which the individual completes such year of service. AX LIABILITY .—For the purpose of providing reim- (3) T bursements for tax liability resulting from payments under paragraph (2) on behalf of an individual— (A) the Secretary shall, in addition to such payments, make payments to the individual in an amount equal to 39 percent of the total amount of loan repayments made for the taxable year involved; and (B) may make such additional payments as the Sec- retary determines to be appropriate with respect to such purpose. AYMENT SCHEDULE .—The Secretary may enter into an (4) P agreement with the holder of any loan for which payments are made under the Loan Repayment Program to establish a schedule for the making of such payments. MPLOYMENT C EILING .—Notwithstanding any other provi- (h) E sion of law, individuals who have entered into written contracts with the Secretary under this section, while undergoing academic or other training, shall not be counted against any employment ceiling affecting the Department. OBLIGATED SERVICE ULL ø 254m ¿ (a) S ERVICE IN F EC - TIME C LINICAL P RAC - . 338C. S .—Except as provided in section 338D, each individual who has TICE entered into a written contract with the Secretary under section 338A or 338B shall provide service in the full-time clinical practice of such individual’s profession as a member of the Corps for the pe- riod of obligated service provided in such contract. The Secretary may treat teaching as clinical practice for up to 20 percent of such period of obligated service. Notwithstanding the preceding sen- tence, with respect to a member of the Corps participating in the teaching health centers graduate medical education program under section 340H, for the purpose of calculating time spent in full-time clinical practice under this section, up to 50 percent of time spent teaching by such member may be counted toward his or her service obligation. (b)(1) If an individual is required under subsection (a) to pro- vide service as specified in section 338A(f)(1)(B)(v) or 338B(f)(1)(B)(iv) (hereinafter in this subsection referred to as ‘‘obli- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00309 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

310 G:\COMP\PHSA\PHSA-MERGED.XML 310 Sec. 338C PUBLIC HEALTH SERVICE ACT gated service’’), the Secretary shall, not later than ninety days be- fore the date described in paragraph (5), determine if the indi- vidual shall provide such service— (A) as a member of the Corps who is a commissioned offi- cer in the Regular or Reserve Corps of the Service or who is a civilian employee of the United States, or (B) as a member of the Corps who is not such an officer or employee, and shall notify such individual of such determination. (2) If the Secretary determines that an individual shall provide obligated service as a member of the Corps who is a commissioned officer in the Service or a civilian employee of the United States, the Secretary shall, not later than sixty days before the date de- scribed in paragraph (5), provide such individual with sufficient in- formation regarding the advantages and disadvantages of service as such a commissioned officer or civilian employee to enable the individual to make a decision on an informed basis. To be eligible to provide obligated service as a commissioned officer in the Serv- ice, an individual shall notify the Secretary, not later than thirty days before the date described in paragraph (5), of the individual’s desire to provide such service as such an officer. If an individual qualifies for an appointment as such an officer, the Secretary shall, as soon as possible after the date described in paragraph (5), ap- point the individual as a commissioned officer of the Regular or Re- serve Corps of the Service and shall designate the individual as a member of the Corps. (3) If an individual provided notice by the Secretary under paragraph (2) does not qualify for appointment as a commissioned officer in the Service, the Secretary shall, as soon as possible after the date described in paragraph (5), appoint such individual as a civilian employee of the United States and designate the individual as a member of the Corps. (4) If the Secretary determines that an individual shall provide obligated service as a member of the Corps who is not an employee of the United States, the Secretary shall, as soon as possible after the date described in paragraph (5), designate such individual as a member of the Corps to provide such service. (5)(A) In the case of the Scholarship Program, the date referred to in paragraphs (1) through (4) shall be the date on which the in- dividual completes the training required for the degree for which the individual receives the scholarship, except that— (i) for an individual receiving such a degree after Sep- tember 30, 2000, from a school of medicine or osteopathic medi- cine, such date shall be the date the individual completes a residency in a specialty that the Secretary determines is con- sistent with the needs of the Corps; and (ii) at the request of an individual, the Secretary may, con- sistent with the needs of the Corps, defer such date until the end of a period of time required for the individual to complete advanced training (including an internship or residency). (B) No period of internship, residency, or other advanced clin- ical training shall be counted toward satisfying a period of obli- gated service under this subpart. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00310 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

311 G:\COMP\PHSA\PHSA-MERGED.XML 311 Sec. 338D PUBLIC HEALTH SERVICE ACT (C) In the case of the Loan Repayment Program, if an indi- vidual is required to provide obligated service under such Program, the date referred to in paragraphs (1) through (4)— (i) shall be the date determined under subparagraph (A) in the case of an individual who is enrolled in the final year of a course of study; (ii) shall, in the case of an individual who is enrolled in an approved graduate training program in medicine, osteopathic medicine, dentistry, or other health profession, be the date the individual completes such training program; and (iii) shall, in the case of an individual who has a degree in medicine, osteopathic medicine, dentistry, or other health profession and who has completed graduate training, be the date the individual enters into an agreement with the Sec- retary under section 338B. (c) An individual shall be considered to have begun serving a period of obligated service— (1) on the date such individual is appointed as an officer in a Regular or Reserve Corps of the Service or is designated as a member of the Corps under subsection (b)(3) or (b)(4), or (2) in the case of an individual who has entered into an agreement with the Secretary under section 338D, on the date specified in such agreement, whichever is earlier. (d) The Secretary shall assign individuals performing obligated service in accordance with a written contract under the Scholarship Program to health professional shortage areas in accordance with sections 331 through 335 and sections 337 and 338. If the Sec- retary determines that there is no need in a health professional shortage area (designated under section 332) for a member of the profession in which an individual is obligated to provide service under a written contract and if such individual is an officer in the Service or a civilian employee of the United States, the Secretary may detail such individual to serve his period of obligated service as a full-time member of such profession in such unit of the De- partment as the Secretary may determine. PRIVATE PRACTICE S ø 254n EC (a) The Secretary shall, to the extent per- . 338D. ¿ mitted by, and consistent with, the requirements of applicable State law, release an individual from all or part of his service obli- gation under section 338C(a) or under section 225 (as in effect on September 30, 1977) if the individual applies for such a release under this section and enters into a written agreement with the Secretary under which the individual agrees to engage for a period equal to the remaining period of his service obligation in the full- time private clinical practice (including service as a salaried em- ployee in an entity directly providing health services) of his health profession— (1) in the case of an individual who received a scholarship under the Scholarship Program or a loan repayment under the Loan Repayment Program and who is performing obligated service as a member of the Corps in a health professional March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00311 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

312 G:\COMP\PHSA\PHSA-MERGED.XML 312 Sec. 338D PUBLIC HEALTH SERVICE ACT shortage area on the date of his application for such a release, in the health professional shortage area in which such indi- vidual is serving on such date or in the case of an individual for whom a loan payment was made under the Loan Repay- ment Program and who is performing obligated service as a member of the Corps in a health professional shortage area on the date of the application of the individual for such a release, in the health professional shortage area selected by the Sec- retary; or (2) in the case of any other individual, in a health profes- sional shortage area (designated under section 332) selected by the Secretary. (b)(1) The written agreement described in subsection (a) shall— (A) provide that, during the period of private practice by an individual pursuant to the agreement, the individual shall comply with the requirements of section 334 that apply to enti- ties; and (B) contain such additional provisions as the Secretary may require to carry out the objectives of this section. (2) The Secretary shall take such action as may be appropriate to ensure that the conditions of the written agreement prescribed by this subsection are adhered to. (c) If an individual breaches the contract entered into under section 338A or 338B by failing (for any reason) to begin his service obligation in accordance with an agreement entered into under sub- section (a) or to complete such service obligation, the Secretary may permit such individual to perform such service obligation as a member of the Corps. (d) The Secretary may pay an individual who has entered into an agreement with the Secretary under subsection (a) an amount to cover all or part of the individual’s expenses reasonably incurred in transporting himself, his family, and his possessions to the loca- tion of his private clinical practice. (e) Upon the expiration of the written agreement under sub- section (a), the Secretary may (notwithstanding any other provision of law) sell to the individual who has entered into an agreement with the Secretary under subsection (a), equipment and other prop- erty of the United States utilized by such individual in providing health services. Sales made under this subsection shall be made at the fair market value (as determined by the Secretary) of the equipment or such other property, except that the Secretary may make such sales for a lesser value to the individual if he deter- mines that the individual is financially unable to pay the full mar- ket value. (f) The Secretary may, out of appropriations authorized under section 338, pay to individuals participating in private practice under this section the cost of such individual’s malpractice insur- ance and the lesser of— (1)(A) $10,000 in the first year of obligated service; (B) $7,500 in the second year of obligated service; (C) $5,000 in the third year of obligated service; and (D) $2,500 in the fourth year of obligated service; or March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00312 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

313 G:\COMP\PHSA\PHSA-MERGED.XML 313 Sec. 338E PUBLIC HEALTH SERVICE ACT (2) an amount determined by subtracting such individual’s net income before taxes from the income the individual would have received as a member of the Corps for each such year of obligated service. (g) The Secretary shall, upon request, provide to each indi- vidual released from service obligation under this section technical assistance to assist such individual in fulfilling his or her agree- ment under this section. BREACH OF SCHOLARSHIP CONTRACT OR LOAN REPAYMENT CONTRACT S ø 254o ¿ (a)(1) An individual who has entered into a EC . 338E. written contract with the Secretary under section 338A and who— (A) fails to maintain an acceptable level of academic stand- ing in the educational institution in which he is enrolled (such level determined by the educational institution under regula- tions of the Secretary); (B) is dismissed from such educational institution for dis- ciplinary reasons; or (C) voluntarily terminates the training in such an edu- cational institution for which he is provided a scholarship under such contract, before the completion of such training, in lieu of any service obligation arising under such contract, shall be liable to the United States for the amount which has been paid to him, or on his behalf, under the contract. (2) An individual who has entered into a written contract with the Secretary under section 338B and who— (A) in the case of an individual who is enrolled in the final year of a course of study, fails to maintain an acceptable level of academic standing in the educational institution in which such individual is enrolled (such level determined by the edu- cational institution under regulations of the Secretary) or vol- untarily terminates such enrollment or is dismissed from such educational institution before completion of such course of study; or (B) in the case of an individual who is enrolled in a grad- uate training program, fails to complete such training program and does not receive a waiver from the Secretary under section 338B(b)(1)(B)(ii), in lieu of any service obligation arising under such contract shall be liable to the United States for the amount that has been paid on behalf of the individual under the contract. (b)(1)(A) Except as provided in paragraph (2), if (for any reason not specified in subsection (a) or section 338G(d)) an individual breaches his written contract by failing to begin such individual’s service obligation under section 338A in accordance with section 338C or 338D, to complete such service obligation, or to complete a required residency as specified in section 338A(f)(1)(B)(iv), the United States shall be entitled to recover from the individual an amount determined in accordance with the formula 3 φ (t ¥ s/t) A= March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00313 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

314 G:\COMP\PHSA\PHSA-MERGED.XML 314 Sec. 338E PUBLIC HEALTH SERVICE ACT in which ‘‘A’’ is the amount the United States is entitled to recover, φ ’’ is the sum of the amounts paid under this subpart to or on be- ‘‘ half of the individual and the interest on such amounts which would be payable if at the time the amounts were paid they were loans bearing interest at the maximum legal prevailing rate, as de- termined by the Treasurer of the United States; ‘‘t’’ is the total number of months in the individual’s period of obligated service; and ‘‘s’’ is the number of months of such period served by him in accordance with section 338C or a written agreement under section 338D. (B)(i) Any amount of damages that the United States is enti- tled to recover under this subsection or under subsection (c) shall, within the 1-year period beginning on the date of the breach of the written contract (or such longer period beginning on such date as specified by the Secretary), be paid to the United States. Amounts not paid within such period shall be subject to collection through deductions in Medicare payments pursuant to section 1892 of the Social Security Act. (ii) If damages described in clause (i) are delinquent for 3 months, the Secretary shall, for the purpose of recovering such damages— (I) utilize collection agencies contracted with by the Ad- ministrator of the General Services Administration; or (II) enter into contracts for the recovery of such damages with collection agencies selected by the Secretary. (iii) Each contract for recovering damages pursuant to this sub- section shall provide that the contractor will, not less than once each 6 months, submit to the Secretary a status report on the suc- cess of the contractor in collecting such damages. Section 3718 of title 31, United States Code, shall apply to any such contract to the extent not inconsistent with this subsection. (iv) To the extent not otherwise prohibited by law, the Sec- retary shall disclose to all appropriate credit reporting agencies in- formation relating to damages of more than $100 that are entitled to be recovered by the United States under this subsection and that are delinquent by more than 60 days or such longer period as is determined by the Secretary. (2) If an individual is released under section 753 from a service obligation under section 225 (as in effect on September 30, 1977) and if the individual does not meet the service obligation incurred under section 753, subsection (f) of such section 225 shall apply to such individual in lieu of paragraph (1) of this subsection. (3) The Secretary may terminate a contract with an individual under section 338A if, not later than 30 days before the end of the school year to which the contract pertains, the individual— (A) submits a written request for such termination; and (B) repays all amounts paid to, or on behalf of, the indi- vidual under section 338A(g). (c)(1) If (for any reason not specified in subsection (a) or section 338G(d)) an individual breaches the written contract of the indi- vidual under section 338B by failing either to begin such individ- ual’s service obligation in accordance with section 338C or 338D or to complete such service obligation, the United States shall be enti- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00314 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

315 G:\COMP\PHSA\PHSA-MERGED.XML 315 Sec. 338E PUBLIC HEALTH SERVICE ACT tled to recover from the individual an amount equal to the sum of— (A) the total of the amounts paid by the United States under section 338B(g) on behalf of the individual for any period of obligated service not served; (B) an amount equal to the product of the number of months of obligated service that were not completed by the in- dividual, multiplied by $7,500; and (C) the interest on the amounts described in subpara- graphs (A) and (B), at the maximum legal prevailing rate, as determined by the Treasurer of the United States, from the date of the breach; except that the amount the United States is entitled to recover under this paragraph shall not be less than $31,000. (2) The Secretary may terminate a contract with an individual under section 338B if, not later than 45 days before the end of the fiscal year in which the contract was entered into, the individual— (A) submits a written request for such termination; and (B) repays all amounts paid on behalf of the individual under section 338B(g). (3) Damages that the United States is entitled to recover shall be paid in accordance with subsection (b)(1)(B). (d)(1) Any obligation of an individual under the Scholarship Program (or a contract thereunder) or the Loan Repayment Pro- gram (or a contract thereunder) for service or payment of damages shall be canceled upon the death of the individual. (2) The Secretary shall by regulation provide for the partial or total waiver or suspension of any obligation of service or payment by an individual under the Scholarship Program (or a contract thereunder) or the Loan Repayment Program (or a contract there- under) whenever compliance by the individual is impossible or would involve extreme hardship to the individual and if enforce- ment of such obligation with respect to any individual would be un- conscionable. (3)(A) Any obligation of an individual under the Scholarship Program (or a contract thereunder) or the Loan Repayment Pro- gram (or a contract thereunder) for payment of damages may be re- leased by a discharge in bankruptcy under title 11 of the United States Code only if such discharge is granted after the expiration of the 7-year period beginning on the first date that payment of such damages is required, and only if the bankruptcy court finds that nondischarge of the obligation would be unconscionable. (B)(i) Subparagraph (A) shall apply to any financial obligation of an individual under the provision of law specified in clause (ii) to the same extent and in the same manner as such subparagraph applies to any obligation of an individual under the Scholarship or Loan Repayment Program (or contract thereunder) for payment of damages. (ii) The provision of law referred to in clause (i) is subsection (f) of section 225 of this Act, as in effect prior to the repeal of such section by section 408(b)(1) of Public Law 94–484. (e) Notwithstanding any other provision of Federal or State law, there shall be no limitation on the period within which suit may be filed, a judgment may be enforced, or an action relating to March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00315 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

316 G:\COMP\PHSA\PHSA-MERGED.XML 316 Sec. 338F PUBLIC HEALTH SERVICE ACT an offset or garnishment, or other action, may be initiated or taken by the Secretary, the Attorney General, or the head of another Fed- eral agency, as the case may be, for the repayment of the amount due from an individual under this section. (f) The amendment made by section 313(a)(4) of the Health Care Safety Net Amendments of 2002 (Public Law 107–251) shall apply to any obligation for which a discharge in bankruptcy has not been granted before the date that is 31 days after the date of enact- ment of such Act. ¿ SEC. 338F. ø 254o–1 FUND REGARDING USE OF AMOUNTS RECOVERED FOR CONTRACT BREACH TO REPLACE SERVICES LOST AS RESULT OF BREACH. F UND .—There is established in the (a) E STABLISHMENT OF Treasury of the United States a fund to be known as the National Health Service Corps Member Replacement Fund (hereafter in this section referred to as the ‘‘Fund’’). The Fund shall consist of such amounts as may be appropriated under subsection (b) to the Fund. Amounts appropriated for the Fund shall remain available until ex- pended. (b) A PPROPRIATIONS TO F UND .—For each UTHORIZATION OF A fiscal year, there is authorized to be appropriated to the Fund an amount equal to the sum of— (1) the amount collected during the preceding fiscal year by the Federal Government pursuant to the liability of individ- uals under section 338E for the breach of contracts entered into under section 338A or 338B; (2) the amount by which grants under section 338I have, for such preceding fiscal year, been reduced under subsection (g)(2)(B) of such section; and (3) the aggregate of the amount of interest accruing during the preceding fiscal year on obligations held in the Fund pur- suant to subsection (d) and the amount of proceeds from the sale or redemption of such obligations during such fiscal year. UND .— SE OF F (c) U AYMENTS TO CERTAIN HEALTH FACILITIES .—Amounts in (1) P the Fund and available pursuant to appropriations Act may, subject to paragraph (2), be expended by the Secretary to make payments to any entity— (A) to which a Corps member has been assigned under section 333; and (B) that has a need for a health professional to provide primary health services as a result of the Corps member having breached the contract entered into under section 338A or 338B by the individual. URPOSE OF PAYMENTS .—An entity receiving payments (2) P pursuant to paragraph (1) may expend the payments to recruit and employ a health professional to provide primary health services to patients of the entity, or to enter into a contract with such a professional to provide the services to the patients. (d) I NVESTMENT .— N GENERAL .—The Secretary of the Treasury shall in- (1) I vest such amounts of the Fund as such Secretary determines are not required to meet current withdrawals from the Fund. Such investments may be made only in interest-bearing obliga- March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00316 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

317 G:\COMP\PHSA\PHSA-MERGED.XML 317 Sec. 338G PUBLIC HEALTH SERVICE ACT tions of the United States. For such purpose, such obligations may be acquired on original issue at the issue price, or by pur- chase of outstanding obligations at the market price. ALE OF OBLIGATIONS .—Any obligation acquired by the (2) S Fund may be sold by the Secretary of the Treasury at the mar- ket price. SPECIAL LOANS FOR FORMER CORPS MEMBERS TO ENTER PRIVATE PRACTICE . 338G. ø 254p ¿ S EC (a) The Secretary may, out of appropria- tions authorized under section 338, make one loan to a Corps mem- ber who has agreed in writing— (1) to engage in the private full-time clinical practice of the profession of the member in a health professional shortage area (designated under section 332) for a period of not less than 2 years which— (A) in the case of a Corps member who is required to complete a period of obligated service under this subpart, begins not later than 1 year after the date on which such individual completes such period of obligated service; and (B) in the case of an individual who is not required to complete a period of obligated service under this subpart, begins at such time as the Secretary considers appropriate; (2) to conduct such practice in accordance with section 338D(b)(1); and (3) to such additional conditions as the Secretary may re- quire to carry out this section. Such a loan shall be used to assist such individual in meeting the costs of beginning the practice of such individual’s profession in ac- cordance with such agreement, including the costs of acquiring equipment and renovating facilities for use in providing health services, and of hiring nurses and other personnel to assist in pro- viding health services. Such loan may not be used for the purchase or construction of any building. (b)(1) The amount of a loan under subsection (a) to an indi- vidual shall not exceed $25,000. (2) The interest rate for any such loan shall not exceed an an- nual rate of 5 percent. (c) The Secretary may not make a loan under this section un- less an application therefor has been submitted to, and approved by, the Secretary. The Secretary shall, by regulation, set interest rates and repayment terms for loans under this section. (d) If the Secretary determines that an individual has breached a written agreement entered into under subsection (a), he shall, as soon as practicable after making such determination notify the in- dividual of such determination. If within 60 days after the date of giving such notice, such individual is not practicing his profession in accordance with the agreement under such subsection and has not provided assurances satisfactory to the Secretary that he will not knowingly violate such agreement again, the United States shall be entitled to recover from such individual— (1) in the case of an individual who has received a grant under this section (as in effect prior to October 1, 1984), an March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00317 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

318 G:\COMP\PHSA\PHSA-MERGED.XML 318 Sec. 338H PUBLIC HEALTH SERVICE ACT amount determined under section 338E(b), except that in ap- plying the formula contained in such section ‘‘ ’’ shall be the φ sum of the amount of the grant made under subsection (a) to such individual and the interest on such amount which would be payable if at the time it was paid it was a loan bearing in- terest at the maximum legal prevailing rate, ‘‘t’’ shall be the number of months that such individual agreed to practice his profession under agreement, and ‘‘s’’ shall be the number of months that such individual practices his profession in accord- ance with such agreement; and (2) in the case of an individual who has received a loan under this section, the full amount of the principal and interest owed by such individual under this section. SEC. 338H. AUTHORIZATION OF APPROPRIATIONS. ø 254q ¿ (a) A A PPROPRIATIONS .—For the purpose of UTHORIZATION OF 43 , there is authorized to be appropriated, carrying out this section out of any funds in the Treasury not otherwise appropriated, the following: (1) For fiscal year 2010, $320,461,632. (2) For fiscal year 2011, $414,095,394. (3) For fiscal year 2012, $535,087,442. (4) For fiscal year 2013, $691,431,432. (5) For fiscal year 2014, $893,456,433. (6) For fiscal year 2015, $1,154,510,336. (7) For fiscal year 2016, and each subsequent fiscal year, the amount appropriated for the preceding fiscal year adjusted by the product of— (A) one plus the average percentage increase in the costs of health professions education during the prior fiscal year; and (B) one plus the average percentage change in the number of individuals residing in health professions short- age areas designated under section 333 during the prior fiscal year, relative to the number of individuals residing in such areas during the previous fiscal year. (b) S CHOLARSHIPS FOR EW P ARTICIPANTS .—Of the amounts N appropriated under subsection (a) for a fiscal year, the Secretary shall obligate not less than 10 percent for the purpose of providing contracts for— (1) scholarships under this subpart to individuals who have not previously received such scholarships; or (2) scholarships or loan repayments under the Loan Re- payment Program under section 338B to individuals from dis- advantaged backgrounds. (c) S CHOLARSHIPS AND L OAN R EPAYMENTS .—With respect to certification as a nurse practitioner, nurse midwife, or physician assistant, the Secretary shall, from amounts appropriated under subsection (a) for a fiscal year, obligate not less than a total of 10 percent for contracts for both scholarships under the Scholarship Program under section 338A and loan repayments under the Loan Repayment Program under section 338B to individuals who are en- 43 The reference to ‘‘this section’’ in section 338H(a) probably should be a reference to ‘‘this subpart’’. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00318 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

319 G:\COMP\PHSA\PHSA-MERGED.XML 319 Sec. 338I PUBLIC HEALTH SERVICE ACT tering the first year of a course of study or program described in section 338A(b)(1)(B) that leads to such a certification or individ- uals who are eligible for the loan repayment program as specified in section 338B(b) for a loan related to such certification. ¿ SEC. 338I. ø GRANTS TO STATES FOR LOAN REPAYMENT PRO- 254q–1 GRAMS. ENERAL .— (a) I N G GRANTS .—The Secretary, acting FOR (1) A UTHORITY through the Administrator of the Health Resources and Serv- ices Administration, may make grants to States for the pur- pose of assisting the States in operating programs described in paragraph (2) in order to provide for the increased availability of primary health care services in health professional shortage areas. The National Advisory Council established under section 337 shall advise the Administrator regarding the program under this section. (2) L .—The programs referred OAN REPAYMENT PROGRAMS to in paragraph (1) are, subject to subsection (c), programs of entering into contracts under which the State involved agrees to pay all or part of the principal, interest, and related ex- penses of the educational loans of health professionals in con- sideration of the professionals agreeing to provide primary health services in health professional shortage areas. (3) D IRECT ADMINISTRATION BY STATE AGENCY .—The Sec- retary may not make a grant under paragraph (1) unless the State involved agrees that the program operated with the grant will be administered directly by a State agency. (b) R M ATCHING F UNDS .— EQUIREMENT OF N GENERAL .—The Secretary may not make a grant (1) I under subsection (a) unless the State agrees that, with respect to the costs of making payments on behalf of individuals under contracts made pursuant to paragraph (2) of such subsection, the State will make available (directly or through donations from public or private entities) non-Federal contributions in cash toward such costs in an amount equal to not less than $1 for each $1 of Federal funds provided in the grant. (2) D ETERMINATION OF AMOUNT OF NON - - FEDERAL CON .—In determining the amount of non-Federal con- TRIBUTION tributions in cash that a State has provided pursuant to para- graph (1), the Secretary may not include any amounts provided to the State by the Federal Government. OORDINATION W ITH F EDERAL P ROGRAM .— (c) C (1) A SSIGNMENTS FOR HEALTH PROFESSIONAL SHORTAGE .—The Secretary may not AREAS UNDER FEDERAL PROGRAM make a grant under subsection (a) unless the State involved agrees that, in carrying out the program operated with the grant, the State will assign health professionals participating in the program only to public and nonprofit private entities lo- cated in and providing health services in health professional shortage areas. EMEDIES FOR BREACH OF CONTRACTS .—The Secretary (2) R may not make a grant under subsection (a) unless the State in- volved agrees that the contracts provided by the State pursu- ant to paragraph (2) of such subsection will provide remedies March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00319 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

320 G:\COMP\PHSA\PHSA-MERGED.XML 320 Sec. 338I PUBLIC HEALTH SERVICE ACT for any breach of the contracts by the health professionals in- volved. IMITATION REGARDING CONTRACT INDUCEMENTS .— (3) L (A) Except as provided in subparagraph (B), the Sec- retary may not make a grant under subsection (a) unless the State involved agrees that the contracts provided by the State pursuant to paragraph (2) of such subsection will not be provided on terms that are more favorable to health professionals than the most favorable terms that the Sec- retary is authorized to provide for contracts under the Loan Repayment Program under section 338B, including terms regarding— (i) the annual amount of payments provided on behalf of the professionals regarding educational loans; and (ii) the availability of remedies for any breach of the contracts by the health professionals involved. (B) With respect to the limitation established in sub- paragraph (A) regarding the annual amount of payments that may be provided to a health professional under a con- tract provided by a State pursuant to subsection (a)(2), such limitation shall not apply with respect to a contract if— (i) the excess of such annual payments above the maximum amount authorized in section 338B(g)(2)(A) for annual payments regarding contracts is paid solely from non-Federal contributions under subsection (b); and (ii) the contract provides that the health profes- sional involved will satisfy the requirement of obli- gated service under the contract solely through the provision of primary health services in a health profes- sional shortage area that is receiving priority for pur- poses of section 333A(a)(1) and that is authorized to receive assignments under section 333 of individuals who are participating in the Scholarship Program under section 338A. (d) R SE OF F ESTRICTIONS ON .—The Secretary may not U UNDS make a grant under subsection (a) unless the State involved agrees that the grant will not be expended— (1) to conduct activities for which Federal funds are ex- pended— (A) within the State to provide technical or other non- financial assistance under subsection (f) of section 330; (B) under a memorandum of agreement entered into with the State under subsection (h) of such section; or (C) under a grant under section 338J; or (2) for any purpose other than making payments on behalf of health professionals under contracts entered into pursuant to subsection (a)(2). EPORTS .—The Secretary may not make a grant under sub- (e) R section (a) unless the State involved agrees— March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00320 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

321 G:\COMP\PHSA\PHSA-MERGED.XML 321 Sec. 338I PUBLIC HEALTH SERVICE ACT (1) to submit to the Secretary such reports regarding the States loan repayment program, as are determined to be ap- propriate by the Secretary; and (2) to submit such a report not later than January 10 of each fiscal year immediately following any fiscal year for which the State has received such a grant. (f) R EQUIREMENT OF PPLICATION .—The Secretary may not A make a grant under subsection (a) unless an application for the grant is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, as- surances, and information as the Secretary determines to be nec- essary to carry out such subsection. (g) N ONCOMPLIANCE .— (1) I N GENERAL .—The Secretary may not make payments under subsection (a) to a State for any fiscal year subsequent to the first fiscal year of such payments unless the Secretary determines that, for the immediately preceding fiscal year, the State has complied with each of the agreements made by the State under this section. (2) R GRANT RELATIVE TO NUMBER OF EDUCTION IN .— BREACHED CONTRACTS (A) Before making a grant under subsection (a) to a State for a fiscal year, the Secretary shall determine the number of contracts provided by the State under para- graph (2) of such subsection with respect to which there has been an initial breach by the health professionals in- volved during the fiscal year preceding the fiscal year for which the State is applying to receive the grant. (B) Subject to paragraph (3), in the case of a State with 1 or more initial breaches for purposes of subpara- graph (A), the Secretary shall reduce the amount of a grant under subsection (a) to the State for the fiscal year involved by an amount equal to the sum of the expendi- tures of Federal funds made regarding the contracts in- volved and an amount representing interest on the amount of such expenditures, determined with respect to each con- tract on the basis of the maximum legal rate prevailing for loans made during the time amounts were paid under the contract, as determined by the Treasurer of the United States. .—The Sec- AIVER REGARDING REDUCTION IN GRANT (3) W retary may waive the requirement established in paragraph (2)(B) with respect to the initial breach of a contract if the Sec- retary determines that such breach by the health professional involved was attributable solely to the professional having a serious illness. EFINITIONS .—For purposes of this section, the term (h) D ‘‘State’’ means each of the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, the United States Virgin Islands, Guam, American Samoa, Palau, the Marshall Islands, and the Commonwealth of the Northern Mariana Islands. (i) A UTHORIZATION OF A PPROPRIATIONS .— N GENERAL .—For the purpose of making grants under (1) I subsection (a), there are authorized to be appropriated March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00321 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

322 G:\COMP\PHSA\PHSA-MERGED.XML 322 Sec. 338J PUBLIC HEALTH SERVICE ACT $12,000,000 for fiscal year 2008, and such sums as may be nec- essary for each of fiscal years 2009 through 2012. (2) A VAILABILITY .—Amounts appropriated under paragraph (1) shall remain available until expended. (j) P H OAN R EPAYMENT UBLIC .— EALTH L .—The Secretary may award grants to (1) I N GENERAL States for the purpose of assisting such States in operating loan repayment programs under which such States enter into contracts to repay all or part of the eligible loans borrowed by, or on behalf of, individuals who agree to serve in State, local, or tribal health departments that serve health professional shortage areas or other areas at risk of a public health emer- gency, as designated by the Secretary. (2) L OANS ELIGIBLE FOR REPAYMENT .—To be eligible for re- payment under this subsection, a loan shall be a loan made, insured, or guaranteed by the Federal Government that is bor- rowed by, or on behalf of, an individual to pay the cost of at- tendance for a program of education leading to a degree appro- priate for serving in a State, local, or tribal health department as determined by the Secretary and the chief executive officer of the State in which the grant is administered, at an institu- tion of higher education (as defined in section 102 of the High- er Education Act of 1965), including principal, interest, and re- lated expenses on such loan. PPLICABILITY OF EXISTING REQUIREMENTS .—With re- (3) A spect to awards made under paragraph (1)— (A) the requirements of subsections (b), (f), and (g) shall apply to such awards; and (B) the requirements of subsection (c) shall apply to such awards except that with respect to paragraph (1) of such subsection, the State involved may assign an indi- vidual only to public and nonprofit private entities that serve health professional shortage areas or areas at risk of a public health emergency, as determined by the Sec- retary. (4) A UTHORIZATION OF APPROPRIATIONS .—There are author- ized to be appropriated to carry out this subsection, such sums as may be necessary for each of fiscal years 2007 through 2010. 254r SEC. 338J. GRANTS TO STATE OFFICES OF RURAL HEALTH. ø ¿ N G ENERAL .—The Secretary, acting through the Director of (a) I the Federal Office of Rural Health Policy (established under section 711 of the Social Security Act), shall make grants to each State Of- fice of Rural Health for the purpose of improving health care in rural areas. .— ATCHING F UNDS M EQUIREMENT OF (b) R (1) I N GENERAL .—Subject to paragraph (2), the Secretary may not make a grant under subsection (a) unless the State of- fice of rural health involved agrees, with respect to the costs to be incurred in carrying out the purpose described in such subsection, to provide non-Federal contributions toward such costs in an amount equal to $3 for each $1 of Federal funds provided in the grant. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00322 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

323 G:\COMP\PHSA\PHSA-MERGED.XML 323 Sec. 338J PUBLIC HEALTH SERVICE ACT .—The Secretary may waive or AIVER OR REDUCTION (2) W reduce the non-Federal contribution if the Secretary deter- mines that requiring matching funds would limit the State of- fice of rural health’s ability to carry out the purpose described in subsection (a). (3) D ETERMINATION OF AMOUNT OF NON - FEDERAL CON - .—Non-Federal contributions required in paragraph TRIBUTION (1) may be in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Gov- ernment, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in de- termining the amount of such non-Federal contributions. (c) C ERTAIN A CTIVITIES .—Recipients of a grant R EQUIRED under subsection (a) shall use the grant funds for purposes of— (1) maintaining within the State office of rural health a clearinghouse for collecting and disseminating information on— (A) rural health care issues; (B) research findings relating to rural health care; and (C) innovative approaches to the delivery of health care in rural areas; (2) coordinating the activities carried out in the State that relate to rural health care, including providing coordination for the purpose of avoiding redundancy in such activities; and (3) identifying Federal and State programs regarding rural health, and providing technical assistance to public and non- profit private entities regarding participation in such pro- grams. EQUIREMENT R EGARDING A NNUAL B UDGET FOR O FFICE .— (d) R The Secretary may not make a grant under subsection (a) unless the State involved agrees that, for any fiscal year for which the State office of rural health receives such a grant, the office oper- ated pursuant to subsection (a) of this section will be provided with an annual budget of not less than $150,000. (e) C SES OF F UNDS .— ERTAIN U .—The Secretary may not make a grant ESTRICTIONS (1) R under subsection (a) unless the State office of rural health in- volved agrees that the grant will not be expended— (A) to provide health care (including providing cash payments regarding such care); (B) to conduct activities for which Federal funds are expended— (i) within the State to provide technical and other nonfinancial assistance under section 330A(f); (ii) under a memorandum of agreement entered into with the State office of rural health under section 330A(h); or (iii) under a grant under section 338I; (C) to purchase medical equipment, to purchase ambu- lances, aircraft, or other vehicles, or to purchase major communications equipment; (D) to purchase or improve real property; or (E) to carry out any activity regarding a certificate of need. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00323 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

324 G:\COMP\PHSA\PHSA-MERGED.XML 324 Sec. 338K PUBLIC HEALTH SERVICE ACT .—Activities for which a State office of (2) A UTHORITIES rural health may expend a grant under subsection (a) in- clude— (A) paying the costs of maintaining an office of rural health for purposes of subsection (a); (B) subject to paragraph (1)(B)(iii), paying the costs of any activity carried out with respect to recruiting and re- taining health professionals to serve in rural areas of the State; and (C) providing grants and contracts to public and non- profit private entities to carry out activities authorized in this section. (3) L .—The Secretary may impose IMIT ON INDIRECT COSTS a limit of no more than 15 percent on indirect costs claimed by the recipient of the grant. .—The Secretary may not make a grant under sub- EPORTS (f) R section (a) unless the State office of rural health involved agrees— (1) to submit to the Secretary reports or performance data containing such information as the Secretary may require re- garding activities carried out under this section; and (2) to submit such a report or performance data not later than September 30 of each fiscal year immediately following any fiscal year for which the State office of rural health has received such a grant. A EQUIREMENT OF .—The Secretary may not PPLICATION (g) R make a grant under subsection (a) unless an application for the grant is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, as- surances, and information as the Secretary determines to be nec- essary to carry out such subsection. ONCOMPLIANCE .—The Secretary may not make payments (h) N under subsection (a) to a State office of rural health for any fiscal year subsequent to the first fiscal year of such payments unless the Secretary determines that, for the immediately preceding fiscal year, the State office of rural health has complied with each of the agreements made by the State office of rural health under this sec- tion. (i) A PPROPRIATIONS UTHORIZATION OF A .— N GENERAL .—For the purpose of making grants under (1) I subsection (a), there are authorized to be appropriated $12,500,000 for each of fiscal years 2018 through 2022. (2) A .—Amounts appropriated under paragraph VAILABILITY (1) shall remain available until expended. SEC. 338K. 254s ¿ NATIVE HAWAIIAN HEALTH SCHOLARSHIPS. ø (a) Subject to the availability of funds appropriated under the authority of subsection (d), the Secretary shall provide scholarship assistance, pursuant to a contract with the Papa Ola Lokahi, to students who— (1) meet the requirements of section 338A(b), and (2) are Native Hawaiians. (b)(1) The scholarship assistance provided under subsection (a) shall be provided under the same terms and subject to the same March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00324 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

325 G:\COMP\PHSA\PHSA-MERGED.XML 325 Sec. 338L PUBLIC HEALTH SERVICE ACT conditions, regulations, and rules that apply to scholarship assist- ance provided under section 338A. (2) The Native Hawaiian Health Scholarship program shall not be administered by or through the Indian Health Service. (c) For purposes of this section, the term ‘‘Native Hawaiian’’ means any individual who is— (1) a citizen of the United States, (2) a resident of the State of Hawaii, and (3) a descendant of the aboriginal people, who prior to 1778, occupied and exercised sovereignty in the area that now constitutes the State of Hawaii, as evidenced by— (A) genealogical records, (B) Kupuna (elders) or Kama’aina (long-term commu- nity residents) verification, or (C) birth records of the State of Hawaii. (d) There are authorized to be appropriated $1,800,000 for each of the fiscal years 1990, 1991, and 1992 for the purpose of funding the scholarship assistance provided under subsection (a). SEC. 338L. ¿ DEMONSTRATION PROJECT. ø 254t ROGRAM UTHORIZED .—The Secretary shall establish a (a) P A demonstration project to provide for the participation of individuals who are chiropractic doctors or pharmacists in the Loan Repay- ment Program described in section 338B. ROCEDURE .—An individual that receives assistance under (b) P this section with regard to the program described in section 338B shall comply with all rules and requirements described in such sec- tion (other than subparagraphs (A) and (B) of section 338B(b)(1)) in order to receive assistance under this section. (c) L IMITATIONS .— (1) I .—The demonstration project described in N GENERAL this section shall provide for the participation of individuals who shall provide services in rural and urban areas. (2) A VAILABILITY OF OTHER HEALTH PROFESSIONALS .—The Secretary may not assign an individual receiving assistance under this section to provide obligated service at a site un- less— (A) the Secretary has assigned a physician (as defined in section 1861(r) of the Social Security Act) or other health professional licensed to prescribe drugs to provide obligated service at such site under section 338C or 338D; and (B) such physician or other health professional will provide obligated service at such site concurrently with the individual receiving assistance under this section. ULES OF CONSTRUCTION .— (3) R (A) S UPERVISION OF INDIVIDUALS .—Nothing in this sec- tion shall be construed to require or imply that a physician or other health professional licensed to prescribe drugs must supervise an individual receiving assistance under the demonstration project under this section, with respect to such project. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00325 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

326 G:\COMP\PHSA\PHSA-MERGED.XML 326 Sec. 338L PUBLIC HEALTH SERVICE ACT (B) L ICENSURE OF HEALTH PROFESSIONALS .—Nothing in this section shall be construed to supersede State law regarding licensure of health professionals. ESIGNATIONS .—The demonstration project described in (d) D this section, and any providers who are selected to participate in such project, shall not be considered by the Secretary in the des- ignation of a health professional shortage area under section 332 during fiscal years 2002 through 2004. ONSTRUCTION C .—This section shall not be con- ULE OF (e) R strued to require any State to participate in the project described in this section. .— EPORT (f) R .—The Secretary shall evaluate the partici- N GENERAL (1) I pation of individuals in the demonstration projects under this section and prepare and submit a report containing the infor- mation described in paragraph (2) to— (A) the Committee on Health, Education, Labor, and Pensions of the Senate; (B) the Subcommittee on Labor, Health and Human Services, and Education of the Committee on Appropria- tions of the Senate; (C) the Committee on Energy and Commerce of the House of Representatives; and (D) the Subcommittee on Labor, Health and Human Services, and Education of the Committee on Appropria- tions of the House of Representatives. ONTENT .—The report described in paragraph (1) shall (2) C detail— (A) the manner in which the demonstration project de- scribed in this section has affected access to primary care services, patient satisfaction, quality of care, and health care services provided for traditionally underserved popu- lations; (B) how the participation of chiropractic doctors and pharmacists in the Loan Repayment Program might affect the designation of health professional shortage areas; and (C) whether adding chiropractic doctors and phar- macists as permanent members of the National Health Service Corps would be feasible and would enhance the ef- fectiveness of the National Health Service Corps. .— PPROPRIATIONS A UTHORIZATION OF (g) A (1) IN GENERAL .—There are authorized to be appropriated to carry out this section, such sums as may be necessary for fiscal years 2002 through 2004. 44 .—If the Secretary determines and (2) F ISCAL YEAR 2005 certifies to Congress by not later than September 30, 2004, that the number of individuals participating in the demonstra- tion project established under this section is insufficient for purposes of performing the evaluation described in subsection 44 So in law. The figure in the heading for paragraph (2) was erroneously enacted so that ‘‘2005’’ appears in full figures. However, the version represented here in the pdf reflects this figure so that it conforms to the proper size for figures that appear in a paragraph or below header. March 1, 2019 As Amended Through P.L. 115-408, Enacted December 31, 2018 VerDate Nov 24 2008 10:49 Mar 01, 2019 Jkt 000000 PO 00000 Frm 00326 Fmt 9001 Sfmt 6601 G:\COMP\PHSA\PHSA.BEL HOLCPC

327 G:\COMP\PHSA\PHSA-MERGED.XML 327 Sec. 338N PUBLIC HEALTH SERVICE ACT (f)(1), the authorization of appropriations under paragraph (1) shall be extended to include fiscal year 2005. ¿ PUBLIC HEALTH DEPARTMENTS. ø SEC. 338M. 254u ENERAL G (a) I N .—To the extent that funds are appropriated under subsection (e), the Secretary shall establish a demonstration project to provide for the participation of individuals who are eligi- ble for the Loan Repayment Program described in section 338B and who agree to complete their service obligation in a State health de- partment that provides a significant amount of service to health professional shortage areas or areas at risk of a public health emer- gency, as determined by the Secretary, or in a local or tribal health department that serves a health professional shortage area or an area at risk of a public health emergency. ROCEDURE .—To be eligible to receive assistance under sub- (b) P section (a), with respect to the program described in section 338B, an individual shall— (1) comply with all rules and requirements described in such section (other than section 338B(f)(1)(B)(iv)); and (2) agree to serve for a time period equal to 2 years, or such longer period as the individual may agree to, in a State, local, or tribal health department, described in subsection (a). ESIGNATIONS .—The demonstration project described in (c) D subsection (a), and any healthcare providers who are selected to participate in such project, shall not be considered by the Secretary in the designation of health professional shortage areas under sec- tion 332 during fiscal years 2007 through 2010. .—Not later than 3 years after the date of enact- (d) R EPORT ment of this section, the Secretary shall submit a report to the rel- evant committees of Congress that evaluates the participation of individuals in the demonstration project under subsection (a), the impact of such participation on State, local, and tribal health de- partments, and the benefit and feasibility of permanently allowing such placements in the Loan Repayment Program. UTHORIZATION OF A PPROPRIATIONS .—There are authorized (e) A to be appropriated to carry out this section, such sums as may be necessary for each of fiscal years 2007 through 2010. 254v CLARIFICATION REGARDING SERVICE IN SCHOOLS ø ¿ SEC. 338N. AND OTHER COMMUNITY-BASED SETTINGS. C OMMUNITY - BASED (a) S ETTINGS