II 

117TH CONGRESS 

2D SESSION S. 3799 

To prepare for, and respond to, existing viruses, emerging new threats, 

and pandemics. 

IN THE SENATE OF THE UNITED STATES 

MARCH 10 (legislative day, MARCH 7), 2022 

Mrs. MURRAY (for herself and Mr. BURR) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To prepare for, and respond to, existing viruses, emerging 

new threats, and pandemics. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Prepare for and Respond to Existing Viruses, Emerging 

6 New Threats, and Pandemics Act’’ or the ‘‘PREVENT 

7 Pandemics Act’’. 

8 (b) TABLE OF CONTENTS.—The table of contents for 

9 this Act is as follows: 

Sec. 1. Short title; table of contents. 


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TITLE I—STRENGTHENING FEDERAL AND STATE 

PREPAREDNESS 

Subtitle A—Federal Leadership and Accountability 

Sec. 101. Comprehensive review of the COVID–19 response. 

Sec. 102. Appointment and authority of the Director of the Centers for Disease 

Control and Prevention. 

Sec. 103. Additional provisions related to the Centers for Disease Control and 

Prevention. 

Sec. 104. Public health and medical preparedness and response coordination. 

Sec. 105. Strengthening public health communication. 

Sec. 106. Office of Pandemic Preparedness and Response Policy. 

Subtitle B—State and Local Readiness 

Sec. 111. Improving State and local public health security. 

Sec. 112. Supporting access to mental health and substance use disorder services during public health emergencies. 

Sec. 113. Trauma care reauthorization. 

Sec. 114. Assessment of containment and mitigation of infectious diseases. 

TITLE II—IMPROVING PUBLIC HEALTH PREPAREDNESS AND 

RESPONSE CAPACITY 

Subtitle A—Addressing Disparities and Improving Public Health Emergency 

Responses 

Sec. 201. Addressing social determinants of health and improving health outcomes. 

Sec. 202. National Academies of Sciences, Engineering, and Medicine report. 

Subtitle B—Improving Public Health Data 

Sec. 211. Modernizing biosurveillance capabilities and infectious disease data 

collection. 

Sec. 212. Genomic sequencing, analytics, and public health surveillance of 

pathogens. 

Sec. 213. Supporting public health data availability and access. 

Sec. 214. Epidemic forecasting and outbreak analytics. 

Sec. 215. Report on CDC data portal. 

Sec. 216. Public health data transparency. 

Subtitle C—Revitalizing the Public Health Workforce 

Sec. 221. Improving recruitment and retention of the frontline public health 

workforce. 

Sec. 222. Awards to support community health workers and community health. 

Sec. 223. Improving public health emergency response capacity. 

Sec. 224. Extension of authorities to support health professional volunteers at 

community health centers. 

Sec. 225. Increasing educational opportunities for allied health professions. 

Sec. 226. Public Health Service Corps annual and sick leave. 

Subtitle D—Improving Public Health Responses 

Sec. 231. Centers for public health preparedness and response. 

Sec. 232. Vaccine distribution plans. 


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Sec. 233. Coordination and collaboration regarding blood supply. 

TITLE III—ACCELERATING RESEARCH AND COUNTERMEASURE 

DISCOVERY 

Subtitle A—Fostering Research and Development and Improving Coordination 

Sec. 301. Research and activities related to long-term health effects of SARS– 

CoV–2 infection. 

Sec. 302. Research centers for pathogens of pandemic concern. 

Sec. 303. Improving medical countermeasure research coordination. 

Sec. 304. Accessing specimen samples and diagnostic tests. 

Subtitle B—Improving Biosafety and Biosecurity 

Sec. 311. Improving control and oversight of select biological agents and toxins. 

Sec. 312. Strategy for Federal high-containment laboratories. 

Sec. 313. National Science Advisory Board for Biosecurity. 

Sec. 314. Research to improve biosafety. 

Sec. 315. Federally-funded research with enhanced pathogens of pandemic potential. 

Subtitle C—Preventing Undue Foreign Influence in Biomedical Research 

Sec. 321. Foreign talent programs. 

Sec. 322. Securing identifiable, sensitive information. 

Sec. 323. Duties of the Director. 

Sec. 324. Protecting America’s biomedical research enterprise. 

Sec. 325. GAO Study. 

Sec. 326. Report on progress to address undue foreign influence. 

TITLE IV—MODERNIZING AND STRENGTHENING THE SUPPLY 

CHAIN FOR VITAL MEDICAL PRODUCTS 

Sec. 401. Warm base manufacturing capacity for medical countermeasures. 

Sec. 402. Supply chain considerations for the Strategic National Stockpile. 

Sec. 403. Strategic National Stockpile equipment maintenance. 

Sec. 404. Improving transparency and predictability of processes of the Strategic National Stockpile. 

Sec. 405. Improving supply chain flexibility for the Strategic National Stockpile. 

Sec. 406. Reimbursement for certain supplies. 

Sec. 407. Action reporting on stockpile depletion. 

Sec. 408. Provision of medical countermeasures to Indian programs and facilities. 

Sec. 409. Grants for State strategic stockpiles. 

TITLE V—ENHANCING DEVELOPMENT AND COMBATING 

SHORTAGES OF MEDICAL PRODUCTS 

Subtitle A—Development and Review 

Sec. 501. Advancing qualified infectious disease product innovation. 

Sec. 502. Modernizing clinical trials. 

Sec. 503. Accelerating countermeasure development and review. 

Sec. 504. Third party test evaluation during emergencies. 

Sec. 505. Facilitating the use of real world evidence. 

Sec. 506. Platform technologies. 


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Sec. 507. Increasing EUA decision transparency. 

Sec. 508. Improving FDA guidance and communication. 

Sec. 509. GAO study and report on hiring challenges at FDA. 

Subtitle B—Mitigating Shortages 

Sec. 511. Ensuring registration of foreign drug and device manufacturers. 

Sec. 512. Extending expiration dates for certain drugs. 

Sec. 513. Unannounced foreign facility inspections pilot program. 

Sec. 514. Combating counterfeit devices. 

Sec. 515. Strengthening medical device supply chains. 

Sec. 516. Preventing medical device shortages. 

Sec. 517. Remote records assessments for medical devices. 

Sec. 518. Advanced manufacturing technologies designation pilot program. 

Sec. 519. Technical corrections. 

1 TITLE I—STRENGTHENING FED2 ERAL AND STATE PREPARED3 NESS 

4 Subtitle A—Federal Leadership 

5 and Accountability 

6 SEC. 101. COMPREHENSIVE REVIEW OF THE COVID–19 RE7 SPONSE. 

8 (a) ESTABLISHMENT OF TASK FORCE.—There is es9 tablished in the legislative branch a task force to be known 

10 as the ‘‘National Task Force on the Response of the 

11 United States to the COVID–19 Pandemic’’ (referred to 

12 in this section as the ‘‘Task Force’’). 

13 (b) PURPOSES.—The purposes of the Task Force are 

14 to— 

15 (1) examine, assess, and report upon the 

16 United States’ preparedness for, and response to, 

17 the COVID–19 pandemic, including— 


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1 (A) the initial Federal, State, local, and 

2 territorial responses in the United States; 

3 (B) the ongoing Federal, State, local, and 

4 territorial responses in the United States, in5 cluding the activities, policies, and decisions of 

6 the Trump Administration and the Biden Ad7 ministration; 

8 (C) the impact of the pandemic on public 

9 health and health care systems; and 

10 (D) the initial outbreak in Wuhan, China, 

11 including efforts to determine the potential 

12 causes for the emergence of the SARS–CoV–2 

13 virus, and Federal actions to mitigate its spread 

14 internationally; 

15 (2) build upon existing or ongoing evaluations 

16 and avoid unnecessary duplication, by reviewing the 

17 findings, conclusions, and recommendations of other 

18 appropriate task forces, committees, commissions, or 

19 entities established by other public or nonprofit pri20 vate entities related to the United States’ prepared21 ness for, and response to, the COVID–19 pandemic; 

22 (3) identify gaps in public health preparedness 

23 and medical response policies, processes, and activi24 ties, including disparities in COVID–19 infection 

25 and mortality rates among people of color, older 


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1 adults, people with disabilities, and other vulnerable 

2 or at-risk groups, and how such gaps impacted the 

3 ability of the United States to respond to the 

4 COVID–19 pandemic; and 

5 (4) submit a report to the President and to 

6 Congress on its findings, conclusions, and rec7 ommendations to improve the United States pre8 paredness for, and response to, future public health 

9 emergencies, including a public health emergency re10 sulting from an emerging infectious disease. 

11 (c) COMPOSITION OF TASK FORCE; MEETINGS.— 

12 (1) MEMBERS.—The Task Force shall be com13 posed of 12 members, of whom— 

14 (A) 1 member shall be appointed by the 

15 majority leader of the Senate; 

16 (B) 1 member shall be appointed by the 

17 minority leader of the Senate; 

18 (C) 2 members shall be appointed by the 

19 chair of the Committee on Health, Education, 

20 Labor, and Pensions of the Senate; 

21 (D) 2 members shall be appointed by the 

22 ranking member of the Committee on Health, 

23 Education, Labor, and Pensions of the Senate; 

24 (E) 1 member shall be appointed by the 

25 Speaker of the House of Representatives; 


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1 (F) 1 member shall be appointed by the 

2 minority leader of the House of Representa3 tives; 

4 (G) 2 members shall be appointed by the 

5 chair of the Committee on Energy and Com6 merce of the House of Representatives; and 

7 (H) 2 members shall be appointed by the 

8 ranking member of the Committee on Energy 

9 and Commerce of the House of Representatives. 

10 (2) CHAIR AND VICE CHAIR.—Not later than 30 

11 days after the date on which all members of the 

12 Task Force are appointed under paragraph (1), such 

13 members shall meet to elect a Chair and Vice Chair 

14 from among such members. The Chair and Vice 

15 Chair shall each be elected to serve upon an affirma16 tive vote from 8 members of the Task Force. The 

17 Chair and Vice Chair shall not be registered mem18 bers of the same political party. 

19 (3) QUALIFICATIONS.— 

20 (A) POLITICAL PARTY AFFILIATION.—Not 

21 more than 6 members of the Task Force shall 

22 be registered members of the same political 

23 party. 

24 (B) NONGOVERNMENTAL APPOINTEES.— 

25 An individual appointed to the Task Force may 


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1 not be an officer or employee of the Federal 

2 Government or any State, local, Tribal, or terri3 torial government. 

4 (C) QUALIFICATIONS.—It is the sense of 

5 Congress that individuals appointed to the Task 

6 Force should be highly qualified citizens of the 

7 United States. Members appointed under para8 graph (1) may include individuals with expertise 

9 in— 

10 (i) public health, health disparities 

11 and at-risk populations, medicine, and re12 lated fields; 

13 (ii) State, local, Tribal, or territorial 

14 government, including public health and 

15 medical preparedness and response and 

16 emergency management and other relevant 

17 public administration; 

18 (iii) research regarding, or the devel19 opment, manufacturing, distribution, and 

20 regulation of, medical products; 

21 (iv) national security and foreign rela22 tions, including global health; and 

23 (v) commerce, including transpor24 tation, supply chains, and small business. 


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1 (4) DEADLINE FOR APPOINTMENT.—All mem2 bers of the Task Force shall be appointed not later 

3 than 90 days after the date of enactment of this 

4 Act. 

5 (5) MEETINGS.—The Task Force shall meet 

6 and begin the operations of the Task Force as soon 

7 as practicable. After its initial meeting, the Task 

8 Force shall meet upon the call of the Chair and Vice 

9 Chair or 8 of its members. 

10 (6) QUORUM; VACANCIES.— 

11 (A) QUORUM.—Eight members of the 

12 Task Force shall constitute a quorum. 

13 (B) VACANCIES.—Any vacancy in the Task 

14 Force shall not affect its powers, but shall be 

15 filled in the same manner in which the original 

16 appointment was made. 

17 (d) FUNCTIONS OF TASK FORCE.—The functions of 

18 the Task Force are to— 

19 (1) conduct a review that— 

20 (A) examines the initial outbreak of the 

21 SARS–CoV–2 virus in Wuhan, China, includ22 ing— 

23 (i) engaging with willing partner gov24 ernments and global experts; 


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1 (ii) seeking access to relevant records; 

2 and 

3 (iii) examining the potential causes of 

4 the emergence and source of the virus; 

5 (B) examines the United States prepara6 tion for, and response to, the COVID–19 pan7 demic, including— 

8 (i) relevant laws, policies, regulations, 

9 and processes that were in place prior to, 

10 or put into place during, the public health 

11 emergency declared by the Secretary of 

12 Health and Human Services under section 

13 319 of the Public Health Service Act (42 

14 U.S.C. 247d) with respect to COVID–19, 

15 including any that are put into place re16 lated to such public health emergency after 

17 the date of enactment of this Act and prior 

18 to the issuance of the final report pursuant 

19 to subsection (j)(2); 

20 (ii) relevant actions taken by, and co21 ordination between, Federal, State, local, 

22 Tribal, and territorial governments, non23 governmental organizations, and inter24 national organizations on preparedness and 

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1 tween governments and other public and 

2 private entities, during the— 

3 (I) initial response in the United 

4 States; 

5 (II) response during the Trump 

6 Administration; and 

7 (III) ongoing response during the 

8 Biden Administration; 

9 (iii) communication of public health 

10 and scientific information related to the 

11 COVID–19 pandemic, including processes 

12 for the development, approval, and dis13 semination of Federal public health and 

14 other relevant public health or scientific 

15 guidance; 

16 (iv) actions taken to support the de17 velopment, manufacturing, and distribution 

18 of medical countermeasures and related 

19 medical supplies to prevent, detect, and 

20 treat COVID–19; and 

21 (C) may include assessments relating to— 

22 (i) the capacity and capabilities of 

23 Federal, State, local, Tribal, and territorial 

24 governments to respond to the COVID–19 

25 pandemic; 


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1 (ii) the capacity and capabilities of 

2 health care facilities and the health care 

3 workforce to respond to the COVID–19 

4 pandemic; 

5 (iii) medical countermeasure research 

6 and development and the supply chains of 

7 medical products necessary to respond to 

8 the COVID–19 pandemic; 

9 (iv) international preparedness for 

10 and response to COVID–19, and Federal 

11 decision-making processes related to new 

12 global health threats; 

13 (v) containment and mitigation meas14 ures related to domestic and international 

15 travel in response to COVID–19; and 

16 (vi) the impact of the COVID–19 pan17 demic and related mitigation efforts on 

18 hard-to-reach and at-risk or underserved 

19 populations, including related health dis20 parities; 

21 (2) identify, review, and evaluate the lessons 

22 learned from the COVID–19 pandemic, including ac23 tivities to prepare for, and respond to, future poten24 tial pandemics and related public health emer25 gencies; and 


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1 (3) submit to the President and Congress such 

2 reports as are required by this Act containing such 

3 findings, conclusions, and recommendations as the 

4 Task Force shall determine. 

5 (e) POWERS OF TASK FORCE.— 

6 (1) HEARINGS.—The Task Force may— 

7 (A) hold such hearings and sit and act at 

8 such times and places, take such testimony, re9 ceive such evidence as determined by the Chair 

10 and Vice Chair, and administer such oaths as 

11 the Task Force or a designated member, as de12 termined by the Chair or Vice Chair, may de13 termine advisable to be necessary to carry out 

14 the functions of the Task Force; and 

15 (B) subject to paragraph (2)(A), require, 

16 by subpoena or otherwise, the attendance and 

17 testimony of such witnesses and the production 

18 of such books, records, correspondence, memo19 randa, papers, and documents, as the person 

20 described in paragraph (2)(A)(i) may determine 

21 advisable. 

22 (2) SUBPOENAS.— 

23 (A) ISSUANCE.— 

24 (i) IN GENERAL.—A subpoena may be 

25 issued under this subsection only— 


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1 (I) by the agreement of the Chair 

2 and the Vice Chair; or 

3 (II) by the affirmative vote of 9 

4 members of the Task Force. 

5 (ii) SIGNATURE.—Subpoenas issued 

6 under this subsection may be issued under 

7 the signature of the Chair or any member 

8 designated by a majority of the Task 

9 Force, and may be served by any person 

10 designated by the Chair or by a member 

11 designated by agreement of the majority of 

12 the Task Force. 

13 (B) ENFORCEMENT.—In the case of contu14 macy or failure to obey a subpoena issued 

15 under subsection, the United States district 

16 court for the judicial district in which the sub17 poenaed person resides, is served, or may be 

18 found, or where the subpoena is returnable, 

19 may issue an order requiring such person to ap20 pear at any designated place to testify or to 

21 produce documentary or other evidence. Any 

22 failure to obey the order of the court may be 

23 punished by the court as a contempt of that 

24 court. 


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1 (3) CONTRACTING.—The Task Force may, to 

2 such extent and in such amounts as are provided in 

3 appropriation Acts, enter into contracts to enable 

4 the Task Force to discharge its duties under this 

5 Act. 

6 (4) INFORMATION FROM FEDERAL AGENCIES.— 

7 (A) IN GENERAL.—The Task Force may 

8 access from any executive department, bureau, 

9 agency, board, commission, office, independent 

10 establishment, or instrumentality of the Federal 

11 Government, such information, documents, sug12 gestions, estimates, and statistics as the Task 

13 Force considers necessary to carry out this sec14 tion. 

15 (B) PROVISION OF INFORMATION.—On 

16 written request of the Chair, each department, 

17 bureau, agency, board, commission, office, inde18 pendent establishment, or instrumentality shall, 

19 to the extent authorized by law, provide such 

20 information to the Task Force. 

21 (C) RECEIPT, HANDLING, STORAGE, AND

22 DISSEMINATION.—Information shall only be re23 ceived, handled, stored, and disseminated by 

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1 sistent with all applicable statutes, regulations, 

2 and executive orders. 

3 (5) ASSISTANCE FROM FEDERAL AGENCIES.— 

4 (A) GENERAL SERVICES ADMINISTRA5 TION.—On request of the Chair and Vice Chair, 

6 the Administrator of General Services Adminis7 tration shall provide to the Task Force, on a re8 imbursable basis, administrative support and 

9 other assistance necessary for the Task Force 

10 to carry out its duties. 

11 (B) OTHER DEPARTMENTS AND AGEN12 CIES.—In addition to the assistance provided 

13 for in subparagraph (A), departments and 

14 agencies of the United States may provide to 

15 the Task Force such assistance as such depart16 ments and agencies may determine advisable 

17 and as authorized by law. 

18 (6) DONATIONS.—The Task Force may accept, 

19 use, and dispose of gifts or donations of services or 

20 property. Not later than 5 days after the acceptance 

21 of a donation under this subsection, the Task Force 

22 shall publicly disclose— 

23 (A) the name of the entity that provided 

24 such donation; 


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1 (B) the service or property provided 

2 through such donation; 

3 (C) the value of such donation; and 

4 (D) how the Task Force plans to use such 

5 donation. 

6 (7) POSTAL SERVICES.—The Task Force may 

7 use the United States mails in the same manner and 

8 under the same conditions as a department or agen9 cy of the United States. 

10 (f) APPLICABILITY OF FEDERAL ADVISORY COM11 MITTEE ACT.— 

12 (1) IN GENERAL.—The Federal Advisory Com13 mittee Act (5 U.S.C. App.) shall apply to the Task 

14 Force. 

15 (2) PUBLIC MEETINGS AND RELEASE OF PUB16 LIC VERSIONS OF REPORTS.—The Task Force 

17 shall— 

18 (A) hold public hearings and meetings to 

19 the extent appropriate; and 

20 (B) release public versions of the reports 

21 required under paragraph (1) and (2) of sub22 section (j). 

23 (3) PUBLIC HEARINGS.—Any public hearings of 

24 the Task Force shall be conducted in a manner con25 sistent with the protection of information provided 


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1 to or developed for or by the Task Force as required 

2 by any applicable statute, regulation, or Executive 

3 order. 

4 (g) STAFF OF TASK FORCE.— 

5 (1) IN GENERAL.— 

6 (A) APPOINTMENT AND COMPENSATION.— 

7 The Chair of the Task Force, in agreement 

8 with the Vice Chair, in accordance with rules 

9 agreed upon by the Task Force, may appoint 

10 and fix the compensation of a staff director and 

11 such other personnel as may be necessary to en12 able the Task Force to carry out its functions, 

13 without regard to the provisions of title 5, 

14 United States Code, governing appointments in 

15 the competitive service, and without regard to 

16 the provisions of chapter 51 and subchapter III 

17 of chapter 53 of such title relating to classifica18 tion and General Schedule pay rates, except 

19 that no rate of pay fixed under this subsection 

20 may exceed the equivalent of that payable for a 

21 position at level V of the Executive Schedule 

22 under section 5316 of title 5, United States 

23 Code. 

24 (B) PERSONNEL AS FEDERAL EMPLOY25 EES.— 


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1 (i) IN GENERAL.—The staff director 

2 and any personnel of the Task Force who 

3 are employees shall be employees under 

4 section 2105 of title 5, United States 

5 Code, for purposes of chapters 63, 81, 83, 

6 84, 85, 87, 89, and 90 of that title. 

7 (ii) MEMBERS OF TASK FORCE.— 

8 Clause (i) shall not be construed to apply 

9 to members of the Task Force. 

10 (2) DETAILEES.—Upon request of the Chair 

11 and Vice Chair of the Task Force, the head of any 

12 executive department, bureau, agency, board, com13 mission, office, independent establishment, or instru14 mentality of the Federal Government employee may 

15 detail, without reimbursement, any of its personnel 

16 to the Task Force to assist in carrying out its duties 

17 under this section. Any such detailee shall be with18 out interruption or loss of civil service status or 

19 privilege. 

20 (3) CONSULTANT SERVICES.—The Task Force 

21 is authorized to procure the services of experts and 

22 consultants in accordance with section 3109 of title 

23 5, United States Code, but at rates not to exceed the 

24 daily rate paid a person occupying a position at level 


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1 IV of the Executive Schedule under section 5315 of 

2 title 5, United States Code. 

3 (h) COMPENSATION AND TRAVEL EXPENSES.—Each 

4 member of the Task Force shall serve without compensa5 tion, but shall receive travel expenses, including per diem 

6 in lieu of subsistence, at rates authorized for an employee 

7 of an agency under subchapter I of chapter 57 of title 

8 5, United States Code. 

9 (i) SECURITY CLEARANCES FOR TASK FORCE MEM10 BERS AND STAFF.—The appropriate Federal agencies or 

11 departments shall cooperate with the Task Force in expe12 ditiously providing to the Task Force members and staff 

13 appropriate security clearances, consistent with existing 

14 procedures and requirements. No person shall be provided 

15 with access to classified information under this section 

16 without the appropriate security clearances. 

17 (j) REPORTS OF TASK FORCE; TERMINATION.— 

18 (1) INTERIM REPORT.—Not later than 180 

19 days after the date of enactment of this Act, the 

20 Task Force shall submit to the President, the Com21 mittee on Health, Education, Labor, and Pensions 

22 of the Senate, and the Committee on Energy and 

23 Commerce of the House of Representatives an in24 terim report containing such findings, conclusions, 

25 and recommendations as have been agreed to by 8 


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1 members of the Task Force. Such interim report 

2 shall be made available online in a manner that does 

3 not compromise national security. 

4 (2) FINAL REPORT.— 

5 (A) IN GENERAL.—Not later than 18 

6 months after the date on which the last member 

7 of the Task Force is appointed, the Task Force 

8 shall submit to the President, the Committee on 

9 Health, Education, Labor, and Pensions of the 

10 Senate, and the Committee on Energy and 

11 Commerce of the House of Representatives a 

12 final report containing such findings, conclu13 sions, and recommendations as have been 

14 agreed to by 8 members of the Task Force. The 

15 final report shall be made available online in a 

16 manner that does not compromise national se17 curity. 

18 (B) EXTENSIONS.— 

19 (i) IN GENERAL.—The submission 

20 and publication of the final report, as de21 scribed in subparagraph (A), may be de22 layed by 6 months upon the agreement of 

23 8 members of the Task Force. 

24 (ii) NOTIFICATION.—The Task Force 

25 shall notify the President, the Committee 


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1 on Health, Education, Labor, and Pen2 sions of the Senate, the Committee on En3 ergy and Commerce of the House of Rep4 resentatives, and the public of any exten5 sion granted under clause (i). 

6 (C) SPECIAL RULES AND CONSIDER7 ATIONS.— 

8 (i) RULE OF CONSTRUCTION.—Noth9 ing in this subsection shall be construed as 

10 authorizing the Task Force to publicly dis11 close information otherwise prohibited from 

12 disclosure by law. 

13 (ii) SPECIAL TIMING CONSIDER14 ATIONS.—Notwithstanding any other pro15 vision of this section, the Task Force shall 

16 not publish or make available any interim 

17 or final report during the during the 60- 

18 day periods ending November 8, 2022, and 

19 November 5, 2024. 

20 (3) TERMINATION.— 

21 (A) IN GENERAL.—The Task Force, and 

22 all the authorities of this section, shall termi23 nate 60 days after the date on which the final 

24 report is submitted under paragraph (2). 


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1 (B) ADMINISTRATIVE ACTIVITIES BEFORE

2 TERMINATION.—The Task Force may use the 

3 60-day period referred to in subparagraph (A) 

4 for the purpose of concluding its activities, in5 cluding providing testimony to committees of 

6 Congress concerning its reports and dissemi7 nating the final report. 

8 (k) FUNDING.— 

9 (1) AUTHORIZATION OF APPROPRIATIONS.— 

10 There is authorized to be appropriated to carry out 

11 this section, a total of $3,000,000 for fiscal years 

12 2023 and 2024. 

13 (2) DURATION OF AVAILABILITY.—Amounts 

14 made available to the Task Force under paragraph 

15 (1) shall remain available until the termination of 

16 the Task Force. 

17 SEC. 102. APPOINTMENT AND AUTHORITY OF THE DIREC18 TOR OF THE CENTERS FOR DISEASE CON19 TROL AND PREVENTION. 

20 (a) IN GENERAL.—Part A of title III of the Public 

21 Health Service Act (42 U.S.C. 241 et seq.) is amended 

22 by inserting after section 304 the following: 


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1 ‘‘SEC. 305. APPOINTMENT AND AUTHORITY OF THE DIREC2 TOR OF THE CENTERS FOR DISEASE CON3 TROL AND PREVENTION. 

4 ‘‘(a) IN GENERAL.—The Centers for Disease Control 

5 and Prevention (referred to in this section as the ‘CDC’) 

6 shall be headed by the Director of the Centers for Disease 

7 Control and Prevention (referred to in this section as the 

8 ‘Director’), who shall be appointed by the President, by 

9 and with the advice and consent of the Senate. Such indi10 vidual shall also serve as the Administrator of the Agency 

11 for Toxic Substances and Disease Registry consistent with 

12 section 104(i) of the Comprehensive Environmental Re13 sponse, Compensation, and Liability Act. The Director 

14 shall perform functions provided for in subsection (b) and 

15 such other functions as the Secretary may prescribe. 

16 ‘‘(b) FUNCTIONS.—The Secretary, acting through the 

17 Director, shall— 

18 ‘‘(1) implement and exercise applicable authori19 ties and responsibilities provided for in this Act or 

20 other applicable law related to the investigation, de21 tection, identification, prevention, or control of dis22 eases or conditions to preserve and improve public 

23 health domestically and globally and address injuries 

24 and occupational and environmental hazards, as ap25 propriate; 


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1 ‘‘(2) be responsible for the overall direction of 

2 the CDC and for the establishment and implementa3 tion of policies related to the management and oper4 ation of programs and activities within the CDC; 

5 ‘‘(3) coordinate and oversee the operation of 

6 centers, institutes, and offices within the CDC; 

7 ‘‘(4) support, in consultation with the heads of 

8 such centers, institutes, and offices, program coordi9 nation across such centers, institutes, and offices, in10 cluding through priority setting reviews and the de11 velopment of strategic plans, to reduce unnecessary 

12 duplication and encourage collaboration between pro13 grams; 

14 ‘‘(5) oversee the development, implementation, 

15 and updating of the strategic plan established pursu16 ant to subsection (c); 

17 ‘‘(6) ensure that appropriate strategic planning, 

18 including the use of performance metrics, is con19 ducted by such centers, institutes, and offices to fa20 cilitate and improve CDC programs and activities; 

21 ‘‘(7) communicate, including through convening 

22 annual meetings, with public and private entities re23 garding relevant public health programs and activi24 ties, and, as applicable, the strategic plan estab25 lished pursuant to subsection (c). 


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1 ‘‘(c) STRATEGIC PLAN.— 

2 ‘‘(1) IN GENERAL.—Not later than 1 year after 

3 the date of enactment of the PREVENT Pandemics 

4 Act, and at least every 4 years thereafter, the Direc5 tor shall develop and submit to the Committee on 

6 Health, Education, Labor, and Pensions and the 

7 Committee on Appropriations of the Senate and the 

8 Committee on Energy and Commerce and the Com9 mittee on Appropriations of the House of Represent10 atives, and post on the website of the CDC, a coordi11 nated strategy to provide strategic direction and fa12 cilitate collaboration across the centers, institutes, 

13 and offices within the CDC. Such strategy shall be 

14 known as the ‘CDC Strategic Plan’. 

15 ‘‘(2) REQUIREMENTS.—The CDC Strategic 

16 Plan shall— 

17 ‘‘(A) identify strategic priorities and objec18 tives related to— 

19 ‘‘(i) preventing, reducing, and elimi20 nating the spread of communicable and 

21 noncommunicable diseases or conditions, 

22 and addressing injuries, and occupational 

23 and environmental hazards; 

24 ‘‘(ii) supporting the efforts of State, 

25 local, and Tribal health departments to 


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1 prevent and reduce the prevalence of the 

2 diseases or conditions under clause (i); 

3 ‘‘(iii) containing, mitigating, and end4 ing disease outbreaks; 

5 ‘‘(iv) enhancing global and domestic 

6 public health capacity, capabilities, and 

7 preparedness, including public health data, 

8 surveillance, workforce, and laboratory ca9 pacity and safety; and 

10 ‘‘(v) other priorities, as established by 

11 the Director; 

12 ‘‘(B) describe the capacity and capabilities 

13 necessary to achieve the priorities and objec14 tives under subparagraph (A), and progress to15 wards achieving such capacity and capabilities, 

16 as appropriate; and 

17 ‘‘(C) include a description of how the CDC 

18 Strategic Plan incorporates— 

19 ‘‘(i) strategic communications; 

20 ‘‘(ii) partnerships with private sector 

21 entities, and State, local, and Tribal health 

22 departments, and other public sector enti23 ties, as appropriate; and 

24 ‘‘(iii) coordination with other agencies 

25 and offices of the Department of Health 


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1 and Human Services and other Federal de2 partments and agencies, as appropriate. 

3 ‘‘(3) USE OF PLANS.—Strategic plans developed 

4 and updated by the centers, institutes, and offices of 

5 the CDC shall be prepared regularly and in such a 

6 manner that such plans will be informed by the CDC 

7 Strategic Plan developed and updated under this 

8 subsection. 

9 ‘‘(d) APPEARANCES BEFORE CONGRESS.— 

10 ‘‘(1) IN GENERAL.—Each fiscal year, the Direc11 tor shall appear before the Committee on Health, 

12 Education, Labor, and Pensions of the Senate and 

13 the Committee on Energy and Commerce of the 

14 House of Representatives at hearings on topics such 

15 as— 

16 ‘‘(A) support for State, local, and Tribal 

17 public health preparedness and responses to any 

18 recent or ongoing public health emergency, in19 cluding— 

20 ‘‘(i) any objectives, activities, or initia21 tives that have been carried out, or are 

22 planned, by the Director to prepare for, or 

23 respond to, the public health emergency, 

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1 lenges identified in such objectives, activi2 ties, or initiatives; 

3 ‘‘(ii) any objectives and planned ac4 tivities for the upcoming fiscal year to ad5 dress gaps in, or otherwise improve, State, 

6 local, and Tribal public health prepared7 ness; and 

8 ‘‘(iii) other potential all-hazard 

9 threats that the Director is preparing to 

10 address; 

11 ‘‘(B) activities related to public health and 

12 functions of the Director described in sub13 section (b); and 

14 ‘‘(C) updates on other relevant activities 

15 supported or conducted by the CDC, or in col16 laboration or coordination with the heads of 

17 other Federal departments, agencies, or stake18 holders, as appropriate. 

19 ‘‘(2) CLARIFICATIONS.— 

20 ‘‘(A) WAIVER AUTHORITY.—The Chair of 

21 the Committee on Health, Education, Labor, 

22 and Pensions of the Senate or the Chair of the 

23 Committee on Energy and Commerce of the 

24 House of Representatives may waive the re25 quirements of paragraph (1) for the applicable 


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1 fiscal year with respect to the applicable Com2 mittee. 

3 ‘‘(B) SCOPE OF REQUIREMENTS.—The re4 quirements of this subsection shall not be con5 strued to impact the appearance of other Fed6 eral officials or the Director at hearings of ei7 ther Committee described in paragraph (1) at 

8 other times and for purposes other than the 

9 times and purposes described in paragraph (1). 

10 ‘‘(3) CLOSED HEARINGS.—Information that is 

11 not appropriate for disclosure during an open hear12 ing under paragraph (1) in order to protect national 

13 security may instead be discussed in a closed hear14 ing that immediately follows the open hearing.’’. 

15 (b) APPLICATION.—The first sentence of section 

16 305(a) of the Public Health Service Act, as added by sub17 section (a), shall not apply to the Director of the Centers 

18 for Disease Control and Prevention who is serving on the 

19 date of enactment of this Act. 

20 SEC. 103. ADDITIONAL PROVISIONS RELATED TO THE CEN21 TERS FOR DISEASE CONTROL AND PREVEN22 TION. 

23 Title III of the Public Health Service Act (42 U.S.C. 

24 241 et seq.) is amended by inserting after section 305, 

25 as added by section 102, the following: 


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1 ‘‘SEC. 305A. ADDITIONAL PROVISIONS RELATED TO THE 

2 CENTERS FOR DISEASE CONTROL AND PRE3 VENTION. 

4 ‘‘(a) APPOINTMENTS.— 

5 ‘‘(1) IN GENERAL.—Unless otherwise specified 

6 in statute, the heads of the centers or institutes of 

7 the Centers for Disease Control and Prevention shall 

8 be appointed by the Secretary, acting through the 

9 Director of the Centers for Disease Control and Pre10 vention (referred to in this section as the ‘Director’). 

11 Each such individual shall be appointed for 5 years. 

12 ‘‘(2) REAPPOINTMENTS.—At the end of a 5- 

13 year term, an individual appointed under paragraph 

14 (1) shall be reappointed in accordance with stand15 ards applicable to the relevant appointment mecha16 nism and as determined by the Secretary, as appli17 cable. 

18 ‘‘(3) NO LIMIT ON TERMS.—There shall be no 

19 limit on the number of terms that any individual ap20 pointed under this subsection may serve. 

21 ‘‘(4) VACANCIES.—If the position of a head of 

22 a center or institute described in paragraph (1) be23 comes vacant before the end of a term, the head of 

24 such center or institute appointed to fill the vacancy 

25 shall be appointed for a 5-year term starting on the 

26 date of such appointment. 


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1 ‘‘(5) CURRENT POSITIONS AND EXEMPTIONS.— 

2 ‘‘(A) IN GENERAL.—Each such individual 

3 who is serving on the date of enactment of the 

4 PREVENT Pandemics Act shall be deemed to 

5 be appointed for a 5-year term under this sub6 section beginning on such date of enactment. 

7 ‘‘(B) EXEMPTIONS.—The Secretary may 

8 exempt the head of a center or institute from 

9 the 5-year term described in subparagraph (A) 

10 if such Secretary determines such exemption is 

11 necessary in order to hire or retain talented in12 dividuals. 

13 ‘‘(6) RULE OF CONSTRUCTION.—Nothing in 

14 this subsection shall be construed to limit the au15 thority of the Secretary or the Director to terminate 

16 the appointment of a head of a center or institute 

17 described in paragraph (1) before the expiration of 

18 such individual’s 5-year term. 

19 ‘‘(7) NATURE OF APPOINTMENT.—Appoint20 ments and reappointments under this subsection 

21 shall be made on the basis of ability and experience 

22 as it relates to the mission of the Centers for Dis23 ease Control and Prevention and its components, in24 cluding compliance with relevant legal requirements. 

25 ‘‘(b) OTHER TRANSACTIONS.— 


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1 ‘‘(1) IN GENERAL.—In carrying out activities of 

2 the Centers for Disease Control and Prevention, the 

3 Director may enter into transactions other than a 

4 contract, grant, or cooperative agreement for pur5 poses of biosurveillance, infectious disease modeling, 

6 and public health preparedness and response, includ7 ing related research. 

8 ‘‘(2) WRITTEN DETERMINATION.—With respect 

9 to a project that is expected to cost the Centers for 

10 Disease Control and Prevention more than 

11 $5,000,000, the Director may exercise the authority 

12 under paragraph (1) only upon a written determina13 tion by the Assistant Secretary for Financial Re14 sources of the Department of Health and Human 

15 Services, that the use of such authority is essential 

16 to promoting the success of the project. The author17 ity of the Assistant Secretary for Financial Re18 sources under this paragraph may not be delegated. 

19 ‘‘(3) GUIDELINES.—The Director, in consulta20 tion with the Secretary, shall establish guidelines re21 garding the use of the authority under paragraph 

22 (1). Such guidelines shall include auditing require23 ments.’’. 


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1 SEC. 104. PUBLIC HEALTH AND MEDICAL PREPAREDNESS 

2 AND RESPONSE COORDINATION. 

3 (a) PUBLIC HEALTH EMERGENCY FUND.—Section 

4 319(b) of the Public Health Service Act (42 U.S.C. 

5 247d(b)) is amended— 

6 (1) in paragraph (2)— 

7 (A) in subparagraph (E), by striking 

8 ‘‘and’’ at the end; 

9 (B) by redesignating subparagraph (F) as 

10 subparagraph (G); and 

11 (C) by inserting after subparagraph (E), 

12 the following: 

13 ‘‘(F) support the initial deployment and 

14 distribution of contents of the Strategic Na15 tional Stockpile, as appropriate; and’’; and 

16 (2) by amending paragraph (3)(A) to read as 

17 follows: 

18 ‘‘(A) the expenditures made from the Pub19 lic Health Emergency Fund in such fiscal year, 

20 including— 

21 ‘‘(i) the amount obligated; 

22 ‘‘(ii) the recipient or recipients of such 

23 obligated funds; 

24 ‘‘(iii) the specific response activities 

25 such obligated funds will support; and 


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1 ‘‘(iv) the declared or potential public 

2 health emergency for which such funds 

3 were obligated; and’’. 

4 (b) IMPROVING PUBLIC HEALTH AND MEDICAL PRE5 PAREDNESS AND RESPONSE COORDINATION.— 

6 (1) COORDINATION WITH FEDERAL AGEN7 CIES.—Section 2801 of the Public Health Service 

8 Act (42 U.S.C. 300hh) is amended by adding at the 

9 end the following: 

10 ‘‘(c) COORDINATION WITH FEDERAL AGENCIES.—In 

11 leading the Federal public health and medical response to 

12 a declared or potential public health emergency, consistent 

13 with this section, the Secretary shall coordinate with, and 

14 may request support from, other Federal departments and 

15 agencies, as appropriate in order to carry out necessary 

16 activities and leverage the expertise of such departments 

17 and agencies, which may include the provision of assist18 ance at the direction of the Secretary related to supporting 

19 the public health and medical response for States, local20 ities, and Tribes.’’. 

21 (2) ASPR DUTIES.—Section 2811(b) of the 

22 Public Health Service Act (42 U.S.C. 300hh–10(b)) 

23 is amended— 

24 (A) in paragraph (1), by inserting ‘‘and, 

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1 work and other applicable provisions of law, as2 sist the Secretary in carrying out the functions 

3 under section 2801’’ before the period; and 

4 (B) in paragraph (4)— 

5 (i) in subparagraph (E) by striking 

6 ‘‘the actions necessary to overcome these 

7 obstacles.’’ and inserting ‘‘recommend ac8 tions necessary to overcome these obsta9 cles, such as— 

10 ‘‘(i) improving coordination with rel11 evant Federal officials; 

12 ‘‘(ii) partnering with other public or 

13 private entities to leverage capabilities 

14 maintained by such entities, as appropriate 

15 and consistent with this subsection; and 

16 ‘‘(iii) coordinating efforts to support 

17 or establish new capabilities, as appro18 priate.’’; and 

19 (ii) in subparagraph (G)— 

20 (I) by redesignating clauses (i) 

21 and (ii) as subclauses (I) and (II) and 

22 adjusting the margins accordingly; 

23 (II) in the matter preceding sub24 clause (I), as so redesignated— 


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1 (aa) by inserting ‘‘each year, 

2 including national-level and 

3 State-level full-scale exercises not 

4 less than once every 5 years’’ 

5 after ‘‘operational exercises’’; and 

6 (bb) by striking ‘‘exercises 

7 based on—’’ and inserting ‘‘exer8 cises— 

9 ‘‘(i) based on’’; 

10 (III) by striking the period and 

11 inserting a semicolon; and 

12 (IV) by adding at the end the fol13 lowing: 

14 ‘‘(ii) that assess the ability of the 

15 Strategic National Stockpile, as appro16 priate, to provide medical countermeasures, 

17 medical products, and other supplies, in18 cluding ancillary medical supplies, to sup19 port the response to a public health emer20 gency or potential public health emergency, 

21 including a threat that requires the large22 scale and simultaneous deployment of 

23 stockpiles and a long-term public health 

24 and medical response; and 


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1 ‘‘(iii) conducted in coordination with 

2 State and local health officials.’’. 

3 (c) APPEARANCES BEFORE AND REPORTS TO CON4 GRESS.—Section 2811 of the Public Health Service Act 

5 (42 U.S.C. 300hh–10) is amended by adding at the end 

6 the following: 

7 ‘‘(g) APPEARANCES BEFORE CONGRESS.— 

8 ‘‘(1) IN GENERAL.—Each fiscal year, the As9 sistant Secretary for Preparedness and Response 

10 shall appear before the Committee on Health, Edu11 cation, Labor, and Pensions of the Senate and the 

12 Committee on Energy and Commerce of the House 

13 of Representatives at hearings, on topics such as— 

14 ‘‘(A) coordination of Federal activities to 

15 prepare for, and respond to, public health emer16 gencies; 

17 ‘‘(B) activities and capabilities of the Stra18 tegic National Stockpile, including whether, and 

19 the degree to which, recommendations made 

20 pursuant to section 2811–1(c)(1)(A) have been 

21 met; 

22 ‘‘(C) support for State, local, and Tribal 

23 public health and medical preparedness; 


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1 ‘‘(D) activities implementing the counter2 measures budget plan described under sub3 section (b)(7), including— 

4 ‘‘(i) any challenges in meeting the full 

5 range of identified medical countermeasure 

6 needs; and 

7 ‘‘(ii) progress in supporting advanced 

8 research, development, and procurement of 

9 medical countermeasures, pursuant to sub10 section (b)(3); 

11 ‘‘(E) the strategic direction of, and activi12 ties related to, the sustainment of manufac13 turing surge capacity and capabilities for med14 ical countermeasures pursuant to section 319L 

15 and the distribution and deployment of such 

16 countermeasures; 

17 ‘‘(F) any additional objectives, activities, 

18 or initiatives that have been carried out or are 

19 planned by the Assistant Secretary for Pre20 paredness and Response and associated chal21 lenges, as appropriate; 

22 ‘‘(G) the specific all-hazards threats that 

23 the Assistant Secretary for Preparedness and 

24 Response is preparing to address, or that are 


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1 being addressed, through the activities de2 scribed in subparagraphs (A) through (F); and 

3 ‘‘(H) objectives, activities, or initiatives re4 lated to the coordination and consultation re5 quired under subsections (b)(4)(H) and 

6 (b)(4)(I), in a manner consistent with para7 graph (3), as appropriate. 

8 ‘‘(2) CLARIFICATIONS.— 

9 ‘‘(A) WAIVER AUTHORITY.—The Chair of 

10 the Committee on Health, Education, Labor, 

11 and Pensions of the Senate or the Chair of the 

12 Committee on Energy and Commerce of the 

13 House of Representatives may waive the re14 quirements of paragraph (1) for the applicable 

15 fiscal year with respect to the applicable Com16 mittee. 

17 ‘‘(B) SCOPE OF REQUIREMENTS.—The re18 quirements of this subsection shall not be con19 strued to impact the appearance of other Fed20 eral officials or the Assistant Secretary at hear21 ings of either Committee described in para22 graph (1) at other times and for purposes other 

23 than the times and purposes described in para24 graph (1). 


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1 ‘‘(3) CLOSED HEARINGS.—Information that is 

2 not appropriate for disclosure during an open hear3 ing under paragraph (1) in order to protect national 

4 security may instead be discussed in a closed hear5 ing that immediately follows such open hearing.’’. 

6 (d) ANNUAL REPORT ON EMERGENCY RESPONSE

7 AND PREPAREDNESS.—Section 2801 of the Public Health 

8 Service Act (42 U.S.C. 300hh), as amended by subsection 

9 (b), is further amended by adding at the end the following: 

10 ‘‘(d) ANNUAL REPORT ON EMERGENCY RESPONSE

11 AND PREPAREDNESS.—The Secretary shall submit a writ12 ten report each fiscal year to the Committee on Health, 

13 Education, Labor, and Pensions of the Senate and the 

14 Committee on Energy and Commerce of the House of 

15 Representatives, containing— 

16 ‘‘(1) updated information related to an assess17 ment of the response to any public health emergency 

18 declared, or otherwise in effect, during the previous 

19 fiscal year; 

20 ‘‘(2) findings related to drills and operational 

21 exercises completed in the previous fiscal year pursu22 ant to section 2811(b)(4)(G); 

23 ‘‘(3) the state of public health preparedness and 

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1 logical, and nuclear threats, including emerging in2 fectious diseases; and 

3 ‘‘(4) any challenges in preparing for or respond4 ing to such threats, as appropriate.’’. 

5 (e) GAO REPORT ON INTERAGENCY AGREEMENTS

6 AND COORDINATION.—Not later than 3 years after the 

7 date of enactment of this Act, the Comptroller General 

8 of the United States shall— 

9 (1) conduct a review of previous and current 

10 interagency agreements established between the Sec11 retary of Health and Human Services and the heads 

12 of other relevant Federal departments or agencies 

13 pursuant to section 2801(b) of the Public Health 

14 Service Act (42 U.S.C. 300hh(b)), including— 

15 (A) the specific roles and responsibilities of 

16 each Federal department or agency that is a 

17 party to any such interagency agreement; 

18 (B) the manner in which specific capabili19 ties of each such Federal department or agency 

20 may be utilized under such interagency agree21 ments; 

22 (C) the frequency with which such inter23 agency agreements have been utilized; 

24 (D) gaps, if any, in interagency agree25 ments that prevent the Secretary from carrying 


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1 out the goals under section 2802 of the Public 

2 Health Service Act (42 U.S.C. 300hh–1); 

3 (E) barriers, if any, to establishing or uti4 lizing such interagency agreements; and 

5 (F) recommendations, if any, on the ways 

6 in which such interagency agreements can be 

7 improved to address the gaps and barriers iden8 tified under subparagraphs (D) and (E); 

9 (2) conduct a review of the implementation and 

10 utilization of the authorities described under section 

11 2801(c) of the Public Health Service Act (42 U.S.C. 

12 300hh(c)); and 

13 (3) submit to the Committee on Health, Edu14 cation, Labor, and Pensions of the Senate and the 

15 Committee on Energy and Commerce of the House 

16 of Representatives a report on the reviews under 

17 paragraphs (1) and (2), including related rec18 ommendations, as applicable. 

19 SEC. 105. STRENGTHENING PUBLIC HEALTH COMMUNICA20 TION. 

21 Subsection (b) of section 319F of the Public Health 

22 Service Act (42 U.S.C. 247d–6) is amended to read as 

23 follows: 

24 ‘‘(b) PUBLIC HEALTH INFORMATION AND COMMU25 NICATIONS ADVISORY COMMITTEE.— 


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1 ‘‘(1) IN GENERAL.—The Secretary shall estab2 lish an advisory committee to be known as the Pub3 lic Health Information and Communications Advi4 sory Committee (referred to in this subsection as the 

5 ‘Advisory Committee’). 

6 ‘‘(2) DUTIES.—The Advisory Committee shall 

7 make recommendations to the Secretary and report 

8 on— 

9 ‘‘(A) critical aspects of communication and 

10 dissemination of scientific and evidence-based 

11 public health information during public health 

12 emergencies, including— 

13 ‘‘(i) the role and impact of misin14 formation on the response to such public 

15 health emergencies; 

16 ‘‘(ii) the role of risk communication 

17 before and during such public health emer18 gencies; and 

19 ‘‘(iii) other relevant factors, as the 

20 Secretary determines appropriate; 

21 ‘‘(B) information from academic institu22 tions, community-based organizations, and 

23 other nongovernmental organizations related to 

24 evidence-based or evidence-informed strategies 


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1 and best practices to effectively communicate 

2 and disseminate such information; 

3 ‘‘(C) strategies to improve communication 

4 and dissemination of scientific and evidence5 based public health information to the public, to 

6 improve such communication between Federal, 

7 State, local, and Tribal health officials, and, as 

8 appropriate, to address misinformation during 

9 public health emergencies, including strategies 

10 to— 

11 ‘‘(i) identify the most effective meth12 ods for the dissemination of information 

13 during a public health emergency, with 

14 consideration of the needs of at-risk popu15 lations; 

16 ‘‘(ii) determine best practices and 

17 communicate information to populations 

18 that may be impacted by such misinforma19 tion; and 

20 ‘‘(iii) adapt approaches for the dis21 semination of information, as appropriate, 

22 to address emerging trends related to mis23 information. 

24 ‘‘(3) COMPOSITION.—The Advisory Committee 

25 shall be composed of— 


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1 ‘‘(A) appropriate Federal officials, ap2 pointed by the Secretary, who shall serve as 

3 nonvoting members; and 

4 ‘‘(B) individuals, appointed by the Sec5 retary, with expertise in public health (including 

6 individuals with experience in State, local, and 

7 Tribal health departments), medicine, commu8 nications, related technology, psychology, men9 tal health and substance use disorders, national 

10 security, and other areas, as the Secretary de11 termines appropriate, who shall serve as voting 

12 members. 

13 ‘‘(4) DISSEMINATION.—The Secretary shall re14 view the recommendations of the Advisory Com15 mittee and, not later than 180 days after receipt of 

16 the report under paragraph (2), shall submit to the 

17 Committee on Health, Education, Labor, and Pen18 sions of the Senate and the Committee on Energy 

19 and Commerce of the House of Representatives a re20 port describing any actions planned by the Secretary 

21 related to the communication and dissemination of 

22 scientific and evidence-based public health informa23 tion, including addressing misinformation, as appro24 priate. 


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1 ‘‘(5) TERMINATION.—The Advisory Committee 

2 shall terminate 4 years after the date of enactment 

3 of the PREVENT Pandemics Act.’’. 

4 SEC. 106. OFFICE OF PANDEMIC PREPAREDNESS AND RE5 SPONSE POLICY. 

6 (a) IN GENERAL.—There is established in the Execu7 tive Office of the President an Office of Pandemic Pre8 paredness and Response Policy (referred to in this section 

9 as the ‘‘Office’’), which shall be headed by a Director (re10 ferred to in this section as the ‘‘Director’’) appointed by 

11 the President and who shall be compensated at the rate 

12 provided for level II of the Executive Schedule in section 

13 5313 of title 5, United States Code. The President is au14 thorized to appoint not more than 2 Associate Directors, 

15 who shall be compensated at a rate not to exceed that pro16 vided for level III of the Executive Schedule in section 

17 5314 of such title. Associate Directors shall perform such 

18 functions as the Director may prescribe. 

19 (b) FUNCTIONS OF THE DIRECTOR.—The primary 

20 function of the Director is to provide advice, within the 

21 Executive Office of the President, on pandemic prepared22 ness and response policy, and support strategic coordina23 tion and communication with respect to relevant activities 

24 across the Federal Government. In addition to such other 

25 functions and activities as the President may assign, the 


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1 Director, consistent with applicable laws and the National 

2 Response Framework, shall— 

3 (1) serve as the principal advisor to the Presi4 dent on all matters related to pandemic prepared5 ness and response policy and make recommendations 

6 to the President regarding pandemic and other bio7 logical threats that may impact national security; 

8 (2) coordinate Federal activities to prepare for, 

9 and respond to, pandemic and other biological 

10 threats, by— 

11 (A) providing strategic direction to the 

12 heads of applicable Federal departments, agen13 cies, and offices, including— 

14 (i) the establishment, implementation, 

15 prioritization, and assessment of policy 

16 goals and objectives across the Executive 

17 Office of the President and such depart18 ments, agencies, and offices; 

19 (ii) supporting the assessment and 

20 clarification of roles and responsibilities re21 lated to such Federal activities; and 

22 (iii) supporting the development and 

23 implementation of metrics and perform24 ance measures to evaluate the extent to 


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1 which applicable activities meet such goals 

2 and objectives; 

3 (B) providing, in consultation with the 

4 Secretary of Health and Human Services and 

5 the heads of other relevant Federal depart6 ments, agencies, and offices, leadership with re7 spect to the National Biodefense Strategy and 

8 related activities pursuant to section 1086 of 

9 the National Defense Authorization Act for Fis10 cal Year 2017 (6 U.S.C. 104) and section 363 

11 of the William M. (Mac) Thornberry National 

12 Defense Authorization Act for Fiscal Year 2021 

13 (6 U.S.C. 105); 

14 (C) facilitating coordination and commu15 nication between such Federal departments, 

16 agencies, and offices to improve preparedness 

17 for, and response to, such threats; 

18 (D) ensuring that the authorities, capabili19 ties, and expertise of each such department, 

20 agency, and office are appropriately leveraged 

21 to facilitate the whole-of-Government response 

22 to such threats; 

23 (E) overseeing coordination of Federal ef24 forts to prepare for and support the production, 

25 supply, and distribution of relevant medical 


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1 products and supplies during a response to a 

2 pandemic or other biological threat, as applica3 ble and appropriate, including supporting Fed4 eral efforts to assess any relevant vulnerabilities 

5 in the supply chain of such products and sup6 plies; 

7 (F) overseeing coordination of Federal ef8 forts for the basic and advanced research, de9 velopment, manufacture, and procurement of 

10 medical countermeasures, including by— 

11 (i) serving, with the Secretary of 

12 Health and Human Services, as co-Chair 

13 of the Public Health Emergency Medical 

14 Countermeasures Enterprise established 

15 pursuant to section 2811–1 of the Public 

16 Health Service Act (42 U.S.C. 300hh– 

17 10a); and 

18 (ii) promoting coordination between 

19 the medical countermeasure research, de20 velopment, and procurement activities of 

21 respective Federal departments and agen22 cies, including to advance the discovery 

23 and development of new medical products 

24 and technologies; 


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1 (G) convening heads of Federal depart2 ments and agencies, as appropriate, on topics 

3 related to capabilities to prepare for, and re4 spond to, such threats; 

5 (H) assessing and advising on inter6 national cooperation in preparing for, and re7 sponding to, such threats to advance the na8 tional security objectives of the United States; 

9 and 

10 (I) overseeing other Federal activities to 

11 assess preparedness for, and responses to, such 

12 threats, including— 

13 (i) drills and operational exercises 

14 conducted pursuant to applicable provi15 sions of law; and 

16 (ii) Federal after-action reports devel17 oped following such drills and exercises or 

18 a response to a pandemic or other biologi19 cal threat; 

20 (3) promote and support the development of 

21 relevant expertise and capabilities within the Federal 

22 Government to ensure that the United States can 

23 quickly detect, identify, and respond to such threats, 

24 and provide recommendations, as appropriate, to the 

25 President; 


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1 (4) consult with the Director of the Office of 

2 Management and Budget and other relevant officials 

3 within the Executive Office of the President, includ4 ing the Assistant to the President for National Secu5 rity Affairs and the Director of the Office of Science 

6 and Technology Policy, regarding activities related 

7 to preparing for, and responding to, such threats 

8 and relevant research and emerging technologies 

9 that may advance the biosecurity and preparedness 

10 and response goals of the Federal Government; 

11 (5) identify opportunities to leverage current 

12 and emerging technologies, including through public13 private partnerships, as appropriate, to address such 

14 threats and advance the preparedness and response 

15 goals of the Federal Government; and 

16 (6) ensure that findings of Federal after-action 

17 reports conducted pursuant to paragraph (2)(I)(ii) 

18 are implemented to the maximum extent feasible 

19 within the Federal Government. 

20 (c) SUPPORT FROM OTHER AGENCIES.—Each de21 partment, agency, and instrumentality of the executive 

22 branch of the Federal Government, including any inde23 pendent agency, is authorized to support the Director by 

24 providing the Director such information as the Director 


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1 determines necessary to carry out the functions of the Di2 rector under this section. 

3 (d) PREPAREDNESS OUTLOOK REPORT.— 

4 (1) IN GENERAL.—Within its first year of oper5 ation, the Director, in consultation with the heads of 

6 relevant Federal departments and agencies and 

7 other officials within the Executive Office of the 

8 President, shall through a report submitted to the 

9 President and made available to the public, to the 

10 extent practicable, identify and describe situations 

11 and conditions which warrant special attention with12 in the next 5 years, involving current and emerging 

13 problems of national significance related to pan14 demic or other biological threats, and opportunities 

15 for, and the barriers to, the research, development, 

16 and procurement of medical countermeasures to ade17 quately respond to such threats. 

18 (2) REVISIONS.—The Office shall revise the re19 port under paragraph (1) not less than once every 

20 5 years and work with relevant Federal officials to 

21 address the problems, barriers, opportunities, and 

22 actions identified under this report through the de23 velopment of the President’s Budgets and programs. 

24 (e) INTERDEPARTMENTAL WORKING GROUP.—The 

25 Director shall lead an interdepartmental working group 


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1 that will meet on a regular basis to evaluate national bio2 security and pandemic preparedness issues and make rec3 ommendations to the heads of applicable Federal depart4 ments, agencies and offices. The working group shall con5 sist of representatives from— 

6 (1) the Office of Pandemic Preparedness and 

7 Response Policy, to serve as the chair; 

8 (2) the Department of Health and Human 

9 Services; 

10 (3) the Department of Homeland Security; 

11 (4) the Department of Defense; 

12 (5) the Office of Management and Budget; and 

13 (6) other Federal Departments and agencies. 

14 (f) ADDITIONAL FUNCTIONS OF THE DIRECTOR.— 

15 The Director, in addition to the other duties and functions 

16 set forth in this section— 

17 (1) shall— 

18 (A) serve as a member of the Domestic 

19 Policy Council and the National Security Coun20 cil; 

21 (B) serve as a member of the Intergovern22 mental Science, Engineering, and Technology 

23 Advisory Panel under section 205(b) of the Na24 tional Science and Technology Policy, Organiza25 tion, and Priorities Act of 1976 (42 U.S.C. 


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1 6614(b)) and the Federal Coordinating Council 

2 for Science, Engineering and Technology under 

3 section 401 of such Act (42 U.S.C. 6651); 

4 (C) consult with State, Tribal, local, and 

5 territorial governments, industry, academia, 

6 professional societies, and other stakeholders, 

7 as appropriate; 

8 (D) use for administrative purposes, on a 

9 reimbursable basis, the available services, equip10 ment, personnel, and facilities of Federal, State, 

11 and local agencies; and 

12 (E) at the President’s request, perform 

13 such other duties and functions and enter into 

14 contracts and other arrangements for studies, 

15 analyses, and related services with public or pri16 vate entities, as applicable and appropriate; and 

17 (2) may hold such hearings in various parts of 

18 the United States as necessary to determine the 

19 views of the entities and individuals referred to in 

20 paragraph (1) and of the general public, concerning 

21 national needs and trends in pandemic preparedness 

22 and response. 

23 (g) STAFFING AND DETAILEES.—In carrying out 

24 functions under this section, the Director may— 


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1 (1) appoint not more than 25 individuals to 

2 serve as employees of the Office as necessary to 

3 carry out this section; 

4 (2) fix the compensation of such personnel at a 

5 rate to be determined by the Director, up to the 

6 amount of annual compensation (excluding expenses) 

7 specified in section 102 of title 3, United States 

8 Code; 

9 (3) utilize the services of consultants, which 

10 may include by obtaining services described under 

11 section 3109(b) of title 5, United States Code, at 

12 rates not to exceed the rate of basic pay for level IV 

13 of the Executive Schedule; and 

14 (4) direct, with the concurrence of the Sec15 retary of a department or head of an agency, the 

16 temporary reassignment within the Federal Govern17 ment of personnel employed by such department or 

18 agency, in order to carry out the functions of the Of19 fice. 

20 (h) PREPAREDNESS REVIEW AND REPORT.—The Di21 rector, in consultation with the heads of applicable Federal 

22 departments, agencies, and offices, shall— 

23 (1) not later than 1 year after the date of en24 actment of this Act, conduct a review of applicable 

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1 tion reports to identify gaps and inefficiencies re2 lated to pandemic preparedness and response; 

3 (2) not later than 18 months after the date of 

4 enactment of this Act, and every 2 years thereafter, 

5 submit to the President and the Committee on 

6 Health, Education, Labor, and Pensions of the Sen7 ate and the Committee on Energy and Commerce of 

8 the House of Representatives a report describing— 

9 (A) current and emerging pandemic and 

10 other biological threats that pose a significant 

11 level of risk to national security; 

12 (B) the roles and responsibilities of the 

13 Federal Government in preparing for, and re14 sponding to, such threats; 

15 (C) the findings of the review conducted 

16 under paragraph (1); 

17 (D) any barriers or limitations related to 

18 addressing such findings; 

19 (E) current and planned activities to up20 date Federal strategies, policies, and procedures 

21 to address such findings, consistent with appli22 cable laws and the National Response Frame23 work; 

24 (F) current and planned activities to sup25 port the development of expertise within the 


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1 Federal Government pursuant to subsection 

2 (b)(3); and 

3 (G) opportunities to improve Federal pre4 paredness and response capacities and capabili5 ties through the use of current and emerging 

6 technologies. 

7 (i) NONDUPLICATION OF EFFORT.—The Director 

8 shall ensure that activities carried out under this section 

9 do not unnecessarily duplicate the efforts of other Federal 

10 departments, agencies, and offices. 

11 (j) CONFORMING AMENDMENTS.— 

12 (1) Section 2811–1 of the Public Health Serv13 ice Act (42 U.S.C. 300hh–10a) is amended— 

14 (A) in the second sentence of subsection 

15 (a), by striking ‘‘shall serve as chair’’ and in16 serting ‘‘and the Director of the Office of Pan17 demic Preparedness and Response Policy shall 

18 serve as co-chairs’’; and 

19 (B) in subsection (b)— 

20 (i) by redesignating paragraph (10) as 

21 paragraph (11); and 

22 (ii) by inserting after paragraph (9) 

23 the following: 

24 ‘‘(10) The Director of the Office of Pandemic 

25 Preparedness and Response Policy.’’. 


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1 (2) Section 101(c)(1) of the National Security 

2 Act of 1947 (50 U.S.C. 3021(c)(1)) is amended by 

3 inserting ‘‘the Director of the Office of Pandemic 

4 Preparedness and Response Policy’’ after ‘‘Treas5 ury,’’. 

6 (3) The National Science and Technology Pol7 icy, Organization, and Priorities Act of 1976 (42 

8 U.S.C. 6601 et seq.) is amended— 

9 (A) in section 205(b)(2) (42 U.S.C. 

10 6614(b)(2))— 

11 (i) by striking ‘‘and (C)’’ and insert12 ing ‘‘(C)’’; and 

13 (ii) by striking the period at the end 

14 and inserting ‘‘; and (D) the Director of 

15 the Office of Pandemic Preparedness and 

16 Response Policy.’’; and 

17 (B) in section 401(b) (42 U.S.C. 6651(b)), 

18 by inserting ‘‘, the Director of the Office of 

19 Pandemic Preparedness and Response Policy,’’ 

20 after ‘‘Technology Policy’’. 


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1 Subtitle B—State and Local 

2 Readiness 

3 SEC. 111. IMPROVING STATE AND LOCAL PUBLIC HEALTH 

4 SECURITY. 

5 (a) IN GENERAL.—Section 319C–1(b)(2) of the Pub6 lic Health Service Act (42 U.S.C. 247d–3a(b)(2)) is 

7 amended— 

8 (1) in subparagraph (A)— 

9 (A) in clause (vii), by inserting ‘‘during 

10 and’’ before ‘‘following a public health emer11 gency’’; 

12 (B) by amending clause (viii) to read as 

13 follows: 

14 ‘‘(viii) a description of how the entity, 

15 as applicable and appropriate, will coordi16 nate with State emergency preparedness 

17 and response plans in public health emer18 gency preparedness, including State edu19 cation agencies (as defined in section 8101 

20 of the Elementary and Secondary Edu21 cation Act of 1965), State child care lead 

22 agencies (designated under section 658D 

23 of the Child Care and Development Block 

24 Grant Act of 1990), and other relevant 

25 State agencies’’; 


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1 (C) in clause (xi), by striking ‘‘; and’’ and 

2 inserting a semicolon; 

3 (D) by redesignating clause (xii) as clause 

4 (xiii); and 

5 (E) by inserting after clause (xi) the fol6 lowing: 

7 ‘‘(xii) a description of how the entity 

8 will provide technical assistance to improve 

9 public health preparedness and response, 

10 as appropriate, to agencies or other enti11 ties that operate facilities within the enti12 ty’s jurisdiction in which there is an in13 creased risk of infectious disease outbreaks 

14 in the event of a public health emergency 

15 declared under section 319, such as resi16 dential care facilities, group homes, and 

17 other similar settings; and’’; 

18 (2) by redesignating subparagraphs (D) 

19 through (H) as subparagraphs (E) through (I), re20 spectively; and 

21 (3) by inserting after subparagraph (C) the fol22 lowing: 

23 ‘‘(D) an assurance that the entity will re24 quire relevant staff to complete relevant pre25 paredness and response trainings, including 


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1 trainings related to efficient and effective oper2 ation during an incident or event within an In3 cident Command System;’’. 

4 (b) APPLICABILITY.—The amendments made by sub5 section (a) shall not apply with respect to any cooperative 

6 agreement entered into prior to the date of enactment of 

7 this Act. 

8 SEC. 112. SUPPORTING ACCESS TO MENTAL HEALTH AND 

9 SUBSTANCE USE DISORDER SERVICES DUR10 ING PUBLIC HEALTH EMERGENCIES. 

11 (a) AUTHORITIES.—Section 501(d) of the Public 

12 Health Service Act (42 U.S.C. 290aa(d)) is amended— 

13 (1) by redesignating paragraphs (24) and (25) 

14 as paragraphs (25) and (26), respectively; and 

15 (2) by inserting after paragraph (23) the fol16 lowing: 

17 ‘‘(24) support the continued access to, or avail18 ability of, mental health and substance use disorder 

19 services during, or in response to, a public health 

20 emergency declared under section 319, including in 

21 consultation with, as appropriate, the Assistant Sec22 retary for Preparedness and Response and the heads 

23 of other relevant agencies, in preparing for, and re24 sponding to, a public health emergency;’’. 


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1 (b) STRATEGIC PLAN.—Section 501(l)(4) of the Pub2 lic Health Service Act (42 U.S.C. 290aa(l)(4)) is amend3 ed— 

4 (1) in subparagraph (E), by striking ‘‘and’’ at 

5 the end; 

6 (2) in subparagraph (F), by striking the period 

7 and inserting ‘‘; and’’; and 

8 (3) by adding at the end the following: 

9 ‘‘(G) specify a strategy to support the con10 tinued access to, or availability of, mental 

11 health and substance use disorder services, in12 cluding to at-risk individuals (as defined in sec13 tion 2802(b)(4)), during, or in response to, 

14 public health emergencies declared pursuant to 

15 section 319.’’. 

16 (c) BIENNIAL REPORT CONCERNING ACTIVITIES AND

17 PROGRESS.—Section 501(m) of the Public Health Service 

18 Act (42 U.S.C. 290aa(m)) is amended— 

19 (1) by redesignating paragraphs (4) through 

20 (7) as paragraphs (5) through (8), respectively; 

21 (2) by inserting after paragraph (3) the fol22 lowing: 

23 ‘‘(4) a description of the Administration’s ac24 tivities to support the continued provision of mental 

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1 cable, in response to public health emergencies de2 clared pursuant to section 319;’’; and 

3 (3) in paragraph (5), as so redesignated— 

4 (A) by redesignating subparagraphs (D) 

5 and (E) as subparagraphs (E) and (F), respec6 tively; and 

7 (B) by inserting after subparagraph (C) 

8 the following: 

9 ‘‘(D) relevant preparedness and response 

10 activities;’’. 

11 (d) ADVISORY COUNCILS.—Not later than 1 year 

12 after the date of enactment of this Act, the Assistant Sec13 retary for Mental Health and Substance Use shall issue 

14 a report to the Committee on Health, Education, Labor, 

15 and Pensions of the Senate and the Committee on Energy 

16 and Commerce of the House of Representatives, reflecting 

17 the feedback of the advisory councils for the Center for 

18 Substance Abuse Treatment, the Center for Substance 

19 Abuse Prevention, and the Center for Mental Health Serv20 ices, pursuant to section 502 of the Public Health Service 

21 Act (42 U.S.C. 290aa–1), with recommendations to im22 prove the continued provision of mental health and sub23 stance use disorder services during a public health emer24 gency declared under section 319 of such Act (42 U.S.C. 

25 247d), and the provision of such services as part of the 


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1 public health and medical response to such an emergency, 

2 consistent with title XXVIII of such Act (42 U.S.C. 300hh 

3 et seq.), including related to the capacity of the mental 

4 health and substance use disorder workforce and flexibili5 ties provided to awardees of mental health and substance 

6 use disorder programs. 

7 (e) GAO REPORT.—Not later than 3 years after the 

8 date of enactment of this Act, the Comptroller General 

9 of the United States shall submit to the Committee on 

10 Health, Education, Labor, and Pensions of the Senate and 

11 the Committee on Energy and Commerce of the House 

12 of Representatives a report on programs and activities of 

13 the Substance Abuse and Mental Health Services Admin14 istration to support the provision of mental health and 

15 substance use disorder services and related activities dur16 ing the COVID–19 pandemic, including the provision of 

17 such services as part of the medical and public health re18 sponse to such pandemic. Such report shall— 

19 (1) examine the role played by the advisory 

20 councils described in section 502 of the Public 

21 Health Service Act (42 U.S.C. 290aa–1) and the 

22 National Mental Health and Substance Use Policy 

23 Laboratory established under section 501A of such 

24 Act (42 U.S.C. 290aa–0) in providing technical as25 sistance and recommendations to the Substance 


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1 Abuse and Mental Health Services Administration to 

2 support the response of such agency to the public 

3 health emergency declared under section 319 of the 

4 Public Health Service Act (42 U.S.C. 247d) with re5 spect to COVID–19; 

6 (2) describe the manner in which existing 

7 awardees of mental health and substance use dis8 order programs provided and altered delivery of 

9 services during such public health emergency, includ10 ing information on the populations served by such 

11 awardees and any barriers faced in delivering serv12 ices; and 

13 (3) describe activities of the Substance Abuse 

14 and Mental Health Services Administration to sup15 port the response to such public health emergency, 

16 including through technical assistance, provision of 

17 services, and any flexibilities provided to such exist18 ing awardees, and any barriers faced in imple19 menting such activities. 

20 SEC. 113. TRAUMA CARE REAUTHORIZATION. 

21 (a) IN GENERAL.—Section 1201 of the Public Health 

22 Service Act (42 U.S.C. 300d) is amended— 

23 (1) in subsection (a)— 

24 (A) in paragraph (3)— 


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1 (i) by inserting ‘‘analyze,’’ after ‘‘com2 pile,’’; and 

3 (ii) by inserting ‘‘and medically under4 served areas’’ before the semicolon; 

5 (B) in paragraph (4), by adding ‘‘and’’ 

6 after the semicolon; 

7 (C) by striking paragraph (5); and 

8 (D) by redesignating paragraph (6) as 

9 paragraph (5); 

10 (2) by redesignating subsection (b) as sub11 section (c); and 

12 (3) by inserting after subsection (a) the fol13 lowing: 

14 ‘‘(b) TRAUMA CARE READINESS AND COORDINA15 TION.—The Secretary, acting through the Assistant Sec16 retary for Preparedness and Response, shall support the 

17 efforts of States and consortia of States to coordinate and 

18 improve emergency medical services and trauma care dur19 ing a public health emergency declared by the Secretary 

20 pursuant to section 319 or a major disaster or emergency 

21 declared by the President under section 401 or 501, re22 spectively, of the Robert T. Stafford Disaster Relief and 

23 Emergency Assistance Act. Such support may include— 

24 ‘‘(1) developing, issuing, and updating guid25 ance, as appropriate, to support the coordinated 


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1 medical triage and evacuation to appropriate medical 

2 institutions based on patient medical need, taking 

3 into account regionalized systems of care; 

4 ‘‘(2) disseminating, as appropriate, information 

5 on evidence-based or evidence-informed trauma care 

6 practices, taking into consideration emergency med7 ical services and trauma care systems, including 

8 such practices identified through activities conducted 

9 under subsection (a) and which may include the 

10 identification and dissemination of performance 

11 metrics, as applicable and appropriate; and 

12 ‘‘(3) other activities, as appropriate, to optimize 

13 a coordinated and flexible approach to the emer14 gency response and medical surge capacity of hos15 pitals, other health care facilities, critical care, and 

16 emergency medical systems.’’. 

17 (b) GRANTS TO IMPROVE TRAUMA CARE IN RURAL

18 AREAS.—Section 1202 of the Public Health Service Act 

19 (42 U.S.C. 300d–3) is amended— 

20 (1) by amending the section heading to read as 

21 follows: ‘‘GRANTS TO IMPROVE TRAUMA CARE

22 IN RURAL AREAS’’; 

23 (2) by amending subsections (a) and (b) to read 

24 as follows: 


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1 ‘‘(a) IN GENERAL.—The Secretary shall award 

2 grants to eligible entities for the purpose of carrying out 

3 research and demonstration projects to support the im4 provement of emergency medical services and trauma care 

5 in rural areas through the development of innovative uses 

6 of technology, training and education, transportation of 

7 seriously injured patients for the purposes of receiving 

8 such emergency medical services, access to prehospital 

9 care, evaluation of protocols for the purposes of improve10 ment of outcomes and dissemination of any related best 

11 practices, activities to facilitate clinical research, as appli12 cable and appropriate, and increasing communication and 

13 coordination with applicable State or Tribal trauma sys14 tems. 

15 ‘‘(b) ELIGIBLE ENTITIES.— 

16 ‘‘(1) IN GENERAL.—To be eligible to receive a 

17 grant under this section, an entity shall be a public 

18 or private entity that provides trauma care in a 

19 rural area. 

20 ‘‘(2) PRIORITY.—In awarding grants under this 

21 section, the Secretary shall give priority to eligible 

22 entities that will provide services under the grant in 

23 any rural area identified by a State under section 

24 1214(d)(1).’’; and 

25 (3) by adding at the end the following: 


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1 ‘‘(d) REPORTS.—An entity that receives a grant 

2 under this section shall submit to the Secretary such re3 ports as the Secretary may require to inform administra4 tion of the program under this section.’’. 

5 (c) PILOT GRANTS FOR TRAUMA CENTERS.—Section 

6 1204 of the Public Health Service Act (42 U.S.C. 300d– 

7 6) is amended— 

8 (1) by amending the section heading to read as 

9 follows: ‘‘PILOT GRANTS FOR TRAUMA CEN10 TERS’’; 

11 (2) in subsection (a)— 

12 (A) by striking ‘‘not fewer than 4’’ and in13 serting ‘‘10’’; 

14 (B) by striking ‘‘that design, implement, 

15 and evaluate’’ and inserting ‘‘to design, imple16 ment, and evaluate new or existing’’; 

17 (C) by striking ‘‘emergency care’’ and in18 serting ‘‘emergency medical’’; and 

19 (D) by inserting ‘‘, and improve access to 

20 trauma care within such systems’’ before the 

21 period; 

22 (3) in subsection (b)(1), by striking subpara23 graphs (A) and (B) and inserting the following: 

24 ‘‘(A) a State or consortia of States; 


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1 ‘‘(B) an Indian Tribe or Tribal organiza2 tion (as defined in section 4 of the Indian Self3 Determination and Education Assistance Act); 

4 ‘‘(C) a consortium of level I, II, or III 

5 trauma centers designated by applicable State 

6 or local agencies within an applicable State or 

7 region, and, as applicable, other emergency 

8 services providers; or 

9 ‘‘(D) a consortium or partnership of non10 profit Indian Health Service, Indian Tribal, and 

11 urban Indian trauma centers.’’; 

12 (4) in subsection (c)— 

13 (A) in the matter preceding paragraph 

14 (1)— 

15 (i) by striking ‘‘that proposes a pilot 

16 project’’; 

17 (ii) by striking ‘‘an emergency medical 

18 and trauma system that—’’ and inserting 

19 ‘‘a new or existing emergency medical and 

20 trauma system. Such eligible entity shall 

21 use amounts awarded under this sub22 section to carry out 2 or more of the fol23 lowing activities:’’; 

24 (B) in paragraph (1) — 


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1 (i) by striking ‘‘coordinates’’ and in2 serting ‘‘Strengthening coordination and 

3 communication’’; and 

4 (ii) by striking ‘‘an approach to emer5 gency medical and trauma system access 

6 throughout the region, including 9–1–1 

7 Public Safety Answering Points and emer8 gency medical dispatch;’’ and inserting 

9 ‘‘approaches to improve situational aware10 ness and emergency medical and trauma 

11 system access, including distribution of pa12 tients during a mass casualty incident, 

13 throughout the region.’’; 

14 (C) in paragraph (2)— 

15 (i) by striking ‘‘includes’’ and insert16 ing ‘‘Providing’’; 

17 (ii) by inserting ‘‘support patient 

18 movement to’’ after ‘‘region to’’; and 

19 (iii) by striking the semicolon and in20 serting a period; 

21 (D) in paragraph (3)— 

22 (i) by striking ‘‘allows for’’ and insert23 ing ‘‘Improving’’; and 

24 (ii) by striking ‘‘; and’’ and inserting 

25 a period; 


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1 (E) in paragraph (4), by striking ‘‘includes 

2 a consistent’’ and inserting ‘‘Supporting a con3 sistent’’; and 

4 (F) by adding at the end the following: 

5 ‘‘(5) Establishing, implementing, and dissemi6 nating, or utilizing existing, as applicable, evidence7 based or evidence-informed practices across facilities 

8 within such emergency medical and trauma system 

9 to improve health outcomes, including such practices 

10 related to management of injuries, and the ability of 

11 such facilities to surge. 

12 ‘‘(6) Conducting activities to facilitate clinical 

13 research, as applicable and appropriate.’’; 

14 (5) in subsection (d)(2)— 

15 (A) in subparagraph (A)— 

16 (i) in the matter preceding clause (i), 

17 by striking ‘‘the proposed’’ and inserting 

18 ‘‘the applicable emergency medical and 

19 trauma system’’; 

20 (ii) in clause (i), by inserting ‘‘or 

21 Tribal entity’’ after ‘‘equivalent State of22 fice’’; and 

23 (iii) in clause (vi), by striking ‘‘; and’’ 

24 and inserting a semicolon; 


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1 (B) by redesignating subparagraph (B) as 

2 subparagraph (C); and 

3 (C) by inserting after subparagraph (A) 

4 the following: 

5 ‘‘(B) for eligible entities described in sub6 paragraph (C) or (D) of subsection (b)(1), a de7 scription of, and evidence of, coordination with 

8 the applicable State Office of Emergency Med9 ical Services (or equivalent State Office) or ap10 plicable such office for a Tribe or Tribal organi11 zation; and’’; 

12 (6) in subsection (e)— 

13 (A) in paragraph (1), by striking ‘‘$1 for 

14 each $3’’ and inserting ‘‘$1 for each $5’’; and 

15 (B) by adding at the end the following: 

16 ‘‘(3) WAIVER.—The Secretary may waive all or 

17 part of the matching requirement described in para18 graph (1) for any fiscal year for a State, consortia 

19 of States, Indian Tribe or Tribal organization, or 

20 trauma center, if the Secretary determines that ap21 plying such matching requirement would result in 

22 serious hardship or an inability to carry out the pur23 poses of the pilot program.’’; 


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1 (7) in subsection (f), by striking ‘‘population in 

2 a medically underserved area’’ and inserting ‘‘medi3 cally underserved population’’; 

4 (8) in subsection (g)— 

5 (A) in the matter preceding paragraph (1), 

6 by striking ‘‘described in’’; 

7 (B) in paragraph (2), by striking ‘‘the sys8 tem characteristics that contribute to’’ and in9 serting ‘‘opportunities for improvement, includ10 ing recommendations for how to improve’’; 

11 (C) by striking paragraph (4); 

12 (D) by redesignating paragraphs (5) and 

13 (6) as paragraphs (4) and (5), respectively; 

14 (E) in paragraph (4), as so redesignated, 

15 by striking ‘‘; and’’ and inserting a semicolon; 

16 (F) in paragraph (5), as so redesignated, 

17 by striking the period and inserting ‘‘; and’’; 

18 and 

19 (G) by adding at the end the following: 

20 ‘‘(6) any evidence-based or evidence-informed 

21 strategies developed or utilized pursuant to sub22 section (c)(5).’’; and 

23 (9) by amending subsection (h) to read as fol24 lows: 


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1 ‘‘(h) DISSEMINATION OF FINDINGS.—Not later than 

2 1 year after the completion of the final project under sub3 section (a), the Secretary shall submit to the Committee 

4 on Health, Education, Labor, and Pensions of the Senate 

5 and the Committee on Energy and Commerce of the 

6 House of Representatives a report describing the informa7 tion contained in each report submitted pursuant to sub8 section (g) and any additional actions planned by the Sec9 retary related to regionalized emergency care and trauma 

10 systems.’’. 

11 (d) PROGRAM FUNDING.—Section 1232(a) of the 

12 Public Health Service Act (42 U.S.C. 300d–32(a)) is 

13 amended by striking ‘‘2010 through 2014’’ and inserting 

14 ‘‘2023 through 2027’’. 

15 SEC. 114. ASSESSMENT OF CONTAINMENT AND MITIGATION 

16 OF INFECTIOUS DISEASES. 

17 (a) GAO STUDY.—The Comptroller General of the 

18 United States shall conduct a study that reviews a geo19 graphically diverse sample of States and territories that, 

20 in response to the COVID–19 pandemic, implemented pre21 paredness and response plans that included isolation and 

22 quarantine recommendations or requirements. Such study 

23 shall include— 

24 (1) a review of such State and territorial pre25 paredness and response plans in place during the 


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1 COVID–19 pandemic, an assessment of the extent 

2 to which such plans facilitated or presented chal3 lenges to State and territorial responses to such 

4 public health emergency, including response activi5 ties relating to isolation and quarantine to prevent 

6 the spread of COVID–19; and 

7 (2) a description of the technical assistance pro8 vided by the Federal Government to help States and 

9 territories facilitate such response activities during 

10 responses to relevant public health emergencies de11 clared by the Secretary of Health and Human Serv12 ices pursuant to section 319 of the Public Health 

13 Service Act, including the public health emergency 

14 with respect to COVID–19, and a review of the de15 gree to which such State and territorial plans were 

16 implemented and subsequently revised in response to 

17 the COVID–19 pandemic to address any challenges. 

18 (b) REPORT.—Not later than 18 months after the 

19 date of enactment of this Act, the Comptroller General 

20 of the United States shall submit a report on the study 

21 under subsection (a) to the Committee on Health, Edu22 cation, Labor, and Pensions of the Senate and the Com23 mittee on Energy and Commerce of the House of Rep24 resentatives. 


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1 TITLE II—IMPROVING PUBLIC 

2 HEALTH PREPAREDNESS AND 

3 RESPONSE CAPACITY 

4 Subtitle A—Addressing Disparities 

5 and Improving Public Health 

6 Emergency Responses 

7 SEC. 201. ADDRESSING SOCIAL DETERMINANTS OF HEALTH 

8 AND IMPROVING HEALTH OUTCOMES. 

9 (a) IN GENERAL.—Part B of title III of the Public 

10 Health Service Act (42 U.S.C. 243 et seq.) is amended— 

11 (1) by inserting after section 317U the fol12 lowing: 

13 ‘‘SEC. 317V. ADDRESSING SOCIAL DETERMINANTS OF 

14 HEALTH AND IMPROVING HEALTH OUT15 COMES. 

16 ‘‘(a) IN GENERAL.—The Secretary shall, as appro17 priate, award grants, contracts, or cooperative agreements 

18 to eligible entities for the conduct of evidence-based or evi19 dence-informed projects, which may include the develop20 ment of networks to improve health outcomes and reduce 

21 health disparities by improving the capacity of such enti22 ties to address social determinants of health in commu23 nities. 

24 ‘‘(b) ELIGIBLE ENTITIES.—To be eligible to receive 

25 an award under this section, an entity shall— 


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1 ‘‘(1)(A) be a State, local, or Tribal health de2 partment, community-based organization, Indian 

3 Tribe or Tribal organization (as such terms are de4 fined in section 4 of the Indian Self-Determination 

5 and Education Assistance Act), urban Indian orga6 nization (as defined in section 4 of the Indian 

7 Health Care Improvement Act), or other public or 

8 private entity, as the Secretary determines appro9 priate; or 

10 ‘‘(B) be a consortia or public-private partner11 ship of entities described in subparagraph (A); 

12 ‘‘(2) submit to the Secretary an application at 

13 such time, in such manner, and containing such in14 formation as the Secretary shall require; 

15 ‘‘(3) in the case of an entity other than a com16 munity-based organization, demonstrate a history of 

17 successfully working with an established community18 based organization to address health disparities; 

19 ‘‘(4) submit a plan to conduct activities de20 scribed in subsection (a) based on a community 

21 needs assessment that takes into account community 

22 input; and 

23 ‘‘(5) demonstrate the capacity to effectively im24 plement evidence-based or evidence-informed strate25 gies to address health disparities among underserved 


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1 populations, which may include rural, racial, and 

2 ethnic minority populations and people with disabil3 ities, in a timely manner. 

4 ‘‘(c) USE OF FUNDS.—An entity described in sub5 section (b) shall use funds received under subsection (a), 

6 in consultation with State, local, and Tribal health depart7 ments, community-based organizations, and other entities 

8 with experience addressing social determinants of health 

9 or reducing health disparities, as applicable, for one or 

10 more of the following purposes: 

11 ‘‘(1) Supporting the implementation, evaluation, 

12 and dissemination of strategies, including culturally13 appropriate strategies, to address social deter14 minants of health, based on the identified needs of 

15 the community that is the subject of the assessment 

16 submitted under subsection (b)(4), through evidence17 informed or evidence-based programs and through 

18 the support and use of public health and health care 

19 professionals to address such social determinants of 

20 health. 

21 ‘‘(2) Establishing, maintaining, or improving, in 

22 consultation with State, local, or Tribal health de23 partments, technology platforms or networks to sup24 port coordination among appropriate entities, and 

25 providing information on health and related social 


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1 services, which may include activities to improve 

2 data collection for public health purposes, in a man3 ner that is consistent with applicable Federal and 

4 State privacy law. 

5 ‘‘(3) Implementing best practices for improving 

6 health outcomes and reducing disease among under7 served populations, including rural or racial and eth8 nic minority populations. 

9 ‘‘(4) Supporting consideration of social deter10 minants of health in preparing for, and responding 

11 to, public health emergencies, through outreach, 

12 education, research, and other relevant activities. 

13 ‘‘(d) BEST PRACTICES AND TECHNICAL ASSIST14 ANCE.—The Secretary, in consultation with the Director 

15 of the Office of Minority Health, may award grants, con16 tracts, and cooperative agreements to public or nonprofit 

17 private entities, including minority serving institutions 

18 (defined, for purposes of this subsection, as institutions 

19 and programs described in section 326(e)(1) of the Higher 

20 Education Act of 1965 and institutions described in sec21 tion 371(a) of such Act of 1965), to— 

22 ‘‘(1) identify or facilitate the development of 

23 best practices to support improved health outcomes 

24 and reduce health disparities by addressing social 

25 determinants of health; 


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1 ‘‘(2) provide technical assistance, training, and 

2 evaluation assistance to award recipients under sub3 section (a); 

4 ‘‘(3) disseminate best practices, including to 

5 award recipients under subsection (a); and 

6 ‘‘(4) establish or operate regional centers to de7 velop, evaluate, and disseminate effective strategies 

8 on the utilization of preventive health care services 

9 to address social determinants of health, including 

10 supporting research and training related to such 

11 strategies. 

12 ‘‘(e) AWARD PERIODS.—The Secretary shall issue 

13 awards under this section for periods of not more than 

14 5 years and may issue extensions of such award periods 

15 for an additional period of up to 3 years. 

16 ‘‘(f) REPORT.—Not later than September 30, 2026, 

17 the Secretary shall submit to the Committee on Health, 

18 Education, Labor, and Pensions of the Senate and the 

19 Committee on Energy and Commerce of the House of 

20 Representatives a report that includes information on ac21 tivities funded under this section. Such report shall in22 clude a description of— 

23 ‘‘(1) changes in the capacity of public health 

24 entities to address social determinants of health in 

25 communities, including any applicable platforms or 


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1 networks developed or utilized to coordinate health 

2 and related social services and any changes in work3 force capacity or capabilities; 

4 ‘‘(2) improvements in health outcomes and in 

5 reducing health disparities in medically underserved 

6 communities; 

7 ‘‘(3) activities conducted to support consider8 ation of social determinants of health in preparing 

9 for, and responding to, public health emergencies, 

10 through outreach, education, and other relevant ac11 tivities; 

12 ‘‘(4) communities and populations served by re13 cipients of awards under subsection (a); 

14 ‘‘(5) activities supported under subsection (e); 

15 and 

16 ‘‘(6) other relevant activities and outcomes, as 

17 determined by the Secretary. 

18 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To 

19 carry out this section, there are authorized to be appro20 priated $70,000,000 for each of fiscal years 2023 through 

21 2027.’’; and 

22 (2) by striking section 330D (42 U.S.C. 254c– 

23 4). 

24 (b) GAO STUDY AND REPORT.—Not later than 4 

25 years after the date of enactment of this Act, the CompVerDate Sep 11 2014 04:50 Mar 11, 2022 Jkt 029200 PO 00000 Frm 00083 Fmt 6652 Sfmt 6201 E:\BILLS\S3799.IS S3799

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1 troller General of the United States shall submit to the 

2 Committee on Health, Education, Labor, and Pensions of 

3 the Senate and the Energy and Committee on Energy and 

4 Commerce of the House of Representatives a report on 

5 the program authorized under section 317V of the Public 

6 Health Service Act, as added by subsection (a), including 

7 a review of the outcomes and effectiveness of the program 

8 and coordination with other programs in the Department 

9 of Health and Human Services with similar goals to en10 sure that there was no unnecessary duplication of efforts. 

11 SEC. 202. NATIONAL ACADEMIES OF SCIENCES, ENGINEER12 ING, AND MEDICINE REPORT. 

13 (a) IN GENERAL.—Not later than 45 days after the 

14 date of enactment of this Act, the Secretary of Health and 

15 Human Services shall seek to enter into a contract with 

16 the National Academies of Sciences, Engineering, and 

17 Medicine (referred to in this section as the ‘‘National 

18 Academies’’) to conduct a study to examine health dispari19 ties and the effect of such disparities on health outcomes, 

20 which may include health outcomes related to pandemic 

21 and other public health emergencies. 

22 (b) REPORT.—Pursuant to the contract under sub23 section (a), the National Academies shall, not later than 

24 3 years after the date of enactment of this Act, issue a 


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1 report informed by the study conducted under such sub2 section that includes— 

3 (1) consideration of previous recommendations 

4 made by the National Academies related to health 

5 disparities, including in the report titled ‘‘Unequal 

6 Treatment: Confronting Racial and Ethnic Dispari7 ties in Healthcare’’; 

8 (2) recommendations for strategies to improve 

9 health outcomes by reducing health disparities, 

10 which may include education and training; and 

11 (3) an assessment of ongoing research and 

12 strategies to reduce health disparities and improve 

13 health outcomes, including effective service delivery 

14 models. 

15 (c) CLARIFICATION.—In completing the requirements 

16 of the contract under this section, the National Academies 

17 may leverage relevant ongoing work of the National Acad18 emies, including ongoing work related to the impact of 

19 Federal policies on health disparities. 

20 (d) AUTHORIZATION OF APPROPRIATIONS.—There is 

21 authorized to be appropriated $2,000,000 for fiscal year 

22 2023 to carry out this section. 


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1 Subtitle B—Improving Public 

2 Health Data 

3 SEC. 211. MODERNIZING BIOSURVEILLANCE CAPABILITIES 

4 AND INFECTIOUS DISEASE DATA COLLEC5 TION. 

6 Section 319D of the Public Health Service Act (42 

7 U.S.C. 247d–4) is amended— 

8 (1) in subsection (b)(1)(A), by striking ‘‘, and 

9 local’’ and inserting ‘‘, local, and Tribal’’; 

10 (2) in subsection (c)— 

11 (A) in paragraph (1), by inserting ‘‘mod12 ernize,’’ after ‘‘establish,’’; 

13 (B) in paragraph (3)(B), by inserting ‘‘, 

14 and make recommendations to improve the 

15 quality of data collected pursuant to subpara16 graph (A) to ensure complete, accurate, and 

17 timely sharing of such data, as appropriate, 

18 across such elements as described in subpara19 graph (A)’’ after ‘‘under subparagraph (A)’’; 

20 (C) in paragraph (5)— 

21 (i) in subparagraph (A)— 

22 (I) in the matter preceding clause 

23 (i), by striking ‘‘and operating’’ and 

24 inserting ‘‘, operating, and updating, 

25 as appropriate,’’; 


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1 (II) in clause (iv), by striking 

2 ‘‘and’’ at the end; 

3 (III) in clause (v), by striking the 

4 period and inserting ‘‘; and’’; and 

5 (IV) by adding at the end the fol6 lowing: 

7 ‘‘(vi) in collaboration with State, local, 

8 and Tribal public health officials, integrate 

9 and update applicable existing public 

10 health data systems and networks of the 

11 Department of Health and Human Serv12 ices to reflect technological advancements, 

13 consistent with section 2823, as applica14 ble.’’; and 

15 (ii) in subparagraph (B)— 

16 (I) in clause (i), by inserting 

17 ‘‘and 180 days after the date of enact18 ment of the PREVENT Pandemics 

19 Act,’’ after ‘‘Innovation Act of 

20 2019,’’; 

21 (II) in clause (ii), by inserting 

22 ‘‘experts in privacy and data secu23 rity;’’ after ‘‘forecasting);’’; and 

24 (III) in clause (iii)— 


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1 (aa) in subclause (V), by 

2 striking ‘‘and’’ at the end; 

3 (bb) in subclause (VI), by 

4 striking the period and inserting 

5 a semicolon; and 

6 (cc) by adding at the end 

7 the following: 

8 ‘‘(VII) strategies to integrate lab9 oratory and public health data sys10 tems and capabilities to support rapid 

11 and accurate reporting of laboratory 

12 test results and associated relevant 

13 data; 

14 ‘‘(VIII) strategies to improve the 

15 collection and reporting of relevant, 

16 aggregated, deidentified demographic 

17 data to inform responses to public 

18 health emergencies, including identi19 fication of at-risk populations and to 

20 address potential health disparities; 

21 and 

22 ‘‘(IX) strategies to improve the 

23 electronic exchange of health informa24 tion between State and local health 

25 departments and health care providers 


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1 and facilities to improve public health 

2 surveillance.’’; and 

3 (D) in paragraph (6)(A)— 

4 (i) in the matter preceding clause (i), 

5 by inserting ‘‘and every 5 years there6 after,’’ after ‘‘Innovation Act of 2019,’’ 

7 (ii) in clause (iii)— 

8 (I) in subclause (III), by striking 

9 ‘‘and’’ at the end; and 

10 (II) by adding at the end the fol11 lowing: 

12 ‘‘(V) improve coordination and 

13 collaboration, as appropriate, with 

14 other Federal departments; and 

15 ‘‘(VI) implement applicable les16 sons learned from recent public health 

17 emergencies to address gaps in situa18 tional awareness and biosurveillance 

19 capabilities;’’; 

20 (iii) in clause (iv), by striking ‘‘and’’ 

21 at the end; 

22 (iv) in clause (v), by striking the pe23 riod and inserting ‘‘, including a descrip24 tion of how such steps will further the 


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1 goals of the network, consistent with para2 graph (1); and’’; and 

3 (v) by adding at the end the following: 

4 ‘‘(vi) identifies and demonstrates 

5 measurable steps the Secretary will take to 

6 further develop and integrate infectious 

7 disease detection, support rapid and accu8 rate reporting of laboratory test results 

9 during a public health emergency, and im10 prove coordination and collaboration with 

11 State, local, and Tribal public health offi12 cials, clinical laboratories, and other enti13 ties with expertise in public health surveil14 lance.’’; 

15 (3) in subsection (d)— 

16 (A) in paragraph (1), by inserting ‘‘, act17 ing through the Director of the Centers for Dis18 ease Control and Prevention and in coordina19 tion with the heads of other appropriate agen20 cies and offices within the Department of 

21 Health and Human Services,’’ after ‘‘the Sec22 retary’’; 

23 (B) in paragraph (2)(C), by inserting ‘‘, 

24 including any public-private partnerships or 


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1 other partnerships entered into to improve such 

2 capacity’’ before the semicolon; and 

3 (C) by adding at the end the following: 

4 ‘‘(6) NON-DUPLICATION OF EFFORT.—The Sec5 retary shall ensure that activities carried out under 

6 an award under this subsection do not unnecessarily 

7 duplicate efforts of other agencies and offices within 

8 the Department of Health and Human Services.’’; 

9 (4) by amending subsection (i) to read as fol10 lows: 

11 ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There 

12 are authorized to be appropriated— 

13 ‘‘(1) to carry out subsection (a), $25,000,000 

14 for each of fiscal years 2022 and 2023; and 

15 ‘‘(2) to carry out subsections (b), (c), and (d), 

16 $136,800,000 for each of fiscal years 2022 and 

17 2023.’’; and 

18 (5) by striking ‘‘tribal’’ each place it appears 

19 and inserting ‘‘Tribal’’. 

20 SEC. 212. GENOMIC SEQUENCING, ANALYTICS, AND PUBLIC 

21 HEALTH SURVEILLANCE OF PATHOGENS. 

22 (a) GUIDANCE SUPPORTING GENOMIC SEQUENCING

23 OF PATHOGENS COLLABORATION.—The Secretary of 

24 Health and Human Services (referred to in this section 

25 as the ‘‘Secretary’’), in consultation with the heads of 


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1 other Federal departments or agencies, as appropriate, 

2 shall issue guidance to support collaboration relating to 

3 genomic sequencing of pathogens, including the use of new 

4 and innovative approaches and technology for the detec5 tion, characterization, and sequencing of pathogens, to im6 prove public health surveillance and preparedness and re7 sponse activities, consistent with section 2824 of the Pub8 lic Health Service Act, as added by subsection (b). Such 

9 guidance shall address the secure sharing, for public 

10 health surveillance purposes, of specimens of such patho11 gens, between appropriate entities and public health au12 thorities, consistent with the regulations promulgated 

13 under section 264(c) of the Health Insurance Portability 

14 and Accountability Act of 1996 (42 U.S.C. 1320d–2 note), 

15 as applicable, and in a manner that protects personal pri16 vacy to the extent required by applicable privacy law, at 

17 a minimum, and the appropriate use of sequence data de18 rived from such specimens. 

19 (b) GENOMIC SEQUENCING PROGRAM.—Title 

20 XXVIII of the Public Health Service Act (42 U.S.C. 

21 300hh et seq.) is amended by adding at the end the fol22 lowing 


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1 ‘‘SEC. 2824. GENOMIC SEQUENCING, ANALYTICS, AND PUB2 LIC HEALTH SURVEILLANCE OF PATHOGENS 

3 PROGRAM. 

4 ‘‘(a) GENOMIC SEQUENCING, ANALYTICS, AND PUB5 LIC HEALTH SURVEILLANCE OF PATHOGENS PRO6 GRAM.—The Secretary, acting through the Director of the 

7 Centers for Disease Control and Prevention and in con8 sultation with the Director of the National Institutes of 

9 Health and heads of other departments and agencies, as 

10 appropriate, shall strengthen and expand activities related 

11 to genomic sequencing of pathogens, including new and 

12 innovative approaches and technology for the detection, 

13 characterization, and sequencing of pathogens, analytics, 

14 and public health surveillance, including— 

15 ‘‘(1) continuing and expanding activities, which 

16 may include existing genomic sequencing activities 

17 related to advanced molecular detection, to— 

18 ‘‘(A) identify and respond to emerging in19 fectious disease threats; and 

20 ‘‘(B) identify the potential use of genomic 

21 sequencing technologies, advanced computing, 

22 and other advanced technology to inform sur23 veillance activities and incorporate the use of 

24 such technologies, as appropriate, into related 

25 activities; 


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1 ‘‘(2) providing technical assistance and guid2 ance to State, Tribal, local, and territorial public 

3 health departments to increase the capacity of such 

4 departments to perform genomic sequencing of 

5 pathogens, including recipients of funding under sec6 tion 2821; 

7 ‘‘(3) carrying out activities to enhance the capa8 bilities of the public health workforce with respect to 

9 pathogen genomics, epidemiology, and 

10 bioinformatics, including through training; and 

11 ‘‘(4) continuing and expanding activities, as ap12 plicable, with public and private entities, including 

13 relevant departments and agencies, laboratories, aca14 demic institutions, and industry. 

15 ‘‘(b) PARTNERSHIPS.—For the purposes of carrying 

16 out the activities described in subsection (a), the Sec17 retary, acting through the Director of the Centers for Dis18 ease Control and Prevention, may award grants, contracts, 

19 or cooperative agreements to entities, including academic 

20 and other laboratories, with expertise in genomic sequenc21 ing for public health purposes, including new and innova22 tive approaches to, and related technology for, the detec23 tion, characterization, and sequencing of pathogens. 

24 ‘‘(c) CENTERS OF EXCELLENCE.— 


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1 ‘‘(1) IN GENERAL.—The Secretary shall, as ap2 propriate, award grants, contracts, or cooperative 

3 agreements to public health agencies for the estab4 lishment or operation of centers of excellence to pro5 mote innovation in pathogen genomics and molecular 

6 epidemiology to improve the control of and response 

7 to pathogens that may cause a public health emer8 gency. Such centers shall, as appropriate— 

9 ‘‘(A) identify and evaluate the use of 

10 genomics, or other related technologies that 

11 may advance public health preparedness and re12 sponse; 

13 ‘‘(B) improve the identification, develop14 ment, and use of tools for integrating and ana15 lyzing genomic and epidemiologic data; 

16 ‘‘(C) assist with genomic surveillance of, 

17 and response to, infectious diseases, including 

18 analysis of pathogen genomic data; 

19 ‘‘(D) conduct applied research to improve 

20 public health surveillance of, and response to, 

21 infectious diseases through innovation in patho22 gen genomics and molecular epidemiology; and 

23 ‘‘(E) develop and provide training mate24 rials for experts in the fields of genomics, 


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1 microbiology, bioinformatics, epidemiology, and 

2 other fields, as appropriate. 

3 ‘‘(2) REQUIREMENTS.—To be eligible for an 

4 award under paragraph (1), an entity shall submit 

5 to the Secretary an application containing such in6 formation as the Secretary may require, including a 

7 description of how the entity will partner, as applica8 ble, with academic institutions or a consortium of 

9 academic partners that have relevant expertise, such 

10 as microbial genomics, molecular epidemiology, or 

11 the application of bioinformatics or statistics. 

12 ‘‘(d) AUTHORIZATION.—For purposes of carrying out 

13 this section, there are authorized to be appropriated 

14 $175,000,000 for each of fiscal years 2023 through 

15 2027.’’. 

16 SEC. 213. SUPPORTING PUBLIC HEALTH DATA AVAIL17 ABILITY AND ACCESS. 

18 (a) DESIGNATION OF PUBLIC HEALTH DATA STAND19 ARDS.—Section 2823(a)(2) of the Public Health Service 

20 Act (42 U.S.C. 300hh–33(a)(2)) is amended— 

21 (1) by striking ‘‘In carrying out’’ and inserting 

22 the following: 

23 ‘‘(A) IN GENERAL.—In carrying out’’; and 

24 (2) by striking ‘‘shall, as appropriate and’’ and 

25 inserting ‘‘shall, not later than 2 years after the date 


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1 of enactment of the PREVENT Pandemics Act,’’; 

2 and 

3 (3) by adding at the end the following: 

4 ‘‘(B) SELECTION OF DATA AND TECH5 NOLOGY STANDARDS.—The standards des6 ignated as described in subparagraph (A) may 

7 include standards to improve— 

8 ‘‘(i) the exchange of electronic health 

9 information for— 

10 ‘‘(I) electronic case reporting; 

11 ‘‘(II) syndromic surveillance; 

12 ‘‘(III) reporting of vital statistics; 

13 and 

14 ‘‘(IV) reporting test orders and 

15 results electronically, including from 

16 laboratories; 

17 ‘‘(ii) automated electronic reporting to 

18 relevant public health data systems of the 

19 Centers for Disease Control and Preven20 tion; and 

21 ‘‘(iii) such other use cases as the Sec22 retary determines appropriate. 

23 ‘‘(C) NO DUPLICATIVE EFFORTS.— 

24 ‘‘(i) IN GENERAL.—In carrying out 

25 the requirements of this paragraph, the 


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1 Secretary, in consultation with the Office 

2 of the National Coordinator for Health In3 formation Technology, may use input gath4 ered (including input and recommendations 

5 gathered from the Health Information 

6 Technology Advisory Committee), and ma7 terials developed, prior to the date of en8 actment of the PREVENT Pandemics Act. 

9 ‘‘(ii) PREVIOUSLY ADOPTED STAND10 ARDS.—The data and technology standards 

11 designated pursuant to this paragraph may 

12 include the adoption of standards pre13 viously adopted by the Secretary pursuant 

14 to section 3004. 

15 ‘‘(D) PRIVACY AND SECURITY.—Nothing 

16 in this paragraph shall be construed as modi17 fying applicable Federal or State information 

18 privacy or security law.’’. 

19 (b) STUDY ON LABORATORY INFORMATION STAND20 ARDS.— 

21 (1) IN GENERAL.—Not later than 1 year after 

22 the date of enactment of this Act, the Office of the 

23 National Coordinator for Health Information Tech24 nology shall conduct a study to review the use of 


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1 standards for electronic ordering and reporting of 

2 laboratory test results. 

3 (2) AREAS OF CONCENTRATION.—In conducting 

4 the study under paragraph (1), the Office of the Na5 tional Coordinator for Health Information Tech6 nology shall— 

7 (A) determine the extent to which clinical 

8 laboratories are using standards for electronic 

9 ordering and reporting of laboratory test re10 sults; 

11 (B) assess trends in laboratory compliance 

12 with standards for ordering and reporting lab13 oratory test results and the effect of such 

14 trends on the interoperability of laboratory data 

15 with public health data systems; 

16 (C) identify challenges related to collection 

17 and reporting of demographic and other data 

18 elements with respect to laboratory test results; 

19 (D) identify any challenges associated with 

20 using or complying with standards and report21 ing laboratory test results with data elements 

22 identified in standards for electronic ordering 

23 and reporting of such results; and 


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1 (E) review other relevant areas determined 

2 appropriate by the Office of the National Coor3 dinator for Health Information Technology. 

4 (3) REPORT.—Not later than 2 years after the 

5 date of enactment of this Act, the Office of the Na6 tional Coordinator for Health Information Tech7 nology shall submit to the Committee on Health, 

8 Education, Labor, and Pensions of the Senate and 

9 the Committee on Energy and Commerce of the 

10 House of Representatives a report concerning the 

11 findings of the study conducted under paragraph 

12 (1). 

13 (c) SUPPORTING INFORMATION SHARING THROUGH

14 DATA USE AGREEMENTS.— 

15 (1) INTERAGENCY DATA USE AGREEMENTS

16 WITHIN THE DEPARTMENT OF HEALTH AND HUMAN

17 SERVICES FOR PUBLIC HEALTH EMERGENCIES.— 

18 (A) IN GENERAL.—The Secretary of 

19 Health and Human Services (referred to in this 

20 subsection as the ‘‘Secretary’’) shall, as appro21 priate, facilitate the development of, or updates 

22 to, memoranda of understanding, data use 

23 agreements, or other applicable interagency 

24 agreements regarding appropriate access, ex25 change, and use of public health data between 


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1 the Centers for Disease Control and Prevention, 

2 the Office of the Assistant Secretary for Pre3 paredness and Response, other relevant agen4 cies or offices within the Department of Health 

5 and Human Services, and other relevant Fed6 eral agencies, in order to prepare for, identify, 

7 monitor, and respond to declared or potential 

8 public health emergencies. 

9 (B) REQUIREMENTS.—In carrying out ac10 tivities pursuant to subparagraph (A), the Sec11 retary shall— 

12 (i) ensure that the agreements and 

13 memoranda of understanding described in 

14 such subparagraph— 

15 (I) address the methods of grant16 ing access to data held by one agency 

17 or office with another to support the 

18 respective missions of such agencies 

19 or offices; 

20 (II) consider minimum necessary 

21 principles of data sharing for appro22 priate use; 

23 (III) include appropriate privacy 

24 and cybersecurity protections; and 


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1 (IV) are subject to regular up2 dates, as appropriate; 

3 (ii) collaborate with the Centers for 

4 Disease Control and Prevention, the Office 

5 of the Assistant Secretary for Prepared6 ness and Response, the Office of the Chief 

7 Information Officer, and, as appropriate, 

8 the Office of the National Coordinator for 

9 Health Information Technology, and other 

10 entities within the Department of Health 

11 and Human Services; and 

12 (iii) consider the terms and conditions 

13 of any existing data use agreements with 

14 other public or private entities and any 

15 need for updates to such existing agree16 ments, consistent with paragraph (2). 

17 (2) DATA USE AGREEMENTS WITH EXTERNAL

18 ENTITIES.—The Secretary, acting through the Di19 rector of the Centers for Disease Control and Pre20 vention and the Assistant Secretary for Prepared21 ness and Response, may update memoranda of un22 derstanding, data use agreements, or other applica23 ble agreements and contracts to improve appropriate 

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1 tion and the Office of the Assistant Secretary for 

2 Preparedness and Response and external entities, in3 cluding State, Tribal, and territorial health depart4 ments, laboratories, hospitals and other health care 

5 providers, electronic health records vendors, and 

6 other entities, as applicable and appropriate, in 

7 order to prepare for, identify, monitor, and respond 

8 to declared or potential public health emergencies. 

9 (3) REPORT.—Not later than 90 days after the 

10 date of enactment of this Act, the Secretary shall re11 port to the Committee on Health, Education, Labor, 

12 and Pensions of the Senate and the Committee on 

13 Energy and Commerce of the House of Representa14 tives on the status of the agreements under this sub15 section. 

16 (d) IMPROVING INFORMATION SHARING AND AVAIL17 ABILITY OF PUBLIC HEALTH DATA.—Part A of title III 

18 of the Public Health Service Act (42 U.S.C. 241 et seq.) 

19 is amended by adding at the end the following: 

20 ‘‘SEC. 310B. IMPROVING INFORMATION SHARING AND 

21 AVAILABILITY OF PUBLIC HEALTH DATA. 

22 ‘‘(a) IN GENERAL.—The Secretary may, in consulta23 tion with State, local, and Tribal public health officials, 

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1 nicable diseases, and information sharing between, the Di2 rector of the Centers for Disease Control and Prevention, 

3 the Assistant Secretary for Preparedness and Response, 

4 and such State, local, and Tribal public health officials, 

5 which may include such data from— 

6 ‘‘(1) health care providers and facilities; 

7 ‘‘(2) public health and clinical laboratories; and 

8 ‘‘(3) State, local, and Tribal health depart9 ments. 

10 ‘‘(b) CONTENT, FORM, AND MANNER.—The Sec11 retary shall, consistent with the requirements of this sec12 tion, work with such officials and relevant stakeholders to 

13 provide information on the content, form, and manner in 

14 which such data may most effectively support the ability 

15 of State, local, and Tribal health departments to respond 

16 to such communicable diseases, including related to the 

17 collection and reporting of demographic and other relevant 

18 data elements. 

19 ‘‘(c) DECREASED BURDEN.—In facilitating the co20 ordination of efforts under subsection (a), the Secretary 

21 shall make reasonable efforts to limit reported public 

22 health data to the minimum necessary information needed 

23 to accomplish the intended public health surveillance pur24 pose. 


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1 ‘‘(d) EXEMPTION OF CERTAIN PUBLIC HEALTH

2 DATA FROM DISCLOSURE.—The Secretary, acting 

3 through the Director of the Centers for Disease Control 

4 and Prevention, may exempt from disclosure under section 

5 552(b)(3) of title 5, United States Code, public health 

6 data that are gathered under this section if— 

7 ‘‘(1) an individual is identified through such 

8 data; or 

9 ‘‘(2) there is at least a very small risk, as deter10 mined by current scientific practices or statistical 

11 methods, that some combination of the information, 

12 the request, and other available data sources or the 

13 application of technology could be used to deduce 

14 the identity of an individual.’’. 

15 (e) IMPROVING PUBLIC HEALTH DATA COLLEC16 TION.— 

17 (1) IN GENERAL.—The Secretary of Health and 

18 Human Services (referred to in this subsection as 

19 the ‘‘Secretary’’) shall award grants, contracts, or 

20 cooperative agreements to eligible entities for pur21 poses of identifying, developing, or disseminating 

22 best practices in the collection of electronic health 

23 information and the use of designated data stand24 ards and implementation specifications to improve 

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1 mographic data, collected, accessed, or used for pub2 lic health purposes and to address health disparities 

3 and related health outcomes. 

4 (2) ELIGIBLE ENTITIES.—To be eligible to re5 ceive an award under this subsection an entity 

6 shall— 

7 (A) be a health care provider, academic 

8 medical center, community-based organization, 

9 State, local governmental entity, Indian Tribe 

10 or Tribal organization (as such terms are de11 fined in section 4 of the Indian Self Determina12 tion and Education Assistance Act (25 U.S.C. 

13 5304)), urban Indian organization (as defined 

14 in section 4 of the Indian Health Care Improve15 ment Act (25 U.S.C. 1603)), or other appro16 priate public or private nonprofit entity, or a 

17 consortia of any such entities; and 

18 (B) submit an application to the Secretary 

19 at such time, in such manner, and containing 

20 such information as the Secretary may require. 

21 (3) ACTIVITIES.—Entities receiving awards 

22 under this subsection shall use such award to de23 velop and test best practices for training health care 

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1 change, and use of electronic health information, in2 cluding demographic information, disability status, 

3 veteran status, housing status, functional status, 

4 and other data elements. Such activities shall in5 clude, at a minimum— 

6 (A) improving, understanding, and using 

7 data standards and implementation specifica8 tions; 

9 (B) developing or identifying methods to 

10 improve communication with patients in a 

11 culturally- and linguistically-appropriate man12 ner, including to better capture information re13 lated to demographics of such individuals; 

14 (C) developing methods for accurately cat15 egorizing and recording patient responses using 

16 available data standards; 

17 (D) educating providers regarding the util18 ity of such information for public health pur19 poses and the importance of accurate collection 

20 and recording of such data; and 

21 (E) other activities, as the Secretary deter22 mines appropriate. 

23 (4) REPORTING.— 

24 (A) REPORTING BY AWARD RECIPIENTS.— 

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1 section shall submit to the Secretary a report 

2 on the results of best practices identified, devel3 oped, or disseminated through such award. 

4 (B) REPORT TO CONGRESS.—Not later 

5 than 1 year after the completion of the program 

6 under this subsection, the Secretary shall sub7 mit a report to Congress on the success of best 

8 practices developed under such program, oppor9 tunities for further dissemination of such best 

10 practices, and recommendations for improving 

11 the capture, access, exchange, and use of infor12 mation to improve public health and reduce 

13 health disparities. 

14 (5) NON-DUPLICATION OF EFFORTS.—The Sec15 retary shall ensure that the activities and programs 

16 carried out under this subsection are free of unnec17 essary duplication of effort. 

18 (6) AUTHORIZATION OF APPROPRIATIONS.— 

19 There are authorized to be appropriated 

20 $10,000,000 for each of fiscal years 2023 through 

21 2025 to carry out this subsection. 


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1 SEC. 214. EPIDEMIC FORECASTING AND OUTBREAK ANA2 LYTICS. 

3 Title XXVIII of the Public Health Service Act (42 

4 U.S.C. 300hh et seq.), as amended by section 212, is fur5 ther amended by adding at the end the following: 

6 ‘‘SEC. 2825. EPIDEMIC FORECASTING AND OUTBREAK ANA7 LYTICS. 

8 ‘‘(a) IN GENERAL.—The Secretary, acting through 

9 the Director of the Centers for Disease Control and Pre10 vention, shall continue activities related to the develop11 ment of infectious disease outbreak analysis capabilities 

12 to enhance the prediction, modeling, and forecasting of po13 tential public health emergencies and other infectious dis14 ease outbreaks, which may include activities to support 

15 preparedness for, and response to, such emergencies and 

16 outbreaks. In carrying out this subsection, the Secretary 

17 shall identify strategies to include and leverage, as appro18 priate, the capabilities to public and private entities, which 

19 may include conducting such activities through collabo20 rative partnerships with public and private entities, includ21 ing academic institutions, and other Federal agencies, con22 sistent with section 319D, as applicable. 

23 ‘‘(b) CONSIDERATIONS.—In carrying out subsection 

24 (a), the Secretary, acting through the Director of the Cen25 ters for Disease Control and Prevention, may consider 

26 public health data and, as appropriate, other data sources 


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1 related to the transmission of such infectious diseases that 

2 affect preparedness for, or response to, public health 

3 emergencies and infectious disease outbreaks. 

4 ‘‘(c) ANNUAL REPORTS.—Not later than 1 year after 

5 the date of enactment of this section, and annually there6 after for each of the subsequent 4 years, the Secretary 

7 shall prepare and submit a report, to the Committee on 

8 Health, Education, Labor, and Pensions of the Senate and 

9 the Committee on Energy and Commerce of the House 

10 of Representatives, regarding an update on progress on 

11 activities conducted under this section to develop infec12 tious disease outbreak analysis capabilities and any addi13 tional information relevant to such efforts.’’. 

14 SEC. 215. REPORT ON CDC DATA PORTAL. 

15 (a) IN GENERAL.—Not later than 2 years after the 

16 date of enactment of this Act, the Secretary of Health and 

17 Human Services, acting through the Director of the Cen18 ters for Disease Control and Prevention, shall submit a 

19 report to the Committee on Health, Education, Labor, and 

20 Pensions of the Senate and the Committee on Energy and 

21 Commerce of the House of Representatives regarding pub22 lic health data modernization initiatives, surveillance in23 vestments, and public health data reporting modernization 

24 initiatives under this Act (including the amendments made 

25 by this Act) and the Public Health Service Act (42 U.S.C. 


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1 201 et seq.), and provide recommendations on the feasi2 bility of the use of a web-based information technology 

3 platform (referred to in this section as the ‘‘platform’’) 

4 for the streamlining of existing voluntary submissions of 

5 public health data for all State, local, Tribal, and terri6 torial entities that report such data to the Centers for Dis7 ease Control and Prevention, and whether such platform 

8 would reduce the reporting burden for such entities. 

9 (b) REQUIREMENTS.—The report under subsection 

10 (a) shall address the extent to which the submission of 

11 such data to the platform may— 

12 (1) support coordination within the Department 

13 of Health and Human Services; 

14 (2) provide appropriate information among and 

15 between State, Tribal, local, and territorial public 

16 health officials; 

17 (3) leverage private sector technologies; and 

18 (4) provide for the streamlining of data report19 ing to the greatest extent possible. 

20 SEC. 216. PUBLIC HEALTH DATA TRANSPARENCY. 

21 (a) REPORT.—Not later than 1 year after the date 

22 of enactment of this Act, the Secretary of Health and 

23 Human Services shall issue a report assessing practices, 

24 objectives, and associated progress and challenges in 

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1 trol and Prevention with respect to the collection and dis2 semination of public health data related to a public health 

3 emergency declared under section 319 of the Public 

4 Health Service Act (42 U.S.C. 247d) or a potential public 

5 health emergency. 

6 (b) PLAN.—Not later than 180 days following the 

7 issuance of the report pursuant to paragraph (1), the Di8 rector of the Centers for Disease Control and Prevention 

9 shall submit to the Committee on Health, Education, 

10 Labor, and Pensions of the Senate and the Committee on 

11 Energy and Commerce of the House of Representatives 

12 a plan that shall include— 

13 (1) steps to improve the timely reporting and 

14 dissemination of public health data related to a pub15 lic health emergency declared under section 319 of 

16 the Public Health Service Act (42 U.S.C. 247d) or 

17 a potential public health emergency that is collected 

18 by the Centers for Disease Control and Prevention, 

19 including any associated barriers; 

20 (2) recommendations to Congress regarding 

21 gaps in such practices and objectives described in 

22 subsection (a); and 

23 (3) considerations regarding the requirements 

24 and limitations of data use agreements for such pur25 poses, as applicable. 


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1 Subtitle C—Revitalizing the Public 

2 Health Workforce 

3 SEC. 221. IMPROVING RECRUITMENT AND RETENTION OF 

4 THE FRONTLINE PUBLIC HEALTH WORK5 FORCE. 

6 (a) IN GENERAL.—Section 776 of the Public Health 

7 Service Act (42 U.S.C. 295f–1) is amended— 

8 (1) in subsection (a)— 

9 (A) by striking ‘‘supply of’’ and inserting 

10 ‘‘supply of, and encourage recruitment and re11 tention of,’’; and 

12 (B) by striking ‘‘Federal,’’; 

13 (2) in subsection (b)— 

14 (A) by amending paragraph (1)(A) to read 

15 as follows: 

16 ‘‘(1)(A)(i) be accepted for enrollment, or be en17 rolled, as a student in an accredited institution of 

18 higher education or school of public health in the 

19 final semester (or equivalent) of a program leading 

20 to a certificate or degree, including a master’s or 

21 doctoral degree, in public health, epidemiology, lab22 oratory sciences, data systems, data science, data 

23 analytics, informatics, statistics, or another subject 

24 matter related to public health; and 


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1 ‘‘(ii) be employed by, or have accepted employ2 ment with, a State, local, or Tribal public health 

3 agency, or a related training fellowship at such 

4 State, local, or Tribal public health agency, as recog5 nized by the Secretary, to commence upon gradua6 tion; or’’; and 

7 (B) in paragraph (1)(B)— 

8 (i) in clause (i)— 

9 (I) by striking ‘‘accredited edu10 cational institution in a State or terri11 tory’’ and inserting ‘‘accredited insti12 tution of higher education or school of 

13 public health’’; and 

14 (II) by striking ‘‘a public health 

15 or health professions degree or certifi16 cate’’ and inserting ‘‘a certificate or 

17 degree, including a master’s or doc18 toral degree, in public health, epidemi19 ology, laboratory sciences, data sys20 tems, data science, data analytics, 

21 informatics, statistics, or another sub22 ject matter related to public health’’; 

23 and 

24 (ii) in clause (ii)— 

25 (I) by striking ‘‘Federal,’’; and 


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1 (II) by striking ‘‘fellowship,’’ and 

2 inserting ‘‘fellowship at such State, 

3 local, or Tribal public health agency,’’; 

4 (3) in subsection (c)(2)— 

5 (A) by striking ‘‘Federal,’’; and 

6 (B) by striking ‘‘equal to the greater of— 

7 ’’ and all that follows through the end of sub8 paragraph (B) and inserting ‘‘of at least 3 con9 secutive years;’’; 

10 (4) in subsection (d)— 

11 (A) by amending paragraph (1) to read as 

12 follows: 

13 ‘‘(1) IN GENERAL.—A loan repayment provided 

14 for an individual under a written contract under the 

15 Program shall consist of payment, in accordance 

16 with paragraph (2), for the individual toward the 

17 outstanding principal and interest on education 

18 loans incurred by the individual in the pursuit of the 

19 relevant degree or certificate described in subsection 

20 (b)(1) in accordance with the terms of the con21 tract.’’; and 

22 (B) in paragraph (2)— 

23 (i) by striking ‘‘For each year’’ and 

24 inserting the following: 

25 ‘‘(A) IN GENERAL.—For each year’’; 


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1 (ii) by striking ‘‘$35,000’’ and insert2 ing ‘‘$50,000’’; 

3 (iii) by striking ‘‘$105,000’’ and in4 serting ‘‘$150,000’’; and 

5 (iv) by adding at the end the fol6 lowing: 

7 ‘‘(B) CONSIDERATIONS.—The Secretary 

8 may take action in making awards under this 

9 section to ensure that— 

10 ‘‘(i) an appropriate proportion of con11 tracts are awarded to individuals who are 

12 eligible to participate in the program pur13 suant to subsection (b)(1)(A); and 

14 ‘‘(ii) contracts awarded under this 

15 section are equitably distributed among— 

16 ‘‘(I) the geographical regions of 

17 the United States; 

18 ‘‘(II) local, State, and Tribal 

19 public health departments; and 

20 ‘‘(III) such public health depart21 ments under subclause (II) serving 

22 rural and urban areas.’’; 

23 (5) in subsection (e), by striking ‘‘receiving a 

24 degree or certificate from a health professions or 


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1 other related school’’ and inserting ‘‘with a contract 

2 to serve under subsection (c)’’; 

3 (6) in subsection (f), by adding at the end the 

4 following: ‘‘In the event that a participant fails to ei5 ther begin or complete the obligated service require6 ment of the loan repayment contract under this sec7 tion, the Secretary may waive or suspend either the 

8 unfulfilled service or the assessed damages as pro9 vided for under section 338E(d), as appropriate.’’; 

10 (7) by redesignating subsection (g) as sub11 section (h); 

12 (8) by inserting after subsection (f) the fol13 lowing: 

14 ‘‘(g) ELIGIBLE LOANS.—The loans eligible for repay15 ment under this section are each of the following: 

16 ‘‘(1) Any loan for education or training for em17 ployment by a health department. 

18 ‘‘(2) Any loan under part E of title VIII (relat19 ing to nursing student loans). 

20 ‘‘(3) Any Federal Direct Stafford Loan, Fed21 eral Direct PLUS Loan, Federal Direct Unsub22 sidized Stafford Loan, or Federal Direct Consolida23 tion Loan (as such terms are used in section 455 of 

24 the Higher Education Act of 1965). 


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1 ‘‘(4) Any Federal Perkins Loan under part E 

2 of title I of the Higher Education Act of 1965. 

3 ‘‘(5) Any other Federal loan, as the Secretary 

4 determines appropriate.’’; 

5 (9) in subsection (h), as so redesignated, by 

6 striking ‘‘$195,000,000 for fiscal year 2010, and 

7 such sums as may be necessary for each of fiscal 

8 years 2011 through 2015’’ and inserting ‘‘such sums 

9 as may be necessary for each of fiscal years 2022 

10 through 2025’’; and 

11 (10) by striking ‘‘tribal’’ each place such term 

12 appears and inserting ‘‘Tribal’’. 

13 (b) GAO STUDY ON PUBLIC HEALTH WORKFORCE

14 .—Not later than 2 years after the date of enactment of 

15 this Act, the Comptroller General of the United States 

16 shall— 

17 (1) conduct an evaluation of what is known 

18 about the public health workforce in the United 

19 States, which shall address— 

20 (A) existing gaps in the Federal, State, 

21 local, Tribal, and territorial public health work22 force, including positions that may be required 

23 to prepare for, and respond to, a public health 

24 emergency such as COVID–19; 


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1 (B) challenges associated with the hiring, 

2 recruitment, and retention of the Federal, 

3 State, local, Tribal, and territorial public health 

4 workforce; and 

5 (C) Federal efforts to improve hiring, re6 cruitment, and retention of the public health 

7 workforce; and 

8 (2) submit to the Committee on Health, Edu9 cation, Labor, and Pensions of the Senate and the 

10 Committee on Energy and Commerce of the House 

11 of Representatives a report on such review. 

12 SEC. 222. AWARDS TO SUPPORT COMMUNITY HEALTH 

13 WORKERS AND COMMUNITY HEALTH. 

14 (a) IN GENERAL.—Section 399V of the Public 

15 Health Service Act (42 U.S.C. 280g–11) is amended— 

16 (1) by amending the section heading to read as 

17 follows: ‘‘AWARDS TO SUPPORT COMMUNITY

18 HEALTH WORKERS AND COMMUNITY HEALTH’’; 

19 (2) by amending subsection (a) to read as fol20 lows: 

21 ‘‘(a) IN GENERAL.—The Secretary, acting through 

22 the Director of the Centers for Disease Control and Pre23 vention and in coordination with the Administrator of the 

24 Health Resources and Services Administration, shall 

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1 gible entities to promote positive health behaviors and out2 comes for populations in medically underserved commu3 nities by leveraging community health workers, including 

4 by addressing ongoing and longer-term community health 

5 needs, and by building the capacity of the community 

6 health worker workforce. Such grants, contracts, and co7 operative agreements shall be awarded in alignment and 

8 coordination with existing funding arrangements sup9 porting community health workers.’’; 

10 (3) in subsection (b)— 

11 (A) in the matter preceding paragraph 

12 (1)— 

13 (i) by striking ‘‘Grants awarded’’ and 

14 inserting ‘‘Subject to any requirements for 

15 the scope of licensure, registration, or cer16 tification of a community health worker 

17 under applicable State law, grants, con18 tracts, and cooperative agreements award19 ed’’; and 

20 (ii) by striking ‘‘support community 

21 health workers’’; 

22 (B) by redesignating paragraphs (3) 

23 through (5) as paragraphs (4) through (6), re24 spectively; 


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1 (C) by striking paragraphs (1) and (2) and 

2 inserting the following: 

3 ‘‘(1) recruit, hire, train, and retain community 

4 health workers that reflect the needs of the commu5 nity; 

6 ‘‘(2) support community health workers in pro7 viding education and outreach, in a community set8 ting, regarding— 

9 ‘‘(A) health conditions prevalent in— 

10 ‘‘(i) medically underserved commu11 nities (as defined in section 799B), par12 ticularly racial and ethnic minority popu13 lations; and 

14 ‘‘(ii) other such at-risk populations or 

15 geographic areas that may require addi16 tional support during public health emer17 gencies, which may include counties identi18 fied by the Secretary using applicable 

19 measures developed by the Centers for Dis20 ease Control and Prevention or other Fed21 eral agencies; and 

22 ‘‘(B) addressing social determinants of 

23 health and eliminating health disparities, in24 cluding by— 


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1 ‘‘(i) promoting awareness of services 

2 and resources to increase access to health 

3 care, mental health and substance use dis4 order services, child services, technology, 

5 housing services, educational services, nu6 trition services, employment services, and 

7 other services; and 

8 ‘‘(ii) assisting in conducting individual 

9 and community needs assessments; 

10 ‘‘(3) educate community members, including re11 garding effective strategies to promote healthy be12 haviors;’’; 

13 (D) in paragraph (4), as so redesignated, 

14 by striking ‘‘to educate’’ and inserting ‘‘edu15 cate’’; 

16 (E) in paragraph (5), as so redesignated— 

17 (i) by striking ‘‘to identify’’ and in18 serting ‘‘identify’’; 

19 (ii) by striking ‘‘healthcare agencies’’ 

20 and inserting ‘‘health care agencies’’; and 

21 (iii) by striking ‘‘healthcare services 

22 and to eliminate duplicative care; or’’ and 

23 inserting ‘‘health care services and to 

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1 son between communities and health care 

2 agencies; and’’; and 

3 (F) in paragraph (6), as so redesignated— 

4 (i) by striking ‘‘to educate, guide, and 

5 provide’’ and inserting ‘‘support commu6 nity health workers in educating, guiding, 

7 or providing’’; and 

8 (ii) by striking ‘‘maternal health and 

9 prenatal care’’ and inserting ‘‘chronic dis10 eases, maternal health, prenatal, and 

11 postpartum care in order to improve ma12 ternal and infant health outcomes’’; 

13 (4) in subsection (c), by striking ‘‘Each eligible 

14 entity’’ and all that follows through ‘‘accompanied 

15 by’’ and inserting ‘‘To be eligible to receive an 

16 award under subsection (a), an entity shall prepare 

17 and submit to the Secretary an application at such 

18 time, in such manner, and containing’’; 

19 (5) in subsection (d)— 

20 (A) in the matter preceding paragraph (1), 

21 by striking ‘‘awarding grants’’ and inserting 

22 ‘‘making awards’’; 

23 (B) by amending paragraph (1) to read as 

24 follows: 

25 ‘‘(1) propose to serve— 


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1 ‘‘(A) areas with populations that have a 

2 high rate of chronic disease, infant mortality, or 

3 maternal morbidity and mortality; 

4 ‘‘(B) low-income populations, including 

5 medically underserved populations (as defined 

6 in section 330(b)(3)); 

7 ‘‘(C) populations residing in health profes8 sional shortage areas (as defined in section 

9 332(a)); 

10 ‘‘(D) populations residing in maternity 

11 care health professional target areas identified 

12 under section 332(k); or 

13 ‘‘(E) rural or traditionally underserved 

14 populations, including racial and ethnic minor15 ity populations or low-income populations;’’; 

16 (C) in paragraph (2), by striking ‘‘; and’’ 

17 and inserting ‘‘, including rural populations and 

18 racial and ethnic minority populations;’’; 

19 (D) in paragraph (3), by striking ‘‘with 

20 community health workers.’’ and inserting ‘‘and 

21 established relationships with community health 

22 workers in the communities expected to be 

23 served by the program;’’ and 

24 (E) by adding at the end the following: 


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1 ‘‘(4) develop a plan for providing services to the 

2 extent practicable, in the language and cultural con3 text most appropriate to individuals expected to be 

4 served by the program; and 

5 ‘‘(5) propose to use evidence-informed or evi6 dence-based practices, as applicable and appro7 priate.’’; 

8 (6) in subsection (e)— 

9 (A) by striking ‘‘community health worker 

10 programs’’ and inserting ‘‘eligible entities’’; and 

11 (B) by striking ‘‘and one-stop delivery sys12 tems under section 121(e)’’ and inserting ‘‘, 

13 health professions schools, minority-serving in14 stitutions (defined, for purposes of this sub15 section, as institutions and programs described 

16 in section 326(e)(1) of the Higher Education 

17 Act of 1965 and institutions described in sec18 tion 371(a) of such Act), area health education 

19 centers under section 751 of this Act, and one20 stop delivery systems under section 121’’; 

21 (7) by striking subsections (f), (g), (h), (i), and 

22 (j) and inserting the following: 

23 ‘‘(f) TECHNICAL ASSISTANCE.—The Secretary may 

24 provide to eligible entities that receive awards under sub25 section (a) technical assistance with respect to planning, 


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1 development, and operation of community health worker 

2 programs authorized or supported under this section. 

3 ‘‘(g) DISSEMINATION OF BEST PRACTICES.—Not 

4 later than 4 years after the date of enactment of the PRE5 VENT Pandemics Act, the Secretary shall, based on ac6 tivities carried out under this section and in consultation 

7 with relevant stakeholders, identify and disseminate evi8 dence-based or evidence-informed practices regarding re9 cruitment and retention of community health workers and 

10 paraprofessionals to address ongoing public health and 

11 community health needs, and to prepare for, and respond 

12 to, future public health emergencies. 

13 ‘‘(h) REPORT TO CONGRESS.—Not later than 4 years 

14 after the date of enactment of the PREVENT Pandemics 

15 Act, the Secretary shall submit to the Committee on 

16 Health, Education, Labor, and Pensions of the Senate and 

17 the Committee on Energy and Commerce of the House 

18 of Representatives a report concerning the effectiveness of 

19 the program under this section in addressing ongoing pub20 lic health and community health needs. Such report shall 

21 include recommendations regarding any improvements to 

22 such program, including recommendations for how to im23 prove recruitment, training, and retention of the commu24 nity health workforce. 


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1 ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—For 

2 purposes of carrying out this section, there are authorized 

3 to be appropriated such sums as may be necessary for 

4 each of fiscal years 2023 through 2027.’’; 

5 (8) by redesignating subsection (k) as sub6 section (j); and 

7 (9) in subsection (j), as so redesignated— 

8 (A) by striking paragraphs (1), (2), and 

9 (4); 

10 (B) by redesignating paragraph (3) as 

11 paragraph (1); 

12 (C) in paragraph (1), as so redesignated— 

13 (i) by striking ‘‘entity (including a 

14 State or public subdivision of a State’’ and 

15 inserting ‘‘entity, including a State or po16 litical subdivision of a State, an Indian 

17 Tribe or Tribal organization, an urban In18 dian organization, a community-based or19 ganization’’; and 

20 (ii) by striking ‘‘as defined in section 

21 1861(aa) of the Social Security Act))’’ and 

22 inserting ‘‘(as defined in section 

23 1861(aa)(4) of the Social Security Act)’’; 

24 and 

25 (D) by adding at the end the following: 


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1 ‘‘(2) INDIAN TRIBE; TRIBAL ORGANIZATION.— 

2 The terms ‘Indian Tribe’ and ‘Tribal organization’ 

3 have the meanings given the terms ‘Indian tribe’ and 

4 ‘tribal organization’, respectively, in section 4 of the 

5 Indian Self-Determination and Education Assistance 

6 Act. 

7 ‘‘(3) URBAN INDIAN ORGANIZATION.—The term 

8 ‘urban Indian organization’ has the meaning given 

9 such term in section 4 of the Indian Health Care 

10 Improvement Act.’’. 

11 (b) GAO STUDY AND REPORT.—Not later than 1 

12 year after the date of submission of the report under sub13 section (h) of section 399V of the Public Health Service 

14 Act (42 U.S.C. 280g–11), as amended by subsection (a), 

15 the Comptroller General of the United States shall submit 

16 to the Committee on Health, Education, Labor, and Pen17 sions of the Senate and the Committee on Energy and 

18 Commerce of the House of Representatives a report on 

19 the program authorized under such section 399V, includ20 ing a review of the efforts of the Secretary of Health and 

21 Human Services to coordinate such program with applica22 ble programs of the Health Resources and Services Ad23 ministration to ensure there is no unnecessary duplication 

24 of efforts among such programs, and identification of any 

25 areas of duplication. 


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1 SEC. 223. IMPROVING PUBLIC HEALTH EMERGENCY RE2 SPONSE CAPACITY. 

3 (a) CERTAIN APPOINTMENTS TO SUPPORT PUBLIC

4 HEALTH EMERGENCY RESPONSES.—Section 319 of the 

5 Public Health Service Act (42 U.S.C. 247d) is amended 

6 by adding at the end the following: 

7 ‘‘(g) CERTAIN APPOINTMENTS TO SUPPORT PUBLIC

8 HEALTH EMERGENCY RESPONSES.— 

9 ‘‘(1) IN GENERAL.—In order to support the ini10 tial response to a public health emergency declared 

11 by the Secretary under this section, the Secretary 

12 may, subject to paragraph (2) and without regard to 

13 sections 3309 through 3318 of title 5, United States 

14 Code, appoint individuals directly to positions in the 

15 Department of Health and Human Services for 

16 which the Secretary has provided public notice in 

17 order to— 

18 ‘‘(A) address a critical hiring need directly 

19 related to responding to a public health emer20 gency declared by the Secretary under this sec21 tion; or 

22 ‘‘(B) address a severe shortage of can23 didates that impacts the operational capacity of 

24 the Department of Health and Human Services 

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1 gency declared by the Secretary under this sec2 tion. 

3 ‘‘(2) NUMBER OF APPOINTMENTS.—Each fiscal 

4 year in which the Secretary makes a determination 

5 of a public health emergency under subsection (a) 

6 (not including a renewal), the Secretary may directly 

7 appoint not more than— 

8 ‘‘(A) 400 individuals under paragraph 

9 (1)(A); and 

10 ‘‘(B) 100 individuals under paragraph 

11 (1)(B). 

12 ‘‘(3) COMPENSATION.—The annual rate of 

13 basic pay of an individual appointed under this sub14 section shall be determined in accordance with chap15 ter 51 and subchapter III of chapter 53 of title 5, 

16 United States Code. 

17 ‘‘(4) REPORTING.—The Secretary shall estab18 lish and maintain records regarding the use of the 

19 authority under this subsection, including— 

20 ‘‘(A) the number of positions filled through 

21 such authority; 

22 ‘‘(B) the types of appointments of such po23 sitions; 

24 ‘‘(C) the titles, occupational series, and 

25 grades of such positions; 


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1 ‘‘(D) the number of positions publicly no2 ticed to be filled under such authority; 

3 ‘‘(E) the number of qualified applicants 

4 who apply for such positions; 

5 ‘‘(F) the qualification criteria for such po6 sitions; and 

7 ‘‘(G) the demographic information of indi8 viduals appointed to such positions. 

9 ‘‘(5) NOTIFICATION TO CONGRESS.—In the 

10 event the Secretary, within a single fiscal year, di11 rectly appoints more than 50 percent of the individ12 uals allowable under either subparagraph (A) or (B) 

13 of paragraph (2), the Secretary shall, not later than 

14 15 days after the date of such action, notify the 

15 Committee on Health, Education, Labor, and Pen16 sions of the Senate and the Committee on Energy 

17 and Commerce of the House of Representatives. 

18 Such notification shall, in a manner that protects 

19 personal privacy, to the extent required by applicable 

20 Federal and State privacy law, at a minimum, in21 clude— 

22 ‘‘(A) information on each such appoint23 ment within such fiscal year; 


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1 ‘‘(B) a description of how each such posi2 tion relates to the requirements of subpara3 graph (A) or (B) of paragraph (1); and 

4 ‘‘(C) the additional number of personnel, if 

5 any, the Secretary anticipates to be necessary 

6 to adequately support a response to a public 

7 health emergency declared under this section 

8 using the authorities described in paragraph (1) 

9 within such fiscal year. 

10 ‘‘(6) REPORTS TO CONGRESS.—Not later than 

11 September 30, 2023, and annually thereafter for 

12 each fiscal year in which the authority under this 

13 subsection is used, the Secretary shall submit to the 

14 Committee on Health, Education, Labor, and Pen15 sions of the Senate and the Committee on Energy 

16 and Commerce of the House of Representatives a re17 port describing the total number of appointments 

18 filled under this subsection within the fiscal year and 

19 a description of how the positions relate to the re20 quirements of subparagraph (A) or (B) of paragraph 

21 (1). 

22 ‘‘(7) SUNSET.—The authority under this sub23 section shall expire on September 30, 2028.’’. 

24 (b) GAO REPORT.—Not later than 1 year after the 

25 issuance of the initial report under subsection (g)(6) of 


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1 section 319 of the Public Health Service Act (42 U.S.C. 

2 247d), as added by subsection (a), and again 180 days 

3 after the date on which the authority provided under sec4 tion 319(g) of such Act expires pursuant to paragraph (7) 

5 of such section, the Comptroller General of the United 

6 States shall submit to the Committee on Health, Edu7 cation, Labor, and Pensions of the Senate and the Com8 mittee on Energy and Commerce of the House of Rep9 resentatives a report on the use of the authority provided 

10 under such section. Such report shall, in a manner that 

11 protects personal privacy, at a minimum, include informa12 tion on— 

13 (1) the number of positions publicly noticed and 

14 filled under the authority of each of subparagraphs 

15 (A) and (B) of such section 319(g)(1); 

16 (2) the occupational series, grades, and types of 

17 appointments of such positions; 

18 (3) how such positions related to addressing a 

19 need or shortage described in subparagraph (A) or 

20 (B) of such section; 

21 (4) how the Secretary of Health and Human 

22 Services made appointment decisions under each of 

23 subparagraphs (A) and (B) of such section; 

24 (5) sources used to identify candidates for fill25 ing such positions; 


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1 (6) the number of individuals appointed under 

2 each such subparagraph; 

3 (7) aggregated demographic information related 

4 to individuals appointed under each such subpara5 graph; and 

6 (8) any challenges, limitations, or gaps related 

7 to the use of the authority under each such subpara8 graph and any related recommendations to address 

9 such challenges, limitations, or gaps. 

10 SEC. 224. EXTENSION OF AUTHORITIES TO SUPPORT 

11 HEALTH PROFESSIONAL VOLUNTEERS AT 

12 COMMUNITY HEALTH CENTERS. 

13 Section 224(q) of the Public Health Service Act (42 

14 U.S.C. 233(q)) is amended by striking paragraph (6). 

15 SEC. 225. INCREASING EDUCATIONAL OPPORTUNITIES FOR 

16 ALLIED HEALTH PROFESSIONS. 

17 Section 755(b) of the Public Health Service Act (42 

18 U.S.C. 294e(b)) is amended by adding at the end the fol19 lowing: 

20 ‘‘(4) Increasing educational opportunities in 

21 physical therapy, occupational therapy, respiratory 

22 therapy, audiology, and speech-language pathology 

23 professions, which may include offering scholarships 

24 or stipends and carrying out other activities to im25 prove retention, for individuals from disadvantaged 


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1 backgrounds or individuals who are underrep2 resented in such professions.’’. 

3 SEC. 226. PUBLIC HEALTH SERVICE CORPS ANNUAL AND 

4 SICK LEAVE. 

5 (a) IN GENERAL.—Section 219 of the Public Health 

6 Service Act (42 U.S.C. 210–1) is amended— 

7 (1) in subsection (a)— 

8 (A) by striking ‘‘Reserve Corps’’ and in9 serting ‘‘Ready Reserve Corps’’; and 

10 (B) by striking ‘‘: Provided, That such reg11 ulations shall not authorize annual leave to be 

12 accumulated in excess of sixty days’’; 

13 (2) by inserting after subsection (a) the fol14 lowing: 

15 ‘‘(b) The regulations described in subsection (a) may 

16 authorize accumulated annual leave of not more than 120 

17 days for any commissioned officer of the Regular Corps 

18 or officer of the Ready Reserve Corps on active duty.’’; 

19 and 

20 (3) by redesignating subsection (d) as sub21 section (c). 

22 (b) APPLICATION.—The amendments made by sub23 section (a) shall apply with respect to accumulated annual 

24 leave (as defined in section 219 of the Public Health Serv25 ice Act (42 U.S.C. 210–1)) that a commissioned officer 


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1 of the Regular Corps or officer of the Ready Reserve 

2 Corps on active duty would, but for the regulations de3 scribed in such section, lose at the end of fiscal year 2022 

4 or a subsequent fiscal year. 

5 Subtitle D—Improving Public 

6 Health Responses 

7 SEC. 231. CENTERS FOR PUBLIC HEALTH PREPAREDNESS 

8 AND RESPONSE. 

9 (a) IN GENERAL.—Section 319F of the Public 

10 Health Service Act (42 U.S.C. 247d–6) is amended— 

11 (1) by striking subsection (d) and inserting the 

12 following: 

13 ‘‘(d) CENTERS FOR PUBLIC HEALTH PREPAREDNESS

14 AND RESPONSE.— 

15 ‘‘(1) IN GENERAL.—The Secretary, acting 

16 through the Director of the Centers for Disease 

17 Control and Prevention, may award grants, con18 tracts, or cooperative agreements to institutions of 

19 higher education, including accredited schools of 

20 public health, or other nonprofit private entities to 

21 establish or maintain a network of Centers for Pub22 lic Health Preparedness and Response (referred to 

23 in this subsection as ‘Centers’). 

24 ‘‘(2) ELIGIBILITY.—To be eligible to receive an 

25 award under this subsection, an entity shall submit 


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1 to the Secretary an application containing such in2 formation as the Secretary may require, including a 

3 description of how the entity will— 

4 ‘‘(A) coordinate relevant activities with ap5 plicable State, local, and Tribal health depart6 ments and officials, health care facilities, and 

7 health care coalitions to improve public health 

8 preparedness and response, as informed by the 

9 public health preparedness and response needs 

10 of the community, or communities, involved; 

11 ‘‘(B) prioritize efforts to implement evi12 dence-informed or evidence-based practices to 

13 improve public health preparedness and re14 sponse, including by helping to reduce the 

15 transmission of emerging infectious diseases; 

16 and 

17 ‘‘(C) use funds awarded under this sub18 section, including by carrying out any activities 

19 described in paragraph (3). 

20 ‘‘(3) USE OF FUNDS.—The Centers established 

21 or maintained under this subsection shall use funds 

22 awarded under this subsection to carry out activities 

23 to advance public health preparedness and response 

24 capabilities, which may include— 


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1 ‘‘(A) identifying, translating, and dissemi2 nating promising research findings or strategies 

3 into evidence-informed or evidence-based prac4 tices to inform preparedness for, and responses 

5 to, chemical, biological, radiological, or nuclear 

6 threats, including emerging infectious diseases, 

7 and other public health emergencies, which may 

8 include conducting research related to public 

9 health preparedness and response systems; 

10 ‘‘(B) improving awareness of such evi11 dence-informed or evidence-based practices and 

12 other relevant scientific or public health infor13 mation among health care professionals, public 

14 health professionals, other stakeholders, and the 

15 public, including through the development, eval16 uation, and dissemination of trainings and 

17 training materials, consistent with section 

18 2802(b)(2), as applicable and appropriate, and 

19 with consideration given to existing training 

20 materials, to support preparedness for, and re21 sponses to, such threats; 

22 ‘‘(C) utilizing and expanding relevant tech23 nological and analytical capabilities to inform 

24 public health and medical preparedness and re25 sponse efforts; 


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1 ‘‘(D) expanding activities, including 

2 through public-private partnerships, related to 

3 public health preparedness and response, in4 cluding participation in drills and exercises and 

5 training public health experts, as appropriate; 

6 and 

7 ‘‘(E) providing technical assistance and ex8 pertise that relies on evidence-based practices, 

9 as applicable, related to responses to public 

10 health emergencies, as appropriate, to State, 

11 local, and Tribal health departments and other 

12 entities pursuant to paragraph (2)(A). 

13 ‘‘(4) DISTRIBUTION OF AWARDS.—In awarding 

14 grants, contracts, or cooperative agreements under 

15 this subsection, the Secretary shall support not 

16 fewer than 10 Centers, subject to the availability of 

17 appropriations, and ensure that such awards are eq18 uitably distributed among the geographical regions 

19 of the United States.’’; and 

20 (2) in subsection (f)(1)(C), by striking ‘‘, of 

21 which $5,000,000 shall be used to carry out para22 graphs (3) through (5) of such subsection’’. 

23 (b) REPEAL.—Section 319G of the Public Health 

24 Service Act (42 U.S.C. 247d–7) is repealed. 


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1 SEC. 232. VACCINE DISTRIBUTION PLANS. 

2 Section 319A of the Public Health Service Act (42 

3 U.S.C. 247d–1) is amended— 

4 (1) in subsection (a)— 

5 (A) by inserting ‘‘, or other federally pur6 chased vaccine to address another pandemic’’ 

7 before the period at the end of the first sen8 tence; and 

9 (B) by inserting ‘‘or other pandemic’’ be10 fore the period at the end of the second sen11 tence; and 

12 (2) in subsection (d), by inserting ‘‘or other 

13 pandemics’’ after ‘‘influenza pandemics’’. 

14 SEC. 233. COORDINATION AND COLLABORATION REGARD15 ING BLOOD SUPPLY. 

16 (a) IN GENERAL.—The Secretary of Health and 

17 Human Services, or the Secretary’s designee, shall— 

18 (1) ensure coordination and collaboration be19 tween relevant Federal departments and agencies re20 lated to the safety and availability of the blood sup21 ply, including— 

22 (A) the Department of Health and Human 

23 Services, including the Office of the Assistant 

24 Secretary for Health, the Centers for Disease 

25 Control and Prevention, the Food and Drug 

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1 retary for Preparedness and Response, the Na2 tional Institutes of Health, the Centers for 

3 Medicare & Medicaid Services, and the Health 

4 Resources and Services Administration; 

5 (B) the Department of Defense; and 

6 (C) the Department of Veterans Affairs; 

7 and 

8 (2) consult and communicate with private 

9 stakeholders, including blood collection establish10 ments, health care providers, accreditation organiza11 tions, researchers, and patients, regarding issues re12 lated to the safety and availability of the blood sup13 ply. 

14 (b) STREAMLINING BLOOD DONOR INPUT.—Chapter 

15 35 of title 44, United States Code, shall not apply to the 

16 collection of information to which a response is voluntary 

17 and that is initiated by the Secretary of Health and 

18 Human Services to solicit information from blood donors 

19 or potential blood donors to support the development of 

20 recommendations by the Secretary concerning blood dona21 tion. 


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1 TITLE III—ACCELERATING RE2 SEARCH AND COUNTER3 MEASURE DISCOVERY 

4 Subtitle A—Fostering Research 

5 and Development and Improv6 ing Coordination 

7 SEC. 301. RESEARCH AND ACTIVITIES RELATED TO LONG8 TERM HEALTH EFFECTS OF SARS–COV–2 IN9 FECTION. 

10 (a) IN GENERAL.—The Secretary of Health and 

11 Human Services (referred to in this section as the ‘‘Sec12 retary’’) shall, as appropriate— 

13 (1) continue to conduct or support basic, clin14 ical, epidemiological, behavioral, and translational 

15 research and public health surveillance related to the 

16 pathogenesis, prevention, diagnosis, and treatment 

17 of the long-term health effects of SARS–CoV–2 in18 fection; and 

19 (2) in consultation with health professional as20 sociations, researchers, and other relevant experts, 

21 develop and inform recommendations, guidance, and 

22 provide educational materials for health care pro23 viders and the general public on the long-term ef24 fects of SARS–CoV–2 infection, consistent with the 


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1 findings of studies and research under paragraph 

2 (1). 

3 (b) CONSIDERATIONS.—In conducting or supporting 

4 research under this section, the Secretary shall consider 

5 the diversity of research participants or cohorts to ensure 

6 inclusion of a broad range of participants, as applicable 

7 and appropriate. 

8 (c) ANNUAL REPORTS.—Not later than 1 year after 

9 the date of enactment of this Act, and annually thereafter 

10 for the next 4 years, the Secretary shall prepare and sub11 mit a report to the Committee on Health, Education, 

12 Labor, and Pensions of the Senate and the Committee on 

13 Energy and Commerce of the House of Representatives 

14 regarding an overview of the research conducted or sup15 ported under this section and any relevant findings. Such 

16 reports may include information about how the research 

17 and relevant findings under this section relate to other re18 search efforts supported by other public or private entities. 

19 SEC. 302. RESEARCH CENTERS FOR PATHOGENS OF PAN20 DEMIC CONCERN. 

21 Subpart 6 of part C of title IV of the Public Health 

22 Service Act is amended by inserting after section 447C 

23 (42 U.S.C. 285f–4) the following: 


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1 ‘‘SEC. 447D. RESEARCH CENTERS FOR PATHOGENS OF PAN2 DEMIC CONCERN. 

3 ‘‘(a) IN GENERAL.—The Director of the Institute, in 

4 collaboration, as appropriate, with the directors of applica5 ble institutes, centers, and divisions of the National Insti6 tutes of Health, the Assistant Secretary for Preparedness 

7 and Response, and the Director of the Biomedical Ad8 vanced Research and Development Authority, shall estab9 lish or continue a multidisciplinary research program to 

10 advance the discovery and preclinical development of med11 ical products for priority virus families and other viral 

12 pathogens with a significant potential to cause a pan13 demic, through support for research centers. 

14 ‘‘(b) USES OF FUNDS.—The Director of the Institute 

15 shall award funding through grants, contracts, or coopera16 tive agreements to public or private entities to provide 

17 support for research centers described in subsection (a) 

18 for the purpose of— 

19 ‘‘(1) conducting basic research through pre20 clinical development of new medical products or 

21 technologies, including platform technologies, to ad22 dress pathogens of pandemic concern; 

23 ‘‘(2) identifying potential targets for thera24 peutic candidates, including antivirals, to treat such 

25 pathogens; 


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1 ‘‘(3) identifying existing medical products with 

2 the potential to address such pathogens, including 

3 candidates that could be used in outpatient settings; 

4 and 

5 ‘‘(4) carrying out or supporting other research 

6 related to medical products to address such patho7 gens, as determined appropriate by the Director. 

8 ‘‘(c) COORDINATION.—The Director of the Institute 

9 shall, as appropriate, provide for the coordination of ac10 tivities among the centers described in subsection (a), in11 cluding through— 

12 ‘‘(1) facilitating the exchange of information 

13 and regular communication among the centers, as 

14 appropriate; and 

15 ‘‘(2) requiring the periodic preparation and sub16 mission to the Director of reports on the activities 

17 of each center. 

18 ‘‘(d) PRIORITY.—In awarding funding through 

19 grants, contracts, or cooperative agreements under sub20 section (a), the Director of the Institute shall, as appro21 priate, give priority to applicants with existing frameworks 

22 and partnerships, as applicable, to support the advance23 ment of such research. 

24 ‘‘(e) COLLABORATION.—The Director of the Institute 

25 shall— 


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1 ‘‘(1) collaborate with the heads of other appro2 priate Federal departments, agencies, and offices 

3 with respect to the identification of additional pri4 ority virus families and other viral pathogens with a 

5 significant potential to cause a pandemic; and 

6 ‘‘(2) collaborate with the Director of the Bio7 medical Advanced Research and Development Au8 thority with respect to the research conducted by 

9 centers described in subsection (a), including, as ap10 propriate, providing any updates on the research ad11 vancements made by such centers, identifying any 

12 advanced research and development needs for such 

13 countermeasures, consistent with section 

14 319L(a)(6), and taking into consideration existing 

15 manufacturing capacity and future capacity needs 

16 for such medical products or technologies, including 

17 platform technologies, supported by the centers de18 scribed in subsection (a). 

19 ‘‘(f) SUPPLEMENT, NOT SUPPLANT.—Any support 

20 received by a center described in subsection (a) under this 

21 section shall be used to supplement, and not supplant, 

22 other public or private support for activities authorized to 

23 be supported.’’. 


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1 SEC. 303. IMPROVING MEDICAL COUNTERMEASURE RE2 SEARCH COORDINATION. 

3 Section 402(b) in the Public Health Service Act (42 

4 U.S.C. 282(b)) is amended— 

5 (1) in paragraph (24), by striking ‘‘and’’ at the 

6 end; 

7 (2) in paragraph (25), by striking the period 

8 and inserting a semicolon; and 

9 (3) by inserting after paragraph (25) the fol10 lowing: 

11 ‘‘(26) shall consult with the Assistant Secretary 

12 for Preparedness and Response, the Director of the 

13 Biomedical Advanced Research and Development 

14 Authority, the Director of the Centers for Disease 

15 Control and Prevention, and the heads of other Fed16 eral agencies and offices, as appropriate, regarding 

17 research needs to advance medical countermeasures 

18 to diagnose, mitigate, prevent, or treat harm from 

19 any biological agent or toxin, including emerging in20 fectious diseases, chemical, radiological, or nuclear 

21 agent that may cause a public health emergency or 

22 other research needs related to emerging public 

23 health threats;’’. 


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1 SEC. 304. ACCESSING SPECIMEN SAMPLES AND DIAG2 NOSTIC TESTS. 

3 (a) IMPROVING RESEARCH AND DEVELOPMENT OF

4 MEDICAL COUNTERMEASURES FOR NOVEL PATHO5 GENS.— 

6 (1) SAMPLE ACCESS.—Not later than 1 year 

7 after the date of enactment of this Act, the Sec8 retary of Health and Human Services (referred to in 

9 this subsection as the ‘‘Secretary’’) shall make pub10 licly available policies and procedures related to pub11 lic and private entities accessing specimens of, or 

12 specimens containing, pathogens or suitable surro13 gates for, or alternatives to, such pathogens as the 

14 Secretary determines appropriate to support public 

15 health preparedness and response activities or bio16 medical research for purposes of the development 

17 and validation, as applicable, of medical products to 

18 address emerging infectious diseases and for use to 

19 otherwise respond to emerging infectious diseases. 

20 Such policies and procedures shall take into account, 

21 as appropriate, any applicable existing Federal re22 sources. 

23 (2) GUIDANCE.—The Secretary shall issue 

24 guidance regarding the procedures for carrying out 

25 paragraph (1), including— 


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1 (A) the method for requesting such sam2 ples; 

3 (B) considerations for sample availability 

4 and use of suitable surrogates or alternatives to 

5 such pathogens, as appropriate, including appli6 cable safeguard and security measures; and 

7 (C) information required to be provided in 

8 order to receive such samples or suitable surro9 gates or alternatives. 

10 (b) EARLIER DEVELOPMENT OF DIAGNOSTIC

11 TESTS.—Title III of the Public Health Service Act is 

12 amended by inserting after section 319A (42 U.S.C. 

13 247d–1) the following: 

14 ‘‘SEC. 319B. EARLIER DEVELOPMENT OF DIAGNOSTIC 

15 TESTS. 

16 ‘‘The Secretary may contract with public and private 

17 entities, as appropriate, to increase capacity in the rapid 

18 development, validation, manufacture, and dissemination 

19 of diagnostic tests, as appropriate, to State, local, and 

20 Tribal health departments and other appropriate entities 

21 for immediate public health response activities to address 

22 an emerging infectious disease with respect to which a 

23 public health emergency is declared under section 319, or 

24 that has significant potential to cause such a public health 

25 emergency.’’. 


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1 Subtitle B—Improving Biosafety 

2 and Biosecurity 

3 SEC. 311. IMPROVING CONTROL AND OVERSIGHT OF SE4 LECT BIOLOGICAL AGENTS AND TOXINS. 

5 Section 351A of the Public Health Service Act (42 

6 U.S.C. 262a) is amended— 

7 (1) in subsection (b)(1), by amending subpara8 graph (A) to read as follows: 

9 ‘‘(A) proper training, including with re10 spect to notification requirements under this 

11 section, of— 

12 ‘‘(i) individuals who are involved in 

13 the handling and use of such agents and 

14 toxins, including appropriate skills to han15 dle such agents and toxins; 

16 ‘‘(ii) individuals whose responsibilities 

17 routinely place them in close proximity to 

18 laboratory facilities in which such agents 

19 and toxins are being transferred, pos20 sessed, or used; and 

21 ‘‘(iii) individuals who perform admin22 istrative or oversight functions of the facil23 ity related to the transfer, possession, or 

24 use of such agents and toxins on behalf of 

25 registered persons;’’; 


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1 (2) in subsection (e)(1), by striking ‘‘(including 

2 the risk of use in domestic or international ter3 rorism)’’ and inserting ‘‘(including risks posed by 

4 the release, theft, or loss of such agent or toxin, or 

5 use in domestic or international terrorism)’’; 

6 (3) in subsection (k)— 

7 (A) by redesignating paragraphs (1) and 

8 (2) as paragraphs (2) and (3), respectively; 

9 (B) by inserting before paragraph (2), as 

10 so redesignated, the following: 

11 ‘‘(1) NOTIFICATION WITH RESPECT TO FED12 ERAL FACILITIES.—In the event of the release, loss, 

13 or theft of an agent or toxin listed by the Secretary 

14 pursuant to subsection (a)(1), or by the Secretary of 

15 Agriculture pursuant to section 212(a)(1) of the Ag16 ricultural Bioterrorism Protection Act of 2002, from 

17 or within a laboratory facility owned or operated by 

18 the Department of Health and Human Services, or 

19 other Federal laboratory facility subject to the re20 quirements of this section, the Secretary, in a man21 ner that does not compromise national security, 

22 shall— 

23 ‘‘(A) not later than 72 hours after such 

24 event is reported to the Secretary, notify the 

25 Committee on Health, Education, Labor, and 


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1 Pensions of the Senate and the Committee on 

2 Energy and Commerce of the House of Rep3 resentatives of such event, including— 

4 ‘‘(i) the Federal laboratory facility in 

5 which such release, loss, or theft occurred; 

6 and 

7 ‘‘(ii) the circumstances of such re8 lease, loss, or theft; and 

9 ‘‘(B) not later than 14 days after such no10 tification, update such Committees on— 

11 ‘‘(i) any actions taken or planned by 

12 the Secretary to mitigate any potential 

13 threat such release, loss, or theft may pose 

14 to public health and safety; and 

15 ‘‘(ii) any actions taken or planned by 

16 the Secretary to review the circumstances 

17 of such release, loss, or theft, and prevent 

18 similar events.’’; and 

19 (C) by amending paragraph (2), as so re20 designated, to read as follows: 

21 ‘‘(2) ANNUAL REPORT.—The Secretary shall 

22 submit to the Committee on Health, Education, 

23 Labor, and Pensions of the Senate and the Com24 mittee on Energy and Commerce of the House of 

25 Representatives on an annual basis a report— 


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1 ‘‘(A) summarizing the number and nature 

2 of notifications received under subsection (e)(8) 

3 (relating to theft or loss) and subsection (j) (re4 lating to releases), during the preceding fiscal 

5 year; 

6 ‘‘(B) describing actions taken by the Sec7 retary to address such incidents, such as any 

8 corrective action plans required and steps taken 

9 to promote adherence to, and compliance with, 

10 safety and security best practices, standards, 

11 and regulations; and 

12 ‘‘(C) describing any gaps, challenges, or 

13 limitations with respect to ensuring that such 

14 safety and security practices are consistently 

15 applied and adhered to, and actions taken to 

16 address such gaps, challenges, or limitations.’’; 

17 and 

18 (4) in subsection (m), by striking ‘‘fiscal years 

19 2002 through 2007’’ and inserting ‘‘fiscal years 

20 2023 through 2027’’. 

21 SEC. 312. STRATEGY FOR FEDERAL HIGH-CONTAINMENT 

22 LABORATORIES. 

23 (a) STRATEGY FOR FEDERAL HIGH-CONTAINMENT

24 LABORATORIES.—Not later than 1 year after the date of 

25 enactment of this Act, the Director of the Office of Science 


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1 and Technology Policy, in consultation with relevant Fed2 eral agencies and departments, shall establish a strategy 

3 for the management, maintenance, and oversight of feder4 ally-owned laboratory facilities capable of operating at 

5 Biosafety Level 3 or 4, including equivalent classification 

6 levels. Such strategy shall include— 

7 (1) a description of the roles and responsibil8 ities of relevant Federal departments and agencies 

9 with respect to the management, maintenance, and 

10 oversight of Biosafety Level 3 or 4 laboratory facili11 ties; 

12 (2) an assessment of the needs of the Federal 

13 Government with respect to Biosafety Level 3 or 4 

14 laboratory facilities; 

15 (3) a summary of existing federally-owned Bio16 safety Level 3 or 4 laboratory facility capacity; 

17 (4) a summary of other Biosafety Level 3 or 4 

18 laboratory facility capacity established through Fed19 eral funds; 

20 (5) a description of how the capacity described 

21 in paragraphs (3) and (4) addresses the needs of the 

22 Federal Government, including— 

23 (A) how relevant Federal departments and 

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1 priate laboratory facilities to reduce unneces2 sary duplication; and 

3 (B) any gaps in such capacity related to 

4 such needs; 

5 (6) a summary of plans that are in place for 

6 the maintenance of such capacity, as applicable and 

7 appropriate, including processes for determining 

8 whether to maintain or expand such capacity, and a 

9 description of how the Federal Government will ad10 dress rapid changes in the need for such capacity 

11 during a public health emergency; and 

12 (7) a description of how the heads of relevant 

13 Federal departments and agencies will coordinate to 

14 ensure appropriate oversight of federally-owned lab15 oratory facility capacity and leverage such capacity, 

16 as appropriate, to fulfill the needs of multiple Fed17 eral departments and agencies in order to reduce un18 necessary duplication and improve collaboration 

19 within the Federal Government. 

20 SEC. 313. NATIONAL SCIENCE ADVISORY BOARD FOR BIO21 SECURITY. 

22 (a) IN GENERAL.—Part A of title IV of the Public 

23 Health Service Act (42 U.S.C. 281 et seq.) is amended 

24 by adding at the end the following: 


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1 ‘‘SEC. 404O. NATIONAL SCIENCE ADVISORY BOARD FOR 

2 BIOSECURITY. 

3 ‘‘(a) ESTABLISHMENT.—The Secretary, acting 

4 through the Director of NIH, shall establish an advisory 

5 committee, to be known as the ‘National Science Advisory 

6 Board for Biosecurity’ (referred to in this section as the 

7 ‘Board’). 

8 ‘‘(b) DUTIES.— 

9 ‘‘(1) IN GENERAL.—The National Science Advi10 sory Board for Biosecurity referred to in section 205 

11 of the Pandemic and All-Hazards Preparedness Act 

12 (Public Law 109–417) (referred to in this section as 

13 the ‘Board’) shall provide technical advice, guidance, 

14 or recommendations, to relevant Federal depart15 ments and agencies related to biosafety and biosecu16 rity oversight of biomedical research, including— 

17 ‘‘(A) oversight of federally-conducted or 

18 federally-supported dual use biomedical re19 search, such as the review of policies or frame20 works used to assess and appropriately manage 

21 safety and security risks associated with such 

22 research, taking into consideration national se23 curity concerns, the potential benefits of such 

24 research, considerations related to the research 

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1 ability of information, and international re2 search collaboration; and 

3 ‘‘(B) continuing to carry out the activities 

4 required under section 205 of the Pandemic 

5 and All-Hazards Preparedness Act (Public Law 

6 109–417). 

7 ‘‘(c) CONSIDERATIONS.—In carrying out the duties 

8 under subsection (b), the Board may consider strategies 

9 to improve the safety and security of biomedical research, 

10 including through— 

11 ‘‘(1) leveraging or using new technologies and 

12 scientific advancements to reduce safety and security 

13 risks associated with such research and improve con14 tainment of pathogens; and 

15 ‘‘(2) outreach to, and education and training of, 

16 researchers, laboratory personnel, and other appro17 priate individuals with respect to safety and security 

18 risks associated with such research and mitigation of 

19 such risks. 

20 ‘‘(d) MEMBERSHIP.—The Board shall be composed of 

21 the following: 

22 ‘‘(1) Non-voting, ex officio members, including 

23 the following: 

24 ‘‘(A) At least one representative of each of 

25 the following: 


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1 ‘‘(i) The Department of Health and 

2 Human Services. 

3 ‘‘(ii) The Department of Defense. 

4 ‘‘(iii) The Department of Agriculture. 

5 ‘‘(iv) The Department of Homeland 

6 Security. 

7 ‘‘(v) The Department of Energy. 

8 ‘‘(vi) The Department of State. 

9 ‘‘(vii) The Office of Science and Tech10 nology Policy. 

11 ‘‘(viii) The Office of the Director of 

12 National Intelligence. 

13 ‘‘(B) Representatives of such other Federal 

14 departments or agencies as the Secretary deter15 mines appropriate to carry out the requirements 

16 of this section. 

17 ‘‘(2) Individuals, appointed by the Secretary, 

18 with expertise in biology, infectious diseases, public 

19 health, ethics, national security, and other fields, as 

20 the Secretary determines appropriate, who shall 

21 serve as voting members.’’. 

22 (b) ORDERLY TRANSITION.—The Secretary of 

23 Health and Human Services shall take such steps as are 

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1 security established under section 404O of the Public 

2 Health Service Act, as added by subsection (a), from any 

3 authority of the Board described in section 205 of the 

4 Pandemic and All-Hazards Preparedness Act (Public Law 

5 109–417), as in effect on the day before the date of enact6 ment of this Act. 

7 (c) APPLICATION.—The requirements under section 

8 404O of the Public Health Service Act, as added by sub9 section (a), related to the mission, activities, or functions 

10 of the National Science Advisory Board for Biosecurity 

11 shall not apply until the completion of any work under12 taken by such Board before the date of enactment of this 

13 Act. 

14 SEC. 314. RESEARCH TO IMPROVE BIOSAFETY. 

15 (a) IN GENERAL.—The Secretary of Health and 

16 Human Services (referred to in this section as the ‘‘Sec17 retary’’) shall, as appropriate, conduct or support research 

18 to improve the safe conduct of biomedical research activi19 ties involving pathogens of pandemic potential or biologi20 cal agents or toxins listed pursuant to section 351A(a)(1) 

21 of the Public Health Service Act (42 U.S.C. 262a(a)(1)). 

22 (b) REPORT.—Not later than 5 years after the date 

23 of enactment of this Act, the Secretary shall prepare and 

24 submit a report to the Committee on Health, Education, 

25 Labor, and Pensions of the Senate and the Committee on 


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1 Energy and Commerce of the House of Representatives 

2 regarding an overview of any research conducted or sup3 ported under this section, any relevant findings, and steps 

4 the Secretary is taking to disseminate any such findings 

5 to support the reduction of risks associated with bio6 medical research involving pathogens of pandemic poten7 tial or biological agents or toxins listed pursuant to section 

8 351A(a)(1) of the Public Health Service Act (42 U.S.C. 

9 262a(a)(1)). 

10 SEC. 315. FEDERALLY-FUNDED RESEARCH WITH EN11 HANCED PATHOGENS OF PANDEMIC POTEN12 TIAL. 

13 (a) REVIEW AND OVERSIGHT OF ENHANCED PATHO14 GENS OF PANDEMIC POTENTIAL.— 

15 (1) IN GENERAL.—The Director of the Office of 

16 Science and Technology Policy (referred to in this 

17 section as the ‘‘Director’’), in consultation with the 

18 heads of relevant Federal departments and agencies, 

19 shall— 

20 (A) not later than 1 years after the date 

21 of enactment of this Act— 

22 (i) continue or conduct a review of ex23 isting Federal policies related to research 

24 proposed for Federal funding that may be 

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1 ation, transfer, or use of pathogens of pan2 demic potential; and 

3 (ii) establish or update a Federal pol4 icy for the consistent review and oversight 

5 of such proposed research that appro6 priately considers the risks associated with, 

7 and potential benefits of, such research; 

8 and 

9 (B) not less than every 4 years thereafter, 

10 review and update such policy, as necessary and 

11 appropriate, to ensure that such policy fully ac12 counts for relevant research that may be rea13 sonably anticipated to involve the creation, 

14 transfer, or use of enhanced pathogens of pan15 demic potential, takes into consideration the 

16 benefits of such research, and supports the 

17 mitigation of related risks. 

18 (2) REQUIREMENTS.—The policy established 

19 pursuant to paragraph (1) shall include— 

20 (A) a clear scope to support the consistent 

21 identification of research proposals subject to 

22 such policy by relevant Federal departments 

23 and agencies; 

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1 ations related to the creation, transfer, or use 

2 of enhanced pathogens of pandemic potential; 

3 (C) measures to enhance the transparency 

4 and public availability of information related to 

5 such research activities in a manner that does 

6 not compromise national security, the safety 

7 and security of such research activities, or any 

8 identifiable, sensitive information of relevant in9 dividuals; and 

10 (D) consistent procedures across relevant 

11 Federal department and agencies to ensure 

12 that— 

13 (i) proposed research that has been 

14 determined to have scientific and technical 

15 merit and may be subject to such policy is 

16 identified and referred for review; 

17 (ii) subjected research activities con18 ducted under an award, including activities 

19 undertaken by any subrecipients of such 

20 award, are monitored regularly throughout 

21 the project period to ensure compliance 

22 with such policy and the terms and condi23 tions of such award; and 

24 (iii) in the event that federally-funded 

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1 icy produce unanticipated results related to 

2 the creation, transfer, or use of enhanced 

3 pathogens of pandemic potential, such re4 search activities are identified and appro5 priately reviewed under such policy. 

6 (3) CLARIFICATION.—Reviews required pursu7 ant to this section shall be in addition to any appli8 cable requirements for research project applications 

9 required under the Public Health Service Act, in10 cluding reviews required under section 492 of such 

11 Act (42 U.S.C. 289a), as applicable, or other appli12 cable laws. 

13 (b) IMPLEMENTATION.— 

14 (1) IN GENERAL.—The Director shall direct all 

15 heads of relevant Federal departments and agencies 

16 to update, modernize, or promulgate applicable im17 plementing regulations and guidance to implement 

18 the requirements of this section. 

19 (2) UPDATES.—Consistent with the require20 ments under subsection (a)(1)(B), the Director shall 

21 require all heads of relevant Federal departments 

22 and agencies to update such policies consistent with 

23 any changes to the policy established pursuant to 

24 subsection (a)(1). 


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1 Subtitle C—Preventing Undue For2 eign Influence in Biomedical 

3 Research 

4 SEC. 321. FOREIGN TALENT PROGRAMS. 

5 The Secretary of Health and Human Services shall 

6 require disclosure of participation in foreign talent pro7 grams, including the provision of copies of all grants, con8 tracts, or other agreements related to such programs, and 

9 other supporting documentation related to such programs, 

10 as a condition of receipt of Federal extramural biomedical 

11 research funding awarded through the Department of 

12 Health and Human Services. 

13 SEC. 322. SECURING IDENTIFIABLE, SENSITIVE INFORMA14 TION. 

15 (a) IN GENERAL.—The Secretary of Health and 

16 Human Services (referred to in this section as the ‘‘Sec17 retary’’), in consultation with the Director of National In18 telligence, the Secretary of State, the Secretary of De19 fense, and other national security experts, as appropriate, 

20 shall ensure that biomedical research supported or con21 ducted by the National Institutes of Health and other rel22 evant agencies and offices within the Department of 

23 Health and Human Services involving the sequencing of 

24 human genomic information, and collection, analysis, or 

25 storage of identifiable, sensitive information, as defined in 


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1 section 301(d)(4) of the Public Health Service Act (42 

2 U.S.C. 241(d)(4)), is conducted in a manner that appro3 priately considers national security risks, including na4 tional security implications related to potential misuse of 

5 such data. Not later than 1 year after the date of enact6 ment of this Act, the Secretary shall ensure that the Na7 tional Institutes of Health and other relevant agencies and 

8 offices within the Department of Health and Human Serv9 ices, working with the heads of agencies and national secu10 rity experts, including the Office of the National Security 

11 within the Department of Health and Human Services— 

12 (1) develop a comprehensive framework for as13 sessing and managing such national security risks 

14 that includes— 

15 (A) criteria for how and when to conduct 

16 risk assessments for projects that may have na17 tional security implications; 

18 (B) security controls and training for re19 searchers or entities, including peer reviewers, 

20 that manage or have access to such data; and 

21 (C) methods to incorporate risk-reduction 

22 in the process for funding such projects that 

23 may have national security implications; 


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1 (2) not later than 1 year after the risk frame2 work is developed under paragraph (1), develop and 

3 implement controls to— 

4 (A) ensure that researchers or entities that 

5 manage or have access to such data have com6 plied with the requirements of paragraph (1) 

7 and ongoing requirements with such paragraph; 

8 and 

9 (B) ensure that data access committees re10 viewing data access requests for projects that 

11 may have national security risks, as appro12 priate, include members with expertise in cur13 rent and emerging national security threats, in 

14 order to make appropriate decisions related to 

15 access to such identifiable, sensitive informa16 tion; and 

17 (3) not later than 2 years after the risk frame18 work is developed under paragraph (1), update data 

19 access and sharing policies related to human 

20 genomic data, as appropriate, based on current and 

21 emerging national security threats. 

22 (b) CONGRESSIONAL BRIEFING.—Not later than 1 

23 year after the date of enactment of this Act, the Secretary 

24 shall provide a briefing to the Committee on Health, Edu25 cation, Labor, and Pensions and the Select Committee on 


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1 Intelligence of the Senate and the Committee on Energy 

2 and Commerce and the Permanent Select Committee on 

3 Intelligence of the House of Representatives on the activi4 ties required under subsection (a). 

5 SEC. 323. DUTIES OF THE DIRECTOR. 

6 Section 402(b) in the Public Health Service Act (42 

7 U.S.C. 282(b)), as amended by section 303, is further 

8 amended by inserting after paragraph (26) (as added by 

9 section 303) the following: 

10 ‘‘(27) shall consult with the Director of the Of11 fice of National Security within the Department of 

12 Health and Human Services, the Assistant Secretary 

13 for Preparedness and Response, the Director of Na14 tional Intelligence, the Director of the Federal Bu15 reau of Investigation, and the heads of other appro16 priate agencies on a regular basis, regarding bio17 medical research conducted or supported by the Na18 tional Institutes of Health that may affect or be af19 fected by matters of national security; 

20 ‘‘(28) shall ensure that recipients of awards 

21 from the National Institutes of Health, and, as ap22 propriate and practicable, entities collaborating with 

23 such recipients, have in place and are adhering to 

24 appropriate technology practices and policies for the 

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1 ing information collected, stored, or analyzed by do2 mestic and non-domestic entities; and 

3 ‘‘(29) shall ensure that recipients of awards 

4 from the National Institutes of Health are in compli5 ance with the terms and conditions of such award, 

6 which may include activities to support awareness of, 

7 and compliance with, such terms and conditions by 

8 any subrecipients of the award.’’. 

9 SEC. 324. PROTECTING AMERICA’S BIOMEDICAL RESEARCH 

10 ENTERPRISE. 

11 (a) IN GENERAL.—The Secretary of Health and 

12 Human Services (referred to in this section as the ‘‘Sec13 retary’’), in collaboration with Assistant to the President 

14 for National Security Affairs, the Director of National In15 telligence, the Director of the Federal Bureau of Inves16 tigation, and the heads of other relevant departments and 

17 agencies, and in consultation with research institutions 

18 and research advocacy organizations or other relevant ex19 perts, as appropriate, shall— 

20 (1) identify ways to improve the protection of 

21 intellectual property and other proprietary informa22 tion, as well as identifiable, sensitive information of 

23 participants in biomedical research and development, 

24 from national security risks and other applicable 

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1 cies and procedures in such areas related to bio2 medical research and development supported by the 

3 Department of Health and Human Services and bio4 medical research supported by other agencies as ap5 plicable, and make recommendations to institutions 

6 of higher education or other entities that have tradi7 tionally received Federal funding for biomedical re8 search to protect such information; 

9 (2) identify or develop strategies to prevent, 

10 mitigate, and address national security threats in 

11 biomedical research and development supported by 

12 the Federal Government, including such threats as13 sociated with foreign talent programs, by countries 

14 seeking to exploit United States technology and 

15 other proprietary information as it relates to such 

16 biomedical research and development; 

17 (3) identify national security risks and potential 

18 misuse of proprietary information, and identifiable, 

19 sensitive information of biomedical research partici20 pants and other applicable risks, including with re21 spect to peer review, and make recommendations for 

22 additional policies and procedures to protect such in23 formation; 

24 (4) develop a framework to identify areas of 

25 biomedical research and development supported by 


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1 the Federal Government that are emerging areas of 

2 interest for state actors and would compromise na3 tional security if they were to be subjected to undue 

4 foreign influence; and 

5 (5) regularly review recommendations or poli6 cies developed under this section and make addi7 tional recommendations or updates, as appropriate. 

8 (b) REPORT TO PRESIDENT AND TO CONGRESS.— 

9 Not later than 1 year after the date of enactment of this 

10 Act, the Secretary shall prepare and submit, in a manner 

11 that does not compromise national security, to the Presi12 dent and the Committee on Health, Education, Labor, and 

13 Pensions and the Select Committee on Intelligence of the 

14 Senate, the Committee on Energy and Commerce and the 

15 Permanent Select Committee on Intelligence of the House 

16 of Representatives, and other congressional committees as 

17 appropriate, a report on the findings and recommenda18 tions pursuant to subsection (a). 

19 SEC. 325. GAO STUDY. 

20 (a) IN GENERAL.—The Comptroller General of the 

21 United States (referred to in this section as the ‘‘Comp22 troller General’’) shall conduct a study to assess the extent 

23 to which the Department of Health and Human Services 

24 (referred to in this section as the ‘‘Department’’) utilizes 

25 or provides funding to entities that utilize such funds for 


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1 human genomic sequencing services or genetic services (as 

2 such term is defined in section 201(6) of the Genetic In3 formation Nondiscrimination Act of 2008 (42 U.S.C. 

4 2000ff(6))) provided by entities, or subsidiaries of such 

5 entities, organized under the laws of a country or coun6 tries of concern, in the estimation of the Director of Na7 tional Intelligence or the head of another Federal depart8 ment or agency, as appropriate. 

9 (b) CONSIDERATIONS.—In carrying out the study 

10 under this section, the Comptroller General shall— 

11 (1) consider— 

12 (A) the extent to which the country or 

13 countries of concern could obtain human 

14 genomic information of citizens and residents of 

15 the United States from such entities that se16 quence, analyze, collect, or store human 

17 genomic information and which the Director of 

18 National Intelligence or the head of another 

19 Federal department or agency reasonably an20 ticipates may use such information in a manner 

21 inconsistent with the national security interests 

22 of the United States; 

23 (B) whether the Department or recipient 

24 of such funds from the Department sought to 

25 provide funding to, or to use, domestic entities 


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1 with no such ties to the country or countries of 

2 concern for such purposes and any barriers to 

3 the use of domestic entities; and 

4 (C) whether data use agreements, data se5 curity measures, and other such measures taken 

6 by the Department or recipient of such funds 

7 from the Department are sufficient to protect 

8 the identifiable, sensitive information of the 

9 people of the United States and the national se10 curity interests of the United States; and 

11 (2) make recommendations to address any 

12 vulnerabilities to the United States national security 

13 identified, as appropriate. 

14 (c) ESTIMATION.—In conducting the study under this 

15 section, the Comptroller General may, as appropriate and 

16 necessary to complete such study, investigate specific in17 stances of such utilization of genetic sequencing services 

18 or genetic services, as described in subsection (a), to 

19 produce estimates of the potential prevalence of such utili20 zation among entities in receipt of Departmental funds. 

21 (d) REPORT.—Not later than 2 years after the date 

22 of enactment of this Act, the Comptroller General shall 

23 submit a report on the study under this section, in a man24 ner that does not compromise national security, to the 

25 Committee on Health, Education, Labor, and Pensions 


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1 and the Select Committee on Intelligence of the Senate, 

2 and the Committee on Energy and Commerce and the Per3 manent Select Committee on Intelligence of the House of 

4 Representatives. The report shall be submitted in unclassi5 fied form, to the extent practicable, but may include a 

6 classified annex. 

7 SEC. 326. REPORT ON PROGRESS TO ADDRESS UNDUE FOR8 EIGN INFLUENCE. 

9 Not later than 1 year after the date of enactment 

10 of this Act and annually thereafter, the Secretary of 

11 Health and Human Services shall prepare and submit to 

12 the Committee on Health, Education, Labor, and Pen13 sions of the Senate and the Committee on Energy and 

14 Commerce in the House of Representatives, in a manner 

15 that does not compromise national security, a report on 

16 actions taken by such Secretary— 

17 (1) to address cases of noncompliance with dis18 closure requirements or research misconduct related 

19 to foreign influence, including— 

20 (A) the number of potential noncompliance 

21 cases investigated by the National Institutes of 

22 Health or reported to the National Institutes of 

23 Health by a research institution, including re24 lating to undisclosed research support, undisVerDate Sep 11 2014 04:50 Mar 11, 2022 Jkt 029200 PO 00000 Frm 00173 Fmt 6652 Sfmt 6201 E:\BILLS\S3799.IS S3799

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1 closed conflicts of interest or other conflicts of 

2 commitment, and peer review violations; 

3 (B) the number of cases referred to the 

4 Office of Inspector General of the Department 

5 of Health and Human Services, the Office of 

6 National Security of the Department of Health 

7 and Human Services, the Federal Bureau of In8 vestigation, or other law enforcement agencies; 

9 (C) a description of enforcement actions 

10 taken for noncompliance related to undue for11 eign influence; and 

12 (D) any other relevant information; and 

13 (2) to prevent, address, and mitigate instances 

14 of noncompliance with disclosure requirements or re15 search misconduct related to foreign influence. 

16 TITLE IV—MODERNIZING AND 

17 STRENGTHENING THE SUP18 PLY CHAIN FOR VITAL MED19 ICAL PRODUCTS 

20 SEC. 401. WARM BASE MANUFACTURING CAPACITY FOR 

21 MEDICAL COUNTERMEASURES. 

22 (a) IN GENERAL.—Section 319L of the Public 

23 Health Service Act (42 U.S.C. 247d–7e) is amended— 

24 (1) in subsection (a)(6)(B)— 


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1 (A) by redesignating clauses (iv) and (v) as 

2 clauses (v) and (vi), respectively; 

3 (B) by inserting after clause (iii), the fol4 lowing: 

5 ‘‘(iv) activities to support, maintain, 

6 and improve domestic manufacturing surge 

7 capacity and capabilities, as appropriate, 

8 including through the utilization of ad9 vanced manufacturing and platform tech10 nologies, to increase the availability of 

11 products that are or may become qualified 

12 countermeasures or qualified pandemic or 

13 epidemic products;’’; and 

14 (C) in clause (vi) (as so redesignated), by 

15 inserting ‘‘manufacturing,’’ after ‘‘improve16 ment,’’; 

17 (2) in subsection (b)— 

18 (A) in the first sentence of paragraph (1), 

19 by inserting ‘‘support for domestic manufac20 turing surge capacity and capabilities,’’ after 

21 ‘‘initiatives for innovation,’’; and 

22 (B) in paragraph (2)— 

23 (i) in subparagraph (B), by striking 

24 ‘‘and’’ at the end; 


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1 (ii) by redesignating subparagraph 

2 (C) as subparagraph (D); and 

3 (iii) by inserting after subparagraph 

4 (B), the following: 

5 ‘‘(C) activities to support, maintain, and 

6 improve domestic manufacturing surge capacity 

7 and capabilities, as appropriate, including 

8 through the utilization of advanced manufac9 turing and platform technologies, to increase 

10 the availability of products that are or may be11 come qualified countermeasures or qualified 

12 pandemic or epidemic products; and’’; 

13 (3) in subsection (c)— 

14 (A) in paragraph (2)(B), by inserting be15 fore the semicolon ‘‘, including through the es16 tablishment and maintenance of domestic man17 ufacturing surge capacity and capabilities, con18 sistent with subsection (a)(6)(B)(iv)’’; 

19 (B) in paragraph (4)— 

20 (i) in subparagraph (A)— 

21 (I) in clause (i)— 

22 (aa) in subclause (I), by 

23 striking ‘‘and’’ at the end; and 

24 (bb) by adding at the end 

25 the following: 


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1 ‘‘(III) facilitating such commu2 nication, as appropriate, regarding 

3 manufacturing surge capacity and ca4 pabilities with respect to qualified 

5 countermeasures and qualified pan6 demic or epidemic products to prepare 

7 for, or respond to, a public health 

8 emergency or potential public health 

9 emergency; and 

10 ‘‘(IV) facilitating such commu11 nication, as appropriate and in a man12 ner that does not compromise national 

13 security, with respect to potential eli14 gibility for the material threat medical 

15 countermeasure priority review vouch16 er program under section 565A of the 

17 Federal Food, Drug, and Cosmetic 

18 Act;’’; 

19 (II) in clause (ii)(III), by striking 

20 ‘‘and’’ at the end; 

21 (III) by redesignating clause (iii) 

22 as clause (iv); and 

23 (IV) by inserting after clause (ii), 

24 the following: 


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1 ‘‘(iii) communicate regularly with enti2 ties in receipt of an award pursuant to 

3 subparagraph (B)(v), and facilitate com4 munication between such entities and other 

5 entities in receipt of an award pursuant to 

6 subparagraph (B)(iv), as appropriate, for 

7 purposes of planning and response regard8 ing the availability of countermeasures and 

9 the maintenance of domestic manufac10 turing surge capacity and capabilities, in11 cluding any planned uses of such capacity 

12 and capabilities in the near- and mid-term, 

13 and identification of any significant chal14 lenges related to the long-term mainte15 nance of such capacity and capabilities; 

16 and’’; 

17 (ii) in subparagraph (B)— 

18 (I) in clause (iii), by striking 

19 ‘‘and’’ at the end; 

20 (II) in clause (iv), by striking the 

21 period and inserting ‘‘; and’’; and 

22 (III) by adding at the end the 

23 following: 

24 ‘‘(v) award contracts, grants, and co25 operative agreements and enter into other 


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1 transactions to support, maintain, and im2 prove domestic manufacturing surge capac3 ity and capabilities, including through sup4 porting flexible or advanced manufac5 turing, to ensure that additional capacity 

6 is available to rapidly manufacture prod7 ucts that are or may become qualified 

8 countermeasures or qualified pandemic or 

9 epidemic products in the event of a public 

10 health emergency declaration or significant 

11 potential for a public health emergency.’’; 

12 (iii) in subparagraph (C)— 

13 (I) in clause (i), by striking 

14 ‘‘and’’ at the end; 

15 (II) in clause (ii), by striking the 

16 period at the end and inserting ‘‘; 

17 and’’; and 

18 (III) by adding at the end the 

19 following: 

20 ‘‘(iii) consult with the Commissioner 

21 of Food and Drugs, pursuant to section 

22 565(b)(2) of the Federal Food, Drug, and 

23 Cosmetic Act, to ensure that facilities per24 forming manufacturing, pursuant to an 

25 award under subparagraph (B)(v), are in 


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1 compliance with applicable requirements 

2 under such Act and this Act, as appro3 priate, including current good manufac4 turing practice pursuant to section 

5 501(a)(2)(B) of the Food, Drug, and Cos6 metic Act; and’’; 

7 (iv) in subparagraph (D)(i), by insert8 ing ‘‘, including to improve manufacturing 

9 capacities and capabilities for medical 

10 countermeasures’’ before the semicolon; 

11 (v) in subparagraph (E)(ix), by strik12 ing ‘‘2023’’ and inserting ‘‘2028’’; and 

13 (vi) by adding at the end the fol14 lowing: 

15 ‘‘(G) ANNUAL REPORTS BY AWARD RECIPI16 ENTS.—As a condition of receiving an award 

17 under subparagraph (B)(v), a recipient shall de18 velop and submit to the Secretary annual re19 ports related to the maintenance of such capac20 ity and capabilities, including ensuring that 

21 such capacity and capabilities are able to sup22 port the rapid manufacture of countermeasures 

23 as required by the Secretary.’’; and 

24 (C) in paragraph (5), by adding at the end 

25 the following: 


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1 ‘‘(H) SUPPORTING WARM-BASE AND SURGE

2 CAPACITY AND CAPABILITIES.—Pursuant to an 

3 award under subparagraph (B)(v), the Sec4 retary may make payments for activities nec5 essary to maintain domestic manufacturing 

6 surge capacity and capabilities supported under 

7 such award to ensure that such capacity and 

8 capabilities are able to support the rapid manu9 facture of countermeasures as required by the 

10 Secretary to prepare for, or respond to, an ex11 isting or potential public health emergency or 

12 otherwise address threats that pose a signifi13 cant level of risk to national security. The Sec14 retary may support the utilization of such ca15 pacity and capabilities under awards for coun16 termeasure and product advanced research and 

17 development, as appropriate, to provide for the 

18 maintenance of such capacity and capabilities.’’; 

19 and 

20 (4) in subsection (f)— 

21 (A) in paragraph (1), by striking ‘‘Not 

22 later than 180 days after the date of enactment 

23 of this subsection’’ and inserting ‘‘Not later 

24 than 180 days after the date of enactment of 

25 the PREVENT Pandemics Act’’; 


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1 (B) in paragraph (2)— 

2 (i) in the matter preceding subpara3 graph (A), by striking ‘‘this subsection’’ 

4 and inserting ‘‘the PREVENT Pandemics 

5 Act’’; 

6 (ii) in subparagraph (B), by striking 

7 ‘‘and’’ at the end; and 

8 (iii) in subparagraph (C), by striking 

9 the period and inserting ‘‘; and’’; and 

10 (C) by adding at the end the following: 

11 ‘‘(D) plans for the near-, mid-, and long12 term sustainment of manufacturing activities 

13 carried out under this section, including such 

14 activities pursuant to subsection (c)(5)(H), spe15 cific actions to regularly assess the ability of re16 cipients of an award under subsection 

17 (c)(4)(B)(v) to rapidly manufacture counter18 measures as required by the Secretary, and rec19 ommendations to address challenges, if any, re20 lated to such activities.’’. 

21 SEC. 402. SUPPLY CHAIN CONSIDERATIONS FOR THE STRA22 TEGIC NATIONAL STOCKPILE. 

23 Subclause (II) of section 319F–2(a)(2)(B)(i) of the 

24 Public Health Service Act (42 U.S.C. 247d– 

25 6b(a)(2)(B)(i)) is amended to read as follows: 


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1 ‘‘(II) planning considerations for 

2 appropriate manufacturing capacity 

3 and capability to meet the goals of 

4 such additions or modifications (with5 out disclosing proprietary informa6 tion), including— 

7 ‘‘(aa) consideration of the 

8 effect such additions or modifica9 tions may have on the availability 

10 of such products and ancillary 

11 medical supplies on the health 

12 care system; and 

13 ‘‘(bb) an assessment of the 

14 current supply chain for such 

15 products, including information 

16 on supply chain redundancies, 

17 any known domestic manufac18 turing capacity for such prod19 ucts, and any related 

20 vulnerabilities;’’. 

21 SEC. 403. STRATEGIC NATIONAL STOCKPILE EQUIPMENT 

22 MAINTENANCE. 

23 Subparagraph (D) of section 319F–2(a)(3) of the 

24 Public Health Service Act (42 U.S.C. 247d–6b(a)(3)) is 

25 amended to read as follows: 


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1 ‘‘(D) review and revise, as appropriate, the 

2 contents of the stockpile on a regular basis to 

3 ensure that— 

4 ‘‘(i) emerging threats, advanced tech5 nologies, and new countermeasures are 

6 adequately considered; 

7 ‘‘(ii) the potential depletion of coun8 termeasures currently in the stockpile is 

9 identified and appropriately addressed, in10 cluding through necessary replenishment; 

11 and 

12 ‘‘(iii) such contents are in working 

13 condition or usable, as applicable, and are 

14 ready for deployment, which may include 

15 conducting maintenance services on such 

16 contents of the stockpile and disposing of 

17 such contents that are no longer in work18 ing condition, or usable, as applicable;’’. 

19 SEC. 404. IMPROVING TRANSPARENCY AND PREDICT20 ABILITY OF PROCESSES OF THE STRATEGIC 

21 NATIONAL STOCKPILE. 

22 (a) GUIDANCE.—Not later than 60 days after the 

23 date of enactment of this Act, the Secretary of Health and 

24 Human Services (referred to in this section as the ‘‘Sec25 retary’’) shall issue guidance describing the processes by 


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1 which the Secretary deploys the contents of the Strategic 

2 National Stockpile under section 319F–2(a) of the Public 

3 Health Service Act (42 U.S.C. 247d–6b(a)), or otherwise 

4 distributes medical countermeasures, as applicable, to 

5 States, territories, Indian Tribes and Tribal organizations 

6 (as such terms are defined under section 4 of the Indian 

7 Self-Determination and Education Assistance Act), and 

8 other applicable entities. Such guidance shall include in9 formation related to processes by which to request access 

10 to the contents of the Strategic National Stockpile, factors 

11 considered by the Secretary when making deployment or 

12 distribution decisions, and processes and points of contact 

13 through which entities may contact the Secretary to ad14 dress any issues related to products requested or received 

15 by such entity from the stockpile, and on other relevant 

16 topics. 

17 (b) ANNUAL MEETINGS.—Section 319F–2(a)(3) of 

18 the Public Health Service Act (42 U.S.C. 247d–6b(a)(3)) 

19 is amended— 

20 (1) in subparagraph (I), by striking ‘‘and’’ at 

21 the end; 

22 (2) in subparagraph (J), by striking the period 

23 at the end and inserting ‘‘; and’’; and 

24 (3) by adding at the end the following: 


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1 ‘‘(K) convene meetings, not less than once 

2 per year, with representatives from State, local, 

3 and Tribal health departments or officials, rel4 evant industries, other Federal agencies, and 

5 other appropriate stakeholders, in a manner 

6 that does not compromise national security, to 

7 coordinate and share information related to 

8 maintenance and use of the stockpile, including 

9 a description of future countermeasure needs 

10 and additions, modifications, and replenish11 ments of the contents of the stockpile, and con12 siderations related to the manufacturing and 

13 procurement of products consistent with the re14 quirements of the Buy American Act of 1933, 

15 as appropriate.’’. 

16 SEC. 405. IMPROVING SUPPLY CHAIN FLEXIBILITY FOR THE 

17 STRATEGIC NATIONAL STOCKPILE. 

18 (a) IN GENERAL.—Section 319F–2 of the Public 

19 Health Service Act (42 U.S.C. 247d–6b) is amended— 

20 (1) in subsection (a)— 

21 (A) in paragraph (3)(F), by striking ‘‘as 

22 required by the Secretary of Homeland Secu23 rity’’ and inserting ‘‘at the discretion of the 

24 Secretary, in consultation with, or at the re25 quest of, the Secretary of Homeland Security,’’; 


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1 (B) by redesignating paragraphs (5) and 

2 (6) as paragraphs (6) and (7), respectively; 

3 (C) by inserting after paragraph (4) the 

4 following: 

5 ‘‘(5) VENDOR-MANAGED INVENTORY AND

6 WARM-BASE SURGE CAPACITY.— 

7 ‘‘(A) IN GENERAL.—For the purposes of 

8 maintaining the stockpile under paragraph (1) 

9 and carrying out procedures under paragraph 

10 (3), the Secretary may enter into contracts or 

11 cooperative agreements with vendors, which 

12 may include manufacturers or distributors of 

13 medical products, with respect to medical prod14 ucts intended to be delivered to the ownership 

15 of the Federal Government. Each such contract 

16 or cooperative agreement shall be subject to 

17 such terms and conditions as the Secretary may 

18 specify, including terms and conditions with re19 spect to— 

20 ‘‘(i) procurement, maintenance, stor21 age, and delivery of reserve amounts of 

22 products under such contract or coopera23 tive agreement, which may consider, as ap24 propriate, costs of transporting and han25 dling such products; and 


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1 ‘‘(ii) maintenance of domestic manu2 facturing capacity and capabilities of such 

3 products to ensure additional reserved pro4 duction capacity and capabilities are avail5 able, and that such capacity and capabili6 ties are able to support the rapid manufac7 ture, purchase, storage, and delivery of 

8 such products, as required by the Sec9 retary to prepare for, or respond to, an ex10 isting or potential public health emergency. 

11 ‘‘(B) REPORT.—Not later than 2 years 

12 after the date of enactment of the PREVENT 

13 Pandemics Act, and annually thereafter, the 

14 Secretary shall submit to the Committee on 

15 Health, Education, Labor, and Pensions of the 

16 Senate and the Committee on Energy and Com17 merce of the House of Representatives a report 

18 on any contracts or cooperative agreements en19 tered into under subparagraph (A) for purposes 

20 of establishing and maintaining vendor-man21 aged inventory or reserve manufacturing capac22 ity and capabilities for products intended for 

23 the stockpile, including a description of— 

24 ‘‘(i) the amount of each award; 

25 ‘‘(ii) the recipient of each award; 


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1 ‘‘(iii) the product or products covered 

2 through each award; and 

3 ‘‘(iv) how the Secretary works with 

4 each recipient to ensure situational aware5 ness related to the manufacturing capacity 

6 for, or inventory of, such products and co7 ordinates the distribution and deployment 

8 of such products, as appropriate and appli9 cable.’’; and 

10 (D) in subparagraph (A) of paragraph (6), 

11 as so redesignated— 

12 (i) in clause (viii), by striking ‘‘; and’’ 

13 and inserting a semicolon; 

14 (ii) in clause (ix), by striking the pe15 riod and inserting ‘‘; and’’; and 

16 (iii) by adding at the end the fol17 lowing: 

18 ‘‘(x) with respect to reports issued in 

19 2027 or any subsequent year, an assess20 ment of selected contracts or cooperative 

21 agreements entered into pursuant to para22 graph (5).’’; and 

23 (2) in subsection (c)(2)(C), by striking ‘‘on an 

24 annual basis’’ and inserting ‘‘not later than March 

25 15 of each year’’. 


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1 (b) AUTHORIZATION OF APPROPRIATIONS.—Section 

2 319F–2(f)(1) of the Public Health Service Act (42 U.S.C. 

3 247d–6b(f)(1)) is amended by striking ‘‘$610,000,000 for 

4 each of fiscal years 2019 through 2023’’ and inserting 

5 ‘‘$610,000,000 for each of fiscal year 2019 through 2021, 

6 and $750,000,000 for each of fiscal years 2022 and 

7 2023’’. 

8 SEC. 406. REIMBURSEMENT FOR CERTAIN SUPPLIES. 

9 Paragraph (7) of section 319F–2(a) of the Public 

10 Health Service Act (42 U.S.C. 247d–6b(a)), as so redesig11 nated by section 405(a)(1)(B), is amended to read as fol12 lows: 

13 ‘‘(7) REIMBURSEMENT FOR CERTAIN SUP14 PLIES.— 

15 ‘‘(A) IN GENERAL.—The Secretary may, at 

16 appropriate intervals, make available for pur17 chase excess contents procured for, and main18 tained within, the stockpile under paragraph (1) 

19 to any Federal agency or State, local, or Tribal 

20 government. The Secretary shall make such 

21 contents available for purchase only if— 

22 ‘‘(i) such contents are in excess of 

23 what is required for appropriate mainte24 nance of such stockpile; 


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1 ‘‘(ii) the Secretary determines that 

2 the costs for maintaining such excess con3 tents are not appropriate to expend to 

4 meet the needs of the stockpile; and 

5 ‘‘(iii) the Secretary determines that 

6 such action does not compromise national 

7 security and is in the national interest. 

8 ‘‘(B) REIMBURSEMENT AND COLLEC9 TION.—The Secretary may require reimburse10 ment for contents that are made available 

11 under subparagraph (A), in an amount that re12 flects the cost of acquiring and maintaining 

13 such contents and the costs incurred to make 

14 available such contents in the time and manner 

15 specified by the Secretary. Amounts collected 

16 under this subsection shall be credited to the 

17 appropriations account or fund that incurred 

18 the costs to procure such contents, and shall re19 main available, without further appropriation, 

20 until expended, for the purposes of the appro21 priation account or fund so credited. 

22 ‘‘(C) RULE OF CONSTRUCTION.—This 

23 paragraph shall not be construed to preclude 

24 transfers of contents in the stockpile under 

25 other authorities. 


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1 ‘‘(D) REPORT.—Not later than 2 years 

2 after the date of enactment of the PREVENT 

3 Pandemics Act, and annually thereafter, the 

4 Secretary shall submit to the Committee on 

5 Health, Education, Labor, and Pensions and 

6 the Committee on Appropriations of the Senate 

7 and the Committee on Energy and Commerce 

8 and the Committee on Appropriations of the 

9 House of Representatives a report on the use of 

10 the authority provided under this paragraph, in11 cluding details of each action taken pursuant to 

12 this paragraph, the account or fund to which 

13 any collected amounts have been credited, and 

14 how the Secretary has used such amounts. 

15 ‘‘(E) SUNSET.—The authority under this 

16 paragraph shall terminate on September 30, 

17 2025.’’. 

18 SEC. 407. ACTION REPORTING ON STOCKPILE DEPLETION. 

19 Section 319 of the Public Health Service Act (42 

20 U.S.C. 247d), as amended by section 223, is further 

21 amended by adding at the end the following: 

22 ‘‘(h) STOCKPILE DEPLETION REPORTING.—The Sec23 retary shall, not later than 30 days after the deployment 

24 of contents of the Strategic National Stockpile under sec25 tion 319F–2(a) to respond to a public health emergency 


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1 declared by the Secretary under this section or an emer2 gency or major disaster declared by the President under 

3 the Robert T. Stafford Disaster Relief and Emergency As4 sistance Act, and every 30 days thereafter until the expira5 tion or termination of such public health emergency, emer6 gency, or major disaster, submit a report to the Com7 mittee on Health, Education, Labor, and Pensions and the 

8 Committee on Appropriations of the Senate and the Com9 mittee on Energy and Commerce and the Committee on 

10 Appropriations of the House of Representatives on— 

11 ‘‘(1) the deployment of the contents of the 

12 stockpile in response to State, local, and Tribal re13 quests; 

14 ‘‘(2) the amount of such products that remain 

15 within the stockpile following such deployment; and 

16 ‘‘(3) plans to replenish such products, as appro17 priate, including related timeframes and any barriers 

18 or limitations to replenishment.’’. 

19 SEC. 408. PROVISION OF MEDICAL COUNTERMEASURES TO 

20 INDIAN PROGRAMS AND FACILITIES. 

21 (a) CLARIFICATION.—Section 319F–2(a)(3) of the 

22 Public Health Service Act (42 U.S.C. 247d–6b(a)(3)) is 

23 amended— 

24 (1) in subparagraph (C), by striking ‘‘and 

25 local’’ and inserting ‘‘local, and Tribal’’; and 


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1 (2) in subparagraph ( J), by striking ‘‘and 

2 local’’ and inserting ‘‘local, and Tribal’’. 

3 (b) DISTRIBUTION OF MEDICAL COUNTERMEASURES

4 TO INDIAN TRIBES.—Title III of the Public Health Serv5 ice Act (42 U.S.C. 241 et seq.) is amended by inserting 

6 after section 319F–4 the following: 

7 ‘‘SEC. 319F–5. PROVISION OF MEDICAL COUNTERMEASURES 

8 TO INDIAN PROGRAMS AND FACILITIES. 

9 ‘‘In the event that the Secretary deploys the contents 

10 of the Strategic National Stockpile under section 319F– 

11 2(a), or otherwise distributes medical countermeasures to 

12 States to respond to a public health emergency declared 

13 by the Secretary under section 319, the Secretary shall, 

14 in consultation with the applicable States, make such con15 tents or countermeasures directly available to Indian 

16 Tribes and Tribal organizations (as such terms are de17 fined in section 4 of the Indian Self-Determination and 

18 Education Assistance Act (25 U.S.C. 5304), which may 

19 include through health programs or facilities operated by 

20 the Indian Health Service, that are affected by such public 

21 health emergency.’’. 

22 SEC. 409. GRANTS FOR STATE STRATEGIC STOCKPILES. 

23 (a) Section 319F–2 of the Public Health Service Act 

24 (42 U.S.C. 247d–6b) is amended by adding at the end 

25 the following: 


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1 ‘‘(i) PILOT PROGRAM TO SUPPORT STATE MEDICAL

2 STOCKPILES.— 

3 ‘‘(1) IN GENERAL.—The Secretary, in consulta4 tion with the Assistant Secretary for Preparedness 

5 and Response and the Director of the Centers for 

6 Disease Control and Prevention, shall award grants 

7 or cooperative agreements to not fewer than 5 

8 States, or consortia of States, with consideration 

9 given to distribution among the geographical regions 

10 of the United States, to establish, expand, or main11 tain a stockpile of appropriate drugs, vaccines and 

12 other biological products, medical devices, and other 

13 medical supplies determined by the State to be nec14 essary to respond to a public health emergency de15 clared by the Governor of a State or by the Sec16 retary under section 319, or a major disaster or 

17 emergency declared by the President under section 

18 401 or 501, respectively, of the Robert T. Stafford 

19 Disaster Relief and Emergency Assistance Act, in 

20 order to support the preparedness goals described in 

21 paragraphs (2) through (6) and (8) of section 

22 2802(b). 

23 ‘‘(2) REQUIREMENTS.— 

24 ‘‘(A) APPLICATION.—To be eligible to re25 ceive an award under paragraph (1), an entity 


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1 shall prepare, in consultation with appropriate 

2 health care entities and health officials within 

3 the jurisdiction of such State or States, and 

4 submit to the Secretary an application that con5 tains such information as the Secretary may re6 quire, including— 

7 ‘‘(i) a plan for such stockpile, con8 sistent with paragraph (4), including a de9 scription of the activities such entity will 

10 carry out under the agreement and an out11 line of proposed expenses; and 

12 ‘‘(ii) a description of how such entity 

13 will coordinate with relevant entities in re14 ceipt of an award under section 319C–1 or 

15 319C–2 pursuant to paragraph (4), includ16 ing through promoting alignment between 

17 the stockpile plan established pursuant to 

18 clause (i) and applicable plans that are es19 tablished by such entity pursuant to sec20 tion 319C–1 or 319C–2. 

21 ‘‘(B) MATCHING FUNDS.— 

22 ‘‘(i) Subject to clause (ii), the Sec23 retary may not make an award under this 

24 subsection unless the applicant agrees, 

25 with respect to the costs to be incurred by 


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1 the applicant in carrying out the purpose 

2 described in this subsection, to make avail3 able non-Federal contributions toward such 

4 costs in an amount equal to— 

5 ‘‘(I) for each of fiscal years 2023 

6 and 2024, not less than $1 for each 

7 $20 of Federal funds provided in the 

8 award; and 

9 ‘‘(II) for fiscal year 2025 and 

10 each fiscal year thereafter, not less 

11 than $1 for each $10 of Federal funds 

12 provided in the award. 

13 ‘‘(ii) WAIVER.—The Secretary may, 

14 upon the request of a State, waive the re15 quirement under clause (i), in whole or in 

16 part, if the Secretary determines that ex17 traordinary economic conditions in the 

18 State in the fiscal year involved or in the 

19 previous fiscal year justify the waiver. A 

20 waiver provided by the Secretary under 

21 this subparagraph shall apply only to the 

22 fiscal year involved. 

23 ‘‘(C) ADMINISTRATIVE EXPENSES.—Not 

24 more than 10 percent of amounts received by 

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1 section may be used for administrative ex2 penses. 

3 ‘‘(3) LEAD ENTITY.—An entity in receipt of an 

4 award under paragraph (1) may designate a lead en5 tity, which may be a public or private entity, as ap6 propriate, to manage the stockpile at the direction of 

7 the State or consortium of States. 

8 ‘‘(4) USE OF FUNDS.—An entity in receipt of 

9 an award under paragraph (1) shall use such funds 

10 to— 

11 ‘‘(A) purchase, store, and maintain a 

12 stockpile of appropriate drugs, vaccines and 

13 other biological products, medical devices, and 

14 other medical supplies to be used during a pub15 lic health emergency, major disaster, or emer16 gency described in paragraph (1), in such num17 bers, types, and amounts as the entity deter18 mines necessary, consistent with such entity’s 

19 stockpile plan established pursuant to para20 graph (2)(A)(i); 

21 ‘‘(B) deploy the stockpile as required by 

22 the entity to respond to an actual or potential 

23 public health emergency, major disaster, or 

24 other emergency described in paragraph (1); 


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1 ‘‘(C) replenish and make necessary addi2 tions or modifications to the contents of such 

3 stockpile, including to address potential deple4 tion; 

5 ‘‘(D) in consultation with Federal, State, 

6 and local officials, take into consideration the 

7 availability, deployment, dispensing, and admin8 istration requirements of medical products with9 in the stockpile; 

10 ‘‘(E) ensure that procedures are followed 

11 for inventory management and accounting, and 

12 for the physical security of the stockpile, as ap13 propriate; 

14 ‘‘(F) review and revise, as appropriate, the 

15 contents of the stockpile on a regular basis to 

16 ensure that, to the extent practicable, new tech17 nologies and medical products are considered; 

18 ‘‘(G) carry out exercises, drills, and other 

19 training for purposes of stockpile deployment, 

20 dispensing, and administration of medical prod21 ucts, and for purposes of assessing the capa22 bility of such stockpile to address the medical 

23 supply needs of public health emergencies, 

24 major disasters, or other emergencies described 

25 in paragraph (1) of varying types and scales, 


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1 which may be conducted in accordance with re2 quirements related to exercises, drills, and other 

3 training for recipients of awards under section 

4 319C–1 or 319C–2, as applicable; and 

5 ‘‘(H) carry out other activities related to 

6 the State strategic stockpile as the entity deter7 mines appropriate, to support State efforts to 

8 prepare for, and respond to, public health 

9 threats. 

10 ‘‘(5) SUPPLEMENT NOT SUPPLANT.—Awards 

11 under paragraph (1) shall supplement, not supplant, 

12 the maintenance and use of the Strategic National 

13 Stockpile by the Secretary under subsection (a). 

14 ‘‘(6) GUIDANCE FOR STATES.—Not later than 

15 180 days after the date of enactment of this sub16 section, the Secretary, in consultation with States, 

17 health officials, and other relevant stakeholders, as 

18 appropriate, shall issue guidance, and update such 

19 guidance as appropriate, for States related to main20 taining and replenishing a stockpile of medical prod21 ucts, which may include strategies and best practices 

22 related to— 

23 ‘‘(A) types of medical products and med24 ical supplies that are critical to respond to pub25 lic health emergencies, and may be appropriate 


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1 for inclusion in a stockpile by States, with con2 sideration of threats that require the large-scale 

3 and simultaneous deployment of stockpiles, in4 cluding the stockpile maintained by the Sec5 retary pursuant to subsection (a), and long6 term public health and medical response needs; 

7 ‘‘(B) appropriate management of the con8 tents of a stockpile, including management by 

9 vendors of reserve amounts of medical products 

10 and supplies intended to be delivered to the 

11 ownership of the State and appropriate disposi12 tion of excess products, as applicable; and 

13 ‘‘(C) the procurement of medical products 

14 and medical supplies consistent with the Buy 

15 American Act of 1933. 

16 ‘‘(7) TECHNICAL ASSISTANCE.—The Secretary 

17 shall provide assistance to States, including technical 

18 assistance, as appropriate, in establishing, maintain19 ing, improving, and utilizing a medical stockpile, in20 cluding appropriate inventory management and dis21 position of products. 

22 ‘‘(8) REPORTING.— 

23 ‘‘(A) STATE REPORTS.—Each entity re24 ceiving an award under paragraph (1) shall up25 date, as appropriate, the plan established purVerDate Sep 11 2014 04:50 Mar 11, 2022 Jkt 029200 PO 00000 Frm 00201 Fmt 6652 Sfmt 6201 E:\BILLS\S3799.IS S3799

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1 suant to paragraph (2)(A)(i) and submit to the 

2 Secretary an annual report on implementation 

3 of such plan, including any changes to the con4 tents of the stockpile supported under such 

5 award. The Secretary shall use information ob6 tained from such reports to inform the mainte7 nance and management of the Strategic Na8 tional Stockpile pursuant to subsection (a). 

9 ‘‘(B) REPORTS TO CONGRESS.—Not later 

10 than 1 year after the initial issuance of awards 

11 pursuant to paragraph (1), and annually there12 after for the duration of the program estab13 lished under this subsection, the Secretary shall 

14 submit to the Committee on Health, Education, 

15 Labor, and Pensions of the Senate and the 

16 Committee on Energy and Commerce of the 

17 House of Representatives a report on such pro18 gram, including— 

19 ‘‘(i) Federal and State expenditures to 

20 support stockpiles under such program; 

21 ‘‘(ii) activities conducted pursuant to 

22 paragraph (4); and 

23 ‘‘(iii) any additional information from 

24 the States that the Secretary determines 

25 relevant. 


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1 ‘‘(9) AUTHORIZATION OF APPROPRIATIONS.— 

2 To carry out this subsection, there is authorized to 

3 be appropriated such sums as may be necessary for 

4 each of fiscal years 2023 through 2028.’’. 

5 (b) GAO REPORT.—Not later than 3 years after the 

6 date on which awards are first issued pursuant to sub7 section (i)(1) of section 319F–2 of the Public Health Serv8 ice Act (42 U.S.C. 247d–6b), as added by subsection (a), 

9 the Comptroller General of the United States shall submit 

10 to the Committee on Health, Education, Labor, and Pen11 sions of the Senate and the Committee on Energy and 

12 Commerce of the House of Representatives a report on 

13 the State stockpiles established or maintained pursuant to 

14 this section. Such report shall include an assessment of— 

15 (1) coordination and communication between 

16 the Secretary of Health and Human Services and 

17 entities in receipt of an award under this section, or 

18 a lead entity designated by such entity; 

19 (2) technical assistance provided by the Sec20 retary of Health and Human Services to such enti21 ties; and 

22 (3) the impact of such stockpiles on the ability 

23 of the State to prepare for and respond to a public 

24 health emergency, major disaster, or other emer25 gency described in subsection (i)(1) of section 319F– 


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1 2 of the Public Health Service Act (42 U.S.C. 247d– 

2 6b), as added by subsection (a), including the avail3 ability and distribution of items from such State 

4 stockpile to health care entities and other applicable 

5 entities. 

6 TITLE V—ENHANCING DEVELOP7 MENT AND COMBATING 

8 SHORTAGES OF MEDICAL 

9 PRODUCTS 

10 Subtitle A—Development and 

11 Review 

12 SEC. 501. ADVANCING QUALIFIED INFECTIOUS DISEASE 

13 PRODUCT INNOVATION. 

14 (a) IN GENERAL.—Section 505E of the Federal 

15 Food, Drug, and Cosmetic Act (21 U.S.C. 355f) is amend16 ed— 

17 (1) in subsection (c)— 

18 (A) in paragraph (2), by striking ‘‘; or’’ 

19 and inserting ‘‘;’’; 

20 (B) in paragraph (3), by striking the pe21 riod and inserting ‘‘; or’’; and 

22 (C) by adding at the end the following: 

23 ‘‘(4) an application pursuant to section 351(a) 

24 of the Public Health Service Act.’’; 


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1 (2) in subsection (d)(1), by inserting ‘‘of this 

2 Act or section 351(a) of the Public Health Service 

3 Act’’ after ‘‘section 505(b)’’; and 

4 (3) by amending subsection (g) to read as fol5 lows: 

6 ‘‘(g) QUALIFIED INFECTIOUS DISEASE PRODUCT.— 

7 The term ‘qualified infectious disease product’ means a 

8 drug, including an antibacterial or antifungal drug or a 

9 biological product, for human use that— 

10 ‘‘(1) acts directly on bacteria or fungi or on 

11 substances produced by such bacteria or fungi; and 

12 ‘‘(2) is intended to treat a serious or life-threat13 ening infection, including such an infection caused 

14 by— 

15 ‘‘(A) an antibacterial or antifungal resist16 ant pathogen, including novel or emerging in17 fectious pathogens; or 

18 ‘‘(B) qualifying pathogens listed by the 

19 Secretary under subsection (f).’’. 

20 (b) PRIORITY REVIEW.—Section 524A(a) of the Fed21 eral Food, Drug, and Cosmetic Act (21 U.S.C. 360n–1(a)) 

22 is amended by inserting ‘‘of this Act, or section 351(a) 

23 of the Public Health Service Act, that requires clinical 

24 data (other than bioavailability studies) to demonstrate 

25 safety or effectiveness’’ before the period. 


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1 SEC. 502. MODERNIZING CLINICAL TRIALS. 

2 (a) CLARIFYING THE USE OF DIGITAL HEALTH

3 TECHNOLOGIES IN CLINICAL TRIALS.— 

4 (1) IN GENERAL.—Not later than 1 year after 

5 the date of enactment of this Act, the Secretary of 

6 Health and Human Services (referred to in this sec7 tion as the ‘‘Secretary’’) shall issue or revise draft 

8 guidance regarding the appropriate use of validated 

9 digital health technologies in clinical trials to help 

10 improve recruitment for, retention in, participation 

11 in, and data collection during, clinical trials, and 

12 provide for novel clinical trial designs utilizing such 

13 technology for purposes of supporting the develop14 ment of, and review of applications for, drugs and 

15 devices. Not later than 18 months after the public 

16 comment period on such draft guidance ends, the 

17 Secretary shall issue a revised draft guidance or 

18 final guidance. 

19 (2) CONTENT.—The guidance described in 

20 paragraph (1) shall include— 

21 (A) recommendations for data collection 

22 methodologies by which sponsors may incor23 porate the use of digital health technologies in 

24 clinical trials to collect data remotely from trial 

25 participants; 


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1 (B) considerations for privacy and security 

2 protections for data collected during a clinical 

3 trial, including— 

4 (i) recommendations for the protec5 tion of trial participant data that is col6 lected or used in research, using digital 

7 health technologies; 

8 (ii) compliance with the regulations 

9 promulgated under section 264(c) of the 

10 Health Insurance Portability and Account11 ability Act of 1996 (42 U.S.C. 1320d–2 

12 note), subpart B of part 50 of title 21, 

13 Code of Federal Regulations, subpart C of 

14 part 56 of title 21, Code of Federal Regu15 lations, the Federal policy for the protec16 tion of human subjects under subpart A of 

17 part 46 of title 45, Code of Federal Regu18 lations (commonly known as the ‘‘Common 

19 Rule’’), and part 2 of title 42, Code of 

20 Federal Regulations (or any successor reg21 ulations); and 

22 (iii) recommendations for protection 

23 of clinical trial participant data against cy24 bersecurity threats, as applicable; 


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1 (C) considerations on data collection meth2 ods to help increase recruitment of clinical trial 

3 participants and the level of participation of 

4 such participants, reduce burden on clinical 

5 trial participants, and optimize data quality; 

6 (D) recommendations for the use of elec7 tronic methods to obtain informed consent from 

8 clinical trial participants, taking into consider9 ation applicable Federal law, including subpart 

10 B of part 50 of title 21, Code of Federal Regu11 lations (or successor regulations), and, as ap12 propriate, State law; 

13 (E) best practices for communication and 

14 early engagement between sponsors and the 

15 Secretary on the development of data collection 

16 methods; 

17 (F) the appropriate format to submit such 

18 data to the Secretary; 

19 (G) a description of the manner in which 

20 the Secretary may assess or evaluate data col21 lected through digital health technologies to 

22 support the development of the drug or device; 

23 (H) recommendations regarding the data 

24 and information needed to demonstrate that a 

25 digital health technology is fit-for-purpose for a 


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1 clinical trial, and a description of how the Sec2 retary will evaluate such data and information; 

3 and 

4 (I) recommendations for increasing access 

5 to, and the use of, digital health technologies in 

6 clinical trials to facilitate the inclusion of di7 verse and underrepresented populations, as ap8 propriate, including considerations for access to, 

9 and the use of, digital health technologies in 

10 clinical trials by people with disabilities and pe11 diatric populations. 

12 (b) ADVANCING DECENTRALIZED CLINICAL

13 TRIALS.— 

14 (1) IN GENERAL.—Not later than 1 year after 

15 the date of enactment of this Act, the Secretary 

16 shall issue or revise draft guidance to provide rec17 ommendations to clarify and advance the use of de18 centralized clinical trials to support the development 

19 of drugs and devices and help improve trial partici20 pant engagement and advance the use of flexible and 

21 novel clinical trial designs. Not later than 18 months 

22 after the public comment period on such draft guid23 ance ends, the Secretary shall issue a revised draft 

24 guidance or final guidance. 


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1 (2) CONTENT.—The guidance described in 

2 paragraph (1) shall include— 

3 (A) recommendations for methods of re4 mote data collection, including trial participant 

5 experience data, though the use of digital health 

6 technologies, telemedicine, local laboratories, 

7 local health care providers, or other options for 

8 data collection; 

9 (B) considerations for sponsors to mini10 mize or reduce burdens for clinical trial partici11 pants associated with participating in a clinical 

12 trial, such as the use of digital technologies, 

13 telemedicine, local laboratories, local health care 

14 providers, or other data collection or assessment 

15 options, health care provider home visits, direct16 to-participant shipping of investigational drugs 

17 and devices, and electronic informed consent, as 

18 appropriate; 

19 (C) recommendations regarding conducting 

20 decentralized clinical trials to facilitate and en21 courage diversity among the clinical trial par22 ticipants, as appropriate; 

23 (D) recommendations for strategies and 

24 methods for recruiting, retaining, and engaging 

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1 munication regarding the role of trial partici2 pants and community partners to facilitate clin3 ical trial recruitment and engagement, including 

4 with respect to diverse and underrepresented 

5 populations, as appropriate; 

6 (E) considerations for review and oversight 

7 by sponsors and institutional review boards, in8 cluding remote trial oversight; 

9 (F) recommendations for decentralized 

10 clinical trial protocol designs and processes for 

11 evaluating such proposed trial designs; 

12 (G) recommendations for digital health 

13 technology and other remote assessment tools 

14 that may support decentralized clinical trials, 

15 including guidance on appropriate technological 

16 platforms and tools, data collection and use, 

17 data integrity, and communication to clinical 

18 trial participants through such technology; 

19 (H) a description of the manner in which 

20 the Secretary will assess or evaluate data col21 lected within a decentralized clinical trial to 

22 support the development of the drug or device, 

23 if the manner is different from that used for a 

24 non-decentralized trial; 


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1 (I) considerations for sponsors to validate 

2 digital technologies and establish appropriate 

3 clinical endpoints for use in decentralized trials; 

4 (J) considerations for privacy and security 

5 of personally identifiable information of trial 

6 participants; and 

7 (K) considerations for conducting clinical 

8 trials using centralized approaches in conjunc9 tion with decentralized approaches. 

10 (c) SEAMLESS AND CONCURRENT CLINICAL

11 TRIALS.— 

12 (1) IN GENERAL.—Not later than 1 year after 

13 the date of enactment of this Act, the Secretary 

14 shall issue or revise draft guidance on the use of 

15 seamless, concurrent, and other innovative clinical 

16 trial designs to support the expedited development 

17 and review of applications for drugs, as appropriate. 

18 Not later than 18 months after the public comment 

19 period on such draft guidance ends, the Secretary 

20 shall issue a revised draft guidance or final guid21 ance. 

22 (2) CONTENT.—The guidance described in 

23 paragraph (1) shall include— 

24 (A) recommendations on the use of expan25 sion cohorts and other seamless clinical trial deVerDate Sep 11 2014 04:50 Mar 11, 2022 Jkt 029200 PO 00000 Frm 00212 Fmt 6652 Sfmt 6201 E:\BILLS\S3799.IS S3799

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1 signs to assess different aspects of product can2 didates in one continuous trial, including how 

3 such clinical trial designs can be used as part 

4 of meeting the substantial evidence standard 

5 under section 505(d) of the Federal Food, 

6 Drug, and Cosmetic Act (21 U.S.C. 355(d)); 

7 (B) recommendations on the use of clinical 

8 trial designs that involve the concurrent con9 duct of different or multiple clinical trial 

10 phases, and the concurrent conduct of pre11 clinical testing, to expedite the development of 

12 new drugs and facilitate the timely collection of 

13 data; 

14 (C) recommendations for how to streamline 

15 trial logistics and facilitate the efficient collec16 tion and analysis of clinical trial data, including 

17 any planned interim analyses and how such 

18 analyses could be used to streamline the prod19 uct development and review processes; 

20 (D) considerations to assist sponsors in en21 suring the rights, safety, and welfare of clinical 

22 trial participants, maintaining compliance with 

23 good clinical practice regulations, minimizing 

24 risks to clinical trial data integrity, and ensur25 ing the reliability of clinical trial results; 


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1 (E) recommendations for communication 

2 and early engagement between sponsors and the 

3 Food and Drug Administration on the develop4 ment of seamless, concurrent, or other adaptive 

5 trial designs, including review of, and feedback 

6 on, clinical trial protocols; and 

7 (F) a description of the manner in which 

8 the Secretary will assess or evaluate data col9 lected through seamless, concurrent, or other 

10 adaptive trial designs to support the develop11 ment of the drug. 

12 (d) INTERNATIONAL HARMONIZATION.—The Sec13 retary shall work with foreign regulators pursuant to 

14 memoranda of understanding or other arrangements gov15 erning the exchange of information to facilitate inter16 national harmonization of the regulation and use of decen17 tralized clinical trials, digital technology in clinical trials, 

18 and seamless, concurrent, and other adaptive or innovative 

19 clinical trial designs. 

20 SEC. 503. ACCELERATING COUNTERMEASURE DEVELOP21 MENT AND REVIEW. 

22 Section 565 of the Federal Food, Drug, and Cosmetic 

23 Act (21 U.S.C. 360bbb–4) is amended by adding at the 

24 end the following: 


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1 ‘‘(h) ACCELERATING COUNTERMEASURE DEVELOP2 MENT AND REVIEW DURING AN EMERGENCY.— 

3 ‘‘(1) ACCELERATION OF COUNTERMEASURE DE4 VELOPMENT AND REVIEW.—The Secretary may, at 

5 the request of the sponsor of a countermeasure, dur6 ing a domestic, military, or public health emergency 

7 or material threat described in section 

8 564A(a)(1)(C), expedite the development and review 

9 of countermeasures that are intended to address 

10 such domestic, military, or public health emergency 

11 or material threat for approval, licensure, clearance, 

12 or authorization under this title or section 351 of 

13 the Public Health Service Act. 

14 ‘‘(2) ACTIONS.—The actions to expedite the de15 velopment and review of a countermeasure under 

16 paragraph (1) may include the following: 

17 ‘‘(A) Expedited review of submissions 

18 made by sponsors of countermeasures to the 

19 Food and Drug Administration, including roll20 ing submissions of countermeasure applications 

21 and other submissions. 

22 ‘‘(B) Expedited and increased engagement 

23 with sponsors regarding countermeasure devel24 opment and manufacturing, including— 


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1 ‘‘(i) holding meetings with the sponsor 

2 and the review team and providing timely 

3 advice to, and interactive communication 

4 with, the sponsor regarding the develop5 ment of the countermeasure to ensure that 

6 the development program to gather the 

7 nonclinical and clinical data necessary for 

8 approval, licensure, clearance, or author9 ization is as efficient as practicable; 

10 ‘‘(ii) involving senior managers and 

11 experienced review staff, as appropriate, in 

12 a collaborative, cross-disciplinary review; 

13 ‘‘(iii) assigning a cross-disciplinary 

14 project lead for the review team to facili15 tate; 

16 ‘‘(iv) taking steps to ensure that the 

17 design of the clinical trials is as efficient as 

18 practicable, when scientifically appropriate, 

19 such as by minimizing the number of pa20 tients exposed to a potentially less effica21 cious treatment; and 

22 ‘‘(v) streamlining the review of ap23 proved, licensed, cleared, or authorized 

24 countermeasures to treat or prevent new or 


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1 emerging threats, including the review of 

2 any changes to such countermeasures. 

3 ‘‘(C) Expedited issuance of guidance docu4 ments and publication of other regulatory infor5 mation regarding countermeasure development 

6 and manufacturing. 

7 ‘‘(D) Other steps to expedite the develop8 ment and review of a countermeasure applica9 tion submitted for approval, licensure, clear10 ance, or authorization, as the Secretary deter11 mines appropriate. 

12 ‘‘(3) LIMITATION OF EFFECT.—Nothing in this 

13 subsection shall be construed to require the Sec14 retary to grant, or take any other action related to, 

15 a request of a sponsor to expedite the development 

16 and review of a countermeasure for approval, licen17 sure, clearance, or authorization under paragraph 

18 (1).’’. 

19 SEC. 504. THIRD PARTY TEST EVALUATION DURING EMER20 GENCIES. 

21 (a) IN GENERAL.—Section 565 of the Federal Food, 

22 Drug, and Cosmetic Act (21 U.S.C. 360bbb–4), as amend23 ed by section 503, is further amended by adding at the 

24 end the following: 


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1 ‘‘(i) THIRD PARTY EVALUATION OF TESTS USED

2 DURING AN EMERGENCY.— 

3 ‘‘(1) IN GENERAL.—For purposes of conducting 

4 evaluations regarding whether an in vitro diagnostic 

5 product (as defined in section 809.3 of title 21, Code 

6 of Federal Regulations (or any successor regula7 tions)) for which a request for emergency use au8 thorization is submitted under section 564 meets the 

9 criteria for issuance of such authorization, the Sec10 retary may, as appropriate, consult with persons 

11 with appropriate expertise with respect to such eval12 uations or enter into cooperative agreements or con13 tracts with such persons under which such persons 

14 conduct such evaluations and make such rec15 ommendations, including, as appropriate, evaluations 

16 and recommendations regarding the scope of author17 ization and conditions of authorization. 

18 ‘‘(2) REQUIREMENTS REGARDING EVALUATIONS

19 AND RECOMMENDATIONS.— 

20 ‘‘(A) IN GENERAL.—In evaluating and 

21 making recommendations to the Secretary re22 garding the validity, accuracy, and reliability of 

23 in vitro diagnostic products, as described in 

24 paragraph (1), a person shall consider and doc25 ument whether the relevant criteria under subVerDate Sep 11 2014 04:50 Mar 11, 2022 Jkt 029200 PO 00000 Frm 00218 Fmt 6652 Sfmt 6201 E:\BILLS\S3799.IS S3799

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1 section (c)(2) of section 564 for issuance of au2 thorization under such section are met with re3 spect to the in vitro diagnostic product. 

4 ‘‘(B) WRITTEN RECOMMENDATIONS.—Rec5 ommendations made by a person under this 

6 subsection shall be submitted to the Secretary 

7 in writing, and shall include the reasons for 

8 such recommendation and other information 

9 that may be requested by the Secretary. 

10 ‘‘(3) RULE OF CONSTRUCTION.— Nothing in 

11 this subsection shall be construed to require the Sec12 retary to consult with, or enter into cooperative 

13 agreements or contracts with, persons as described 

14 in paragraph (1) for purposes of authorizing an in 

15 vitro diagnostic product or otherwise affecting the 

16 emergency use authorization authorities under this 

17 section or section 564.’’. 

18 (b) GUIDANCE.—Not later than 1 year after the date 

19 of enactment of this Act, the Secretary of Health and 

20 Human Services (referred to in this subsection as the 

21 ‘‘Secretary’’) shall issue draft guidance on consultations 

22 with persons under subsection (i) of section 565 of the 

23 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

24 360bbb–4), as added by subsection (a), including consider25 ations concerning conflicts of interest, compensation arVerDate Sep 11 2014 04:50 Mar 11, 2022 Jkt 029200 PO 00000 Frm 00219 Fmt 6652 Sfmt 6201 E:\BILLS\S3799.IS S3799

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1 rangements, and information sharing. Not later than 1 

2 year after the public comment period on such draft guid3 ance ends, the Secretary shall issue a revised draft guid4 ance or final guidance. 

5 SEC. 505. FACILITATING THE USE OF REAL WORLD EVI6 DENCE. 

7 Not later than 1 year after the date of enactment 

8 of this Act, the Secretary of Health and Human Services 

9 shall issue or revise existing guidance on considerations 

10 for the use of real world data and real world evidence to 

11 support regulatory decision-making, as follows: 

12 (1) With respect to drugs, such guidance shall 

13 address the use of such data and evidence to support 

14 the approval of a drug application under section 505 

15 of the Federal Food, Drug, and Cosmetic Act (21 

16 U.S.C. 355) or a biological product application 

17 under section 351 of the Public Health Service Act 

18 (42 U.S.C. 262), or to support an investigational use 

19 exemption under section 505(i) of the Federal Food, 

20 Drug, and Cosmetic Act or section 351(a)(3) of the 

21 Public Health Service Act. Such guidance shall in22 clude considerations for the inclusion, in such appli23 cations, of real world data and real world evidence 

24 obtained as a result of the use of drugs authorized 

25 for emergency use under section 564 of the Federal 


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1 Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb– 

2 3), and considerations for standards and methodolo3 gies for collection and analysis of real world evidence 

4 included in such applications, submissions, or re5 quests, as appropriate. 

6 (2) With respect to devices, such guidance shall 

7 address the use of such data and evidence to support 

8 the approval, clearance, or classification of a device 

9 pursuant to an application or submission submitted 

10 under section 510(k), 513(f)(2), or 515 of the Fed11 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

12 360(k), 360c(f)(2), 360e), or to support an inves13 tigational use exemption under section 520(g) of 

14 such Act (21 U.S.C. 360j(g)). Such guidance shall 

15 include considerations for the inclusion, in such ap16 plications, submissions, or requests, of real world 

17 data and real world evidence obtained as a result of 

18 the use of devices authorized for emergency use 

19 under section 564 of the Federal Food, Drug, and 

20 Cosmetic Act (21 U.S.C. 360bbb–3), and consider21 ations for standards and methodologies for collection 

22 and analysis of real world evidence included in such 

23 applications, submissions, or requests, as appro24 priate. 


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1 SEC. 506. PLATFORM TECHNOLOGIES. 

2 (a) IN GENERAL.—Chapter V of the Federal Food, 

3 Drug, and Cosmetic Act is amended by inserting after sec4 tion 506J of such Act (21 U.S.C. 356j) the following: 

5 ‘‘SEC. 506K. PLATFORM TECHNOLOGIES. 

6 ‘‘(a) IN GENERAL.—The Secretary shall establish a 

7 process for the designation of platform technologies that 

8 meet the criteria described in subsection (b). 

9 ‘‘(b) CRITERIA.—A platform technology incorporated 

10 within or utilized by a drug is eligible for designation as 

11 a designated platform technology under this section if— 

12 ‘‘(1) the platform technology is incorporated in, 

13 or utilized by, a drug approved under section 505 of 

14 this Act or a biological product licensed under sec15 tion 351 of the Public Health Service Act; 

16 ‘‘(2) preliminary evidence submitted by the 

17 sponsor of the approved or licensed drug described 

18 in paragraph (1), or a sponsor that has been grant19 ed a right of reference to data submitted in the ap20 plication for such drug, demonstrates that the plat21 form technology has the potential to be incorporated 

22 in, or utilized by, more than one drug without an ad23 verse effect on quality, manufacturing, or safety; 

24 and 

25 ‘‘(3) data or information submitted by the ap26 plicable person under paragraph (2) indicates that 


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1 incorporation or utilization of the platform tech2 nology has a reasonable likelihood to bring signifi3 cant efficiencies to the drug development or manu4 facturing process and to the review processes. 

5 ‘‘(c) REQUEST FOR DESIGNATION.—A person may 

6 request the Secretary designate a platform technology as 

7 a designated platform technology concurrently with, or at 

8 any time after, submission under section 505(i) of this Act 

9 or section 351(a)(3) of the Public Health Service Act for 

10 the investigation of a drug that incorporates or utilizes 

11 the platform technology that is the subject of the request. 

12 ‘‘(d) DESIGNATION.— 

13 ‘‘(1) IN GENERAL.—Not later than 60 calendar 

14 days after the receipt of a request under subsection 

15 (c), the Secretary shall determine whether the plat16 form technology that is the subject of the request 

17 meets the criteria described in subsection (b). 

18 ‘‘(2) DESIGNATION.—If the Secretary deter19 mines that the platform technology meets the cri20 teria described in subsection (b), the Secretary shall 

21 designate the platform technology as a designated 

22 platform technology and may expedite the develop23 ment and review of any subsequent application sub24 mitted under section 505(b) of this Act or section 

25 351(a) of the Public Health Service Act for a drug 


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1 that uses or incorporates the platform technology 

2 pursuant to subsection (e), as appropriate. 

3 ‘‘(3) DETERMINATION NOT TO DESIGNATE.—If 

4 the Secretary determines that the platform tech5 nology does not meet the criteria under subsection 

6 (b), the Secretary shall include with the determina7 tion not to designate the technology a written de8 scription of the rationale for such determination. 

9 ‘‘(4) REVOCATION OF DESIGNATION.—The Sec10 retary may revoke a designation made under para11 graph (2), if the Secretary determines that the des12 ignated platform technology no longer meets the cri13 teria described in subsection (b). The Secretary shall 

14 communicate the determination to revoke a designa15 tion to the requesting sponsor in writing, including 

16 a description of the rationale for such determination. 

17 ‘‘(5) APPLICABILITY.—Nothing in this section 

18 shall prevent a product that uses or incorporates a 

19 designated platform technology from being eligible 

20 for expedited approval pathways if it is otherwise eli21 gible under this Act or the Public Health Service 

22 Act. 

23 ‘‘(e) ACTIONS.—The Secretary may take actions to 

24 expedite the development and review of an application for 


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1 a drug that incorporates or utilizes a designated platform 

2 technology, including— 

3 ‘‘(1) engaging in early interactions with the 

4 sponsor to discuss the use of the designated plat5 form technology and what is known about such tech6 nology, including data previously submitted that is 

7 relevant to establishing, as applicable, safety or effi8 cacy under section 505(b) of this Act or safety, pu9 rity, or potency under section 351(a) of the Public 

10 Health Service Act; 

11 ‘‘(2) providing timely advice to, and interactive 

12 communication with, the sponsor regarding the de13 velopment of the drug that proposes to use the des14 ignated platform technology to ensure that the devel15 opment program designed to gather data necessary 

16 for approval or licensure is as efficient as prac17 ticable, which may include holding meetings with the 

18 sponsor and the review team throughout the develop19 ment of the drug; and 

20 ‘‘(3) considering inspectional findings, including 

21 prior findings, related to the manufacture of a drug 

22 that incorporates or utilizes the designated platform 

23 technology. 

24 ‘‘(f) LEVERAGING DATA FROM DESIGNATED PLAT25 FORM TECHNOLOGIES.—The Secretary shall, consistent 


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1 with applicable standards for approval, authorization, or 

2 licensure under this Act and section 351(a) of the Public 

3 Health Service Act, allow the sponsor of an application 

4 under section 505(b) of this Act or section 351(a) of the 

5 Public Health Service Act or a request for emergency use 

6 authorization under section 564, in order to support ap7 proval, licensure, or authorization, to reference or rely 

8 upon data and information within such application or re9 quest that incorporates or utilizes the same or substan10 tially similar platform technology designated under sub11 section (d), provided that— 

12 ‘‘(1) such data and information was submitted 

13 by the same sponsor, pursuant to the application for 

14 the drug with respect to which designation of the 

15 designated platform technology under subsection (d) 

16 was granted; or 

17 ‘‘(2) the sponsor relying on such data and in18 formation received a right of reference to such data 

19 and information from the sponsor described in para20 graph (1). 

21 ‘‘(g) CHANGES TO A DESIGNATED PLATFORM TECH22 NOLOGY.—A sponsor of one or more applications approved 

23 under section 505(b) of this Act or section 351(a) of the 

24 Public Health Service Act for a drug or biological product 

25 that incorporates or utilizes the same designated platform 


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1 technology may submit a single supplemental application 

2 for the same proposed changes to the designated platform 

3 technology that is applicable to more than one drug or 

4 biological product that incorporates or utilizes such des5 ignated platform technology that may be cross referenced 

6 in other applications incorporating such change. Such ap7 plication may include one or more comparability protocols 

8 regarding how such changes to the platform technology 

9 would be made for each applicable application. 

10 ‘‘(h) GUIDANCE.—Not later than 1 year after the 

11 date of enactment of this section, the Secretary shall issue 

12 draft guidance on the implementation of this section. Such 

13 guidance shall include examples of drugs that can be man14 ufactured using platform technologies, including drugs 

15 that contain or consist of vectors and nucleic acids, infor16 mation about the Secretary’s review of platform tech17 nologies, information regarding submitting for designa18 tion, consideration for persons submitting a request for 

19 designation who has been granted a right of reference, the 

20 implementation of the designated platform technology des21 ignation program, efficiencies that may be achieved in the 

22 development and review of products that incorporate or 

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1 facturing changes to a designated platform technology in 

2 accordance with section 506A. 

3 ‘‘(i) DEFINITIONS.—For purposes of this section: 

4 ‘‘(1) The term ‘platform technology’ means— 

5 ‘‘(A) a technology incorporated into a drug 

6 or biological product, such as a nucleic acid se7 quence, molecular structure, mechanism of ac8 tion, delivery method, or other technology the 

9 Secretary determines to be appropriate, or com10 bination of any such technologies, that— 

11 ‘‘(i) is essential to the characterization 

12 of the drug or biological product; and 

13 ‘‘(ii) can be adapted for, or incor14 porated or utilized in, more than one drug 

15 or biological product sharing common 

16 structural elements; or 

17 ‘‘(B) a standardized production or manu18 facturing process that is used to create or de19 velop more than one drug sharing common 

20 structural elements that can be incorporated 

21 into multiple different drugs. 

22 ‘‘(2) The term ‘designated platform technology’ 

23 means a platform technology that is designated as a 

24 platform technology under subsection (d). 


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1 ‘‘(j) RULE OF CONSTRUCTION.—Nothing in this sec2 tion shall be construed to— 

3 ‘‘(1) alter the authority of the Secretary to ap4 prove drugs pursuant to section 505 of this Act or 

5 license biological products pursuant to section 351 of 

6 the Public Health Service Act, including standards 

7 of evidence and applicable conditions for approval or 

8 licensure under the applicable Act; or 

9 ‘‘(2) confer any new rights with respect to the 

10 permissibility of a sponsor of an application for a 

11 drug product or biological product referencing infor12 mation contained in another application submitted 

13 by the holder of an approved application under sec14 tion 505(c) of this Act or of a license under section 

15 351(a) of the Public Health Service Act.’’. 

16 (b) REPORT.—Not later than 2 years after the date 

17 of enactment of this Act, the Secretary of Health and 

18 Human Services shall issue a report to the Committee on 

19 Health, Education, Labor, and Pensions of the Senate and 

20 the Committee on Energy and Commerce of the House 

21 of Representatives, on the platform technology designation 

22 program under section 506K of the Federal Food, Drug, 

23 and Cosmetic Act, as added by subsection (a). Such report 

24 shall include— 


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1 (1) the number of requests for designation 

2 under such program; 

3 (2) the number of designations under such pro4 gram issued, active, and revoked; 

5 (3) the resources required to carry out such 

6 program (including the review time used for full7 time equivalent employees); 

8 (4) any efficiencies gained in the development, 

9 manufacturing, and review processes associated with 

10 such designations; and 

11 (5) recommendations, if any, to strengthen the 

12 program to better leverage platform technologies 

13 that can be used in more than one drug and meet 

14 patient needs in a manner as timely as possible, tak15 ing into consideration the resources available to the 

16 Secretary of Health and Human Services for car17 rying out such program. 

18 SEC. 507. INCREASING EUA DECISION TRANSPARENCY. 

19 Section 564(h)(1) of the Federal Food, Drug, and 

20 Cosmetic Act (21 U.S.C. 360bbb–3(h)(1)) is amended— 

21 (1) by inserting ‘‘on the internet website of the 

22 Food and Drug Administration and’’ after ‘‘prompt23 ly publish’’; and 

24 (2) by striking ‘‘application under section 

25 505(i), 512(j), or 520(g), even if such summary may 


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1 indirectly reveal the existence of such application’’ 

2 and inserting ‘‘application, request, or submission 

3 under this section or section 505(b), 505(i), 505(j), 

4 512(b), 512(j), 512(n), 515, 510(k), 513(f)(2), 

5 520(g), 520(m), 571, or 572 of this Act, or section 

6 351(a) or 351(k) of the Public Health Service Act, 

7 even if such summary may reveal the existence of 

8 such an application, request, or submission, or data 

9 contained in such application, request, or submis10 sion’’. 

11 SEC. 508. IMPROVING FDA GUIDANCE AND COMMUNICA12 TION. 

13 (a) FDA REPORT AND IMPLEMENTATION OF GOOD

14 GUIDANCE PRACTICES.—The Secretary of Health and 

15 Human Services (referred to in this section as the ‘‘Sec16 retary’’) shall develop, and publish on the website of the 

17 Food and Drug Administration— 

18 (1) a report identifying best practices for the 

19 efficient prioritization, development, issuance, and 

20 use of guidance documents, within centers, across 

21 the Food and Drug Administration, and across other 

22 applicable agencies; and 

23 (2) a plan for implementation of such best 

24 practices, including across other applicable agencies, 

25 which shall address— 


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1 (A) streamlining development and review 

2 of guidance documents within centers and 

3 across the Food and Drug Administration; 

4 (B) streamlining processes for regulatory 

5 submissions to the Food and Drug Administra6 tion, including through the revision or issuance 

7 of guidance documents; and 

8 (C) implementing innovative guidance de9 velopment processes and practices and 

10 transitioning or updating guidance issued dur11 ing the COVID–19 public health emergency, as 

12 appropriate. 

13 (b) REPORT AND IMPLEMENTATION OF FDA BEST

14 PRACTICES FOR COMMUNICATING WITH EXTERNAL

15 STAKEHOLDERS.—The Secretary, acting through the 

16 Commissioner of Food and Drugs, shall develop and pub17 lish on the website of the Food and Drug Administration 

18 a report on the practices of the Food and Drug Adminis19 tration to broadly communicate with external stake20 holders, other than through guidance documents, which 

21 shall include— 

22 (1) a review of the types and methods of public 

23 communication that the Food and Drug Administra24 tion uses to communicate and interact with medical 

25 product sponsors and other external stakeholders; 


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1 (2) the identification of best practices for the 

2 efficient development, issuance, and use of such 

3 communications; and 

4 (3) a plan for implementation of best practices 

5 for communication with external stakeholders, which 

6 shall address— 

7 (A) advancing the use of innovative forms 

8 of communication, including novel document 

9 types and formats, to provide increased regu10 latory clarity to product sponsors and other 

11 stakeholders, and advancing methods of com12 municating and interacting with medical prod13 uct sponsors and other external stakeholders, 

14 including the use of tools such as product sub15 mission templates, webinars, and frequently 

16 asked questions communications; 

17 (B) streamlining processes for regulatory 

18 submissions; and 

19 (C) implementing innovative communica20 tion development processes and transitioning or 

21 updating communication practices used during 

22 the COVID–19 public health emergency, as ap23 propriate. 

24 (c) CONSULTATION.—In developing and publishing 

25 the report and implementation plan under this section, the 


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1 Secretary shall consult with stakeholders, including re2 searchers, academic organizations, pharmaceutical, bio3 technology, and medical device developers, clinical re4 search organizations, clinical laboratories, health care pro5 viders, patient groups, and other appropriate stakeholders. 

6 (d) MANNER OF ISSUANCE.—For purposes of car7 rying out this section, the Secretary may update an exist8 ing report or plan, and may combine the reports and im9 plementation plans described in subsections (a) and (b) 

10 into one or more documents. 

11 (e) TIMING.—The Secretary shall— 

12 (1) not later than 1 year after the date of en13 actment of this Act, publish a draft of the reports 

14 and plans required under this section; and 

15 (2) not later than 180 days after publication of 

16 the draft reports and plans under paragraph (1)— 

17 (A) publish a final report and plan; and 

18 (B) begin implementation of the best prac19 tices pursuant to such final plan. 

20 SEC. 509. GAO STUDY AND REPORT ON HIRING CHAL21 LENGES AT FDA. 

22 (a) IN GENERAL.—Not later than 18 months after 

23 the date of enactment of this Act, the Comptroller General 

24 of the United States shall submit to the Committee on 

25 Health, Education, Labor, and Pensions of the Senate and 


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1 the Committee on Energy and Commerce of the House 

2 of Representatives a report assessing the policies, prac3 tices, processes, and programs of the Food and Drug Ad4 ministration with respect to hiring, recruiting, and reten5 tion, and the impact of such policies, practices, processes, 

6 and programs on the agency’s ability to carry out its pub7 lic health mission, including the agency’s ability to respond 

8 to the COVID–19 public health emergency. Such report 

9 may involve policies, practices, processes, and programs 

10 of the Department of Health and Human Services and 

11 other agencies, as applicable. 

12 (b) CONTENT OF REPORT.—The report required 

13 under subsection (a) shall include an assessment of— 

14 (1) challenges related to the efficient hiring, re15 cruiting, professional development, and retention of 

16 the Food and Drug Administration workforce, in17 cluding, as applicable, the end-to-end hiring process, 

18 time to hire, multiple hiring authorities, salary lev19 els, vacancy rates, and identification and availability 

20 of candidates with necessary expertise; 

21 (2) causes of the challenges identified under 

22 paragraph (1), including an analysis of relevant poli23 cies, practices, processes, programs, organizational 

24 structure, resources, training, remote work capabili25 ties, and data systems; 


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1 (3) challenges facing the Food and Drug Ad2 ministration workforce, including with respect to 

3 workload, diversity, employee engagement, and mo4 rale; 

5 (4) the impact of challenges identified under 

6 paragraphs (1) and (3) on operations of the Food 

7 and Drug Administration, including on meeting user 

8 fee agreement performance goals and inspection ac9 tivities; 

10 (5) any hiring or retention plans of the Food 

11 and Drug Administration, and progress towards im12 plementation and the metrics to measure success of 

13 such plans; 

14 (6) successful or efficient hiring policies or au15 thorities, including any relevant hiring authorities 

16 that resulted in efficient hiring for vacant positions, 

17 such as temporary direct hiring authorities during 

18 the COVID–19 public health emergency response; 

19 (7) whether policies, practices, processes, and 

20 programs related to hiring, recruiting, professional 

21 development, and retention are implemented consist22 ently across the Food and Drug Administration; 

23 (8) recommendations to address challenges 

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1 grams of the Food and Drug Administration with 

2 respect to hiring, recruiting, professional develop3 ment, and retention; and 

4 (9) challenges related to hiring, recruiting, and 

5 retaining a qualified workforce to meet public health 

6 emergency response needs, including any such chal7 lenges identified during the COVID–19 public health 

8 emergency. 

9 Subtitle B—Mitigating Shortages 

10 SEC. 511. ENSURING REGISTRATION OF FOREIGN DRUG 

11 AND DEVICE MANUFACTURERS. 

12 (a) REGISTRATION OF CERTAIN FOREIGN ESTAB13 LISHMENTS.—Section 510(i) of the Federal Food, Drug, 

14 and Cosmetic Act (21 U.S.C. 360(i)) is amended by add15 ing at the end the following: 

16 ‘‘(5) The requirements of paragraphs (1) and (2) 

17 shall apply regardless of whether the drug or device under18 goes further manufacture, preparation, propagation, 

19 compounding, or processing at a separate establishment 

20 outside the United States prior to being imported or of21 fered for import into the United States.’’. 

22 (b) UPDATING REGULATIONS.—Not later than 2 

23 years after the date of enactment of this Act, the Sec24 retary of Health and Human Services shall update regulaVerDate Sep 11 2014 04:50 Mar 11, 2022 Jkt 029200 PO 00000 Frm 00237 Fmt 6652 Sfmt 6201 E:\BILLS\S3799.IS S3799

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1 tions, as appropriate, to implement the amendment made 

2 by subsection (a). 

3 SEC. 512. EXTENDING EXPIRATION DATES FOR CERTAIN 

4 DRUGS. 

5 (a) IN GENERAL.—Not later than 1 year after the 

6 date of enactment of this Act, the Secretary of Health and 

7 Human Services (referred to in this section as the ‘‘Sec8 retary’’) shall issue draft guidance, or revise existing guid9 ance, to address recommendations for sponsors of applica10 tions submitted under section 505 of the Federal Food, 

11 Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 

12 of the Public Health Service Act (42 U.S.C. 262) regard13 ing— 

14 (1) the submission of stability testing data in 

15 such applications, including considerations for data 

16 requirements that could be streamlined or reduced 

17 to facilitate faster review of longer proposed expira18 tion dates; 

19 (2) establishing in the labeling of drugs the 

20 longest feasible expiration date scientifically sup21 ported by such data, taking into consideration how 

22 extended expiration dates may— 

23 (A) help prevent or mitigate drug short24 ages; and 

25 (B) affect product quality; and 


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1 (3) the use of innovative approaches for drug 

2 and combination product stability modeling to sup3 port initial product expiration dates and expiration 

4 date extensions. 

5 (b) REPORT.—Not later than 2 years after the date 

6 of enactment of this Act, and again 2 years thereafter, 

7 the Secretary shall submit to the Committee on Health, 

8 Education, Labor, and Pensions of the Senate and the 

9 Committee on Energy and Commerce of the House of 

10 Representatives a report that includes— 

11 (1) the number of drugs for which the Sec12 retary has requested the manufacturer make a label13 ing change regarding the expiration date; and 

14 (2) for each drug for which the Secretary has 

15 requested a labeling change with respect to the expi16 ration date, information regarding the circumstances 

17 of such request, including— 

18 (A) the name and dose of such drug; 

19 (B) the rationale for the request; 

20 (C) whether the drug, at the time of the 

21 request, was listed on the drug shortage list 

22 under section 506E of the Federal Food, Drug, 

23 and Cosmetic Act (21 U.S.C. 356e), or was at 

24 risk of shortage; 


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1 (D) whether the request was made during 

2 a public health emergency declared under sec3 tion 319 of the Public Health Service Act (42 

4 U.S.C. 247d); and 

5 (E) whether the manufacturer made the 

6 requested change by the requested date, and for 

7 instances where the manufacturer does not 

8 make the requested change, the manufacturer’s 

9 justification for not making the change, if the 

10 manufacturer agrees to provide such justifica11 tion for inclusion in the report. 

12 SEC. 513. UNANNOUNCED FOREIGN FACILITY INSPECTIONS 

13 PILOT PROGRAM. 

14 (a) IN GENERAL.—The Secretary of Health and 

15 Human Services (referred to in this section as the ‘‘Sec16 retary’’) shall conduct a pilot program under which the 

17 Secretary increases the conduct of unannounced inspec18 tions of foreign human drug facilities and evaluates the 

19 differences between inspections of domestic and foreign 

20 human drug facilities, including the impact of announcing 

21 inspections to persons who own or operate foreign human 

22 drug facilities in advance of an inspection. Such pilot pro23 gram shall evaluate— 

24 (1) differences in the number and type of viola25 tions of section 501(a)(2)(B) of the Federal Food, 


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1 Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(B)) 

2 identified during unannounced and announced in3 spections of foreign human drug facilities and any 

4 other significant differences between each type of in5 spection; 

6 (2) costs and benefits associated with con7 ducting announced and unannounced inspections of 

8 foreign human drug facilities; 

9 (3) barriers to conducting unannounced inspec10 tions of foreign human drug facilities and any chal11 lenges to achieving parity between domestic and for12 eign human drug facility inspections; and 

13 (4) approaches for mitigating any negative ef14 fects of conducting announced inspections of foreign 

15 human drug facilities. 

16 (b) PILOT PROGRAM INITIATION.—The Secretary 

17 shall initiate the pilot program under this section not later 

18 than 180 days after the date of enactment of this Act. 

19 (c) REPORT.—The Secretary shall, not later than 180 

20 days following the completion of the pilot program, make 

21 available on the website of the Food and Drug Administra22 tion a final report on the pilot program under this section, 

23 including— 

24 (1) findings and any associated recommenda25 tions with respect to the evaluation under subsection 


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1 (a), including any recommendations to address iden2 tified barriers to conducting unannounced inspec3 tions of foreign human drug facilities; 

4 (2) findings and any associated recommenda5 tions regarding how the Secretary may achieve par6 ity between domestic and foreign human drug in7 spections; and 

8 (3) the number of unannounced inspections 

9 during the pilot that would not be unannounced 

10 under existing practices. 

11 SEC. 514. COMBATING COUNTERFEIT DEVICES. 

12 (a) PROHIBITED ACTS.—Section 301 of the Federal 

13 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend14 ed by adding at the end the following: 

15 ‘‘(fff)(1) Forging, counterfeiting, simulating, or false16 ly representing, or without proper authority using any 

17 mark, stamp, tag, label, or other identification upon any 

18 device or container, packaging, or labeling thereof so as 

19 to render such device a counterfeit device. 

20 ‘‘(2) Making, selling, disposing of, or keeping in pos21 session, control, or custody, or concealing any punch, die, 

22 plate, stone, or other thing designed to print, imprint, or 

23 reproduce the trademark, trade name, or other identifying 

24 mark or imprint of another or any likeness of any of the 

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1 beling thereof so as to render such device a counterfeit 

2 device. 

3 ‘‘(3) The doing of any act which causes a device to 

4 be a counterfeit device, or the sale or dispensing, or the 

5 holding for sale or dispensing, of a counterfeit device.’’. 

6 (b) PENALTIES.—Section 303 of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 333) is amended— 

8 (1) in subsection (b)(8), by inserting ‘‘, or who 

9 violates section 301(fff)(3) by knowingly making, 

10 selling or dispensing, or holding for sale or dis11 pensing, a counterfeit device,’’ after ‘‘a counterfeit 

12 drug’’; and 

13 (2) in subsection (c), by inserting ‘‘; or (6) for 

14 having violated section 301(fff)(2) if such person 

15 acted in good faith and had no reason to believe that 

16 use of the punch, die, plate, stone, or other thing in17 volved would result in a device being a counterfeit 

18 device, or for having violated section 301(fff)(3) if 

19 the person doing the act or causing it to be done 

20 acted in good faith and had no reason to believe that 

21 the device was a counterfeit device’’ before the pe22 riod. 

23 (c) SEIZURE.—Section 304(a)(2) of the Federal 

24 Food, Drug, and Cosmetic Act (21 U.S.C. 334(a)(2)) is 

25 amended— 


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1 (1) by striking ‘‘, and (E)’’ and inserting ‘‘, 

2 (E)’’; and 

3 (2) by inserting ‘‘, (F) Any device that is a 

4 counterfeit device, (G) Any container, packaging, or 

5 labeling of a counterfeit device, and (H) Any punch, 

6 die, plate, stone, labeling, container, or other thing 

7 used or designed for use in making a counterfeit de8 vice or devices’’ before the period. 

9 SEC. 515. STRENGTHENING MEDICAL DEVICE SUPPLY 

10 CHAINS. 

11 (a) IN GENERAL.—Section 506J of the Federal 

12 Food, Drug, and Cosmetic Act (21 U.S.C. 356j) is amend13 ed— 

14 (1) by redesignating subsections (h) and (i) as 

15 subsections (j) and (k), respectively; and 

16 (2) by inserting after subsection (g) the fol17 lowing: 

18 ‘‘(h) RISK MANAGEMENT PLANS.—Each manufac19 turer of a device that is critical to public health, including 

20 devices that are life-supporting, life-sustaining, or in21 tended for use in emergency medical care, shall develop, 

22 maintain, and, as appropriate, implement a redundancy 

23 risk management plan that identifies and evaluates risks 

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1 lishment in which such device is manufactured. A risk 

2 management plan under this subsection— 

3 ‘‘(1) may identify and evaluate risks to the sup4 ply of more than one device, or device category, 

5 manufactured at the same establishment; and 

6 ‘‘(2) shall be subject to inspection and copying 

7 by the Secretary pursuant to section 704 or at the 

8 request of the Secretary.’’. 

9 (b) REPORT.—Not later than 2 years after the date 

10 of enactment of this Act, and annually for 4 years there11 after, the Secretary of Health and Human Services shall 

12 prepare and submit to the Committee on Health, Edu13 cation, Labor, and Pensions of the Senate and the Com14 mittee on Energy and Commerce of the House of Rep15 resentatives a report on the use of information manufac16 turers submit pursuant to section 506J of the Federal 

17 Food, Drug, and Cosmetic Act (21 U.S.C. 356j) and ap18 plicable guidance issued with respect to such section. 

19 SEC. 516. PREVENTING MEDICAL DEVICE SHORTAGES. 

20 (a) NOTIFICATIONS.—Section 506J of the Federal 

21 Food, Drug, and Cosmetic Act (21 U.S.C. 356j), as 

22 amended by section 515, is further amended— 

23 (1) in the flush text at the end of subsection 

24 (a), by inserting ‘‘or of any other circumstance that 

25 is likely to lead to a meaningful disruption in the 


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1 supply of the device or a shortage of the device, and 

2 there is no other available device that could reason3 ably be substituted for that device in the United 

4 States’’ before the period; 

5 (2) in subsection (f), by inserting ‘‘or (i)’’ after 

6 ‘‘subsection (a)’’; and 

7 (3) by inserting after subsection (h), as added 

8 by section 515, the following: 

9 ‘‘(i) ADDITIONAL NOTIFICATIONS.—The Secretary 

10 may receive notifications from a manufacturers of a device 

11 that is life-supporting, life-sustaining, or intended for use 

12 in emergency medical care or during surgery, or any other 

13 device the Secretary determines to be critical to the public 

14 health, pertaining to a permanent discontinuance in the 

15 manufacture of the device (except for any discontinuance 

16 as a result of an approved modification of the device) or 

17 an interruption of the manufacture of the device that is 

18 likely to lead to a meaningful disruption in the supply of 

19 that device in the United States, and the reasons for such 

20 discontinuance or interruption.’’. 

21 (b) GUIDANCE ON VOLUNTARY NOTIFICATIONS OF

22 DISCONTINUANCE OR INTERRUPTION OF DEVICE MANU23 FACTURE.—Not later than 1 year after the date of enact24 ment of this Act, the Secretary shall issue draft guidance 

25 to facilitate voluntary notifications under subsection (i) of 


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1 section 506J of the Federal Food, Drug, and Cosmetic 

2 Act (21 U.S.C. 356j), as added by subsection (a). Such 

3 guidance shall include a description of circumstances in 

4 which a voluntary notification under such subsection (i) 

5 may be appropriate, recommended timeframes within 

6 which sponsors should submit such a notification, the 

7 process for receiving such notifications, and actions the 

8 Secretary may take to mitigate or prevent a shortage re9 sulting from a discontinuance or interruption in the manu10 facture of a device for which such notification is received. 

11 The Secretary shall issue final guidance not later than 1 

12 year after the close of the comment period for the draft 

13 guidance. 

14 SEC. 517. REMOTE RECORDS ASSESSMENTS FOR MEDICAL 

15 DEVICES. 

16 (a) FACTORY INSPECTION.—Section 704(a)(4)(A) of 

17 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

18 374(a)(4)(A)) is amended— 

19 (1) in the first sentence, by inserting ‘‘or de20 vice’’ after ‘‘processing of a drug’’; and 

21 (2) in the second sentence, by striking ‘‘shall 

22 include’’ and all that follows through the period at 

23 the end and inserting the following: ‘‘shall include— 

24 ‘‘(A) a description of the records re25 quested; and 


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1 ‘‘(B) a rationale for requesting such infor2 mation in advance of, or in lieu of, an inspec3 tion.’’. 

4 (b) GUIDANCE.—Not later than 1 year after the date 

5 of enactment of this Act, the Secretary shall issue draft 

6 guidance describing circumstances in which the Secretary 

7 intends to issue requests for records or other information 

8 in advance of, or in lieu of, an inspection, processes for 

9 responding to such requests electronically or in physical 

10 form, and factors the Secretary intends to consider in eval11 uating whether such records are provided within a reason12 able timeframe, within reasonable limits, and in a reason13 able manner, accounting for resource and other limitations 

14 that may exist, including for small businesses. The Sec15 retary shall issue final guidance not later than 1 year after 

16 the close of the comment period for the draft guidance. 

17 SEC. 518. ADVANCED MANUFACTURING TECHNOLOGIES 

18 DESIGNATION PILOT PROGRAM. 

19 Subchapter A of chapter V of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.), as 

21 amended by section 506, is further amended by inserting 

22 after section 506K the following: 


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1 ‘‘SEC. 506L. ADVANCED MANUFACTURING TECHNOLOGIES 

2 DESIGNATION PILOT PROGRAM. 

3 ‘‘(a) IN GENERAL.—Not later than 1 year after the 

4 date of enactment of this section, the Secretary shall ini5 tiate a pilot program under which persons may request 

6 designation of an advanced manufacturing technology as 

7 described in subsection (b). 

8 ‘‘(b) DESIGNATION PROCESS.—The Secretary shall 

9 establish a process for the designation under this section 

10 of methods of manufacturing drugs, including biological 

11 products, and active pharmaceutical ingredients of such 

12 drugs, as advanced manufacturing technologies. A method 

13 of manufacturing, or a combination of manufacturing 

14 methods, is eligible for designation as an advanced manu15 facturing technology if such method or combination of 

16 methods incorporates a novel technology, or uses an estab17 lished technique or technology in a novel way, that will 

18 substantially— 

19 ‘‘(1) enhance drug quality; or 

20 ‘‘(2) improve the manufacturing process for a 

21 drug and maintain drug quality, including by— 

22 ‘‘(A) reducing development time for a drug 

23 using the designated manufacturing method; or 

24 ‘‘(B) increasing or maintaining the supply 

25 of— 


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1 ‘‘(i) a drug that is life-supporting, 

2 life-sustaining, or of critical importance to 

3 providing health care; or 

4 ‘‘(ii) a drug that is on the drug short5 age list under section 506E. 

6 ‘‘(c) EVALUATION AND DESIGNATION OF AN AD7 VANCED MANUFACTURING TECHNOLOGY.— 

8 ‘‘(1) SUBMISSION.—A person who requests des9 ignation of a method of manufacturing as an ad10 vanced manufacturing technology under this section 

11 shall submit to the Secretary data or information 

12 demonstrating that the method of manufacturing 

13 meets the criteria described in subsection (b) in a 

14 particular context of use. The Secretary may facili15 tate the development and review of such data or in16 formation by— 

17 ‘‘(A) providing timely advice to, and inter18 active communication with, such person regard19 ing the development of the method of manufac20 turing; and 

21 ‘‘(B) involving senior managers and experi22 enced staff of the Food and Drug Administra23 tion, as appropriate, in a collaborative, cross24 disciplinary review of the method of manufac25 turing, as applicable. 


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1 ‘‘(2) EVALUATION AND DESIGNATION.—Not 

2 later than 180 calendar days after the receipt of a 

3 request under paragraph (1), the Secretary shall de4 termine whether to designate such method of manu5 facturing as an advanced manufacturing technology, 

6 in a particular context of use, based on the data and 

7 information submitted under paragraph (1) and the 

8 criteria described in subsection (b). 

9 ‘‘(d) REVIEW OF ADVANCED MANUFACTURING

10 TECHNOLOGIES.—If the Secretary designates a method of 

11 manufacturing as an advanced manufacturing technology, 

12 the Secretary shall— 

13 ‘‘(1) expedite the development and review of an 

14 application submitted under section 505 of this Act 

15 or section 351 of the Public Health Service Act, in16 cluding supplemental applications, for drugs that are 

17 manufactured using a designated advanced manufac18 turing technology; and 

19 ‘‘(2) allow the holder of an advanced technology 

20 designation, or a person authorized by the advanced 

21 manufacturing technology designation holder, to ref22 erence or rely upon, in an application submitted 

23 under section 505 of this Act or section 351 of the 

24 Public Health Service Act, including a supplemental 

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1 ignated advanced manufacturing technology for use 

2 in manufacturing drugs in the same context of use 

3 for which the designation was granted. 

4 ‘‘(e) IMPLEMENTATION AND EVALUATION OF AD5 VANCED MANUFACTURING TECHNOLOGIES PILOT.— 

6 ‘‘(1) PUBLIC MEETING.—The Secretary shall 

7 publish in the Federal Register a notice of a public 

8 meeting, to be held not later than 180 days after the 

9 date of enactment of this section, to discuss, and ob10 tain input and recommendations from relevant 

11 stakeholders regarding— 

12 ‘‘(A) the goals and scope of the pilot pro13 gram, and a suitable framework, procedures, 

14 and requirements for such program; and 

15 ‘‘(B) ways in which the Food and Drug 

16 Administration will support the use of advanced 

17 manufacturing technologies and other innova18 tive manufacturing approaches for drugs. 

19 ‘‘(2) PILOT PROGRAM GUIDANCE.— 

20 ‘‘(A) IN GENERAL.—The Secretary shall— 

21 ‘‘(i) not later than 180 days after the 

22 public meeting under paragraph (1), issue 

23 draft guidance regarding the goals and im24 plementation of the pilot program under 

25 this section; and 


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1 ‘‘(ii) not later than 2 years after the 

2 date of enactment of this section, issue 

3 final guidance regarding the implementa4 tion of such program. 

5 ‘‘(B) CONTENT.—The guidance described 

6 in subparagraph (A) shall address— 

7 ‘‘(i) the process by which a person 

8 may request a designation under sub9 section (b); 

10 ‘‘(ii) the data and information that a 

11 person requesting such a designation is re12 quired to submit under subsection (c), and 

13 how the Secretary intends to evaluate such 

14 submissions; 

15 ‘‘(iii) the process to expedite the de16 velopment and review of applications under 

17 subsection (d); and 

18 ‘‘(iv) the criteria described in sub19 section (b) for eligibility for such a des20 ignation. 

21 ‘‘(3) REPORT.—Not later than 3 years after the 

22 date of enactment of this section and annually there23 after, the Secretary shall publish on the website of 

24 the Food and Drug Administration and submit to 

25 the Committee on Health, Education, Labor, and 


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1 Pensions of the Senate and the Committee on En2 ergy and Commerce of the House of Representatives 

3 a report containing a description and evaluation of 

4 the pilot program being conducted under this sec5 tion, including the types of innovative manufacturing 

6 approaches supported under the program. Such re7 port shall include the following: 

8 ‘‘(A) The number of persons that have re9 quested designations and that have been grant10 ed designations. 

11 ‘‘(B) The number of methods of manufac12 turing that have been the subject of designation 

13 requests and that have been granted designa14 tions. 

15 ‘‘(C) The average number of calendar days 

16 for completion of evaluations under subsection 

17 (c)(2). 

18 ‘‘(D) An analysis of the factors in data 

19 submissions that result in determinations to 

20 designate and not to designate after evaluation 

21 under subsection (c)(2). 

22 ‘‘(E) The number of applications received 

23 under section 505 of this Act or section 351 of 

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1 vanced manufacturing technology designated 

2 under this section, and the number of such ap3 plications approved. 

4 ‘‘(f) SUNSET.—The Secretary— 

5 ‘‘(1) may not consider any requests for designa6 tion submitted under subsection (c) after October 1, 

7 2029; and 

8 ‘‘(2) may continue all activities under this sec9 tion with respect to advanced manufacturing tech10 nologies that were designated pursuant to subsection 

11 (d) prior to such date, if the Secretary determines 

12 such activities are in the interest of the public 

13 health.’’. 

14 SEC. 519. TECHNICAL CORRECTIONS. 

15 (a) TECHNICAL CORRECTIONS TO THE CARES 

16 ACT.—Division A of the CARES Act (Public Law 116– 

17 136) is amended— 

18 (1) in section 3111(1), by striking ‘‘in para19 graph (1)’’ and inserting ‘‘in the matter preceding 

20 paragraph (1)’’; 

21 (2) in section 3112(d)(1), by striking ‘‘and sub22 paragraphs (A) and (B)’’ and inserting ‘‘as subpara23 graphs (A) and (B)’’; and 


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1 (3) in section 3112(e), by striking ‘‘Federal 

2 Food, Drug, Cosmetic Act’’ and inserting ‘‘Federal 

3 Food, Drug, and Cosmetic Act’’. 

4 (b) TECHNICAL CORRECTIONS TO THE FEDERAL

5 FOOD, DRUG, AND COSMETIC ACT RELATED TO THE

6 CARES ACT.— 

7 (1) SECTION 506C.—Section 506C(a) of the 

8 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

9 356c(a)) is amended, in the flush text at the end, by 

10 striking the second comma after ‘‘in the United 

11 States’’. 

12 (2) EFFECTIVE DATE.—The amendment made 

13 by paragraph (1) shall take effect as if included in 

14 section 3112 of division A of the CARES Act (Pub15 lic Law 116–136). 

16 (c) OTHER TECHNICAL CORRECTION TO THE FED17 ERAL FOOD, DRUG, AND COSMETIC ACT.—Section 

18 505B(f)(6)(I) of the Federal Food, Drug, and Cosmetic 

19 Act (21 U.S.C. 355c(f)(6)(I)) is amended by striking 

20 ‘‘subsection (a)(3)(B)’’ and inserting ‘‘subsection 

21 (a)(4)(C)’’. 

Æ 


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