116TH CONGRESS 

1ST SESSION S. 1379 

AN ACT 

To reauthorize certain programs under the Public Health 

Service Act and the Federal Food, Drug, and Cosmetic 

Act with respect to public health security and all-hazards 

preparedness and response, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

3 ‘‘Pandemic and All-Hazards Preparedness and Advancing 

4 Innovation Act of 2019’’. 

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

6 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. References in Act. 

TITLE I—STRENGTHENING THE NATIONAL HEALTH SECURITY 

STRATEGY 

Sec. 101. National Health Security Strategy. 

TITLE II—IMPROVING PREPAREDNESS AND RESPONSE 

Sec. 201. Improving benchmarks and standards for preparedness and response. 

Sec. 202. Amendments to preparedness and response programs. 

Sec. 203. Regional health care emergency preparedness and response systems. 

Sec. 204. Military and civilian partnership for trauma readiness. 

Sec. 205. Public health and health care system situational awareness and biosurveillance capabilities. 

Sec. 206. Strengthening and supporting the public health emergency rapid response fund. 

Sec. 207. Improving all-hazards preparedness and response by public health 

emergency volunteers. 

Sec. 208. Clarifying State liability law for volunteer health care professionals. 

Sec. 209. Report on adequate national blood supply. 

Sec. 210. Report on the public health preparedness and response capabilities 

and capacities of hospitals, long-term care facilities, and other 

health care facilities. 

TITLE III—REACHING ALL COMMUNITIES 

Sec. 301. Strengthening and assessing the emergency response workforce. 

Sec. 302. Health system infrastructure to improve preparedness and response. 

Sec. 303. Considerations for at-risk individuals. 

Sec. 304. Improving emergency preparedness and response considerations for 

children. 

Sec. 305. National advisory committees on disasters. 

Sec. 306. Guidance for participation in exercises and drills. 

TITLE IV—PRIORITIZING A THREAT-BASED APPROACH 

Sec. 401. Assistant Secretary for Preparedness and Response. 

Sec. 402. Public Health Emergency Medical Countermeasures Enterprise. 

Sec. 403. Strategic National Stockpile. 

Sec. 404. Preparing for pandemic influenza, antimicrobial resistance, and other 

significant threats. 

Sec. 405. Reporting on the Federal Select Agent Program. 
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TITLE V—INCREASING COMMUNICATION IN MEDICAL 

COUNTERMEASURE ADVANCED RESEARCH AND DEVELOPMENT 

Sec. 501. Medical countermeasure budget plan. 

Sec. 502. Material threat and medical countermeasure notifications. 

Sec. 503. Availability of regulatory management plans. 

Sec. 504. The Biomedical Advanced Research and Development Authority and 

the BioShield Special Reserve Fund. 

Sec. 505. Additional strategies for combating antibiotic resistance. 

TITLE VI—ADVANCING TECHNOLOGIES FOR MEDICAL 

COUNTERMEASURES 

Sec. 601. Administration of countermeasures. 

Sec. 602. Updating definitions of other transactions. 

Sec. 603. Medical countermeasure master files. 

Sec. 604. Animal rule report. 

Sec. 605. Review of the benefits of genomic engineering technologies and their 

potential role in national security. 

Sec. 606. Report on vaccines development. 

Sec. 607. Strengthening mosquito abatement for safety and health. 

TITLE VII—MISCELLANEOUS PROVISIONS 

Sec. 701. Reauthorizations and extensions. 

Sec. 702. Location of materials in the stockpile. 

Sec. 703. Cybersecurity. 

Sec. 704. Strategy and report. 

Sec. 705. Technical amendments. 

1 SEC. 2. REFERENCES IN ACT. 

2 Except as otherwise specified, amendments made by 

3 this Act to a section or other provision of law are amend4 ments to such section or other provision of the Public 

5 Health Service Act (42 U.S.C. 201 et seq.). 

6 TITLE I—STRENGTHENING THE 

7 NATIONAL HEALTH SECURITY 

8 STRATEGY 

9 SEC. 101. NATIONAL HEALTH SECURITY STRATEGY. 

10 Section 2802 (42 U.S.C. 300hh–1) is amended— 

11 (1) in subsection (a)— 

12 (A) in paragraph (1)— 
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1 (i) by striking ‘‘2014’’ and inserting 

2 ‘‘2018’’; and 

3 (ii) by striking the second sentence 

4 and inserting the following: ‘‘Such Na5 tional Health Security Strategy shall de6 scribe potential emergency health security 

7 threats and identify the process for achiev8 ing the preparedness goals described in 

9 subsection (b) to be prepared to identify 

10 and respond to such threats and shall be 

11 consistent with the national preparedness 

12 goal (as described in section 504(a)(19) of 

13 the Homeland Security Act of 2002), the 

14 National Incident Management System (as 

15 defined in section 501(7) of such Act), and 

16 the National Response Plan developed pur17 suant to section 504 of such Act, or any 

18 successor plan.’’; 

19 (B) in paragraph (2), by inserting before 

20 the period at the end of the second sentence the 

21 following: ‘‘, and an analysis of any changes to 

22 the evidence-based benchmarks and objective 

23 standards under sections 319C–1 and 319C–2’’; 

24 and 

25 (C) in paragraph (3)— 
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1 (i) by striking ‘‘2009’’ and inserting 

2 ‘‘2022’’; 

3 (ii) by inserting ‘‘(including gaps in 

4 the environmental health and animal 

5 health workforces, as applicable), describ6 ing the status of such workforce’’ after 

7 ‘‘gaps in such workforce’’; 

8 (iii) by striking ‘‘and identifying strat9 egies’’ and inserting ‘‘identifying strate10 gies’’; and 

11 (iv) by inserting before the period at 

12 the end ‘‘, and identifying current capabili13 ties to meet the requirements of section 

14 2803’’; and 

15 (2) in subsection (b)— 

16 (A) in paragraph (2)— 

17 (i) in subparagraph (A), by striking 

18 ‘‘and investigation’’ and inserting ‘‘inves19 tigation, and related information tech20 nology activities’’; 

21 (ii) in subparagraph (B), by striking 

22 ‘‘and decontamination’’ and inserting ‘‘de23 contamination, relevant health care serv24 ices and supplies, and transportation and 

25 disposal of medical waste’’; and 
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1 (iii) by adding at the end the fol2 lowing: 

3 ‘‘(E) Response to environmental hazards.’’; 

4 (B) in paragraph (3)— 

5 (i) in the matter preceding subpara6 graph (A), by striking ‘‘including mental 

7 health’’ and inserting ‘‘including phar8 macies, mental health facilities,’’; and 

9 (ii) in subparagraph (F), by inserting 

10 ‘‘or exposures to agents that could cause a 

11 public health emergency’’ before the pe12 riod; 

13 (C) in paragraph (5), by inserting ‘‘and 

14 other applicable compacts’’ after ‘‘Compact’’; 

15 and 

16 (D) by adding at the end the following: 

17 ‘‘(9) ZOONOTIC DISEASE, FOOD, AND AGRI18 CULTURE.—Improving coordination among Federal, 

19 State, local, Tribal, and territorial entities (including 

20 through consultation with the Secretary of Agri21 culture) to prevent, detect, and respond to outbreaks 

22 of plant or animal disease (including zoonotic dis23 ease) that could compromise national security result24 ing from a deliberate attack, a naturally occurring 

25 threat, the intentional adulteration of food, or other 
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1 public health threats, taking into account inter2 actions between animal health, human health, and 

3 animals’ and humans’ shared environment as di4 rectly related to public health emergency prepared5 ness and response capabilities, as applicable. 

6 ‘‘(10) GLOBAL HEALTH SECURITY.—Assessing 

7 current or potential health security threats from 

8 abroad to inform domestic public health prepared9 ness and response capabilities.’’. 

10 TITLE II—IMPROVING 

11 PREPAREDNESS AND RESPONSE 

12 SEC. 201. IMPROVING BENCHMARKS AND STANDARDS FOR 

13 PREPAREDNESS AND RESPONSE. 

14 (a) EVALUATING MEASURABLE EVIDENCE-BASED

15 BENCHMARKS AND OBJECTIVE STANDARDS.—Section 

16 319C–1 (42 U.S.C. 247d–3a) is amended by inserting 

17 after subsection (j) the following: 

18 ‘‘(k) EVALUATION.— 

19 ‘‘(1) IN GENERAL.—Not later than 2 years 

20 after the date of enactment of the Pandemic and 

21 All-Hazards Preparedness and Advancing Innovation 

22 Act of 2019 and every 2 years thereafter, the Sec23 retary shall conduct an evaluation of the evidence24 based benchmarks and objective standards required 

25 under subsection (g). Such evaluation shall be sub-
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1 mitted to the congressional committees of jurisdic2 tion together with the National Health Security 

3 Strategy under section 2802, at such time as such 

4 strategy is submitted. 

5 ‘‘(2) CONTENT.—The evaluation under this 

6 paragraph shall include— 

7 ‘‘(A) a review of evidence-based bench8 marks and objective standards, and associated 

9 metrics and targets; 

10 ‘‘(B) a discussion of changes to any evi11 dence-based benchmarks and objective stand12 ards, and the effect of such changes on the abil13 ity to track whether entities are meeting or 

14 making progress toward the goals under this 

15 section and, to the extent practicable, the appli16 cable goals of the National Health Security 

17 Strategy under section 2802; 

18 ‘‘(C) a description of amounts received by 

19 eligible entities described in subsection (b) and 

20 section 319C–2(b), and amounts received by 

21 subrecipients and the effect of such funding on 

22 meeting evidence-based benchmarks and objec23 tive standards; and 

24 ‘‘(D) recommendations, as applicable and 

25 appropriate, to improve evidence-based bench-
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1 marks and objective standards to more accu2 rately assess the ability of entities receiving 

3 awards under this section to better achieve the 

4 goals under this section and section 2802.’’. 

5 (b) EVALUATING THE PARTNERSHIP FOR STATE AND

6 REGIONAL HOSPITAL PREPAREDNESS.—Section 319C– 

7 2(i)(1) (42 U.S.C. 247–3b(i)(1)) is amended by striking 

8 ‘‘section 319C–1(g), (i), and (j)’’ and inserting ‘‘section 

9 319C–1(g), (i), (j), and (k)’’. 

10 SEC. 202. AMENDMENTS TO PREPAREDNESS AND RE11 SPONSE PROGRAMS. 

12 (a) COOPERATIVE AGREEMENT APPLICATIONS FOR

13 IMPROVING STATE AND LOCAL PUBLIC HEALTH SECU14 RITY.—Section 319C–1 (42 U.S.C. 247d–3a) is amend15 ed— 

16 (1) in subsection (a), by inserting ‘‘, acting 

17 through the Director of the Centers for Disease 

18 Control and Prevention,’’ after ‘‘the Secretary’’; and 

19 (2) in subsection (b)(2)(A)— 

20 (A) in clause (vi), by inserting ‘‘, including 

21 public health agencies with specific expertise 

22 that may be relevant to public health security, 

23 such as environmental health agencies,’’ after 

24 ‘‘stakeholders’’; 
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1 (B) by redesignating clauses (vii) through 

2 (ix) as clauses (viii) through (x); 

3 (C) by inserting after clause (vi) the fol4 lowing: 

5 ‘‘(vii) a description of how, as applica6 ble, such entity may integrate information 

7 to account for individuals with behavioral 

8 health needs following a public health 

9 emergency;’’; 

10 (D) in clause (ix), as so redesignated, by 

11 striking ‘‘; and’’ and inserting a semicolon; and 

12 (E) by adding at the end the following: 

13 ‘‘(xi) a description of how the entity 

14 will partner with health care facilities, in15 cluding hospitals and nursing homes and 

16 other long-term care facilities, to promote 

17 and improve public health preparedness 

18 and response; and 

19 ‘‘(xii) a description of how, as appro20 priate and practicable, the entity will in21 clude critical infrastructure partners, such 

22 as utility companies within the entity’s ju23 risdiction, in planning pursuant to this 

24 subparagraph to help ensure that critical 

25 infrastructure will remain functioning dur-
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1 ing, or return to function as soon as prac2 ticable after, a public health emergency;’’. 

3 (b) EXCEPTION RELATING TO APPLICATION OF CER4 TAIN REQUIREMENTS.— 

5 (1) IN GENERAL.—Section 319C–1(g) (42 

6 U.S.C. 247d–3a(g)) is amended— 

7 (A) in paragraph (5)— 

8 (i) in the matter preceding subpara9 graph (A), by striking ‘‘Beginning with fis10 cal year 2009’’ and inserting ‘‘Beginning 

11 with fiscal year 2019’’; and 

12 (ii) in subparagraph (A)— 

13 (I) by striking ‘‘for the imme14 diately preceding fiscal year’’ and in15 serting ‘‘for either of the 2 imme16 diately preceding fiscal years’’; and 

17 (II) by striking ‘‘2008’’ and in18 serting ‘‘2018’’; and 

19 (B) in paragraph (6), by amending sub20 paragraph (A) to read as follows: 

21 ‘‘(A) IN GENERAL.—The amounts de22 scribed in this paragraph are the following 

23 amounts that are payable to an entity for ac24 tivities described in this section or section 

25 319C–2: 
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1 ‘‘(i) For no more than one of each of 

2 the first 2 fiscal years immediately fol3 lowing a fiscal year in which an entity ex4 perienced a failure described in subpara5 graph (A) or (B) of paragraph (5), an 

6 amount equal to 10 percent of the amount 

7 the entity was eligible to receive for the re8 spective fiscal year. 

9 ‘‘(ii) For no more than one of the first 

10 2 fiscal years immediately following the 

11 third consecutive fiscal year in which an 

12 entity experienced such a failure, in lieu of 

13 applying clause (i), an amount equal to 15 

14 percent of the amount the entity was eligi15 ble to receive for the respective fiscal 

16 year.’’. 

17 (2) EFFECTIVE DATE.—The amendments made 

18 by paragraph (1) shall apply with respect to cooper19 ative agreements awarded on or after the date of en20 actment of this Act. 

21 (c) PARTNERSHIP FOR STATE AND REGIONAL HOS22 PITAL PREPAREDNESS TO IMPROVE SURGE CAPACITY.— 

23 Section 319C–2 (42 U.S.C. 247d–3b) is amended— 

24 (1) in subsection (a)— 
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1 (A) by inserting ‘‘, acting through the As2 sistant Secretary for Preparedness and Re3 sponse,’’ after ‘‘The Secretary’’; and 

4 (B) by striking ‘‘preparedness for public 

5 health emergencies’’ and inserting ‘‘prepared6 ness for, and response to, public health emer7 gencies in accordance with subsection (c)’’; 

8 (2) in subsection (b)(1)(A)— 

9 (A) by striking ‘‘partnership consisting of’’ 

10 and inserting ‘‘coalition that includes’’; 

11 (B) in clause (ii), by striking ‘‘; and’’ and 

12 inserting a semicolon; and 

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

14 ‘‘(iv) one or more emergency medical serv15 ice organizations or emergency management or16 ganizations; and’’; 

17 (3) in subsection (d)— 

18 (A) in paragraph (1)(B), by striking ‘‘part19 nership’’ each place it appears and inserting 

20 ‘‘coalition’’; and 

21 (B) in paragraph (2)(C), by striking ‘‘med22 ical preparedness’’ and inserting ‘‘preparedness 

23 and response’’; 

24 (4) in subsection (f), by striking ‘‘partnership’’ 

25 and inserting ‘‘coalition’’; 
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1 (5) in subsection (g)(2)— 

2 (A) by striking ‘‘Partnerships’’ and insert3 ing ‘‘Coalitions’’; 

4 (B) by striking ‘‘partnerships’’ and insert5 ing ‘‘coalitions’’; and 

6 (C) by inserting ‘‘and response’’ after 

7 ‘‘preparedness’’; and 

8 (6) in subsection (i)(1)— 

9 (A) by striking ‘‘An entity’’ and inserting 

10 ‘‘A coalition’’; and 

11 (B) by striking ‘‘such partnership’’ and in12 serting ‘‘such coalition’’. 

13 (d) PUBLIC HEALTH SECURITY GRANTS AUTHORIZA14 TION OF APPROPRIATIONS.—Section 319C–1(h)(1)(A) 

15 (42 U.S.C. 247d–3a(h)(1)(A)) is amended by striking 

16 ‘‘$641,900,000 for fiscal year 2014’’ and all that follows 

17 through the period at the end and inserting 

18 ‘‘$685,000,000 for each of fiscal years 2019 through 2023 

19 for awards pursuant to paragraph (3) (subject to the au20 thority of the Secretary to make awards pursuant to para21 graphs (4) and (5)).’’. 

22 (e) PARTNERSHIP FOR STATE AND REGIONAL HOS23 PITAL PREPAREDNESS AUTHORIZATION OF APPROPRIA24 TIONS.—Section 319C–2(j) (42 U.S.C. 247d–3b(j)) is 

25 amended— 
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1 (1) by amending paragraph (1) to read as fol2 lows: 

3 ‘‘(1) IN GENERAL.— 

4 ‘‘(A) AUTHORIZATION OF APPROPRIA5 TIONS.—For purposes of carrying out this sec6 tion and section 319C–3, in accordance with 

7 subparagraph (B), there is authorized to be ap8 propriated $385,000,000 for each of fiscal years 

9 2019 through 2023. 

10 ‘‘(B) RESERVATION OF AMOUNTS FOR RE11 GIONAL SYSTEMS.— 

12 ‘‘(i) IN GENERAL.—Subject to clause 

13 (ii), of the amount appropriated under sub14 paragraph (A) for a fiscal year, the Sec15 retary may reserve up to 5 percent for the 

16 purpose of carrying out section 319C–3. 

17 ‘‘(ii) RESERVATION CONTINGENT ON

18 CONTINUED APPROPRIATIONS FOR THIS

19 SECTION.—If for fiscal year 2019 or a sub20 sequent fiscal year, the amount appro21 priated under subparagraph (A) is such 

22 that, after application of clause (i), the 

23 amount remaining for the purpose of car24 rying out this section would be less than 

25 the amount available for such purpose for 
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1 the previous fiscal year, the amount that 

2 may be reserved under clause (i) shall be 

3 reduced such that the amount remaining 

4 for the purpose of carrying out this section 

5 is not less than the amount available for 

6 such purpose for the previous fiscal year. 

7 ‘‘(iii) SUNSET.—The authority to re8 serve amounts under clause (i) shall expire 

9 on September 30, 2023.’’; 

10 (2) in paragraph (2), by striking ‘‘paragraph 

11 (1) for a fiscal year’’ and inserting ‘‘paragraph 

12 (1)(A) for a fiscal year and not reserved for the pur13 pose described in paragraph (1)(B)(i)’’; and 

14 (3) in paragraph (3)(A), by striking ‘‘paragraph 

15 (1) and not reserved under paragraph (2)’’ and in16 serting ‘‘paragraph (1)(A) and not reserved under 

17 paragraph (1)(B)(i) or (2)’’. 

18 SEC. 203. REGIONAL HEALTH CARE EMERGENCY PRE19 PAREDNESS AND RESPONSE SYSTEMS. 

20 (a) IN GENERAL.—Part B of title III (42 U.S.C. 243 

21 et seq.) is amended by inserting after section 319C–2 the 

22 following: 
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1 ‘‘SEC. 319C–3. GUIDELINES FOR REGIONAL HEALTH CARE 

2 EMERGENCY PREPAREDNESS AND RESPONSE 

3 SYSTEMS. 

4 ‘‘(a) PURPOSE.—It is the purpose of this section to 

5 identify and provide guidelines for regional systems of hos6 pitals, health care facilities, and other public and private 

7 sector entities, with varying levels of capability to treat 

8 patients and increase medical surge capacity during, in ad9 vance of, and immediately following a public health emer10 gency, including threats posed by one or more chemical, 

11 biological, radiological, or nuclear agents, including emerg12 ing infectious diseases. 

13 ‘‘(b) GUIDELINES.—The Assistant Secretary for Pre14 paredness and Response, in consultation with the Director 

15 of the Centers for Disease Control and Prevention, the Ad16 ministrator of the Centers for Medicare & Medicaid Serv17 ices, the Administrator of the Health Resources and Serv18 ices Administration, the Commissioner of Food and 

19 Drugs, the Assistant Secretary for Mental Health and 

20 Substance Use, the Assistant Secretary of Labor for Occu21 pational Safety and Health, the Secretary of Veterans Af22 fairs, the heads of such other Federal agencies as the Sec23 retary determines to be appropriate, and State, local, 

24 Tribal, and territorial public health officials, shall, not 

25 later than 2 years after the date of enactment of this sec26 tion— 
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1 ‘‘(1) identify and develop a set of guidelines re2 lating to practices and protocols for all-hazards pub3 lic health emergency preparedness and response for 

4 hospitals and health care facilities to provide appro5 priate patient care during, in advance of, or imme6 diately following, a public health emergency, result7 ing from one or more chemical, biological, radio8 logical, or nuclear agents, including emerging infec9 tious diseases (which may include existing practices, 

10 such as trauma care and medical surge capacity and 

11 capabilities), with respect to— 

12 ‘‘(A) a regional approach to identifying 

13 hospitals and health care facilities based on 

14 varying capabilities and capacity to treat pa15 tients affected by such emergency, including— 

16 ‘‘(i) the manner in which the system 

17 will coordinate with and integrate the part18 nerships and health care coalitions estab19 lished under section 319C–2(b); and 

20 ‘‘(ii) informing and educating appro21 priate first responders and health care sup22 ply chain partners of the regional emer23 gency preparedness and response capabili24 ties and medical surge capacity of such 
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1 hospitals and health care facilities in the 

2 community; 

3 ‘‘(B) physical and technological infrastruc4 ture, laboratory capacity, staffing, blood supply, 

5 and other supply chain needs, taking into ac6 count resiliency, geographic considerations, and 

7 rural considerations; 

8 ‘‘(C) protocols or best practices for the 

9 safety and personal protection of workers who 

10 handle human remains and health care workers 

11 (including with respect to protective equipment 

12 and supplies, waste management processes, and 

13 decontamination), sharing of specialized experi14 ence among the health care workforce, behav15 ioral health, psychological resilience, and train16 ing of the workforce, as applicable; 

17 ‘‘(D) in a manner that allows for disease 

18 containment (within the meaning of section 

19 2802(b)(2)(B)), coordinated medical triage, 

20 treatment, and transportation of patients, based 

21 on patient medical need (including patients in 

22 rural areas), to the appropriate hospitals or 

23 health care facilities within the regional system 

24 or, as applicable and appropriate, between sys25 tems in different States or regions; and 
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1 ‘‘(E) the needs of children and other at2 risk individuals; 

3 ‘‘(2) make such guidelines available on the 

4 internet website of the Department of Health and 

5 Human Services in a manner that does not com6 promise national security; and 

7 ‘‘(3) update such guidelines as appropriate, in8 cluding based on input received pursuant to sub9 sections (c) and (e) and information resulting from 

10 applicable reports required under the Pandemic and 

11 All-Hazards Preparedness and Advancing Innovation 

12 Act of 2019 (including any amendments made by 

13 such Act), to address new and emerging public 

14 health threats. 

15 ‘‘(c) CONSIDERATIONS.—In identifying, developing, 

16 and updating guidelines under subsection (b), the Assist17 ant Secretary for Preparedness and Response shall— 

18 ‘‘(1) include input from hospitals and health 

19 care facilities (including health care coalitions under 

20 section 319C–2), State, local, Tribal, and territorial 

21 public health departments, and health care or sub22 ject matter experts (including experts with relevant 

23 expertise in chemical, biological, radiological, or nu24 clear threats, including emerging infectious dis-
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1 eases), as the Assistant Secretary determines appro2 priate, to meet the goals under section 2802(b)(3); 

3 ‘‘(2) consult and engage with appropriate 

4 health care providers and professionals, including 

5 physicians, nurses, first responders, health care fa6 cilities (including hospitals, primary care clinics, 

7 community health centers, mental health facilities, 

8 ambulatory care facilities, and dental health facili9 ties), pharmacies, emergency medical providers, 

10 trauma care providers, environmental health agen11 cies, public health laboratories, poison control cen12 ters, blood banks, tissue banks, and other experts 

13 that the Assistant Secretary determines appropriate, 

14 to meet the goals under section 2802(b)(3); 

15 ‘‘(3) consider feedback related to financial im16 plications for hospitals, health care facilities, public 

17 health agencies, laboratories, blood banks, tissue 

18 banks, and other entities engaged in regional pre19 paredness planning to implement and follow such 

20 guidelines, as applicable; and 

21 ‘‘(4) consider financial requirements and poten22 tial incentives for entities to prepare for, and re23 spond to, public health emergencies as part of the 

24 regional health care emergency preparedness and re25 sponse system. 
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1 ‘‘(d) TECHNICAL ASSISTANCE.—The Assistant Sec2 retary for Preparedness and Response, in consultation 

3 with the Director of the Centers for Disease Control and 

4 Prevention and the Assistant Secretary of Labor for Occu5 pational Safety and Health, may provide technical assist6 ance and consultation toward meeting the guidelines de7 scribed in subsection (b). 

8 ‘‘(e) DEMONSTRATION PROJECT FOR REGIONAL

9 HEALTH CARE PREPAREDNESS AND RESPONSE SYS10 TEMS.— 

11 ‘‘(1) IN GENERAL.—The Assistant Secretary for 

12 Preparedness and Response may establish a dem13 onstration project pursuant to the development and 

14 implementation of guidelines under subsection (b) to 

15 award grants to improve medical surge capacity for 

16 all hazards, build and integrate regional medical re17 sponse capabilities, improve specialty care expertise 

18 for all-hazards response, and coordinate medical pre19 paredness and response across State, local, Tribal, 

20 territorial, and regional jurisdictions. 

21 ‘‘(2) SUNSET.—The authority under this sub22 section shall expire on September 30, 2023.’’. 

23 (b) GAO REPORT TO CONGRESS.— 

24 (1) REPORT.—Not later than 3 years after the 

25 date of enactment of this Act, the Comptroller Gen-
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1 eral of the United States (referred to in this sub2 section as the ‘‘Comptroller General’’) shall submit 

3 to the Committee on Health, Education, Labor, and 

4 Pensions and the Committee on Finance of the Sen5 ate and the Committee on Energy and Commerce 

6 and the Committee on Ways and Means of the 

7 House of Representatives, a report on the extent to 

8 which hospitals and health care facilities have imple9 mented the recommended guidelines under section 

10 319C–3(b) of the Public Health Service Act (as 

11 added by subsection (a)), including an analysis and 

12 evaluation of any challenges hospitals or health care 

13 facilities experienced in implementing such guide14 lines. 

15 (2) CONTENT.—The Comptroller General shall 

16 include in the report under paragraph (1)— 

17 (A) data on the preparedness and response 

18 capabilities that have been informed by the 

19 guidelines under section 319C–3(b) of the Pub20 lic Health Service Act to improve regional emer21 gency health care preparedness and response 

22 capability, including hospital and health care 

23 facility capacity and medical surge capabilities 

24 to prepare for, and respond to, public health 

25 emergencies; and 
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1 (B) recommendations to reduce gaps in in2 centives for regional health partners, including 

3 hospitals and health care facilities, to improve 

4 capacity and medical surge capabilities to pre5 pare for, and respond to, public health emer6 gencies, consistent with subsection (a), which 

7 may include consideration of facilities partici8 pating in programs under section 319C–2 of 

9 the Public Health Service Act (42 U.S.C. 

10 247d–3b) or in programs under the Centers for 

11 Medicare & Medicaid Services (including inno12 vative health care delivery and payment mod13 els), and input from private sector financial in14 stitutions. 

15 (3) CONSULTATION.—In carrying out para16 graphs (1) and (2), the Comptroller General shall 

17 consult with the heads of appropriate Federal agen18 cies, including— 

19 (A) the Assistant Secretary for Prepared20 ness and Response; 

21 (B) the Director of the Centers for Disease 

22 Control and Prevention; 

23 (C) the Administrator of the Centers for 

24 Medicare & Medicaid Services; 
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1 (D) the Assistant Secretary for Mental 

2 Health and Substance Use; 

3 (E) the Assistant Secretary of Labor for 

4 Occupational Safety and Health; and 

5 (F) the Secretary of Veterans Affairs. 

6 (c) ANNUAL REPORTS.—Section 319C–2(i)(1) (42 

7 U.S.C. 247d–3b(i)(1)) is amended by inserting after the 

8 first sentence the following: ‘‘In submitting reports under 

9 this paragraph, a coalition shall include information on the 

10 progress that the coalition has made toward the implemen11 tation of section 319C–3 (or barriers to progress, if 

12 any).’’. 

13 (d) NATIONAL HEALTH SECURITY STRATEGY INCOR14 PORATION OF REGIONALIZED EMERGENCY PREPARED15 NESS AND RESPONSE.—Subparagraph (G) of section 

16 2802(b)(3) (42 U.S.C. 300hh–1(b)(3)) is amended to read 

17 as follows: 

18 ‘‘(G) Optimizing a coordinated and flexible 

19 approach to the emergency response and med20 ical surge capacity of hospitals, other health 

21 care facilities, critical care, trauma care (which 

22 may include trauma centers), and emergency 

23 medical systems.’’. 

24 (e) IMPROVING STATE AND LOCAL PUBLIC HEALTH

25 SECURITY.— 
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1 (1) STATE AND LOCAL SECURITY.—Section 

2 319C–1(e) (42 U.S.C. 247d–3a(e)) is amended by 

3 striking ‘‘, and local emergency plans.’’ and inserting 

4 ‘‘, local emergency plans, and any regional health 

5 care emergency preparedness and response system 

6 established pursuant to the applicable guidelines 

7 under section 319C–3.’’. 

8 (2) PARTNERSHIPS.—Section 319C–2(d)(1)(A) 

9 (42 U.S.C. 247d–3b(d)(1)(A)) is amended— 

10 (A) in clause (i), by striking ‘‘; and’’ and 

11 inserting ‘‘;’’; 

12 (B) by redesignating clause (ii) as clause 

13 (iii); and 

14 (C) by inserting after clause (i) the fol15 lowing: 

16 ‘‘(ii) among one or more facilities in a 

17 regional health care emergency system 

18 under section 319C–3; and’’. 

19 SEC. 204. MILITARY AND CIVILIAN PARTNERSHIP FOR 

20 TRAUMA READINESS. 

21 Title XII (42 U.S.C. 300d et seq.) is amended by 

22 adding at the end the following new part: 
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1 ‘‘PART I—MILITARY AND CIVILIAN PARTNERSHIP 

2 FOR TRAUMA READINESS GRANT PROGRAM 

3 ‘‘SEC. 1291. MILITARY AND CIVILIAN PARTNERSHIP FOR 

4 TRAUMA READINESS GRANT PROGRAM. 

5 ‘‘(a) MILITARY TRAUMA TEAM PLACEMENT PRO6 GRAM.— 

7 ‘‘(1) IN GENERAL.—The Secretary, acting 

8 through the Assistant Secretary for Preparedness 

9 and Response and in consultation with the Secretary 

10 of Defense, shall award grants to not more than 20 

11 eligible high-acuity trauma centers to enable military 

12 trauma teams to provide, on a full-time basis, trau13 ma care and related acute care at such trauma cen14 ters. 

15 ‘‘(2) LIMITATIONS.—In the case of a grant 

16 awarded under paragraph (1) to an eligible high17 acuity trauma center, such grant— 

18 ‘‘(A) shall be for a period of at least 3 

19 years and not more than 5 years (and may be 

20 renewed at the end of such period); and 

21 ‘‘(B) shall be in an amount that does not 

22 exceed $1,000,000 per year. 

23 ‘‘(3) AVAILABILITY OF FUNDS.—Notwith24 standing section 1552 of title 31, United States 

25 Code, or any other provision of law, funds available 

26 to the Secretary for obligation for a grant under this 
28 

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1 subsection shall remain available for expenditure for 

2 100 days after the last day of the performance pe3 riod of such grant. 

4 ‘‘(b) MILITARY TRAUMA CARE PROVIDER PLACE5 MENT PROGRAM.— 

6 ‘‘(1) IN GENERAL.—The Secretary, acting 

7 through the Assistant Secretary for Preparedness 

8 and Response and in consultation with the Secretary 

9 of Defense, shall award grants to eligible trauma 

10 centers to enable military trauma care providers to 

11 provide trauma care and related acute care at such 

12 trauma centers. 

13 ‘‘(2) LIMITATIONS.—In the case of a grant 

14 awarded under paragraph (1) to an eligible trauma 

15 center, such grant— 

16 ‘‘(A) shall be for a period of at least 1 year 

17 and not more than 3 years (and may be re18 newed at the end of such period); and 

19 ‘‘(B) shall be in an amount that does not 

20 exceed, in a year— 

21 ‘‘(i) $100,000 for each military trau22 ma care provider that is a physician at 

23 such eligible trauma center; and 
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1 ‘‘(ii) $50,000 for each other military 

2 trauma care provider at such eligible trau3 ma center. 

4 ‘‘(c) GRANT REQUIREMENTS.— 

5 ‘‘(1) DEPLOYMENT AND PUBLIC HEALTH EMER6 GENCIES.—As a condition of receipt of a grant 

7 under this section, a grant recipient shall agree to 

8 allow military trauma care providers providing care 

9 pursuant to such grant to— 

10 ‘‘(A) be deployed by the Secretary of De11 fense for military operations, for training, or 

12 for response to a mass casualty incident; and 

13 ‘‘(B) be deployed by the Secretary of De14 fense, in consultation with the Secretary of 

15 Health and Human Services, for response to a 

16 public health emergency pursuant to section 

17 319. 

18 ‘‘(2) USE OF FUNDS.—Grants awarded under 

19 this section to an eligible trauma center may be used 

20 to train and incorporate military trauma care pro21 viders into such trauma center, including incorpora22 tion into operational exercises and training drills re23 lated to public health emergencies, expenditures for 

24 malpractice insurance, office space, information 

25 technology, specialty education and supervision, 
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1 trauma programs, research, and applicable license 

2 fees for such military trauma care providers. 

3 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec4 tion shall be construed to affect any other provision of law 

5 that preempts State licensing requirements for health care 

6 professionals, including with respect to military trauma 

7 care providers. 

8 ‘‘(e) REPORTING REQUIREMENTS.— 

9 ‘‘(1) REPORT TO THE SECRETARY AND THE

10 SECRETARY OF DEFENSE.—Each eligible trauma 

11 center or eligible high-acuity trauma center awarded 

12 a grant under subsection (a) or (b) for a year shall 

13 submit to the Secretary and the Secretary of De14 fense a report for such year that includes informa15 tion on— 

16 ‘‘(A) the number and types of trauma 

17 cases managed by military trauma teams or 

18 military trauma care providers pursuant to such 

19 grant during such year; 

20 ‘‘(B) the ability to maintain the integration 

21 of the military trauma providers or teams of 

22 providers as part of the trauma center, includ23 ing the financial effect of such grant on the 

24 trauma center; 
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1 ‘‘(C) the educational effect on resident 

2 trainees in centers where military trauma teams 

3 are assigned; 

4 ‘‘(D) any research conducted during such 

5 year supported by such grant; and 

6 ‘‘(E) any other information required by the 

7 Secretaries for the purpose of evaluating the ef8 fect of such grant. 

9 ‘‘(2) REPORT TO CONGRESS.—Not less than 

10 once every 2 years, the Secretary, in consultation 

11 with the Secretary of Defense, shall submit a report 

12 to the congressional committees of jurisdiction that 

13 includes information on the effect of placing military 

14 trauma care providers in trauma centers awarded 

15 grants under this section on— 

16 ‘‘(A) maintaining military trauma care 

17 providers’ readiness and ability to respond to 

18 and treat battlefield injuries; 

19 ‘‘(B) providing health care to civilian trau20 ma patients in urban and rural settings; 

21 ‘‘(C) the capability of trauma centers and 

22 military trauma care providers to increase med23 ical surge capacity, including as a result of a 

24 large-scale event; 
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1 ‘‘(D) the ability of grant recipients to 

2 maintain the integration of the military trauma 

3 providers or teams of providers as part of the 

4 trauma center; 

5 ‘‘(E) efforts to incorporate military trauma 

6 care providers into operational exercises and 

7 training and drills for public health emer8 gencies; and 

9 ‘‘(F) the capability of military trauma care 

10 providers to participate as part of a medical re11 sponse during or in advance of a public health 

12 emergency, as determined by the Secretary, or 

13 a mass casualty incident. 

14 ‘‘(f) DEFINITIONS.—For purposes of this part: 

15 ‘‘(1) ELIGIBLE HIGH-ACUITY TRAUMA CEN16 TER.—The term ‘eligible high-acuity trauma center’ 

17 means a Level I trauma center that satisfies each of 

18 the following: 

19 ‘‘(A) Such trauma center has an agree20 ment with the Secretary of Defense to enable 

21 military trauma teams to provide trauma care 

22 and related acute care at such trauma center. 

23 ‘‘(B) At least 20 percent of patients treat24 ed at such trauma center in the most recent 3- 

25 month period for which data are available are 
33 

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1 treated for a major trauma at such trauma cen2 ter. 

3 ‘‘(C) Such trauma center utilizes a risk-ad4 justed benchmarking system and metrics to 

5 measure performance, quality, and patient out6 comes. 

7 ‘‘(D) Such trauma center is an academic 

8 training center— 

9 ‘‘(i) affiliated with a medical school; 

10 ‘‘(ii) that maintains residency pro11 grams and fellowships in critical trauma 

12 specialties and subspecialties, and provides 

13 education and supervision of military trau14 ma team members according to those spe15 cialties and subspecialties; and 

16 ‘‘(iii) that undertakes research in the 

17 prevention and treatment of traumatic in18 jury. 

19 ‘‘(E) Such trauma center serves as a med20 ical and public health preparedness and re21 sponse leader for its community, such as by 

22 participating in a partnership for State and re23 gional hospital preparedness established under 

24 section 319C–2 or 319C–3. 
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1 ‘‘(2) ELIGIBLE TRAUMA CENTER.—The term 

2 ‘eligible trauma center’ means a Level I, II, or III 

3 trauma center that satisfies each of the following: 

4 ‘‘(A) Such trauma center has an agree5 ment with the Secretary of Defense to enable 

6 military trauma care providers to provide trau7 ma care and related acute care at such trauma 

8 center. 

9 ‘‘(B) Such trauma center utilizes a risk-ad10 justed benchmarking system and metrics to 

11 measure performance, quality, and patient out12 comes. 

13 ‘‘(C) Such trauma center demonstrates a 

14 need for integrated military trauma care pro15 viders to maintain or improve the trauma clin16 ical capability of such trauma center. 

17 ‘‘(3) MAJOR TRAUMA.—The term ‘major trau18 ma’ means an injury that is greater than or equal 

19 to 15 on the injury severity score. 

20 ‘‘(4) MILITARY TRAUMA TEAM.—The term 

21 ‘military trauma team’ means a complete military 

22 trauma team consisting of military trauma care pro23 viders. 

24 ‘‘(5) MILITARY TRAUMA CARE PROVIDER.—The 

25 term ‘military trauma care provider’ means a mem-
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1 ber of the Armed Forces who furnishes emergency, 

2 critical care, and other trauma acute care services 

3 (including a physician, surgeon, physician assistant, 

4 nurse, nurse practitioner, respiratory therapist, 

5 flight paramedic, combat medic, or enlisted medical 

6 technician) or other military trauma care provider as 

7 the Secretary determines appropriate. 

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

9 carry out this section, there is authorized to be appro10 priated $11,500,000 for each of fiscal years 2019 through 

11 2023.’’. 

12 SEC. 205. PUBLIC HEALTH AND HEALTH CARE SYSTEM SIT13 UATIONAL AWARENESS AND BIOSURVEIL14 LANCE CAPABILITIES. 

15 (a) FACILITIES, CAPACITIES, AND BIOSURVEILLANCE

16 CAPABILITIES.—Section 319D (42 U.S.C. 247d–4) is 

17 amended— 

18 (1) in the section heading, by striking ‘‘REVI19 TALIZING’’ and inserting ‘‘FACILITIES AND CA20 PACITIES OF’’; 

21 (2) in subsection (a)— 

22 (A) in the subsection heading, by striking 

23 ‘‘FACILITIES; CAPACITIES’’ and inserting ‘‘IN

24 GENERAL’’; 
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1 (B) in paragraph (1), by striking ‘‘and im2 proved’’ and inserting ‘‘, improved, and appro3 priately maintained’’; 

4 (C) in paragraph (3), in the matter pre5 ceding subparagraph (A), by striking ‘‘expand, 

6 enhance, and improve’’ and inserting ‘‘expand, 

7 improve, enhance, and appropriately maintain’’; 

8 and 

9 (D) by adding at the end the following: 

10 ‘‘(4) STUDY OF RESOURCES FOR FACILITIES

11 AND CAPACITIES.—Not later than June 1, 2022, the 

12 Comptroller General of the United States shall con13 duct a study on Federal spending in fiscal years 

14 2013 through 2018 for activities authorized under 

15 this subsection. Such study shall include a review 

16 and assessment of obligations and expenditures di17 rectly related to each activity under paragraphs (2) 

18 and (3), including a specific accounting of, and de19 lineation between, obligations and expenditures in20 curred for the construction, renovation, equipping, 

21 and security upgrades of facilities and associated 

22 contracts under this subsection, and the obligations 

23 and expenditures incurred to establish and improve 

24 the situational awareness and biosurveillance net25 work under subsection (b), and shall identify the 
37 

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1 agency or agencies incurring such obligations and 

2 expenditures.’’; 

3 (3) in subsection (b)— 

4 (A) in the subsection heading, by striking 

5 ‘‘NATIONAL’’ and inserting ‘‘ESTABLISHMENT

6 OF SYSTEMS OF PUBLIC HEALTH’’; 

7 (B) in paragraph (1)(B), by inserting ‘‘im8 munization information systems,’’ after ‘‘cen9 ters,’’; 

10 (C) in paragraph (2)— 

11 (i) by inserting ‘‘develop a plan to, 

12 and’’ after ‘‘The Secretary shall’’; and 

13 (ii) by inserting ‘‘and in a form read14 ily usable for analytical approaches’’ after 

15 ‘‘in a secure manner’’; and 

16 (D) by amending paragraph (3) to read as 

17 follows: 

18 ‘‘(3) STANDARDS.— 

19 ‘‘(A) IN GENERAL.—Not later than 1 year 

20 after the date of the enactment of the Pan21 demic and All-Hazards Preparedness and Ad22 vancing Innovation Act of 2019, the Secretary, 

23 in cooperation with health care providers, State, 

24 local, Tribal, and territorial public health offi25 cials, and relevant Federal agencies (including 
38 

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1 the Office of the National Coordinator for 

2 Health Information Technology and the Na3 tional Institute of Standards and Technology), 

4 shall, as necessary, adopt technical and report5 ing standards, including standards for inter6 operability as defined by section 3000, for net7 works under paragraph (1) and update such 

8 standards as necessary. Such standards shall be 

9 made available on the internet website of the 

10 Department of Health and Human Services, in 

11 a manner that does not compromise national se12 curity. 

13 ‘‘(B) DEFERENCE TO STANDARDS DEVEL14 OPMENT ORGANIZATIONS.—In adopting and im15 plementing standards under this subsection and 

16 subsection (c), the Secretary shall give def17 erence to standards published by standards de18 velopment organizations and voluntary con19 sensus-based standards entities.’’; 

20 (4) in subsection (c)— 

21 (A) in paragraph (1)— 

22 (i) by striking ‘‘Not later than 2 years 

23 after the date of enactment of the Pan24 demic and All-Hazards Preparedness Re-
39 

†S 1379 ES

1 authorization Act of 2013, the Secretary’’ 

2 and inserting ‘‘The Secretary’’; 

3 (ii) by inserting ‘‘, and improve as ap4 plicable and appropriate,’’ after ‘‘shall es5 tablish’’; 

6 (iii) by striking ‘‘of rapid’’ and insert7 ing ‘‘of, rapid’’; and 

8 (iv) by striking ‘‘such connectivity’’ 

9 and inserting ‘‘such interoperability’’; 

10 (B) by amending paragraph (2) to read as 

11 follows: 

12 ‘‘(2) COORDINATION AND CONSULTATION.—In 

13 establishing and improving the network under para14 graph (1), the Secretary shall— 

15 ‘‘(A) facilitate coordination among agencies 

16 within the Department of Health and Human 

17 Services that provide, or have the potential to 

18 provide, information and data to, and analyses 

19 for, the situational awareness and biosurveil20 lance network under paragraph (1), including 

21 coordination among relevant agencies related to 

22 health care services, the facilitation of health 

23 information exchange (including the Office of 

24 the National Coordinator for Health Informa-
40 

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1 tion Technology), and public health emergency 

2 preparedness and response; and 

3 ‘‘(B) consult with the Secretary of Agri4 culture, the Secretary of Commerce (and the 

5 Director of the National Institute of Standards 

6 and Technology), the Secretary of Defense, the 

7 Secretary of Homeland Security, the Secretary 

8 of Veterans Affairs, and the heads of other 

9 Federal agencies, as the Secretary determines 

10 appropriate.’’; 

11 (C) in paragraph (3)— 

12 (i) by redesignating subparagraphs 

13 (A) through (E) as clauses (i) through (v), 

14 respectively, and adjusting the margins ac15 cordingly; 

16 (ii) in clause (iv), as so redesig17 nated— 

18 (I) by inserting ‘‘immunization 

19 information systems,’’ after ‘‘poison 

20 control,’’; and 

21 (II) by striking ‘‘and clinical lab22 oratories’’ and inserting ‘‘, clinical 

23 laboratories, and public environmental 

24 health agencies’’; 
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1 (iii) by striking ‘‘The network’’ and 

2 inserting the following: 

3 ‘‘(A) IN GENERAL.—The network’’; and 

4 (iv) by adding at the end the fol5 lowing: 

6 ‘‘(B) REVIEW.—Not later than 2 years 

7 after the date of the enactment of the Pan8 demic and All-Hazards Preparedness and Ad9 vancing Innovation Act of 2019 and every 6 

10 years thereafter, the Secretary shall conduct a 

11 review of the elements described in subpara12 graph (A). Such review shall include a discus13 sion of the addition of any elements pursuant to 

14 clause (v), including elements added to advanc15 ing new technologies, and identify any chal16 lenges in the incorporation of elements under 

17 subparagraph (A). The Secretary shall provide 

18 such review to the congressional committees of 

19 jurisdiction.’’; 

20 (D) in paragraph (5)— 

21 (i) by redesignating subparagraphs 

22 (A) through (D) as clauses (i) through 

23 (iv), respectively, and adjusting the mar24 gins accordingly; 
42 

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1 (ii) by striking ‘‘In establishing’’ and 

2 inserting the following: 

3 ‘‘(A) IN GENERAL.—In establishing’’; 

4 (iii) by adding at the end the fol5 lowing: 

6 ‘‘(B) PUBLIC MEETING.— 

7 ‘‘(i) IN GENERAL.—Not later than 

8 180 days after the date of enactment of 

9 the Pandemic and All-Hazards Prepared10 ness and Advancing Innovation Act of 

11 2019, the Secretary shall convene a public 

12 meeting for purposes of discussing and 

13 providing input on the potential goals, 

14 functions, and uses of the network de15 scribed in paragraph (1) and incorporating 

16 the elements described in paragraph 

17 (3)(A). 

18 ‘‘(ii) EXPERTS.—The public meeting 

19 shall include representatives of relevant 

20 Federal agencies (including representatives 

21 from the Office of the National Coordi22 nator for Health Information Technology 

23 and the National Institute of Standards 

24 and Technology); State, local, Tribal, and 

25 territorial public health officials; stake-
43 

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1 holders with expertise in biosurveillance 

2 and situational awareness; stakeholders 

3 with expertise in capabilities relevant to 

4 biosurveillance and situational awareness, 

5 such as experts in informatics and data 

6 analytics (including experts in prediction, 

7 modeling, or forecasting); and other rep8 resentatives as the Secretary determines 

9 appropriate. 

10 ‘‘(iii) TOPICS.—Such public meeting 

11 shall include a discussion of— 

12 ‘‘(I) data elements, including 

13 minimal or essential data elements, 

14 that are voluntarily provided for such 

15 network, which may include elements 

16 from public health and public and pri17 vate health care entities, to the extent 

18 practicable; 

19 ‘‘(II) standards and implementa20 tion specifications that may improve 

21 the collection, analysis, and interpre22 tation of data during a public health 

23 emergency; 
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1 ‘‘(III) strategies to encourage the 

2 access, exchange, and use of informa3 tion; 

4 ‘‘(IV) considerations for State, 

5 local, Tribal, and territorial capabili6 ties and infrastructure related to data 

7 exchange and interoperability; 

8 ‘‘(V) privacy and security protec9 tions provided at the Federal, State, 

10 local, Tribal, and territorial levels, 

11 and by nongovernmental stakeholders; 

12 and 

13 ‘‘(VI) opportunities for the incor14 poration of innovative technologies to 

15 improve the network.’’; and 

16 (iv) in subparagraph (A), as so des17 ignated by clause (ii)— 

18 (I) in clause (i), as so redesig19 nated— 

20 (aa) by striking ‘‘as deter21 mined’’ and inserting ‘‘as adopt22 ed’’; and 

23 (bb) by inserting ‘‘and the 

24 National Institute of Standards 

25 and Technology’’ after ‘‘Office of 
45 

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1 the National Coordinator for 

2 Health Information Technology’’; 

3 (II) in clause (iii), as so redesig4 nated, by striking ‘‘; and’’ and insert5 ing a semicolon; 

6 (III) in clause (iv), as so redesig7 nated, by striking the period and in8 serting ‘‘; and’’; and 

9 (IV) by adding at the end the fol10 lowing: 

11 ‘‘(v) pilot test standards and imple12 mentation specifications, consistent with 

13 the process described in section 

14 3002(b)(3)(C), which State, local, Tribal, 

15 and territorial public health entities may 

16 utilize, on a voluntary basis, as a part of 

17 the network.’’; 

18 (E) by redesignating paragraph (6) as 

19 paragraph (7); 

20 (F) by inserting after paragraph (5) the 

21 following: 

22 ‘‘(6) STRATEGY AND IMPLEMENTATION

23 PLAN.— 

24 ‘‘(A) IN GENERAL.—Not later than 18 

25 months after the date of enactment of the Pan-
46 

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1 demic and All-Hazards Preparedness and Ad2 vancing Innovation Act of 2019, the Secretary 

3 shall submit to the congressional committees of 

4 jurisdiction a coordinated strategy and an ac5 companying implementation plan that— 

6 ‘‘(i) is informed by the public meeting 

7 under paragraph (5)(B); 

8 ‘‘(ii) includes a review and assessment 

9 of existing capabilities of the network and 

10 related infrastructure, including input pro11 vided by the public meeting under para12 graph (5)(B); 

13 ‘‘(iii) identifies and demonstrates the 

14 measurable steps the Secretary will carry 

15 out to— 

16 ‘‘(I) develop, implement, and 

17 evaluate the network described in 

18 paragraph (1), utilizing elements de19 scribed in paragraph (3)(A); 

20 ‘‘(II) modernize and enhance bio21 surveillance activities, including strat22 egies to include innovative tech23 nologies and analytical approaches 

24 (including prediction and forecasting 
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1 for pandemics and all-hazards) from 

2 public and private entities; 

3 ‘‘(III) improve information shar4 ing, coordination, and communication 

5 among disparate biosurveillance sys6 tems supported by the Department of 

7 Health and Human Services, includ8 ing the identification of methods to 

9 improve accountability, better utilize 

10 resources and workforce capabilities, 

11 and incorporate innovative tech12 nologies within and across agencies; 

13 and 

14 ‘‘(IV) test and evaluate capabili15 ties of the interoperable network of 

16 systems to improve situational aware17 ness and biosurveillance capabilities; 

18 ‘‘(iv) includes performance measures 

19 and the metrics by which performance 

20 measures will be assessed with respect to 

21 the measurable steps under clause (iii); 

22 and 

23 ‘‘(v) establishes dates by which each 

24 measurable step under clause (iii) will be 

25 implemented. 
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1 ‘‘(B) ANNUAL BUDGET PLAN.—Not later 

2 than 2 years after the date of enactment of the 

3 Pandemic and All-Hazards Preparedness and 

4 Advancing Innovation Act of 2019 and on an 

5 annual basis thereafter, in accordance with the 

6 strategy and implementation plan under this 

7 paragraph, the Secretary shall, taking into ac8 count recommendations provided by the Na9 tional Biodefense Science Board, develop a 

10 budget plan based on the strategy and imple11 mentation plan under this section. Such budget 

12 plan shall include— 

13 ‘‘(i) a summary of resources pre14 viously expended to establish, improve, and 

15 utilize the nationwide public health situa16 tional awareness and biosurveillance net17 work under paragraph (1); 

18 ‘‘(ii) estimates of costs and resources 

19 needed to establish and improve the net20 work under paragraph (1) according to the 

21 strategy and implementation plan under 

22 subparagraph (A); 

23 ‘‘(iii) the identification of gaps and in24 efficiencies in nationwide public health sit25 uational awareness and biosurveillance ca-
49 

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1 pabilities, resources, and authorities need2 ed to address such gaps; and 

3 ‘‘(iv) a strategy to minimize and ad4 dress such gaps and improve inefficien5 cies.’’; 

6 (G) in paragraph (7), as so redesignated— 

7 (i) in subparagraph (A), by inserting 

8 ‘‘(taking into account zoonotic disease, in9 cluding gaps in scientific understanding of 

10 the interactions between human, animal, 

11 and environmental health)’’ after ‘‘human 

12 health’’; 

13 (ii) in subparagraph (B)— 

14 (I) by inserting ‘‘and gaps in sur15 veillance programs’’ after ‘‘surveil16 lance programs’’; and 

17 (II) by striking ‘‘; and’’ and in18 serting a semicolon; 

19 (iii) in subparagraph (C)— 

20 (I) by inserting ‘‘, animal health 

21 organizations related to zoonotic dis22 ease,’’ after ‘‘health care entities’’; 

23 and 

24 (II) by striking the period and 

25 inserting ‘‘; and’’; and 
50 

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1 (iv) by adding at the end the fol2 lowing: 

3 ‘‘(D) provide recommendations to the Sec4 retary on policies and procedures to complete 

5 the steps described in this paragraph in a man6 ner that is consistent with section 2802.’’; and 

7 (H) by adding at the end the following: 

8 ‘‘(8) SITUATIONAL AWARENESS AND BIO9 SURVEILLANCE AS A NATIONAL SECURITY PRI10 ORITY.—The Secretary, on a periodic basis as appli11 cable and appropriate, shall meet with the Director 

12 of National Intelligence to inform the development 

13 and capabilities of the nationwide public health situ14 ational awareness and biosurveillance network.’’; 

15 (5) in subsection (d)— 

16 (A) in paragraph (1)— 

17 (i) by inserting ‘‘environmental health 

18 agencies,’’ after ‘‘public health agencies,’’; 

19 and 

20 (ii) by inserting ‘‘immunization pro21 grams,’’ after ‘‘poison control centers,’’; 

22 (B) in paragraph (2)— 

23 (i) in subparagraph (B), by striking 

24 ‘‘and’’ at the end; 
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1 (ii) in subparagraph (C), by striking 

2 the period and inserting ‘‘; and’’; and 

3 (iii) by adding after subparagraph (C) 

4 the following: 

5 ‘‘(D) an implementation plan that may in6 clude measurable steps to achieve the purposes 

7 described in paragraph (1).’’; and 

8 (C) by striking paragraph (5) and insert9 ing the following: 

10 ‘‘(5) TECHNICAL ASSISTANCE.—The Secretary 

11 may provide technical assistance to States, localities, 

12 Tribes, and territories or a consortium of States, lo13 calities, Tribes, and territories receiving an award 

14 under this subsection regarding interoperability and 

15 the technical standards set forth by the Secretary.’’; 

16 (6) by redesignating subsections (f) and (g) as 

17 subsections (i) and (j), respectively; and 

18 (7) by inserting after subsection (e) the fol19 lowing: 

20 ‘‘(f) PERSONNEL AUTHORITIES.— 

21 ‘‘(1) SPECIALLY QUALIFIED PERSONNEL.—In 

22 addition to any other personnel authorities, to carry 

23 out subsections (b) and (c), the Secretary may— 

24 ‘‘(A) appoint highly qualified individuals to 

25 scientific or professional positions at the Cen-
52 

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1 ters for Disease Control and Prevention, not to 

2 exceed 30 such employees at any time (specific 

3 to positions authorized by this subsection), with 

4 expertise in capabilities relevant to biosurveil5 lance and situational awareness, such as experts 

6 in informatics and data analytics (including ex7 perts in prediction, modeling, or forecasting), 

8 and other related scientific or technical fields; 

9 and 

10 ‘‘(B) compensate individuals appointed 

11 under subparagraph (A) in the same manner 

12 and subject to the same terms and conditions in 

13 which individuals appointed under 9903 of title 

14 5, United States Code, are compensated, with15 out regard to the provisions of chapter 51 and 

16 subchapter III of chapter 53 of such title relat17 ing to classification and General Schedule pay 

18 rates. 

19 ‘‘(2) LIMITATIONS.—The Secretary shall exer20 cise the authority under paragraph (1) in a manner 

21 that is consistent with the limitations described in 

22 section 319F–1(e)(2). 

23 ‘‘(g) TIMELINE.—The Secretary shall accomplish the 

24 purposes under subsections (b) and (c) no later than Sep25 tember 30, 2023, and shall provide a justification to the 
53 

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1 congressional committees of jurisdiction for any missed or 

2 delayed implementation of measurable steps identified 

3 under subsection (c)(6)(A)(iii). 

4 ‘‘(h) INDEPENDENT EVALUATION.—Not later than 3 

5 years after the date of enactment of the Pandemic and 

6 All-Hazards Preparedness and Advancing Innovation Act 

7 of 2019, the Comptroller General of the United States 

8 shall conduct an independent evaluation and submit to the 

9 Secretary and the congressional committees of jurisdiction 

10 a report concerning the activities conducted under sub11 sections (b) and (c), and provide recommendations, as ap12 plicable and appropriate, on necessary improvements to 

13 the biosurveillance and situational awareness network.’’. 

14 (b) AUTHORIZATION OF APPROPRIATIONS.—Sub15 section (i) of section 319D (42 U.S.C. 247d–4), as redes16 ignated by subsection (a)(6), is amended by striking 

17 ‘‘$138,300,000 for each of fiscal years 2014 through 

18 2018’’ and inserting ‘‘$161,800,000 for each of fiscal 

19 years 2019 through 2023’’. 

20 (c) BIOLOGICAL THREAT DETECTION REPORT.—The 

21 Secretary of Health and Human Services shall, in coordi22 nation with the Secretary of Defense and the Secretary 

23 of Homeland Security, not later than 180 days after the 

24 date of enactment of this Act, report to the Committee 

25 on Energy and Commerce, the Committee on Armed Serv-
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1 ices, and the Committee on Homeland Security of the 

2 House of Representatives and the Committee on Health, 

3 Education, Labor, and Pensions, the Committee on Armed 

4 Services, and the Committee on Homeland Security and 

5 Governmental Affairs of the Senate on the state of Fed6 eral biological threat detection efforts, including the fol7 lowing: 

8 (1) An identification of technological, oper9 ational, and programmatic successes and failures of 

10 domestic detection programs supported by Federal 

11 departments and agencies for intentionally intro12 duced or accidentally released biological threat 

13 agents and naturally occurring infectious diseases. 

14 (2) A description of Federal efforts to facilitate 

15 the exchange of information related to the informa16 tion described in paragraph (1) among Federal de17 partments and agencies that utilize biological threat 

18 detection technology. 

19 (3) A description of the capabilities of detection 

20 systems in use by Federal departments and agencies 

21 including the capability to— 

22 (A) rapidly detect, identify, characterize, 

23 and confirm the presence of biological threat 

24 agents; 
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1 (B) recover live biological agents from col2 lection devices; 

3 (C) determine the geographical distribution 

4 of biological agents; 

5 (D) determine the extent of environmental 

6 contamination and persistence of biological 

7 agents; and 

8 (E) provide advanced molecular diagnostics 

9 to State, local, Tribal, and territorial public 

10 health and other laboratories that support bio11 logical threat detection activities. 

12 (4) A description of Federal interagency coordi13 nation related to biological threat detection. 

14 (5) A description of efforts by Federal depart15 ments and agencies that utilize biological threat de16 tection technology to collaborate with State, local, 

17 Tribal, and territorial public health laboratories and 

18 other users of biological threat detection systems, in19 cluding collaboration regarding the development of— 

20 (A) biological threat detection require21 ments or standards; 

22 (B) a standardized integration strategy; 

23 (C) training requirements or guidelines; 

24 (D) guidelines for a coordinated public 

25 health response, including preparedness capa-
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1 bilities, and, as applicable, for coordination with 

2 public health surveillance systems; and 

3 (E) a coordinated environmental remedi4 ation plan, as applicable. 

5 (6) Recommendations related to research, ad6 vanced research, development, and procurement for 

7 Federal departments and agencies to improve and 

8 enhance biological threat detection systems, includ9 ing recommendations on the transfer of biological 

10 threat detection technology among Federal depart11 ments and agencies, as necessary and appropriate. 

12 SEC. 206. STRENGTHENING AND SUPPORTING THE PUBLIC 

13 HEALTH EMERGENCY RAPID RESPONSE 

14 FUND. 

15 Section 319 (42 U.S.C. 247d) is amended— 

16 (1) in subsection (b)— 

17 (A) in paragraph (1)— 

18 (i) in the first sentence, by inserting 

19 ‘‘or if the Secretary determines there is the 

20 significant potential for a public health 

21 emergency, to allow the Secretary to rap22 idly respond to the immediate needs result23 ing from such public health emergency or 

24 potential public health emergency’’ before 

25 the period; and 
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1 (ii) by inserting ‘‘The Secretary shall 

2 plan for the expedited distribution of funds 

3 to appropriate agencies and entities.’’ after 

4 the first sentence; 

5 (B) by redesignating paragraph (2) as 

6 paragraph (3); 

7 (C) by inserting after paragraph (1) the 

8 following: 

9 ‘‘(2) USES.—The Secretary may use amounts 

10 in the Fund established under paragraph (1), to— 

11 ‘‘(A) facilitate coordination between and 

12 among Federal, State, local, Tribal, and terri13 torial entities and public and private health 

14 care entities that the Secretary determines may 

15 be affected by a public health emergency or po16 tential public health emergency referred to in 

17 paragraph (1) (including communication of 

18 such entities with relevant international enti19 ties, as applicable); 

20 ‘‘(B) make grants, provide for awards, 

21 enter into contracts, and conduct supportive in22 vestigations pertaining to a public health emer23 gency or potential public health emergency, in24 cluding further supporting programs under sec25 tion 319C–1, 319C–2, or 319C–3; 
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1 ‘‘(C) facilitate and accelerate, as applica2 ble, advanced research and development of secu3 rity countermeasures (as defined in section 

4 319F–2), qualified countermeasures (as defined 

5 in section 319F–1), or qualified pandemic or 

6 epidemic products (as defined in section 319F– 

7 3), that are applicable to the public health 

8 emergency or potential public health emergency 

9 under paragraph (1); 

10 ‘‘(D) strengthen biosurveillance capabilities 

11 and laboratory capacity to identify, collect, and 

12 analyze information regarding such public 

13 health emergency or potential public health 

14 emergency, including the systems under section 

15 319D; 

16 ‘‘(E) support initial emergency operations 

17 and assets related to preparation and deploy18 ment of intermittent disaster response per19 sonnel under section 2812 and the Medical Re20 serve Corps under section 2813; and 

21 ‘‘(F) carry out other activities, as the Sec22 retary determines applicable and appropriate.’’; 

23 and 

24 (D) by inserting after paragraph (3), as so 

25 redesignated, the following: 
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1 ‘‘(4) REVIEW.—Not later than 2 years after the 

2 date of enactment of the Pandemic and All-Hazards 

3 Preparedness and Advancing Innovation Act of 

4 2019, the Secretary, in coordination with the Assist5 ant Secretary for Preparedness and Response, shall 

6 conduct a review of the Fund under this section and 

7 provide recommendations to the Committee on 

8 Health, Education, Labor, and Pensions and the 

9 Committee on Appropriations of the Senate and the 

10 Committee on Energy and Commerce and the Com11 mittee on Appropriations of the House of Represent12 atives on policies to improve such Fund for the uses 

13 described in paragraph (2). 

14 ‘‘(5) GAO REPORT.—Not later than 4 years 

15 after the date of enactment of the Pandemic and 

16 All-Hazards Preparedness and Advancing Innovation 

17 Act of 2019, the Comptroller General of the United 

18 States shall— 

19 ‘‘(A) conduct a review of the Fund under 

20 this section, including its uses and the re21 sources available in the Fund; and 

22 ‘‘(B) submit to the Committee on Health, 

23 Education, Labor, and Pensions of the Senate 

24 and the Committee on Energy and Commerce 

25 of the House of Representatives a report on 
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1 such review, including recommendations related 

2 to such review, as applicable.’’; and 

3 (2) in subsection (c)— 

4 (A) by inserting ‘‘rapidly respond to public 

5 health emergencies or potential public health 

6 emergencies and’’ after ‘‘used to’’; and 

7 (B) by striking ‘‘section.’’ and inserting 

8 ‘‘Act or funds otherwise provided for emergency 

9 response.’’. 

10 SEC. 207. IMPROVING ALL-HAZARDS PREPAREDNESS AND 

11 RESPONSE BY PUBLIC HEALTH EMERGENCY 

12 VOLUNTEERS. 

13 (a) IN GENERAL.—Section 319I (42 U.S.C. 247d– 

14 7b) is amended— 

15 (1) in the section heading, by striking 

16 ‘‘HEALTH PROFESSIONS VOLUNTEERS’’ and in17 serting ‘‘VOLUNTEER HEALTH PROFESSIONAL’’; 

18 (2) in subsection (a), by adding at the end the 

19 following: ‘‘Such health care professionals may in20 clude members of the National Disaster Medical 

21 System, members of the Medical Reserve Corps, and 

22 individual health care professionals.’’; 

23 (3) in subsection (i), by adding at the end the 

24 following: ‘‘In order to inform the development of 

25 such mechanisms by States, the Secretary shall 
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1 make available information and material provided by 

2 States that have developed mechanisms to waive the 

3 application of licensing requirements to applicable 

4 health professionals seeking to provide medical serv5 ices during a public health emergency. Such infor6 mation shall be made publicly available in a manner 

7 that does not compromise national security.’’; and 

8 (4) in subsection (k), by striking ‘‘2014 through 

9 2018’’ and inserting ‘‘2019 through 2023’’. 

10 (b) ALL-HAZARDS PUBLIC HEALTH EMERGENCY

11 PREPAREDNESS AND RESPONSE PLAN.—Section 319C– 

12 1(b)(2)(A)(iv) (42 U.S.C. 247d–3a(b)(2)(A)(iv)) is 

13 amended to read as follows: 

14 ‘‘(iv) a description of the mechanism the 

15 entity will implement to utilize the Emergency 

16 Management Assistance Compact, or other mu17 tual aid agreement, for medical and public 

18 health mutual aid, and, as appropriate, the ac19 tivities such entity will implement pursuant to 

20 section 319I to improve enrollment and coordi21 nation of volunteer health care professionals 

22 seeking to provide medical services during a 

23 public health emergency, which may include— 
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1 ‘‘(I) providing a public method of 

2 communication for purposes of volunteer 

3 coordination (such as a phone number); 

4 ‘‘(II) providing for optional registra5 tion to participate in volunteer services 

6 during processes related to State medical 

7 licensing, registration, or certification or 

8 renewal of such licensing, registration, or 

9 certification; or 

10 ‘‘(III) other mechanisms as the State 

11 determines appropriate;’’. 

12 SEC. 208. CLARIFYING STATE LIABILITY LAW FOR VOLUN13 TEER HEALTH CARE PROFESSIONALS. 

14 (a) IN GENERAL.—Title II (42 U.S.C. 202 et seq.) 

15 is amended by inserting after section 224 the following: 

16 ‘‘SEC. 225. HEALTH CARE PROFESSIONALS ASSISTING DUR17 ING A PUBLIC HEALTH EMERGENCY. 

18 ‘‘(a) LIMITATION ON LIABILITY.—Notwithstanding 

19 any other provision of law, a health care professional who 

20 is a member of the Medical Reserve Corps under section 

21 2813 or who is included in the Emergency System for Ad22 vance Registration of Volunteer Health Professionals 

23 under section 319I and who— 

24 ‘‘(1) is responding— 
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1 ‘‘(A) to a public health emergency deter2 mined under section 319(a), during the initial 

3 period of not more than 90 days (as determined 

4 by the Secretary) of the public health emer5 gency determination (excluding any period cov6 ered by a renewal of such determination); or 

7 ‘‘(B) to a major disaster or an emergency 

8 as declared by the President under section 401 

9 of the Robert T. Stafford Disaster Relief and 

10 Emergency Assistance Act (42 U.S.C. 5170) or 

11 under section 201 of the National Emergencies 

12 Act (50 U.S.C. 1621) during the initial period 

13 of such declaration; 

14 ‘‘(2) is alleged to be liable for an act or omis15 sion— 

16 ‘‘(A) during the initial period of a deter17 mination or declaration described in paragraph 

18 (1) and related to the treatment of individuals 

19 in need of health care services due to such pub20 lic health emergency, major disaster, or emer21 gency; 

22 ‘‘(B) in the State or States for which such 

23 determination or declaration is made; 

24 ‘‘(C) in the health care professional’s ca25 pacity as a member of the Medical Reserve 
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1 Corps or a professional included in the Emer2 gency System for Advance Registration of Vol3 unteer Health Professionals under section 319I; 

4 and 

5 ‘‘(D) in the course of providing services 

6 that are within the scope of the license, reg7 istration, or certification of the professional, as 

8 defined by the State of licensure, registration, 

9 or certification; and 

10 ‘‘(3) prior to the rendering of such act or omis11 sion, was authorized by the State’s authorization of 

12 deploying such State’s Emergency System for Ad13 vance Registration of Volunteer Health Professionals 

14 described in section 319I or the Medical Reserve 

15 Corps established under section 2813, to provide 

16 health care services, 

17 shall be subject only to the State liability laws of the State 

18 in which such act or omission occurred, in the same man19 ner and to the same extent as a similar health care profes20 sional who is a resident of such State would be subject 

21 to such State laws, except with respect to the licensure, 

22 registration, and certification of such individual. 

23 ‘‘(b) VOLUNTEER PROTECTION ACT.—Nothing in 

24 this section shall be construed to affect an individual’s 
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1 right to protections under the Volunteer Protection Act 

2 of 1997. 

3 ‘‘(c) PREEMPTION.—This section shall supersede the 

4 laws of any State that would subject a health care profes5 sional described in subsection (a) to the liability laws of 

6 any State other than the State liability laws to which such 

7 individual is subject pursuant to such subsection. 

8 ‘‘(d) DEFINITIONS.—In this section: 

9 ‘‘(1) The term ‘health care professional’ means 

10 an individual licensed, registered, or certified under 

11 Federal or State laws or regulations to provide 

12 health care services. 

13 ‘‘(2) The term ‘health care services’ means any 

14 services provided by a health care professional, or by 

15 any individual working under the supervision of a 

16 health care professional, that relate to— 

17 ‘‘(A) the diagnosis, prevention, or treat18 ment of any human disease or impairment; or 

19 ‘‘(B) the assessment or care of the health 

20 of human beings. 

21 ‘‘(e) EFFECTIVE DATE.— 

22 ‘‘(1) IN GENERAL.—This section shall take ef23 fect 90 days after the date of the enactment of the 

24 Pandemic and All-Hazards Preparedness and Ad25 vancing Innovation Act of 2019. 
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1 ‘‘(2) APPLICATION.—This section shall apply to 

2 a claim for harm only if the act or omission that 

3 caused such harm occurred on or after the effective 

4 date described in paragraph (1).’’. 

5 (b) GAO STUDY.—Not later than one year after the 

6 date of enactment of this Act, the Comptroller General 

7 of the United States shall conduct a review of— 

8 (1) the number of health care providers who 

9 register under the Emergency System for Advance 

10 Registration of Volunteer Health Professionals 

11 under section 319I of the Public Health Service Act 

12 (42 U.S.C. 247d–7b) in advance to provide services 

13 during a public health emergency; 

14 (2) the number of health care providers who are 

15 credentialed to provide services during the period of 

16 a public health emergency declaration, including 

17 those who are credentialed though programs estab18 lished in the Emergency System for Advance Reg19 istration of Volunteer Health Professionals under 

20 such section 319I and those credentialed by authori21 ties within the State in which the emergency oc22 curred; 

23 (3) the average time to verify the credentials of 

24 a health care provider during the period of a public 

25 health emergency declaration, including the average 
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1 time pursuant to the Emergency System for Ad2 vance Registration of Volunteer Health Professionals 

3 under such section 319I and for an individual’s cre4 dentials to be verified by an authority within the 

5 State; and 

6 (4) the Emergency System for Advance Reg7 istration of Volunteer Health Professionals program 

8 in States, including whether physician or medical 

9 groups, associations, or other relevant provider orga10 nizations utilize such program for purposes of volun11 teering during public health emergencies. 

12 SEC. 209. REPORT ON ADEQUATE NATIONAL BLOOD SUP13 PLY. 

14 Not later than 1 year after the date of the enactment 

15 of this Act, the Secretary of Health and Human Services 

16 shall submit to Congress a report containing recommenda17 tions related to maintaining an adequate national blood 

18 supply, including— 

19 (1) challenges associated with the continuous 

20 recruitment of blood donors (including those newly 

21 eligible to donate); 

22 (2) ensuring the adequacy of the blood supply 

23 in the case of public health emergencies; 

24 (3) implementation of the transfusion trans25 mission monitoring system; and 
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1 (4) other measures to promote safety and inno2 vation, such as the development, use, or implementa3 tion of new technologies, processes, and procedures 

4 to improve the safety and reliability of the blood 

5 supply. 

6 SEC. 210. REPORT ON THE PUBLIC HEALTH PREPARED7 NESS AND RESPONSE CAPABILITIES AND CA8 PACITIES OF HOSPITALS, LONG-TERM CARE 

9 FACILITIES, AND OTHER HEALTH CARE FA10 CILITIES. 

11 (a) STUDY.— 

12 (1) IN GENERAL.—Not later than one year 

13 after the date of enactment of this Act, the Sec14 retary of Health and Human Services shall enter 

15 into an agreement with an appropriate entity to con16 duct a study regarding the public health prepared17 ness and response capabilities and medical surge ca18 pacities of hospitals, long-term care facilities, and 

19 other health care facilities to prepare for, and re20 spond to, public health emergencies, including nat21 ural disasters. 

22 (2) CONSULTATION.—In conducting the study 

23 under paragraph (1), the entity shall consult with 

24 Federal, State, local, Tribal, and territorial public 

25 health officials (as appropriate), and health care 
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1 providers and facilities with experience in public 

2 health preparedness and response activities. 

3 (3) EVALUATION.—The study under paragraph 

4 (1) shall include— 

5 (A) an evaluation of the current bench6 marks and objective standards, as applicable, 

7 related to programs that support hospitals, 

8 long-term care facilities, and other health care 

9 facilities, and their effect on improving public 

10 health preparedness and response capabilities 

11 and medical surge capacities, including the 

12 Hospital Preparedness Program, the Public 

13 Health Emergency Preparedness cooperative 

14 agreements, and the Regional Health Care 

15 Emergency Preparedness and Response Sys16 tems under section 319C–3 of the Public 

17 Health Service Act (as added by section 203); 

18 (B) the identification of gaps in prepared19 ness, including with respect to such benchmarks 

20 and objective standards, such as those identified 

21 during recent public health emergencies, for 

22 hospitals, long-term care facilities, and other 

23 health care facilities to address future potential 

24 public health threats; 
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1 (C) an evaluation of coordination efforts 

2 between the recipients of Federal funding for 

3 programs described in subparagraph (A) and 

4 entities with expertise in emergency power sys5 tems and other critical infrastructure partners 

6 during a public health emergency, to ensure a 

7 functioning critical infrastructure, to the great8 est extent practicable, during a public health 

9 emergency; 

10 (D) an evaluation of coordination efforts 

11 between the recipients of Federal funding for 

12 programs described in subparagraph (A) and 

13 environmental health agencies with expertise in 

14 emergency preparedness and response planning 

15 for hospitals, long-term care facilities, and other 

16 health care facilities; and 

17 (E) an evaluation of current public health 

18 preparedness and response capabilities and 

19 medical surge capacities related to at-risk indi20 viduals during public health emergencies, in21 cluding an identification of gaps in such pre22 paredness as they relate to such individuals. 

23 (b) REPORT.— 

24 (1) IN GENERAL.—The agreement under sub25 section (a) shall require the entity to submit to the 
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1 Secretary of Health and Human Services and the 

2 congressional committees of jurisdiction, not later 

3 than 3 years after the date of enactment of this Act, 

4 a report on the results of the study conducted pur5 suant to this section. 

6 (2) CONTENTS.—The report under paragraph 

7 (1) shall— 

8 (A) describe the findings and conclusions 

9 of the evaluation conducted pursuant to sub10 section (a); and 

11 (B) provide recommendations for improv12 ing public health preparedness and response ca13 pability and medical surge capacity for hos14 pitals, long-term care facilities, and other health 

15 care facilities, including— 

16 (i) improving the existing benchmarks 

17 and objective standards for the Federal 

18 grant programs described in subsection 

19 (a)(3)(A) or developing new benchmarks 

20 and standards for such programs; and 

21 (ii) identifying best practices for im22 proving public health preparedness and re23 sponse programs and medical surge capac24 ity at hospitals, long-term care facilities, 

25 and other health care facilities, including 
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1 recommendations for the evaluation under 

2 subparagraphs (C) and (D) of subsection 

3 (a)(3). 

4 TITLE III—REACHING ALL 

5 COMMUNITIES 

6 SEC. 301. STRENGTHENING AND ASSESSING THE EMER7 GENCY RESPONSE WORKFORCE. 

8 (a) NATIONAL DISASTER MEDICAL SYSTEM.— 

9 (1) STRENGTHENING THE NATIONAL DISASTER

10 MEDICAL SYSTEM.—Clause (ii) of section 

11 2812(a)(3)(A) (42 U.S.C. 300hh–11(a)(3)(A)) is 

12 amended to read as follows: 

13 ‘‘(ii) be present at locations, and for 

14 limited periods of time, specified by the 

15 Secretary on the basis that the Secretary 

16 has determined that a location is at risk of 

17 a public health emergency during the time 

18 specified, or there is a significant potential 

19 for a public health emergency.’’. 

20 (2) REVIEW OF THE NATIONAL DISASTER MED21 ICAL SYSTEM.—Section 2812(b)(2) (42 U.S.C. 

22 300hh–11(b)(2)) is amended to read as follows: 

23 ‘‘(2) JOINT REVIEW AND MEDICAL SURGE CA24 PACITY STRATEGIC PLAN.— 
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1 ‘‘(A) REVIEW.—Not later than 180 days 

2 after the date of enactment of the Pandemic 

3 and All-Hazards Preparedness and Advancing 

4 Innovation Act of 2019, the Secretary, in co5 ordination with the Secretary of Homeland Se6 curity, the Secretary of Defense, and the Sec7 retary of Veterans Affairs, shall conduct a joint 

8 review of the National Disaster Medical System. 

9 Such review shall include— 

10 ‘‘(i) an evaluation of medical surge ca11 pacity, as described in section 2803(a); 

12 ‘‘(ii) an assessment of the available 

13 workforce of the intermittent disaster re14 sponse personnel described in subsection 

15 (c); 

16 ‘‘(iii) the capacity of the workforce de17 scribed in clause (ii) to respond to all haz18 ards, including capacity to simultaneously 

19 respond to multiple public health emer20 gencies and the capacity to respond to a 

21 nationwide public health emergency; 

22 ‘‘(iv) the effectiveness of efforts to re23 cruit, retain, and train such workforce; and 
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1 ‘‘(v) gaps that may exist in such 

2 workforce and recommendations for ad3 dressing such gaps. 

4 ‘‘(B) UPDATES.—As part of the National 

5 Health Security Strategy under section 2802, 

6 the Secretary shall update the findings from the 

7 review under subparagraph (A) and provide rec8 ommendations to modify the policies of the Na9 tional Disaster Medical System as necessary.’’. 

10 (3) NOTIFICATION OF SHORTAGE.—Section 

11 2812(c) (42 U.S.C. 300hh–11(c)) is amended by 

12 adding at the end the following: 

13 ‘‘(3) NOTIFICATION.—Not later than 30 days 

14 after the date on which the Secretary determines the 

15 number of intermittent disaster-response personnel 

16 of the National Disaster Medical System is insuffi17 cient to address a public health emergency or poten18 tial public health emergency, the Secretary shall sub19 mit to the congressional committees of jurisdiction a 

20 notification detailing— 

21 ‘‘(A) the impact such shortage could have 

22 on meeting public health needs and emergency 

23 medical personnel needs during a public health 

24 emergency; and 
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1 ‘‘(B) any identified measures to address 

2 such shortage. 

3 ‘‘(4) CERTAIN APPOINTMENTS.— 

4 ‘‘(A) IN GENERAL.—If the Secretary deter5 mines that the number of intermittent disaster 

6 response personnel within the National Disaster 

7 Medical System under this section is insuffi8 cient to address a public health emergency or 

9 potential public health emergency, the Secretary 

10 may appoint candidates directly to personnel 

11 positions for intermittent disaster response 

12 within such system. The Secretary shall provide 

13 updates on the number of vacant or unfilled po14 sitions within such system to the congressional 

15 committees of jurisdiction each quarter for 

16 which this authority is in effect. 

17 ‘‘(B) SUNSET.—The authority under this 

18 paragraph shall expire on September 30, 

19 2021.’’. 

20 (4) AUTHORIZATION OF APPROPRIATIONS.— 

21 Section 2812(g) (42 U.S.C. 300hh–11(g)) is amend22 ed by striking ‘‘$52,700,000 for each of fiscal years 

23 2014 through 2018’’ and inserting ‘‘$57,400,000 for 

24 each of fiscal years 2019 through 2023’’. 

25 (b) VOLUNTEER MEDICAL RESERVE CORPS.— 
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1 (1) IN GENERAL.—Section 2813(a) (42 U.S.C. 

2 42 U.S.C. 300hh–15(a)) is amended by striking the 

3 second sentence and inserting ‘‘The Secretary may 

4 appoint a Director to head the Corps and oversee 

5 the activities of the Corps chapters that exist at the 

6 State, local, Tribal, and territorial levels.’’. 

7 (2) AUTHORIZATION OF APPROPRIATIONS.— 

8 Section 2813(i) (42 U.S.C. 300hh–15(i)) is amended 

9 by striking ‘‘2014 through 2018’’ and inserting 

10 ‘‘2019 through 2023’’. 

11 (c) STRENGTHENING THE EPIDEMIC INTELLIGENCE

12 SERVICE.—Section 317F (42 U.S.C. Sec. 247b–7) is 

13 amended— 

14 (1) in subsection (a)— 

15 (A) in paragraph (1)— 

16 (i) by inserting ‘‘or preparedness and 

17 response activities, including rapid re18 sponse to public health emergencies and 

19 significant public health threats’’ after 

20 ‘‘conduct prevention activities’’; and 

21 (ii) by striking ‘‘$35,000’’ and insert22 ing ‘‘$50,000’’; and 

23 (B) in paragraph (2)(B), by striking ‘‘3 

24 years’’ and inserting ‘‘2 years’’; and 

25 (2) in subsection (c)— 
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1 (A) by striking ‘‘For the purpose of car2 rying out this section’’ and inserting the fol3 lowing: 

4 ‘‘(1) IN GENERAL.—For the purpose of car5 rying out this section, except as described in para6 graph (2)’’; and 

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

8 ‘‘(2) EPIDEMIC INTELLIGENCE SERVICE PRO9 GRAM.—For purposes of carrying out this section 

10 with respect to qualified health professionals serving 

11 in the Epidemic Intelligence Service, as authorized 

12 under section 317G, there is authorized to be appro13 priated $1,000,000 for each of fiscal years 2019 

14 through 2023.’’. 

15 (d) SERVICE BENEFIT FOR NATIONAL DISASTER

16 MEDICAL SYSTEM VOLUNTEERS.— 

17 (1) IN GENERAL.—Section 2812(c) (42 U.S.C. 

18 300hh–11(c)), as amended by subsection (a)(3), is 

19 further amended by adding at the end the following: 

20 ‘‘(5) SERVICE BENEFIT.—Individuals appointed 

21 to serve under this subsection shall be considered eli22 gible for benefits under part L of title I of the Om23 nibus Crime Control and Safe Streets Act of 1968. 

24 The Secretary shall provide notification to any eligi25 ble individual of any effect such designation may 
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1 have on other benefits for which such individual is 

2 eligible, including benefits from private entities.’’. 

3 (2) PUBLIC SAFETY OFFICER BENEFITS.—Sec4 tion 1204(9) of title I of the Omnibus Crime Control 

5 and Safe Streets Act of 1968 (34 U.S.C. 10284(9)) 

6 is amended— 

7 (A) in subparagraph (C)(ii), by striking 

8 ‘‘or’’ at the end; 

9 (B) in subparagraph (D), by striking the 

10 period and inserting ‘‘; or’’; and 

11 (C) by inserting after subparagraph (D) 

12 the following: 

13 ‘‘(E) an individual appointed to the Na14 tional Disaster Medical System under section 

15 2812 of the Public Health Service Act (42 

16 U.S.C. 300hh–11) who is performing official 

17 duties of the Department of Health and Human 

18 Services, if those official duties are— 

19 ‘‘(i) related to responding to a public 

20 health emergency or potential public health 

21 emergency, or other activities for which the 

22 Secretary of Health and Human Services 

23 has activated such National Disaster Med24 ical System; and 
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1 ‘‘(ii) determined by the Secretary of 

2 Health and Human Services to be haz3 ardous.’’. 

4 (3) SUNSET.—The amendments made by para5 graphs (1) and (2) shall cease to have force or effect 

6 on October 1, 2021. 

7 (e) MISSION READINESS REPORT TO CONGRESS.— 

8 (1) REPORT.—Not later than one year after the 

9 date of enactment of this section, the Comptroller 

10 General of the United States (referred to in this 

11 subsection as the ‘‘Comptroller General’’) shall sub12 mit to the Committee on Health, Education, Labor, 

13 and Pensions of the Senate and the Committee on 

14 Energy and Commerce of the House of Representa15 tives, a report on the medical surge capacity of the 

16 United States in the event of a public health emer17 gency, including the capacity and capability of the 

18 current health care workforce to prepare for, and re19 spond to, the full range of public health emergencies 

20 or potential public health emergencies, and rec21 ommendations to address any gaps identified in such 

22 workforce. 

23 (2) CONTENTS.—The Comptroller General shall 

24 include in the report under paragraph (1)— 
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1 (A) the number of health care providers 

2 who have volunteered to provide health care 

3 services during a public health emergency, in4 cluding members of the National Disaster Med5 ical System, the Disaster Medical Assistant 

6 Teams, the Medical Reserve Corps, and other 

7 volunteer health care professionals in the 

8 verification network pursuant to section 319I of 

9 the Public Health Service Act (42 U.S.C. 

10 247d–7b); 

11 (B) the capacity of the workforce described 

12 in subparagraph (A) to respond to a public 

13 health emergency or potential public health 

14 emergency, including the capacity to respond to 

15 multiple concurrent public health emergencies 

16 and the capacity to respond to a nationwide 

17 public health emergency; 

18 (C) the preparedness and response capa19 bilities and mission readiness of the workforce 

20 described in subparagraph (A) taking into ac21 count areas of health care expertise and consid22 erations for at-risk individuals (as defined in 

23 section 2802(b)(4)(B) of the Public Health 

24 Service Act (42 U.S.C. 300hh–1(b)(4)(B))); 
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1 (D) an assessment of the effectiveness of 

2 efforts to recruit, retain, and train such work3 force; and 

4 (E) identification of gaps that may exist in 

5 such workforce and recommendations for ad6 dressing such gaps, the extent to which the As7 sistant Secretary for Preparedness and Re8 sponse plans to address such gaps, and any rec9 ommendations from the Comptroller General to 

10 address such gaps. 

11 SEC. 302. HEALTH SYSTEM INFRASTRUCTURE TO IMPROVE 

12 PREPAREDNESS AND RESPONSE. 

13 (a) COORDINATION OF PREPAREDNESS.—Section 

14 2811(b)(5) (42 U.S.C. 300hh–10(b)(5)) is amended by 

15 adding at the end the following: ‘‘Such logistical support 

16 shall include working with other relevant Federal, State, 

17 local, Tribal, and territorial public health officials and pri18 vate sector entities to identify the critical infrastructure 

19 assets, systems, and networks needed for the proper func20 tioning of the health care and public health sectors that 

21 need to be maintained through any emergency or disaster, 

22 including entities capable of assisting with, responding to, 

23 and mitigating the effect of a public health emergency, 

24 including a public health emergency determined by the 

25 Secretary pursuant to section 319(a) or an emergency or 
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1 major disaster declared by the President under the Robert 

2 T. Stafford Disaster Relief and Emergency Assistance Act 

3 or the National Emergencies Act, including by estab4 lishing methods to exchange critical information and de5 liver products consumed or used to preserve, protect, or 

6 sustain life, health, or safety, and sharing of specialized 

7 expertise.’’. 

8 (b) MANUFACTURING CAPACITY.—Section 

9 2811(d)(2)(C) (42 U.S.C. 300hh–10(d)(2)(C)) is amended 

10 by inserting ‘‘, and ancillary medical supplies to assist 

11 with the utilization of such countermeasures or products,’’ 

12 after ‘‘products’’. 

13 (c) EVALUATION OF BARRIERS TO RAPID DELIVERY

14 OF MEDICAL COUNTERMEASURES.— 

15 (1) RAPID DELIVERY STUDY.—The Assistant 

16 Secretary for Preparedness and Response may con17 duct a study on issues that have the potential to ad18 versely affect the handling and rapid delivery of 

19 medical countermeasures to individuals during public 

20 health emergencies occurring in the United States. 

21 (2) NOTICE TO CONGRESS.—Not later than 9 

22 months after the date of the enactment of this Act, 

23 the Assistant Secretary for Preparedness and Re24 sponse shall notify the Committee on Energy and 

25 Commerce of the House of Representatives and the 
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1 Committee on Health, Education, Labor, and Pen2 sions of the Senate if the Assistant Secretary for 

3 Preparedness and Response does not plan to conduct 

4 the study under paragraph (1) and shall provide 

5 such committees a summary explanation for such de6 cision. 

7 (3) REPORT TO CONGRESS.—Not later than 1 

8 year after the Assistant Secretary for Preparedness 

9 and Response conducts the study under paragraph 

10 (1), such Assistant Secretary shall submit a report 

11 to the Committee on Energy and Commerce of the 

12 House of Representatives and the Committee on 

13 Health, Education, Labor, and Pensions of the Sen14 ate containing the findings of such study. 

15 SEC. 303. CONSIDERATIONS FOR AT-RISK INDIVIDUALS. 

16 (a) AT-RISK INDIVIDUALS IN THE NATIONAL

17 HEALTH SECURITY STRATEGY.—Section 2802(b)(4)(B) 

18 (42 U.S.C. 300hh–1(b)(4)(B)) is amended— 

19 (1) by striking ‘‘this section and sections 319C– 

20 1, 319F, and 319L,’’ and inserting ‘‘this Act,’’; and 

21 (2) by striking ‘‘special’’ and inserting ‘‘access 

22 or functional’’. 

23 (b) COUNTERMEASURE CONSIDERATIONS.—Section 

24 319L(c)(6) (42 U.S.C. 247d–7e(c)(6)) is amended— 
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1 (1) by striking ‘‘elderly’’ and inserting ‘‘older 

2 adults’’; and 

3 (2) by inserting ‘‘with relevant characteristics 

4 that warrant consideration during the process of re5 searching and developing such countermeasures and 

6 products’’ before the period. 

7 (c) BIOSURVEILLANCE OF EMERGING PUBLIC

8 HEALTH THREATS.—Section 2814 is amended— 

9 (1) in paragraph (7), by striking ‘‘; and’’ and 

10 inserting a semicolon; 

11 (2) in paragraph (8), by striking the period and 

12 inserting ‘‘; and’’; and 

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

14 ‘‘(9) facilitate coordination to ensure that, in 

15 implementing the situational awareness and bio16 surveillance network under section 319D, the Sec17 retary considers incorporating data and information 

18 from Federal, State, local, Tribal, and territorial 

19 public health officials and entities relevant to detect20 ing emerging public health threats that may affect 

21 at-risk individuals, such as pregnant and postpartum 

22 women and infants, including adverse health out23 comes of such populations related to such emerging 

24 public health threats.’’. 
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1 SEC. 304. IMPROVING EMERGENCY PREPAREDNESS AND 

2 RESPONSE CONSIDERATIONS FOR CHIL3 DREN. 

4 Part B of title III (42 U.S.C. 243 et seq.) is amended 

5 by inserting after section 319D the following: 

6 ‘‘SEC. 319D–1. CHILDREN’S PREPAREDNESS UNIT. 

7 ‘‘(a) ENHANCING EMERGENCY PREPAREDNESS FOR

8 CHILDREN.—The Secretary, acting through the Director 

9 of the Centers for Disease Control and Prevention (re10 ferred to in this subsection as the ‘Director’), shall main11 tain an internal team of experts, to be known as the Chil12 dren’s Preparedness Unit (referred to in this subsection 

13 as the ‘Unit’), to work collaboratively to provide guidance 

14 on the considerations for, and the specific needs of, chil15 dren before, during, and after public health emergencies. 

16 The Unit shall inform the Director regarding emergency 

17 preparedness and response efforts pertaining to children 

18 at the Centers for Disease Control and Prevention. 

19 ‘‘(b) EXPERTISE.—The team described in subsection 

20 (a) shall include one or more pediatricians, which may be 

21 a developmental-behavioral pediatrician, and may also in22 clude behavioral scientists, child psychologists, epidemiolo23 gists, biostatisticians, health communications staff, and 

24 individuals with other areas of expertise, as the Secretary 

25 determines appropriate. 
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1 ‘‘(c) DUTIES.—The team described in subsection (a) 

2 may— 

3 ‘‘(1) assist State, local, Tribal, and territorial 

4 emergency planning and response activities related 

5 to children, which may include developing, identi6 fying, and sharing best practices; 

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

8 consultation to Federal, State, local, Tribal, and ter9 ritorial public health officials to improve prepared10 ness and response capabilities with respect to the 

11 needs of children, including providing such technical 

12 assistance, training, and consultation to eligible enti13 ties in order to support the achievement of measur14 able evidence-based benchmarks and objective stand15 ards applicable to sections 319C–1 and 319C–2; 

16 ‘‘(3) improve the utilization of methods to in17 corporate the needs of children in planning for and 

18 responding to a public health emergency, including 

19 public awareness of such methods; 

20 ‘‘(4) coordinate with, and improve, public-pri21 vate partnerships, such as health care coalitions pur22 suant to sections 319C–2 and 319C–3, to address 

23 gaps and inefficiencies in emergency preparedness 

24 and response efforts for children; 
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1 ‘‘(5) provide expertise and input during the de2 velopment of guidance and clinical recommendations 

3 to address the needs of children when preparing for, 

4 and responding to, public health emergencies, includ5 ing pursuant to section 319C–3; and 

6 ‘‘(6) carry out other duties related to prepared7 ness and response activities for children, as the Sec8 retary determines appropriate.’’. 

9 SEC. 305. NATIONAL ADVISORY COMMITTEES ON DISAS10 TERS. 

11 (a) REAUTHORIZING THE NATIONAL ADVISORY COM12 MITTEE ON CHILDREN AND DISASTERS.—Section 2811A 

13 (42 U.S.C. 300hh–10a) is amended— 

14 (1) in subsection (b)(2), by inserting ‘‘, mental 

15 and behavioral,’’ after ‘‘medical’’; 

16 (2) in subsection (d)— 

17 (A) in paragraph (1), by striking ‘‘15’’ and 

18 inserting ‘‘25’’; and 

19 (B) by striking paragraph (2) and insert20 ing the following: 

21 ‘‘(2) REQUIRED NON-FEDERAL MEMBERS.—The 

22 Secretary, in consultation with such other heads of 

23 Federal agencies as may be appropriate, shall ap24 point to the Advisory Committee under paragraph 

25 (1) at least 13 individuals, including— 
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1 ‘‘(A) at least 2 non-Federal professionals 

2 with expertise in pediatric medical disaster 

3 planning, preparedness, response, or recovery; 

4 ‘‘(B) at least 2 representatives from State, 

5 local, Tribal, or territorial agencies with exper6 tise in pediatric disaster planning, prepared7 ness, response, or recovery; 

8 ‘‘(C) at least 4 members representing 

9 health care professionals, which may include 

10 members with expertise in pediatric emergency 

11 medicine; pediatric trauma, critical care, or sur12 gery; the treatment of pediatric patients af13 fected by chemical, biological, radiological, or 

14 nuclear agents, including emerging infectious 

15 diseases; pediatric mental or behavioral health 

16 related to children affected by a public health 

17 emergency; or pediatric primary care; and 

18 ‘‘(D) other members as the Secretary de19 termines appropriate, of whom— 

20 ‘‘(i) at least one such member shall 

21 represent a children’s hospital; 

22 ‘‘(ii) at least one such member shall 

23 be an individual with expertise in schools 

24 or child care settings; 
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1 ‘‘(iii) at least one such member shall 

2 be an individual with expertise in children 

3 and youth with special health care needs; 

4 and 

5 ‘‘(iv) at least one such member shall 

6 be an individual with expertise in the needs 

7 of parents or family caregivers, including 

8 the parents or caregivers of children with 

9 disabilities. 

10 ‘‘(3) FEDERAL MEMBERS.—The Advisory Com11 mittee under paragraph (1) shall include the fol12 lowing Federal members or their designees (who 

13 may be nonvoting members, as determined by the 

14 Secretary): 

15 ‘‘(A) The Assistant Secretary for Pre16 paredness and Response. 

17 ‘‘(B) The Director of the Biomedical Ad18 vanced Research and Development Authority. 

19 ‘‘(C) The Director of the Centers for Dis20 ease Control and Prevention. 

21 ‘‘(D) The Commissioner of Food and 

22 Drugs. 

23 ‘‘(E) The Director of the National Insti24 tutes of Health. 
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1 ‘‘(F) The Assistant Secretary of the Ad2 ministration for Children and Families. 

3 ‘‘(G) The Administrator of the Health Re4 sources and Services Administration. 

5 ‘‘(H) The Administrator of the Federal 

6 Emergency Management Agency. 

7 ‘‘(I) The Administrator of the Administra8 tion for Community Living. 

9 ‘‘(J) The Secretary of Education. 

10 ‘‘(K) Representatives from such Federal 

11 agencies (such as the Substance Abuse and 

12 Mental Health Services Administration and the 

13 Department of Homeland Security) as the Sec14 retary determines appropriate to fulfill the du15 ties of the Advisory Committee under sub16 sections (b) and (c). 

17 ‘‘(4) TERM OF APPOINTMENT.—Each member 

18 of the Advisory Committee appointed under para19 graph (2) shall serve for a term of 3 years, except 

20 that the Secretary may adjust the terms of the Advi21 sory Committee appointees serving on the date of 

22 enactment of the Pandemic and All-Hazards Pre23 paredness and Advancing Innovation Act of 2019, or 

24 appointees who are initially appointed after such 
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1 date of enactment, in order to provide for a stag2 gered term of appointment for all members. 

3 ‘‘(5) CONSECUTIVE APPOINTMENTS; MAXIMUM

4 TERMS.—A member appointed under paragraph (2) 

5 may serve not more than 3 terms on the Advisory 

6 Committee, and not more than two of such terms 

7 may be served consecutively.’’; 

8 (3) in subsection (e), by adding at the end ‘‘At 

9 least one meeting per year shall be an in-person 

10 meeting.’’; 

11 (4) by redesignating subsection (f) as sub12 section (g); 

13 (5) by inserting after subsection (e) the fol14 lowing: 

15 ‘‘(f) COORDINATION.—The Secretary shall coordinate 

16 duties and activities authorized under this section in ac17 cordance with section 2811D.’’; and 

18 (6) in subsection (g), as so redesignated, by 

19 striking ‘‘2018’’ and inserting ‘‘2023’’. 

20 (b) AUTHORIZING THE NATIONAL ADVISORY COM21 MITTEE ON SENIORS AND DISASTERS.—Subtitle B of title 

22 XXVIII (42 U.S.C. 300hh et seq.) is amended by inserting 

23 after section 2811A the following: 
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1 ‘‘SEC. 2811B. NATIONAL ADVISORY COMMITTEE ON SEN2 IORS AND DISASTERS. 

3 ‘‘(a) ESTABLISHMENT.—The Secretary, in consulta4 tion with the Secretary of Homeland Security and the Sec5 retary of Veterans Affairs, shall establish an advisory com6 mittee to be known as the National Advisory Committee 

7 on Seniors and Disasters (referred to in this section as 

8 the ‘Advisory Committee’). 

9 ‘‘(b) DUTIES.—The Advisory Committee shall— 

10 ‘‘(1) provide advice and consultation with re11 spect to the activities carried out pursuant to section 

12 2814, as applicable and appropriate; 

13 ‘‘(2) evaluate and provide input with respect to 

14 the medical and public health needs of seniors re15 lated to preparation for, response to, and recovery 

16 from all-hazards emergencies; and 

17 ‘‘(3) provide advice and consultation with re18 spect to State emergency preparedness and response 

19 activities relating to seniors, including related drills 

20 and exercises pursuant to the preparedness goals 

21 under section 2802(b). 

22 ‘‘(c) ADDITIONAL DUTIES.—The Advisory Committee 

23 may provide advice and recommendations to the Secretary 

24 with respect to seniors and the medical and public health 

25 grants and cooperative agreements as applicable to pre-
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1 paredness and response activities under this title and title 

2 III. 

3 ‘‘(d) MEMBERSHIP.— 

4 ‘‘(1) IN GENERAL.—The Secretary, in consulta5 tion with such other heads of agencies as appro6 priate, shall appoint not more than 17 members to 

7 the Advisory Committee. In appointing such mem8 bers, the Secretary shall ensure that the total mem9 bership of the Advisory Committee is an odd num10 ber. 

11 ‘‘(2) REQUIRED MEMBERS.—The Advisory 

12 Committee shall include Federal members or their 

13 designees (who may be nonvoting members, as deter14 mined by the Secretary) and non-Federal members, 

15 as follows: 

16 ‘‘(A) The Assistant Secretary for Pre17 paredness and Response. 

18 ‘‘(B) The Director of the Biomedical Ad19 vanced Research and Development Authority. 

20 ‘‘(C) The Director of the Centers for Dis21 ease Control and Prevention. 

22 ‘‘(D) The Commissioner of Food and 

23 Drugs. 

24 ‘‘(E) The Director of the National Insti25 tutes of Health. 
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1 ‘‘(F) The Administrator of the Centers for 

2 Medicare & Medicaid Services. 

3 ‘‘(G) The Administrator of the Administra4 tion for Community Living. 

5 ‘‘(H) The Administrator of the Federal 

6 Emergency Management Agency. 

7 ‘‘(I) The Under Secretary for Health of 

8 the Department of Veterans Affairs. 

9 ‘‘(J) At least 2 non-Federal health care 

10 professionals with expertise in geriatric medical 

11 disaster planning, preparedness, response, or 

12 recovery. 

13 ‘‘(K) At least 2 representatives of State, 

14 local, Tribal, or territorial agencies with exper15 tise in geriatric disaster planning, preparedness, 

16 response, or recovery. 

17 ‘‘(L) Representatives of such other Federal 

18 agencies (such as the Department of Energy 

19 and the Department of Homeland Security) as 

20 the Secretary determines necessary to fulfill the 

21 duties of the Advisory Committee. 

22 ‘‘(e) MEETINGS.—The Advisory Committee shall 

23 meet not less frequently than biannually. At least one 

24 meeting per year shall be an in-person meeting. 
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1 ‘‘(f) COORDINATION.—The Secretary shall coordinate 

2 duties and activities authorized under this section in ac3 cordance with section 2811D. 

4 ‘‘(g) SUNSET.— 

5 ‘‘(1) IN GENERAL.—The Advisory Committee 

6 shall terminate on September 30, 2023. 

7 ‘‘(2) EXTENSION OF COMMITTEE.—Not later 

8 than October 1, 2022, the Secretary shall submit to 

9 Congress a recommendation on whether the Advisory 

10 Committee should be extended.’’. 

11 (c) NATIONAL ADVISORY COMMITTEE ON INDIVID12 UALS WITH DISABILITIES AND DISASTERS.—Subtitle B 

13 of title XXVIII (42 U.S.C. 300hh et seq.), as amended 

14 by subsection (b), is further amended by inserting after 

15 section 2811B the following: 

16 ‘‘SEC. 2811C. NATIONAL ADVISORY COMMITTEE ON INDIVID17 UALS WITH DISABILITIES AND DISASTERS. 

18 ‘‘(a) ESTABLISHMENT.—The Secretary, in consulta19 tion with the Secretary of Homeland Security, shall estab20 lish a national advisory committee to be known as the Na21 tional Advisory Committee on Individuals with Disabilities 

22 and Disasters (referred to in this section as the ‘Advisory 

23 Committee’). 

24 ‘‘(b) DUTIES.—The Advisory Committee shall— 
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1 ‘‘(1) provide advice and consultation with re2 spect to activities carried out pursuant to section 

3 2814, as applicable and appropriate; 

4 ‘‘(2) evaluate and provide input with respect to 

5 the medical, public health, and accessibility needs of 

6 individuals with disabilities related to preparation 

7 for, response to, and recovery from all-hazards emer8 gencies; and 

9 ‘‘(3) provide advice and consultation with re10 spect to State emergency preparedness and response 

11 activities, including related drills and exercises pur12 suant to the preparedness goals under section 

13 2802(b). 

14 ‘‘(c) MEMBERSHIP.— 

15 ‘‘(1) IN GENERAL.—The Secretary, in consulta16 tion with such other heads of agencies and depart17 ments as appropriate, shall appoint not more than 

18 17 members to the Advisory Committee. In appoint19 ing such members, the Secretary shall ensure that 

20 the total membership of the Advisory Committee is 

21 an odd number. 

22 ‘‘(2) REQUIRED MEMBERS.—The Advisory 

23 Committee shall include Federal members or their 

24 designees (who may be nonvoting members, as deter-
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1 mined by the Secretary) and non-Federal members, 

2 as follows: 

3 ‘‘(A) The Assistant Secretary for Pre4 paredness and Response. 

5 ‘‘(B) The Administrator of the Administra6 tion for Community Living. 

7 ‘‘(C) The Director of the Biomedical Ad8 vanced Research and Development Authority. 

9 ‘‘(D) The Director of the Centers for Dis10 ease Control and Prevention. 

11 ‘‘(E) The Commissioner of Food and 

12 Drugs. 

13 ‘‘(F) The Director of the National Insti14 tutes of Health. 

15 ‘‘(G) The Administrator of the Federal 

16 Emergency Management Agency. 

17 ‘‘(H) The Chair of the National Council on 

18 Disability. 

19 ‘‘(I) The Chair of the United States Access 

20 Board. 

21 ‘‘(J) The Under Secretary for Health of 

22 the Department of Veterans Affairs. 

23 ‘‘(K) At least 2 non-Federal health care 

24 professionals with expertise in disability accessi25 bility before, during, and after disasters, med-
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1 ical and mass care disaster planning, prepared2 ness, response, or recovery. 

3 ‘‘(L) At least 2 representatives from State, 

4 local, Tribal, or territorial agencies with exper5 tise in disaster planning, preparedness, re6 sponse, or recovery for individuals with disabil7 ities. 

8 ‘‘(M) At least 2 individuals with a dis9 ability with expertise in disaster planning, pre10 paredness, response, or recovery for individuals 

11 with disabilities. 

12 ‘‘(d) MEETINGS.—The Advisory Committee shall 

13 meet not less frequently than biannually. At least one 

14 meeting per year shall be an in-person meeting. 

15 ‘‘(e) DISABILITY DEFINED.—For purposes of this 

16 section, the term ‘disability’ has the meaning given such 

17 term in section 3 of the Americans with Disabilities Act 

18 of 1990. 

19 ‘‘(f) COORDINATION.—The Secretary shall coordinate 

20 duties and activities authorized under this section in ac21 cordance with section 2811D. 

22 ‘‘(g) SUNSET.— 

23 ‘‘(1) IN GENERAL.—The Advisory Committee 

24 shall terminate on September 30, 2023. 
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1 ‘‘(2) RECOMMENDATION.—Not later than Octo2 ber 1, 2022, the Secretary shall submit to Congress 

3 a recommendation on whether the Advisory Com4 mittee should be extended.’’. 

5 (d) ADVISORY COMMITTEE COORDINATION.—Sub6 title B of title XXVIII (42 U.S.C. 300hh et seq.), as 

7 amended by subsection (c), is further amended by insert8 ing after section 2811C the following: 

9 ‘‘SEC. 2811D. ADVISORY COMMITTEE COORDINATION. 

10 ‘‘(a) IN GENERAL.—The Secretary shall coordinate 

11 duties and activities authorized under sections 2811A, 

12 2811B, and 2811C, and make efforts to reduce unneces13 sary or duplicative reporting, or unnecessary duplicative 

14 meetings and recommendations under such sections, as 

15 practicable. Members of the advisory committees author16 ized under such sections, or their designees, shall annually 

17 meet to coordinate any recommendations, as appropriate, 

18 that may be similar, duplicative, or overlapping with re19 spect to addressing the needs of children, seniors, and in20 dividuals with disabilities during public health emer21 gencies. If such coordination occurs through an in-person 

22 meeting, it shall not be considered the required in-person 

23 meetings under any of sections 2811A(e), 2811B(e), or 

24 2811C(d). 
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1 ‘‘(b) COORDINATION AND ALIGNMENT.—The Sec2 retary, acting through the employee designated pursuant 

3 to section 2814, shall align preparedness and response 

4 programs or activities to address similar, dual, or overlap5 ping needs of children, seniors, and individuals with dis6 abilities, and any challenges in preparing for and respond7 ing to such needs. 

8 ‘‘(c) NOTIFICATION.—The Secretary shall annually 

9 notify the congressional committees of jurisdiction regard10 ing the steps taken to coordinate, as appropriate, the rec11 ommendations under this section, and provide a summary 

12 description of such coordination.’’. 

13 SEC. 306. GUIDANCE FOR PARTICIPATION IN EXERCISES 

14 AND DRILLS. 

15 Not later than 2 years after the date of enactment 

16 of this Act, the Secretary of Health and Human Services 

17 shall issue final guidance regarding the ability of per18 sonnel funded by programs authorized under this Act (in19 cluding the amendments made by this Act) to participate 

20 in drills and operational exercises related to all-hazards 

21 medical and public health preparedness and response. 

22 Such drills and operational exercises may include activities 

23 that incorporate medical surge capacity planning, medical 

24 countermeasure distribution and administration, and pre25 paring for and responding to identified threats for that 
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1 region. Such personnel may include State, local, Tribal, 

2 and territorial public health department or agency per3 sonnel funded under this Act (including the amendments 

4 made by this Act). The Secretary shall consult with the 

5 Department of Homeland Security, the Department of 

6 Defense, the Department of Veterans Affairs, and other 

7 applicable Federal departments and agencies as necessary 

8 and appropriate in the development of such guidance. The 

9 Secretary shall make the guidance available on the inter10 net website of the Department of Health and Human 

11 Services. 

12 TITLE IV—PRIORITIZING A 

13 THREAT-BASED APPROACH 

14 SEC. 401. ASSISTANT SECRETARY FOR PREPAREDNESS AND 

15 RESPONSE. 

16 Section 2811(b) (42 U.S.C. 300hh–10(b)) is amend17 ed— 

18 (1) in the matter preceding paragraph (1), by 

19 inserting ‘‘utilize experience related to public health 

20 emergency preparedness and response, biodefense, 

21 medical countermeasures, and other relevant topics 

22 to’’ after ‘‘shall’’; and 

23 (2) in paragraph (4), by adding at the end the 

24 following: 
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1 ‘‘(I) THREAT AWARENESS.—Coordinate 

2 with the Director of the Centers for Disease 

3 Control and Prevention, the Director of Na4 tional Intelligence, the Secretary of Homeland 

5 Security, the Assistant to the President for Na6 tional Security Affairs, the Secretary of De7 fense, and other relevant Federal officials, such 

8 as the Secretary of Agriculture, to maintain a 

9 current assessment of national security threats 

10 and inform preparedness and response capabili11 ties based on the range of the threats that have 

12 the potential to result in a public health emer13 gency.’’. 

14 SEC. 402. PUBLIC HEALTH EMERGENCY MEDICAL COUN15 TERMEASURES ENTERPRISE. 

16 (a) IN GENERAL.—Title XXVIII is amended by in17 serting after section 2811 (42 U.S.C. 300hh–10) the fol18 lowing: 

19 ‘‘SEC. 2811–1. PUBLIC HEALTH EMERGENCY MEDICAL 

20 COUNTERMEASURES ENTERPRISE. 

21 ‘‘(a) IN GENERAL.—The Secretary shall establish the 

22 Public Health Emergency Medical Countermeasures En23 terprise (referred to in this section as the ‘PHEMCE’). 

24 The Assistant Secretary for Preparedness and Response 

25 shall serve as chair of the PHEMCE. 
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1 ‘‘(b) MEMBERS.—The PHEMCE shall include each 

2 of the following members, or the designee of such mem3 bers: 

4 ‘‘(1) The Assistant Secretary for Preparedness 

5 and Response. 

6 ‘‘(2) The Director of the Centers for Disease 

7 Control and Prevention. 

8 ‘‘(3) The Director of the National Institutes of 

9 Health. 

10 ‘‘(4) The Commissioner of Food and Drugs. 

11 ‘‘(5) The Secretary of Defense. 

12 ‘‘(6) The Secretary of Homeland Security. 

13 ‘‘(7) The Secretary of Agriculture. 

14 ‘‘(8) The Secretary of Veterans Affairs. 

15 ‘‘(9) The Director of National Intelligence. 

16 ‘‘(10) Representatives of any other Federal 

17 agency, which may include the Director of the Bio18 medical Advanced Research and Development Au19 thority, the Director of the Strategic National Stock20 pile, the Director of the National Institute of Allergy 

21 and Infectious Diseases, and the Director of the Of22 fice of Public Health Preparedness and Response, as 

23 the Secretary determines appropriate. 

24 ‘‘(c) FUNCTIONS.— 
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1 ‘‘(1) IN GENERAL.—The functions of the 

2 PHEMCE shall include the following: 

3 ‘‘(A) Utilize a process to make rec4 ommendations to the Secretary regarding re5 search, advanced research, development, pro6 curement, stockpiling, deployment, distribution, 

7 and utilization with respect to countermeasures, 

8 as defined in section 319F–2(c), including 

9 prioritization based on the health security needs 

10 of the United States. Such recommendations 

11 shall be informed by, when available and prac12 ticable, the National Health Security Strategy 

13 pursuant to section 2802, the Strategic Na14 tional Stockpile needs pursuant to section 

15 319F–2, and assessments of current national 

16 security threats, including chemical, biological, 

17 radiological, and nuclear threats, including 

18 emerging infectious diseases. In the event that 

19 members of the PHEMCE do not agree upon a 

20 recommendation, the Secretary shall provide a 

21 determination regarding such recommendation. 

22 ‘‘(B) Identify national health security 

23 needs, including gaps in public health prepared24 ness and response related to countermeasures 

25 and challenges to addressing such needs (in-
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1 cluding any regulatory challenges), and support 

2 alignment of countermeasure procurement with 

3 recommendations to address such needs under 

4 subparagraph (A). 

5 ‘‘(C) Assist the Secretary in developing 

6 strategies related to logistics, deployment, dis7 tribution, dispensing, and use of counter8 measures that may be applicable to the activi9 ties of the strategic national stockpile under 

10 section 319F–2(a). 

11 ‘‘(D) Provide consultation for the develop12 ment of the strategy and implementation plan 

13 under section 2811(d). 

14 ‘‘(2) INPUT.—In carrying out subparagraphs 

15 (B) and (C) of paragraph (1), the PHEMCE shall 

16 solicit and consider input from State, local, Tribal, 

17 and territorial public health departments or officials, 

18 as appropriate.’’. 

19 (b) PUBLIC HEALTH EMERGENCY MEDICAL COUN20 TERMEASURES ENTERPRISE STRATEGY AND IMPLEMEN21 TATION PLAN.—Section 2811(d) (42 U.S.C. 300hh– 

22 10(d)) is amended— 

23 (1) in paragraph (1)— 

24 (A) by striking ‘‘Not later than 180 days 

25 after the date of enactment of this subsection, 
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1 and every year thereafter’’ and inserting ‘‘Not 

2 later than March 15, 2020, and biennially 

3 thereafter’’; and 

4 (B) by striking ‘‘Director of the Bio5 medical’’ and all that follows through ‘‘Food 

6 and Drugs’’ and inserting ‘‘Public Health 

7 Emergency Medical Countermeasures Enter8 prise established under section 2811–1’’; and 

9 (2) in paragraph (2)(J)(v), by striking ‘‘one10 year period’’ and inserting ‘‘2-year period’’. 

11 SEC. 403. STRATEGIC NATIONAL STOCKPILE. 

12 (a) IN GENERAL.—Section 319F–2(a) (42 U.S.C. 

13 247d–6b(a)) is amended— 

14 (1) by redesignating paragraphs (2) and (3) as 

15 paragraphs (3) and (4), respectively; and 

16 (2) in paragraph (1)— 

17 (A) by inserting ‘‘the Assistant Secretary 

18 for Preparedness and Response and’’ after ‘‘col19 laboration with’’; 

20 (B) by inserting ‘‘and optimize’’ after 

21 ‘‘provide for’’; 

22 (C) by inserting ‘‘and, as informed by ex23 isting recommendations of, or consultations 

24 with, the Public Health Emergency Medical 

25 Countermeasure Enterprise established under 
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1 section 2811–1, make necessary additions or 

2 modifications to the contents of such stockpile 

3 or stockpiles based on the review conducted 

4 under paragraph (2)’’ before the period of the 

5 first sentence; and 

6 (D) by striking the second sentence; 

7 (3) by inserting after paragraph (1) the fol8 lowing: 

9 ‘‘(2) THREAT-BASED REVIEW.— 

10 ‘‘(A) IN GENERAL.—The Secretary shall 

11 conduct an annual threat-based review (taking 

12 into account at-risk individuals) of the contents 

13 of the stockpile under paragraph (1), including 

14 non-pharmaceutical supplies, and, in consulta15 tion with the Public Health Emergency Medical 

16 Countermeasures Enterprise established under 

17 section 2811–1, review contents within the 

18 stockpile and assess whether such contents are 

19 consistent with the recommendations made pur20 suant to section 2811–1(c)(1)(A). Such review 

21 shall be submitted on June 15, 2019, and on 

22 March 15 of each year thereafter, to the Com23 mittee on Health, Education, Labor, and Pen24 sions and the Committee on Appropriations of 

25 the Senate and the Committee on Energy and 
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1 Commerce and the Committee on Appropria2 tions of the House of Representatives, in a 

3 manner that does not compromise national se4 curity. 

5 ‘‘(B) ADDITIONS, MODIFICATIONS, AND

6 REPLENISHMENTS.—Each annual threat-based 

7 review under subparagraph (A) shall, for each 

8 new or modified countermeasure procurement 

9 or replenishment, provide— 

10 ‘‘(i) information regarding— 

11 ‘‘(I) the quantities of the addi12 tional or modified countermeasure 

13 procured for, or contracted to be pro14 cured for, the stockpile; 

15 ‘‘(II) planning considerations for 

16 appropriate manufacturing capacity 

17 and capability to meet the goals of 

18 such additions or modifications (with19 out disclosing proprietary informa20 tion), including consideration of the 

21 effect such additions or modifications 

22 may have on the availability of such 

23 products and ancillary medical sup24 plies in the health care system; 
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1 ‘‘(III) the presence or lack of a 

2 commercial market for the counter3 measure at the time of procurement; 

4 ‘‘(IV) the emergency health secu5 rity threat or threats such counter6 measure procurement is intended to 

7 address, including whether such pro8 curement is consistent with meeting 

9 emergency health security needs asso10 ciated with such threat or threats; 

11 ‘‘(V) an assessment of whether 

12 the emergency health security threat 

13 or threats described in subclause (IV) 

14 could be addressed in a manner that 

15 better utilizes the resources of the 

16 stockpile and permits the greatest 

17 possible increase in the level of emer18 gency preparedness to address such 

19 threats; 

20 ‘‘(VI) whether such counter21 measure is replenishing an expiring or 

22 expired countermeasure, is a different 

23 countermeasure with the same indica24 tion that is replacing an expiring or 
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1 expired countermeasure, or is a new 

2 addition to the stockpile; 

3 ‘‘(VII) a description of how such 

4 additions or modifications align with 

5 projected investments under previous 

6 countermeasures budget plans under 

7 section 2811(b)(7), including expected 

8 life-cycle costs, expenditures related to 

9 countermeasure procurement to ad10 dress the threat or threats described 

11 in subclause (IV), replenishment dates 

12 (including the ability to extend the 

13 maximum shelf life of a counter14 measure), and the manufacturing ca15 pacity required to replenish such 

16 countermeasure; and 

17 ‘‘(VIII) appropriate protocols and 

18 processes for the deployment, distribu19 tion, or dispensing of the counter20 measure at the State and local level, 

21 including plans for relevant capabili22 ties of State and local entities to dis23 pense, distribute, and administer the 

24 countermeasure; and 
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1 ‘‘(ii) an assurance, which need not be 

2 provided in advance of procurement, that 

3 for each countermeasure procured or re4 plenished under this subsection, the Sec5 retary completed a review addressing each 

6 item listed under this subsection in ad7 vance of such procurement or replenish8 ment.’’; 

9 (4) in paragraph (3), as so redesignated— 

10 (A) in subparagraph (A), by inserting 

11 ‘‘and the Public Health Emergency Medical 

12 Countermeasures Enterprise established under 

13 section 2811–1’’ before the semicolon; 

14 (B) in subparagraph (C), by inserting ‘‘, 

15 and the availability, deployment, dispensing, 

16 and administration of countermeasures’’ before 

17 the semicolon; 

18 (C) by amending subparagraph (E) to read 

19 as follows: 

20 ‘‘(E) devise plans for effective and timely 

21 supply-chain management of the stockpile, in 

22 consultation with the Director of the Centers 

23 for Disease Control and Prevention, the Assist24 ant Secretary for Preparedness and Response, 

25 the Secretary of Transportation, the Secretary 
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1 of Homeland Security, the Secretary of Vet2 erans Affairs, and the heads of other appro3 priate Federal agencies; State, local, Tribal, 

4 and territorial agencies; and the public and pri5 vate health care infrastructure, as applicable, 

6 taking into account the manufacturing capacity 

7 and other available sources of products and ap8 propriate alternatives to supplies in the stock9 pile;’’; 

10 (D) in subparagraph (G), by striking ‘‘; 

11 and’’ and inserting a semicolon; 

12 (E) in subparagraph (H), by striking the 

13 period and inserting a semicolon; and 

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

15 ‘‘(I) ensure that each countermeasure or 

16 product under consideration for procurement 

17 pursuant to this subsection receives the same 

18 consideration regardless of whether such coun19 termeasure or product receives or had received 

20 funding under section 319L, including with re21 spect to whether the countermeasure or product 

22 is most appropriate to meet the emergency 

23 health security needs of the United States; and 

24 ‘‘(J) provide assistance, including technical 

25 assistance, to maintain and improve State and 
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1 local public health preparedness capabilities to 

2 distribute and dispense medical counter3 measures and products from the stockpile, as 

4 appropriate.’’; and 

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

6 ‘‘(5) GAO REPORT.— 

7 ‘‘(A) IN GENERAL.—Not later than 3 years 

8 after the date of enactment of the Pandemic 

9 and All-Hazards Preparedness and Advancing 

10 Innovation Act of 2019, and every 5 years 

11 thereafter, the Comptroller General of the 

12 United States shall conduct a review of any 

13 changes to the contents or management of the 

14 stockpile since January 1, 2015. Such review 

15 shall include— 

16 ‘‘(i) an assessment of the comprehen17 siveness and completeness of each annual 

18 threat-based review under paragraph (2), 

19 including whether all newly procured or re20 plenished countermeasures within the 

21 stockpile were described in each annual re22 view, and whether, consistent with para23 graph (2)(B), the Secretary conducted the 

24 necessary internal review in advance of 

25 such procurement or replenishment; 
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1 ‘‘(ii) an assessment of whether the 

2 Secretary established health security and 

3 science-based justifications, and a descrip4 tion of such justifications for procurement 

5 decisions related to health security needs 

6 with respect to the identified threat, for 

7 additions or modifications to the stockpile 

8 based on the information provided in such 

9 reviews under paragraph (2)(B), including 

10 whether such review was conducted prior 

11 to procurement, modification, or replenish12 ment; 

13 ‘‘(iii) an assessment of the plans de14 veloped by the Secretary for the deploy15 ment, distribution, and dispensing of coun16 termeasures procured, modified, or replen17 ished under paragraph (1), including 

18 whether such plans were developed prior to 

19 procurement, modification, or replenish20 ment; 

21 ‘‘(iv) an accounting of counter22 measures procured, modified, or replen23 ished under paragraph (1) that received 

24 advanced research and development fund-
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1 ing from the Biomedical Advanced Re2 search and Development Authority; 

3 ‘‘(v) an analysis of how such procure4 ment decisions made progress toward 

5 meeting emergency health security needs 

6 related to the identified threats for coun7 termeasures added, modified, or replen8 ished under paragraph (1); 

9 ‘‘(vi) a description of the resources ex10 pended related to the procurement of coun11 termeasures (including additions, modifica12 tions, and replenishments) in the stockpile, 

13 and how such expenditures relate to the 

14 ability of the stockpile to meet emergency 

15 health security needs; 

16 ‘‘(vii) an assessment of the extent to 

17 which additions, modifications, and replen18 ishments reviewed under paragraph (2) 

19 align with previous relevant reports or re20 views by the Secretary or the Comptroller 

21 General; 

22 ‘‘(viii) with respect to any change in 

23 the Federal organizational management of 

24 the stockpile, an assessment and compari25 son of the processes affected by such 
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1 change, including planning for potential 

2 countermeasure deployment, distribution, 

3 or dispensing capabilities and processes re4 lated to procurement decisions, use of 

5 stockpiled countermeasures, and use of re6 sources for such activities; and 

7 ‘‘(ix) an assessment of whether the 

8 processes and procedures described by the 

9 Secretary pursuant to section 403(b) of 

10 the Pandemic and All-Hazards Prepared11 ness and Advancing Innovation Act of 

12 2019 are sufficient to ensure counter13 measures and products under consideration 

14 for procurement pursuant to subsection (a) 

15 receive the same consideration regardless 

16 of whether such countermeasures and 

17 products receive or had received funding 

18 under section 319L, including with respect 

19 to whether such countermeasures and 

20 products are most appropriate to meet the 

21 emergency health security needs of the 

22 United States. 

23 ‘‘(B) SUBMISSION.—Not later than 6 

24 months after completing a classified version of 

25 the review under subparagraph (A), the Comp-
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1 troller General shall submit an unclassified 

2 version of the review to the congressional com3 mittees of jurisdiction.’’. 

4 (b) ADDITIONAL REPORTING.—In the first threat5 based review submitted after the date of enactment of this 

6 Act pursuant to paragraph (2) of section 319F–2(a) of 

7 the Public Health Service Act (42 U.S.C. 247d–6b(a)), as 

8 amended by subsection (a), the Secretary shall include a 

9 description of the processes and procedures through which 

10 the Director of the Strategic National Stockpile and the 

11 Director of the Biomedical Advanced Research and Devel12 opment Authority coordinate with respect to counter13 measures and products procured under such section 

14 319F–2(a), including such processes and procedures in 

15 place to ensure countermeasures and products under con16 sideration for procurement pursuant to such section 

17 319F–2(a) receive the same consideration regardless of 

18 whether such countermeasures or products receive or had 

19 received funding under section 319L of the Public Health 

20 Service Act (42 U.S.C. 247d–7e), and whether such coun21 termeasures and products are the most appropriate to 

22 meet the emergency health security needs of the United 

23 States. 

24 (c) AUTHORIZATION OF APPROPRIATIONS, STRA25 TEGIC NATIONAL STOCKPILE.—Section 319F–2(f)(1) (42 
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1 U.S.C. 247d–6b(f)(1)) is amended by striking 

2 ‘‘$533,800,000 for each of fiscal years 2014 through 

3 2018’’ and inserting ‘‘$610,000,000 for each of fiscal 

4 years 2019 through 2023, to remain available until ex5 pended’’. 

6 SEC. 404. PREPARING FOR PANDEMIC INFLUENZA, ANTI7 MICROBIAL RESISTANCE, AND OTHER SIG8 NIFICANT THREATS. 

9 (a) STRATEGIC INITIATIVES.—Section 319L(c)(4) 

10 (247d–7e(c)(4)) is amended by adding at the end the fol11 lowing: 

12 ‘‘(F) STRATEGIC INITIATIVES.—The Sec13 retary, acting through the Director of BARDA, 

14 may implement strategic initiatives, including 

15 by building on existing programs and by award16 ing contracts, grants, and cooperative agree17 ments, or entering into other transactions, to 

18 support innovative candidate products in pre19 clinical and clinical development that address 

20 priority, naturally occurring and man-made 

21 threats that, as determined by the Secretary, 

22 pose a significant level of risk to national secu23 rity based on the characteristics of a chemical, 

24 biological, radiological or nuclear threat, or ex25 isting capabilities to respond to such a threat 
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1 (including medical response and treatment ca2 pabilities and manufacturing infrastructure). 

3 Such initiatives shall accelerate and support the 

4 advanced research, development, and procure5 ment of countermeasures and products, as ap6 plicable, to address areas including— 

7 ‘‘(i) chemical, biological, radiological, 

8 or nuclear threats, including emerging in9 fectious diseases, for which insufficient ap10 proved, licensed, or authorized counter11 measures exist, or for which such threat, 

12 or the result of an exposure to such threat, 

13 may become resistant to countermeasures 

14 or existing countermeasures may be ren15 dered ineffective; 

16 ‘‘(ii) threats that consistently exist or 

17 continually circulate and have a significant 

18 potential to become a pandemic, such as 

19 pandemic influenza, which may include the 

20 advanced research and development, manu21 facturing, and appropriate stockpiling of 

22 qualified pandemic or epidemic products, 

23 and products, technologies, or processes to 

24 support the advanced research and devel25 opment of such countermeasures (including 
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1 multiuse platform technologies for 

2 diagnostics, vaccines, and therapeutics; 

3 virus seeds; clinical trial lots; novel virus 

4 strains; and antigen and adjuvant mate5 rial); and 

6 ‘‘(iii) threats that may result pri7 marily or secondarily from a chemical, bio8 logical, radiological, or nuclear agent, or 

9 emerging infectious diseases, and which 

10 may present increased treatment complica11 tions such as the occurrence of resistance 

12 to available countermeasures or potential 

13 countermeasures, including antimicrobial 

14 resistant pathogens.’’. 

15 (b) PROTECTION OF NATIONAL SECURITY FROM

16 THREATS.—Section 2811 (42 U.S.C. 300hh–10) is 

17 amended by adding at the end the following: 

18 ‘‘(f) PROTECTION OF NATIONAL SECURITY FROM

19 THREATS.— 

20 ‘‘(1) IN GENERAL.—In carrying out subsection 

21 (b)(3), the Assistant Secretary for Preparedness and 

22 Response shall implement strategic initiatives or ac23 tivities to address threats, including pandemic influ24 enza and which may include a chemical, biological, 

25 radiological, or nuclear agent (including any such 
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1 agent with a significant potential to become a pan2 demic), that pose a significant level of risk to public 

3 health and national security based on the character4 istics of such threat. Such initiatives shall include 

5 activities to— 

6 ‘‘(A) accelerate and support the advanced 

7 research, development, manufacturing capacity, 

8 procurement, and stockpiling of counter9 measures, including initiatives under section 

10 319L(c)(4)(F); 

11 ‘‘(B) support the development and manu12 facturing of virus seeds, clinical trial lots, and 

13 stockpiles of novel virus strains; and 

14 ‘‘(C) maintain or improve preparedness ac15 tivities, including for pandemic influenza. 

16 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 

17 ‘‘(A) IN GENERAL.—To carry out this sub18 section, there is authorized to be appropriated 

19 $250,000,000 for each of fiscal years 2019 

20 through 2023. 

21 ‘‘(B) SUPPLEMENT, NOT SUPPLANT.— 

22 Amounts appropriated under this paragraph 

23 shall be used to supplement and not supplant 

24 funds provided under sections 319L(d) and 

25 319F–2(g). 
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1 ‘‘(C) DOCUMENTATION REQUIRED.—The 

2 Assistant Secretary for Preparedness and Re3 sponse, in accordance with subsection (b)(7), 

4 shall document amounts expended for purposes 

5 of carrying out this subsection, including 

6 amounts appropriated under the heading ‘Pub7 lic Health and Social Services Emergency 

8 Fund’ under the heading ‘Office of the Sec9 retary’ under title II of division H of the Con10 solidated Appropriations Act, 2018 (Public Law 

11 115–141) and allocated to carrying out section 

12 319L(c)(4)(F).’’. 

13 SEC. 405. REPORTING ON THE FEDERAL SELECT AGENT 

14 PROGRAM. 

15 Section 351A(k) (42 U.S.C. 262a(k)) is amended— 

16 (1) by striking ‘‘The Secretary’’ and inserting 

17 the following: 

18 ‘‘(1) IN GENERAL.—The Secretary’’; and 

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

20 ‘‘(2) IMPLEMENTATION OF RECOMMENDATIONS

21 OF THE FEDERAL EXPERTS SECURITY ADVISORY

22 PANEL AND THE FAST TRACK ACTION COMMITTEE

23 ON SELECT AGENT REGULATIONS.— 

24 ‘‘(A) IN GENERAL.—Not later than 1 year 

25 after the date of the enactment of the Pan-
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1 demic and All-Hazards Preparedness and Ad2 vancing Innovation Act of 2019, the Secretary 

3 shall report to the congressional committees of 

4 jurisdiction on the implementation of rec5 ommendations of the Federal Experts Security 

6 Advisory Panel concerning the select agent pro7 gram. 

8 ‘‘(B) CONTINUED UPDATES.—The Sec9 retary shall report to the congressional commit10 tees of jurisdiction annually following the sub11 mission of the report under subparagraph (A) 

12 until the recommendations described in such 

13 subparagraph are fully implemented, or a jus14 tification is provided for the delay in, or lack of, 

15 implementation.’’. 

16 TITLE V—INCREASING COMMU17 NICATION IN MEDICAL COUN18 TERMEASURE ADVANCED RE19 SEARCH AND DEVELOPMENT 

20 SEC. 501. MEDICAL COUNTERMEASURE BUDGET PLAN. 

21 Section 2811(b)(7) (42 U.S.C. 300hh–10(b)(7)) is 

22 amended— 

23 (1) in the matter preceding subparagraph (A), 

24 by striking ‘‘March 1’’ and inserting ‘‘March 15’’; 

25 (2) in subparagraph (A)— 
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1 (A) in clause (ii), by striking ‘‘; and’’ and 

2 inserting ‘‘;’’; and 

3 (B) by striking clause (iii) and inserting 

4 the following: 

5 ‘‘(iii) procurement, stockpiling, main6 tenance, and potential replenishment (in7 cluding manufacturing capabilities) of all 

8 products in the Strategic National Stock9 pile; 

10 ‘‘(iv) the availability of technologies 

11 that may assist in the advanced research 

12 and development of countermeasures and 

13 opportunities to use such technologies to 

14 accelerate and navigate challenges unique 

15 to countermeasure research and develop16 ment; and 

17 ‘‘(v) potential deployment, distribu18 tion, and utilization of medical counter19 measures; development of clinical guidance 

20 and emergency use instructions for the use 

21 of medical countermeasures; and, as appli22 cable, potential postdeployment activities 

23 related to medical countermeasures;’’; 

24 (3) by redesignating subparagraphs (D) and 

25 (E) as subparagraphs (E) and (F), respectively; and 
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1 (4) by inserting after subparagraph (C), the fol2 lowing: 

3 ‘‘(D) identify the full range of anticipated 

4 medical countermeasure needs related to re5 search and development, procurement, and 

6 stockpiling, including the potential need for in7 dications, dosing, and administration tech8 nologies, and other countermeasure needs as 

9 applicable and appropriate;’’. 

10 SEC. 502. MATERIAL THREAT AND MEDICAL COUNTER11 MEASURE NOTIFICATIONS. 

12 (a) CONGRESSIONAL NOTIFICATION OF MATERIAL

13 THREAT DETERMINATION.—Section 319F–2(c)(2)(C) (42 

14 U.S.C. 247d–6b(c)(2)(C)) is amended by striking ‘‘The 

15 Secretary and the Homeland Security Secretary shall 

16 promptly notify the appropriate committees of Congress’’ 

17 and inserting ‘‘The Secretary and the Secretary of Home18 land Security shall send to Congress, on an annual basis, 

19 all current material threat determinations and shall 

20 promptly notify the Committee on Health, Education, 

21 Labor, and Pensions and the Committee on Homeland Se22 curity and Governmental Affairs of the Senate and the 

23 Committee on Energy and Commerce and the Committee 

24 on Homeland Security of the House of Representatives’’. 
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1 (b) CONTRACTING COMMUNICATION.—Section 319F– 

2 2(c)(7)(B)(ii)(III) (42 U.S.C. 247d–6b(c)(7)(B)(ii)(III)) 

3 is amended by adding at the end the following: ‘‘The Sec4 retary shall notify the vendor within 90 days of a deter5 mination by the Secretary to renew, extend, or terminate 

6 such contract.’’. 

7 SEC. 503. AVAILABILITY OF REGULATORY MANAGEMENT 

8 PLANS. 

9 Section 565(f) of the Federal Food, Drug, and Cos10 metic Act (21 U.S.C. 360bbb–4(f)) is amended— 

11 (1) by redesignating paragraphs (3) through 

12 (6) as paragraphs (4) through (7), respectively; 

13 (2) by inserting after paragraph (2) the fol14 lowing: 

15 ‘‘(3) PUBLICATION.—The Secretary shall make 

16 available on the internet website of the Food and 

17 Drug Administration information regarding regu18 latory management plans, including— 

19 ‘‘(A) the process by which an applicant 

20 may submit a request for a regulatory manage21 ment plan; 

22 ‘‘(B) the timeframe by which the Secretary 

23 is required to respond to such request; 

24 ‘‘(C) the information required for the sub25 mission of such request; 
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1 ‘‘(D) a description of the types of develop2 ment milestones and performance targets that 

3 could be discussed and included in such plans; 

4 and 

5 ‘‘(E) contact information for beginning the 

6 regulatory management plan process.’’; 

7 (3) in paragraph (6), as so redesignated, in the 

8 matter preceding subparagraph (A)— 

9 (A) by striking ‘‘paragraph (4)(A)’’ and in10 serting ‘‘paragraph (5)(A)’’; and 

11 (B) by striking ‘‘paragraph (4)(B)’’ and 

12 inserting ‘‘paragraph (5)(B)’’; and 

13 (4) in paragraph (7)(A), as so redesignated, by 

14 striking ‘‘paragraph (3)(A)’’ and inserting ‘‘para15 graph (4)(A)’’. 

16 SEC. 504. THE BIOMEDICAL ADVANCED RESEARCH AND DE17 VELOPMENT AUTHORITY AND THE BIO18 SHIELD SPECIAL RESERVE FUND. 

19 (a) BIOSHIELD SPECIAL RESERVE FUND.—Section 

20 319F–2(g)(1) (42 U.S.C. 247d–6b(g)(1)) is amended— 

21 (1) by striking ‘‘$2,800,000,000 for the period 

22 of fiscal years 2014 through 2018’’ and inserting 

23 ‘‘$7,100,000,000 for the period of fiscal years 2019 

24 through 2028, to remain available until expended’’; 

25 and 
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1 (2) by striking the second sentence. 

2 (b) THE BIOMEDICAL ADVANCED RESEARCH AND

3 DEVELOPMENT AUTHORITY.—Section 319L(d)(2) (42 

4 U.S.C. 247d–7e(d)(2)) is amended by striking 

5 ‘‘$415,000,000 for each of fiscal years 2014 through 

6 2018’’ and inserting ‘‘$611,700,000 for each of fiscal 

7 years 2019 through 2023’’. 

8 SEC. 505. ADDITIONAL STRATEGIES FOR COMBATING ANTI9 BIOTIC RESISTANCE. 

10 (a) ADVISORY COUNCIL.—The Secretary of Health 

11 and Human Services (referred to in this section as the 

12 ‘‘Secretary’’) may continue the Presidential Advisory 

13 Council on Combating Antibiotic-Resistant Bacteria, re14 ferred to in this section as the ‘‘Advisory Council’’. 

15 (b) DUTIES.—The Advisory Council shall advise and 

16 provide information and recommendations to the Sec17 retary regarding programs and policies intended to reduce 

18 or combat antibiotic-resistant bacteria that may present 

19 a public health threat and improve capabilities to prevent, 

20 diagnose, mitigate, or treat such resistance. Such advice, 

21 information, and recommendations may be related to im22 proving— 

23 (1) the effectiveness of antibiotics; 

24 (2) research and advanced research on, and the 

25 development of, improved and innovative methods 
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1 for combating or reducing antibiotic resistance, in2 cluding new treatments, rapid point-of-care 

3 diagnostics, alternatives to antibiotics, including al4 ternatives to animal antibiotics, and antimicrobial 

5 stewardship activities; 

6 (3) surveillance of antibiotic-resistant bacterial 

7 infections, including publicly available and up-to8 date information on resistance to antibiotics; 

9 (4) education for health care providers and the 

10 public with respect to up-to-date information on an11 tibiotic resistance and ways to reduce or combat 

12 such resistance to antibiotics related to humans and 

13 animals; 

14 (5) methods to prevent or reduce the trans15 mission of antibiotic-resistant bacterial infections, 

16 including stewardship programs; and 

17 (6) coordination with respect to international 

18 efforts in order to inform and advance United States 

19 capabilities to combat antibiotic resistance. 

20 (c) MEETINGS AND COORDINATION.— 

21 (1) MEETINGS.—The Advisory Council shall 

22 meet not less than biannually and, to the extent 

23 practicable, in coordination with meetings of the 

24 Antimicrobial Resistance Task Force established in 

25 section 319E(a) of the Public Health Service Act. 
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1 (2) COORDINATION.—The Advisory Council 

2 shall, to the greatest extent practicable, coordinate 

3 activities carried out by the Council with the Anti4 microbial Resistance Task Force established under 

5 section 319E(a) of the Public Health Service Act 

6 (42 U.S.C. 247d–5(a)). 

7 (d) FACA.—The Federal Advisory Committee Act (5 

8 U.S.C. App.) shall apply to the activities and duties of 

9 the Advisory Council. 

10 (e) EXTENSION OF ADVISORY COUNCIL.—Not later 

11 than October 1, 2022, the Secretary shall submit to the 

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

13 the Senate and the Committee on Energy and Commerce 

14 of the House of Representatives a recommendation on 

15 whether the Advisory Council should be extended, and in 

16 addition, identify whether there are other committees, 

17 councils, or task forces that have overlapping or similar 

18 duties to that of the Advisory Council, and whether such 

19 committees, councils, or task forces should be combined, 

20 including with respect to section 319E(a) of the Public 

21 Health Service Act (42 U.S.C. 247d–5(a)). 
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1 TITLE VI—ADVANCING TECH2 NOLOGIES FOR MEDICAL 

3 COUNTERMEASURES 

4 SEC. 601. ADMINISTRATION OF COUNTERMEASURES. 

5 Section 319L(c)(4)(D)(iii) (42 U.S.C. 247d– 

6 7e(c)(4)(D)(iii)) is amended by striking ‘‘and platform 

7 technologies’’ and inserting ‘‘platform technologies, tech8 nologies to administer countermeasures, and technologies 

9 to improve storage and transportation of counter10 measures’’. 

11 SEC. 602. UPDATING DEFINITIONS OF OTHER TRANS12 ACTIONS. 

13 Section 319L (42 U.S.C. 247d–7e) is amended— 

14 (1) in subsection (a)(3), by striking ‘‘, such as’’ 

15 and all that follows through ‘‘Code’’; and 

16 (2) in subsection (c)(5)(A)— 

17 (A) in clause (i), by striking ‘‘under this 

18 subsection’’ and all that follows through ‘‘Code’’ 

19 and inserting ‘‘(as defined in subsection (a)(3)) 

20 under this subsection’’; and 

21 (B) in clause (ii)— 

22 (i) by amending subclause (I) to read 

23 as follows: 

24 ‘‘(I) IN GENERAL.—To the max25 imum extent practicable, competitive 
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1 procedures shall be used when enter2 ing into transactions to carry out 

3 projects under this subsection.’’; and 

4 (ii) in subclause (II)— 

5 (I) by striking ‘‘$20,000,000’’ 

6 and inserting ‘‘$100,000,000’’; 

7 (II) by striking ‘‘senior procure8 ment executive for the Department 

9 (as designated for purpose of section 

10 16(c) of the Office of Federal Pro11 curement Policy Act (41 U.S.C. 

12 414(c)))’’ and inserting ‘‘Assistant 

13 Secretary for Financial Resources’’; 

14 and 

15 (III) by striking ‘‘senior procure16 ment executive under’’ and inserting 

17 ‘‘Assistant Secretary for Financial Re18 sources under’’. 

19 SEC. 603. MEDICAL COUNTERMEASURE MASTER FILES. 

20 (a) IN GENERAL.—The purpose of this section (in21 cluding section 565B of the Federal Food, Drug, and Cos22 metic Act, as added by subsection (b)) is to support and 

23 advance the development or manufacture of security coun24 termeasures, qualified countermeasures, and qualified 

25 pandemic or epidemic products by facilitating and encour-
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1 aging submission of data and information to support the 

2 development of such products, and through clarifying the 

3 authority to cross-reference to data and information pre4 viously submitted to the Secretary of Health and Human 

5 Services (referred to in this section as the ‘‘Secretary’’), 

6 including data and information submitted to medical coun7 termeasure master files or other master files. 

8 (b) MEDICAL COUNTERMEASURE MASTER FILES.— 

9 Chapter V of the Federal Food, Drug, and Cosmetic Act 

10 (21 U.S.C. 351 et seq.) is amended by inserting after sec11 tion 565A the following: 

12 ‘‘SEC. 565B. MEDICAL COUNTERMEASURE MASTER FILES. 

13 ‘‘(a) APPLICABILITY OF REFERENCE.— 

14 ‘‘(1) IN GENERAL.—A person may submit data 

15 and information in a master file to the Secretary 

16 with the intent to reference, or to authorize, in writ17 ing, another person to reference, such data or infor18 mation to support a medical countermeasure submis19 sion (including a supplement or amendment to any 

20 such submission), without requiring the master file 

21 holder to disclose the data and information to any 

22 such persons authorized to reference the master file. 

23 Such data and information shall be available for ref24 erence by the master file holder or by a person au25 thorized by the master file holder, in accordance 
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1 with applicable privacy and confidentiality protocols 

2 and regulations. 

3 ‘‘(2) REFERENCE OF CERTAIN MASTER

4 FILES.—In the case that data or information within 

5 a medical countermeasure master file is used only to 

6 support the conditional approval of an application 

7 filed under section 571, such master file may be re8 lied upon to support the effectiveness of a product 

9 that is the subject of a subsequent medical counter10 measure submission only if such application is sup11 plemented by additional data or information to sup12 port review and approval in a manner consistent 

13 with the standards applicable to such review and ap14 proval for such countermeasure, qualified counter15 measure, or qualified pandemic or epidemic product. 

16 ‘‘(b) MEDICAL COUNTERMEASURE MASTER FILE

17 CONTENT.— 

18 ‘‘(1) IN GENERAL.—A master file under this 

19 section may include data or information to sup20 port— 

21 ‘‘(A) the development of medical counter22 measure submissions to support the approval, 

23 licensure, classification, clearance, conditional 

24 approval, or authorization of one or more secu25 rity countermeasures, qualified counter-
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1 measures, or qualified pandemic or epidemic 

2 products; and 

3 ‘‘(B) the manufacture of security counter4 measures, qualified countermeasures, or quali5 fied pandemic or epidemic products. 

6 ‘‘(2) REQUIRED UPDATES.—The Secretary may 

7 require, as appropriate, that the master file holder 

8 ensure that the contents of such master file are up9 dated during the time such master file is referenced 

10 for a medical countermeasure submission. 

11 ‘‘(c) SPONSOR REFERENCE.— 

12 ‘‘(1) IN GENERAL.—Each incorporation of data 

13 or information within a medical countermeasure 

14 master file shall describe the incorporated material 

15 in a manner in which the Secretary determines ap16 propriate and that permits the review of such infor17 mation within such master file without necessitating 

18 resubmission of such data or information. Master 

19 files shall be submitted in an electronic format in ac20 cordance with sections 512(b)(4), 571(a)(4), and 

21 745A, as applicable, and as specified in applicable 

22 guidance. 

23 ‘‘(2) REFERENCE BY A MASTER FILE HOLD24 ER.—A master file holder that is the sponsor of a 

25 medical countermeasure submission shall notify the 
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1 Secretary in writing of the intent to reference the 

2 medical countermeasure master file as a part of the 

3 submission. 

4 ‘‘(3) REFERENCE BY AN AUTHORIZED PER5 SON.—A person submitting an application for review 

6 may, where the Secretary determines appropriate, 

7 incorporate by reference all or part of the contents 

8 of a medical countermeasure master file, if the mas9 ter file holder authorizes the incorporation in writ10 ing. 

11 ‘‘(d) ACKNOWLEDGMENT OF AND RELIANCE UPON A

12 MASTER FILE BY THE SECRETARY.— 

13 ‘‘(1) IN GENERAL.—The Secretary shall provide 

14 the master file holder with a written notification in15 dicating that the Secretary has reviewed and relied 

16 upon specified data or information within a master 

17 file and the purposes for which such data or infor18 mation was incorporated by reference if the Sec19 retary has reviewed and relied upon such specified 

20 data or information to support the approval, classi21 fication, conditional approval, clearance, licensure, or 

22 authorization of a security countermeasure, qualified 

23 countermeasure, or qualified pandemic or epidemic 

24 product. The Secretary may rely upon the data and 

25 information within the medical countermeasure mas-
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1 ter file for which such written notification was pro2 vided in additional applications, as applicable and 

3 appropriate and upon the request of the master file 

4 holder so notified in writing or by an authorized per5 son of such holder. 

6 ‘‘(2) CERTAIN APPLICATIONS.—If the Secretary 

7 has reviewed and relied upon specified data or infor8 mation within a medical countermeasure master file 

9 to support the conditional approval of an application 

10 under section 571 to subsequently support the ap11 proval, clearance, licensure, or authorization of a se12 curity countermeasure, qualified countermeasure, or 

13 qualified pandemic or epidemic product, the Sec14 retary shall provide a brief written description to the 

15 master file holder regarding the elements of the ap16 plication fulfilled by the data or information within 

17 the master file and how such data or information 

18 contained in such application meets the standards of 

19 evidence under subsection (c) or (d) of section 505, 

20 subsection (d) of section 512, or section 351 of the 

21 Public Health Service Act (as applicable), which 

22 shall not include any trade secret or confidential 

23 commercial information. 

24 ‘‘(e) RULES OF CONSTRUCTION.—Nothing in this 

25 section shall be construed to— 
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1 ‘‘(1) limit the authority of the Secretary to ap2 prove, license, clear, conditionally approve, or au3 thorize drugs, biological products, or devices pursu4 ant to, as applicable, this Act or section 351 of the 

5 Public Health Service Act (as such applicable Act is 

6 in effect on the day before the date of enactment of 

7 the Pandemic and All-Hazards Preparedness and 

8 Advancing Innovation Act of 2019), including the 

9 standards of evidence, and applicable conditions, for 

10 approval under the applicable Act; 

11 ‘‘(2) alter the standards of evidence with re12 spect to approval, licensure, or clearance, as applica13 ble, of drugs, biological products, or devices under 

14 this Act or section 351 of the Public Health Service 

15 Act, including, as applicable, the substantial evi16 dence standards under sections 505(d) and 512(d) 

17 or this Act and section 351(a) of the Public Health 

18 Service Act; or 

19 ‘‘(3) alter the authority of the Secretary under 

20 this Act or the Public Health Service Act to deter21 mine the types of data or information previously 

22 submitted by a sponsor or any other person that 

23 may be incorporated by reference in an application, 

24 request, or notification for a drug, biological prod25 uct, or device submitted under sections 505(i), 
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1 505(b), 505(j), 512(b)(1), 512(b)(2), 512(j), 564, 

2 571, 520(g), 515(c), 513(f)(2), or 510(k) of this 

3 Act, or subsection (a) or (k) of section 351 of the 

4 Public Health Service Act, including a supplement 

5 or amendment to any such submission, and the re6 quirements associated with such reference. 

7 ‘‘(f) DEFINITIONS.—In this section: 

8 ‘‘(1) The term ‘master file holder’ means a per9 son who submits data and information to the Sec10 retary with the intent to reference or authorize an11 other person to reference such data or information 

12 to support a medical countermeasure submission, as 

13 described in subsection (a). 

14 ‘‘(2) The term ‘medical countermeasure submis15 sion’ means an investigational new drug application 

16 under section 505(i), a new drug application under 

17 section 505(b), or an abbreviated new drug applica18 tion under section 505(j) of this Act, a biological 

19 product license application under section 351(a) of 

20 the Public Health Service Act or a biosimilar biologi21 cal product license application under section 351(k) 

22 of the Public Health Service Act, a new animal drug 

23 application under section 512(b)(1) or abbreviated 

24 new animal drug application under section 

25 512(b)(2), an application for conditional approval of 
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1 a new animal drug under section 571, an investiga2 tional device application under section 520(g), an 

3 application with respect to a device under section 

4 515(c), a request for classification of a device under 

5 section 513(f)(2), a notification with respect to a de6 vice under section 510(k), or a request for an emer7 gency use authorization under section 564 to sup8 port— 

9 ‘‘(A) the approval, licensure, classification, 

10 clearance, conditional approval, or authorization 

11 of a security countermeasure, qualified counter12 measure, or qualified pandemic or epidemic 

13 product; or 

14 ‘‘(B) a new indication to an approved secu15 rity countermeasure, qualified countermeasure, 

16 or qualified pandemic or epidemic product. 

17 ‘‘(3) The terms ‘qualified countermeasure’, ‘se18 curity countermeasure’, and ‘qualified pandemic or 

19 epidemic product’ have the meanings given such 

20 terms in sections 319F–1, 319F–2, and 319F–3, re21 spectively, of the Public Health Service Act.’’. 

22 (c) STAKEHOLDER INPUT.—Not later than 18 

23 months after the date of enactment of this Act, the Sec24 retary, acting through the Commissioner of Food and 

25 Drugs and in consultation with the Assistant Secretary 
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1 for Preparedness and Response, shall solicit input from 

2 stakeholders, including stakeholders developing security 

3 countermeasures, qualified countermeasures, or qualified 

4 pandemic or epidemic products, and stakeholders devel5 oping technologies to assist in the development of such 

6 countermeasures with respect to how the Food and Drug 

7 Administration can advance the use of tools and tech8 nologies to support and advance the development or manu9 facture of security countermeasures, qualified counter10 measures, and qualified pandemic or epidemic products, 

11 including through reliance on cross-referenced data and 

12 information contained within master files and submissions 

13 previously submitted to the Secretary as set forth in sec14 tion 565B of the Federal Food, Drug, and Cosmetic Act, 

15 as added by subsection (b). 

16 (d) GUIDANCE.—Not later than 2 years after the 

17 date of enactment of this Act, the Secretary, acting 

18 through the Commissioner of Food and Drugs, shall pub19 lish draft guidance about how reliance on cross-referenced 

20 data and information contained within master files under 

21 section 565B of the Federal Food, Drug, and Cosmetic 

22 Act, as added by subsection (b) or submissions otherwise 

23 submitted to the Secretary may be used for specific tools 

24 or technologies (including platform technologies) that have 

25 the potential to support and advance the development or 
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1 manufacture of security countermeasures, qualified coun2 termeasures, and qualified pandemic or epidemic products. 

3 The Secretary, acting through the Commissioner of Food 

4 and Drugs, shall publish the final guidance not later than 

5 3 years after the enactment of this Act. 

6 SEC. 604. ANIMAL RULE REPORT. 

7 (a) STUDY.—The Comptroller General of the United 

8 States shall conduct a study on the application of the re9 quirements under subsections (c) and (d) of section 565 

10 of the of the Federal Food, Drug, and Cosmetic Act (21 

11 U.S.C. 360bbb–4) (referred to in this section as the ‘‘ani12 mal rule’’) as a component of medical countermeasure ad13 vanced development under the Biomedical Advanced Re14 search and Development Authority and regulatory review 

15 by the Food and Drug Administration. In conducting such 

16 study, the Comptroller General shall examine the fol17 lowing: 

18 (1) The extent to which advanced development 

19 and review of a medical countermeasure are coordi20 nated between the Biomedical Advanced Research 

21 and Development Authority and the Food and Drug 

22 Administration, including activities that facilitate 

23 appropriate and efficient design of studies to sup24 port approval, licensure, and authorization under the 

25 animal rule, consistent with the recommendations in 
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1 the animal rule guidance, issued pursuant to section 

2 565(c) of the Federal Food, Drug, and Cosmetic Act 

3 (21 U.S.C. 360bbb–4(c)) and entitled ‘‘Product De4 velopment Under the Animal Rule: Guidance for In5 dustry’’ (issued in October 2015), to resolve discrep6 ancies in the design of adequate and well-controlled 

7 efficacy studies conducted in animal models related 

8 to the provision of substantial evidence of effective9 ness for the product approved, licensed, or author10 ized under the animal rule. 

11 (2) The consistency of the application of the 

12 animal rule among and between review divisions 

13 within the Food and Drug Administration. 

14 (3) The flexibility pursuant to the animal rule 

15 to address variations in countermeasure development 

16 and review processes, including the extent to which 

17 qualified animal models are adopted and used within 

18 the Food and Drug Administration in regulatory de19 cisionmaking with respect to medical counter20 measures. 

21 (4) The extent to which the guidance issued 

22 under section 565(c) of the Federal Food, Drug, and 

23 Cosmetic Act (21 U.S.C. 360bbb–4(c)), entitled, 

24 ‘‘Product Development Under the Animal Rule: 

25 Guidance for Industry’’ (issued in October 2015), 
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1 has assisted in achieving the purposes described in 

2 paragraphs (1), (2), and (3). 

3 (b) CONSULTATIONS.—In conducting the study under 

4 subsection (a), the Comptroller General of the United 

5 States shall consult with— 

6 (1) the Federal agencies responsible for advanc7 ing, reviewing, and procuring medical counter8 measures, including the Office of the Assistant Sec9 retary for Preparedness and Response, the Bio10 medical Advanced Research and Development Au11 thority, the Food and Drug Administration, and the 

12 Department of Defense; 

13 (2) manufacturers involved in the research and 

14 development of medical countermeasures to address 

15 biological, chemical, radiological, or nuclear threats; 

16 and 

17 (3) other biodefense stakeholders, as applicable. 

18 (c) REPORT.—Not later than 3 years after the date 

19 of enactment of this Act, the Comptroller General of the 

20 United States shall submit to the Committee on Health, 

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

22 Committee on Energy and Commerce of the House of 

23 Representatives a report containing the results of the 

24 study conducted under subsection (a) and recommenda25 tions to improve the application and consistency of the re-
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1 quirements under subsections (c) and (d) of section 565 

2 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

3 360bbb–4) to support and expedite the research and devel4 opment of medical countermeasures, as applicable. 

5 (d) PROTECTION OF NATIONAL SECURITY.—The 

6 Comptroller General of the United States shall conduct 

7 the study and issue the assessment and report under this 

8 section in a manner that does not compromise national 

9 security. 

10 SEC. 605. REVIEW OF THE BENEFITS OF GENOMIC ENGI11 NEERING TECHNOLOGIES AND THEIR POTEN12 TIAL ROLE IN NATIONAL SECURITY. 

13 (a) MEETING.— 

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

15 the date of enactment of this Act, the Secretary of 

16 Health and Human Services (referred to in this sec17 tion as the ‘‘Secretary’’) shall convene a meeting to 

18 discuss the potential role advancements in genomic 

19 engineering technologies (including genome editing 

20 technologies) may have in advancing national health 

21 security. Such meeting shall be held in a manner 

22 that does not compromise national security. 

23 (2) ATTENDEES.—The attendees of the meeting 

24 under paragraph (1)— 

25 (A) shall include— 
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1 (i) representatives from the Office of 

2 the Assistant Secretary for Preparedness 

3 and Response, the National Institutes of 

4 Health, the Centers for Disease Control 

5 and Prevention, and the Food and Drug 

6 Administration; and 

7 (ii) representatives from academic, 

8 private, and nonprofit entities with exper9 tise in genome engineering technologies, 

10 biopharmaceuticals, medicine, or bio11 defense, and other relevant stakeholders; 

12 and 

13 (B) may include— 

14 (i) other representatives from the De15 partment of Health and Human Services, 

16 as the Secretary determines appropriate; 

17 and 

18 (ii) representatives from the Depart19 ment of Homeland Security, the Depart20 ment of Defense, the Department of Agri21 culture, and other departments, as the Sec22 retary may request for the meeting. 

23 (3) TOPICS.—The meeting under paragraph (1) 

24 shall include a discussion of— 
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1 (A) the current state of the science of 

2 genomic engineering technologies related to na3 tional health security, including— 

4 (i) medical countermeasure develop5 ment, including potential efficiencies in the 

6 development pathway and detection tech7 nologies; and 

8 (ii) the international and domestic 

9 regulation of products utilizing genome ed10 iting technologies; and 

11 (B) national security implications, includ12 ing— 

13 (i) capabilities of the United States to 

14 leverage genomic engineering technologies 

15 as a part of the medical countermeasure 

16 enterprise, including current applicable re17 search, development, and application ef18 forts underway within the Department of 

19 Defense; 

20 (ii) the potential for state and non21 state actors to utilize genomic engineering 

22 technologies as a national health security 

23 threat; and 

24 (iii) security measures to monitor and 

25 assess the potential threat that may result 
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1 from utilization of genomic engineering 

2 technologies and related technologies for 

3 the purpose of compromising national 

4 health security. 

5 (b) REPORT.—Not later than 270 days after the 

6 meeting described in subsection (a) is held, the Assistant 

7 Secretary for Preparedness and Response shall issue a re8 port to the congressional committees of jurisdiction on the 

9 topics discussed at such meeting, and provide rec10 ommendations, as applicable, to utilize innovations in 

11 genomic engineering (including genome editing) and re12 lated technologies as a part of preparedness and response 

13 activities to advance national health security. Such report 

14 shall be issued in a manner that does not compromise na15 tional security. 

16 SEC. 606. REPORT ON VACCINES DEVELOPMENT. 

17 Not later than one year after the date of the enact18 ment of this Act, the Secretary of Health and Human 

19 Services shall submit to the Committee on Health, Edu20 cation, Labor, and Pensions of the Senate and the Com21 mittee on Energy and Commerce of the House of Rep22 resentatives a report describing efforts and activities to 

23 coordinate with other countries and international partners 

24 during recent public health emergencies with respect to 

25 the research and advanced research on, and development 
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1 of, qualified pandemic or epidemic products (as defined 

2 in section 319F–3 of the Public Health Service Act (42 

3 U.S.C. 247d–6d)). Such report may include information 

4 regarding relevant work carried out under section 

5 319L(c)(5)(E) of the Public Health Service Act (42 

6 U.S.C. 247d–7e(c)(5)(E)), through public-private partner7 ships, and through collaborations with other countries to 

8 assist with or expedite the research and development of 

9 qualified pandemic or epidemic products. Such report shall 

10 not include information that may compromise national se11 curity. 

12 SEC. 607. STRENGTHENING MOSQUITO ABATEMENT FOR 

13 SAFETY AND HEALTH. 

14 (a) REAUTHORIZATION OF MOSQUITO ABATEMENT

15 FOR SAFETY AND HEALTH PROGRAM.—Section 317S (42 

16 U.S.C. 247b–21) is amended— 

17 (1) in subsection (a)(1)(B)— 

18 (A) by inserting ‘‘including programs to 

19 address emerging infectious mosquito-borne dis20 eases,’’ after ‘‘subdivisions for control pro21 grams,’’; and 

22 (B) by inserting ‘‘or improving existing 

23 control programs’’ before the period at the end; 

24 (2) in subsection (b)— 
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1 (A) in paragraph (1), by inserting ‘‘, in2 cluding improvement,’’ after ‘‘operation’’; 

3 (B) in paragraph (2)— 

4 (i) in subparagraph (A)— 

5 (I) in clause (ii), by striking ‘‘or’’ 

6 at the end; 

7 (II) in clause (iii), by striking the 

8 semicolon at the end and inserting ‘‘, 

9 including an emerging infectious mos10 quito-borne disease that presents a se11 rious public health threat; or’’; and 

12 (III) by adding at the end the 

13 following: 

14 ‘‘(iv) a public health emergency due to 

15 the incidence or prevalence of a mosquito16 borne disease that presents a serious pub17 lic health threat;’’; and 

18 (ii) by amending subparagraph (D) to 

19 read as follows: 

20 ‘‘(D)(i) is located in a State that has re21 ceived a grant under subsection (a); or 

22 ‘‘(ii) that demonstrates to the Secretary 

23 that the control program is consistent with ex24 isting State mosquito control plans or policies, 

25 or other applicable State preparedness plans.’’; 
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1 (C) in paragraph (4)(C), by striking ‘‘that 

2 extraordinary’’ and all that follows through the 

3 period at the end and inserting the following: 

4 ‘‘that— 

5 ‘‘(i) extraordinary economic conditions 

6 in the political subdivision or consortium of 

7 political subdivisions involved justify the 

8 waiver; or 

9 ‘‘(ii) the geographical area covered by 

10 a political subdivision or consortium for a 

11 grant under paragraph (1) has an extreme 

12 mosquito control need due to— 

13 ‘‘(I) the size or density of the po14 tentially impacted human population; 

15 ‘‘(II) the size or density of a 

16 mosquito population that requires 

17 heightened control; or 

18 ‘‘(III) the severity of the mos19 quito-borne disease, such that ex20 pected serious adverse health out21 comes for the human population jus22 tify the waiver.’’; and 

23 (D) by amending paragraph (6) to read as 

24 follows: 
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1 ‘‘(6) NUMBER OF GRANTS.—A political subdivi2 sion or a consortium of political subdivisions may 

3 not receive more than one grant under paragraph 

4 (1).’’; and 

5 (3) in subsection (f)— 

6 (A) in paragraph (1) by striking ‘‘for fiscal 

7 year 2003, and such sums as may be necessary 

8 for each of fiscal years 2004 through 2007’’ 

9 and inserting ‘‘for each of fiscal years 2019 

10 through 2023’’; 

11 (B) in paragraph (2), by striking ‘‘the 

12 Public Health Security and Bioterrorism Pre13 paredness and Response Act of 2002’’ and in14 serting ‘‘this Act and other medical and public 

15 health preparedness and response laws’’; and 

16 (C) in paragraph (3)— 

17 (i) in the paragraph heading, by strik18 ing ‘‘2004’’ and inserting ‘‘2019’’; and 

19 (ii) by striking ‘‘2004,’’ and inserting 

20 ‘‘2019,’’. 

21 (b) EPIDEMIOLOGY-LABORATORY CAPACITY

22 GRANTS.—Section 2821 (42 U.S.C. 300hh–31) is amend23 ed— 
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1 (1) in subsection (a)(1), by inserting ‘‘, includ2 ing mosquito and other vector-borne diseases,’’ after 

3 ‘‘infectious diseases’’; and 

4 (2) in subsection (b), by striking ‘‘2010 through 

5 2013’’ and inserting ‘‘2019 through 2023’’. 

6 TITLE VII—MISCELLANEOUS 

7 PROVISIONS 

8 SEC. 701. REAUTHORIZATIONS AND EXTENSIONS. 

9 (a) VETERANS AFFAIRS.—Section 8117(g) of title 

10 38, United States Code, is amended by striking ‘‘2014 

11 through 2018’’ and inserting ‘‘2019 through 2023’’. 

12 (b) VACCINE TRACKING AND DISTRIBUTION.—Sec13 tion 319A(e) (42 U.S.C. 247d–1(e)) is amended by strik14 ing ‘‘2014 through 2018’’ and inserting ‘‘2019 through 

15 2023’’. 

16 (c) TEMPORARY REASSIGNMENT.—Section 319(e)(8) 

17 (42 U.S.C. 247d(e)(8)) is amended by striking ‘‘2018’’ 

18 and inserting ‘‘2023’’. 

19 (d) STRATEGIC INNOVATION PARTNER.—Section 

20 319L(c)(4)(E)(ix) (42 U.S.C. 247d–7e(c)(4)(E)(ix)) is 

21 amended by striking ‘‘2022’’ and inserting ‘‘2023’’. 

22 (e) LIMITED ANTITRUST EXEMPTION.— 

23 (1) IN GENERAL.—Section 405 of the Pandemic 

24 and All-Hazards Preparedness Act (Public Law 

25 109–417; 42 U.S.C. 247d–6a note) is amended— 
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1 (A) in subsection (a)(1)(A)— 

2 (i) by striking ‘‘Secretary of Health 

3 and Human Services (referred to in this 

4 subsection as the ‘Secretary’)’’ and insert5 ing ‘‘Secretary’’; 

6 (ii) by striking ‘‘of the Public Health 

7 Service Act (42 U.S.C. 247d–6b)) (as 

8 amended by this Act’’; 

9 (iii) by striking ‘‘of the Public Health 

10 Service Act (42 U.S.C. 247d–6a)) (as 

11 amended by this Act’’; and 

12 (iv) by striking ‘‘of the Public Health 

13 Service Act (42 U.S.C. 247d–6d)’’; 

14 (B) in subsection (b), by striking ‘‘12- 

15 year’’ and inserting ‘‘17-year’’; 

16 (C) by redesignating such section 405 as 

17 section 319L–1; and 

18 (D) by transferring such section 319L–1, 

19 as redesignated, to the Public Health Service 

20 Act (42 U.S.C. 201 et seq.), to appear after 

21 section 319L of such Act (42 U.S.C. 247d–7e). 

22 (2) CONFORMING AMENDMENTS.— 

23 (A) TABLE OF CONTENTS.—The table of 

24 contents in section 1(b) of the Pandemic and 

25 All-Hazards Preparedness Act (Public Law 
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1 109–417) is amended by striking the item re2 lated to section 405. 

3 (B) REFERENCE.—Section 

4 319L(c)(4)(A)(iii) (42 U.S.C. 247d–7e) is 

5 amended by striking ‘‘section 405 of the Pan6 demic and All-Hazards Preparedness Act’’ and 

7 inserting ‘‘section 319L–1’’. 

8 (f) INAPPLICABILITY OF CERTAIN PROVISIONS.— 

9 Subsection (e)(1) of section 319L (42 U.S.C. 247d– 

10 7e(e)(1)) is amended— 

11 (1) by amending subparagraph (A) to read as 

12 follows: 

13 ‘‘(A) NONDISCLOSURE OF INFORMA14 TION.— 

15 ‘‘(i) IN GENERAL.—Information de16 scribed in clause (ii) shall be deemed to be 

17 information described in section 552(b)(3) 

18 of title 5, United States Code. 

19 ‘‘(ii) INFORMATION DESCRIBED.—The 

20 information described in this clause is in21 formation relevant to programs of the De22 partment of Health and Human Services 

23 that could compromise national security 

24 and reveal significant and not otherwise 

25 publicly known vulnerabilities of existing 
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1 medical or public health defenses against 

2 chemical, biological, radiological, or nuclear 

3 threats, and is comprised of— 

4 ‘‘(I) specific technical data or sci5 entific information that is created or 

6 obtained during the countermeasure 

7 and product advanced research and 

8 development carried out under sub9 section (c); 

10 ‘‘(II) information pertaining to 

11 the location security, personnel, and 

12 research materials and methods of 

13 high-containment laboratories con14 ducting research with select agents, 

15 toxins, or other agents with a material 

16 threat determination under section 

17 319F–2(c)(2); or 

18 ‘‘(III) security and vulnerability 

19 assessments.’’; 

20 (2) by redesignating subparagraph (C) as sub21 paragraph (D); 

22 (3) by inserting after subparagraph (B) the fol23 lowing: 

24 ‘‘(C) REPORTING.—One year after the 

25 date of enactment of the Pandemic and All- 
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1 Hazards Preparedness and Advancing Innova2 tion Act of 2019, and annually thereafter, the 

3 Secretary shall report to the Committee on 

4 Health, Education, Labor, and Pensions of the 

5 Senate and the Committee on Energy and Com6 merce of the House of Representatives on the 

7 number of instances in which the Secretary has 

8 used the authority under this subsection to 

9 withhold information from disclosure, as well as 

10 the nature of any request under section 552 of 

11 title 5, United States Code that was denied 

12 using such authority.’’; and 

13 (4) in subparagraph (D), as so redesignated, by 

14 striking ‘‘12’’ and inserting ‘‘17’’. 

15 SEC. 702. LOCATION OF MATERIALS IN THE STOCKPILE. 

16 Subsection (d) of section 319F–2 (42 U.S.C. 247d– 

17 6b) is amended to read as follows: 

18 ‘‘(d) DISCLOSURES.—No Federal agency may dis19 close under section 552 of title 5, United States Code any 

20 information identifying the location at which materials in 

21 the stockpile described in subsection (a) are stored, or 

22 other information regarding the contents or deployment 

23 capability of the stockpile that could compromise national 

24 security.’’. 
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1 SEC. 703. CYBERSECURITY. 

2 (a) STRATEGY FOR PUBLIC HEALTH PREPAREDNESS

3 AND RESPONSE TO CYBERSECURITY THREATS.— 

4 (1) STRATEGY.—Not later than 18 months 

5 after the date of enactment of this Act, the Sec6 retary of Health and Human Services (referred to in 

7 this section as the ‘‘Secretary’’) shall prepare and 

8 submit to the relevant committees of Congress a 

9 strategy for public health preparedness and response 

10 to address cybersecurity threats (as defined in sec11 tion 102 of Cybersecurity Information Sharing Act 

12 of 2015 (6 U.S.C. 1501)) that present a threat to 

13 national health security. Such strategy shall in14 clude— 

15 (A) identifying the duties, functions, and 

16 preparedness goals for which the Secretary is 

17 responsible in order to prepare for and respond 

18 to such cybersecurity threats, including metrics 

19 by which to measure success in meeting pre20 paredness goals; 

21 (B) identifying gaps in public health capa22 bilities to achieve such preparedness goals; and 

23 (C) strategies to address identified gaps 

24 and strengthen public health emergency pre25 paredness and response capabilities to address 

26 such cybersecurity threats. 
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1 (2) PROTECTION OF NATIONAL SECURITY.— 

2 The Secretary shall make such strategy available to 

3 the Committee on Health, Education, Labor, and 

4 Pensions of the Senate, the Committee on Energy 

5 and Commerce of the House of Representatives, and 

6 other congressional committees of jurisdiction, in a 

7 manner that does not compromise national security. 

8 (b) COORDINATION OF PREPAREDNESS FOR AND RE9 SPONSE TO ALL-HAZARDS PUBLIC HEALTH EMER10 GENCIES.—Subparagraph (D) of section 2811(b)(4) (42 

11 U.S.C. 300hh–10(b)(4)) is amended to read as follows: 

12 ‘‘(D) POLICY COORDINATION AND STRA13 TEGIC DIRECTION.—Provide integrated policy 

14 coordination and strategic direction, before, 

15 during, and following public health emergencies, 

16 with respect to all matters related to Federal 

17 public health and medical preparedness and 

18 execution and deployment of the Federal re19 sponse for public health emergencies and inci20 dents covered by the National Response Plan 

21 described in section 504(a)(6) of the Homeland 

22 Security Act of 2002 (6 U.S.C. 314(a)(6)), or 

23 any successor plan; and such Federal responses 

24 covered by the National Cybersecurity Incident 

25 Response Plan developed under section 228(c) 
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1 of the Homeland Security Act of 2002 (6 

2 U.S.C. 149(c)), including public health emer3 gencies or incidents related to cybersecurity 

4 threats that present a threat to national health 

5 security.’’. 

6 SEC. 704. STRATEGY AND REPORT. 

7 Not later than 14 days after the date of the enact8 ment of this Act, the Secretary of Health and Human 

9 Services, in coordination with the Assistant Secretary for 

10 Preparedness and Response and the Assistant Secretary 

11 for the Administration on Children and Families or other 

12 appropriate office, and in collaboration with other depart13 ments, as appropriate, shall submit to the Committee on 

14 Energy and Commerce of the House of Representatives, 

15 the Committee on Health, Education, Labor, and Pen16 sions of the Senate, and other relevant congressional com17 mittees— 

18 (1) a formal strategy, including interdepart19 mental actions and efforts to reunify children with 

20 their parents or guardians, in all cases in which such 

21 children have been separated from their parents or 

22 guardians as a result of the initiative announced on 

23 April 6, 2018, and due to prosecution under section 

24 275(a) of the Immigration and Nationality Act (8 
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1 U.S.C. 1325(a)), if the parent or guardian chooses 

2 such reunification and the child— 

3 (A) was separated from a parent or guard4 ian and placed into a facility funded by the De5 partment of Health and Human Services; 

6 (B) as of the date of the enactment of this 

7 Act, remains in the care of the Department of 

8 Health and Human Services; and 

9 (C) can be safely reunited with such parent 

10 or guardian; and 

11 (2) a report on challenges and deficiencies re12 lated to the oversight of, and care for, unaccom13 panied alien children and appropriately reuniting 

14 such children with their parents or guardians, and 

15 the actions taken to address any challenges and defi16 ciencies related to unaccompanied alien children in 

17 the custody of the Department of Health and 

18 Human Services, including deficiencies identified 

19 and publicly reported by Congress, the Government 

20 Accountability Office, or the inspectors general of 

21 the Department of Health and Human Services or 

22 other Federal departments. 

23 SEC. 705. TECHNICAL AMENDMENTS. 

24 (a) PUBLIC HEALTH SERVICE ACT.—Title III (42 

25 U.S.C. 241 et seq.) is amended— 
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1 (1) in paragraphs (1) and (5) of section 319F– 

2 1(a) (42 U.S.C. 247d–6a(a)), by striking ‘‘section 

3 319F(h)’’ each place such term appears and insert4 ing ‘‘section 319F(e)’’; and 

5 (2) in section 319K(a) (42 U.S.C. 247d–7d(a)), 

6 by striking ‘‘section 319F(h)(4)’’ and inserting ‘‘sec7 tion 319F(e)(4)’’. 

8 (b) PUBLIC HEALTH SECURITY GRANTS.—Section 

9 319C–1(b)(2) (42 U.S.C. 247d–3a(b)(2)) is amended— 

10 (1) in subparagraph (C), by striking ‘‘individ11 uals,,’’ and inserting ‘‘individuals,’’; and 

12 (2) in subparagraph (F), by striking ‘‘make sat13 isfactory annual improvement and describe’’ and in14 serting ‘‘makes satisfactory annual improvement and 

15 describes’’. 

16 (c) EMERGENCY USE INSTRUCTIONS.—Subpara17 graph (A) of section 564A(e)(2) of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 360bbb–3a(e)(2)) is 

19 amended by striking ‘‘subsection (a)(1)(C)(i)’’ and insert20 ing ‘‘subsection (a)(1)(C)’’. 

21 (d) PRODUCTS HELD FOR EMERGENCY USE.—Sec22 tion 564B(2) of the Federal Food, Drug, and Cosmetic 

23 Act (21 U.S.C. 360bbb–3b) is amended— 

24 (1) in subparagraph (B), by inserting a comma 

25 after ‘‘505’’; and 
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1 (2) in subparagraph (C), by inserting ‘‘or sec2 tion 564A’’ before the period at the end. 

3 (e) TRANSPARENCY.—Section 507(c)(3) of the Fed4 eral Food, Drug, and Cosmetic Act (21 U.S.C. 357(c)(3)) 

5 is amended— 

6 (1) by striking ‘‘Nothing in’’ and inserting the 

7 following: 

8 ‘‘(A) IN GENERAL.—Nothing in’’; 

9 (2) by inserting ‘‘or directing’’ after ‘‘author10 izing’’; 

11 (3) by striking ‘‘disclose any’’ and inserting 

12 ‘‘disclose— 

13 ‘‘(i) any’’; 

14 (4) by striking the period and inserting ‘‘; or’’; 

15 and 

16 (5) by adding at the end the following: 

17 ‘‘(ii) in the case of a drug develop18 ment tool that may be used to support the 

19 development of a qualified countermeasure, 

20 security countermeasure, or qualified pan21 demic or epidemic product, as defined in 

22 sections 319F–1, 319F–2, and 319F–3, 

23 respectively, of the Public Health Service 

24 Act, any information that the Secretary 
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1 determines has a significant potential to 

2 affect national security. 

3 ‘‘(B) PUBLIC ACKNOWLEDGMENT.—In the 

4 case that the Secretary, pursuant to subpara5 graph (A)(ii), does not make information pub6 licly available, the Secretary shall provide on 

7 the internet website of the Food and Drug Ad8 ministration an acknowledgment of the informa9 tion that has not been disclosed, pursuant to 

10 subparagraph (A)(ii).’’. 

Passed the Senate May 16, 2019. 

Attest: 

Secretary. 

116TH CONGRESS 

1ST SESSION S. 1379 

AN ACT 

To reauthorize certain programs under the Public 

sponse, and for other purposes. security and all-hazards preparedness and reand Cosmetic Act with respect to public health Health Service Act and the Federal Food, Drug,