II 

116TH CONGRESS 

1ST SESSION S. 1379 

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. 

IN THE SENATE OF THE UNITED STATES 

MAY 8, 2019 

Mr. BURR (for himself, Mr. CASEY, Mr. ALEXANDER, and Mrs. MURRAY) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

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, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

5 ‘‘Pandemic and All-Hazards Preparedness and Advancing 

6 Innovation Act of 2019’’. 


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

2 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. 

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. 


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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)— 

13 (i) by striking ‘‘2014’’ and inserting 

14 ‘‘2018’’; and 

15 (ii) by striking the second sentence 

16 and inserting the following: ‘‘Such NaVerDate Sep 11 2014 22:22 May 15, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 \\ALPHA3\E\BILLS\S1379.IS S1379

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1 tional Health Security Strategy shall de2 scribe potential emergency health security 

3 threats and identify the process for achiev4 ing the preparedness goals described in 

5 subsection (b) to be prepared to identify 

6 and respond to such threats and shall be 

7 consistent with the national preparedness 

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

9 the Homeland Security Act of 2002), the 

10 National Incident Management System (as 

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

12 the National Response Plan developed pur13 suant to section 504 of such Act, or any 

14 successor plan.’’; 

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

16 the period at the end of the second sentence the 

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

18 the evidence-based benchmarks and objective 

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

20 and 

21 (C) in paragraph (3)— 

22 (i) by striking ‘‘2009’’ and inserting 

23 ‘‘2022’’; 

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

25 the environmental health and animal 


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1 health workforces, as applicable), describ2 ing the status of such workforce’’ after 

3 ‘‘gaps in such workforce’’; 

4 (iii) by striking ‘‘and identifying strat5 egies’’ and inserting ‘‘identifying strate6 gies’’; and 

7 (iv) by inserting before the period at 

8 the end ‘‘, and identifying current capabili9 ties to meet the requirements of section 

10 2803’’; and 

11 (2) in subsection (b)— 

12 (A) in paragraph (2)— 

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

14 ‘‘and investigation’’ and inserting ‘‘inves15 tigation, and related information tech16 nology activities’’; 

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

18 ‘‘and decontamination’’ and inserting ‘‘de19 contamination, relevant health care serv20 ices and supplies, and transportation and 

21 disposal of medical waste’’; and 

22 (iii) by adding at the end the fol23 lowing: 

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

25 (B) in paragraph (3)— 


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1 (i) in the matter preceding subpara2 graph (A), by striking ‘‘including mental 

3 health’’ and inserting ‘‘including phar4 macies, mental health facilities,’’; and 

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

6 ‘‘or exposures to agents that could cause a 

7 public health emergency’’ before the pe8 riod; 

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

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

11 and 

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

13 ‘‘(9) ZOONOTIC DISEASE, FOOD, AND AGRI14 CULTURE.—Improving coordination among Federal, 

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

16 through consultation with the Secretary of Agri17 culture) to prevent, detect, and respond to outbreaks 

18 of plant or animal disease (including zoonotic dis19 ease) that could compromise national security result20 ing from a deliberate attack, a naturally occurring 

21 threat, the intentional adulteration of food, or other 

22 public health threats, taking into account inter23 actions between animal health, human health, and 

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1 rectly related to public health emergency prepared2 ness and response capabilities, as applicable. 

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

4 current or potential health security threats from 

5 abroad to inform domestic public health prepared6 ness and response capabilities.’’. 

7 TITLE II—IMPROVING 

8 PREPAREDNESS AND RESPONSE 

9 SEC. 201. IMPROVING BENCHMARKS AND STANDARDS FOR 

10 PREPAREDNESS AND RESPONSE. 

11 (a) EVALUATING MEASURABLE EVIDENCE-BASED

12 BENCHMARKS AND OBJECTIVE STANDARDS.—Section 

13 319C–1 (42 U.S.C. 247d–3a) is amended by inserting 

14 after subsection (j) the following: 

15 ‘‘(k) EVALUATION.— 

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

17 after the date of enactment of the Pandemic and 

18 All-Hazards Preparedness and Advancing Innovation 

19 Act of 2019 and every 2 years thereafter, the Sec20 retary shall conduct an evaluation of the evidence21 based benchmarks and objective standards required 

22 under subsection (g). Such evaluation shall be sub23 mitted to the congressional committees of jurisdic24 tion together with the National Health Security 


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1 Strategy under section 2802, at such time as such 

2 strategy is submitted. 

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

4 paragraph shall include— 

5 ‘‘(A) a review of evidence-based bench6 marks and objective standards, and associated 

7 metrics and targets; 

8 ‘‘(B) a discussion of changes to any evi9 dence-based benchmarks and objective stand10 ards, and the effect of such changes on the abil11 ity to track whether entities are meeting or 

12 making progress toward the goals under this 

13 section and, to the extent practicable, the appli14 cable goals of the National Health Security 

15 Strategy under section 2802; 

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

17 eligible entities described in subsection (b) and 

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

19 subrecipients and the effect of such funding on 

20 meeting evidence-based benchmarks and objec21 tive standards; and 

22 ‘‘(D) recommendations, as applicable and 

23 appropriate, to improve evidence-based bench24 marks and objective standards to more accu25 rately assess the ability of entities receiving 


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1 awards under this section to better achieve the 

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

3 (b) EVALUATING THE PARTNERSHIP FOR STATE AND

4 REGIONAL HOSPITAL PREPAREDNESS.—Section 319C– 

5 2(i)(1) (42 U.S.C. 247–3b(i)(1)) is amended by striking 

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

7 319C–1(g), (i), (j), and (k)’’. 

8 SEC. 202. AMENDMENTS TO PREPAREDNESS AND RE9 SPONSE PROGRAMS. 

10 (a) COOPERATIVE AGREEMENT APPLICATIONS FOR

11 IMPROVING STATE AND LOCAL PUBLIC HEALTH SECU12 RITY.—Section 319C–1 (42 U.S.C. 247d–3a) is amend13 ed— 

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

15 through the Director of the Centers for Disease 

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

17 (2) in subsection (b)(2)(A)— 

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

19 public health agencies with specific expertise 

20 that may be relevant to public health security, 

21 such as environmental health agencies,’’ after 

22 ‘‘stakeholders’’; 

23 (B) by redesignating clauses (vii) through 

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


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1 (C) by inserting after clause (vi) the fol2 lowing: 

3 ‘‘(vii) a description of how, as applica4 ble, such entity may integrate information 

5 to account for individuals with behavioral 

6 health needs following a public health 

7 emergency;’’; 

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

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

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

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

12 will partner with health care facilities, in13 cluding hospitals and nursing homes and 

14 other long-term care facilities, to promote 

15 and improve public health preparedness 

16 and response; and 

17 ‘‘(xii) a description of how, as appro18 priate and practicable, the entity will in19 clude critical infrastructure partners, such 

20 as utility companies within the entity’s ju21 risdiction, in planning pursuant to this 

22 subparagraph to help ensure that critical 

23 infrastructure will remain functioning dur24 ing, or return to function as soon as prac25 ticable after, a public health emergency;’’. 


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1 (b) EXCEPTION RELATING TO APPLICATION OF CER2 TAIN REQUIREMENTS.— 

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

4 U.S.C. 247d–3a(g)) is amended— 

5 (A) in paragraph (5)— 

6 (i) in the matter preceding subpara7 graph (A), by striking ‘‘Beginning with fis8 cal year 2009’’ and inserting ‘‘Beginning 

9 with fiscal year 2019’’; and 

10 (ii) in subparagraph (A)— 

11 (I) by striking ‘‘for the imme12 diately preceding fiscal year’’ and in13 serting ‘‘for either of the 2 imme14 diately preceding fiscal years’’; and 

15 (II) by striking ‘‘2008’’ and in16 serting ‘‘2018’’; and 

17 (B) in paragraph (6), by amending sub18 paragraph (A) to read as follows: 

19 ‘‘(A) IN GENERAL.—The amounts de20 scribed in this paragraph are the following 

21 amounts that are payable to an entity for ac22 tivities described in this section or section 

23 319C–2: 

24 ‘‘(i) For no more than one of each of 

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1 lowing a fiscal year in which an entity ex2 perienced a failure described in subpara3 graph (A) or (B) of paragraph (5), an 

4 amount equal to 10 percent of the amount 

5 the entity was eligible to receive for the re6 spective fiscal year. 

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

8 2 fiscal years immediately following the 

9 third consecutive fiscal year in which an 

10 entity experienced such a failure, in lieu of 

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

12 percent of the amount the entity was eligi13 ble to receive for the respective fiscal 

14 year.’’. 

15 (2) EFFECTIVE DATE.—The amendments made 

16 by paragraph (1) shall apply with respect to cooper17 ative agreements awarded on or after the date of en18 actment of this Act. 

19 (c) PARTNERSHIP FOR STATE AND REGIONAL HOS20 PITAL PREPAREDNESS TO IMPROVE SURGE CAPACITY.— 

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

22 (1) in subsection (a)— 

23 (A) by inserting ‘‘, acting through the As24 sistant Secretary for Preparedness and Re25 sponse,’’ after ‘‘The Secretary’’; and 


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1 (B) by striking ‘‘preparedness for public 

2 health emergencies’’ and inserting ‘‘prepared3 ness for, and response to, public health emer4 gencies in accordance with subsection (c)’’; 

5 (2) in subsection (b)(1)(A)— 

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

7 and inserting ‘‘coalition that includes’’; 

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

9 inserting a semicolon; and 

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

11 ‘‘(iv) one or more emergency medical serv12 ice organizations or emergency management or13 ganizations; and’’; 

14 (3) in subsection (d)— 

15 (A) in paragraph (1)(B), by striking ‘‘part16 nership’’ each place it appears and inserting 

17 ‘‘coalition’’; and 

18 (B) in paragraph (2)(C), by striking ‘‘med19 ical preparedness’’ and inserting ‘‘preparedness 

20 and response’’; 

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

22 and inserting ‘‘coalition’’; 

23 (5) in subsection (g)(2)— 

24 (A) by striking ‘‘Partnerships’’ and insert25 ing ‘‘Coalitions’’; 


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1 (B) by striking ‘‘partnerships’’ and insert2 ing ‘‘coalitions’’; and 

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

4 ‘‘preparedness’’; and 

5 (6) in subsection (i)(1)— 

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

7 ‘‘A coalition’’; and 

8 (B) by striking ‘‘such partnership’’ and in9 serting ‘‘such coalition’’. 

10 (d) PUBLIC HEALTH SECURITY GRANTS AUTHORIZA11 TION OF APPROPRIATIONS.—Section 319C–1(h)(1)(A) 

12 (42 U.S.C. 247d–3a(h)(1)(A)) is amended by striking 

13 ‘‘$641,900,000 for fiscal year 2014’’ and all that follows 

14 through the period at the end and inserting 

15 ‘‘$685,000,000 for each of fiscal years 2019 through 2023 

16 for awards pursuant to paragraph (3) (subject to the au17 thority of the Secretary to make awards pursuant to para18 graphs (4) and (5)).’’. 

19 (e) PARTNERSHIP FOR STATE AND REGIONAL HOS20 PITAL PREPAREDNESS AUTHORIZATION OF APPROPRIA21 TIONS.—Section 319C–2(j) (42 U.S.C. 247d–3b(j)) is 

22 amended— 

23 (1) by amending paragraph (1) to read as fol24 lows: 

25 ‘‘(1) IN GENERAL.— 


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1 ‘‘(A) AUTHORIZATION OF APPROPRIA2 TIONS.—For purposes of carrying out this sec3 tion and section 319C–3, in accordance with 

4 subparagraph (B), there is authorized to be ap5 propriated $385,000,000 for each of fiscal years 

6 2019 through 2023. 

7 ‘‘(B) RESERVATION OF AMOUNTS FOR RE8 GIONAL SYSTEMS.— 

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

10 (ii), of the amount appropriated under sub11 paragraph (A) for a fiscal year, the Sec12 retary may reserve up to 5 percent for the 

13 purpose of carrying out section 319C–3. 

14 ‘‘(ii) RESERVATION CONTINGENT ON

15 CONTINUED APPROPRIATIONS FOR THIS

16 SECTION.—If for fiscal year 2019 or a sub17 sequent fiscal year, the amount appro18 priated under subparagraph (A) is such 

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

20 amount remaining for the purpose of car21 rying out this section would be less than 

22 the amount available for such purpose for 

23 the previous fiscal year, the amount that 

24 may be reserved under clause (i) shall be 

25 reduced such that the amount remaining 


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1 for the purpose of carrying out this section 

2 is not less than the amount available for 

3 such purpose for the previous fiscal year. 

4 ‘‘(iii) SUNSET.—The authority to re5 serve amounts under clause (i) shall expire 

6 on September 30, 2023.’’; 

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

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

9 (1)(A) for a fiscal year and not reserved for the pur10 pose described in paragraph (1)(B)(i)’’; and 

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

12 (1) and not reserved under paragraph (2)’’ and in13 serting ‘‘paragraph (1)(A) and not reserved under 

14 paragraph (1)(B)(i) or (2)’’. 

15 SEC. 203. REGIONAL HEALTH CARE EMERGENCY PRE16 PAREDNESS AND RESPONSE SYSTEMS. 

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

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

19 following: 

20 ‘‘SEC. 319C–3. GUIDELINES FOR REGIONAL HEALTH CARE 

21 EMERGENCY PREPAREDNESS AND RESPONSE 

22 SYSTEMS. 

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

24 identify and provide guidelines for regional systems of hos25 pitals, health care facilities, and other public and private 


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1 sector entities, with varying levels of capability to treat 

2 patients and increase medical surge capacity during, in ad3 vance of, and immediately following a public health emer4 gency, including threats posed by one or more chemical, 

5 biological, radiological, or nuclear agents, including emerg6 ing infectious diseases. 

7 ‘‘(b) GUIDELINES.—The Assistant Secretary for Pre8 paredness and Response, in consultation with the Director 

9 of the Centers for Disease Control and Prevention, the Ad10 ministrator of the Centers for Medicare & Medicaid Serv11 ices, the Administrator of the Health Resources and Serv12 ices Administration, the Commissioner of Food and 

13 Drugs, the Assistant Secretary for Mental Health and 

14 Substance Use, the Assistant Secretary of Labor for Occu15 pational Safety and Health, the Secretary of Veterans Af16 fairs, the heads of such other Federal agencies as the Sec17 retary determines to be appropriate, and State, local, 

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

19 later than 2 years after the date of enactment of this sec20 tion— 

21 ‘‘(1) identify and develop a set of guidelines re22 lating to practices and protocols for all-hazards pub23 lic health emergency preparedness and response for 

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1 diately following, a public health emergency, result2 ing from one or more chemical, biological, radio3 logical, or nuclear agents, including emerging infec4 tious diseases (which may include existing practices, 

5 such as trauma care and medical surge capacity and 

6 capabilities), with respect to— 

7 ‘‘(A) a regional approach to identifying 

8 hospitals and health care facilities based on 

9 varying capabilities and capacity to treat pa10 tients affected by such emergency, including— 

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

12 will coordinate with and integrate the part13 nerships and health care coalitions estab14 lished under section 319C–2(b); and 

15 ‘‘(ii) informing and educating appro16 priate first responders and health care sup17 ply chain partners of the regional emer18 gency preparedness and response capabili19 ties and medical surge capacity of such 

20 hospitals and health care facilities in the 

21 community; 

22 ‘‘(B) physical and technological infrastruc23 ture, laboratory capacity, staffing, blood supply, 

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1 count resiliency, geographic considerations, and 

2 rural considerations; 

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

4 safety and personal protection of workers who 

5 handle human remains and health care workers 

6 (including with respect to protective equipment 

7 and supplies, waste management processes, and 

8 decontamination), sharing of specialized experi9 ence among the health care workforce, behav10 ioral health, psychological resilience, and train11 ing of the workforce, as applicable; 

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

13 containment (within the meaning of section 

14 2802(b)(2)(B)), coordinated medical triage, 

15 treatment, and transportation of patients, based 

16 on patient medical need (including patients in 

17 rural areas), to the appropriate hospitals or 

18 health care facilities within the regional system 

19 or, as applicable and appropriate, between sys20 tems in different States or regions; and 

21 ‘‘(E) the needs of children and other at22 risk individuals; 

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

24 internet website of the Department of Health and 


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1 Human Services in a manner that does not com2 promise national security; and 

3 ‘‘(3) update such guidelines as appropriate, in4 cluding based on input received pursuant to sub5 sections (c) and (e) and information resulting from 

6 applicable reports required under the Pandemic and 

7 All-Hazards Preparedness and Advancing Innovation 

8 Act of 2019 (including any amendments made by 

9 such Act), to address new and emerging public 

10 health threats. 

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

12 and updating guidelines under subsection (b), the Assist13 ant Secretary for Preparedness and Response shall— 

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

15 care facilities (including health care coalitions under 

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

17 public health departments, and health care or sub18 ject matter experts (including experts with relevant 

19 expertise in chemical, biological, radiological, or nu20 clear threats, including emerging infectious dis21 eases), as the Assistant Secretary determines appro22 priate, to meet the goals under section 2802(b)(3); 

23 ‘‘(2) consult and engage with appropriate 

24 health care providers and professionals, including 

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1 cilities (including hospitals, primary care clinics, 

2 community health centers, mental health facilities, 

3 ambulatory care facilities, and dental health facili4 ties), pharmacies, emergency medical providers, 

5 trauma care providers, environmental health agen6 cies, public health laboratories, poison control cen7 ters, blood banks, tissue banks, and other experts 

8 that the Assistant Secretary determines appropriate, 

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

10 ‘‘(3) consider feedback related to financial im11 plications for hospitals, health care facilities, public 

12 health agencies, laboratories, blood banks, tissue 

13 banks, and other entities engaged in regional pre14 paredness planning to implement and follow such 

15 guidelines, as applicable; and 

16 ‘‘(4) consider financial requirements and poten17 tial incentives for entities to prepare for, and re18 spond to, public health emergencies as part of the 

19 regional health care emergency preparedness and re20 sponse system. 

21 ‘‘(d) TECHNICAL ASSISTANCE.—The Assistant Sec22 retary for Preparedness and Response, in consultation 

23 with the Director of the Centers for Disease Control and 

24 Prevention and the Assistant Secretary of Labor for Occu25 pational Safety and Health, may provide technical assistVerDate Sep 11 2014 22:22 May 15, 2019 Jkt 089200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 \\ALPHA3\E\BILLS\S1379.IS S1379

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1 ance and consultation toward meeting the guidelines de2 scribed in subsection (b). 

3 ‘‘(e) DEMONSTRATION PROJECT FOR REGIONAL

4 HEALTH CARE PREPAREDNESS AND RESPONSE SYS5 TEMS.— 

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

7 Preparedness and Response may establish a dem8 onstration project pursuant to the development and 

9 implementation of guidelines under subsection (b) to 

10 award grants to improve medical surge capacity for 

11 all hazards, build and integrate regional medical re12 sponse capabilities, improve specialty care expertise 

13 for all-hazards response, and coordinate medical pre14 paredness and response across State, local, Tribal, 

15 territorial, and regional jurisdictions. 

16 ‘‘(2) SUNSET.—The authority under this sub17 section shall expire on September 30, 2023.’’. 

18 (b) GAO REPORT TO CONGRESS.— 

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

20 date of enactment of this Act, the Comptroller Gen21 eral of the United States (referred to in this sub22 section as the ‘‘Comptroller General’’) shall submit 

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

24 Pensions and the Committee on Finance of the Sen25 ate and the Committee on Energy and Commerce 


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1 and the Committee on Ways and Means of the 

2 House of Representatives, a report on the extent to 

3 which hospitals and health care facilities have imple4 mented the recommended guidelines under section 

5 319C–3(b) of the Public Health Service Act (as 

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

7 evaluation of any challenges hospitals or health care 

8 facilities experienced in implementing such guide9 lines. 

10 (2) CONTENT.—The Comptroller General shall 

11 include in the report under paragraph (1)— 

12 (A) data on the preparedness and response 

13 capabilities that have been informed by the 

14 guidelines under section 319C–3(b) of the Pub15 lic Health Service Act to improve regional emer16 gency health care preparedness and response 

17 capability, including hospital and health care 

18 facility capacity and medical surge capabilities 

19 to prepare for, and respond to, public health 

20 emergencies; and 

21 (B) recommendations to reduce gaps in in22 centives for regional health partners, including 

23 hospitals and health care facilities, to improve 

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1 gencies, consistent with subsection (a), which 

2 may include consideration of facilities partici3 pating in programs under section 319C–2 of 

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

5 247d–3b) or in programs under the Centers for 

6 Medicare & Medicaid Services (including inno7 vative health care delivery and payment mod8 els), and input from private sector financial in9 stitutions. 

10 (3) CONSULTATION.—In carrying out para11 graphs (1) and (2), the Comptroller General shall 

12 consult with the heads of appropriate Federal agen13 cies, including— 

14 (A) the Assistant Secretary for Prepared15 ness and Response; 

16 (B) the Director of the Centers for Disease 

17 Control and Prevention; 

18 (C) the Administrator of the Centers for 

19 Medicare & Medicaid Services; 

20 (D) the Assistant Secretary for Mental 

21 Health and Substance Use; 

22 (E) the Assistant Secretary of Labor for 

23 Occupational Safety and Health; and 

24 (F) the Secretary of Veterans Affairs. 


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

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

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

4 this paragraph, a coalition shall include information on the 

5 progress that the coalition has made toward the implemen6 tation of section 319C–3 (or barriers to progress, if 

7 any).’’. 

8 (d) NATIONAL HEALTH SECURITY STRATEGY INCOR9 PORATION OF REGIONALIZED EMERGENCY PREPARED10 NESS AND RESPONSE.—Subparagraph (G) of section 

11 2802(b)(3) (42 U.S.C. 300hh–1(b)(3)) is amended to read 

12 as follows: 

13 ‘‘(G) Optimizing a coordinated and flexible 

14 approach to the emergency response and med15 ical surge capacity of hospitals, other health 

16 care facilities, critical care, trauma care (which 

17 may include trauma centers), and emergency 

18 medical systems.’’. 

19 (e) IMPROVING STATE AND LOCAL PUBLIC HEALTH

20 SECURITY.— 

21 (1) STATE AND LOCAL SECURITY.—Section 

22 319C–1(e) (42 U.S.C. 247d–3a(e)) is amended by 

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

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

25 care emergency preparedness and response system 


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1 established pursuant to the applicable guidelines 

2 under section 319C–3.’’. 

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

4 (42 U.S.C. 247d–3b(d)(1)(A)) is amended— 

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

6 inserting ‘‘;’’; 

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

8 (iii); and 

9 (C) by inserting after clause (i) the fol10 lowing: 

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

12 regional health care emergency system 

13 under section 319C–3; and’’. 

14 SEC. 204. MILITARY AND CIVILIAN PARTNERSHIP FOR 

15 TRAUMA READINESS. 

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

17 adding at the end the following new part: 

18 ‘‘PART I—MILITARY AND CIVILIAN PARTNERSHIP 

19 FOR TRAUMA READINESS GRANT PROGRAM 

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

21 TRAUMA READINESS GRANT PROGRAM. 

22 ‘‘(a) MILITARY TRAUMA TEAM PLACEMENT PRO23 GRAM.— 

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

25 through the Assistant Secretary for Preparedness 


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1 and Response and in consultation with the Secretary 

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

3 eligible high-acuity trauma centers to enable military 

4 trauma teams to provide, on a full-time basis, trau5 ma care and related acute care at such trauma cen6 ters. 

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

8 awarded under paragraph (1) to an eligible high9 acuity trauma center, such grant— 

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

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

12 renewed at the end of such period); and 

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

14 exceed $1,000,000 per year. 

15 ‘‘(3) AVAILABILITY OF FUNDS.—Notwith16 standing section 1552 of title 31, United States 

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

18 to the Secretary for obligation for a grant under this 

19 subsection shall remain available for expenditure for 

20 100 days after the last day of the performance pe21 riod of such grant. 

22 ‘‘(b) MILITARY TRAUMA CARE PROVIDER PLACE23 MENT PROGRAM.— 

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

25 through the Assistant Secretary for Preparedness 


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1 and Response and in consultation with the Secretary 

2 of Defense, shall award grants to eligible trauma 

3 centers to enable military trauma care providers to 

4 provide trauma care and related acute care at such 

5 trauma centers. 

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

7 awarded under paragraph (1) to an eligible trauma 

8 center, such grant— 

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

10 and not more than 3 years (and may be re11 newed at the end of such period); and 

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

13 exceed, in a year— 

14 ‘‘(i) $100,000 for each military trau15 ma care provider that is a physician at 

16 such eligible trauma center; and 

17 ‘‘(ii) $50,000 for each other military 

18 trauma care provider at such eligible trau19 ma center. 

20 ‘‘(c) GRANT REQUIREMENTS.— 

21 ‘‘(1) DEPLOYMENT AND PUBLIC HEALTH EMER22 GENCIES.—As a condition of receipt of a grant 

23 under this section, a grant recipient shall agree to 

24 allow military trauma care providers providing care 

25 pursuant to such grant to— 


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1 ‘‘(A) be deployed by the Secretary of De2 fense for military operations, for training, or 

3 for response to a mass casualty incident; and 

4 ‘‘(B) be deployed by the Secretary of De5 fense, in consultation with the Secretary of 

6 Health and Human Services, for response to a 

7 public health emergency pursuant to section 

8 319. 

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

10 this section to an eligible trauma center may be used 

11 to train and incorporate military trauma care pro12 viders into such trauma center, including incorpora13 tion into operational exercises and training drills re14 lated to public health emergencies, expenditures for 

15 malpractice insurance, office space, information 

16 technology, specialty education and supervision, 

17 trauma programs, research, and applicable license 

18 fees for such military trauma care providers. 

19 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec20 tion shall be construed to affect any other provision of law 

21 that preempts State licensing requirements for health care 

22 professionals, including with respect to military trauma 

23 care providers. 

24 ‘‘(e) REPORTING REQUIREMENTS.— 


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

2 SECRETARY OF DEFENSE.—Each eligible trauma 

3 center or eligible high-acuity trauma center awarded 

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

5 submit to the Secretary and the Secretary of De6 fense a report for such year that includes informa7 tion on— 

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

9 cases managed by military trauma teams or 

10 military trauma care providers pursuant to such 

11 grant during such year; 

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

13 of the military trauma providers or teams of 

14 providers as part of the trauma center, includ15 ing the financial effect of such grant on the 

16 trauma center; 

17 ‘‘(C) the educational effect on resident 

18 trainees in centers where military trauma teams 

19 are assigned; 

20 ‘‘(D) any research conducted during such 

21 year supported by such grant; and 

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

23 Secretaries for the purpose of evaluating the ef24 fect of such grant. 


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

2 once every 2 years, the Secretary, in consultation 

3 with the Secretary of Defense, shall submit a report 

4 to the congressional committees of jurisdiction that 

5 includes information on the effect of placing military 

6 trauma care providers in trauma centers awarded 

7 grants under this section on— 

8 ‘‘(A) maintaining military trauma care 

9 providers’ readiness and ability to respond to 

10 and treat battlefield injuries; 

11 ‘‘(B) providing health care to civilian trau12 ma patients in urban and rural settings; 

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

14 military trauma care providers to increase med15 ical surge capacity, including as a result of a 

16 large-scale event; 

17 ‘‘(D) the ability of grant recipients to 

18 maintain the integration of the military trauma 

19 providers or teams of providers as part of the 

20 trauma center; 

21 ‘‘(E) efforts to incorporate military trauma 

22 care providers into operational exercises and 

23 training and drills for public health emer24 gencies; and 


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

2 providers to participate as part of a medical re3 sponse during or in advance of a public health 

4 emergency, as determined by the Secretary, or 

5 a mass casualty incident. 

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

7 ‘‘(1) ELIGIBLE HIGH-ACUITY TRAUMA CEN8 TER.—The term ‘eligible high-acuity trauma center’ 

9 means a Level I trauma center that satisfies each of 

10 the following: 

11 ‘‘(A) Such trauma center has an agree12 ment with the Secretary of Defense to enable 

13 military trauma teams to provide trauma care 

14 and related acute care at such trauma center. 

15 ‘‘(B) At least 20 percent of patients treat16 ed at such trauma center in the most recent 3- 

17 month period for which data are available are 

18 treated for a major trauma at such trauma cen19 ter. 

20 ‘‘(C) Such trauma center utilizes a risk-ad21 justed benchmarking system and metrics to 

22 measure performance, quality, and patient out23 comes. 

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

25 training center— 


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

2 ‘‘(ii) that maintains residency pro3 grams and fellowships in critical trauma 

4 specialties and subspecialties, and provides 

5 education and supervision of military trau6 ma team members according to those spe7 cialties and subspecialties; and 

8 ‘‘(iii) that undertakes research in the 

9 prevention and treatment of traumatic in10 jury. 

11 ‘‘(E) Such trauma center serves as a med12 ical and public health preparedness and re13 sponse leader for its community, such as by 

14 participating in a partnership for State and re15 gional hospital preparedness established under 

16 section 319C–2 or 319C–3. 

17 ‘‘(2) ELIGIBLE TRAUMA CENTER.—The term 

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

19 trauma center that satisfies each of the following: 

20 ‘‘(A) Such trauma center has an agree21 ment with the Secretary of Defense to enable 

22 military trauma care providers to provide trau23 ma care and related acute care at such trauma 

24 center. 


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1 ‘‘(B) Such trauma center utilizes a risk-ad2 justed benchmarking system and metrics to 

3 measure performance, quality, and patient out4 comes. 

5 ‘‘(C) Such trauma center demonstrates a 

6 need for integrated military trauma care pro7 viders to maintain or improve the trauma clin8 ical capability of such trauma center. 

9 ‘‘(3) MAJOR TRAUMA.—The term ‘major trau10 ma’ means an injury that is greater than or equal 

11 to 15 on the injury severity score. 

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

13 ‘military trauma team’ means a complete military 

14 trauma team consisting of military trauma care pro15 viders. 

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

17 term ‘military trauma care provider’ means a mem18 ber of the Armed Forces who furnishes emergency, 

19 critical care, and other trauma acute care services 

20 (including a physician, surgeon, physician assistant, 

21 nurse, nurse practitioner, respiratory therapist, 

22 flight paramedic, combat medic, or enlisted medical 

23 technician) or other military trauma care provider as 

24 the Secretary determines appropriate. 


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

2 carry out this section, there is authorized to be appro3 priated $11,500,000 for each of fiscal years 2019 through 

4 2023.’’. 

5 SEC. 205. PUBLIC HEALTH AND HEALTH CARE SYSTEM SIT6 UATIONAL AWARENESS AND BIOSURVEIL7 LANCE CAPABILITIES. 

8 (a) FACILITIES, CAPACITIES, AND BIOSURVEILLANCE

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

10 amended— 

11 (1) in the section heading, by striking ‘‘REVI12 TALIZING’’ and inserting ‘‘FACILITIES AND CA13 PACITIES OF’’; 

14 (2) in subsection (a)— 

15 (A) in the subsection heading, by striking 

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

17 GENERAL’’; 

18 (B) in paragraph (1), by striking ‘‘and im19 proved’’ and inserting ‘‘, improved, and appro20 priately maintained’’; 

21 (C) in paragraph (3), in the matter pre22 ceding subparagraph (A), by striking ‘‘expand, 

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

24 improve, enhance, and appropriately maintain’’; 

25 and 


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

2 ‘‘(4) STUDY OF RESOURCES FOR FACILITIES

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

4 Comptroller General of the United States shall con5 duct a study on Federal spending in fiscal years 

6 2013 through 2018 for activities authorized under 

7 this subsection. Such study shall include a review 

8 and assessment of obligations and expenditures di9 rectly related to each activity under paragraphs (2) 

10 and (3), including a specific accounting of, and de11 lineation between, obligations and expenditures in12 curred for the construction, renovation, equipping, 

13 and security upgrades of facilities and associated 

14 contracts under this subsection, and the obligations 

15 and expenditures incurred to establish and improve 

16 the situational awareness and biosurveillance net17 work under subsection (b), and shall identify the 

18 agency or agencies incurring such obligations and 

19 expenditures.’’; 

20 (3) in subsection (b)— 

21 (A) in the subsection heading, by striking 

22 ‘‘NATIONAL’’ and inserting ‘‘ESTABLISHMENT

23 OF SYSTEMS OF PUBLIC HEALTH’’; 


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1 (B) in paragraph (1)(B), by inserting ‘‘im2 munization information systems,’’ after ‘‘cen3 ters,’’; 

4 (C) in paragraph (2)— 

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

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

7 (ii) by inserting ‘‘and in a form read8 ily usable for analytical approaches’’ after 

9 ‘‘in a secure manner’’; and 

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

11 follows: 

12 ‘‘(3) STANDARDS.— 

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

14 after the date of the enactment of the Pan15 demic and All-Hazards Preparedness and Ad16 vancing Innovation Act of 2019, the Secretary, 

17 in cooperation with health care providers, State, 

18 local, Tribal, and territorial public health offi19 cials, and relevant Federal agencies (including 

20 the Office of the National Coordinator for 

21 Health Information Technology and the Na22 tional Institute of Standards and Technology), 

23 shall, as necessary, adopt technical and report24 ing standards, including standards for inter25 operability as defined by section 3000, for netVerDate Sep 11 2014 22:22 May 15, 2019 Jkt 089200 PO 00000 Frm 00037 Fmt 6652 Sfmt 6201 \\ALPHA3\E\BILLS\S1379.IS S1379

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1 works under paragraph (1) and update such 

2 standards as necessary. Such standards shall be 

3 made available on the internet website of the 

4 Department of Health and Human Services, in 

5 a manner that does not compromise national se6 curity. 

7 ‘‘(B) DEFERENCE TO STANDARDS DEVEL8 OPMENT ORGANIZATIONS.—In adopting and im9 plementing standards under this subsection and 

10 subsection (c), the Secretary shall give def11 erence to standards published by standards de12 velopment organizations and voluntary con13 sensus-based standards entities.’’; 

14 (4) in subsection (c)— 

15 (A) in paragraph (1)— 

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

17 after the date of enactment of the Pan18 demic and All-Hazards Preparedness Re19 authorization Act of 2013, the Secretary’’ 

20 and inserting ‘‘The Secretary’’; 

21 (ii) by inserting ‘‘, and improve as ap22 plicable and appropriate,’’ after ‘‘shall es23 tablish’’; 

24 (iii) by striking ‘‘of rapid’’ and insert25 ing ‘‘of, rapid’’; and 


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

2 and inserting ‘‘such interoperability’’; 

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

4 follows: 

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

6 establishing and improving the network under para7 graph (1), the Secretary shall— 

8 ‘‘(A) facilitate coordination among agencies 

9 within the Department of Health and Human 

10 Services that provide, or have the potential to 

11 provide, information and data to, and analyses 

12 for, the situational awareness and biosurveil13 lance network under paragraph (1), including 

14 coordination among relevant agencies related to 

15 health care services, the facilitation of health 

16 information exchange (including the Office of 

17 the National Coordinator for Health Informa18 tion Technology), and public health emergency 

19 preparedness and response; and 

20 ‘‘(B) consult with the Secretary of Agri21 culture, the Secretary of Commerce (and the 

22 Director of the National Institute of Standards 

23 and Technology), the Secretary of Defense, the 

24 Secretary of Homeland Security, the Secretary 

25 of Veterans Affairs, and the heads of other 


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1 Federal agencies, as the Secretary determines 

2 appropriate.’’; 

3 (C) in paragraph (3)— 

4 (i) by redesignating subparagraphs 

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

6 respectively, and adjusting the margins ac7 cordingly; 

8 (ii) in clause (iv), as so redesig9 nated— 

10 (I) by inserting ‘‘immunization 

11 information systems,’’ after ‘‘poison 

12 control,’’; and 

13 (II) by striking ‘‘and clinical lab14 oratories’’ and inserting ‘‘, clinical 

15 laboratories, and public environmental 

16 health agencies’’; 

17 (iii) by striking ‘‘The network’’ and 

18 inserting the following: 

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

20 (iv) by adding at the end the fol21 lowing: 

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

23 after the date of the enactment of the Pan24 demic and All-Hazards Preparedness and Ad25 vancing Innovation Act of 2019 and every 6 


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1 years thereafter, the Secretary shall conduct a 

2 review of the elements described in subpara3 graph (A). Such review shall include a discus4 sion of the addition of any elements pursuant to 

5 clause (v), including elements added to advanc6 ing new technologies, and identify any chal7 lenges in the incorporation of elements under 

8 subparagraph (A). The Secretary shall provide 

9 such review to the congressional committees of 

10 jurisdiction.’’; 

11 (D) in paragraph (5)— 

12 (i) by redesignating subparagraphs 

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

14 (iv), respectively, and adjusting the mar15 gins accordingly; 

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

17 inserting the following: 

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

19 (iii) by adding at the end the fol20 lowing: 

21 ‘‘(B) PUBLIC MEETING.— 

22 ‘‘(i) IN GENERAL.—Not later than 

23 180 days after the date of enactment of 

24 the Pandemic and All-Hazards Prepared25 ness and Advancing Innovation Act of 


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1 2019, the Secretary shall convene a public 

2 meeting for purposes of discussing and 

3 providing input on the potential goals, 

4 functions, and uses of the network de5 scribed in paragraph (1) and incorporating 

6 the elements described in paragraph 

7 (3)(A). 

8 ‘‘(ii) EXPERTS.—The public meeting 

9 shall include representatives of relevant 

10 Federal agencies (including representatives 

11 from the Office of the National Coordi12 nator for Health Information Technology 

13 and the National Institute of Standards 

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

15 territorial public health officials; stake16 holders with expertise in biosurveillance 

17 and situational awareness; stakeholders 

18 with expertise in capabilities relevant to 

19 biosurveillance and situational awareness, 

20 such as experts in informatics and data 

21 analytics (including experts in prediction, 

22 modeling, or forecasting); and other rep23 resentatives as the Secretary determines 

24 appropriate. 


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

2 shall include a discussion of— 

3 ‘‘(I) data elements, including 

4 minimal or essential data elements, 

5 that are voluntarily provided for such 

6 network, which may include elements 

7 from public health and public and pri8 vate health care entities, to the extent 

9 practicable; 

10 ‘‘(II) standards and implementa11 tion specifications that may improve 

12 the collection, analysis, and interpre13 tation of data during a public health 

14 emergency; 

15 ‘‘(III) strategies to encourage the 

16 access, exchange, and use of informa17 tion; 

18 ‘‘(IV) considerations for State, 

19 local, Tribal, and territorial capabili20 ties and infrastructure related to data 

21 exchange and interoperability; 

22 ‘‘(V) privacy and security protec23 tions provided at the Federal, State, 

24 local, Tribal, and territorial levels, 


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1 and by nongovernmental stakeholders; 

2 and 

3 ‘‘(VI) opportunities for the incor4 poration of innovative technologies to 

5 improve the network.’’; and 

6 (iv) in subparagraph (A), as so des7 ignated by clause (ii)— 

8 (I) in clause (i), as so redesig9 nated— 

10 (aa) by striking ‘‘as deter11 mined’’ and inserting ‘‘as adopt12 ed’’; and 

13 (bb) by inserting ‘‘and the 

14 National Institute of Standards 

15 and Technology’’ after ‘‘Office of 

16 the National Coordinator for 

17 Health Information Technology’’; 

18 (II) in clause (iii), as so redesig19 nated, by striking ‘‘; and’’ and insert20 ing a semicolon; 

21 (III) in clause (iv), as so redesig22 nated, by striking the period and in23 serting ‘‘; and’’; and 

24 (IV) by adding at the end the fol25 lowing: 


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1 ‘‘(v) pilot test standards and imple2 mentation specifications, consistent with 

3 the process described in section 

4 3002(b)(3)(C), which State, local, Tribal, 

5 and territorial public health entities may 

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

7 the network.’’; 

8 (E) by redesignating paragraph (6) as 

9 paragraph (7); 

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

11 following: 

12 ‘‘(6) STRATEGY AND IMPLEMENTATION

13 PLAN.— 

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

15 months after the date of enactment of the Pan16 demic and All-Hazards Preparedness and Ad17 vancing Innovation Act of 2019, the Secretary 

18 shall submit to the congressional committees of 

19 jurisdiction a coordinated strategy and an ac20 companying implementation plan that— 

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

22 under paragraph (5)(B); 

23 ‘‘(ii) includes a review and assessment 

24 of existing capabilities of the network and 

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1 vided by the public meeting under para2 graph (5)(B); 

3 ‘‘(iii) identifies and demonstrates the 

4 measurable steps the Secretary will carry 

5 out to— 

6 ‘‘(I) develop, implement, and 

7 evaluate the network described in 

8 paragraph (1), utilizing elements de9 scribed in paragraph (3)(A); 

10 ‘‘(II) modernize and enhance bio11 surveillance activities, including strat12 egies to include innovative tech13 nologies and analytical approaches 

14 (including prediction and forecasting 

15 for pandemics and all-hazards) from 

16 public and private entities; 

17 ‘‘(III) improve information shar18 ing, coordination, and communication 

19 among disparate biosurveillance sys20 tems supported by the Department of 

21 Health and Human Services, includ22 ing the identification of methods to 

23 improve accountability, better utilize 

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1 nologies within and across agencies; 

2 and 

3 ‘‘(IV) test and evaluate capabili4 ties of the interoperable network of 

5 systems to improve situational aware6 ness and biosurveillance capabilities; 

7 ‘‘(iv) includes performance measures 

8 and the metrics by which performance 

9 measures will be assessed with respect to 

10 the measurable steps under clause (iii); 

11 and 

12 ‘‘(v) establishes dates by which each 

13 measurable step under clause (iii) will be 

14 implemented. 

15 ‘‘(B) ANNUAL BUDGET PLAN.—Not later 

16 than 2 years after the date of enactment of the 

17 Pandemic and All-Hazards Preparedness and 

18 Advancing Innovation Act of 2019 and on an 

19 annual basis thereafter, in accordance with the 

20 strategy and implementation plan under this 

21 paragraph, the Secretary shall, taking into ac22 count recommendations provided by the Na23 tional Biodefense Science Board, develop a 

24 budget plan based on the strategy and impleVerDate Sep 11 2014 22:22 May 15, 2019 Jkt 089200 PO 00000 Frm 00047 Fmt 6652 Sfmt 6201 \\ALPHA3\E\BILLS\S1379.IS S1379

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1 mentation plan under this section. Such budget 

2 plan shall include— 

3 ‘‘(i) a summary of resources pre4 viously expended to establish, improve, and 

5 utilize the nationwide public health situa6 tional awareness and biosurveillance net7 work under paragraph (1); 

8 ‘‘(ii) estimates of costs and resources 

9 needed to establish and improve the net10 work under paragraph (1) according to the 

11 strategy and implementation plan under 

12 subparagraph (A); 

13 ‘‘(iii) the identification of gaps and in14 efficiencies in nationwide public health sit15 uational awareness and biosurveillance ca16 pabilities, resources, and authorities need17 ed to address such gaps; and 

18 ‘‘(iv) a strategy to minimize and ad19 dress such gaps and improve inefficien20 cies.’’; 

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

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

23 ‘‘(taking into account zoonotic disease, in24 cluding gaps in scientific understanding of 

25 the interactions between human, animal, 


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1 and environmental health)’’ after ‘‘human 

2 health’’; 

3 (ii) in subparagraph (B)— 

4 (I) by inserting ‘‘and gaps in sur5 veillance programs’’ after ‘‘surveil6 lance programs’’; and 

7 (II) by striking ‘‘; and’’ and in8 serting a semicolon; 

9 (iii) in subparagraph (C)— 

10 (I) by inserting ‘‘, animal health 

11 organizations related to zoonotic dis12 ease,’’ after ‘‘health care entities’’; 

13 and 

14 (II) by striking the period and 

15 inserting ‘‘; and’’; and 

16 (iv) by adding at the end the fol17 lowing: 

18 ‘‘(D) provide recommendations to the Sec19 retary on policies and procedures to complete 

20 the steps described in this paragraph in a man21 ner that is consistent with section 2802.’’; and 

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

23 ‘‘(8) SITUATIONAL AWARENESS AND BIO24 SURVEILLANCE AS A NATIONAL SECURITY PRI25 ORITY.—The Secretary, on a periodic basis as appliVerDate Sep 11 2014 22:22 May 15, 2019 Jkt 089200 PO 00000 Frm 00049 Fmt 6652 Sfmt 6201 \\ALPHA3\E\BILLS\S1379.IS S1379

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1 cable and appropriate, shall meet with the Director 

2 of National Intelligence to inform the development 

3 and capabilities of the nationwide public health situ4 ational awareness and biosurveillance network.’’; 

5 (5) in subsection (d)— 

6 (A) in paragraph (1)— 

7 (i) by inserting ‘‘environmental health 

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

9 and 

10 (ii) by inserting ‘‘immunization pro11 grams,’’ after ‘‘poison control centers,’’; 

12 (B) in paragraph (2)— 

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

14 ‘‘and’’ at the end; 

15 (ii) in subparagraph (C), by striking 

16 the period and inserting ‘‘; and’’; and 

17 (iii) by adding after subparagraph (C) 

18 the following: 

19 ‘‘(D) an implementation plan that may in20 clude measurable steps to achieve the purposes 

21 described in paragraph (1).’’; and 

22 (C) by striking paragraph (5) and insert23 ing the following: 

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

25 may provide technical assistance to States, localities, 


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1 Tribes, and territories or a consortium of States, lo2 calities, Tribes, and territories receiving an award 

3 under this subsection regarding interoperability and 

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

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

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

7 (7) by inserting after subsection (e) the fol8 lowing: 

9 ‘‘(f) PERSONNEL AUTHORITIES.— 

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

11 addition to any other personnel authorities, to carry 

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

13 ‘‘(A) appoint highly qualified individuals to 

14 scientific or professional positions at the Cen15 ters for Disease Control and Prevention, not to 

16 exceed 30 such employees at any time (specific 

17 to positions authorized by this subsection), with 

18 expertise in capabilities relevant to biosurveil19 lance and situational awareness, such as experts 

20 in informatics and data analytics (including ex21 perts in prediction, modeling, or forecasting), 

22 and other related scientific or technical fields; 

23 and 

24 ‘‘(B) compensate individuals appointed 

25 under subparagraph (A) in the same manner 


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1 and subject to the same terms and conditions in 

2 which individuals appointed under 9903 of title 

3 5, United States Code, are compensated, with4 out regard to the provisions of chapter 51 and 

5 subchapter III of chapter 53 of such title relat6 ing to classification and General Schedule pay 

7 rates. 

8 ‘‘(2) LIMITATIONS.—The Secretary shall exer9 cise the authority under paragraph (1) in a manner 

10 that is consistent with the limitations described in 

11 section 319F–1(e)(2). 

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

13 purposes under subsections (b) and (c) no later than Sep14 tember 30, 2023, and shall provide a justification to the 

15 congressional committees of jurisdiction for any missed or 

16 delayed implementation of measurable steps identified 

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

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

19 years after the date of enactment of the Pandemic and 

20 All-Hazards Preparedness and Advancing Innovation Act 

21 of 2019, the Comptroller General of the United States 

22 shall conduct an independent evaluation and submit to the 

23 Secretary and the congressional committees of jurisdiction 

24 a report concerning the activities conducted under sub25 sections (b) and (c), and provide recommendations, as apVerDate Sep 11 2014 22:22 May 15, 2019 Jkt 089200 PO 00000 Frm 00052 Fmt 6652 Sfmt 6201 \\ALPHA3\E\BILLS\S1379.IS S1379

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1 plicable and appropriate, on necessary improvements to 

2 the biosurveillance and situational awareness network.’’. 

3 (b) AUTHORIZATION OF APPROPRIATIONS.—Sub4 section (i) of section 319D (42 U.S.C. 247d–4), as redes5 ignated by subsection (a)(6), is amended by striking 

6 ‘‘$138,300,000 for each of fiscal years 2014 through 

7 2018’’ and inserting ‘‘$161,800,000 for each of fiscal 

8 years 2019 through 2023’’. 

9 (c) BIOLOGICAL THREAT DETECTION REPORT.—The 

10 Secretary of Health and Human Services shall, in coordi11 nation with the Secretary of Defense and the Secretary 

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

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

14 on Energy and Commerce, the Committee on Armed Serv15 ices, and the Committee on Homeland Security of the 

16 House of Representatives and the Committee on Health, 

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

18 Services, and the Committee on Homeland Security and 

19 Governmental Affairs of the Senate on the state of Fed20 eral biological threat detection efforts, including the fol21 lowing: 

22 (1) An identification of technological, oper23 ational, and programmatic successes and failures of 

24 domestic detection programs supported by Federal 

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1 duced or accidentally released biological threat 

2 agents and naturally occurring infectious diseases. 

3 (2) A description of Federal efforts to facilitate 

4 the exchange of information related to the informa5 tion described in paragraph (1) among Federal de6 partments and agencies that utilize biological threat 

7 detection technology. 

8 (3) A description of the capabilities of detection 

9 systems in use by Federal departments and agencies 

10 including the capability to— 

11 (A) rapidly detect, identify, characterize, 

12 and confirm the presence of biological threat 

13 agents; 

14 (B) recover live biological agents from col15 lection devices; 

16 (C) determine the geographical distribution 

17 of biological agents; 

18 (D) determine the extent of environmental 

19 contamination and persistence of biological 

20 agents; and 

21 (E) provide advanced molecular diagnostics 

22 to State, local, Tribal, and territorial public 

23 health and other laboratories that support bio24 logical threat detection activities. 


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1 (4) A description of Federal interagency coordi2 nation related to biological threat detection. 

3 (5) A description of efforts by Federal depart4 ments and agencies that utilize biological threat de5 tection technology to collaborate with State, local, 

6 Tribal, and territorial public health laboratories and 

7 other users of biological threat detection systems, in8 cluding collaboration regarding the development of— 

9 (A) biological threat detection require10 ments or standards; 

11 (B) a standardized integration strategy; 

12 (C) training requirements or guidelines; 

13 (D) guidelines for a coordinated public 

14 health response, including preparedness capa15 bilities, and, as applicable, for coordination with 

16 public health surveillance systems; and 

17 (E) a coordinated environmental remedi18 ation plan, as applicable. 

19 (6) Recommendations related to research, ad20 vanced research, development, and procurement for 

21 Federal departments and agencies to improve and 

22 enhance biological threat detection systems, includ23 ing recommendations on the transfer of biological 

24 threat detection technology among Federal depart25 ments and agencies, as necessary and appropriate. 


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1 SEC. 206. STRENGTHENING AND SUPPORTING THE PUBLIC 

2 HEALTH EMERGENCY RAPID RESPONSE 

3 FUND. 

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

5 (1) in subsection (b)— 

6 (A) in paragraph (1)— 

7 (i) in the first sentence, by inserting 

8 ‘‘or if the Secretary determines there is the 

9 significant potential for a public health 

10 emergency, to allow the Secretary to rap11 idly respond to the immediate needs result12 ing from such public health emergency or 

13 potential public health emergency’’ before 

14 the period; and 

15 (ii) by inserting ‘‘The Secretary shall 

16 plan for the expedited distribution of funds 

17 to appropriate agencies and entities.’’ after 

18 the first sentence; 

19 (B) by redesignating paragraph (2) as 

20 paragraph (3); 

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

22 following: 

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

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

25 ‘‘(A) facilitate coordination between and 

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1 torial entities and public and private health 

2 care entities that the Secretary determines may 

3 be affected by a public health emergency or po4 tential public health emergency referred to in 

5 paragraph (1) (including communication of 

6 such entities with relevant international enti7 ties, as applicable); 

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

9 enter into contracts, and conduct supportive in10 vestigations pertaining to a public health emer11 gency or potential public health emergency, in12 cluding further supporting programs under sec13 tion 319C–1, 319C–2, or 319C–3; 

14 ‘‘(C) facilitate and accelerate, as applica15 ble, advanced research and development of secu16 rity countermeasures (as defined in section 

17 319F–2), qualified countermeasures (as defined 

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

19 epidemic products (as defined in section 319F– 

20 3), that are applicable to the public health 

21 emergency or potential public health emergency 

22 under paragraph (1); 

23 ‘‘(D) strengthen biosurveillance capabilities 

24 and laboratory capacity to identify, collect, and 

25 analyze information regarding such public 


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1 health emergency or potential public health 

2 emergency, including the systems under section 

3 319D; 

4 ‘‘(E) support initial emergency operations 

5 and assets related to preparation and deploy6 ment of intermittent disaster response per7 sonnel under section 2812 and the Medical Re8 serve Corps under section 2813; and 

9 ‘‘(F) carry out other activities, as the Sec10 retary determines applicable and appropriate.’’; 

11 and 

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

13 redesignated, the following: 

14 ‘‘(4) REVIEW.—Not later than 2 years after the 

15 date of enactment of the Pandemic and All-Hazards 

16 Preparedness and Advancing Innovation Act of 

17 2019, the Secretary, in coordination with the Assist18 ant Secretary for Preparedness and Response, shall 

19 conduct a review of the Fund under this section and 

20 provide recommendations to the Committee on 

21 Health, Education, Labor, and Pensions and the 

22 Committee on Appropriations of the Senate and the 

23 Committee on Energy and Commerce and the Com24 mittee on Appropriations of the House of RepresentVerDate Sep 11 2014 22:22 May 15, 2019 Jkt 089200 PO 00000 Frm 00058 Fmt 6652 Sfmt 6201 \\ALPHA3\E\BILLS\S1379.IS S1379

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1 atives on policies to improve such Fund for the uses 

2 described in paragraph (2). 

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

4 after the date of enactment of the Pandemic and 

5 All-Hazards Preparedness and Advancing Innovation 

6 Act of 2019, the Comptroller General of the United 

7 States shall— 

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

9 this section, including its uses and the re10 sources available in the Fund; and 

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

12 Education, Labor, and Pensions of the Senate 

13 and the Committee on Energy and Commerce 

14 of the House of Representatives a report on 

15 such review, including recommendations related 

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

17 (2) in subsection (c)— 

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

19 health emergencies or potential public health 

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

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

22 ‘‘Act or funds otherwise provided for emergency 

23 response.’’. 


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1 SEC. 207. IMPROVING ALL-HAZARDS PREPAREDNESS AND 

2 RESPONSE BY PUBLIC HEALTH EMERGENCY 

3 VOLUNTEERS. 

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

5 7b) is amended— 

6 (1) in the section heading, by striking 

7 ‘‘HEALTH PROFESSIONS VOLUNTEERS’’ and in8 serting ‘‘VOLUNTEER HEALTH PROFESSIONAL’’; 

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

10 following: ‘‘Such health care professionals may in11 clude members of the National Disaster Medical 

12 System, members of the Medical Reserve Corps, and 

13 individual health care professionals.’’; 

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

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

16 such mechanisms by States, the Secretary shall 

17 make available information and material provided by 

18 States that have developed mechanisms to waive the 

19 application of licensing requirements to applicable 

20 health professionals seeking to provide medical serv21 ices during a public health emergency. Such infor22 mation shall be made publicly available in a manner 

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

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

25 2018’’ and inserting ‘‘2019 through 2023’’. 


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1 (b) ALL-HAZARDS PUBLIC HEALTH EMERGENCY

2 PREPAREDNESS AND RESPONSE PLAN.—Section 319C– 

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

4 amended to read as follows: 

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

6 entity will implement to utilize the Emergency 

7 Management Assistance Compact, or other mu8 tual aid agreement, for medical and public 

9 health mutual aid, and, as appropriate, the ac10 tivities such entity will implement pursuant to 

11 section 319I to improve enrollment and coordi12 nation of volunteer health care professionals 

13 seeking to provide medical services during a 

14 public health emergency, which may include— 

15 ‘‘(I) providing a public method of 

16 communication for purposes of volunteer 

17 coordination (such as a phone number); 

18 ‘‘(II) providing for optional registra19 tion to participate in volunteer services 

20 during processes related to State medical 

21 licensing, registration, or certification or 

22 renewal of such licensing, registration, or 

23 certification; or 

24 ‘‘(III) other mechanisms as the State 

25 determines appropriate;’’. 


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1 SEC. 208. CLARIFYING STATE LIABILITY LAW FOR VOLUN2 TEER HEALTH CARE PROFESSIONALS. 

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

4 is amended by inserting after section 224 the following: 

5 ‘‘SEC. 225. HEALTH CARE PROFESSIONALS ASSISTING DUR6 ING A PUBLIC HEALTH EMERGENCY. 

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

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

9 is a member of the Medical Reserve Corps under section 

10 2813 or who is included in the Emergency System for Ad11 vance Registration of Volunteer Health Professionals 

12 under section 319I and who— 

13 ‘‘(1) is responding— 

14 ‘‘(A) to a public health emergency deter15 mined under section 319(a), during the initial 

16 period of not more than 90 days (as determined 

17 by the Secretary) of the public health emer18 gency determination (excluding any period cov19 ered by a renewal of such determination); or 

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

21 as declared by the President under section 401 

22 of the Robert T. Stafford Disaster Relief and 

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

24 under section 201 of the National Emergencies 

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

26 of such declaration; 


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1 ‘‘(2) is alleged to be liable for an act or omis2 sion— 

3 ‘‘(A) during the initial period of a deter4 mination or declaration described in paragraph 

5 (1) and related to the treatment of individuals 

6 in need of health care services due to such pub7 lic health emergency, major disaster, or emer8 gency; 

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

10 determination or declaration is made; 

11 ‘‘(C) in the health care professional’s ca12 pacity as a member of the Medical Reserve 

13 Corps or a professional included in the Emer14 gency System for Advance Registration of Vol15 unteer Health Professionals under section 319I; 

16 and 

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

18 that are within the scope of the license, reg19 istration, or certification of the professional, as 

20 defined by the State of licensure, registration, 

21 or certification; and 

22 ‘‘(3) prior to the rendering of such act or omis23 sion, was authorized by the State’s authorization of 

24 deploying such State’s Emergency System for Ad25 vance Registration of Volunteer Health Professionals 


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1 described in section 319I or the Medical Reserve 

2 Corps established under section 2813, to provide 

3 health care services, 

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

5 in which such act or omission occurred, in the same man6 ner and to the same extent as a similar health care profes7 sional who is a resident of such State would be subject 

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

9 registration, and certification of such individual. 

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

11 this section shall be construed to affect an individual’s 

12 right to protections under the Volunteer Protection Act 

13 of 1997. 

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

15 laws of any State that would subject a health care profes16 sional described in subsection (a) to the liability laws of 

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

18 individual is subject pursuant to such subsection. 

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

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

21 an individual licensed, registered, or certified under 

22 Federal or State laws or regulations to provide 

23 health care services. 

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

25 services provided by a health care professional, or by 


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1 any individual working under the supervision of a 

2 health care professional, that relate to— 

3 ‘‘(A) the diagnosis, prevention, or treat4 ment of any human disease or impairment; or 

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

6 of human beings. 

7 ‘‘(e) EFFECTIVE DATE.— 

8 ‘‘(1) IN GENERAL.—This section shall take ef9 fect 90 days after the date of the enactment of the 

10 Pandemic and All-Hazards Preparedness and Ad11 vancing Innovation Act of 2019. 

12 ‘‘(2) APPLICATION.—This section shall apply to 

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

14 caused such harm occurred on or after the effective 

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

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

17 date of enactment of this Act, the Comptroller General 

18 of the United States shall conduct a review of— 

19 (1) the number of health care providers who 

20 register under the Emergency System for Advance 

21 Registration of Volunteer Health Professionals 

22 under section 319I of the Public Health Service Act 

23 (42 U.S.C. 247d–7b) in advance to provide services 

24 during a public health emergency; 


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

2 credentialed to provide services during the period of 

3 a public health emergency declaration, including 

4 those who are credentialed though programs estab5 lished in the Emergency System for Advance Reg6 istration of Volunteer Health Professionals under 

7 such section 319I and those credentialed by authori8 ties within the State in which the emergency oc9 curred; 

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

11 a health care provider during the period of a public 

12 health emergency declaration, including the average 

13 time pursuant to the Emergency System for Ad14 vance Registration of Volunteer Health Professionals 

15 under such section 319I and for an individual’s cre16 dentials to be verified by an authority within the 

17 State; and 

18 (4) the Emergency System for Advance Reg19 istration of Volunteer Health Professionals program 

20 in States, including whether physician or medical 

21 groups, associations, or other relevant provider orga22 nizations utilize such program for purposes of volun23 teering during public health emergencies. 


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1 SEC. 209. REPORT ON ADEQUATE NATIONAL BLOOD SUP2 PLY. 

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

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

5 shall submit to Congress a report containing recommenda6 tions related to maintaining an adequate national blood 

7 supply, including— 

8 (1) challenges associated with the continuous 

9 recruitment of blood donors (including those newly 

10 eligible to donate); 

11 (2) ensuring the adequacy of the blood supply 

12 in the case of public health emergencies; 

13 (3) implementation of the transfusion trans14 mission monitoring system; and 

15 (4) other measures to promote safety and inno16 vation, such as the development, use, or implementa17 tion of new technologies, processes, and procedures 

18 to improve the safety and reliability of the blood 

19 supply. 

20 SEC. 210. REPORT ON THE PUBLIC HEALTH PREPARED21 NESS AND RESPONSE CAPABILITIES AND CA22 PACITIES OF HOSPITALS, LONG-TERM CARE 

23 FACILITIES, AND OTHER HEALTH CARE FA24 CILITIES. 

25 (a) STUDY.— 


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

2 after the date of enactment of this Act, the Sec3 retary of Health and Human Services shall enter 

4 into an agreement with an appropriate entity to con5 duct a study regarding the public health prepared6 ness and response capabilities and medical surge ca7 pacities of hospitals, long-term care facilities, and 

8 other health care facilities to prepare for, and re9 spond to, public health emergencies, including nat10 ural disasters. 

11 (2) CONSULTATION.—In conducting the study 

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

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

14 health officials (as appropriate), and health care 

15 providers and facilities with experience in public 

16 health preparedness and response activities. 

17 (3) EVALUATION.—The study under paragraph 

18 (1) shall include— 

19 (A) an evaluation of the current bench20 marks and objective standards, as applicable, 

21 related to programs that support hospitals, 

22 long-term care facilities, and other health care 

23 facilities, and their effect on improving public 

24 health preparedness and response capabilities 

25 and medical surge capacities, including the 


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1 Hospital Preparedness Program, the Public 

2 Health Emergency Preparedness cooperative 

3 agreements, and the Regional Health Care 

4 Emergency Preparedness and Response Sys5 tems under section 319C–3 of the Public 

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

7 (B) the identification of gaps in prepared8 ness, including with respect to such benchmarks 

9 and objective standards, such as those identified 

10 during recent public health emergencies, for 

11 hospitals, long-term care facilities, and other 

12 health care facilities to address future potential 

13 public health threats; 

14 (C) an evaluation of coordination efforts 

15 between the recipients of Federal funding for 

16 programs described in subparagraph (A) and 

17 entities with expertise in emergency power sys18 tems and other critical infrastructure partners 

19 during a public health emergency, to ensure a 

20 functioning critical infrastructure, to the great21 est extent practicable, during a public health 

22 emergency; 

23 (D) an evaluation of coordination efforts 

24 between the recipients of Federal funding for 

25 programs described in subparagraph (A) and 


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1 environmental health agencies with expertise in 

2 emergency preparedness and response planning 

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

4 health care facilities; and 

5 (E) an evaluation of current public health 

6 preparedness and response capabilities and 

7 medical surge capacities related to at-risk indi8 viduals during public health emergencies, in9 cluding an identification of gaps in such pre10 paredness as they relate to such individuals. 

11 (b) REPORT.— 

12 (1) IN GENERAL.—The agreement under sub13 section (a) shall require the entity to submit to the 

14 Secretary of Health and Human Services and the 

15 congressional committees of jurisdiction, not later 

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

17 a report on the results of the study conducted pur18 suant to this section. 

19 (2) CONTENTS.—The report under paragraph 

20 (1) shall— 

21 (A) describe the findings and conclusions 

22 of the evaluation conducted pursuant to sub23 section (a); and 

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1 pability and medical surge capacity for hos2 pitals, long-term care facilities, and other health 

3 care facilities, including— 

4 (i) improving the existing benchmarks 

5 and objective standards for the Federal 

6 grant programs described in subsection 

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

8 and standards for such programs; and 

9 (ii) identifying best practices for im10 proving public health preparedness and re11 sponse programs and medical surge capac12 ity at hospitals, long-term care facilities, 

13 and other health care facilities, including 

14 recommendations for the evaluation under 

15 subparagraphs (C) and (D) of subsection 

16 (a)(3). 

17 TITLE III—REACHING ALL 

18 COMMUNITIES 

19 SEC. 301. STRENGTHENING AND ASSESSING THE EMER20 GENCY RESPONSE WORKFORCE. 

21 (a) NATIONAL DISASTER MEDICAL SYSTEM.— 

22 (1) STRENGTHENING THE NATIONAL DISASTER

23 MEDICAL SYSTEM.—Clause (ii) of section 

24 2812(a)(3)(A) (42 U.S.C. 300hh–11(a)(3)(A)) is 

25 amended to read as follows: 


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

2 limited periods of time, specified by the 

3 Secretary on the basis that the Secretary 

4 has determined that a location is at risk of 

5 a public health emergency during the time 

6 specified, or there is a significant potential 

7 for a public health emergency.’’. 

8 (2) REVIEW OF THE NATIONAL DISASTER MED9 ICAL SYSTEM.—Section 2812(b)(2) (42 U.S.C. 

10 300hh–11(b)(2)) is amended to read as follows: 

11 ‘‘(2) JOINT REVIEW AND MEDICAL SURGE CA12 PACITY STRATEGIC PLAN.— 

13 ‘‘(A) REVIEW.—Not later than 180 days 

14 after the date of enactment of the Pandemic 

15 and All-Hazards Preparedness and Advancing 

16 Innovation Act of 2019, the Secretary, in co17 ordination with the Secretary of Homeland Se18 curity, the Secretary of Defense, and the Sec19 retary of Veterans Affairs, shall conduct a joint 

20 review of the National Disaster Medical System. 

21 Such review shall include— 

22 ‘‘(i) an evaluation of medical surge ca23 pacity, as described in section 2803(a); 

24 ‘‘(ii) an assessment of the available 

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1 sponse personnel described in subsection 

2 (c); 

3 ‘‘(iii) the capacity of the workforce de4 scribed in clause (ii) to respond to all haz5 ards, including capacity to simultaneously 

6 respond to multiple public health emer7 gencies and the capacity to respond to a 

8 nationwide public health emergency; 

9 ‘‘(iv) the effectiveness of efforts to re10 cruit, retain, and train such workforce; and 

11 ‘‘(v) gaps that may exist in such 

12 workforce and recommendations for ad13 dressing such gaps. 

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

15 Health Security Strategy under section 2802, 

16 the Secretary shall update the findings from the 

17 review under subparagraph (A) and provide rec18 ommendations to modify the policies of the Na19 tional Disaster Medical System as necessary.’’. 

20 (3) NOTIFICATION OF SHORTAGE.—Section 

21 2812(c) (42 U.S.C. 300hh–11(c)) is amended by 

22 adding at the end the following: 

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

24 after the date on which the Secretary determines the 

25 number of intermittent disaster-response personnel 


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1 of the National Disaster Medical System is insuffi2 cient to address a public health emergency or poten3 tial public health emergency, the Secretary shall sub4 mit to the congressional committees of jurisdiction a 

5 notification detailing— 

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

7 on meeting public health needs and emergency 

8 medical personnel needs during a public health 

9 emergency; and 

10 ‘‘(B) any identified measures to address 

11 such shortage. 

12 ‘‘(4) CERTAIN APPOINTMENTS.— 

13 ‘‘(A) IN GENERAL.—If the Secretary deter14 mines that the number of intermittent disaster 

15 response personnel within the National Disaster 

16 Medical System under this section is insuffi17 cient to address a public health emergency or 

18 potential public health emergency, the Secretary 

19 may appoint candidates directly to personnel 

20 positions for intermittent disaster response 

21 within such system. The Secretary shall provide 

22 updates on the number of vacant or unfilled po23 sitions within such system to the congressional 

24 committees of jurisdiction each quarter for 

25 which this authority is in effect. 


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

2 paragraph shall expire on September 30, 

3 2021.’’. 

4 (4) AUTHORIZATION OF APPROPRIATIONS.— 

5 Section 2812(g) (42 U.S.C. 300hh–11(g)) is amend6 ed by striking ‘‘$52,700,000 for each of fiscal years 

7 2014 through 2018’’ and inserting ‘‘$57,400,000 for 

8 each of fiscal years 2019 through 2023’’. 

9 (b) VOLUNTEER MEDICAL RESERVE CORPS.— 

10 (1) IN GENERAL.—Section 2813(a) (42 U.S.C. 

11 42 U.S.C. 300hh–15(a)) is amended by striking the 

12 second sentence and inserting ‘‘The Secretary may 

13 appoint a Director to head the Corps and oversee 

14 the activities of the Corps chapters that exist at the 

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

16 (2) AUTHORIZATION OF APPROPRIATIONS.— 

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

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

19 ‘‘2019 through 2023’’. 

20 (c) STRENGTHENING THE EPIDEMIC INTELLIGENCE

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

22 amended— 

23 (1) in subsection (a)— 

24 (A) in paragraph (1)— 


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1 (i) by inserting ‘‘or preparedness and 

2 response activities, including rapid re3 sponse to public health emergencies and 

4 significant public health threats’’ after 

5 ‘‘conduct prevention activities’’; and 

6 (ii) by striking ‘‘$35,000’’ and insert7 ing ‘‘$50,000’’; and 

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

9 years’’ and inserting ‘‘2 years’’; and 

10 (2) in subsection (c)— 

11 (A) by striking ‘‘For the purpose of car12 rying out this section’’ and inserting the fol13 lowing: 

14 ‘‘(1) IN GENERAL.—For the purpose of car15 rying out this section, except as described in para16 graph (2)’’; and 

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

18 ‘‘(2) EPIDEMIC INTELLIGENCE SERVICE PRO19 GRAM.—For purposes of carrying out this section 

20 with respect to qualified health professionals serving 

21 in the Epidemic Intelligence Service, as authorized 

22 under section 317G, there is authorized to be appro23 priated $1,000,000 for each of fiscal years 2019 

24 through 2023.’’. 


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1 (d) SERVICE BENEFIT FOR NATIONAL DISASTER

2 MEDICAL SYSTEM VOLUNTEERS.— 

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

4 300hh–11(c)), as amended by subsection (a)(3), is 

5 further amended by adding at the end the following: 

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

7 to serve under this subsection shall be considered eli8 gible for benefits under part L of title I of the Om9 nibus Crime Control and Safe Streets Act of 1968. 

10 The Secretary shall provide notification to any eligi11 ble individual of any effect such designation may 

12 have on other benefits for which such individual is 

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

14 (2) PUBLIC SAFETY OFFICER BENEFITS.—Sec15 tion 1204(9) of title I of the Omnibus Crime Control 

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

17 is amended— 

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

19 ‘‘or’’ at the end; 

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

21 period and inserting ‘‘; or’’; and 

22 (C) by inserting after subparagraph (D) 

23 the following: 

24 ‘‘(E) an individual appointed to the Na25 tional Disaster Medical System under section 


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1 2812 of the Public Health Service Act (42 

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

3 duties of the Department of Health and Human 

4 Services, if those official duties are— 

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

6 health emergency or potential public health 

7 emergency, or other activities for which the 

8 Secretary of Health and Human Services 

9 has activated such National Disaster Med10 ical System; and 

11 ‘‘(ii) determined by the Secretary of 

12 Health and Human Services to be haz13 ardous.’’. 

14 (3) SUNSET.—The amendments made by para15 graphs (1) and (2) shall cease to have force or effect 

16 on October 1, 2021. 

17 (e) MISSION READINESS REPORT TO CONGRESS.— 

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

19 date of enactment of this section, the Comptroller 

20 General of the United States (referred to in this 

21 subsection as the ‘‘Comptroller General’’) shall sub22 mit to the Committee on Health, Education, Labor, 

23 and Pensions of the Senate and the Committee on 

24 Energy and Commerce of the House of Representa25 tives, a report on the medical surge capacity of the 


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1 United States in the event of a public health emer2 gency, including the capacity and capability of the 

3 current health care workforce to prepare for, and re4 spond to, the full range of public health emergencies 

5 or potential public health emergencies, and rec6 ommendations to address any gaps identified in such 

7 workforce. 

8 (2) CONTENTS.—The Comptroller General shall 

9 include in the report under paragraph (1)— 

10 (A) the number of health care providers 

11 who have volunteered to provide health care 

12 services during a public health emergency, in13 cluding members of the National Disaster Med14 ical System, the Disaster Medical Assistant 

15 Teams, the Medical Reserve Corps, and other 

16 volunteer health care professionals in the 

17 verification network pursuant to section 319I of 

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

19 247d–7b); 

20 (B) the capacity of the workforce described 

21 in subparagraph (A) to respond to a public 

22 health emergency or potential public health 

23 emergency, including the capacity to respond to 

24 multiple concurrent public health emergencies 


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1 and the capacity to respond to a nationwide 

2 public health emergency; 

3 (C) the preparedness and response capa4 bilities and mission readiness of the workforce 

5 described in subparagraph (A) taking into ac6 count areas of health care expertise and consid7 erations for at-risk individuals (as defined in 

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

9 Service Act (42 U.S.C. 300hh–1(b)(4)(B))); 

10 (D) an assessment of the effectiveness of 

11 efforts to recruit, retain, and train such work12 force; and 

13 (E) identification of gaps that may exist in 

14 such workforce and recommendations for ad15 dressing such gaps, the extent to which the As16 sistant Secretary for Preparedness and Re17 sponse plans to address such gaps, and any rec18 ommendations from the Comptroller General to 

19 address such gaps. 

20 SEC. 302. HEALTH SYSTEM INFRASTRUCTURE TO IMPROVE 

21 PREPAREDNESS AND RESPONSE. 

22 (a) COORDINATION OF PREPAREDNESS.—Section 

23 2811(b)(5) (42 U.S.C. 300hh–10(b)(5)) is amended by 

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

25 shall include working with other relevant Federal, State, 


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1 local, Tribal, and territorial public health officials and pri2 vate sector entities to identify the critical infrastructure 

3 assets, systems, and networks needed for the proper func4 tioning of the health care and public health sectors that 

5 need to be maintained through any emergency or disaster, 

6 including entities capable of assisting with, responding to, 

7 and mitigating the effect of a public health emergency, 

8 including a public health emergency determined by the 

9 Secretary pursuant to section 319(a) or an emergency or 

10 major disaster declared by the President under the Robert 

11 T. Stafford Disaster Relief and Emergency Assistance Act 

12 or the National Emergencies Act, including by estab13 lishing methods to exchange critical information and de14 liver products consumed or used to preserve, protect, or 

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

16 expertise.’’. 

17 (b) MANUFACTURING CAPACITY.—Section 

18 2811(d)(2)(C) (42 U.S.C. 300hh–10(d)(2)(C)) is amended 

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

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

21 after ‘‘products’’. 

22 (c) EVALUATION OF BARRIERS TO RAPID DELIVERY

23 OF MEDICAL COUNTERMEASURES.— 

24 (1) RAPID DELIVERY STUDY.—The Assistant 

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1 duct a study on issues that have the potential to ad2 versely affect the handling and rapid delivery of 

3 medical countermeasures to individuals during public 

4 health emergencies occurring in the United States. 

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

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

7 the Assistant Secretary for Preparedness and Re8 sponse shall notify the Committee on Energy and 

9 Commerce of the House of Representatives and the 

10 Committee on Health, Education, Labor, and Pen11 sions of the Senate if the Assistant Secretary for 

12 Preparedness and Response does not plan to conduct 

13 the study under paragraph (1) and shall provide 

14 such committees a summary explanation for such de15 cision. 

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

17 year after the Assistant Secretary for Preparedness 

18 and Response conducts the study under paragraph 

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

20 to the Committee on Energy and Commerce of the 

21 House of Representatives and the Committee on 

22 Health, Education, Labor, and Pensions of the Sen23 ate containing the findings of such study. 


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

2 (a) AT-RISK INDIVIDUALS IN THE NATIONAL

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

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

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

6 1, 319F, and 319L,’’ and inserting ‘‘this Act,’’; and 

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

8 or functional’’. 

9 (b) COUNTERMEASURE CONSIDERATIONS.—Section 

10 319L(c)(6) (42 U.S.C. 247d–7e(c)(6)) is amended— 

11 (1) by striking ‘‘elderly’’ and inserting ‘‘older 

12 adults’’; and 

13 (2) by inserting ‘‘with relevant characteristics 

14 that warrant consideration during the process of re15 searching and developing such countermeasures and 

16 products’’ before the period. 

17 (c) BIOSURVEILLANCE OF EMERGING PUBLIC

18 HEALTH THREATS.—Section 2814 is amended— 

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

20 inserting a semicolon; 

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

22 inserting ‘‘; and’’; and 

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

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

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1 retary considers incorporating data and information 

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

3 public health officials and entities relevant to detect4 ing emerging public health threats that may affect 

5 at-risk individuals, such as pregnant and postpartum 

6 women and infants, including adverse health out7 comes of such populations related to such emerging 

8 public health threats.’’. 

9 SEC. 304. IMPROVING EMERGENCY PREPAREDNESS AND 

10 RESPONSE CONSIDERATIONS FOR CHIL11 DREN. 

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

13 by inserting after section 319D the following: 

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

15 ‘‘(a) ENHANCING EMERGENCY PREPAREDNESS FOR

16 CHILDREN.—The Secretary, acting through the Director 

17 of the Centers for Disease Control and Prevention (re18 ferred to in this subsection as the ‘Director’), shall main19 tain an internal team of experts, to be known as the Chil20 dren’s Preparedness Unit (referred to in this subsection 

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

22 on the considerations for, and the specific needs of, chil23 dren before, during, and after public health emergencies. 

24 The Unit shall inform the Director regarding emergency 


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1 preparedness and response efforts pertaining to children 

2 at the Centers for Disease Control and Prevention. 

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

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

5 a developmental-behavioral pediatrician, and may also in6 clude behavioral scientists, child psychologists, epidemiolo7 gists, biostatisticians, health communications staff, and 

8 individuals with other areas of expertise, as the Secretary 

9 determines appropriate. 

10 ‘‘(c) DUTIES.—The team described in subsection (a) 

11 may— 

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

13 emergency planning and response activities related 

14 to children, which may include developing, identi15 fying, and sharing best practices; 

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

17 consultation to Federal, State, local, Tribal, and ter18 ritorial public health officials to improve prepared19 ness and response capabilities with respect to the 

20 needs of children, including providing such technical 

21 assistance, training, and consultation to eligible enti22 ties in order to support the achievement of measur23 able evidence-based benchmarks and objective stand24 ards applicable to sections 319C–1 and 319C–2; 


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1 ‘‘(3) improve the utilization of methods to in2 corporate the needs of children in planning for and 

3 responding to a public health emergency, including 

4 public awareness of such methods; 

5 ‘‘(4) coordinate with, and improve, public-pri6 vate partnerships, such as health care coalitions pur7 suant to sections 319C–2 and 319C–3, to address 

8 gaps and inefficiencies in emergency preparedness 

9 and response efforts for children; 

10 ‘‘(5) provide expertise and input during the de11 velopment of guidance and clinical recommendations 

12 to address the needs of children when preparing for, 

13 and responding to, public health emergencies, includ14 ing pursuant to section 319C–3; and 

15 ‘‘(6) carry out other duties related to prepared16 ness and response activities for children, as the Sec17 retary determines appropriate.’’. 

18 SEC. 305. NATIONAL ADVISORY COMMITTEES ON DISAS19 TERS. 

20 (a) REAUTHORIZING THE NATIONAL ADVISORY COM21 MITTEE ON CHILDREN AND DISASTERS.—Section 2811A 

22 (42 U.S.C. 300hh–10a) is amended— 

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

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

25 (2) in subsection (d)— 


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

2 inserting ‘‘25’’; and 

3 (B) by striking paragraph (2) and insert4 ing the following: 

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

6 Secretary, in consultation with such other heads of 

7 Federal agencies as may be appropriate, shall ap8 point to the Advisory Committee under paragraph 

9 (1) at least 13 individuals, including— 

10 ‘‘(A) at least 2 non-Federal professionals 

11 with expertise in pediatric medical disaster 

12 planning, preparedness, response, or recovery; 

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

14 local, Tribal, or territorial agencies with exper15 tise in pediatric disaster planning, prepared16 ness, response, or recovery; 

17 ‘‘(C) at least 4 members representing 

18 health care professionals, which may include 

19 members with expertise in pediatric emergency 

20 medicine; pediatric trauma, critical care, or sur21 gery; the treatment of pediatric patients af22 fected by chemical, biological, radiological, or 

23 nuclear agents, including emerging infectious 

24 diseases; pediatric mental or behavioral health 


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1 related to children affected by a public health 

2 emergency; or pediatric primary care; and 

3 ‘‘(D) other members as the Secretary de4 termines appropriate, of whom— 

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

6 represent a children’s hospital; 

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

8 be an individual with expertise in schools 

9 or child care settings; 

10 ‘‘(iii) at least one such member shall 

11 be an individual with expertise in children 

12 and youth with special health care needs; 

13 and 

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

15 be an individual with expertise in the needs 

16 of parents or family caregivers, including 

17 the parents or caregivers of children with 

18 disabilities. 

19 ‘‘(3) FEDERAL MEMBERS.—The Advisory Com20 mittee under paragraph (1) shall include the fol21 lowing Federal members or their designees (who 

22 may be nonvoting members, as determined by the 

23 Secretary): 

24 ‘‘(A) The Assistant Secretary for Pre25 paredness and Response. 


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1 ‘‘(B) The Director of the Biomedical Ad2 vanced Research and Development Authority. 

3 ‘‘(C) The Director of the Centers for Dis4 ease Control and Prevention. 

5 ‘‘(D) The Commissioner of Food and 

6 Drugs. 

7 ‘‘(E) The Director of the National Insti8 tutes of Health. 

9 ‘‘(F) The Assistant Secretary of the Ad10 ministration for Children and Families. 

11 ‘‘(G) The Administrator of the Health Re12 sources and Services Administration. 

13 ‘‘(H) The Administrator of the Federal 

14 Emergency Management Agency. 

15 ‘‘(I) The Administrator of the Administra16 tion for Community Living. 

17 ‘‘(J) The Secretary of Education. 

18 ‘‘(K) Representatives from such Federal 

19 agencies (such as the Substance Abuse and 

20 Mental Health Services Administration and the 

21 Department of Homeland Security) as the Sec22 retary determines appropriate to fulfill the du23 ties of the Advisory Committee under sub24 sections (b) and (c). 


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

2 of the Advisory Committee appointed under para3 graph (2) shall serve for a term of 3 years, except 

4 that the Secretary may adjust the terms of the Advi5 sory Committee appointees serving on the date of 

6 enactment of the Pandemic and All-Hazards Pre7 paredness and Advancing Innovation Act of 2019, or 

8 appointees who are initially appointed after such 

9 date of enactment, in order to provide for a stag10 gered term of appointment for all members. 

11 ‘‘(5) CONSECUTIVE APPOINTMENTS; MAXIMUM

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

13 may serve not more than 3 terms on the Advisory 

14 Committee, and not more than two of such terms 

15 may be served consecutively.’’; 

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

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

18 meeting.’’; 

19 (4) by redesignating subsection (f) as sub20 section (g); 

21 (5) by inserting after subsection (e) the fol22 lowing: 

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

24 duties and activities authorized under this section in ac25 cordance with section 2811D.’’; and 


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

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

3 (b) AUTHORIZING THE NATIONAL ADVISORY COM4 MITTEE ON SENIORS AND DISASTERS.—Subtitle B of title 

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

6 after section 2811A the following: 

7 ‘‘SEC. 2811B. NATIONAL ADVISORY COMMITTEE ON SEN8 IORS AND DISASTERS. 

9 ‘‘(a) ESTABLISHMENT.—The Secretary, in consulta10 tion with the Secretary of Homeland Security and the Sec11 retary of Veterans Affairs, shall establish an advisory com12 mittee to be known as the National Advisory Committee 

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

14 the ‘Advisory Committee’). 

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

16 ‘‘(1) provide advice and consultation with re17 spect to the activities carried out pursuant to section 

18 2814, as applicable and appropriate; 

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

20 the medical and public health needs of seniors re21 lated to preparation for, response to, and recovery 

22 from all-hazards emergencies; and 

23 ‘‘(3) provide advice and consultation with re24 spect to State emergency preparedness and response 

25 activities relating to seniors, including related drills 


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1 and exercises pursuant to the preparedness goals 

2 under section 2802(b). 

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

4 may provide advice and recommendations to the Secretary 

5 with respect to seniors and the medical and public health 

6 grants and cooperative agreements as applicable to pre7 paredness and response activities under this title and title 

8 III. 

9 ‘‘(d) MEMBERSHIP.— 

10 ‘‘(1) IN GENERAL.—The Secretary, in consulta11 tion with such other heads of agencies as appro12 priate, shall appoint not more than 17 members to 

13 the Advisory Committee. In appointing such mem14 bers, the Secretary shall ensure that the total mem15 bership of the Advisory Committee is an odd num16 ber. 

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

18 Committee shall include Federal members or their 

19 designees (who may be nonvoting members, as deter20 mined by the Secretary) and non-Federal members, 

21 as follows: 

22 ‘‘(A) The Assistant Secretary for Pre23 paredness and Response. 

24 ‘‘(B) The Director of the Biomedical Ad25 vanced Research and Development Authority. 


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1 ‘‘(C) The Director of the Centers for Dis2 ease Control and Prevention. 

3 ‘‘(D) The Commissioner of Food and 

4 Drugs. 

5 ‘‘(E) The Director of the National Insti6 tutes of Health. 

7 ‘‘(F) The Administrator of the Centers for 

8 Medicare & Medicaid Services. 

9 ‘‘(G) The Administrator of the Administra10 tion for Community Living. 

11 ‘‘(H) The Administrator of the Federal 

12 Emergency Management Agency. 

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

14 the Department of Veterans Affairs. 

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

16 professionals with expertise in geriatric medical 

17 disaster planning, preparedness, response, or 

18 recovery. 

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

20 local, Tribal, or territorial agencies with exper21 tise in geriatric disaster planning, preparedness, 

22 response, or recovery. 

23 ‘‘(L) Representatives of such other Federal 

24 agencies (such as the Department of Energy 

25 and the Department of Homeland Security) as 


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1 the Secretary determines necessary to fulfill the 

2 duties of the Advisory Committee. 

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

4 meet not less frequently than biannually. At least one 

5 meeting per year shall be an in-person meeting. 

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

7 duties and activities authorized under this section in ac8 cordance with section 2811D. 

9 ‘‘(g) SUNSET.— 

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

11 shall terminate on September 30, 2023. 

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

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

14 Congress a recommendation on whether the Advisory 

15 Committee should be extended.’’. 

16 (c) NATIONAL ADVISORY COMMITTEE ON INDIVID17 UALS WITH DISABILITIES AND DISASTERS.—Subtitle B 

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

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

20 section 2811B the following: 

21 ‘‘SEC. 2811C. NATIONAL ADVISORY COMMITTEE ON INDIVID22 UALS WITH DISABILITIES AND DISASTERS. 

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1 tional Advisory Committee on Individuals with Disabilities 

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

3 Committee’). 

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

5 ‘‘(1) provide advice and consultation with re6 spect to activities carried out pursuant to section 

7 2814, as applicable and appropriate; 

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

9 the medical, public health, and accessibility needs of 

10 individuals with disabilities related to preparation 

11 for, response to, and recovery from all-hazards emer12 gencies; and 

13 ‘‘(3) provide advice and consultation with re14 spect to State emergency preparedness and response 

15 activities, including related drills and exercises pur16 suant to the preparedness goals under section 

17 2802(b). 

18 ‘‘(c) MEMBERSHIP.— 

19 ‘‘(1) IN GENERAL.—The Secretary, in consulta20 tion with such other heads of agencies and depart21 ments as appropriate, shall appoint not more than 

22 17 members to the Advisory Committee. In appoint23 ing such members, the Secretary shall ensure that 

24 the total membership of the Advisory Committee is 

25 an odd number. 


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

2 Committee shall include Federal members or their 

3 designees (who may be nonvoting members, as deter4 mined by the Secretary) and non-Federal members, 

5 as follows: 

6 ‘‘(A) The Assistant Secretary for Pre7 paredness and Response. 

8 ‘‘(B) The Administrator of the Administra9 tion for Community Living. 

10 ‘‘(C) The Director of the Biomedical Ad11 vanced Research and Development Authority. 

12 ‘‘(D) The Director of the Centers for Dis13 ease Control and Prevention. 

14 ‘‘(E) The Commissioner of Food and 

15 Drugs. 

16 ‘‘(F) The Director of the National Insti17 tutes of Health. 

18 ‘‘(G) The Administrator of the Federal 

19 Emergency Management Agency. 

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

21 Disability. 

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

23 Board. 

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

25 the Department of Veterans Affairs. 


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

2 professionals with expertise in disability accessi3 bility before, during, and after disasters, med4 ical and mass care disaster planning, prepared5 ness, response, or recovery. 

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

7 local, Tribal, or territorial agencies with exper8 tise in disaster planning, preparedness, re9 sponse, or recovery for individuals with disabil10 ities. 

11 ‘‘(M) At least 2 individuals with a dis12 ability with expertise in disaster planning, pre13 paredness, response, or recovery for individuals 

14 with disabilities. 

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

16 meet not less frequently than biannually. At least one 

17 meeting per year shall be an in-person meeting. 

18 ‘‘(e) DISABILITY DEFINED.—For purposes of this 

19 section, the term ‘disability’ has the meaning given such 

20 term in section 3 of the Americans with Disabilities Act 

21 of 1990. 

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

23 duties and activities authorized under this section in ac24 cordance with section 2811D. 

25 ‘‘(g) SUNSET.— 


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

2 shall terminate on September 30, 2023. 

3 ‘‘(2) RECOMMENDATION.—Not later than Octo4 ber 1, 2022, the Secretary shall submit to Congress 

5 a recommendation on whether the Advisory Com6 mittee should be extended.’’. 

7 (d) ADVISORY COMMITTEE COORDINATION.—Sub8 title B of title XXVIII (42 U.S.C. 300hh et seq.), as 

9 amended by subsection (c), is further amended by insert10 ing after section 2811C the following: 

11 ‘‘SEC. 2811D. ADVISORY COMMITTEE COORDINATION. 

12 ‘‘(a) IN GENERAL.—The Secretary shall coordinate 

13 duties and activities authorized under sections 2811A, 

14 2811B, and 2811C, and make efforts to reduce unneces15 sary or duplicative reporting, or unnecessary duplicative 

16 meetings and recommendations under such sections, as 

17 practicable. Members of the advisory committees author18 ized under such sections, or their designees, shall annually 

19 meet to coordinate any recommendations, as appropriate, 

20 that may be similar, duplicative, or overlapping with re21 spect to addressing the needs of children, seniors, and in22 dividuals with disabilities during public health emer23 gencies. If such coordination occurs through an in-person 

24 meeting, it shall not be considered the required in-person 


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1 meetings under any of sections 2811A(e), 2811B(e), or 

2 2811C(d). 

3 ‘‘(b) COORDINATION AND ALIGNMENT.—The Sec4 retary, acting through the employee designated pursuant 

5 to section 2814, shall align preparedness and response 

6 programs or activities to address similar, dual, or overlap7 ping needs of children, seniors, and individuals with dis8 abilities, and any challenges in preparing for and respond9 ing to such needs. 

10 ‘‘(c) NOTIFICATION.—The Secretary shall annually 

11 notify the congressional committees of jurisdiction regard12 ing the steps taken to coordinate, as appropriate, the rec13 ommendations under this section, and provide a summary 

14 description of such coordination.’’. 

15 SEC. 306. GUIDANCE FOR PARTICIPATION IN EXERCISES 

16 AND DRILLS. 

17 Not later than 2 years after the date of enactment 

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

19 shall issue final guidance regarding the ability of per20 sonnel funded by programs authorized under this Act (in21 cluding the amendments made by this Act) to participate 

22 in drills and operational exercises related to all-hazards 

23 medical and public health preparedness and response. 

24 Such drills and operational exercises may include activities 

25 that incorporate medical surge capacity planning, medical 


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1 countermeasure distribution and administration, and pre2 paring for and responding to identified threats for that 

3 region. Such personnel may include State, local, Tribal, 

4 and territorial public health department or agency per5 sonnel funded under this Act (including the amendments 

6 made by this Act). The Secretary shall consult with the 

7 Department of Homeland Security, the Department of 

8 Defense, the Department of Veterans Affairs, and other 

9 applicable Federal departments and agencies as necessary 

10 and appropriate in the development of such guidance. The 

11 Secretary shall make the guidance available on the inter12 net website of the Department of Health and Human 

13 Services. 

14 TITLE IV—PRIORITIZING A 

15 THREAT-BASED APPROACH 

16 SEC. 401. ASSISTANT SECRETARY FOR PREPAREDNESS AND 

17 RESPONSE. 

18 Section 2811(b) (42 U.S.C. 300hh–10(b)) is amend19 ed— 

20 (1) in the matter preceding paragraph (1), by 

21 inserting ‘‘utilize experience related to public health 

22 emergency preparedness and response, biodefense, 

23 medical countermeasures, and other relevant topics 

24 to’’ after ‘‘shall’’; and 


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1 (2) in paragraph (4), by adding at the end the 

2 following: 

3 ‘‘(I) THREAT AWARENESS.—Coordinate 

4 with the Director of the Centers for Disease 

5 Control and Prevention, the Director of Na6 tional Intelligence, the Secretary of Homeland 

7 Security, the Assistant to the President for Na8 tional Security Affairs, the Secretary of De9 fense, and other relevant Federal officials, such 

10 as the Secretary of Agriculture, to maintain a 

11 current assessment of national security threats 

12 and inform preparedness and response capabili13 ties based on the range of the threats that have 

14 the potential to result in a public health emer15 gency.’’. 

16 SEC. 402. PUBLIC HEALTH EMERGENCY MEDICAL COUN17 TERMEASURES ENTERPRISE. 

18 (a) IN GENERAL.—Title XXVIII is amended by in19 serting after section 2811 (42 U.S.C. 300hh–10) the fol20 lowing: 

21 ‘‘SEC. 2811–1. PUBLIC HEALTH EMERGENCY MEDICAL 

22 COUNTERMEASURES ENTERPRISE. 

23 ‘‘(a) IN GENERAL.—The Secretary shall establish the 

24 Public Health Emergency Medical Countermeasures En25 terprise (referred to in this section as the ‘PHEMCE’). 


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1 The Assistant Secretary for Preparedness and Response 

2 shall serve as chair of the PHEMCE. 

3 ‘‘(b) MEMBERS.—The PHEMCE shall include each 

4 of the following members, or the designee of such mem5 bers: 

6 ‘‘(1) The Assistant Secretary for Preparedness 

7 and Response. 

8 ‘‘(2) The Director of the Centers for Disease 

9 Control and Prevention. 

10 ‘‘(3) The Director of the National Institutes of 

11 Health. 

12 ‘‘(4) The Commissioner of Food and Drugs. 

13 ‘‘(5) The Secretary of Defense. 

14 ‘‘(6) The Secretary of Homeland Security. 

15 ‘‘(7) The Secretary of Agriculture. 

16 ‘‘(8) The Secretary of Veterans Affairs. 

17 ‘‘(9) The Director of National Intelligence. 

18 ‘‘(10) Representatives of any other Federal 

19 agency, which may include the Director of the Bio20 medical Advanced Research and Development Au21 thority, the Director of the Strategic National Stock22 pile, the Director of the National Institute of Allergy 

23 and Infectious Diseases, and the Director of the Of24 fice of Public Health Preparedness and Response, as 

25 the Secretary determines appropriate. 


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1 ‘‘(c) FUNCTIONS.— 

2 ‘‘(1) IN GENERAL.—The functions of the 

3 PHEMCE shall include the following: 

4 ‘‘(A) Utilize a process to make rec5 ommendations to the Secretary regarding re6 search, advanced research, development, pro7 curement, stockpiling, deployment, distribution, 

8 and utilization with respect to countermeasures, 

9 as defined in section 319F–2(c), including 

10 prioritization based on the health security needs 

11 of the United States. Such recommendations 

12 shall be informed by, when available and prac13 ticable, the National Health Security Strategy 

14 pursuant to section 2802, the Strategic Na15 tional Stockpile needs pursuant to section 

16 319F–2, and assessments of current national 

17 security threats, including chemical, biological, 

18 radiological, and nuclear threats, including 

19 emerging infectious diseases. In the event that 

20 members of the PHEMCE do not agree upon a 

21 recommendation, the Secretary shall provide a 

22 determination regarding such recommendation. 

23 ‘‘(B) Identify national health security 

24 needs, including gaps in public health prepared25 ness and response related to countermeasures 


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1 and challenges to addressing such needs (in2 cluding any regulatory challenges), and support 

3 alignment of countermeasure procurement with 

4 recommendations to address such needs under 

5 subparagraph (A). 

6 ‘‘(C) Assist the Secretary in developing 

7 strategies related to logistics, deployment, dis8 tribution, dispensing, and use of counter9 measures that may be applicable to the activi10 ties of the strategic national stockpile under 

11 section 319F–2(a). 

12 ‘‘(D) Provide consultation for the develop13 ment of the strategy and implementation plan 

14 under section 2811(d). 

15 ‘‘(2) INPUT.—In carrying out subparagraphs 

16 (B) and (C) of paragraph (1), the PHEMCE shall 

17 solicit and consider input from State, local, Tribal, 

18 and territorial public health departments or officials, 

19 as appropriate.’’. 

20 (b) PUBLIC HEALTH EMERGENCY MEDICAL COUN21 TERMEASURES ENTERPRISE STRATEGY AND IMPLEMEN22 TATION PLAN.—Section 2811(d) (42 U.S.C. 300hh– 

23 10(d)) is amended— 

24 (1) in paragraph (1)— 


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1 (A) by striking ‘‘Not later than 180 days 

2 after the date of enactment of this subsection, 

3 and every year thereafter’’ and inserting ‘‘Not 

4 later than March 15, 2020, and biennially 

5 thereafter’’; and 

6 (B) by striking ‘‘Director of the Bio7 medical’’ and all that follows through ‘‘Food 

8 and Drugs’’ and inserting ‘‘Public Health 

9 Emergency Medical Countermeasures Enter10 prise established under section 2811–1’’; and 

11 (2) in paragraph (2)(J)(v), by striking ‘‘one12 year period’’ and inserting ‘‘2-year period’’. 

13 SEC. 403. STRATEGIC NATIONAL STOCKPILE. 

14 (a) IN GENERAL.—Section 319F–2(a) (42 U.S.C. 

15 247d–6b(a)) is amended— 

16 (1) by redesignating paragraphs (2) and (3) as 

17 paragraphs (3) and (4), respectively; and 

18 (2) in paragraph (1)— 

19 (A) by inserting ‘‘the Assistant Secretary 

20 for Preparedness and Response and’’ after ‘‘col21 laboration with’’; 

22 (B) by inserting ‘‘and optimize’’ after 

23 ‘‘provide for’’; 

24 (C) by inserting ‘‘and, as informed by ex25 isting recommendations of, or consultations 


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1 with, the Public Health Emergency Medical 

2 Countermeasure Enterprise established under 

3 section 2811–1, make necessary additions or 

4 modifications to the contents of such stockpile 

5 or stockpiles based on the review conducted 

6 under paragraph (2)’’ before the period of the 

7 first sentence; and 

8 (D) by striking the second sentence; 

9 (3) by inserting after paragraph (1) the fol10 lowing: 

11 ‘‘(2) THREAT-BASED REVIEW.— 

12 ‘‘(A) IN GENERAL.—The Secretary shall 

13 conduct an annual threat-based review (taking 

14 into account at-risk individuals) of the contents 

15 of the stockpile under paragraph (1), including 

16 non-pharmaceutical supplies, and, in consulta17 tion with the Public Health Emergency Medical 

18 Countermeasures Enterprise established under 

19 section 2811–1, review contents within the 

20 stockpile and assess whether such contents are 

21 consistent with the recommendations made pur22 suant to section 2811–1(c)(1)(A). Such review 

23 shall be submitted on June 15, 2019, and on 

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1 sions and the Committee on Appropriations of 

2 the Senate and the Committee on Energy and 

3 Commerce and the Committee on Appropria4 tions of the House of Representatives, in a 

5 manner that does not compromise national se6 curity. 

7 ‘‘(B) ADDITIONS, MODIFICATIONS, AND

8 REPLENISHMENTS.—Each annual threat-based 

9 review under subparagraph (A) shall, for each 

10 new or modified countermeasure procurement 

11 or replenishment, provide— 

12 ‘‘(i) information regarding— 

13 ‘‘(I) the quantities of the addi14 tional or modified countermeasure 

15 procured for, or contracted to be pro16 cured for, the stockpile; 

17 ‘‘(II) planning considerations for 

18 appropriate manufacturing capacity 

19 and capability to meet the goals of 

20 such additions or modifications (with21 out disclosing proprietary informa22 tion), including consideration of the 

23 effect such additions or modifications 

24 may have on the availability of such 


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1 products and ancillary medical sup2 plies in the health care system; 

3 ‘‘(III) the presence or lack of a 

4 commercial market for the counter5 measure at the time of procurement; 

6 ‘‘(IV) the emergency health secu7 rity threat or threats such counter8 measure procurement is intended to 

9 address, including whether such pro10 curement is consistent with meeting 

11 emergency health security needs asso12 ciated with such threat or threats; 

13 ‘‘(V) an assessment of whether 

14 the emergency health security threat 

15 or threats described in subclause (IV) 

16 could be addressed in a manner that 

17 better utilizes the resources of the 

18 stockpile and permits the greatest 

19 possible increase in the level of emer20 gency preparedness to address such 

21 threats; 

22 ‘‘(VI) whether such counter23 measure is replenishing an expiring or 

24 expired countermeasure, is a different 

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1 tion that is replacing an expiring or 

2 expired countermeasure, or is a new 

3 addition to the stockpile; 

4 ‘‘(VII) a description of how such 

5 additions or modifications align with 

6 projected investments under previous 

7 countermeasures budget plans under 

8 section 2811(b)(7), including expected 

9 life-cycle costs, expenditures related to 

10 countermeasure procurement to ad11 dress the threat or threats described 

12 in subclause (IV), replenishment dates 

13 (including the ability to extend the 

14 maximum shelf life of a counter15 measure), and the manufacturing ca16 pacity required to replenish such 

17 countermeasure; and 

18 ‘‘(VIII) appropriate protocols and 

19 processes for the deployment, distribu20 tion, or dispensing of the counter21 measure at the State and local level, 

22 including plans for relevant capabili23 ties of State and local entities to dis24 pense, distribute, and administer the 

25 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 

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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 

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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 

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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 

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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 

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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 masVerDate Sep 11 2014 22:22 May 15, 2019 Jkt 089200 PO 00000 Frm 00135 Fmt 6652 Sfmt 6201 \\ALPHA3\E\BILLS\S1379.IS S1379

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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 

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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 AllVerDate Sep 11 2014 22:22 May 15, 2019 Jkt 089200 PO 00000 Frm 00155 Fmt 6652 Sfmt 6201 \\ALPHA3\E\BILLS\S1379.IS S1379

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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).’’. 

Æ 


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