II 

Calendar No. 467 

115TH CONGRESS 

2D SESSION S. 2852 

To reauthorize certain programs under the Pandemic and All-Hazards 

Preparedness Reauthorization Act. 

IN THE SENATE OF THE UNITED STATES 

MAY 15, 2018 

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 

JUNE 18, 2018 

Reported by Mr. ALEXANDER, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

A BILL 

To reauthorize certain programs under the Pandemic and 

All-Hazards Preparedness Reauthorization Act. 

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 2018’’. 


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

Sec. 205. Strengthening and supporting the public health emergency rapid response fund. 

Sec. 206. Improving preparedness for and response to all-hazards by public 

health emergency volunteers. 

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. Reauthorizing the National Advisory Committee on Children and 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. 

TITLE VI—ADVANCING TECHNOLOGIES FOR MEDICAL 

COUNTERMEASURES 

Sec. 601. Administration of countermeasures. 

Sec. 602. Medical countermeasure master files. 


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Sec. 603. Animal rule report. 

TITLE VII—MISCELLANEOUS PROVISIONS 

Sec. 701. Reauthorizations and extensions. 

Sec. 702. 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 Na17 tional Health Security Strategy shall de18 scribe potential emergency health security 

19 threats and identify the process for achiev20 ing the preparedness goals described in 

21 subsection (b) to be prepared to identify 

22 and respond to such threats and shall be 

23 consistent with the national preparedness 


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

2 the Homeland Security Act of 2002), the 

3 National Incident Management System (as 

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

5 the National Response Plan developed pur6 suant to section 504 of such Act, or any 

7 successor plan.’’; 

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

9 the period at the end of the second sentence the 

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

11 the evidence-based benchmarks and objective 

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

13 and 

14 (C) in paragraph (3)— 

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

16 ‘‘2022’’; 

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

18 the environmental health workforce), de19 scribing the status of such workforce’’ 

20 after ‘‘gaps in such workforce’’; 

21 (iii) by striking ‘‘and identifying strat22 egies’’ and inserting ‘‘identifying strate23 gies’’; and 

24 (iv) by inserting before the period at 

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1 ties to meet the requirements of section 

2 2803’’; and 

3 (2) in subsection (b)— 

4 (A) in paragraph (2)— 

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

6 ‘‘and investigation’’ and inserting ‘‘inves7 tigation, and related information tech8 nology activities’’; 

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

10 ‘‘and decontamination’’ and inserting ‘‘de11 contamination, relevant health care serv12 ices and supplies, and transportation and 

13 disposal of medical waste’’; and 

14 (iii) by adding at the end the fol15 lowing: 

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

17 (B) in paragraph (3)(F), by inserting ‘‘or 

18 exposures to agents that could cause a public 

19 health emergency’’ before the period; 

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

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

22 and 

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

24 ‘‘(9) ZOONOTIC DISEASE, FOOD, AND AGRI25 CULTURE.—In consultation with the Secretary of 


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1 Agriculture, improving coordination among Federal, 

2 State, local, tribal, and territorial entities to prevent, 

3 detect, and respond to outbreaks of plant or animal 

4 disease (including zoonotic disease) that could com5 promise national security resulting from a deliberate 

6 attack, a naturally occurring threat, the intentional 

7 adulteration of food, or other public health threats, 

8 taking into account interactions between animal 

9 health, human health, and animals’ and humans’ 

10 shared environment as directly related to public 

11 health emergency preparedness and response capa12 bilities, as applicable. 

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

14 current or potential health security threats from 

15 abroad to inform domestic public health prepared16 ness and response capabilities.’’. 

17 TITLE II—IMPROVING 

18 PREPAREDNESS AND RESPONSE 

19 SEC. 201. IMPROVING BENCHMARKS AND STANDARDS FOR 

20 PREPAREDNESS AND RESPONSE. 

21 (a) EVALUATING MEASURABLE EVIDENCE-BASED

22 BENCHMARKS AND OBJECTIVE STANDARDS.—Section 

23 319C–1 (42 U.S.C. 247d–3a) is amended by inserting 

24 after subsection (j) the following: 

25 ‘‘(k) EVALUATION.— 


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

2 after the date of enactment of the Pandemic and 

3 All-Hazards Preparedness and Advancing Innovation 

4 Act of 2018 and every 2 years thereafter, the Sec5 retary shall conduct an evaluation of the evidence6 based benchmarks and objective standards required 

7 under subsection (g). Such evaluation shall be sub8 mitted to the congressional committees of jurisdic9 tion together with the National Health Security 

10 Strategy under section 2802, at such time as such 

11 strategy is submitted. 

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

13 paragraph shall include— 

14 ‘‘(A) a review of evidence-based bench15 marks and objective standards, and associated 

16 metrics and targets; 

17 ‘‘(B) a discussion of changes to any evi18 dence-based benchmarks and objective stand19 ards, and the effect of such changes on the abil20 ity to track whether entities are meeting or 

21 making progress toward the goals under this 

22 section and, to the extent practicable, the appli23 cable goals of the National Health Security 

24 Strategy under section 2802; 


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

2 eligible entities, as described in subsection (b) 

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

4 by sub-recipients and the effect of such funding 

5 on meeting evidence-based benchmarks and ob6 jective standards; and 

7 ‘‘(D) recommendations, as applicable and 

8 appropriate, to improve evidence-based bench9 marks and objective standards to more accu10 rately assess the ability of entities receiving 

11 awards under this section to better achieve the 

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

13 (b) EVALUATING THE PARTNERSHIP FOR STATE AND

14 REGIONAL HOSPITAL PREPAREDNESS.—Section 319C– 

15 2(i)(1) (42 U.S.C. 247–3b(i)(1)) is amended by striking 

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

17 319C–1(g), (i), (j), and (k)’’. 

18 SEC. 202. AMENDMENTS TO PREPAREDNESS AND RE19 SPONSE PROGRAMS. 

20 (a) COOPERATIVE AGREEMENT APPLICATIONS FOR

21 IMPROVING STATE AND LOCAL PUBLIC HEALTH SECU22 RITY.—Section 319C–1 (42 U.S.C. 247d–3a) is amend23 ed— 


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

2 through the Director of the Centers for Disease 

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

4 (2) in subsection (b)(2)(A)— 

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

6 public health agencies with specific expertise 

7 that may be relevant to public health security, 

8 such as environmental health agencies,’’ after 

9 ‘‘stakeholders’’; 

10 (B) by redesignating clauses (vii) through 

11 (ix) as clauses (viii) through (x); and 

12 (C) by inserting after clause (vi) the fol13 lowing: 

14 ‘‘(vii) a description of how, as applica15 ble, such entity may integrate information 

16 to account for individuals with behavioral 

17 health needs following a public health 

18 emergency;’’. 

19 (b) 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)’’; and 

5 (2) in subsection (b)(1)(A)— 

6 (A) in clause (iii), by redesignating sub7 clauses (I) through (III) as items (aa) through 

8 (cc), respectively, and adjusting the margins ac9 cordingly; 

10 (B) by redesignating clauses (i) through 

11 (iii) as subclauses (I) through (III) respectively, 

12 and adjusting the margins accordingly; 

13 (C) by striking ‘‘partnership consisting 

14 of—’’ and inserting ‘‘partnership— 

15 ‘‘(i) consisting of—’’; and 

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

17 ‘‘(ii) that may include one or more 

18 emergency medical service organizations or 

19 emergency management organizations; 

20 and’’. 

21 (c) PUBLIC HEALTH SECURITY GRANTS AUTHORIZA22 TION OF APPROPRIATIONS.—Section 319C–1(h)(1)(A) 

23 (42 U.S.C. 247d–3a(h)(1)(A)) is amended by striking 

24 ‘‘$641,900,000 for fiscal year 2014’’ and all that follows 

25 through the period at the end and inserting 


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1 ‘‘$685,000,000 for each of fiscal years 2019 through 2023 

2 for awards pursuant to paragraph (3) (subject to the au3 thority of the Secretary to make awards pursuant to para4 graphs (4) and (5)).’’. 

5 (d) PARTNERSHIP FOR STATE AND REGIONAL HOS6 PITAL PREPAREDNESS AUTHORIZATION OF APPROPRIA7 TIONS.—Section 319C–2(j) (42 U.S.C. 247d–3b(j)) is 

8 amended— 

9 (1) by amending paragraph (1) to read as fol10 lows: 

11 ‘‘(1) IN GENERAL.— 

12 ‘‘(A) AUTHORIZATION OF APPROPRIA13 TIONS.—For purposes of carrying out this sec14 tion and section 319C–3, in accordance with 

15 subparagraph (B), there is authorized to be ap16 propriated $385,000,000 for each of fiscal years 

17 2019 through 2023. 

18 ‘‘(B) RESERVATIONS OF AMOUNTS FOR RE19 GIONAL SYSTEMS.— 

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

21 (ii), of the amount appropriated under sub22 paragraph (A) for a fiscal year, the Sec23 retary may reserve up to 5 percent for the 

24 purpose of carrying out section 319C–3. 


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1 ‘‘(ii) RESERVATIONS CONTINGENT ON

2 CONTINUED APPROPRIATIONS.—If the 

3 amount appropriated under subparagraph 

4 (A) for fiscal year 2019 or a subsequent 

5 fiscal year is less than or equal the amount 

6 so appropriated for the previous fiscal 

7 year, the amount that may be reserved 

8 under clause (i) shall be reduced such that 

9 the amount remaining for the purpose of 

10 carrying out this section is not less than 

11 the amount available for such purpose for 

12 the previous fiscal year.’’; 

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

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

15 (1)(A) for a fiscal year and not reserved for the pur16 pose described in paragraph (1)(B)(i)’’; and 

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

18 (1) and not reserved under paragraph (2)’’ and in19 serting ‘‘paragraph (1)(A) and not reserved under 

20 paragraph (1)(B)(i) or (2)’’. 

21 SEC. 203. REGIONAL HEALTH CARE EMERGENCY PRE22 PAREDNESS AND RESPONSE SYSTEMS. 

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

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

25 following: 


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

2 EMERGENCY PREPAREDNESS AND RESPONSE 

3 SYSTEMS. 

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

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

7 sector entities, with varying levels of capability to treat 

8 patients and increase medical surge capacity during, and 

9 in advance of, a public health emergency, including threats 

10 posed by one or more chemical, biological, radiological, 

11 and nuclear agents, including emerging infectious dis12 eases. 

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

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

19 Drugs, the Assistant Secretary for Mental Health and 

20 Substance Use, the Assistant Secretary of Labor for Occu21 pational Safety and Health, the Secretary of Veterans Af22 fairs, heads of such other Federal agencies as the Sec23 retary determines to be appropriate, and State, local, trib24 al, and territorial public health officials, shall, not later 

25 than 2 years after the date of enactment of this section— 


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1 ‘‘(1) identify and develop a set of guidelines re2 lating to practices and protocols for all-hazards pub3 lic health emergency preparedness and response for 

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

10 such as trauma care and medical surge capacity and 

11 capabilities), with respect to— 

12 ‘‘(A) a regional approach to identifying 

13 hospitals and health care facilities based on 

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

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

17 will coordinate with and integrate the part18 nerships established under section 319C– 

19 2(b); and 

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


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1 hospitals and health care facilities in the 

2 community; 

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

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

7 rural considerations; 

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

9 safety and personal protection of workers who 

10 handle human remains and health care workers 

11 (including with respect to protective equipment 

12 and supplies, waste management processes, and 

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

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

18 containment (within the meaning of section 

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

20 treatment, and transportation of patients, based 

21 on patient medical need (including patients in 

22 rural areas), to the appropriate hospitals or 

23 health care facilities within the regional system 

24 or, as applicable and appropriate, between sys25 tems in different States or regions; and 


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1 ‘‘(E) the needs of children and other at2 risk individuals; 

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

4 internet website of the Department of Health and 

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

7 ‘‘(3) update such guidelines as appropriate, in8 cluding based on input received pursuant to sub9 sections (c), (e), and (f), to address new and emerg10 ing public 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, and emerging infectious disease as the 

21 Assistant Secretary determines appropriate, to meet 

22 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, and other experts that the Assist8 ant Secretary determines appropriate, to meet the 

9 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, and other entities en13 gaged in regional preparedness planning to imple14 ment and follow such guidelines, as applicable; and 

15 ‘‘(4) consider financial requirements and poten16 tial incentives for entities to prepare for, and re17 spond to, public health emergencies as part of the 

18 regional health care emergency preparedness and re19 sponse system. 

20 ‘‘(d) TECHNICAL ASSISTANCE.—The Assistant Sec21 retary for Preparedness and Response, in consultation 

22 with the Director of the Centers for Disease Control and 

23 Prevention and the Assistant Secretary of Labor for Occu24 pational Safety and Health, may provide technical assistVerDate Sep 11 2014 00:21 Jun 19, 2018 Jkt 079200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6401 E:\BILLS\S2852.RS S2852

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1 ance and consultation towards 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 improve medical surge capacity for all hazards, build 

11 and integrate regional medical response capabilities, 

12 improve specialty care expertise for all-hazards re13 sponse, and coordinate medical preparedness and re14 sponse across State, local, tribal, territorial, and re15 gional jurisdictions. 

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

18 ‘‘(f) GAO REPORT TO CONGRESS.— 

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

20 date of enactment of this section, the Comptroller 

21 General of the United States (referred to in this 

22 subsection 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 sub5 section (b), including an analysis and evaluation of 

6 any challenges hospitals or health care facilities ex7 perienced in implementing such guidelines. 

8 ‘‘(2) CONTENT.—The Comptroller General shall 

9 include in the report under paragraph (1)— 

10 ‘‘(A) data on the preparedness and re11 sponse capabilities that have been informed by 

12 the guidelines under subsection (b) to improve 

13 regional emergency health care preparedness 

14 and response capability, including hospital and 

15 health care facility capacity and medical surge 

16 capabilities to prepare for, and respond to, pub17 lic health emergencies; and 

18 ‘‘(B) recommendations to reduce gaps in 

19 incentives for regional health partners, includ20 ing hospitals and health care facilities to im21 prove capacity and medical surge capabilities to 

22 prepare for, and respond to, public health emer23 gencies, consistent with subsection (a), which 

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1 grams under the Centers for Medicare & Med2 icaid Services (including innovative health care 

3 delivery and payment models), and input from 

4 private sector financial institutions. 

5 ‘‘(3) CONSULTATION.—In carrying out para6 graphs (1) and (2), the Comptroller General shall 

7 consult with the heads of appropriate Federal agen8 cies, including— 

9 ‘‘(A) the Assistant Secretary for Prepared10 ness and Response; 

11 ‘‘(B) the Director of the Centers for Dis12 ease Control and Prevention; 

13 ‘‘(C) the Administrator of the Centers for 

14 Medicare & Medicaid Services; 

15 ‘‘(D) the Assistant Secretary for Mental 

16 Health and Substance Use; 

17 ‘‘(E) the Assistant Secretary of Labor for 

18 Occupational Safety and Health; 

19 ‘‘(F) the Secretary of Veterans Affairs; 

20 and 

21 ‘‘(G) the heads of such other Federal agen22 cies as the Secretary determines appropriate.’’. 

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

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

25 first sentence the following ‘‘The reports submitted under 


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1 this paragraph shall also include progress towards the im2 plementation of section 319C–3.’’. 

3 (c) NATIONAL HEALTH SECURITY STRATEGY INCOR4 PORATION OF REGIONALIZED EMERGENCY PREPARED5 NESS AND RESPONSE.—Section 2802(b)(3) (42 U.S.C. 

6 300hh–1(b)(3)) is amended— 

7 (1) in the matter preceding subparagraph (A), 

8 by striking ‘‘including mental health’’ and inserting 

9 ‘‘including pharmacies, mental health facilities,’’; 

10 and 

11 (2) by amending subparagraph (G) to read as 

12 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, which may include the imple19 mentation of guidelines for regional health care 

20 emergency preparedness and response systems 

21 under section 319C–3.’’. 

22 (d) IMPROVING STATE AND LOCAL PUBLIC HEALTH

23 SECURITY.— 

24 (1) STATE AND LOCAL SECURITY.—Section 

25 319C–1(e) (42 U.S.C. 247d–3a(e)) is amended by 


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

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

3 care emergency preparedness and response system 

4 established pursuant to the applicable guidelines 

5 under section 319C–3.’’. 

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

7 (42 U.S.C. 247d–3b(d)(1)(A)) is amended— 

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

9 inserting ‘‘;’’; 

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

11 (iii); and 

12 (C) inserting after clause (i), the following: 

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

14 regional health care emergency system 

15 under section 319C–3; and’’. 

16 SEC. 204. PUBLIC HEALTH AND HEALTH CARE SYSTEM SIT17 UATIONAL AWARENESS AND BIOSURVEIL18 LANCE CAPABILITIES. 

19 (a) FACILITIES, CAPACITIES, AND BIOSURVEILLANCE

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

21 amended— 

22 (1) in the section heading, by striking ‘‘REVI23 TALIZING’’ and inserting ‘‘FACILITIES AND CA24 PACITIES OF’’; 

25 (2) in subsection (a)— 


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1 (A) in the subsection heading, by striking 

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

3 GENERAL’’; 

4 (B) in paragraph (1), by striking ‘‘and im5 proved’’ and inserting ‘‘, improved, and appro6 priately maintained’’; 

7 (C) in paragraph (3), in the matter pre8 ceding subparagraph (A), by striking ‘‘expand, 

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

10 improve, enhance, and appropriately maintain’’; 

11 and 

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

13 ‘‘(4) STUDY OF RESOURCES FOR FACILITIES

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

15 Comptroller General of the United States shall con16 duct a study on Federal spending in fiscal years 

17 2013 through 2018 for activities authorized under 

18 this subsection. Such study shall include a review 

19 and assessment of obligations and expenditures di20 rectly related to each activity under paragraphs (2) 

21 and (3), including a specific accounting of, and de22 lineation between, obligations and expenditures in23 curred for the construction, renovation, equipping, 

24 and security upgrades of facilities and associated 

25 contracts under this subsection, and the obligations 


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1 and expenditures incurred to establish and improve 

2 the situational awareness and biosurveillance net3 work under subsection (b), and shall identify the 

4 agency or agencies incurring such obligations and 

5 expenditures.’’; 

6 (3) in subsection (b)— 

7 (A) in the subsection heading, by striking 

8 ‘‘NATIONAL’’ and inserting ‘‘ESTABLISHMENT

9 OF SYSTEMS OF PUBLIC HEALTH ’’; 

10 (B) in paragraph (1)(B), by inserting ‘‘im11 munization information systems,’’ after ‘‘cen12 ters,’’; 

13 (C) in paragraph (2)— 

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

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

16 (ii) by inserting ‘‘and in a form read17 ily usable for analytical approaches’’ after 

18 ‘‘in a secure manner’’; and 

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

20 follows: 

21 ‘‘(3) STANDARDS.— 

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

23 after the date of the enactment of the Pan24 demic and All-Hazards Preparedness and Ad25 vancing Innovation Act of 2018, the Secretary, 


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1 in cooperation with health care providers, State, 

2 local, tribal, and territorial public health offi3 cials, and relevant Federal agencies (including 

4 the Office of the National Coordinator for 

5 Health Information Technology and the Na6 tional Institute of Standards and Technology), 

7 shall, as necessary, adopt technical and report8 ing standards, including standards for inter9 operability as defined by section 3000, for net10 works under paragraph (1) and update such 

11 standards as necessary. Such standards shall be 

12 made available on the internet website of the 

13 Department of Health and Human Services, in 

14 a manner that does not compromise national se15 curity. 

16 ‘‘(B) DEFERENCE TO STANDARDS DEVEL17 OPMENT ORGANIZATIONS.—In adopting and im18 plementing standards under this subsection and 

19 subsection (c), the Secretary shall give def20 erence to standards published by standards de21 velopment organizations and voluntary con22 sensus-based standards entities.’’; 

23 (4) in subsection (c)— 

24 (A) in paragraph (1)— 


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

2 after the date of enactment of the Pan3 demic and All-Hazards Preparedness Re4 authorization Act of 2013, the Secretary’’ 

5 and inserting ‘‘The Secretary’’; 

6 (ii) by inserting ‘‘, and improve as ap7 plicable and appropriate,’’ after ‘‘shall es8 tablish’’; 

9 (iii) by striking ‘‘of rapid’’ and insert10 ing ‘‘of, rapid’’; and 

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

12 and inserting ‘‘such interoperability’’; 

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

14 follows: 

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

16 establishing and improving the network under para17 graph (1) the Secretary shall— 

18 ‘‘(A) facilitate coordination among agencies 

19 within the Department of Health and Human 

20 Services that provide or have the potential to 

21 provide information and data to, and analyses 

22 for, the situational awareness and biosurveil23 lance network under paragraph (1), including 

24 coordination among relevant agencies related to 

25 health care services, the facilitation of health 


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1 information exchange (including the Office of 

2 the National Coordinator for Health Informa3 tion Technology), and public health emergency 

4 preparedness and response; and 

5 ‘‘(B) consult with the Secretary of Agri6 culture, the Secretary of Commerce (and the 

7 Director of the National Institute of Standards 

8 and Technology), the Secretary of Defense, the 

9 Secretary of Homeland Security, and the Sec10 retary of Veterans Affairs, and the heads of 

11 other Federal agencies, as the Secretary deter12 mines appropriate.’’; 

13 (C) in paragraph (3)— 

14 (i) by redesignating subparagraphs 

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

16 respectively, and adjusting the margins ac17 cordingly; 

18 (ii) in clause (iv), as so redesig19 nated— 

20 (I) by inserting ‘‘immunization 

21 information programs,’’ after ‘‘poison 

22 control,’’; and 

23 (II) by striking ‘‘and clinical lab24 oratories’’ and inserting ‘‘, clinical 


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1 laboratories, and public environmental 

2 health agencies’’; 

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

4 inserting the following: 

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

6 (iv) by adding at the end the fol7 lowing: 

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

9 after the date of the enactment of the Pan10 demic and All-Hazards Preparedness and Ad11 vancing Innovation Act of 2018 and every 6 

12 years thereafter, the Secretary shall conduct a 

13 review of the elements described in subpara14 graph (A). Such review shall include a discus15 sion of the addition of any elements pursuant to 

16 clause (v), including elements added to advanc17 ing new technologies, and identify any chal18 lenges in the incorporation of elements under 

19 subparagraph (A). The Secretary shall provide 

20 such review to the congressional committees of 

21 jurisdiction.’’; 

22 (D) in paragraph (5)— 

23 (i) by redesignating subparagraphs 

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


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1 (iv), respectively, and adjusting the mar2 gins accordingly; 

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

4 inserting the following: 

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

6 (iii) by adding at the end the fol7 lowing: 

8 ‘‘(B) PUBLIC MEETING.— 

9 ‘‘(i) IN GENERAL.—Not later than 

10 180 days after the date of enactment of 

11 the Pandemic and All-Hazards Prepared12 ness and Advancing Innovation Act of 

13 2018, the Secretary shall convene a public 

14 meeting for purposes of discussing and 

15 providing input on the potential goals, 

16 functions, and uses of the network de17 scribed in paragraph (1) and incorporating 

18 the elements described in paragraph 

19 (3)(A). 

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

21 shall include representatives of relevant 

22 Federal agencies (including representatives 

23 from the Office of the National Coordi24 nator for Health Information Technology 

25 and the National Institute of Standards 


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1 and Technology), State, local, tribal, and 

2 territorial public health officials, stake3 holders with expertise in biosurveillance 

4 and situational awareness, and stake5 holders with expertise in capabilities rel6 evant to biosurveillance and situational 

7 awareness, such as experts in informatics 

8 and data analytics (including experts in 

9 prediction and forecasting), and other rep10 resentatives as the Secretary determines 

11 appropriate. 

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

13 shall include a discussion of— 

14 ‘‘(I) data elements, including 

15 minimal or essential data elements, 

16 that are voluntarily provided for such 

17 network, which may include elements 

18 from public health and public and pri19 vate health care entities, to the extent 

20 practicable; 

21 ‘‘(II) standards and implementa22 tion specifications that may improve 

23 the collection, analysis, and interpre24 tation of data during a public health 

25 emergency; 


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1 ‘‘(III) strategies to encourage the 

2 access, exchange, and use of informa3 tion; 

4 ‘‘(IV) considerations for State, 

5 local, tribal, and territorial capabilities 

6 and infrastructure related to data ex7 change and interoperability; 

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

10 local, tribal, and territorial levels, and 

11 by nongovernmental stakeholders; and 

12 ‘‘(VI) opportunities for the incor13 poration of innovative technologies to 

14 improve the network.’’; and 

15 (iv) in subparagraph (A), as so des16 ignated by clause (ii)— 

17 (I) in clause (i), as so redesig18 nated— 

19 (aa) by striking ‘‘as deter20 mined’’ and inserting ‘‘as adopt21 ed’’; and 

22 (bb) by inserting ‘‘and the 

23 National Institute of Standards 

24 and Technology’’ after ‘‘Office of 


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1 the National Coordinator for 

2 Health Information Technology’’; 

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

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

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

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

13 the process described in section 

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

15 and territorial public health entities may 

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

17 the network.’’; 

18 (E) by redesignating paragraph (6) as 

19 paragraph (7); 

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

21 following: 

22 ‘‘(6) STRATEGY AND IMPLEMENTATION

23 PLAN.— 

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

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1 demic and All-Hazards Preparedness and Ad2 vancing Innovation Act of 2018, the Secretary 

3 shall submit to the appropriate committees of 

4 Congress a coordinated strategy and an accom5 panying implementation plan that— 

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

7 under paragraph (5)(B); 

8 ‘‘(ii) includes a review and assessment 

9 of existing capabilities of the network and 

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

13 ‘‘(iii) identifies and demonstrates the 

14 measurable steps the Secretary will carry 

15 out to— 

16 ‘‘(I) develop, implement, and 

17 evaluate the network described in 

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

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

24 (including prediction and forecasting 


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1 for pandemics and all-hazards) from 

2 public and private entities; 

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

5 among disparate biosurveillance sys6 tems supported by the Department of 

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

9 improve accountability, better utilize 

10 resources and workforce capabilities, 

11 and incorporate innovative tech12 nologies within and across agencies; 

13 and 

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

16 systems to improve situational aware17 ness and biosurveillance capabilities; 

18 ‘‘(iv) includes performance measures 

19 and the metrics by which performance 

20 measures will be assessed with respect to 

21 the measurable steps under clause (iii); 

22 and 

23 ‘‘(v) establishes dates by which each 

24 measurable step under clause (iii) will be 

25 implemented.’’. 


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

2 than 2 years after the date of enactment of the 

3 Pandemic and All-Hazards Preparedness and 

4 Advancing Innovation Act of 2018 and on an 

5 annual basis thereafter, in accordance with the 

6 strategy and implementation plan under this 

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

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

12 plan shall include— 

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

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

18 ‘‘(ii) estimates of costs and resources 

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

21 strategy and implementation plan under 

22 subparagraph (A); 

23 ‘‘(iii) the identification of gaps and in24 efficiencies in nationwide public health sit25 uational awareness and biosurveillance caVerDate Sep 11 2014 00:21 Jun 19, 2018 Jkt 079200 PO 00000 Frm 00035 Fmt 6652 Sfmt 6401 E:\BILLS\S2852.RS S2852

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

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

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

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

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

10 the interactions between human, animal, 

11 and environmental health)’’ after ‘‘human 

12 health’’; 

13 (ii) in subparagraph (B)— 

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

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

19 (iii) in subparagraph (C)— 

20 (I) by inserting ‘‘, animal health 

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

23 and 

24 (II) by striking the period and 

25 inserting ‘‘; and’’; and 


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

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

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

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

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

12 of National Intelligence to inform the development 

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

15 (5) in subsection (d)— 

16 (A) in paragraph (1)— 

17 (i) by inserting ‘‘environmental health 

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

19 and 

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

22 and 

23 (B) in paragraph (2)— 

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

25 ‘‘and’’ at the end; 


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

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

3 (iii) by adding after subparagraph (C) 

4 the following: 

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

7 described in paragraph (1).’’; and 

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

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

11 may provide technical assistance to States, localities, 

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

14 under this subsection regarding interoperability and 

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

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

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

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

20 ‘‘(f) TIMELINE.—The Secretary shall accomplish the 

21 purposes under subsections (b) and (c) no later than Sep22 tember 30, 2023, and shall provide a justification to Con23 gress for any missed or delayed implementation of measur24 able steps identified under subsection (c)(6)(A)(iii). 


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1 ‘‘(g) INDEPENDENT EVALUATION.—Not later than 3 

2 years after the date of enactment of the Pandemic and 

3 All-Hazards Preparedness and Advancing Innovation Act 

4 of 2018, the Comptroller General of the United States 

5 shall conduct an independent evaluation, and submit to 

6 the Secretary and the appropriate committees of Congress 

7 a report concerning the activities conducted under sub8 sections (b) and (c), and provide recommendations, as ap9 plicable and appropriate, on necessary improvements to 

10 the biosurveillance and situational awareness network.’’. 

11 (b) AUTHORIZATION OF APPROPRIATIONS.—Sub12 section (h) of section 319D (42 U.S.C. 247d–4), as redes13 ignated by subsection (a)(6), is amended by striking 

14 ‘‘$138,300,000 for each of fiscal years 2014 through 

15 2018’’ and inserting ‘‘$161,800,000 for each of fiscal 

16 years 2019 through 2023’’. 

17 SEC. 205. STRENGTHENING AND SUPPORTING THE PUBLIC 

18 HEALTH EMERGENCY RAPID RESPONSE 

19 FUND. 

20 Section 319 of the Public Health Service Act (42 

21 U.S.C. 247d) is amended— 

22 (1) in subsection (b)— 

23 (A) in paragraph (1)— 

24 (i) in the first sentence, by inserting 

25 ‘‘or if the Secretary determines there is the 


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1 significant potential for a public health 

2 emergency, to allow the Secretary to rap3 idly respond to the immediate needs result4 ing from such public health emergency or 

5 potential public health emergency’’ before 

6 the period; and 

7 (ii) by inserting ‘‘The Secretary shall 

8 plan for the expedited distribution of funds 

9 to appropriate agencies and entities.’’ after 

10 the first sentence; 

11 (B) by redesignating paragraph (2) as 

12 paragraph (3); 

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

14 following: 

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

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

17 ‘‘(A) facilitate coordination between and 

18 among Federal, State, local, tribal, and terri19 torial entities and public and private health 

20 care entities that the Secretary determines may 

21 be affected by a public health emergency or po22 tential public health emergency (including com23 munication of such entities with relevant inter24 national entities, as applicable); 


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

2 enter into contracts, and conduct supportive in3 vestigations pertaining to a public health emer4 gency or potential public health emergency, in5 cluding further supporting programs under sec6 tion 319C–1 or 319C–2; 

7 ‘‘(C) facilitate and accelerate, as applica8 ble, advanced research and development of secu9 rity countermeasures (as defined in section 

10 319F–2), qualified countermeasures (as defined 

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

12 epidemic products (as defined in section 319F– 

13 3), that are applicable to the public health 

14 emergency or potential public health emergency 

15 under paragraph (1); 

16 ‘‘(D) strengthen biosurveillance capabilities 

17 and laboratory capacity to identify, collect, and 

18 analyze information on such public health emer19 gency or potential public health emergency, in20 cluding the systems under section 319D; 

21 ‘‘(E) support initial emergency operations 

22 and assets related to preparation and deploy23 ment of intermittent disaster response per24 sonnel expenses under section 2812, and the 

25 Medical Reserve Corps under section 2813; and 


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1 ‘‘(F) other activities, as the Secretary de2 termines applicable and appropriate.’’; and 

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

4 redesignated, the following: 

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

6 date of enactment of the Pandemic and All-Hazards 

7 Preparedness and Advancing Innovation Act of 

8 2018, the Secretary, in coordination with the Assist9 ant Secretary for Preparedness and Response, shall 

10 conduct a review of the Fund under this section, and 

11 provide recommendations to the Committee on 

12 Health, Education, Labor, and Pensions and the 

13 Committee on Appropriations of the Senate and the 

14 Committee on Energy and Commerce and the Com15 mittee on Appropriations of the House of Represent16 atives on policies to improve such Fund for the uses 

17 described in paragraph (2). 

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

19 after the date of enactment of the Pandemic and 

20 All-Hazards Preparedness and Advancing Innovation 

21 Act of 2018, the Comptroller General of the United 

22 States shall conduct a review of the Fund under this 

23 section, including the uses and the resources avail24 able in the Fund.’’; and 

25 (2) in subsection (c)— 


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

2 health emergencies or potential public health 

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

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

5 ‘‘Act or funds otherwise provided for emergency 

6 response.’’. 

7 SEC. 206. IMPROVING PREPAREDNESS FOR AND RESPONSE 

8 TO ALL-HAZARDS BY PUBLIC HEALTH EMER9 GENCY VOLUNTEERS. 

10 Section 319I (42 U.S.C. 247d–7b) is amended: 

11 (1) in subsection (a), by adding at the end the 

12 following: ‘‘Such health care professionals may in13 clude members of the National Disaster Medical 

14 System, members of the Medical Reserve Corps, and 

15 individual health care professionals.’’; 

16 (2) in subsection (i) by adding at the end ‘‘In 

17 order to inform the development of such mechanisms 

18 by States, the Secretary shall make available infor19 mation and material provided by States that have 

20 developed mechanisms to waive the application of li21 censing requirements to applicable health profes22 sionals seeking to provide medical services during a 

23 public health emergency. Such information shall be 

24 made publicly available in a manner that does not 

25 jeopardize national security.’’; and 


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1 (3) in subsection (k) by striking ‘‘$2014 

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

3 TITLE III—REACHING ALL 

4 COMMUNITIES 

5 SEC. 301. STRENGTHENING AND ASSESSING THE EMER6 GENCY RESPONSE WORKFORCE. 

7 (a) NATIONAL DISASTER MEDICAL SYSTEM.—Clause 

8 (ii) of section 2812(a)(3)(A) (42 U.S.C. 300hh– 

9 11(a)(3)(A)) is amended to read as follows: 

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

11 limited periods of time, specified by the 

12 Secretary on the basis that the Secretary 

13 has determined that a location is at risk of 

14 a public health emergency during the time 

15 specified, or there is a significant potential 

16 for a public health emergency.’’. 

17 (b) VOLUNTEER MEDICAL RESERVE CORPS.—Sec18 tion 2813(a) (42 U.S.C. 42 U.S.C. 300hh–15(a)) is 

19 amended by striking the second sentence and inserting 

20 ‘‘The Secretary may appoint a Director to head the Corps 

21 and oversee the activities of the Corps chapters that exist 

22 at the State, local, and tribal levels.’’ 

23 (c) REVIEW OF THE NATIONAL DISASTER MEDICAL

24 SYSTEM.—Section 2812(b)(2) (42 U.S.C. 300hh– 

25 11(b)(2)) is amended to read as follows: 


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1 ‘‘(2) JOINT REVIEW AND MEDICAL SURGE CA2 PACITY STRATEGIC PLAN.— 

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

4 after the date of enactment of the Pandemic 

5 and All-Hazards Preparedness and Advancing 

6 Innovation Act of 2018, the Secretary, in co7 ordination with the Secretary of Homeland Se8 curity, the Secretary of Defense, and the Sec9 retary of Veterans Affairs, shall conduct a joint 

10 review of the National Disaster Medical System. 

11 Such review shall include— 

12 ‘‘(i) an evaluation of medical surge ca13 pacity, as described in section 2803(a); 

14 ‘‘(ii) an assessment of the available 

15 workforce of the intermittent disaster re16 sponse personnel described in subsection 

17 (c); 

18 ‘‘(iii) the capacity of the workforce de19 scribed in clause (ii) to respond to all haz20 ards, including capacity to simultaneously 

21 respond to multiple public health emer22 gencies and the capacity to respond to a 

23 nationwide public health emergency; 

24 ‘‘(iv) the effectiveness of efforts to re25 cruit, retain, and train such workforce; and 


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1 ‘‘(v) gaps that may exist in such 

2 workforce and recommendations for ad3 dressing such gaps. 

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

5 Health Security Strategy under section 2802, 

6 the Secretary shall update the findings from the 

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

10 (d) NOTIFICATION OF NDMS SHORTAGE.—Section 

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

12 at the end the following: 

13 ‘‘(3) SERVICE BENEFIT.—Individuals appointed 

14 to serve under this subsection shall be considered 

15 public safety officers under part L of title I of the 

16 Omnibus Crime Control and Safe Streets Act of 

17 1968. The Secretary shall provide notification to eli18 gible individuals of any effect such designation may 

19 have on other benefits for which such individuals are 

20 eligible, including benefits from private entities. 

21 ‘‘(4) NOTIFICATION.—Not later than 30 days 

22 after the date on which the Secretary determines the 

23 number of intermittent disaster response personnel 

24 of such System is insufficient to address a public 

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1 gency, the Secretary shall submit to the congres2 sional committees of jurisdiction a notification de3 tailing the impact such shortage could have on meet4 ing public health needs and emergency medical per5 sonnel needs during a public health emergency, and 

6 any identified measures to address such shortage. 

7 ‘‘(5) CERTAIN APPOINTMENTS.— 

8 ‘‘(A) IN GENERAL.—If the Secretary deter9 mines that the number of intermittent disaster 

10 response personnel within the National Disaster 

11 Medical System under this section is insuffi12 cient to address a public health emergency or 

13 potential public health emergency, the Secretary 

14 may appoint candidates directly to personnel 

15 positions for intermittent disaster response 

16 within such system. The Secretary shall provide 

17 updates on the number of vacant or unfilled po18 sitions within such system to the congressional 

19 committees of jurisdiction each quarter for 

20 which this authority is in effect. 

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

22 paragraph shall expire on September 30, 

23 2021.’’. 


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1 (e) PUBLIC SAFETY OFFICER BENEFITS.—Section 

2 1204(9) of title I of the Omnibus Crime Control and Safe 

3 Streets Act of 1968 (34 U.S.C. 10284(9)) is amended— 

4 (1) in subparagraph (C)(ii), by striking ‘‘or’’ at 

5 the end; 

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

7 and inserting ‘‘; or’’; and 

8 (3) by inserting after subparagraph (D) the fol9 lowing: 

10 ‘‘(E) an individual appointed to the Na11 tional Disaster Medical System under section 

12 2812 of the Public Health Service Act (42 

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

14 duties of the Department of Health and Human 

15 Services, if those official duties are related to 

16 responding to a public health emergency or po17 tential public health emergency, or other activi18 ties for which the Secretary of Health and 

19 Human Services has activated such National 

20 Disaster Medical System.’’. 

21 (f) NATIONAL DISASTER MEDICAL SYSTEM AUTHOR22 IZATION OF APPROPRIATIONS.—Section 2812(g) (42 

23 U.S.C. 300hh–11(g)) is amended by striking 

24 ‘‘$52,700,000 for each of fiscal years 2014 through 2018’’ 


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1 and inserting ‘‘$57,400,000 for each of fiscal years 2019 

2 through 2023’’. 

3 (g) MEDICAL RESERVE CORPS AUTHORIZATION OF

4 APPROPRIATIONS.—Section 2813(i) (42 U.S.C. 300hh– 

5 15(i)) is amended by striking ‘‘2014 through 2018’’ and 

6 inserting ‘‘2019 through 2023’’. 

7 SEC. 302. HEALTH SYSTEM INFRASTRUCTURE TO IMPROVE 

8 PREPAREDNESS AND RESPONSE. 

9 (a) COORDINATION OF PREPAREDNESS.—Section 

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

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

12 shall include working with other relevant Federal, State, 

13 local, tribal, and territorial public health officials and pri14 vate sector partners to identify the critical infrastructure 

15 assets, systems, and networks needed for the proper func16 tioning of the health care and public health sectors that 

17 need to be maintained through any emergency or disaster, 

18 including entities capable of assisting with, responding to, 

19 and mitigating the effect of a public health emergency, 

20 including an emergency under section 319, an emergency 

21 or major disaster under the Robert T. Stafford Disaster 

22 Relief and Emergency Assistance Act, or the National 

23 Emergencies Act, including by establishing methods to ex24 change critical information and deliver products consumed 


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1 or used to preserve, protect, or sustain life, health, or safe2 ty, and sharing of specialized expertise.’’. 

3 (b) MANUFACTURING CAPACITY.—Section 

4 2811(d)(2)(C) (42 U.S.C. 300hh–10(d)(2)(C)) is amended 

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

6 with the utilization of such products,’’ after ‘‘products’’. 

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

8 (a) AT-RISK INDIVIDUALS IN THE NATIONAL

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

10 (42 U.S.C. 300hh–1(b)(4)(B)) is amended— 

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

12 1, 319F, and 319L,’’ and inserting ‘‘this Act’’; and 

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

14 or functional’’. 

15 (b) COUNTERMEASURE CONSIDERATIONS.—Section 

16 319L(c)(6) (42 U.S.C. 247d–7e(c)(6)) is amended— 

17 (1) by striking ‘‘elderly’’ and inserting ‘‘senior 

18 citizens’’; and 

19 (2) by inserting ‘‘with relevant characteristics 

20 that warrant consideration during the process of re21 searching and developing such countermeasures and 

22 products’’ before the period. 


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1 SEC. 304. IMPROVING EMERGENCY PREPAREDNESS AND 

2 RESPONSE CONSIDERATIONS FOR CHIL3 DREN. 

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

5 by inserting after section 319D the following: 

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

7 ‘‘(a) ENHANCING EMERGENCY PREPAREDNESS FOR

8 CHILDREN.—The Secretary, acting through the Director 

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

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

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

16 The Unit shall inform the Director regarding emergency 

17 preparedness and response efforts pertaining to children 

18 at the Centers for Disease Control and Prevention. 

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

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

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

24 individuals with other areas of expertise, as the Secretary 

25 determines appropriate. 


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

2 may— 

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

4 emergency planning and response activities related 

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

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

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

11 needs of children, including providing such technical 

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

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

18 responding to a public health emergency, including 

19 public awareness of such methods; 

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

23 gaps and inefficiencies in emergency preparedness 

24 and response efforts for children; 


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1 ‘‘(5) provide expertise and input during the de2 velopment of guidance and clinical recommendations 

3 to address the needs of children when preparing for, 

4 and responding to, public health emergencies; and 

5 ‘‘(6) carry out other duties related to prepared6 ness and response activities for children, as the Sec7 retary determines appropriate.’’. 

8 SEC. 305. REAUTHORIZING THE NATIONAL ADVISORY COM9 MITTEE ON CHILDREN AND DISASTERS. 

10 Section 2811A (42 U.S.C. 300hh–10a) is amended— 

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

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

13 (2) in subsection (d)— 

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

15 inserting ‘‘25’’; and 

16 (B) by striking paragraph (2) and insert17 ing the following: 

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

19 Secretary, in consultation with such other heads of 

20 Federal agencies as may be appropriate, shall ap21 point to the Advisory Committee under paragraph 

22 (1) at least 13 individuals to perform the duties de23 scribed in subsections (b) and (c), including— 


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

2 with expertise in pediatric medical disaster 

3 planning, preparedness, response, or recovery; 

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

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

8 ‘‘(C) at least 4 members representing 

9 health care professionals, which may include 

10 members with expertise in pediatric emergency 

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

14 nuclear agents and emerging infectious dis15 eases; pediatric mental or behavioral health re16 lated to children affected by a public health 

17 emergency; or pediatric primary care; and 

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

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

21 represent a children’s hospital; 

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

23 be an individual with expertise in schools 

24 or child care settings; 


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

2 be an individual with expertise in children 

3 and youth with special health care needs; 

4 and 

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

6 be an individual with expertise in the needs 

7 of parents or family caregivers, including 

8 the parents or caregivers of children with 

9 disabilities.’’. 

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

13 ‘‘(A) The Assistant Secretary for Pre14 paredness and Response. 

15 ‘‘(B) The Director of the Biomedical Ad16 vanced Research and Development Authority. 

17 ‘‘(C) The Director of the Centers for Dis18 ease Control and Prevention. 

19 ‘‘(D) The Commissioner of Food and 

20 Drugs. 

21 ‘‘(E) The Director of the National Insti22 tutes of Health. 

23 ‘‘(F) The Assistant Secretary of the Ad24 ministration for Children and Families. 


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1 ‘‘(G) The Administrator of the Health Re2 sources and Services Administration. 

3 ‘‘(H) The Administrator of the Federal 

4 Emergency Management Agency. 

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

7 ‘‘(J) The Secretary of Education. 

8 ‘‘(K) Representatives from such Federal 

9 agencies (such as the Substance Abuse and 

10 Mental Health Services Administration and the 

11 Department of Homeland Security) as the Sec12 retary determines appropriate to fulfill the du13 ties of the Advisory Committee under sub14 sections (b) and (c).’’. 

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

16 of the Advisory Committee appointed under para17 graph (2) shall serve for a term of 3 years, except 

18 that the Secretary may adjust the terms of the Advi19 sory Committee appointees serving on the date of 

20 enactment of the Pandemic and All-Hazards Pre21 paredness and Advancing Innovation Act of 2018, or 

22 appointees who are initially appointed after such 

23 date of enactment, in order to provide for a stag24 gered term of appointment for all members. 


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1 ‘‘(5) CONSECUTIVE APPOINTMENTS; MAXIMUM

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

3 may serve not more than 3 terms on the Advisory 

4 Committee, and not more than 2 of which may be 

5 served consecutively.’’; 

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

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

8 meeting.’’; and 

9 (4) in subsection (f) by striking ‘‘2018’’ and in10 serting ‘‘2023’’. 

11 SEC. 306. GUIDANCE FOR PARTICIPATION IN EXERCISES 

12 AND DRILLS. 

13 Not later than 2 years after the date of enactment 

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

15 shall issue final guidance regarding the participation of 

16 State, local, tribal, and territorial public health depart17 ment or agency personnel funded in whole or in part 

18 through programs authorized under this Act in drills and 

19 operational exercises in order to identify, inform, and ad20 dress the gaps in and policies related to all-hazards med21 ical and public health preparedness and response, which 

22 may include drills and operational exercises that incor23 porate medical surge capacity planning, medical counter24 measure distribution and administration, and preparing 

25 for and responding to identified threats for that region. 


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1 The Secretary shall consult with the Department of 

2 Homeland Security, the Department of Defense, the De3 partment of Veterans Affairs, and other applicable Fed4 eral departments and agencies as necessary and appro5 priate in the development of such guidance. The Secretary 

6 shall make the guidance available on the internet website 

7 of the Department of Health and Human Services. 

8 TITLE IV—PRIORITIZING A 

9 THREAT-BASED APPROACH 

10 SEC. 401. ASSISTANT SECRETARY FOR PREPAREDNESS AND 

11 RESPONSE. 

12 Section 2811(b) (42 U.S.C. 300hh–10(b)) is amend13 ed— 

14 (1) in the matter preceding paragraph (1) by 

15 inserting ‘‘utilize experience related to public health 

16 emergency preparedness and response, biodefense, 

17 medical countermeasures, and other relevant topics 

18 to’’ after ‘‘shall’’; and 

19 (2) in paragraph (4) by adding at the end the 

20 following: 

21 ‘‘(I) THREAT AWARENESS.—Coordinate 

22 with the Director of the Centers for Disease 

23 Control and Prevention, the Director of Na24 tional Intelligence, the Secretary of Homeland 

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1 tional Security Affairs, the Secretary of De2 fense, and other relevant Federal officials, to 

3 maintain a current assessment of national secu4 rity threats and inform preparedness and re5 sponse capabilities based on the range of the 

6 threats that have the potential to result in a 

7 public health emergency.’’. 

8 SEC. 402. PUBLIC HEALTH EMERGENCY MEDICAL COUN9 TERMEASURES ENTERPRISE. 

10 (a) IN GENERAL.—Title XXVIII is amended by in11 serting after section 2811 (42 U.S.C. 300hh–10) the fol12 lowing: 

13 ‘‘SEC. 2811–1. PUBLIC HEALTH EMERGENCY MEDICAL 

14 COUNTERMEASURES ENTERPRISE. 

15 ‘‘(a) IN GENERAL.—The Secretary shall establish the 

16 Public Health Emergency Medical Countermeasures En17 terprise (referred to in this section as the ‘PHEMCE’). 

18 The Assistant Secretary for Preparedness and Response 

19 shall serve as chair of the PHEMCE. 

20 ‘‘(b) MEMBERS.—The PHEMCE shall include each 

21 of the following members, or the designee of such mem22 bers: 

23 ‘‘(1) The Assistant Secretary for Preparedness 

24 and Response. 


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1 ‘‘(2) The Director of the Centers for Disease 

2 Control and Prevention. 

3 ‘‘(3) The Director of the National Institutes of 

4 Health. 

5 ‘‘(4) The Commissioner of Food and Drugs. 

6 ‘‘(5) The Secretary of Defense. 

7 ‘‘(6) The Secretary of Homeland Security. 

8 ‘‘(7) The Secretary of Agriculture. 

9 ‘‘(8) The Secretary of Veterans Affairs. 

10 ‘‘(9) Representatives of any other Federal agen11 cy, which may include the Director of the Bio12 medical Advanced Research and Development Au13 thority, and the Director of the Strategic National 

14 Stockpile, as the Secretary determines appropriate. 

15 ‘‘(c) FUNCTIONS.— 

16 ‘‘(1) IN GENERAL.—The functions of the 

17 PHEMCE shall include the following: 

18 ‘‘(A) Establish a process pursuant to sec19 tion 2811(d)(2)(B) to make recommendations 

20 to the Secretary regarding the prioritization of 

21 research, development, and procurement of 

22 countermeasures, as defined in section 319F– 

23 2(c), based on the health security needs of the 

24 United States. Such recommendations shall be 

25 informed by the National Health Security 


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1 Strategy pursuant to section 2802, the Stra2 tegic National Stockpile review required under 

3 section 319F–2(a)(2), the countermeasures 

4 budget plan pursuant to section 2811(b)(7), 

5 and an assessment of current national security 

6 threats, including chemical, biological, radio7 logical and nuclear threats, including emerging 

8 infectious diseases. In the event that members 

9 of the PHEMCE do not agree upon a rec10 ommendation, the Secretary shall provide a de11 termination regarding such recommendation. 

12 ‘‘(B) Identify national health security 

13 needs, including gaps in public health prepared14 ness and response related to countermeasures 

15 and challenges to addressing such needs (in16 cluding any regulatory challenges), and provide 

17 for alignment of countermeasure procurement 

18 with recommendations under subparagraph (A). 

19 ‘‘(C) Develop strategies related to logistics, 

20 deployment, distribution, dispensing, and use of 

21 countermeasures that may be applicable to the 

22 activities of the strategic national stockpile 

23 under section 319F–2(a). 


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1 ‘‘(D) Provide consultation for the develop2 ment of the strategy and implementation plan 

3 under section 2811(d). 

4 ‘‘(2) INPUT.—In carrying out subparagraphs 

5 (B) and (C) of paragraph (1), the PHEMCE shall 

6 solicit and consider input from State, local, tribal, 

7 and territorial public health departments, as appro8 priate.’’. 

9 (b) PUBLIC HEALTH EMERGENCY MEDICAL COUN10 TERMEASURES ENTERPRISE STRATEGY AND IMPLEMEN11 TATION PLAN.—Section 2811(d)(1) (42 U.S.C. 300hh– 

12 10(d)(1)) is amended— 

13 (1) by striking ‘‘Not later than 180 days after 

14 the date of enactment of this subsection, and every 

15 year thereafter’’ and inserting ‘‘Not later than 

16 March 15, 2020, and biennially thereafter’’; and 

17 (2) by striking ‘‘Director of Biomedical’’ and all 

18 that follows through ‘‘Food and Drugs’’ and insert19 ing ‘‘Public Health Emergency Medical Counter20 measures Enterprise established under section 

21 2811–1’’. 

22 SEC. 403. STRATEGIC NATIONAL STOCKPILE. 

23 (a) Section 319F–2(a) (42 U.S.C. 247d–6b(a)) is 

24 amended— 


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1 (1) by redesignating paragraphs (2) and (3) as 

2 paragraphs (3) and (4), respectively; and 

3 (2) in paragraph (1)— 

4 (A) by inserting ‘‘and optimize’’ after 

5 ‘‘provide for’’; 

6 (B) by inserting ‘‘and, as informed by ex7 isting recommendations of, or consultations 

8 with, the Public Health Emergency Medical 

9 Countermeasure Enterprise established under 

10 section 2811–1, make necessary additions or 

11 modifications to the contents of such stockpile 

12 or stockpiles based on the review conducted 

13 under paragraph (2)’’ before the period of the 

14 first sentence; and 

15 (C) by striking the second sentence; 

16 (3) by inserting after paragraph (1) the fol17 lowing: 

18 ‘‘(2) THREAT-BASED REVIEW.— 

19 ‘‘(A) IN GENERAL.—The Secretary shall 

20 conduct a biennial threat-based review (taking 

21 into account at-risk individuals) of the contents 

22 of the stockpile under paragraph (1), including 

23 non-pharmaceutical supplies, and, in consulta24 tion with the Public Health Emergency Medical 

25 Countermeasures Enterprise established under 


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1 section 2811–1, review contents within the 

2 stockpile and assess whether such contents are 

3 consistent with the recommendations made pur4 suant to section 2811–1(c)(1)(A). Such review 

5 shall be submitted biennially, beginning on 

6 March 15, 2019, to the Committee on Health, 

7 Education, Labor, and Pensions and the Com8 mittee on Appropriations of the Senate and the 

9 Committee on Energy and Commerce and the 

10 Committee on Appropriations of the House of 

11 Representatives, in a manner that does not 

12 compromise national security. 

13 ‘‘(B) ADDITIONS, MODIFICATIONS, AND

14 REPLENISHMENTS.—Each biennial threat-based 

15 review under subparagraph (A) shall, for each 

16 new or modified countermeasure procurement 

17 or replenishment, provide— 

18 ‘‘(i) information regarding— 

19 ‘‘(I) the quantities of the addi20 tional or modified countermeasure 

21 procured for, or contracted to be pro22 cured for, the stockpile; 

23 ‘‘(II) planning considerations for 

24 appropriate manufacturing capacity 

25 and capability to meet the goals of 


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1 such additions or modifications (with2 out disclosing proprietary informa3 tion), including consideration of the 

4 effect such additions or modifications 

5 may have on the availability of such 

6 products and ancillary medical sup7 plies in the health care system; 

8 ‘‘(III) the presence or lack of a 

9 commercial market for the counter10 measure at the time of procurement; 

11 ‘‘(IV) the emergency health secu12 rity threat or threats such counter13 measure procurement is intended to 

14 address, including whether such pro15 curement is consistent with meeting 

16 emergency health security needs asso17 ciated with such threat or threats; 

18 ‘‘(V) an assessment of whether 

19 the emergency health security threat 

20 or threats described in subclause (IV) 

21 could be addressed in a manner that 

22 better utilizes the resources of the 

23 stockpile and permits the greatest 

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1 gency preparedness to address such 

2 threats; 

3 ‘‘(VI) whether such counter4 measure is replenishing an expired 

5 countermeasure, is a different coun6 termeasure with the same indication 

7 that is replacing an expired counter8 measure, or is a new addition to the 

9 stockpile; 

10 ‘‘(VII) a description of how such 

11 additions or modifications align with 

12 the countermeasures budget plan as 

13 required under section 2811(b)(7), in14 cluding expected life-cycle costs, ex15 penditures related to countermeasure 

16 procurement to address the threat or 

17 threats described in subclause (IV), 

18 replenishment dates (including the 

19 ability to extend the maximum shelf 

20 life of a countermeasure), and the 

21 manufacturing capacity required to 

22 replenish such countermeasure; and 

23 ‘‘(VIII) appropriate protocols and 

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1 measure at the State and local level, 

2 including plans for relevant capabili3 ties of State and local entities to dis4 pense, distribute, and administer the 

5 countermeasure; and 

6 ‘‘(ii) an assurance that for each coun7 termeasure produced or replenished under 

8 this subsection, the Secretary completed a 

9 review addressing each item listed under 

10 this subsection in advance of such procure11 ment or replenishment, which need not be 

12 provided in advance of procurement.’’; 

13 (4) in paragraph (3), as so redesignated— 

14 (A) in subparagraph (A), by inserting 

15 ‘‘and the Public Health Emergency Medical 

16 Countermeasures Enterprise established under 

17 section 2811–1’’ before the semicolon; 

18 (B) in subparagraph (C), by inserting ‘‘, 

19 and the availability, deployment, dispensing, 

20 and administration of countermeasures’’ before 

21 the semicolon; and 

22 (C) by amending subparagraph (E) to read 

23 as follows: 

24 ‘‘(E) devise plans for effective and timely 

25 supply-chain management of the stockpile, in 


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1 consultation with the Director of the Centers 

2 for Disease Control and Prevention, the Assist3 ant Secretary for Preparedness and Response, 

4 the Secretary of Transportation, the Secretary 

5 of Homeland Security, the Secretary of Vet6 erans Affairs, and the heads of other appro7 priate Federal agencies, State, local, tribal, and 

8 territorial agencies, and the public and private 

9 health care infrastructure, as applicable, taking 

10 into account the manufacturing capacity and 

11 other available sources of products and appro12 priate alternatives to supplies in the stockpile’’; 

13 and 

14 (5) by adding at the end the following: 

15 ‘‘(5) GAO REPORT.— 

16 ‘‘(A) IN GENERAL.—Not later than 3 years 

17 after the date of enactment of the Pandemic 

18 and All-Hazards Preparedness and Advancing 

19 Innovation Act of 2018, and every 5 years 

20 thereafter, the Comptroller General of the 

21 United States shall conduct a review of any 

22 changes to the contents or management of the 

23 stockpile since January 1, 2015. Such review 

24 shall include— 


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1 ‘‘(i) an assessment of the comprehen2 siveness and completeness of each biennial 

3 threat-based review under paragraph (2), 

4 including whether all newly procured or re5 plenished countermeasures within the 

6 stockpile were described in each annual re7 view, and whether, consistent with para8 graph (2)(B), the Secretary conducted the 

9 necessary internal review in advance of 

10 such procurement or replenishment; 

11 ‘‘(ii) an assessment of whether the 

12 Secretary established health security and 

13 science-based justifications, and a descrip14 tion of such justifications for procurement 

15 decisions related to health security needs 

16 with respect to the identified threat, for 

17 additions or modifications to the stockpile 

18 based on the information provided in such 

19 reviews under paragraph (2)(B), including 

20 whether such review was conducted prior 

21 to procurement, modification, or replenish22 ment; 

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1 termeasures procured, modified, or replen2 ished under paragraph (1), including 

3 whether such plans were developed prior to 

4 procurement, modification, or replenish5 ment; 

6 ‘‘(iv) an accounting of counter7 measures procured, modified, or replen8 ished under paragraph (1) that received 

9 advanced research and development fund10 ing from the Biomedical Advanced Re11 search and Development Authority; 

12 ‘‘(v) an analysis of how such procure13 ment decisions made progress towards 

14 meeting emergency health security needs 

15 related to the identified threats for coun16 termeasures added, modified, or replen17 ished under paragraph (1); 

18 ‘‘(vi) a description of the resources ex19 pended related to the procurement of coun20 termeasures (including additions, modifica21 tions, and replenishments) in the stockpile, 

22 and how such expenditures relate to the 

23 emergency health security needs of the 

24 stockpile; 


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1 ‘‘(vii) an assessment of the extent to 

2 which additions, modifications, and replen3 ishments reviewed under paragraph (2) 

4 align with previous relevant reports or re5 views by the Secretary or the Comptroller 

6 General; and 

7 ‘‘(viii) with respect to any change in 

8 the Federal organizational management of 

9 the stockpile, an assessment and compari10 son of the processes affected by such 

11 change, including planning for potential 

12 countermeasure deployment, distribution, 

13 or dispensing capabilities and processes re14 lated to procurement decisions, use of 

15 stockpiled countermeasures, and use of re16 sources for such activities. 

17 ‘‘(B) SUBMISSION.—Not later than 6 

18 months after completing a classified version of 

19 the review under subparagraph (A), the Comp20 troller General shall submit an unclassified 

21 version of the review to the appropriate commit22 tees of Congress.’’. 

23 (b) AUTHORIZATION OF APPROPRIATIONS, STRA24 TEGIC NATIONAL STOCKPILE.—Section 319F–2(f)(1) (42 

25 U.S.C. 247d–6b(f)(1)) is amended by striking 


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1 ‘‘$533,800,000 for each of fiscal years 2014 through 

2 2018’’ and inserting ‘‘$610,000,000 for each of fiscal 

3 years 2019 through 2023’’. 

4 SEC. 404. PREPARING FOR PANDEMIC INFLUENZA, ANTI5 MICROBIAL RESISTANCE, AND OTHER SIG6 NIFICANT THREATS. 

7 Section 319L(c)(4) (247d–7e(c)(4)) is amended by 

8 adding at the end the following: 

9 ‘‘(F) STRATEGIC INITIATIVES.—The Sec10 retary, acting through the Director of BARDA, 

11 may implement strategic initiatives, including 

12 by building on existing programs, supporting 

13 innovative candidate products in preclinical and 

14 clinical development, to address priority, natu15 rally occurring and man-made threats that, as 

16 determined by the Secretary, pose a significant 

17 level of risk to national security based on the 

18 characteristics of a chemical, biological, radio19 logical or nuclear threat, or existing capabilities 

20 to respond to such a threat (including medical 

21 response and treatment capabilities and manu22 facturing infrastructure). Such initiatives shall 

23 accelerate and support the advanced research, 

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1 measures and products, as applicable, to ad2 dress areas including— 

3 ‘‘(i) chemical, biological, radiological, 

4 or nuclear threats, including emerging in5 fectious diseases, for which insufficient ap6 proved, licensed, or authorized counter7 measures exist, or for which such threat, 

8 or the result of an exposure to such threat, 

9 may become resistant to countermeasures 

10 or existing countermeasures may be ren11 dered ineffective; 

12 ‘‘(ii) threats that consistently exist or 

13 continually circulate and have significant 

14 potential to become a pandemic, such as 

15 pandemic influenza, which may include the 

16 advanced research and development, manu17 facturing, and appropriate stockpiling of 

18 qualified pandemic or epidemic products, 

19 and products, technologies, or processes to 

20 support the advanced research and devel21 opment of such countermeasures (including 

22 multiuse platform technologies for 

23 diagnostics, vaccines, and therapeutics; 

24 virus seeds; clinical trial lots; novel virus 


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1 strains; and antigen and adjuvant mate2 rial); and 

3 ‘‘(iii) threats that may result pri4 marily or secondarily from a chemical, bio5 logical, radiological, or nuclear agent, or 

6 emerging infectious disease, and which 

7 may present increased treatment complica8 tions such as the occurrence of resistance 

9 to available countermeasures or potential 

10 countermeasures, including antimicrobial 

11 resistant pathogens.’’. 

12 SEC. 405. REPORTING ON THE FEDERAL SELECT AGENT 

13 PROGRAM. 

14 Section 351A(k) (42 U.S.C. 262a) is amended— 

15 (1) by striking ‘‘The Secretary’’ and inserting 

16 the following: 

17 ‘‘(1) IN GENERAL.—The Secretary’’; and 

18 (2) by adding at the end the following: 

19 ‘‘(2) IMPLEMENTATION OF RECOMMENDATIONS

20 OF THE FEDERAL EXPERTS SECURITY ADVISORY

21 PANEL AND THE FAST TRACK ACTION COMMITTEE

22 ON SELECT AGENT REGULATIONS.— 

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

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1 vancing Innovation Act of 2018, the Secretary 

2 shall provide an update to the appropriate com3 mittees of Congress on the implementation of 

4 recommendations of the Federal Experts Secu5 rity Advisory Panel concerning the select agent 

6 program. 

7 ‘‘(B) CONTINUED UPDATES.—The Sec8 retary shall provide status updates at 6-month 

9 intervals following the submission of the update 

10 under subparagraph (A) until the recommenda11 tions described in such subparagraph are fully 

12 implemented, or a justification is provided for 

13 the delay in, or lack of, implementation.’’. 

14 TITLE V—INCREASING COMMU15 NICATION IN MEDICAL COUN16 TERMEASURE ADVANCED RE17 SEARCH AND DEVELOPMENT 

18 SEC. 501. MEDICAL COUNTERMEASURE BUDGET PLAN. 

19 Section 2811(b)(7) (42 U.S.C. 300hh–10(b)(7)) is 

20 amended— 

21 (1) in the matter preceding subparagraph (A), 

22 by striking ‘‘March 1 of each year’’ and inserting 

23 ‘‘March 15, 2020 and every 2 years thereafter’’; 

24 (2) by striking subparagraph (A) and inserting 

25 the following: 


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1 ‘‘(A) include consideration of the entire 

2 medical countermeasures enterprise, includ3 ing— 

4 ‘‘(i) basic research and advanced re5 search and development; 

6 ‘‘(ii) approval, clearance, licensure, 

7 and authorized uses of products; 

8 ‘‘(iii) procurement, stockpiling, main9 tenance, and potential replenishment (in10 cluding manufacturing capabilities) of all 

11 products in the Strategic National Stock12 pile; and 

13 ‘‘(iv) the availability of technologies 

14 that may assist in the advanced research 

15 and development of countermeasures and 

16 opportunities to use such technologies to 

17 accelerate and navigate challenges unique 

18 to countermeasure research and develop19 ment;’’. 

20 (3) by redesignating subparagraphs (D) and 

21 (E) as subparagraphs (E) and (F), respectively; 

22 (4) by inserting after subparagraph (C), the fol23 lowing: 

24 ‘‘(D) identify the full range of anticipated 

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1 search and development, procurement, and 

2 stockpiling, including the potential need for in3 dications, dosing, and administration tech4 nologies, and other countermeasure needs as 

5 applicable and appropriate;’’; and 

6 (5) in subparagraph (E), as so redesignated, by 

7 striking ‘‘March 15 of each year’’ and inserting 

8 ‘‘March 15, 2020, and every 2 years thereafter’’. 

9 SEC. 502. MATERIAL THREAT AND MEDICAL COUNTER10 MEASURE NOTIFICATIONS. 

11 (a) CONGRESSIONAL NOTIFICATION OF MATERIAL

12 THREAT DETERMINATION.—Section 319F–2(c)(2)(C) (42 

13 U.S.C. 247d–6b(c)(2)(C)) is amended by striking ‘‘The 

14 Secretary and the Homeland Security Secretary shall 

15 promptly notify the appropriate committees of Congress’’ 

16 and inserting ‘‘The Secretary and the Secretary of Home17 land Security shall send to Congress, on an annual basis, 

18 all current material threat determinations and shall 

19 promptly notify the Committee on Health, Education, 

20 Labor, and Pensions and the Committee on Homeland Se21 curity and Government Affairs of the Senate and the Com22 mittee on Energy and Commerce and the Committee on 

23 Homeland Security of the House of Representatives’’. 

24 (b) CONTRACTING COMMUNICATIONS.— 


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1 (1) CONTRACT DURATION.—Section 319F– 

2 2(c)(7)(B)(ii)(III) (42 U.S.C. 247d– 

3 6b(c)(7)(B)(ii)(III)) is amended by adding at the 

4 end the following: ‘‘The Secretary shall notify the 

5 vendor within 90 days of a determination by the 

6 Secretary to renew such contract.’’. 

7 (2) EXPEDITED AUTHORITIES.—Section 

8 319L(c)(5)(B)(i) (42 U.S.C. 247d–7e(c)(5)(B)(i)) is 

9 amended by adding at the end the following: ‘‘Upon 

10 award, extension, or termination of any such con11 tract, grant, cooperative agreement, and other trans12 action, the Secretary shall provide a written notifica13 tion to the receiving entity that includes a justifica14 tion for such award, extension, or termination.’’. 

15 SEC. 503. AVAILABILITY OF REGULATORY MANAGEMENT 

16 PLANS. 

17 Section 565(f) of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 360bbb–4(f)) is amended— 

19 (1) by redesignating paragraphs (3) through 

20 (6) as paragraphs (4) through (7), respectively; 

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

23 ‘‘(3) PUBLICATION.—The Secretary shall make 

24 available on the internet website of the Food and 


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1 Drug Administration information regarding regu2 latory management plans, including— 

3 ‘‘(A) the process by which an applicant 

4 may submit a request for a regulatory manage5 ment plan; 

6 ‘‘(B) the timeframe by which the Secretary 

7 is required to respond to such request; 

8 ‘‘(C) the information required for the sub9 mission of such request; 

10 ‘‘(D) a description of the types of develop11 ment milestones and performance targets that 

12 could be discussed and included in such plans; 

13 and 

14 ‘‘(E) contact information for beginning the 

15 regulatory management plan process.’’; 

16 (3) in paragraph (6), as so redesignated, in the 

17 matter preceding subparagraph (A)— 

18 (A) by striking ‘‘paragraph (4)(A)’’ and in19 serting ‘‘paragraph (5)(A)’’; and 

20 (B) by striking ‘‘paragraph (4)(B)’’ and 

21 inserting ‘‘paragraph (5)(B)’’; and 

22 (4) in paragraph (7)(A), as so redesignated, by 

23 striking ‘‘paragraph (3)(A)’’ and inserting ‘‘para24 graph (4)(A)’’. 


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1 SEC. 504. THE BIOMEDICAL ADVANCED RESEARCH AND DE2 VELOPMENT AUTHORITY AND THE BIO3 SHIELD SPECIAL RESERVE FUND. 

4 (a) BIOSHIELD SPECIAL RESERVE FUND.—Section 

5 319F–2(g)(1) (42 U.S.C. 247d–6b(g)(1)) is amended— 

6 (1) by striking ‘‘$2,800,000,000 for the period 

7 of fiscal years 2014 through 2018’’ and inserting 

8 ‘‘$3,500,000,000 for the period of fiscal years 2019 

9 through 2023, to remain available until expended’’; 

10 and 

11 (2) by striking the second sentence. 

12 (b) THE BIOMEDICAL ADVANCED RESEARCH AND

13 DEVELOPMENT AUTHORITY.—Section 319L(d)(2) (42 

14 U.S.C. 247d–7e(d)(2)) is amended by striking 

15 ‘‘$415,000,000 for each of fiscal years 2014 through 

16 2018’’ and inserting ‘‘$611,700,000 for each of fiscal 

17 years 2019 through 2023’’. 

18 TITLE VI—ADVANCING TECH19 NOLOGIES FOR MEDICAL 

20 COUNTERMEASURES 

21 SEC. 601. ADMINISTRATION OF COUNTERMEASURES. 

22 Section 319L(c)(4)(D)(iii) (42 U.S.C. 247d– 

23 7e(c)(4)(D)(iii)) is amended by striking ‘‘and platform 

24 technologies’’ inserting ‘‘platform technologies, tech25 nologies to administer countermeasures, technologies to 

26 improve storage, and transportation of countermeasures’’. 


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1 SEC. 602. MEDICAL COUNTERMEASURE MASTER FILES. 

2 (a) IN GENERAL.—Chapter V of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend4 ed by inserting after section 565A the following: 

5 ‘‘SEC. 565B. MEDICAL COUNTERMEASURE MASTER FILES. 

6 ‘‘(a) PURPOSE.—The purpose of this section is to 

7 support and accelerate the development or manufacture 

8 of security countermeasures, qualified countermeasures, 

9 and qualified pandemic or epidemic products by facili10 tating and encouraging submission of data and informa11 tion to support such products to master files, and through 

12 clarifying the authority to cross-reference to data and in13 formation previously submitted to the Secretary. 

14 ‘‘(b) APPLICABILITY OF REFERENCE.— 

15 ‘‘(1) IN GENERAL.—A person may submit data 

16 and information to the Secretary with the intent to 

17 reference, or to authorize, in writing, another person 

18 to reference, such data or information, in accordance 

19 with subsections (d) and (e) of section 314.420 of 

20 title 21, Code of Federal Regulations (or any suc21 cessor regulations), to support a medical counter22 measure submission (including a supplement or 

23 amendment to any such submission), without requir24 ing the master file holder to disclose the data and 

25 information to any such persons authorized to ref26 erence the master file. 


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1 ‘‘(2) MASTER FILE HOLDER.—In this section, 

2 the term ‘master file holder’ means a person who 

3 submits data and information to the Secretary with 

4 the intent to reference or authorize to reference such 

5 data or information to support a medical counter6 measure submission, as described in paragraph (1). 

7 ‘‘(c) MEDICAL COUNTERMEASURE MASTER FILE

8 CONTENT.— 

9 ‘‘(1) IN GENERAL.—A master file under this 

10 section may include information to support and ac11 celerate— 

12 ‘‘(A) the development of medical counter13 measure submissions to support the approval, 

14 licensure, classification, clearance, conditional 

15 approval, or authorization of one or more secu16 rity countermeasures, qualified counter17 measures, or qualified pandemic or epidemic 

18 products; and 

19 ‘‘(B) the manufacture of security counter20 measures, qualified countermeasures, or quali21 fied pandemic or epidemic products. 

22 ‘‘(2) REQUIRED UPDATES.—The Secretary may 

23 require, as appropriate, that the master file holder 

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1 dated during the time such master file is referenced 

2 for a medical countermeasure submission. 

3 ‘‘(d) SPONSOR REFERENCE.— 

4 ‘‘(1) IN GENERAL.—Each incorporation of in5 formation or data contained in a master file by ref6 erence shall describe the incorporated material in a 

7 manner in which the Secretary determines appro8 priate and that permits the review of such informa9 tion without necessitating resubmission of such in10 formation or data. Master files shall be submitted in 

11 an electronic format in accordance with section 

12 745A and as specified in applicable guidance. 

13 ‘‘(2) REFERENCE BY A MASTER FILE HOLD14 ER.—A master file holder that is the sponsor of a 

15 medical countermeasure submission shall notify the 

16 Secretary in writing of the intent to reference the 

17 medical countermeasure master file as a part of the 

18 submission. 

19 ‘‘(3) REFERENCE BY AN AUTHORIZED PER20 SON.—A sponsor of a medical countermeasure sub21 mission may, where the Secretary determines appro22 priate, incorporate by reference all or part of the 

23 contents of a medical countermeasure master file, if 

24 the master file holder authorizes the incorporation in 

25 writing. 


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1 ‘‘(e) ACKNOWLEDGEMENT OF MASTER FILE BY THE

2 SECRETARY.—The Secretary shall provide the master file 

3 holder with a written notification indicating that the Sec4 retary has reviewed and relied upon specified information 

5 or data within a master file and the purposes for which 

6 such information or data was incorporated by reference 

7 if the Secretary has reviewed and relied upon such speci8 fied information or data to support the approval, classi9 fication, conditional approval, clearance, licensure, or au10 thorization of a security countermeasure, qualified coun11 termeasure, or qualified pandemic or epidemic product. 

12 The Secretary may rely upon the data and information 

13 within the medical countermeasure master file for which 

14 such written notification was provided in additional appli15 cations, as applicable and appropriate and upon the re16 quest of the master file holder so notified in writing or 

17 by an authorized person of such holder. 

18 ‘‘(f) RULES OF CONSTRUCTION.—Nothing in this 

19 section shall be construed to— 

20 ‘‘(1) alter the authority of the Secretary to ap21 prove, license, classify, clear, conditionally approve, 

22 or authorize drugs, biological products, or devices 

23 pursuant to this Act or section 351 of the Public 

24 Health Service Act (as authorized prior to the date 

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1 paredness and Advancing Innovation Act of 2018), 

2 including the standards of evidence, and applicable 

3 conditions, for approval under the applicable Act; or 

4 ‘‘(2) alter the authority of the Secretary under 

5 this Act or the Public Health Service Act to deter6 mine the types of information or data previously 

7 submitted by a sponsor or any other person that 

8 may be incorporated by reference in an application, 

9 request, or notification for a drug, biological prod10 uct, or device submitted under sections 505(i), 

11 505(b), 505(j), 512(b)(1), 512(b)(2), 564, 571, 

12 520(g), 515(c), 513(f)(2), or 510(k) of this Act, or 

13 subsection (a) or (k) of section 351 of the Public 

14 Health Service Act, including a supplement or 

15 amendment to any such submission, and the require16 ments associated with such reference. 

17 ‘‘(g) DEFINITIONS.—In this section: 

18 ‘‘(1) The term ‘medical countermeasure submis19 sion’ means an investigational new drug application 

20 under section 505(i), a new drug application under 

21 section 505(b), or an abbreviated new drug applica22 tion under section 505(j) of this Act, a biological 

23 product license application under section 351(a) of 

24 the Public Health Service Act or a biosimilar biologi25 cal product license application under section 351(k) 


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1 of the Public Health Service Act, a new animal drug 

2 application under section 512(b)(1) or abbreviated 

3 new animal drug application under section 

4 512(b)(2), an application for conditional approval of 

5 a new animal drug under 571, an investigational de6 vice application under section 520(g), an application 

7 with respect to a device under section 515(c), a re8 quest for classification of a device under section 

9 513(f)(2), a notification with respect to a device 

10 under section 510(k), or request for an emergency 

11 use authorization under section 564 to support— 

12 ‘‘(A) the approval, licensure, classification, 

13 clearance, conditional approval, or authorization 

14 of a security countermeasure, qualified counter15 measure, or qualified pandemic or epidemic 

16 product; or 

17 ‘‘(B) a new indication to an approved secu18 rity countermeasure, qualified countermeasure, 

19 or qualified pandemic or epidemic product. 

20 ‘‘(2) The terms ‘qualified countermeasure’, ‘se21 curity countermeasure’, and ‘qualified pandemic or 

22 epidemic product’ have the meanings given such 

23 terms in sections 319F–1, 319F–2, and 319F–3, re24 spectively, of the Public Health Service Act.’’. 


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1 (b) STAKEHOLDER INPUT.—Not later than 18 

2 months after the date of enactment of this Act, the Sec3 retary of Health and Human Services (referred to in this 

4 section as the ‘‘Secretary’’), acting through the Commis5 sioner of Food and Drugs and in consultation with the 

6 Assistant Secretary for Preparedness and Response, shall 

7 solicit input from stakeholders, including stakeholders de8 veloping security countermeasures, qualified counter9 measures, or qualified pandemic or epidemic products, and 

10 stakeholders developing technologies to assist in the devel11 opment of such countermeasures with respect to how the 

12 Food and Drug Administration can advance the use of 

13 tools and technologies to support and accelerate the devel14 opment or manufacture of security countermeasures, 

15 qualified countermeasures, and qualified pandemic or epi16 demic products, including through the reliance on cross17 referenced data and information contained within master 

18 files and submissions previously submitted to the Sec19 retary as set forth in section 565B of the Federal Food, 

20 Drug, and Cosmetic Act, as added by subsection (a). 

21 (c) GUIDANCE.—Not later than 2 years after the 

22 after the date of enactment of this Act, the Secretary, act23 ing through the Commissioner of Food and Drugs, shall 

24 publish draft guidance about how reliance on cross-ref25 erenced data and information contained within master 


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1 files under section 565B of the Federal Food, Drug, and 

2 Cosmetic Act, as added by subsection (a) or submissions 

3 otherwise submitted to the Secretary may be used for spe4 cific tools or technologies (including platform technologies) 

5 that have the potential to support and accelerate the devel6 opment or manufacture of security countermeasures, 

7 qualified countermeasures, qualified pandemic or epidemic 

8 products. The Secretary, acting through the Commissioner 

9 of Food and Drugs, shall publish the final guidance not 

10 later than 3 years after the enactment of this Act. 

11 SEC. 603. ANIMAL RULE REPORT. 

12 (a) STUDY.—The Comptroller General of the United 

13 States shall conduct a study on the application of the re14 quirements under section 565(d) of the of the Federal 

15 Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4(d)) 

16 (referred to in this section as the ‘‘animal rule’’) as a com17 ponent of medical countermeasure advanced development 

18 under the Biomedical Advanced Research and Develop19 ment Authority and regulatory review by the Food and 

20 Drug Administration. In conducting such study, the 

21 Comptroller General shall examine the following: 

22 (1) The extent to which advanced development 

23 and review of a medical countermeasure are coordi24 nated between the Biomedical Advanced Research 

25 and Development Authority and the Food and Drug 


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1 Administration, including activities facilitate appro2 priate and efficient design of studies to support ap3 proval, licensure, and authorization under the ani4 mal rule, consistent with the recommendations in the 

5 animal rule guidance, issued pursuant to section 

6 565(c) of the Federal Food, Drug, and Cosmetic Act 

7 (21 U.S.C. 360bbb–4(c)) and entitled ‘‘Product De8 velopment Under the Animal Rule Guidance for In9 dustry’’ (issued in October 2015), to resolve discrep10 ancies in the design of adequate and well-controlled 

11 efficacy studies conducted in animal models related 

12 to the provision of substantial evidence of effective13 ness for the product approved, licensed, or author14 ized under the animal rule. 

15 (2) The consistency of the application of the 

16 animal rule among and between review divisions 

17 within the Food and Drug Administration. 

18 (3) The flexibilities pursuant to the animal rule 

19 to address variations in countermeasure development 

20 and review processes, including the extent to which 

21 qualified animal models are adopted and used within 

22 the Food and Drug Administration in regulatory de23 cisionmaking with respect to medical counter24 measures. 


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1 (4) The extent to which the guidance issued 

2 under section 565(c) of the Federal Food, Drug, and 

3 Cosmetic Act (21 U.S.C. 360bbb–4(c)), entitled, 

4 ‘‘Product Development Under the Animal Rule 

5 Guidance for Industry’’ (issued in October 2015), 

6 has assisted in achieving the purposes described in 

7 paragraphs (1), (2), and (3). 

8 (b) CONSULTATIONS.—In conducting the study under 

9 subsection (a), the Comptroller General of the United 

10 States shall consult with— 

11 (1) the Federal agencies responsible for advanc12 ing, reviewing, and procuring medical counter13 measures, including the Office of the Assistant Sec14 retary for Preparedness and Response, the Bio15 medical Advanced Research and Development Au16 thority, the Food and Drug Administration, and the 

17 Department of Defense; 

18 (2) manufacturers involved in the research and 

19 development of medical countermeasures to address 

20 biological, chemical, radiological, and nuclear 

21 threats; and 

22 (3) other biodefense stakeholders, as applicable. 

23 (c) REPORT.—Not later than 3 years after the date 

24 of enactment of this Act, the Comptroller General of the 

25 United States shall submit to the Committee on Health, 


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

2 Committee on Energy and Commerce of the House of 

3 Representatives a report containing the results of the 

4 study conducted under subsection (a) and recommenda5 tions to improve the application and consistency of the re6 quirements under subsections (c) and (d) of section 565 

7 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

8 360bbb–4) to support and expedite the research and devel9 opment of medical countermeasures, as applicable. 

10 (d) PROTECTION OF NATIONAL SECURITY.—The 

11 Comptroller General of the United States shall conduct 

12 the study and issue the assessment and report under this 

13 section in a manner that does not compromise national 

14 security. 

15 TITLE VII—MISCELLANEOUS 

16 PROVISIONS 

17 SEC. 701. REAUTHORIZATIONS AND EXTENSIONS. 

18 (a) VETERANS AFFAIRS.—Section 8117(g) of title 

19 38, United States Code, is amended by striking ‘‘2014 

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

21 (b) VACCINE TRACKING AND DISTRIBUTION.—Sec22 tion 319A(e) (42 U.S.C. 247d–1(e)) is amended by strik23 ing ‘‘2014 through 2018’’ and inserting ‘‘2019 through 

24 2023’’. 


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1 (c) TEMPORARY REASSIGNMENT.—Section 319(e)(8) 

2 (42 U.S.C. 247d(e)(8)) is amended by striking ‘‘2018’’ 

3 and inserting ‘‘2023’’. 

4 (d) STRATEGIC INNOVATION PARTNER.—Section 

5 319L(c)(4)(E)(ix) (42 U.S.C. 247d–7e(c)(4)(E)(ix)) is 

6 amended by striking ‘‘2022’’ and inserting ‘‘2023’’. 

7 (e) PUBLIC DISCLOSURE EXEMPTION.—Section 

8 319L(e)(1)(C) (42 U.S.C. 247d–7e(e)(1)(C)) is amended 

9 by striking ‘‘12’’ and inserting ‘‘17’’. 

10 (f) LIMITED ANTITRUST EXEMPTION.— 

11 (1) IN GENERAL.—Section 405 of the Pandemic 

12 and All-Hazards Preparedness Act (42 U.S.C. 

13 247d–6a note) is amended— 

14 (A) by redesignating such section as sec15 tion 319L–1; 

16 (B) transferring such section to the Public 

17 Health Service Act (42 U.S.C. 201 et seq.), to 

18 appear after section 319L of such Act (42 

19 U.S.C. 247d–7e); 

20 (C) in subsection (a)(1)— 

21 (i) by striking ‘‘Secretary of Health 

22 and Human Services (referred to in this 

23 subsection as the ‘Secretary’)’’ and insert24 ing ‘‘Secretary’’; 


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1 (ii) by striking ‘‘of the Public Health 

2 Service Act (42 U.S.C. 247d–6b)) (as 

3 amended by this Act’’; 

4 (iii) by striking ‘‘of the Public Health 

5 Service Act (42 U.S.C. 247d–6a)) (as 

6 amended by this Act’’; and 

7 (iv) by striking ‘‘of the Public Health 

8 Service Act (42 U.S.C. 247d–6d)’’; and 

9 (D) in subsection (b), by striking ‘‘12- 

10 year’’ and inserting ‘‘17-year’’. 

11 (2) EFFECTIVE DATE.—The amendment made 

12 by paragraph (1)(D) shall take effect as if enacted 

13 on December 17, 2012. 

14 (3) CONFORMING AMENDMENT.—The table of 

15 contents in section 1(b) of the Pandemic and All16 Hazards Preparedness Act (Public Law 109–417) is 

17 amended by striking the item related to section 405. 

18 SEC. 702. TECHNICAL AMENDMENTS. 

19 (a) PUBLIC HEALTH SERVICE ACT.—Title III (42 

20 U.S.C. 241 et seq.) is amended— 

21 (1) in paragraphs (1) and (5) of section 319F– 

22 1(a) (42 U.S.C. 247d–6a(a)), by striking ‘‘section 

23 319F(h)’’ each place such term appears and insert24 ing ‘‘section 319F(e)’’; and 


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1 (2) in section 319K(a) (42 U.S.C. 247d–7d(a)), 

2 by striking ‘‘section 319F(h)(4)’’ and inserting ‘‘sec3 tion 319F(e)(4)’’. 

4 (b) PUBLIC HEALTH SECURITY GRANTS.—Section 

5 319C–1(b)(2) (42 U.S.C. 247d–3a(b)(2)) is amended— 

6 (1) in subparagraph (C), by striking ‘‘individ7 uals,,’’ and inserting ‘‘individuals,’’; and 

8 (2) in subparagraph (F), by striking ‘‘make sat9 isfactory annual improvement and describe’’ and in10 serting ‘‘makes satisfactory annual improvement and 

11 describes’’. 

12 (c) FEDERAL FOOD, DRUG, AND COSMETIC ACT.— 

13 The Federal Food, Drug, and Cosmetic Act is amended— 

14 (1) in section 564A(e)(2)(A) (21 U.S.C. 

15 360bbb–3a(e)(2)(A)), by striking ‘‘subsection 

16 (a)(1)(C)(i)’’ and inserting ‘‘subsection (a)(1)(C)’’; 

17 and 

18 (2) in section 564B(2)(C) (21 U.S.C. 360bbb– 

19 3b(2)(C)), by inserting ‘‘or section 564A’’. 

20 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

22 ‘‘Pandemic and All-Hazards Preparedness and Advancing 

23 Innovation Act of 2018’’. 

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

25 this Act is as follows: 

Sec. 1. Short title; table of contents. 


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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 preparedness for and response to all-hazards by public health 

emergency volunteers. 

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

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. Reauthorizing the National Advisory Committee on Children and Disasters. 

Sec. 306. Authorizing the National Advisory Committee on Seniors and Disasters. 

Sec. 307. 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. 

TITLE VI—ADVANCING TECHNOLOGIES FOR MEDICAL 

COUNTERMEASURES 

Sec. 601. Administration of countermeasures. 

Sec. 602. Medical countermeasure master files. 

Sec. 603. Priority zoonotic animal drugs. 

Sec. 604. Animal rule report. 


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Sec. 605. Review of the benefits of genomic engineering technologies and their potential role in national security. 

TITLE VII—MISCELLANEOUS PROVISIONS 

Sec. 701. Reauthorizations and extensions. 

Sec. 702. 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 Health 

5 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 and 

16 inserting the following: ‘‘Such National 

17 Health Security Strategy shall describe po18 tential emergency health security threats 

19 and identify the process for achieving the 

20 preparedness goals described in subsection 

21 (b) to be prepared to identify and respond 

22 to such threats and shall be consistent with 


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1 the national preparedness goal (as described 

2 in section 504(a)(19) of the Homeland Se3 curity Act of 2002), the National Incident 

4 Management System (as defined in section 

5 501(7) of such Act), and the National Re6 sponse Plan developed pursuant to section 

7 504 of such Act, or any successor plan.’’; 

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

9 the period at the end of the second sentence the 

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

11 the evidence-based benchmarks and objective 

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

13 and 

14 (C) in paragraph (3)— 

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

16 ‘‘2022’’; 

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

18 the environmental health and animal health 

19 workforces, as applicable), describing the 

20 status of such workforce’’ after ‘‘gaps in 

21 such workforce’’; 

22 (iii) by striking ‘‘and identifying 

23 strategies’’ and inserting ‘‘identifying strat24 egies’’; and 


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1 (iv) by inserting before the period at 

2 the end ‘‘, and identifying current capabili3 ties to meet the requirements of section 

4 2803’’; and 

5 (2) in subsection (b)— 

6 (A) in paragraph (2)— 

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

8 ‘‘and investigation’’ and inserting ‘‘inves9 tigation, and related information technology 

10 activities’’; 

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

12 ‘‘and decontamination’’ and inserting ‘‘de13 contamination, relevant health care services 

14 and supplies, and transportation and dis15 posal of medical waste’’; and 

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

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

19 (B) in paragraph (3)(F), by inserting ‘‘or 

20 exposures to agents that could cause a public 

21 health emergency’’ before the period; 

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

23 other applicable compacts’’ after ‘‘Compact’’; and 

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


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1 ‘‘(9) ZOONOTIC DISEASE, FOOD, AND AGRI2 CULTURE.—Improving coordination among Federal, 

3 State, local, tribal, and territorial entities (including 

4 through consultation with the Secretary of Agri5 culture) to prevent, detect, and respond to outbreaks 

6 of plant or animal disease (including zoonotic dis7 ease) that could compromise national security result8 ing from a deliberate attack, a naturally occurring 

9 threat, the intentional adulteration of food, or other 

10 public health threats, taking into account interactions 

11 between animal health, human health, and animals’ 

12 and humans’ shared environment as directly related 

13 to public health emergency preparedness and response 

14 capabilities, as applicable. 

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

16 current or potential health security threats from 

17 abroad to inform domestic public health preparedness 

18 and response capabilities.’’. 

19 TITLE II—IMPROVING 

20 PREPAREDNESS AND RESPONSE 

21 SEC. 201. IMPROVING BENCHMARKS AND STANDARDS FOR 

22 PREPAREDNESS AND RESPONSE. 

23 (a) EVALUATING MEASURABLE EVIDENCE-BASED

24 BENCHMARKS AND OBJECTIVE STANDARDS.—Section 


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

2 subsection (j) the following: 

3 ‘‘(k) EVALUATION.— 

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

5 the date of enactment of the Pandemic and All-Haz6 ards Preparedness and Advancing Innovation Act of 

7 2018 and every 2 years thereafter, the Secretary shall 

8 conduct an evaluation of the evidence-based bench9 marks and objective standards required under sub10 section (g). Such evaluation shall be submitted to the 

11 congressional committees of jurisdiction together with 

12 the National Health Security Strategy under section 

13 2802, at such time as such strategy is submitted. 

14 ‘‘(2) CONTENT.—The evaluation under this para15 graph shall include— 

16 ‘‘(A) a review of evidence-based benchmarks 

17 and objective standards, and associated metrics 

18 and targets; 

19 ‘‘(B) a discussion of changes to any evi20 dence-based benchmarks and objective standards, 

21 and the effect of such changes on the ability to 

22 track whether entities are meeting or making 

23 progress toward the goals under this section and, 

24 to the extent practicable, the applicable goals of 


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1 the National Health Security Strategy under sec2 tion 2802; 

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

4 eligible entities, as described in subsection (b) 

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

6 subrecipients and the effect of such funding on 

7 meeting evidence-based benchmarks and objective 

8 standards; and 

9 ‘‘(D) recommendations, as applicable and 

10 appropriate, to improve evidence-based bench11 marks and objective standards to more accu12 rately assess the ability of entities receiving 

13 awards under this section to better achieve the 

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

15 (b) EVALUATING THE PARTNERSHIP FOR STATE AND

16 REGIONAL HOSPITAL PREPAREDNESS.—Section 319C– 

17 2(i)(1) (42 U.S.C. 247–3b(i)(1)) is amended by striking 

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

19 319C–1(g), (i), (j), and (k)’’. 

20 SEC. 202. AMENDMENTS TO PREPAREDNESS AND RE21 SPONSE PROGRAMS. 

22 (a) COOPERATIVE AGREEMENT APPLICATIONS FOR IM23 PROVING STATE AND LOCAL PUBLIC HEALTH SECURITY.— 

24 Section 319C–1 (42 U.S.C. 247d–3a) is amended— 


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

2 through the Director of the Centers for Disease Con3 trol and Prevention,’’ after ‘‘the Secretary’’; and 

4 (2) in subsection (b)(2)(A)— 

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

6 public health agencies with specific expertise that 

7 may be relevant to public health security, such 

8 as environmental health agencies,’’ after ‘‘stake9 holders’’; 

10 (B) by redesignating clauses (vii) through 

11 (ix) as clauses (viii) through (x); and 

12 (C) by inserting after clause (vi) the fol13 lowing: 

14 ‘‘(vii) a description of how, as applica15 ble, such entity may integrate information 

16 to account for individuals with behavioral 

17 health needs following a public health emer18 gency;’’. 

19 (b) 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 ‘‘preparedness 

3 for, and response to, public health emergencies in 

4 accordance with subsection (c)’’; and 

5 (2) in subsection (b)(1)(A)— 

6 (A) in clause (iii), by redesignating sub7 clauses (I) through (III) as items (aa) through 

8 (cc), respectively, and adjusting the margins ac9 cordingly; 

10 (B) by redesignating clauses (i) through 

11 (iii) as subclauses (I) through (III) respectively, 

12 and adjusting the margins accordingly; 

13 (C) by striking ‘‘partnership consisting of— 

14 ’’ and inserting ‘‘partnership— 

15 ‘‘(i) consisting of—’’; and 

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

17 ‘‘(ii) that may include one or more 

18 emergency medical service organizations or 

19 emergency management organizations; 

20 and’’. 

21 (c) PUBLIC HEALTH SECURITY GRANTS AUTHORIZA22 TION OF APPROPRIATIONS.—Section 319C–1(h)(1)(A) (42 

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

24 ‘‘$641,900,000 for fiscal year 2014’’ and all that follows 

25 through the period at the end and inserting ‘‘$685,000,000 


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1 for each of fiscal years 2019 through 2023 for awards pur2 suant to paragraph (3) (subject to the authority of the Sec3 retary to make awards pursuant to paragraphs (4) and 

4 (5)).’’. 

5 (d) PARTNERSHIP FOR STATE AND REGIONAL HOS6 PITAL PREPAREDNESS AUTHORIZATION OF APPROPRIA7 TIONS.—Section 319C–2(j) (42 U.S.C. 247d–3b(j)) is 

8 amended— 

9 (1) by amending paragraph (1) to read as fol10 lows: 

11 ‘‘(1) IN GENERAL.— 

12 ‘‘(A) AUTHORIZATION OF APPROPRIA13 TIONS.—For purposes of carrying out this sec14 tion and section 319C–3, in accordance with 

15 subparagraph (B), there is authorized to be ap16 propriated $385,000,000 for each of fiscal years 

17 2019 through 2023. 

18 ‘‘(B) RESERVATIONS OF AMOUNTS FOR RE19 GIONAL SYSTEMS.— 

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

21 (ii), of the amount appropriated under sub22 paragraph (A) for a fiscal year, the Sec23 retary may reserve up to 5 percent for the 

24 purpose of carrying out section 319C–3. 


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1 ‘‘(ii) RESERVATIONS CONTINGENT ON

2 CONTINUED APPROPRIATIONS FOR THIS

3 SECTION.—If for fiscal year 2019 or a sub4 sequent fiscal year, the amount appro5 priated under subparagraph (A) is such 

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

7 amount remaining for the purpose of car8 rying out this section would be less than the 

9 amount available for such purpose for the 

10 previous fiscal year, the amount that may 

11 be reserved under clause (i) shall be reduced 

12 such that the amount remaining for the 

13 purpose of carrying out this section is not 

14 less than the amount available for such pur15 pose for the previous fiscal year. 

16 ‘‘(iii) SUNSET.—The authority to re17 serve amounts under clause (i) shall expire 

18 on September 30, 2023.’’; 

19 (2) in paragraph (2), by striking ‘‘paragraph (1) 

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

21 for a fiscal year and not reserved for the purpose de22 scribed in paragraph (1)(B)(i)’’; and 

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

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1 serting ‘‘paragraph (1)(A) and not reserved under 

2 paragraph (1)(B)(i) or (2)’’. 

3 SEC. 203. REGIONAL HEALTH CARE EMERGENCY PRE4 PAREDNESS AND RESPONSE SYSTEMS. 

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

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

7 following: 

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

9 EMERGENCY PREPAREDNESS AND RESPONSE 

10 SYSTEMS. 

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

12 identify and provide guidelines for regional systems of hos13 pitals, health care facilities, and other public and private 

14 sector entities, with varying levels of capability to treat pa15 tients and increase medical surge capacity during, in ad16 vance of, and immediately following a public health emer17 gency, including threats posed by one or more chemical, bio18 logical, radiological, and nuclear agents, including emerg19 ing infectious diseases. 

20 ‘‘(b) GUIDELINES.—The Assistant Secretary for Pre21 paredness and Response, in consultation with the Director 

22 of the Centers for Disease Control and Prevention, the Ad23 ministrator of the Centers for Medicare & Medicaid Serv24 ices, the Administrator of the Health Resources and Services 

25 Administration, the Commissioner of Food and Drugs, the 


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1 Assistant Secretary for Mental Health and Substance Use, 

2 the Assistant Secretary of Labor for Occupational Safety 

3 and Health, the Secretary of Veterans Affairs, the heads of 

4 such other Federal agencies as the Secretary determines to 

5 be appropriate, and State, local, tribal, and territorial pub6 lic health officials, shall, not later than 2 years after the 

7 date of enactment of this section— 

8 ‘‘(1) identify and develop a set of guidelines re9 lating to practices and protocols for all-hazards pub10 lic health emergency preparedness and response for 

11 hospitals and health care facilities to provide appro12 priate patient care during, in advance of, or imme13 diately following, a public health emergency, resulting 

14 from one or more chemical, biological, radiological, or 

15 nuclear agents, including emerging infectious diseases 

16 (which may include existing practices, such as trau17 ma care and medical surge capacity and capabili18 ties), with respect to— 

19 ‘‘(A) a regional approach to identifying 

20 hospitals and health care facilities based on 

21 varying capabilities and capacity to treat pa22 tients affected by such emergency, including— 

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

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1 nerships and health care coalitions estab2 lished under section 319C–2(b); and 

3 ‘‘(ii) informing and educating appro4 priate first responders and health care sup5 ply chain partners of the regional emer6 gency preparedness and response capabili7 ties and medical surge capacity of such hos8 pitals and health care facilities in the com9 munity; 

10 ‘‘(B) physical and technological infrastruc11 ture, laboratory capacity, staffing, blood supply, 

12 and other supply chain needs, taking into ac13 count resiliency, geographic considerations, and 

14 rural considerations; 

15 ‘‘(C) protocols or best practices for the safe16 ty and personal protection of workers who handle 

17 human remains and health care workers (includ18 ing with respect to protective equipment and 

19 supplies, waste management processes, and de20 contamination), sharing of specialized experience 

21 among the health care workforce, behavioral 

22 health, psychological resilience, and training of 

23 the workforce, as applicable; 

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

25 containment (within the meaning of section 


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1 2802(b)(2)(B)), coordinated medical triage, 

2 treatment, and transportation of patients, based 

3 on patient medical need (including patients in 

4 rural areas), to the appropriate hospitals or 

5 health care facilities within the regional system 

6 or, as applicable and appropriate, between sys7 tems in different States or regions; and 

8 ‘‘(E) the needs of children and other at-risk 

9 individuals; 

10 ‘‘(2) make such guidelines available on the inter11 net website of the Department of Health and Human 

12 Services in a manner that does not compromise na13 tional security; and 

14 ‘‘(3) update such guidelines as appropriate, in15 cluding based on input received pursuant to sub16 sections (c), (e), and (f), to address new and emerging 

17 public health threats. 

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

19 and updating guidelines under subsection (b), the Assistant 

20 Secretary for Preparedness and Response shall— 

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

22 care facilities (including health care coalitions under 

23 section 319C–2), State, local, tribal, and territorial 

24 public health departments, and health care or subject 

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1 tise in chemical, biological, radiological, or nuclear 

2 threats, and emerging infectious disease), as the As3 sistant Secretary determines appropriate, to meet the 

4 goals under section 2802(b)(3); 

5 ‘‘(2) consult and engage with appropriate health 

6 care providers and professionals, including physi7 cians, nurses, first responders, health care facilities 

8 (including hospitals, primary care clinics, commu9 nity health centers, mental health facilities, ambula10 tory care facilities, and dental health facilities), phar11 macies, emergency medical providers, trauma care 

12 providers, environmental health agencies, public 

13 health laboratories, poison control centers, blood 

14 banks, and other experts that the Assistant Secretary 

15 determines appropriate, to meet the goals under sec16 tion 2802(b)(3); 

17 ‘‘(3) consider feedback related to financial impli18 cations for hospitals, health care facilities, public 

19 health agencies, laboratories, and other entities en20 gaged in regional preparedness planning to imple21 ment and follow such guidelines, as applicable; and 

22 ‘‘(4) consider financial requirements and poten23 tial incentives for entities to prepare for, and respond 

24 to, public health emergencies as part of the regional 


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1 health care emergency preparedness and response sys2 tem. 

3 ‘‘(d) TECHNICAL ASSISTANCE.—The Assistant Sec4 retary for Preparedness and Response, in consultation with 

5 the Director of the Centers for Disease Control and Preven6 tion and the Assistant Secretary of Labor for Occupational 

7 Safety and Health, may provide technical assistance and 

8 consultation towards meeting the guidelines described in 

9 subsection (b). 

10 ‘‘(e) DEMONSTRATION PROJECT FOR REGIONAL

11 HEALTH CARE PREPAREDNESS AND RESPONSE SYS12 TEMS.— 

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

14 Preparedness and Response may establish a dem15 onstration project pursuant to the development and 

16 implementation of guidelines under subsection (b) to 

17 award grants to improve medical surge capacity for 

18 all hazards, build and integrate regional medical re19 sponse capabilities, improve specialty care expertise 

20 for all-hazards response, and coordinate medical pre21 paredness and response across State, local, tribal, ter22 ritorial, and regional jurisdictions. 

23 ‘‘(2) SUNSET.—The authority under this sub24 section shall expire on September 30, 2023. 

25 ‘‘(f) GAO REPORT TO CONGRESS.— 


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

2 date of enactment of this section, the Comptroller 

3 General of the United States (referred to in this sub4 section as the ‘Comptroller General’) shall submit to 

5 the Committee on Health, Education, Labor, and 

6 Pensions and the Committee on Finance of the Senate 

7 and the Committee on Energy and Commerce and the 

8 Committee on Ways and Means of the House of Rep9 resentatives, a report on the extent to which hospitals 

10 and health care facilities have implemented the rec11 ommended guidelines under subsection (b), including 

12 an analysis and evaluation of any challenges hos13 pitals or health care facilities experienced in imple14 menting such guidelines. 

15 ‘‘(2) CONTENT.—The Comptroller General shall 

16 include in the report under paragraph (1)— 

17 ‘‘(A) data on the preparedness and response 

18 capabilities that have been informed by the 

19 guidelines under subsection (b) to improve re20 gional emergency health care preparedness and 

21 response capability, including hospital and 

22 health care facility capacity and medical surge 

23 capabilities to prepare for, and respond to, pub24 lic health emergencies; and 


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1 ‘‘(B) recommendations to reduce gaps in in2 centives for regional health partners, including 

3 hospitals and health care facilities, to improve 

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

7 may include consideration of facilities partici8 pating in programs under section 319C–2, pro9 grams under the Centers for Medicare & Med10 icaid Services (including innovative health care 

11 delivery and payment models), and input from 

12 private sector financial institutions. 

13 ‘‘(3) CONSULTATION.—In carrying out para14 graphs (1) and (2), the Comptroller General shall 

15 consult with the heads of appropriate Federal agen16 cies, including— 

17 ‘‘(A) the Assistant Secretary for Prepared18 ness and Response; 

19 ‘‘(B) the Director of the Centers for Disease 

20 Control and Prevention; 

21 ‘‘(C) the Administrator of the Centers for 

22 Medicare & Medicaid Services; 

23 ‘‘(D) the Assistant Secretary for Mental 

24 Health and Substance Use; 


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1 ‘‘(E) the Assistant Secretary of Labor for 

2 Occupational Safety and Health; 

3 ‘‘(F) the Secretary of Veterans Affairs; and 

4 ‘‘(G) the heads of such other Federal agen5 cies as the Secretary determines appropriate.’’. 

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

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

8 first sentence the following ‘‘The reports submitted under 

9 this paragraph shall also include progress towards the im10 plementation of section 319C–3.’’. 

11 (c) NATIONAL HEALTH SECURITY STRATEGY INCOR12 PORATION OF REGIONALIZED EMERGENCY PREPAREDNESS

13 AND RESPONSE.—Section 2802(b)(3) (42 U.S.C. 300hh– 

14 1(b)(3)) is amended— 

15 (1) in the matter preceding subparagraph (A), 

16 by striking ‘‘including mental health’’ and inserting 

17 ‘‘including pharmacies, mental health facilities,’’; and 

18 (2) by amending subparagraph (G) to read as 

19 follows: 

20 ‘‘(G) Optimizing a coordinated and flexible 

21 approach to the emergency response and medical 

22 surge capacity of hospitals, other health care fa23 cilities, critical care, trauma care (which may 

24 include trauma centers), and emergency medical 

25 systems, which may include the implementation 


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1 of guidelines for regional health care emergency 

2 preparedness and response systems under section 

3 319C–3.’’. 

4 (d) IMPROVING STATE AND LOCAL PUBLIC HEALTH

5 SECURITY.— 

6 (1) STATE AND LOCAL SECURITY.—Section 

7 319C–1(e) (42 U.S.C. 247d–3a(e)) is amended by 

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

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

10 care emergency preparedness and response system es11 tablished pursuant to the applicable guidelines under 

12 section 319C–3.’’. 

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

14 (42 U.S.C. 247d-3b(d)(1)(A)) is amended— 

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

16 inserting ‘‘;’’ 

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

18 (iii); and 

19 (C) inserting after clause (i), the following: 

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

21 regional health care emergency system 

22 under section 319C–3; and’’. 


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1 SEC. 204. MILITARY AND CIVILIAN PARTNERSHIP FOR 

2 TRAUMA READINESS. 

3 Title XII (42 U.S.C. 300d et seq.) is amended by add4 ing at the end the following new part: 

5 ‘‘PART I—MILITARY AND CIVILIAN PARTNERSHIP 

6 FOR TRAUMA READINESS GRANT PROGRAM 

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

8 TRAUMA READINESS GRANT PROGRAM. 

9 ‘‘(a) MILITARY TRAUMA TEAM PLACEMENT PRO10 GRAM.— 

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

12 through the Assistant Secretary for Preparedness and 

13 Response and in consultation with the Secretary of 

14 Defense, shall award grants to not more than 20 eligi15 ble high acuity trauma centers to enable military 

16 trauma teams to provide, on a full-time basis, trauma 

17 care and related acute care at such trauma centers. 

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

19 awarded under paragraph (1) to an eligible high acu20 ity trauma center, such grant— 

21 ‘‘(A) shall be for a period of not fewer than 

22 3 fiscal years and not more than 5 fiscal years 

23 (and may be renewed at the end of such period); 

24 and 

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

26 exceed $1,000,000 per fiscal year. 


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1 ‘‘(b) MILITARY TRAUMA CARE PROVIDER PLACEMENT

2 PROGRAM.— 

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

4 through the Assistant Secretary for Preparedness and 

5 Response and in consultation with the Secretary of 

6 Defense, shall award grants to eligible trauma centers 

7 to enable military trauma care providers to provide 

8 trauma care and related acute care at such trauma 

9 centers. 

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

11 awarded under paragraph (1) to an eligible trauma 

12 center, such grant— 

13 ‘‘(A) shall be for a period of at least 1 fiscal 

14 year and not more than 3 fiscal years (and may 

15 be renewed at the end of such period); and 

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

17 exceed, in a fiscal year— 

18 ‘‘(i) $100,000 for each military trauma 

19 care provider that is a physician at such el20 igible trauma center; and 

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

22 trauma care provider at such eligible trau23 ma center. 

24 ‘‘(c) GRANT REQUIREMENTS.— 


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1 ‘‘(1) DEPLOYMENT AND PUBLIC HEALTH EMER2 GENCIES.—As a condition of receipt of a grant under 

3 this section, a grant recipient shall agree to allow 

4 military trauma care providers providing care pursu5 ant to such grant to— 

6 ‘‘(A) be deployed by the Secretary of Defense 

7 for military operations, for training, or for re8 sponse to a mass casualty incident; and 

9 ‘‘(B) be deployed by the Secretary of Health 

10 and Human Services for response to a public 

11 health emergency pursuant to section 319. 

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

13 this section to an eligible trauma center may be used 

14 to train and incorporate military trauma care pro15 viders into such trauma center, including incorpora16 tion into operational exercises and training drills re17 lated to public health emergencies, expenditures for 

18 malpractice insurance, office space, information tech19 nology, specialty education and supervision, trauma 

20 programs, and State license fees for such military 

21 trauma care providers. 

22 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec23 tion shall be construed to affect any other provision of law 

24 that preempts State licensing requirements for health care 


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1 professionals with respect to military trauma care pro2 viders. 

3 ‘‘(e) REPORTING REQUIREMENTS.— 

4 ‘‘(1) REPORT TO THE SECRETARY AND THE SEC5 RETARY OF DEFENSE.—Each eligible trauma center 

6 or eligible high acuity trauma center awarded a grant 

7 under subsection (a) or (b) for a fiscal year shall sub8 mit to the Secretary and the Secretary of Defense a 

9 report for such fiscal year that includes information 

10 on— 

11 ‘‘(A) the number and types of trauma cases 

12 managed by military trauma teams or military 

13 trauma care providers pursuant to such grant 

14 during such fiscal year; 

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

16 of the military trauma providers or teams of 

17 providers as part of the trauma center, including 

18 the financial effect of such grant on the trauma 

19 center; 

20 ‘‘(C) the educational effect on resident 

21 trainees in centers where military trauma teams 

22 are assigned; 

23 ‘‘(D) any research conducted during such 

24 fiscal year supported by such grant; and 


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

2 Secretaries for the purpose of evaluating the ef3 fect of such grant. 

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

5 every 2 fiscal years, the Secretary, in consultation 

6 with the Secretary of Defense, shall submit a report 

7 to the congressional committees of jurisdiction that 

8 includes information on the effect of placing military 

9 trauma care providers in trauma centers awarded 

10 grants under this section on— 

11 ‘‘(A) maintaining military trauma care 

12 providers’ readiness and ability to respond to 

13 and treat battlefield injuries; 

14 ‘‘(B) providing health care to civilian trau15 ma patients in urban and rural settings; 

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

17 military trauma care providers to increase med18 ical surge capacity, including as a result of a 

19 large scale event; 

20 ‘‘(D) the ability of grant recipients to main21 tain the integration of the military trauma pro22 viders or teams of providers as part of the trau23 ma center; 

24 ‘‘(E) efforts to incorporate military trauma 

25 care providers into operational exercises and 


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1 training and drills for public health emergencies; 

2 and 

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

4 providers to participate as part of a medical re5 sponse during or in advance of a declared public 

6 health emergency. 

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

8 ‘‘(1) ELIGIBLE TRAUMA CENTER.—The term ‘eli9 gible trauma center’ means a Level I, II, or III trau10 ma center that satisfies each of the following: 

11 ‘‘(A) Such trauma center has an agreement 

12 with the Secretary of Defense to enable military 

13 trauma care providers to provide trauma care 

14 and related acute care at such trauma center. 

15 ‘‘(B) Such trauma center utilizes a risk-ad16 justed benchmarking system and metrics to 

17 measure performance, quality, and patient out18 comes. 

19 ‘‘(C) Such trauma center demonstrates a 

20 need for integrated military trauma care pro21 viders to maintain or improve the trauma clin22 ical capability of such trauma center. 

23 ‘‘(2) ELIGIBLE HIGH ACUITY TRAUMA CENTER.— 

24 The term ‘eligible high acuity trauma center’ means 


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1 a Level I trauma center that satisfies each of the fol2 lowing: 

3 ‘‘(A) Such trauma center has an agreement 

4 with the Secretary of Defense to enable military 

5 trauma teams to provide trauma care and re6 lated acute care at such trauma center. 

7 ‘‘(B) At least 20 percent of patients treated 

8 at such trauma center in the most recent 3- 

9 month period for which data is available are 

10 treated for a major trauma at such trauma cen11 ter. 

12 ‘‘(C) Such trauma center utilizes a risk-ad13 justed benchmarking system and metrics to 

14 measure performance, quality, and patient out15 comes. 

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

17 training center— 

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

19 ‘‘(ii) that maintains residency pro20 grams and fellowships in critical trauma 

21 specialties and subspecialties, and provides 

22 education and supervision of military trau23 ma team members according to those spe24 cialties and subspecialties; and 


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1 ‘‘(iii) that undertakes research in the 

2 prevention and treatment of traumatic in3 jury. 

4 ‘‘(E) Such trauma center serves as a med5 ical and public health preparedness and response 

6 leader for its community, such as by partici7 pating in a partnership for State and regional 

8 hospital preparedness established under section 

9 319C–2 or 319C–3. 

10 ‘‘(3) MAJOR TRAUMA.—The term ‘major trauma’ 

11 means an injury that is greater than or equal to 15 

12 on the injury severity score. 

13 ‘‘(4) MILITARY TRAUMA TEAM.—The term ‘mili14 tary trauma team’ means a complete military trau15 ma team consisting of military trauma care providers 

16 specializing in providing trauma care. 

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

18 term ‘military trauma care provider’ means a mem19 ber of the Armed Forces who furnishes emergency, 

20 critical care, and other trauma acute care services, 

21 including a physician, surgeon or military surgeon, 

22 physician assistant, nurse, nurse practitioner, res23 piratory therapist, flight paramedic, combat medic, 

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1 ma care provider as the Secretary determines appro2 priate. 

3 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To carry 

4 out this section, there are authorized to be appropriated 

5 $6,800,000 for each of fiscal years 2019 through 2023.’’. 

6 SEC. 205. PUBLIC HEALTH AND HEALTH CARE SYSTEM SIT7 UATIONAL AWARENESS AND BIOSURVEIL8 LANCE CAPABILITIES. 

9 (a) FACILITIES, CAPACITIES, AND BIOSURVEILLANCE

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

11 amended— 

12 (1) in the section heading, by striking ‘‘REVI13 TALIZING’’ and inserting ‘‘FACILITIES AND CA14 PACITIES OF’’; 

15 (2) in subsection (a)— 

16 (A) in the subsection heading, by striking 

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

18 GENERAL’’; 

19 (B) in paragraph (1), by striking ‘‘and im20 proved’’ and inserting ‘‘, improved, and appro21 priately maintained’’; 

22 (C) in paragraph (3), in the matter pre23 ceding subparagraph (A), by striking ‘‘expand, 

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


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1 improve, enhance, and appropriately maintain’’; 

2 and 

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

4 ‘‘(4) STUDY OF RESOURCES FOR FACILITIES AND

5 CAPACITIES.—Not later than June 1, 2022, the Comp6 troller General of the United States shall conduct a 

7 study on Federal spending in fiscal years 2013 

8 through 2018 for activities authorized under this sub9 section. Such study shall include a review and assess10 ment of obligations and expenditures directly related 

11 to each activity under paragraphs (2) and (3), in12 cluding a specific accounting of, and delineation be13 tween, obligations and expenditures incurred for the 

14 construction, renovation, equipping, and security up15 grades of facilities and associated contracts under this 

16 subsection, and the obligations and expenditures in17 curred to establish and improve the situational 

18 awareness and biosurveillance network under sub19 section (b), and shall identify the agency or agencies 

20 incurring such obligations and expenditures.’’; 

21 (3) in subsection (b)— 

22 (A) in the subsection heading, by striking 

23 ‘‘NATIONAL’’ and inserting ‘‘ESTABLISHMENT OF

24 SYSTEMS OF PUBLIC HEALTH ’’; 


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

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 Pandemic 

15 and All-Hazards Preparedness and Advancing 

16 Innovation Act of 2018, the Secretary, in co17 operation 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 Health 

21 Information Technology and the National Insti22 tute of Standards and Technology), shall, as nec23 essary, adopt technical and reporting standards, 

24 including standards for interoperability as de25 fined by section 3000, for networks under paraVerDate Sep 11 2014 00:21 Jun 19, 2018 Jkt 079200 PO 00000 Frm 00126 Fmt 6652 Sfmt 6203 E:\BILLS\S2852.RS S2852

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1 graph (1) and update such standards as nec2 essary. Such standards shall be made available 

3 on the internet website of the Department of 

4 Health and Human Services, in a manner that 

5 does not compromise national security. 

6 ‘‘(B) DEFERENCE TO STANDARDS DEVELOP7 MENT ORGANIZATIONS.—In adopting and imple8 menting standards under this subsection and 

9 subsection (c), the Secretary shall give deference 

10 to standards published by standards development 

11 organizations and voluntary consensus-based 

12 standards entities.’’; 

13 (4) in subsection (c)— 

14 (A) in paragraph (1)— 

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

16 after the date of enactment of the Pandemic 

17 and All-Hazards Preparedness Reauthoriza18 tion Act of 2013, the Secretary’’ and insert19 ing ‘‘The Secretary’’; 

20 (ii) by inserting ‘‘, and improve as ap21 plicable and appropriate,’’ after ‘‘shall es22 tablish’’; 

23 (iii) by striking ‘‘of rapid’’ and insert24 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 es6 tablishing 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 in16 formation exchange (including the Office of the 

17 National Coordinator for Health Information 

18 Technology), and public health emergency pre19 paredness and response; and 

20 ‘‘(B) consult with the Secretary of Agri21 culture, the Secretary of Commerce (and the Di22 rector of the National Institute of Standards and 

23 Technology), the Secretary of Defense, the Sec24 retary of Homeland Security, and the Secretary 

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1 eral agencies, as the Secretary determines appro2 priate.’’; 

3 (C) in paragraph (3)— 

4 (i) by redesignating subparagraphs (A) 

5 through (E) as clauses (i) through (v), re6 spectively, and adjusting the margins ac7 cordingly; 

8 (ii) in clause (iv), as so redesignated— 

9 (I) by inserting ‘‘immunization 

10 information systems,’’ after ‘‘poison 

11 control,’’; and 

12 (II) by striking ‘‘ and clinical 

13 laboratories’’ and inserting ‘‘, clinical 

14 laboratories, and public environmental 

15 health agencies’’; 

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

17 inserting the following: 

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

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

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

21 the date of the enactment of the Pandemic and 

22 All-Hazards Preparedness and Advancing Inno23 vation Act of 2018 and every 6 years thereafter, 

24 the Secretary shall conduct a review of the ele25 ments described in subparagraph (A). Such reVerDate Sep 11 2014 00:21 Jun 19, 2018 Jkt 079200 PO 00000 Frm 00129 Fmt 6652 Sfmt 6203 E:\BILLS\S2852.RS S2852

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1 view shall include a discussion of the addition of 

2 any elements pursuant to clause (v), including 

3 elements added to advancing new technologies, 

4 and identify any challenges in the incorporation 

5 of elements under subparagraph (A). The Sec6 retary shall provide such review to the congres7 sional committees of jurisdiction.’’; 

8 (D) in paragraph (5)— 

9 (i) by redesignating subparagraphs (A) 

10 through (D) as clauses (i) through (iv), re11 spectively, and adjusting the margins ac12 cordingly; 

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

14 inserting the following: 

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

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

18 ‘‘(B) PUBLIC MEETING.— 

19 ‘‘(i) IN GENERAL.—Not later than 180 

20 days after the date of enactment of the Pan21 demic and All-Hazards Preparedness and 

22 Advancing Innovation Act of 2018, the Sec23 retary shall convene a public meeting for 

24 purposes of discussing and providing input 

25 on the potential goals, functions, and uses of 


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1 the network described in paragraph (1) and 

2 incorporating the elements described in 

3 paragraph (3)(A). 

4 ‘‘(ii) EXPERTS.—The public meeting 

5 shall include representatives of relevant 

6 Federal agencies (including representatives 

7 from the Office of the National Coordinator 

8 for Health Information Technology and the 

9 National Institute of Standards and Tech10 nology); State, local, tribal, and territorial 

11 public health officials; stakeholders with ex12 pertise in biosurveillance and situational 

13 awareness; stakeholders with expertise in ca14 pabilities relevant to biosurveillance and 

15 situational awareness, such as experts in 

16 informatics and data analytics (including 

17 experts in prediction, modeling, or fore18 casting); and other representatives as the 

19 Secretary determines appropriate. 

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

21 shall include a discussion of— 

22 ‘‘(I) data elements, including 

23 minimal or essential data elements, 

24 that are voluntarily provided for such 

25 network, which may include elements 


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1 from public health and public and pri2 vate health care entities, to the extent 

3 practicable; 

4 ‘‘(II) standards and implementa5 tion specifications that may improve 

6 the collection, analysis, and interpreta7 tion of data during a public health 

8 emergency; 

9 ‘‘(III) strategies to encourage the 

10 access, exchange, and use of informa11 tion; 

12 ‘‘(IV) considerations for State, 

13 local, tribal, and territorial capabili14 ties and infrastructure related to data 

15 exchange and interoperability; 

16 ‘‘(V) privacy and security protec17 tions provided at the Federal, State, 

18 local, tribal, and territorial levels, and 

19 by nongovernmental stakeholders; and 

20 ‘‘(VI) opportunities for the incor21 poration of innovative technologies to 

22 improve the network.’’; and 

23 (iv) in subparagraph (A), as so des24 ignated by clause (ii)— 


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1 (I) in clause (i), as so redesig2 nated— 

3 (aa) by striking ‘‘as deter4 mined’’ and inserting ‘‘as adopt5 ed’’; and 

6 (bb) by inserting ‘‘and the 

7 National Institute of Standards 

8 and Technology’’ after ‘‘Office of 

9 the National Coordinator for 

10 Health Information Technology’’; 

11 (II) in clause (iii), as so redesig12 nated, by striking ‘‘; and’’ and insert13 ing a semicolon; 

14 (III) in clause (iv), as so redesig15 nated, by striking the period and in16 serting ‘‘; and’’; and 

17 (IV) by adding at the end the fol18 lowing: 

19 ‘‘(v) pilot test standards and imple20 mentation specifications, consistent with the 

21 process described in section 3002(b)(3)(C), 

22 which State, local, tribal, and territorial 

23 public health entities may utilize, on a vol24 untary basis, as a part of the network.’’; 


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1 (E) by redesignating paragraph (6) as 

2 paragraph (7); 

3 (F) by inserting after paragraph (5) the fol4 lowing: 

5 ‘‘(6) STRATEGY AND IMPLEMENTATION PLAN.— 

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

7 months after the date of enactment of the Pan8 demic and All-Hazards Preparedness and Ad9 vancing Innovation Act of 2018, the Secretary 

10 shall submit to the congressional committees of 

11 jurisdiction a coordinated strategy and an ac12 companying implementation plan that— 

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

14 under paragraph (5)(B); 

15 ‘‘(ii) includes a review and assessment 

16 of existing capabilities of the network and 

17 related infrastructure, including input pro18 vided by the public meeting under para19 graph (5)(B); 

20 ‘‘(iii) identifies and demonstrates the 

21 measurable steps the Secretary will carry 

22 out to— 

23 ‘‘(I) develop, implement, and 

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1 graph (1), utilizing elements described 

2 in paragraph (3)(A); 

3 ‘‘(II) modernize and enhance bio4 surveillance activities, including strat5 egies to include innovative technologies 

6 and analytical approaches (including 

7 prediction and forecasting for 

8 pandemics and all-hazards) from pub9 lic and private entities; 

10 ‘‘(III) improve information shar11 ing, coordination, and communication 

12 among disparate biosurveillance sys13 tems supported by the Department of 

14 Health and Human Services, including 

15 the identification of methods to im16 prove accountability, better utilize re17 sources and workforce capabilities, and 

18 incorporate innovative technologies 

19 within and across agencies; and 

20 ‘‘(IV) test and evaluate capabili21 ties of the interoperable network of sys22 tems to improve situational awareness 

23 and biosurveillance capabilities; 

24 ‘‘(iv) includes performance measures 

25 and the metrics by which performance 


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1 measures will be assessed with respect to the 

2 measurable steps under clause (iii); and 

3 ‘‘(v) establishes dates by which each 

4 measurable step under clause (iii) will be 

5 implemented.’’. 

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

7 than 2 years after the date of enactment of the 

8 Pandemic and All-Hazards Preparedness and 

9 Advancing Innovation Act of 2018 and on an 

10 annual basis thereafter, in accordance with the 

11 strategy and implementation plan under this 

12 paragraph, the Secretary shall, taking into ac13 count recommendations provided by the National 

14 Biodefense Science Board, develop a budget plan 

15 based on the strategy and implementation plan 

16 under this section. Such budget plan shall in17 clude— 

18 ‘‘(i) a summary of resources previously 

19 expended to establish, improve, and utilize 

20 the nationwide public health situational 

21 awareness and biosurveillance network 

22 under paragraph (1); 

23 ‘‘(ii) estimates of costs and resources 

24 needed to establish and improve the network 

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1 egy and implementation plan under sub2 paragraph (A); 

3 ‘‘(iii) the identification of gaps and in4 efficiencies in nationwide public health situ5 ational awareness and biosurveillance capa6 bilities, resources, and authorities needed to 

7 address such gaps; and 

8 ‘‘(iv) a strategy to minimize and ad9 dress such gaps and improve inefficien10 cies.’’; 

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

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

13 ‘‘(taking into account zoonotic disease, in14 cluding gaps in scientific understanding of 

15 the interactions between human, animal, 

16 and environmental health)’’ after ‘‘human 

17 health’’; 

18 (ii) in subparagraph (B)— 

19 (I) by inserting ‘‘and gaps in sur20 veillance programs’’ after ‘‘surveillance 

21 programs’’; and 

22 (II) by striking ‘‘; and’’ and in23 serting a semicolon; 

24 (iii) in subparagraph (C)— 


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1 (I) by inserting ‘‘, animal health 

2 organizations related to zoonotic dis3 ease,’’ after ‘‘health care entities’’; and 

4 (II) by striking the period and in5 serting ‘‘; and’’; and 

6 (iv) by adding at the end the following: 

7 ‘‘(D) provide recommendations to the Sec8 retary on policies and procedures to complete the 

9 steps described in this paragraph in a manner 

10 that is consistent with section 2802.’’; and 

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

12 ‘‘(8) SITUATIONAL AWARENESS AND BIOSURVEIL13 LANCE AS A NATIONAL SECURITY PRIORITY.—The Sec14 retary, on a periodic basis as applicable and appro15 priate, shall meet with the Director of National Intel16 ligence to inform the development and capabilities of 

17 the nationwide public health situational awareness 

18 and biosurveillance network.’’; 

19 (5) in subsection (d)— 

20 (A) in paragraph (1)— 

21 (i) by inserting ‘‘environmental health 

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

23 and 

24 (ii) by inserting ‘‘immunization pro25 grams,’’ after ‘‘poison control centers,’’; and 


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1 (B) in paragraph (2)— 

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

3 ‘‘and’’ at the end; 

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

5 the period and inserting ‘‘; and’’; and 

6 (iii) by adding after subparagraph (C) 

7 the following: 

8 ‘‘(D) an implementation plan that may in9 clude measurable steps to achieve the purposes 

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

11 (C) by striking paragraph (5) and inserting 

12 the following: 

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

14 may provide technical assistance to States, localities, 

15 tribes, and territories or a consortium of States, local16 ities, tribes, and territories receiving an award under 

17 this subsection regarding interoperability and the 

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

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

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

21 (7) by inserting after subsection (e) the following: 

22 ‘‘(f) PERSONNEL AUTHORITIES.— 

23 ‘‘(1) SPECIALLY QUALIFIED PERSONNEL.—In ad24 dition to any other personnel authorities, to carry out 


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1 subsection (b) and subsection (c), the Secretary 

2 may— 

3 ‘‘(A) appoint highly qualified individuals to 

4 scientific or professional positions at the Centers 

5 for Disease Control and Prevention, not to exceed 

6 30 such employees at any time (specific to posi7 tions authorized by this subsection), with exper8 tise in capabilities relevant to biosurveillance 

9 and situational awareness, such as experts in 

10 informatics and data analytics (including ex11 perts in prediction, modeling, or forecasting), 

12 and other related scientific or technical fields; 

13 and 

14 ‘‘(B) compensate individuals appointed 

15 under subparagraph (A) in the same manner 

16 and subject to the same terms and conditions in 

17 which individuals appointed under 9903 of title 

18 5, United States Code, are compensated, without 

19 regard to the provisions of chapter 51 and sub20 chapter III of chapter 53 of that title relating to 

21 classification and General Schedule pay rates. 

22 ‘‘(2) LIMITATIONS.—The Secretary shall exercise 

23 the authority under paragraph (1) in a manner that 

24 is consistent with the limitations described in section 

25 319F–1(e)(2). 


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

2 purposes under subsections (b) and (c) no later than Sep3 tember 30, 2023, and shall provide a justification to the 

4 congressional committees of jurisdiction for any missed or 

5 delayed implementation of measurable steps identified 

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

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

8 years after the date of enactment of the Pandemic and All9 Hazards Preparedness and Advancing Innovation Act of 

10 2018, the Comptroller General of the United States shall 

11 conduct an independent evaluation, and submit to the Sec12 retary and the congressional committees of jurisdiction a 

13 report concerning the activities conducted under subsections 

14 (b) and (c), and provide recommendations, as applicable 

15 and appropriate, on necessary improvements to the bio16 surveillance and situational awareness network.’’. 

17 (b) AUTHORIZATION OF APPROPRIATIONS.—Sub18 section (i) of section 319D (42 U.S.C. 247d–4), as redesig19 nated by subsection (a)(6), is amended by striking 

20 ‘‘$138,300,000 for each of fiscal years 2014 through 2018’’ 

21 and inserting ‘‘$161,800,000 for each of fiscal years 2019 

22 through 2023’’. 


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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 rapidly 

11 respond to the immediate needs resulting 

12 from such public health emergency or poten13 tial public health emergency’’ before the pe14 riod; 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 fol22 lowing: 

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

24 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 care 

2 entities that the Secretary determines may be af3 fected by a public health emergency or potential 

4 public health emergency (including communica5 tion of such entities with relevant international 

6 entities, as applicable); 

7 ‘‘(B) make grants, provide for awards, enter 

8 into contracts, and conduct supportive investiga9 tions pertaining to a public health emergency or 

10 potential public health emergency, including fur11 ther supporting programs under section 319C–1, 

12 319C–2, or 319C–3; 

13 ‘‘(C) facilitate and accelerate, as applicable, 

14 advanced research and development of security 

15 countermeasures (as defined in section 319F–2), 

16 qualified countermeasures (as defined in section 

17 319F–1), or qualified pandemic or epidemic 

18 products (as defined in section 319F–3), that are 

19 applicable to the public health emergency or po20 tential public health emergency under paragraph 

21 (1); 

22 ‘‘(D) strengthen biosurveillance capabilities 

23 and laboratory capacity to identify, collect, and 

24 analyze information regarding such public 

25 health emergency or potential public health 


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1 emergency, including the systems under section 

2 319D; 

3 ‘‘(E) support initial emergency operations 

4 and assets related to preparation and deploy5 ment of intermittent disaster response personnel 

6 expenses under section 2812, and the Medical Re7 serve Corps under section 2813; and 

8 ‘‘(F) other activities, as the Secretary deter9 mines applicable and appropriate.’’; and 

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

11 redesignated, the following: 

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

13 date of enactment of the Pandemic and All-Hazards 

14 Preparedness and Advancing Innovation Act of 2018, 

15 the Secretary, in coordination with the Assistant Sec16 retary for Preparedness and Response, shall conduct 

17 a review of the Fund under this section, and provide 

18 recommendations to the Committee on Health, Edu19 cation, Labor, and Pensions and the Committee on 

20 Appropriations of the Senate and the Committee on 

21 Energy and Commerce and the Committee on Appro22 priations of the House of Representatives on policies 

23 to improve such Fund for the uses described in para24 graph (2). 


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

2 the date of enactment of the Pandemic and All-Haz3 ards Preparedness and Advancing Innovation Act of 

4 2018, the Comptroller General of the United States 

5 shall conduct a review of the Fund under this section, 

6 including the uses and the resources available in the 

7 Fund.’’; and 

8 (2) in subsection (c)— 

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

10 health emergencies or potential public health 

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

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

13 ‘‘Act or funds otherwise provided for emergency 

14 response.’’. 

15 SEC. 207. IMPROVING PREPAREDNESS FOR AND RESPONSE 

16 TO ALL-HAZARDS BY PUBLIC HEALTH EMER17 GENCY VOLUNTEERS. 

18 Section 319I (42 U.S.C. 247d–7b) is amended: 

19 (1) in subsection (a), by adding at the end the 

20 following: ‘‘Such health care professionals may in21 clude members of the National Disaster Medical Sys22 tem, members of the Medical Reserve Corps, and indi23 vidual health care professionals.’’; 

24 (2) in subsection (i) by adding at the end ‘‘In 

25 order to inform the development of such mechanisms 


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1 by States, the Secretary shall make available informa2 tion and material provided by States that have devel3 oped mechanisms to waive the application of licens4 ing requirements to applicable health professionals 

5 seeking to provide medical services during a public 

6 health emergency. Such information shall be made 

7 publicly available in a manner that does not com8 promise national security.’’; and 

9 (3) in subsection (k) by striking ‘‘2014 through 

10 2018’’ and inserting ‘‘2019 through 2023’’. 

11 SEC. 208. CLARIFYING STATE LIABILITY LAW FOR VOLUN12 TEER HEALTH CARE PROFESSIONALS. 

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

14 et seq.) is amended by inserting after section 319I the fol15 lowing: 

16 ‘‘SEC. 319I–1. HEALTH CARE PROFESSIONALS ASSISTING 

17 DURING A PUBLIC HEALTH EMERGENCY. 

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

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

20 is a member of the Medical Reserve Corps under section 

21 2813 or who is included in the verification network under 

22 section 319I and who— 

23 ‘‘(1) is responding to a public health emergency 

24 declared under section 319(a) during the initial 90- 

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1 tion (excluding any period covered by a renewal of 

2 such determination); 

3 ‘‘(2) is alleged to be liable for an act or omis4 sion— 

5 ‘‘(A) during the 90-day period of the public 

6 health emergency described in paragraph (1) and 

7 related to the treatment of individuals in need of 

8 health care services due to such public health 

9 emergency; 

10 ‘‘(B) in the State or States in which the 

11 public health emergency is declared; 

12 ‘‘(C) in the health care professional’s capac13 ity as a member of the Medical Reserve Corps or 

14 a professional included in the verification net15 work under section 319I; and 

16 ‘‘(D) in the course of providing services that 

17 are within the scope of the license, registration, 

18 or certification of the professional, as defined by 

19 the State of licensure, registration, or certifi20 cation; and 

21 ‘‘(3) prior to the rendering of such act or omis22 sion, was authorized by the State’s authorization of a 

23 deploying State’s Emergency System for Advance 

24 Registration of Volunteer Health Professionals de25 scribed in section 319I or the Medical Reserve Corps 


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1 established under section 2813, to provide health care 

2 services, 

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

4 in which such act or omission occurred, in the same manner 

5 and to the same extent as a similar health care professional 

6 who is a resident of such State would be subject to such 

7 State laws, except with respect to the licensure, registration, 

8 and certification of such individual. 

9 ‘‘(b) VOLUNTEER PROTECTION ACT.—Nothing in this 

10 section shall be construed to affect an individual’s right to 

11 protections under the Volunteer Protection Act of 1997. 

12 ‘‘(c) PREEMPTION.—This section shall supercede the 

13 laws of any State that would subject a health care profes14 sional described in subsection (a) to the liability laws of 

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

16 individual is subject pursuant to such subsection. 

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

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

19 an individual licensed, registered, or certified under 

20 Federal or State laws or regulations to provide health 

21 care services. 

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

23 services provided by a health care professional, or by 

24 any individual working under the supervision of a 

25 health care professional, that relate to— 


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1 ‘‘(A) the diagnosis, prevention, or treatment 

2 of any human disease or impairment; or 

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

4 human beings.’’. 

5 (b) EFFECTIVE DATE.— 

6 (1) IN GENERAL.—Section 319I–1 of the Public 

7 Health Service Act, as added by subsection (a), shall 

8 take effect 90 days after the date of the enactment of 

9 this Act. 

10 (2) APPLICATION.—Section 319I–1 of the Public 

11 Health Service Act, as added by subsection (a), ap12 plies to a claim for harm only if the act or omission 

13 that caused such harm occurred on or after the effec14 tive date described in paragraph (1). 

15 (c) GAO STUDY.—Not later than one year after the 

16 date of enactment of this Act, the Comptroller General of 

17 the United States shall conduct a review of— 

18 (1) the number of health care providers who reg19 ister under the verification network pursuant to sec20 tion 319I of the Public Health Service Act (42 U.S.C. 

21 247d–7b) in advance to provide services during a 

22 public health emergency; 

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

24 credentialed to provide services during the period of 

25 a public health emergency declaration, including 


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1 those who are credentialed though programs estab2 lished in the verification network pursuant to such 

3 section 319I and those credentialed by authorities 

4 within the State in which the emergency occurred; 

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

6 a health care provider during the period of a public 

7 health emergency declaration, including the average 

8 time pursuant to the verification network under such 

9 section 319I and for an individual’s credentials to be 

10 verified by an authority within the State; and 

11 (4) the States’ Emergency System for Advance 

12 Registration of Volunteer Health Professionals volun13 teer program, including whether physician or medical 

14 groups, associations, or other relevant provider orga15 nizations utilize such program for purposes of volun16 teering during public health emergencies. 

17 TITLE III—REACHING ALL 

18 COMMUNITIES 

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

21 (a) NATIONAL DISASTER MEDICAL SYSTEM.—Clause 

22 (ii) of section 2812(a)(3)(A) (42 U.S.C. 300hh–11(a)(3)(A)) 

23 is amended to read as follows: 

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

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1 retary on the basis that the Secretary has 

2 determined that a location is at risk of a 

3 public health emergency during the time 

4 specified, or there is a significant potential 

5 for a public health emergency.’’. 

6 (b) VOLUNTEER MEDICAL RESERVE CORPS.—Section 

7 2813(a) (42 U.S.C. 42 U.S.C. 300hh–15(a)) is amended by 

8 striking the second sentence and inserting ‘‘The Secretary 

9 may appoint a Director to head the Corps and oversee the 

10 activities of the Corps chapters that exist at the State, local, 

11 tribal, and territorial levels.’’ 

12 (c) REVIEW OF THE NATIONAL DISASTER MEDICAL

13 SYSTEM.—Section 2812(b)(2) (42 U.S.C. 300hh–11(b)(2)) 

14 is amended to read as follows: 

15 ‘‘(2) JOINT REVIEW AND MEDICAL SURGE CAPAC16 ITY STRATEGIC PLAN.— 

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

18 after the date of enactment of the Pandemic and 

19 All-Hazards Preparedness and Advancing Inno20 vation Act of 2018, the Secretary, in coordina21 tion with the Secretary of Homeland Security, 

22 the Secretary of Defense, and the Secretary of 

23 Veterans Affairs, shall conduct a joint review of 

24 the National Disaster Medical System. Such re25 view shall include— 


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1 ‘‘(i) an evaluation of medical surge ca2 pacity, as described in section 2803(a); 

3 ‘‘(ii) an assessment of the available 

4 workforce of the intermittent disaster re5 sponse personnel described in subsection (c); 

6 ‘‘(iii) the capacity of the workforce de7 scribed in clause (ii) to respond to all haz8 ards, including capacity to simultaneously 

9 respond to multiple public health emer10 gencies and the capacity to respond to a na11 tionwide public health emergency; 

12 ‘‘(iv) the effectiveness of efforts to re13 cruit, retain, and train such workforce; and 

14 ‘‘(v) gaps that may exist in such work15 force and recommendations for addressing 

16 such gaps. 

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

18 Health Security Strategy under section 2802, the 

19 Secretary shall update the findings from the re20 view under subparagraph (A) and provide rec21 ommendations to modify the policies of the Na22 tional Disaster Medical System as necessary.’’. 

23 (d) NOTIFICATION OF NDMS SHORTAGE.—Section 

24 2812(c) (42 U.S.C. 300hh–11(c)) is amended by adding at 

25 the end the following: 


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1 ‘‘(3) SERVICE BENEFIT.—Individuals appointed 

2 to serve under this subsection shall be considered pub3 lic safety officers under part L of title I of the Omni4 bus Crime Control and Safe Streets Act of 1968. The 

5 Secretary shall provide notification to eligible indi6 viduals of any effect such designation may have on 

7 other benefits for which such individuals are eligible, 

8 including benefits from private entities. 

9 ‘‘(4) NOTIFICATION.—Not later than 30 days 

10 after the date on which the Secretary determines the 

11 number of intermittent disaster response personnel of 

12 such System is insufficient to address a public health 

13 emergency or potential public health emergency, the 

14 Secretary shall submit to the congressional committees 

15 of jurisdiction a notification detailing the impact 

16 such shortage could have on meeting public health 

17 needs and emergency medical personnel needs during 

18 a public health emergency, and any identified meas19 ures to address such shortage. 

20 ‘‘(5) CERTAIN APPOINTMENTS.— 

21 ‘‘(A) IN GENERAL.—If the Secretary deter22 mines that the number of intermittent disaster 

23 response personnel within the National Disaster 

24 Medical System under this section is insufficient 

25 to address a public health emergency or potential 


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1 public health emergency, the Secretary may ap2 point candidates directly to personnel positions 

3 for intermittent disaster response within such 

4 system. The Secretary shall provide updates on 

5 the number of vacant or unfilled positions within 

6 such system to the congressional committees of 

7 jurisdiction each quarter for which this author8 ity is in effect. 

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

10 paragraph shall expire on September 30, 2021.’’. 

11 (e) PUBLIC SAFETY OFFICER BENEFITS.—Section 

12 1204(9) of title I of the Omnibus Crime Control and Safe 

13 Streets Act of 1968 (34 U.S.C. 10284(9)) is amended— 

14 (1) in subparagraph (C)(ii), by striking ‘‘or’’ at 

15 the end; 

16 (2) in subparagraph (D), by striking the period 

17 and inserting ‘‘; or’’; and 

18 (3) by inserting after subparagraph (D) the fol19 lowing: 

20 ‘‘(E) an individual appointed to the Na21 tional Disaster Medical System under section 

22 2812 of the Public Health Service Act (42 U.S.C. 

23 300hh–11) who is performing official duties of 

24 the Department of Health and Human Services, 

25 if those official duties are related to responding 


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1 to a public health emergency or potential public 

2 health emergency, or other activities for which 

3 the Secretary of Health and Human Services has 

4 activated such National Disaster Medical Sys5 tem.’’. 

6 (f) NATIONAL DISASTER MEDICAL SYSTEM AUTHOR7 IZATION OF APPROPRIATIONS.—Section 2812(g) (42 U.S.C. 

8 300hh–11(g)) is amended by striking ‘‘$52,700,000 for each 

9 of fiscal years 2014 through 2018’’ and inserting 

10 ‘‘$57,400,000 for each of fiscal years 2019 through 2023’’. 

11 (g) MEDICAL RESERVE CORPS. AUTHORIZATION OF

12 APPROPRIATIONS.—Section 2813(i) (42 U.S.C. 300hh– 

13 15(i)) is amended by striking ‘‘2014 through 2018’’ and in14 serting ‘‘2019 through 2023’’. 

15 SEC. 302. HEALTH SYSTEM INFRASTRUCTURE TO IMPROVE 

16 PREPAREDNESS AND RESPONSE. 

17 (a) COORDINATION OF PREPAREDNESS.—Section 

18 2811(b)(5) (42 U.S.C. 300hh–10(b)(5)) is amended by add19 ing at the end the following: ‘‘Such logistical support shall 

20 include working with other relevant Federal, State, local, 

21 tribal, and territorial public health officials and private 

22 sector entities to identify the critical infrastructure assets, 

23 systems, and networks needed for the proper functioning of 

24 the health care and public health sectors that need to be 

25 maintained through any emergency or disaster, including 


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1 entities capable of assisting with, responding to, and miti2 gating the effect of a public health emergency, including an 

3 emergency under section 319, an emergency or major dis4 aster under the Robert T. Stafford Disaster Relief and 

5 Emergency Assistance Act, or the National Emergencies 

6 Act, including by establishing methods to exchange critical 

7 information and deliver products consumed or used to pre8 serve, protect, or sustain life, health, or safety, and sharing 

9 of specialized expertise.’’. 

10 (b) MANUFACTURING CAPACITY.—Section 

11 2811(d)(2)(C) (42 U.S.C. 300hh–10(d)(2)(C)) is amended 

12 by inserting ‘‘, and ancillary medical supplies to assist with 

13 the utilization of such products,’’ after ‘‘products’’. 

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

15 (a) AT-RISK INDIVIDUALS IN THE NATIONAL HEALTH

16 SECURITY STRATEGY.—Section 2802(b)(4)(B) (42 U.S.C. 

17 300hh–1(b)(4)(B)) is amended— 

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

19 1, 319F, and 319L,’’ and inserting ‘‘this Act’’; and 

20 (2) by striking ‘‘special’’ and inserting ‘‘access or 

21 functional’’. 

22 (b) COUNTERMEASURE CONSIDERATIONS.—Section 

23 319L(c)(6) (42 U.S.C. 247d–7e(c)(6)) is amended— 

24 (1) by striking ‘‘elderly’’ and inserting ‘‘senior 

25 citizens’’; and 


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1 (2) by inserting ‘‘with relevant characteristics 

2 that warrant consideration during the process of re3 searching and developing such countermeasures and 

4 products’’ before the period. 

5 SEC. 304. IMPROVING EMERGENCY PREPAREDNESS AND RE6 SPONSE CONSIDERATIONS FOR CHILDREN. 

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

8 by inserting after section 319D the following: 

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

10 ‘‘(a) ENHANCING EMERGENCY PREPAREDNESS FOR

11 CHILDREN.—The Secretary, acting through the Director of 

12 the Centers for Disease Control and Prevention (referred to 

13 in this subsection as the ‘Director’), shall maintain an in14 ternal team of experts, to be known as the Children’s Pre15 paredness Unit (referred to in this subsection as the ‘Unit’), 

16 to work collaboratively to provide guidance on the consider17 ations for, and the specific needs of, children before, during, 

18 and after public health emergencies. The Unit shall inform 

19 the Director regarding emergency preparedness and re20 sponse efforts pertaining to children at the Centers for Dis21 ease Control and Prevention. 

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

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

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1 gists, biostatisticians, health communications staff, and in2 dividuals with other areas of expertise, as the Secretary de3 termines appropriate. 

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

5 may— 

6 ‘‘(1) assist State, local, tribal, and territorial 

7 emergency planning and response activities related to 

8 children, which may include developing, identifying, 

9 and sharing best practices; 

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

11 consultation to Federal, State, local, tribal, and terri12 torial public health officials to improve preparedness 

13 and response capabilities with respect to the needs of 

14 children, including providing such technical assist15 ance, training, and consultation to eligible entities in 

16 order to support the achievement of measurable evi17 dence-based benchmarks and objective standards ap18 plicable to sections 319C–1 and 319C–2 ; 

19 ‘‘(3) improve the utilization of methods to incor20 porate the needs of children in planning for and re21 sponding to a public health emergency, including 

22 public awareness of such methods; 

23 ‘‘(4) coordinate with, and improve, public-pri24 vate partnerships, such as health care coalitions pur25 suant to sections 319C–2 and 319C–3, to address gaps 


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1 and inefficiencies in emergency preparedness and re2 sponse efforts for children; 

3 ‘‘(5) provide expertise and input during the de4 velopment of guidance and clinical recommendations 

5 to address the needs of children when preparing for, 

6 and responding to, public health emergencies, includ7 ing pursuant to section 319C–3; and 

8 ‘‘(6) carry out other duties related to prepared9 ness and response activities for children, as the Sec10 retary determines appropriate.’’. 

11 SEC. 305. REAUTHORIZING THE NATIONAL ADVISORY COM12 MITTEE ON CHILDREN AND DISASTERS. 

13 Section 2811A (42 U.S.C. 300hh–10a) is amended— 

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

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

16 (2) in subsection (d)— 

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

18 inserting ‘‘25’’; and 

19 (B) by striking paragraph (2) and inserting 

20 the following: 

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

22 Secretary, in consultation with such other heads of 

23 Federal agencies as may be appropriate, shall ap24 point to the Advisory Committee under paragraph (1) 


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1 at least 13 individuals to perform the duties described 

2 in subsections (b) and (c), including— 

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

4 with expertise in pediatric medical disaster 

5 planning, preparedness, response, or recovery; 

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

7 local, tribal, or territorial agencies with expertise 

8 in pediatric disaster planning, preparedness, re9 sponse, or recovery; 

10 ‘‘(C) at least 4 members representing health 

11 care professionals, which may include members 

12 with expertise in pediatric emergency medicine; 

13 pediatric trauma, critical care, or surgery; the 

14 treatment of pediatric patients affected by chem15 ical, biological, radiological, or nuclear agents 

16 and emerging infectious diseases; pediatric men17 tal or behavioral health related to children af18 fected by a public health emergency; or pediatric 

19 primary care; and 

20 ‘‘(D) other members as the Secretary deter21 mines appropriate, of whom— 

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

23 represent a children’s hospital; 


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1 ‘‘(ii) at least one such member shall be 

2 an individual with expertise in schools or 

3 child care settings; 

4 ‘‘(iii) at least one such member shall be 

5 an individual with expertise in children 

6 and youth with special health care needs; 

7 and 

8 ‘‘(iv) at least one such member shall be 

9 an individual with expertise in the needs of 

10 parents or family caregivers, including the 

11 parents or caregivers of children with dis12 abilities.’’. 

13 ‘‘(3) FEDERAL MEMBERS.—The Advisory Com14 mittee under paragraph (1) shall include the fol15 lowing Federal members or their designees: 

16 ‘‘(A) The Assistant Secretary for Prepared17 ness and Response. 

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

20 ‘‘(C) The Director of the Centers for Disease 

21 Control and Prevention. 

22 ‘‘(D) The Commissioner of Food and Drugs. 

23 ‘‘(E) The Director of the National Institutes 

24 of Health. 


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1 ‘‘(F) The Assistant Secretary of the Admin2 istration for Children and Families. 

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

5 ‘‘(H) The Administrator of the Federal 

6 Emergency Management Agency. 

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

9 ‘‘(J) The Secretary of Education. 

10 ‘‘(K) Representatives from such Federal 

11 agencies (such as the Substance Abuse and Men12 tal Health Services Administration and the De13 partment of Homeland Security) as the Sec14 retary determines appropriate to fulfill the du15 ties of the Advisory Committee under subsections 

16 (b) and (c).’’. 

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

18 the Advisory Committee appointed under paragraph 

19 (2) shall serve for a term of 3 years, except that the 

20 Secretary may adjust the terms of the Advisory Com21 mittee appointees serving on the date of enactment of 

22 the Pandemic and All-Hazards Preparedness and Ad23 vancing Innovation Act of 2018, or appointees who 

24 are initially appointed after such date of enactment, 


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1 in order to provide for a staggered term of appoint2 ment for all members. 

3 ‘‘(5) CONSECUTIVE APPOINTMENTS; MAXIMUM

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

5 may serve not more than 3 terms on the Advisory 

6 Committee, and not more than 2 of which may be 

7 served consecutively.’’; 

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

9 least one meeting per year shall be an in-person meet10 ing.’’; 

11 (4) by redesignating subsection (f) as subsection 

12 (g); 

13 (5) by inserting after subsection (e) the following: 

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

15 activities authorized under this section and section 2811B, 

16 in accordance with section 2811B(d).’’; and 

17 (6) in subsection (g), as so redesignated, by strik18 ing ‘‘2018’’ and inserting ‘‘2023’’. 

19 SEC. 306. AUTHORIZING THE NATIONAL ADVISORY COM20 MITTEE ON SENIORS AND DISASTERS. 

21 Subtitle B of title XXVIII (42 U.S.C. 300hh et seq.) 

22 is amended by inserting after section 2811A the following: 


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1 ‘‘SEC. 2811B. NATIONAL ADVISORY COMMITTEE ON SENIORS 

2 AND DISASTERS. 

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

7 Seniors and Disasters (referred to in this section as the ‘Ad8 visory Committee’). 

9 ‘‘(b) DUTIES.— 

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

11 shall— 

12 ‘‘(A) provide advice and consultation with 

13 respect to the activities carried out pursuant to 

14 section 2814, as applicable and appropriate; 

15 ‘‘(B) evaluate and provide input with re16 spect to the medical and public health needs of 

17 seniors related to the preparation for, response 

18 to, and recovery from all-hazards emergencies; 

19 and 

20 ‘‘(C) provide advice and consultation with 

21 respect to State emergency preparedness and re22 sponse activities and seniors, including related 

23 drills and exercises pursuant to the preparedness 

24 goals under section 2802(b). 

25 ‘‘(2) ADDITIONAL DUTIES.—The Advisory Com26 mittee may provide advice and recommendations to 


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1 the Secretary with respect to seniors and the medical 

2 and public health grants and cooperative agreements 

3 as applicable to preparedness and response activities 

4 under this title and title III. 

5 ‘‘(3) MEMBERSHIP.— 

6 ‘‘(A) IN GENERAL.—The Secretary, in con7 sultation with such other heads of agencies as 

8 appropriate, shall appoint not more than 15 

9 members to the Advisory Committee. In appoint10 ing such members, the Secretary shall ensure 

11 that the total membership of the Advisory Com12 mittee is an odd number. 

13 ‘‘(B) REQUIRED MEMBERS.—The members 

14 appointed under paragraph (1) shall include— 

15 ‘‘(i) the Assistant Secretary for Pre16 paredness and Response; 

17 ‘‘(ii) the Director of the Biomedical 

18 Advanced Research and Development Au19 thority; 

20 ‘‘(iii) the Director of the Centers for 

21 Disease Control and Prevention; 

22 ‘‘(iv) the Commissioner of Food and 

23 Drugs; 

24 ‘‘(v) the Director of the National Insti25 tutes of Health; 


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1 ‘‘(vi) the Administrator of the Centers 

2 for Medicare & Medicaid Services; 

3 ‘‘(vii) the Administrator of the Admin4 istration for Community Living; 

5 ‘‘(viii) the Administrator of the Fed6 eral Emergency Management Agency; 

7 ‘‘(ix) the Under Secretary for Health of 

8 the Department of Veterans Affairs; 

9 ‘‘(x) at least 2 non-Federal health care 

10 professionals with expertise in medical dis11 aster planning, preparedness, response, or 

12 recovery; 

13 ‘‘(xi) at least 2 representatives of State, 

14 local, territorial, or tribal agencies with ex15 pertise in disaster planning, preparedness, 

16 response, or recovery; and 

17 ‘‘(xii) representatives of such other 

18 Federal agencies (such as the Department of 

19 Energy and the Department of Homeland 

20 Security) as the Secretary determines nec21 essary to fulfill the duties of the Advisory 

22 Committee. 

23 ‘‘(c) MEETINGS.—The Advisory Committee shall meet 

24 not less frequently than biannually. 

25 ‘‘(d) ADVISORY COMMITTEE COORDINATION.— 


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1 ‘‘(1) IN GENERAL.—The Secretary shall coordi2 nate activities authorized under this section and sec3 tion 2811A, and make efforts to reduce unnecessary or 

4 duplication of meetings, recommendations, and re5 porting under such sections. Members of the advisory 

6 committees under this section and section 2811A, or 

7 their designees, shall meet periodically, and not less 

8 than annually, to— 

9 ‘‘(A) review the recommendations developed 

10 by such committees to coordinate, as appro11 priate, the implementation of recommendations, 

12 in order to reduce gaps, overlap, and duplication 

13 of effort in Federal programs or by Federal 

14 grantees; and 

15 ‘‘(B) align preparedness and response pro16 grams or activities to address the dual or over17 lapping needs of children and seniors and any 

18 challenges in preparing for and responding to 

19 such needs. 

20 ‘‘(2) NOTIFICATION.—The Secretary shall notify 

21 the congressional committees of jurisdiction upon the 

22 convening of each meeting under paragraph (1), and 

23 provide minutes from such meeting not later than 90 

24 days after the meeting. 


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1 ‘‘(e) SUNSET.—The Advisory Committee shall termi2 nate on September 30, 2023.’’. 

3 SEC. 307. GUIDANCE FOR PARTICIPATION IN EXERCISES 

4 AND DRILLS. 

5 Not later than 2 years after the date of enactment of 

6 this Act, the Secretary of Health and Human Services shall 

7 issue final guidance regarding the participation of State, 

8 local, tribal, and territorial public health department or 

9 agency personnel funded in whole or in part through pro10 grams authorized under this Act in drills and operational 

11 exercises in order to identify, inform, and address the gaps 

12 in and policies related to all-hazards medical and public 

13 health preparedness and response, which may include drills 

14 and operational exercises that incorporate medical surge ca15 pacity planning, medical countermeasure distribution and 

16 administration, and preparing for and responding to iden17 tified threats for that region. The Secretary shall consult 

18 with the Department of Homeland Security, the Depart19 ment of Defense, the Department of Veterans Affairs, and 

20 other applicable Federal departments and agencies as nec21 essary and appropriate in the development of such guid22 ance. The Secretary shall make the guidance available on 

23 the internet website of the Department of Health and 

24 Human Services. 


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1 TITLE IV—PRIORITIZING A 

2 THREAT-BASED APPROACH 

3 SEC. 401. ASSISTANT SECRETARY FOR PREPAREDNESS AND 

4 RESPONSE. 

5 Section 2811(b) (42 U.S.C. 300hh–10(b)) is amend6 ed— 

7 (1) in the matter preceding paragraph (1) by in8 serting ‘‘utilize experience related to public health 

9 emergency preparedness and response, biodefense, 

10 medical countermeasures, and other relevant topics 

11 to’’ after ‘‘shall’’; and 

12 (2) in paragraph (4) by adding at the end the 

13 following: 

14 ‘‘(I) THREAT AWARENESS.—Coordinate 

15 with the Director of the Centers for Disease Con16 trol and Prevention, the Director of National In17 telligence, the Secretary of Homeland Security, 

18 the Assistant to the President for National Secu19 rity Affairs, the Secretary of Defense, and other 

20 relevant Federal officials, such as the Secretary 

21 of Agriculture, to maintain a current assessment 

22 of national security threats and inform pre23 paredness and response capabilities based on the 

24 range of the threats that have the potential to re25 sult in a public health emergency.’’. 


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1 SEC. 402. PUBLIC HEALTH EMERGENCY MEDICAL COUNTER2 MEASURES ENTERPRISE. 

3 (a) IN GENERAL.—Title XXVIII is amended by insert4 ing after section 2811 (42 U.S.C. 300hh–10) the following: 

5 ‘‘SEC. 2811–1. PUBLIC HEALTH EMERGENCY MEDICAL COUN6 TERMEASURES ENTERPRISE. 

7 ‘‘(a) IN GENERAL.—The Secretary shall establish the 

8 Public Health Emergency Medical Countermeasures Enter9 prise (referred to in this section as the ‘PHEMCE’). The 

10 Assistant Secretary for Preparedness and Response shall 

11 serve as chair of the PHEMCE. 

12 ‘‘(b) MEMBERS.—The PHEMCE shall include each of 

13 the following members, or the designee of such members: 

14 ‘‘(1) The Assistant Secretary for Preparedness 

15 and Response. 

16 ‘‘(2) The Director of the Centers for Disease Con17 trol and Prevention. 

18 ‘‘(3) The Director of the National Institutes of 

19 Health. 

20 ‘‘(4) The Commissioner of Food and Drugs. 

21 ‘‘(5) The Secretary of Defense. 

22 ‘‘(6) The Secretary of Homeland Security. 

23 ‘‘(7) The Secretary of Agriculture. 

24 ‘‘(8) The Secretary of Veterans Affairs. 

25 ‘‘(9) Representatives of any other Federal agen26 cy, which may include the Director of the Biomedical 


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1 Advanced Research and Development Authority, the 

2 Director of the Strategic National Stockpile, the Di3 rector of the National Institute of Allergy and Infec4 tious Diseases, and the Director of the Office of Public 

5 Health Preparedness and Response, as the Secretary 

6 determines appropriate. 

7 ‘‘(c) FUNCTIONS.— 

8 ‘‘(1) IN GENERAL.—The functions of the 

9 PHEMCE shall include the following: 

10 ‘‘(A) Establish a process pursuant to section 

11 2811(d)(2)(B) to make recommendations to the 

12 Secretary regarding the prioritization of re13 search, development, and procurement of counter14 measures, as defined in section 319F–2(c), based 

15 on the health security needs of the United States. 

16 Such recommendations shall be informed by the 

17 National Health Security Strategy pursuant to 

18 section 2802, the Strategic National Stockpile re19 view required under section 319F–2(a)(2), the 

20 countermeasures budget plan pursuant to section 

21 2811(b)(7), and an assessment of current na22 tional security threats, including chemical, bio23 logical, radiological and nuclear threats, includ24 ing emerging infectious diseases. In the event 

25 that members of the PHEMCE do not agree 


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1 upon a recommendation, the Secretary shall pro2 vide a determination regarding such rec3 ommendation. 

4 ‘‘(B) Identify national health security 

5 needs, including gaps in public health prepared6 ness and response related to countermeasures and 

7 challenges to addressing such needs (including 

8 any regulatory challenges), and provide for 

9 alignment of countermeasure procurement with 

10 recommendations under subparagraph (A). 

11 ‘‘(C) Develop strategies related to logistics, 

12 deployment, distribution, dispensing, and use of 

13 countermeasures that may be applicable to the 

14 activities of the strategic national stockpile 

15 under section 319F–2(a). 

16 ‘‘(D) Provide consultation for the develop17 ment of the strategy and implementation plan 

18 under section 2811(d). 

19 ‘‘(2) INPUT.—In carrying out subparagraphs (B) 

20 and (C) of paragraph (1), the PHEMCE shall solicit 

21 and consider input from State, local, tribal, and ter22 ritorial public health departments, as appropriate.’’. 

23 (b) PUBLIC HEALTH EMERGENCY MEDICAL COUNTER24 MEASURES ENTERPRISE STRATEGY AND IMPLEMENTATION


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1 PLAN.—Section 2811(d) (42 U.S.C. 300hh–10(d)) is 

2 amended— 

3 (1) in paragraph (1)— 

4 (A) by striking ‘‘Not later than 180 days 

5 after the date of enactment of this subsection, 

6 and every year thereafter’’ and inserting ‘‘Not 

7 later than March 15, 2020, and biennially there8 after’’; and 

9 (B) by striking ‘‘Director of Biomedical’’ 

10 and all that follows through ‘‘Food and Drugs’’ 

11 and inserting ‘‘Public Health Emergency Med12 ical Countermeasures Enterprise established 

13 under section 2811–1’’; and 

14 (2) in paragraph (2)(J)(v), by striking ‘‘one-year 

15 period’’ and inserting ‘‘2-year period’’. 

16 SEC. 403. STRATEGIC NATIONAL STOCKPILE. 

17 (a) Section 319F–2(a) (42 U.S.C. 247d–6b(a)) is 

18 amended— 

19 (1) by redesignating paragraphs (2) and (3) as 

20 paragraphs (3) and (4), respectively; and 

21 (2) in paragraph (1)— 

22 (A) by inserting ‘‘and optimize’’ after ‘‘pro23 vide for’’; 

24 (B) by inserting ‘‘and, as informed by exist25 ing recommendations of, or consultations with, 


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1 the Public Health Emergency Medical Counter2 measure Enterprise established under section 

3 2811–1, make necessary additions or modifica4 tions to the contents of such stockpile or stock5 piles based on the review conducted under para6 graph (2)’’ before the period of the first sentence; 

7 and 

8 (C) 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 stock20 pile and assess whether such contents are con21 sistent with the recommendations made pursuant 

22 to section 2811–1(c)(1)(A). Such review shall be 

23 submitted annually, beginning on March 15, 

24 2019, to the Committee on Health, Education, 

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1 propriations of the Senate and the Committee on 

2 Energy and Commerce and the Committee on 

3 Appropriations of the House of Representatives, 

4 in a manner that does not compromise national 

5 security. 

6 ‘‘(B) ADDITIONS, MODIFICATIONS, AND RE7 PLENISHMENTS.—Each annual threat-based re8 view under subparagraph (A) shall, for each new 

9 or modified countermeasure procurement or re10 plenishment, provide— 

11 ‘‘(i) information regarding— 

12 ‘‘(I) the quantities of the addi13 tional or modified countermeasure pro14 cured for, or contracted to be procured 

15 for, the stockpile; 

16 ‘‘(II) planning considerations for 

17 appropriate manufacturing capacity 

18 and capability to meet the goals of 

19 such additions or modifications (with20 out disclosing proprietary informa21 tion), including consideration of the ef22 fect such additions or modifications 

23 may have on the availability of such 

24 products and ancillary medical sup25 plies in the health care system; 


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1 ‘‘(III) the presence or lack of a 

2 commercial market for the counter3 measure at the time of procurement; 

4 ‘‘(IV) the emergency health secu5 rity threat or threats such counter6 measure procurement is intended to 

7 address, including whether such pro8 curement is consistent with meeting 

9 emergency health security needs associ10 ated with such threat or threats; 

11 ‘‘(V) an assessment of whether the 

12 emergency health security threat or 

13 threats described in subclause (IV) 

14 could be addressed in a manner that 

15 better utilizes the resources of the stock16 pile and permits the greatest possible 

17 increase in the level of emergency pre18 paredness to address such threats; 

19 ‘‘(VI) whether such counter20 measure is replenishing an expired 

21 countermeasure, is a different counter22 measure with the same indication that 

23 is replacing an expired counter24 measure, or is a new addition to the 

25 stockpile; 


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1 ‘‘(VII) a description of how such 

2 additions or modifications align with 

3 the countermeasures budget plan as re4 quired under section 2811(b)(7), in5 cluding expected life-cycle costs, ex6 penditures related to countermeasure 

7 procurement to address the threat or 

8 threats described in subclause (IV), re9 plenishment dates (including the abil10 ity to extend the maximum shelf life of 

11 a countermeasure), and the manufac12 turing capacity required to replenish 

13 such countermeasure; and 

14 ‘‘(VIII) appropriate protocols and 

15 processes for the deployment, distribu16 tion, or dispensing of the counter17 measure at the State and local level, 

18 including plans for relevant capabili19 ties of State and local entities to dis20 pense, distribute, and administer the 

21 countermeasure; and 

22 ‘‘(ii) an assurance that for each coun23 termeasure produced or replenished under 

24 this subsection, the Secretary completed a 

25 review addressing each item listed under 


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1 this subsection in advance of such procure2 ment or replenishment, which need not be 

3 provided in advance of procurement.’’; 

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

5 (A) in subparagraph (A), by inserting ‘‘and 

6 the Public Health Emergency Medical Counter7 measures Enterprise established under section 

8 2811–1’’ before the semicolon; 

9 (B) in subparagraph (C), by inserting ‘‘, 

10 and the availability, deployment, dispensing, 

11 and administration of countermeasures’’ before 

12 the semicolon; and 

13 (C) by amending subparagraph (E) to read 

14 as follows: 

15 ‘‘(E) devise plans for effective and timely 

16 supply-chain management of the stockpile, in 

17 consultation with the Director of the Centers for 

18 Disease Control and Prevention, the Assistant 

19 Secretary for Preparedness and Response, the 

20 Secretary of Transportation, the Secretary of 

21 Homeland Security, the Secretary of Veterans 

22 Affairs, and the heads of other appropriate Fed23 eral agencies, State, local, tribal, and territorial 

24 agencies, and the public and private health care 

25 infrastructure, as applicable, taking into account 


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1 the manufacturing capacity and other available 

2 sources of products and appropriate alternatives 

3 to supplies in the stockpile;’’ and 

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

5 ‘‘(5) GAO REPORT.— 

6 ‘‘(A) IN GENERAL.—Not later than 3 years 

7 after the date of enactment of the Pandemic and 

8 All-Hazards Preparedness and Advancing Inno9 vation Act of 2018, and every 5 years thereafter, 

10 the Comptroller General of the United States 

11 shall conduct a review of any changes to the con12 tents or management of the stockpile since Janu13 ary 1, 2015. Such review shall include— 

14 ‘‘(i) an assessment of the comprehen15 siveness and completeness of each annual 

16 threat-based review under paragraph (2), 

17 including whether all newly procured or re18 plenished countermeasures within the stock19 pile were described in each annual review, 

20 and whether, consistent with paragraph 

21 (2)(B), the Secretary conducted the nec22 essary internal review in advance of such 

23 procurement or replenishment; 

24 ‘‘(ii) an assessment of whether the Sec25 retary established health security and 


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1 science-based justifications, and a descrip2 tion of such justifications for procurement 

3 decisions related to health security needs 

4 with respect to the identified threat, for ad5 ditions or modifications to the stockpile 

6 based on the information provided in such 

7 reviews under paragraph (2)(B), including 

8 whether such review was conducted prior to 

9 procurement, modification, or replenish10 ment; 

11 ‘‘(iii) an assessment of the plans devel12 oped by the Secretary for the deployment, 

13 distribution, and dispensing of counter14 measures procured, modified, or replenished 

15 under paragraph (1), including whether 

16 such plans were developed prior to procure17 ment, modification, or replenishment; 

18 ‘‘(iv) an accounting of countermeasures 

19 procured, modified, or replenished under 

20 paragraph (1) that received advanced re21 search and development funding from the 

22 Biomedical Advanced Research and Devel23 opment Authority; 

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1 ing emergency health security needs related 

2 to the identified threats for countermeasures 

3 added, modified, or replenished under para4 graph (1); 

5 ‘‘(vi) a description of the resources ex6 pended related to the procurement of coun7 termeasures (including additions, modifica8 tions, and replenishments) in the stockpile, 

9 and how such expenditures relate to the 

10 emergency health security needs of the stock11 pile; 

12 ‘‘(vii) an assessment of the extent to 

13 which additions, modifications, and replen14 ishments reviewed under paragraph (2) 

15 align with previous relevant reports or re16 views by the Secretary or the Comptroller 

17 General; and 

18 ‘‘(viii) with respect to any change in 

19 the Federal organizational management of 

20 the stockpile, an assessment and comparison 

21 of the processes affected by such change, in22 cluding planning for potential counter23 measure deployment, distribution, or dis24 pensing capabilities and processes related to 

25 procurement decisions, use of stockpiled 


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1 countermeasures, and use of resources for 

2 such activities. 

3 ‘‘(B) SUBMISSION.—Not later than 6 

4 months after completing a classified version of 

5 the review under subparagraph (A), the Comp6 troller General shall submit an unclassified 

7 version of the review to the congressional com8 mittees of jurisdiction.’’. 

9 (b) AUTHORIZATION OF APPROPRIATIONS, STRATEGIC

10 NATIONAL STOCKPILE.—Section 319F–2(f)(1) (42 U.S.C. 

11 247d–6b(f)(1)) is amended by striking ‘‘$533,800,000 for 

12 each of fiscal years 2014 through 2018’’ and inserting 

13 ‘‘$610,000,000 for each of fiscal years 2019 through 2023’’. 

14 SEC. 404. PREPARING FOR PANDEMIC INFLUENZA, ANTI15 MICROBIAL RESISTANCE, AND OTHER SIG16 NIFICANT THREATS. 

17 Section 319L(c)(4) (247d–7e(c)(4)) is amended by 

18 adding at the end the following: 

19 ‘‘(F) STRATEGIC INITIATIVES.—The Sec20 retary, acting through the Director of BARDA, 

21 may implement strategic initiatives, including 

22 by building on existing programs and by award23 ing grants supporting innovative candidate 

24 products in preclinical and clinical development, 

25 to address priority, naturally occurring and 


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1 man-made threats that, as determined by the 

2 Secretary, pose a significant level of risk to na3 tional security based on the characteristics of a 

4 chemical, biological, radiological or nuclear 

5 threat, or existing capabilities to respond to such 

6 a threat (including medical response and treat7 ment capabilities and manufacturing infrastruc8 ture). Such initiatives shall accelerate and sup9 port the advanced research, development, and 

10 procurement of, countermeasures and products, 

11 as applicable, to address areas including— 

12 ‘‘(i) chemical, biological, radiological, 

13 or nuclear threats, including emerging in14 fectious diseases, for which insufficient ap15 proved, licensed, or authorized counter16 measures exist, or for which such threat, or 

17 the result of an exposure to such threat, 

18 may become resistant to countermeasures or 

19 existing countermeasures may be rendered 

20 ineffective; 

21 ‘‘(ii) threats that consistently exist or 

22 continually circulate and have significant 

23 potential to become a pandemic, such as 

24 pandemic influenza, which may include the 

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1 facturing, and appropriate stockpiling of 

2 qualified pandemic or epidemic products, 

3 and products, technologies, or processes to 

4 support the advanced research and develop5 ment of such countermeasures (including 

6 multiuse platform technologies for 

7 diagnostics, vaccines, and therapeutics; 

8 virus seeds; clinical trial lots; novel virus 

9 strains; and antigen and adjuvant mate10 rial); and 

11 ‘‘(iii) threats that may result pri12 marily or secondarily from a chemical, bio13 logical, radiological, or nuclear agent, or 

14 emerging infectious disease, and which may 

15 present increased treatment complications 

16 such as the occurrence of resistance to avail17 able countermeasures or potential counter18 measures, including antimicrobial resistant 

19 pathogens.’’. 

20 SEC. 405. REPORTING ON THE FEDERAL SELECT AGENT 

21 PROGRAM. 

22 Section 351A(k) (42 U.S.C. 262a) is amended— 

23 (1) by striking ‘‘The Secretary’’ and inserting 

24 the following: 

25 ‘‘(1) IN GENERAL.—The Secretary’’; and 


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

2 ‘‘(2) IMPLEMENTATION OF RECOMMENDATIONS

3 OF THE FEDERAL EXPERTS SECURITY ADVISORY

4 PANEL AND THE FAST TRACK ACTION COMMITTEE ON

5 SELECT AGENT REGULATIONS.— 

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

7 after the date of the enactment of the Pandemic 

8 and All-Hazards Preparedness and Advancing 

9 Innovation Act of 2018, the Secretary shall re10 port to the congressional committees of jurisdic11 tion on the implementation of recommendations 

12 of the Federal Experts Security Advisory Panel 

13 concerning the select agent program. 

14 ‘‘(B) CONTINUED UPDATES.—The Secretary 

15 shall report to the congressional committees of 

16 jurisdiction annually following the submission of 

17 the report under subparagraph (A) until the rec18 ommendations described in such subparagraph 

19 are fully implemented, or a justification is pro20 vided for the delay in, or lack of, implementa21 tion.’’. 


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1 TITLE V—INCREASING COMMU2 NICATION IN MEDICAL COUN3 TERMEASURE ADVANCED RE4 SEARCH AND DEVELOPMENT 

5 SEC. 501. MEDICAL COUNTERMEASURE BUDGET PLAN. 

6 Section 2811(b)(7) (42 U.S.C. 300hh–10(b)(7)) is 

7 amended— 

8 (1) in the matter preceding subparagraph (A), 

9 by striking ‘‘March 1’’ and inserting ‘‘March 15’’; 

10 (2) by striking subparagraph (A) and inserting 

11 the following: 

12 ‘‘(A) include consideration of the entire 

13 medical countermeasures enterprise, including— 

14 ‘‘(i) basic research and advanced re15 search and development; 

16 ‘‘(ii) approval, clearance, licensure, 

17 and authorized uses of products; 

18 ‘‘(iii) procurement, stockpiling, main19 tenance, and potential replenishment (in20 cluding manufacturing capabilities) of all 

21 products in the Strategic National Stock22 pile; and 

23 ‘‘(iv) the availability of technologies 

24 that may assist in the advanced research 

25 and development of countermeasures and 


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1 opportunities to use such technologies to ac2 celerate and navigate challenges unique to 

3 countermeasure research and development;’’. 

4 (3) by redesignating subparagraphs (D) and (E) 

5 as subparagraphs (E) and (F), respectively; and 

6 (4) by inserting after subparagraph (C), the fol7 lowing: 

8 ‘‘(D) identify the full range of anticipated 

9 medical countermeasure needs related to research 

10 and development, procurement, and stockpiling, 

11 including the potential need for indications, dos12 ing, and administration technologies, and other 

13 countermeasure needs as applicable and appro14 priate;’’. 

15 SEC. 502. MATERIAL THREAT AND MEDICAL COUNTER16 MEASURE NOTIFICATIONS. 

17 (a) CONGRESSIONAL NOTIFICATION OF MATERIAL

18 THREAT DETERMINATION.—Section 319F–2(c)(2)(C) (42 

19 U.S.C. 247d-6b(c)(2)(C)) is amended by striking ‘‘The Sec20 retary and the Homeland Security Secretary shall prompt21 ly notify the appropriate committees of Congress’’ and in22 serting ‘‘The Secretary and the Secretary of Homeland Se23 curity shall send to Congress, on an annual basis, all cur24 rent material threat determinations and shall promptly no25 tify the Committee on Health, Education, Labor, and PenVerDate Sep 11 2014 00:21 Jun 19, 2018 Jkt 079200 PO 00000 Frm 00187 Fmt 6652 Sfmt 6203 E:\BILLS\S2852.RS S2852

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1 sions and the Committee on Homeland Security and Gov2 ernment Affairs of the Senate and the Committee on Energy 

3 and Commerce and the Committee on Homeland Security 

4 of the House of Representatives’’. 

5 (b) CONTRACTING COMMUNICATIONS.— 

6 (1) CONTRACT DURATION.—Section 319F– 

7 2(c)(7)(B)(ii)(III) (42 U.S.C. 247d– 

8 6b(c)(7)(B)(ii)(III)) is amended by adding at the end 

9 the following: ‘‘The Secretary shall notify the vendor 

10 within 90 days of a determination by the Secretary 

11 to renew such contract.’’. 

12 (2) EXPEDITED AUTHORITIES.—Section 

13 319L(c)(5)(B)(i) (42 U.S.C. 247d–7e(c)(5)(B)(i)) is 

14 amended by adding at the end the following: ‘‘Upon 

15 award, extension, or termination of any such con16 tract, grant, cooperative agreement, and other trans17 action, the Secretary shall provide a written notifica18 tion to the receiving entity that includes a justifica19 tion for such award, extension, or termination.’’. 

20 SEC. 503. AVAILABILITY OF REGULATORY MANAGEMENT 

21 PLANS. 

22 Section 565(f) of the Federal Food, Drug and Cosmetic 

23 Act (21 U.S.C. 360bbb–4(f)) is amended— 

24 (1) by redesignating paragraphs (3) through (6) 

25 as paragraphs (4) through (7), respectively; 


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1 (2) by inserting after paragraph (2) the fol2 lowing: 

3 ‘‘(3) PUBLICATION.—The Secretary shall make 

4 available on the internet website of the Food and 

5 Drug Administration information regarding regu6 latory management plans, including— 

7 ‘‘(A) the process by which an applicant 

8 may submit a request for a regulatory manage9 ment plan; 

10 ‘‘(B) the timeframe by which the Secretary 

11 is required to respond to such request; 

12 ‘‘(C) the information required for the sub13 mission of such request; 

14 ‘‘(D) a description of the types of develop15 ment milestones and performance targets that 

16 could be discussed and included in such plans; 

17 and 

18 ‘‘(E) contact information for beginning the 

19 regulatory management plan process.’’; 

20 (3) in paragraph (6), as so redesignated, in the 

21 matter preceding subparagraph (A)— 

22 (A) by striking ‘‘paragraph (4)(A)’’ and in23 serting ‘‘paragraph (5)(A)’’; and 

24 (B) by striking ‘‘paragraph (4)(B)’’ and in25 serting ‘‘paragraph (5)(B)’’; and 


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1 (4) in paragraph (7)(A), as so redesignated, by 

2 striking ‘‘paragraph (3)(A)’’ and inserting ‘‘para3 graph (4)(A)’’. 

4 SEC. 504. THE BIOMEDICAL ADVANCED RESEARCH AND DE5 VELOPMENT AUTHORITY AND THE BIO6 SHIELD SPECIAL RESERVE FUND. 

7 (a) BIOSHIELD SPECIAL RESERVE FUND.—Section 

8 319F–2(g)(1) (42 U.S.C. 247d–6b(g)(1)) is amended— 

9 (1) by striking ‘‘$2,800,000,000 for the period of 

10 fiscal years 2014 through 2018’’ and inserting 

11 ‘‘$3,500,000,000 for the period of fiscal years 2019 

12 through 2023, to remain available until expended’’; 

13 and 

14 (2) by striking the second sentence. 

15 (b) THE BIOMEDICAL ADVANCED RESEARCH AND DE16 VELOPMENT AUTHORITY.—Section 319L(d)(2) (42 U.S.C. 

17 247d–7e(d)(2)) is amended by striking ‘‘$415,000,000 for 

18 each of fiscal years 2014 through 2018’’ and inserting 

19 ‘‘$611,700,000 for each of fiscal years 2019 through 2023’’. 

20 TITLE VI—ADVANCING TECH21 NOLOGIES FOR MEDICAL 

22 COUNTERMEASURES 

23 SEC. 601. ADMINISTRATION OF COUNTERMEASURES. 

24 Section 319L(c)(4)(D)(iii) (42 U.S.C. 247d– 

25 7e(c)(4)(D)(iii)) is amended by striking ‘‘and platform 


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1 technologies’’ inserting ‘‘platform technologies, technologies 

2 to administer countermeasures, and technologies to improve 

3 storage and transportation of countermeasures’’. 

4 SEC. 602. MEDICAL COUNTERMEASURE MASTER FILES. 

5 (a) IN GENERAL.—Chapter V of the Federal Food, 

6 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended 

7 by inserting after section 565A the following: 

8 ‘‘SEC. 565B. MEDICAL COUNTERMEASURE MASTER FILES. 

9 ‘‘(a) PURPOSE.—The purpose of this section is to sup10 port and accelerate the development or manufacture of secu11 rity countermeasures, qualified countermeasures, and quali12 fied pandemic or epidemic products by facilitating and en13 couraging submission of data and information to support 

14 such products to master files, and through clarifying the 

15 authority to cross-reference to data and information pre16 viously submitted to the Secretary. 

17 ‘‘(b) APPLICABILITY OF REFERENCE.— 

18 ‘‘(1) IN GENERAL.—A person may submit data 

19 and information to the Secretary with the intent to 

20 reference, or to authorize, in writing, another person 

21 to reference, such data or information to support a 

22 medical countermeasure submission (including a sup23 plement or amendment to any such submission), 

24 without requiring the master file holder to disclose the 

25 data and information to any such persons authorized 


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1 to reference the master file. Such data and informa2 tion shall be available for reference by the master file 

3 holder or a person authorized by the master file hold4 er only in accordance with applicable privacy and 

5 confidentiality protocols and regulations. 

6 ‘‘(2) MASTER FILE HOLDER.—In this section, the 

7 term ‘master file holder’ means a person who submits 

8 data and information to the Secretary with the intent 

9 to reference or authorize to reference such data or in10 formation to support a medical countermeasure sub11 mission, as described in paragraph (1). 

12 ‘‘(c) MEDICAL COUNTERMEASURE MASTER FILE CON13 TENT.— 

14 ‘‘(1) IN GENERAL.—A master file under this sec15 tion may include information to support and accel16 erate— 

17 ‘‘(A) the development of medical counter18 measure submissions to support the approval, li19 censure, classification, clearance, conditional ap20 proval, or authorization of one or more security 

21 countermeasures, qualified countermeasures, or 

22 qualified pandemic or epidemic products; and 

23 ‘‘(B) the manufacture of security counter24 measures, qualified countermeasures, or qualified 

25 pandemic or epidemic products. 


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1 ‘‘(2) REQUIRED UPDATES.—The Secretary may 

2 require, as appropriate, that the master file holder en3 sure that the contents of such master file are updated 

4 during the time such master file is referenced for a 

5 medical countermeasure submission. 

6 ‘‘(d) SPONSOR REFERENCE.— 

7 ‘‘(1) IN GENERAL.—Each incorporation of infor8 mation or data contained in a master file by ref9 erence shall describe the incorporated material in a 

10 manner in which the Secretary determines appro11 priate and that permits the review of such informa12 tion without necessitating resubmission of such infor13 mation or data. Master files shall be submitted in an 

14 electronic format in accordance with section 745A 

15 and as specified in applicable guidance. 

16 ‘‘(2) REFERENCE BY A MASTER FILE HOLDER.— 

17 A master file holder that is the sponsor of a medical 

18 countermeasure submission shall notify the Secretary 

19 in writing of the intent to reference the medical coun20 termeasure master file as a part of the submission. 

21 ‘‘(3) REFERENCE BY AN AUTHORIZED PERSON.— 

22 A sponsor of a medical countermeasure submission 

23 may, where the Secretary determines appropriate, in24 corporate by reference all or part of the contents of a 


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1 medical countermeasure master file, if the master file 

2 holder authorizes the incorporation in writing. 

3 ‘‘(e) ACKNOWLEDGEMENT OF MASTER FILE BY THE

4 SECRETARY.—The Secretary shall provide the master file 

5 holder with a written notification indicating that the Sec6 retary has reviewed and relied upon specified information 

7 or data within a master file and the purposes for which 

8 such information or data was incorporated by reference if 

9 the Secretary has reviewed and relied upon such specified 

10 information or data to support the approval, classification, 

11 conditional approval, clearance, licensure, or authorization 

12 of a security countermeasure, qualified countermeasure, or 

13 qualified pandemic or epidemic product. The Secretary 

14 may rely upon the data and information within the med15 ical countermeasure master file for which such written noti16 fication was provided in additional applications, as appli17 cable and appropriate and upon the request of the master 

18 file holder so notified in writing or by an authorized person 

19 of such holder. 

20 ‘‘(f) RULES OF CONSTRUCTION.—Nothing in this sec21 tion shall be construed to— 

22 ‘‘(1) alter the authority of the Secretary to ap23 prove, license, classify, clear, conditionally approve, 

24 or authorize drugs, biological products, or devices 

25 pursuant to this Act or section 351 of the Public 


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1 Health Service Act (as authorized prior to the date of 

2 enactment of the Pandemic and All-Hazards Pre3 paredness and Advancing Innovation Act of 2018), 

4 including the standards of evidence, and applicable 

5 conditions, for approval under the applicable Act; or 

6 ‘‘(2) alter the authority of the Secretary under 

7 this Act or the Public Health Service Act to determine 

8 the types of information or data previously submitted 

9 by a sponsor or any other person that may be incor10 porated by reference in an application, request, or no11 tification for a drug, biological product, or device sub12 mitted under sections 505(i), 505(b), 505(j), 

13 512(b)(1), 512(b)(2), 564, 571, 520(g), 515(c), 

14 513(f)(2), or 510(k) of this Act, or subsection (a) or 

15 (k) of section 351 of the Public Health Service Act, 

16 including a supplement or amendment to any such 

17 submission, and the requirements associated with 

18 such reference. 

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

20 ‘‘(1) The term ‘medical countermeasure submis21 sion’ means an investigational new drug application 

22 under section 505(i), a new drug application under 

23 section 505(b), or an abbreviated new drug applica24 tion under section 505(j) of this Act, a biological 

25 product license application under section 351(a) of 


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1 the Public Health Service Act or a biosimilar biologi2 cal product license application under section 351(k) 

3 of the Public Health Service Act, a new animal drug 

4 application under section 512(b)(1) or abbreviated 

5 new animal drug application under section 512(b)(2), 

6 an application for conditional approval of a new ani7 mal drug under 571, an investigational device appli8 cation under section 520(g), an application with re9 spect to a device under section 515(c), a request for 

10 classification of a device under section 513(f)(2), a 

11 notification with respect to a device under section 

12 510(k), or request for an emergency use authorization 

13 under section 564 to support— 

14 ‘‘(A) the approval, licensure, classification, 

15 clearance, conditional approval, or authorization 

16 of a security countermeasure, qualified counter17 measure, or qualified pandemic or epidemic 

18 product; or 

19 ‘‘(B) a new indication to an approved secu20 rity countermeasure, qualified countermeasure, 

21 or qualified pandemic or epidemic product. 

22 ‘‘(2) The terms ‘qualified countermeasure’, ‘secu23 rity countermeasure’, and ‘qualified pandemic or epi24 demic product’ have the meanings given such terms in 


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1 sections 319F–1, 319F–2, and 319F–3, respectively, of 

2 the Public Health Service Act.’’. 

3 (b) STAKEHOLDER INPUT.—Not later than 18 months 

4 after the date of enactment of this Act, the Secretary of 

5 Health and Human Services (referred to in this section as 

6 the ‘‘Secretary’’), acting through the Commissioner of Food 

7 and Drugs and in consultation with the Assistant Secretary 

8 for Preparedness and Response, shall solicit input from 

9 stakeholders, including stakeholders developing security 

10 countermeasures, qualified countermeasures, or qualified 

11 pandemic or epidemic products, and stakeholders devel12 oping technologies to assist in the development of such coun13 termeasures with respect to how the Food and Drug Admin14 istration can advance the use of tools and technologies to 

15 support and accelerate the development or manufacture of 

16 security countermeasures, qualified countermeasures, and 

17 qualified pandemic or epidemic products, including through 

18 the reliance on cross-referenced data and information con19 tained within master files and submissions previously sub20 mitted to the Secretary as set forth in section 565B of the 

21 Federal Food, Drug, and Cosmetic Act, as added by sub22 section (a). 

23 (c) GUIDANCE.—Not later than 2 years after the after 

24 the date of enactment of this Act, the Secretary, acting 

25 through the Commissioner of Food and Drugs, shall publish 


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1 draft guidance about how reliance on cross-referenced data 

2 and information contained within master files under sec3 tion 565B of the Federal Food, Drug, and Cosmetic Act, 

4 as added by subsection (a) or submissions otherwise sub5 mitted to the Secretary may be used for specific tools or 

6 technologies (including platform technologies) that have the 

7 potential to support and accelerate the development or man8 ufacture of security countermeasures, qualified counter9 measures, qualified pandemic or epidemic products. The 

10 Secretary, acting through the Commissioner of Food and 

11 Drugs, shall publish the final guidance not later than 3 

12 years after the enactment of this Act. 

13 SEC. 603. PRIORITY ZOONOTIC ANIMAL DRUGS. 

14 Chapter V of the Federal Food, Drug, and Cosmetic 

15 Act (21 U.S.C. 351 et seq.) is amended by inserting after 

16 section 512 the following: 

17 ‘‘SEC. 512A. PRIORITY ZOONOTIC ANIMAL DRUGS. 

18 ‘‘(a) DESIGNATION OF A NEW ANIMAL DRUG AS A PRI19 ORITY ZOONOTIC ANIMAL DRUG.— 

20 ‘‘(1) IN GENERAL.—The Secretary shall, at the 

21 request of the sponsor of an application for approval 

22 of a new animal drug under section 512(b)(1) or an 

23 application for conditional approval of a new animal 

24 drug under section 571, expedite the development and 

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1 ical evidence indicates that the new animal drug, 

2 alone or in combination with 1 or more other animal 

3 drugs, has the potential to prevent or treat a zoonotic 

4 disease in animals, including a vector borne-disease, 

5 that has the potential to cause serious adverse health 

6 consequences for, or serious or life-threatening diseases 

7 in, humans. 

8 ‘‘(2) REQUEST FOR DESIGNATION.—The sponsor 

9 of a new animal drug may request the Secretary to 

10 designate a new animal drug described in paragraph 

11 (1) as a priority zoonotic animal drug. A request for 

12 the designation may be made concurrently with, or at 

13 any time after, the opening of an investigational new 

14 animal drug file under section 512(j) or the filing of 

15 an application under section 512(b)(1) or 571. 

16 ‘‘(3) DESIGNATION.— 

17 ‘‘(A) IN GENERAL.—Not later than 60 cal18 endar days after the receipt of a request under 

19 paragraph (2), the Secretary shall determine 

20 whether the new animal drug that is the subject 

21 of the request meets the criteria described in 

22 paragraph (1). If the Secretary determines that 

23 the new animal drug meets the criteria, the Sec24 retary shall designate the new animal drug as a 

25 priority zoonotic animal drug and shall take 


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1 such actions as are appropriate to expedite the 

2 development and review of the application for 

3 approval or conditional approval of such new 

4 animal drug. 

5 ‘‘(B) ACTIONS.—The actions to expedite the 

6 development and review of an application under 

7 subparagraph (A) may include, as appro8 priate— 

9 ‘‘(i) taking steps to ensure that the de10 sign of clinical trials is as efficient as prac11 ticable, when scientifically appropriate, 

12 such as by utilizing novel trial designs or 

13 drug development tools (including biomark14 ers) that may reduce the number of animals 

15 needed for studies; 

16 ‘‘(ii) providing timely advice to, and 

17 interactive communication with, the spon18 sor (which may include meetings with the 

19 sponsor and review team) regarding the de20 velopment of the new animal drug to ensure 

21 that the development program to gather the 

22 nonclinical and clinical data necessary for 

23 approval is as efficient as practicable; 

24 ‘‘(iii) involving senior managers and 

25 review staff with experience in zoonotic or 


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1 vector-borne disease to facilitate collabo2 rative, cross-disciplinary review, including, 

3 as appropriate, across agency centers; and 

4 ‘‘(iv) implementing additional admin5 istrative or process enhancements, as nec6 essary, to facilitate an efficient review and 

7 development program.’’. 

8 SEC. 604. ANIMAL RULE REPORT. 

9 (a) STUDY.—The Comptroller General of the United 

10 States shall conduct a study on the application of the re11 quirements under section 565(d) of the of the Federal Food, 

12 Drug, and Cosmetic Act (21 U.S.C. 360bbb–4(d)) (referred 

13 to in this section as the ‘‘animal rule’’) as a component 

14 of medical countermeasure advanced development under the 

15 Biomedical Advanced Research and Development Authority 

16 and regulatory review by the Food and Drug Administra17 tion. In conducting such study, the Comptroller General 

18 shall examine the following: 

19 (1) The extent to which advanced development 

20 and review of a medical countermeasure are coordi21 nated between the Biomedical Advanced Research and 

22 Development Authority and the Food and Drug Ad23 ministration, including activities facilitate appro24 priate and efficient design of studies to support ap25 proval, licensure, and authorization under the animal 


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1 rule, consistent with the recommendations in the ani2 mal rule guidance, issued pursuant to section 565(c) 

3 of the Federal Food Drug and Cosmetic Act (21 

4 U.S.C. 360bbb–4(c)) and entitled ‘‘Product Develop5 ment Under the Animal Rule Guidance for Industry’’ 

6 (issued in October 2015), to resolve discrepancies in 

7 the design of adequate and well-controlled efficacy 

8 studies conducted in animal models related to the 

9 provision of substantial evidence of effectiveness for 

10 the product approved, licensed, or authorized under 

11 the animal rule. 

12 (2) The consistency of the application of the ani13 mal rule among and between review divisions within 

14 the Food and Drug Administration. 

15 (3) The flexibilities pursuant to the animal rule 

16 to address variations in countermeasure development 

17 and review processes, including the extent to which 

18 qualified animal models are adopted and used within 

19 the Food and Drug Administration in regulatory de20 cisionmaking with respect to medical counter21 measures. 

22 (4) The extent to which the guidance issued 

23 under section 565(c) of the Federal Food Drug and 

24 Cosmetic Act (21 U.S.C. 360bbb–4(c)), entitled, 

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1 ance for Industry’’ (issued in October 2015), has as2 sisted in achieving the purposes described in para3 graphs (1), (2), and (3). 

4 (b) CONSULTATIONS.—In conducting the study under 

5 subsection (a), the Comptroller General of the United States 

6 shall consult with— 

7 (1) the Federal agencies responsible for advanc8 ing, reviewing, and procuring medical counter9 measures, including the Office of the Assistant Sec10 retary for Preparedness and Response, the Biomedical 

11 Advanced Research and Development Authority, the 

12 Food and Drug Administration, and the Department 

13 of Defense; 

14 (2) manufacturers involved in the research and 

15 development of medical countermeasures to address 

16 biological, chemical, radiological, and nuclear threats; 

17 and 

18 (3) other biodefense stakeholders, as applicable. 

19 (c) REPORT.—Not later than 3 years after the date of 

20 enactment of this Act, the Comptroller General of the United 

21 States shall submit to the Committee on Health, Education, 

22 Labor, and Pensions of the Senate and the Committee on 

23 Energy and Commerce of the House of Representatives a 

24 report containing the results of the study conducted under 

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1 cation and consistency of the requirements under sub2 sections (c) and (d) of section 565 of the Federal Food, Drug 

3 and Cosmetic Act (21 U.S.C. 360bbb–4) to support and ex4 pedite the research and development of medical counter5 measures, as applicable. 

6 (d) PROTECTION OF NATIONAL SECURITY.—The 

7 Comptroller General of the United States shall conduct the 

8 study and issue the assessment and report under this section 

9 in a manner that does not compromise national 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 that 

22 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 and 

5 Prevention, and the Food and Drug Admin6 istration; and 

7 (ii) representatives from academic, pri8 vate, and non-profit entities with expertise 

9 in genome engineering technologies, bio10 pharmaceuticals, medicine, or biodefense, 

11 and other relevant stakeholders; and 

12 (B) may include— 

13 (i) other representatives from the De14 partment of Health and Human Services, 

15 as the Secretary determines appropriate; 

16 and 

17 (ii) representatives from the Depart18 ment of Homeland Security, the Depart19 ment of Defense, the Department of Agri20 culture, and other departments, as the Sec21 retary may request for the meeting. 

22 (3) TOPICS.—The meeting under paragraph (1) 

23 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 reg9 ulation of products utilizing genome editing 

10 technologies; and 

11 (B) national security implications, includ12 ing— 

13 (i) capabilities of the United States to 

14 leverage genomic engineering technologies as 

15 a part of the medical countermeasure enter16 prise, including current applicable research, 

17 development, and application efforts under18 way within the Department of Defense; 

19 (ii) the potential for state and non20 state actors to utilize genomic engineering 

21 technologies as a national health security 

22 threat; and 

23 (iii) security measures to monitor and 

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1 neering technologies and related tech2 nologies. 

3 (b) REPORT.—Not later than 180 days after the meet4 ing described in subsection (a) is held, the Assistant Sec5 retary for Preparedness and Response shall issue a report 

6 to the congressional committees of jurisdiction on the topics 

7 discussed at such meeting, and provide recommendations, 

8 as applicable, to utilize innovations in genomic engineering 

9 (including genome editing) and related technologies as a 

10 part of preparedness and response activities to advance na11 tional health security. Such report shall be issued in a man12 ner that does not compromise national security. 

13 TITLE VII—MISCELLANEOUS 

14 PROVISIONS 

15 SEC. 701. REAUTHORIZATIONS AND EXTENSIONS. 

16 (a) VETERANS AFFAIRS.—Section 8117(g) of title 38, 

17 United States Code, is amended by striking ‘‘2014 through 

18 2018’’ and inserting ‘‘2019 through 2023’’. 

19 (b) VACCINE TRACKING AND DISTRIBUTION.—Section 

20 319A(e) (42 U.S.C. 247d–1(e)) is amended by striking 

21 ‘‘2014 through 2018’’ and inserting ‘‘2019 through 2023’’. 

22 (c) TEMPORARY REASSIGNMENT.—Section 319(e)(8) 

23 (42 U.S.C. 247d(e)(8)) is amended by striking ‘‘2018’’ and 

24 inserting ‘‘2023’’. 


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1 (d) STRATEGIC INNOVATION PARTNER.—Section 

2 319L(c)(4)(E)(ix) (42 U.S.C. 247d–7e(c)(4)(E)(ix)) is 

3 amended by striking ‘‘2022’’ and inserting ‘‘2023’’. 

4 (e) PUBLIC DISCLOSURE EXEMPTION.—Section 

5 319L(e)(1)(C) (42 U.S.C. 247d–7e(e)(1)(C)) is amended by 

6 striking ‘‘12’’ and inserting ‘‘17’’. 

7 (f) LIMITED ANTITRUST EXEMPTION.— 

8 (1) IN GENERAL.—Section 405 of the Pandemic 

9 and All-Hazards Preparedness Act (42 U.S.C. 247d– 

10 6a note) is amended— 

11 (A) by redesignating such section as section 

12 319L–1; 

13 (B) transferring such section to the Public 

14 Health Service Act (42 U.S.C. 201 et seq.), to 

15 appear after section 319L of such Act (42 U.S.C. 

16 247d–7e); 

17 (C) in subsection (a)(1)— 

18 (i) by striking ‘‘Secretary of Health 

19 and Human Services (referred to in this 

20 subsection as the ‘Secretary’)’’ and inserting 

21 ‘‘Secretary’’; 

22 (ii) by striking ‘‘of the Public Health 

23 Service Act (42 U.S.C. 247d–6b)) (as 

24 amended by this Act’’; 


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1 (iii) by striking ‘‘of the Public Health 

2 Service Act (42 U.S.C. 247d– 6a)) (as 

3 amended by this Act’’; and 

4 (iv) by striking ‘‘of the Public Health 

5 Service Act (42 U.S.C. 247d–6d)’’; and 

6 (D) in subsection (b), by striking ‘‘12-year’’ 

7 and inserting ‘‘17-year’’. 

8 (2) EFFECTIVE DATE.—The amendment made by 

9 paragraph (1)(D) shall take effect as if enacted on 

10 December 17, 2012. 

11 (3) CONFORMING AMENDMENT.—The table of 

12 contents in section 1(b) of the Pandemic and All-Haz13 ards Preparedness Act (Public Law 109–417) is 

14 amended by striking the item related to section 405. 

15 SEC. 702. TECHNICAL AMENDMENTS. 

16 (a) PUBLIC HEALTH SERVICE ACT.—Title III (42 

17 U.S.C. 241 et seq.) is amended— 

18 (1) in paragraphs (1) and (5) of section 319F– 

19 1(a) (42 U.S.C. 247d–6a(a)), by striking ‘‘section 

20 319F(h)’’ each place such term appears and inserting 

21 ‘‘section 319F(e)’’; and 

22 (2) in section 319K(a) (42 U.S.C. 247d–7d(a)), 

23 by striking ‘‘section 319F(h)(4)’’ and inserting ‘‘sec24 tion 319F(e)(4)’’. 


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1 (b) PUBLIC HEALTH SECURITY GRANTS.—Section 

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

3 (1) in subparagraph (C), by striking ‘‘individ4 uals,,’’ and inserting ‘‘individuals,’’; and 

5 (2) in subparagraph (F), by striking ‘‘make sat6 isfactory annual improvement and describe’’ and in7 serting ‘‘makes satisfactory annual improvement and 

8 describes’’. 

9 (c) FEDERAL FOOD, DRUG, AND COSMETIC ACT.—The 

10 Federal Food, Drug, and Cosmetic Act is amended— 

11 (1) in section 564A(e)(2)(A) (21 U.S.C. 360bbb– 

12 3a(e)(2)(A)), by striking ‘‘subsection (a)(1)(C)(i)’’ 

13 and inserting ‘‘subsection (a)(1)(C)’’; and 

14 (2) in section 564B(2)(C) (21 U.S.C. 360bbb– 

15 3b(2)(C)), by inserting ‘‘or section 564A’’. 


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Calendar No. 467 

115TH CONGRESS 

2D SESSION S. 2852 

A BILL 

To reauthorize certain programs under the Panization Act. demic and All-Hazards Preparedness ReauthorJUNE 18, 2018 

Reported with an amendment 


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