II 

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 

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’’. 

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

8 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. References in Act. 


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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. 

Sec. 603. Animal rule report. 

TITLE VII—MISCELLANEOUS PROVISIONS 

Sec. 701. Reauthorizations and extensions. 

Sec. 702. Technical amendments. 


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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 

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

25 the Homeland Security Act of 2002), the 

26 National Incident Management System (as 


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

2 the National Response Plan developed pur3 suant to section 504 of such Act, or any 

4 successor plan.’’; 

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

6 the period at the end of the second sentence the 

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

8 the evidence-based benchmarks and objective 

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

10 and 

11 (C) in paragraph (3)— 

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

13 ‘‘2022’’; 

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

15 the environmental health workforce), de16 scribing the status of such workforce’’ 

17 after ‘‘gaps in such workforce’’; 

18 (iii) by striking ‘‘and identifying strat19 egies’’ and inserting ‘‘identifying strate20 gies’’; and 

21 (iv) by inserting before the period at 

22 the end ‘‘, and identifying current capabili23 ties to meet the requirements of section 

24 2803’’; and 

25 (2) in subsection (b)— 


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1 (A) in paragraph (2)— 

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

3 ‘‘and investigation’’ and inserting ‘‘inves4 tigation, and related information tech5 nology activities’’; 

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

7 ‘‘and decontamination’’ and inserting ‘‘de8 contamination, relevant health care serv9 ices and supplies, and transportation and 

10 disposal of medical waste’’; and 

11 (iii) by adding at the end the fol12 lowing: 

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

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

15 exposures to agents that could cause a public 

16 health emergency’’ before the period; 

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

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

19 and 

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

21 ‘‘(9) ZOONOTIC DISEASE, FOOD, AND AGRI22 CULTURE.—In consultation with the Secretary of 

23 Agriculture, improving coordination among Federal, 

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

25 detect, and respond to outbreaks of plant or animal 


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1 disease (including zoonotic disease) that could com2 promise national security resulting from a deliberate 

3 attack, a naturally occurring threat, the intentional 

4 adulteration of food, or other public health threats, 

5 taking into account interactions between animal 

6 health, human health, and animals’ and humans’ 

7 shared environment as directly related to public 

8 health emergency preparedness and response capa9 bilities, as applicable. 

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

11 current or potential health security threats from 

12 abroad to inform domestic public health prepared13 ness and response capabilities.’’. 

14 TITLE II—IMPROVING 

15 PREPAREDNESS AND RESPONSE 

16 SEC. 201. IMPROVING BENCHMARKS AND STANDARDS FOR 

17 PREPAREDNESS AND RESPONSE. 

18 (a) EVALUATING MEASURABLE EVIDENCE-BASED

19 BENCHMARKS AND OBJECTIVE STANDARDS.—Section 

20 319C–1 (42 U.S.C. 247d–3a) is amended by inserting 

21 after subsection (j) the following: 

22 ‘‘(k) EVALUATION.— 

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

24 after the date of enactment of the Pandemic and 

25 All-Hazards Preparedness and Advancing Innovation 


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1 Act of 2018 and every 2 years thereafter, the Sec2 retary shall conduct an evaluation of the evidence3 based benchmarks and objective standards required 

4 under subsection (g). Such evaluation shall be sub5 mitted to the congressional committees of jurisdic6 tion together with the National Health Security 

7 Strategy under section 2802, at such time as such 

8 strategy is submitted. 

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

10 paragraph shall include— 

11 ‘‘(A) a review of evidence-based bench12 marks and objective standards, and associated 

13 metrics and targets; 

14 ‘‘(B) a discussion of changes to any evi15 dence-based benchmarks and objective stand16 ards, and the effect of such changes on the abil17 ity to track whether entities are meeting or 

18 making progress toward the goals under this 

19 section and, to the extent practicable, the appli20 cable goals of the National Health Security 

21 Strategy under section 2802; 

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

23 eligible entities, as described in subsection (b) 

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

25 by sub-recipients and the effect of such funding 


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1 on meeting evidence-based benchmarks and ob2 jective standards; and 

3 ‘‘(D) recommendations, as applicable and 

4 appropriate, to improve evidence-based bench5 marks and objective standards to more accu6 rately assess the ability of entities receiving 

7 awards under this section to better achieve the 

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

9 (b) EVALUATING THE PARTNERSHIP FOR STATE AND

10 REGIONAL HOSPITAL PREPAREDNESS.—Section 319C– 

11 2(i)(1) (42 U.S.C. 247–3b(i)(1)) is amended by striking 

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

13 319C–1(g), (i), (j), and (k)’’. 

14 SEC. 202. AMENDMENTS TO PREPAREDNESS AND RE15 SPONSE PROGRAMS. 

16 (a) COOPERATIVE AGREEMENT APPLICATIONS FOR

17 IMPROVING STATE AND LOCAL PUBLIC HEALTH SECU18 RITY.—Section 319C–1 (42 U.S.C. 247d–3a) is amend19 ed— 

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

21 through the Director of the Centers for Disease 

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

23 (2) in subsection (b)(2)(A)— 

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

25 public health agencies with specific expertise 


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1 that may be relevant to public health security, 

2 such as environmental health agencies,’’ after 

3 ‘‘stakeholders’’; 

4 (B) by redesignating clauses (vii) through 

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

6 (C) by inserting after clause (vi) the fol7 lowing: 

8 ‘‘(vii) a description of how, as applica9 ble, such entity may integrate information 

10 to account for individuals with behavioral 

11 health needs following a public health 

12 emergency;’’. 

13 (b) PARTNERSHIP FOR STATE AND REGIONAL HOS14 PITAL PREPAREDNESS TO IMPROVE SURGE CAPACITY.— 

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

16 (1) in subsection (a)— 

17 (A) by inserting ‘‘, acting through the As18 sistant Secretary for Preparedness and Re19 sponse,’’ after ‘‘The Secretary’’; and 

20 (B) by striking ‘‘preparedness for public 

21 health emergencies’’ and inserting ‘‘prepared22 ness for, and response to, public health emer23 gencies in accordance with subsection (c)’’; and 

24 (2) in subsection (b)(1)(A)— 


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1 (A) in clause (iii), by redesignating sub2 clauses (I) through (III) as items (aa) through 

3 (cc), respectively, and adjusting the margins ac4 cordingly; 

5 (B) by redesignating clauses (i) through 

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

7 and adjusting the margins accordingly; 

8 (C) by striking ‘‘partnership consisting 

9 of—’’ and inserting ‘‘partnership— 

10 ‘‘(i) consisting of—’’; and 

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

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

13 emergency medical service organizations or 

14 emergency management organizations; 

15 and’’. 

16 (c) PUBLIC HEALTH SECURITY GRANTS AUTHORIZA17 TION OF APPROPRIATIONS.—Section 319C–1(h)(1)(A) 

18 (42 U.S.C. 247d–3a(h)(1)(A)) is amended by striking 

19 ‘‘$641,900,000 for fiscal year 2014’’ and all that follows 

20 through the period at the end and inserting 

21 ‘‘$685,000,000 for each of fiscal years 2019 through 2023 

22 for awards pursuant to paragraph (3) (subject to the au23 thority of the Secretary to make awards pursuant to para24 graphs (4) and (5)).’’. 


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1 (d) PARTNERSHIP FOR STATE AND REGIONAL HOS2 PITAL PREPAREDNESS AUTHORIZATION OF APPROPRIA3 TIONS.—Section 319C–2(j) (42 U.S.C. 247d–3b(j)) is 

4 amended— 

5 (1) by amending paragraph (1) to read as fol6 lows: 

7 ‘‘(1) IN GENERAL.— 

8 ‘‘(A) AUTHORIZATION OF APPROPRIA9 TIONS.—For purposes of carrying out this sec10 tion and section 319C–3, in accordance with 

11 subparagraph (B), there is authorized to be ap12 propriated $385,000,000 for each of fiscal years 

13 2019 through 2023. 

14 ‘‘(B) RESERVATIONS OF AMOUNTS FOR RE15 GIONAL SYSTEMS.— 

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

17 (ii), of the amount appropriated under sub18 paragraph (A) for a fiscal year, the Sec19 retary may reserve up to 5 percent for the 

20 purpose of carrying out section 319C–3. 

21 ‘‘(ii) RESERVATIONS CONTINGENT ON

22 CONTINUED APPROPRIATIONS.—If the 

23 amount appropriated under subparagraph 

24 (A) for fiscal year 2019 or a subsequent 

25 fiscal year is less than or equal the amount 


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1 so appropriated for the previous fiscal 

2 year, the amount that may be reserved 

3 under clause (i) shall be reduced such that 

4 the amount remaining for the purpose of 

5 carrying out this section is not less than 

6 the amount available for such purpose for 

7 the previous fiscal year.’’; 

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

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

10 (1)(A) for a fiscal year and not reserved for the pur11 pose described in paragraph (1)(B)(i)’’; and 

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

13 (1) and not reserved under paragraph (2)’’ and in14 serting ‘‘paragraph (1)(A) and not reserved under 

15 paragraph (1)(B)(i) or (2)’’. 

16 SEC. 203. REGIONAL HEALTH CARE EMERGENCY PRE17 PAREDNESS AND RESPONSE SYSTEMS. 

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

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

20 following: 

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

22 EMERGENCY PREPAREDNESS AND RESPONSE 

23 SYSTEMS. 

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

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1 pitals, health care facilities, and other public and private 

2 sector entities, with varying levels of capability to treat 

3 patients and increase medical surge capacity during, and 

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

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

6 and nuclear agents, including emerging infectious dis7 eases. 

8 ‘‘(b) GUIDELINES.—The Assistant Secretary for Pre9 paredness and Response, in consultation with the Director 

10 of the Centers for Disease Control and Prevention, the Ad11 ministrator of the Centers for Medicare & Medicaid Serv12 ices, the Administrator of the Health Resources and Serv13 ices Administration, the Commissioner of Food and 

14 Drugs, the Assistant Secretary for Mental Health and 

15 Substance Use, the Assistant Secretary of Labor for Occu16 pational Safety and Health, the Secretary of Veterans Af17 fairs, heads of such other Federal agencies as the Sec18 retary determines to be appropriate, and State, local, trib19 al, and territorial public health officials, shall, not later 

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

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

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

5 such as trauma care and medical surge capacity and 

6 capabilities), with respect to— 

7 ‘‘(A) a regional approach to identifying 

8 hospitals and health care facilities based on 

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

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

12 will coordinate with and integrate the part13 nerships established under section 319C– 

14 2(b); and 

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

20 hospitals and health care facilities in the 

21 community; 

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

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1 count resiliency, geographic considerations, and 

2 rural considerations; 

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

4 safety and personal protection of workers who 

5 handle human remains and health care workers 

6 (including with respect to protective equipment 

7 and supplies, waste management processes, and 

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

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

13 containment (within the meaning of section 

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

15 treatment, and transportation of patients, based 

16 on patient medical need (including patients in 

17 rural areas), to the appropriate hospitals or 

18 health care facilities within the regional system 

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

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

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

24 internet website of the Department of Health and 


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

3 ‘‘(3) update such guidelines as appropriate, in4 cluding based on input received pursuant to sub5 sections (c), (e), and (f), to address new and emerg6 ing public health threats. 

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

8 and updating guidelines under subsection (b), the Assist9 ant Secretary for Preparedness and Response shall— 

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

11 care facilities, including health care coalitions under 

12 section 319C–2, State, local, tribal, and territorial 

13 public health departments, and health care or sub14 ject matter experts, including experts with relevant 

15 expertise in chemical, biological, radiological, or nu16 clear threats, and emerging infectious disease as the 

17 Assistant Secretary determines appropriate, to meet 

18 the goals under section 2802(b)(3); 

19 ‘‘(2) consult and engage with appropriate 

20 health care providers and professionals, including 

21 physicians, nurses, first responders, health care fa22 cilities (including hospitals, primary care clinics, 

23 community health centers, mental health facilities, 

24 ambulatory care facilities, and dental health facili25 ties), pharmacies, emergency medical providers, 


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1 trauma care providers, environmental health agen2 cies, public health laboratories, poison control cen3 ters, blood banks, and other experts that the Assist4 ant Secretary determines appropriate, to meet the 

5 goals under section 2802(b)(3); 

6 ‘‘(3) consider feedback related to financial im7 plications for hospitals, health care facilities, public 

8 health agencies, laboratories, and other entities en9 gaged in regional preparedness planning to imple10 ment and follow such guidelines, as applicable; and 

11 ‘‘(4) consider financial requirements and poten12 tial incentives for entities to prepare for, and re13 spond to, public health emergencies as part of the 

14 regional health care emergency preparedness and re15 sponse system. 

16 ‘‘(d) TECHNICAL ASSISTANCE.—The Assistant Sec17 retary for Preparedness and Response, in consultation 

18 with the Director of the Centers for Disease Control and 

19 Prevention and the Assistant Secretary of Labor for Occu20 pational Safety and Health, may provide technical assist21 ance and consultation towards meeting the guidelines de22 scribed in subsection (b). 

23 ‘‘(e) DEMONSTRATION PROJECT FOR REGIONAL

24 HEALTH CARE PREPAREDNESS AND RESPONSE SYS25 TEMS.— 


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

2 Preparedness and Response may establish a dem3 onstration project pursuant to the development and 

4 implementation of guidelines under subsection (b) to 

5 improve medical surge capacity for all hazards, build 

6 and integrate regional medical response capabilities, 

7 improve specialty care expertise for all-hazards re8 sponse, and coordinate medical preparedness and re9 sponse across State, local, tribal, territorial, and re10 gional jurisdictions. 

11 ‘‘(2) SUNSET.—The authority under this sub12 section shall expire on September 30, 2023. 

13 ‘‘(f) GAO REPORT TO CONGRESS.— 

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

15 date of enactment of this section, the Comptroller 

16 General of the United States (referred to in this 

17 subsection as the ‘Comptroller General’) shall submit 

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

19 Pensions and the Committee on Finance of the Sen20 ate and the Committee on Energy and Commerce 

21 and the Committee on Ways and Means of the 

22 House of Representatives, a report on the extent to 

23 which hospitals and health care facilities have imple24 mented the recommended guidelines under sub25 section (b), including an analysis and evaluation of 


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1 any challenges hospitals or health care facilities ex2 perienced in implementing such guidelines. 

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

4 include in the report under paragraph (1)— 

5 ‘‘(A) data on the preparedness and re6 sponse capabilities that have been informed by 

7 the guidelines under subsection (b) to improve 

8 regional emergency health care preparedness 

9 and response capability, including hospital and 

10 health care facility capacity and medical surge 

11 capabilities to prepare for, and respond to, pub12 lic health emergencies; and 

13 ‘‘(B) recommendations to reduce gaps in 

14 incentives for regional health partners, includ15 ing hospitals and health care facilities to im16 prove capacity and medical surge capabilities to 

17 prepare for, and respond to, public health emer18 gencies, consistent with subsection (a), which 

19 may include consideration of facilities partici20 pating in programs under section 319C–2, pro21 grams under the Centers for Medicare & Med22 icaid Services (including innovative health care 

23 delivery and payment models), and input from 

24 private sector financial institutions. 


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1 ‘‘(3) CONSULTATION.—In carrying out para2 graphs (1) and (2), the Comptroller General shall 

3 consult with the heads of appropriate Federal agen4 cies, including— 

5 ‘‘(A) the Assistant Secretary for Prepared6 ness and Response; 

7 ‘‘(B) the Director of the Centers for Dis8 ease Control and Prevention; 

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

10 Medicare & Medicaid Services; 

11 ‘‘(D) the Assistant Secretary for Mental 

12 Health and Substance Use; 

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

14 Occupational Safety and Health; 

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

16 and 

17 ‘‘(G) the heads of such other Federal agen18 cies as the Secretary determines appropriate.’’. 

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

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

21 first sentence the following ‘‘The reports submitted under 

22 this paragraph shall also include progress towards the im23 plementation of section 319C–3.’’. 

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1 NESS AND RESPONSE.—Section 2802(b)(3) (42 U.S.C. 

2 300hh–1(b)(3)) is amended— 

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

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

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

6 and 

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

8 follows: 

9 ‘‘(G) Optimizing a coordinated and flexible 

10 approach to the emergency response and med11 ical surge capacity of hospitals, other health 

12 care facilities, critical care, trauma care (which 

13 may include trauma centers), and emergency 

14 medical systems, which may include the imple15 mentation of guidelines for regional health care 

16 emergency preparedness and response systems 

17 under section 319C–3.’’. 

18 (d) IMPROVING STATE AND LOCAL PUBLIC HEALTH

19 SECURITY.— 

20 (1) STATE AND LOCAL SECURITY.—Section 

21 319C–1(e) (42 U.S.C. 247d–3a(e)) is amended by 

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

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

24 care emergency preparedness and response system 


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1 established pursuant to the applicable guidelines 

2 under section 319C–3.’’. 

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

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

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

6 inserting ‘‘;’’; 

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

8 (iii); and 

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

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

11 regional health care emergency system 

12 under section 319C–3; and’’. 

13 SEC. 204. PUBLIC HEALTH AND HEALTH CARE SYSTEM SIT14 UATIONAL AWARENESS AND BIOSURVEIL15 LANCE CAPABILITIES. 

16 (a) FACILITIES, CAPACITIES, AND BIOSURVEILLANCE

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

18 amended— 

19 (1) in the section heading, by striking ‘‘REVI20 TALIZING’’ and inserting ‘‘FACILITIES AND CA21 PACITIES OF’’; 

22 (2) in subsection (a)— 

23 (A) in the subsection heading, by striking 

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

25 GENERAL’’; 


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

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

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

7 improve, enhance, and appropriately maintain’’; 

8 and 

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

10 ‘‘(4) STUDY OF RESOURCES FOR FACILITIES

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

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

14 2013 through 2018 for activities authorized under 

15 this subsection. Such study shall include a review 

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

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

21 and security upgrades of facilities and associated 

22 contracts under this subsection, and the obligations 

23 and expenditures incurred to establish and improve 

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


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1 agency or agencies incurring such obligations and 

2 expenditures.’’; 

3 (3) in subsection (b)— 

4 (A) in the subsection heading, by striking 

5 ‘‘NATIONAL’’ and inserting ‘‘ESTABLISHMENT

6 OF SYSTEMS OF PUBLIC HEALTH ’’; 

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

10 (C) in paragraph (2)— 

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

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

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

15 ‘‘in a secure manner’’; and 

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

17 follows: 

18 ‘‘(3) STANDARDS.— 

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

20 after the date of the enactment of the Pan21 demic and All-Hazards Preparedness and Ad22 vancing Innovation Act of 2018, the Secretary, 

23 in cooperation with health care providers, State, 

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


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1 the Office of the National Coordinator for 

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

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

8 standards as necessary. Such standards shall be 

9 made available on the internet website of the 

10 Department of Health and Human Services, in 

11 a manner that does not compromise national se12 curity. 

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

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

20 (4) in subsection (c)— 

21 (A) in paragraph (1)— 

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

23 after the date of enactment of the Pan24 demic and All-Hazards Preparedness ReVerDate Sep 11 2014 02:22 May 23, 2018 Jkt 079200 PO 00000 Frm 00025 Fmt 6652 Sfmt 6201 E:\BILLS\S2852.IS S2852

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1 authorization Act of 2013, the Secretary’’ 

2 and inserting ‘‘The Secretary’’; 

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

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

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

9 and inserting ‘‘such interoperability’’; 

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

11 follows: 

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

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

15 ‘‘(A) facilitate coordination among agencies 

16 within the Department of Health and Human 

17 Services that provide or have the potential to 

18 provide information and data to, and analyses 

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

21 coordination among relevant agencies related to 

22 health care services, the facilitation of health 

23 information exchange (including the Office of 

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1 tion Technology), and public health emergency 

2 preparedness and response; and 

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

5 Director of the National Institute of Standards 

6 and Technology), the Secretary of Defense, the 

7 Secretary of Homeland Security, and the Sec8 retary of Veterans Affairs, and the heads of 

9 other Federal agencies, as the Secretary deter10 mines appropriate.’’; 

11 (C) in paragraph (3)— 

12 (i) by redesignating subparagraphs 

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

14 respectively, and adjusting the margins ac15 cordingly; 

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

18 (I) by inserting ‘‘immunization 

19 information programs,’’ after ‘‘poison 

20 control,’’; and 

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

23 laboratories, and public environmental 

24 health agencies’’; 


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

2 inserting the following: 

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

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

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

7 after the date of the enactment of the Pan8 demic and All-Hazards Preparedness and Ad9 vancing Innovation Act of 2018 and every 6 

10 years thereafter, the Secretary shall conduct a 

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

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

17 subparagraph (A). The Secretary shall provide 

18 such review to the congressional committees of 

19 jurisdiction.’’; 

20 (D) in paragraph (5)— 

21 (i) by redesignating subparagraphs 

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

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


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

2 inserting the following: 

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

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

6 ‘‘(B) PUBLIC MEETING.— 

7 ‘‘(i) IN GENERAL.—Not later than 

8 180 days after the date of enactment of 

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

11 2018, the Secretary shall convene a public 

12 meeting for purposes of discussing and 

13 providing input on the potential goals, 

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

16 the elements described in paragraph 

17 (3)(A). 

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

19 shall include representatives of relevant 

20 Federal agencies (including representatives 

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

23 and the National Institute of Standards 

24 and Technology), State, local, tribal, and 

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1 holders with expertise in biosurveillance 

2 and situational awareness, and stake3 holders with expertise in capabilities rel4 evant to biosurveillance and situational 

5 awareness, such as experts in informatics 

6 and data analytics (including experts in 

7 prediction and forecasting), and other rep8 resentatives as the Secretary determines 

9 appropriate. 

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

11 shall include a discussion of— 

12 ‘‘(I) data elements, including 

13 minimal or essential data elements, 

14 that are voluntarily provided for such 

15 network, which may include elements 

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

18 practicable; 

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

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

23 emergency; 


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1 ‘‘(III) strategies to encourage the 

2 access, exchange, and use of informa3 tion; 

4 ‘‘(IV) considerations for State, 

5 local, tribal, and territorial 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 02:22 May 23, 2018 Jkt 079200 PO 00000 Frm 00035 Fmt 6652 Sfmt 6201 E:\BILLS\S2852.IS 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’’. 

Æ 


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