In the Senate of the United States, 

February 27, 2013. 

Resolved, That the bill from the House of Representatives (H.R. 307) entitled ‘‘An Act to reauthorize certain programs under the Public Health Service Act and the Federal 

Food, Drug, and Cosmetic Act with respect to public health 

security and all-hazards preparedness and response, and for 

other purposes.’’, do pass with the following 

AMENDMENT: 

Strike out all after the enacting clause and insert: 

1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

3 ‘‘Pandemic and All-Hazards Preparedness Reauthorization 

4 Act of 2013’’. 

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

6 Act is as follows: 

Sec. 1. Short title; table of contents. 

TITLE I—STRENGTHENING NATIONAL PREPAREDNESS AND 

RESPONSE FOR PUBLIC HEALTH EMERGENCIES 

Sec. 101. National Health Security Strategy. 

Sec. 102. Assistant Secretary for Preparedness and Response. 

Sec. 103. National Advisory Committee on Children and Disasters. 
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Sec. 104. Modernization of the National Disaster Medical System. 

Sec. 105. Continuing the role of the Department of Veterans Affairs. 

TITLE II—OPTIMIZING STATE AND LOCAL ALL-HAZARDS 

PREPAREDNESS AND RESPONSE 

Sec. 201. Temporary reassignment of State and local personnel during a public 

health emergency. 

Sec. 202. Improving State and local public health security. 

Sec. 203. Hospital preparedness and medical surge capacity. 

Sec. 204. Enhancing situational awareness and biosurveillance. 

Sec. 205. Eliminating duplicative Project Bioshield reports. 

TITLE III—ENHANCING MEDICAL COUNTERMEASURE REVIEW 

Sec. 301. Special protocol assessment. 

Sec. 302. Authorization for medical products for use in emergencies. 

Sec. 303. Definitions. 

Sec. 304. Enhancing medical countermeasure activities. 

Sec. 305. Regulatory management plans. 

Sec. 306. Report. 

Sec. 307. Pediatric medical countermeasures. 

TITLE IV—ACCELERATING MEDICAL COUNTERMEASURE ADVANCED 

RESEARCH AND DEVELOPMENT 

Sec. 401. BioShield. 

Sec. 402. Biomedical Advanced Research and Development Authority. 

Sec. 403. Strategic National Stockpile. 

Sec. 404. National Biodefense Science Board. 

1 TITLE I—STRENGTHENING NA2 TIONAL PREPAREDNESS AND 

3 RESPONSE FOR PUBLIC 

4 HEALTH EMERGENCIES 

5 SEC. 101. NATIONAL HEALTH SECURITY STRATEGY. 

6 (a) IN GENERAL.—Section 2802 of the Public Health 

7 Service Act (42 U.S.C. 300hh–1) is amended— 

8 (1) in subsection (a)(1), by striking ‘‘2009’’ and 

9 inserting ‘‘2014’’; and 

10 (2) in subsection (b)— 

11 (A) in paragraph (1)(A), by inserting ‘‘, in12 cluding drills and exercises to ensure medical 
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1 surge capacity for events without notice’’ after 

2 ‘‘exercises’’; and 

3 (B) in paragraph (3)— 

4 (i) in the matter preceding subpara5 graph (A)— 

6 (I) by striking ‘‘facilities), and 

7 trauma care’’ and inserting ‘‘and am8 bulatory care facilities and which may 

9 include dental health facilities), and 

10 trauma care, critical care,’’; and 

11 (II) by inserting ‘‘(including re12 lated availability, accessibility, and co13 ordination)’’ after ‘‘public health emer14 gencies’’; 

15 (ii) in subparagraph (A), by inserting 

16 ‘‘and trauma’’ after ‘‘medical’’; 

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

18 ‘‘Medical evacuation and fatality manage19 ment’’ and inserting ‘‘Fatality manage20 ment’’; 

21 (iv) by redesignating subparagraphs 

22 (C), (D), and (E) as subparagraphs (D), 

23 (E), and (F), respectively; 

24 (v) by inserting after subparagraph 

25 (B), the following the new subparagraph: 
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1 ‘‘(C) Coordinated medical triage and evacu2 ation to appropriate medical institutions based 

3 on patient medical need, taking into account re4 gionalized systems of care.’’; 

5 (vi) in subparagraph (E), as redesig6 nated by clause (iv), by inserting ‘‘(which 

7 may include such dental health assets)’’ 

8 after ‘‘medical assets’’; and 

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

11 ‘‘(G) Optimizing a coordinated and flexible 

12 approach to the medical surge capacity of hos13 pitals, other health care facilities, critical care, 

14 trauma care (which may include trauma cen15 ters), and emergency medical systems.’’; 

16 (C) in paragraph (4)— 

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

18 ‘‘, including the unique needs and consider19 ations of individuals with disabilities,’’ 

20 after ‘‘medical needs of at-risk individuals’’; 

21 and 

22 (ii) in subparagraph (B), by inserting 

23 ‘‘the’’ before ‘‘purpose of this section’’; and 

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

25 ‘‘(7) COUNTERMEASURES.— 
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1 ‘‘(A) Promoting strategic initiatives to ad2 vance countermeasures to diagnose, mitigate, 

3 prevent, or treat harm from any biological agent 

4 or toxin, chemical, radiological, or nuclear agent 

5 or agents, whether naturally occurring, uninten6 tional, or deliberate. 

7 ‘‘(B) For purposes of this paragraph, the 

8 term ‘countermeasures’ has the same meaning as 

9 the terms ‘qualified countermeasures’ under sec10 tion 319F–1, ‘qualified pandemic and epidemic 

11 products’ under section 319F–3, and ‘security 

12 countermeasures’ under section 319F–2. 

13 ‘‘(8) MEDICAL AND PUBLIC HEALTH COMMUNITY

14 RESILIENCY.—Strengthening the ability of States, 

15 local communities, and tribal communities to prepare 

16 for, respond to, and be resilient in the event of public 

17 health emergencies, whether naturally occurring, un18 intentional, or deliberate by— 

19 ‘‘(A) optimizing alignment and integration 

20 of medical and public health preparedness and 

21 response planning and capabilities with and 

22 into routine daily activities; and 

23 ‘‘(B) promoting familiarity with local med24 ical and public health systems.’’. 
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1 (b) AT-RISK INDIVIDUALS.—Section 2814 of the Public 

2 Health Service Act (42 U.S.C. 300hh–16) is amended— 

3 (1) by striking paragraphs (5), (7), and (8); 

4 (2) in paragraph (4), by striking 

5 ‘‘2811(b)(3)(B)’’ and inserting ‘‘2802(b)(4)(B)’’; 

6 (3) by redesignating paragraphs (1) through (4) 

7 as paragraphs (2) through (5), respectively; 

8 (4) by inserting before paragraph (2) (as so re9 designated), the following: 

10 ‘‘(1) monitor emerging issues and concerns as 

11 they relate to medical and public health preparedness 

12 and response for at-risk individuals in the event of a 

13 public health emergency declared by the Secretary 

14 under section 319;’’; 

15 (5) by amending paragraph (2) (as so redesig16 nated) to read as follows: 

17 ‘‘(2) oversee the implementation of the prepared18 ness goals described in section 2802(b) with respect to 

19 the public health and medical needs of at-risk indi20 viduals in the event of a public health emergency, as 

21 described in section 2802(b)(4);’’; and 

22 (6) by inserting after paragraph (6), the fol23 lowing: 

24 ‘‘(7) disseminate and, as appropriate, update 

25 novel and best practices of outreach to and care of at- 
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1 risk individuals before, during, and following public 

2 health emergencies in as timely a manner as is prac3 ticable, including from the time a public health threat 

4 is identified; and 

5 ‘‘(8) ensure that public health and medical infor6 mation distributed by the Department of Health and 

7 Human Services during a public health emergency is 

8 delivered in a manner that takes into account the 

9 range of communication needs of the intended recipi10 ents, including at-risk individuals.’’. 

11 SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND 

12 RESPONSE. 

13 (a) IN GENERAL.—Section 2811 of the Public Health 

14 Service Act (42 U.S.C. 300hh–10) is amended— 

15 (1) in subsection (b)— 

16 (A) in paragraph (3), by inserting ‘‘, secu17 rity countermeasures (as defined in section 

18 319F–2),’’ after ‘‘qualified countermeasures (as 

19 defined in section 319F–1)’’; 

20 (B) in paragraph (4), by adding at the end 

21 the following: 

22 ‘‘(D) POLICY COORDINATION AND STRA23 TEGIC DIRECTION.—Provide integrated policy co24 ordination and strategic direction with respect to 

25 all matters related to Federal public health and 
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1 medical preparedness and execution and deploy2 ment of the Federal response for public health 

3 emergencies and incidents covered by the Na4 tional Response Plan developed pursuant to sec5 tion 504(6) of the Homeland Security Act of 

6 2002, or any successor plan, before, during, and 

7 following public health emergencies. 

8 ‘‘(E) IDENTIFICATION OF INEFFICIEN9 CIES.—Identify and minimize gaps, duplication, 

10 and other inefficiencies in medical and public 

11 health preparedness and response activities and 

12 the actions necessary to overcome these obstacles. 

13 ‘‘(F) COORDINATION OF GRANTS AND

14 AGREEMENTS.—Align and coordinate medical 

15 and public health grants and cooperative agree16 ments as applicable to preparedness and re17 sponse activities authorized under this Act, to the 

18 extent possible, including program requirements, 

19 timelines, and measurable goals, and in con20 sultation with the Secretary of Homeland Secu21 rity, to— 

22 ‘‘(i) optimize and streamline medical 

23 and public health preparedness and re24 sponse capabilities and the ability of local 
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1 communities to respond to public health 

2 emergencies; and 

3 ‘‘(ii) gather and disseminate best prac4 tices among grant and cooperative agree5 ment recipients, as appropriate. 

6 ‘‘(G) DRILL AND OPERATIONAL EXER7 CISES.—Carry out drills and operational exer8 cises, in consultation with the Department of 

9 Homeland Security, the Department of Defense, 

10 the Department of Veterans Affairs, and other 

11 applicable Federal departments and agencies, as 

12 necessary and appropriate, to identify, inform, 

13 and address gaps in and policies related to all14 hazards medical and public health preparedness 

15 and response, including exercises based on— 

16 ‘‘(i) identified threats for which coun17 termeasures are available and for which no 

18 countermeasures are available; and 

19 ‘‘(ii) unknown threats for which no 

20 countermeasures are available. 

21 ‘‘(H) NATIONAL SECURITY PRIORITY.—On a 

22 periodic basis consult with, as applicable and 

23 appropriate, the Assistant to the President for 

24 National Security Affairs, to provide an update 

25 on, and discuss, medical and public health pre-
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1 paredness and response activities pursuant to 

2 this Act and the Federal Food, Drug, and Cos3 metic Act, including progress on the develop4 ment, approval, clearance, and licensure of med5 ical countermeasures.’’; and 

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

7 ‘‘(7) COUNTERMEASURES BUDGET PLAN.—De8 velop, and update on an annual basis, a coordinated 

9 5-year budget plan based on the medical counter10 measure priorities described in subsection (d). Each 

11 such plan shall— 

12 ‘‘(A) include consideration of the entire 

13 medical countermeasures enterprise, including— 

14 ‘‘(i) basic research and advanced re15 search and development; 

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

17 and authorized uses of products; and 

18 ‘‘(iii) procurement, stockpiling, main19 tenance, and replenishment of all products 

20 in the Strategic National Stockpile; 

21 ‘‘(B) inform prioritization of resources and 

22 include measurable outputs and outcomes to 

23 allow for the tracking of the progress made to24 ward identified priorities; 
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1 ‘‘(C) identify medical countermeasure life2 cycle costs to inform planning, budgeting, and 

3 anticipated needs within the continuum of the 

4 medical countermeasure enterprise consistent 

5 with section 319F–2; and 

6 ‘‘(D) be made available to the appropriate 

7 committees of Congress upon request.’’; 

8 (2) by striking subsection (c) and inserting the 

9 following: 

10 ‘‘(c) FUNCTIONS.—The Assistant Secretary for Pre11 paredness and Response shall— 

12 ‘‘(1) have lead responsibility within the Depart13 ment of Health and Human Services for emergency 

14 preparedness and response policy coordination and 

15 strategic direction; 

16 ‘‘(2) have authority over and responsibility for— 

17 ‘‘(A) the National Disaster Medical System 

18 pursuant to section 2812; 

19 ‘‘(B) the Hospital Preparedness Cooperative 

20 Agreement Program pursuant to section 319C–2; 

21 ‘‘(C) the Biomedical Advanced Research 

22 and Development Authority pursuant to section 

23 319L; 

24 ‘‘(D) the Medical Reserve Corps pursuant to 

25 section 2813; 
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1 ‘‘(E) the Emergency System for Advance 

2 Registration of Volunteer Health Professionals 

3 pursuant to section 319I; and 

4 ‘‘(F) administering grants and related au5 thorities related to trauma care under parts A 

6 through C of title XII, such authority to be 

7 transferred by the Secretary from the Adminis8 trator of the Health Resources and Services Ad9 ministration to such Assistant Secretary; 

10 ‘‘(3) exercise the responsibilities and authorities 

11 of the Secretary with respect to the coordination of— 

12 ‘‘(A) the Public Health Emergency Pre13 paredness Cooperative Agreement Program pur14 suant to section 319C–1; 

15 ‘‘(B) the Strategic National Stockpile pur16 suant to section 319F–2; and 

17 ‘‘(C) the Cities Readiness Initiative; and 

18 ‘‘(4) assume other duties as determined appro19 priate by the Secretary.’’; and 

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

21 ‘‘(d) PUBLIC HEALTH EMERGENCY MEDICAL COUN22 TERMEASURES ENTERPRISE STRATEGY AND IMPLEMENTA23 TION PLAN.— 

24 ‘‘(1) IN GENERAL.—Not later than 180 days 

25 after the date of enactment of this subsection, and 
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1 every year thereafter, the Assistant Secretary for Pre2 paredness and Response shall develop and submit to 

3 the appropriate committees of Congress a coordinated 

4 strategy and accompanying implementation plan for 

5 medical countermeasures to address chemical, biologi6 cal, radiological, and nuclear threats. In developing 

7 such a plan, the Assistant Secretary for Preparedness 

8 and Response shall consult with the Director of the 

9 Biomedical Advanced Research and Development Au10 thority, the Director of the National Institutes of 

11 Health, the Director of the Centers for Disease Control 

12 and Prevention, and the Commissioner of Food and 

13 Drugs. Such strategy and plan shall be known as the 

14 ‘Public Health Emergency Medical Countermeasures 

15 Enterprise Strategy and Implementation Plan’. 

16 ‘‘(2) REQUIREMENTS.—The plan under para17 graph (1) shall— 

18 ‘‘(A) describe the chemical, biological, radio19 logical, and nuclear agent or agents that may 

20 present a threat to the Nation and the cor21 responding efforts to develop qualified counter22 measures (as defined in section 319F–1), secu23 rity countermeasures (as defined in section 

24 319F–2), or qualified pandemic or epidemic 
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1 products (as defined in section 319F–3) for each 

2 threat; 

3 ‘‘(B) evaluate the progress of all activities 

4 with respect to such countermeasures or prod5 ucts, including research, advanced research, de6 velopment, procurement, stockpiling, deployment, 

7 distribution, and utilization; 

8 ‘‘(C) identify and prioritize near-, mid-, 

9 and long-term needs with respect to such coun10 termeasures or products to address a chemical, 

11 biological, radiological, and nuclear threat or 

12 threats; 

13 ‘‘(D) identify, with respect to each category 

14 of threat, a summary of all awards and con15 tracts, including advanced research and develop16 ment and procurement, that includes— 

17 ‘‘(i) the time elapsed from the issuance 

18 of the initial solicitation or request for a 

19 proposal to the adjudication (such as the 

20 award, denial of award, or solicitation ter21 mination); and 

22 ‘‘(ii) an identification of projected 

23 timelines, anticipated funding allocations, 

24 benchmarks, and milestones for each med25 ical countermeasure priority under sub-
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1 paragraph (C), including projected needs 

2 with regard to replenishment of the Stra3 tegic National Stockpile; 

4 ‘‘(E) be informed by the recommendations of 

5 the National Biodefense Science Board pursuant 

6 to section 319M; 

7 ‘‘(F) evaluate progress made in meeting 

8 timelines, allocations, benchmarks, and mile9 stones identified under subparagraph (D)(ii); 

10 ‘‘(G) report on the amount of funds avail11 able for procurement in the special reserve fund 

12 as defined in section 319F–2(h) and the impact 

13 this funding will have on meeting the require14 ments under section 319F–2; 

15 ‘‘(H) incorporate input from Federal, State, 

16 local, and tribal stakeholders; 

17 ‘‘(I) identify the progress made in meeting 

18 the medical countermeasure priorities for at-risk 

19 individuals (as defined in 2802(b)(4)(B)), as ap20 plicable under subparagraph (C), including with 

21 regard to the projected needs for related stock22 piling and replenishment of the Strategic Na23 tional Stockpile, including by addressing the 

24 needs of pediatric populations with respect to 
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1 such countermeasures and products in the Stra2 tegic National Stockpile, including— 

3 ‘‘(i) a list of such countermeasures and 

4 products necessary to address the needs of 

5 pediatric populations; 

6 ‘‘(ii) a description of measures taken to 

7 coordinate with the Office of Pediatric 

8 Therapeutics of the Food and Drug Admin9 istration to maximize the labeling, dosages, 

10 and formulations of such countermeasures 

11 and products for pediatric populations; 

12 ‘‘(iii) a description of existing gaps in 

13 the Strategic National Stockpile and the de14 velopment of such countermeasures and 

15 products to address the needs of pediatric 

16 populations; and 

17 ‘‘(iv) an evaluation of the progress 

18 made in addressing priorities identified 

19 pursuant to subparagraph (C); 

20 ‘‘(J) identify the use of authority and ac21 tivities undertaken pursuant to sections 319F– 

22 1(b)(1), 319F–1(b)(2), 319F–1(b)(3), 319F–1(c), 

23 319F–1(d), 319F–1(e), 319F–2(c)(7)(C)(iii), 

24 319F–2(c)(7)(C)(iv), and 319F–2(c)(7)(C)(v) of 

25 this Act, and subsections (a)(1), (b)(1), and (e) 
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1 of section 564 of the Federal Food, Drug, and 

2 Cosmetic Act, by summarizing— 

3 ‘‘(i) the particular actions that were 

4 taken under the authorities specified, in5 cluding, as applicable, the identification of 

6 the threat agent, emergency, or the bio7 medical countermeasure with respect to 

8 which the authority was used; 

9 ‘‘(ii) the reasons underlying the deci10 sion to use such authorities, including, as 

11 applicable, the options that were considered 

12 and rejected with respect to the use of such 

13 authorities; 

14 ‘‘(iii) the number of, nature of, and 

15 other information concerning the persons 

16 and entities that received a grant, coopera17 tive agreement, or contract pursuant to the 

18 use of such authorities, and the persons and 

19 entities that were considered and rejected 

20 for such a grant, cooperative agreement, or 

21 contract, except that the report need not dis22 close the identity of any such person or en23 tity; 

24 ‘‘(iv) whether, with respect to each pro25 curement that is approved by the President 
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1 under section 319F–2(c)(6), a contract was 

2 entered into within one year after such ap3 proval by the President; and 

4 ‘‘(v) with respect to section 319F–1(d), 

5 for the one-year period for which the report 

6 is submitted, the number of persons who 

7 were paid amounts totaling $100,000 or 

8 greater and the number of persons who were 

9 paid amounts totaling at least $50,000 but 

10 less than $100,000; and 

11 ‘‘(K) be made publicly available. 

12 ‘‘(3) GAO REPORT.— 

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

14 after the date of the submission to the Congress 

15 of the first Public Health Emergency Medical 

16 Countermeasures Enterprise Strategy and Imple17 mentation Plan, the Comptroller General of the 

18 United States shall conduct an independent eval19 uation, and submit to the appropriate commit20 tees of Congress a report, concerning such Strat21 egy and Implementation Plan. 

22 ‘‘(B) CONTENT.—The report described in 

23 subparagraph (A) shall review and assess— 

24 ‘‘(i) the near-term, mid-term, and 

25 long-term medical countermeasure needs 
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1 and identified priorities of the Federal Gov2 ernment pursuant to paragraph (2)(C); 

3 ‘‘(ii) the activities of the Department of 

4 Health and Human Services with respect to 

5 advanced research and development pursu6 ant to section 319L; and 

7 ‘‘(iii) the progress made toward meet8 ing the timelines, allocations, benchmarks, 

9 and milestones identified in the Public 

10 Health Emergency Medical Counter11 measures Enterprise Strategy and Imple12 mentation Plan under this subsection. 

13 ‘‘(e) PROTECTION OF NATIONAL SECURITY.—In car14 rying out subsections (b)(7) and (d), the Secretary shall en15 sure that information and items that could compromise na16 tional security, contain confidential commercial informa17 tion, or contain proprietary information are not dis18 closed.’’. 

19 (b) INTERAGENCY COORDINATION PLAN.—In the first 

20 Public Health Emergency Countermeasures Enterprise 

21 Strategy and Implementation Plan submitted under sub22 section (d) of section 2811 of the Public Health Service Act 

23 (42 U.S.C. 300hh–10) (as added by subsection (a)(3)), the 

24 Secretary of Health and Human Services, in consultation 

25 with the Secretary of Defense, shall include a description 
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1 of the manner in which the Department of Health and 

2 Human Services is coordinating with the Department of 

3 Defense regarding countermeasure activities to address 

4 chemical, biological, radiological, and nuclear threats. Such 

5 report shall include information with respect to— 

6 (1) the research, advanced research, development, 

7 procurement, stockpiling, and distribution of counter8 measures to meet identified needs; and 

9 (2) the coordination of efforts between the De10 partment of Health and Human Services and the De11 partment of Defense to address countermeasure needs 

12 for various segments of the population. 

13 SEC. 103. NATIONAL ADVISORY COMMITTEE ON CHILDREN 

14 AND DISASTERS. 

15 Subtitle B of title XXVIII of the Public Health Service 

16 Act (42 U.S.C. 300hh et seq.) is amended by inserting after 

17 section 2811 the following: 

18 ‘‘SEC. 2811A. NATIONAL ADVISORY COMMITTEE ON CHIL19 DREN AND DISASTERS. 

20 ‘‘(a) ESTABLISHMENT.—The Secretary, in consulta21 tion with the Secretary of Homeland Security, shall estab22 lish an advisory committee to be known as the ‘National 

23 Advisory Committee on Children and Disasters’ (referred 

24 to in this section as the ‘Advisory Committee’). 

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

3 2814, as applicable and appropriate; 

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

5 the medical and public health needs of children as 

6 they relate to preparation for, response to, and recov7 ery from all-hazards emergencies; and 

8 ‘‘(3) provide advice and consultation with re9 spect to State emergency preparedness and response 

10 activities and children, including related drills and 

11 exercises pursuant to the preparedness goals under 

12 section 2802(b). 

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

14 may provide advice and recommendations to the Secretary 

15 with respect to children and the medical and public health 

16 grants and cooperative agreements as applicable to pre17 paredness and response activities authorized under this title 

18 and title III. 

19 ‘‘(d) MEMBERSHIP.— 

20 ‘‘(1) IN GENERAL.—The Secretary, in consulta21 tion with such other Secretaries as may be appro22 priate, shall appoint not to exceed 15 members to the 

23 Advisory Committee. In appointing such members, 

24 the Secretary shall ensure that the total membership 

25 of the Advisory Committee is an odd number. 
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1 ‘‘(2) REQUIRED MEMBERS.—The Secretary, in 

2 consultation with such other Secretaries as may be 

3 appropriate, may appoint to the Advisory Committee 

4 under paragraph (1) such individuals as may be ap5 propriate to perform the duties described in sub6 sections (b) and (c), which may include— 

7 ‘‘(A) the Assistant Secretary for Prepared8 ness and Response; 

9 ‘‘(B) the Director of the Biomedical Ad10 vanced Research and Development Authority; 

11 ‘‘(C) the Director of the Centers for Disease 

12 Control and Prevention; 

13 ‘‘(D) the Commissioner of Food and Drugs; 

14 ‘‘(E) the Director of the National Institutes 

15 of Health; 

16 ‘‘(F) the Assistant Secretary of the Admin17 istration for Children and Families; 

18 ‘‘(G) the Administrator of the Federal 

19 Emergency Management Agency; 

20 ‘‘(H) at least two non-Federal health care 

21 professionals with expertise in pediatric medical 

22 disaster planning, preparedness, response, or re23 covery; 

24 ‘‘(I) at least two representatives from State, 

25 local, territorial, or tribal agencies with expertise 
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1 in pediatric disaster planning, preparedness, re2 sponse, or recovery; and 

3 ‘‘(J) representatives from such Federal 

4 agencies (such as the Department of Education 

5 and the Department of Homeland Security) as 

6 determined necessary to fulfill the duties of the 

7 Advisory Committee, as established under sub8 sections (b) and (c). 

9 ‘‘(e) MEETINGS.—The Advisory Committee shall meet 

10 not less than biannually. 

11 ‘‘(f) SUNSET.—The Advisory Committee shall termi12 nate on September 30, 2018.’’. 

13 SEC. 104. MODERNIZATION OF THE NATIONAL DISASTER 

14 MEDICAL SYSTEM. 

15 Section 2812 of the Public Health Service Act (42 

16 U.S.C. 300hh–11) is amended— 

17 (1) in subsection (a)(3)— 

18 (A) in subparagraph (A), in clause (i) by 

19 inserting ‘‘, including at-risk individuals as ap20 plicable’’ after ‘‘victims of a public health emer21 gency’’; 

22 (B) by redesignating subparagraph (C) as 

23 subparagraph (E); and 

24 (C) by inserting after subparagraph (B), 

25 the following: 
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1 ‘‘(C) CONSIDERATIONS FOR AT-RISK POPU2 LATIONS.—The Secretary shall take steps to en3 sure that an appropriate specialized and focused 

4 range of public health and medical capabilities 

5 are represented in the National Disaster Medical 

6 System, which take into account the needs of at7 risk individuals, in the event of a public health 

8 emergency.’’. 

9 ‘‘(D) ADMINISTRATION.—The Secretary 

10 may determine and pay claims for reimburse11 ment for services under subparagraph (A) di12 rectly or through contracts that provide for pay13 ment in advance or by way of reimbursement.’’; 

14 and 

15 (2) in subsection (g), by striking ‘‘such sums as 

16 may be necessary for each of the fiscal years 2007 

17 through 2011’’ and inserting ‘‘$52,700,000 for each of 

18 fiscal years 2014 through 2018’’. 

19 SEC. 105. CONTINUING THE ROLE OF THE DEPARTMENT OF 

20 VETERANS AFFAIRS. 

21 Section 8117(g) of title 38, United States Code, is 

22 amended by striking ‘‘such sums as may be necessary to 

23 carry out this section for each of fiscal years 2007 through 

24 2011’’ and inserting ‘‘$155,300,000 for each of fiscal years 

25 2014 through 2018 to carry out this section’’. 
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1 TITLE II—OPTIMIZING STATE 

2 AND LOCAL ALL-HAZARDS 

3 PREPAREDNESS AND RE4 SPONSE 

5 SEC. 201. TEMPORARY REASSIGNMENT OF STATE AND 

6 LOCAL PERSONNEL DURING A PUBLIC 

7 HEALTH EMERGENCY. 

8 Section 319 of the Public Health Service Act (42 

9 U.S.C. 247d) is amended by adding at the end the fol10 lowing: 

11 ‘‘(e) TEMPORARY REASSIGNMENT OF STATE AND

12 LOCAL PERSONNEL DURING A PUBLIC HEALTH EMER13 GENCY.— 

14 ‘‘(1) EMERGENCY REASSIGNMENT OF FEDERALLY

15 FUNDED PERSONNEL.—Notwithstanding any other 

16 provision of law, and subject to paragraph (2), upon 

17 request by the Governor of a State or a tribal organi18 zation or such Governor or tribal organization’s des19 ignee, the Secretary may authorize the requesting 

20 State or Indian tribe to temporarily reassign, for 

21 purposes of immediately addressing a public health 

22 emergency in the State or Indian tribe, State and 

23 local public health department or agency personnel 

24 funded in whole or in part through programs author25 ized under this Act, as appropriate. 
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1 ‘‘(2) ACTIVATION OF EMERGENCY REASSIGN2 MENT.— 

3 ‘‘(A) PUBLIC HEALTH EMERGENCY.—The 

4 Secretary may authorize a temporary reassign5 ment of personnel under paragraph (1) only dur6 ing the period of a public health emergency de7 termined pursuant to subsection (a). 

8 ‘‘(B) CONTENTS OF REQUEST.—To seek au9 thority for a temporary reassignment of per10 sonnel under paragraph (1), the Governor of a 

11 State or a tribal organization shall submit to the 

12 Secretary a request for such reassignment flexi13 bility and shall include in the request each of the 

14 following: 

15 ‘‘(i) An assurance that the public 

16 health emergency in the geographic area of 

17 the requesting State or Indian tribe cannot 

18 be adequately and appropriately addressed 

19 by the public health workforce otherwise 

20 available. 

21 ‘‘(ii) An assurance that the public 

22 health emergency would be addressed more 

23 efficiently and effectively through the re24 quested temporary reassignment of State 
27 

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1 and local personnel described in paragraph 

2 (1). 

3 ‘‘(iii) An assurance that the requested 

4 temporary reassignment of personnel is con5 sistent with any applicable All-Hazards 

6 Public Health Emergency Preparedness and 

7 Response Plan under section 319C–1. 

8 ‘‘(iv) An identification of— 

9 ‘‘(I) each Federal program from 

10 which personnel would be temporarily 

11 reassigned pursuant to the requested 

12 authority; and 

13 ‘‘(II) the number of personnel who 

14 would be so reassigned from each such 

15 program. 

16 ‘‘(v) Such other information and as17 surances upon which the Secretary and 

18 Governor of a State or tribal organization 

19 agree. 

20 ‘‘(C) CONSIDERATION.—In reviewing a re21 quest for temporary reassignment under para22 graph (1), the Secretary shall consider the degree 

23 to which the program or programs funded in 

24 whole or in part by programs authorized under 
28 

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1 this Act would be adversely affected by the reas2 signment. 

3 ‘‘(D) TERMINATION AND EXTENSION.— 

4 ‘‘(i) TERMINATION.—A State or Indian 

5 tribe’s temporary reassignment of personnel 

6 under paragraph (1) shall terminate upon 

7 the earlier of the following: 

8 ‘‘(I) The Secretary’s determina9 tion that the public health emergency 

10 no longer exists. 

11 ‘‘(II) Subject to clause (ii), the ex12 piration of the 30-day period following 

13 the date on which the Secretary ap14 proved the State or Indian tribe’s re15 quest for such reassignment flexibility. 

16 ‘‘(ii) EXTENSION OF REASSIGNMENT

17 FLEXIBILITY.—The Secretary may extend 

18 reassignment flexibility of personnel under 

19 paragraph (1) beyond the date otherwise 

20 applicable under clause (i)(II) if the public 

21 health emergency still exists as of such date, 

22 but only if— 

23 ‘‘(I) the State or Indian tribe that 

24 submitted the initial request for a tem25 porary reassignment of personnel sub-
29 

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1 mits a request for an extension of such 

2 temporary reassignment; and 

3 ‘‘(II) the request for an extension 

4 contains the same information and as5 surances necessary for the approval of 

6 an initial request for such temporary 

7 reassignment pursuant to subpara8 graph (B). 

9 ‘‘(3) VOLUNTARY NATURE OF TEMPORARY REAS10 SIGNMENT OF STATE AND LOCAL PERSONNEL.— 

11 ‘‘(A) IN GENERAL.—Unless otherwise pro12 vided under the law or regulation of the State or 

13 Indian tribe that receives authorization for tem14 porary reassignment of personnel under para15 graph (1), personnel eligible for reassignment 

16 pursuant to such authorization— 

17 ‘‘(i) shall have the opportunity to vol18 unteer for temporary reassignment; and 

19 ‘‘(ii) shall not be required to agree to 

20 a temporary reassignment. 

21 ‘‘(B) PROHIBITION ON CONDITIONING FED22 ERAL AWARDS.—The Secretary may not condi23 tion the award of a grant, contract, or coopera24 tive agreement under this Act on the requirement 

25 that a State or Indian tribe require that per-
30 

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1 sonnel eligible for reassignment pursuant to an 

2 authorization under paragraph (1) agree to such 

3 reassignment. 

4 ‘‘(4) NOTICE TO CONGRESS.—The Secretary shall 

5 give notice to the Congress in conjunction with the 

6 approval under this subsection of— 

7 ‘‘(A) any initial request for temporary reas8 signment of personnel; and 

9 ‘‘(B) any request for an extension of such 

10 temporary reassignment. 

11 ‘‘(5) GUIDANCE.—The Secretary shall— 

12 ‘‘(A) not later than 6 months after the en13 actment of this subsection, issue proposed guid14 ance on the temporary reassignment of personnel 

15 under this subsection; and 

16 ‘‘(B) after providing notice and a 60-day 

17 period for public comment, finalize such guid18 ance. 

19 ‘‘(6) REPORT TO CONGRESS.—Not later than 4 

20 years after the date of enactment of the Pandemic and 

21 All-Hazards Preparedness Reauthorization Act of 

22 2013, the Comptroller General of the United States 

23 shall conduct an independent evaluation, and submit 

24 to the appropriate committees of the Congress a re-
31 

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1 port, on temporary reassignment under this sub2 section, including— 

3 ‘‘(A) a description of how, and under what 

4 circumstances, such temporary reassignment has 

5 been used by States and Indian tribes; 

6 ‘‘(B) an analysis of how such temporary re7 assignment has assisted States and Indian tribes 

8 in responding to public health emergencies; 

9 ‘‘(C) an evaluation of how such temporary 

10 reassignment has improved operational effi11 ciencies in responding to public health emer12 gencies; 

13 ‘‘(D) an analysis of the extent to which, if 

14 any, Federal programs from which personnel 

15 have been temporarily reassigned have been ad16 versely affected by the reassignment; and 

17 ‘‘(E) recommendations on how medical 

18 surge capacity could be improved in responding 

19 to public health emergencies and the impact of 

20 the reassignment flexibility under this section on 

21 such surge capacity. 

22 ‘‘(7) DEFINITIONS.—In this subsection— 

23 ‘‘(A) the terms ‘Indian tribe’ and ‘tribal or24 ganization’ have the meanings given such terms 
32 

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1 in section 4 of the Indian Self-Determination 

2 and Education Assistance Act; and 

3 ‘‘(B) the term ‘State’ includes, in addition 

4 to the entities listed in the definition of such 

5 term in section 2, the Freely Associated States. 

6 ‘‘(8) SUNSET.—This subsection shall terminate 

7 on September 30, 2018.’’. 

8 SEC. 202. IMPROVING STATE AND LOCAL PUBLIC HEALTH 

9 SECURITY. 

10 (a) COOPERATIVE AGREEMENTS.—Section 319C–1 of 

11 the Public Health Service Act (42 U.S.C. 247d–3a) is 

12 amended— 

13 (1) in subsection (b)(1)(C), by striking ‘‘consor14 tium of entities described in subparagraph (A)’’ and 

15 inserting ‘‘consortium of States’’; 

16 (2) in subsection (b)(2)— 

17 (A) in subparagraph (A)— 

18 (i) by striking clauses (i) and (ii) and 

19 inserting the following: 

20 ‘‘(i) a description of the activities such 

21 entity will carry out under the agreement to 

22 meet the goals identified under section 2802, 

23 including with respect to chemical, biologi24 cal, radiological, or nuclear threats, whether 
33 

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1 naturally occurring, unintentional, or delib2 erate; 

3 ‘‘(ii) a description of the activities such 

4 entity will carry out with respect to pan5 demic influenza, as a component of the ac6 tivities carried out under clause (i), and 

7 consistent with the requirements of para8 graphs (2) and (5) of subsection (g);’’; 

9 (ii) in clause (iv), by striking ‘‘and’’ at 

10 the end; and 

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

13 ‘‘(vi) a description of how, as appro14 priate, the entity may partner with relevant 

15 public and private stakeholders in public 

16 health emergency preparedness and re17 sponse; 

18 ‘‘(vii) a description of how the entity, 

19 as applicable and appropriate, will coordi20 nate with State emergency preparedness 

21 and response plans in public health emer22 gency preparedness, including State edu23 cational agencies (as defined in section 

24 9101(41) of the Elementary and Secondary 

25 Education Act of 1965) and State child care 
34 

† HR 307 EAS 

1 lead agencies (designated under section 

2 658D of the Child Care and Development 

3 Block Grant Act of 1990); 

4 ‘‘(viii) in the case of entities that oper5 ate on the United States-Mexico border or 

6 the United States-Canada border, a descrip7 tion of the activities such entity will carry 

8 out under the agreement that are specific to 

9 the border area including disease detection, 

10 identification, investigation, and prepared11 ness and response activities related to 

12 emerging diseases and infectious disease 

13 outbreaks whether naturally occurring or 

14 due to bioterrorism, consistent with the re15 quirements of this section; and 

16 ‘‘(ix) a description of any activities 

17 that such entity will use to analyze real18 time clinical specimens for pathogens of 

19 public health or bioterrorism significance, 

20 including any utilization of poison control 

21 centers;’’; and 

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

23 including addressing the needs of at-risk individ24 uals,’’ after ‘‘capabilities of such entity’’; 

25 (3) in subsection (f)— 
35 

† HR 307 EAS 

1 (A) in paragraph (2), by adding ‘‘and’’ at 

2 the end; 

3 (B) in paragraph (3), by striking ‘‘; and’’ 

4 and inserting a period; and 

5 (C) by striking paragraph (4); 

6 (4) in subsection (g)— 

7 (A) in paragraph (1), by striking subpara8 graph (A) and inserting the following: 

9 ‘‘(A) include outcome goals representing 

10 operational achievements of the National Pre11 paredness Goals developed under section 2802(b) 

12 with respect to all-hazards, including chemical, 

13 biological, radiological, or nuclear threats; and’’; 

14 and 

15 (B) in paragraph (2)(A), by adding at the 

16 end the following: ‘‘The Secretary shall periodi17 cally update, as necessary and appropriate, such 

18 pandemic influenza plan criteria and shall re19 quire the integration of such criteria into the 

20 benchmarks and standards described in para21 graph (1).’’; 

22 (5) by striking subsection (h); 

23 (6) by redesignating subsections (i), (j), and (k) 

24 as subsections (h), (i), and (j), respectively; 

25 (7) in subsection (h), as so redesignated— 
36 

† HR 307 EAS 

1 (A) in paragraph (1)— 

2 (i) in subparagraph (A)— 

3 (I) by striking ‘‘$824,000,000 for 

4 fiscal year 2007, of which $35,000,000 

5 shall be used to carry out subsection 

6 (h),’’ and inserting ‘‘$641,900,000 for 

7 fiscal year 2014’’; and 

8 (II) by striking ‘‘such sums as 

9 may be necessary for each of fiscal 

10 years 2008 through 2011’’ and insert11 ing ‘‘$641,900,000 for each of fiscal 

12 years 2015 through 2018’’; 

13 (ii) by striking subparagraph (B); 

14 (iii) by redesignating subparagraphs 

15 (C) and (D) as subparagraphs (B) and (C), 

16 respectively; and 

17 (iv) in subparagraph (C), as so redes18 ignated, by striking ‘‘subparagraph (C)’’ 

19 and inserting ‘‘subparagraph (B)’’; 

20 (B) in subparagraphs (C) and (D) of para21 graph (3), by striking ‘‘(1)(A)(i)(I)’’ each place 

22 it appears and inserting ‘‘(1)(A)’’; 

23 (C) in paragraph (4)(B), by striking ‘‘sub24 section (c)’’ and inserting ‘‘subsection (b)’’; and 

25 (D) by adding at the end the following: 
37 

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1 ‘‘(7) AVAILABILITY OF COOPERATIVE AGREEMENT

2 FUNDS.— 

3 ‘‘(A) IN GENERAL.—Amounts provided to 

4 an eligible entity under a cooperative agreement 

5 under subsection (a) for a fiscal year and re6 maining unobligated at the end of such year 

7 shall remain available to such entity for the next 

8 fiscal year for the purposes for which such funds 

9 were provided. 

10 ‘‘(B) FUNDS CONTINGENT ON ACHIEVING

11 BENCHMARKS.—The continued availability of 

12 funds under subparagraph (A) with respect to an 

13 entity shall be contingent upon such entity 

14 achieving the benchmarks and submitting the 

15 pandemic influenza plan as described in sub16 section (g).’’; and 

17 (8) in subsection (i), as so redesignated— 

18 (A) in paragraph (1)(E), by striking ‘‘sub19 section (k)’’ and inserting ‘‘subsection (j)’’; 

20 (B) by striking paragraph (3). 

21 (b) VACCINE TRACKING AND DISTRIBUTION.—Section 

22 319A(e) of the Public Health Service Act (42 U.S.C. 247d– 

23 1(e)) is amended by striking ‘‘such sums for each of fiscal 

24 years 2007 through 2011’’ and inserting ‘‘$30,800,000 for 

25 each of fiscal years 2014 through 2018’’. 
38 

† HR 307 EAS 

1 (c) TECHNICAL AND CONFORMING AMENDMENTS.— 

2 (1) Section 319C–1(b)(1)(B) of the Public Health 

3 Service Act (42 U.S.C. 247d–3a(b)(1)(B)) is amended 

4 by striking ‘‘subsection (i)(4)’’ and inserting ‘‘sub5 section (h)(4)’’. 

6 (2) Section 319C–2 of the Public Health Service 

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

8 (A) in subsection (i), by striking ‘‘(j), and 

9 (k)’’ and inserting ‘‘(i), and (j)’’; and 

10 (B) in subsection (j)(3), by striking ‘‘319C– 

11 1(i)’’ and inserting ‘‘319C–1(h)’’. 

12 SEC. 203. HOSPITAL PREPAREDNESS AND MEDICAL SURGE 

13 CAPACITY. 

14 (a) ALL-HAZARDS PUBLIC HEALTH AND MEDICAL

15 RESPONSE CURRICULA AND TRAINING.—Section 

16 319F(a)(5)(B) of the Public Health Service Act (42 U.S.C. 

17 247d–6(a)(5)(B)) is amended by striking ‘‘public health or 

18 medical’’ and inserting ‘‘public health, medical, or dental’’. 

19 (b) ENCOURAGING HEALTH PROFESSIONAL VOLUN20 TEERS.— 

21 (1) EMERGENCY SYSTEM FOR ADVANCE REG22 ISTRATION OF VOLUNTEER HEALTH PROFES23 SIONALS.—Section 319I(k) of the Public Health Serv24 ice Act (42 U.S.C. 247d–7b(k)) is amended by strik25 ing ‘‘$2,000,000 for fiscal year 2002, and such sums 
39 

† HR 307 EAS 

1 as may be necessary for each of the fiscal years 2003 

2 through 2011’’ and inserting ‘‘$5,000,000 for each of 

3 fiscal years 2014 through 2018’’. 

4 (2) VOLUNTEERS.—Section 2813 of the Public 

5 Health Service Act (42 U.S.C. 300hh–15) is amend6 ed— 

7 (A) in subsection (d)(2), by adding at the 

8 end the following: ‘‘Such training exercises shall, 

9 as appropriate and applicable, incorporate the 

10 needs of at-risk individuals in the event of a 

11 public health emergency.’’; and 

12 (B) in subsection (i), by striking 

13 ‘‘$22,000,000 for fiscal year 2007, and such sums 

14 as may be necessary for each of fiscal years 2008 

15 through 2011’’ and inserting ‘‘$11,200,000 for 

16 each of fiscal years 2014 through 2018’’. 

17 (c) PARTNERSHIPS FOR STATE AND REGIONAL PRE18 PAREDNESS TO IMPROVE SURGE CAPACITY.—Section 

19 319C–2 of the Public Health Service Act (42 U.S.C. 247d– 

20 3b) is amended— 

21 (1) in subsection (a), by inserting ‘‘, including, 

22 as appropriate, capacity and preparedness to address 

23 the needs of children and other at-risk individuals’’ 

24 before the period at the end; 
40 

† HR 307 EAS 

1 (2) in subsection (b)(1)(A)(ii), by striking ‘‘cen2 ters, primary’’ and inserting ‘‘centers, community 

3 health centers, primary’’; 

4 (3) by striking subsection (c) and inserting the 

5 following: 

6 ‘‘(c) USE OF FUNDS.—An award under subsection (a) 

7 shall be expended for activities to achieve the preparedness 

8 goals described under paragraphs (1), (3), (4), (5), and (6) 

9 of section 2802(b) with respect to all-hazards, including 

10 chemical, biological, radiological, or nuclear threats.’’; 

11 (4) by striking subsection (g) and inserting the 

12 following: 

13 ‘‘(g) COORDINATION.— 

14 ‘‘(1) LOCAL RESPONSE CAPABILITIES.—An eligi15 ble entity shall, to the extent practicable, ensure that 

16 activities carried out under an award under sub17 section (a) are coordinated with activities of relevant 

18 local Metropolitan Medical Response Systems, local 

19 Medical Reserve Corps, the local Cities Readiness Ini20 tiative, and local emergency plans. 

21 ‘‘(2) NATIONAL COLLABORATION.—Partnerships 

22 consisting of one or more eligible entities under this 

23 section may, to the extent practicable, collaborate 

24 with other partnerships consisting of one or more eli25 gible entities under this section for purposes of na-
41 

† HR 307 EAS 

1 tional coordination and collaboration with respect to 

2 activities to achieve the preparedness goals described 

3 under paragraphs (1), (3), (4), (5), and (6) of section 

4 2802(b).’’; 

5 (5) in subsection (i)— 

6 (A) by striking ‘‘The requirements of’’ and 

7 inserting the following: 

8 ‘‘(1) IN GENERAL.—The requirements of’’; and 

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

10 ‘‘(2) MEETING GOALS OF NATIONAL HEALTH SE11 CURITY STRATEGY.—The Secretary shall implement 

12 objective, evidence-based metrics to ensure that enti13 ties receiving awards under this section are meeting, 

14 to the extent practicable, the applicable goals of the 

15 National Health Security Strategy under section 

16 2802.’’; and 

17 (6) in subsection (j)— 

18 (A) by amending paragraph (1) to read as 

19 follows: 

20 ‘‘(1) IN GENERAL.—For purposes of carrying out 

21 this section, there is authorized to be appropriated 

22 $374,700,000 for each of fiscal years 2014 through 

23 2018.’’; and 

24 (B) by adding at the end the following: 
42 

† HR 307 EAS 

1 ‘‘(4) AVAILABILITY OF COOPERATIVE AGREEMENT

2 FUNDS.— 

3 ‘‘(A) IN GENERAL.—Amounts provided to 

4 an eligible entity under a cooperative agreement 

5 under subsection (a) for a fiscal year and re6 maining unobligated at the end of such year 

7 shall remain available to such entity for the next 

8 fiscal year for the purposes for which such funds 

9 were provided. 

10 ‘‘(B) FUNDS CONTINGENT ON ACHIEVING

11 BENCHMARKS.—The continued availability of 

12 funds under subparagraph (A) with respect to an 

13 entity shall be contingent upon such entity 

14 achieving the benchmarks and submitting the 

15 pandemic influenza plan as required under sub16 section (i).’’. 

17 SEC. 204. ENHANCING SITUATIONAL AWARENESS AND BIO18 SURVEILLANCE. 

19 (a) IN GENERAL.—Section 319D of the Public Health 

20 Service Act (42 U.S.C. 247d–4) is amended— 

21 (1) in subsection (b)— 

22 (A) in paragraph (1)(B), by inserting ‘‘poi23 son control centers,’’ after ‘‘hospitals,’’; 

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

25 the period at the end the following: ‘‘, allowing 
43 

† HR 307 EAS 

1 for coordination to maximize all-hazards medical 

2 and public health preparedness and response and 

3 to minimize duplication of effort’’; and 

4 (C) in paragraph (3), by inserting before 

5 the period at the end the following: ‘‘and update 

6 such standards as necessary’’; 

7 (2) by striking subsection (c); 

8 (3) by redesignating subsections (d) through (g) 

9 as subsections (c) through (f), respectively; 

10 (4) in subsection (c), as so redesignated— 

11 (A) in the subsection heading, by striking 

12 ‘‘PUBLIC HEALTH SITUATIONAL AWARENESS’’ 

13 and inserting ‘‘MODERNIZING PUBLIC HEALTH

14 SITUATIONAL AWARENESS AND BIOSURVEIL15 LANCE’’; 

16 (B) in paragraph (1)— 

17 (i) by striking ‘‘Pandemic and All18 Hazards Preparedness Act’’ and inserting 

19 ‘‘Pandemic and All-Hazards Preparedness 

20 Reauthorization Act of 2013’’; and 

21 (ii) by inserting ‘‘, novel emerging 

22 threats,’’ after ‘‘disease outbreaks’’; 

23 (C) by striking paragraph (2) and inserting 

24 the following: 
44 

† HR 307 EAS 

1 ‘‘(2) STRATEGY AND IMPLEMENTATION PLAN.— 

2 Not later than 180 days after the date of enactment 

3 of the Pandemic and All-Hazards Preparedness Reau4 thorization Act of 2013, the Secretary shall submit to 

5 the appropriate committees of Congress a coordinated 

6 strategy and an accompanying implementation plan 

7 that identifies and demonstrates the measurable steps 

8 the Secretary will carry out to— 

9 ‘‘(A) develop, implement, and evaluate the 

10 network described in paragraph (1), utilizing the 

11 elements described in paragraph (3); 

12 ‘‘(B) modernize and enhance biosurveillance 

13 activities; and 

14 ‘‘(C) improve information sharing, coordi15 nation, and communication among disparate 

16 biosurveillance systems supported by the Depart17 ment of Health and Human Services.’’; 

18 (D) in paragraph (3)(D), by inserting 

19 ‘‘community health centers, health centers’’ after 

20 ‘‘poison control,’’; 

21 (E) in paragraph (5), by striking subpara22 graph (A) and inserting the following: 

23 ‘‘(A) utilize applicable interoperability 

24 standards as determined by the Secretary, and 

25 in consultation with the Office of the National 
45 

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1 Coordinator for Health Information Technology, 

2 through a joint public and private sector proc3 ess;’’; and 

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

5 ‘‘(6) CONSULTATION WITH THE NATIONAL BIO6 DEFENSE SCIENCE BOARD.—In carrying out this sec7 tion and consistent with section 319M, the National 

8 Biodefense Science Board shall provide expert advice 

9 and guidance, including recommendations, regarding 

10 the measurable steps the Secretary should take to 

11 modernize and enhance biosurveillance activities pur12 suant to the efforts of the Department of Health and 

13 Human Services to ensure comprehensive, real-time, 

14 all-hazards biosurveillance capabilities. In complying 

15 with the preceding sentence, the National Biodefense 

16 Science Board shall— 

17 ‘‘(A) identify the steps necessary to achieve 

18 a national biosurveillance system for human 

19 health, with international connectivity, where 

20 appropriate, that is predicated on State, re21 gional, and community level capabilities and 

22 creates a networked system to allow for two-way 

23 information flow between and among Federal, 

24 State, and local government public health au25 thorities and clinical health care providers; 
46 

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1 ‘‘(B) identify any duplicative surveillance 

2 programs under the authority of the Secretary, 

3 or changes that are necessary to existing pro4 grams, in order to enhance and modernize such 

5 activities, minimize duplication, strengthen and 

6 streamline such activities under the authority of 

7 the Secretary, and achieve real-time and appro8 priate data that relate to disease activity, both 

9 human and zoonotic; and 

10 ‘‘(C) coordinate with applicable existing ad11 visory committees of the Director of the Centers 

12 for Disease Control and Prevention, including 

13 such advisory committees consisting of represent14 atives from State, local, and tribal public health 

15 authorities and appropriate public and private 

16 sector health care entities and academic institu17 tions, in order to provide guidance on public 

18 health surveillance activities.’’; 

19 (5) in subsection (d), as so redesignated— 

20 (A) in paragraph (1), by striking ‘‘sub21 section (d)’’ and inserting ‘‘subsection (c)’’; 

22 (B) in paragraph (4)(B), by striking ‘‘sub23 section (d)’’ and inserting ‘‘subsection (c)’’; and 

24 (C) in paragraph (5)— 
47 

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1 (i) by striking ‘‘4 years after the date 

2 of enactment of the Pandemic and All-Haz3 ards Preparedness Act’’ and inserting ‘‘3 

4 years after the date of enactment of the 

5 Pandemic and All-Hazards Preparedness 

6 Reauthorization Act of 2013’’; and 

7 (ii) by striking ‘‘subsection (d)’’ and 

8 inserting ‘‘subsection (c)’’; 

9 (6) in subsection (f), as so redesignated, by strik10 ing ‘‘such sums as may be necessary in each of fiscal 

11 years 2007 through 2011’’ and inserting 

12 ‘‘$138,300,000 for each of fiscal years 2014 through 

13 2018’’; and 

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

15 ‘‘(g) DEFINITION.—For purposes of this section the 

16 term ‘biosurveillance’ means the process of gathering near 

17 real-time biological data that relates to human and zoonotic 

18 disease activity and threats to human or animal health, in 

19 order to achieve early warning and identification of such 

20 health threats, early detection and prompt ongoing tracking 

21 of health events, and overall situational awareness of disease 

22 activity.’’. 

23 (b) TECHNICAL AND CONFORMING AMENDMENT.—Sec24 tion 319C–1(b)(2)(D) of the Public Health Service Act (42 
48 

† HR 307 EAS 

1 U.S.C. 247d–3a(b)(2)(D)) is amended by striking ‘‘section 

2 319D(d)(3)’’ and inserting ‘‘section 319D(c)(3)’’. 

3 SEC. 205. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD 

4 REPORTS. 

5 Section 5 of the Project Bioshield Act of 2004 (42 

6 U.S.C. 247d–6c) is repealed. 

7 TITLE III—ENHANCING MEDICAL 

8 COUNTERMEASURE REVIEW 

9 SEC. 301. SPECIAL PROTOCOL ASSESSMENT. 

10 Section 505(b)(5)(B) of the Federal Food, Drug, and 

11 Cosmetic Act (21 U.S.C. 355(b)(5)(B)) is amended by strik12 ing ‘‘size of clinical trials intended’’ and all that follows 

13 through ‘‘. The sponsor or applicant’’ and inserting the fol14 lowing: ‘‘size— 

15 ‘‘(i)(I) of clinical trials intended to form the pri16 mary basis of an effectiveness claim; or 

17 ‘‘(II) in the case where human efficacy studies 

18 are not ethical or feasible, of animal and any associ19 ated clinical trials which, in combination, are in20 tended to form the primary basis of an effectiveness 

21 claim; or 

22 ‘‘(ii) with respect to an application for approval 

23 of a biological product under section 351(k) of the 

24 Public Health Service Act, of any necessary clinical 

25 study or studies. 
49 

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1 The sponsor or applicant’’. 

2 SEC. 302. AUTHORIZATION FOR MEDICAL PRODUCTS FOR 

3 USE IN EMERGENCIES. 

4 (a) IN GENERAL.—Section 564 of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) is amend6 ed— 

7 (1) in subsection (a)— 

8 (A) in paragraph (1), by striking ‘‘sections 

9 505, 510(k), and 515 of this Act’’ and inserting 

10 ‘‘any provision of this Act’’; 

11 (B) in paragraph (2)(A), by striking 

12 ‘‘under a provision of law referred to in such 

13 paragraph’’ and inserting ‘‘under section 505, 

14 510(k), or 515 of this Act or section 351 of the 

15 Public Health Service Act’’; and 

16 (C) in paragraph (3), by striking ‘‘a provi17 sion of law referred to in such paragraph’’ and 

18 inserting ‘‘a section of this Act or the Public 

19 Health Service Act referred to in paragraph 

20 (2)(A)’’; 

21 (2) in subsection (b)— 

22 (A) in the subsection heading, by striking 

23 ‘‘EMERGENCY’’ and inserting ‘‘EMERGENCY OR

24 THREAT JUSTIFYING EMERGENCY AUTHORIZED

25 USE’’; 
50 

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1 (B) in paragraph (1)— 

2 (i) in the matter preceding subpara3 graph (A), by striking ‘‘may declare an 

4 emergency’’ and inserting ‘‘may make a 

5 declaration that the circumstances exist’’; 

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

7 ‘‘specified’’; 

8 (iii) in subparagraph (B)— 

9 (I) by striking ‘‘specified’’; and 

10 (II) by striking ‘‘; or’’ and insert11 ing a semicolon; 

12 (iv) by amending subparagraph (C) to 

13 read as follows: 

14 ‘‘(C) a determination by the Secretary that 

15 there is a public health emergency, or a signifi16 cant potential for a public health emergency, 

17 that affects, or has a significant potential to af18 fect, national security or the health and security 

19 of United States citizens living abroad, and that 

20 involves a biological, chemical, radiological, or 

21 nuclear agent or agents, or a disease or condition 

22 that may be attributable to such agent or agents; 

23 or’’; and 

24 (v) by adding at the end the following: 
51 

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1 ‘‘(D) the identification of a material threat 

2 pursuant to section 319F–2 of the Public Health 

3 Service Act sufficient to affect national security 

4 or the health and security of United States citi5 zens living abroad.’’; 

6 (C) in paragraph (2)— 

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

8 clause (ii) to read as follows: 

9 ‘‘(ii) a change in the approval status of 

10 the product such that the circumstances de11 scribed in subsection (a)(2) have ceased to 

12 exist.’’; 

13 (ii) by striking subparagraph (B); and 

14 (iii) by redesignating subparagraph 

15 (C) as subparagraph (B); 

16 (D) in paragraph (4), by striking ‘‘advance 

17 notice of termination, and renewal under this 

18 subsection.’’ and inserting ‘‘, and advance notice 

19 of termination under this subsection.’’; and 

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

21 ‘‘(5) EXPLANATION BY SECRETARY.—If an au22 thorization under this section with respect to an un23 approved product or an unapproved use of an ap24 proved product has been in effect for more than 1 

25 year, the Secretary shall provide in writing to the 
52 

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1 sponsor of such product an explanation of the sci2 entific, regulatory, or other obstacles to approval, li3 censure, or clearance of such product or use, including 

4 specific actions to be taken by the Secretary and the 

5 sponsor to overcome such obstacles.’’; 

6 (3) in subsection (c)— 

7 (A) in the matter preceding paragraph 

8 (1)— 

9 (i) by inserting ‘‘the Assistant Sec10 retary for Preparedness and Response,’’ 

11 after ‘‘consultation with’’; 

12 (ii) by striking ‘‘Health and’’ and in13 serting ‘‘Health, and’’; and 

14 (iii) by striking ‘‘circumstances of the 

15 emergency involved’’ and inserting ‘‘appli16 cable circumstances described in subsection 

17 (b)(1)’’; 

18 (B) in paragraph (1), by striking ‘‘speci19 fied’’ and inserting ‘‘referred to’’; and 

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

21 taking into consideration the material threat 

22 posed by the agent or agents identified in a dec23 laration under subsection (b)(1)(D), if applica24 ble’’ after ‘‘risks of the product’’; 
53 

† HR 307 EAS 

1 (4) in subsection (d)(3), by inserting ‘‘, to the ex2 tent practicable given the circumstances of the emer3 gency,’’ after ‘‘including’’; 

4 (5) in subsection (e)— 

5 (A) in paragraph (1)(A), by striking ‘‘cir6 cumstances of the emergency’’ and inserting ‘‘ap7 plicable circumstances described in subsection 

8 (b)(1)’’; 

9 (B) in paragraph (1)(B), by amending 

10 clause (iii) to read as follows: 

11 ‘‘(iii) Appropriate conditions with re12 spect to collection and analysis of informa13 tion concerning the safety and effectiveness 

14 of the product with respect to the use of such 

15 product during the period when the author16 ization is in effect and a reasonable time 

17 following such period.’’; 

18 (C) in paragraph (2)— 

19 (i) in subparagraph (A)— 

20 (I) by striking ‘‘manufacturer of 

21 the product’’ and inserting ‘‘person’’; 

22 (II) by striking ‘‘circumstances of 

23 the emergency’’ and inserting ‘‘appli24 cable circumstances described in sub25 section (b)(1)’’; and 
54 

† HR 307 EAS 

1 (III) by inserting at the end be2 fore the period ‘‘or in paragraph 

3 (1)(B)’’; 

4 (ii) in subparagraph (B)(i), by insert5 ing before the period at the end ‘‘, except as 

6 provided in section 564A with respect to au7 thorized changes to the product expiration 

8 date’’; and 

9 (iii) by amending subparagraph (C) to 

10 read as follows: 

11 ‘‘(C) In establishing conditions under this 

12 paragraph with respect to the distribution and 

13 administration of the product for the unap14 proved use, the Secretary shall not impose condi15 tions that would restrict distribution or adminis16 tration of the product when distributed or ad17 ministered for the approved use.’’; and 

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

19 follows: 

20 ‘‘(3) GOOD MANUFACTURING PRACTICE; PRE21 SCRIPTION.—With respect to the emergency use of a 

22 product for which an authorization under this section 

23 is issued (whether an unapproved product or an un24 approved use of an approved product), the Secretary 

25 may waive or limit, to the extent appropriate given 
55 

† HR 307 EAS 

1 the applicable circumstances described in subsection 

2 (b)(1)— 

3 ‘‘(A) requirements regarding current good 

4 manufacturing practice otherwise applicable to 

5 the manufacture, processing, packing, or holding 

6 of products subject to regulation under this Act, 

7 including such requirements established under 

8 section 501 or 520(f)(1), and including relevant 

9 conditions prescribed with respect to the product 

10 by an order under section 520(f)(2); 

11 ‘‘(B) requirements established under section 

12 503(b); and 

13 ‘‘(C) requirements established under section 

14 520(e).’’; 

15 (6) in subsection (g)— 

16 (A) in the subsection heading, by inserting 

17 ‘‘REVIEW AND’’ before ‘‘REVOCATION’’; 

18 (B) in paragraph (1), by inserting after the 

19 period at the end the following: ‘‘As part of such 

20 review, the Secretary shall regularly review the 

21 progress made with respect to the approval, li22 censure, or clearance of— 

23 ‘‘(A) an unapproved product for which an 

24 authorization was issued under this section; or 
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† HR 307 EAS 

1 ‘‘(B) an unapproved use of an approved 

2 product for which an authorization was issued 

3 under this section.’’; and 

4 (C) by amending paragraph (2) to read as 

5 follows: 

6 ‘‘(2) REVISION AND REVOCATION.—The Secretary 

7 may revise or revoke an authorization under this sec8 tion if— 

9 ‘‘(A) the circumstances described under sub10 section (b)(1) no longer exist; 

11 ‘‘(B) the criteria under subsection (c) for 

12 issuance of such authorization are no longer met; 

13 or 

14 ‘‘(C) other circumstances make such revision 

15 or revocation appropriate to protect the public 

16 health or safety.’’; 

17 (7) in subsection (h)(1), by adding after the pe18 riod at the end the following: ‘‘The Secretary shall 

19 make any revisions to an authorization under this 

20 section available on the Internet Web site of the Food 

21 and Drug Administration.’’; 

22 (8) by adding at the end of subsection (j) the fol23 lowing: 

24 ‘‘(4) Nothing in this section shall be construed as 

25 authorizing a delay in the review or other consider-
57 

† HR 307 EAS 

1 ation by the Secretary of any application or submis2 sion pending before the Food and Drug Administra3 tion for a product for which an authorization under 

4 this section is issued.’’; and 

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

6 ‘‘(m) CATEGORIZATION OF LABORATORY TESTS ASSO7 CIATED WITH DEVICES SUBJECT TO AUTHORIZATION.— 

8 ‘‘(1) IN GENERAL.—In issuing an authorization 

9 under this section with respect to a device, the Sec10 retary may, subject to the provisions of this section, 

11 determine that a laboratory examination or procedure 

12 associated with such device shall be deemed, for pur13 poses of section 353 of the Public Health Service Act, 

14 to be in a particular category of examinations and 

15 procedures (including the category described by sub16 section (d)(3) of such section) if, based on the totality 

17 of scientific evidence available to the Secretary— 

18 ‘‘(A) such categorization would be beneficial 

19 to protecting the public health; and 

20 ‘‘(B) the known and potential benefits of 

21 such categorization under the circumstances of 

22 the authorization outweigh the known and poten23 tial risks of the categorization. 

24 ‘‘(2) CONDITIONS OF DETERMINATION.—The Sec25 retary may establish appropriate conditions on the 
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† HR 307 EAS 

1 performance of the examination or procedure pursu2 ant to such determination. 

3 ‘‘(3) EFFECTIVE PERIOD.—A determination 

4 under this subsection shall be effective for purposes of 

5 section 353 of the Public Health Service Act notwith6 standing any other provision of that section during 

7 the effective period of the relevant declaration under 

8 subsection (b).’’. 

9 (b) EMERGENCY USE OF MEDICAL PRODUCTS.—Sub10 chapter E of chapter V of the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 360bbb et seq.) is amended by insert12 ing after section 564 the following: 

13 ‘‘SEC. 564A. EMERGENCY USE OF MEDICAL PRODUCTS. 

14 ‘‘(a) DEFINITIONS.—In this section: 

15 ‘‘(1) ELIGIBLE PRODUCT.—The term ‘eligible 

16 product’ means a product that— 

17 ‘‘(A) is approved or cleared under this 

18 chapter or licensed under section 351 of the Pub19 lic Health Service Act; 

20 ‘‘(B)(i) is intended for use to prevent, diag21 nose, or treat a disease or condition involving a 

22 biological, chemical, radiological, or nuclear 

23 agent or agents; or 

24 ‘‘(ii) is intended for use to prevent, diag25 nose, or treat a serious or life-threatening disease 
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1 or condition caused by a product described in 

2 clause (i); and 

3 ‘‘(C) is intended for use during the cir4 cumstances under which— 

5 ‘‘(i) a determination described in sub6 paragraph (A), (B), or (C) of section 

7 564(b)(1) has been made by the Secretary of 

8 Homeland Security, the Secretary of De9 fense, or the Secretary, respectively; or 

10 ‘‘(ii) the identification of a material 

11 threat described in subparagraph (D) of sec12 tion 564(b)(1) has been made pursuant to 

13 section 319F–2 of the Public Health Service 

14 Act. 

15 ‘‘(2) PRODUCT.—The term ‘product’ means a 

16 drug, device, or biological product. 

17 ‘‘(b) EXPIRATION DATING.— 

18 ‘‘(1) IN GENERAL.—The Secretary may extend 

19 the expiration date and authorize the introduction or 

20 delivery for introduction into interstate commerce of 

21 an eligible product after the expiration date provided 

22 by the manufacturer if— 

23 ‘‘(A) the expiration date extension is in24 tended to support the United States ability to 

25 protect— 
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1 ‘‘(i) the public health; or 

2 ‘‘(ii) military preparedness and effec3 tiveness; and 

4 ‘‘(B) the expiration date extension is sup5 ported by an appropriate scientific evaluation 

6 that is conducted or accepted by the Secretary. 

7 ‘‘(2) REQUIREMENTS AND CONDITIONS.—Any ex8 tension of an expiration date under paragraph (1) 

9 shall, as part of the extension, identify— 

10 ‘‘(A) each specific lot, batch, or other unit 

11 of the product for which extended expiration is 

12 authorized; 

13 ‘‘(B) the duration of the extension; and 

14 ‘‘(C) any other requirements or conditions 

15 as the Secretary may deem appropriate for the 

16 protection of the public health, which may in17 clude requirements for, or conditions on, product 

18 sampling, storage, packaging or repackaging, 

19 transport, labeling, notice to product recipients, 

20 recordkeeping, periodic testing or retesting, or 

21 product disposition. 

22 ‘‘(3) EFFECT.—Notwithstanding any other pro23 vision of this Act or the Public Health Service Act, 

24 an eligible product shall not be considered an unap25 proved product (as defined in section 564(a)(2)(A)) 
61 

† HR 307 EAS 

1 and shall not be deemed adulterated or misbranded 

2 under this Act because, with respect to such product, 

3 the Secretary has, under paragraph (1), extended the 

4 expiration date and authorized the introduction or 

5 delivery for introduction into interstate commerce of 

6 such product after the expiration date provided by the 

7 manufacturer. 

8 ‘‘(4) EXPIRATION DATE.—For purposes of this 

9 subsection, the term ‘expiration date’ means the date 

10 established through appropriate stability testing re11 quired by the regulations issued by the Secretary to 

12 ensure that the product meets applicable standards of 

13 identity, strength, quality, and purity at the time of 

14 use. 

15 ‘‘(c) CURRENT GOOD MANUFACTURING PRACTICE.— 

16 ‘‘(1) IN GENERAL.—The Secretary may, when 

17 the circumstances of a domestic, military, or public 

18 health emergency or material threat described in sub19 section (a)(1)(C) so warrant, authorize, with respect 

20 to an eligible product, deviations from current good 

21 manufacturing practice requirements otherwise appli22 cable to the manufacture, processing, packing, or 

23 holding of products subject to regulation under this 

24 Act, including requirements under section 501 or 

25 520(f)(1) or applicable conditions prescribed with re-
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† HR 307 EAS 

1 spect to the eligible product by an order under section 

2 520(f)(2). 

3 ‘‘(2) EFFECT.—Notwithstanding any other pro4 vision of this Act or the Public Health Service Act, 

5 an eligible product shall not be considered an unap6 proved product (as defined in section 564(a)(2)(A)) 

7 and shall not be deemed adulterated or misbranded 

8 under this Act because, with respect to such product, 

9 the Secretary has authorized deviations from current 

10 good manufacturing practices under paragraph (1). 

11 ‘‘(d) EMERGENCY DISPENSING.—The requirements of 

12 sections 503(b) and 520(e) shall not apply to an eligible 

13 product, and the product shall not be considered an unap14 proved product (as defined in section 564(a)(2)(A)) and 

15 shall not be deemed adulterated or misbranded under this 

16 Act because it is dispensed without an individual prescrip17 tion, if— 

18 ‘‘(1) the product is dispensed during the cir19 cumstances described in subsection (a)(1)(C); and 

20 ‘‘(2) such dispensing without an individual pre21 scription occurs— 

22 ‘‘(A) as permitted under the law of the 

23 State in which the product is dispensed; or 

24 ‘‘(B) in accordance with an order issued by 

25 the Secretary, for the purposes and duration of 
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1 the circumstances described in subsection 

2 (a)(1)(C). 

3 ‘‘(e) EMERGENCY USE INSTRUCTIONS.— 

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

5 through an appropriate official within the Depart6 ment of Health and Human Services, may create and 

7 issue emergency use instructions to inform health care 

8 providers or individuals to whom an eligible product 

9 is to be administered concerning such product’s ap10 proved, licensed, or cleared conditions of use. 

11 ‘‘(2) EFFECT.—Notwithstanding any other pro12 visions of this Act or the Public Health Service Act, 

13 a product shall not be considered an unapproved 

14 product and shall not be deemed adulterated or mis15 branded under this Act because of the issuance of 

16 emergency use instructions under paragraph (1) with 

17 respect to such product or the introduction or delivery 

18 for introduction of such product into interstate com19 merce accompanied by such instructions— 

20 ‘‘(A) during an emergency response to an 

21 actual emergency that is the basis for a deter22 mination described in subsection (a)(1)(C)(i); or 

23 ‘‘(B) by a government entity (including a 

24 Federal, State, local, or tribal government enti25 ty), or a person acting on behalf of such a gov-
64 

† HR 307 EAS 

1 ernment entity, in preparation for an emergency 

2 response.’’. 

3 (c) RISK EVALUATION AND MITIGATION STRATE4 GIES.—Section 505–1 of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 355–1), is amended— 

6 (1) in subsection (f), by striking paragraph (7); 

7 and 

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

9 ‘‘(k) WAIVER IN PUBLIC HEALTH EMERGENCIES.— 

10 The Secretary may waive any requirement of this section 

11 with respect to a qualified countermeasure (as defined in 

12 section 319F–1(a)(2) of the Public Health Service Act) to 

13 which a requirement under this section has been applied, 

14 if the Secretary determines that such waiver is required to 

15 mitigate the effects of, or reduce the severity of, the cir16 cumstances under which— 

17 ‘‘(1) a determination described in subparagraph 

18 (A), (B), or (C) of section 564(b)(1) has been made 

19 by the Secretary of Homeland Security, the Secretary 

20 of Defense, or the Secretary, respectively; or 

21 ‘‘(2) the identification of a material threat de22 scribed in subparagraph (D) of section 564(b)(1) has 

23 been made pursuant to section 319F–2 of the Public 

24 Health Service Act.’’. 
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1 (d) PRODUCTS HELD FOR EMERGENCY USE.—The 

2 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 

3 seq.) is amended by inserting after section 564A, as added 

4 by subsection (b), the following: 

5 ‘‘SEC. 564B. PRODUCTS HELD FOR EMERGENCY USE. 

6 ‘‘It is not a violation of any section of this Act or of 

7 the Public Health Service Act for a government entity (in8 cluding a Federal, State, local, or tribal government entity), 

9 or a person acting on behalf of such a government entity, 

10 to introduce into interstate commerce a product (as defined 

11 in section 564(a)(4)) intended for emergency use, if that 

12 product— 

13 ‘‘(1) is intended to be held and not used; and 

14 ‘‘(2) is held and not used, unless and until that 

15 product— 

16 ‘‘(A) is approved, cleared, or licensed under 

17 section 505, 510(k), or 515 of this Act or section 

18 351 of the Public Health Service Act; 

19 ‘‘(B) is authorized for investigational use 

20 under section 505 or 520 of this Act or section 

21 351 of the Public Health Service Act; or 

22 ‘‘(C) is authorized for use under section 

23 564.’’. 
66 

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1 SEC. 303. DEFINITIONS. 

2 Section 565 of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 360bbb–4) is amended by striking ‘‘The Sec4 retary, in consultation’’ and inserting the following: 

5 ‘‘(a) DEFINITIONS.—In this section— 

6 ‘‘(1) the term ‘countermeasure’ means a qualified 

7 countermeasure, a security countermeasure, and a 

8 qualified pandemic or epidemic product; 

9 ‘‘(2) the term ‘qualified countermeasure’ has the 

10 meaning given such term in section 319F–1 of the 

11 Public Health Service Act; 

12 ‘‘(3) the term ‘security countermeasure’ has the 

13 meaning given such term in section 319F–2 of such 

14 Act; and 

15 ‘‘(4) the term ‘qualified pandemic or epidemic 

16 product’ means a product that meets the definition 

17 given such term in section 319F–3 of the Public 

18 Health Service Act and— 

19 ‘‘(A) that has been identified by the Depart20 ment of Health and Human Services or the De21 partment of Defense as receiving funding directly 

22 related to addressing chemical, biological, radio23 logical, or nuclear threats, including pandemic 

24 influenza; or 

25 ‘‘(B) is included under this paragraph pur26 suant to a determination by the Secretary. 
67 

† HR 307 EAS 

1 ‘‘(b) GENERAL DUTIES.—The Secretary, in consulta2 tion’’. 

3 SEC. 304. ENHANCING MEDICAL COUNTERMEASURE ACTIVI4 TIES. 

5 Section 565 of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 360bbb–4), as amended by section 303, is 

7 further amended— 

8 (1) in the section heading, by striking ‘‘TECH9 NICAL ASSISTANCE’’ and inserting ‘‘COUNTER10 MEASURE DEVELOPMENT, REVIEW, AND TECH11 NICAL ASSISTANCE’’; 

12 (2) in subsection (b), by striking the subsection 

13 enumerator and all that follows through ‘‘shall estab14 lish’’ and inserting the following: 

15 ‘‘(b) GENERAL DUTIES.—In order to accelerate the de16 velopment, stockpiling, approval, licensure, and clearance 

17 of qualified countermeasures, security countermeasures, and 

18 qualified pandemic or epidemic products, the Secretary, in 

19 consultation with the Assistant Secretary for Preparedness 

20 and Response, shall— 

21 ‘‘(1) ensure the appropriate involvement of Food 

22 and Drug Administration personnel in interagency 

23 activities related to countermeasure advanced research 

24 and development, consistent with sections 319F, 
68 

† HR 307 EAS 

1 319F–1, 319F–2, 319F–3, 319L, and 2811 of the 

2 Public Health Service Act; 

3 ‘‘(2) ensure the appropriate involvement and 

4 consultation of Food and Drug Administration per5 sonnel in any flexible manufacturing activities car6 ried out under section 319L of the Public Health 

7 Service Act, including with respect to meeting regu8 latory requirements set forth in this Act; 

9 ‘‘(3) promote countermeasure expertise within 

10 the Food and Drug Administration by— 

11 ‘‘(A) ensuring that Food and Drug Admin12 istration personnel involved in reviewing coun13 termeasures for approval, licensure, or clearance 

14 are informed by the Assistant Secretary for Pre15 paredness and Response on the material threat 

16 assessment conducted under section 319F–2 of 

17 the Public Health Service Act for the agent or 

18 agents for which the countermeasure under re19 view is intended; 

20 ‘‘(B) training Food and Drug Administra21 tion personnel regarding review of counter22 measures for approval, licensure, or clearance; 

23 ‘‘(C) holding public meetings at least twice 

24 annually to encourage the exchange of scientific 

25 ideas; and 
69 

† HR 307 EAS 

1 ‘‘(D) establishing protocols to ensure that 

2 countermeasure reviewers have sufficient train3 ing or experience with countermeasures; 

4 ‘‘(4) maintain teams, composed of Food and 

5 Drug Administration personnel with expertise on 

6 countermeasures, including specific countermeasures, 

7 populations with special clinical needs (including 

8 children and pregnant women that may use counter9 measures, as applicable and appropriate), classes or 

10 groups of countermeasures, or other countermeasure11 related technologies and capabilities, that shall— 

12 ‘‘(A) consult with countermeasure experts, 

13 including countermeasure sponsors and appli14 cants, to identify and help resolve scientific 

15 issues related to the approval, licensure, or clear16 ance of countermeasures, through workshops or 

17 public meetings; and 

18 ‘‘(B) improve and advance the science relat19 ing to the development of new tools, standards, 

20 and approaches to assessing and evaluating 

21 countermeasures— 

22 ‘‘(i) in order to inform the process for 

23 countermeasure approval, clearance, and li24 censure; and 
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† HR 307 EAS 

1 ‘‘(ii) with respect to the development of 

2 countermeasures for populations with spe3 cial clinical needs, including children and 

4 pregnant women, in order to meet the needs 

5 of such populations, as necessary and ap6 propriate; and 

7 ‘‘(5) establish’’; and 

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

9 ‘‘(c) FINAL GUIDANCE ON DEVELOPMENT OF ANIMAL

10 MODELS.— 

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

12 the date of the enactment of the Pandemic and All13 Hazards Preparedness Reauthorization Act of 2013, 

14 the Secretary shall provide final guidance to industry 

15 regarding the development of animal models to sup16 port approval, clearance, or licensure of counter17 measures referred to in subsection (a) when human ef18 ficacy studies are not ethical or feasible. 

19 ‘‘(2) AUTHORITY TO EXTEND DEADLINE.—The 

20 Secretary may extend the deadline for providing final 

21 guidance under paragraph (1) by not more than 6 

22 months upon submission by the Secretary of a report 

23 on the status of such guidance to the Committee on 

24 Energy and Commerce of the House of Representa-
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1 tives and the Committee on Health, Education, 

2 Labor, and Pensions of the Senate. 

3 ‘‘(d) DEVELOPMENT AND ANIMAL MODELING PROCE4 DURES.— 

5 ‘‘(1) AVAILABILITY OF ANIMAL MODEL MEET6 INGS.—To facilitate the timely development of animal 

7 models and support the development, stockpiling, li8 censure, approval, and clearance of countermeasures, 

9 the Secretary shall, not later than 180 days after the 

10 enactment of this subsection, establish a procedure by 

11 which a sponsor or applicant that is developing a 

12 countermeasure for which human efficacy studies are 

13 not ethical or practicable, and that has an approved 

14 investigational new drug application or investiga15 tional device exemption, may request and receive— 

16 ‘‘(A) a meeting to discuss proposed animal 

17 model development activities; and 

18 ‘‘(B) a meeting prior to initiating pivotal 

19 animal studies. 

20 ‘‘(2) PEDIATRIC MODELS.—To facilitate the de21 velopment and selection of animal models that could 

22 translate to pediatric studies, any meeting conducted 

23 under paragraph (1) shall include discussion of ani24 mal models for pediatric populations, as appropriate. 
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1 ‘‘(e) REVIEW AND APPROVAL OF COUNTER2 MEASURES.— 

3 ‘‘(1) MATERIAL THREAT.—When evaluating an 

4 application or submission for approval, licensure, or 

5 clearance of a countermeasure, the Secretary shall 

6 take into account the material threat posed by the 

7 chemical, biological, radiological, or nuclear agent or 

8 agents identified under section 319F–2 of the Public 

9 Health Service Act for which the countermeasure 

10 under review is intended. 

11 ‘‘(2) REVIEW EXPERTISE.—When practicable 

12 and appropriate, teams of Food and Drug Adminis13 tration personnel reviewing applications or submis14 sions described under paragraph (1) shall include a 

15 reviewer with sufficient training or experience with 

16 countermeasures pursuant to the protocols established 

17 under subsection (b)(3)(D).’’. 

18 SEC. 305. REGULATORY MANAGEMENT PLANS. 

19 Section 565 of the Federal Food, Drug, and Cosmetic 

20 Act (21 U.S.C. 360bbb–4), as amended by section 304, is 

21 further amended by adding at the end the following: 

22 ‘‘(f) REGULATORY MANAGEMENT PLAN.— 

23 ‘‘(1) DEFINITION.—In this subsection, the term 

24 ‘eligible countermeasure’ means— 
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1 ‘‘(A) a security countermeasure with respect 

2 to which the Secretary has entered into a pro3 curement contract under section 319F–2(c) of the 

4 Public Health Service Act; or 

5 ‘‘(B) a countermeasure with respect to 

6 which the Biomedical Advanced Research and 

7 Development Authority has provided funding 

8 under section 319L of the Public Health Service 

9 Act for advanced research and development. 

10 ‘‘(2) REGULATORY MANAGEMENT PLAN PROC11 ESS.—The Secretary, in consultation with the Assist12 ant Secretary for Preparedness and Response and the 

13 Director of the Biomedical Advanced Research and 

14 Development Authority, shall establish a formal proc15 ess for obtaining scientific feedback and interactions 

16 regarding the development and regulatory review of 

17 eligible countermeasures by facilitating the develop18 ment of written regulatory management plans in ac19 cordance with this subsection. 

20 ‘‘(3) SUBMISSION OF REQUEST AND PROPOSED

21 PLAN BY SPONSOR OR APPLICANT.— 

22 ‘‘(A) IN GENERAL.—A sponsor or applicant 

23 of an eligible countermeasure may initiate the 

24 process described under paragraph (2) upon sub25 mission of a written request to the Secretary. 
74 

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1 Such request shall include a proposed regulatory 

2 management plan. 

3 ‘‘(B) TIMING OF SUBMISSION.—A sponsor 

4 or applicant may submit a written request 

5 under subparagraph (A) after the eligible coun6 termeasure has an investigational new drug or 

7 investigational device exemption in effect. 

8 ‘‘(C) RESPONSE BY SECRETARY.—The Sec9 retary shall direct the Food and Drug Adminis10 tration, upon submission of a written request by 

11 a sponsor or applicant under subparagraph (A), 

12 to work with the sponsor or applicant to agree 

13 on a regulatory management plan within a rea14 sonable time not to exceed 90 days. If the Sec15 retary determines that no plan can be agreed 

16 upon, the Secretary shall provide to the sponsor 

17 or applicant, in writing, the scientific or regu18 latory rationale why such agreement cannot be 

19 reached. 

20 ‘‘(4) PLAN.—The content of a regulatory man21 agement plan agreed to by the Secretary and a spon22 sor or applicant shall include— 

23 ‘‘(A) an agreement between the Secretary 

24 and the sponsor or applicant regarding develop-
75 

† HR 307 EAS 

1 mental milestones that will trigger responses by 

2 the Secretary as described in subparagraph (B); 

3 ‘‘(B) performance targets and goals for 

4 timely and appropriate responses by the Sec5 retary to the triggers described under subpara6 graph (A), including meetings between the Sec7 retary and the sponsor or applicant, written 

8 feedback, decisions by the Secretary, and other 

9 activities carried out as part of the development 

10 and review process; and 

11 ‘‘(C) an agreement on how the plan shall be 

12 modified, if needed. 

13 ‘‘(5) MILESTONES AND PERFORMANCE TAR14 GETS.—The developmental milestones described in 

15 paragraph (4)(A) and the performance targets and 

16 goals described in paragraph (4)(B) shall include— 

17 ‘‘(A) feedback from the Secretary regarding 

18 the data required to support the approval, clear19 ance, or licensure of the eligible countermeasure 

20 involved; 

21 ‘‘(B) feedback from the Secretary regarding 

22 the data necessary to inform any authorization 

23 under section 564; 

24 ‘‘(C) feedback from the Secretary regarding 

25 the data necessary to support the positioning 
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1 and delivery of the eligible countermeasure, in2 cluding to the Strategic National Stockpile; 

3 ‘‘(D) feedback from the Secretary regarding 

4 the data necessary to support the submission of 

5 protocols for review under section 505(b)(5)(B); 

6 ‘‘(E) feedback from the Secretary regarding 

7 any gaps in scientific knowledge that will need 

8 resolution prior to approval, licensure, or clear9 ance of the eligible countermeasure and plans for 

10 conducting the necessary scientific research; 

11 ‘‘(F) identification of the population for 

12 which the countermeasure sponsor or applicant 

13 seeks approval, licensure, or clearance and the 

14 population for which desired labeling would not 

15 be appropriate, if known; and 

16 ‘‘(G) as necessary and appropriate, and to 

17 the extent practicable, a plan for demonstrating 

18 safety and effectiveness in pediatric populations, 

19 and for developing pediatric dosing, formulation, 

20 and administration with respect to the eligible 

21 countermeasure, provided that such plan would 

22 not delay authorization under section 564, ap23 proval, licensure, or clearance for adults. 

24 ‘‘(6) PRIORITIZATION.— 
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1 ‘‘(A) PLANS FOR SECURITY COUNTER2 MEASURES.—The Secretary shall establish regu3 latory management plans for all security coun4 termeasures for which a request is submitted 

5 under paragraph (3)(A). 

6 ‘‘(B) PLANS FOR OTHER ELIGIBLE COUN7 TERMEASURES.—The Secretary shall determine 

8 whether resources are available to establish regu9 latory management plans for eligible counter10 measures that are not security countermeasures. 

11 If resources are available to establish regulatory 

12 management plans for eligible countermeasures 

13 that are not security countermeasures, and if re14 sources are not available to establish regulatory 

15 management plans for all eligible counter16 measures for which requests have been submitted, 

17 the Director of the Biomedical Advanced Re18 search and Development Authority, in consulta19 tion with the Commissioner, shall prioritize 

20 which eligible countermeasures may receive regu21 latory management plans.’’. 

22 SEC. 306. REPORT. 

23 Section 565 of the Federal Food, Drug, and Cosmetic 

24 Act (21 U.S.C. 360bbb–4), as amended by section 305, is 

25 further amended by adding at the end the following: 
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1 ‘‘(g) ANNUAL REPORT.—Not later than 180 days after 

2 the date of enactment of this subsection, and annually there3 after, the Secretary shall make publicly available on the 

4 Web site of the Food and Drug Administration a report 

5 that details the countermeasure development and review ac6 tivities of the Food and Drug Administration, including— 

7 ‘‘(1) with respect to the development of new tools, 

8 standards, and approaches to assess and evaluate 

9 countermeasures— 

10 ‘‘(A) the identification of the priorities of 

11 the Food and Drug Administration and the 

12 progress made on such priorities; and 

13 ‘‘(B) the identification of scientific gaps 

14 that impede the development, approval, licensure, 

15 or clearance of countermeasures for populations 

16 with special clinical needs, including children 

17 and pregnant women, and the progress made on 

18 resolving these challenges; 

19 ‘‘(2) with respect to countermeasures for which a 

20 regulatory management plan has been agreed upon 

21 under subsection (f), the extent to which the perform22 ance targets and goals set forth in subsection (f)(4)(B) 

23 and the regulatory management plan have been met, 

24 including, for each such countermeasure— 
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1 ‘‘(A) whether the regulatory management 

2 plan was completed within the required time3 frame, and the length of time taken to complete 

4 such plan; 

5 ‘‘(B) whether the Secretary adhered to the 

6 timely and appropriate response times set forth 

7 in such plan; and 

8 ‘‘(C) explanations for any failure to meet 

9 such performance targets and goals; 

10 ‘‘(3) the number of regulatory teams established 

11 pursuant to subsection (b)(4), the number of products, 

12 classes of products, or technologies assigned to each 

13 such team, and the number of, type of, and any 

14 progress made as a result of consultations carried out 

15 under subsection (b)(4)(A); 

16 ‘‘(4) an estimate of resources obligated to coun17 termeasure development and regulatory assessment, 

18 including— 

19 ‘‘(A) Center-specific objectives and accom20 plishments; and 

21 ‘‘(B) the number of full-time equivalent em22 ployees of the Food and Drug Administration 

23 who directly support the review of counter24 measures; 
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1 ‘‘(5) the number of countermeasure applications 

2 and submissions submitted, the number of counter3 measures approved, licensed, or cleared, the status of 

4 remaining submitted applications and submissions, 

5 and the number of each type of authorization issued 

6 pursuant to section 564; 

7 ‘‘(6) the number of written requests for a regu8 latory management plan submitted under subsection 

9 (f)(3)(A), the number of regulatory management plans 

10 developed, and the number of such plans developed for 

11 security countermeasures; and 

12 ‘‘(7) the number, type, and frequency of meetings 

13 between the Food and Drug Administration and— 

14 ‘‘(A) sponsors of a countermeasure as de15 fined in subsection (a); or 

16 ‘‘(B) another agency engaged in develop17 ment or management of portfolios for such coun18 termeasures, including the Centers for Disease 

19 Control and Prevention, the Biomedical Ad20 vanced Research and Development Authority, the 

21 National Institutes of Health, and the appro22 priate agencies of the Department of Defense.’’. 
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1 SEC. 307. PEDIATRIC MEDICAL COUNTERMEASURES. 

2 (a) PEDIATRIC STUDIES OF DRUGS.—Section 505A of 

3 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) 

4 is amended— 

5 (1) in subsection (d), by adding at the end the 

6 following: 

7 ‘‘(5) CONSULTATION.—With respect to a drug 

8 that is a qualified countermeasure (as defined in sec9 tion 319F–1 of the Public Health Service Act), a secu10 rity countermeasure (as defined in section 319F–2 of 

11 the Public Health Service Act), or a qualified pan12 demic or epidemic product (as defined in section 

13 319F–3 of the Public Health Service Act), the Sec14 retary shall solicit input from the Assistant Secretary 

15 for Preparedness and Response regarding the need for 

16 and, from the Director of the Biomedical Advanced 

17 Research and Development Authority regarding the 

18 conduct of, pediatric studies under this section.’’; and 

19 (2) in subsection (n)(1), by adding at the end the 

20 following: 

21 ‘‘(C) For a drug that is a qualified counter22 measure (as defined in section 319F–1 of the 

23 Public Health Service Act), a security counter24 measure (as defined in section 319F–2 of the 

25 Public Health Service Act), or a qualified pan26 demic or epidemic product (as defined in section 
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1 319F–3 of such Act), in addition to any action 

2 with respect to such drug under subparagraph 

3 (A) or (B), the Secretary shall notify the Assist4 ant Secretary for Preparedness and Response 

5 and the Director of the Biomedical Advanced Re6 search and Development Authority of all pedi7 atric studies in the written request issued by the 

8 Commissioner of Food and Drugs.’’. 

9 (b) ADDITION TO PRIORITY LIST CONSIDERATIONS.— 

10 Section 409I of the Public Health Service Act (42 U.S.C. 

11 284m) is amended— 

12 (1) by striking subsection (a)(2) and inserting 

13 the following: 

14 ‘‘(2) CONSIDERATION OF AVAILABLE INFORMA15 TION.—In developing and prioritizing the list under 

16 paragraph (1), the Secretary— 

17 ‘‘(A) shall consider— 

18 ‘‘(i) therapeutic gaps in pediatrics that 

19 may include developmental pharmacology, 

20 pharmacogenetic determinants of drug re21 sponse, metabolism of drugs and biologics in 

22 children, and pediatric clinical trials; 

23 ‘‘(ii) particular pediatric diseases, dis24 orders or conditions where more complete 

25 knowledge and testing of therapeutics, in-
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1 cluding drugs and biologics, may be bene2 ficial in pediatric populations; and 

3 ‘‘(iii) the adequacy of necessary infra4 structure to conduct pediatric pharma5 cological research, including research net6 works and trained pediatric investigators; 

7 and 

8 ‘‘(B) may consider the availability of quali9 fied countermeasures (as defined in section 

10 319F–1), security countermeasures (as defined in 

11 section 319F–2), and qualified pandemic or epi12 demic products (as defined in section 319F–3) to 

13 address the needs of pediatric populations, in 

14 consultation with the Assistant Secretary for 

15 Preparedness and Response, consistent with the 

16 purposes of this section.’’; and 

17 (2) in subsection (b), by striking ‘‘subsection (a)’’ 

18 and inserting ‘‘paragraphs (1) and (2)(A) of sub19 section (a)’’. 

20 (c) ADVICE AND RECOMMENDATIONS OF THE PEDI21 ATRIC ADVISORY COMMITTEE REGARDING COUNTER22 MEASURES FOR PEDIATRIC POPULATIONS.—Subsection 

23 (b)(2) of section 14 of the Best Pharmaceuticals for Children 

24 Act (42 U.S.C. 284m note) is amended— 
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1 (1) in subparagraph (C), by striking the period 

2 and inserting ‘‘; and’’; and 

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

4 ‘‘(D) the development of countermeasures 

5 (as defined in section 565(a) of the Federal Food, 

6 Drug, and Cosmetic Act) for pediatric popu7 lations.’’. 

8 TITLE IV—ACCELERATING MED9 ICAL COUNTERMEASURE AD10 VANCED RESEARCH AND DE11 VELOPMENT 

12 SEC. 401. BIOSHIELD. 

13 (a) PROCUREMENT OF COUNTERMEASURES.—Section 

14 319F–2(c) of the Public Health Service Act (42 U.S.C. 

15 247d–6b(c)) is amended— 

16 (1) in paragraph (1)(B)(i)(III)(bb), by striking 

17 ‘‘eight years’’ and inserting ‘‘10 years’’; 

18 (2) in paragraph (2)(C), by striking ‘‘the des19 ignated congressional committees (as defined in para20 graph (10))’’ and inserting ‘‘the appropriate commit21 tees of Congress’’; 

22 (3) in paragraph (5)(B)(ii), by striking ‘‘eight 

23 years’’ and inserting ‘‘10 years’’; 

24 (4) in subparagraph (C) of paragraph (6)— 
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1 (A) in the subparagraph heading, by strik2 ing ‘‘DESIGNATED CONGRESSIONAL COMMIT3 TEES’’ and inserting ‘‘APPROPRIATE CONGRES4 SIONAL COMMITTEES’’; and 

5 (B) by striking ‘‘the designated congres6 sional committees’’ and inserting ‘‘the appro7 priate congressional committees’’; and 

8 (5) in paragraph (7)(C)— 

9 (A) in clause (i)(I), by inserting ‘‘including 

10 advanced research and development,’’ after ‘‘as 

11 may reasonably be required,’’; 

12 (B) in clause (ii)— 

13 (i) in subclause (III), by striking 

14 ‘‘eight years’’ and inserting ‘‘10 years’’; and 

15 (ii) by striking subclause (IX) and in16 serting the following: 

17 ‘‘(IX) CONTRACT TERMS.—The 

18 Secretary, in any contract for procure19 ment under this section— 

20 ‘‘(aa) may specify— 

21 ‘‘(AA) the dosing and 

22 administration requirements 

23 for the countermeasure to be 

24 developed and procured; 
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1 ‘‘(BB) the amount of 

2 funding that will be dedi3 cated by the Secretary for 

4 advanced research, develop5 ment, and procurement of the 

6 countermeasure; and 

7 ‘‘(CC) the specifications 

8 the countermeasure must 

9 meet to qualify for procure10 ment under a contract under 

11 this section; and 

12 ‘‘(bb) shall provide a clear 

13 statement of defined Government 

14 purpose limited to uses related to 

15 a security countermeasure, as de16 fined in paragraph (1)(B).’’; and 

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

18 ‘‘(viii) FLEXIBILITY.—In carrying out 

19 this section, the Secretary may, consistent 

20 with the applicable provisions of this sec21 tion, enter into contracts and other agree22 ments that are in the best interest of the 

23 Government in meeting identified security 

24 countermeasure needs, including with re25 spect to reimbursement of the cost of ad-
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1 vanced research and development as a rea2 sonable, allowable, and allocable direct cost 

3 of the contract involved.’’. 

4 (b) REAUTHORIZATION OF THE SPECIAL RESERVE

5 FUND.—Section 319F–2 of the Public Health Service Act 

6 (42 U.S.C. 247d–6b) is amended— 

7 (1) in subsection (c)— 

8 (A) by striking ‘‘special reserve fund under 

9 paragraph (10)’’ each place it appears and in10 serting ‘‘special reserve fund as defined in sub11 section (h)’’; and 

12 (B) by striking paragraphs (9) and (10); 

13 and 

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

15 ‘‘(g) SPECIAL RESERVE FUND.— 

16 ‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—In 

17 addition to amounts appropriated to the special re18 serve fund prior to the date of the enactment of this 

19 subsection, there is authorized to be appropriated, for 

20 the procurement of security countermeasures under 

21 subsection (c) and for carrying out section 319L (re22 lating to the Biomedical Advanced Research and De23 velopment Authority), $2,800,000,000 for the period 

24 of fiscal years 2014 through 2018. Amounts appro25 priated pursuant to the preceding sentence are au-
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1 thorized to remain available until September 30, 

2 2019. 

3 ‘‘(2) USE OF SPECIAL RESERVE FUND FOR AD4 VANCED RESEARCH AND DEVELOPMENT.—The Sec5 retary may utilize not more than 50 percent of the 

6 amounts authorized to be appropriated under para7 graph (1) to carry out section 319L (related to the 

8 Biomedical Advanced Research and Development Au9 thority). Amounts authorized to be appropriated 

10 under this subsection to carry out section 319L are in 

11 addition to amounts otherwise authorized to be ap12 propriated to carry out such section. 

13 ‘‘(3) RESTRICTIONS ON USE OF FUNDS.— 

14 Amounts in the special reserve fund shall not be used 

15 to pay costs other than payments made by the Sec16 retary to a vendor for advanced development (under 

17 section 319L) or for procurement of a security coun18 termeasure under subsection (c)(7). 

19 ‘‘(4) REPORT.—Not later than 30 days after any 

20 date on which the Secretary determines that the 

21 amount of funds in the special reserve fund available 

22 for procurement is less than $1,500,000,000, the Sec23 retary shall submit to the appropriate committees of 

24 Congress a report detailing the amount of such funds 
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1 available for procurement and the impact such reduc2 tion in funding will have— 

3 ‘‘(A) in meeting the security countermeasure 

4 needs identified under this section; and 

5 ‘‘(B) on the annual Public Health Emer6 gency Medical Countermeasures Enterprise and 

7 Strategy Implementation Plan (pursuant to sec8 tion 2811(d)). 

9 ‘‘(h) DEFINITIONS.—In this section: 

10 ‘‘(1) The term ‘advanced research and develop11 ment’ has the meaning given such term in section 

12 319L(a). 

13 ‘‘(2) The term ‘special reserve fund’ means the 

14 ‘Biodefense Countermeasures’ appropriations account, 

15 any appropriation made available pursuant to sec16 tion 521(a) of the Homeland Security Act of 2002, 

17 and any appropriation made available pursuant to 

18 subsection (g)(1).’’. 

19 SEC. 402. BIOMEDICAL ADVANCED RESEARCH AND DEVEL20 OPMENT AUTHORITY. 

21 (a) DUTIES.—Section 319L(c)(4) of the Public Health 

22 Service Act (42 U.S.C. 247d–7e(c)(4)) is amended— 

23 (1) in subparagraph (B)(iii), by inserting 

24 ‘‘(which may include advanced research and develop25 ment for purposes of fulfilling requirements under the 
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1 Federal Food, Drug, and Cosmetic Act or section 351 

2 of this Act)’’ after ‘‘development’’; and 

3 (2) in subparagraph (D)(iii), by striking ‘‘and 

4 vaccine manufacturing technologies’’ and inserting 

5 ‘‘vaccine-manufacturing technologies, dose-sparing 

6 technologies, efficacy-increasing technologies, and 

7 platform technologies’’. 

8 (b) TRANSACTION AUTHORITIES.—Section 319L(c)(5) 

9 of the Public Health Service Act (42 U.S.C. 247d–7e(c)(5)) 

10 is amended by adding at the end the following: 

11 ‘‘(G) GOVERNMENT PURPOSE.—In award12 ing contracts, grants, and cooperative agreements 

13 under this section, the Secretary shall provide a 

14 clear statement of defined Government purpose 

15 related to activities included in subsection 

16 (a)(6)(B) for a qualified countermeasure or 

17 qualified pandemic or epidemic product.’’. 

18 (c) FUND.—Paragraph (2) of section 319L(d) of the 

19 Public Health Service Act (42 U.S.C. 247d–7e(d)(2)) is 

20 amended to read as follows: 

21 ‘‘(2) FUNDING.—To carry out the purposes of 

22 this section, there is authorized to be appropriated to 

23 the Fund $415,000,000 for each of fiscal years 2014 

24 through 2018, such amounts to remain available until 

25 expended.’’. 
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1 (d) CONTINUED INAPPLICABILITY OF CERTAIN PROVI2 SIONS.—Section 319L(e)(1)(C) of the Public Health Service 

3 Act (42 U.S.C. 247d–7e(e)(1)(C)) is amended by striking 

4 ‘‘7 years’’ and inserting ‘‘12 years’’. 

5 (e) EXTENSION OF LIMITED ANTITRUST EXEMP6 TION.— 

7 (1) IN GENERAL.—Section 405(b) of the Pan8 demic and All-Hazards Preparedness Act (42 U.S.C. 

9 247d–6a note) is amended by striking ‘‘6-year’’ and 

10 inserting ‘‘12-year’’. 

11 (2) EFFECTIVE DATE.—This subsection shall take 

12 effect as if enacted on December 17, 2012. 

13 (f) INDEPENDENT EVALUATION.—Section 319L of the 

14 Public Health Service Act (42 U.S.C. 247d–7e) is amended 

15 by adding at the end the following: 

16 ‘‘(f) INDEPENDENT EVALUATION.— 

17 ‘‘(1) IN GENERAL.—Not later than 180 days 

18 after the date of enactment of this subsection, the 

19 Comptroller General of the United States shall con20 duct an independent evaluation of the activities car21 ried out to facilitate flexible manufacturing capacity 

22 pursuant to this section. 

23 ‘‘(2) REPORT.—Not later than 1 year after the 

24 date of enactment of this subsection, the Comptroller 

25 General of the United States shall submit to the ap-
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1 propriate committees of Congress a report concerning 

2 the results of the evaluation conducted under para3 graph (1). Such report shall review and assess— 

4 ‘‘(A) the extent to which flexible manufac5 turing capacity under this section is dedicated to 

6 chemical, biological, radiological, and nuclear 

7 threats; 

8 ‘‘(B) the activities supported by flexible 

9 manufacturing initiatives; and 

10 ‘‘(C) the ability of flexible manufacturing 

11 activities carried out under this section to— 

12 ‘‘(i) secure and leverage leading tech13 nical expertise with respect to counter14 measure advanced research, development, 

15 and manufacturing processes; and 

16 ‘‘(ii) meet the surge manufacturing ca17 pacity needs presented by novel and emerg18 ing threats, including chemical, biological, 

19 radiological, and nuclear agents.’’. 

20 (g) DEFINITIONS.— 

21 (1) QUALIFIED COUNTERMEASURE.—Section 

22 319F–1(a)(2)(A) of the Public Health Service Act (42 

23 U.S.C. 247d–6a(a)(2)(A)) is amended— 

24 (A) in the matter preceding clause (i), by 

25 striking ‘‘to—’’ and inserting ‘‘—’’; 
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1 (B) in clause (i)— 

2 (i) by striking ‘‘diagnose’’ and insert3 ing ‘‘to diagnose’’; and 

4 (ii) by striking ‘‘; or’’ and inserting a 

5 semicolon; 

6 (C) in clause (ii)— 

7 (i) by striking ‘‘diagnose’’ and insert8 ing ‘‘to diagnose’’; and 

9 (ii) by striking the period at the end 

10 and inserting ‘‘; or’’; and 

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

12 ‘‘(iii) is a product or technology in13 tended to enhance the use or effect of a drug, 

14 biological product, or device described in 

15 clause (i) or (ii).’’. 

16 (2) QUALIFIED PANDEMIC OR EPIDEMIC PROD17 UCT.—Section 319F–3(i)(7)(A) of the Public Health 

18 Service Act (42 U.S.C. 247d–6d(i)(7)(A)) is amend19 ed— 

20 (A) in clause (i)(II), by striking ‘‘; or’’ and 

21 inserting ‘‘;’’; 

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

23 inserting ‘‘; or’’; and 

24 (C) by adding at the end the following: 
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1 ‘‘(iii) a product or technology intended 

2 to enhance the use or effect of a drug, bio3 logical product, or device described in clause 

4 (i) or (ii); and’’. 

5 (3) TECHNICAL AMENDMENTS.—Section 319F– 

6 3(i) of the Public Health Service Act (42 U.S.C. 

7 247d–6d(i)) is amended— 

8 (A) in paragraph (1)(C), by inserting ‘‘, 

9 564A, or 564B’’ after ‘‘564’’; and 

10 (B) in paragraph (7)(B)(iii), by inserting 

11 ‘‘, 564A, or 564B’’ after ‘‘564’’. 

12 SEC. 403. STRATEGIC NATIONAL STOCKPILE. 

13 Section 319F–2 of the Public Health Service Act (42 

14 U.S.C. 247d–6b) is amended— 

15 (1) in subsection (a)— 

16 (A) in paragraph (1)— 

17 (i) by inserting ‘‘consistent with sec18 tion 2811’’ before ‘‘by the Secretary to be 

19 appropriate’’; and 

20 (ii) by inserting before the period at 

21 the end of the second sentence the following: 

22 ‘‘and shall submit such review annually to 

23 the appropriate congressional committees of 

24 jurisdiction to the extent that disclosure of 
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1 such information does not compromise na2 tional security’’; and 

3 (B) in paragraph (2)(D), by inserting be4 fore the semicolon at the end the following: ‘‘and 

5 that the potential depletion of countermeasures 

6 currently in the stockpile is identified and ap7 propriately addressed, including through nec8 essary replenishment’’; and 

9 (2) in subsection (f)(1), by striking 

10 ‘‘$640,000,000 for fiscal year 2002, and such sums as 

11 may be necessary for each of fiscal years 2003 through 

12 2006. Such authorization is in addition to amounts 

13 in the special reserve fund referred to in subsection 

14 (c)(10)(A).’’ and inserting ‘‘$533,800,000 for each of 

15 fiscal years 2014 through 2018. Such authorization is 

16 in addition to amounts in the special reserve fund re17 ferred to in subsection (h).’’. 

18 SEC. 404. NATIONAL BIODEFENSE SCIENCE BOARD. 

19 Section 319M(a) of the Public Health Service Act (42 

20 U.S.C. 247d–f(a)) is amended— 

21 (1) in paragraph (2)— 

22 (A) in subparagraph (D)— 

23 (i) in clause (i), by striking ‘‘and’’ at 

24 the end; 
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1 (ii) in clause (ii), by striking the pe2 riod and inserting a semicolon; and 

3 (iii) by adding at the end the fol4 lowing: 

5 ‘‘(iii) one such member shall be an in6 dividual with pediatric subject matter ex7 pertise; and 

8 ‘‘(iv) one such member shall be a State, 

9 tribal, territorial, or local public health offi10 cial.’’; and 

11 (B) by adding at the end the following flush 

12 sentence: 

13 ‘‘Nothing in this paragraph shall preclude a member 

14 of the Board from satisfying two or more of the re15 quirements described in subparagraph (D).’’; and 

16 (2) in paragraph (5)— 

17 (A) in subparagraph (B), by striking ‘‘and’’ 

18 at the end; 

19 (B) in subparagraph (C), by striking the 

20 period and inserting ‘‘; and’’; and 

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

22 ‘‘(D) provide any recommendation, finding, 

23 or report provided to the Secretary under this 
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1 paragraph to the appropriate committees of Con2 gress.’’. 

Attest: 

Secretary. 
113TH CONGRESS 

1ST SESSION H.R. 307 

AMENDMENT