II 

Calendar No. 14 

113TH CONGRESS 

1ST SESSION H. R. 307 

IN THE SENATE OF THE UNITED STATES 

JANUARY 23 (legislative day, JANUARY 3), 2013 

Received; read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

FEBRUARY 14, 2013 

Reported by Mr. HARKIN, with an amendment 

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

AN ACT 

To reauthorize certain programs under the Public Health 

Service Act and the Federal Food, Drug, and Cosmetic 

Act with respect to public health security and all-hazards 

preparedness and response, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

5 ‘‘Pandemic and All-Hazards Preparedness Reauthoriza6 tion Act of 2013’’. 


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

2 this 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. 

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 redeployment of federally funded 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. 


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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 ‘‘, 

12 including drills and exercises to ensure medical 

13 surge capacity for events without notice’’ after 

14 ‘‘exercises’’; and 

15 (B) in paragraph (3)— 

16 (i) in the matter preceding subpara17 graph (A)— 

18 (I) by striking ‘‘facilities), and 

19 trauma care’’ and inserting ‘‘and am20 bulatory care facilities and which may 

21 include dental health facilities), and 

22 trauma care, critical care,’’; and 

23 (II) by inserting ‘‘(including re24 lated availability, accessibility, and coVerDate Mar 15 2010 22:31 Feb 14, 2013 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6401 E:\BILLS\H307.RS H307

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1 ordination)’’ after ‘‘public health 

2 emergencies’’; 

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

4 ‘‘and trauma’’ after ‘‘medical’’; 

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

6 ‘‘Medical evacuation and fatality manage7 ment’’ and inserting ‘‘Fatality manage8 ment’’; 

9 (iv) by redesignating subparagraphs 

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

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

12 (v) by inserting after subparagraph 

13 (B), the following the new subparagraph: 

14 ‘‘(C) Coordinated medical triage and evac15 uation to appropriate medical institutions based 

16 on patient medical need, taking into account re17 gionalized systems of care.’’; 

18 (vi) in subparagraph (E), as redesig19 nated by clause (iv), by inserting ‘‘(which 

20 may include such dental health assets)’’ 

21 after ‘‘medical assets’’; and 

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

24 ‘‘(G) Optimizing a coordinated and flexible 

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1 pitals, other health care facilities, critical care, 

2 and trauma care (which may include trauma 

3 centers) and emergency medical systems.’’; 

4 (C) in paragraph (4)— 

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

6 ‘‘, including the unique needs and consider7 ations of individuals with disabilities,’’ 

8 after ‘‘medical needs of at-risk individ9 uals’’; and 

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

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

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

13 ‘‘(7) COUNTERMEASURES.— 

14 ‘‘(A) Promoting strategic initiatives to ad15 vance countermeasures to diagnose, mitigate, 

16 prevent, or treat harm from any biological 

17 agent or toxin, chemical, radiological, or nuclear 

18 agent or agents, whether naturally occurring, 

19 unintentional, or deliberate. 

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

21 term ‘countermeasures’ has the same meaning 

22 as the terms ‘qualified countermeasures’ under 

23 section 319F–1, ‘qualified pandemic and epi24 demic products’ under section 319F–3, and ‘se25 curity countermeasures’ under section 319F–2. 


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1 ‘‘(8) MEDICAL AND PUBLIC HEALTH COMMU2 NITY RESILIENCY.—Strengthening the ability of 

3 States, local communities, and tribal communities to 

4 prepare for, respond to, and be resilient in the event 

5 of public health emergencies, whether naturally oc6 curring, unintentional, or deliberate by— 

7 ‘‘(A) optimizing alignment and integration 

8 of medical and public health preparedness and 

9 response planning and capabilities with and into 

10 routine daily activities; and 

11 ‘‘(B) promoting familiarity with local med12 ical and public health systems.’’. 

13 (b) AT-RISK INDIVIDUALS.—Section 2814 of the 

14 Public Health Service Act (42 U.S.C. 300hh–16) is 

15 amended— 

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

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

18 ‘‘2811(b)(3)(B)’’ and inserting ‘‘2802(b)(4)(B)’’; 

19 (3) by redesignating paragraphs (1) through 

20 (4) as paragraphs (2) through (5), respectively; 

21 (4) by inserting before paragraph (2) (as so re22 designated), the following: 

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

24 they relate to medical and public health prepared25 ness and response for at-risk individuals in the event 


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1 of a public health emergency declared by the Sec2 retary under section 319;’’; 

3 (5) by amending paragraph (2) (as so redesig4 nated) to read as follows: 

5 ‘‘(2) oversee the implementation of the pre6 paredness goals described in section 2802(b) with re7 spect to the public health and medical needs of at8 risk individuals in the event of a public health emer9 gency, as described in section 2802(b)(4);’’; and 

10 (6) by inserting after paragraph (6), the fol11 lowing: 

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

13 novel and best practices of outreach to and care of 

14 at-risk individuals before, during, and following pub15 lic health emergencies in as timely a manner as is 

16 practicable, including from the time a public health 

17 threat is identified; and 

18 ‘‘(8) ensure that public health and medical in19 formation distributed by the Department of Health 

20 and Human Services during a public health emer21 gency is delivered in a manner that takes into ac22 count the range of communication needs of the in23 tended recipients, including at-risk individuals.’’. 


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1 SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND 

2 RESPONSE. 

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

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

5 (1) in subsection (b)— 

6 (A) in paragraph (3), by inserting ‘‘, secu7 rity countermeasures (as defined in section 

8 319F–2),’’ after ‘‘qualified countermeasures (as 

9 defined in section 319F–1)’’; 

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

11 the following: 

12 ‘‘(D) POLICY COORDINATION AND STRA13 TEGIC DIRECTION.—Provide integrated policy 

14 coordination and strategic direction with re15 spect to all matters related to Federal public 

16 health and medical preparedness and execution 

17 and deployment of the Federal response for 

18 public health emergencies and incidents covered 

19 by the National Response Plan developed pur20 suant to section 504(6) of the Homeland Secu21 rity Act of 2002, or any successor plan, before, 

22 during, and following public health emergencies. 

23 ‘‘(E) IDENTIFICATION OF INEFFICIEN24 CIES.—Identify and minimize gaps, duplication, 

25 and other inefficiencies in medical and public 

26 health preparedness and response activities and 


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1 the actions necessary to overcome these obsta2 cles. 

3 ‘‘(F) COORDINATION OF GRANTS AND

4 AGREEMENTS.—Align and coordinate medical 

5 and public health grants and cooperative agree6 ments as applicable to preparedness and re7 sponse activities authorized under this Act, to 

8 the extent possible, including program require9 ments, timelines, and measurable goals, and in 

10 consultation with the Secretary of Homeland 

11 Security, to— 

12 ‘‘(i) optimize and streamline medical 

13 and public health preparedness and re14 sponse capabilities and the ability of local 

15 communities to respond to public health 

16 emergencies; and 

17 ‘‘(ii) gather and disseminate best 

18 practices among grant and cooperative 

19 agreement recipients, as appropriate. 

20 ‘‘(G) DRILL AND OPERATIONAL EXER21 CISES.—Carry out drills and operational exer22 cises, in consultation with the Department of 

23 Homeland Security, the Department of De24 fense, the Department of Veterans Affairs, and 

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1 cies, as necessary and appropriate, to identify, 

2 inform, and address gaps in and policies related 

3 to all-hazards medical and public health pre4 paredness and response, including exercises 

5 based on— 

6 ‘‘(i) identified threats for which coun7 termeasures are available and for which no 

8 countermeasures are available; and 

9 ‘‘(ii) unknown threats for which no 

10 countermeasures are available. 

11 ‘‘(H) NATIONAL SECURITY PRIORITY.—On 

12 a periodic basis consult with, as applicable and 

13 appropriate, the Assistant to the President for 

14 National Security Affairs, to provide an update 

15 on, and discuss, medical and public health pre16 paredness and response activities pursuant to 

17 this Act and the Federal Food, Drug, and Cos18 metic Act, including progress on the develop19 ment, approval, clearance, and licensure of 

20 medical countermeasures.’’; and 

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

22 ‘‘(7) COUNTERMEASURES BUDGET PLAN.—De23 velop, and update on an annual basis, a coordinated 

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1 measure priorities described in subsection (d). Each 

2 such plan shall— 

3 ‘‘(A) include consideration of the entire 

4 medical countermeasures enterprise, includ5 ing— 

6 ‘‘(i) basic research and advanced re7 search and development; 

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

9 and authorized uses of products; and 

10 ‘‘(iii) procurement, stockpiling, main11 tenance, and replenishment of all products 

12 in the Strategic National Stockpile; 

13 ‘‘(B) inform prioritization of resources and 

14 include measurable outputs and outcomes to 

15 allow for the tracking of the progress made to16 ward identified priorities; 

17 ‘‘(C) identify medical countermeasure life18 cycle costs to inform planning, budgeting, and 

19 anticipated needs within the continuum of the 

20 medical countermeasure enterprise consistent 

21 with section 319F–2; and 

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

23 committees of Congress upon request.’’; 

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

25 following: 


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1 ‘‘(c) FUNCTIONS.—The Assistant Secretary for Pre2 paredness and Response shall— 

3 ‘‘(1) have lead responsibility within the Depart4 ment of Health and Human Services for emergency 

5 preparedness and response policy coordination and 

6 strategic direction; 

7 ‘‘(2) have authority over and responsibility 

8 for— 

9 ‘‘(A) the National Disaster Medical System 

10 pursuant to section 2812; 

11 ‘‘(B) the Hospital Preparedness Coopera12 tive Agreement Program pursuant to section 

13 319C–2; 

14 ‘‘(C) the Biomedical Advanced Research 

15 and Development Authority pursuant to section 

16 319L; 

17 ‘‘(D) the Medical Reserve Corps pursuant 

18 to section 2813; 

19 ‘‘(E) the Emergency System for Advance 

20 Registration of Volunteer Health Professionals 

21 pursuant to section 319I; and 

22 ‘‘(F) administering grants and related au23 thorities related to trauma care under parts A 

24 through C of title XII, such authority to be 

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1 trator of the Health Resources and Services Ad2 ministration to such Assistant Secretary; 

3 ‘‘(3) exercise the responsibilities and authorities 

4 of the Secretary with respect to the coordination 

5 of— 

6 ‘‘(A) the Public Health Emergency Pre7 paredness Cooperative Agreement Program pur8 suant to section 319C–1; 

9 ‘‘(B) the Strategic National Stockpile pur10 suant to section 319F–2; and 

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

12 ‘‘(4) assume other duties as determined appro13 priate by the Secretary.’’; and 

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

15 ‘‘(d) PUBLIC HEALTH EMERGENCY MEDICAL COUN16 TERMEASURES ENTERPRISE STRATEGY AND IMPLEMEN17 TATION PLAN.— 

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

19 after the date of enactment of this subsection, and 

20 every year thereafter, the Assistant Secretary for 

21 Preparedness and Response shall develop and submit 

22 to the appropriate committees of Congress a coordi23 nated strategy and accompanying implementation 

24 plan for medical countermeasures to address chem25 ical, biological, radiological, and nuclear threats. In 


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1 developing such a plan, the Assistant Secretary for 

2 Preparedness and Response shall consult with the 

3 Director of the Biomedical Advanced Research and 

4 Development Authority, the Director of the National 

5 Institutes of Health, the Director of the Centers for 

6 Disease Control and Prevention, and the Commis7 sioner of Food and Drugs. Such strategy and plan 

8 shall be known as the ‘Public Health Emergency 

9 Medical Countermeasures Enterprise Strategy and 

10 Implementation Plan’. 

11 ‘‘(2) REQUIREMENTS.—The plan under para12 graph (1) shall— 

13 ‘‘(A) describe the chemical, biological, radi14 ological, and nuclear agent or agents that may 

15 present a threat to the Nation and the cor16 responding efforts to develop qualified counter17 measures (as defined in section 319F–1), secu18 rity countermeasures (as defined in section 

19 319F–2), or qualified pandemic or epidemic 

20 products (as defined in section 319F–3) for 

21 each threat; 

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

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1 velopment, procurement, stockpiling, deploy2 ment, distribution, and utilization; 

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

4 and long-term needs with respect to such coun5 termeasures or products to address a chemical, 

6 biological, radiological, and nuclear threat or 

7 threats; 

8 ‘‘(D) identify, with respect to each cat9 egory of threat, a summary of all awards and 

10 contracts, including advanced research and de11 velopment and procurement, that includes— 

12 ‘‘(i) the time elapsed from the 

13 issuance of the initial solicitation or re14 quest for a proposal to the adjudication 

15 (such as the award, denial of award, or so16 licitation termination); and 

17 ‘‘(ii) an identification of projected 

18 timelines, anticipated funding allocations, 

19 benchmarks, and milestones for each med20 ical countermeasure priority under sub21 paragraph (C), including projected needs 

22 with regard to replenishment of the Stra23 tegic National Stockpile; 


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1 ‘‘(E) be informed by the recommendations 

2 of the National Biodefense Science Board pur3 suant to section 319M; 

4 ‘‘(F) evaluate progress made in meeting 

5 timelines, allocations, benchmarks, and mile6 stones identified under subparagraph (D)(ii); 

7 ‘‘(G) report on the amount of funds avail8 able for procurement in the special reserve fund 

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

10 this funding will have on meeting the require11 ments under section 319F–2; 

12 ‘‘(H) incorporate input from Federal, 

13 State, local, and tribal stakeholders; 

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

15 the medical countermeasure priorities for at16 risk individuals (as defined in 2802(b)(4)(B)), 

17 as applicable under subparagraph (C), including 

18 with regard to the projected needs for related 

19 stockpiling and replenishment of the Strategic 

20 National Stockpile, including by addressing the 

21 needs of pediatric populations with respect to 

22 such countermeasures and products in the Stra23 tegic National Stockpile, including— 


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1 ‘‘(i) a list of such countermeasures 

2 and products necessary to address the 

3 needs of pediatric populations; 

4 ‘‘(ii) a description of measures taken 

5 to coordinate with the Office of Pediatric 

6 Therapeutics of the Food and Drug Ad7 ministration to maximize the labeling, dos8 ages, and formulations of such counter9 measures and products for pediatric popu10 lations; 

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

12 the Strategic National Stockpile and the 

13 development of such countermeasures and 

14 products to address the needs of pediatric 

15 populations; and 

16 ‘‘(iv) an evaluation of the progress 

17 made in addressing priorities identified 

18 pursuant to subparagraph (C); 

19 ‘‘(J) identify the use of authority and ac20 tivities undertaken pursuant to sections 319F– 

21 1(b)(1), 319F–1(b)(2), 319F–1(b)(3), 319F– 

22 1(c), 319F–1(d), 319F–1(e), 319F– 

23 2(c)(7)(C)(iii), 319F–2(c)(7)(C)(iv), and 319F– 

24 2(c)(7)(C)(v) of this Act, and subsections 

25 (a)(1), (b)(1), and (e) of section 564 of the 


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1 Federal Food, Drug, and Cosmetic Act, by 

2 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 consid12 ered and rejected with respect to the use of 

13 such 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 

19 and entities that were considered and re20 jected for such a grant, cooperative agree21 ment, or contract, except that the report 

22 need not disclose the identity of any such 

23 person or entity; 

24 ‘‘(iv) whether, with respect to each 

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1 dent under section 319F–2(c)(6), a con2 tract was entered into within one year 

3 after such approval by the President; and 

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

5 1(d), for the one-year period for which the 

6 report is submitted, the number of persons 

7 who were paid amounts totaling $100,000 

8 or greater and the number of persons who 

9 were paid amounts totaling at least 

10 $50,000 but 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 Im17 plementation Plan, the Comptroller General of 

18 the United States shall conduct an independent 

19 evaluation, and submit to the appropriate com20 mittees of Congress a report, concerning such 

21 Strategy 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 

2 Government pursuant to paragraph (2)(C); 

3 ‘‘(ii) the activities of the Department 

4 of Health and Human Services with re5 spect to advanced research and develop6 ment pursuant 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 

15 ensure that information and items that could compromise 

16 national security, contain confidential commercial infor17 mation, or contain proprietary information are not dis18 closed.’’. 

19 (b) INTERAGENCY COORDINATION PLAN.—In the 

20 first Public Health Emergency Countermeasures Enter21 prise Strategy and Implementation Plan submitted under 

22 subsection (d) of section 2811 of the Public Health Service 

23 Act (42 U.S.C. 300hh–10) (as added by subsection 

24 (a)(3)), the Secretary of Health and Human Services, in 

25 consultation with the Secretary of Defense, shall include 


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1 a description of the manner in which the Department of 

2 Health and Human Services is coordinating with the De3 partment of Defense regarding countermeasure activities 

4 to address chemical, biological, radiological, and nuclear 

5 threats. Such report shall include information with respect 

6 to— 

7 (1) the research, advanced research, develop8 ment, procurement, stockpiling, and distribution of 

9 countermeasures to meet identified needs; and 

10 (2) the coordination of efforts between the De11 partment of Health and Human Services and the 

12 Department of Defense to address countermeasure 

13 needs for various segments of the population. 

14 SEC. 103. NATIONAL ADVISORY COMMITTEE ON CHILDREN 

15 AND DISASTERS. 

16 Subtitle B of title XXVIII of the Public Health Serv17 ice Act (42 U.S.C. 300hh et seq.) is amended by inserting 

18 after section 2811 the following: 

19 ‘‘SEC. 2811A. NATIONAL ADVISORY COMMITTEE ON CHIL20 DREN AND DISASTERS. 

21 ‘‘(a) ESTABLISHMENT.—The Secretary, in consulta22 tion with the Secretary of Homeland Security, shall estab23 lish an advisory committee to be known as the ‘National 

24 Advisory Committee on Children and Disasters’ (referred 

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


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

2 ‘‘(1) provide advice and consultation with re3 spect to the activities carried out pursuant to section 

4 2814, as applicable and appropriate; 

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

6 the medical and public health needs of children as 

7 they relate to preparation for, response to, and re8 covery from all-hazards emergencies; and 

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

11 activities and children, including related drills and 

12 exercises pursuant to the preparedness goals under 

13 section 2802(b). 

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

15 may provide advice and recommendations to the Secretary 

16 with respect to children and the medical and public health 

17 grants and cooperative agreements as applicable to pre18 paredness and response activities authorized under this 

19 title and title III. 

20 ‘‘(d) MEMBERSHIP.— 

21 ‘‘(1) IN GENERAL.—The Secretary, in consulta22 tion with such other Secretaries as may be appro23 priate, shall appoint not to exceed 15 members to 

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1 bership of the Advisory Committee is an odd num2 ber. 

3 ‘‘(2) REQUIRED MEMBERS.—The Secretary, in 

4 consultation with such other Secretaries as may be 

5 appropriate, may appoint to the Advisory Committee 

6 under paragraph (1) such individuals as may be ap7 propriate to perform the duties described in sub8 sections (b) and (c), which may include— 

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

11 ‘‘(B) the Director of the Biomedical Ad12 vanced Research and Development Authority; 

13 ‘‘(C) the Director of the Centers for Dis14 ease Control and Prevention; 

15 ‘‘(D) the Commissioner of Food and 

16 Drugs; 

17 ‘‘(E) the Director of the National Insti18 tutes of Health; 

19 ‘‘(F) the Assistant Secretary of the Admin20 istration for Children and Families; 

21 ‘‘(G) the Administrator of the Federal 

22 Emergency Management Agency; 

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

24 professionals with expertise in pediatric medical 


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1 disaster planning, preparedness, response, or 

2 recovery; 

3 ‘‘(I) at least two representatives from 

4 State, local, territorial, or tribal agencies with 

5 expertise in pediatric disaster planning, pre6 paredness, response, or recovery; and 

7 ‘‘(J) representatives from such Federal 

8 agencies (such as the Department of Education 

9 and the Department of Homeland Security) as 

10 determined necessary to fulfill the duties of the 

11 Advisory Committee, as established under sub12 sections (b) and (c). 

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

14 meet not less than biannually. 

15 ‘‘(f) SUNSET.—The Advisory Committee shall termi16 nate on the date that is 5 years after the date of enact17 ment of the Pandemic and All-Hazards Preparedness Re18 authorization Act of 2013.’’. 

19 SEC. 104. MODERNIZATION OF THE NATIONAL DISASTER 

20 MEDICAL SYSTEM. 

21 Section 2812 of the Public Health Service Act (42 

22 U.S.C. 300hh–11) is amended— 

23 (1) in subsection (a)(3)— 

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

25 inserting ‘‘, including at-risk individuals as apVerDate Mar 15 2010 22:31 Feb 14, 2013 Jkt 029200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6401 E:\BILLS\H307.RS H307

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1 plicable’’ after ‘‘victims of a public health emer2 gency’’; 

3 (B) by redesignating subparagraph (C) as 

4 subparagraph (E); and 

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

6 the following: 

7 ‘‘(C) CONSIDERATIONS FOR AT-RISK POPU8 LATIONS.—The Secretary shall take steps to 

9 ensure that an appropriate specialized and fo10 cused range of public health and medical capa11 bilities are represented in the National Disaster 

12 Medical System, which take into account the 

13 needs of at-risk individuals, in the event of a 

14 public health emergency.’’. 

15 ‘‘(D) ADMINISTRATION.—The Secretary 

16 may determine and pay claims for reimburse17 ment for services under subparagraph (A) di18 rectly or through contracts that provide for 

19 payment in advance or by way of reimburse20 ment.’’; and 

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

22 may be necessary for each of the fiscal years 2007 

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

24 of fiscal years 2013 through 2017’’. 


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

2 VETERANS AFFAIRS. 

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

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

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

6 2011’’ and inserting ‘‘$155,300,000 for each of fiscal 

7 years 2013 through 2017 to carry out this section’’. 

8 TITLE II—OPTIMIZING STATE 

9 AND LOCAL ALL-HAZARDS 

10 PREPAREDNESS AND RE11 SPONSE 

12 SEC. 201. TEMPORARY REDEPLOYMENT OF FEDERALLY 

13 FUNDED PERSONNEL DURING A PUBLIC 

14 HEALTH EMERGENCY. 

15 Section 319 of the Public Health Service Act (42 

16 U.S.C. 247d) is amended by adding at the end the fol17 lowing: 

18 ‘‘(e) TEMPORARY REDEPLOYMENT OF FEDERALLY

19 FUNDED PERSONNEL DURING A PUBLIC HEALTH EMER20 GENCY.— 

21 ‘‘(1) EMERGENCY REDEPLOYMENT OF FEDER22 ALLY FUNDED PERSONNEL.—Notwithstanding any 

23 other provision of law, and subject to paragraph (2), 

24 upon request by the Governor of a State or the chief 

25 of a tribe or such Governor or chief’s designee, the 

26 Secretary may authorize the requesting State or 


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1 tribe to temporarily redeploy, for purposes of imme2 diately addressing a public health emergency in the 

3 State or tribe, non-Federal personnel funded in 

4 whole or in part through, as appropriate, programs 

5 under this Act. 

6 ‘‘(2) ACTIVATION OF EMERGENCY REDEPLOY7 MENT.— 

8 ‘‘(A) PUBLIC HEALTH EMERGENCY.—The 

9 Secretary may authorize a temporary redeploy10 ment of personnel under paragraph (1) only 

11 during the period of a public health emergency 

12 determined pursuant to subsection (a). 

13 ‘‘(B) CONTENTS OF REQUEST.—To seek 

14 authority for a temporary redeployment of per15 sonnel under paragraph (1), the Governor of a 

16 State or the chief of a tribe shall submit to the 

17 Secretary a request for such authority and shall 

18 include in the request each of the following: 

19 ‘‘(i) An assurance that the public 

20 health emergency in the geographic area of 

21 the requesting State or tribe cannot be 

22 adequately and appropriately addressed by 

23 the public health workforce otherwise avail24 able. 


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1 ‘‘(ii) An assurance that the public 

2 health emergency would be addressed more 

3 efficiently and effectively through the re4 quested temporary redeployment of per5 sonnel. 

6 ‘‘(iii) An assurance that the requested 

7 temporary redeployment of personnel is 

8 consistent with any applicable All-Hazards 

9 Public Health Emergency Preparedness 

10 and Response Plan under section 319C–1. 

11 ‘‘(iv) An identification of— 

12 ‘‘(I) each Federal program from 

13 which personnel would be temporarily 

14 redeployed pursuant to the requested 

15 authority; and 

16 ‘‘(II) the number of personnel 

17 who would be so redeployed from each 

18 such program. 

19 ‘‘(v) Such other information and as20 surances as the Secretary may require. 

21 ‘‘(C) CONSIDERATION.—In reviewing a re22 quest for temporary redeployment under para23 graph (1) of personnel funded through a Fed24 eral program, the Secretary shall consider the 


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1 degree to which the program would be adversely 

2 affected by the redeployment. 

3 ‘‘(D) TERMINATION AND EXTENSION.— 

4 ‘‘(i) TERMINATION.—A State or 

5 tribe’s authority for a temporary redeploy6 ment of personnel under paragraph (1) 

7 shall terminate upon the earlier of the fol8 lowing: 

9 ‘‘(I) The Secretary’s determina10 tion that the public health emergency 

11 no longer exists. 

12 ‘‘(II) Subject to clause (ii), the 

13 expiration of the 30-day period fol14 lowing the date on which the Sec15 retary approved the State or tribe’s 

16 request for such authority. 

17 ‘‘(ii) EXTENSION AUTHORITY.—The 

18 Secretary may extend the authority to au19 thorize a temporary redeployment of per20 sonnel under paragraph (1) beyond the 

21 date otherwise applicable under clause 

22 (i)(II) if the public health emergency still 

23 exists as of such date, but only if— 

24 ‘‘(I) the State or tribe that sub25 mitted the initial request for authority 


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1 for a temporary redeployment of per2 sonnel submits a request for an exten3 sion of such authority; and 

4 ‘‘(II) the request for an extension 

5 contains the same type of information 

6 and assurances necessary for the ap7 proval of an initial request for such 

8 authority. 

9 ‘‘(3) NOTICE TO PERSONNEL OF POSSIBILITY

10 OF REDEPLOYMENT.—The Secretary shall ensure 

11 that, if a State or tribe receives Federal funds for 

12 personnel who are subject to the Secretary’s rede13 ployment authority under this subsection, the State 

14 or tribe gives notice to such personnel of the possi15 bility of redeployment— 

16 ‘‘(A) at the time of hiring; or 

17 ‘‘(B) in the case of personnel hired before 

18 the date of the enactment of this subsection, as 

19 soon as practicable. 

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

21 shall give notice to the Congress in conjunction with 

22 the approval under this subsection of— 

23 ‘‘(A) any initial request for authority for a 

24 temporary redeployment of personnel; and 


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

2 authority. 

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

4 ‘‘(A) not later than 6 months after the en5 actment of this subsection, issue proposed guid6 ance on the temporary redeployment of per7 sonnel under this subsection; and 

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

9 period for public comment, finalize such guid10 ance. 

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

12 years after the date of enactment of the Pandemic 

13 and All-Hazards Preparedness Reauthorization Act 

14 of 2013, the Comptroller General of the United 

15 States shall conduct an independent evaluation, and 

16 submit to the appropriate committees of the Con17 gress a report, on the Secretary’s authority under 

18 this subsection, including— 

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

20 circumstances, such authority has been used by 

21 States and tribes; 

22 ‘‘(B) an analysis of how such authority has 

23 assisted States and tribes in responding to pub24 lic health emergencies; 


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1 ‘‘(C) an evaluation of how such authority 

2 has improved operational efficiencies in re3 sponding to public health emergencies; 

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

5 any, Federal programs from which personnel 

6 have been temporarily redeployed pursuant to 

7 such authority have been adversely affected by 

8 the redeployment; and 

9 ‘‘(E) recommendations on how such au10 thority could be improved to further assist in 

11 responding to public health emergencies. 

12 ‘‘(7) DEFINITION.—In this subsection, the term 

13 ‘State’ includes, in addition to the entities listed in 

14 the definition of such term in section 2, the Freely 

15 Associated States. 

16 ‘‘(8) SUNSET.—The authority under this sub17 section shall terminate on the date that is 5 years 

18 after the date of enactment of the Pandemic and 

19 All-Hazards Preparedness Reauthorization Act of 

20 2013.’’. 

21 SEC. 202. IMPROVING STATE AND LOCAL PUBLIC HEALTH 

22 SECURITY. 

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

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

25 amended— 


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1 (1) in subsection (b)(1)(C), by striking ‘‘consor2 tium of entities described in subparagraph (A)’’ and 

3 inserting ‘‘consortium of States’’; 

4 (2) in subsection (b)(2)— 

5 (A) in subparagraph (A)— 

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

7 inserting the following: 

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

9 entity will carry out under the agreement 

10 to meet the goals identified under section 

11 2802, including with respect to chemical, 

12 biological, radiological, or nuclear threats, 

13 whether naturally occurring, unintentional, 

14 or deliberate; 

15 ‘‘(ii) a description of the activities 

16 such entity will carry out with respect to 

17 pandemic influenza, as a component of the 

18 activities carried out under clause (i), and 

19 consistent with the requirements of para20 graphs (2) and (5) of subsection (g);’’; 

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

22 the end; and 

23 (iii) by adding at the end the fol24 lowing: 


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1 ‘‘(vi) a description of how, as appro2 priate, the entity may partner with rel3 evant public and private stakeholders in 

4 public health emergency preparedness and 

5 response; 

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

7 as applicable and appropriate, will coordi8 nate with State emergency preparedness 

9 and response plans in public health emer10 gency preparedness, including State edu11 cational agencies (as defined in section 

12 9101(41) of the Elementary and Sec13 ondary Education Act of 1965) and State 

14 child care lead agencies (designated under 

15 section 658D of the Child Care and Devel16 opment Block Grant Act of 1990); 

17 ‘‘(viii) in the case of entities that op18 erate on the United States-Mexico border 

19 or the United States-Canada border, a de20 scription of the activities such entity will 

21 carry out under the agreement that are 

22 specific to the border area including dis23 ease detection, identification, investigation, 

24 and preparedness and response activities 

25 related to emerging diseases and infectious 


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1 disease outbreaks whether naturally occur2 ring or due to bioterrorism, consistent with 

3 the requirements of this section; and 

4 ‘‘(ix) a description of any activities 

5 that such entity will use to analyze real6 time clinical specimens for pathogens of 

7 public health or bioterrorism significance, 

8 including any utilization of poison control 

9 centers;’’; and 

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

11 including addressing the needs of at-risk indi12 viduals,’’ after ‘‘capabilities of such entity’’; 

13 (3) in subsection (f)— 

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

15 the end; 

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

17 and inserting a period; and 

18 (C) by striking paragraph (4); 

19 (4) in subsection (g)— 

20 (A) in paragraph (1), by striking subpara21 graph (A) and inserting the following: 

22 ‘‘(A) include outcome goals representing 

23 operational achievements of the National Pre24 paredness Goals developed under section 

25 2802(b) with respect to all-hazards, including 


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1 chemical, biological, radiological, or nuclear 

2 threats; and’’; and 

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

4 end the following: ‘‘The Secretary shall periodi5 cally update, as necessary and appropriate, 

6 such pandemic influenza plan criteria and shall 

7 require the integration of such criteria into the 

8 benchmarks and standards described in para9 graph (1).’’; 

10 (5) by striking subsection (h); 

11 (6) in subsection (i)— 

12 (A) in paragraph (1)— 

13 (i) in subparagraph (A)— 

14 (I) by striking ‘‘$824,000,000 for 

15 fiscal year 2007, of which 

16 $35,000,000 shall be used to carry 

17 out subsection (h),’’ and inserting 

18 ‘‘$641,900,000 for fiscal year 2013’’; 

19 and 

20 (II) by striking ‘‘such sums as 

21 may be necessary for each of fiscal 

22 years 2008 through 2011’’ and insert23 ing ‘‘$641,900,000 for each of fiscal 

24 years 2014 through 2017’’; 

25 (ii) by striking subparagraph (B); 


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1 (iii) by redesignating subparagraphs 

2 (C) and (D) as subparagraphs (B) and 

3 (C), respectively; and 

4 (iv) in subparagraph (C), as so redes5 ignated, by striking ‘‘subparagraph (C)’’ 

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

7 (B) in subparagraphs (C) and (D) of para8 graph (3), by striking ‘‘(1)(A)(i)(I)’’ each place 

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

10 (C) in paragraph (4)(B), by striking ‘‘sub11 section (c)’’ and inserting ‘‘subsection (b)’’; and 

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

13 ‘‘(7) AVAILABILITY OF COOPERATIVE AGREE14 MENT FUNDS.— 

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

16 an eligible entity under a cooperative agreement 

17 under subsection (a) for a fiscal year and re18 maining unobligated at the end of such year 

19 shall remain available to such entity for the 

20 next fiscal year for the purposes for which such 

21 funds were provided. 

22 ‘‘(B) FUNDS CONTINGENT ON ACHIEVING

23 BENCHMARKS.—The continued availability of 

24 funds under subparagraph (A) with respect to 

25 an entity shall be contingent upon such entity 


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1 achieving the benchmarks and submitting the 

2 pandemic influenza plan as described in sub3 section (g).’’; and 

4 (7) in subsection (j), by striking paragraph (3). 

5 (b) VACCINE TRACKING AND DISTRIBUTION.—Sec6 tion 319A(e) of the Public Health Service Act (42 U.S.C. 

7 247d–1(e)) is amended by striking ‘‘such sums for each 

8 of fiscal years 2007 through 2011’’ and inserting 

9 ‘‘$30,800,000 for each of fiscal years 2013 through 

10 2017’’. 

11 SEC. 203. HOSPITAL PREPAREDNESS AND MEDICAL SURGE 

12 CAPACITY. 

13 (a) ALL-HAZARDS PUBLIC HEALTH AND MEDICAL

14 RESPONSE CURRICULA AND TRAINING.—Section 

15 319F(a)(5)(B) of the Public Health Service Act (42 

16 U.S.C. 247d–6(a)(5)(B)) is amended by striking ‘‘public 

17 health or medical’’ and inserting ‘‘public health, medical, 

18 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 

24 Service Act (42 U.S.C. 247d–7b(k)) is amended by 

25 striking ‘‘$2,000,000 for fiscal year 2002, and such 


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1 sums as may be necessary for each of the fiscal 

2 years 2003 through 2011’’ and inserting 

3 ‘‘$5,000,000 for each of fiscal years 2013 through 

4 2017’’. 

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

6 Health Service Act (42 U.S.C. 300hh–15) is amend7 ed— 

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

9 end the following: ‘‘Such training exercises 

10 shall, as appropriate and applicable, incorporate 

11 the needs of at-risk individuals in the event of 

12 a public health emergency.’’; and 

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

14 ‘‘$22,000,000 for fiscal year 2007, and such 

15 sums as may be necessary for each of fiscal 

16 years 2008 through 2011’’ and inserting 

17 ‘‘$11,200,000 for each of fiscal years 2013 

18 through 2017’’. 

19 (c) PARTNERSHIPS FOR STATE AND REGIONAL PRE20 PAREDNESS TO IMPROVE SURGE CAPACITY.—Section 

21 319C–2 of the Public Health Service Act (42 U.S.C. 

22 247d–3b) is amended— 

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

24 capacity and preparedness to address the needs of 


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1 pediatric and other at-risk populations’’ before the 

2 period at the end; 

3 (2) in subsection (b)(1)(A)(ii), by striking ‘‘cen4 ters, primary’’ and inserting ‘‘centers, community 

5 health centers, primary’’; 

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

7 following: 

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

9 (a) shall be expended for activities to achieve the prepared10 ness goals described under paragraphs (1), (3), (4), (5), 

11 and (6) of section 2802(b) with respect to all-hazards, in12 cluding chemical, biological, radiological, or nuclear 

13 threats.’’; 

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

15 following: 

16 ‘‘(g) COORDINATION.— 

17 ‘‘(1) LOCAL RESPONSE CAPABILITIES.—An eli18 gible entity shall, to the extent practicable, ensure 

19 that activities carried out under an award under 

20 subsection (a) are coordinated with activities of rel21 evant local Metropolitan Medical Response Systems, 

22 local Medical Reserve Corps, the local Cities Readi23 ness Initiative, and local emergency plans. 

24 ‘‘(2) NATIONAL COLLABORATION.—Partner25 ships consisting of one or more eligible entities 


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1 under this section may, to the extent practicable, 

2 collaborate with other partnerships consisting of one 

3 or more eligible entities under this section for pur4 poses of national coordination and collaboration with 

5 respect to activities to achieve the preparedness 

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

7 and (6) of section 2802(b).’’; 

8 (5) in subsection (i)— 

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

10 inserting the following: 

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

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

13 ‘‘(2) MEETING GOALS OF NATIONAL HEALTH

14 SECURITY STRATEGY.—The Secretary shall imple15 ment objective, evidence-based metrics to ensure that 

16 entities receiving awards under this section are 

17 meeting, to the extent practicable, the applicable 

18 goals of the National Health Security Strategy 

19 under section 2802.’’; and 

20 (6) in subsection (j)— 

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

22 follows: 

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

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1 priated $374,700,000 for each of fiscal years 2013 

2 through 2017.’’; and 

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

4 ‘‘(4) AVAILABILITY OF COOPERATIVE AGREE5 MENT FUNDS.— 

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

7 an eligible entity under a cooperative agreement 

8 under subsection (a) for a fiscal year and re9 maining unobligated at the end of such year 

10 shall remain available to such entity for the 

11 next fiscal year for the purposes for which such 

12 funds were provided. 

13 ‘‘(B) FUNDS CONTINGENT ON ACHIEVING

14 BENCHMARKS.—The continued availability of 

15 funds under subparagraph (A) with respect to 

16 an entity shall be contingent upon such entity 

17 achieving the benchmarks and submitting the 

18 pandemic influenza plan as required under sub19 section (i).’’. 

20 SEC. 204. ENHANCING SITUATIONAL AWARENESS AND BIO21 SURVEILLANCE. 

22 Section 319D of the Public Health Service Act (42 

23 U.S.C. 247d–4) is amended— 

24 (1) in subsection (b)— 


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1 (A) in paragraph (1)(B), by inserting ‘‘poi2 son control centers,’’ after ‘‘hospitals,’’; 

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

4 the period at the end the following: ‘‘, allowing 

5 for coordination to maximize all-hazards med6 ical and public health preparedness and re7 sponse and to minimize duplication of effort’’; 

8 and 

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

10 the period at the end the following: ‘‘and up11 date such standards as necessary’’; 

12 (2) by striking subsection (c); and 

13 (3) in subsection (d)— 

14 (A) in the subsection heading, by striking 

15 ‘‘PUBLIC HEALTH SITUATIONAL AWARENESS’’ 

16 and inserting ‘‘MODERNIZING PUBLIC HEALTH

17 SITUATIONAL AWARENESS AND BIOSURVEIL18 LANCE’’; 

19 (B) in paragraph (1)— 

20 (i) by striking ‘‘Pandemic and All21 Hazards Preparedness Act’’ and inserting 

22 ‘‘Pandemic and All-Hazards Preparedness 

23 Reauthorization Act of 2013’’; and 

24 (ii) by inserting ‘‘, novel emerging 

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


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1 (C) by striking paragraph (2) and insert2 ing the following: 

3 ‘‘(2) STRATEGY AND IMPLEMENTATION

4 PLAN.—Not later than 180 days after the date of 

5 enactment of the Pandemic and All-Hazards Pre6 paredness Reauthorization Act of 2013, the Sec7 retary shall submit to the appropriate committees of 

8 Congress a coordinated strategy and an accom9 panying implementation plan that identifies and 

10 demonstrates the measurable steps the Secretary will 

11 carry out to— 

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

13 network described in paragraph (1), utilizing 

14 the elements described in paragraph (3); 

15 ‘‘(B) modernize and enhance biosurveil16 lance activities; and 

17 ‘‘(C) improve information sharing, coordi18 nation, and communication among disparate 

19 biosurveillance systems supported by the De20 partment of Health and Human Services.’’; 

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

22 ‘‘community health centers, health centers’’ 

23 after ‘‘poison control,’’; 

24 (E) in paragraph (5), by striking subpara25 graph (A) and inserting the following: 


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1 ‘‘(A) utilize applicable interoperability 

2 standards as determined by the Secretary, and 

3 in consultation with the Office of the National 

4 Coordinator for Health Information Tech5 nology, through a joint public and private sec6 tor process;’’; and 

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

8 ‘‘(6) CONSULTATION WITH THE NATIONAL BIO9 DEFENSE SCIENCE BOARD.—In carrying out this 

10 section and consistent with section 319M, the Na11 tional Biodefense Science Board shall provide expert 

12 advice and guidance, including recommendations, re13 garding the measurable steps the Secretary should 

14 take to modernize and enhance biosurveillance activi15 ties pursuant to the efforts of the Department of 

16 Health and Human Services to ensure comprehen17 sive, real-time, all-hazards biosurveillance capabili18 ties. In complying with the preceding sentence, the 

19 National Biodefense Science Board shall— 

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

21 a national biosurveillance system for human 

22 health, with international connectivity, where 

23 appropriate, that is predicated on State, re24 gional, and community level capabilities and 

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1 way information flow between and among Fed2 eral, State, and local government public health 

3 authorities and clinical health care providers; 

4 ‘‘(B) identify any duplicative surveillance 

5 programs under the authority of the Secretary, 

6 or changes that are necessary to existing pro7 grams, in order to enhance and modernize such 

8 activities, minimize duplication, strengthen and 

9 streamline such activities under the authority of 

10 the Secretary, and achieve real-time and appro11 priate data that relate to disease activity, both 

12 human and zoonotic; and 

13 ‘‘(C) coordinate with applicable existing 

14 advisory committees of the Director of the Cen15 ters for Disease Control and Prevention, includ16 ing such advisory committees consisting of rep17 resentatives from State, local, and tribal public 

18 health authorities and appropriate public and 

19 private sector health care entities and academic 

20 institutions, in order to provide guidance on 

21 public health surveillance activities.’’; 

22 (4) in subsection (e)(5), by striking ‘‘4 years 

23 after the date of enactment of the Pandemic and 

24 All-Hazards Preparedness Act’’ and inserting ‘‘3 

25 years after the date of enactment of the Pandemic 


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1 and All-Hazards Preparedness Reauthorization Act 

2 of 2013’’; 

3 (5) in subsection (g), by striking ‘‘such sums as 

4 may be necessary in each of fiscal years 2007 

5 through 2011’’ and inserting ‘‘$138,300,000 for 

6 each of fiscal years 2013 through 2017’’; and 

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

8 ‘‘(h) DEFINITION.—For purposes of this section the 

9 term ‘biosurveillance’ means the process of gathering near 

10 real-time biological data that relates to human and 

11 zoonotic disease activity and threats to human or animal 

12 health, in order to achieve early warning and identification 

13 of such health threats, early detection and prompt ongoing 

14 tracking of health events, and overall situational aware15 ness of disease activity.’’. 

16 SEC. 205. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD 

17 REPORTS. 

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

19 U.S.C. 247d–6c) is repealed. 

20 TITLE III—ENHANCING MEDICAL 

21 COUNTERMEASURE REVIEW 

22 SEC. 301. SPECIAL PROTOCOL ASSESSMENT. 

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

24 Cosmetic Act (21 U.S.C. 355(b)(5)(B)) is amended by 

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1 lows through ‘‘. The sponsor or applicant’’ and inserting 

2 the following: ‘‘size— 

3 ‘‘(i)(I) of clinical trials intended to form the 

4 primary basis of an effectiveness claim; or 

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

6 are not ethical or feasible, of animal and any associ7 ated clinical trials which, in combination, are in8 tended to form the primary basis of an effectiveness 

9 claim; or 

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

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

12 Public Health Service Act, of any necessary clinical 

13 study or studies. 

14 The sponsor or applicant’’. 

15 SEC. 302. AUTHORIZATION FOR MEDICAL PRODUCTS FOR 

16 USE IN EMERGENCIES. 

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

18 Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) is amend19 ed— 

20 (1) in subsection (a)— 

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

22 505, 510(k), and 515 of this Act’’ and inserting 

23 ‘‘any provision of this Act’’; 

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

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


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

2 510(k), or 515 of this Act or section 351 of the 

3 Public Health Service Act’’; and 

4 (C) in paragraph (3), by striking ‘‘a provi5 sion of law referred to in such paragraph’’ and 

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

7 Health Service Act referred to in paragraph 

8 (2)(A)’’; 

9 (2) in subsection (b)— 

10 (A) in the subsection heading, by striking 

11 ‘‘EMERGENCY’’ and inserting ‘‘EMERGENCY OR

12 THREAT JUSTIFYING EMERGENCY AUTHOR13 IZED USE’’; 

14 (B) in paragraph (1)— 

15 (i) in the matter preceding subpara16 graph (A), by striking ‘‘may declare an 

17 emergency’’ and inserting ‘‘may make a 

18 declaration that the circumstances exist’’; 

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

20 ‘‘specified’’; 

21 (iii) in subparagraph (B)— 

22 (I) by striking ‘‘specified’’; and 

23 (II) by striking ‘‘; or’’ and insert24 ing a semicolon; 


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1 (iv) by amending subparagraph (C) to 

2 read as follows: 

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

4 there is a public health emergency, or a signifi5 cant potential for a public health emergency, 

6 that affects, or has a significant potential to af7 fect, national security or the health and security 

8 of United States citizens living abroad, and that 

9 involves a biological, chemical, radiological, or 

10 nuclear agent or agents, or a disease or condi11 tion that may be attributable to such agent or 

12 agents; or’’; and 

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

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

15 pursuant to section 319F–2 of the Public 

16 Health Service Act sufficient to affect national 

17 security or the health and security of United 

18 States citizens living abroad.’’; 

19 (C) in paragraph (2)— 

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

21 clause (ii) to read as follows: 

22 ‘‘(ii) a change in the approval status 

23 of the product such that the circumstances 

24 described in subsection (a)(2) have ceased 

25 to exist.’’; 


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

2 (iii) by redesignating subparagraph 

3 (C) as subparagraph (B); 

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

5 notice of termination, and renewal under this 

6 subsection.’’ and inserting ‘‘, and advance no7 tice of termination under this subsection.’’; and 

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

9 ‘‘(5) EXPLANATION BY SECRETARY.—If an au10 thorization under this section with respect to an un11 approved product or an unapproved use of an ap12 proved product has been in effect for more than 1 

13 year, the Secretary shall provide in writing to the 

14 sponsor of such product an explanation of the sci15 entific, regulatory, or other obstacles to approval, li16 censure, or clearance of such product or use, includ17 ing specific actions to be taken by the Secretary and 

18 the sponsor to overcome such obstacles.’’; 

19 (3) in subsection (c)— 

20 (A) in the matter preceding paragraph 

21 (1)— 

22 (i) by inserting ‘‘the Assistant Sec23 retary for Preparedness and Response,’’ 

24 after ‘‘consultation with’’; 


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1 (ii) by striking ‘‘Health and’’ and in2 serting ‘‘Health, and’’; and 

3 (iii) by striking ‘‘circumstances of the 

4 emergency involved’’ and inserting ‘‘appli5 cable circumstances described in subsection 

6 (b)(1)’’; 

7 (B) in paragraph (1), by striking ‘‘speci8 fied’’ and inserting ‘‘referred to’’; and 

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

10 taking into consideration the material threat 

11 posed by the agent or agents identified in a dec12 laration under subsection (b)(1)(D), if applica13 ble’’ after ‘‘risks of the product’’; 

14 (4) in subsection (d)(3), by inserting ‘‘, to the 

15 extent practicable given the circumstances of the 

16 emergency,’’ after ‘‘including’’; 

17 (5) in subsection (e)— 

18 (A) in paragraph (1)(A), by striking ‘‘cir19 cumstances of the emergency’’ and inserting 

20 ‘‘applicable circumstances described in sub21 section (b)(1)’’; 

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

23 clause (iii) to read as follows: 

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1 tion concerning the safety and effectiveness 

2 of the product with respect to the use of 

3 such product during the period when the 

4 authorization is in effect and a reasonable 

5 time following such period.’’; 

6 (C) in paragraph (2)— 

7 (i) in subparagraph (A)— 

8 (I) by striking ‘‘manufacturer of 

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

10 (II) by striking ‘‘circumstances of 

11 the emergency’’ and inserting ‘‘appli12 cable circumstances described in sub13 section (b)(1)’’; and 

14 (III) by inserting at the end be15 fore the period ‘‘or in paragraph 

16 (1)(B)’’; 

17 (ii) in subparagraph (B)(i), by insert18 ing before the period at the end ‘‘, except 

19 as provided in section 564A with respect to 

20 authorized changes to the product expira21 tion date’’; and 

22 (iii) by amending subparagraph (C) to 

23 read as follows: 

24 ‘‘(C) In establishing conditions under this 

25 paragraph with respect to the distribution and 


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1 administration of the product for the unap2 proved use, the Secretary shall not impose con3 ditions that would restrict distribution or ad4 ministration of the product when distributed or 

5 administered for the approved use.’’; and 

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

7 follows: 

8 ‘‘(3) GOOD MANUFACTURING PRACTICE; PRE9 SCRIPTION.—With respect to the emergency use of a 

10 product for which an authorization under this sec11 tion is issued (whether an unapproved product or an 

12 unapproved use of an approved product), the Sec13 retary may waive or limit, to the extent appropriate 

14 given the applicable circumstances described in sub15 section (b)(1)— 

16 ‘‘(A) requirements regarding current good 

17 manufacturing practice otherwise applicable to 

18 the manufacture, processing, packing, or hold19 ing of products subject to regulation under this 

20 Act, including such requirements established 

21 under section 501 or 520(f)(1), and including 

22 relevant conditions prescribed with respect to 

23 the product by an order under section 

24 520(f)(2); 


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1 ‘‘(B) requirements established under sec2 tion 503(b); and 

3 ‘‘(C) requirements established under sec4 tion 520(e).’’; 

5 (6) in subsection (g)— 

6 (A) in the subsection heading, by inserting 

7 ‘‘REVIEW AND’’ before ‘‘REVOCATION’’; 

8 (B) in paragraph (1), by inserting after 

9 the period at the end the following: ‘‘As part of 

10 such review, the Secretary shall regularly review 

11 the progress made with respect to the approval, 

12 licensure, or clearance of— 

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

14 authorization was issued under this section; or 

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

16 product for which an authorization was issued 

17 under this section.’’; and 

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

19 follows: 

20 ‘‘(2) REVISION AND REVOCATION.—The Sec21 retary may revise or revoke an authorization under 

22 this section if— 

23 ‘‘(A) the circumstances described under 

24 subsection (b)(1) no longer exist; 


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

2 issuance of such authorization are no longer 

3 met; or 

4 ‘‘(C) other circumstances make such revi5 sion or revocation appropriate to protect the 

6 public health or safety.’’; 

7 (7) in subsection (h)(1), by adding after the pe8 riod at the end the following: ‘‘The Secretary shall 

9 make any revisions to an authorization under this 

10 section available on the Internet Web site of the 

11 Food and Drug Administration.’’; 

12 (8) by adding at the end of subsection (j) the 

13 following: 

14 ‘‘(4) Nothing in this section shall be construed 

15 as authorizing a delay in the review or other consid16 eration by the Secretary of any application or sub17 mission pending before the Food and Drug Adminis18 tration for a product for which an authorization 

19 under this section is issued.’’; and 

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

21 ‘‘(m) CATEGORIZATION OF LABORATORY TESTS AS22 SOCIATED WITH DEVICES SUBJECT TO AUTHORIZA23 TION.— 

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

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1 retary may, subject to the provisions of this section, 

2 determine that a laboratory examination or proce3 dure associated with such device shall be deemed, for 

4 purposes of section 353 of the Public Health Service 

5 Act, to be in a particular category of examinations 

6 and procedures (including the category described by 

7 subsection (d)(3) of such section) if, based on the to8 tality of scientific evidence available to the Sec9 retary— 

10 ‘‘(A) such categorization would be bene11 ficial to protecting the public health; and 

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

13 such categorization under the circumstances of 

14 the authorization outweigh the known and po15 tential risks of the categorization. 

16 ‘‘(2) CONDITIONS OF DETERMINATION.—The 

17 Secretary may establish appropriate conditions on 

18 the performance of the examination or procedure 

19 pursuant to such determination. 

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

21 under this subsection shall be effective for purposes 

22 of section 353 of the Public Health Service Act not23 withstanding any other provision of that section dur24 ing the effective period of the relevant declaration 

25 under subsection (b).’’. 


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1 (b) EMERGENCY USE OF MEDICAL PRODUCTS.— 

2 Subchapter E of chapter V of the Federal Food, Drug, 

3 and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended 

4 by inserting after section 564 the following: 

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

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

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

8 product’ means a product that— 

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

10 chapter or licensed under section 351 of the 

11 Public Health Service Act; 

12 ‘‘(B)(i) is intended for use to prevent, di13 agnose, or treat a disease or condition involving 

14 a biological, chemical, radiological, or nuclear 

15 agent or agents; or 

16 ‘‘(ii) is intended for use to prevent, diag17 nose, or treat a serious or life-threatening dis18 ease or condition caused by a product described 

19 in clause (i); and 

20 ‘‘(C) is intended for use during the cir21 cumstances under which— 

22 ‘‘(i) a determination described in sub23 paragraph (A), (B), or (C) of section 

24 564(b)(1) has been made by the Secretary 


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1 of Homeland Security, the Secretary of 

2 Defense, or the Secretary, respectively; or 

3 ‘‘(ii) the identification of a material 

4 threat described in subparagraph (D) of 

5 section 564(b)(1) has been made pursuant 

6 to section 319F–2 of the Public Health 

7 Service Act. 

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

9 drug, device, or biological product. 

10 ‘‘(b) EXPIRATION DATING.— 

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

12 the expiration date and authorize the introduction or 

13 delivery for introduction into interstate commerce of 

14 an eligible product after the expiration date provided 

15 by the manufacturer if— 

16 ‘‘(A) the expiration date extension is in17 tended to support the United States ability to 

18 protect— 

19 ‘‘(i) the public health; or 

20 ‘‘(ii) military preparedness and effec21 tiveness; and 

22 ‘‘(B) the expiration date extension is sup23 ported by an appropriate scientific evaluation 

24 that is conducted or accepted by the Secretary. 


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1 ‘‘(2) REQUIREMENTS AND CONDITIONS.—Any 

2 extension of an expiration date under paragraph (1) 

3 shall, as part of the extension, identify— 

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

5 of the product for which extended expiration is 

6 authorized; 

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

8 ‘‘(C) any other requirements or conditions 

9 as the Secretary may deem appropriate for the 

10 protection of the public health, which may in11 clude requirements for, or conditions on, prod12 uct sampling, storage, packaging or repack13 aging, transport, labeling, notice to product re14 cipients, recordkeeping, periodic testing or re15 testing, or product disposition. 

16 ‘‘(3) EFFECT.—Notwithstanding any other pro17 vision of this Act or the Public Health Service Act, 

18 an eligible product shall not be considered an unap19 proved product (as defined in section 564(a)(2)(A)) 

20 and shall not be deemed adulterated or misbranded 

21 under this Act because, with respect to such prod22 uct, the Secretary has, under paragraph (1), ex23 tended the expiration date and authorized the intro24 duction or delivery for introduction into interstate 


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1 commerce of such product after the expiration date 

2 provided by the manufacturer. 

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

4 subsection, the term ‘expiration date’ means the 

5 date established through appropriate stability testing 

6 required by the regulations issued by the Secretary 

7 to ensure that the product meets applicable stand8 ards of identity, strength, quality, and purity at the 

9 time of use. 

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

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

12 the circumstances of a domestic, military, or public 

13 health emergency or material threat described in 

14 subsection (a)(1)(C) so warrant, authorize, with re15 spect to an eligible product, deviations from current 

16 good manufacturing practice requirements otherwise 

17 applicable to the manufacture, processing, packing, 

18 or holding of products subject to regulation under 

19 this Act, including requirements under section 501 

20 or 520(f)(1) or applicable conditions prescribed with 

21 respect to the eligible product by an order under sec22 tion 520(f)(2). 

23 ‘‘(2) EFFECT.—Notwithstanding any other pro24 vision of this Act or the Public Health Service Act, 

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1 proved product (as defined in section 564(a)(2)(A)) 

2 and shall not be deemed adulterated or misbranded 

3 under this Act because, with respect to such prod4 uct, the Secretary has authorized deviations from 

5 current good manufacturing practices under para6 graph (1). 

7 ‘‘(d) EMERGENCY DISPENSING.—The requirements 

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

9 product, and the product shall not be considered an unap10 proved product (as defined in section 564(a)(2)(A)) and 

11 shall not be deemed adulterated or misbranded under this 

12 Act because it is dispensed without an individual prescrip13 tion, if— 

14 ‘‘(1) the product is dispensed during the cir15 cumstances described in subsection (a)(1)(C); and 

16 ‘‘(2) such dispensing without an individual pre17 scription occurs— 

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

19 State in which the product is dispensed; or 

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

21 the Secretary, for the purposes and duration of 

22 the circumstances described in subsection 

23 (a)(1)(C). 

24 ‘‘(e) EMERGENCY USE INSTRUCTIONS.— 


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

2 through an appropriate official within the Depart3 ment of Health and Human Services, may create 

4 and issue emergency use instructions to inform 

5 health care providers or individuals to whom an eli6 gible product is to be administered concerning such 

7 product’s approved, licensed, or cleared conditions of 

8 use. 

9 ‘‘(2) EFFECT.—Notwithstanding any other pro10 visions of this Act or the Public Health Service Act, 

11 a product shall not be considered an unapproved 

12 product and shall not be deemed adulterated or mis13 branded under this Act because of the issuance of 

14 emergency use instructions under paragraph (1) 

15 with respect to such product or the introduction or 

16 delivery for introduction of such product into inter17 state commerce accompanied by such instructions— 

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

19 actual emergency that is the basis for a deter20 mination described in subsection (a)(1)(C)(i); or 

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

22 Federal, State, local, or tribal government enti23 ty), or a person acting on behalf of such a gov24 ernment entity, in preparation for an emer25 gency response.’’. 


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1 (c) RISK EVALUATION AND MITIGATION STRATE2 GIES.—Section 505–1 of the Federal Food, Drug, and 

3 Cosmetic Act (21 U.S.C. 355–1), is amended— 

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

5 and 

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

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

8 The Secretary may waive any requirement of this section 

9 with respect to a qualified countermeasure (as defined in 

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

11 to which a requirement under this section has been ap12 plied, if the Secretary determines that such waiver is re13 quired to mitigate the effects of, or reduce the severity 

14 of, the circumstances under which— 

15 ‘‘(1) a determination described in subparagraph 

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

17 by the Secretary of Homeland Security, the Sec18 retary of Defense, or the Secretary, respectively; or 

19 ‘‘(2) the identification of a material threat de20 scribed in subparagraph (D) of section 564(b)(1) 

21 has been made pursuant to section 319F–2 of the 

22 Public Health Service Act.’’. 

23 (d) PRODUCTS HELD FOR EMERGENCY USE.—The 

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


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1 et seq.) is amended by inserting after section 564A, as 

2 added by subsection (b), the following: 

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

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

5 of the Public Health Service Act for a government entity 

6 (including a Federal, State, local, or tribal government en7 tity), or a person acting on behalf of such a government 

8 entity, to introduce into interstate commerce a product (as 

9 defined in section 564(a)(4)) intended for emergency use, 

10 if that product— 

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

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

13 product— 

14 ‘‘(A) is approved, cleared, or licensed 

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

16 or section 351 of the Public Health Service Act; 

17 ‘‘(B) is authorized for investigational use 

18 under section 505 or 520 of this Act or section 

19 351 of the Public Health Service Act; or 

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

21 564.’’. 

22 SEC. 303. DEFINITIONS. 

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

24 Act (21 U.S.C. 360bbb–4) is amended by striking ‘‘The 

25 Secretary, in consultation’’ and inserting the following: 


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

2 ‘‘(1) the term ‘countermeasure’ means a quali3 fied countermeasure, a security countermeasure, and 

4 a qualified pandemic or epidemic product; 

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

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

7 the Public Health Service Act; 

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

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

10 Act; and 

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

12 product’ means a product that meets the definition 

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

14 Health Service Act and— 

15 ‘‘(A) that has been identified by the De16 partment of Health and Human Services or the 

17 Department of Defense as receiving funding di18 rectly related to addressing chemical, biological, 

19 radiological, or nuclear threats, including pan20 demic influenza; or 

21 ‘‘(B) is included under this paragraph pur22 suant to a determination by the Secretary. 

23 ‘‘(b) GENERAL DUTIES.—The Secretary, in consulta24 tion’’. 


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1 SEC. 304. ENHANCING MEDICAL COUNTERMEASURE AC2 TIVITIES. 

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

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

5 is further amended— 

6 (1) in the section heading, by striking ‘‘TECH7 NICAL ASSISTANCE’’ and inserting ‘‘COUNTER8 MEASURE DEVELOPMENT, REVIEW, AND TECH9 NICAL ASSISTANCE’’; 

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

11 enumerator and all that follows through ‘‘shall es12 tablish’’ and inserting the following: 

13 ‘‘(b) GENERAL DUTIES.—In order to accelerate the 

14 development, stockpiling, approval, licensure, and clear15 ance of qualified countermeasures, security counter16 measures, and qualified pandemic or epidemic products, 

17 the Secretary, in consultation with the Assistant Secretary 

18 for Preparedness and Response, shall— 

19 ‘‘(1) ensure the appropriate involvement of 

20 Food and Drug Administration personnel in inter21 agency activities related to countermeasure advanced 

22 research and development, consistent with sections 

23 319F, 319F–1, 319F–2, 319F–3, 319L, and 2811 

24 of the Public Health Service Act; 

25 ‘‘(2) ensure the appropriate involvement and 

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1 sonnel in any flexible manufacturing activities car2 ried out under section 319L of the Public Health 

3 Service Act, including with respect to meeting regu4 latory requirements set forth in this Act; 

5 ‘‘(3) promote countermeasure expertise within 

6 the Food and Drug Administration by— 

7 ‘‘(A) ensuring that Food and Drug Admin8 istration personnel involved in reviewing coun9 termeasures for approval, licensure, or clear10 ance are informed by the Assistant Secretary 

11 for Preparedness and Response on the material 

12 threat assessment conducted under section 

13 319F–2 of the Public Health Service Act for 

14 the agent or agents for which the counter15 measure under review is intended; 

16 ‘‘(B) training Food and Drug Administra17 tion personnel regarding review of counter18 measures for approval, licensure, or clearance; 

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

20 annually to encourage the exchange of scientific 

21 ideas; and 

22 ‘‘(D) establishing protocols to ensure that 

23 countermeasure reviewers have sufficient train24 ing or experience with countermeasures; 


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

2 Drug Administration personnel with expertise on 

3 countermeasures, including specific counter4 measures, populations with special clinical needs (in5 cluding children and pregnant women that may use 

6 countermeasures, as applicable and appropriate), 

7 classes or groups of countermeasures, or other coun8 termeasure-related technologies and capabilities, that 

9 shall— 

10 ‘‘(A) consult with countermeasure experts, 

11 including countermeasure sponsors and appli12 cants, to identify and help resolve scientific 

13 issues related to the approval, licensure, or 

14 clearance of countermeasures, through work15 shops or public meetings; and 

16 ‘‘(B) improve and advance the science re17 lating to the development of new tools, stand18 ards, and approaches to assessing and evalu19 ating countermeasures— 

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

21 countermeasure approval, clearance, and li22 censure; and 

23 ‘‘(ii) with respect to the development 

24 of countermeasures for populations with 

25 special clinical needs, including children 


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1 and pregnant women, in order to meet the 

2 needs of such populations, as necessary 

3 and appropriate; and 

4 ‘‘(5) establish’’; and 

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

6 ‘‘(c) FINAL GUIDANCE ON DEVELOPMENT OF ANI7 MAL MODELS.— 

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

9 the date of the enactment of the Pandemic and All10 Hazards Preparedness Reauthorization Act of 2013, 

11 the Secretary shall provide final guidance to indus12 try regarding the development of animal models to 

13 support approval, clearance, or licensure of counter14 measures referred to in subsection (a) when human 

15 efficacy studies are not ethical or feasible. 

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

17 Secretary may extend the deadline for providing 

18 final guidance under paragraph (1) by not more 

19 than 6 months upon submission by the Secretary of 

20 a report on the status of such guidance to the Com21 mittee on Energy and Commerce of the House of 

22 Representatives and the Committee on Health, Edu23 cation, Labor, and Pensions of the Senate. 

24 ‘‘(d) DEVELOPMENT AND ANIMAL MODELING PRO25 CEDURES.— 


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1 ‘‘(1) AVAILABILITY OF ANIMAL MODEL MEET2 INGS.—To facilitate the timely development of ani3 mal models and support the development, stock4 piling, licensure, approval, and clearance of counter5 measures, the Secretary shall, not later than 180 

6 days after the enactment of this subsection, establish 

7 a procedure by which a sponsor or applicant that is 

8 developing a countermeasure for which human effi9 cacy studies are not ethical or practicable, and that 

10 has an approved investigational new drug application 

11 or investigational device exemption, may request and 

12 receive— 

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

14 model development activities; and 

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

16 animal studies. 

17 ‘‘(2) PEDIATRIC MODELS.—To facilitate the de18 velopment and selection of animal models that could 

19 translate to pediatric studies, any meeting conducted 

20 under paragraph (1) shall include discussion of ani21 mal models for pediatric populations, as appropriate. 

22 ‘‘(e) REVIEW AND APPROVAL OF COUNTER23 MEASURES.— 

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

25 application or submission for approval, licensure, or 


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1 clearance of a countermeasure, the Secretary shall 

2 take into account the material threat posed by the 

3 chemical, biological, radiological, or nuclear agent or 

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

5 Health Service Act for which the countermeasure 

6 under review is intended. 

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

8 and appropriate, teams of Food and Drug Adminis9 tration personnel reviewing applications or submis10 sions described under paragraph (1) shall include a 

11 reviewer with sufficient training or experience with 

12 countermeasures pursuant to the protocols estab13 lished under subsection (b)(3)(D).’’. 

14 SEC. 305. REGULATORY MANAGEMENT PLANS. 

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

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

17 is further amended by adding at the end the following: 

18 ‘‘(f) REGULATORY MANAGEMENT PLAN.— 

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

20 ‘eligible countermeasure’ means— 

21 ‘‘(A) a security countermeasure with re22 spect to which the Secretary has entered into a 

23 procurement contract under section 319F–2(c) 

24 of the Public Health Service Act; or 


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1 ‘‘(B) a countermeasure with respect to 

2 which the Biomedical Advanced Research and 

3 Development Authority has provided funding 

4 under section 319L of the Public Health Serv5 ice Act for advanced research and development. 

6 ‘‘(2) REGULATORY MANAGEMENT PLAN PROC7 ESS.—The Secretary, in consultation with the As8 sistant Secretary for Preparedness and Response 

9 and the Director of the Biomedical Advanced Re10 search and Development Authority, shall establish a 

11 formal process for obtaining scientific feedback and 

12 interactions regarding the development and regu13 latory review of eligible countermeasures by facili14 tating the development of written regulatory man15 agement plans in accordance with this subsection. 

16 ‘‘(3) SUBMISSION OF REQUEST AND PROPOSED

17 PLAN BY SPONSOR OR APPLICANT.— 

18 ‘‘(A) IN GENERAL.—A sponsor or appli19 cant of an eligible countermeasure may initiate 

20 the process described under paragraph (2) upon 

21 submission of a written request to the Sec22 retary. Such request shall include a proposed 

23 regulatory management plan. 

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

25 or applicant may submit a written request 


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1 under subparagraph (A) after the eligible coun2 termeasure has an investigational new drug or 

3 investigational device exemption in effect. 

4 ‘‘(C) RESPONSE BY SECRETARY.—The 

5 Secretary shall direct the Food and Drug Ad6 ministration, upon submission of a written re7 quest by a sponsor or applicant under subpara8 graph (A), to work with the sponsor or appli9 cant to agree on a regulatory management plan 

10 within a reasonable time not to exceed 90 days. 

11 If the Secretary determines that no plan can be 

12 agreed upon, the Secretary shall provide to the 

13 sponsor or applicant, in writing, the scientific 

14 or regulatory rationale why such agreement 

15 cannot be reached. 

16 ‘‘(4) PLAN.—The content of a regulatory man17 agement plan agreed to by the Secretary and a spon18 sor or applicant shall include— 

19 ‘‘(A) an agreement between the Secretary 

20 and the sponsor or applicant regarding develop21 mental milestones that will trigger responses by 

22 the Secretary as described in subparagraph (B); 

23 ‘‘(B) performance targets and goals for 

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1 graph (A), including meetings between the Sec2 retary and the sponsor or applicant, written 

3 feedback, decisions by the Secretary, and other 

4 activities carried out as part of the development 

5 and review process; and 

6 ‘‘(C) an agreement on how the plan shall 

7 be modified, if needed. 

8 ‘‘(5) MILESTONES AND PERFORMANCE TAR9 GETS.—The developmental milestones described in 

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

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

12 ‘‘(A) feedback from the Secretary regard13 ing the data required to support the approval, 

14 clearance, or licensure of the eligible counter15 measure involved; 

16 ‘‘(B) feedback from the Secretary regard17 ing the data necessary to inform any authoriza18 tion under section 564; 

19 ‘‘(C) feedback from the Secretary regard20 ing the data necessary to support the posi21 tioning and delivery of the eligible counter22 measure, including to the Strategic National 

23 Stockpile; 

24 ‘‘(D) feedback from the Secretary regard25 ing the data necessary to support the submisVerDate Mar 15 2010 22:31 Feb 14, 2013 Jkt 029200 PO 00000 Frm 00075 Fmt 6652 Sfmt 6401 E:\BILLS\H307.RS H307

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1 sion of protocols for review under section 

2 505(b)(5)(B); 

3 ‘‘(E) feedback from the Secretary regard4 ing any gaps in scientific knowledge that will 

5 need resolution prior to approval, licensure, or 

6 clearance of the eligible countermeasure and 

7 plans for conducting the necessary scientific re8 search; 

9 ‘‘(F) identification of the population for 

10 which the countermeasure sponsor or applicant 

11 seeks approval, licensure, or clearance and the 

12 population for which desired labeling would not 

13 be appropriate, if known; and 

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

15 the extent practicable, a plan for demonstrating 

16 safety and effectiveness in pediatric popu17 lations, and for developing pediatric dosing, for18 mulation, and administration with respect to 

19 the eligible countermeasure, provided that such 

20 plan would not delay authorization under sec21 tion 564, approval, licensure, or clearance for 

22 adults. 

23 ‘‘(6) PRIORITIZATION.— 

24 ‘‘(A) PLANS FOR SECURITY COUNTER25 MEASURES.—The Secretary shall establish regVerDate Mar 15 2010 22:31 Feb 14, 2013 Jkt 029200 PO 00000 Frm 00076 Fmt 6652 Sfmt 6401 E:\BILLS\H307.RS H307

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1 ulatory management plans for all security coun2 termeasures for which a request is submitted 

3 under paragraph (3)(A). 

4 ‘‘(B) PLANS FOR OTHER ELIGIBLE COUN5 TERMEASURES.—The Secretary shall determine 

6 whether resources are available to establish reg7 ulatory management plans for eligible counter8 measures that are not security counter9 measures. If resources are available to establish 

10 regulatory management plans for eligible coun11 termeasures that are not security counter12 measures, and if resources are not available to 

13 establish regulatory management plans for all 

14 eligible countermeasures for which requests 

15 have been submitted, the Director of the Bio16 medical Advanced Research and Development 

17 Authority, in consultation with the Commis18 sioner, shall prioritize which eligible counter19 measures may receive regulatory management 

20 plans.’’. 

21 SEC. 306. REPORT. 

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

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

24 is further amended by adding at the end the following: 


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1 ‘‘(g) ANNUAL REPORT.—Not later than 180 days 

2 after the date of enactment of this subsection, and annu3 ally thereafter, the Secretary shall make publicly available 

4 on the Web site of the Food and Drug Administration a 

5 report that details the countermeasure development and 

6 review activities of the Food and Drug Administration, in7 cluding— 

8 ‘‘(1) with respect to the development of new 

9 tools, standards, and approaches to assess and 

10 evaluate countermeasures— 

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

12 the Food and Drug Administration and the 

13 progress made on such priorities; and 

14 ‘‘(B) the identification of scientific gaps 

15 that impede the development, approval, licen16 sure, or clearance of countermeasures for popu17 lations with special clinical needs, including 

18 children and pregnant women, and the progress 

19 made on resolving these challenges; 

20 ‘‘(2) with respect to countermeasures for which 

21 a regulatory management plan has been agreed upon 

22 under subsection (f), the extent to which the per23 formance targets and goals set forth in subsection 

24 (f)(4)(B) and the regulatory management plan have 

25 been met, 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 estab11 lished pursuant to subsection (b)(4), the number of 

12 products, classes of products, or technologies as13 signed to each such team, and the number of, type 

14 of, and any progress made as a result of consulta15 tions carried out 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 

22 employees of the Food and Drug Administra23 tion 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 

4 of remaining submitted applications and submis5 sions, and the number of each type of authorization 

6 issued 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 

10 plans developed, and the number of such plans de11 veloped for security countermeasures; and 

12 ‘‘(7) the number, type, and frequency of meet13 ings between the Food and Drug Administration 

14 and— 

15 ‘‘(A) sponsors of a countermeasure as de16 fined in subsection (a); or 

17 ‘‘(B) another agency engaged in develop18 ment or management of portfolios for such 

19 countermeasures, including the Centers for Dis20 ease Control and Prevention, the Biomedical 

21 Advanced Research and Development Authority, 

22 the National Institutes of Health, and the ap23 propriate agencies of the Department of De24 fense.’’. 


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1 SEC. 307. PEDIATRIC MEDICAL COUNTERMEASURES. 

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

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

4 355a) 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 se10 curity countermeasure (as defined in section 319F– 

11 2 of the Public Health Service Act), or a qualified 

12 pandemic 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 Sec15 retary for Preparedness and Response regarding the 

16 need for and, from the Director of the Biomedical 

17 Advanced Research and Development Authority re18 garding the conduct of, pediatric studies under this 

19 section.’’; and 

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

21 the following: 

22 ‘‘(C) For a drug that is a qualified coun23 termeasure (as defined in section 319F–1 of the 

24 Public Health Service Act), a security counter25 measure (as defined in section 319F–2 of the 

26 Public Health Service Act), or a qualified panVerDate Mar 15 2010 22:31 Feb 14, 2013 Jkt 029200 PO 00000 Frm 00081 Fmt 6652 Sfmt 6401 E:\BILLS\H307.RS H307

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1 demic or epidemic product (as defined in sec2 tion 319F–3 of such Act), in addition to any 

3 action with respect to such drug under subpara4 graph (A) or (B), the Secretary shall notify the 

5 Assistant Secretary for Preparedness and Re6 sponse and the Director of the Biomedical Ad7 vanced Research and Development Authority of 

8 all pediatric studies in the written request 

9 issued by the Commissioner of Food and 

10 Drugs.’’. 

11 (b) ADDITION TO PRIORITY LIST CONSIDER12 ATIONS.—Section 409I of the Public Health Service Act 

13 (42 U.S.C. 284m) is amended— 

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

15 the following: 

16 ‘‘(2) CONSIDERATION OF AVAILABLE INFORMA17 TION.—In developing and prioritizing the list under 

18 paragraph (1), the Secretary— 

19 ‘‘(A) shall consider— 

20 ‘‘(i) therapeutic gaps in pediatrics 

21 that may include developmental pharma22 cology, pharmacogenetic determinants of 

23 drug response, metabolism of drugs and 

24 biologics in children, and pediatric clinical 

25 trials; 


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1 ‘‘(ii) particular pediatric diseases, dis2 orders or conditions where more complete 

3 knowledge and testing of therapeutics, in4 cluding drugs and biologics, may be bene5 ficial in pediatric populations; and 

6 ‘‘(iii) the adequacy of necessary infra7 structure to conduct pediatric pharma8 cological research, including research net9 works and trained pediatric investigators; 

10 and 

11 ‘‘(B) may consider the availability of quali12 fied countermeasures (as defined in section 

13 319F–1), security countermeasures (as defined 

14 in section 319F–2), and qualified pandemic or 

15 epidemic products (as defined in section 319F– 

16 3) to address the needs of pediatric populations, 

17 in consultation with the Assistant Secretary for 

18 Preparedness and Response, consistent with the 

19 purposes of this section.’’; and 

20 (2) in subsection (b), by striking ‘‘subsection 

21 (a)’’ and inserting ‘‘paragraphs (1) and (2)(A) of 

22 subsection (a)’’. 

23 (c) ADVICE AND RECOMMENDATIONS OF THE PEDI24 ATRIC ADVISORY COMMITTEE REGARDING COUNTER25 MEASURES FOR PEDIATRIC POPULATIONS.—Subsection 


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1 (b)(2) of section 14 of the Best Pharmaceuticals for Chil2 dren Act (42 U.S.C. 284m note) is amended— 

3 (1) in subparagraph (C), by striking the period 

4 and inserting ‘‘; and’’; and 

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

6 ‘‘(D) the development of countermeasures 

7 (as defined in section 565(a) of the Federal 

8 Food, Drug, and Cosmetic Act) for pediatric 

9 populations.’’. 

10 TITLE IV—ACCELERATING MED11 ICAL COUNTERMEASURE AD12 VANCED RESEARCH AND DE13 VELOPMENT 

14 SEC. 401. BIOSHIELD. 

15 (a) PROCUREMENT OF COUNTERMEASURES.—Sec16 tion 319F–2(c) of the Public Health Service Act (42 

17 U.S.C. 247d–6b(c)) is amended— 

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

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

20 (2) in paragraph (2)(C), by striking ‘‘the des21 ignated congressional committees (as defined in 

22 paragraph (10))’’ and inserting ‘‘the appropriate 

23 committees of Congress’’; 

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

25 years’’ and inserting ‘‘10 years’’; 


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1 (4) in subparagraph (C) of paragraph (6)— 

2 (A) in the subparagraph heading, by strik3 ing ‘‘DESIGNATED CONGRESSIONAL COMMIT4 TEES’’ and inserting ‘‘APPROPRIATE CONGRES5 SIONAL COMMITTEES’’; and 

6 (B) by striking ‘‘the designated congres7 sional committees’’ and inserting ‘‘the appro8 priate congressional committees’’; and 

9 (5) in paragraph (7)(C)— 

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

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

12 may reasonably be required,’’; 

13 (B) in clause (ii)— 

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

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

16 and 

17 (ii) by striking subclause (IX) and in18 serting the following: 

19 ‘‘(IX) CONTRACT TERMS.—The 

20 Secretary, in any contract for procure21 ment under this section— 

22 ‘‘(aa) may specify— 

23 ‘‘(AA) the dosing and 

24 administration requirements 


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1 for the countermeasure to be 

2 developed and procured; 

3 ‘‘(BB) the amount of 

4 funding that will be dedi5 cated by the Secretary for 

6 advanced research, develop7 ment, and procurement of 

8 the countermeasure; and 

9 ‘‘(CC) the specifications 

10 the countermeasure must 

11 meet to qualify for procure12 ment under a contract under 

13 this section; and 

14 ‘‘(bb) shall provide a clear 

15 statement of defined Government 

16 purpose limited to uses related to 

17 a security countermeasure, as de18 fined in paragraph (1)(B).’’; and 

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

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

21 this section, the Secretary may, consistent 

22 with the applicable provisions of this sec23 tion, enter into contracts and other agree24 ments that are in the best interest of the 

25 Government in meeting identified security 


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1 countermeasure needs, including with re2 spect to reimbursement of the cost of ad3 vanced research and development as a rea4 sonable, allowable, and allocable direct cost 

5 of the contract involved.’’. 

6 (b) REAUTHORIZATION OF THE SPECIAL RESERVE

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

8 (42 U.S.C. 247d–6b) is amended— 

9 (1) in subsection (c)— 

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

11 paragraph (10)’’ each place it appears and in12 serting ‘‘special reserve fund as defined in sub13 section (h)’’; and 

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

15 and 

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

17 ‘‘(g) SPECIAL RESERVE FUND.— 

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

19 addition to amounts appropriated to the special re20 serve fund prior to the date of the enactment of this 

21 subsection, there is authorized to be appropriated, 

22 for the procurement of security countermeasures 

23 under subsection (c) and for carrying out section 

24 319L (relating to the Biomedical Advanced Research 

25 and Development Authority), $2,800,000,000 for the 


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1 period of fiscal years 2014 through 2018. Amounts 

2 appropriated pursuant to the preceding sentence are 

3 authorized to remain available until September 30, 

4 2019. 

5 ‘‘(2) USE OF SPECIAL RESERVE FUND FOR AD6 VANCED RESEARCH AND DEVELOPMENT.—The Sec7 retary may utilize not more than 50 percent of the 

8 amounts authorized to be appropriated under para9 graph (1) to carry out section 319L (related to the 

10 Biomedical Advanced Research and Development 

11 Authority). Amounts authorized to be appropriated 

12 under this subsection to carry out section 319L are 

13 in addition to amounts otherwise authorized to be 

14 appropriated to carry out such section. 

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

16 Amounts in the special reserve fund shall not be 

17 used to pay costs other than payments made by the 

18 Secretary to a vendor for advanced development 

19 (under section 319L) or for procurement of a secu20 rity countermeasure under subsection (c)(7). 

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

22 any date on which the Secretary determines that the 

23 amount of funds in the special reserve fund available 

24 for procurement is less than $1,500,000,000, the 

25 Secretary shall submit to the appropriate committees 


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1 of Congress a report detailing the amount of such 

2 funds available for procurement and the impact such 

3 reduction in funding will have— 

4 ‘‘(A) in meeting the security counter5 measure needs identified under this section; and 

6 ‘‘(B) on the annual Public Health Emer7 gency Medical Countermeasures Enterprise and 

8 Strategy Implementation Plan (pursuant to sec9 tion 2811(d)). 

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

11 ‘‘(1) The term ‘advanced research and develop12 ment’ has the meaning given such term in section 

13 319L(a). 

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

15 ‘Biodefense Countermeasures’ appropriations ac16 count, any appropriation made available pursuant to 

17 section 521(a) of the Homeland Security Act of 

18 2002, and any appropriation made available pursu19 ant to subsection (g)(1).’’. 

20 SEC. 402. BIOMEDICAL ADVANCED RESEARCH AND DEVEL21 OPMENT AUTHORITY. 

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

23 Health Service Act (42 U.S.C. 247d–7e(c)(4)) is amend24 ed— 


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

2 ‘‘(which may include advanced research and develop3 ment for purposes of fulfilling requirements under 

4 the Federal Food, Drug, and Cosmetic Act or sec5 tion 351 of this Act)’’ after ‘‘development’’; and 

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

7 vaccine manufacturing technologies’’ and inserting 

8 ‘‘vaccine-manufacturing technologies, dose-sparing 

9 technologies, efficacy-increasing technologies, and 

10 platform technologies’’. 

11 (b) TRANSACTION AUTHORITIES.—Section 

12 319L(c)(5) of the Public Health Service Act (42 U.S.C. 

13 247d–7e(c)(5)) is amended by adding at the end the fol14 lowing: 

15 ‘‘(G) GOVERNMENT PURPOSE.—In award16 ing contracts, grants, and cooperative agree17 ments under this section, the Secretary shall 

18 provide a clear statement of defined Govern19 ment purpose related to activities included in 

20 subsection (a)(6)(B) for a qualified counter21 measure or qualified pandemic or epidemic 

22 product.’’. 

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

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

25 amended to read as follows: 


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

2 this section, there is authorized to be appropriated 

3 to the Fund $415,000,000 for each of fiscal years 

4 2013 through 2017, such amounts to remain avail5 able until expended.’’. 

6 (d) CONTINUED INAPPLICABILITY OF CERTAIN PRO7 VISIONS.—Section 319L(e)(1)(C) of the Public Health 

8 Service Act (42 U.S.C. 247d–7e(e)(1)(C)) is amended by 

9 striking ‘‘7 years’’ and inserting ‘‘11 years’’. 

10 (e) EXTENSION OF LIMITED ANTITRUST EXEMP11 TION.— 

12 (1) IN GENERAL.—Section 405(b) of the Pan13 demic and All-Hazards Preparedness Act (42 U.S.C. 

14 247d–6a note) is amended by striking ‘‘6-year’’ and 

15 inserting ‘‘11-year’’. 

16 (2) EFFECTIVE DATE.—This subsection shall 

17 take effect as if enacted on December 17, 2012. 

18 (f) INDEPENDENT EVALUATION.—Section 319L of 

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

20 amended by adding at the end the following: 

21 ‘‘(f) INDEPENDENT EVALUATION.— 

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

23 after the date of enactment of this subsection, the 

24 Comptroller General of the United States shall con25 duct an independent evaluation of the activities carVerDate Mar 15 2010 22:31 Feb 14, 2013 Jkt 029200 PO 00000 Frm 00091 Fmt 6652 Sfmt 6401 E:\BILLS\H307.RS H307

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1 ried out to facilitate flexible manufacturing capacity 

2 pursuant to this section. 

3 ‘‘(2) REPORT.—Not later than 1 year after the 

4 date of enactment of this subsection, the Comp5 troller General of the United States shall submit to 

6 the appropriate committees of Congress a report 

7 concerning the results of the evaluation conducted 

8 under paragraph (1). Such report shall review and 

9 assess— 

10 ‘‘(A) the extent to which flexible manufac11 turing capacity under this section is dedicated 

12 to chemical, biological, radiological, and nuclear 

13 threats; 

14 ‘‘(B) the activities supported by flexible 

15 manufacturing initiatives; and 

16 ‘‘(C) the ability of flexible manufacturing 

17 activities carried out under this section to— 

18 ‘‘(i) secure and leverage leading tech19 nical expertise with respect to counter20 measure advanced research, development, 

21 and manufacturing processes; and 

22 ‘‘(ii) meet the surge manufacturing 

23 capacity needs presented by novel and 

24 emerging threats, including chemical, bio25 logical, radiological, and nuclear agents.’’. 


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1 (g) DEFINITIONS.— 

2 (1) QUALIFIED COUNTERMEASURE.—Section 

3 319F–1(a)(2)(A) of the Public Health Service Act 

4 (42 U.S.C. 247d–6a(a)(2)(A)) is amended— 

5 (A) in the matter preceding clause (i), by 

6 striking ‘‘to—’’ and inserting ‘‘—’’; 

7 (B) in clause (i)— 

8 (i) by striking ‘‘diagnose’’ and insert9 ing ‘‘to diagnose’’; and 

10 (ii) by striking ‘‘; or’’ and inserting a 

11 semicolon; 

12 (C) in clause (ii)— 

13 (i) by striking ‘‘diagnose’’ and insert14 ing ‘‘to diagnose’’; and 

15 (ii) by striking the period at the end 

16 and inserting ‘‘; or’’; and 

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

18 ‘‘(iii) is a product or technology in19 tended to enhance the use or effect of a 

20 drug, biological product, or device de21 scribed in clause (i) or (ii).’’. 

22 (2) QUALIFIED PANDEMIC OR EPIDEMIC PROD23 UCT.—Section 319F–3(i)(7)(A) of the Public Health 

24 Service Act (42 U.S.C. 247d–6d(i)(7)(A)) is amend25 ed— 


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1 (A) in clause (i)(II), by striking ‘‘; or’’ and 

2 inserting ‘‘;’’; 

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

4 inserting ‘‘; or’’; and 

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

6 ‘‘(iii) a product or technology intended 

7 to enhance the use or effect of a drug, bio8 logical product, or device described in 

9 clause (i) or (ii); and’’. 

10 (3) TECHNICAL AMENDMENTS.—Section 319F– 

11 3(i) of the Public Health Service Act (42 U.S.C. 

12 247d–6d(i)) is amended— 

13 (A) in paragraph (1)(C), by inserting ‘‘, 

14 564A, or 564B’’ after ‘‘564’’; and 

15 (B) in paragraph (7)(B)(iii), by inserting 

16 ‘‘, 564A, or 564B’’ after ‘‘564’’. 

17 SEC. 403. STRATEGIC NATIONAL STOCKPILE. 

18 Section 319F–2 of the Public Health Service Act (42 

19 U.S.C. 247d–6b) is amended— 

20 (1) in subsection (a)— 

21 (A) in paragraph (1)— 

22 (i) by inserting ‘‘consistent with sec23 tion 2811’’ before ‘‘by the Secretary to be 

24 appropriate’’; and 


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1 (ii) by inserting before the period at 

2 the end of the second sentence the fol3 lowing: ‘‘and shall submit such review an4 nually to the appropriate congressional 

5 committees of jurisdiction to the extent 

6 that disclosure of such information does 

7 not compromise national security’’; and 

8 (B) in paragraph (2)(D), by inserting be9 fore the semicolon at the end the following: 

10 ‘‘and that the potential depletion of counter11 measures currently in the stockpile is identified 

12 and appropriately addressed, including through 

13 necessary replenishment’’; and 

14 (2) in subsection (f)(1), by striking 

15 ‘‘$640,000,000 for fiscal year 2002, and such sums 

16 as may be necessary for each of fiscal years 2003 

17 through 2006. Such authorization is in addition to 

18 amounts in the special reserve fund referred to in 

19 subsection (c)(10)(A).’’ and inserting ‘‘$533,800,000 

20 for each of fiscal years 2013 through 2017. Such 

21 authorization is in addition to amounts in the special 

22 reserve fund referred to in subsection (h).’’. 

23 SEC. 404. NATIONAL BIODEFENSE SCIENCE BOARD. 

24 Section 319M(a) of the Public Health Service Act (42 

25 U.S.C. 247d–f(a)) is amended— 


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1 (1) in paragraph (2)— 

2 (A) in subparagraph (D)— 

3 (i) in clause (i), by striking ‘‘and’’ at 

4 the end; 

5 (ii) in clause (ii), by striking the pe6 riod and inserting a semicolon; and 

7 (iii) by adding at the end the fol8 lowing: 

9 ‘‘(iii) one such member shall be an in10 dividual with pediatric subject matter ex11 pertise; and 

12 ‘‘(iv) one such member shall be a 

13 State, tribal, territorial, or local public 

14 health official.’’; and 

15 (B) by adding at the end the following 

16 flush sentence: 

17 ‘‘Nothing in this paragraph shall preclude a member 

18 of the Board from satisfying two or more of the re19 quirements described in subparagraph (D).’’; and 

20 (2) in paragraph (5)— 

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

22 ‘‘and’’ at the end; 

23 (B) in subparagraph (C), by striking the 

24 period and inserting ‘‘; and’’; and 

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


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1 ‘‘(D) provide any recommendation, finding, 

2 or report provided to the Secretary under this 

3 paragraph to the appropriate committees of 

4 Congress.’’. 

5 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

7 ‘‘Pandemic and All-Hazards Preparedness Reauthorization 

8 Act of 2013’’. 

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

10 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. 

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. 


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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 

13 surge capacity for events without notice’’ after 

14 ‘‘exercises’’; and 

15 (B) in paragraph (3)— 

16 (i) in the matter preceding subpara17 graph (A)— 

18 (I) by striking ‘‘facilities), and 

19 trauma care’’ and inserting ‘‘and am20 bulatory care facilities and which may 

21 include dental health facilities), and 

22 trauma care, critical care,’’; and 

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1 ordination)’’ after ‘‘public health emer2 gencies’’; 

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

4 ‘‘and trauma’’ after ‘‘medical’’; 

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

6 ‘‘Medical evacuation and fatality manage7 ment’’ and inserting ‘‘Fatality manage8 ment’’; 

9 (iv) by redesignating subparagraphs 

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

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

12 (v) by inserting after subparagraph 

13 (B), the following the new subparagraph: 

14 ‘‘(C) Coordinated medical triage and evacu15 ation to appropriate medical institutions based 

16 on patient medical need, taking into account re17 gionalized systems of care.’’; 

18 (vi) in subparagraph (E), as redesig19 nated by clause (iv), by inserting ‘‘(which 

20 may include such dental health assets)’’ 

21 after ‘‘medical assets’’; and 

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

24 ‘‘(G) Optimizing a coordinated and flexible 

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1 pitals, other health care facilities, critical care, 

2 trauma care (which may include trauma cen3 ters), and emergency medical systems.’’; 

4 (C) in paragraph (4)— 

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

6 ‘‘, including the unique needs and consider7 ations of individuals with disabilities,’’ 

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

9 and 

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

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

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

13 ‘‘(7) COUNTERMEASURES.— 

14 ‘‘(A) Promoting strategic initiatives to ad15 vance countermeasures to diagnose, mitigate, 

16 prevent, or treat harm from any biological agent 

17 or toxin, chemical, radiological, or nuclear agent 

18 or agents, whether naturally occurring, uninten19 tional, or deliberate. 

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

21 term ‘countermeasures’ has the same meaning as 

22 the terms ‘qualified countermeasures’ under sec23 tion 319F–1, ‘qualified pandemic and epidemic 

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

25 countermeasures’ under section 319F–2. 


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1 ‘‘(8) MEDICAL AND PUBLIC HEALTH COMMUNITY

2 RESILIENCY.—Strengthening the ability of States, 

3 local communities, and tribal communities to prepare 

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

5 health emergencies, whether naturally occurring, un6 intentional, or deliberate by— 

7 ‘‘(A) optimizing alignment and integration 

8 of medical and public health preparedness and 

9 response planning and capabilities with and 

10 into routine daily activities; and 

11 ‘‘(B) promoting familiarity with local med12 ical and public health systems.’’. 

13 (b) AT-RISK INDIVIDUALS.—Section 2814 of the Public 

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

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

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

17 ‘‘2811(b)(3)(B)’’ and inserting ‘‘2802(b)(4)(B)’’; 

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

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

20 (4) by inserting before paragraph (2) (as so re21 designated), the following: 

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

23 they relate to medical and public health preparedness 

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


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1 public health emergency declared by the Secretary 

2 under section 319;’’; 

3 (5) by amending paragraph (2) (as so redesig4 nated) to read as follows: 

5 ‘‘(2) oversee the implementation of the prepared6 ness goals described in section 2802(b) with respect to 

7 the public health and medical needs of at-risk indi8 viduals in the event of a public health emergency, as 

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

10 (6) by inserting after paragraph (6), the fol11 lowing: 

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

13 novel and best practices of outreach to and care of at14 risk individuals before, during, and following public 

15 health emergencies in as timely a manner as is prac16 ticable, including from the time a public health threat 

17 is identified; and 

18 ‘‘(8) ensure that public health and medical infor19 mation distributed by the Department of Health and 

20 Human Services during a public health emergency is 

21 delivered in a manner that takes into account the 

22 range of communication needs of the intended recipi23 ents, including at-risk individuals.’’. 


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1 SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND 

2 RESPONSE. 

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

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

5 (1) in subsection (b)— 

6 (A) in paragraph (3), by inserting ‘‘, secu7 rity countermeasures (as defined in section 

8 319F–2),’’ after ‘‘qualified countermeasures (as 

9 defined in section 319F–1)’’; 

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

11 the following: 

12 ‘‘(D) POLICY COORDINATION AND STRA13 TEGIC DIRECTION.—Provide integrated policy co14 ordination and strategic direction with respect to 

15 all matters related to Federal public health and 

16 medical preparedness and execution and deploy17 ment of the Federal response for public health 

18 emergencies and incidents covered by the Na19 tional Response Plan developed pursuant to sec20 tion 504(6) of the Homeland Security Act of 

21 2002, or any successor plan, before, during, and 

22 following public health emergencies. 

23 ‘‘(E) IDENTIFICATION OF INEFFICIEN24 CIES.—Identify and minimize gaps, duplication, 

25 and other inefficiencies in medical and public 


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1 health preparedness and response activities and 

2 the actions necessary to overcome these obstacles. 

3 ‘‘(F) COORDINATION OF GRANTS AND

4 AGREEMENTS.—Align and coordinate medical 

5 and public health grants and cooperative agree6 ments as applicable to preparedness and re7 sponse activities authorized under this Act, to the 

8 extent possible, including program requirements, 

9 timelines, and measurable goals, and in con10 sultation with the Secretary of Homeland Secu11 rity, to— 

12 ‘‘(i) optimize and streamline medical 

13 and public health preparedness and re14 sponse capabilities and the ability of local 

15 communities to respond to public health 

16 emergencies; and 

17 ‘‘(ii) gather and disseminate best prac18 tices among grant and cooperative agree19 ment recipients, as appropriate. 

20 ‘‘(G) DRILL AND OPERATIONAL EXER21 CISES.—Carry out drills and operational exer22 cises, in consultation with the Department of 

23 Homeland Security, the Department of Defense, 

24 the Department of Veterans Affairs, and other 

25 applicable Federal departments and agencies, as 


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1 necessary and appropriate, to identify, inform, 

2 and address gaps in and policies related to all3 hazards medical and public health preparedness 

4 and response, including exercises based on— 

5 ‘‘(i) identified threats for which coun6 termeasures are available and for which no 

7 countermeasures are available; and 

8 ‘‘(ii) unknown threats for which no 

9 countermeasures are available. 

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

11 periodic basis consult with, as applicable and 

12 appropriate, the Assistant to the President for 

13 National Security Affairs, to provide an update 

14 on, and discuss, medical and public health pre15 paredness and response activities pursuant to 

16 this Act and the Federal Food, Drug, and Cos17 metic Act, including progress on the develop18 ment, approval, clearance, and licensure of med19 ical countermeasures.’’; and 

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

21 ‘‘(7) COUNTERMEASURES BUDGET PLAN.—De22 velop, and update on an annual basis, a coordinated 

23 5-year budget plan based on the medical counter24 measure priorities described in subsection (d). Each 

25 such plan shall— 


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1 ‘‘(A) include consideration of the entire 

2 medical countermeasures enterprise, including— 

3 ‘‘(i) basic research and advanced re4 search and development; 

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

6 and authorized uses of products; and 

7 ‘‘(iii) procurement, stockpiling, main8 tenance, and replenishment of all products 

9 in the Strategic National Stockpile; 

10 ‘‘(B) inform prioritization of resources and 

11 include measurable outputs and outcomes to 

12 allow for the tracking of the progress made to13 ward identified priorities; 

14 ‘‘(C) identify medical countermeasure life15 cycle costs to inform planning, budgeting, and 

16 anticipated needs within the continuum of the 

17 medical countermeasure enterprise consistent 

18 with section 319F–2; and 

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

20 committees of Congress upon request.’’; 

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

22 following: 

23 ‘‘(c) FUNCTIONS.—The Assistant Secretary for Pre24 paredness and Response shall— 


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1 ‘‘(1) have lead responsibility within the Depart2 ment of Health and Human Services for emergency 

3 preparedness and response policy coordination and 

4 strategic direction; 

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

6 ‘‘(A) the National Disaster Medical System 

7 pursuant to section 2812; 

8 ‘‘(B) the Hospital Preparedness Cooperative 

9 Agreement Program pursuant to section 319C–2; 

10 ‘‘(C) the Biomedical Advanced Research 

11 and Development Authority pursuant to section 

12 319L; 

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

14 section 2813; 

15 ‘‘(E) the Emergency System for Advance 

16 Registration of Volunteer Health Professionals 

17 pursuant to section 319I; and 

18 ‘‘(F) administering grants and related au19 thorities related to trauma care under parts A 

20 through C of title XII, such authority to be 

21 transferred by the Secretary from the Adminis22 trator of the Health Resources and Services Ad23 ministration to such Assistant Secretary; 

24 ‘‘(3) exercise the responsibilities and authorities 

25 of the Secretary with respect to the coordination of— 


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1 ‘‘(A) the Public Health Emergency Pre2 paredness Cooperative Agreement Program pur3 suant to section 319C–1; 

4 ‘‘(B) the Strategic National Stockpile pur5 suant to section 319F–2; and 

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

7 ‘‘(4) assume other duties as determined appro8 priate by the Secretary.’’; and 

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

10 ‘‘(d) PUBLIC HEALTH EMERGENCY MEDICAL COUN11 TERMEASURES ENTERPRISE STRATEGY AND IMPLEMENTA12 TION PLAN.— 

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

14 after the date of enactment of this subsection, and 

15 every year thereafter, the Assistant Secretary for Pre16 paredness and Response shall develop and submit to 

17 the appropriate committees of Congress a coordinated 

18 strategy and accompanying implementation plan for 

19 medical countermeasures to address chemical, biologi20 cal, radiological, and nuclear threats. In developing 

21 such a plan, the Assistant Secretary for Preparedness 

22 and Response shall consult with the Director of the 

23 Biomedical Advanced Research and Development Au24 thority, the Director of the National Institutes of 

25 Health, the Director of the Centers for Disease Control 


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1 and Prevention, and the Commissioner of Food and 

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

3 ‘Public Health Emergency Medical Countermeasures 

4 Enterprise Strategy and Implementation Plan’. 

5 ‘‘(2) REQUIREMENTS.—The plan under para6 graph (1) shall— 

7 ‘‘(A) describe the chemical, biological, radio8 logical, and nuclear agent or agents that may 

9 present a threat to the Nation and the cor10 responding efforts to develop qualified counter11 measures (as defined in section 319F–1), secu12 rity countermeasures (as defined in section 

13 319F–2), or qualified pandemic or epidemic 

14 products (as defined in section 319F–3) for each 

15 threat; 

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

17 with respect to such countermeasures or prod18 ucts, including research, advanced research, de19 velopment, procurement, stockpiling, deployment, 

20 distribution, and utilization; 

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

22 and long-term needs with respect to such coun23 termeasures or products to address a chemical, 

24 biological, radiological, and nuclear threat or 

25 threats; 


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

2 of threat, a summary of all awards and con3 tracts, including advanced research and develop4 ment and procurement, that includes— 

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

6 of the initial solicitation or request for a 

7 proposal to the adjudication (such as the 

8 award, denial of award, or solicitation ter9 mination); and 

10 ‘‘(ii) an identification of projected 

11 timelines, anticipated funding allocations, 

12 benchmarks, and milestones for each med13 ical countermeasure priority under sub14 paragraph (C), including projected needs 

15 with regard to replenishment of the Stra16 tegic National Stockpile; 

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

18 the National Biodefense Science Board pursuant 

19 to section 319M; 

20 ‘‘(F) evaluate progress made in meeting 

21 timelines, allocations, benchmarks, and mile22 stones identified under subparagraph (D)(ii); 

23 ‘‘(G) report on the amount of funds avail24 able for procurement in the special reserve fund 

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


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1 this funding will have on meeting the require2 ments under section 319F–2; 

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

4 local, and tribal stakeholders; 

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

6 the medical countermeasure priorities for at-risk 

7 individuals (as defined in 2802(b)(4)(B)), as ap8 plicable under subparagraph (C), including with 

9 regard to the projected needs for related stock10 piling and replenishment of the Strategic Na11 tional Stockpile, including by addressing the 

12 needs of pediatric populations with respect to 

13 such countermeasures and products in the Stra14 tegic National Stockpile, including— 

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

16 products necessary to address the needs of 

17 pediatric populations; 

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

19 coordinate with the Office of Pediatric 

20 Therapeutics of the Food and Drug Admin21 istration to maximize the labeling, dosages, 

22 and formulations of such countermeasures 

23 and products for pediatric populations; 

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

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1 velopment of such countermeasures and 

2 products to address the needs of pediatric 

3 populations; and 

4 ‘‘(iv) an evaluation of the progress 

5 made in addressing priorities identified 

6 pursuant to subparagraph (C); 

7 ‘‘(J) identify the use of authority and ac8 tivities undertaken pursuant to sections 319F– 

9 1(b)(1), 319F–1(b)(2), 319F–1(b)(3), 319F–1(c), 

10 319F–1(d), 319F–1(e), 319F–2(c)(7)(C)(iii), 

11 319F–2(c)(7)(C)(iv), and 319F–2(c)(7)(C)(v) of 

12 this Act, and subsections (a)(1), (b)(1), and (e) 

13 of section 564 of the Federal Food, Drug, and 

14 Cosmetic Act, by summarizing— 

15 ‘‘(i) the particular actions that were 

16 taken under the authorities specified, in17 cluding, as applicable, the identification of 

18 the threat agent, emergency, or the bio19 medical countermeasure with respect to 

20 which the authority was used; 

21 ‘‘(ii) the reasons underlying the deci22 sion to use such authorities, including, as 

23 applicable, the options that were considered 

24 and rejected with respect to the use of such 

25 authorities; 


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

2 other information concerning the persons 

3 and entities that received a grant, coopera4 tive agreement, or contract pursuant to the 

5 use of such authorities, and the persons and 

6 entities that were considered and rejected 

7 for such a grant, cooperative agreement, or 

8 contract, except that the report need not dis9 close the identity of any such person or en10 tity; 

11 ‘‘(iv) whether, with respect to each pro12 curement that is approved by the President 

13 under section 319F–2(c)(6), a contract was 

14 entered into within one year after such ap15 proval by the President; and 

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

17 for the one-year period for which the report 

18 is submitted, the number of persons who 

19 were paid amounts totaling $100,000 or 

20 greater and the number of persons who were 

21 paid amounts totaling at least $50,000 but 

22 less than $100,000; and 

23 ‘‘(K) be made publicly available. 

24 ‘‘(3) GAO REPORT.— 


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

2 after the date of the submission to the Congress 

3 of the first Public Health Emergency Medical 

4 Countermeasures Enterprise Strategy and Imple5 mentation Plan, the Comptroller General of the 

6 United States shall conduct an independent eval7 uation, and submit to the appropriate commit8 tees of Congress a report, concerning such Strat9 egy and Implementation Plan. 

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

11 subparagraph (A) shall review and assess— 

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

13 long-term medical countermeasure needs 

14 and identified priorities of the Federal Gov15 ernment pursuant to paragraph (2)(C); 

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

17 Health and Human Services with respect to 

18 advanced research and development pursu19 ant to section 319L; and 

20 ‘‘(iii) the progress made toward meet21 ing the timelines, allocations, benchmarks, 

22 and milestones identified in the Public 

23 Health Emergency Medical Counter24 measures Enterprise Strategy and Imple25 mentation Plan under this subsection. 


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1 ‘‘(e) PROTECTION OF NATIONAL SECURITY.—In car2 rying out subsections (b)(7) and (d), the Secretary shall en3 sure that information and items that could compromise na4 tional security, contain confidential commercial informa5 tion, or contain proprietary information are not dis6 closed.’’. 

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

8 Public Health Emergency Countermeasures Enterprise 

9 Strategy and Implementation Plan submitted under sub10 section (d) of section 2811 of the Public Health Service Act 

11 (42 U.S.C. 300hh–10) (as added by subsection (a)(3)), the 

12 Secretary of Health and Human Services, in consultation 

13 with the Secretary of Defense, shall include a description 

14 of the manner in which the Department of Health and 

15 Human Services is coordinating with the Department of 

16 Defense regarding countermeasure activities to address 

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

18 report shall include information with respect to— 

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

20 procurement, stockpiling, and distribution of counter21 measures to meet identified needs; and 

22 (2) the coordination of efforts between the De23 partment of Health and Human Services and the De24 partment of Defense to address countermeasure needs 

25 for various segments of the population. 


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1 SEC. 103. NATIONAL ADVISORY COMMITTEE ON CHILDREN 

2 AND DISASTERS. 

3 Subtitle B of title XXVIII of the Public Health Service 

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

5 section 2811 the following: 

6 ‘‘SEC. 2811A. NATIONAL ADVISORY COMMITTEE ON CHIL7 DREN AND DISASTERS. 

8 ‘‘(a) ESTABLISHMENT.—The Secretary, in consulta9 tion with the Secretary of Homeland Security, shall estab10 lish an advisory committee to be known as the ‘National 

11 Advisory Committee on Children and Disasters’ (referred 

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

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

14 ‘‘(1) provide advice and consultation with re15 spect to the activities carried out pursuant to section 

16 2814, as applicable and appropriate; 

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

18 the medical and public health needs of children as 

19 they relate to preparation for, response to, and recov20 ery from all-hazards emergencies; and 

21 ‘‘(3) provide advice and consultation with re22 spect to State emergency preparedness and response 

23 activities and children, including related drills and 

24 exercises pursuant to the preparedness goals under 

25 section 2802(b). 


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

2 may provide advice and recommendations to the Secretary 

3 with respect to children and the medical and public health 

4 grants and cooperative agreements as applicable to pre5 paredness and response activities authorized under this title 

6 and title III. 

7 ‘‘(d) MEMBERSHIP.— 

8 ‘‘(1) IN GENERAL.—The Secretary, in consulta9 tion with such other Secretaries as may be appro10 priate, shall appoint not to exceed 15 members to the 

11 Advisory Committee. In appointing such members, 

12 the Secretary shall ensure that the total membership 

13 of the Advisory Committee is an odd number. 

14 ‘‘(2) REQUIRED MEMBERS.—The Secretary, in 

15 consultation with such other Secretaries as may be 

16 appropriate, may appoint to the Advisory Committee 

17 under paragraph (1) such individuals as may be ap18 propriate to perform the duties described in sub19 sections (b) and (c), which may include— 

20 ‘‘(A) the Assistant Secretary for Prepared21 ness and Response; 

22 ‘‘(B) the Director of the Biomedical Ad23 vanced Research and Development Authority; 

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

25 Control and Prevention; 


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

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

3 of Health; 

4 ‘‘(F) the Assistant Secretary of the Admin5 istration for Children and Families; 

6 ‘‘(G) the Administrator of the Federal 

7 Emergency Management Agency; 

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

9 professionals with expertise in pediatric medical 

10 disaster planning, preparedness, response, or re11 covery; 

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

13 local, territorial, or tribal agencies with expertise 

14 in pediatric disaster planning, preparedness, re15 sponse, or recovery; and 

16 ‘‘(J) representatives from such Federal 

17 agencies (such as the Department of Education 

18 and the Department of Homeland Security) as 

19 determined necessary to fulfill the duties of the 

20 Advisory Committee, as established under sub21 sections (b) and (c). 

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

23 not less than biannually. 

24 ‘‘(f) SUNSET.—The Advisory Committee shall termi25 nate on September 30, 2018.’’. 


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1 SEC. 104. MODERNIZATION OF THE NATIONAL DISASTER 

2 MEDICAL SYSTEM. 

3 Section 2812 of the Public Health Service Act (42 

4 U.S.C. 300hh–11) is amended— 

5 (1) in subsection (a)(3)— 

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

7 inserting ‘‘, including at-risk individuals as ap8 plicable’’ after ‘‘victims of a public health emer9 gency’’; 

10 (B) by redesignating subparagraph (C) as 

11 subparagraph (E); and 

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

13 the following: 

14 ‘‘(C) CONSIDERATIONS FOR AT-RISK POPU15 LATIONS.—The Secretary shall take steps to en16 sure that an appropriate specialized and focused 

17 range of public health and medical capabilities 

18 are represented in the National Disaster Medical 

19 System, which take into account the needs of at20 risk individuals, in the event of a public health 

21 emergency.’’. 

22 ‘‘(D) ADMINISTRATION.—The Secretary 

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1 ment in advance or by way of reimbursement.’’; 

2 and 

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

4 may be necessary for each of the fiscal years 2007 

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

6 fiscal years 2014 through 2018’’. 

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

8 VETERANS AFFAIRS. 

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

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

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

12 2011’’ and inserting ‘‘$155,300,000 for each of fiscal years 

13 2014 through 2018 to carry out this section’’. 

14 TITLE II—OPTIMIZING STATE 

15 AND LOCAL ALL-HAZARDS 

16 PREPAREDNESS AND RE17 SPONSE 

18 SEC. 201. TEMPORARY REASSIGNMENT OF STATE AND 

19 LOCAL PERSONNEL DURING A PUBLIC 

20 HEALTH EMERGENCY. 

21 Section 319 of the Public Health Service Act (42 

22 U.S.C. 247d) is amended by adding at the end the fol23 lowing: 


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1 ‘‘(e) TEMPORARY REASSIGNMENT OF STATE AND

2 LOCAL PERSONNEL DURING A PUBLIC HEALTH EMER3 GENCY.— 

4 ‘‘(1) EMERGENCY REASSIGNMENT OF FEDERALLY

5 FUNDED PERSONNEL.—Notwithstanding any other 

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

7 request by the Governor of a State or a tribal organi8 zation or such Governor or tribal organization’s des9 ignee, the Secretary may authorize the requesting 

10 State or Indian tribe to temporarily reassign, for 

11 purposes of immediately addressing a public health 

12 emergency in the State or Indian tribe, State and 

13 local public health department or agency personnel 

14 funded in whole or in part through programs author15 ized under this Act, as appropriate. 

16 ‘‘(2) ACTIVATION OF EMERGENCY REASSIGN17 MENT.— 

18 ‘‘(A) PUBLIC HEALTH EMERGENCY.—The 

19 Secretary may authorize a temporary reassign20 ment of personnel under paragraph (1) only dur21 ing the period of a public health emergency de22 termined pursuant to subsection (a). 

23 ‘‘(B) CONTENTS OF REQUEST.—To seek au24 thority for a temporary reassignment of per25 sonnel under paragraph (1), the Governor of a 


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1 State or a tribal organization shall submit to the 

2 Secretary a request for such reassignment flexi3 bility and shall include in the request each of the 

4 following: 

5 ‘‘(i) An assurance that the public 

6 health emergency in the geographic area of 

7 the requesting State or Indian tribe cannot 

8 be adequately and appropriately addressed 

9 by the public health workforce otherwise 

10 available. 

11 ‘‘(ii) An assurance that the public 

12 health emergency would be addressed more 

13 efficiently and effectively through the re14 quested temporary reassignment of State 

15 and local personnel described in paragraph 

16 (1). 

17 ‘‘(iii) An assurance that the requested 

18 temporary reassignment of personnel is con19 sistent with any applicable All-Hazards 

20 Public Health Emergency Preparedness and 

21 Response Plan under section 319C–1. 

22 ‘‘(iv) An identification of— 

23 ‘‘(I) each Federal program from 

24 which personnel would be temporarily 


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1 reassigned pursuant to the requested 

2 authority; and 

3 ‘‘(II) the number of personnel who 

4 would be so reassigned from each such 

5 program. 

6 ‘‘(v) Such other information and as7 surances upon which the Secretary and 

8 Governor of a State or tribal organization 

9 agree. 

10 ‘‘(C) CONSIDERATION.—In reviewing a re11 quest for temporary reassignment under para12 graph (1), the Secretary shall consider the degree 

13 to which the program or programs funded in 

14 whole or in part by programs authorized under 

15 this Act would be adversely affected by the reas16 signment. 

17 ‘‘(D) TERMINATION AND EXTENSION.— 

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

19 tribe’s temporary reassignment of personnel 

20 under paragraph (1) shall terminate upon 

21 the earlier of the following: 

22 ‘‘(I) The Secretary’s determina23 tion that the public health emergency 

24 no longer exists. 


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1 ‘‘(II) Subject to clause (ii), the ex2 piration of the 30-day period following 

3 the date on which the Secretary ap4 proved the State or Indian tribe’s re5 quest for such reassignment flexibility. 

6 ‘‘(ii) EXTENSION OF REASSIGNMENT

7 FLEXIBILITY.—The Secretary may extend 

8 reassignment flexibility of personnel under 

9 paragraph (1) beyond the date otherwise 

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

11 health emergency still exists as of such date, 

12 but only if— 

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

14 submitted the initial request for a tem15 porary reassignment of personnel sub16 mits a request for an extension of such 

17 temporary reassignment; and 

18 ‘‘(II) the request for an extension 

19 contains the same information and as20 surances necessary for the approval of 

21 an initial request for such temporary 

22 reassignment pursuant to subpara23 graph (B). 

24 ‘‘(3) VOLUNTARY NATURE OF TEMPORARY REAS25 SIGNMENT OF STATE AND LOCAL PERSONNEL.— 


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1 ‘‘(A) IN GENERAL.—Unless otherwise pro2 vided under the law or regulation of the State or 

3 Indian tribe that receives authorization for tem4 porary reassignment of personnel under para5 graph (1), personnel eligible for reassignment 

6 pursuant to such authorization— 

7 ‘‘(i) shall have the opportunity to vol8 unteer for temporary reassignment; and 

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

10 a temporary reassignment. 

11 ‘‘(B) PROHIBITION ON CONDITIONING FED12 ERAL AWARDS.—The Secretary may not condi13 tion the award of a grant, contract, or coopera14 tive agreement under this Act on the requirement 

15 that a State or Indian tribe require that per16 sonnel eligible for reassignment pursuant to an 

17 authorization under paragraph (1) agree to such 

18 reassignment. 

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

20 give notice to the Congress in conjunction with the 

21 approval under this subsection of— 

22 ‘‘(A) any initial request for temporary reas23 signment of personnel; and 

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

25 temporary reassignment. 


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

2 ‘‘(A) not later than 6 months after the en3 actment of this subsection, issue proposed guid4 ance on the temporary reassignment of personnel 

5 under this subsection; and 

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

7 period for public comment, finalize such guid8 ance. 

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

10 years after the date of enactment of the Pandemic and 

11 All-Hazards Preparedness Reauthorization Act of 

12 2013, the Comptroller General of the United States 

13 shall conduct an independent evaluation, and submit 

14 to the appropriate committees of the Congress a re15 port, on temporary reassignment under this sub16 section, including— 

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

18 circumstances, such temporary reassignment has 

19 been used by States and Indian tribes; 

20 ‘‘(B) an analysis of how such temporary re21 assignment has assisted States and Indian tribes 

22 in responding to public health emergencies; 

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

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1 ciencies in responding to public health emer2 gencies; 

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

4 any, Federal programs from which personnel 

5 have been temporarily reassigned have been ad6 versely affected by the reassignment; and 

7 ‘‘(E) recommendations on how medical 

8 surge capacity could be improved in responding 

9 to public health emergencies and the impact of 

10 the reassignment flexibility under this section on 

11 such surge capacity. 

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

13 ‘‘(A) the terms ‘Indian tribe’ and ‘tribal or14 ganization’ have the meanings given such terms 

15 in section 4 of the Indian Self-Determination 

16 and Education Assistance Act; and 

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

18 to the entities listed in the definition of such 

19 term in section 2, the Freely Associated States. 

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

21 on September 30, 2018.’’. 


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1 SEC. 202. IMPROVING STATE AND LOCAL PUBLIC HEALTH 

2 SECURITY. 

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

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

5 amended— 

6 (1) in subsection (b)(1)(C), by striking ‘‘consor7 tium of entities described in subparagraph (A)’’ and 

8 inserting ‘‘consortium of States’’; 

9 (2) in subsection (b)(2)— 

10 (A) in subparagraph (A)— 

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

12 inserting the following: 

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

14 entity will carry out under the agreement to 

15 meet the goals identified under section 2802, 

16 including with respect to chemical, biologi17 cal, radiological, or nuclear threats, whether 

18 naturally occurring, unintentional, or delib19 erate; 

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

21 entity will carry out with respect to pan22 demic influenza, as a component of the ac23 tivities carried out under clause (i), and 

24 consistent with the requirements of para25 graphs (2) and (5) of subsection (g);’’; 


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

2 the end; and 

3 (iii) by adding at the end the fol4 lowing: 

5 ‘‘(vi) a description of how, as appro6 priate, the entity may partner with relevant 

7 public and private stakeholders in public 

8 health emergency preparedness and re9 sponse; 

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

11 as applicable and appropriate, will coordi12 nate with State emergency preparedness 

13 and response plans in public health emer14 gency preparedness, including State edu15 cational agencies (as defined in section 

16 9101(41) of the Elementary and Secondary 

17 Education Act of 1965) and State child care 

18 lead agencies (designated under section 

19 658D of the Child Care and Development 

20 Block Grant Act of 1990); 

21 ‘‘(viii) in the case of entities that oper22 ate on the United States-Mexico border or 

23 the United States-Canada border, a descrip24 tion of the activities such entity will carry 

25 out under the agreement that are specific to 


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1 the border area including disease detection, 

2 identification, investigation, and prepared3 ness and response activities related to 

4 emerging diseases and infectious disease 

5 outbreaks whether naturally occurring or 

6 due to bioterrorism, consistent with the re7 quirements of this section; and 

8 ‘‘(ix) a description of any activities 

9 that such entity will use to analyze real10 time clinical specimens for pathogens of 

11 public health or bioterrorism significance, 

12 including any utilization of poison control 

13 centers;’’; and 

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

15 including addressing the needs of at-risk individ16 uals,’’ after ‘‘capabilities of such entity’’; 

17 (3) in subsection (f)— 

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

19 the end; 

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

21 and inserting a period; and 

22 (C) by striking paragraph (4); 

23 (4) in subsection (g)— 

24 (A) in paragraph (1), by striking subpara25 graph (A) and inserting the following: 


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1 ‘‘(A) include outcome goals representing 

2 operational achievements of the National Pre3 paredness Goals developed under section 2802(b) 

4 with respect to all-hazards, including chemical, 

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

6 and 

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

8 end the following: ‘‘The Secretary shall periodi9 cally update, as necessary and appropriate, such 

10 pandemic influenza plan criteria and shall re11 quire the integration of such criteria into the 

12 benchmarks and standards described in para13 graph (1).’’; 

14 (5) by striking subsection (h); 

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

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

17 (7) in subsection (h), as so redesignated— 

18 (A) in paragraph (1)— 

19 (i) in subparagraph (A)— 

20 (I) by striking ‘‘$824,000,000 for 

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

22 shall be used to carry out subsection 

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

24 fiscal year 2014’’; and 


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1 (II) by striking ‘‘such sums as 

2 may be necessary for each of fiscal 

3 years 2008 through 2011’’ and insert4 ing ‘‘$641,900,000 for each of fiscal 

5 years 2015 through 2018’’; 

6 (ii) by striking subparagraph (B); 

7 (iii) by redesignating subparagraphs 

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

9 respectively; and 

10 (iv) in subparagraph (C), as so redes11 ignated, by striking ‘‘subparagraph (C)’’ 

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

13 (B) in subparagraphs (C) and (D) of para14 graph (3), by striking ‘‘(1)(A)(i)(I)’’ each place 

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

16 (C) in paragraph (4)(B), by striking ‘‘sub17 section (c)’’ and inserting ‘‘subsection (b)’’; and 

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

19 ‘‘(7) AVAILABILITY OF COOPERATIVE AGREEMENT

20 FUNDS.— 

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

22 an eligible entity under a cooperative agreement 

23 under subsection (a) for a fiscal year and re24 maining unobligated at the end of such year 

25 shall remain available to such entity for the next 


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1 fiscal year for the purposes for which such funds 

2 were provided. 

3 ‘‘(B) FUNDS CONTINGENT ON ACHIEVING

4 BENCHMARKS.—The continued availability of 

5 funds under subparagraph (A) with respect to an 

6 entity shall be contingent upon such entity 

7 achieving the benchmarks and submitting the 

8 pandemic influenza plan as described in sub9 section (g).’’; and 

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

11 (A) in paragraph (1)(E), by striking ‘‘sub12 section (k)’’ and inserting ‘‘subsection (j)’’; 

13 (B) by striking paragraph (3). 

14 (b) VACCINE TRACKING AND DISTRIBUTION.—Section 

15 319A(e) of the Public Health Service Act (42 U.S.C. 247d– 

16 1(e)) is amended by striking ‘‘such sums for each of fiscal 

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

18 each of fiscal years 2014 through 2018’’. 

19 (c) TECHNICAL AND CONFORMING AMENDMENTS.— 

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

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

22 by striking ‘‘subsection (i)(4)’’ and inserting ‘‘sub23 section (h)(4)’’. 

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

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


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

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

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

4 1(i)’’ and inserting ‘‘319C–1(h)’’. 

5 SEC. 203. HOSPITAL PREPAREDNESS AND MEDICAL SURGE 

6 CAPACITY. 

7 (a) ALL-HAZARDS PUBLIC HEALTH AND MEDICAL

8 RESPONSE CURRICULA AND TRAINING.—Section 

9 319F(a)(5)(B) of the Public Health Service Act (42 U.S.C. 

10 247d–6(a)(5)(B)) is amended by striking ‘‘public health or 

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

12 (b) ENCOURAGING HEALTH PROFESSIONAL VOLUN13 TEERS.— 

14 (1) EMERGENCY SYSTEM FOR ADVANCE REG15 ISTRATION OF VOLUNTEER HEALTH PROFES16 SIONALS.—Section 319I(k) of the Public Health Serv17 ice Act (42 U.S.C. 247d–7b(k)) is amended by strik18 ing ‘‘$2,000,000 for fiscal year 2002, and such sums 

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

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

21 fiscal years 2014 through 2018’’. 

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

23 Health Service Act (42 U.S.C. 300hh–15) is amend24 ed— 


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

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

3 as appropriate and applicable, incorporate the 

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

5 public health emergency.’’; and 

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

7 ‘‘$22,000,000 for fiscal year 2007, and such sums 

8 as may be necessary for each of fiscal years 2008 

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

10 each of fiscal years 2014 through 2018’’. 

11 (c) PARTNERSHIPS FOR STATE AND REGIONAL PRE12 PAREDNESS TO IMPROVE SURGE CAPACITY.—Section 

13 319C–2 of the Public Health Service Act (42 U.S.C. 247d– 

14 3b) is amended— 

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

16 as appropriate, capacity and preparedness to address 

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

18 before the period at the end; 

19 (2) in subsection (b)(1)(A)(ii), by striking ‘‘cen20 ters, primary’’ and inserting ‘‘centers, community 

21 health centers, primary’’; 

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

23 following: 

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

25 shall be expended for activities to achieve the preparedness 


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

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

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

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

5 following: 

6 ‘‘(g) COORDINATION.— 

7 ‘‘(1) LOCAL RESPONSE CAPABILITIES.—An eligi8 ble entity shall, to the extent practicable, ensure that 

9 activities carried out under an award under sub10 section (a) are coordinated with activities of relevant 

11 local Metropolitan Medical Response Systems, local 

12 Medical Reserve Corps, the local Cities Readiness Ini13 tiative, and local emergency plans. 

14 ‘‘(2) NATIONAL COLLABORATION.—Partnerships 

15 consisting of one or more eligible entities under this 

16 section may, to the extent practicable, collaborate 

17 with other partnerships consisting of one or more eli18 gible entities under this section for purposes of na19 tional coordination and collaboration with respect to 

20 activities to achieve the preparedness goals described 

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

22 2802(b).’’; 

23 (5) in subsection (i)— 

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

25 inserting the following: 


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

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

3 ‘‘(2) MEETING GOALS OF NATIONAL HEALTH SE4 CURITY STRATEGY.—The Secretary shall implement 

5 objective, evidence-based metrics to ensure that enti6 ties receiving awards under this section are meeting, 

7 to the extent practicable, the applicable goals of the 

8 National Health Security Strategy under section 

9 2802.’’; and 

10 (6) in subsection (j)— 

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

12 follows: 

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

14 this section, there is authorized to be appropriated 

15 $374,700,000 for each of fiscal years 2014 through 

16 2018.’’; and 

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

18 ‘‘(4) AVAILABILITY OF COOPERATIVE AGREEMENT

19 FUNDS.— 

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

21 an eligible entity under a cooperative agreement 

22 under subsection (a) for a fiscal year and re23 maining unobligated at the end of such year 

24 shall remain available to such entity for the next 


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1 fiscal year for the purposes for which such funds 

2 were provided. 

3 ‘‘(B) FUNDS CONTINGENT ON ACHIEVING

4 BENCHMARKS.—The continued availability of 

5 funds under subparagraph (A) with respect to an 

6 entity shall be contingent upon such entity 

7 achieving the benchmarks and submitting the 

8 pandemic influenza plan as required under sub9 section (i).’’. 

10 SEC. 204. ENHANCING SITUATIONAL AWARENESS AND BIO11 SURVEILLANCE. 

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

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

14 (1) in subsection (b)— 

15 (A) in paragraph (1)(B), by inserting ‘‘poi16 son control centers,’’ after ‘‘hospitals,’’; 

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

18 the period at the end the following: ‘‘, allowing 

19 for coordination to maximize all-hazards medical 

20 and public health preparedness and response and 

21 to minimize duplication of effort’’; and 

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

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

24 such standards as necessary’’; 

25 (2) by striking subsection (c); 


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

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

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

4 (A) in the subsection heading, by striking 

5 ‘‘PUBLIC HEALTH SITUATIONAL AWARENESS’’ 

6 and inserting ‘‘MODERNIZING PUBLIC HEALTH

7 SITUATIONAL AWARENESS AND BIOSURVEIL8 LANCE’’; 

9 (B) in paragraph (1)— 

10 (i) by striking ‘‘Pandemic and All11 Hazards Preparedness Act’’ and inserting 

12 ‘‘Pandemic and All-Hazards Preparedness 

13 Reauthorization Act of 2013’’; and 

14 (ii) by inserting ‘‘, novel emerging 

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

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

17 the following: 

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

19 Not later than 180 days after the date of enactment 

20 of the Pandemic and All-Hazards Preparedness Reau21 thorization Act of 2013, the Secretary shall submit to 

22 the appropriate committees of Congress a coordinated 

23 strategy and an accompanying implementation plan 

24 that identifies and demonstrates the measurable steps 

25 the Secretary will carry out to— 


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

2 network described in paragraph (1), utilizing the 

3 elements described in paragraph (3); 

4 ‘‘(B) modernize and enhance biosurveillance 

5 activities; and 

6 ‘‘(C) improve information sharing, coordi7 nation, and communication among disparate 

8 biosurveillance systems supported by the Depart9 ment of Health and Human Services.’’; 

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

11 ‘‘community health centers, health centers’’ after 

12 ‘‘poison control,’’; 

13 (E) in paragraph (5), by striking subpara14 graph (A) and inserting the following: 

15 ‘‘(A) utilize applicable interoperability 

16 standards as determined by the Secretary, and 

17 in consultation with the Office of the National 

18 Coordinator for Health Information Technology, 

19 through a joint public and private sector proc20 ess;’’; and 

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

22 ‘‘(6) CONSULTATION WITH THE NATIONAL BIO23 DEFENSE SCIENCE BOARD.—In carrying out this sec24 tion and consistent with section 319M, the National 

25 Biodefense Science Board shall provide expert advice 


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1 and guidance, including recommendations, regarding 

2 the measurable steps the Secretary should take to 

3 modernize and enhance biosurveillance activities pur4 suant to the efforts of the Department of Health and 

5 Human Services to ensure comprehensive, real-time, 

6 all-hazards biosurveillance capabilities. In complying 

7 with the preceding sentence, the National Biodefense 

8 Science Board shall— 

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

10 a national biosurveillance system for human 

11 health, with international connectivity, where 

12 appropriate, that is predicated on State, re13 gional, and community level capabilities and 

14 creates a networked system to allow for two-way 

15 information flow between and among Federal, 

16 State, and local government public health au17 thorities and clinical health care providers; 

18 ‘‘(B) identify any duplicative surveillance 

19 programs under the authority of the Secretary, 

20 or changes that are necessary to existing pro21 grams, in order to enhance and modernize such 

22 activities, minimize duplication, strengthen and 

23 streamline such activities under the authority of 

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1 priate data that relate to disease activity, both 

2 human and zoonotic; and 

3 ‘‘(C) coordinate with applicable existing ad4 visory committees of the Director of the Centers 

5 for Disease Control and Prevention, including 

6 such advisory committees consisting of represent7 atives from State, local, and tribal public health 

8 authorities and appropriate public and private 

9 sector health care entities and academic institu10 tions, in order to provide guidance on public 

11 health surveillance activities.’’; 

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

13 (A) in paragraph (1), by striking ‘‘sub14 section (d)’’ and inserting ‘‘subsection (c)’’; 

15 (B) in paragraph (4)(B), by striking ‘‘sub16 section (d)’’ and inserting ‘‘subsection (c)’’; and 

17 (C) in paragraph (5)— 

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

19 of enactment of the Pandemic and All-Haz20 ards Preparedness Act’’ and inserting ‘‘3 

21 years after the date of enactment of the 

22 Pandemic and All-Hazards Preparedness 

23 Reauthorization Act of 2013’’; and 

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

25 inserting ‘‘subsection (c)’’; 


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1 (6) in subsection (f), as so redesignated, by strik2 ing ‘‘such sums as may be necessary in each of fiscal 

3 years 2007 through 2011’’ and inserting 

4 ‘‘$138,300,000 for each of fiscal years 2014 through 

5 2018’’; and 

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

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

8 term ‘biosurveillance’ means the process of gathering near 

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

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

11 order to achieve early warning and identification of such 

12 health threats, early detection and prompt ongoing tracking 

13 of health events, and overall situational awareness of disease 

14 activity.’’. 

15 (b) TECHNICAL AND CONFORMING AMENDMENT.—Sec16 tion 319C–1(b)(2)(D) of the Public Health Service Act (42 

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

18 319D(d)(3)’’ and inserting ‘‘section 319D(c)(3)’’. 

19 SEC. 205. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD 

20 REPORTS. 

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

22 U.S.C. 247d–6c) is repealed. 


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1 TITLE III—ENHANCING MEDICAL 

2 COUNTERMEASURE REVIEW 

3 SEC. 301. SPECIAL PROTOCOL ASSESSMENT. 

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

5 Cosmetic Act (21 U.S.C. 355(b)(5)(B)) is amended by strik6 ing ‘‘size of clinical trials intended’’ and all that follows 

7 through ‘‘. The sponsor or applicant’’ and inserting the fol8 lowing: ‘‘size— 

9 ‘‘(i)(I) of clinical trials intended to form the pri10 mary basis of an effectiveness claim; or 

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

12 are not ethical or feasible, of animal and any associ13 ated clinical trials which, in combination, are in14 tended to form the primary basis of an effectiveness 

15 claim; or 

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

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

18 Public Health Service Act, of any necessary clinical 

19 study or studies. 

20 The sponsor or applicant’’. 

21 SEC. 302. AUTHORIZATION FOR MEDICAL PRODUCTS FOR 

22 USE IN EMERGENCIES. 

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

24 Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) is amend25 ed— 


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1 (1) in subsection (a)— 

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

3 505, 510(k), and 515 of this Act’’ and inserting 

4 ‘‘any provision of this Act’’; 

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

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

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

8 510(k), or 515 of this Act or section 351 of the 

9 Public Health Service Act’’; and 

10 (C) in paragraph (3), by striking ‘‘a provi11 sion of law referred to in such paragraph’’ and 

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

13 Health Service Act referred to in paragraph 

14 (2)(A)’’; 

15 (2) in subsection (b)— 

16 (A) in the subsection heading, by striking 

17 ‘‘EMERGENCY’’ and inserting ‘‘EMERGENCY OR

18 THREAT JUSTIFYING EMERGENCY AUTHORIZED

19 USE’’; 

20 (B) in paragraph (1)— 

21 (i) in the matter preceding subpara22 graph (A), by striking ‘‘may declare an 

23 emergency’’ and inserting ‘‘may make a 

24 declaration that the circumstances exist’’; 


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

2 ‘‘specified’’; 

3 (iii) in subparagraph (B)— 

4 (I) by striking ‘‘specified’’; and 

5 (II) by striking ‘‘; or’’ and insert6 ing a semicolon; 

7 (iv) by amending subparagraph (C) to 

8 read as follows: 

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

10 there is a public health emergency, or a signifi11 cant potential for a public health emergency, 

12 that affects, or has a significant potential to af13 fect, national security or the health and security 

14 of United States citizens living abroad, and that 

15 involves a biological, chemical, radiological, or 

16 nuclear agent or agents, or a disease or condition 

17 that may be attributable to such agent or agents; 

18 or’’; and 

19 (v) by adding at the end the following: 

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

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

22 Service Act sufficient to affect national security 

23 or the health and security of United States citi24 zens living abroad.’’; 

25 (C) in paragraph (2)— 


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

2 clause (ii) to read as follows: 

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

4 the product such that the circumstances de5 scribed in subsection (a)(2) have ceased to 

6 exist.’’; 

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

8 (iii) by redesignating subparagraph 

9 (C) as subparagraph (B); 

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

11 notice of termination, and renewal under this 

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

13 of termination under this subsection.’’; and 

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

15 ‘‘(5) EXPLANATION BY SECRETARY.—If an au16 thorization under this section with respect to an un17 approved product or an unapproved use of an ap18 proved product has been in effect for more than 1 

19 year, the Secretary shall provide in writing to the 

20 sponsor of such product an explanation of the sci21 entific, regulatory, or other obstacles to approval, li22 censure, or clearance of such product or use, including 

23 specific actions to be taken by the Secretary and the 

24 sponsor to overcome such obstacles.’’; 

25 (3) in subsection (c)— 


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1 (A) in the matter preceding paragraph 

2 (1)— 

3 (i) by inserting ‘‘the Assistant Sec4 retary for Preparedness and Response,’’ 

5 after ‘‘consultation with’’; 

6 (ii) by striking ‘‘Health and’’ and in7 serting ‘‘Health, and’’; and 

8 (iii) by striking ‘‘circumstances of the 

9 emergency involved’’ and inserting ‘‘appli10 cable circumstances described in subsection 

11 (b)(1)’’; 

12 (B) in paragraph (1), by striking ‘‘speci13 fied’’ and inserting ‘‘referred to’’; and 

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

15 taking into consideration the material threat 

16 posed by the agent or agents identified in a dec17 laration under subsection (b)(1)(D), if applica18 ble’’ after ‘‘risks of the product’’; 

19 (4) in subsection (d)(3), by inserting ‘‘, to the ex20 tent practicable given the circumstances of the emer21 gency,’’ after ‘‘including’’; 

22 (5) in subsection (e)— 

23 (A) in paragraph (1)(A), by striking ‘‘cir24 cumstances of the emergency’’ and inserting ‘‘apVerDate Mar 15 2010 22:31 Feb 14, 2013 Jkt 029200 PO 00000 Frm 00148 Fmt 6652 Sfmt 6203 E:\BILLS\H307.RS H307

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1 plicable circumstances described in subsection 

2 (b)(1)’’; 

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

4 clause (iii) to read as follows: 

5 ‘‘(iii) Appropriate conditions with re6 spect to collection and analysis of informa7 tion concerning the safety and effectiveness 

8 of the product with respect to the use of such 

9 product during the period when the author10 ization is in effect and a reasonable time 

11 following such period.’’; 

12 (C) in paragraph (2)— 

13 (i) in subparagraph (A)— 

14 (I) by striking ‘‘manufacturer of 

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

16 (II) by striking ‘‘circumstances of 

17 the emergency’’ and inserting ‘‘appli18 cable circumstances described in sub19 section (b)(1)’’; and 

20 (III) by inserting at the end be21 fore the period ‘‘or in paragraph 

22 (1)(B)’’; 

23 (ii) in subparagraph (B)(i), by insert24 ing before the period at the end ‘‘, except as 

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1 thorized changes to the product expiration 

2 date’’; and 

3 (iii) by amending subparagraph (C) to 

4 read as follows: 

5 ‘‘(C) In establishing conditions under this 

6 paragraph with respect to the distribution and 

7 administration of the product for the unap8 proved use, the Secretary shall not impose condi9 tions that would restrict distribution or adminis10 tration of the product when distributed or ad11 ministered for the approved use.’’; and 

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

13 follows: 

14 ‘‘(3) GOOD MANUFACTURING PRACTICE; PRE15 SCRIPTION.—With respect to the emergency use of a 

16 product for which an authorization under this section 

17 is issued (whether an unapproved product or an un18 approved use of an approved product), the Secretary 

19 may waive or limit, to the extent appropriate given 

20 the applicable circumstances described in subsection 

21 (b)(1)— 

22 ‘‘(A) requirements regarding current good 

23 manufacturing practice otherwise applicable to 

24 the manufacture, processing, packing, or holding 

25 of products subject to regulation under this Act, 


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1 including such requirements established under 

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

3 conditions prescribed with respect to the product 

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

5 ‘‘(B) requirements established under section 

6 503(b); and 

7 ‘‘(C) requirements established under section 

8 520(e).’’; 

9 (6) in subsection (g)— 

10 (A) in the subsection heading, by inserting 

11 ‘‘REVIEW AND’’ before ‘‘REVOCATION’’; 

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

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

14 review, the Secretary shall regularly review the 

15 progress made with respect to the approval, li16 censure, or clearance of— 

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

18 authorization was issued under this section; or 

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

20 product for which an authorization was issued 

21 under this section.’’; and 

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

23 follows: 


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

2 may revise or revoke an authorization under this sec3 tion if— 

4 ‘‘(A) the circumstances described under sub5 section (b)(1) no longer exist; 

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

7 issuance of such authorization are no longer met; 

8 or 

9 ‘‘(C) other circumstances make such revision 

10 or revocation appropriate to protect the public 

11 health or safety.’’; 

12 (7) in subsection (h)(1), by adding after the pe13 riod at the end the following: ‘‘The Secretary shall 

14 make any revisions to an authorization under this 

15 section available on the Internet Web site of the Food 

16 and Drug Administration.’’; 

17 (8) by adding at the end of subsection (j) the fol18 lowing: 

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

20 authorizing a delay in the review or other consider21 ation by the Secretary of any application or submis22 sion pending before the Food and Drug Administra23 tion for a product for which an authorization under 

24 this section is issued.’’; and 

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


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1 ‘‘(m) CATEGORIZATION OF LABORATORY TESTS ASSO2 CIATED WITH DEVICES SUBJECT TO AUTHORIZATION.— 

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

4 under this section with respect to a device, the Sec5 retary may, subject to the provisions of this section, 

6 determine that a laboratory examination or procedure 

7 associated with such device shall be deemed, for pur8 poses of section 353 of the Public Health Service Act, 

9 to be in a particular category of examinations and 

10 procedures (including the category described by sub11 section (d)(3) of such section) if, based on the totality 

12 of scientific evidence available to the Secretary— 

13 ‘‘(A) such categorization would be beneficial 

14 to protecting the public health; and 

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

16 such categorization under the circumstances of 

17 the authorization outweigh the known and poten18 tial risks of the categorization. 

19 ‘‘(2) CONDITIONS OF DETERMINATION.—The Sec20 retary may establish appropriate conditions on the 

21 performance of the examination or procedure pursu22 ant to such determination. 

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

24 under this subsection shall be effective for purposes of 

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1 standing any other provision of that section during 

2 the effective period of the relevant declaration under 

3 subsection (b).’’. 

4 (b) EMERGENCY USE OF MEDICAL PRODUCTS.—Sub5 chapter E of chapter V of the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 360bbb et seq.) is amended by insert7 ing after section 564 the following: 

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

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

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

11 product’ means a product that— 

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

13 chapter or licensed under section 351 of the Pub14 lic Health Service Act; 

15 ‘‘(B)(i) is intended for use to prevent, diag16 nose, or treat a disease or condition involving a 

17 biological, chemical, radiological, or nuclear 

18 agent or agents; or 

19 ‘‘(ii) is intended for use to prevent, diag20 nose, or treat a serious or life-threatening disease 

21 or condition caused by a product described in 

22 clause (i); and 

23 ‘‘(C) is intended for use during the cir24 cumstances under which— 


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1 ‘‘(i) a determination described in sub2 paragraph (A), (B), or (C) of section 

3 564(b)(1) has been made by the Secretary of 

4 Homeland Security, the Secretary of De5 fense, or the Secretary, respectively; or 

6 ‘‘(ii) the identification of a material 

7 threat described in subparagraph (D) of sec8 tion 564(b)(1) has been made pursuant to 

9 section 319F–2 of the Public Health Service 

10 Act. 

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

12 drug, device, or biological product. 

13 ‘‘(b) EXPIRATION DATING.— 

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

15 the expiration date and authorize the introduction or 

16 delivery for introduction into interstate commerce of 

17 an eligible product after the expiration date provided 

18 by the manufacturer if— 

19 ‘‘(A) the expiration date extension is in20 tended to support the United States ability to 

21 protect— 

22 ‘‘(i) the public health; or 

23 ‘‘(ii) military preparedness and effec24 tiveness; and 


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1 ‘‘(B) the expiration date extension is sup2 ported by an appropriate scientific evaluation 

3 that is conducted or accepted by the Secretary. 

4 ‘‘(2) REQUIREMENTS AND CONDITIONS.—Any ex5 tension of an expiration date under paragraph (1) 

6 shall, as part of the extension, identify— 

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

8 of the product for which extended expiration is 

9 authorized; 

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

11 ‘‘(C) any other requirements or conditions 

12 as the Secretary may deem appropriate for the 

13 protection of the public health, which may in14 clude requirements for, or conditions on, product 

15 sampling, storage, packaging or repackaging, 

16 transport, labeling, notice to product recipients, 

17 recordkeeping, periodic testing or retesting, or 

18 product disposition. 

19 ‘‘(3) EFFECT.—Notwithstanding any other pro20 vision of this Act or the Public Health Service Act, 

21 an eligible product shall not be considered an unap22 proved product (as defined in section 564(a)(2)(A)) 

23 and shall not be deemed adulterated or misbranded 

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

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


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1 expiration date and authorized the introduction or 

2 delivery for introduction into interstate commerce of 

3 such product after the expiration date provided by the 

4 manufacturer. 

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

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

7 established through appropriate stability testing re8 quired by the regulations issued by the Secretary to 

9 ensure that the product meets applicable standards of 

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

11 use. 

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

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

14 the circumstances of a domestic, military, or public 

15 health emergency or material threat described in sub16 section (a)(1)(C) so warrant, authorize, with respect 

17 to an eligible product, deviations from current good 

18 manufacturing practice requirements otherwise appli19 cable to the manufacture, processing, packing, or 

20 holding of products subject to regulation under this 

21 Act, including requirements under section 501 or 

22 520(f)(1) or applicable conditions prescribed with re23 spect to the eligible product by an order under section 

24 520(f)(2). 


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1 ‘‘(2) EFFECT.—Notwithstanding any other pro2 vision of this Act or the Public Health Service Act, 

3 an eligible product shall not be considered an unap4 proved product (as defined in section 564(a)(2)(A)) 

5 and shall not be deemed adulterated or misbranded 

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

7 the Secretary has authorized deviations from current 

8 good manufacturing practices under paragraph (1). 

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

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

11 product, and the product shall not be considered an unap12 proved product (as defined in section 564(a)(2)(A)) and 

13 shall not be deemed adulterated or misbranded under this 

14 Act because it is dispensed without an individual prescrip15 tion, if— 

16 ‘‘(1) the product is dispensed during the cir17 cumstances described in subsection (a)(1)(C); and 

18 ‘‘(2) such dispensing without an individual pre19 scription occurs— 

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

21 State in which the product is dispensed; or 

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

23 the Secretary, for the purposes and duration of 

24 the circumstances described in subsection 

25 (a)(1)(C). 


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1 ‘‘(e) EMERGENCY USE INSTRUCTIONS.— 

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

3 through an appropriate official within the Depart4 ment of Health and Human Services, may create and 

5 issue emergency use instructions to inform health care 

6 providers or individuals to whom an eligible product 

7 is to be administered concerning such product’s ap8 proved, licensed, or cleared conditions of use. 

9 ‘‘(2) EFFECT.—Notwithstanding any other pro10 visions of this Act or the Public Health Service Act, 

11 a product shall not be considered an unapproved 

12 product and shall not be deemed adulterated or mis13 branded under this Act because of the issuance of 

14 emergency use instructions under paragraph (1) with 

15 respect to such product or the introduction or delivery 

16 for introduction of such product into interstate com17 merce accompanied by such instructions— 

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

19 actual emergency that is the basis for a deter20 mination described in subsection (a)(1)(C)(i); or 

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

22 Federal, State, local, or tribal government enti23 ty), or a person acting on behalf of such a gov24 ernment entity, in preparation for an emergency 

25 response.’’. 


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1 (c) RISK EVALUATION AND MITIGATION STRATE2 GIES.—Section 505–1 of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 355–1), is amended— 

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

5 and 

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

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

8 The Secretary may waive any requirement of this section 

9 with respect to a qualified countermeasure (as defined in 

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

11 which a requirement under this section has been applied, 

12 if the Secretary determines that such waiver is required to 

13 mitigate the effects of, or reduce the severity of, the cir14 cumstances under which— 

15 ‘‘(1) a determination described in subparagraph 

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

17 by the Secretary of Homeland Security, the Secretary 

18 of Defense, or the Secretary, respectively; or 

19 ‘‘(2) the identification of a material threat de20 scribed in subparagraph (D) of section 564(b)(1) has 

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

22 Health Service Act.’’. 

23 (d) PRODUCTS HELD FOR EMERGENCY USE.—The 

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


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

2 by subsection (b), the following: 

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

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

5 the Public Health Service Act for a government entity (in6 cluding a Federal, State, local, or tribal government entity), 

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

8 to introduce into interstate commerce a product (as defined 

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

10 product— 

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

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

13 product— 

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

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

16 351 of the Public Health Service Act; 

17 ‘‘(B) is authorized for investigational use 

18 under section 505 or 520 of this Act or section 

19 351 of the Public Health Service Act; or 

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

21 564.’’. 

22 SEC. 303. DEFINITIONS. 

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

24 Act (21 U.S.C. 360bbb–4) is amended by striking ‘‘The Sec25 retary, in consultation’’ and inserting the following: 


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

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

3 countermeasure, a security countermeasure, and a 

4 qualified pandemic or epidemic product; 

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

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

7 Public Health Service Act; 

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

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

10 Act; and 

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

12 product’ means a product that meets the definition 

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

14 Health Service Act and— 

15 ‘‘(A) that has been identified by the Depart16 ment of Health and Human Services or the De17 partment of Defense as receiving funding directly 

18 related to addressing chemical, biological, radio19 logical, or nuclear threats, including pandemic 

20 influenza; or 

21 ‘‘(B) is included under this paragraph pur22 suant to a determination by the Secretary. 

23 ‘‘(b) GENERAL DUTIES.—The Secretary, in consulta24 tion’’. 


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1 SEC. 304. ENHANCING MEDICAL COUNTERMEASURE ACTIVI2 TIES. 

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

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

5 further amended— 

6 (1) in the section heading, by striking ‘‘TECH7 NICAL ASSISTANCE’’ and inserting ‘‘COUNTER8 MEASURE DEVELOPMENT, REVIEW, AND TECH9 NICAL ASSISTANCE’’; 

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

11 enumerator and all that follows through ‘‘shall estab12 lish’’ and inserting the following: 

13 ‘‘(b) GENERAL DUTIES.—In order to accelerate the de14 velopment, stockpiling, approval, licensure, and clearance 

15 of qualified countermeasures, security countermeasures, and 

16 qualified pandemic or epidemic products, the Secretary, in 

17 consultation with the Assistant Secretary for Preparedness 

18 and Response, shall— 

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

20 and Drug Administration personnel in interagency 

21 activities related to countermeasure advanced research 

22 and development, consistent with sections 319F, 

23 319F–1, 319F–2, 319F–3, 319L, and 2811 of the 

24 Public Health Service Act; 

25 ‘‘(2) ensure the appropriate involvement and 

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1 sonnel in any flexible manufacturing activities car2 ried out under section 319L of the Public Health 

3 Service Act, including with respect to meeting regu4 latory requirements set forth in this Act; 

5 ‘‘(3) promote countermeasure expertise within 

6 the Food and Drug Administration by— 

7 ‘‘(A) ensuring that Food and Drug Admin8 istration personnel involved in reviewing coun9 termeasures for approval, licensure, or clearance 

10 are informed by the Assistant Secretary for Pre11 paredness and Response on the material threat 

12 assessment conducted under section 319F–2 of 

13 the Public Health Service Act for the agent or 

14 agents for which the countermeasure under re15 view is intended; 

16 ‘‘(B) training Food and Drug Administra17 tion personnel regarding review of counter18 measures for approval, licensure, or clearance; 

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

20 annually to encourage the exchange of scientific 

21 ideas; and 

22 ‘‘(D) establishing protocols to ensure that 

23 countermeasure reviewers have sufficient train24 ing or experience with countermeasures; 


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

2 Drug Administration personnel with expertise on 

3 countermeasures, including specific countermeasures, 

4 populations with special clinical needs (including 

5 children and pregnant women that may use counter6 measures, as applicable and appropriate), classes or 

7 groups of countermeasures, or other countermeasure8 related technologies and capabilities, that shall— 

9 ‘‘(A) consult with countermeasure experts, 

10 including countermeasure sponsors and appli11 cants, to identify and help resolve scientific 

12 issues related to the approval, licensure, or clear13 ance of countermeasures, through workshops or 

14 public meetings; and 

15 ‘‘(B) improve and advance the science relat16 ing to the development of new tools, standards, 

17 and approaches to assessing and evaluating 

18 countermeasures— 

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

20 countermeasure approval, clearance, and li21 censure; and 

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

23 countermeasures for populations with spe24 cial clinical needs, including children and 

25 pregnant women, in order to meet the needs 


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1 of such populations, as necessary and ap2 propriate; and 

3 ‘‘(5) establish’’; and 

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

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

6 MODELS.— 

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

8 the date of the enactment of the Pandemic and All9 Hazards Preparedness Reauthorization Act of 2013, 

10 the Secretary shall provide final guidance to industry 

11 regarding the development of animal models to sup12 port approval, clearance, or licensure of counter13 measures referred to in subsection (a) when human ef14 ficacy studies are not ethical or feasible. 

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

16 Secretary may extend the deadline for providing final 

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

18 months upon submission by the Secretary of a report 

19 on the status of such guidance to the Committee on 

20 Energy and Commerce of the House of Representa21 tives and the Committee on Health, Education, 

22 Labor, and Pensions of the Senate. 

23 ‘‘(d) DEVELOPMENT AND ANIMAL MODELING PROCE24 DURES.— 


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1 ‘‘(1) AVAILABILITY OF ANIMAL MODEL MEET2 INGS.—To facilitate the timely development of animal 

3 models and support the development, stockpiling, li4 censure, approval, and clearance of countermeasures, 

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

6 enactment of this subsection, establish a procedure by 

7 which a sponsor or applicant that is developing a 

8 countermeasure for which human efficacy studies are 

9 not ethical or practicable, and that has an approved 

10 investigational new drug application or investiga11 tional device exemption, may request and receive— 

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

13 model development activities; and 

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

15 animal studies. 

16 ‘‘(2) PEDIATRIC MODELS.—To facilitate the de17 velopment and selection of animal models that could 

18 translate to pediatric studies, any meeting conducted 

19 under paragraph (1) shall include discussion of ani20 mal models for pediatric populations, as appropriate. 

21 ‘‘(e) REVIEW AND APPROVAL OF COUNTER22 MEASURES.— 

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

24 application or submission for approval, licensure, or 

25 clearance of a countermeasure, the Secretary shall 


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1 take into account the material threat posed by the 

2 chemical, biological, radiological, or nuclear agent or 

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

4 Health Service Act for which the countermeasure 

5 under review is intended. 

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

7 and appropriate, teams of Food and Drug Adminis8 tration personnel reviewing applications or submis9 sions described under paragraph (1) shall include a 

10 reviewer with sufficient training or experience with 

11 countermeasures pursuant to the protocols established 

12 under subsection (b)(3)(D).’’. 

13 SEC. 305. REGULATORY MANAGEMENT PLANS. 

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

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

16 further amended by adding at the end the following: 

17 ‘‘(f) REGULATORY MANAGEMENT PLAN.— 

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

19 ‘eligible countermeasure’ means— 

20 ‘‘(A) a security countermeasure with respect 

21 to which the Secretary has entered into a pro22 curement contract under section 319F–2(c) of the 

23 Public Health Service Act; or 

24 ‘‘(B) a countermeasure with respect to 

25 which the Biomedical Advanced Research and 


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1 Development Authority has provided funding 

2 under section 319L of the Public Health Service 

3 Act for advanced research and development. 

4 ‘‘(2) REGULATORY MANAGEMENT PLAN PROC5 ESS.—The Secretary, in consultation with the Assist6 ant Secretary for Preparedness and Response and the 

7 Director of the Biomedical Advanced Research and 

8 Development Authority, shall establish a formal proc9 ess for obtaining scientific feedback and interactions 

10 regarding the development and regulatory review of 

11 eligible countermeasures by facilitating the develop12 ment of written regulatory management plans in ac13 cordance with this subsection. 

14 ‘‘(3) SUBMISSION OF REQUEST AND PROPOSED

15 PLAN BY SPONSOR OR APPLICANT.— 

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

17 of an eligible countermeasure may initiate the 

18 process described under paragraph (2) upon sub19 mission of a written request to the Secretary. 

20 Such request shall include a proposed regulatory 

21 management plan. 

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

23 or applicant may submit a written request 

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1 termeasure has an investigational new drug or 

2 investigational device exemption in effect. 

3 ‘‘(C) RESPONSE BY SECRETARY.—The Sec4 retary shall direct the Food and Drug Adminis5 tration, upon submission of a written request by 

6 a sponsor or applicant under subparagraph (A), 

7 to work with the sponsor or applicant to agree 

8 on a regulatory management plan within a rea9 sonable time not to exceed 90 days. If the Sec10 retary determines that no plan can be agreed 

11 upon, the Secretary shall provide to the sponsor 

12 or applicant, in writing, the scientific or regu13 latory rationale why such agreement cannot be 

14 reached. 

15 ‘‘(4) PLAN.—The content of a regulatory man16 agement plan agreed to by the Secretary and a spon17 sor or applicant shall include— 

18 ‘‘(A) an agreement between the Secretary 

19 and the sponsor or applicant regarding develop20 mental milestones that will trigger responses by 

21 the Secretary as described in subparagraph (B); 

22 ‘‘(B) performance targets and goals for 

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1 retary and the sponsor or applicant, written 

2 feedback, decisions by the Secretary, and other 

3 activities carried out as part of the development 

4 and review process; and 

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

6 modified, if needed. 

7 ‘‘(5) MILESTONES AND PERFORMANCE TAR8 GETS.—The developmental milestones described in 

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

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

11 ‘‘(A) feedback from the Secretary regarding 

12 the data required to support the approval, clear13 ance, or licensure of the eligible countermeasure 

14 involved; 

15 ‘‘(B) feedback from the Secretary regarding 

16 the data necessary to inform any authorization 

17 under section 564; 

18 ‘‘(C) feedback from the Secretary regarding 

19 the data necessary to support the positioning 

20 and delivery of the eligible countermeasure, in21 cluding to the Strategic National Stockpile; 

22 ‘‘(D) feedback from the Secretary regarding 

23 the data necessary to support the submission of 

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


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1 ‘‘(E) feedback from the Secretary regarding 

2 any gaps in scientific knowledge that will need 

3 resolution prior to approval, licensure, or clear4 ance of the eligible countermeasure and plans for 

5 conducting the necessary scientific research; 

6 ‘‘(F) identification of the population for 

7 which the countermeasure sponsor or applicant 

8 seeks approval, licensure, or clearance and the 

9 population for which desired labeling would not 

10 be appropriate, if known; and 

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

12 the extent practicable, a plan for demonstrating 

13 safety and effectiveness in pediatric populations, 

14 and for developing pediatric dosing, formulation, 

15 and administration with respect to the eligible 

16 countermeasure, provided that such plan would 

17 not delay authorization under section 564, ap18 proval, licensure, or clearance for adults. 

19 ‘‘(6) PRIORITIZATION.— 

20 ‘‘(A) PLANS FOR SECURITY COUNTER21 MEASURES.—The Secretary shall establish regu22 latory management plans for all security coun23 termeasures for which a request is submitted 

24 under paragraph (3)(A). 


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1 ‘‘(B) PLANS FOR OTHER ELIGIBLE COUN2 TERMEASURES.—The Secretary shall determine 

3 whether resources are available to establish regu4 latory management plans for eligible counter5 measures that are not security countermeasures. 

6 If resources are available to establish regulatory 

7 management plans for eligible countermeasures 

8 that are not security countermeasures, and if re9 sources are not available to establish regulatory 

10 management plans for all eligible counter11 measures for which requests have been submitted, 

12 the Director of the Biomedical Advanced Re13 search and Development Authority, in consulta14 tion with the Commissioner, shall prioritize 

15 which eligible countermeasures may receive regu16 latory management plans.’’. 

17 SEC. 306. REPORT. 

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

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

20 further amended by adding at the end the following: 

21 ‘‘(g) ANNUAL REPORT.—Not later than 180 days after 

22 the date of enactment of this subsection, and annually there23 after, the Secretary shall make publicly available on the 

24 Web site of the Food and Drug Administration a report 


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1 that details the countermeasure development and review ac2 tivities of the Food and Drug Administration, including— 

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

4 standards, and approaches to assess and evaluate 

5 countermeasures— 

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

7 the Food and Drug Administration and the 

8 progress made on such priorities; and 

9 ‘‘(B) the identification of scientific gaps 

10 that impede the development, approval, licensure, 

11 or clearance of countermeasures for populations 

12 with special clinical needs, including children 

13 and pregnant women, and the progress made on 

14 resolving these challenges; 

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

16 regulatory management plan has been agreed upon 

17 under subsection (f), the extent to which the perform18 ance targets and goals set forth in subsection (f)(4)(B) 

19 and the regulatory management plan have been met, 

20 including, for each such countermeasure— 

21 ‘‘(A) whether the regulatory management 

22 plan was completed within the required time23 frame, and the length of time taken to complete 

24 such plan; 


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

2 timely and appropriate response times set forth 

3 in such plan; and 

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

5 such performance targets and goals; 

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

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

8 classes of products, or technologies assigned to each 

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

10 progress made as a result of consultations carried out 

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

12 ‘‘(4) an estimate of resources obligated to coun13 termeasure development and regulatory assessment, 

14 including— 

15 ‘‘(A) Center-specific objectives and accom16 plishments; and 

17 ‘‘(B) the number of full-time equivalent em18 ployees of the Food and Drug Administration 

19 who directly support the review of counter20 measures; 

21 ‘‘(5) the number of countermeasure applications 

22 and submissions submitted, the number of counter23 measures approved, licensed, or cleared, the status of 

24 remaining submitted applications and submissions, 


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1 and the number of each type of authorization issued 

2 pursuant to section 564; 

3 ‘‘(6) the number of written requests for a regu4 latory management plan submitted under subsection 

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

6 developed, and the number of such plans developed for 

7 security countermeasures; and 

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

9 between the Food and Drug Administration and— 

10 ‘‘(A) sponsors of a countermeasure as de11 fined in subsection (a); or 

12 ‘‘(B) another agency engaged in develop13 ment or management of portfolios for such coun14 termeasures, including the Centers for Disease 

15 Control and Prevention, the Biomedical Ad16 vanced Research and Development Authority, the 

17 National Institutes of Health, and the appro18 priate agencies of the Department of Defense.’’. 

19 SEC. 307. PEDIATRIC MEDICAL COUNTERMEASURES. 

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

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

22 is amended— 

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

24 following: 


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

2 that is a qualified countermeasure (as defined in sec3 tion 319F–1 of the Public Health Service Act), a secu4 rity countermeasure (as defined in section 319F–2 of 

5 the Public Health Service Act), or a qualified pan6 demic or epidemic product (as defined in section 

7 319F–3 of the Public Health Service Act), the Sec8 retary shall solicit input from the Assistant Secretary 

9 for Preparedness and Response regarding the need for 

10 and, from the Director of the Biomedical Advanced 

11 Research and Development Authority regarding the 

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

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

14 following: 

15 ‘‘(C) For a drug that is a qualified counter16 measure (as defined in section 319F–1 of the 

17 Public Health Service Act), a security counter18 measure (as defined in section 319F–2 of the 

19 Public Health Service Act), or a qualified pan20 demic or epidemic product (as defined in section 

21 319F–3 of such Act), in addition to any action 

22 with respect to such drug under subparagraph 

23 (A) or (B), the Secretary shall notify the Assist24 ant Secretary for Preparedness and Response 

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1 search and Development Authority of all pedi2 atric studies in the written request issued by the 

3 Commissioner of Food and Drugs.’’. 

4 (b) ADDITION TO PRIORITY LIST CONSIDERATIONS.— 

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

6 284m) is amended— 

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

8 the following: 

9 ‘‘(2) CONSIDERATION OF AVAILABLE INFORMA10 TION.—In developing and prioritizing the list under 

11 paragraph (1), the Secretary— 

12 ‘‘(A) shall consider— 

13 ‘‘(i) therapeutic gaps in pediatrics that 

14 may include developmental pharmacology, 

15 pharmacogenetic determinants of drug re16 sponse, metabolism of drugs and biologics in 

17 children, and pediatric clinical trials; 

18 ‘‘(ii) particular pediatric diseases, dis19 orders or conditions where more complete 

20 knowledge and testing of therapeutics, in21 cluding drugs and biologics, may be bene22 ficial in pediatric populations; and 

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1 works and trained pediatric investigators; 

2 and 

3 ‘‘(B) may consider the availability of quali4 fied countermeasures (as defined in section 

5 319F–1), security countermeasures (as defined in 

6 section 319F–2), and qualified pandemic or epi7 demic products (as defined in section 319F–3) to 

8 address the needs of pediatric populations, in 

9 consultation with the Assistant Secretary for 

10 Preparedness and Response, consistent with the 

11 purposes of this section.’’; and 

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

13 and inserting ‘‘paragraphs (1) and (2)(A) of sub14 section (a)’’. 

15 (c) ADVICE AND RECOMMENDATIONS OF THE PEDI16 ATRIC ADVISORY COMMITTEE REGARDING COUNTER17 MEASURES FOR PEDIATRIC POPULATIONS.—Subsection 

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

19 Act (42 U.S.C. 284m note) is amended— 

20 (1) in subparagraph (C), by striking the period 

21 and inserting ‘‘; and’’; and 

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

23 ‘‘(D) the development of countermeasures 

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


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1 Drug, and Cosmetic Act) for pediatric popu2 lations.’’. 

3 TITLE IV—ACCELERATING MED4 ICAL COUNTERMEASURE AD5 VANCED RESEARCH AND DE6 VELOPMENT 

7 SEC. 401. BIOSHIELD. 

8 (a) PROCUREMENT OF COUNTERMEASURES.—Section 

9 319F–2(c) of the Public Health Service Act (42 U.S.C. 

10 247d–6b(c)) is amended— 

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

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

13 (2) in paragraph (2)(C), by striking ‘‘the des14 ignated congressional committees (as defined in para15 graph (10))’’ and inserting ‘‘the appropriate commit16 tees of Congress’’; 

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

18 years’’ and inserting ‘‘10 years’’; 

19 (4) in subparagraph (C) of paragraph (6)— 

20 (A) in the subparagraph heading, by strik21 ing ‘‘DESIGNATED CONGRESSIONAL COMMIT22 TEES’’ and inserting ‘‘APPROPRIATE CONGRES23 SIONAL COMMITTEES’’; and 


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1 (B) by striking ‘‘the designated congres2 sional committees’’ and inserting ‘‘the appro3 priate congressional committees’’; and 

4 (5) in paragraph (7)(C)— 

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

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

7 may reasonably be required,’’; 

8 (B) in clause (ii)— 

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

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

11 (ii) by striking subclause (IX) and in12 serting the following: 

13 ‘‘(IX) CONTRACT TERMS.—The 

14 Secretary, in any contract for procure15 ment under this section— 

16 ‘‘(aa) may specify— 

17 ‘‘(AA) the dosing and 

18 administration requirements 

19 for the countermeasure to be 

20 developed and procured; 

21 ‘‘(BB) the amount of 

22 funding that will be dedi23 cated by the Secretary for 

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1 ment, and procurement of the 

2 countermeasure; and 

3 ‘‘(CC) the specifications 

4 the countermeasure must 

5 meet to qualify for procure6 ment under a contract under 

7 this section; and 

8 ‘‘(bb) shall provide a clear 

9 statement of defined Government 

10 purpose limited to uses related to 

11 a security countermeasure, as de12 fined in paragraph (1)(B).’’; and 

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

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

15 this section, the Secretary may, consistent 

16 with the applicable provisions of this sec17 tion, enter into contracts and other agree18 ments that are in the best interest of the 

19 Government in meeting identified security 

20 countermeasure needs, including with re21 spect to reimbursement of the cost of ad22 vanced research and development as a rea23 sonable, allowable, and allocable direct cost 

24 of the contract involved.’’. 


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1 (b) REAUTHORIZATION OF THE SPECIAL RESERVE

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

3 (42 U.S.C. 247d–6b) is amended— 

4 (1) in subsection (c)— 

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

6 paragraph (10)’’ each place it appears and in7 serting ‘‘special reserve fund as defined in sub8 section (h)’’; and 

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

10 and 

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

12 ‘‘(g) SPECIAL RESERVE FUND.— 

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

14 addition to amounts appropriated to the special re15 serve fund prior to the date of the enactment of this 

16 subsection, there is authorized to be appropriated, for 

17 the procurement of security countermeasures under 

18 subsection (c) and for carrying out section 319L (re19 lating to the Biomedical Advanced Research and De20 velopment Authority), $2,800,000,000 for the period 

21 of fiscal years 2014 through 2018. Amounts appro22 priated pursuant to the preceding sentence are au23 thorized to remain available until September 30, 

24 2019. 


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1 ‘‘(2) USE OF SPECIAL RESERVE FUND FOR AD2 VANCED RESEARCH AND DEVELOPMENT.—The Sec3 retary may utilize not more than 50 percent of the 

4 amounts authorized to be appropriated under para5 graph (1) to carry out section 319L (related to the 

6 Biomedical Advanced Research and Development Au7 thority). Amounts authorized to be appropriated 

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

9 addition to amounts otherwise authorized to be ap10 propriated to carry out such section. 

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

12 Amounts in the special reserve fund shall not be used 

13 to pay costs other than payments made by the Sec14 retary to a vendor for advanced development (under 

15 section 319L) or for procurement of a security coun16 termeasure under subsection (c)(7). 

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

18 date on which the Secretary determines that the 

19 amount of funds in the special reserve fund available 

20 for procurement is less than $1,500,000,000, the Sec21 retary shall submit to the appropriate committees of 

22 Congress a report detailing the amount of such funds 

23 available for procurement and the impact such reduc24 tion in funding will have— 


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1 ‘‘(A) in meeting the security countermeasure 

2 needs identified under this section; and 

3 ‘‘(B) on the annual Public Health Emer4 gency Medical Countermeasures Enterprise and 

5 Strategy Implementation Plan (pursuant to sec6 tion 2811(d)). 

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

8 ‘‘(1) The term ‘advanced research and develop9 ment’ has the meaning given such term in section 

10 319L(a). 

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

12 ‘Biodefense Countermeasures’ appropriations account, 

13 any appropriation made available pursuant to sec14 tion 521(a) of the Homeland Security Act of 2002, 

15 and any appropriation made available pursuant to 

16 subsection (g)(1).’’. 

17 SEC. 402. BIOMEDICAL ADVANCED RESEARCH AND DEVEL18 OPMENT AUTHORITY. 

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

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

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

22 ‘‘(which may include advanced research and develop23 ment for purposes of fulfilling requirements under the 

24 Federal Food, Drug, and Cosmetic Act or section 351 

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


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

2 vaccine manufacturing technologies’’ and inserting 

3 ‘‘vaccine-manufacturing technologies, dose-sparing 

4 technologies, efficacy-increasing technologies, and 

5 platform technologies’’. 

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

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

8 is amended by adding at the end the following: 

9 ‘‘(G) GOVERNMENT PURPOSE.—In award10 ing contracts, grants, and cooperative agreements 

11 under this section, the Secretary shall provide a 

12 clear statement of defined Government purpose 

13 related to activities included in subsection 

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

15 qualified pandemic or epidemic product.’’. 

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

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

18 amended to read as follows: 

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

20 this section, there is authorized to be appropriated to 

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

22 through 2018, such amounts to remain available until 

23 expended.’’. 

24 (d) CONTINUED INAPPLICABILITY OF CERTAIN PROVI25 SIONS.—Section 319L(e)(1)(C) of the Public Health Service 


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1 Act (42 U.S.C. 247d–7e(e)(1)(C)) is amended by striking 

2 ‘‘7 years’’ and inserting ‘‘12 years’’. 

3 (e) EXTENSION OF LIMITED ANTITRUST EXEMP4 TION.— 

5 (1) IN GENERAL.—Section 405(b) of the Pan6 demic and All-Hazards Preparedness Act (42 U.S.C. 

7 247d–6a note) is amended by striking ‘‘6-year’’ and 

8 inserting ‘‘12-year’’. 

9 (2) EFFECTIVE DATE.—This subsection shall take 

10 effect as if enacted on December 17, 2012. 

11 (f) INDEPENDENT EVALUATION.—Section 319L of the 

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

13 by adding at the end the following: 

14 ‘‘(f) INDEPENDENT EVALUATION.— 

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

16 after the date of enactment of this subsection, the 

17 Comptroller General of the United States shall con18 duct an independent evaluation of the activities car19 ried out to facilitate flexible manufacturing capacity 

20 pursuant to this section. 

21 ‘‘(2) REPORT.—Not later than 1 year after the 

22 date of enactment of this subsection, the Comptroller 

23 General of the United States shall submit to the ap24 propriate committees of Congress a report concerning 


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1 the results of the evaluation conducted under para2 graph (1). Such report shall review and assess— 

3 ‘‘(A) the extent to which flexible manufac4 turing capacity under this section is dedicated to 

5 chemical, biological, radiological, and nuclear 

6 threats; 

7 ‘‘(B) the activities supported by flexible 

8 manufacturing initiatives; and 

9 ‘‘(C) the ability of flexible manufacturing 

10 activities carried out under this section to— 

11 ‘‘(i) secure and leverage leading tech12 nical expertise with respect to counter13 measure advanced research, development, 

14 and manufacturing processes; and 

15 ‘‘(ii) meet the surge manufacturing ca16 pacity needs presented by novel and emerg17 ing threats, including chemical, biological, 

18 radiological, and nuclear agents.’’. 

19 (g) DEFINITIONS.— 

20 (1) QUALIFIED COUNTERMEASURE.—Section 

21 319F–1(a)(2)(A) of the Public Health Service Act (42 

22 U.S.C. 247d–6a(a)(2)(A)) is amended— 

23 (A) in the matter preceding clause (i), by 

24 striking ‘‘to—’’ and inserting ‘‘—’’; 

25 (B) in clause (i)— 


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1 (i) by striking ‘‘diagnose’’ and insert2 ing ‘‘to diagnose’’; and 

3 (ii) by striking ‘‘; or’’ and inserting a 

4 semicolon; 

5 (C) in clause (ii)— 

6 (i) by striking ‘‘diagnose’’ and insert7 ing ‘‘to diagnose’’; and 

8 (ii) by striking the period at the end 

9 and inserting ‘‘; or’’; and 

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

11 ‘‘(iii) is a product or technology in12 tended to enhance the use or effect of a drug, 

13 biological product, or device described in 

14 clause (i) or (ii).’’. 

15 (2) QUALIFIED PANDEMIC OR EPIDEMIC PROD16 UCT.—Section 319F–3(i)(7)(A) of the Public Health 

17 Service Act (42 U.S.C. 247d–6d(i)(7)(A)) is amend18 ed— 

19 (A) in clause (i)(II), by striking ‘‘; or’’ and 

20 inserting ‘‘;’’; 

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

22 inserting ‘‘; or’’; and 

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

24 ‘‘(iii) a product or technology intended 

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1 logical product, or device described in clause 

2 (i) or (ii); and’’. 

3 (3) TECHNICAL AMENDMENTS.—Section 319F– 

4 3(i) of the Public Health Service Act (42 U.S.C. 

5 247d–6d(i)) is amended— 

6 (A) in paragraph (1)(C), by inserting ‘‘, 

7 564A, or 564B’’ after ‘‘564’’; and 

8 (B) in paragraph (7)(B)(iii), by inserting 

9 ‘‘, 564A, or 564B’’ after ‘‘564’’. 

10 SEC. 403. STRATEGIC NATIONAL STOCKPILE. 

11 Section 319F–2 of the Public Health Service Act (42 

12 U.S.C. 247d–6b) is amended— 

13 (1) in subsection (a)— 

14 (A) in paragraph (1)— 

15 (i) by inserting ‘‘consistent with sec16 tion 2811’’ before ‘‘by the Secretary to be 

17 appropriate’’; and 

18 (ii) by inserting before the period at 

19 the end of the second sentence the following: 

20 ‘‘and shall submit such review annually to 

21 the appropriate congressional committees of 

22 jurisdiction to the extent that disclosure of 

23 such information does not compromise na24 tional security’’; and 


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1 (B) in paragraph (2)(D), by inserting be2 fore the semicolon at the end the following: ‘‘and 

3 that the potential depletion of countermeasures 

4 currently in the stockpile is identified and ap5 propriately addressed, including through nec6 essary replenishment’’; and 

7 (2) in subsection (f)(1), by striking 

8 ‘‘$640,000,000 for fiscal year 2002, and such sums as 

9 may be necessary for each of fiscal years 2003 through 

10 2006. Such authorization is in addition to amounts 

11 in the special reserve fund referred to in subsection 

12 (c)(10)(A).’’ and inserting ‘‘$533,800,000 for each of 

13 fiscal years 2014 through 2018. Such authorization is 

14 in addition to amounts in the special reserve fund re15 ferred to in subsection (h).’’. 

16 SEC. 404. NATIONAL BIODEFENSE SCIENCE BOARD. 

17 Section 319M(a) of the Public Health Service Act (42 

18 U.S.C. 247d–f(a)) is amended— 

19 (1) in paragraph (2)— 

20 (A) in subparagraph (D)— 

21 (i) in clause (i), by striking ‘‘and’’ at 

22 the end; 

23 (ii) in clause (ii), by striking the pe24 riod and inserting a semicolon; and 


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

3 ‘‘(iii) one such member shall be an in4 dividual with pediatric subject matter ex5 pertise; and 

6 ‘‘(iv) one such member shall be a State, 

7 tribal, territorial, or local public health offi8 cial.’’; and 

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

10 sentence: 

11 ‘‘Nothing in this paragraph shall preclude a member 

12 of the Board from satisfying two or more of the re13 quirements described in subparagraph (D).’’; and 

14 (2) in paragraph (5)— 

15 (A) in subparagraph (B), by striking ‘‘and’’ 

16 at the end; 

17 (B) in subparagraph (C), by striking the 

18 period and inserting ‘‘; and’’; and 

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

20 ‘‘(D) provide any recommendation, finding, 

21 or report provided to the Secretary under this 

22 paragraph to the appropriate committees of Con23 gress.’’. 


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srobinson on DSK4SPTVN1PROD with BILLS
Calendar No. 14 

113TH CONGRESS 

1ST SESSION H. R. 307 

AN ACT 

To reauthorize certain programs under the Public 

sponse, and for other purposes. security and all-hazards preparedness and reand Cosmetic Act with respect to public health Health Service Act and the Federal Food, Drug, 

FEBRUARY 14, 2013 

Reported with an amendment 


srobinson on DSK4SPTVN1PROD with BILLS