II 

113TH CONGRESS 

1ST SESSION S. 242 

To reauthorize certain programs under the Public Health Service Act and 

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

security and all-hazards preparedness and response, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 7, 2013 

Mr. BURR (for himself, Mr. HARKIN, Mr. ENZI, Mr. CASEY, Mr. ALEXANDER, 

Ms. MIKULSKI, Mr. ISAKSON, Mr. ROBERTS, and Mr. CHAMBLISS) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To reauthorize certain programs under the Public Health 

Service Act and the Federal Food, Drug, and Cosmetic 

Act with respect to public health security and all-hazards 

preparedness and response, and for other purposes. 

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

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

5 ‘‘Pandemic and All-Hazards Preparedness 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 reassignment of State and local personnel during a public 

health emergency. 

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

Sec. 203. Hospital preparedness and medical surge capacity. 

Sec. 204. Enhancing situational awareness and biosurveillance. 

Sec. 205. Eliminating duplicative Project Bioshield reports. 

TITLE III—ENHANCING MEDICAL COUNTERMEASURE REVIEW 

Sec. 301. Special protocol assessment. 

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

Sec. 303. Definitions. 

Sec. 304. Enhancing medical countermeasure activities. 

Sec. 305. Regulatory management plans. 

Sec. 306. Report. 

Sec. 307. Pediatric medical countermeasures. 

TITLE IV—ACCELERATING MEDICAL COUNTERMEASURE 

ADVANCED RESEARCH AND DEVELOPMENT 

Sec. 401. BioShield. 

Sec. 402. Biomedical Advanced Research and Development Authority. 

Sec. 403. Strategic National Stockpile. 

Sec. 404. National Biodefense Science Board. 


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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 00:19 Feb 08, 2013 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S242.IS S242

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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 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 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 September 30, 2018.’’. 

17 SEC. 104. MODERNIZATION OF THE NATIONAL DISASTER 

18 MEDICAL SYSTEM. 

19 Section 2812 of the Public Health Service Act (42 

20 U.S.C. 300hh–11) is amended— 

21 (1) in subsection (a)(3)— 

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

23 inserting ‘‘, including at-risk individuals as ap24 plicable’’ after ‘‘victims of a public health emer25 gency’’; 


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1 (B) by redesignating subparagraph (C) as 

2 subparagraph (E); and 

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

4 the following: 

5 ‘‘(C) CONSIDERATIONS FOR AT-RISK POPU6 LATIONS.—The Secretary shall take steps to 

7 ensure that an appropriate specialized and fo8 cused range of public health and medical capa9 bilities are represented in the National Disaster 

10 Medical System, which take into account the 

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

12 public health emergency.’’. 

13 ‘‘(D) ADMINISTRATION.—The Secretary 

14 may determine and pay claims for reimburse15 ment for services under subparagraph (A) di16 rectly or through contracts that provide for 

17 payment in advance or by way of reimburse18 ment.’’; and 

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

20 may be necessary for each of the fiscal years 2007 

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

22 of fiscal years 2014 through 2018’’. 


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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 2014 through 2018 to carry out this section’’. 

8 TITLE II—OPTIMIZING STATE 

9 AND LOCAL ALL-HAZARDS 

10 PREPAREDNESS AND RE11 SPONSE 

12 SEC. 201. TEMPORARY REASSIGNMENT OF STATE AND 

13 LOCAL 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 REASSIGNMENT OF STATE AND

19 LOCAL PERSONNEL DURING A PUBLIC HEALTH EMER20 GENCY.— 

21 ‘‘(1) EMERGENCY REASSIGNMENT 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 a tribal 

25 organization or such Governor or tribal organiza26 tion’s designee, the Secretary may authorize the reVerDate Mar 15 2010 00:19 Feb 08, 2013 Jkt 029200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6201 E:\BILLS\S242.IS S242

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1 questing State or Indian tribe to temporarily reas2 sign, for purposes of immediately addressing a pub3 lic health emergency in the State or Indian tribe, 

4 State and local public health department or agency 

5 personnel funded in whole or in part through pro6 grams authorized under this Act, as appropriate. 

7 ‘‘(2) ACTIVATION OF EMERGENCY REASSIGN8 MENT.— 

9 ‘‘(A) PUBLIC HEALTH EMERGENCY.—The 

10 Secretary may authorize a temporary reassign11 ment of personnel under paragraph (1) only 

12 during the period of a public health emergency 

13 determined pursuant to subsection (a). 

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

15 authority for a temporary reassignment of per16 sonnel under paragraph (1), the Governor of a 

17 State or a tribal organization shall submit to 

18 the Secretary a request for such reassignment 

19 flexibility and shall include in the request each 

20 of the following: 

21 ‘‘(i) An assurance that the public 

22 health emergency in the geographic area of 

23 the requesting State or Indian tribe cannot 

24 be adequately and appropriately addressed 


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1 by the public health workforce otherwise 

2 available. 

3 ‘‘(ii) An assurance that the public 

4 health emergency would be addressed more 

5 efficiently and effectively through the re6 quested temporary reassignment of State 

7 and local personnel described in paragraph 

8 (1). 

9 ‘‘(iii) An assurance that the requested 

10 temporary reassignment of personnel is 

11 consistent with any applicable All-Hazards 

12 Public Health Emergency Preparedness 

13 and Response Plan under section 319C–1. 

14 ‘‘(iv) An identification of— 

15 ‘‘(I) each Federal program from 

16 which personnel would be temporarily 

17 reassigned pursuant to the requested 

18 authority; and 

19 ‘‘(II) the number of personnel 

20 who would be so reassigned from each 

21 such program. 

22 ‘‘(v) Such other information and as23 surances upon which the Secretary and 

24 Governor of a State or tribal organization 

25 agree. 


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1 ‘‘(C) CONSIDERATION.—In reviewing a re2 quest for temporary reassignment under para3 graph (1), the Secretary shall consider the de4 gree to which the program or programs funded 

5 in whole or in part by programs authorized 

6 under this Act would be adversely affected by 

7 the reassignment. 

8 ‘‘(D) TERMINATION AND EXTENSION.— 

9 ‘‘(i) TERMINATION.—A State or In10 dian tribe’s temporary reassignment of 

11 personnel under paragraph (1) shall termi12 nate upon the earlier of the following: 

13 ‘‘(I) The Secretary’s determina14 tion that the public health emergency 

15 no longer exists. 

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

17 expiration of the 30-day period fol18 lowing the date on which the Sec19 retary approved the State or Indian 

20 tribe’s request for such reassignment 

21 flexibility. 

22 ‘‘(ii) EXTENSION OF REASSIGNMENT

23 FLEXIBILITY.—The Secretary may extend 

24 a temporary reassignment of personnel 

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1 erwise applicable under clause (i)(II) if the 

2 public health emergency still exists as of 

3 such date, but only if— 

4 ‘‘(I) the State or Indian tribe 

5 that submitted the initial request for 

6 a temporary reassignment of per7 sonnel submits a request for an exten8 sion of such temporary reassignment; 

9 and 

10 ‘‘(II) the request for an extension 

11 contains the same information and as12 surances necessary for the approval of 

13 an initial request for such temporary 

14 reassignment pursuant to subpara15 graph (B). 

16 ‘‘(3) VOLUNTARY NATURE OF TEMPORARY RE17 ASSIGNMENT OF STATE AND LOCAL PERSONNEL.— 

18 ‘‘(A) IN GENERAL.—Unless otherwise pro19 vided under the law of the State or Indian tribe 

20 that receives authorization for temporary reas21 signment of personnel under paragraph (1), 

22 personnel eligible for reassignment pursuant to 

23 such authorization— 

24 ‘‘(i) shall have the opportunity to vol25 unteer for temporary reassignment; and 


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

2 a temporary reassignment. 

3 ‘‘(B) PROHIBITION ON CONDITIONING

4 FEDERAL AWARDS.—The Secretary may not 

5 condition the award of a grant, contract, or co6 operative agreement under this Act on the re7 quirement that a State or Indian tribe require 

8 that personnel eligible for reassignment pursu9 ant to an authorization under paragraph (1) 

10 agree to such reassignment. 

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

12 shall give notice to the Congress in conjunction with 

13 the approval under this subsection of— 

14 ‘‘(A) any initial request for temporary re15 assignment of personnel; and 

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

17 temporary reassignment. 

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

19 ‘‘(A) not later than 6 months after the en20 actment of this subsection, issue proposed guid21 ance on the temporary reassignment of per22 sonnel under this subsection; and 

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

24 period for public comment, finalize such guid25 ance. 


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

2 years after the date of enactment of the Pandemic 

3 and All-Hazards Preparedness Reauthorization Act 

4 of 2013, the Comptroller General of the United 

5 States shall conduct an independent evaluation, and 

6 submit to the appropriate committees of the Con7 gress a report, on temporary reassignment under 

8 this subsection, including— 

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

10 circumstances, such temporary reassignment 

11 has been used by States and Indian tribes; 

12 ‘‘(B) an analysis of how such temporary 

13 reassignment has assisted States and Indian 

14 tribes in responding to public health emer15 gencies; 

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

17 reassignment has improved operational effi18 ciencies in responding to public health emer19 gencies; 

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

21 any, Federal programs from which personnel 

22 have been temporarily reassigned have been ad23 versely affected by the reassignment; and 

24 ‘‘(E) recommendations on how medical 

25 surge capacity could be improved in responding 


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1 to public health emergencies and the impact of 

2 the reassignment flexibility under this section 

3 on such surge capacity. 

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

5 ‘‘(A) the terms ‘Indian tribe’ and ‘tribal 

6 organization’ have the meanings given such 

7 terms in section 4 of the Indian Self-Deter8 mination and Education Assistance Act; and 

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

10 to the entities listed in the definition of such 

11 term in section 2, the Freely Associated States. 

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

13 on September 30, 2018.’’. 

14 SEC. 202. IMPROVING STATE AND LOCAL PUBLIC HEALTH 

15 SECURITY. 

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

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

18 amended— 

19 (1) in subsection (b)(1)(C), by striking ‘‘consor20 tium of entities described in subparagraph (A)’’ and 

21 inserting ‘‘consortium of States’’; 

22 (2) in subsection (b)(2)— 

23 (A) in subparagraph (A)— 

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

25 inserting the following: 


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

2 entity will carry out under the agreement 

3 to meet the goals identified under section 

4 2802, including with respect to chemical, 

5 biological, radiological, or nuclear threats, 

6 whether naturally occurring, unintentional, 

7 or deliberate; 

8 ‘‘(ii) a description of the activities 

9 such entity will carry out with respect to 

10 pandemic influenza, as a component of the 

11 activities carried out under clause (i), and 

12 consistent with the requirements of para13 graphs (2) and (5) of subsection (g);’’; 

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

15 the end; and 

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

18 ‘‘(vi) a description of how, as appro19 priate, the entity may partner with rel20 evant public and private stakeholders in 

21 public health emergency preparedness and 

22 response; 

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

24 as applicable and appropriate, will coordi25 nate with State emergency preparedness 


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1 and response plans in public health emer2 gency preparedness, including State edu3 cational agencies (as defined in section 

4 9101(41) of the Elementary and Sec5 ondary Education Act of 1965) and State 

6 child care lead agencies (designated under 

7 section 658D of the Child Care and Devel8 opment Block Grant Act of 1990); 

9 ‘‘(viii) in the case of entities that op10 erate on the United States-Mexico border 

11 or the United States-Canada border, a de12 scription of the activities such entity will 

13 carry out under the agreement that are 

14 specific to the border area including dis15 ease detection, identification, investigation, 

16 and preparedness and response activities 

17 related to emerging diseases and infectious 

18 disease outbreaks whether naturally occur19 ring or due to bioterrorism, consistent with 

20 the requirements of this section; and 

21 ‘‘(ix) a description of any activities 

22 that such entity will use to analyze real23 time clinical specimens for pathogens of 

24 public health or bioterrorism significance, 


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1 including any utilization of poison control 

2 centers;’’; and 

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

4 including addressing the needs of at-risk indi5 viduals,’’ after ‘‘capabilities of such entity’’; 

6 (3) in subsection (f)— 

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

8 the end; 

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

10 and inserting a period; and 

11 (C) by striking paragraph (4); 

12 (4) in subsection (g)— 

13 (A) in paragraph (1), by striking subpara14 graph (A) and inserting the following: 

15 ‘‘(A) include outcome goals representing 

16 operational achievements of the National Pre17 paredness Goals developed under section 

18 2802(b) with respect to all-hazards, including 

19 chemical, biological, radiological, or nuclear 

20 threats; and’’; and 

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

22 end the following: ‘‘The Secretary shall periodi23 cally update, as necessary and appropriate, 

24 such pandemic influenza plan criteria and shall 

25 require the integration of such criteria into the 


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1 benchmarks and standards described in para2 graph (1).’’; 

3 (5) by striking subsection (h); 

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

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

6 (7) in subsection (h), as so redesignated— 

7 (A) in paragraph (1)— 

8 (i) in subparagraph (A)— 

9 (I) by striking ‘‘$824,000,000 for 

10 fiscal year 2007, of which 

11 $35,000,000 shall be used to carry 

12 out subsection (h),’’ and inserting 

13 ‘‘$641,900,000 for fiscal year 2014’’; 

14 and 

15 (II) by striking ‘‘such sums as 

16 may be necessary for each of fiscal 

17 years 2008 through 2011’’ and insert18 ing ‘‘$641,900,000 for each of fiscal 

19 years 2015 through 2018’’; 

20 (ii) by striking subparagraph (B); 

21 (iii) by redesignating subparagraphs 

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

23 (C), respectively; and 


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1 (iv) in subparagraph (C), as so redes2 ignated, by striking ‘‘subparagraph (C)’’ 

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

4 (B) in subparagraphs (C) and (D) of para5 graph (3), by striking ‘‘(1)(A)(i)(I)’’ each place 

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

7 (C) in paragraph (4)(B), by striking ‘‘sub8 section (c)’’ and inserting ‘‘subsection (b)’’; and 

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

10 ‘‘(7) AVAILABILITY OF COOPERATIVE AGREE11 MENT FUNDS.— 

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

13 an eligible entity under a cooperative agreement 

14 under subsection (a) for a fiscal year and re15 maining unobligated at the end of such year 

16 shall remain available to such entity for the 

17 next fiscal year for the purposes for which such 

18 funds were provided. 

19 ‘‘(B) FUNDS CONTINGENT ON ACHIEVING

20 BENCHMARKS.—The continued availability of 

21 funds under subparagraph (A) with respect to 

22 an entity shall be contingent upon such entity 

23 achieving the benchmarks and submitting the 

24 pandemic influenza plan as described in sub25 section (g).’’; and 


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

2 (A) in paragraph (1)(E), by striking ‘‘sub3 section (k)’’ and inserting ‘‘subsection (j)’’; and 

4 (B) 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 2014 through 

10 2018’’. 

11 (c) TECHNICAL AND CONFORMING AMENDMENTS.— 

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

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

14 amended by striking ‘‘subsection (i)(4)’’ and insert15 ing ‘‘subsection (h)(4)’’. 

16 (2) Section 319C–2 of the Public Health Serv17 ice Act (42 U.S.C. 247d–3b) is amended— 

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

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

20 (B) in subsection (j)(3), by striking 

21 ‘‘319C–1(i)’’ and inserting ‘‘319C–1(h)’’. 

22 SEC. 203. HOSPITAL PREPAREDNESS AND MEDICAL SURGE 

23 CAPACITY. 

24 (a) ALL-HAZARDS PUBLIC HEALTH AND MEDICAL

25 RESPONSE CURRICULA AND TRAINING.—Section 


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1 319F(a)(5)(B) of the Public Health Service Act (42 

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

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

4 or dental’’. 

5 (b) ENCOURAGING HEALTH PROFESSIONAL VOLUN6 TEERS.— 

7 (1) EMERGENCY SYSTEM FOR ADVANCE REG8 ISTRATION OF VOLUNTEER HEALTH PROFES9 SIONALS.—Section 319I(k) of the Public Health 

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

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

12 sums as may be necessary for each of the fiscal 

13 years 2003 through 2011’’ and inserting 

14 ‘‘$5,000,000 for each of fiscal years 2014 through 

15 2018’’. 

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

17 Health Service Act (42 U.S.C. 300hh–15) is amend18 ed— 

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

20 end the following: ‘‘Such training exercises 

21 shall, as appropriate and applicable, incorporate 

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

23 a public health emergency.’’; and 

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

25 ‘‘$22,000,000 for fiscal year 2007, and such 


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1 sums as may be necessary for each of fiscal 

2 years 2008 through 2011’’ and inserting 

3 ‘‘$11,200,000 for each of fiscal years 2014 

4 through 2018’’. 

5 (c) PARTNERSHIPS FOR STATE AND REGIONAL PRE6 PAREDNESS TO IMPROVE SURGE CAPACITY.—Section 

7 319C–2 of the Public Health Service Act (42 U.S.C. 

8 247d–3b) is amended— 

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

10 as appropriate, capacity and preparedness to address 

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

12 before the period at the end; 

13 (2) in subsection (b)(1)(A)(ii), by striking ‘‘cen14 ters, primary’’ and inserting ‘‘centers, community 

15 health centers, primary’’; 

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

17 following: 

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

19 (a) shall be expended for activities to achieve the prepared20 ness goals described under paragraphs (1), (3), (4), (5), 

21 and (6) of section 2802(b) with respect to all-hazards, in22 cluding chemical, biological, radiological, or nuclear 

23 threats.’’; 

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

25 following: 


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1 ‘‘(g) COORDINATION.— 

2 ‘‘(1) LOCAL RESPONSE CAPABILITIES.—An eli3 gible entity shall, to the extent practicable, ensure 

4 that activities carried out under an award under 

5 subsection (a) are coordinated with activities of rel6 evant local Metropolitan Medical Response Systems, 

7 local Medical Reserve Corps, the local Cities Readi8 ness Initiative, and local emergency plans. 

9 ‘‘(2) NATIONAL COLLABORATION.—Partner10 ships consisting of one or more eligible entities 

11 under this section may, to the extent practicable, 

12 collaborate with other partnerships consisting of one 

13 or more eligible entities under this section for pur14 poses of national coordination and collaboration with 

15 respect to activities to achieve the preparedness 

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

17 and (6) of section 2802(b).’’; 

18 (5) in subsection (i)— 

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

20 inserting the following: 

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

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

23 ‘‘(2) MEETING GOALS OF NATIONAL HEALTH

24 SECURITY STRATEGY.—The Secretary shall imple25 ment objective, evidence-based metrics to ensure that 


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1 entities receiving awards under this section are 

2 meeting, to the extent practicable, the applicable 

3 goals of the National Health Security Strategy 

4 under section 2802.’’; and 

5 (6) in subsection (j)— 

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

7 follows: 

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

9 out this section, there is authorized to be appro10 priated $374,700,000 for each of fiscal years 2014 

11 through 2018.’’; and 

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

13 ‘‘(4) 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 required under sub3 section (i).’’. 

4 SEC. 204. ENHANCING SITUATIONAL AWARENESS AND BIO5 SURVEILLANCE. 

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

7 U.S.C. 247d–4) is amended— 

8 (1) in subsection (b)— 

9 (A) in paragraph (1)(B), by inserting ‘‘poi10 son control centers,’’ after ‘‘hospitals,’’; 

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

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

13 for coordination to maximize all-hazards med14 ical and public health preparedness and re15 sponse and to minimize duplication of effort’’; 

16 and 

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

18 the period at the end the following: ‘‘and up19 date such standards as necessary’’; 

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

21 (3) in subsection (d)— 

22 (A) in the subsection heading, by striking 

23 ‘‘PUBLIC HEALTH SITUATIONAL AWARENESS’’ 

24 and inserting ‘‘MODERNIZING PUBLIC HEALTH


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1 SITUATIONAL AWARENESS AND BIOSURVEIL2 LANCE’’; 

3 (B) in paragraph (1)— 

4 (i) by striking ‘‘Pandemic and All5 Hazards Preparedness Act’’ and inserting 

6 ‘‘Pandemic and All-Hazards Preparedness 

7 Reauthorization Act of 2013’’; and 

8 (ii) by inserting ‘‘, novel emerging 

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

10 (C) by striking paragraph (2) and insert11 ing the following: 

12 ‘‘(2) STRATEGY AND IMPLEMENTATION

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

14 enactment of the Pandemic and All-Hazards Pre15 paredness Reauthorization Act of 2013, the Sec16 retary shall submit to the appropriate committees of 

17 Congress a coordinated strategy and an accom18 panying implementation plan that identifies and 

19 demonstrates the measurable steps the Secretary will 

20 carry out to— 

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

22 network described in paragraph (1), utilizing 

23 the elements described in paragraph (3); 

24 ‘‘(B) modernize and enhance biosurveil25 lance activities; and 


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1 ‘‘(C) improve information sharing, coordi2 nation, and communication among disparate 

3 biosurveillance systems supported by the De4 partment of Health and Human Services.’’; 

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

6 ‘‘community health centers, health centers’’ 

7 after ‘‘poison control,’’; 

8 (E) in paragraph (5), by striking subpara9 graph (A) and inserting the following: 

10 ‘‘(A) utilize applicable interoperability 

11 standards as determined by the Secretary, and 

12 in consultation with the Office of the National 

13 Coordinator for Health Information Tech14 nology, through a joint public and private sec15 tor process;’’; and 

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

17 ‘‘(6) CONSULTATION WITH THE NATIONAL BIO18 DEFENSE SCIENCE BOARD.—In carrying out this 

19 section and consistent with section 319M, the Na20 tional Biodefense Science Board shall provide expert 

21 advice and guidance, including recommendations, re22 garding the measurable steps the Secretary should 

23 take to modernize and enhance biosurveillance activi24 ties pursuant to the efforts of the Department of 

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1 sive, real-time, all-hazards biosurveillance capabili2 ties. In complying with the preceding sentence, the 

3 National Biodefense Science Board shall— 

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

5 a national biosurveillance system for human 

6 health, with international connectivity, where 

7 appropriate, that is predicated on State, re8 gional, and community level capabilities and 

9 creates a networked system to allow for two10 way information flow between and among Fed11 eral, State, and local government public health 

12 authorities and clinical health care providers; 

13 ‘‘(B) identify any duplicative surveillance 

14 programs under the authority of the Secretary, 

15 or changes that are necessary to existing pro16 grams, in order to enhance and modernize such 

17 activities, minimize duplication, strengthen and 

18 streamline such activities under the authority of 

19 the Secretary, and achieve real-time and appro20 priate data that relate to disease activity, both 

21 human and zoonotic; and 

22 ‘‘(C) coordinate with applicable existing 

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1 resentatives from State, local, and tribal public 

2 health authorities and appropriate public and 

3 private sector health care entities and academic 

4 institutions, in order to provide guidance on 

5 public health surveillance activities.’’; 

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

7 after the date of enactment of the Pandemic and 

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

9 years after the date of enactment of the Pandemic 

10 and All-Hazards Preparedness Reauthorization Act 

11 of 2013’’; 

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

13 may be necessary in each of fiscal years 2007 

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

15 each of fiscal years 2014 through 2018’’; and 

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

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

18 term ‘biosurveillance’ means the process of gathering near 

19 real-time biological data that relates to human and 

20 zoonotic disease activity and threats to human or animal 

21 health, in order to achieve early warning and identification 

22 of such health threats, early detection and prompt ongoing 

23 tracking of health events, and overall situational aware24 ness of disease activity.’’. 


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1 SEC. 205. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD 

2 REPORTS. 

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

4 U.S.C. 247d–6c) is repealed. 

5 TITLE III—ENHANCING MEDICAL 

6 COUNTERMEASURE REVIEW 

7 SEC. 301. SPECIAL PROTOCOL ASSESSMENT. 

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

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

10 striking ‘‘size of clinical trials intended’’ and all that fol11 lows through ‘‘. The sponsor or applicant’’ and inserting 

12 the following: ‘‘size— 

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

14 primary basis of an effectiveness claim; or 

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

16 are not ethical or feasible, of animal and any associ17 ated clinical trials which, in combination, are in18 tended to form the primary basis of an effectiveness 

19 claim; or 

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

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

22 Public Health Service Act, of any necessary clinical 

23 study or studies. 

24 The sponsor or applicant’’. 


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1 SEC. 302. AUTHORIZATION FOR MEDICAL PRODUCTS FOR 

2 USE IN EMERGENCIES. 

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

4 Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) is amend5 ed— 

6 (1) in subsection (a)— 

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

8 505, 510(k), and 515 of this Act’’ and inserting 

9 ‘‘any provision of this Act’’; 

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

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

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

13 510(k), or 515 of this Act or section 351 of the 

14 Public Health Service Act’’; and 

15 (C) in paragraph (3), by striking ‘‘a provi16 sion of law referred to in such paragraph’’ and 

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

18 Health Service Act referred to in paragraph 

19 (2)(A)’’; 

20 (2) in subsection (b)— 

21 (A) in the subsection heading, by striking 

22 ‘‘EMERGENCY’’ and inserting ‘‘EMERGENCY OR

23 THREAT JUSTIFYING EMERGENCY AUTHOR24 IZED USE’’; 

25 (B) in paragraph (1)— 


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1 (i) in the matter preceding subpara2 graph (A), by striking ‘‘may declare an 

3 emergency’’ and inserting ‘‘may make a 

4 declaration that the circumstances exist’’; 

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

6 ‘‘specified’’; 

7 (iii) in subparagraph (B)— 

8 (I) by striking ‘‘specified’’; and 

9 (II) by striking ‘‘; or’’ and insert10 ing a semicolon; 

11 (iv) by amending subparagraph (C) to 

12 read as follows: 

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

14 there is a public health emergency, or a signifi15 cant potential for a public health emergency, 

16 that affects, or has a significant potential to af17 fect, national security or the health and security 

18 of United States citizens living abroad, and that 

19 involves a biological, chemical, radiological, or 

20 nuclear agent or agents, or a disease or condi21 tion that may be attributable to such agent or 

22 agents; or’’; and 

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

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

25 pursuant to section 319F–2 of the Public 


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1 Health Service Act sufficient to affect national 

2 security or the health and security of United 

3 States citizens living abroad.’’; 

4 (C) in paragraph (2)— 

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

6 clause (ii) to read as follows: 

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

8 of the product such that the circumstances 

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

10 to exist.’’; 

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

12 (iii) by redesignating subparagraph 

13 (C) as subparagraph (B); 

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

15 notice of termination, and renewal under this 

16 subsection.’’ and inserting ‘‘, and advance no17 tice of termination under this subsection.’’; and 

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

19 ‘‘(5) EXPLANATION BY SECRETARY.—If an au20 thorization under this section with respect to an un21 approved product or an unapproved use of an ap22 proved product has been in effect for more than 1 

23 year, the Secretary shall provide in writing to the 

24 sponsor of such product an explanation of the sci25 entific, regulatory, or other obstacles to approval, liVerDate Mar 15 2010 00:19 Feb 08, 2013 Jkt 029200 PO 00000 Frm 00052 Fmt 6652 Sfmt 6201 E:\BILLS\S242.IS S242

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1 censure, or clearance of such product or use, includ2 ing specific actions to be taken by the Secretary and 

3 the sponsor to overcome such obstacles.’’; 

4 (3) in subsection (c)— 

5 (A) in the matter preceding paragraph 

6 (1)— 

7 (i) by inserting ‘‘the Assistant Sec8 retary for Preparedness and Response,’’ 

9 after ‘‘consultation with’’; 

10 (ii) by striking ‘‘Health and’’ and in11 serting ‘‘Health, and’’; and 

12 (iii) by striking ‘‘circumstances of the 

13 emergency involved’’ and inserting ‘‘appli14 cable circumstances described in subsection 

15 (b)(1)’’; 

16 (B) in paragraph (1), by striking ‘‘speci17 fied’’ and inserting ‘‘referred to’’; and 

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

19 taking into consideration the material threat 

20 posed by the agent or agents identified in a dec21 laration under subsection (b)(1)(D), if applica22 ble’’ after ‘‘risks of the product’’; 

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

24 extent practicable given the circumstances of the 

25 emergency,’’ after ‘‘including’’; 


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1 (5) in subsection (e)— 

2 (A) in paragraph (1)(A), by striking ‘‘cir3 cumstances of the emergency’’ and inserting 

4 ‘‘applicable circumstances described in sub5 section (b)(1)’’; 

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

7 clause (iii) to read as follows: 

8 ‘‘(iii) Appropriate conditions with re9 spect to collection and analysis of informa10 tion concerning the safety and effectiveness 

11 of the product with respect to the use of 

12 such product during the period when the 

13 authorization is in effect and a reasonable 

14 time following such period.’’; 

15 (C) in paragraph (2)— 

16 (i) in subparagraph (A)— 

17 (I) by striking ‘‘manufacturer of 

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

19 (II) by striking ‘‘circumstances of 

20 the emergency’’ and inserting ‘‘appli21 cable circumstances described in sub22 section (b)(1)’’; and 

23 (III) by inserting at the end be24 fore the period ‘‘or in paragraph 

25 (1)(B)’’; 


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1 (ii) in subparagraph (B)(i), by insert2 ing before the period at the end ‘‘, except 

3 as provided in section 564A with respect to 

4 authorized changes to the product expira5 tion date’’; and 

6 (iii) by amending subparagraph (C) to 

7 read as follows: 

8 ‘‘(C) In establishing conditions under this 

9 paragraph with respect to the distribution and 

10 administration of the product for the unap11 proved use, the Secretary shall not impose con12 ditions that would restrict distribution or ad13 ministration of the product when distributed or 

14 administered for the approved use.’’; and 

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

16 follows: 

17 ‘‘(3) GOOD MANUFACTURING PRACTICE; PRE18 SCRIPTION.—With respect to the emergency use of a 

19 product for which an authorization under this sec20 tion is issued (whether an unapproved product or an 

21 unapproved use of an approved product), the Sec22 retary may waive or limit, to the extent appropriate 

23 given the applicable circumstances described in sub24 section (b)(1)— 


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1 ‘‘(A) requirements regarding current good 

2 manufacturing practice otherwise applicable to 

3 the manufacture, processing, packing, or hold4 ing of products subject to regulation under this 

5 Act, including such requirements established 

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

7 relevant conditions prescribed with respect to 

8 the product by an order under section 

9 520(f)(2); 

10 ‘‘(B) requirements established under sec11 tion 503(b); and 

12 ‘‘(C) requirements established under sec13 tion 520(e).’’; 

14 (6) in subsection (g)— 

15 (A) in the subsection heading, by inserting 

16 ‘‘REVIEW AND’’ before ‘‘REVOCATION’’; 

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

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

19 such review, the Secretary shall regularly review 

20 the progress made with respect to the approval, 

21 licensure, or clearance of— 

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

23 authorization was issued under this section; or 


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

2 product for which an authorization was issued 

3 under this section.’’; and 

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

5 follows: 

6 ‘‘(2) REVISION AND REVOCATION.—The Sec7 retary may revise or revoke an authorization under 

8 this section if— 

9 ‘‘(A) the circumstances described under 

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

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

12 issuance of such authorization are no longer 

13 met; or 

14 ‘‘(C) other circumstances make such revi15 sion or revocation appropriate to protect the 

16 public health or safety.’’; 

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

19 make any revisions to an authorization under this 

20 section available on the Internet Web site of the 

21 Food and Drug Administration.’’; 

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

23 following: 

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

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1 eration by the Secretary of any application or sub2 mission pending before the Food and Drug Adminis3 tration for a product for which an authorization 

4 under this section is issued.’’; and 

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

6 ‘‘(m) CATEGORIZATION OF LABORATORY TESTS AS7 SOCIATED WITH DEVICES SUBJECT TO AUTHORIZA8 TION.— 

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

10 under this section with respect to a device, the Sec11 retary may, subject to the provisions of this section, 

12 determine that a laboratory examination or proce13 dure associated with such device shall be deemed, for 

14 purposes of section 353 of the Public Health Service 

15 Act, to be in a particular category of examinations 

16 and procedures (including the category described by 

17 subsection (d)(3) of such section) if, based on the to18 tality of scientific evidence available to the Sec19 retary— 

20 ‘‘(A) such categorization would be bene21 ficial to protecting the public health; and 

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

23 such categorization under the circumstances of 

24 the authorization outweigh the known and po25 tential risks of the categorization. 


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

2 Secretary may establish appropriate conditions on 

3 the performance of the examination or procedure 

4 pursuant to such determination. 

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

6 under this subsection shall be effective for purposes 

7 of section 353 of the Public Health Service Act not8 withstanding any other provision of that section dur9 ing the effective period of the relevant declaration 

10 under subsection (b).’’. 

11 (b) EMERGENCY USE OF MEDICAL PRODUCTS.— 

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

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

14 by inserting after section 564 the following: 

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

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

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

18 product’ means a product that— 

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

20 chapter or licensed under section 351 of the 

21 Public Health Service Act; 

22 ‘‘(B)(i) is intended for use to prevent, di23 agnose, or treat a disease or condition involving 

24 a biological, chemical, radiological, or nuclear 

25 agent or agents; or 


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1 ‘‘(ii) is intended for use to prevent, diag2 nose, or treat a serious or life-threatening dis3 ease or condition caused by a product described 

4 in clause (i); and 

5 ‘‘(C) is intended for use during the cir6 cumstances under which— 

7 ‘‘(i) a determination described in sub8 paragraph (A), (B), or (C) of section 

9 564(b)(1) has been made by the Secretary 

10 of Homeland Security, the Secretary of 

11 Defense, or the Secretary, respectively; or 

12 ‘‘(ii) the identification of a material 

13 threat described in subparagraph (D) of 

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

15 to section 319F–2 of the Public Health 

16 Service Act. 

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

18 drug, device, or biological product. 

19 ‘‘(b) EXPIRATION DATING.— 

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

21 the expiration date and authorize the introduction or 

22 delivery for introduction into interstate commerce of 

23 an eligible product after the expiration date provided 

24 by the manufacturer if— 


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1 ‘‘(A) the expiration date extension is in2 tended to support the United States ability to 

3 protect— 

4 ‘‘(i) the public health; or 

5 ‘‘(ii) military preparedness and effec6 tiveness; and 

7 ‘‘(B) the expiration date extension is sup8 ported by an appropriate scientific evaluation 

9 that is conducted or accepted by the Secretary. 

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

11 extension of an expiration date under paragraph (1) 

12 shall, as part of the extension, identify— 

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

14 of the product for which extended expiration is 

15 authorized; 

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

17 ‘‘(C) any other requirements or conditions 

18 as the Secretary may deem appropriate for the 

19 protection of the public health, which may in20 clude requirements for, or conditions on, prod21 uct sampling, storage, packaging or repack22 aging, transport, labeling, notice to product re23 cipients, recordkeeping, periodic testing or re24 testing, or product disposition. 


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1 ‘‘(3) 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 prod7 uct, the Secretary has, under paragraph (1), ex8 tended the expiration date and authorized the intro9 duction or delivery for introduction into interstate 

10 commerce of such product after the expiration date 

11 provided by the manufacturer. 

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

13 subsection, the term ‘expiration date’ means the 

14 date established through appropriate stability testing 

15 required by the regulations issued by the Secretary 

16 to ensure that the product meets applicable stand17 ards of identity, strength, quality, and purity at the 

18 time of use. 

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

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

21 the circumstances of a domestic, military, or public 

22 health emergency or material threat described in 

23 subsection (a)(1)(C) so warrant, authorize, with re24 spect to an eligible product, deviations from current 

25 good manufacturing practice requirements otherwise 


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1 applicable to the manufacture, processing, packing, 

2 or holding of products subject to regulation under 

3 this Act, including requirements under section 501 

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

5 respect to the eligible product by an order under sec6 tion 520(f)(2). 

7 ‘‘(2) EFFECT.—Notwithstanding any other pro8 vision of this Act or the Public Health Service Act, 

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

11 and shall not be deemed adulterated or misbranded 

12 under this Act because, with respect to such prod13 uct, the Secretary has authorized deviations from 

14 current good manufacturing practices under para15 graph (1). 

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

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

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

20 shall not be deemed adulterated or misbranded under this 

21 Act because it is dispensed without an individual prescrip22 tion, if— 

23 ‘‘(1) the product is dispensed during the cir24 cumstances described in subsection (a)(1)(C); and 


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1 ‘‘(2) such dispensing without an individual pre2 scription occurs— 

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

4 State in which the product is dispensed; or 

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

6 the Secretary, for the purposes and duration of 

7 the circumstances described in subsection 

8 (a)(1)(C). 

9 ‘‘(e) EMERGENCY USE INSTRUCTIONS.— 

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

11 through an appropriate official within the Depart12 ment of Health and Human Services, may create 

13 and issue emergency use instructions to inform 

14 health care providers or individuals to whom an eli15 gible product is to be administered concerning such 

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

17 use. 

18 ‘‘(2) EFFECT.—Notwithstanding any other pro19 visions of this Act or the Public Health Service Act, 

20 a product shall not be considered an unapproved 

21 product and shall not be deemed adulterated or mis22 branded under this Act because of the issuance of 

23 emergency use instructions under paragraph (1) 

24 with respect to such product or the introduction or 


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1 delivery for introduction of such product into inter2 state commerce accompanied by such instructions— 

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

4 actual emergency that is the basis for a deter5 mination described in subsection (a)(1)(C)(i); or 

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

7 Federal, State, local, or tribal government enti8 ty), or a person acting on behalf of such a gov9 ernment entity, in preparation for an emer10 gency response.’’. 

11 (c) RISK EVALUATION AND MITIGATION STRATE12 GIES.—Section 505–1 of the Federal Food, Drug, and 

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

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

15 and 

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

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

18 The Secretary may waive any requirement of this section 

19 with respect to a qualified countermeasure (as defined in 

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

21 to which a requirement under this section has been ap22 plied, if the Secretary determines that such waiver is re23 quired to mitigate the effects of, or reduce the severity 

24 of, the circumstances under which— 


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1 ‘‘(1) a determination described in subparagraph 

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

3 by the Secretary of Homeland Security, the Sec4 retary of Defense, or the Secretary, respectively; or 

5 ‘‘(2) the identification of a material threat de6 scribed in subparagraph (D) of section 564(b)(1) 

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

8 Public Health Service Act.’’. 

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

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

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

12 added by subsection (b), the following: 

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

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

15 of the Public Health Service Act for a government entity 

16 (including a Federal, State, local, or tribal government en17 tity), or a person acting on behalf of such a government 

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

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

20 if that product— 

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

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

23 product— 


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

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

3 or section 351 of the Public Health Service Act; 

4 ‘‘(B) is authorized for investigational use 

5 under section 505 or 520 of this Act or section 

6 351 of the Public Health Service Act; or 

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

8 564.’’. 

9 SEC. 303. DEFINITIONS. 

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

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

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

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

14 ‘‘(1) the term ‘countermeasure’ means a quali15 fied countermeasure, a security countermeasure, and 

16 a qualified pandemic or epidemic product; 

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

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

19 the Public Health Service Act; 

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

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

22 Act; and 

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

24 product’ means a product that meets the definition 


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

2 Health Service Act and— 

3 ‘‘(A) that has been identified by the De4 partment of Health and Human Services or the 

5 Department of Defense as receiving funding di6 rectly related to addressing chemical, biological, 

7 radiological, or nuclear threats, including pan8 demic influenza; or 

9 ‘‘(B) is included under this paragraph pur10 suant to a determination by the Secretary. 

11 ‘‘(b) GENERAL DUTIES.—The Secretary, in consulta12 tion’’. 

13 SEC. 304. ENHANCING MEDICAL COUNTERMEASURE AC14 TIVITIES. 

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

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

17 is further amended— 

18 (1) in the section heading, by striking ‘‘TECH19 NICAL ASSISTANCE’’ and inserting ‘‘COUNTER20 MEASURE DEVELOPMENT, REVIEW, AND TECH21 NICAL ASSISTANCE’’; 

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

23 enumerator and all that follows through ‘‘shall es24 tablish’’ and inserting the following: 


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

2 development, stockpiling, approval, licensure, and clear3 ance of qualified countermeasures, security counter4 measures, and qualified pandemic or epidemic products, 

5 the Secretary, in consultation with the Assistant Secretary 

6 for Preparedness and Response, shall— 

7 ‘‘(1) ensure the appropriate involvement of 

8 Food and Drug Administration personnel in inter9 agency activities related to countermeasure advanced 

10 research and development, consistent with sections 

11 319F, 319F–1, 319F–2, 319F–3, 319L, and 2811 

12 of the Public Health Service Act; 

13 ‘‘(2) ensure the appropriate involvement and 

14 consultation of Food and Drug Administration per15 sonnel in any flexible manufacturing activities car16 ried out under section 319L of the Public Health 

17 Service Act, including with respect to meeting regu18 latory requirements set forth in this Act; 

19 ‘‘(3) promote countermeasure expertise within 

20 the Food and Drug Administration by— 

21 ‘‘(A) ensuring that Food and Drug Admin22 istration personnel involved in reviewing coun23 termeasures for approval, licensure, or clear24 ance are informed by the Assistant Secretary 

25 for Preparedness and Response on the material 


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1 threat assessment conducted under section 

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

3 the agent or agents for which the counter4 measure under review is intended; 

5 ‘‘(B) training Food and Drug Administra6 tion personnel regarding review of counter7 measures for approval, licensure, or clearance; 

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

9 annually to encourage the exchange of scientific 

10 ideas; and 

11 ‘‘(D) establishing protocols to ensure that 

12 countermeasure reviewers have sufficient train13 ing or experience with countermeasures; 

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

15 Drug Administration personnel with expertise on 

16 countermeasures, including specific counter17 measures, populations with special clinical needs (in18 cluding children and pregnant women that may use 

19 countermeasures, as applicable and appropriate), 

20 classes or groups of countermeasures, or other coun21 termeasure-related technologies and capabilities, that 

22 shall— 

23 ‘‘(A) consult with countermeasure experts, 

24 including countermeasure sponsors and appli25 cants, to identify and help resolve scientific 


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1 issues related to the approval, licensure, or 

2 clearance of countermeasures, through work3 shops or public meetings; and 

4 ‘‘(B) improve and advance the science re5 lating to the development of new tools, stand6 ards, and approaches to assessing and evalu7 ating countermeasures— 

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

9 countermeasure approval, clearance, and li10 censure; and 

11 ‘‘(ii) with respect to the development 

12 of countermeasures for populations with 

13 special clinical needs, including children 

14 and pregnant women, in order to meet the 

15 needs of such populations, as necessary 

16 and appropriate; and 

17 ‘‘(5) establish’’; and 

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

19 ‘‘(c) FINAL GUIDANCE ON DEVELOPMENT OF ANI20 MAL MODELS.— 

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

22 the date of the enactment of the Pandemic and All23 Hazards Preparedness Reauthorization Act of 2013, 

24 the Secretary shall provide final guidance to indus25 try regarding the development of animal models to 


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1 support approval, clearance, or licensure of counter2 measures referred to in subsection (a) when human 

3 efficacy studies are not ethical or feasible. 

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

5 Secretary may extend the deadline for providing 

6 final guidance under paragraph (1) by not more 

7 than 6 months upon submission by the Secretary of 

8 a report on the status of such guidance to the Com9 mittee on Energy and Commerce of the House of 

10 Representatives and the Committee on Health, Edu11 cation, Labor, and Pensions of the Senate. 

12 ‘‘(d) DEVELOPMENT AND ANIMAL MODELING PRO13 CEDURES.— 

14 ‘‘(1) AVAILABILITY OF ANIMAL MODEL MEET15 INGS.—To facilitate the timely development of ani16 mal models and support the development, stock17 piling, licensure, approval, and clearance of counter18 measures, the Secretary shall, not later than 180 

19 days after the enactment of this subsection, establish 

20 a procedure by which a sponsor or applicant that is 

21 developing a countermeasure for which human effi22 cacy studies are not ethical or practicable, and that 

23 has an approved investigational new drug application 

24 or investigational device exemption, may request and 

25 receive— 


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

2 model development activities; and 

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

4 animal studies. 

5 ‘‘(2) PEDIATRIC MODELS.—To facilitate the de6 velopment and selection of animal models that could 

7 translate to pediatric studies, any meeting conducted 

8 under paragraph (1) shall include discussion of ani9 mal models for pediatric populations, as appropriate. 

10 ‘‘(e) REVIEW AND APPROVAL OF COUNTER11 MEASURES.— 

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

13 application or submission for approval, licensure, or 

14 clearance of a countermeasure, the Secretary shall 

15 take into account the material threat posed by the 

16 chemical, biological, radiological, or nuclear agent or 

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

18 Health Service Act for which the countermeasure 

19 under review is intended. 

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

21 and appropriate, teams of Food and Drug Adminis22 tration personnel reviewing applications or submis23 sions described under paragraph (1) shall include a 

24 reviewer with sufficient training or experience with 


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1 countermeasures pursuant to the protocols estab2 lished under subsection (b)(3)(D).’’. 

3 SEC. 305. REGULATORY MANAGEMENT PLANS. 

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

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

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

7 ‘‘(f) REGULATORY MANAGEMENT PLAN.— 

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

9 ‘eligible countermeasure’ means— 

10 ‘‘(A) a security countermeasure with re11 spect to which the Secretary has entered into a 

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

13 of the Public Health Service Act; or 

14 ‘‘(B) a countermeasure with respect to 

15 which the Biomedical Advanced Research and 

16 Development Authority has provided funding 

17 under section 319L of the Public Health Serv18 ice Act for advanced research and development. 

19 ‘‘(2) REGULATORY MANAGEMENT PLAN PROC20 ESS.—The Secretary, in consultation with the As21 sistant Secretary for Preparedness and Response 

22 and the Director of the Biomedical Advanced Re23 search and Development Authority, shall establish a 

24 formal process for obtaining scientific feedback and 

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1 latory review of eligible countermeasures by facili2 tating the development of written regulatory man3 agement plans in accordance with this subsection. 

4 ‘‘(3) SUBMISSION OF REQUEST AND PROPOSED

5 PLAN BY SPONSOR OR APPLICANT.— 

6 ‘‘(A) IN GENERAL.—A sponsor or appli7 cant of an eligible countermeasure may initiate 

8 the process described under paragraph (2) upon 

9 submission of a written request to the Sec10 retary. Such request shall include a proposed 

11 regulatory management plan. 

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

13 or applicant may submit a written request 

14 under subparagraph (A) after the eligible coun15 termeasure has an investigational new drug or 

16 investigational device exemption in effect. 

17 ‘‘(C) RESPONSE BY SECRETARY.—The 

18 Secretary shall direct the Food and Drug Ad19 ministration, upon submission of a written re20 quest by a sponsor or applicant under subpara21 graph (A), to work with the sponsor or appli22 cant to agree on a regulatory management plan 

23 within a reasonable time not to exceed 90 days. 

24 If the Secretary determines that no plan can be 

25 agreed upon, the Secretary shall provide to the 


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1 sponsor or applicant, in writing, the scientific 

2 or regulatory rationale why such agreement 

3 cannot be reached. 

4 ‘‘(4) PLAN.—The content of a regulatory man5 agement plan agreed to by the Secretary and a spon6 sor or applicant shall include— 

7 ‘‘(A) an agreement between the Secretary 

8 and the sponsor or applicant regarding develop9 mental milestones that will trigger responses by 

10 the Secretary as described in subparagraph (B); 

11 ‘‘(B) performance targets and goals for 

12 timely and appropriate responses by the Sec13 retary to the triggers described under subpara14 graph (A), including meetings between the Sec15 retary and the sponsor or applicant, written 

16 feedback, decisions by the Secretary, and other 

17 activities carried out as part of the development 

18 and review process; and 

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

20 be modified, if needed. 

21 ‘‘(5) MILESTONES AND PERFORMANCE TAR22 GETS.—The developmental milestones described in 

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

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


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1 ‘‘(A) feedback from the Secretary regard2 ing the data required to support the approval, 

3 clearance, or licensure of the eligible counter4 measure involved; 

5 ‘‘(B) feedback from the Secretary regard6 ing the data necessary to inform any authoriza7 tion under section 564; 

8 ‘‘(C) feedback from the Secretary regard9 ing the data necessary to support the posi10 tioning and delivery of the eligible counter11 measure, including to the Strategic National 

12 Stockpile; 

13 ‘‘(D) feedback from the Secretary regard14 ing the data necessary to support the submis15 sion of protocols for review under section 

16 505(b)(5)(B); 

17 ‘‘(E) feedback from the Secretary regard18 ing any gaps in scientific knowledge that will 

19 need resolution prior to approval, licensure, or 

20 clearance of the eligible countermeasure and 

21 plans for conducting the necessary scientific re22 search; 

23 ‘‘(F) identification of the population for 

24 which the countermeasure sponsor or applicant 

25 seeks approval, licensure, or clearance and the 


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1 population for which desired labeling would not 

2 be appropriate, if known; and 

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

4 the extent practicable, a plan for demonstrating 

5 safety and effectiveness in pediatric popu6 lations, and for developing pediatric dosing, for7 mulation, and administration with respect to 

8 the eligible countermeasure, provided that such 

9 plan would not delay authorization under sec10 tion 564, approval, licensure, or clearance for 

11 adults. 

12 ‘‘(6) PRIORITIZATION.— 

13 ‘‘(A) PLANS FOR SECURITY COUNTER14 MEASURES.—The Secretary shall establish reg15 ulatory management plans for all security coun16 termeasures for which a request is submitted 

17 under paragraph (3)(A). 

18 ‘‘(B) PLANS FOR OTHER ELIGIBLE COUN19 TERMEASURES.—The Secretary shall determine 

20 whether resources are available to establish reg21 ulatory management plans for eligible counter22 measures that are not security counter23 measures. If resources are available to establish 

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1 measures, and if resources are not available to 

2 establish regulatory management plans for all 

3 eligible countermeasures for which requests 

4 have been submitted, the Director of the Bio5 medical Advanced Research and Development 

6 Authority, in consultation with the Commis7 sioner, shall prioritize which eligible counter8 measures may receive regulatory management 

9 plans.’’. 

10 SEC. 306. REPORT. 

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

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

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

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

15 after the date of enactment of this subsection, and annu16 ally thereafter, the Secretary shall make publicly available 

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

18 report that details the countermeasure development and 

19 review activities of the Food and Drug Administration, in20 cluding— 

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

22 tools, standards, and approaches to assess and 

23 evaluate countermeasures— 


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

2 the Food and Drug Administration and the 

3 progress made on such priorities; and 

4 ‘‘(B) the identification of scientific gaps 

5 that impede the development, approval, licen6 sure, or clearance of countermeasures for popu7 lations with special clinical needs, including 

8 children and pregnant women, and the progress 

9 made on resolving these challenges; 

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

11 a regulatory management plan has been agreed upon 

12 under subsection (f), the extent to which the per13 formance targets and goals set forth in subsection 

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

15 been met, including, for each such countermeasure— 

16 ‘‘(A) whether the regulatory management 

17 plan was completed within the required time18 frame, and the length of time taken to complete 

19 such plan; 

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

21 timely and appropriate response times set forth 

22 in such plan; and 

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

24 such performance targets and goals; 


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1 ‘‘(3) the number of regulatory teams estab2 lished pursuant to subsection (b)(4), the number of 

3 products, classes of products, or technologies as4 signed to each such team, and the number of, type 

5 of, and any progress made as a result of consulta6 tions carried out under subsection (b)(4)(A); 

7 ‘‘(4) an estimate of resources obligated to coun8 termeasure development and regulatory assessment, 

9 including— 

10 ‘‘(A) Center-specific objectives and accom11 plishments; and 

12 ‘‘(B) the number of full-time equivalent 

13 employees of the Food and Drug Administra14 tion who directly support the review of counter15 measures; 

16 ‘‘(5) the number of countermeasure applications 

17 and submissions submitted, the number of counter18 measures approved, licensed, or cleared, the status 

19 of remaining submitted applications and submis20 sions, and the number of each type of authorization 

21 issued pursuant to section 564; 

22 ‘‘(6) the number of written requests for a regu23 latory management plan submitted under subsection 

24 (f)(3)(A), the number of regulatory management 


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1 plans developed, and the number of such plans de2 veloped for security countermeasures; and 

3 ‘‘(7) the number, type, and frequency of meet4 ings between the Food and Drug Administration 

5 and— 

6 ‘‘(A) sponsors of a countermeasure as de7 fined in subsection (a); or 

8 ‘‘(B) another agency engaged in develop9 ment or management of portfolios for such 

10 countermeasures, including the Centers for Dis11 ease Control and Prevention, the Biomedical 

12 Advanced Research and Development Authority, 

13 the National Institutes of Health, and the ap14 propriate agencies of the Department of De15 fense.’’. 

16 SEC. 307. PEDIATRIC MEDICAL COUNTERMEASURES. 

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

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

19 355a) is amended— 

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

21 following: 

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

23 that is a qualified countermeasure (as defined in sec24 tion 319F–1 of the Public Health Service Act), a se25 curity countermeasure (as defined in section 319F– 


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1 2 of the Public Health Service Act), or a qualified 

2 pandemic or epidemic product (as defined in section 

3 319F–3 of the Public Health Service Act), the Sec4 retary shall solicit input from the Assistant Sec5 retary for Preparedness and Response regarding the 

6 need for and, from the Director of the Biomedical 

7 Advanced Research and Development Authority re8 garding the conduct of, pediatric studies under this 

9 section.’’; and 

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

11 the following: 

12 ‘‘(C) For a drug that is a qualified coun13 termeasure (as defined in section 319F–1 of the 

14 Public Health Service Act), a security counter15 measure (as defined in section 319F–2 of the 

16 Public Health Service Act), or a qualified pan17 demic or epidemic product (as defined in sec18 tion 319F–3 of such Act), in addition to any 

19 action with respect to such drug under subpara20 graph (A) or (B), the Secretary shall notify the 

21 Assistant Secretary for Preparedness and Re22 sponse and the Director of the Biomedical Ad23 vanced Research and Development Authority of 

24 all pediatric studies in the written request 


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1 issued by the Commissioner of Food and 

2 Drugs.’’. 

3 (b) ADDITION TO PRIORITY LIST CONSIDER4 ATIONS.—Section 409I of the Public Health Service Act 

5 (42 U.S.C. 284m) is amended— 

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

7 the following: 

8 ‘‘(2) CONSIDERATION OF AVAILABLE INFORMA9 TION.—In developing and prioritizing the list under 

10 paragraph (1), the Secretary— 

11 ‘‘(A) shall consider— 

12 ‘‘(i) therapeutic gaps in pediatrics 

13 that may include developmental pharma14 cology, pharmacogenetic determinants of 

15 drug response, metabolism of drugs and 

16 biologics in children, and pediatric clinical 

17 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 

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

7 epidemic products (as defined in section 319F– 

8 3) to address the needs of pediatric populations, 

9 in 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 

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

14 subsection (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 Chil19 dren 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 


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1 Food, Drug, and Cosmetic Act) for pediatric 

2 populations.’’. 

3 TITLE IV—ACCELERATING MED4 ICAL COUNTERMEASURE AD5 VANCED RESEARCH AND DE6 VELOPMENT 

7 SEC. 401. BIOSHIELD. 

8 (a) PROCUREMENT OF COUNTERMEASURES.—Sec9 tion 319F–2(c) of the Public Health Service Act (42 

10 U.S.C. 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 

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

16 committees 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’’; 

11 and 

12 (ii) by striking subclause (IX) and in13 serting the following: 

14 ‘‘(IX) CONTRACT TERMS.—The 

15 Secretary, in any contract for procure16 ment under this section— 

17 ‘‘(aa) may specify— 

18 ‘‘(AA) the dosing and 

19 administration requirements 

20 for the countermeasure to be 

21 developed and procured; 

22 ‘‘(BB) the amount of 

23 funding that will be dedi24 cated by the Secretary for 

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1 ment, and procurement of 

2 the 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, 

17 for the procurement of security countermeasures 

18 under subsection (c) and for carrying out section 

19 319L (relating to the Biomedical Advanced Research 

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

21 period of fiscal years 2014 through 2018. Amounts 

22 appropriated pursuant to the preceding sentence are 

23 authorized 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 

7 Authority). Amounts authorized to be appropriated 

8 under this subsection to carry out section 319L are 

9 in addition to amounts otherwise authorized to be 

10 appropriated to carry out such section. 

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

12 Amounts in the special reserve fund shall not be 

13 used to pay costs other than payments made by the 

14 Secretary to a vendor for advanced development 

15 (under section 319L) or for procurement of a secu16 rity countermeasure under subsection (c)(7). 

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

18 any 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 

21 Secretary shall submit to the appropriate committees 

22 of Congress a report detailing the amount of such 

23 funds available for procurement and the impact such 

24 reduction in funding will have— 


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1 ‘‘(A) in meeting the security counter2 measure 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 ac13 count, any appropriation made available pursuant to 

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

15 2002, and any appropriation made available pursu16 ant to subsection (g)(1).’’. 

17 SEC. 402. BIOMEDICAL ADVANCED RESEARCH AND DEVEL18 OPMENT AUTHORITY. 

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

20 Health Service Act (42 U.S.C. 247d–7e(c)(4)) is amend21 ed— 

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

23 ‘‘(which may include advanced research and develop24 ment for purposes of fulfilling requirements under 


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1 the Federal Food, Drug, and Cosmetic Act or sec2 tion 351 of this Act)’’ after ‘‘development’’; and 

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

4 vaccine manufacturing technologies’’ and inserting 

5 ‘‘vaccine-manufacturing technologies, dose-sparing 

6 technologies, efficacy-increasing technologies, and 

7 platform technologies’’. 

8 (b) TRANSACTION AUTHORITIES.—Section 

9 319L(c)(5) of the Public Health Service Act (42 U.S.C. 

10 247d–7e(c)(5)) is amended by adding at the end the fol11 lowing: 

12 ‘‘(G) GOVERNMENT PURPOSE.—In award13 ing contracts, grants, and cooperative agree14 ments under this section, the Secretary shall 

15 provide a clear statement of defined Govern16 ment purpose related to activities included in 

17 subsection (a)(6)(B) for a qualified counter18 measure or qualified pandemic or epidemic 

19 product.’’. 

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

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

22 amended to read as follows: 

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

24 this section, there is authorized to be appropriated 

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


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1 2014 through 2018, such amounts to remain avail2 able until expended.’’. 

3 (d) CONTINUED INAPPLICABILITY OF CERTAIN PRO4 VISIONS.—Section 319L(e)(1)(C) of the Public Health 

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

6 striking ‘‘7 years’’ and inserting ‘‘12 years’’. 

7 (e) EXTENSION OF LIMITED ANTITRUST EXEMP8 TION.— 

9 (1) IN GENERAL.—Section 405(b) of the Pan10 demic and All-Hazards Preparedness Act (42 U.S.C. 

11 247d–6a note) is amended by striking ‘‘6-year’’ and 

12 inserting ‘‘12-year’’. 

13 (2) EFFECTIVE DATE.—This subsection shall 

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

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

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

17 amended by adding at the end the following: 

18 ‘‘(f) INDEPENDENT EVALUATION.— 

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

20 after the date of enactment of this subsection, the 

21 Comptroller General of the United States shall con22 duct an independent evaluation of the activities car23 ried out to facilitate flexible manufacturing capacity 

24 pursuant to this section. 


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

2 date of enactment of this subsection, the Comp3 troller General of the United States shall submit to 

4 the appropriate committees of Congress a report 

5 concerning the results of the evaluation conducted 

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

7 assess— 

8 ‘‘(A) the extent to which flexible manufac9 turing capacity under this section is dedicated 

10 to chemical, biological, radiological, and nuclear 

11 threats; 

12 ‘‘(B) the activities supported by flexible 

13 manufacturing initiatives; and 

14 ‘‘(C) the ability of flexible manufacturing 

15 activities carried out under this section to— 

16 ‘‘(i) secure and leverage leading tech17 nical expertise with respect to counter18 measure advanced research, development, 

19 and manufacturing processes; and 

20 ‘‘(ii) meet the surge manufacturing 

21 capacity needs presented by novel and 

22 emerging threats, including chemical, bio23 logical, radiological, and nuclear agents.’’. 

24 (g) DEFINITIONS.— 


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1 (1) QUALIFIED COUNTERMEASURE.—Section 

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

3 (42 U.S.C. 247d–6a(a)(2)(A)) is amended— 

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

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

6 (B) in clause (i)— 

7 (i) by striking ‘‘diagnose’’ and insert8 ing ‘‘to diagnose’’; and 

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

10 semicolon; 

11 (C) in clause (ii)— 

12 (i) by striking ‘‘diagnose’’ and insert13 ing ‘‘to diagnose’’; and 

14 (ii) by striking the period at the end 

15 and inserting ‘‘; or’’; and 

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

17 ‘‘(iii) is a product or technology in18 tended to enhance the use or effect of a 

19 drug, biological product, or device de20 scribed in clause (i) or (ii).’’. 

21 (2) QUALIFIED PANDEMIC OR EPIDEMIC PROD22 UCT.—Section 319F–3(i)(7)(A) of the Public Health 

23 Service Act (42 U.S.C. 247d–6d(i)(7)(A)) is amend24 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 2014 through 2018. 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.’’. 

Æ 


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