H. R. 307 

One Hundred Thirteenth Congress 

of the 

United States of America 

AT THE FIRST SESSION 

Begun and held at the City of Washington on Thursday, 

the third day of January, two thousand and thirteen 

An Act 

To reauthorize certain programs under the Public Health Service Act and the 

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

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

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

and All-Hazards Preparedness Reauthorization Act of 2013’’. 

(b) TABLE OF CONTENTS.—The table of contents of 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. 
H. R. 307—2 

TITLE I—STRENGTHENING NATIONAL 

PREPAREDNESS AND RESPONSE FOR 

PUBLIC HEALTH EMERGENCIES 

SEC. 101. NATIONAL HEALTH SECURITY STRATEGY. 

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

Act (42 U.S.C. 300hh–1) is amended— 

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

‘‘2014’’; and 

(2) in subsection (b)— 

(A) in paragraph (1)(A), by inserting ‘‘, including drills 

and exercises to ensure medical surge capacity for events 

without notice’’ after ‘‘exercises’’; and 

(B) in paragraph (3)— 

(i) in the matter preceding subparagraph (A)— 

(I) by striking ‘‘facilities), and trauma care’’ 

and inserting ‘‘and ambulatory care facilities and 

which may include dental health facilities), and 

trauma care, critical care,’’; and 

(II) by inserting ‘‘(including related availability, accessibility, and coordination)’’ after 

‘‘public health emergencies’’; 

(ii) in subparagraph (A), by inserting ‘‘and trauma’’ 

after ‘‘medical’’; 

(iii) in subparagraph (B), by striking ‘‘Medical 

evacuation and fatality management’’ and inserting 

‘‘Fatality management’’; 

(iv) by redesignating subparagraphs (C), (D), and 

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

(v) by inserting after subparagraph (B), the following the new subparagraph: 

‘‘(C) Coordinated medical triage and evacuation to 

appropriate medical institutions based on patient medical 

need, taking into account regionalized systems of care.’’; 

(vi) in subparagraph (E), as redesignated by clause 

(iv), by inserting ‘‘(which may include such dental 

health assets)’’ after ‘‘medical assets’’; and 

(vii) by adding at the end the following: 

‘‘(G) Optimizing a coordinated and flexible approach 

to the medical surge capacity of hospitals, other health 

care facilities, critical care, trauma care (which may include 

trauma centers), and emergency medical systems.’’; 

(C) in paragraph (4)— 

(i) in subparagraph (A), by inserting ‘‘, including 

the unique needs and considerations of individuals 

with disabilities,’’ after ‘‘medical needs of at-risk 

individuals’’; and 

(ii) in subparagraph (B), by inserting ‘‘the’’ before 

‘‘purpose of this section’’; and 

(D) by adding at the end the following: 

‘‘(7) COUNTERMEASURES.— 

‘‘(A) Promoting strategic initiatives to advance countermeasures to diagnose, mitigate, prevent, or treat harm 

from any biological agent or toxin, chemical, radiological, 
H. R. 307—3 

or nuclear agent or agents, whether naturally occurring, 

unintentional, or deliberate. 

‘‘(B) For purposes of this paragraph, the term ‘countermeasures’ has the same meaning as the terms ‘qualified 

countermeasures’ under section 319F–1, ‘qualified pandemic and epidemic products’ under section 319F–3, and 

‘security countermeasures’ under section 319F–2. 

‘‘(8) MEDICAL AND PUBLIC HEALTH COMMUNITY RESILIENCY.—Strengthening the ability of States, local communities, 

and tribal communities to prepare for, respond to, and be 

resilient in the event of public health emergencies, whether 

naturally occurring, unintentional, or deliberate by— 

‘‘(A) optimizing alignment and integration of medical 

and public health preparedness and response planning and 

capabilities with and into routine daily activities; and 

‘‘(B) promoting familiarity with local medical and 

public health systems.’’. 

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

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

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

(2) in paragraph (4), by striking ‘‘2811(b)(3)(B)’’ and 

inserting ‘‘2802(b)(4)(B)’’; 

(3) by redesignating paragraphs (1) through (4) as paragraphs (2) through (5), respectively; 

(4) by inserting before paragraph (2) (as so redesignated), 

the following: 

‘‘(1) monitor emerging issues and concerns as they relate 

to medical and public health preparedness and response for 

at-risk individuals in the event of a public health emergency 

declared by the Secretary under section 319;’’; 

(5) by amending paragraph (2) (as so redesignated) to read 

as follows: 

‘‘(2) oversee the implementation of the preparedness goals 

described in section 2802(b) with respect to the public health 

and medical needs of at-risk individuals in the event of a 

public health emergency, as described in section 2802(b)(4);’’; 

and 

(6) by inserting after paragraph (6), the following: 

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

best practices of outreach to and care of at-risk individuals 

before, during, and following public health emergencies in as 

timely a manner as is practicable, including from the time 

a public health threat is identified; and 

‘‘(8) ensure that public health and medical information 

distributed by the Department of Health and Human Services 

during a public health emergency is delivered in a manner 

that takes into account the range of communication needs of 

the intended recipients, including at-risk individuals.’’. 

SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND 

RESPONSE. 

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

Act (42 U.S.C. 300hh–10) is amended— 

(1) in subsection (b)— 

(A) in paragraph (3), by inserting ‘‘, security countermeasures (as defined in section 319F–2),’’ after ‘‘qualified 

countermeasures (as defined in section 319F–1)’’; 
H. R. 307—4 

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

‘‘(D) POLICY COORDINATION AND STRATEGIC DIRECTION.—Provide integrated policy coordination and strategic 

direction with respect to all matters related to Federal 

public health and medical preparedness and execution and 

deployment of the Federal response for public health emergencies and incidents covered by the National Response 

Plan developed pursuant to section 504(6) of the Homeland 

Security Act of 2002, or any successor plan, before, during, 

and following public health emergencies. 

‘‘(E) IDENTIFICATION OF INEFFICIENCIES.—Identify and 

minimize gaps, duplication, and other inefficiencies in medical and public health preparedness and response activities 

and the actions necessary to overcome these obstacles. 

‘‘(F) COORDINATION OF GRANTS AND AGREEMENTS.— 

Align and coordinate medical and public health grants 

and cooperative agreements as applicable to preparedness 

and response activities authorized under this Act, to the 

extent possible, including program requirements, timelines, 

and measurable goals, and in consultation with the Secretary of Homeland Security, to— 

‘‘(i) optimize and streamline medical and public 

health preparedness and response capabilities and the 

ability of local communities to respond to public health 

emergencies; and 

‘‘(ii) gather and disseminate best practices among 

grant and cooperative agreement recipients, as appropriate. 

‘‘(G) DRILL AND OPERATIONAL EXERCISES.—Carry out 

drills and operational exercises, in consultation with the 

Department of Homeland Security, the Department of 

Defense, the Department of Veterans Affairs, and other 

applicable Federal departments and agencies, as necessary 

and appropriate, to identify, inform, and address gaps in 

and policies related to all-hazards medical and public 

health preparedness and response, including exercises 

based on— 

‘‘(i) identified threats for which countermeasures 

are available and for which no countermeasures are 

available; and 

‘‘(ii) unknown threats for which no countermeasures are available. 

‘‘(H) NATIONAL SECURITY PRIORITY.—On a periodic basis 

consult with, as applicable and appropriate, the Assistant 

to the President for National Security Affairs, to provide 

an update on, and discuss, medical and public health 

preparedness and response activities pursuant to this Act 

and the Federal Food, Drug, and Cosmetic Act, including 

progress on the development, approval, clearance, and 

licensure of medical countermeasures.’’; and 

(C) by adding at the end the following: 

‘‘(7) COUNTERMEASURES BUDGET PLAN.—Develop, and 

update on an annual basis, a coordinated 5-year budget plan 

based on the medical countermeasure priorities described in 

subsection (d). Each such plan shall— 

‘‘(A) include consideration of the entire medical 

countermeasures enterprise, including— 
H. R. 307—5 

‘‘(i) basic research and advanced research and 

development; 

‘‘(ii) approval, clearance, licensure, and authorized 

uses of products; and 

‘‘(iii) procurement, stockpiling, maintenance, and 

replenishment of all products in the Strategic National 

Stockpile; 

‘‘(B) inform prioritization of resources and include 

measurable outputs and outcomes to allow for the tracking 

of the progress made toward identified priorities; 

‘‘(C) identify medical countermeasure life-cycle costs 

to inform planning, budgeting, and anticipated needs 

within the continuum of the medical countermeasure enterprise consistent with section 319F–2; and 

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

of Congress upon request.’’; 

(2) by striking subsection (c) and inserting the following: 

‘‘(c) FUNCTIONS.—The Assistant Secretary for Preparedness and 

Response shall— 

‘‘(1) have lead responsibility within the Department of 

Health and Human Services for emergency preparedness and 

response policy coordination and strategic direction; 

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

‘‘(A) the National Disaster Medical System pursuant 

to section 2812; 

‘‘(B) the Hospital Preparedness Cooperative Agreement 

Program pursuant to section 319C–2; 

‘‘(C) the Biomedical Advanced Research and Development Authority pursuant to section 319L; 

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

2813; 

‘‘(E) the Emergency System for Advance Registration 

of Volunteer Health Professionals pursuant to section 319I; 

and 

‘‘(F) administering grants and related authorities 

related to trauma care under parts A through C of title 

XII, such authority to be transferred by the Secretary from 

the Administrator of the Health Resources and Services 

Administration to such Assistant Secretary; 

‘‘(3) exercise the responsibilities and authorities of the Secretary with respect to the coordination of— 

‘‘(A) the Public Health Emergency Preparedness 

Cooperative Agreement Program pursuant to section 319C– 

1; 

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

‘‘(C) the Cities Readiness Initiative; and 

‘‘(4) assume other duties as determined appropriate by 

the Secretary.’’; and 

(3) by adding at the end the following: 

‘‘(d) PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES

ENTERPRISE STRATEGY AND IMPLEMENTATION PLAN.— ‘‘(1) IN GENERAL.—Not later than 180 days after the date 

of enactment of this subsection, and every year thereafter, 

the Assistant Secretary for Preparedness and Response shall 

develop and submit to the appropriate committees of Congress 

a coordinated strategy and accompanying implementation plan 
H. R. 307—6 

for medical countermeasures to address chemical, biological, 

radiological, and nuclear threats. In developing such a plan, 

the Assistant Secretary for Preparedness and Response shall 

consult with the Director of the Biomedical Advanced Research 

and Development Authority, the Director of the National 

Institutes of Health, the Director of the Centers for Disease 

Control and Prevention, and the Commissioner of Food and 

Drugs. Such strategy and plan shall be known as the ‘Public 

Health Emergency Medical Countermeasures Enterprise 

Strategy and Implementation Plan’. 

‘‘(2) REQUIREMENTS.—The plan under paragraph (1) shall— 

‘‘(A) describe the chemical, biological, radiological, and 

nuclear agent or agents that may present a threat to the 

Nation and the corresponding efforts to develop qualified 

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

countermeasures (as defined in section 319F–2), or qualified pandemic or epidemic products (as defined in section 

319F–3) for each threat; 

‘‘(B) evaluate the progress of all activities with respect 

to such countermeasures or products, including research, 

advanced research, development, procurement, stockpiling, 

deployment, distribution, and utilization; 

‘‘(C) identify and prioritize near-, mid-, and long-term 

needs with respect to such countermeasures or products 

to address a chemical, biological, radiological, and nuclear 

threat or threats; 

‘‘(D) identify, with respect to each category of threat, 

a summary of all awards and contracts, including advanced 

research and development and procurement, that 

includes— 

‘‘(i) the time elapsed from the issuance of the initial 

solicitation or request for a proposal to the adjudication 

(such as the award, denial of award, or solicitation 

termination); and 

‘‘(ii) an identification of projected timelines, anticipated funding allocations, benchmarks, and milestones 

for each medical countermeasure priority under 

subparagraph (C), including projected needs with 

regard to replenishment of the Strategic National 

Stockpile; 

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

National Biodefense Science Board pursuant to section 

319M; 

‘‘(F) evaluate progress made in meeting timelines, 

allocations, benchmarks, and milestones identified under 

subparagraph (D)(ii); 

‘‘(G) report on the amount of funds available for 

procurement in the special reserve fund as defined in section 319F–2(h) and the impact this funding will have on 

meeting the requirements under section 319F–2; 

‘‘(H) incorporate input from Federal, State, local, and 

tribal stakeholders; 

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

countermeasure priorities for at-risk individuals (as defined 

in 2802(b)(4)(B)), as applicable under subparagraph (C), 

including with regard to the projected needs for related 

stockpiling and replenishment of the Strategic National 
H. R. 307—7 

Stockpile, including by addressing the needs of pediatric 

populations with respect to such countermeasures and 

products in the Strategic National Stockpile, including— 

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

necessary to address the needs of pediatric populations; 

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

with the Office of Pediatric Therapeutics of the Food 

and Drug Administration to maximize the labeling, 

dosages, and formulations of such countermeasures 

and products for pediatric populations; 

‘‘(iii) a description of existing gaps in the Strategic 

National Stockpile and the development of such 

countermeasures and products to address the needs 

of pediatric populations; and 

‘‘(iv) an evaluation of the progress made in 

addressing priorities identified pursuant to subparagraph (C); 

‘‘(J) identify the use of authority and activities undertaken pursuant to sections 319F–1(b)(1), 319F–1(b)(2), 

319F–1(b)(3), 319F–1(c), 319F–1(d), 319F–1(e), 319F– 

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

this Act, and subsections (a)(1), (b)(1), and (e) of section 

564 of the Federal Food, Drug, and Cosmetic Act, by 

summarizing— 

‘‘(i) the particular actions that were taken under 

the authorities specified, including, as applicable, the 

identification of the threat agent, emergency, or the 

biomedical countermeasure with respect to which the 

authority was used; 

‘‘(ii) the reasons underlying the decision to use 

such authorities, including, as applicable, the options 

that were considered and rejected with respect to the 

use of such authorities; 

‘‘(iii) the number of, nature of, and other information concerning the persons and entities that received 

a grant, cooperative agreement, or contract pursuant 

to the use of such authorities, and the persons and 

entities that were considered and rejected for such 

a grant, cooperative agreement, or contract, except that 

the report need not disclose the identity of any such 

person or entity; 

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

that is approved by the President under section 319F– 

2(c)(6), a contract was entered into within one year 

after such approval by the President; and 

‘‘(v) with respect to section 319F–1(d), for the oneyear period for which the report is submitted, the 

number of persons who were paid amounts totaling 

$100,000 or greater and the number of persons who 

were paid amounts totaling at least $50,000 but less 

than $100,000; and 

‘‘(K) be made publicly available. 

‘‘(3) GAO REPORT.— 

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

date of the submission to the Congress of the first Public 

Health Emergency Medical Countermeasures Enterprise 
H. R. 307—8 

Strategy and Implementation Plan, the Comptroller General of the United States shall conduct an independent 

evaluation, and submit to the appropriate committees of 

Congress a report, concerning such Strategy and 

Implementation Plan. 

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

(A) shall review and assess— 

‘‘(i) the near-term, mid-term, and long-term medical countermeasure needs and identified priorities of 

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

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

and Human Services with respect to advanced research 

and development pursuant to section 319L; and 

‘‘(iii) the progress made toward meeting the 

timelines, allocations, benchmarks, and milestones 

identified in the Public Health Emergency Medical 

Countermeasures Enterprise Strategy and 

Implementation Plan under this subsection. 

‘‘(e) PROTECTION OF NATIONAL SECURITY.—In carrying out subsections (b)(7) and (d), the Secretary shall ensure that information 

and items that could compromise national security, contain confidential commercial information, or contain proprietary information 

are not disclosed.’’. 

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

Health Emergency Countermeasures Enterprise Strategy and 

Implementation Plan submitted under subsection (d) of section 2811 

of the Public Health Service Act (42 U.S.C. 300hh–10) (as added 

by subsection (a)(3)), the Secretary of Health and Human Services, 

in consultation with the Secretary of Defense, shall include a 

description of the manner in which the Department of Health 

and Human Services is coordinating with the Department of 

Defense regarding countermeasure activities to address chemical, 

biological, radiological, and nuclear threats. Such report shall 

include information with respect to— 

(1) the research, advanced research, development, procurement, stockpiling, and distribution of countermeasures to meet 

identified needs; and 

(2) the coordination of efforts between the Department 

of Health and Human Services and the Department of Defense 

to address countermeasure needs for various segments of the 

population. 

SEC. 103. NATIONAL ADVISORY COMMITTEE ON CHILDREN AND DISASTERS. 

Subtitle B of title XXVIII of the Public Health Service Act 

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

2811 the following: 

‘‘SEC. 2811A. NATIONAL ADVISORY COMMITTEE ON CHILDREN AND 

DISASTERS. 

‘‘(a) ESTABLISHMENT.—The Secretary, in consultation with the 

Secretary of Homeland Security, shall establish an advisory committee to be known as the ‘National Advisory Committee on Children and Disasters’ (referred to in this section as the ‘Advisory 

Committee’). 

‘‘(b) DUTIES.—The Advisory Committee shall— 
H. R. 307—9 

‘‘(1) provide advice and consultation with respect to the 

activities carried out pursuant to section 2814, as applicable 

and appropriate; 

‘‘(2) evaluate and provide input with respect to the medical 

and public health needs of children as they relate to preparation 

for, response to, and recovery from all-hazards emergencies; 

and 

‘‘(3) provide advice and consultation with respect to State 

emergency preparedness and response activities and children, 

including related drills and exercises pursuant to the preparedness goals under section 2802(b). 

‘‘(c) ADDITIONAL DUTIES.—The Advisory Committee may provide 

advice and recommendations to the Secretary with respect to children and the medical and public health grants and cooperative 

agreements as applicable to preparedness and response activities 

authorized under this title and title III. 

‘‘(d) MEMBERSHIP.— 

‘‘(1) IN GENERAL.—The Secretary, in consultation with such 

other Secretaries as may be appropriate, shall appoint not 

to exceed 15 members to the Advisory Committee. In appointing 

such members, the Secretary shall ensure that the total membership of the Advisory Committee is an odd number. 

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

with such other Secretaries as may be appropriate, may appoint 

to the Advisory Committee under paragraph (1) such individuals as may be appropriate to perform the duties described 

in subsections (b) and (c), which may include— 

‘‘(A) the Assistant Secretary for Preparedness and 

Response; 

‘‘(B) the Director of the Biomedical Advanced Research 

and Development Authority; 

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

and Prevention; 

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

‘‘(E) the Director of the National Institutes of Health; 

‘‘(F) the Assistant Secretary of the Administration for 

Children and Families; 

‘‘(G) the Administrator of the Federal Emergency 

Management Agency; 

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

with expertise in pediatric medical disaster planning, 

preparedness, response, or recovery; 

‘‘(I) at least two representatives from State, local, territorial, or tribal agencies with expertise in pediatric disaster 

planning, preparedness, response, or recovery; and 

‘‘(J) representatives from such Federal agencies (such 

as the Department of Education and the Department of 

Homeland Security) as determined necessary to fulfill the 

duties of the Advisory Committee, as established under 

subsections (b) and (c). 

‘‘(e) MEETINGS.—The Advisory Committee shall meet not less 

than biannually. 

‘‘(f) SUNSET.—The Advisory Committee shall terminate on September 30, 2018.’’. 
H. R. 307—10 

SEC. 104. MODERNIZATION OF THE NATIONAL DISASTER MEDICAL 

SYSTEM. 

Section 2812 of the Public Health Service Act (42 U.S.C. 300hh– 

11) is amended— 

(1) in subsection (a)(3)— 

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

‘‘, including at-risk individuals as applicable’’ after ‘‘victims 

of a public health emergency’’; 

(B) by redesignating subparagraph (C) as subparagraph (E); and 

(C) by inserting after subparagraph (B), the following: 

‘‘(C) CONSIDERATIONS FOR AT-RISK POPULATIONS.—The 

Secretary shall take steps to ensure that an appropriate 

specialized and focused range of public health and medical 

capabilities are represented in the National Disaster Medical System, which take into account the needs of at-risk 

individuals, in the event of a public health emergency.’’. 

‘‘(D) ADMINISTRATION.—The Secretary may determine 

and pay claims for reimbursement for services under 

subparagraph (A) directly or through contracts that provide 

for payment in advance or by way of reimbursement.’’; 

and 

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

necessary for each of the fiscal years 2007 through 2011’’ and 

inserting ‘‘$52,700,000 for each of fiscal years 2014 through 

2018’’. 

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

AFFAIRS. 

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

by striking ‘‘such sums as may be necessary to carry out this 

section for each of fiscal years 2007 through 2011’’ and inserting 

‘‘$155,300,000 for each of fiscal years 2014 through 2018 to carry 

out this section’’. 

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. 

Section 319 of the Public Health Service Act (42 U.S.C. 247d) 

is amended by adding at the end the following: 

‘‘(e) TEMPORARY REASSIGNMENT OF STATE AND LOCAL PERSONNEL DURING A PUBLIC HEALTH EMERGENCY.— 

‘‘(1) EMERGENCY REASSIGNMENT OF FEDERALLY FUNDED PERSONNEL.—Notwithstanding any other provision of law, and subject to paragraph (2), upon request by the Governor of a State 

or a tribal organization or such Governor or tribal organization’s 

designee, the Secretary may authorize the requesting State 

or Indian tribe to temporarily reassign, for purposes of immediately addressing a public health emergency in the State or 

Indian tribe, State and local public health department or agency 

personnel funded in whole or in part through programs authorized under this Act, as appropriate. 
H. R. 307—11 

‘‘(2) ACTIVATION OF EMERGENCY REASSIGNMENT.— 

‘‘(A) PUBLIC HEALTH EMERGENCY.—The Secretary may 

authorize a temporary reassignment of personnel under 

paragraph (1) only during the period of a public health 

emergency determined pursuant to subsection (a). 

‘‘(B) CONTENTS OF REQUEST.—To seek authority for 

a temporary reassignment of personnel under paragraph 

(1), the Governor of a State or a tribal organization shall 

submit to the Secretary a request for such reassignment 

flexibility and shall include in the request each of the 

following: 

‘‘(i) An assurance that the public health emergency 

in the geographic area of the requesting State or Indian 

tribe cannot be adequately and appropriately addressed 

by the public health workforce otherwise available. 

‘‘(ii) An assurance that the public health emergency would be addressed more efficiently and effectively through the requested temporary reassignment 

of State and local personnel described in paragraph 

(1). 

‘‘(iii) An assurance that the requested temporary 

reassignment of personnel is consistent with any 

applicable All-Hazards Public Health Emergency 

Preparedness and Response Plan under section 319C– 

1. 

‘‘(iv) An identification of— 

‘‘(I) each Federal program from which personnel would be temporarily reassigned pursuant 

to the requested authority; and 

‘‘(II) the number of personnel who would be 

so reassigned from each such program. 

‘‘(v) Such other information and assurances upon 

which the Secretary and Governor of a State or tribal 

organization agree. 

‘‘(C) CONSIDERATION.—In reviewing a request for temporary reassignment under paragraph (1), the Secretary 

shall consider the degree to which the program or programs 

funded in whole or in part by programs authorized under 

this Act would be adversely affected by the reassignment. 

‘‘(D) TERMINATION AND EXTENSION.— 

‘‘(i) TERMINATION.—A State or Indian tribe’s temporary reassignment of personnel under paragraph (1) 

shall terminate upon the earlier of the following: 

‘‘(I) The Secretary’s determination that the 

public health emergency no longer exists. 

‘‘(II) Subject to clause (ii), the expiration of 

the 30-day period following the date on which the 

Secretary approved the State or Indian tribe’s 

request for such reassignment flexibility. 

‘‘(ii) EXTENSION OF REASSIGNMENT FLEXIBILITY.— 

The Secretary may extend reassignment flexibility of 

personnel under paragraph (1) beyond the date otherwise applicable under clause (i)(II) if the public health 

emergency still exists as of such date, but only if— 

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

the initial request for a temporary reassignment 
H. R. 307—12 

of personnel submits a request for an extension 

of such temporary reassignment; and 

‘‘(II) the request for an extension contains the 

same information and assurances necessary for 

the approval of an initial request for such temporary reassignment pursuant to subparagraph 

(B). 

‘‘(3) VOLUNTARY NATURE OF TEMPORARY REASSIGNMENT OF

STATE AND LOCAL PERSONNEL.— 

‘‘(A) IN GENERAL.—Unless otherwise provided under 

the law or regulation of the State or Indian tribe that 

receives authorization for temporary reassignment of personnel under paragraph (1), personnel eligible for reassignment pursuant to such authorization— 

‘‘(i) shall have the opportunity to volunteer for 

temporary reassignment; and 

‘‘(ii) shall not be required to agree to a temporary 

reassignment. 

‘‘(B) PROHIBITION ON CONDITIONING FEDERAL AWARDS.— 

The Secretary may not condition the award of a grant, 

contract, or cooperative agreement under this Act on the 

requirement that a State or Indian tribe require that personnel eligible for reassignment pursuant to an authorization under paragraph (1) agree to such reassignment. 

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

to the Congress in conjunction with the approval under this 

subsection of— 

‘‘(A) any initial request for temporary reassignment 

of personnel; and 

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

reassignment. 

‘‘(5) GUIDANCE.—The Secretary shall— 

‘‘(A) not later than 6 months after the enactment of 

this subsection, issue proposed guidance on the temporary 

reassignment of personnel under this subsection; and 

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

public comment, finalize such guidance. 

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

the date of enactment of the Pandemic and All-Hazards 

Preparedness Reauthorization Act of 2013, the Comptroller 

General of the United States shall conduct an independent 

evaluation, and submit to the appropriate committees of the 

Congress a report, on temporary reassignment under this subsection, including— 

‘‘(A) a description of how, and under what circumstances, such temporary reassignment has been used 

by States and Indian tribes; 

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

has assisted States and Indian tribes in responding to 

public health emergencies; 

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

has improved operational efficiencies in responding to 

public health emergencies; 

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

programs from which personnel have been temporarily 

reassigned have been adversely affected by the reassignment; and 
H. R. 307—13 

‘‘(E) recommendations on how medical surge capacity 

could be improved in responding to public health emergencies and the impact of the reassignment flexibility under 

this section on such surge capacity. 

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

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

have the meanings given such terms in section 4 of the 

Indian Self-Determination and Education Assistance Act; 

and 

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

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

Associated States. 

‘‘(8) SUNSET.—This subsection shall terminate on September 30, 2018.’’. 

SEC. 202. IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY. 

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

Health Service Act (42 U.S.C. 247d–3a) is amended— 

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

of States’’; 

(2) in subsection (b)(2)— 

(A) in subparagraph (A)— 

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

the following: 

‘‘(i) a description of the activities such entity will 

carry out under the agreement to meet the goals identified under section 2802, including with respect to chemical, biological, radiological, or nuclear threats, whether 

naturally occurring, unintentional, or deliberate; 

‘‘(ii) a description of the activities such entity will 

carry out with respect to pandemic influenza, as a 

component of the activities carried out under clause 

(i), and consistent with the requirements of paragraphs 

(2) and (5) of subsection (g);’’; 

(ii) in clause (iv), by striking ‘‘and’’ at the end; 

and 

(iii) by adding at the end the following: 

‘‘(vi) a description of how, as appropriate, the entity 

may partner with relevant public and private stakeholders in public health emergency preparedness and 

response; 

‘‘(vii) a description of how the entity, as applicable 

and appropriate, will coordinate with State emergency 

preparedness and response plans in public health 

emergency preparedness, including State educational 

agencies (as defined in section 9101(41) of the 

Elementary and Secondary Education Act of 1965) and 

State child care lead agencies (designated under section 

658D of the Child Care and Development Block Grant 

Act of 1990); 

‘‘(viii) in the case of entities that operate on the 

United States-Mexico border or the United StatesCanada border, a description of the activities such 

entity will carry out under the agreement that are 

specific to the border area including disease detection, 

identification, investigation, and preparedness and 
H. R. 307—14 

response activities related to emerging diseases and 

infectious disease outbreaks whether naturally occurring or due to bioterrorism, consistent with the requirements of this section; and 

‘‘(ix) a description of any activities that such entity 

will use to analyze real-time clinical specimens for 

pathogens of public health or bioterrorism significance, 

including any utilization of poison control centers;’’; 

and 

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

addressing the needs of at-risk individuals,’’ after ‘‘capabilities of such entity’’; 

(3) in subsection (f)— 

(A) in paragraph (2), by adding ‘‘and’’ at the end; 

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

a period; and 

(C) by striking paragraph (4); 

(4) in subsection (g)— 

(A) in paragraph (1), by striking subparagraph (A) 

and inserting the following: 

‘‘(A) include outcome goals representing operational 

achievements of the National Preparedness Goals developed under section 2802(b) with respect to all-hazards, 

including chemical, biological, radiological, or nuclear 

threats; and’’; and 

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

following: ‘‘The Secretary shall periodically update, as necessary and appropriate, such pandemic influenza plan criteria and shall require the integration of such criteria 

into the benchmarks and standards described in paragraph 

(1).’’; 

(5) by striking subsection (h); 

(6) by redesignating subsections (i), (j), and (k) as subsections (h), (i), and (j), respectively; 

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

(A) in paragraph (1)— 

(i) in subparagraph (A)— (I) by striking ‘‘$824,000,000 for fiscal year 2007, of which $35,000,000 shall be used to carry 

out subsection (h),’’ and inserting ‘‘$641,900,000 

for fiscal year 2014’’; and 

(II) by striking ‘‘such sums as may be necessary for each of fiscal years 2008 through 2011’’ 

and inserting ‘‘$641,900,000 for each of fiscal years 

2015 through 2018’’; 

(ii) by striking subparagraph (B); 

(iii) by redesignating subparagraphs (C) and (D) 

as subparagraphs (B) and (C), respectively; and 

(iv) in subparagraph (C), as so redesignated, by 

striking ‘‘subparagraph (C)’’ and inserting ‘‘subparagraph (B)’’; 

(B) in subparagraphs (C) and (D) of paragraph (3), 

by striking ‘‘(1)(A)(i)(I)’’ each place it appears and inserting 

‘‘(1)(A)’’; 

(C) in paragraph (4)(B), by striking ‘‘subsection (c)’’ 

and inserting ‘‘subsection (b)’’; and 

(D) by adding at the end the following: 
H. R. 307—15 

‘‘(7) AVAILABILITY OF COOPERATIVE AGREEMENT FUNDS.— 

‘‘(A) IN GENERAL.—Amounts provided to an eligible 

entity under a cooperative agreement under subsection (a) 

for a fiscal year and remaining unobligated at the end 

of such year shall remain available to such entity for the 

next fiscal year for the purposes for which such funds 

were provided. 

‘‘(B) FUNDS CONTINGENT ON ACHIEVING BENCHMARKS.— 

The continued availability of funds under subparagraph 

(A) with respect to an entity shall be contingent upon 

such entity achieving the benchmarks and submitting the 

pandemic influenza plan as described in subsection (g).’’; 

and 

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

(A) in paragraph (1)(E), by striking ‘‘subsection (k)’’ 

and inserting ‘‘subsection (j)’’; 

(B) by striking paragraph (3). 

(b) VACCINE TRACKING AND DISTRIBUTION.—Section 319A(e) of 

the Public Health Service Act (42 U.S.C. 247d–1(e)) is amended 

by striking ‘‘such sums for each of fiscal years 2007 through 2011’’ 

and inserting ‘‘$30,800,000 for each of fiscal years 2014 through 

2018’’. 

(c) TECHNICAL AND CONFORMING AMENDMENTS.— 

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

Act (42 U.S.C. 247d–3a(b)(1)(B)) is amended by striking ‘‘subsection (i)(4)’’ and inserting ‘‘subsection (h)(4)’’. 

(2) Section 319C–2 of the Public Health Service Act (42 

U.S.C. 247d–3b) is amended— 

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

inserting ‘‘(i), and (j)’’; and 

(B) in subsection (j)(3), by striking ‘‘319C–1(i)’’ and 

inserting ‘‘319C–1(h)’’. 

SEC. 203. HOSPITAL PREPAREDNESS AND MEDICAL SURGE CAPACITY. 

(a) ALL-HAZARDS PUBLIC HEALTH AND MEDICAL RESPONSE CUR- RICULA AND TRAINING.—Section 319F(a)(5)(B) of the Public Health 

Service Act (42 U.S.C. 247d–6(a)(5)(B)) is amended by striking 

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

or dental’’. 

(b) ENCOURAGING HEALTH PROFESSIONAL VOLUNTEERS.— (1) EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF VOLUNTEER HEALTH PROFESSIONALS.—Section 319I(k) of the Public 

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

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

may be necessary for each of the fiscal years 2003 through 

2011’’ and inserting ‘‘$5,000,000 for each of fiscal years 2014 

through 2018’’. 

(2) VOLUNTEERS.—Section 2813 of the Public Health Service 

Act (42 U.S.C. 300hh–15) is amended— 

(A) in subsection (d)(2), by adding at the end the following: ‘‘Such training exercises shall, as appropriate and 

applicable, incorporate the needs of at-risk individuals in 

the event of a public health emergency.’’; and 

(B) in subsection (i), by striking ‘‘$22,000,000 for fiscal 

year 2007, and such sums as may be necessary for each 

of fiscal years 2008 through 2011’’ and inserting 

‘‘$11,200,000 for each of fiscal years 2014 through 2018’’. 
H. R. 307—16 

(c) PARTNERSHIPS FOR STATE AND REGIONAL PREPAREDNESS TO

IMPROVE SURGE CAPACITY.—Section 319C–2 of the Public Health 

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

(1) in subsection (a), by inserting ‘‘, including, as appropriate, capacity and preparedness to address the needs of children and other at-risk individuals’’ before the period at the 

end; 

(2) in subsection (b)(1)(A)(ii), by striking ‘‘centers, primary’’ 

and inserting ‘‘centers, community health centers, primary’’; 

(3) by striking subsection (c) and inserting the following: 

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

expended for activities to achieve the preparedness goals described 

under paragraphs (1), (3), (4), (5), and (6) of section 2802(b) with 

respect to all-hazards, including chemical, biological, radiological, 

or nuclear threats.’’; 

(4) by striking subsection (g) and inserting the following: 

‘‘(g) COORDINATION.— 

‘‘(1) LOCAL RESPONSE CAPABILITIES.—An eligible entity 

shall, to the extent practicable, ensure that activities carried 

out under an award under subsection (a) are coordinated with 

activities of relevant local Metropolitan Medical Response Systems, local Medical Reserve Corps, the local Cities Readiness 

Initiative, and local emergency plans. 

‘‘(2) NATIONAL COLLABORATION.—Partnerships consisting of 

one or more eligible entities under this section may, to the 

extent practicable, collaborate with other partnerships consisting of one or more eligible entities under this section for 

purposes of national coordination and collaboration with respect 

to activities to achieve the preparedness goals described under 

paragraphs (1), (3), (4), (5), and (6) of section 2802(b).’’; 

(5) in subsection (i)— 

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

the following: 

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

(B) by adding at the end the following: 

‘‘(2) MEETING GOALS OF NATIONAL HEALTH SECURITY

STRATEGY.—The Secretary shall implement objective, evidencebased metrics to ensure that entities receiving awards under 

this section are meeting, to the extent practicable, the 

applicable goals of the National Health Security Strategy under 

section 2802.’’; and 

(6) in subsection (j)— 

(A) by amending paragraph (1) to read as follows: 

‘‘(1) IN GENERAL.—For purposes of carrying out this section, 

there is authorized to be appropriated $374,700,000 for each 

of fiscal years 2014 through 2018.’’; and 

(B) by adding at the end the following: 

‘‘(4) AVAILABILITY OF COOPERATIVE AGREEMENT FUNDS.— ‘‘(A) IN GENERAL.—Amounts provided to an eligible 

entity under a cooperative agreement under subsection (a) 

for a fiscal year and remaining unobligated at the end 

of such year shall remain available to such entity for the 

next fiscal year for the purposes for which such funds 

were provided. 

‘‘(B) FUNDS CONTINGENT ON ACHIEVING BENCHMARKS.— The continued availability of funds under subparagraph 

(A) with respect to an entity shall be contingent upon 
H. R. 307—17 

such entity achieving the benchmarks and submitting the 

pandemic influenza plan as required under subsection (i).’’. 

SEC. 204. ENHANCING SITUATIONAL AWARENESS AND BIOSURVEILLANCE. 

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

Act (42 U.S.C. 247d–4) is amended— 

(1) in subsection (b)— 

(A) in paragraph (1)(B), by inserting ‘‘poison control 

centers,’’ after ‘‘hospitals,’’; 

(B) in paragraph (2), by inserting before the period 

at the end the following: ‘‘, allowing for coordination to 

maximize all-hazards medical and public health preparedness and response and to minimize duplication of effort’’; 

and 

(C) in paragraph (3), by inserting before the period 

at the end the following: ‘‘and update such standards as 

necessary’’; 

(2) by striking subsection (c); 

(3) by redesignating subsections (d) through (g) as subsections (c) through (f), respectively; 

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

(A) in the subsection heading, by striking ‘‘PUBLIC

HEALTH SITUATIONAL AWARENESS’’ and inserting ‘‘MODERNIZING PUBLIC HEALTH SITUATIONAL AWARENESS AND BIOSURVEILLANCE’’; 

(B) in paragraph (1)— 

(i) by striking ‘‘Pandemic and All-Hazards 

Preparedness Act’’ and inserting ‘‘Pandemic and AllHazards Preparedness Reauthorization Act of 2013’’; 

and 

(ii) by inserting ‘‘, novel emerging threats,’’ after 

‘‘disease outbreaks’’; 

(C) by striking paragraph (2) and inserting the following: 

‘‘(2) STRATEGY AND IMPLEMENTATION PLAN.—Not later than 

180 days after the date of enactment of the Pandemic and 

All-Hazards Preparedness Reauthorization Act of 2013, the Secretary shall submit to the appropriate committees of Congress 

a coordinated strategy and an accompanying implementation 

plan that identifies and demonstrates the measurable steps 

the Secretary will carry out to— 

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

described in paragraph (1), utilizing the elements described 

in paragraph (3); 

‘‘(B) modernize and enhance biosurveillance activities; 

and 

‘‘(C) improve information sharing, coordination, and 

communication among disparate biosurveillance systems 

supported by the Department of Health and Human Services.’’; 

(D) in paragraph (3)(D), by inserting ‘‘community 

health centers, health centers’’ after ‘‘poison control,’’; 

(E) in paragraph (5), by striking subparagraph (A) 

and inserting the following: 

‘‘(A) utilize applicable interoperability standards as 

determined by the Secretary, and in consultation with the 
H. R. 307—18 

Office of the National Coordinator for Health Information 

Technology, through a joint public and private sector 

process;’’; and 

(F) by adding at the end the following: 

‘‘(6) CONSULTATION WITH THE NATIONAL BIODEFENSE

SCIENCE BOARD.—In carrying out this section and consistent 

with section 319M, the National Biodefense Science Board shall 

provide expert advice and guidance, including recommendations, regarding the measurable steps the Secretary should 

take to modernize and enhance biosurveillance activities pursuant to the efforts of the Department of Health and Human 

Services to ensure comprehensive, real-time, all-hazards biosurveillance capabilities. In complying with the preceding sentence, the National Biodefense Science Board shall— 

‘‘(A) identify the steps necessary to achieve a national 

biosurveillance system for human health, with international connectivity, where appropriate, that is predicated 

on State, regional, and community level capabilities and 

creates a networked system to allow for two-way information flow between and among Federal, State, and local 

government public health authorities and clinical health 

care providers; 

‘‘(B) identify any duplicative surveillance programs 

under the authority of the Secretary, or changes that are 

necessary to existing programs, in order to enhance and 

modernize such activities, minimize duplication, strengthen 

and streamline such activities under the authority of the 

Secretary, and achieve real-time and appropriate data that 

relate to disease activity, both human and zoonotic; and 

‘‘(C) coordinate with applicable existing advisory 

committees of the Director of the Centers for Disease Control and Prevention, including such advisory committees 

consisting of representatives from State, local, and tribal 

public health authorities and appropriate public and private sector health care entities and academic institutions, 

in order to provide guidance on public health surveillance 

activities.’’; 

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

(A) in paragraph (1), by striking ‘‘subsection (d)’’ and 

inserting ‘‘subsection (c)’’; 

(B) in paragraph (4)(B), by striking ‘‘subsection (d)’’ 

and inserting ‘‘subsection (c)’’; and 

(C) in paragraph (5)— 

(i) by striking ‘‘4 years after the date of enactment 

of the Pandemic and All-Hazards Preparedness Act’’ 

and inserting ‘‘3 years after the date of enactment 

of the Pandemic and All-Hazards Preparedness 

Reauthorization Act of 2013’’; and 

(ii) by striking ‘‘subsection (d)’’ and inserting ‘‘subsection (c)’’; 

(6) in subsection (f), as so redesignated, by striking ‘‘such 

sums as may be necessary in each of fiscal years 2007 through 

2011’’ and inserting ‘‘$138,300,000 for each of fiscal years 2014 

through 2018’’; and 

(7) by adding at the end the following: 

‘‘(g) DEFINITION.—For purposes of this section the term ‘biosurveillance’ means the process of gathering near real-time 
H. R. 307—19 

biological data that relates to human and zoonotic disease activity 

and threats to human or animal health, in order to achieve early 

warning and identification of such health threats, early detection 

and prompt ongoing tracking of health events, and overall situational awareness of disease activity.’’. 

(b) TECHNICAL AND CONFORMING AMENDMENT.—Section 319C– 

1(b)(2)(D) of the Public Health Service Act (42 U.S.C. 247d– 

3a(b)(2)(D)) is amended by striking ‘‘section 319D(d)(3)’’ and 

inserting ‘‘section 319D(c)(3)’’. 

SEC. 205. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD REPORTS. 

Section 5 of the Project Bioshield Act of 2004 (42 U.S.C. 247d– 

6c) is repealed. 

TITLE III—ENHANCING MEDICAL 

COUNTERMEASURE REVIEW 

SEC. 301. SPECIAL PROTOCOL ASSESSMENT. 

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

Act (21 U.S.C. 355(b)(5)(B)) is amended by striking ‘‘size of clinical 

trials intended’’ and all that follows through ‘‘. The sponsor or 

applicant’’ and inserting the following: ‘‘size— 

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

of an effectiveness claim; or 

‘‘(II) in the case where human efficacy studies are not 

ethical or feasible, of animal and any associated clinical trials 

which, in combination, are intended to form the primary basis 

of an effectiveness claim; or 

‘‘(ii) with respect to an application for approval of a 

biological product under section 351(k) of the Public Health 

Service Act, of any necessary clinical study or studies. 

The sponsor or applicant’’. 

SEC. 302. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN 

EMERGENCIES. 

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

Cosmetic Act (21 U.S.C. 360bbb–3) is amended— 

(1) in subsection (a)— 

(A) in paragraph (1), by striking ‘‘sections 505, 510(k), 

and 515 of this Act’’ and inserting ‘‘any provision of this 

Act’’; 

(B) in paragraph (2)(A), by striking ‘‘under a provision 

of law referred to in such paragraph’’ and inserting ‘‘under 

section 505, 510(k), or 515 of this Act or section 351 of 

the Public Health Service Act’’; and 

(C) in paragraph (3), by striking ‘‘a provision of law 

referred to in such paragraph’’ and inserting ‘‘a section 

of this Act or the Public Health Service Act referred to 

in paragraph (2)(A)’’; 

(2) in subsection (b)— 

(A) in the subsection heading, by striking ‘‘EMERGENCY’’ 

and inserting ‘‘EMERGENCY OR THREAT JUSTIFYING EMERGENCY AUTHORIZED USE’’; 

(B) in paragraph (1)— 
H. R. 307—20 

(i) in the matter preceding subparagraph (A), by 

striking ‘‘may declare an emergency’’ and inserting 

‘‘may make a declaration that the circumstances exist’’; 

(ii) in subparagraph (A), by striking ‘‘specified’’; 

(iii) in subparagraph (B)— 

(I) by striking ‘‘specified’’; and 

(II) by striking ‘‘; or’’ and inserting a semicolon; 

(iv) by amending subparagraph (C) to read as follows: 

‘‘(C) a determination by the Secretary that there is 

a public health emergency, or a significant potential for 

a public health emergency, that affects, or has a significant 

potential to affect, national security or the health and 

security of United States citizens living abroad, and that 

involves a biological, chemical, radiological, or nuclear 

agent or agents, or a disease or condition that may be 

attributable to such agent or agents; or’’; and 

(v) by adding at the end the following: 

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

to section 319F–2 of the Public Health Service Act sufficient 

to affect national security or the health and security of 

United States citizens living abroad.’’; 

(C) in paragraph (2)— 

(i) in subparagraph (A), by amending clause (ii) 

to read as follows: 

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

such that the circumstances described in subsection 

(a)(2) have ceased to exist.’’; 

(ii) by striking subparagraph (B); and 

(iii) by redesignating subparagraph (C) as subparagraph (B); 

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

termination, and renewal under this subsection.’’ and 

inserting ‘‘, and advance notice of termination under this 

subsection.’’; and 

(E) by adding at the end the following: 

‘‘(5) EXPLANATION BY SECRETARY.—If an authorization 

under this section with respect to an unapproved product or 

an unapproved use of an approved product has been in effect 

for more than 1 year, the Secretary shall provide in writing 

to the sponsor of such product an explanation of the scientific, 

regulatory, or other obstacles to approval, licensure, or clearance of such product or use, including specific actions to be 

taken by the Secretary and the sponsor to overcome such 

obstacles.’’; 

(3) in subsection (c)— 

(A) in the matter preceding paragraph (1)— 

(i) by inserting ‘‘the Assistant Secretary for 

Preparedness and Response,’’ after ‘‘consultation with’’; 

(ii) by striking ‘‘Health and’’ and inserting ‘‘Health, 

and’’; and 

(iii) by striking ‘‘circumstances of the emergency 

involved’’ and inserting ‘‘applicable circumstances 

described in subsection (b)(1)’’; 

(B) in paragraph (1), by striking ‘‘specified’’ and 

inserting ‘‘referred to’’; and 
H. R. 307—21 

(C) in paragraph (2)(B), by inserting ‘‘, taking into 

consideration the material threat posed by the agent or 

agents identified in a declaration under subsection 

(b)(1)(D), if applicable’’ after ‘‘risks of the product’’; 

(4) in subsection (d)(3), by inserting ‘‘, to the extent practicable given the circumstances of the emergency,’’ after 

‘‘including’’; 

(5) in subsection (e)— 

(A) in paragraph (1)(A), by striking ‘‘circumstances of 

the emergency’’ and inserting ‘‘applicable circumstances 

described in subsection (b)(1)’’; 

(B) in paragraph (1)(B), by amending clause (iii) to 

read as follows: 

‘‘(iii) Appropriate conditions with respect to collection and analysis of information concerning the safety 

and effectiveness of the product with respect to the 

use of such product during the period when the 

authorization is in effect and a reasonable time following such period.’’; 

(C) in paragraph (2)— 

(i) in subparagraph (A)— 

(I) by striking ‘‘manufacturer of the product’’ 

and inserting ‘‘person’’; 

(II) by striking ‘‘circumstances of the emergency’’ and inserting ‘‘applicable circumstances 

described in subsection (b)(1)’’; and 

(III) by inserting at the end before the period 

‘‘or in paragraph (1)(B)’’; 

(ii) in subparagraph (B)(i), by inserting before the 

period at the end ‘‘, except as provided in section 564A 

with respect to authorized changes to the product 

expiration date’’; and 

(iii) by amending subparagraph (C) to read as follows: 

‘‘(C) In establishing conditions under this paragraph 

with respect to the distribution and administration of the 

product for the unapproved use, the Secretary shall not 

impose conditions that would restrict distribution or 

administration of the product when distributed or administered for the approved use.’’; and 

(D) by amending paragraph (3) to read as follows: 

‘‘(3) GOOD MANUFACTURING PRACTICE; PRESCRIPTION.—With 

respect to the emergency use of a product for which an 

authorization under this section is issued (whether an 

unapproved product or an unapproved use of an approved 

product), the Secretary may waive or limit, to the extent appropriate given the applicable circumstances described in subsection (b)(1)— 

‘‘(A) requirements regarding current good manufacturing practice otherwise applicable to the manufacture, 

processing, packing, or holding of products subject to regulation under this Act, including such requirements established under section 501 or 520(f)(1), and including relevant 

conditions prescribed with respect to the product by an 

order under section 520(f)(2); 

‘‘(B) requirements established under section 503(b); and 

‘‘(C) requirements established under section 520(e).’’; 
H. R. 307—22 

(6) in subsection (g)— 

(A) in the subsection heading, by inserting ‘‘REVIEW

AND’’ before ‘‘REVOCATION’’; 

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

at the end the following: ‘‘As part of such review, the 

Secretary shall regularly review the progress made with 

respect to the approval, licensure, or clearance of— 

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

was issued under this section; or 

‘‘(B) an unapproved use of an approved product for 

which an authorization was issued under this section.’’; 

and 

(C) by amending paragraph (2) to read as follows: 

‘‘(2) REVISION AND REVOCATION.—The Secretary may revise 

or revoke an authorization under this section if— 

‘‘(A) the circumstances described under subsection 

(b)(1) no longer exist; 

‘‘(B) the criteria under subsection (c) for issuance of 

such authorization are no longer met; or 

‘‘(C) other circumstances make such revision or revocation appropriate to protect the public health or safety.’’; 

(7) in subsection (h)(1), by adding after the period at the 

end the following: ‘‘The Secretary shall make any revisions 

to an authorization under this section available on the Internet 

Web site of the Food and Drug Administration.’’; 

(8) by adding at the end of subsection (j) the following: 

‘‘(4) Nothing in this section shall be construed as authorizing a delay in the review or other consideration by the Secretary of any application or submission pending before the 

Food and Drug Administration for a product for which an 

authorization under this section is issued.’’; and 

(9) by adding at the end the following: 

‘‘(m) CATEGORIZATION OF LABORATORY TESTS ASSOCIATED WITH

DEVICES SUBJECT TO AUTHORIZATION.— ‘‘(1) IN GENERAL.—In issuing an authorization under this 

section with respect to a device, the Secretary may, subject 

to the provisions of this section, determine that a laboratory 

examination or procedure associated with such device shall 

be deemed, for purposes of section 353 of the Public Health 

Service Act, to be in a particular category of examinations 

and procedures (including the category described by subsection 

(d)(3) of such section) if, based on the totality of scientific 

evidence available to the Secretary— 

‘‘(A) such categorization would be beneficial to protecting the public health; and 

‘‘(B) the known and potential benefits of such categorization under the circumstances of the authorization 

outweigh the known and potential risks of the categorization. 

‘‘(2) CONDITIONS OF DETERMINATION.—The Secretary may 

establish appropriate conditions on the performance of the 

examination or procedure pursuant to such determination. 

‘‘(3) EFFECTIVE PERIOD.—A determination under this subsection shall be effective for purposes of section 353 of the 

Public Health Service Act notwithstanding any other provision 

of that section during the effective period of the relevant declaration under subsection (b).’’. 
H. R. 307—23 

(b) EMERGENCY USE OF MEDICAL PRODUCTS.—Subchapter E 

of chapter V of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 360bbb et seq.) is amended by inserting after section 564 

the following: 

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

‘‘(a) DEFINITIONS.—In this section: 

‘‘(1) ELIGIBLE PRODUCT.—The term ‘eligible product’ means 

a product that— 

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

licensed under section 351 of the Public Health Service 

Act; 

‘‘(B)(i) is intended for use to prevent, diagnose, or treat 

a disease or condition involving a biological, chemical, 

radiological, or nuclear agent or agents; or 

‘‘(ii) is intended for use to prevent, diagnose, or treat 

a serious or life-threatening disease or condition caused 

by a product described in clause (i); and 

‘‘(C) is intended for use during the circumstances under 

which— 

‘‘(i) a determination described in subparagraph (A), 

(B), or (C) of section 564(b)(1) has been made by the 

Secretary of Homeland Security, the Secretary of 

Defense, or the Secretary, respectively; or 

‘‘(ii) the identification of a material threat 

described in subparagraph (D) of section 564(b)(1) has 

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

Health Service Act. 

‘‘(2) PRODUCT.—The term ‘product’ means a drug, device, 

or biological product. 

‘‘(b) EXPIRATION DATING.— ‘‘(1) IN GENERAL.—The Secretary may extend the expiration 

date and authorize the introduction or delivery for introduction 

into interstate commerce of an eligible product after the expiration date provided by the manufacturer if— 

‘‘(A) the expiration date extension is intended to support the United States ability to protect— 

‘‘(i) the public health; or 

‘‘(ii) military preparedness and effectiveness; and 

‘‘(B) the expiration date extension is supported by an 

appropriate scientific evaluation that is conducted or 

accepted by the Secretary. 

‘‘(2) REQUIREMENTS AND CONDITIONS.—Any extension of an 

expiration date under paragraph (1) shall, as part of the extension, identify— 

‘‘(A) each specific lot, batch, or other unit of the product 

for which extended expiration is authorized; 

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

‘‘(C) any other requirements or conditions as the Secretary may deem appropriate for the protection of the public 

health, which may include requirements for, or conditions 

on, product sampling, storage, packaging or repackaging, 

transport, labeling, notice to product recipients, recordkeeping, periodic testing or retesting, or product disposition. 

‘‘(3) EFFECT.—Notwithstanding any other provision of this 

Act or the Public Health Service Act, an eligible product shall 
H. R. 307—24 

not be considered an unapproved product (as defined in section 

564(a)(2)(A)) and shall not be deemed adulterated or misbranded under this Act because, with respect to such product, 

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

date and authorized the introduction or delivery for introduction 

into interstate commerce of such product after the expiration 

date provided by the manufacturer. 

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

the term ‘expiration date’ means the date established through 

appropriate stability testing required by the regulations issued 

by the Secretary to ensure that the product meets applicable 

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

of use. 

‘‘(c) CURRENT GOOD MANUFACTURING PRACTICE.— 

‘‘(1) IN GENERAL.—The Secretary may, when the circumstances of a domestic, military, or public health emergency 

or material threat described in subsection (a)(1)(C) so warrant, 

authorize, with respect to an eligible product, deviations from 

current good manufacturing practice requirements otherwise 

applicable to the manufacture, processing, packing, or holding 

of products subject to regulation under this Act, including 

requirements under section 501 or 520(f)(1) or applicable conditions prescribed with respect to the eligible product by an 

order under section 520(f)(2). 

‘‘(2) EFFECT.—Notwithstanding any other provision of this 

Act or the Public Health Service Act, an eligible product shall 

not be considered an unapproved product (as defined in section 

564(a)(2)(A)) and shall not be deemed adulterated or misbranded under this Act because, with respect to such product, 

the Secretary has authorized deviations from current good 

manufacturing practices under paragraph (1). 

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

503(b) and 520(e) shall not apply to an eligible product, and the 

product shall not be considered an unapproved product (as defined 

in section 564(a)(2)(A)) and shall not be deemed adulterated or 

misbranded under this Act because it is dispensed without an 

individual prescription, if— 

‘‘(1) the product is dispensed during the circumstances 

described in subsection (a)(1)(C); and 

‘‘(2) such dispensing without an individual prescription 

occurs— 

‘‘(A) as permitted under the law of the State in which 

the product is dispensed; or 

‘‘(B) in accordance with an order issued by the Secretary, for the purposes and duration of the circumstances 

described in subsection (a)(1)(C). 

‘‘(e) EMERGENCY USE INSTRUCTIONS.— ‘‘(1) IN GENERAL.—The Secretary, acting through an appropriate official within the Department of Health and Human 

Services, may create and issue emergency use instructions to 

inform health care providers or individuals to whom an eligible 

product is to be administered concerning such product’s 

approved, licensed, or cleared conditions of use. 

‘‘(2) EFFECT.—Notwithstanding any other provisions of this 

Act or the Public Health Service Act, a product shall not be 

considered an unapproved product and shall not be deemed 

adulterated or misbranded under this Act because of the 
H. R. 307—25 

issuance of emergency use instructions under paragraph (1) 

with respect to such product or the introduction or delivery 

for introduction of such product into interstate commerce 

accompanied by such instructions— 

‘‘(A) during an emergency response to an actual emergency that is the basis for a determination described in 

subsection (a)(1)(C)(i); or 

‘‘(B) by a government entity (including a Federal, State, 

local, or tribal government entity), or a person acting on 

behalf of such a government entity, in preparation for 

an emergency response.’’. 

(c) RISK EVALUATION AND MITIGATION STRATEGIES.—Section 

505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

355–1), is amended— 

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

(2) by adding at the end the following: 

‘‘(k) WAIVER IN PUBLIC HEALTH EMERGENCIES.—The Secretary 

may waive any requirement of this section with respect to a qualified countermeasure (as defined in section 319F–1(a)(2) of the Public 

Health Service Act) to which a requirement under this section 

has been applied, if the Secretary determines that such waiver 

is required to mitigate the effects of, or reduce the severity of, 

the circumstances under which— 

‘‘(1) a determination described in subparagraph (A), (B), 

or (C) of section 564(b)(1) has been made by the Secretary 

of Homeland Security, the Secretary of Defense, or the Secretary, respectively; or 

‘‘(2) the identification of a material threat described in 

subparagraph (D) of section 564(b)(1) has been made pursuant 

to section 319F–2 of the Public Health Service Act.’’. 

(d) PRODUCTS HELD FOR EMERGENCY USE.—The Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended by 

inserting after section 564A, as added by subsection (b), the following: 

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

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

Public Health Service Act for a government entity (including a 

Federal, State, local, or tribal government entity), or a person 

acting on behalf of such a government entity, to introduce into 

interstate commerce a product (as defined in section 564(a)(4)) 

intended for emergency use, if that product— 

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

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

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

505, 510(k), or 515 of this Act or section 351 of the Public 

Health Service Act; 

‘‘(B) is authorized for investigational use under section 

505 or 520 of this Act or section 351 of the Public Health 

Service Act; or 

‘‘(C) is authorized for use under section 564.’’. 

SEC. 303. DEFINITIONS. 

Section 565 of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 360bbb–4) is amended by striking ‘‘The Secretary, in consultation’’ and inserting the following: 

‘‘(a) DEFINITIONS.—In this section— 
H. R. 307—26 

‘‘(1) the term ‘countermeasure’ means a qualified countermeasure, a security countermeasure, and a qualified pandemic 

or epidemic product; 

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

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

Act; 

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

given such term in section 319F–2 of such Act; and 

‘‘(4) the term ‘qualified pandemic or epidemic product’ 

means a product that meets the definition given such term 

in section 319F–3 of the Public Health Service Act and— 

‘‘(A) that has been identified by the Department of 

Health and Human Services or the Department of Defense 

as receiving funding directly related to addressing chemical, biological, radiological, or nuclear threats, including 

pandemic influenza; or 

‘‘(B) is included under this paragraph pursuant to a 

determination by the Secretary. 

‘‘(b) GENERAL DUTIES.—The Secretary, in consultation’’. 

SEC. 304. ENHANCING MEDICAL COUNTERMEASURE ACTIVITIES. 

Section 565 of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 360bbb–4), as amended by section 303, is further amended— 

(1) in the section heading, by striking ‘‘TECHNICAL ASSISTANCE’’ and inserting ‘‘COUNTERMEASURE DEVELOPMENT, 

REVIEW, AND TECHNICAL ASSISTANCE’’; 

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

and all that follows through ‘‘shall establish’’ and inserting 

the following: 

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

stockpiling, approval, licensure, and clearance of qualified countermeasures, security countermeasures, and qualified pandemic or epidemic products, the Secretary, in consultation with the Assistant 

Secretary for Preparedness and Response, shall— 

‘‘(1) ensure the appropriate involvement of Food and Drug 

Administration personnel in interagency activities related to 

countermeasure advanced research and development, consistent 

with sections 319F, 319F–1, 319F–2, 319F–3, 319L, and 2811 

of the Public Health Service Act; 

‘‘(2) ensure the appropriate involvement and consultation 

of Food and Drug Administration personnel in any flexible 

manufacturing activities carried out under section 319L of the 

Public Health Service Act, including with respect to meeting 

regulatory requirements set forth in this Act; 

‘‘(3) promote countermeasure expertise within the Food 

and Drug Administration by— 

‘‘(A) ensuring that Food and Drug Administration personnel involved in reviewing countermeasures for approval, 

licensure, or clearance are informed by the Assistant Secretary for Preparedness and Response on the material 

threat assessment conducted under section 319F–2 of the 

Public Health Service Act for the agent or agents for which 

the countermeasure under review is intended; 

‘‘(B) training Food and Drug Administration personnel 

regarding review of countermeasures for approval, licensure, or clearance; 
H. R. 307—27 

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

to encourage the exchange of scientific ideas; and 

‘‘(D) establishing protocols to ensure that countermeasure reviewers have sufficient training or experience 

with countermeasures; 

‘‘(4) maintain teams, composed of Food and Drug Administration personnel with expertise on countermeasures, including 

specific countermeasures, populations with special clinical 

needs (including children and pregnant women that may use 

countermeasures, as applicable and appropriate), classes or 

groups of countermeasures, or other countermeasure-related 

technologies and capabilities, that shall— 

‘‘(A) consult with countermeasure experts, including 

countermeasure sponsors and applicants, to identify and 

help resolve scientific issues related to the approval, licensure, or clearance of countermeasures, through workshops 

or public meetings; and 

‘‘(B) improve and advance the science relating to the 

development of new tools, standards, and approaches to 

assessing and evaluating countermeasures— 

‘‘(i) in order to inform the process for countermeasure approval, clearance, and licensure; and 

‘‘(ii) with respect to the development of countermeasures for populations with special clinical needs, 

including children and pregnant women, in order to 

meet the needs of such populations, as necessary and 

appropriate; and 

‘‘(5) establish’’; and 

(3) by adding at the end the following: 

‘‘(c) FINAL GUIDANCE ON DEVELOPMENT OF ANIMAL MODELS.— ‘‘(1) IN GENERAL.—Not later than 1 year after the date 

of the enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, the Secretary shall provide 

final guidance to industry regarding the development of animal 

models to support approval, clearance, or licensure of countermeasures referred to in subsection (a) when human efficacy 

studies are not ethical or feasible. 

‘‘(2) AUTHORITY TO EXTEND DEADLINE.—The Secretary may 

extend the deadline for providing final guidance under paragraph (1) by not more than 6 months upon submission by 

the Secretary of a report on the status of such guidance to 

the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, 

and Pensions of the Senate. 

‘‘(d) DEVELOPMENT AND ANIMAL MODELING PROCEDURES.— 

‘‘(1) AVAILABILITY OF ANIMAL MODEL MEETINGS.—To facilitate the timely development of animal models and support 

the development, stockpiling, licensure, approval, and clearance 

of countermeasures, the Secretary shall, not later than 180 

days after the enactment of this subsection, establish a procedure by which a sponsor or applicant that is developing a 

countermeasure for which human efficacy studies are not ethical or practicable, and that has an approved investigational 

new drug application or investigational device exemption, may 

request and receive— 

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

development activities; and 
H. R. 307—28 

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

studies. 

‘‘(2) PEDIATRIC MODELS.—To facilitate the development and 

selection of animal models that could translate to pediatric 

studies, any meeting conducted under paragraph (1) shall 

include discussion of animal models for pediatric populations, 

as appropriate. 

‘‘(e) REVIEW AND APPROVAL OF COUNTERMEASURES.— 

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

or submission for approval, licensure, or clearance of a countermeasure, the Secretary shall take into account the material 

threat posed by the chemical, biological, radiological, or nuclear 

agent or agents identified under section 319F–2 of the Public 

Health Service Act for which the countermeasure under review 

is intended. 

‘‘(2) REVIEW EXPERTISE.—When practicable and appropriate, teams of Food and Drug Administration personnel 

reviewing applications or submissions described under paragraph (1) shall include a reviewer with sufficient training or 

experience with countermeasures pursuant to the protocols 

established under subsection (b)(3)(D).’’. 

SEC. 305. REGULATORY MANAGEMENT PLANS. 

Section 565 of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 360bbb–4), as amended by section 304, is further amended 

by adding at the end the following: 

‘‘(f) REGULATORY MANAGEMENT PLAN.— ‘‘(1) DEFINITION.—In this subsection, the term ‘eligible 

countermeasure’ means— 

‘‘(A) a security countermeasure with respect to which 

the Secretary has entered into a procurement contract 

under section 319F–2(c) of the Public Health Service Act; 

or 

‘‘(B) a countermeasure with respect to which the Biomedical Advanced Research and Development Authority 

has provided funding under section 319L of the Public 

Health Service Act for advanced research and development. 

‘‘(2) REGULATORY MANAGEMENT PLAN PROCESS.—The Secretary, in consultation with the Assistant Secretary for 

Preparedness and Response and the Director of the Biomedical 

Advanced Research and Development Authority, shall establish 

a formal process for obtaining scientific feedback and interactions regarding the development and regulatory review of 

eligible countermeasures by facilitating the development of 

written regulatory management plans in accordance with this 

subsection. 

‘‘(3) SUBMISSION OF REQUEST AND PROPOSED PLAN BY

SPONSOR OR APPLICANT.— ‘‘(A) IN GENERAL.—A sponsor or applicant of an eligible 

countermeasure may initiate the process described under 

paragraph (2) upon submission of a written request to 

the Secretary. Such request shall include a proposed regulatory management plan. 

‘‘(B) TIMING OF SUBMISSION.—A sponsor or applicant 

may submit a written request under subparagraph (A) 

after the eligible countermeasure has an investigational 

new drug or investigational device exemption in effect. 
H. R. 307—29 

‘‘(C) RESPONSE BY SECRETARY.—The Secretary shall 

direct the Food and Drug Administration, upon submission 

of a written request by a sponsor or applicant under 

subparagraph (A), to work with the sponsor or applicant 

to agree on a regulatory management plan within a reasonable time not to exceed 90 days. If the Secretary determines 

that no plan can be agreed upon, the Secretary shall provide to the sponsor or applicant, in writing, the scientific 

or regulatory rationale why such agreement cannot be 

reached. 

‘‘(4) PLAN.—The content of a regulatory management plan 

agreed to by the Secretary and a sponsor or applicant shall 

include— 

‘‘(A) an agreement between the Secretary and the 

sponsor or applicant regarding developmental milestones 

that will trigger responses by the Secretary as described 

in subparagraph (B); 

‘‘(B) performance targets and goals for timely and 

appropriate responses by the Secretary to the triggers 

described under subparagraph (A), including meetings 

between the Secretary and the sponsor or applicant, written 

feedback, decisions by the Secretary, and other activities 

carried out as part of the development and review process; 

and 

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

if needed. 

‘‘(5) MILESTONES AND PERFORMANCE TARGETS.—The 

developmental milestones described in paragraph (4)(A) and 

the performance targets and goals described in paragraph (4)(B) 

shall include— 

‘‘(A) feedback from the Secretary regarding the data 

required to support the approval, clearance, or licensure 

of the eligible countermeasure involved; 

‘‘(B) feedback from the Secretary regarding the data 

necessary to inform any authorization under section 564; 

‘‘(C) feedback from the Secretary regarding the data 

necessary to support the positioning and delivery of the 

eligible countermeasure, including to the Strategic National 

Stockpile; 

‘‘(D) feedback from the Secretary regarding the data 

necessary to support the submission of protocols for review 

under section 505(b)(5)(B); 

‘‘(E) feedback from the Secretary regarding any gaps 

in scientific knowledge that will need resolution prior to 

approval, licensure, or clearance of the eligible countermeasure and plans for conducting the necessary scientific 

research; 

‘‘(F) identification of the population for which the 

countermeasure sponsor or applicant seeks approval, licensure, or clearance and the population for which desired 

labeling would not be appropriate, if known; and 

‘‘(G) as necessary and appropriate, and to the extent 

practicable, a plan for demonstrating safety and effectiveness in pediatric populations, and for developing pediatric 

dosing, formulation, and administration with respect to 

the eligible countermeasure, provided that such plan would 
H. R. 307—30 

not delay authorization under section 564, approval, licensure, or clearance for adults. 

‘‘(6) PRIORITIZATION.— 

‘‘(A) PLANS FOR SECURITY COUNTERMEASURES.—The 

Secretary shall establish regulatory management plans for 

all security countermeasures for which a request is submitted under paragraph (3)(A). 

‘‘(B) PLANS FOR OTHER ELIGIBLE COUNTERMEASURES.— 

The Secretary shall determine whether resources are available to establish regulatory management plans for eligible 

countermeasures that are not security countermeasures. 

If resources are available to establish regulatory management plans for eligible countermeasures that are not security countermeasures, and if resources are not available 

to establish regulatory management plans for all eligible 

countermeasures for which requests have been submitted, 

the Director of the Biomedical Advanced Research and 

Development Authority, in consultation with the Commissioner, shall prioritize which eligible countermeasures may 

receive regulatory management plans.’’. 

SEC. 306. REPORT. 

Section 565 of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 360bbb–4), as amended by section 305, is further amended 

by adding at the end the following: 

‘‘(g) ANNUAL REPORT.—Not later than 180 days after the date 

of enactment of this subsection, and annually thereafter, the Secretary shall make publicly available on the Web site of the Food 

and Drug Administration a report that details the countermeasure 

development and review activities of the Food and Drug Administration, including— 

‘‘(1) with respect to the development of new tools, standards, and approaches to assess and evaluate countermeasures— 

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

and Drug Administration and the progress made on such 

priorities; and 

‘‘(B) the identification of scientific gaps that impede 

the development, approval, licensure, or clearance of 

countermeasures for populations with special clinical needs, 

including children and pregnant women, and the progress 

made on resolving these challenges; 

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

management plan has been agreed upon under subsection (f), 

the extent to which the performance targets and goals set 

forth in subsection (f)(4)(B) and the regulatory management 

plan have been met, including, for each such countermeasure— 

‘‘(A) whether the regulatory management plan was 

completed within the required timeframe, and the length 

of time taken to complete such plan; 

‘‘(B) whether the Secretary adhered to the timely and 

appropriate response times set forth in such plan; and 

‘‘(C) explanations for any failure to meet such performance targets and goals; 

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

to subsection (b)(4), the number of products, classes of products, 

or technologies assigned to each such team, and the number 
H. R. 307—31 

of, type of, and any progress made as a result of consultations 

carried out under subsection (b)(4)(A); 

‘‘(4) an estimate of resources obligated to countermeasure 

development and regulatory assessment, including— 

‘‘(A) Center-specific objectives and accomplishments; 

and 

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

the Food and Drug Administration who directly support 

the review of countermeasures; 

‘‘(5) the number of countermeasure applications and 

submissions submitted, the number of countermeasures 

approved, licensed, or cleared, the status of remaining submitted applications and submissions, and the number of each 

type of authorization issued pursuant to section 564; 

‘‘(6) the number of written requests for a regulatory 

management plan submitted under subsection (f)(3)(A), the 

number of regulatory management plans developed, and the 

number of such plans developed for security countermeasures; 

and 

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

the Food and Drug Administration and— 

‘‘(A) sponsors of a countermeasure as defined in subsection (a); or 

‘‘(B) another agency engaged in development or 

management of portfolios for such countermeasures, 

including the Centers for Disease Control and Prevention, 

the Biomedical Advanced Research and Development 

Authority, the National Institutes of Health, and the appropriate agencies of the Department of Defense.’’. 

SEC. 307. PEDIATRIC MEDICAL COUNTERMEASURES. 

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

Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended— 

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

‘‘(5) CONSULTATION.—With respect to a drug that is a qualified countermeasure (as defined in section 319F–1 of the Public 

Health Service Act), a security countermeasure (as defined 

in section 319F–2 of the Public Health Service Act), or a qualified pandemic or epidemic product (as defined in section 319F– 

3 of the Public Health Service Act), the Secretary shall solicit 

input from the Assistant Secretary for Preparedness and 

Response regarding the need for and, from the Director of 

the Biomedical Advanced Research and Development Authority 

regarding the conduct of, pediatric studies under this section.’’; 

and 

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

‘‘(C) For a drug that is a qualified countermeasure 

(as defined in section 319F–1 of the Public Health Service 

Act), a security countermeasure (as defined in section 

319F–2 of the Public Health Service Act), or a qualified 

pandemic or epidemic product (as defined in section 319F– 

3 of such Act), in addition to any action with respect 

to such drug under subparagraph (A) or (B), the Secretary 

shall notify the Assistant Secretary for Preparedness and 

Response and the Director of the Biomedical Advanced 

Research and Development Authority of all pediatric 
H. R. 307—32 

studies in the written request issued by the Commissioner 

of Food and Drugs.’’. 

(b) ADDITION TO PRIORITY LIST CONSIDERATIONS.—Section 409I 

of the Public Health Service Act (42 U.S.C. 284m) is amended— 

(1) by striking subsection (a)(2) and inserting the following: 

‘‘(2) CONSIDERATION OF AVAILABLE INFORMATION.—In developing and prioritizing the list under paragraph (1), the Secretary— 

‘‘(A) shall consider— 

‘‘(i) therapeutic gaps in pediatrics that may include 

developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and 

biologics in children, and pediatric clinical trials; 

‘‘(ii) particular pediatric diseases, disorders or 

conditions where more complete knowledge and testing 

of therapeutics, including drugs and biologics, may be 

beneficial in pediatric populations; and 

‘‘(iii) the adequacy of necessary infrastructure to 

conduct pediatric pharmacological research, including 

research networks and trained pediatric investigators; 

and 

‘‘(B) may consider the availability of qualified countermeasures (as defined in section 319F–1), security countermeasures (as defined in section 319F–2), and qualified 

pandemic or epidemic products (as defined in section 319F– 

3) to address the needs of pediatric populations, in consultation with the Assistant Secretary for Preparedness and 

Response, consistent with the purposes of this section.’’; 

and 

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

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

(c) ADVICE AND RECOMMENDATIONS OF THE PEDIATRIC ADVISORY

COMMITTEE REGARDING COUNTERMEASURES FOR PEDIATRIC POPULATIONS.—Subsection (b)(2) of section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended— 

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

inserting ‘‘; and’’; and 

(2) by adding at the end the following: 

‘‘(D) the development of countermeasures (as defined 

in section 565(a) of the Federal Food, Drug, and Cosmetic 

Act) for pediatric populations.’’. 

TITLE IV—ACCELERATING MEDICAL 

COUNTERMEASURE ADVANCED RESEARCH AND DEVELOPMENT 

SEC. 401. BIOSHIELD. 

(a) PROCUREMENT OF COUNTERMEASURES.—Section 319F–2(c) 

of the Public Health Service Act (42 U.S.C. 247d–6b(c)) is 

amended— 

(1) in paragraph (1)(B)(i)(III)(bb), by striking ‘‘eight years’’ 

and inserting ‘‘10 years’’; 

(2) in paragraph (2)(C), by striking ‘‘the designated congressional committees (as defined in paragraph (10))’’ and inserting 

‘‘the appropriate committees of Congress’’; 
H. R. 307—33 

(3) in paragraph (5)(B)(ii), by striking ‘‘eight years’’ and 

inserting ‘‘10 years’’; 

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

(A) in the subparagraph heading, by striking ‘‘DESIGNATED CONGRESSIONAL COMMITTEES’’ and inserting 

‘‘APPROPRIATE CONGRESSIONAL COMMITTEES’’; and 

(B) by striking ‘‘the designated congressional committees’’ and inserting ‘‘the appropriate congressional committees’’; and 

(5) in paragraph (7)(C)— 

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

research and development,’’ after ‘‘as may reasonably be 

required,’’; 

(B) in clause (ii)— 

(i) in subclause (III), by striking ‘‘eight years’’ and 

inserting ‘‘10 years’’; and 

(ii) by striking subclause (IX) and inserting the 

following: 

‘‘(IX) CONTRACT TERMS.—The Secretary, in any 

contract for procurement under this section— 

‘‘(aa) may specify— 

‘‘(AA) the dosing and administration 

requirements for the countermeasure to 

be developed and procured; 

‘‘(BB) the amount of funding that will 

be dedicated by the Secretary for advanced 

research, development, and procurement 

of the countermeasure; and 

‘‘(CC) the specifications the countermeasure must meet to qualify for procurement under a contract under this section; 

and 

‘‘(bb) shall provide a clear statement of 

defined Government purpose limited to uses 

related to a security countermeasure, as 

defined in paragraph (1)(B).’’; and 

(C) by adding at the end the following: 

‘‘(viii) FLEXIBILITY.—In carrying out this section, 

the Secretary may, consistent with the applicable 

provisions of this section, enter into contracts and other 

agreements that are in the best interest of the Government in meeting identified security countermeasure 

needs, including with respect to reimbursement of the 

cost of advanced research and development as a reasonable, allowable, and allocable direct cost of the contract 

involved.’’. 

(b) REAUTHORIZATION OF THE SPECIAL RESERVE FUND.—Section 

319F–2 of the Public Health Service Act (42 U.S.C. 247d–6b) is 

amended— 

(1) in subsection (c)— 

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

(10)’’ each place it appears and inserting ‘‘special reserve 

fund as defined in subsection (h)’’; and 

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

(2) by adding at the end the following: 

‘‘(g) SPECIAL RESERVE FUND.— 
H. R. 307—34 

‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—In addition to 

amounts appropriated to the special reserve fund prior to the 

date of the enactment of this subsection, there is authorized 

to be appropriated, for the procurement of security countermeasures under subsection (c) and for carrying out section 

319L (relating to the Biomedical Advanced Research and 

Development Authority), $2,800,000,000 for the period of fiscal 

years 2014 through 2018. Amounts appropriated pursuant to 

the preceding sentence are authorized to remain available until 

September 30, 2019. 

‘‘(2) USE OF SPECIAL RESERVE FUND FOR ADVANCED

RESEARCH AND DEVELOPMENT.—The Secretary may utilize not 

more than 50 percent of the amounts authorized to be appropriated under paragraph (1) to carry out section 319L (related 

to the Biomedical Advanced Research and Development 

Authority). Amounts authorized to be appropriated under this 

subsection to carry out section 319L are in addition to amounts 

otherwise authorized to be appropriated to carry out such section. 

‘‘(3) RESTRICTIONS ON USE OF FUNDS.—Amounts in the special reserve fund shall not be used to pay costs other than 

payments made by the Secretary to a vendor for advanced 

development (under section 319L) or for procurement of a security countermeasure under subsection (c)(7). 

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

which the Secretary determines that the amount of funds in 

the special reserve fund available for procurement is less than 

$1,500,000,000, the Secretary shall submit to the appropriate 

committees of Congress a report detailing the amount of such 

funds available for procurement and the impact such reduction 

in funding will have— 

‘‘(A) in meeting the security countermeasure needs 

identified under this section; and 

‘‘(B) on the annual Public Health Emergency Medical 

Countermeasures Enterprise and Strategy Implementation 

Plan (pursuant to section 2811(d)). 

‘‘(h) DEFINITIONS.—In this section: 

‘‘(1) The term ‘advanced research and development’ has 

the meaning given such term in section 319L(a). 

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

Countermeasures’ appropriations account, any appropriation 

made available pursuant to section 521(a) of the Homeland 

Security Act of 2002, and any appropriation made available 

pursuant to subsection (g)(1).’’. 

SEC. 402. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT 

AUTHORITY. 

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

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

(1) in subparagraph (B)(iii), by inserting ‘‘(which may 

include advanced research and development for purposes of 

fulfilling requirements under the Federal Food, Drug, and Cosmetic Act or section 351 of this Act)’’ after ‘‘development’’; 

and 

(2) in subparagraph (D)(iii), by striking ‘‘and vaccine manufacturing technologies’’ and inserting ‘‘vaccine-manufacturing 
H. R. 307—35 

technologies, dose-sparing technologies, efficacy-increasing technologies, and platform technologies’’. 

(b) TRANSACTION AUTHORITIES.—Section 319L(c)(5) of the Public 

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

at the end the following: 

‘‘(G) GOVERNMENT PURPOSE.—In awarding contracts, 

grants, and cooperative agreements under this section, the 

Secretary shall provide a clear statement of defined Government purpose related to activities included in subsection 

(a)(6)(B) for a qualified countermeasure or qualified pandemic or epidemic product.’’. 

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

Service Act (42 U.S.C. 247d–7e(d)(2)) is amended to read as follows: 

‘‘(2) FUNDING.—To carry out the purposes of this section, 

there is authorized to be appropriated to the Fund $415,000,000 

for each of fiscal years 2014 through 2018, such amounts to 

remain available until expended.’’. 

(d) CONTINUED INAPPLICABILITY OF CERTAIN PROVISIONS.—Section 319L(e)(1)(C) of the Public Health Service Act (42 U.S.C. 247d– 

7e(e)(1)(C)) is amended by striking ‘‘7 years’’ and inserting ‘‘12 

years’’. 

(e) EXTENSION OF LIMITED ANTITRUST EXEMPTION.— 

(1) IN GENERAL.—Section 405(b) of the Pandemic and AllHazards Preparedness Act (42 U.S.C. 247d–6a note) is amended 

by striking ‘‘6-year’’ and inserting ‘‘12-year’’. 

(2) EFFECTIVE DATE.—This subsection shall take effect as 

if enacted on December 17, 2012. 

(f) INDEPENDENT EVALUATION.—Section 319L of the Public 

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

at the end the following: 

‘‘(f) INDEPENDENT EVALUATION.— 

‘‘(1) IN GENERAL.—Not later than 180 days after the date 

of enactment of this subsection, the Comptroller General of 

the United States shall conduct an independent evaluation 

of the activities carried out to facilitate flexible manufacturing 

capacity pursuant to this section. 

‘‘(2) REPORT.—Not later than 1 year after the date of enactment of this subsection, the Comptroller General of the United 

States shall submit to the appropriate committees of Congress 

a report concerning the results of the evaluation conducted 

under paragraph (1). Such report shall review and assess— 

‘‘(A) the extent to which flexible manufacturing 

capacity under this section is dedicated to chemical, 

biological, radiological, and nuclear threats; 

‘‘(B) the activities supported by flexible manufacturing 

initiatives; and 

‘‘(C) the ability of flexible manufacturing activities carried out under this section to— 

‘‘(i) secure and leverage leading technical expertise 

with respect to countermeasure advanced research, 

development, and manufacturing processes; and 

‘‘(ii) meet the surge manufacturing capacity needs 

presented by novel and emerging threats, including 

chemical, biological, radiological, and nuclear agents.’’. 

(g) DEFINITIONS.— 
H. R. 307—36 

(1) QUALIFIED COUNTERMEASURE.—Section 319F–1(a)(2)(A) 

of the Public Health Service Act (42 U.S.C. 247d–6a(a)(2)(A)) 

is amended— 

(A) in the matter preceding clause (i), by striking ‘‘to— 

’’ and inserting ‘‘—’’; 

(B) in clause (i)— 

(i) by striking ‘‘diagnose’’ and inserting ‘‘to 

diagnose’’; and 

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

(C) in clause (ii)— 

(i) by striking ‘‘diagnose’’ and inserting ‘‘to 

diagnose’’; and 

(ii) by striking the period at the end and inserting 

‘‘; or’’; and 

(D) by adding at the end the following: 

‘‘(iii) is a product or technology intended to enhance 

the use or effect of a drug, biological product, or device 

described in clause (i) or (ii).’’. 

(2) QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT.—Section 

319F–3(i)(7)(A) of the Public Health Service Act (42 U.S.C. 

247d–6d(i)(7)(A)) is amended— 

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

‘‘;’’; 

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

‘‘; or’’; and 

(C) by adding at the end the following: 

‘‘(iii) a product or technology intended to enhance 

the use or effect of a drug, biological product, or device 

described in clause (i) or (ii); and’’. 

(3) TECHNICAL AMENDMENTS.—Section 319F–3(i) of the 

Public Health Service Act (42 U.S.C. 247d–6d(i)) is amended— 

(A) in paragraph (1)(C), by inserting ‘‘, 564A, or 564B’’ 

after ‘‘564’’; and 

(B) in paragraph (7)(B)(iii), by inserting ‘‘, 564A, or 

564B’’ after ‘‘564’’. 

SEC. 403. STRATEGIC NATIONAL STOCKPILE. 

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

247d–6b) is amended— 

(1) in subsection (a)— 

(A) in paragraph (1)— 

(i) by inserting ‘‘consistent with section 2811’’ 

before ‘‘by the Secretary to be appropriate’’; and 

(ii) by inserting before the period at the end of 

the second sentence the following: ‘‘and shall submit 

such review annually to the appropriate congressional 

committees of jurisdiction to the extent that disclosure 

of such information does not compromise national security’’; and 

(B) in paragraph (2)(D), by inserting before the semicolon at the end the following: ‘‘and that the potential 

depletion of countermeasures currently in the stockpile 

is identified and appropriately addressed, including 

through necessary replenishment’’; and 

(2) in subsection (f)(1), by striking ‘‘$640,000,000 for fiscal 

year 2002, and such sums as may be necessary for each of 
H. R. 307—37 

fiscal years 2003 through 2006. Such authorization is in addition to amounts in the special reserve fund referred to in 

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

fiscal years 2014 through 2018. Such authorization is in addition to amounts in the special reserve fund referred to in 

subsection (h).’’. 

SEC. 404. NATIONAL BIODEFENSE SCIENCE BOARD. 

Section 319M(a) of the Public Health Service Act (42 U.S.C. 

247d–f(a)) is amended— 

(1) in paragraph (2)— 

(A) in subparagraph (D)— 

(i) in clause (i), by striking ‘‘and’’ at the end; 

(ii) in clause (ii), by striking the period and 

inserting a semicolon; and 

(iii) by adding at the end the following: 

‘‘(iii) one such member shall be an individual with 

pediatric subject matter expertise; and 

‘‘(iv) one such member shall be a State, tribal, 

territorial, or local public health official.’’; and 

(B) by adding at the end the following flush sentence: 

‘‘Nothing in this paragraph shall preclude a member of the 

Board from satisfying two or more of the requirements 

described in subparagraph (D).’’; and 

(2) in paragraph (5)— 

(A) in subparagraph (B), by striking ‘‘and’’ at the end; 

(B) in subparagraph (C), by striking the period and 

inserting ‘‘; and’’; and 

(C) by adding at the end the following: 

‘‘(D) provide any recommendation, finding, or report 

provided to the Secretary under this paragraph to the 

appropriate committees of Congress.’’. 

Speaker of the House of Representatives. 

Vice President of the United States and

President of the Senate.