H. R. 307—4 
(B) in paragraph (4), by adding at the end the following: 
‘‘(D) POLICY
COORDINATION
AND
STRATEGIC
DIREC-
TION.—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 emer-
gencies 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 med-
ical 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 Sec-
retary 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 appro-
priate. 
‘‘(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 counter-
measures 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 enter-
prise 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 Develop-
ment 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 Sec-
retary 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 sec-
tion 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 quali-
fied 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, antici-
pated 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 sec-
tion 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 subpara-
graph (C); 
‘‘(J) identify the use of authority and activities under-
taken 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 informa-
tion 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 one- 
year 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 Gen-
eral 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 med-
ical 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 sub-
sections (b)(7) and (d), the Secretary shall ensure that information 
and items that could compromise national security, contain con-
fidential 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, procure-
ment, 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 DISAS-
TERS. 
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 com-
mittee to be known as the ‘National Advisory Committee on Chil-
dren 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 prepared-
ness goals under section 2802(b). 
‘‘(c) ADDITIONAL DUTIES.—The Advisory Committee may provide 
advice and recommendations to the Secretary with respect to chil-
dren 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 mem-
bership 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 individ-
uals 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, terri-
torial, 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 Sep-
tember 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 subpara-
graph (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 Med-
ical 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 PER-
SONNEL 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 PER-
SONNEL DURING A PUBLIC HEALTH EMERGENCY.— 
‘‘(1) EMERGENCY REASSIGNMENT OF FEDERALLY FUNDED PER-
SONNEL.—Notwithstanding any other provision of law, and sub-
ject 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 imme-
diately 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 author-
ized 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 emer-
gency would be addressed more efficiently and effec-
tively 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 per-
sonnel 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 tem-
porary 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 tem-
porary 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 other-
wise 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 tem-
porary 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 per-
sonnel under paragraph (1), personnel eligible for reassign-
ment 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 per-
sonnel eligible for reassignment pursuant to an authoriza-
tion 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 sub-
section, including— 
‘‘(A) a description of how, and under what cir-
cumstances, 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 reassign-
ment; and
H. R. 307—13 
‘‘(E) recommendations on how medical surge capacity 
could be improved in responding to public health emer-
gencies 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 Sep-
tember 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 enti-
ties 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 identi-
fied under section 2802, including with respect to chem-
ical, 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 stake-
holders 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 States- 
Canada 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 occur-
ring or due to bioterrorism, consistent with the require-
ments 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 ‘‘capabili-
ties 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 devel-
oped 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 nec-
essary and appropriate, such pandemic influenza plan cri-
teria 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 sub-
sections (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 nec-
essary 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 ‘‘subpara-
graph (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 ‘‘sub-
section (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 VOL-
UNTEER 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 fol-
lowing: ‘‘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 appro-
priate, capacity and preparedness to address the needs of chil-
dren 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 Sys-
tems, 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 con-
sisting 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, evidence- 
based 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 BIOSURVEIL-
LANCE. 
(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 prepared-
ness 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 sub-
sections (c) through (f), respectively; 
(4) in subsection (c), as so redesignated— 
(A) in the subsection heading, by striking ‘‘PUBLIC 
HEALTH SITUATIONAL AWARENESS’’ and inserting ‘‘MODERN-
IZING PUBLIC HEALTH SITUATIONAL AWARENESS AND BIO-
SURVEILLANCE’’; 
(B) in paragraph (1)— 
(i) 
by 
striking 
‘‘Pandemic 
and 
All-Hazards 
Preparedness Act’’ and inserting ‘‘Pandemic and All- 
Hazards Preparedness Reauthorization Act of 2013’’; 
and 
(ii) by inserting ‘‘, novel emerging threats,’’ after 
‘‘disease outbreaks’’; 
(C) by striking paragraph (2) and inserting the fol-
lowing: 
‘‘(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 Sec-
retary 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 Serv-
ices.’’; 
(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 recommenda-
tions, regarding the measurable steps the Secretary should 
take to modernize and enhance biosurveillance activities pursu-
ant to the efforts of the Department of Health and Human 
Services to ensure comprehensive, real-time, all-hazards bio-
surveillance capabilities. In complying with the preceding sen-
tence, the National Biodefense Science Board shall— 
‘‘(A) identify the steps necessary to achieve a national 
biosurveillance system for human health, with inter-
national connectivity, where appropriate, that is predicated 
on State, regional, and community level capabilities and 
creates a networked system to allow for two-way informa-
tion 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 Con-
trol and Prevention, including such advisory committees 
consisting of representatives from State, local, and tribal 
public health authorities and appropriate public and pri-
vate 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 ‘‘sub-
section (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 ‘bio-
surveillance’ 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 situa-
tional 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 EMER-
GENCY 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 fol-
lows: 
‘‘(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 subpara-
graph (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 clear-
ance 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 prac-
ticable 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 collec-
tion 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 fol-
lowing 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 emer-
gency’’ 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 fol-
lows: 
‘‘(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 adminis-
tered 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 appro-
priate given the applicable circumstances described in sub-
section (b)(1)— 
‘‘(A) requirements regarding current good manufac-
turing practice otherwise applicable to the manufacture, 
processing, packing, or holding of products subject to regu-
lation under this Act, including such requirements estab-
lished 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 revoca-
tion 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 author-
izing a delay in the review or other consideration by the Sec-
retary 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 pro-
tecting the public health; and 
‘‘(B) the known and potential benefits of such cat-
egorization under the circumstances of the authorization 
outweigh the known and potential risks of the categoriza-
tion. 
‘‘(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 sub-
section 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 dec-
laration 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 expira-
tion date provided by the manufacturer if— 
‘‘(A) the expiration date extension is intended to sup-
port 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 exten-
sion, 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 Sec-
retary 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, record-
keeping, periodic testing or retesting, or product disposi-
tion. 
‘‘(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 mis-
branded 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 cir-
cumstances 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 condi-
tions 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 mis-
branded 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 Sec-
retary, 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 appro-
priate 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 emer-
gency 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 quali-
fied 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 Sec-
retary, 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 fol-
lowing: 
‘‘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 con-
sultation’’ and inserting the following: 
‘‘(a) DEFINITIONS.—In this section—
H. R. 307—26 
‘‘(1) the term ‘countermeasure’ means a qualified counter-
measure, 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 chem-
ical, 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 ASSIST-
ANCE’’ 
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 counter-
measures, security countermeasures, and qualified pandemic or epi-
demic 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 per-
sonnel involved in reviewing countermeasures for approval, 
licensure, or clearance are informed by the Assistant Sec-
retary 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, licen-
sure, 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 counter-
measure reviewers have sufficient training or experience 
with countermeasures; 
‘‘(4) maintain teams, composed of Food and Drug Adminis-
tration 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, licen-
sure, 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 counter-
measure approval, clearance, and licensure; and 
‘‘(ii) with respect to the development of counter-
measures 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 Prepared-
ness 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 counter-
measures 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 para-
graph (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 Rep-
resentatives 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 facili-
tate 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 proce-
dure by which a sponsor or applicant that is developing a 
countermeasure for which human efficacy studies are not eth-
ical 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 counter-
measure, 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 appro-
priate, teams of Food and Drug Administration personnel 
reviewing applications or submissions described under para-
graph (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 Bio-
medical 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 Sec-
retary, 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 inter-
actions 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 regu-
latory 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 reason-
able time not to exceed 90 days. If the Secretary determines 
that no plan can be agreed upon, the Secretary shall pro-
vide 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 counter-
measure and plans for conducting the necessary scientific 
research; 
‘‘(F) identification of the population for which the 
countermeasure sponsor or applicant seeks approval, licen-
sure, 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 effective-
ness 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, licen-
sure, 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 sub-
mitted under paragraph (3)(A). 
‘‘(B) PLANS FOR OTHER ELIGIBLE COUNTERMEASURES.— 
The Secretary shall determine whether resources are avail-
able to establish regulatory management plans for eligible 
countermeasures that are not security countermeasures. 
If resources are available to establish regulatory manage-
ment plans for eligible countermeasures that are not secu-
rity 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 Commis-
sioner, 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 Sec-
retary 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 Administra-
tion, including— 
‘‘(1) with respect to the development of new tools, stand-
ards, 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 perform-
ance 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 sub-
mitted 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 sub-
section (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 appro-
priate 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 quali-
fied 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 quali-
fied 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 devel-
oping and prioritizing the list under paragraph (1), the Sec-
retary— 
‘‘(A) shall consider— 
‘‘(i) therapeutic gaps in pediatrics that may include 
developmental pharmacology, pharmacogenetic deter-
minants 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 counter-
measures (as defined in section 319F–1), security counter-
measures (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 consulta-
tion 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 POPU-
LATIONS.—Subsection (b)(2) of section 14 of the Best Pharma-
ceuticals 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 
RE-
SEARCH 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 congres-
sional 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 ‘‘DES-
IGNATED
CONGRESSIONAL
COMMITTEES’’ 
and 
inserting 
‘‘APPROPRIATE CONGRESSIONAL COMMITTEES’’; and 
(B) by striking ‘‘the designated congressional commit-
tees’’ and inserting ‘‘the appropriate congressional commit-
tees’’; 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 counter-
measure must meet to qualify for procure-
ment 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 Govern-
ment in meeting identified security countermeasure 
needs, including with respect to reimbursement of the 
cost of advanced research and development as a reason-
able, 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 counter-
measures 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 appro-
priated 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 sec-
tion. 
‘‘(3) RESTRICTIONS ON USE OF FUNDS.—Amounts in the spe-
cial 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 secu-
rity 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 Cos-
metic Act or section 351 of this Act)’’ after ‘‘development’’; 
and 
(2) in subparagraph (D)(iii), by striking ‘‘and vaccine manu-
facturing technologies’’ and inserting ‘‘vaccine-manufacturing
H. R. 307—35 
technologies, dose-sparing technologies, efficacy-increasing tech-
nologies, 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 Govern-
ment purpose related to activities included in subsection 
(a)(6)(B) for a qualified countermeasure or qualified pan-
demic 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.—Sec-
tion 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 All- 
Hazards 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 enact-
ment 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 car-
ried 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 secu-
rity’’; and 
(B) in paragraph (2)(D), by inserting before the semi-
colon 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 addi-
tion 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 addi-
tion 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.