I 
112TH CONGRESS 
2D SESSION 
H. R. 6672 
To reauthorize certain programs under the Public Health Service Act and 
the Federal Food, Drug, and Cosmetic Act with respect to public health 
security and all-hazards preparedness and response, and for other pur-
poses. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 17, 2012 
Mr. ROGERS of Michigan (for himself, Mr. WAXMAN, Mr. PALLONE, Ms. 
ESHOO, Mr. BURGESS, Mr. TOWNS, Mr. GENE GREEN of Texas, Mr. 
PITTS, and Mr. UPTON) introduced the following bill; which was referred 
to the Committee on Energy and Commerce, and in addition to the Com-
mittee on Veterans’ Affairs, for a period to be subsequently determined 
by the Speaker, in each case for consideration of such provisions as fall 
within the jurisdiction of the committee concerned 
A BILL 
To reauthorize certain programs under the Public Health 
Service Act and the Federal Food, Drug, and Cosmetic 
Act with respect to public health security and all-hazards 
preparedness and response, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Pandemic and All-Hazards Preparedness Reauthoriza-
tion Act of 2012’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
TITLE I—STRENGTHENING NATIONAL PREPAREDNESS AND 
RESPONSE FOR PUBLIC HEALTH EMERGENCIES 
Sec. 101. National Health Security Strategy. 
Sec. 102. Assistant Secretary for Preparedness and Response. 
Sec. 103. National Advisory Committee on Children and Disasters. 
Sec. 104. Modernization of the National Disaster Medical System. 
Sec. 105. Continuing the role of the Department of Veterans Affairs. 
TITLE II—OPTIMIZING STATE AND LOCAL ALL-HAZARDS 
PREPAREDNESS AND RESPONSE 
Sec. 201. Temporary redeployment of federally funded personnel during a pub-
lic health emergency. 
Sec. 202. Improving State and local public health security. 
Sec. 203. Hospital preparedness and medical surge capacity. 
Sec. 204. Enhancing situational awareness and biosurveillance. 
Sec. 205. Eliminating duplicative Project Bioshield reports. 
TITLE III—ENHANCING MEDICAL COUNTERMEASURE REVIEW 
Sec. 301. Special protocol assessment. 
Sec. 302. Authorization for medical products for use in emergencies. 
Sec. 303. Definitions. 
Sec. 304. Enhancing medical countermeasure activities. 
Sec. 305. Regulatory management plans. 
Sec. 306. Report. 
Sec. 307. Pediatric medical countermeasures. 
TITLE IV—ACCELERATING MEDICAL COUNTERMEASURE 
ADVANCED RESEARCH AND DEVELOPMENT 
Sec. 401. BioShield. 
Sec. 402. Biomedical Advanced Research and Development Authority. 
Sec. 403. Strategic National Stockpile. 
Sec. 404. National Biodefense Science Board. 
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TITLE I—STRENGTHENING NA-
TIONAL PREPAREDNESS AND 
RESPONSE 
FOR 
PUBLIC 
HEALTH EMERGENCIES 
SEC. 101. NATIONAL HEALTH SECURITY STRATEGY. 
(a) IN GENERAL.—Section 2802 of the Public Health 
Service Act (42 U.S.C. 300hh–1) is amended— 
(1) in subsection (a)(1), by striking ‘‘2009’’ and 
inserting ‘‘2014’’; and 
(2) in subsection (b)— 
(A) in paragraph (1)(A), by inserting ‘‘, 
including drills and exercises to ensure medical 
surge capacity for events without notice’’ after 
‘‘exercises’’; and 
(B) in paragraph (3)— 
(i) in the matter preceding subpara-
graph (A)— 
(I) by striking ‘‘facilities), and 
trauma care’’ and inserting ‘‘and am-
bulatory care facilities and which may 
include dental health facilities), and 
trauma care, critical care,’’; and 
(II) by inserting ‘‘(including re-
lated availability, accessibility, and co-
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ordination)’’ 
after 
‘‘public 
health 
emergencies’’; 
(ii) in subparagraph (A), by inserting 
‘‘and trauma’’ after ‘‘medical’’; 
(iii) in subparagraph (B), by striking 
‘‘Medical evacuation and fatality manage-
ment’’ and inserting ‘‘Fatality manage-
ment’’; 
(iv) by redesignating subparagraphs 
(C), (D), and (E) as subparagraphs (D), 
(E), and (F), respectively; 
(v) by inserting after subparagraph 
(B), the following the new subparagraph: 
‘‘(C) Coordinated medical triage and evac-
uation to appropriate medical institutions based 
on patient medical need, taking into account re-
gionalized systems of care.’’; 
(vi) in subparagraph (E), as redesig-
nated by clause (iv), by inserting ‘‘(which 
may include such dental health assets)’’ 
after ‘‘medical assets’’; and 
(vii) by adding at the end the fol-
lowing: 
‘‘(G) Optimizing a coordinated and flexible 
approach to the medical surge capacity of hos-
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pitals, other health care facilities, critical care, 
and trauma care (which may include trauma 
centers) and emergency medical systems.’’; 
(C) in paragraph (4)— 
(i) in subparagraph (A), by inserting 
‘‘, including the unique needs and consider-
ations of individuals with disabilities,’’ 
after ‘‘medical needs of at-risk individ-
uals’’; and 
(ii) in subparagraph (B), by inserting 
‘‘the’’ before ‘‘purpose of this section’’; and 
(D) by adding at the end the following: 
‘‘(7) COUNTERMEASURES.— 
‘‘(A) Promoting strategic initiatives to ad-
vance countermeasures to diagnose, mitigate, 
prevent, or treat harm from any biological 
agent or toxin, chemical, radiological, or nuclear 
agent or agents, whether naturally occurring, 
unintentional, or deliberate. 
‘‘(B) For purposes of this paragraph, the 
term ‘countermeasures’ has the same meaning 
as the terms ‘qualified countermeasures’ under 
section 319F–1, ‘qualified pandemic and epi-
demic products’ under section 319F–3, and ‘se-
curity countermeasures’ under section 319F–2. 
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‘‘(8) MEDICAL AND PUBLIC HEALTH COMMU-
NITY
RESILIENCY.—Strengthening the ability of 
States, local communities, and tribal communities to 
prepare for, respond to, and be resilient in the event 
of public health emergencies, whether naturally oc-
curring, unintentional, or deliberate by— 
‘‘(A) optimizing alignment and integration 
of medical and public health preparedness and 
response planning and capabilities with and into 
routine daily activities; and 
‘‘(B) promoting familiarity with local med-
ical and public health systems.’’. 
(b) AT-RISK INDIVIDUALS.—Section 2814 of the 
Public Health Service Act (42 U.S.C. 300hh–16) is 
amended— 
(1) by striking paragraphs (5), (7), and (8); 
(2) 
in 
paragraph 
(4), 
by 
striking 
‘‘2811(b)(3)(B)’’ and inserting ‘‘2802(b)(4)(B)’’; 
(3) by redesignating paragraphs (1) through 
(4) as paragraphs (2) through (5), respectively; 
(4) by inserting before paragraph (2) (as so re-
designated), the following: 
‘‘(1) monitor emerging issues and concerns as 
they relate to medical and public health prepared-
ness and response for at-risk individuals in the event 
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of a public health emergency declared by the Sec-
retary under section 319;’’; 
(5) by amending paragraph (2) (as so redesig-
nated) to read as follows: 
‘‘(2) oversee the implementation of the pre-
paredness goals described in section 2802(b) with re-
spect to the public health and medical needs of at- 
risk individuals in the event of a public health emer-
gency, as described in section 2802(b)(4);’’; 
(6) by inserting after paragraph (6), the fol-
lowing: 
‘‘(7) disseminate and, as appropriate, update 
novel and best practices of outreach to and care of 
at-risk individuals before, during, and following pub-
lic health emergencies in as timely a manner as is 
practicable, including from the time a public health 
threat is identified; and 
‘‘(8) ensure that public health and medical in-
formation distributed by the Department of Health 
and Human Services during a public health emer-
gency is delivered in a manner that takes into ac-
count the range of communication needs of the in-
tended recipients, including at-risk individuals.’’. 
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SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND 
RESPONSE. 
(a) IN GENERAL.—Section 2811 of the Public Health 
Service Act (42 U.S.C. 300hh–10) is amended— 
(1) in subsection (b)— 
(A) in paragraph (3), by inserting ‘‘, secu-
rity countermeasures (as defined in section 
319F–2),’’ after ‘‘qualified countermeasures (as 
defined in section 319F–1)’’; 
(B) in paragraph (4), by adding at the end 
the following: 
‘‘(D) POLICY
COORDINATION
AND
STRA-
TEGIC
DIRECTION.—Provide integrated policy 
coordination and strategic direction with re-
spect to all matters related to Federal public 
health and medical preparedness and execution 
and deployment of the Federal response for 
public health emergencies and incidents covered 
by the National Response Plan developed pur-
suant to section 504(6) of the Homeland Secu-
rity Act of 2002, or any successor plan, before, 
during, and following public health emergencies. 
‘‘(E) IDENTIFICATION
OF
INEFFICIEN-
CIES.—Identify and minimize gaps, duplication, 
and other inefficiencies in medical and public 
health preparedness and response activities and 
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the actions necessary to overcome these obsta-
cles. 
‘‘(F) COORDINATION
OF
GRANTS
AND 
AGREEMENTS.—Align and coordinate medical 
and public health grants and cooperative agree-
ments as applicable to preparedness and re-
sponse activities authorized under this Act, to 
the extent possible, including program require-
ments, timelines, and measurable goals, and in 
consultation with the Secretary of Homeland 
Security, to— 
‘‘(i) optimize and streamline medical 
and public health preparedness and re-
sponse capabilities and the ability of local 
communities to respond to public health 
emergencies; and 
‘‘(ii) gather and disseminate best 
practices among grant and cooperative 
agreement recipients, as appropriate. 
‘‘(G) DRILL
AND
OPERATIONAL
EXER-
CISES.—Carry out drills and operational exer-
cises, in consultation with the Department of 
Homeland Security, the Department of De-
fense, the Department of Veterans Affairs, and 
other applicable Federal departments and agen-
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cies, as necessary and appropriate, to identify, 
inform, and address gaps in and policies related 
to all-hazards medical and public health pre-
paredness and response, including exercises 
based on— 
‘‘(i) identified threats for which coun-
termeasures are available and for which no 
countermeasures are available; and 
‘‘(ii) unknown threats for which no 
countermeasures are available. 
‘‘(H) NATIONAL SECURITY PRIORITY.—On 
a periodic basis consult with, as applicable and 
appropriate, the Assistant to the President for 
National Security Affairs, to provide an update 
on, and discuss, medical and public health pre-
paredness and response activities pursuant to 
this Act and the Federal Food, Drug, and Cos-
metic Act, including progress on the develop-
ment, approval, clearance, and licensure of 
medical countermeasures.’’; and 
(C) by adding at the end the following: 
‘‘(7) COUNTERMEASURES BUDGET PLAN.—De-
velop, and update on an annual basis, a coordinated 
5-year budget plan based on the medical counter-
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measure priorities described in subsection (d). Each 
such plan shall— 
‘‘(A) include consideration of the entire 
medical countermeasures enterprise, includ-
ing— 
‘‘(i) basic research and advanced re-
search and development; 
‘‘(ii) approval, clearance, licensure, 
and authorized uses of products; and 
‘‘(iii) procurement, stockpiling, main-
tenance, 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 to-
ward identified priorities; 
‘‘(C) identify medical countermeasure life- 
cycle costs to inform planning, budgeting, and 
anticipated needs within the continuum of the 
medical countermeasure enterprise consistent 
with section 319F–2; and 
‘‘(D) be made available to the appropriate 
committees of Congress upon request.’’; 
(2) by striking subsection (c) and inserting the 
following: 
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‘‘(c) FUNCTIONS.—The Assistant Secretary for Pre-
paredness and Response shall— 
‘‘(1) have lead responsibility within the Depart-
ment 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 Coopera-
tive Agreement Program pursuant to section 
319C–2; 
‘‘(C) the Biomedical Advanced Research 
and Development Authority pursuant to section 
319L; 
‘‘(D) the Medical Reserve Corps pursuant 
to section 2813; 
‘‘(E) the Emergency System for Advance 
Registration of Volunteer Health Professionals 
pursuant to section 319I; and 
‘‘(F) administering grants and related au-
thorities related to trauma care under parts A 
through C of title XII, such authority to be 
transferred by the Secretary from the Adminis-
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trator of the Health Resources and Services Ad-
ministration to such Assistant Secretary; 
‘‘(3) exercise the responsibilities and authorities 
of the Secretary with respect to the coordination 
of— 
‘‘(A) the Public Health Emergency Pre-
paredness Cooperative Agreement Program pur-
suant to section 319C–1; 
‘‘(B) the Strategic National Stockpile pur-
suant to section 319F–2; and 
‘‘(C) the Cities Readiness Initiative; and 
‘‘(4) assume other duties as determined appro-
priate by the Secretary.’’; and 
(3) by adding at the end the following: 
‘‘(d) PUBLIC HEALTH EMERGENCY MEDICAL COUN-
TERMEASURES ENTERPRISE STRATEGY AND IMPLEMEN-
TATION 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 coordi-
nated strategy and accompanying implementation 
plan for medical countermeasures to address chem-
ical, biological, radiological, and nuclear threats. In 
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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 Commis-
sioner 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 para-
graph (1) shall— 
‘‘(A) describe the chemical, biological, radi-
ological, and nuclear agent or agents that may 
present a threat to the Nation and the cor-
responding efforts to develop qualified counter-
measures (as defined in section 319F–1), secu-
rity countermeasures (as defined in section 
319F–2), or qualified pandemic or epidemic 
products (as defined in section 319F–3) for 
each threat; 
‘‘(B) evaluate the progress of all activities 
with respect to such countermeasures or prod-
ucts, including research, advanced research, de-
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velopment, procurement, stockpiling, deploy-
ment, distribution, and utilization; 
‘‘(C) identify and prioritize near-, mid-, 
and long-term needs with respect to such coun-
termeasures or products to address a chemical, 
biological, radiological, and nuclear threat or 
threats; 
‘‘(D) identify, with respect to each cat-
egory of threat, a summary of all awards and 
contracts, including advanced research and de-
velopment and procurement, that includes— 
‘‘(i) the time elapsed from the 
issuance of the initial solicitation or re-
quest for a proposal to the adjudication 
(such as the award, denial of award, or so-
licitation termination); and 
‘‘(ii) an identification of projected 
timelines, anticipated funding allocations, 
benchmarks, and milestones for each med-
ical countermeasure priority under sub-
paragraph (C), including projected needs 
with regard to replenishment of the Stra-
tegic National Stockpile; 
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‘‘(E) be informed by the recommendations 
of the National Biodefense Science Board pur-
suant to section 319M; 
‘‘(F) evaluate progress made in meeting 
timelines, allocations, benchmarks, and mile-
stones identified under subparagraph (D)(ii); 
‘‘(G) report on the amount of funds avail-
able for procurement in the special reserve fund 
as defined in section 319F–2(h) and the impact 
this funding will have on meeting the require-
ments 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 Stockpile, including by addressing the 
needs of pediatric populations with respect to 
such countermeasures and products in the Stra-
tegic National Stockpile, including— 
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‘‘(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 Ad-
ministration to maximize the labeling, dos-
ages, and formulations of such counter-
measures and products for pediatric popu-
lations; 
‘‘(iii) a description of existing gaps in 
the Strategic National Stockpile and the 
development of such countermeasures and 
products to address the needs of pediatric 
populations; and 
‘‘(iv) an evaluation of the progress 
made in addressing priorities identified 
pursuant to subparagraph (C); 
‘‘(J) identify the use of authority and ac-
tivities undertaken pursuant to sections 319F– 
1(b)(1), 319F–1(b)(2), 319F–1(b)(3), 319F– 
1(c), 
319F–1(d), 
319F–1(e), 
319F– 
2(c)(7)(C)(iii), 
319F–2 
(c)(7)(C)(iv), 
and 
319F–2(c)(7)(C)(v) of this Act, and subsections 
(a)(1), (b)(1), and (e) of section 564 of the 
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Federal Food, Drug, and Cosmetic Act, by 
summarizing— 
‘‘(i) the particular actions that were 
taken under the authorities specified, in-
cluding, as applicable, the identification of 
the threat agent, emergency, or the bio-
medical countermeasure with respect to 
which the authority was used; 
‘‘(ii) the reasons underlying the deci-
sion to use such authorities, including, as 
applicable, the options that were consid-
ered and rejected with respect to the use of 
such authorities; 
‘‘(iii) the number of, nature of, and 
other information concerning the persons 
and entities that received a grant, coopera-
tive agreement, or contract pursuant to the 
use of such authorities, and the persons 
and entities that were considered and re-
jected for such a grant, cooperative agree-
ment, 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 Presi-
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dent under section 319F–2(c)(6), a con-
tract 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 Strategy and Im-
plementation Plan, the Comptroller General of 
the United States shall conduct an independent 
evaluation, and submit to the appropriate com-
mittees of Congress a report, concerning such 
Strategy and Implementation Plan. 
‘‘(B) CONTENT.—The report described in 
subparagraph (A) shall review and assess— 
‘‘(i) the near-term, mid-term, and 
long-term medical countermeasure needs 
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and identified priorities of the Federal 
Government pursuant to paragraph (2)(C); 
‘‘(ii) the activities of the Department 
of Health and Human Services with re-
spect to advanced research and develop-
ment pursuant to section 319L; and 
‘‘(iii) the progress made toward meet-
ing the timelines, allocations, benchmarks, 
and milestones identified in the Public 
Health 
Emergency 
Medical 
Counter-
measures Enterprise Strategy and Imple-
mentation Plan under this subsection. 
‘‘(e) PROTECTION OF NATIONAL SECURITY.—In car-
rying out subsections (b)(7) and (d), the Secretary shall 
ensure that information and items that could compromise 
national security, contain confidential commercial infor-
mation, or contain proprietary information are not dis-
closed.’’. 
(b) INTERAGENCY COORDINATION PLAN.—In the 
first Public Health Emergency Countermeasures Enter-
prise 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 
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a description of the manner in which the Department of 
Health and Human Services is coordinating with the De-
partment 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, develop-
ment, procurement, stockpiling, and distribution of 
countermeasures to meet identified needs; and 
(2) the coordination of efforts between the De-
partment of Health and Human Services and the 
Department of Defense to address countermeasure 
needs for various segments of the population. 
SEC. 103. NATIONAL ADVISORY COMMITTEE ON CHILDREN 
AND DISASTERS. 
Subtitle B of title XXVIII of the Public Health Serv-
ice Act (42 U.S.C. 300hh et seq.) is amended by inserting 
after section 2811 the following: 
‘‘SEC. 2811A. NATIONAL ADVISORY COMMITTEE ON CHIL-
DREN AND DISASTERS. 
‘‘(a) ESTABLISHMENT.—The Secretary, in consulta-
tion with the Secretary of Homeland Security, shall estab-
lish an advisory committee to be known as the ‘National 
Advisory Committee on Children and Disasters’ (referred 
to in this section as the ‘Advisory Committee’). 
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‘‘(b) DUTIES.—The Advisory Committee shall— 
‘‘(1) provide advice and consultation with re-
spect 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 re-
covery from all-hazards emergencies; and 
‘‘(3) provide advice and consultation with re-
spect to State emergency preparedness and response 
activities and children, including related drills and 
exercises pursuant to the preparedness goals under 
section 2802(b). 
‘‘(c) ADDITIONAL DUTIES.—The Advisory Committee 
may provide advice and recommendations to the Secretary 
with respect to children and the medical and public health 
grants and cooperative agreements as applicable to pre-
paredness and response activities authorized under this 
title and title III. 
‘‘(d) MEMBERSHIP.— 
‘‘(1) IN GENERAL.—The Secretary, in consulta-
tion with such other Secretaries as may be appro-
priate, shall appoint not to exceed 15 members to 
the Advisory Committee. In appointing such mem-
bers, the Secretary shall ensure that the total mem-
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bership of the Advisory Committee is an odd num-
ber. 
‘‘(2) REQUIRED MEMBERS.—The Secretary, in 
consultation with such other Secretaries as may be 
appropriate, may appoint to the Advisory Committee 
under paragraph (1) such individuals as may be ap-
propriate to perform the duties described in sub-
sections (b) and (c), which may include— 
‘‘(A) the Assistant Secretary for Prepared-
ness and Response; 
‘‘(B) the Director of the Biomedical Ad-
vanced Research and Development Authority; 
‘‘(C) the Director of the Centers for Dis-
ease Control and Prevention; 
‘‘(D) the Commissioner of Food and 
Drugs; 
‘‘(E) the Director of the National Insti-
tutes of Health; 
‘‘(F) the Assistant Secretary of the Admin-
istration 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 
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disaster planning, preparedness, response, or 
recovery; 
‘‘(I) at least two representatives from 
State, local, territorial, or tribal agencies with 
expertise in pediatric disaster planning, pre-
paredness, 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 sub-
sections (b) and (c). 
‘‘(e) MEETINGS.—The Advisory Committee shall 
meet not less than biannually. 
‘‘(f) SUNSET.—The Advisory Committee shall termi-
nate on the date that is 5 years after the date of enact-
ment of the Pandemic and All-Hazards Preparedness Re-
authorization Act of 2012.’’. 
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 ap-
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plicable’’ after ‘‘victims of a public health emer-
gency’’; 
(B) by redesignating subparagraph (C) as 
subparagraph (E); and 
(C) by inserting after subparagraph (B), 
the following: 
‘‘(C) CONSIDERATIONS FOR AT-RISK POPU-
LATIONS.—The Secretary shall take steps to 
ensure that an appropriate specialized and fo-
cused range of public health and medical capa-
bilities are represented in the National Disaster 
Medical System, which take into account the 
needs of at-risk individuals, in the event of a 
public health emergency.’’. 
‘‘(D) ADMINISTRATION.—The Secretary 
may determine and pay claims for reimburse-
ment for services under subparagraph (A) di-
rectly or through contracts that provide for 
payment in advance or by way of reimburse-
ment.’’; 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 2013 through 2017’’. 
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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 2013 through 2017 to carry out this section’’. 
TITLE 
II—OPTIMIZING 
STATE 
AND 
LOCAL 
ALL-HAZARDS 
PREPAREDNESS 
AND 
RE-
SPONSE 
SEC. 201. TEMPORARY REDEPLOYMENT OF FEDERALLY 
FUNDED 
PERSONNEL 
DURING 
A 
PUBLIC 
HEALTH EMERGENCY. 
Section 319 of the Public Health Service Act (42 
U.S.C. 247d) is amended by adding at the end the fol-
lowing: 
‘‘(e) TEMPORARY REDEPLOYMENT OF FEDERALLY 
FUNDED PERSONNEL DURING A PUBLIC HEALTH EMER-
GENCY.— 
‘‘(1) EMERGENCY REDEPLOYMENT OF FEDER-
ALLY
FUNDED
PERSONNEL.—Notwithstanding any 
other provision of law, and subject to paragraph (2), 
upon request by the Governor of a State or the chief 
of a tribe or such Governor or chief’s designee, the 
Secretary may authorize the requesting State or 
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tribe to temporarily redeploy, for purposes of imme-
diately addressing a public health emergency in the 
State or tribe, non-Federal personnel funded in 
whole or in part through, as appropriate, programs 
under this Act. 
‘‘(2) ACTIVATION OF EMERGENCY REDEPLOY-
MENT.— 
‘‘(A) PUBLIC HEALTH EMERGENCY.—The 
Secretary may authorize a temporary redeploy-
ment 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 redeployment of per-
sonnel under paragraph (1), the Governor of a 
State or the chief of a tribe shall submit to the 
Secretary a request for such authority 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 tribe cannot be 
adequately and appropriately addressed by 
the public health workforce otherwise avail-
able. 
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‘‘(ii) An assurance that the public 
health emergency would be addressed more 
efficiently and effectively through the re-
quested temporary redeployment of per-
sonnel. 
‘‘(iii) An assurance that the requested 
temporary redeployment of personnel is 
consistent with the any applicable All-Haz-
ards Public Health Emergency Prepared-
ness and Response Plan under section 
319C–1. 
‘‘(iv) An identification of— 
‘‘(I) each Federal program from 
which personnel would be temporarily 
redeployed pursuant to the requested 
authority; and 
‘‘(II) the number of personnel 
who would be so redeployed from each 
such program. 
‘‘(v) Such other information and as-
surances as the Secretary may require. 
‘‘(C) CONSIDERATION.—In reviewing a re-
quest for temporary redeployment under para-
graph (1) of personnel funded through a Fed-
eral program, the Secretary shall consider the 
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degree to which the program would be adversely 
affected by the redeployment. 
‘‘(D) TERMINATION AND EXTENSION.— 
‘‘(i) 
TERMINATION.—A 
State 
or 
tribe’s authority for a temporary redeploy-
ment of personnel under paragraph (1) 
shall terminate upon the earlier of the fol-
lowing: 
‘‘(I) The Secretary’s determina-
tion that the public health emergency 
no longer exists. 
‘‘(II) Subject to clause (ii), the 
expiration of the 30-day period fol-
lowing the date on which the Sec-
retary approved the State or tribe’s 
request for such authority. 
‘‘(ii) EXTENSION
AUTHORITY.—The 
Secretary may extend the authority to au-
thorize a temporary redeployment of per-
sonnel under paragraph (1) beyond the 
date otherwise applicable under clause 
(i)(II) if the public health emergency still 
exists as of such date, but only if— 
‘‘(I) the State or tribe that sub-
mitted the initial request for authority 
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for a temporary redeployment of per-
sonnel submits a request for an exten-
sion of such authority; and 
‘‘(II) the request for an extension 
contains the same type of information 
and assurances necessary for the ap-
proval of an initial request for such 
authority. 
‘‘(3) NOTICE TO PERSONNEL OF POSSIBILITY 
OF
REDEPLOYMENT.—The Secretary shall ensure 
that, if a State or tribe receives Federal funds for 
personnel who are subject to the Secretary’s rede-
ployment authority under this subsection, the State 
or tribe gives notice to such personnel of the possi-
bility of redeployment— 
‘‘(A) at the time of hiring; or 
‘‘(B) in the case of personnel hired before 
the date of the enactment of this subsection, as 
soon as practicable. 
‘‘(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 authority for a 
temporary redeployment of personnel; and 
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‘‘(B) any request for an extension of such 
authority. 
‘‘(5) GUIDANCE.—The Secretary shall— 
‘‘(A) not later than 6 months after the en-
actment of this subsection, issue proposed guid-
ance on the temporary redeployment of per-
sonnel under this subsection; and 
‘‘(B) after providing notice and a 60-day 
period for public comment, finalize such guid-
ance. 
‘‘(6) REPORT TO CONGRESS.—Not later than 4 
years after the date of enactment of the Pandemic 
and All-Hazards Preparedness Reauthorization Act 
of 2012, the Comptroller General of the United 
States shall conduct an independent evaluation, and 
submit to the appropriate committees of the Con-
gress a report, on the Secretary’s authority under 
this subsection, including— 
‘‘(A) a description of how, and under what 
circumstances, such authority has been used by 
States and tribes; 
‘‘(B) an analysis of how such authority has 
assisted States and tribes in responding to pub-
lic health emergencies; 
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‘‘(C) an evaluation of how such authority 
has improved operational efficiencies in re-
sponding to public health emergencies; 
‘‘(D) an analysis of the extent to which, if 
any, Federal programs from which personnel 
have been temporarily redeployed pursuant to 
such authority have been adversely affected by 
the redeployment; and 
‘‘(E) recommendations on how such au-
thority could be improved to further assist in 
responding to public health emergencies. 
‘‘(7) DEFINITION.—In this subsection, 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.—The authority under this sub-
section shall terminate on the date that is 5 years 
after the date of enactment of the Pandemic and 
All-Hazards Preparedness Reauthorization Act of 
2012.’’. 
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— 
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(1) in subsection (b)(1)(C), by striking ‘‘consor-
tium of entities described in subparagraph (A)’’ and 
inserting ‘‘consortium of States’’; 
(2) in subsection (b)(2)— 
(A) in subparagraph (A)— 
(i) by striking clauses (i) and (ii) and 
inserting the following: 
‘‘(i) a description of the activities such 
entity will carry out under the agreement 
to meet the goals identified under section 
2802, including with respect to chemical, 
biological, radiological, or nuclear threats, 
whether naturally occurring, unintentional, 
or deliberate; 
‘‘(ii) a description of the activities 
such entity will carry out with respect to 
pandemic influenza, as a component of the 
activities carried out under clause (i), and 
consistent with the requirements of para-
graphs (2) and (5) of subsection (g);’’; 
(ii) in clause (iv), by striking ‘‘and’’ at 
the end; and 
(iii) by adding at the end the fol-
lowing: 
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‘‘(vi) a description of how, as appro-
priate, the entity may partner with rel-
evant public and private stakeholders in 
public health emergency preparedness and 
response; 
‘‘(vii) a description of how the entity, 
as applicable and appropriate, will coordi-
nate with State emergency preparedness 
and response plans in public health emer-
gency preparedness, including State edu-
cational agencies (as defined in section 
9101(41) of the Elementary and Sec-
ondary Education Act of 1965) and State 
child care lead agencies (designated under 
section 658D of the Child Care and Devel-
opment Block Grant Act of 1990); 
‘‘(viii) in the case of entities that op-
erate on the United States-Mexico border 
or the United States-Canada border, a de-
scription of the activities such entity will 
carry out under the agreement that are 
specific to the border area including dis-
ease detection, identification, investigation, 
and preparedness and response activities 
related to emerging diseases and infectious 
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disease outbreaks whether naturally occur-
ring or due to bioterrorism, consistent with 
the requirements of this section; and 
‘‘(ix) a description of any activities 
that such entity will use to analyze real- 
time clinical specimens for pathogens of 
public health or bioterrorism significance, 
including any utilization of poison control 
centers;’’; and 
(B) in subparagraph (C), by inserting ‘‘, 
including addressing the needs of at-risk indi-
viduals,’’ after ‘‘capabilities of such entity’’; 
(3) in subsection (f)— 
(A) in paragraph (2), by adding ‘‘and’’ at 
the end; 
(B) in paragraph (3), by striking ‘‘; and’’ 
and inserting a period; and 
(C) by striking paragraph (4); 
(4) in subsection (g)— 
(A) in paragraph (1), by striking subpara-
graph (A) and inserting the following: 
‘‘(A) include outcome goals representing 
operational achievements of the National Pre-
paredness 
Goals 
developed 
under 
section 
2802(b) with respect to all-hazards, including 
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chemical, biological, radiological, or nuclear 
threats; and’’; and 
(B) in paragraph (2)(A), by adding at the 
end the following: ‘‘The Secretary shall periodi-
cally update, as necessary and appropriate, 
such pandemic influenza plan criteria and shall 
require the integration of such criteria into the 
benchmarks and standards described in para-
graph (1).’’; 
(5) by striking subsection (h); 
(6) in subsection (i)— 
(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 2013’’; 
and 
(II) by striking ‘‘such sums as 
may be necessary for each of fiscal 
years 2008 through 2011’’ and insert-
ing ‘‘$641,900,000 for each of fiscal 
years 2014 through 2017’’; 
(ii) by striking subparagraph (B); 
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(iii) by redesignating subparagraphs 
(C) and (D) as subparagraphs (B) and 
(C), respectively; and 
(iv) in subparagraph (C), as so redes-
ignated, by striking ‘‘subparagraph (C)’’ 
and inserting ‘‘subparagraph (B)’’; 
(B) in subparagraphs (C) and (D) of para-
graph (3), by striking ‘‘(1)(A)(i)(I)’’ each place 
it appears and inserting ‘‘(1)(A)’’; 
(C) in paragraph (4)(B), by striking ‘‘sub-
section (c)’’ and inserting ‘‘subsection (b)’’; and 
(D) by adding at the end the following: 
‘‘(7) AVAILABILITY
OF
COOPERATIVE
AGREE-
MENT FUNDS.— 
‘‘(A) IN GENERAL.—Amounts provided to 
an eligible entity under a cooperative agreement 
under subsection (a) for a fiscal year and re-
maining 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 
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achieving the benchmarks and submitting the 
pandemic influenza plan as described in sub-
section (g).’’; and 
(7) in subsection (j), by striking paragraph (3). 
(b) VACCINE TRACKING AND DISTRIBUTION.—Sec-
tion 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 2013 through 
2017’’. 
SEC. 203. HOSPITAL PREPAREDNESS AND MEDICAL SURGE 
CAPACITY. 
(a) ALL-HAZARDS PUBLIC HEALTH AND MEDICAL 
RESPONSE
CURRICULA
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 VOLUN-
TEERS.— 
(1) EMERGENCY SYSTEM FOR ADVANCE REG-
ISTRATION
OF
VOLUNTEER
HEALTH
PROFES-
SIONALS.—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 
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sums as may be necessary for each of the fiscal 
years 
2003 
through 
2011’’ 
and 
inserting 
‘‘$5,000,000 for each of fiscal years 2013 through 
2017’’. 
(2) VOLUNTEERS.—Section 2813 of the Public 
Health Service Act (42 U.S.C. 300hh–15) is amend-
ed— 
(A) in subsection (d)(2), by adding at the 
end the following: ‘‘Such training exercises 
shall, as appropriate and applicable, incorporate 
the needs of at-risk individuals in the event of 
a public health emergency.’’; and 
(B) 
in 
subsection 
(i), 
by 
striking 
‘‘$22,000,000 for fiscal year 2007, and such 
sums as may be necessary for each of fiscal 
years 2008 through 2011’’ and inserting 
‘‘$11,200,000 for each of fiscal years 2013 
through 2017’’. 
(c) PARTNERSHIPS FOR STATE AND REGIONAL PRE-
PAREDNESS 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 
capacity and preparedness to address the needs of 
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pediatric and other at-risk populations’’ before the 
period at the end; 
(2) in subsection (b)(1)(A)(ii), by striking ‘‘cen-
ters, 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 prepared-
ness goals described under paragraphs (1), (3), (4), (5), 
and (6) of section 2802(b) with respect to all-hazards, in-
cluding chemical, biological, radiological, or nuclear 
threats.’’; 
(4) by striking subsection (g) and inserting the 
following: 
‘‘(g) COORDINATION.— 
‘‘(1) LOCAL RESPONSE CAPABILITIES.—An eli-
gible entity shall, to the extent practicable, ensure 
that activities carried out under an award under 
subsection (a) are coordinated with activities of rel-
evant local Metropolitan Medical Response Systems, 
local Medical Reserve Corps, the local Cities Readi-
ness Initiative, and local emergency plans. 
‘‘(2) 
NATIONAL
COLLABORATION.—Partner-
ships consisting of one or more eligible entities 
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under this section may, to the extent practicable, 
collaborate with other partnerships consisting of one 
or more eligible entities under this section for pur-
poses 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 imple-
ment 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 appro-
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priated $374,700,000 for each of fiscal years 2013 
through 2017.’’; and 
(B) by adding at the end the following: 
‘‘(4) AVAILABILITY
OF
COOPERATIVE
AGREE-
MENT FUNDS.— 
‘‘(A) IN GENERAL.—Amounts provided to 
an eligible entity under a cooperative agreement 
under subsection (a) for a fiscal year and re-
maining 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 required under sub-
section (i).’’. 
SEC. 204. ENHANCING SITUATIONAL AWARENESS AND BIO-
SURVEILLANCE. 
Section 319D of the Public Health Service Act (42 
U.S.C. 247d–4) is amended— 
(1) in subsection (b)— 
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(A) in paragraph (1)(B), by inserting ‘‘poi-
son 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 med-
ical and public health preparedness and re-
sponse and to minimize duplication of effort’’; 
and 
(C) in paragraph (3), by inserting before 
the period at the end the following: ‘‘and up-
date such standards as necessary’’; 
(2) by striking subsection (c); and 
(3) in subsection (d)— 
(A) in the subsection heading, by striking 
‘‘PUBLIC HEALTH SITUATIONAL AWARENESS’’ 
and inserting ‘‘MODERNIZING PUBLIC HEALTH 
SITUATIONAL AWARENESS
AND BIOSURVEIL-
LANCE’’; 
(B) in paragraph (1)— 
(i) by striking ‘‘Pandemic and All- 
Hazards Preparedness Act’’ and inserting 
‘‘Pandemic and All-Hazards Preparedness 
Reauthorization Act of 2012’’; and 
(ii) by inserting ‘‘, novel emerging 
threats,’’ after ‘‘disease outbreaks’’; 
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(C) by striking paragraph (2) and insert-
ing the following: 
‘‘(2) 
STRATEGY
AND
IMPLEMENTATION 
PLAN.—Not later than 180 days after the date of 
enactment of the Pandemic and All-Hazards Pre-
paredness Reauthorization Act of 2012, the Sec-
retary shall submit to the appropriate committees of 
Congress a coordinated strategy and an accom-
panying 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 biosurveil-
lance activities; and 
‘‘(C) improve information sharing, coordi-
nation, and communication among disparate 
biosurveillance systems supported by the De-
partment of Health and Human Services.’’; 
(D) in paragraph (3)(D), by inserting 
‘‘community health centers, health centers’’ 
after ‘‘poison control,’’; 
(E) in paragraph (5), by striking subpara-
graph (A) and inserting the following: 
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‘‘(A) 
utilize 
applicable 
interoperability 
standards as determined by the Secretary, and 
in consultation with the Office of the National 
Coordinator for Health Information Tech-
nology, through a joint public and private sec-
tor process;’’; and 
(F) by adding at the end the following: 
‘‘(6) CONSULTATION WITH THE NATIONAL BIO-
DEFENSE
SCIENCE
BOARD.—In carrying out this 
section and consistent with section 319M, the Na-
tional Biodefense Science Board shall provide expert 
advice and guidance, including recommendations, re-
garding the measurable steps the Secretary should 
take to modernize and enhance biosurveillance activi-
ties pursuant to the efforts of the Department of 
Health and Human Services to ensure comprehen-
sive, real-time, all-hazards biosurveillance capabili-
ties. In complying with the preceding sentence, the 
National Biodefense Science Board shall— 
‘‘(A) identify the steps necessary to achieve 
a national biosurveillance system for human 
health, with international connectivity, where 
appropriate, that is predicated on State, re-
gional, and community level capabilities and 
creates a networked system to allow for two- 
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way information flow between and among Fed-
eral, 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 pro-
grams, 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 appro-
priate data that relate to disease activity, both 
human and zoonotic; and 
‘‘(C) coordinate with applicable existing 
advisory committees of the Director of the Cen-
ters for Disease Control and Prevention, includ-
ing such advisory committees consisting of rep-
resentatives from State, local, and tribal public 
health authorities and appropriate public and 
private sector health care entities and academic 
institutions, in order to provide guidance on 
public health surveillance activities.’’; 
(4) in subsection (e)(5), 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 
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and All-Hazards Preparedness Reauthorization Act 
of 2012’’; 
(5) in subsection (g), 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 2013 through 2017’’; and 
(6) by adding at the end the following: 
‘‘(h) DEFINITION.—For purposes of this section the 
term ‘biosurveillance’ means the process of gathering near 
real-time biological data that relates to human and 
zoonotic disease activity and threats to human or animal 
health, in order to achieve early warning and identification 
of such health threats, early detection and prompt ongoing 
tracking of health events, and overall situational aware-
ness of disease activity.’’. 
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 fol-
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lows 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 associ-
ated clinical trials which, in combination, are in-
tended 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 amend-
ed— 
(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 
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(iv) by amending subparagraph (C) to 
read as follows: 
‘‘(C) a determination by the Secretary that 
there is a public health emergency, or a signifi-
cant potential for a public health emergency, 
that affects, or has a significant potential to af-
fect, 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 condi-
tion 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.’’; 
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(ii) by striking subparagraph (B); and 
(iii) by redesignating subparagraph 
(C) as subparagraph (B); 
(D) in paragraph (4), by striking ‘‘advance 
notice of termination, and renewal under this 
subsection.’’ and inserting ‘‘, and advance no-
tice of termination under this subsection.’’; and 
(E) by adding at the end the following: 
‘‘(5) EXPLANATION BY SECRETARY.—If an au-
thorization under this section with respect to an un-
approved product or an unapproved use of an ap-
proved 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 sci-
entific, regulatory, or other obstacles to approval, li-
censure, or clearance of such product or use, includ-
ing 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 Sec-
retary for Preparedness and Response,’’ 
after ‘‘consultation with’’; 
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(ii) by striking ‘‘Health and’’ and in-
serting ‘‘Health, and’’; and 
(iii) by striking ‘‘circumstances of the 
emergency involved’’ and inserting ‘‘appli-
cable circumstances described in subsection 
(b)(1)’’; 
(B) in paragraph (1), by striking ‘‘speci-
fied’’ and inserting ‘‘referred to’’; and 
(C) in paragraph (2)(B), by inserting ‘‘, 
taking into consideration the material threat 
posed by the agent or agents identified in a dec-
laration under subsection (b)(1)(D), if applica-
ble’’ after ‘‘risks of the product’’; 
(4) in subsection (d)(3), by inserting ‘‘, to the 
extent practicable given the circumstances of the 
emergency,’’ after ‘‘including’’; 
(5) in subsection (e)— 
(A) in paragraph (1)(A), by striking ‘‘cir-
cumstances of the emergency’’ and inserting 
‘‘applicable circumstances described in sub-
section (b)(1)’’; 
(B) in paragraph (1)(B), by amending 
clause (iii) to read as follows: 
‘‘(iii) Appropriate conditions with re-
spect to collection and analysis of informa-
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tion concerning the safety and effectiveness 
of the product with respect to the use of 
such product during the period when the 
authorization is in effect and a reasonable 
time following such period.’’; 
(C) in paragraph (2)— 
(i) in subparagraph (A)— 
(I) by striking ‘‘manufacturer of 
the product’’ and inserting ‘‘person’’; 
(II) by striking ‘‘circumstances of 
the emergency’’ and inserting ‘‘appli-
cable circumstances described in sub-
section (b)(1)’’; and 
(III) by inserting at the end be-
fore the period ‘‘or in paragraph 
(1)(B)’’; 
(ii) in subparagraph (B)(i), by insert-
ing before the period at the end ‘‘, except 
as provided in section 564A with respect to 
authorized changes to the product expira-
tion date’’; and 
(iii) by amending subparagraph (C) to 
read as follows: 
‘‘(C) In establishing conditions under this 
paragraph with respect to the distribution and 
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administration of the product for the unap-
proved use, the Secretary shall not impose con-
ditions that would restrict distribution or ad-
ministration of the product when distributed or 
administered for the approved use.’’; and 
(D) by amending paragraph (3) to read as 
follows: 
‘‘(3) GOOD
MANUFACTURING
PRACTICE; PRE-
SCRIPTION.—With respect to the emergency use of a 
product for which an authorization under this sec-
tion is issued (whether an unapproved product or an 
unapproved use of an approved product), the Sec-
retary may waive or limit, to the extent appropriate 
given the applicable circumstances described in sub-
section (b)(1)— 
‘‘(A) requirements regarding current good 
manufacturing practice otherwise applicable to 
the manufacture, processing, packing, or hold-
ing of products subject to regulation under this 
Act, including such requirements established 
under section 501 or 520(f)(1), and including 
relevant conditions prescribed with respect to 
the product by an order under section 
520(f)(2); 
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‘‘(B) requirements established under sec-
tion 503(b); and 
‘‘(C) requirements established under sec-
tion 520(e).’’; 
(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 Sec-
retary may revise or revoke an authorization under 
this section if— 
‘‘(A) the circumstances described under 
subsection (b)(1) no longer exist; 
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‘‘(B) the criteria under subsection (c) for 
issuance of such authorization are no longer 
met; or 
‘‘(C) other circumstances make such revi-
sion or revocation appropriate to protect the 
public health or safety.’’; 
(7) in subsection (h)(1), by adding after the pe-
riod at the end the following: ‘‘The Secretary shall 
make any revisions to an authorization under this 
section available on the Internet Web site of the 
Food and Drug Administration.’’; 
(8) by adding at the end of subsection (j) the 
following: 
‘‘(4) Nothing in this section shall be construed 
as authorizing a delay in the review or other consid-
eration by the Secretary of any application or sub-
mission pending before the Food and Drug Adminis-
tration 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 AS-
SOCIATED WITH DEVICES SUBJECT
TO AUTHORIZA-
TION.— 
‘‘(1) IN GENERAL.—In issuing an authorization 
under this section with respect to a device, the Sec-
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retary may, subject to the provisions of this section, 
determine that a laboratory examination or proce-
dure 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 to-
tality of scientific evidence available to the Sec-
retary— 
‘‘(A) such categorization would be bene-
ficial to protecting the public health; and 
‘‘(B) the known and potential benefits of 
such categorization under the circumstances of 
the authorization outweigh the known and po-
tential risks of the categorization. 
‘‘(2) CONDITIONS
OF
DETERMINATION.—The 
Secretary may establish appropriate conditions on 
the performance of the examination or procedure 
pursuant to such determination. 
‘‘(3) EFFECTIVE
PERIOD.—A determination 
under this subsection shall be effective for purposes 
of section 353 of the Public Health Service Act not-
withstanding any other provision of that section dur-
ing the effective period of the relevant declaration 
under subsection (b).’’. 
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(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, di-
agnose, or treat a disease or condition involving 
a biological, chemical, radiological, or nuclear 
agent or agents; or 
‘‘(ii) is intended for use to prevent, diag-
nose, or treat a serious or life-threatening dis-
ease or condition caused by a product described 
in clause (i); and 
‘‘(C) is intended for use during the cir-
cumstances under which— 
‘‘(i) a determination described in sub-
paragraph (A), (B), or (C) of section 
564(b)(1) has been made by the Secretary 
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of Homeland Security, the Secretary of 
Defense, or the Secretary, respectively; or 
‘‘(ii) the identification of a material 
threat described in subparagraph (D) of 
section 564(b)(1) has been made pursuant 
to section 319F–2 of the Public Health 
Service Act. 
‘‘(2) PRODUCT.—The term ‘product’ means a 
drug, device, or biological product. 
‘‘(b) EXPIRATION DATING.— 
‘‘(1) IN GENERAL.—The Secretary may extend 
the expiration date and authorize the introduction or 
delivery for introduction into interstate commerce of 
an eligible product after the expiration date provided 
by the manufacturer if— 
‘‘(A) the expiration date extension is in-
tended to support the United States ability to 
protect— 
‘‘(i) the public health; or 
‘‘(ii) military preparedness and effec-
tiveness; and 
‘‘(B) the expiration date extension is sup-
ported by an appropriate scientific evaluation 
that is conducted or accepted by the Secretary. 
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‘‘(2) REQUIREMENTS
AND
CONDITIONS.—Any 
extension of an expiration date under paragraph (1) 
shall, as part of the extension, identify— 
‘‘(A) each specific lot, batch, or other unit 
of the product for which extended expiration is 
authorized; 
‘‘(B) the duration of the extension; and 
‘‘(C) any other requirements or conditions 
as the Secretary may deem appropriate for the 
protection of the public health, which may in-
clude requirements for, or conditions on, prod-
uct sampling, storage, packaging or repack-
aging, transport, labeling, notice to product re-
cipients, recordkeeping, periodic testing or re-
testing, or product disposition. 
‘‘(3) EFFECT.—Notwithstanding any other pro-
vision of this Act or the Public Health Service Act, 
an eligible product shall not be considered an unap-
proved product (as defined in section 564(a)(2)(A)) 
and shall not be deemed adulterated or misbranded 
under this Act because, with respect to such prod-
uct, the Secretary has, under paragraph (1), ex-
tended the expiration date and authorized the intro-
duction or delivery for introduction into interstate 
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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 stand-
ards of identity, strength, quality, and purity at the 
time of use. 
‘‘(c) CURRENT GOOD MANUFACTURING PRACTICE.— 
‘‘(1) IN GENERAL.—The Secretary may, when 
the circumstances of a domestic, military, or public 
health emergency or material threat described in 
subsection (a)(1)(C) so warrant, authorize, with re-
spect to an eligible product, deviations from current 
good manufacturing practice requirements otherwise 
applicable to the manufacture, processing, packing, 
or holding of products subject to regulation under 
this Act, including requirements under section 501 
or 520(f)(1) or applicable conditions prescribed with 
respect to the eligible product by an order under sec-
tion 520(f)(2). 
‘‘(2) EFFECT.—Notwithstanding any other pro-
vision of this Act or the Public Health Service Act, 
an eligible product shall not be considered an unap-
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proved product (as defined in section 564(a)(2)(A)) 
and shall not be deemed adulterated or misbranded 
under this Act because, with respect to such prod-
uct, the Secretary has authorized deviations from 
current good manufacturing practices under para-
graph (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 unap-
proved 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 prescrip-
tion, if— 
‘‘(1) the product is dispensed during the cir-
cumstances described in subsection (a)(1)(C); and 
‘‘(2) such dispensing without an individual pre-
scription occurs— 
‘‘(A) as permitted under the law of the 
State in which the product is dispensed; or 
‘‘(B) in accordance with an order issued by 
the Secretary, for the purposes and duration of 
the circumstances described in subsection 
(a)(1)(C). 
‘‘(e) EMERGENCY USE INSTRUCTIONS.— 
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‘‘(1) IN
GENERAL.—The Secretary, acting 
through an appropriate official within the Depart-
ment of Health and Human Services, may create 
and issue emergency use instructions to inform 
health care providers or individuals to whom an eli-
gible product is to be administered concerning such 
product’s approved, licensed, or cleared conditions of 
use. 
‘‘(2) EFFECT.—Notwithstanding any other pro-
visions 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 mis-
branded under this Act because of the issuance of 
emergency use instructions under paragraph (1) 
with respect to such product or the introduction or 
delivery for introduction of such product into inter-
state commerce accompanied by such instructions— 
‘‘(A) during an emergency response to an 
actual emergency that is the basis for a deter-
mination described in subsection (a)(1)(C)(i); or 
‘‘(B) by a government entity (including a 
Federal, State, local, or tribal government enti-
ty), or a person acting on behalf of such a gov-
ernment entity, in preparation for an emer-
gency response.’’. 
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(c) RISK EVALUATION AND MITIGATION STRATE-
GIES.—Section 505–1 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355–1), is amended— 
(1) in subsection (f), by striking paragraph (7); 
and 
(2) by adding at the end the following: 
‘‘(k) WAIVER IN PUBLIC HEALTH EMERGENCIES.— 
The Secretary may waive any requirement of this section 
with respect to a qualified countermeasure (as defined in 
section 319F–1(a)(2) of the Public Health Service Act) 
to which a requirement under this section has been ap-
plied, if the Secretary determines that such waiver is re-
quired 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 Sec-
retary of Defense, or the Secretary, respectively; or 
‘‘(2) the identification of a material threat de-
scribed 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 
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et seq.) is amended by inserting after section 564A, as 
added by subsection (b), the following: 
‘‘SEC. 564B. PRODUCTS HELD FOR EMERGENCY USE. 
‘‘It is not a violation of any section of this Act or 
of the Public Health Service Act for a government entity 
(including a Federal, State, local, or tribal government en-
tity), or a person acting on behalf of such a government 
entity, to introduce into interstate commerce a product (as 
defined in section 564(a)(4)) intended for emergency use, 
if that product— 
‘‘(1) is intended to be held and not used; and 
‘‘(2) is held and not used, unless and until that 
product— 
‘‘(A) is approved, cleared, or licensed 
under section 505, 510(k), or 515 of this Act 
or section 351 of the Public Health Service Act; 
‘‘(B) is authorized for investigational use 
under section 505 or 520 of this Act or section 
351 of the Public Health Service Act; or 
‘‘(C) is authorized for use under section 
564.’’. 
SEC. 303. DEFINITIONS. 
Section 565 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb–4) is amended by striking ‘‘The 
Secretary, in consultation’’ and inserting the following: 
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‘‘(a) DEFINITIONS.—In this section— 
‘‘(1) the term ‘countermeasure’ means a quali-
fied countermeasure, a security countermeasure, and 
a qualified pandemic or epidemic product; 
‘‘(2) the term ‘qualified countermeasure’ has 
the meaning given such term in section 319F–1 of 
the Public Health Service Act; 
‘‘(3) the term ‘security countermeasure’ has the 
meaning given such term in section 319F–2 of such 
Act; and 
‘‘(4) the term ‘qualified pandemic or epidemic 
product’ means a product that meets the definition 
given such term in section 319F–3 of the Public 
Health Service Act and— 
‘‘(A) that has been identified by the De-
partment of Health and Human Services or the 
Department of Defense as receiving funding di-
rectly related to addressing chemical, biological, 
radiological, or nuclear threats, including pan-
demic influenza; or 
‘‘(B) is included under this paragraph pur-
suant to a determination by the Secretary. 
‘‘(b) GENERAL DUTIES.—The Secretary, in consulta-
tion’’. 
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SEC. 304. ENHANCING MEDICAL COUNTERMEASURE AC-
TIVITIES. 
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 ‘‘TECH-
NICAL
ASSISTANCE’’ and inserting ‘‘COUNTER-
MEASURE DEVELOPMENT, REVIEW, AND TECH-
NICAL ASSISTANCE’’; 
(2) in subsection (b), by striking the subsection 
enumerator and all that follows through ‘‘shall es-
tablish’’ and inserting the following: 
‘‘(b) GENERAL DUTIES.—In order to accelerate the 
development, stockpiling, approval, licensure, and clear-
ance of qualified countermeasures, security counter-
measures, and qualified pandemic or epidemic products, 
the Secretary, in consultation with the Assistant Secretary 
for Preparedness and Response, shall— 
‘‘(1) ensure the appropriate involvement of 
Food and Drug Administration personnel in inter-
agency 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 per-
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sonnel in any flexible manufacturing activities car-
ried out under section 319L of the Public Health 
Service Act, including with respect to meeting regu-
latory requirements set forth in this Act; 
‘‘(3) promote countermeasure expertise within 
the Food and Drug Administration by— 
‘‘(A) ensuring that Food and Drug Admin-
istration personnel involved in reviewing coun-
termeasures for approval, licensure, or clear-
ance are informed by the Assistant Secretary 
for Preparedness and Response on the material 
threat assessment conducted under section 
319F–2 of the Public Health Service Act for 
the agent or agents for which the counter-
measure under review is intended; 
‘‘(B) training Food and Drug Administra-
tion personnel regarding review of counter-
measures for approval, licensure, or clearance; 
‘‘(C) holding public meetings at least twice 
annually to encourage the exchange of scientific 
ideas; and 
‘‘(D) establishing protocols to ensure that 
countermeasure reviewers have sufficient train-
ing or experience with countermeasures; 
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‘‘(4) maintain teams, composed of Food and 
Drug Administration personnel with expertise on 
countermeasures, 
including 
specific 
counter-
measures, populations with special clinical needs (in-
cluding children and pregnant women that may use 
countermeasures, as applicable and appropriate), 
classes or groups of countermeasures, or other coun-
termeasure-related technologies and capabilities, that 
shall— 
‘‘(A) consult with countermeasure experts, 
including countermeasure sponsors and appli-
cants, to identify and help resolve scientific 
issues related to the approval, licensure, or 
clearance of countermeasures, through work-
shops or public meetings; and 
‘‘(B) improve and advance the science re-
lating to the development of new tools, stand-
ards, and approaches to assessing and evalu-
ating countermeasures— 
‘‘(i) in order to inform the process for 
countermeasure approval, clearance, and li-
censure; and 
‘‘(ii) with respect to the development 
of countermeasures for populations with 
special clinical needs, including children 
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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 ANI-
MAL MODELS.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the date of the enactment of the Pandemic and All- 
Hazards Preparedness Reauthorization Act of 2012, 
the Secretary shall provide final guidance to indus-
try 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 paragraph (1) by not more 
than 6 months upon submission by the Secretary of 
a report on the status of such guidance to the Com-
mittee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate. 
‘‘(d) DEVELOPMENT AND ANIMAL MODELING PRO-
CEDURES.— 
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‘‘(1) AVAILABILITY OF ANIMAL MODEL MEET-
INGS.—To facilitate the timely development of ani-
mal models and support the development, stock-
piling, licensure, approval, and clearance of counter-
measures, the Secretary shall, not later than 180 
days after the enactment of this subsection, establish 
a procedure by which a sponsor or applicant that is 
developing a countermeasure for which human effi-
cacy studies are not ethical or practicable, and that 
has an approved investigational new drug application 
or investigational device exemption, may request and 
receive— 
‘‘(A) a meeting to discuss proposed animal 
model development activities; and 
‘‘(B) a meeting prior to initiating pivotal 
animal studies. 
‘‘(2) PEDIATRIC MODELS.—To facilitate the de-
velopment and selection of animal models that could 
translate to pediatric studies, any meeting conducted 
under paragraph (1) shall include discussion of ani-
mal models for pediatric populations, as appropriate. 
‘‘(e) 
REVIEW
AND
APPROVAL
OF
COUNTER-
MEASURES.— 
‘‘(1) MATERIAL THREAT.—When evaluating an 
application or submission for approval, licensure, or 
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clearance of a countermeasure, the Secretary shall 
take into account the material threat posed by the 
chemical, biological, radiological, or nuclear agent or 
agents identified under section 319F–2 of the Public 
Health Service Act for which the countermeasure 
under review is intended. 
‘‘(2) REVIEW
EXPERTISE.—When practicable 
and appropriate, teams of Food and Drug Adminis-
tration personnel reviewing applications or submis-
sions described under paragraph (1) shall include a 
reviewer with sufficient training or experience with 
countermeasures pursuant to the protocols estab-
lished 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 re-
spect to which the Secretary has entered into a 
procurement contract under section 319F–2(c) 
of the Public Health Service Act; or 
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‘‘(B) a countermeasure with respect to 
which the Biomedical Advanced Research and 
Development Authority has provided funding 
under section 319L of the Public Health Serv-
ice Act for advanced research and development. 
‘‘(2) REGULATORY MANAGEMENT PLAN PROC-
ESS.—The Secretary, in consultation with the As-
sistant Secretary for Preparedness and Response 
and the Director of the Biomedical Advanced Re-
search and Development Authority, shall establish a 
formal process for obtaining scientific feedback and 
interactions regarding the development and regu-
latory review of eligible countermeasures by facili-
tating the development of written regulatory man-
agement plans in accordance with this subsection. 
‘‘(3) SUBMISSION OF REQUEST AND PROPOSED 
PLAN BY SPONSOR OR APPLICANT.— 
‘‘(A) IN GENERAL.—A sponsor or appli-
cant of an eligible countermeasure may initiate 
the process described under paragraph (2) upon 
submission of a written request to the Sec-
retary. Such request shall include a proposed 
regulatory management plan. 
‘‘(B) TIMING OF SUBMISSION.—A sponsor 
or applicant may submit a written request 
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under subparagraph (A) after the eligible coun-
termeasure has an investigational new drug or 
investigational device exemption in effect. 
‘‘(C) RESPONSE
BY
SECRETARY.—The 
Secretary shall direct the Food and Drug Ad-
ministration, upon submission of a written re-
quest by a sponsor or applicant under subpara-
graph (A), to work with the sponsor or appli-
cant to agree on a regulatory management plan 
within a reasonable time not to exceed 90 days. 
If the Secretary determines that no plan can be 
agreed upon, the Secretary shall provide to the 
sponsor or applicant, in writing, the scientific 
or regulatory rationale why such agreement 
cannot be reached. 
‘‘(4) PLAN.—The content of a regulatory man-
agement plan agreed to by the Secretary and a spon-
sor or applicant shall include— 
‘‘(A) an agreement between the Secretary 
and the sponsor or applicant regarding develop-
mental 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 Sec-
retary to the triggers described under subpara-
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graph (A), including meetings between the Sec-
retary 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
TAR-
GETS.—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 regard-
ing the data required to support the approval, 
clearance, or licensure of the eligible counter-
measure involved; 
‘‘(B) feedback from the Secretary regard-
ing the data necessary to inform any authoriza-
tion under section 564; 
‘‘(C) feedback from the Secretary regard-
ing the data necessary to support the posi-
tioning and delivery of the eligible counter-
measure, including to the Strategic National 
Stockpile; 
‘‘(D) feedback from the Secretary regard-
ing the data necessary to support the submis-
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sion of protocols for review under section 
505(b)(5)(B); 
‘‘(E) feedback from the Secretary regard-
ing any gaps in scientific knowledge that will 
need resolution prior to approval, licensure, or 
clearance of the eligible countermeasure and 
plans for conducting the necessary scientific re-
search; 
‘‘(F) identification of the population for 
which the countermeasure sponsor or applicant 
seeks approval, licensure, or clearance and the 
population for which desired labeling would not 
be appropriate, if known; and 
‘‘(G) as necessary and appropriate, and to 
the extent practicable, a plan for demonstrating 
safety and effectiveness in pediatric popu-
lations, and for developing pediatric dosing, for-
mulation, and administration with respect to 
the eligible countermeasure, provided that such 
plan would not delay authorization under sec-
tion 564, approval, licensure, or clearance for 
adults. 
‘‘(6) PRIORITIZATION.— 
‘‘(A) PLANS
FOR
SECURITY
COUNTER-
MEASURES.—The Secretary shall establish reg-
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ulatory management plans for all security coun-
termeasures for which a request is submitted 
under paragraph (3)(A). 
‘‘(B) PLANS FOR OTHER ELIGIBLE COUN-
TERMEASURES.—The Secretary shall determine 
whether resources are available to establish reg-
ulatory management plans for eligible counter-
measures 
that 
are 
not 
security 
counter-
measures. If resources are available to establish 
regulatory management plans for eligible coun-
termeasures that are not security counter-
measures, 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 Bio-
medical Advanced Research and Development 
Authority, in consultation with the Commis-
sioner, shall prioritize which eligible counter-
measures 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: 
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‘‘(g) ANNUAL REPORT.—Not later than 180 days 
after the date of enactment of this subsection, and annu-
ally thereafter, the Secretary shall make publicly available 
on the Web site of the Food and Drug Administration a 
report that details the countermeasure development and 
review activities of the Food and Drug Administration, in-
cluding— 
‘‘(1) with respect to the development of new 
tools, standards, and approaches to assess and 
evaluate countermeasures— 
‘‘(A) the identification of the priorities of 
the Food and Drug Administration and the 
progress made on such priorities; and 
‘‘(B) the identification of scientific gaps 
that impede the development, approval, licen-
sure, or clearance of countermeasures for popu-
lations 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 per-
formance targets and goals set forth in subsection 
(f)(4)(B) and the regulatory management plan have 
been met, including, for each such countermeasure— 
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‘‘(A) whether the regulatory management 
plan was completed within the required time-
frame, and the length of time taken to complete 
such plan; 
‘‘(B) whether the Secretary adhered to the 
timely and appropriate response times set forth 
in such plan; and 
‘‘(C) explanations for any failure to meet 
such performance targets and goals; 
‘‘(3) the number of regulatory teams estab-
lished pursuant to subsection (b)(4), the number of 
products, classes of products, or technologies as-
signed to each such team, and the number of, type 
of, and any progress made as a result of consulta-
tions carried out under subsection (b)(4)(A); 
‘‘(4) an estimate of resources obligated to coun-
termeasure development and regulatory assessment, 
including— 
‘‘(A) Center-specific objectives and accom-
plishments; and 
‘‘(B) the number of full-time equivalent 
employees of the Food and Drug Administra-
tion who directly support the review of counter-
measures; 
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‘‘(5) the number of countermeasure applications 
and submissions submitted, the number of counter-
measures approved, licensed, or cleared, the status 
of remaining submitted applications and submis-
sions, and the number of each type of authorization 
issued pursuant to section 564; 
‘‘(6) the number of written requests for a regu-
latory management plan submitted under subsection 
(f)(3)(A), the number of regulatory management 
plans developed, and the number of such plans de-
veloped for security countermeasures; and 
‘‘(7) the number, type, and frequency of meet-
ings between the Food and Drug Administration 
and— 
‘‘(A) sponsors of a countermeasure as de-
fined in subsection (a); or 
‘‘(B) another agency engaged in develop-
ment or management of portfolios for such 
countermeasures, including the Centers for Dis-
ease Control and Prevention, the Biomedical 
Advanced Research and Development Authority, 
the National Institutes of Health, and the ap-
propriate agencies of the Department of De-
fense.’’. 
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