PAHPA Reauthorization

Attachment C
PUBLIC LAW 113–5—MAR. 13, 2013

127 STAT. 161

Public Law 113–5
113th Congress
An Act
To reauthorize certain programs under the Public Health Service Act and the
Federal Food, Drug, and Cosmetic Act with respect to public health security
and all-hazards preparedness and response, and for other purposes.

Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) SHORT TITLE.—This Act may be cited as the ‘‘Pandemic
and All-Hazards Preparedness Reauthorization Act of 2013’’.
(b) TABLE OF CONTENTS.—The table of contents of this Act
is as follows:

Mar. 13, 2013
[H.R. 307]

Pandemic and
All-Hazards
Preparedness
Reauthorization
Act of 2013.
42 USC 201 note.

Sec. 1. Short title; table of contents.
TITLE I—STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE
FOR PUBLIC HEALTH EMERGENCIES
Sec.
Sec.
Sec.
Sec.
Sec.

101.
102.
103.
104.
105.

National Health Security Strategy.
Assistant Secretary for Preparedness and Response.
National Advisory Committee on Children and Disasters.
Modernization of the National Disaster Medical System.
Continuing the role of the Department of Veterans Affairs.

TITLE II—OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS
AND RESPONSE
Sec. 201. Temporary reassignment of State and local personnel during a public
health emergency.
Sec. 202. Improving State and local public health security.
Sec. 203. Hospital preparedness and medical surge capacity.
Sec. 204. Enhancing situational awareness and biosurveillance.
Sec. 205. Eliminating duplicative Project Bioshield reports.
TITLE III—ENHANCING MEDICAL COUNTERMEASURE REVIEW
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.

301.
302.
303.
304.
305.
306.
307.

Special protocol assessment.
Authorization for medical products for use in emergencies.
Definitions.
Enhancing medical countermeasure activities.
Regulatory management plans.
Report.
Pediatric medical countermeasures.

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TITLE IV—ACCELERATING MEDICAL COUNTERMEASURE ADVANCED
RESEARCH AND DEVELOPMENT
Sec.
Sec.
Sec.
Sec.

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401.
402.
403.
404.

BioShield.
Biomedical Advanced Research and Development Authority.
Strategic National Stockpile.
National Biodefense Science Board.

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127 STAT. 162

PUBLIC LAW 113–5—MAR. 13, 2013

TITLE I—STRENGTHENING NATIONAL
PREPAREDNESS AND RESPONSE FOR
PUBLIC HEALTH EMERGENCIES

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SEC. 101. NATIONAL HEALTH SECURITY STRATEGY.

(a) IN GENERAL.—Section 2802 of the Public Health Service
Act (42 U.S.C. 300hh–1) is amended—
(1) in subsection (a)(1), by striking ‘‘2009’’ and inserting
‘‘2014’’; and
(2) in subsection (b)—
(A) in paragraph (1)(A), by inserting ‘‘, including drills
and exercises to ensure medical surge capacity for events
without notice’’ after ‘‘exercises’’; and
(B) in paragraph (3)—
(i) in the matter preceding subparagraph (A)—
(I) by striking ‘‘facilities), and trauma care’’
and inserting ‘‘and ambulatory care facilities and
which may include dental health facilities), and
trauma care, critical care,’’; and
(II) by inserting ‘‘(including related availability, accessibility, and coordination)’’ after
‘‘public health emergencies’’;
(ii) in subparagraph (A), by inserting ‘‘and trauma’’
after ‘‘medical’’;
(iii) in subparagraph (B), by striking ‘‘Medical
evacuation and fatality management’’ and inserting
‘‘Fatality management’’;
(iv) by redesignating subparagraphs (C), (D), and
(E) as subparagraphs (D), (E), and (F), respectively;
(v) by inserting after subparagraph (B), the following the new subparagraph:
‘‘(C) Coordinated medical triage and evacuation to
appropriate medical institutions based on patient medical
need, taking into account regionalized systems of care.’’;
(vi) in subparagraph (E), as redesignated by clause
(iv), by inserting ‘‘(which may include such dental
health assets)’’ after ‘‘medical assets’’; and
(vii) by adding at the end the following:
‘‘(G) Optimizing a coordinated and flexible approach
to the medical surge capacity of hospitals, other health
care facilities, critical care, trauma care (which may include
trauma centers), and emergency medical systems.’’;
(C) in paragraph (4)—
(i) in subparagraph (A), by inserting ‘‘, including
the unique needs and considerations of individuals
with disabilities,’’ after ‘‘medical needs of at-risk
individuals’’; and
(ii) in subparagraph (B), by inserting ‘‘the’’ before
‘‘purpose of this section’’; and
(D) by adding at the end the following:
‘‘(7) COUNTERMEASURES.—
‘‘(A) Promoting strategic initiatives to advance countermeasures to diagnose, mitigate, prevent, or treat harm
from any biological agent or toxin, chemical, radiological,

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PUBLIC LAW 113–5—MAR. 13, 2013

127 STAT. 163

or nuclear agent or agents, whether naturally occurring,
unintentional, or deliberate.
‘‘(B) For purposes of this paragraph, the term ‘countermeasures’ has the same meaning as the terms ‘qualified
countermeasures’ under section 319F–1, ‘qualified pandemic and epidemic products’ under section 319F–3, and
‘security countermeasures’ under section 319F–2.
‘‘(8) MEDICAL AND PUBLIC HEALTH COMMUNITY RESILIENCY.—Strengthening the ability of States, local communities,
and tribal communities to prepare for, respond to, and be
resilient in the event of public health emergencies, whether
naturally occurring, unintentional, or deliberate by—
‘‘(A) optimizing alignment and integration of medical
and public health preparedness and response planning and
capabilities with and into routine daily activities; and
‘‘(B) promoting familiarity with local medical and
public health systems.’’.
(b) AT-RISK INDIVIDUALS.—Section 2814 of the Public Health
Service Act (42 U.S.C. 300hh–16) is amended—
(1) by striking paragraphs (5), (7), and (8);
(2) in paragraph (4), by striking ‘‘2811(b)(3)(B)’’ and
inserting ‘‘2802(b)(4)(B)’’;
(3) by redesignating paragraphs (1) through (4) as paragraphs (2) through (5), respectively;
(4) by inserting before paragraph (2) (as so redesignated),
the following:
‘‘(1) monitor emerging issues and concerns as they relate
to medical and public health preparedness and response for
at-risk individuals in the event of a public health emergency
declared by the Secretary under section 319;’’;
(5) by amending paragraph (2) (as so redesignated) to read
as follows:
‘‘(2) oversee the implementation of the preparedness goals
described in section 2802(b) with respect to the public health
and medical needs of at-risk individuals in the event of a
public health emergency, as described in section 2802(b)(4);’’;
and
(6) by inserting after paragraph (6), the following:
‘‘(7) disseminate and, as appropriate, update novel and
best practices of outreach to and care of at-risk individuals
before, during, and following public health emergencies in as
timely a manner as is practicable, including from the time
a public health threat is identified; and
‘‘(8) ensure that public health and medical information
distributed by the Department of Health and Human Services
during a public health emergency is delivered in a manner
that takes into account the range of communication needs of
the intended recipients, including at-risk individuals.’’.

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SEC.

102.

ASSISTANT
RESPONSE.

SECRETARY

FOR

PREPAREDNESS

Definition.

AND

(a) IN GENERAL.—Section 2811 of the Public Health Service
Act (42 U.S.C. 300hh–10) is amended—
(1) in subsection (b)—
(A) in paragraph (3), by inserting ‘‘, security countermeasures (as defined in section 319F–2),’’ after ‘‘qualified
countermeasures (as defined in section 319F–1)’’;

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127 STAT. 164

(B) in paragraph (4), by adding at the end the following:
‘‘(D) POLICY COORDINATION AND STRATEGIC DIRECTION.—Provide integrated policy coordination and strategic
direction with respect to all matters related to Federal
public health and medical preparedness and execution and
deployment of the Federal response for public health emergencies and incidents covered by the National Response
Plan developed pursuant to section 504(6) of the Homeland
Security Act of 2002, or any successor plan, before, during,
and following public health emergencies.
‘‘(E) IDENTIFICATION OF INEFFICIENCIES.—Identify and
minimize gaps, duplication, and other inefficiencies in medical and public health preparedness and response activities
and the actions necessary to overcome these obstacles.
‘‘(F) COORDINATION OF GRANTS AND AGREEMENTS.—
Align and coordinate medical and public health grants
and cooperative agreements as applicable to preparedness
and response activities authorized under this Act, to the
extent possible, including program requirements, timelines,
and measurable goals, and in consultation with the Secretary of Homeland Security, to—
‘‘(i) optimize and streamline medical and public
health preparedness and response capabilities and the
ability of local communities to respond to public health
emergencies; and
‘‘(ii) gather and disseminate best practices among
grant and cooperative agreement recipients, as appropriate.
‘‘(G) DRILL AND OPERATIONAL EXERCISES.—Carry out
drills and operational exercises, in consultation with the
Department of Homeland Security, the Department of
Defense, the Department of Veterans Affairs, and other
applicable Federal departments and agencies, as necessary
and appropriate, to identify, inform, and address gaps in
and policies related to all-hazards medical and public
health preparedness and response, including exercises
based on—
‘‘(i) identified threats for which countermeasures
are available and for which no countermeasures are
available; and
‘‘(ii) unknown threats for which no countermeasures are available.
‘‘(H) NATIONAL SECURITY PRIORITY.—On a periodic basis
consult with, as applicable and appropriate, the Assistant
to the President for National Security Affairs, to provide
an update on, and discuss, medical and public health
preparedness and response activities pursuant to this Act
and the Federal Food, Drug, and Cosmetic Act, including
progress on the development, approval, clearance, and
licensure of medical countermeasures.’’; and
(C) by adding at the end the following:
‘‘(7) COUNTERMEASURES BUDGET PLAN.—Develop, and
update on an annual basis, a coordinated 5-year budget plan
based on the medical countermeasure priorities described in
subsection (d). Each such plan shall—
‘‘(A) include consideration of the entire medical
countermeasures enterprise, including—

Consultation.

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Consultation.

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PUBLIC LAW 113–5—MAR. 13, 2013

127 STAT. 165

‘‘(i) basic research and advanced research and
development;
‘‘(ii) approval, clearance, licensure, and authorized
uses of products; and
‘‘(iii) procurement, stockpiling, maintenance, and
replenishment of all products in the Strategic National
Stockpile;
‘‘(B) inform prioritization of resources and include
measurable outputs and outcomes to allow for the tracking
of the progress made toward identified priorities;
‘‘(C) identify medical countermeasure life-cycle costs
to inform planning, budgeting, and anticipated needs
within the continuum of the medical countermeasure enterprise consistent with section 319F–2; and
‘‘(D) be made available to the appropriate committees
of Congress upon request.’’;
(2) by striking subsection (c) and inserting the following:
‘‘(c) FUNCTIONS.—The Assistant Secretary for Preparedness and
Response shall—
‘‘(1) have lead responsibility within the Department of
Health and Human Services for emergency preparedness and
response policy coordination and strategic direction;
‘‘(2) have authority over and responsibility for—
‘‘(A) the National Disaster Medical System pursuant
to section 2812;
‘‘(B) the Hospital Preparedness Cooperative Agreement
Program pursuant to section 319C–2;
‘‘(C) the Biomedical Advanced Research and Development Authority pursuant to section 319L;
‘‘(D) the Medical Reserve Corps pursuant to section
2813;
‘‘(E) the Emergency System for Advance Registration
of Volunteer Health Professionals pursuant to section 319I;
and
‘‘(F) administering grants and related authorities
related to trauma care under parts A through C of title
XII, such authority to be transferred by the Secretary from
the Administrator of the Health Resources and Services
Administration to such Assistant Secretary;
‘‘(3) exercise the responsibilities and authorities of the Secretary with respect to the coordination of—
‘‘(A) the Public Health Emergency Preparedness
Cooperative Agreement Program pursuant to section 319C–
1;
‘‘(B) the Strategic National Stockpile pursuant to section 319F–2; and
‘‘(C) the Cities Readiness Initiative; and
‘‘(4) assume other duties as determined appropriate by
the Secretary.’’; and
(3) by adding at the end the following:
‘‘(d) PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES
ENTERPRISE STRATEGY AND IMPLEMENTATION PLAN.—
‘‘(1) IN GENERAL.—Not later than 180 days after the date
of enactment of this subsection, and every year thereafter,
the Assistant Secretary for Preparedness and Response shall
develop and submit to the appropriate committees of Congress
a coordinated strategy and accompanying implementation plan

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Deadline.

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127 STAT. 166

for medical countermeasures to address chemical, biological,
radiological, and nuclear threats. In developing such a plan,
the Assistant Secretary for Preparedness and Response shall
consult with the Director of the Biomedical Advanced Research
and Development Authority, the Director of the National
Institutes of Health, the Director of the Centers for Disease
Control and Prevention, and the Commissioner of Food and
Drugs. Such strategy and plan shall be known as the ‘Public
Health Emergency Medical Countermeasures Enterprise
Strategy and Implementation Plan’.
‘‘(2) REQUIREMENTS.—The plan under paragraph (1) shall—
‘‘(A) describe the chemical, biological, radiological, and
nuclear agent or agents that may present a threat to the
Nation and the corresponding efforts to develop qualified
countermeasures (as defined in section 319F–1), security
countermeasures (as defined in section 319F–2), or qualified pandemic or epidemic products (as defined in section
319F–3) for each threat;
‘‘(B) evaluate the progress of all activities with respect
to such countermeasures or products, including research,
advanced research, development, procurement, stockpiling,
deployment, distribution, and utilization;
‘‘(C) identify and prioritize near-, mid-, and long-term
needs with respect to such countermeasures or products
to address a chemical, biological, radiological, and nuclear
threat or threats;
‘‘(D) identify, with respect to each category of threat,
a summary of all awards and contracts, including advanced
research and development and procurement, that
includes—
‘‘(i) the time elapsed from the issuance of the initial
solicitation or request for a proposal to the adjudication
(such as the award, denial of award, or solicitation
termination); and
‘‘(ii) an identification of projected timelines, anticipated funding allocations, benchmarks, and milestones
for each medical countermeasure priority under
subparagraph (C), including projected needs with
regard to replenishment of the Strategic National
Stockpile;
‘‘(E) be informed by the recommendations of the
National Biodefense Science Board pursuant to section
319M;
‘‘(F) evaluate progress made in meeting timelines,
allocations, benchmarks, and milestones identified under
subparagraph (D)(ii);
‘‘(G) report on the amount of funds available for
procurement in the special reserve fund as defined in section 319F–2(h) and the impact this funding will have on
meeting the requirements under section 319F–2;
‘‘(H) incorporate input from Federal, State, local, and
tribal stakeholders;
‘‘(I) identify the progress made in meeting the medical
countermeasure priorities for at-risk individuals (as defined
in 2802(b)(4)(B)), as applicable under subparagraph (C),
including with regard to the projected needs for related
stockpiling and replenishment of the Strategic National

Evaluation.

Evaluation.

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Reports.

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PUBLIC LAW 113–5—MAR. 13, 2013

127 STAT. 167

Stockpile, including by addressing the needs of pediatric
populations with respect to such countermeasures and
products in the Strategic National Stockpile, including—
‘‘(i) a list of such countermeasures and products
necessary to address the needs of pediatric populations;
‘‘(ii) a description of measures taken to coordinate
with the Office of Pediatric Therapeutics of the Food
and Drug Administration to maximize the labeling,
dosages, and formulations of such countermeasures
and products for pediatric populations;
‘‘(iii) a description of existing gaps in the Strategic
National Stockpile and the development of such
countermeasures and products to address the needs
of pediatric populations; and
‘‘(iv) an evaluation of the progress made in
addressing priorities identified pursuant to subparagraph (C);
‘‘(J) identify the use of authority and activities undertaken pursuant to sections 319F–1(b)(1), 319F–1(b)(2),
319F–1(b)(3), 319F–1(c), 319F–1(d), 319F–1(e), 319F–
2(c)(7)(C)(iii), 319F–2(c)(7)(C)(iv), and 319F–2(c)(7)(C)(v) of
this Act, and subsections (a)(1), (b)(1), and (e) of section
564 of the Federal Food, Drug, and Cosmetic Act, by
summarizing—
‘‘(i) the particular actions that were taken under
the authorities specified, including, as applicable, the
identification of the threat agent, emergency, or the
biomedical countermeasure with respect to which the
authority was used;
‘‘(ii) the reasons underlying the decision to use
such authorities, including, as applicable, the options
that were considered and rejected with respect to the
use of such authorities;
‘‘(iii) the number of, nature of, and other information concerning the persons and entities that received
a grant, cooperative agreement, or contract pursuant
to the use of such authorities, and the persons and
entities that were considered and rejected for such
a grant, cooperative agreement, or contract, except that
the report need not disclose the identity of any such
person or entity;
‘‘(iv) whether, with respect to each procurement
that is approved by the President under section 319F–
2(c)(6), a contract was entered into within one year
after such approval by the President; and
‘‘(v) with respect to section 319F–1(d), for the oneyear period for which the report is submitted, the
number of persons who were paid amounts totaling
$100,000 or greater and the number of persons who
were paid amounts totaling at least $50,000 but less
than $100,000; and
‘‘(K) be made publicly available.
‘‘(3) GAO REPORT.—
‘‘(A) IN GENERAL.—Not later than 1 year after the
date of the submission to the Congress of the first Public
Health Emergency Medical Countermeasures Enterprise

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Lists.

Evaluation.

Public
information.
Evaluation.

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127 STAT. 168

42 USC
300hh–10 note.

PUBLIC LAW 113–5—MAR. 13, 2013

Strategy and Implementation Plan, the Comptroller General of the United States shall conduct an independent
evaluation, and submit to the appropriate committees of
Congress a report, concerning such Strategy and
Implementation Plan.
‘‘(B) CONTENT.—The report described in subparagraph
(A) shall review and assess—
‘‘(i) the near-term, mid-term, and long-term medical countermeasure needs and identified priorities of
the Federal Government pursuant to paragraph (2)(C);
‘‘(ii) the activities of the Department of Health
and Human Services with respect to advanced research
and development pursuant to section 319L; and
‘‘(iii) the progress made toward meeting the
timelines, allocations, benchmarks, and milestones
identified in the Public Health Emergency Medical
Countermeasures
Enterprise
Strategy
and
Implementation Plan under this subsection.
‘‘(e) PROTECTION OF NATIONAL SECURITY.—In carrying out subsections (b)(7) and (d), the Secretary shall ensure that information
and items that could compromise national security, contain confidential commercial information, or contain proprietary information
are not disclosed.’’.
(b) INTERAGENCY COORDINATION PLAN.—In the first Public
Health Emergency Countermeasures Enterprise Strategy and
Implementation Plan submitted under subsection (d) of section 2811
of the Public Health Service Act (42 U.S.C. 300hh–10) (as added
by subsection (a)(3)), the Secretary of Health and Human Services,
in consultation with the Secretary of Defense, shall include a
description of the manner in which the Department of Health
and Human Services is coordinating with the Department of
Defense regarding countermeasure activities to address chemical,
biological, radiological, and nuclear threats. Such report shall
include information with respect to—
(1) the research, advanced research, development, procurement, stockpiling, and distribution of countermeasures to meet
identified needs; and
(2) the coordination of efforts between the Department
of Health and Human Services and the Department of Defense
to address countermeasure needs for various segments of the
population.
SEC. 103. NATIONAL ADVISORY COMMITTEE ON CHILDREN AND DISASTERS.

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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:

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42 USC
300hh–10a.

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

Consultation.

‘‘(a) ESTABLISHMENT.—The Secretary, in consultation with the
Secretary of Homeland Security, shall establish an advisory committee to be known as the ‘National Advisory Committee on Children and Disasters’ (referred to in this section as the ‘Advisory
Committee’).
‘‘(b) DUTIES.—The Advisory Committee shall—

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‘‘(1) provide advice and consultation with respect to the
activities carried out pursuant to section 2814, as applicable
and appropriate;
‘‘(2) evaluate and provide input with respect to the medical
and public health needs of children as they relate to preparation
for, response to, and recovery from all-hazards emergencies;
and
‘‘(3) provide advice and consultation with respect to State
emergency preparedness and response activities and children,
including related drills and exercises pursuant to the preparedness goals under section 2802(b).
‘‘(c) ADDITIONAL DUTIES.—The Advisory Committee may provide
advice and recommendations to the Secretary with respect to children and the medical and public health grants and cooperative
agreements as applicable to preparedness and response activities
authorized under this title and title III.
‘‘(d) MEMBERSHIP.—
‘‘(1) IN GENERAL.—The Secretary, in consultation with such
other Secretaries as may be appropriate, shall appoint not
to exceed 15 members to the Advisory Committee. In appointing
such members, the Secretary shall ensure that the total membership of the Advisory Committee is an odd number.
‘‘(2) REQUIRED MEMBERS.—The Secretary, in consultation
with such other Secretaries as may be appropriate, may appoint
to the Advisory Committee under paragraph (1) such individuals as may be appropriate to perform the duties described
in subsections (b) and (c), which may include—
‘‘(A) the Assistant Secretary for Preparedness and
Response;
‘‘(B) the Director of the Biomedical Advanced Research
and Development Authority;
‘‘(C) the Director of the Centers for Disease Control
and Prevention;
‘‘(D) the Commissioner of Food and Drugs;
‘‘(E) the Director of the National Institutes of Health;
‘‘(F) the Assistant Secretary of the Administration for
Children and Families;
‘‘(G) the Administrator of the Federal Emergency
Management Agency;
‘‘(H) at least two non-Federal health care professionals
with expertise in pediatric medical disaster planning,
preparedness, response, or recovery;
‘‘(I) at least two representatives from State, local, territorial, or tribal agencies with expertise in pediatric disaster
planning, preparedness, response, or recovery; and
‘‘(J) representatives from such Federal agencies (such
as the Department of Education and the Department of
Homeland Security) as determined necessary to fulfill the
duties of the Advisory Committee, as established under
subsections (b) and (c).
‘‘(e) MEETINGS.—The Advisory Committee shall meet not less
than biannually.
‘‘(f) SUNSET.—The Advisory Committee shall terminate on September 30, 2018.’’.

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Consultation.

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127 STAT. 170

PUBLIC LAW 113–5—MAR. 13, 2013

SEC. 104. MODERNIZATION OF THE NATIONAL DISASTER MEDICAL
SYSTEM.

Section 2812 of the Public Health Service Act (42 U.S.C. 300hh–
11) is amended—
(1) in subsection (a)(3)—
(A) in subparagraph (A), in clause (i) by inserting
‘‘, including at-risk individuals as applicable’’ after ‘‘victims
of a public health emergency’’;
(B) by redesignating subparagraph (C) as subparagraph (E); and
(C) by inserting after subparagraph (B), the following:
‘‘(C) CONSIDERATIONS FOR AT-RISK POPULATIONS.—The
Secretary shall take steps to ensure that an appropriate
specialized and focused range of public health and medical
capabilities are represented in the National Disaster Medical System, which take into account the needs of at-risk
individuals, in the event of a public health emergency.’’.
‘‘(D) ADMINISTRATION.—The Secretary may determine
and pay claims for reimbursement for services under
subparagraph (A) directly or through contracts that provide
for payment in advance or by way of reimbursement.’’;
and
(2) in subsection (g), by striking ‘‘such sums as may be
necessary for each of the fiscal years 2007 through 2011’’ and
inserting ‘‘$52,700,000 for each of fiscal years 2014 through
2018’’.
SEC. 105. CONTINUING THE ROLE OF THE DEPARTMENT OF VETERANS
AFFAIRS.

Section 8117(g) of title 38, United States Code, is amended
by striking ‘‘such sums as may be necessary to carry out this
section for each of fiscal years 2007 through 2011’’ and inserting
‘‘$155,300,000 for each of fiscal years 2014 through 2018 to carry
out this section’’.

TITLE II—OPTIMIZING STATE AND
LOCAL ALL-HAZARDS PREPAREDNESS
AND RESPONSE

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SEC. 201. TEMPORARY REASSIGNMENT OF STATE AND LOCAL PERSONNEL DURING A PUBLIC HEALTH EMERGENCY.

Section 319 of the Public Health Service Act (42 U.S.C. 247d)
is amended by adding at the end the following:
‘‘(e) TEMPORARY REASSIGNMENT OF STATE AND LOCAL PERSONNEL DURING A PUBLIC HEALTH EMERGENCY.—
‘‘(1) EMERGENCY REASSIGNMENT OF FEDERALLY FUNDED PERSONNEL.—Notwithstanding any other provision of law, and subject to paragraph (2), upon request by the Governor of a State
or a tribal organization or such Governor or tribal organization’s
designee, the Secretary may authorize the requesting State
or Indian tribe to temporarily reassign, for purposes of immediately addressing a public health emergency in the State or
Indian tribe, State and local public health department or agency
personnel funded in whole or in part through programs authorized under this Act, as appropriate.

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PUBLIC LAW 113–5—MAR. 13, 2013

127 STAT. 171

‘‘(2) ACTIVATION OF EMERGENCY REASSIGNMENT.—
‘‘(A) PUBLIC HEALTH EMERGENCY.—The Secretary may
authorize a temporary reassignment of personnel under
paragraph (1) only during the period of a public health
emergency determined pursuant to subsection (a).
‘‘(B) CONTENTS OF REQUEST.—To seek authority for
a temporary reassignment of personnel under paragraph
(1), the Governor of a State or a tribal organization shall
submit to the Secretary a request for such reassignment
flexibility and shall include in the request each of the
following:
‘‘(i) An assurance that the public health emergency
in the geographic area of the requesting State or Indian
tribe cannot be adequately and appropriately addressed
by the public health workforce otherwise available.
‘‘(ii) An assurance that the public health emergency would be addressed more efficiently and effectively through the requested temporary reassignment
of State and local personnel described in paragraph
(1).
‘‘(iii) An assurance that the requested temporary
reassignment of personnel is consistent with any
applicable All-Hazards Public Health Emergency
Preparedness and Response Plan under section 319C–
1.
‘‘(iv) An identification of—
‘‘(I) each Federal program from which personnel would be temporarily reassigned pursuant
to the requested authority; and
‘‘(II) the number of personnel who would be
so reassigned from each such program.
‘‘(v) Such other information and assurances upon
which the Secretary and Governor of a State or tribal
organization agree.
‘‘(C) CONSIDERATION.—In reviewing a request for temporary reassignment under paragraph (1), the Secretary
shall consider the degree to which the program or programs
funded in whole or in part by programs authorized under
this Act would be adversely affected by the reassignment.
‘‘(D) TERMINATION AND EXTENSION.—
‘‘(i) TERMINATION.—A State or Indian tribe’s temporary reassignment of personnel under paragraph (1)
shall terminate upon the earlier of the following:
‘‘(I) The Secretary’s determination that the
public health emergency no longer exists.
‘‘(II) Subject to clause (ii), the expiration of
the 30-day period following the date on which the
Secretary approved the State or Indian tribe’s
request for such reassignment flexibility.
‘‘(ii) EXTENSION OF REASSIGNMENT FLEXIBILITY.—
The Secretary may extend reassignment flexibility of
personnel under paragraph (1) beyond the date otherwise applicable under clause (i)(II) if the public health
emergency still exists as of such date, but only if—
‘‘(I) the State or Indian tribe that submitted
the initial request for a temporary reassignment

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PUBLIC LAW 113–5—MAR. 13, 2013
of personnel submits a request for an extension
of such temporary reassignment; and
‘‘(II) the request for an extension contains the
same information and assurances necessary for
the approval of an initial request for such temporary reassignment pursuant to subparagraph
(B).

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‘‘(3) VOLUNTARY NATURE OF TEMPORARY REASSIGNMENT OF
STATE AND LOCAL PERSONNEL.—
‘‘(A) IN GENERAL.—Unless otherwise provided under

the law or regulation of the State or Indian tribe that
receives authorization for temporary reassignment of personnel under paragraph (1), personnel eligible for reassignment pursuant to such authorization—
‘‘(i) shall have the opportunity to volunteer for
temporary reassignment; and
‘‘(ii) shall not be required to agree to a temporary
reassignment.
‘‘(B) PROHIBITION ON CONDITIONING FEDERAL AWARDS.—
The Secretary may not condition the award of a grant,
contract, or cooperative agreement under this Act on the
requirement that a State or Indian tribe require that personnel eligible for reassignment pursuant to an authorization under paragraph (1) agree to such reassignment.
‘‘(4) NOTICE TO CONGRESS.—The Secretary shall give notice
to the Congress in conjunction with the approval under this
subsection of—
‘‘(A) any initial request for temporary reassignment
of personnel; and
‘‘(B) any request for an extension of such temporary
reassignment.
‘‘(5) GUIDANCE.—The Secretary shall—
‘‘(A) not later than 6 months after the enactment of
this subsection, issue proposed guidance on the temporary
reassignment of personnel under this subsection; and
‘‘(B) after providing notice and a 60-day period for
public comment, finalize such guidance.
‘‘(6) REPORT TO CONGRESS.—Not later than 4 years after
the date of enactment of the Pandemic and All-Hazards
Preparedness Reauthorization Act of 2013, the Comptroller
General of the United States shall conduct an independent
evaluation, and submit to the appropriate committees of the
Congress a report, on temporary reassignment under this subsection, including—
‘‘(A) a description of how, and under what circumstances, such temporary reassignment has been used
by States and Indian tribes;
‘‘(B) an analysis of how such temporary reassignment
has assisted States and Indian tribes in responding to
public health emergencies;
‘‘(C) an evaluation of how such temporary reassignment
has improved operational efficiencies in responding to
public health emergencies;
‘‘(D) an analysis of the extent to which, if any, Federal
programs from which personnel have been temporarily
reassigned have been adversely affected by the reassignment; and

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‘‘(E) recommendations on how medical surge capacity
could be improved in responding to public health emergencies and the impact of the reassignment flexibility under
this section on such surge capacity.
‘‘(7) DEFINITIONS.—In this subsection—
‘‘(A) the terms ‘Indian tribe’ and ‘tribal organization’
have the meanings given such terms in section 4 of the
Indian Self-Determination and Education Assistance Act;
and
‘‘(B) the term ‘State’ includes, in addition to the entities
listed in the definition of such term in section 2, the Freely
Associated States.
‘‘(8) SUNSET.—This subsection shall terminate on September 30, 2018.’’.

Recommendations.

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

(a) COOPERATIVE AGREEMENTS.—Section 319C–1 of the Public
Health Service Act (42 U.S.C. 247d–3a) is amended—
(1) in subsection (b)(1)(C), by striking ‘‘consortium of entities described in subparagraph (A)’’ and inserting ‘‘consortium
of States’’;
(2) in subsection (b)(2)—
(A) in subparagraph (A)—
(i) by striking clauses (i) and (ii) and inserting
the following:
‘‘(i) a description of the activities such entity will
carry out under the agreement to meet the goals identified under section 2802, including with respect to chemical, biological, radiological, or nuclear threats, whether
naturally occurring, unintentional, or deliberate;
‘‘(ii) a description of the activities such entity will
carry out with respect to pandemic influenza, as a
component of the activities carried out under clause
(i), and consistent with the requirements of paragraphs
(2) and (5) of subsection (g);’’;
(ii) in clause (iv), by striking ‘‘and’’ at the end;
and
(iii) by adding at the end the following:
‘‘(vi) a description of how, as appropriate, the entity
may partner with relevant public and private stakeholders in public health emergency preparedness and
response;
‘‘(vii) a description of how the entity, as applicable
and appropriate, will coordinate with State emergency
preparedness and response plans in public health
emergency preparedness, including State educational
agencies (as defined in section 9101(41) of the
Elementary and Secondary Education Act of 1965) and
State child care lead agencies (designated under section
658D of the Child Care and Development Block Grant
Act of 1990);
‘‘(viii) in the case of entities that operate on the
United States-Mexico border or the United StatesCanada border, a description of the activities such
entity will carry out under the agreement that are
specific to the border area including disease detection,
identification, investigation, and preparedness and

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127 STAT. 174

response activities related to emerging diseases and
infectious disease outbreaks whether naturally occurring or due to bioterrorism, consistent with the requirements of this section; and
‘‘(ix) a description of any activities that such entity
will use to analyze real-time clinical specimens for
pathogens of public health or bioterrorism significance,
including any utilization of poison control centers;’’;
and
(B) in subparagraph (C), by inserting ‘‘, including
addressing the needs of at-risk individuals,’’ after ‘‘capabilities of such entity’’;
(3) in subsection (f)—
(A) in paragraph (2), by adding ‘‘and’’ at the end;
(B) in paragraph (3), by striking ‘‘; and’’ and inserting
a period; and
(C) by striking paragraph (4);
(4) in subsection (g)—
(A) in paragraph (1), by striking subparagraph (A)
and inserting the following:
‘‘(A) include outcome goals representing operational
achievements of the National Preparedness Goals developed under section 2802(b) with respect to all-hazards,
including chemical, biological, radiological, or nuclear
threats; and’’; and
(B) in paragraph (2)(A), by adding at the end the
following: ‘‘The Secretary shall periodically update, as necessary and appropriate, such pandemic influenza plan criteria and shall require the integration of such criteria
into the benchmarks and standards described in paragraph
(1).’’;
(5) by striking subsection (h);
(6) by redesignating subsections (i), (j), and (k) as subsections (h), (i), and (j), respectively;
(7) in subsection (h), as so redesignated—
(A) in paragraph (1)—
(i) in subparagraph (A)—
(I) by striking ‘‘$824,000,000 for fiscal year
2007, of which $35,000,000 shall be used to carry
out subsection (h),’’ and inserting ‘‘$641,900,000
for fiscal year 2014’’; and
(II) by striking ‘‘such sums as may be necessary for each of fiscal years 2008 through 2011’’
and inserting ‘‘$641,900,000 for each of fiscal years
2015 through 2018’’;
(ii) by striking subparagraph (B);
(iii) by redesignating subparagraphs (C) and (D)
as subparagraphs (B) and (C), respectively; and
(iv) in subparagraph (C), as so redesignated, by
striking ‘‘subparagraph (C)’’ and inserting ‘‘subparagraph (B)’’;
(B) in subparagraphs (C) and (D) of paragraph (3),
by striking ‘‘(1)(A)(i)(I)’’ each place it appears and inserting
‘‘(1)(A)’’;
(C) in paragraph (4)(B), by striking ‘‘subsection (c)’’
and inserting ‘‘subsection (b)’’; and
(D) by adding at the end the following:

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Criteria.

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127 STAT. 175

‘‘(7) AVAILABILITY OF COOPERATIVE AGREEMENT FUNDS.—
‘‘(A) IN GENERAL.—Amounts provided to an eligible
entity under a cooperative agreement under subsection (a)
for a fiscal year and remaining unobligated at the end
of such year shall remain available to such entity for the
next fiscal year for the purposes for which such funds
were provided.
‘‘(B) FUNDS CONTINGENT ON ACHIEVING BENCHMARKS.—
The continued availability of funds under subparagraph
(A) with respect to an entity shall be contingent upon
such entity achieving the benchmarks and submitting the
pandemic influenza plan as described in subsection (g).’’;
and
(8) in subsection (i), as so redesignated—
(A) in paragraph (1)(E), by striking ‘‘subsection (k)’’
and inserting ‘‘subsection (j)’’;
(B) by striking paragraph (3).
(b) VACCINE TRACKING AND DISTRIBUTION.—Section 319A(e) of
the Public Health Service Act (42 U.S.C. 247d–1(e)) is amended
by striking ‘‘such sums for each of fiscal years 2007 through 2011’’
and inserting ‘‘$30,800,000 for each of fiscal years 2014 through
2018’’.
(c) TECHNICAL AND CONFORMING AMENDMENTS.—
(1) Section 319C–1(b)(1)(B) of the Public Health Service
Act (42 U.S.C. 247d–3a(b)(1)(B)) is amended by striking ‘‘subsection (i)(4)’’ and inserting ‘‘subsection (h)(4)’’.
(2) Section 319C–2 of the Public Health Service Act (42
U.S.C. 247d–3b) is amended—
(A) in subsection (i), by striking ‘‘(j), and (k)’’ and
inserting ‘‘(i), and (j)’’; and
(B) in subsection (j)(3), by striking ‘‘319C–1(i)’’ and
inserting ‘‘319C–1(h)’’.
SEC. 203. HOSPITAL PREPAREDNESS AND MEDICAL SURGE CAPACITY.

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(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 VOLUNTEERS.—
(1) EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF VOLUNTEER HEALTH PROFESSIONALS.—Section 319I(k) of the Public
Health Service Act (42 U.S.C. 247d–7b(k)) is amended by
striking ‘‘$2,000,000 for fiscal year 2002, and such sums as
may be necessary for each of the fiscal years 2003 through
2011’’ and inserting ‘‘$5,000,000 for each of fiscal years 2014
through 2018’’.
(2) VOLUNTEERS.—Section 2813 of the Public Health Service
Act (42 U.S.C. 300hh–15) is amended—
(A) in subsection (d)(2), by adding at the end the following: ‘‘Such training exercises shall, as appropriate and
applicable, incorporate the needs of at-risk individuals in
the event of a public health emergency.’’; and
(B) in subsection (i), by striking ‘‘$22,000,000 for fiscal
year 2007, and such sums as may be necessary for each
of fiscal years 2008 through 2011’’ and inserting
‘‘$11,200,000 for each of fiscal years 2014 through 2018’’.

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Appropriation
authorization.

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(c) PARTNERSHIPS FOR STATE AND REGIONAL PREPAREDNESS TO
IMPROVE SURGE CAPACITY.—Section 319C–2 of the Public Health
Service Act (42 U.S.C. 247d–3b) is amended—
(1) in subsection (a), by inserting ‘‘, including, as appropriate, capacity and preparedness to address the needs of children and other at-risk individuals’’ before the period at the
end;
(2) in subsection (b)(1)(A)(ii), by striking ‘‘centers, primary’’
and inserting ‘‘centers, community health centers, primary’’;
(3) by striking subsection (c) and inserting the following:
‘‘(c) USE OF FUNDS.—An award under subsection (a) shall be
expended for activities to achieve the preparedness goals described
under paragraphs (1), (3), (4), (5), and (6) of section 2802(b) with
respect to all-hazards, including chemical, biological, radiological,
or nuclear threats.’’;
(4) by striking subsection (g) and inserting the following:
‘‘(g) COORDINATION.—
‘‘(1) LOCAL RESPONSE CAPABILITIES.—An eligible entity
shall, to the extent practicable, ensure that activities carried
out under an award under subsection (a) are coordinated with
activities of relevant local Metropolitan Medical Response Systems, local Medical Reserve Corps, the local Cities Readiness
Initiative, and local emergency plans.
‘‘(2) NATIONAL COLLABORATION.—Partnerships consisting of
one or more eligible entities under this section may, to the
extent practicable, collaborate with other partnerships consisting of one or more eligible entities under this section for
purposes of national coordination and collaboration with respect
to activities to achieve the preparedness goals described under
paragraphs (1), (3), (4), (5), and (6) of section 2802(b).’’;
(5) in subsection (i)—
(A) by striking ‘‘The requirements of’’ and inserting
the following:
‘‘(1) IN GENERAL.—The requirements of’’; and
(B) by adding at the end the following:
‘‘(2) MEETING GOALS OF NATIONAL HEALTH SECURITY
STRATEGY.—The Secretary shall implement objective, evidencebased metrics to ensure that entities receiving awards under
this section are meeting, to the extent practicable, the
applicable goals of the National Health Security Strategy under
section 2802.’’; and
(6) in subsection (j)—
(A) by amending paragraph (1) to read as follows:
‘‘(1) IN GENERAL.—For purposes of carrying out this section,
there is authorized to be appropriated $374,700,000 for each
of fiscal years 2014 through 2018.’’; and
(B) by adding at the end the following:
‘‘(4) AVAILABILITY OF COOPERATIVE AGREEMENT FUNDS.—
‘‘(A) IN GENERAL.—Amounts provided to an eligible
entity under a cooperative agreement under subsection (a)
for a fiscal year and remaining unobligated at the end
of such year shall remain available to such entity for the
next fiscal year for the purposes for which such funds
were provided.
‘‘(B) FUNDS CONTINGENT ON ACHIEVING BENCHMARKS.—
The continued availability of funds under subparagraph
(A) with respect to an entity shall be contingent upon

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such entity achieving the benchmarks and submitting the
pandemic influenza plan as required under subsection (i).’’.

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SEC. 204. ENHANCING SITUATIONAL AWARENESS AND BIOSURVEILLANCE.

(a) IN GENERAL.—Section 319D of the Public Health Service
Act (42 U.S.C. 247d–4) is amended—
(1) in subsection (b)—
(A) in paragraph (1)(B), by inserting ‘‘poison control
centers,’’ after ‘‘hospitals,’’;
(B) in paragraph (2), by inserting before the period
at the end the following: ‘‘, allowing for coordination to
maximize all-hazards medical and public health preparedness and response and to minimize duplication of effort’’;
and
(C) in paragraph (3), by inserting before the period
at the end the following: ‘‘and update such standards as
necessary’’;
(2) by striking subsection (c);
(3) by redesignating subsections (d) through (g) as subsections (c) through (f), respectively;
(4) in subsection (c), as so redesignated—
(A) in the subsection heading, by striking ‘‘PUBLIC
HEALTH SITUATIONAL AWARENESS’’ and inserting ‘‘MODERNIZING PUBLIC HEALTH SITUATIONAL AWARENESS AND BIOSURVEILLANCE’’;
(B) in paragraph (1)—
(i) by striking ‘‘Pandemic and All-Hazards
Preparedness Act’’ and inserting ‘‘Pandemic and AllHazards Preparedness Reauthorization Act of 2013’’;
and
(ii) by inserting ‘‘, novel emerging threats,’’ after
‘‘disease outbreaks’’;
(C) by striking paragraph (2) and inserting the following:
‘‘(2) STRATEGY AND IMPLEMENTATION PLAN.—Not later than
180 days after the date of enactment of the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013, the Secretary shall submit to the appropriate committees of Congress
a coordinated strategy and an accompanying implementation
plan that identifies and demonstrates the measurable steps
the Secretary will carry out to—
‘‘(A) develop, implement, and evaluate the network
described in paragraph (1), utilizing the elements described
in paragraph (3);
‘‘(B) modernize and enhance biosurveillance activities;
and
‘‘(C) improve information sharing, coordination, and
communication among disparate biosurveillance systems
supported by the Department of Health and Human Services.’’;
(D) in paragraph (3)(D), by inserting ‘‘community
health centers, health centers’’ after ‘‘poison control,’’;
(E) in paragraph (5), by striking subparagraph (A)
and inserting the following:
‘‘(A) utilize applicable interoperability standards as
determined by the Secretary, and in consultation with the

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Determination.
Consultation.

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Guidance.
Recommendations.

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Coordination.

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Office of the National Coordinator for Health Information
Technology, through a joint public and private sector
process;’’; and
(F) by adding at the end the following:
‘‘(6) CONSULTATION WITH THE NATIONAL BIODEFENSE
SCIENCE BOARD.—In carrying out this section and consistent
with section 319M, the National Biodefense Science Board shall
provide expert advice and guidance, including recommendations, regarding the measurable steps the Secretary should
take to modernize and enhance biosurveillance activities pursuant to the efforts of the Department of Health and Human
Services to ensure comprehensive, real-time, all-hazards biosurveillance capabilities. In complying with the preceding sentence, the National Biodefense Science Board shall—
‘‘(A) identify the steps necessary to achieve a national
biosurveillance system for human health, with international connectivity, where appropriate, that is predicated
on State, regional, and community level capabilities and
creates a networked system to allow for two-way information flow between and among Federal, State, and local
government public health authorities and clinical health
care providers;
‘‘(B) identify any duplicative surveillance programs
under the authority of the Secretary, or changes that are
necessary to existing programs, in order to enhance and
modernize such activities, minimize duplication, strengthen
and streamline such activities under the authority of the
Secretary, and achieve real-time and appropriate data that
relate to disease activity, both human and zoonotic; and
‘‘(C) coordinate with applicable existing advisory
committees of the Director of the Centers for Disease Control and Prevention, including such advisory committees
consisting of representatives from State, local, and tribal
public health authorities and appropriate public and private sector health care entities and academic institutions,
in order to provide guidance on public health surveillance
activities.’’;
(5) in subsection (d), as so redesignated—
(A) in paragraph (1), by striking ‘‘subsection (d)’’ and
inserting ‘‘subsection (c)’’;
(B) in paragraph (4)(B), by striking ‘‘subsection (d)’’
and inserting ‘‘subsection (c)’’; and
(C) in paragraph (5)—
(i) by striking ‘‘4 years after the date of enactment
of the Pandemic and All-Hazards Preparedness Act’’
and inserting ‘‘3 years after the date of enactment
of the Pandemic and All-Hazards Preparedness
Reauthorization Act of 2013’’; and
(ii) by striking ‘‘subsection (d)’’ and inserting ‘‘subsection (c)’’;
(6) in subsection (f), as so redesignated, by striking ‘‘such
sums as may be necessary in each of fiscal years 2007 through
2011’’ and inserting ‘‘$138,300,000 for each of fiscal years 2014
through 2018’’; and
(7) by adding at the end the following:
‘‘(g) DEFINITION.—For purposes of this section the term ‘biosurveillance’ means the process of gathering near real-time

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biological data that relates to human and zoonotic disease activity
and threats to human or animal health, in order to achieve early
warning and identification of such health threats, early detection
and prompt ongoing tracking of health events, and overall situational awareness of disease activity.’’.
(b) TECHNICAL AND CONFORMING AMENDMENT.—Section 319C–
1(b)(2)(D) of the Public Health Service Act (42 U.S.C. 247d–
3a(b)(2)(D)) is amended by striking ‘‘section 319D(d)(3)’’ and
inserting ‘‘section 319D(c)(3)’’.
SEC. 205. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD REPORTS.

Section 5 of the Project Bioshield Act of 2004 (42 U.S.C. 247d–
6c) is repealed.

Repeal.

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’’.

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SEC. 302. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN
EMERGENCIES.

(a) IN GENERAL.—Section 564 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb–3) is amended—
(1) in subsection (a)—
(A) in paragraph (1), by striking ‘‘sections 505, 510(k),
and 515 of this Act’’ and inserting ‘‘any provision of this
Act’’;
(B) in paragraph (2)(A), by striking ‘‘under a provision
of law referred to in such paragraph’’ and inserting ‘‘under
section 505, 510(k), or 515 of this Act or section 351 of
the Public Health Service Act’’; and
(C) in paragraph (3), by striking ‘‘a provision of law
referred to in such paragraph’’ and inserting ‘‘a section
of this Act or the Public Health Service Act referred to
in paragraph (2)(A)’’;
(2) in subsection (b)—
(A) in the subsection heading, by striking ‘‘EMERGENCY’’
and inserting ‘‘EMERGENCY OR THREAT JUSTIFYING EMERGENCY AUTHORIZED USE’’;
(B) in paragraph (1)—

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(i) in the matter preceding subparagraph (A), by
striking ‘‘may declare an emergency’’ and inserting
‘‘may make a declaration that the circumstances exist’’;
(ii) in subparagraph (A), by striking ‘‘specified’’;
(iii) in subparagraph (B)—
(I) by striking ‘‘specified’’; and
(II) by striking ‘‘; or’’ and inserting a semicolon;
(iv) by amending subparagraph (C) to read as follows:
‘‘(C) a determination by the Secretary that there is
a public health emergency, or a significant potential for
a public health emergency, that affects, or has a significant
potential to affect, national security or the health and
security of United States citizens living abroad, and that
involves a biological, chemical, radiological, or nuclear
agent or agents, or a disease or condition that may be
attributable to such agent or agents; or’’; and
(v) by adding at the end the following:
‘‘(D) the identification of a material threat pursuant
to section 319F–2 of the Public Health Service Act sufficient
to affect national security or the health and security of
United States citizens living abroad.’’;
(C) in paragraph (2)—
(i) in subparagraph (A), by amending clause (ii)
to read as follows:
‘‘(ii) a change in the approval status of the product
such that the circumstances described in subsection
(a)(2) have ceased to exist.’’;
(ii) by striking subparagraph (B); and
(iii) by redesignating subparagraph (C) as subparagraph (B);
(D) in paragraph (4), by striking ‘‘advance notice of
termination, and renewal under this subsection.’’ and
inserting ‘‘, and advance notice of termination under this
subsection.’’; and
(E) by adding at the end the following:
‘‘(5) EXPLANATION BY SECRETARY.—If an authorization
under this section with respect to an unapproved product or
an unapproved use of an approved product has been in effect
for more than 1 year, the Secretary shall provide in writing
to the sponsor of such product an explanation of the scientific,
regulatory, or other obstacles to approval, licensure, or clearance of such product or use, including specific actions to be
taken by the Secretary and the sponsor to overcome such
obstacles.’’;
(3) in subsection (c)—
(A) in the matter preceding paragraph (1)—
(i) by inserting ‘‘the Assistant Secretary for
Preparedness and Response,’’ after ‘‘consultation with’’;
(ii) by striking ‘‘Health and’’ and inserting ‘‘Health,
and’’; and
(iii) by striking ‘‘circumstances of the emergency
involved’’ and inserting ‘‘applicable circumstances
described in subsection (b)(1)’’;
(B) in paragraph (1), by striking ‘‘specified’’ and
inserting ‘‘referred to’’; and

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(C) in paragraph (2)(B), by inserting ‘‘, taking into
consideration the material threat posed by the agent or
agents identified in a declaration under subsection
(b)(1)(D), if applicable’’ after ‘‘risks of the product’’;
(4) in subsection (d)(3), by inserting ‘‘, to the extent practicable given the circumstances of the emergency,’’ after
‘‘including’’;
(5) in subsection (e)—
(A) in paragraph (1)(A), by striking ‘‘circumstances of
the emergency’’ and inserting ‘‘applicable circumstances
described in subsection (b)(1)’’;
(B) in paragraph (1)(B), by amending clause (iii) to
read as follows:
‘‘(iii) Appropriate conditions with respect to collection and analysis of information concerning the safety
and effectiveness of the product with respect to the
use of such product during the period when the
authorization is in effect and a reasonable time following such period.’’;
(C) in paragraph (2)—
(i) in subparagraph (A)—
(I) by striking ‘‘manufacturer of the product’’
and inserting ‘‘person’’;
(II) by striking ‘‘circumstances of the emergency’’ and inserting ‘‘applicable circumstances
described in subsection (b)(1)’’; and
(III) by inserting at the end before the period
‘‘or in paragraph (1)(B)’’;
(ii) in subparagraph (B)(i), by inserting before the
period at the end ‘‘, except as provided in section 564A
with respect to authorized changes to the product
expiration date’’; and
(iii) by amending subparagraph (C) to read as follows:
‘‘(C) In establishing conditions under this paragraph
with respect to the distribution and administration of the
product for the unapproved use, the Secretary shall not
impose conditions that would restrict distribution or
administration of the product when distributed or administered for the approved use.’’; and
(D) by amending paragraph (3) to read as follows:
‘‘(3) GOOD MANUFACTURING PRACTICE; PRESCRIPTION.—With
respect to the emergency use of a product for which an
authorization under this section is issued (whether an
unapproved product or an unapproved use of an approved
product), the Secretary may waive or limit, to the extent appropriate given the applicable circumstances described in subsection (b)(1)—
‘‘(A) requirements regarding current good manufacturing practice otherwise applicable to the manufacture,
processing, packing, or holding of products subject to regulation under this Act, including such requirements established under section 501 or 520(f)(1), and including relevant
conditions prescribed with respect to the product by an
order under section 520(f)(2);
‘‘(B) requirements established under section 503(b); and
‘‘(C) requirements established under section 520(e).’’;

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Limitations.

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Review.

Web posting.

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Determination.

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(6) in subsection (g)—
(A) in the subsection heading, by inserting ‘‘REVIEW
AND’’ before ‘‘REVOCATION’’;
(B) in paragraph (1), by inserting after the period
at the end the following: ‘‘As part of such review, the
Secretary shall regularly review the progress made with
respect to the approval, licensure, or clearance of—
‘‘(A) an unapproved product for which an authorization
was issued under this section; or
‘‘(B) an unapproved use of an approved product for
which an authorization was issued under this section.’’;
and
(C) by amending paragraph (2) to read as follows:
‘‘(2) REVISION AND REVOCATION.—The Secretary may revise
or revoke an authorization under this section if—
‘‘(A) the circumstances described under subsection
(b)(1) no longer exist;
‘‘(B) the criteria under subsection (c) for issuance of
such authorization are no longer met; or
‘‘(C) other circumstances make such revision or revocation appropriate to protect the public health or safety.’’;
(7) in subsection (h)(1), by adding after the period at the
end the following: ‘‘The Secretary shall make any revisions
to an authorization under this section available on the Internet
Web site of the Food and Drug Administration.’’;
(8) by adding at the end of subsection (j) the following:
‘‘(4) Nothing in this section shall be construed as authorizing a delay in the review or other consideration by the Secretary of any application or submission pending before the
Food and Drug Administration for a product for which an
authorization under this section is issued.’’; and
(9) by adding at the end the following:
‘‘(m) CATEGORIZATION OF LABORATORY TESTS ASSOCIATED WITH
DEVICES SUBJECT TO AUTHORIZATION.—
‘‘(1) IN GENERAL.—In issuing an authorization under this
section with respect to a device, the Secretary may, subject
to the provisions of this section, determine that a laboratory
examination or procedure associated with such device shall
be deemed, for purposes of section 353 of the Public Health
Service Act, to be in a particular category of examinations
and procedures (including the category described by subsection
(d)(3) of such section) if, based on the totality of scientific
evidence available to the Secretary—
‘‘(A) such categorization would be beneficial to protecting the public health; and
‘‘(B) the known and potential benefits of such categorization under the circumstances of the authorization
outweigh the known and potential risks of the categorization.
‘‘(2) CONDITIONS OF DETERMINATION.—The Secretary may
establish appropriate conditions on the performance of the
examination or procedure pursuant to such determination.
‘‘(3) EFFECTIVE PERIOD.—A determination under this subsection shall be effective for purposes of section 353 of the
Public Health Service Act notwithstanding any other provision
of that section during the effective period of the relevant declaration under subsection (b).’’.

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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:

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

‘‘(a) DEFINITIONS.—In this section:
‘‘(1) ELIGIBLE PRODUCT.—The term ‘eligible product’ means
a product that—
‘‘(A) is approved or cleared under this chapter or
licensed under section 351 of the Public Health Service
Act;
‘‘(B)(i) is intended for use to prevent, diagnose, or treat
a disease or condition involving a biological, chemical,
radiological, or nuclear agent or agents; or
‘‘(ii) is intended for use to prevent, diagnose, or treat
a serious or life-threatening disease or condition caused
by a product described in clause (i); and
‘‘(C) is intended for use during the circumstances under
which—
‘‘(i) a determination described in subparagraph (A),
(B), or (C) of section 564(b)(1) has been made by the
Secretary of Homeland Security, the Secretary of
Defense, or the Secretary, respectively; or
‘‘(ii) the identification of a material threat
described in subparagraph (D) of section 564(b)(1) has
been made pursuant to section 319F–2 of the Public
Health Service Act.
‘‘(2) PRODUCT.—The term ‘product’ means a drug, device,
or biological product.
‘‘(b) EXPIRATION DATING.—
‘‘(1) IN GENERAL.—The Secretary may extend the expiration
date and authorize the introduction or delivery for introduction
into interstate commerce of an eligible product after the expiration date provided by the manufacturer if—
‘‘(A) the expiration date extension is intended to support the United States ability to protect—
‘‘(i) the public health; or
‘‘(ii) military preparedness and effectiveness; and
‘‘(B) the expiration date extension is supported by an
appropriate scientific evaluation that is conducted or
accepted by the Secretary.
‘‘(2) REQUIREMENTS AND CONDITIONS.—Any extension of an
expiration date under paragraph (1) shall, as part of the extension, identify—
‘‘(A) each specific lot, batch, or other unit of the product
for which extended expiration is authorized;
‘‘(B) the duration of the extension; and
‘‘(C) any other requirements or conditions as the Secretary may deem appropriate for the protection of the public
health, which may include requirements for, or conditions
on, product sampling, storage, packaging or repackaging,
transport, labeling, notice to product recipients, recordkeeping, periodic testing or retesting, or product disposition.
‘‘(3) EFFECT.—Notwithstanding any other provision of this
Act or the Public Health Service Act, an eligible product shall

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Definition.

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not be considered an unapproved product (as defined in section
564(a)(2)(A)) and shall not be deemed adulterated or misbranded under this Act because, with respect to such product,
the Secretary has, under paragraph (1), extended the expiration
date and authorized the introduction or delivery for introduction
into interstate commerce of such product after the expiration
date provided by the manufacturer.
‘‘(4) EXPIRATION DATE.—For purposes of this subsection,
the term ‘expiration date’ means the date established through
appropriate stability testing required by the regulations issued
by the Secretary to ensure that the product meets applicable
standards of identity, strength, quality, and purity at the time
of use.
‘‘(c) CURRENT GOOD MANUFACTURING PRACTICE.—
‘‘(1) IN GENERAL.—The Secretary may, when the circumstances of a domestic, military, or public health emergency
or material threat described in subsection (a)(1)(C) so warrant,
authorize, with respect to an eligible product, deviations from
current good manufacturing practice requirements otherwise
applicable to the manufacture, processing, packing, or holding
of products subject to regulation under this Act, including
requirements under section 501 or 520(f)(1) or applicable conditions prescribed with respect to the eligible product by an
order under section 520(f)(2).
‘‘(2) EFFECT.—Notwithstanding any other provision of this
Act or the Public Health Service Act, an eligible product shall
not be considered an unapproved product (as defined in section
564(a)(2)(A)) and shall not be deemed adulterated or misbranded under this Act because, with respect to such product,
the Secretary has authorized deviations from current good
manufacturing practices under paragraph (1).
‘‘(d) EMERGENCY DISPENSING.—The requirements of sections
503(b) and 520(e) shall not apply to an eligible product, and the
product shall not be considered an unapproved product (as defined
in section 564(a)(2)(A)) and shall not be deemed adulterated or
misbranded under this Act because it is dispensed without an
individual prescription, if—
‘‘(1) the product is dispensed during the circumstances
described in subsection (a)(1)(C); and
‘‘(2) such dispensing without an individual prescription
occurs—
‘‘(A) as permitted under the law of the State in which
the product is dispensed; or
‘‘(B) in accordance with an order issued by the Secretary, for the purposes and duration of the circumstances
described in subsection (a)(1)(C).
‘‘(e) EMERGENCY USE INSTRUCTIONS.—
‘‘(1) IN GENERAL.—The Secretary, acting through an appropriate official within the Department of Health and Human
Services, may create and issue emergency use instructions to
inform health care providers or individuals to whom an eligible
product is to be administered concerning such product’s
approved, licensed, or cleared conditions of use.
‘‘(2) EFFECT.—Notwithstanding any other provisions of this
Act or the Public Health Service Act, a product shall not be
considered an unapproved product and shall not be deemed
adulterated or misbranded under this Act because of the

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127 STAT. 185

issuance of emergency use instructions under paragraph (1)
with respect to such product or the introduction or delivery
for introduction of such product into interstate commerce
accompanied by such instructions—
‘‘(A) during an emergency response to an actual emergency that is the basis for a determination described in
subsection (a)(1)(C)(i); or
‘‘(B) by a government entity (including a Federal, State,
local, or tribal government entity), or a person acting on
behalf of such a government entity, in preparation for
an emergency response.’’.
(c) RISK EVALUATION AND MITIGATION STRATEGIES.—Section
505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355–1), is amended—
(1) in subsection (f), by striking paragraph (7); and
(2) by adding at the end the following:
‘‘(k) WAIVER IN PUBLIC HEALTH EMERGENCIES.—The Secretary
may waive any requirement of this section with respect to a qualified countermeasure (as defined in section 319F–1(a)(2) of the Public
Health Service Act) to which a requirement under this section
has been applied, if the Secretary determines that such waiver
is required to mitigate the effects of, or reduce the severity of,
the circumstances under which—
‘‘(1) a determination described in subparagraph (A), (B),
or (C) of section 564(b)(1) has been made by the Secretary
of Homeland Security, the Secretary of Defense, or the Secretary, respectively; or
‘‘(2) the identification of a material threat described in
subparagraph (D) of section 564(b)(1) has been made pursuant
to section 319F–2 of the Public Health Service Act.’’.
(d) PRODUCTS HELD FOR EMERGENCY USE.—The Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended by
inserting after section 564A, as added by subsection (b), the following:
‘‘SEC. 564B. PRODUCTS HELD FOR EMERGENCY USE.

‘‘It is not a violation of any section of this Act or of the
Public Health Service Act for a government entity (including a
Federal, State, local, or tribal government entity), or a person
acting on behalf of such a government entity, to introduce into
interstate commerce a product (as defined in section 564(a)(4))
intended for emergency use, if that product—
‘‘(1) is intended to be held and not used; and
‘‘(2) is held and not used, unless and until that product—
‘‘(A) is approved, cleared, or licensed under section
505, 510(k), or 515 of this Act or section 351 of the Public
Health Service Act;
‘‘(B) is authorized for investigational use under section
505 or 520 of this Act or section 351 of the Public Health
Service Act; or
‘‘(C) is authorized for use under section 564.’’.

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21 USC
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SEC. 303. DEFINITIONS.

Section 565 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb–4) is amended by striking ‘‘The Secretary, in consultation’’ and inserting the following:
‘‘(a) DEFINITIONS.—In this section—

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‘‘(1) the term ‘countermeasure’ means a qualified countermeasure, a security countermeasure, and a qualified pandemic
or epidemic product;
‘‘(2) the term ‘qualified countermeasure’ has the meaning
given such term in section 319F–1 of the Public Health Service
Act;
‘‘(3) the term ‘security countermeasure’ has the meaning
given such term in section 319F–2 of such Act; and
‘‘(4) the term ‘qualified pandemic or epidemic product’
means a product that meets the definition given such term
in section 319F–3 of the Public Health Service Act and—
‘‘(A) that has been identified by the Department of
Health and Human Services or the Department of Defense
as receiving funding directly related to addressing chemical, biological, radiological, or nuclear threats, including
pandemic influenza; or
‘‘(B) is included under this paragraph pursuant to a
determination by the Secretary.
‘‘(b) GENERAL DUTIES.—The Secretary, in consultation’’.

SEC. 304. ENHANCING MEDICAL COUNTERMEASURE ACTIVITIES.

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Consultations.

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Section 565 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb–4), as amended by section 303, is further amended—
(1) in the section heading, by striking ‘‘TECHNICAL ASSISTANCE’’ and inserting ‘‘COUNTERMEASURE DEVELOPMENT,
REVIEW, AND TECHNICAL ASSISTANCE’’;
(2) in subsection (b), by striking the subsection enumerator
and all that follows through ‘‘shall establish’’ and inserting
the following:
‘‘(b) GENERAL DUTIES.—In order to accelerate the development,
stockpiling, approval, licensure, and clearance of qualified countermeasures, security countermeasures, and qualified pandemic or epidemic products, the Secretary, in consultation with the Assistant
Secretary for Preparedness and Response, shall—
‘‘(1) ensure the appropriate involvement of Food and Drug
Administration personnel in interagency activities related to
countermeasure advanced research and development, consistent
with sections 319F, 319F–1, 319F–2, 319F–3, 319L, and 2811
of the Public Health Service Act;
‘‘(2) ensure the appropriate involvement and consultation
of Food and Drug Administration personnel in any flexible
manufacturing activities carried out under section 319L of the
Public Health Service Act, including with respect to meeting
regulatory requirements set forth in this Act;
‘‘(3) promote countermeasure expertise within the Food
and Drug Administration by—
‘‘(A) ensuring that Food and Drug Administration personnel involved in reviewing countermeasures for approval,
licensure, or clearance are informed by the Assistant Secretary for Preparedness and Response on the material
threat assessment conducted under section 319F–2 of the
Public Health Service Act for the agent or agents for which
the countermeasure under review is intended;
‘‘(B) training Food and Drug Administration personnel
regarding review of countermeasures for approval, licensure, or clearance;

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‘‘(C) holding public meetings at least twice annually
to encourage the exchange of scientific ideas; and
‘‘(D) establishing protocols to ensure that countermeasure reviewers have sufficient training or experience
with countermeasures;
‘‘(4) maintain teams, composed of Food and Drug Administration personnel with expertise on countermeasures, including
specific countermeasures, populations with special clinical
needs (including children and pregnant women that may use
countermeasures, as applicable and appropriate), classes or
groups of countermeasures, or other countermeasure-related
technologies and capabilities, that shall—
‘‘(A) consult with countermeasure experts, including
countermeasure sponsors and applicants, to identify and
help resolve scientific issues related to the approval, licensure, or clearance of countermeasures, through workshops
or public meetings; and
‘‘(B) improve and advance the science relating to the
development of new tools, standards, and approaches to
assessing and evaluating countermeasures—
‘‘(i) in order to inform the process for countermeasure approval, clearance, and licensure; and
‘‘(ii) with respect to the development of countermeasures for populations with special clinical needs,
including children and pregnant women, in order to
meet the needs of such populations, as necessary and
appropriate; and
‘‘(5) establish’’; and
(3) by adding at the end the following:
‘‘(c) FINAL GUIDANCE ON DEVELOPMENT OF ANIMAL MODELS.—
‘‘(1) IN GENERAL.—Not later than 1 year after the date
of the enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, the Secretary shall provide
final guidance to industry regarding the development of animal
models to support approval, clearance, or licensure of countermeasures referred to in subsection (a) when human efficacy
studies are not ethical or feasible.
‘‘(2) AUTHORITY TO EXTEND DEADLINE.—The Secretary may
extend the deadline for providing final guidance under paragraph (1) by not more than 6 months upon submission by
the Secretary of a report on the status of such guidance to
the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate.
‘‘(d) DEVELOPMENT AND ANIMAL MODELING PROCEDURES.—
‘‘(1) AVAILABILITY OF ANIMAL MODEL MEETINGS.—To facilitate the timely development of animal models and support
the development, stockpiling, licensure, approval, and clearance
of countermeasures, the Secretary shall, not later than 180
days after the enactment of this subsection, establish a procedure by which a sponsor or applicant that is developing a
countermeasure for which human efficacy studies are not ethical or practicable, and that has an approved investigational
new drug application or investigational device exemption, may
request and receive—
‘‘(A) a meeting to discuss proposed animal model
development activities; and

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‘‘(B) a meeting prior to initiating pivotal animal
studies.
‘‘(2) PEDIATRIC MODELS.—To facilitate the development and
selection of animal models that could translate to pediatric
studies, any meeting conducted under paragraph (1) shall
include discussion of animal models for pediatric populations,
as appropriate.
‘‘(e) REVIEW AND APPROVAL OF COUNTERMEASURES.—
‘‘(1) MATERIAL THREAT.—When evaluating an application
or submission for approval, licensure, or clearance of a countermeasure, the Secretary shall take into account the material
threat posed by the chemical, biological, radiological, or nuclear
agent or agents identified under section 319F–2 of the Public
Health Service Act for which the countermeasure under review
is intended.
‘‘(2) REVIEW EXPERTISE.—When practicable and appropriate, teams of Food and Drug Administration personnel
reviewing applications or submissions described under paragraph (1) shall include a reviewer with sufficient training or
experience with countermeasures pursuant to the protocols
established under subsection (b)(3)(D).’’.

SEC. 305. REGULATORY MANAGEMENT PLANS.

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Section 565 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb–4), as amended by section 304, is further amended
by adding at the end the following:
‘‘(f) REGULATORY MANAGEMENT PLAN.—
‘‘(1) DEFINITION.—In this subsection, the term ‘eligible
countermeasure’ means—
‘‘(A) a security countermeasure with respect to which
the Secretary has entered into a procurement contract
under section 319F–2(c) of the Public Health Service Act;
or
‘‘(B) a countermeasure with respect to which the Biomedical Advanced Research and Development Authority
has provided funding under section 319L of the Public
Health Service Act for advanced research and development.
‘‘(2) REGULATORY MANAGEMENT PLAN PROCESS.—The Secretary, in consultation with the Assistant Secretary for
Preparedness and Response and the Director of the Biomedical
Advanced Research and Development Authority, shall establish
a formal process for obtaining scientific feedback and interactions regarding the development and regulatory review of
eligible countermeasures by facilitating the development of
written regulatory management plans in accordance with this
subsection.
‘‘(3) SUBMISSION OF REQUEST AND PROPOSED PLAN BY
SPONSOR OR APPLICANT.—
‘‘(A) IN GENERAL.—A sponsor or applicant of an eligible
countermeasure may initiate the process described under
paragraph (2) upon submission of a written request to
the Secretary. Such request shall include a proposed regulatory management plan.
‘‘(B) TIMING OF SUBMISSION.—A sponsor or applicant
may submit a written request under subparagraph (A)
after the eligible countermeasure has an investigational
new drug or investigational device exemption in effect.

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‘‘(C) RESPONSE BY SECRETARY.—The Secretary shall
direct the Food and Drug Administration, upon submission
of a written request by a sponsor or applicant under
subparagraph (A), to work with the sponsor or applicant
to agree on a regulatory management plan within a reasonable time not to exceed 90 days. If the Secretary determines
that no plan can be agreed upon, the Secretary shall provide to the sponsor or applicant, in writing, the scientific
or regulatory rationale why such agreement cannot be
reached.
‘‘(4) PLAN.—The content of a regulatory management plan
agreed to by the Secretary and a sponsor or applicant shall
include—
‘‘(A) an agreement between the Secretary and the
sponsor or applicant regarding developmental milestones
that will trigger responses by the Secretary as described
in subparagraph (B);
‘‘(B) performance targets and goals for timely and
appropriate responses by the Secretary to the triggers
described under subparagraph (A), including meetings
between the Secretary and the sponsor or applicant, written
feedback, decisions by the Secretary, and other activities
carried out as part of the development and review process;
and
‘‘(C) an agreement on how the plan shall be modified,
if needed.
‘‘(5) MILESTONES AND PERFORMANCE TARGETS.—The
developmental milestones described in paragraph (4)(A) and
the performance targets and goals described in paragraph (4)(B)
shall include—
‘‘(A) feedback from the Secretary regarding the data
required to support the approval, clearance, or licensure
of the eligible countermeasure involved;
‘‘(B) feedback from the Secretary regarding the data
necessary to inform any authorization under section 564;
‘‘(C) feedback from the Secretary regarding the data
necessary to support the positioning and delivery of the
eligible countermeasure, including to the Strategic National
Stockpile;
‘‘(D) feedback from the Secretary regarding the data
necessary to support the submission of protocols for review
under section 505(b)(5)(B);
‘‘(E) feedback from the Secretary regarding any gaps
in scientific knowledge that will need resolution prior to
approval, licensure, or clearance of the eligible countermeasure and plans for conducting the necessary scientific
research;
‘‘(F) identification of the population for which the
countermeasure sponsor or applicant seeks approval, licensure, or clearance and the population for which desired
labeling would not be appropriate, if known; and
‘‘(G) as necessary and appropriate, and to the extent
practicable, a plan for demonstrating safety and effectiveness in pediatric populations, and for developing pediatric
dosing, formulation, and administration with respect to
the eligible countermeasure, provided that such plan would

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not delay authorization under section 564, approval, licensure, or clearance for adults.
‘‘(6) PRIORITIZATION.—
‘‘(A) PLANS FOR SECURITY COUNTERMEASURES.—The
Secretary shall establish regulatory management plans for
all security countermeasures for which a request is submitted under paragraph (3)(A).
‘‘(B) PLANS FOR OTHER ELIGIBLE COUNTERMEASURES.—
The Secretary shall determine whether resources are available to establish regulatory management plans for eligible
countermeasures that are not security countermeasures.
If resources are available to establish regulatory management plans for eligible countermeasures that are not security countermeasures, and if resources are not available
to establish regulatory management plans for all eligible
countermeasures for which requests have been submitted,
the Director of the Biomedical Advanced Research and
Development Authority, in consultation with the Commissioner, shall prioritize which eligible countermeasures may
receive regulatory management plans.’’.

Determination.

Consultation.
Prioritization.

SEC. 306. REPORT.

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Public
information.
Web posting.

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06:22 Mar 19, 2013

Section 565 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb–4), as amended by section 305, is further amended
by adding at the end the following:
‘‘(g) ANNUAL REPORT.—Not later than 180 days after the date
of enactment of this subsection, and annually thereafter, the Secretary shall make publicly available on the Web site of the Food
and Drug Administration a report that details the countermeasure
development and review activities of the Food and Drug Administration, including—
‘‘(1) with respect to the development of new tools, standards, and approaches to assess and evaluate countermeasures—
‘‘(A) the identification of the priorities of the Food
and Drug Administration and the progress made on such
priorities; and
‘‘(B) the identification of scientific gaps that impede
the development, approval, licensure, or clearance of
countermeasures for populations with special clinical needs,
including children and pregnant women, and the progress
made on resolving these challenges;
‘‘(2) with respect to countermeasures for which a regulatory
management plan has been agreed upon under subsection (f),
the extent to which the performance targets and goals set
forth in subsection (f)(4)(B) and the regulatory management
plan have been met, including, for each such countermeasure—
‘‘(A) whether the regulatory management plan was
completed within the required timeframe, and the length
of time taken to complete such plan;
‘‘(B) whether the Secretary adhered to the timely and
appropriate response times set forth in such plan; and
‘‘(C) explanations for any failure to meet such performance targets and goals;
‘‘(3) the number of regulatory teams established pursuant
to subsection (b)(4), the number of products, classes of products,
or technologies assigned to each such team, and the number

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of, type of, and any progress made as a result of consultations
carried out under subsection (b)(4)(A);
‘‘(4) an estimate of resources obligated to countermeasure
development and regulatory assessment, including—
‘‘(A) Center-specific objectives and accomplishments;
and
‘‘(B) the number of full-time equivalent employees of
the Food and Drug Administration who directly support
the review of countermeasures;
‘‘(5) the number of countermeasure applications and
submissions submitted, the number of countermeasures
approved, licensed, or cleared, the status of remaining submitted applications and submissions, and the number of each
type of authorization issued pursuant to section 564;
‘‘(6) the number of written requests for a regulatory
management plan submitted under subsection (f)(3)(A), the
number of regulatory management plans developed, and the
number of such plans developed for security countermeasures;
and
‘‘(7) the number, type, and frequency of meetings between
the Food and Drug Administration and—
‘‘(A) sponsors of a countermeasure as defined in subsection (a); or
‘‘(B) another agency engaged in development or
management of portfolios for such countermeasures,
including the Centers for Disease Control and Prevention,
the Biomedical Advanced Research and Development
Authority, the National Institutes of Health, and the appropriate agencies of the Department of Defense.’’.

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SEC. 307. PEDIATRIC MEDICAL COUNTERMEASURES.

(a) PEDIATRIC STUDIES OF DRUGS.—Section 505A of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended—
(1) in subsection (d), by adding at the end the following:
‘‘(5) CONSULTATION.—With respect to a drug that is a qualified countermeasure (as defined in section 319F–1 of the Public
Health Service Act), a security countermeasure (as defined
in section 319F–2 of the Public Health Service Act), or a qualified pandemic or epidemic product (as defined in section 319F–
3 of the Public Health Service Act), the Secretary shall solicit
input from the Assistant Secretary for Preparedness and
Response regarding the need for and, from the Director of
the Biomedical Advanced Research and Development Authority
regarding the conduct of, pediatric studies under this section.’’;
and
(2) in subsection (n)(1), by adding at the end the following:
‘‘(C) For a drug that is a qualified countermeasure
(as defined in section 319F–1 of the Public Health Service
Act), a security countermeasure (as defined in section
319F–2 of the Public Health Service Act), or a qualified
pandemic or epidemic product (as defined in section 319F–
3 of such Act), in addition to any action with respect
to such drug under subparagraph (A) or (B), the Secretary
shall notify the Assistant Secretary for Preparedness and
Response and the Director of the Biomedical Advanced
Research and Development Authority of all pediatric

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Consultation.

42 USC 284m–1.

PUBLIC LAW 113–5—MAR. 13, 2013

studies in the written request issued by the Commissioner
of Food and Drugs.’’.
(b) ADDITION TO PRIORITY LIST CONSIDERATIONS.—Section 409I
of the Public Health Service Act (42 U.S.C. 284m) is amended—
(1) by striking subsection (a)(2) and inserting the following:
‘‘(2) CONSIDERATION OF AVAILABLE INFORMATION.—In developing and prioritizing the list under paragraph (1), the Secretary—
‘‘(A) shall consider—
‘‘(i) therapeutic gaps in pediatrics that may include
developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and
biologics in children, and pediatric clinical trials;
‘‘(ii) particular pediatric diseases, disorders or
conditions where more complete knowledge and testing
of therapeutics, including drugs and biologics, may be
beneficial in pediatric populations; and
‘‘(iii) the adequacy of necessary infrastructure to
conduct pediatric pharmacological research, including
research networks and trained pediatric investigators;
and
‘‘(B) may consider the availability of qualified countermeasures (as defined in section 319F–1), security countermeasures (as defined in section 319F–2), and qualified
pandemic or epidemic products (as defined in section 319F–
3) to address the needs of pediatric populations, in consultation with the Assistant Secretary for Preparedness and
Response, consistent with the purposes of this section.’’;
and
(2) in subsection (b), by striking ‘‘subsection (a)’’ and
inserting ‘‘paragraphs (1) and (2)(A) of subsection (a)’’.
(c) ADVICE AND RECOMMENDATIONS OF THE PEDIATRIC ADVISORY
COMMITTEE REGARDING COUNTERMEASURES FOR PEDIATRIC POPULATIONS.—Subsection (b)(2) of section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended—
(1) in subparagraph (C), by striking the period and
inserting ‘‘; and’’; and
(2) by adding at the end the following:
‘‘(D) the development of countermeasures (as defined
in section 565(a) of the Federal Food, Drug, and Cosmetic
Act) for pediatric populations.’’.

TITLE IV—ACCELERATING MEDICAL
COUNTERMEASURE ADVANCED RESEARCH AND DEVELOPMENT

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SEC. 401. BIOSHIELD.

(a) PROCUREMENT OF COUNTERMEASURES.—Section 319F–2(c)
of the Public Health Service Act (42 U.S.C. 247d–6b(c)) is
amended—
(1) in paragraph (1)(B)(i)(III)(bb), by striking ‘‘eight years’’
and inserting ‘‘10 years’’;
(2) in paragraph (2)(C), by striking ‘‘the designated congressional committees (as defined in paragraph (10))’’ and inserting
‘‘the appropriate committees of Congress’’;

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PUBLIC LAW 113–5—MAR. 13, 2013

127 STAT. 193

(3) in paragraph (5)(B)(ii), by striking ‘‘eight years’’ and
inserting ‘‘10 years’’;
(4) in subparagraph (C) of paragraph (6)—
(A) in the subparagraph heading, by striking ‘‘DESIGNATED CONGRESSIONAL COMMITTEES’’ and inserting
‘‘APPROPRIATE CONGRESSIONAL COMMITTEES’’; and
(B) by striking ‘‘the designated congressional committees’’ and inserting ‘‘the appropriate congressional committees’’; and
(5) in paragraph (7)(C)—
(A) in clause (i)(I), by inserting ‘‘including advanced
research and development,’’ after ‘‘as may reasonably be
required,’’;
(B) in clause (ii)—
(i) in subclause (III), by striking ‘‘eight years’’ and
inserting ‘‘10 years’’; and
(ii) by striking subclause (IX) and inserting the
following:
‘‘(IX) CONTRACT TERMS.—The Secretary, in any
contract for procurement under this section—
‘‘(aa) may specify—
‘‘(AA) the dosing and administration
requirements for the countermeasure to
be developed and procured;
‘‘(BB) the amount of funding that will
be dedicated by the Secretary for advanced
research, development, and procurement
of the countermeasure; and
‘‘(CC) the specifications the countermeasure must meet to qualify for procurement under a contract under this section;
and
‘‘(bb) shall provide a clear statement of
defined Government purpose limited to uses
related to a security countermeasure, as
defined in paragraph (1)(B).’’; and
(C) by adding at the end the following:
‘‘(viii) FLEXIBILITY.—In carrying out this section,
the Secretary may, consistent with the applicable
provisions of this section, enter into contracts and other
agreements that are in the best interest of the Government in meeting identified security countermeasure
needs, including with respect to reimbursement of the
cost of advanced research and development as a reasonable, allowable, and allocable direct cost of the contract
involved.’’.
(b) REAUTHORIZATION OF THE SPECIAL RESERVE FUND.—Section
319F–2 of the Public Health Service Act (42 U.S.C. 247d–6b) is
amended—
(1) in subsection (c)—
(A) by striking ‘‘special reserve fund under paragraph
(10)’’ each place it appears and inserting ‘‘special reserve
fund as defined in subsection (h)’’; and
(B) by striking paragraphs (9) and (10); and
(2) by adding at the end the following:
‘‘(g) SPECIAL RESERVE FUND.—

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127 STAT. 194

PUBLIC LAW 113–5—MAR. 13, 2013
‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—In addition to
amounts appropriated to the special reserve fund prior to the
date of the enactment of this subsection, there is authorized
to be appropriated, for the procurement of security countermeasures under subsection (c) and for carrying out section
319L (relating to the Biomedical Advanced Research and
Development Authority), $2,800,000,000 for the period of fiscal
years 2014 through 2018. Amounts appropriated pursuant to
the preceding sentence are authorized to remain available until
September 30, 2019.
‘‘(2) USE OF SPECIAL RESERVE FUND FOR ADVANCED
RESEARCH AND DEVELOPMENT.—The Secretary may utilize not
more than 50 percent of the amounts authorized to be appropriated under paragraph (1) to carry out section 319L (related
to the Biomedical Advanced Research and Development
Authority). Amounts authorized to be appropriated under this
subsection to carry out section 319L are in addition to amounts
otherwise authorized to be appropriated to carry out such section.
‘‘(3) RESTRICTIONS ON USE OF FUNDS.—Amounts in the special reserve fund shall not be used to pay costs other than
payments made by the Secretary to a vendor for advanced
development (under section 319L) or for procurement of a security countermeasure under subsection (c)(7).
‘‘(4) REPORT.—Not later than 30 days after any date on
which the Secretary determines that the amount of funds in
the special reserve fund available for procurement is less than
$1,500,000,000, the Secretary shall submit to the appropriate
committees of Congress a report detailing the amount of such
funds available for procurement and the impact such reduction
in funding will have—
‘‘(A) in meeting the security countermeasure needs
identified under this section; and
‘‘(B) on the annual Public Health Emergency Medical
Countermeasures Enterprise and Strategy Implementation
Plan (pursuant to section 2811(d)).
‘‘(h) DEFINITIONS.—In this section:
‘‘(1) The term ‘advanced research and development’ has
the meaning given such term in section 319L(a).
‘‘(2) The term ‘special reserve fund’ means the ‘Biodefense
Countermeasures’ appropriations account, any appropriation
made available pursuant to section 521(a) of the Homeland
Security Act of 2002, and any appropriation made available
pursuant to subsection (g)(1).’’.

Determination.
Procurement.

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SEC. 402. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT
AUTHORITY.

(a) DUTIES.—Section 319L(c)(4) of the Public Health Service
Act (42 U.S.C. 247d–7e(c)(4)) is amended—
(1) in subparagraph (B)(iii), by inserting ‘‘(which may
include advanced research and development for purposes of
fulfilling requirements under the Federal Food, Drug, and Cosmetic Act or section 351 of this Act)’’ after ‘‘development’’;
and
(2) in subparagraph (D)(iii), by striking ‘‘and vaccine manufacturing technologies’’ and inserting ‘‘vaccine-manufacturing

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technologies, dose-sparing technologies, efficacy-increasing technologies, and platform technologies’’.
(b) TRANSACTION AUTHORITIES.—Section 319L(c)(5) of the Public
Health Service Act (42 U.S.C. 247d–7e(c)(5)) is amended by adding
at the end the following:
‘‘(G) GOVERNMENT PURPOSE.—In awarding contracts,
grants, and cooperative agreements under this section, the
Secretary shall provide a clear statement of defined Government purpose related to activities included in subsection
(a)(6)(B) for a qualified countermeasure or qualified pandemic or epidemic product.’’.
(c) FUND.—Paragraph (2) of section 319L(d) of the Public Health
Service Act (42 U.S.C. 247d–7e(d)(2)) is amended to read as follows:
‘‘(2) FUNDING.—To carry out the purposes of this section,
there is authorized to be appropriated to the Fund $415,000,000
for each of fiscal years 2014 through 2018, such amounts to
remain available until expended.’’.
(d) CONTINUED INAPPLICABILITY OF CERTAIN PROVISIONS.—Section 319L(e)(1)(C) of the Public Health Service Act (42 U.S.C. 247d–
7e(e)(1)(C)) is amended by striking ‘‘7 years’’ and inserting ‘‘12
years’’.
(e) EXTENSION OF LIMITED ANTITRUST EXEMPTION.—
(1) IN GENERAL.—Section 405(b) of the Pandemic and AllHazards Preparedness Act (42 U.S.C. 247d–6a note) is amended
by striking ‘‘6-year’’ and inserting ‘‘12-year’’.
(2) EFFECTIVE DATE.—This subsection shall take effect as
if enacted on December 17, 2012.
(f) INDEPENDENT EVALUATION.—Section 319L of the Public
Health Service Act (42 U.S.C. 247d–7e) is amended by adding
at the end the following:
‘‘(f) INDEPENDENT EVALUATION.—
‘‘(1) IN GENERAL.—Not later than 180 days after the date
of enactment of this subsection, the Comptroller General of
the United States shall conduct an independent evaluation
of the activities carried out to facilitate flexible manufacturing
capacity pursuant to this section.
‘‘(2) REPORT.—Not later than 1 year after the date of enactment of this subsection, the Comptroller General of the United
States shall submit to the appropriate committees of Congress
a report concerning the results of the evaluation conducted
under paragraph (1). Such report shall review and assess—
‘‘(A) the extent to which flexible manufacturing
capacity under this section is dedicated to chemical,
biological, radiological, and nuclear threats;
‘‘(B) the activities supported by flexible manufacturing
initiatives; and
‘‘(C) the ability of flexible manufacturing activities carried out under this section to—
‘‘(i) secure and leverage leading technical expertise
with respect to countermeasure advanced research,
development, and manufacturing processes; and
‘‘(ii) meet the surge manufacturing capacity needs
presented by novel and emerging threats, including
chemical, biological, radiological, and nuclear agents.’’.
(g) DEFINITIONS.—

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42 USC 247d–6a
note.

Deadline.

Review.
Assessment.

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PUBLIC LAW 113–5—MAR. 13, 2013
(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.

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Review.
Deadline.

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Section 319F–2 of the Public Health Service Act (42 U.S.C.
247d–6b) is amended—
(1) in subsection (a)—
(A) in paragraph (1)—
(i) by inserting ‘‘consistent with section 2811’’
before ‘‘by the Secretary to be appropriate’’; and
(ii) by inserting before the period at the end of
the second sentence the following: ‘‘and shall submit
such review annually to the appropriate congressional
committees of jurisdiction to the extent that disclosure
of such information does not compromise national security’’; and
(B) in paragraph (2)(D), by inserting before the semicolon at the end the following: ‘‘and that the potential
depletion of countermeasures currently in the stockpile
is identified and appropriately addressed, including
through necessary replenishment’’; and
(2) in subsection (f)(1), by striking ‘‘$640,000,000 for fiscal
year 2002, and such sums as may be necessary for each of

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fiscal years 2003 through 2006. Such authorization is in addition to amounts in the special reserve fund referred to in
subsection (c)(10)(A).’’ and inserting ‘‘$533,800,000 for each of
fiscal years 2014 through 2018. Such authorization is in addition to amounts in the special reserve fund referred to in
subsection (h).’’.
SEC. 404. NATIONAL BIODEFENSE SCIENCE BOARD.

Section 319M(a) of the Public Health Service Act (42 U.S.C.
247d–f(a)) is amended—
(1) in paragraph (2)—
(A) in subparagraph (D)—
(i) in clause (i), by striking ‘‘and’’ at the end;
(ii) in clause (ii), by striking the period and
inserting a semicolon; and
(iii) by adding at the end the following:
‘‘(iii) one such member shall be an individual with
pediatric subject matter expertise; and
‘‘(iv) one such member shall be a State, tribal,
territorial, or local public health official.’’; and
(B) by adding at the end the following flush sentence:
‘‘Nothing in this paragraph shall preclude a member of the
Board from satisfying two or more of the requirements
described in subparagraph (D).’’; and
(2) in paragraph (5)—
(A) in subparagraph (B), by striking ‘‘and’’ at the end;
(B) in subparagraph (C), by striking the period and
inserting ‘‘; and’’; and
(C) by adding at the end the following:
‘‘(D) provide any recommendation, finding, or report
provided to the Secretary under this paragraph to the
appropriate committees of Congress.’’.

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Approved March 13, 2013.

LEGISLATIVE HISTORY—H.R. 307:
CONGRESSIONAL RECORD, Vol. 159 (2013):
Jan. 22, considered and passed House.
Feb. 27, considered and passed Senate, amended.
Mar. 4, House concurred in Senate amendment.

Æ

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