[113th Congress Public Law 5]
[From the U.S. Government Publishing Office]
[[Page 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. <<NOTE: Mar. 13, 2013 - [H.R. 307]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013. 42 USC 201
note.>>
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Pandemic and All-
Hazards Preparedness Reauthorization Act of 2013''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE FOR PUBLIC
HEALTH EMERGENCIES
Sec. 101. National Health Security Strategy.
Sec. 102. Assistant Secretary for Preparedness and Response.
Sec. 103. National Advisory Committee on Children and Disasters.
Sec. 104. Modernization of the National Disaster Medical System.
Sec. 105. Continuing the role of the Department of Veterans Affairs.
TITLE II--OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS AND
RESPONSE
Sec. 201. Temporary reassignment of State and local personnel during a
public health emergency.
Sec. 202. Improving State and local public health security.
Sec. 203. Hospital preparedness and medical surge capacity.
Sec. 204. Enhancing situational awareness and biosurveillance.
Sec. 205. Eliminating duplicative Project Bioshield reports.
TITLE III--ENHANCING MEDICAL COUNTERMEASURE REVIEW
Sec. 301. Special protocol assessment.
Sec. 302. Authorization for medical products for use in emergencies.
Sec. 303. Definitions.
Sec. 304. Enhancing medical countermeasure activities.
Sec. 305. Regulatory management plans.
Sec. 306. Report.
Sec. 307. Pediatric medical countermeasures.
TITLE IV--ACCELERATING MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND
DEVELOPMENT
Sec. 401. BioShield.
Sec. 402. Biomedical Advanced Research and Development Authority.
Sec. 403. Strategic National Stockpile.
Sec. 404. National Biodefense Science Board.
[[Page 127 STAT. 162]]
TITLE I--STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE FOR PUBLIC
HEALTH EMERGENCIES
SEC. 101. NATIONAL HEALTH SECURITY STRATEGY.
(a) In General.--Section 2802 of the Public Health Service Act (42
U.S.C. 300hh-1) is amended--
(1) in subsection (a)(1), by striking ``2009'' and inserting
``2014''; and
(2) in subsection (b)--
(A) in paragraph (1)(A), by inserting ``, including
drills and exercises to ensure medical surge capacity
for events without notice'' after ``exercises''; and
(B) in paragraph (3)--
(i) in the matter preceding subparagraph (A)--
(I) by striking ``facilities), and
trauma care'' and inserting ``and
ambulatory care facilities and which may
include dental health facilities), and
trauma care, critical care,''; and
(II) by inserting ``(including
related availability, accessibility, and
coordination)'' after ``public health
emergencies'';
(ii) in subparagraph (A), by inserting ``and
trauma'' after ``medical'';
(iii) in subparagraph (B), by striking
``Medical evacuation and fatality management'' and
inserting ``Fatality management'';
(iv) by redesignating subparagraphs (C), (D),
and (E) as subparagraphs (D), (E), and (F),
respectively;
(v) by inserting after subparagraph (B), the
following the new subparagraph:
``(C) Coordinated medical triage and evacuation to
appropriate medical institutions based on patient
medical need, taking into account regionalized systems
of care.'';
(vi) in subparagraph (E), as redesignated by
clause (iv), by inserting ``(which may include
such dental health assets)'' after ``medical
assets''; and
(vii) by adding at the end the following:
``(G) Optimizing a coordinated and flexible approach
to the medical surge capacity of hospitals, other health
care facilities, critical care, trauma care (which may
include trauma centers), and emergency medical
systems.'';
(C) in paragraph (4)--
(i) in subparagraph (A), by inserting ``,
including the unique needs and considerations of
individuals with disabilities,'' after ``medical
needs of at-risk individuals''; and
(ii) in subparagraph (B), by inserting ``the''
before ``purpose of this section''; and
(D) by adding at the end the following:
``(7) Countermeasures.--
``(A) Promoting strategic initiatives to advance
countermeasures to diagnose, mitigate, prevent, or treat
harm from any biological agent or toxin, chemical,
radiological,
[[Page 127 STAT. 163]]
or nuclear agent or agents, whether naturally occurring,
unintentional, or deliberate.
``(B) <<NOTE: Definition.>> For purposes of this
paragraph, the term `countermeasures' has the same
meaning as the terms `qualified countermeasures' under
section 319F-1, `qualified pandemic and epidemic
products' under section 319F-3, and `security
countermeasures' under section 319F-2.
``(8) Medical and public health community resiliency.--
Strengthening the ability of States, local communities, and
tribal communities to prepare for, respond to, and be resilient
in the event of public health emergencies, whether naturally
occurring, unintentional, or deliberate by--
``(A) optimizing alignment and integration of
medical and public health preparedness and response
planning and capabilities with and into routine daily
activities; and
``(B) promoting familiarity with local medical and
public health systems.''.
(b) At-Risk Individuals.--Section 2814 of the Public Health Service
Act (42 U.S.C. 300hh-16) is amended--
(1) by striking paragraphs (5), (7), and (8);
(2) in paragraph (4), by striking ``2811(b)(3)(B)'' and
inserting ``2802(b)(4)(B)'';
(3) by redesignating paragraphs (1) through (4) as
paragraphs (2) through (5), respectively;
(4) by inserting before paragraph (2) (as so redesignated),
the following:
``(1) monitor emerging issues and concerns as they relate to
medical and public health preparedness and response for at-risk
individuals in the event of a public health emergency declared
by the Secretary under section 319;'';
(5) by amending paragraph (2) (as so redesignated) to read
as follows:
``(2) oversee the implementation of the preparedness goals
described in section 2802(b) with respect to the public health
and medical needs of at-risk individuals in the event of a
public health emergency, as described in section 2802(b)(4);'';
and
(6) by inserting after paragraph (6), the following:
``(7) disseminate and, as appropriate, update novel and best
practices of outreach to and care of at-risk individuals before,
during, and following public health emergencies in as timely a
manner as is practicable, including from the time a public
health threat is identified; and
``(8) ensure that public health and medical information
distributed by the Department of Health and Human Services
during a public health emergency is delivered in a manner that
takes into account the range of communication needs of the
intended recipients, including at-risk individuals.''.
SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.
(a) In General.--Section 2811 of the Public Health Service Act (42
U.S.C. 300hh-10) is amended--
(1) in subsection (b)--
(A) in paragraph (3), by inserting ``, security
countermeasures (as defined in section 319F-2),'' after
``qualified countermeasures (as defined in section 319F-
1)'';
[[Page 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) <<NOTE: Consultation.>> 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) <<NOTE: Consultation.>> 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--
[[Page 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) <<NOTE: Deadline.>> 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
[[Page 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) <<NOTE: Evaluation.>> 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) <<NOTE: Evaluation.>> evaluate progress made
in meeting timelines, allocations, benchmarks, and
milestones identified under subparagraph (D)(ii);
``(G) <<NOTE: Reports.>> 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
[[Page 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) <<NOTE: Lists.>> 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) <<NOTE: Evaluation.>> 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 one-year period for which the report is
submitted, the number of persons who were paid
amounts totaling $100,000 or greater and the
number of persons who were paid amounts totaling
at least $50,000 but less than $100,000; and
``(K) <<NOTE: Public information.>> be made
publicly available.
``(3) GAO report.--
``(A) <<NOTE: Evaluation.>> 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
[[Page 127 STAT. 168]]
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) <<NOTE: 42 USC 300hh-10 note.>> Interagency Coordination
Plan.--In the first Public Health Emergency Countermeasures Enterprise
Strategy and Implementation Plan submitted under subsection (d) of
section 2811 of the Public Health Service Act (42 U.S.C. 300hh-10) (as
added by subsection (a)(3)), the Secretary of Health and Human Services,
in consultation with the Secretary of Defense, shall include a
description of the manner in which the Department of Health and Human
Services is coordinating with the Department of Defense regarding
countermeasure activities to address chemical, biological, radiological,
and nuclear threats. Such report shall include information with respect
to--
(1) the research, advanced research, development,
procurement, stockpiling, and distribution of countermeasures to
meet identified needs; and
(2) the coordination of efforts between the Department of
Health and Human Services and the Department of Defense to
address countermeasure needs for various segments of the
population.
SEC. 103. NATIONAL ADVISORY COMMITTEE ON CHILDREN AND DISASTERS.
Subtitle B of title XXVIII of the Public Health Service Act (42
U.S.C. 300hh et seq.) is amended by inserting after section 2811 the
following:
``SEC. 2811A. <<NOTE: 42 USC 300hh-10a.>> NATIONAL ADVISORY
COMMITTEE ON CHILDREN AND DISASTERS.
``(a) <<NOTE: Consultation.>> 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--
[[Page 127 STAT. 169]]
``(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) <<NOTE: Consultation.>> 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.''.
[[Page 127 STAT. 170]]
SEC. 104. MODERNIZATION OF THE NATIONAL DISASTER MEDICAL SYSTEM.
Section 2812 of the Public Health Service Act (42 U.S.C. 300hh-11)
is amended--
(1) in subsection (a)(3)--
(A) in subparagraph (A), in clause (i) by inserting
``, including at-risk individuals as applicable'' after
``victims of a public health emergency'';
(B) by redesignating subparagraph (C) as
subparagraph (E); and
(C) by inserting after subparagraph (B), the
following:
``(C) Considerations for at-risk populations.--The
Secretary shall take steps to ensure that an appropriate
specialized and focused range of public health and
medical capabilities are represented in the National
Disaster Medical System, which take into account the
needs of at-risk individuals, in the event of a public
health emergency.''.
``(D) Administration.--The Secretary may determine
and pay claims for reimbursement for services under
subparagraph (A) directly or through contracts that
provide for payment in advance or by way of
reimbursement.''; and
(2) in subsection (g), by striking ``such sums as may be
necessary for each of the fiscal years 2007 through 2011'' and
inserting ``$52,700,000 for each of fiscal years 2014 through
2018''.
SEC. 105. CONTINUING THE ROLE OF THE DEPARTMENT OF VETERANS
AFFAIRS.
Section 8117(g) of title 38, United States Code, is amended by
striking ``such sums as may be necessary to carry out this section for
each of fiscal years 2007 through 2011'' and inserting ``$155,300,000
for each of fiscal years 2014 through 2018 to carry out this section''.
TITLE II--OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS AND
RESPONSE
SEC. 201. TEMPORARY REASSIGNMENT OF STATE AND LOCAL PERSONNEL
DURING A PUBLIC HEALTH EMERGENCY.
Section 319 of the Public Health Service Act (42 U.S.C. 247d) is
amended by adding at the end the following:
``(e) Temporary Reassignment of State and Local Personnel During a
Public Health Emergency.--
``(1) Emergency reassignment of federally funded
personnel.--Notwithstanding any other provision of law, and
subject to paragraph (2), upon request by the Governor of a
State or a tribal organization or such Governor or tribal
organization's designee, the Secretary may authorize the
requesting State or Indian tribe to temporarily reassign, for
purposes of immediately addressing a public health emergency in
the State or Indian tribe, State and local public health
department or agency personnel funded in whole or in part
through programs authorized under this Act, as appropriate.
[[Page 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) <<NOTE: Determination.>> The
Secretary's determination that the
public health emergency no longer
exists.
``(II) <<NOTE: Time period.>>
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
[[Page 127 STAT. 172]]
of personnel submits a request for an
extension of such temporary
reassignment; and
``(II) the request for an extension
contains the same information and
assurances necessary for the approval of
an initial request for such temporary
reassignment pursuant to subparagraph
(B).
``(3) Voluntary nature of temporary reassignment of state
and local personnel.--
``(A) In general.--Unless otherwise provided under
the law or regulation of the State or Indian tribe that
receives authorization for temporary reassignment of
personnel under paragraph (1), personnel eligible for
reassignment pursuant to such authorization--
``(i) shall have the opportunity to volunteer
for temporary reassignment; and
``(ii) shall not be required to agree to a
temporary reassignment.
``(B) Prohibition on conditioning federal awards.--
The Secretary may not condition the award of a grant,
contract, or cooperative agreement under this Act on the
requirement that a State or Indian tribe require that
personnel eligible for reassignment pursuant to an
authorization under paragraph (1) agree to such
reassignment.
``(4) Notice to congress.--The Secretary shall give notice
to the Congress in conjunction with the approval under this
subsection of--
``(A) any initial request for temporary reassignment
of personnel; and
``(B) any request for an extension of such temporary
reassignment.
``(5) Guidance.--The Secretary shall--
``(A) not later than 6 months after the enactment of
this subsection, issue proposed guidance on the
temporary reassignment of personnel under this
subsection; and
``(B) after providing notice and a 60-day period for
public comment, finalize such guidance.
``(6) Report to congress.--Not later than 4 years after the
date of enactment of the Pandemic and All-Hazards Preparedness
Reauthorization Act of 2013, the Comptroller General of the
United States shall conduct an independent evaluation, and
submit to the appropriate committees of the Congress a report,
on temporary reassignment under this subsection, including--
``(A) a description of how, and under what
circumstances, such temporary reassignment has been used
by States and Indian tribes;
``(B) an analysis of how such temporary reassignment
has assisted States and Indian tribes in responding to
public health emergencies;
``(C) an evaluation of how such temporary
reassignment has improved operational efficiencies in
responding to public health emergencies;
``(D) an analysis of the extent to which, if any,
Federal programs from which personnel have been
temporarily reassigned have been adversely affected by
the reassignment; and
[[Page 127 STAT. 173]]
``(E) <<NOTE: Recommenda- tions.>> recommendations
on how medical surge capacity could be improved in
responding to public health emergencies and the impact
of the reassignment flexibility under this section on
such surge capacity.
``(7) Definitions.--In this subsection--
``(A) the terms `Indian tribe' and `tribal
organization' have the meanings given such terms in
section 4 of the Indian Self-Determination and Education
Assistance Act; and
``(B) the term `State' includes, in addition to the
entities listed in the definition of such term in
section 2, the Freely Associated States.
``(8) Sunset.--This subsection shall terminate on September
30, 2018.''.
SEC. 202. IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY.
(a) Cooperative Agreements.--Section 319C-1 of the Public Health
Service Act (42 U.S.C. 247d-3a) is amended--
(1) in subsection (b)(1)(C), by striking ``consortium of
entities described in subparagraph (A)'' and inserting
``consortium of States'';
(2) in subsection (b)(2)--
(A) in subparagraph (A)--
(i) by striking clauses (i) and (ii) and
inserting the following:
``(i) a description of the activities such
entity will carry out under the agreement to meet
the goals identified under section 2802, including
with respect to chemical, biological,
radiological, or nuclear threats, whether
naturally occurring, unintentional, or deliberate;
``(ii) a description of the activities such
entity will carry out with respect to pandemic
influenza, as a component of the activities
carried out under clause (i), and consistent with
the requirements of paragraphs (2) and (5) of
subsection (g);'';
(ii) in clause (iv), by striking ``and'' at
the end; and
(iii) by adding at the end the following:
``(vi) a description of how, as appropriate,
the entity may partner with relevant public and
private stakeholders in public health emergency
preparedness and response;
``(vii) a description of how the entity, as
applicable and appropriate, will coordinate with
State emergency preparedness and response plans in
public health emergency preparedness, including
State educational agencies (as defined in section
9101(41) of the Elementary and Secondary Education
Act of 1965) and State child care lead agencies
(designated under section 658D of the Child Care
and Development Block Grant Act of 1990);
``(viii) in the case of entities that operate
on the United States-Mexico border or the United
States-Canada border, a description of the
activities such entity will carry out under the
agreement that are specific to the border area
including disease detection, identification,
investigation, and preparedness and
[[Page 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 <<NOTE: Criteria.>> 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:
[[Page 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.
(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''.
[[Page 127 STAT. 176]]
(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, evidence-based metrics
to ensure that entities receiving awards under this section are
meeting, to the extent practicable, the applicable goals of the
National Health Security Strategy under section 2802.''; and
(6) in subsection (j)--
(A) by amending paragraph (1) to read as follows:
``(1) <<NOTE: Appropriation authorization.>> 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
[[Page 127 STAT. 177]]
such entity achieving the benchmarks and submitting the
pandemic influenza plan as required under subsection
(i).''.
SEC. 204. ENHANCING SITUATIONAL AWARENESS AND BIOSURVEILLANCE.
(a) In General.--Section 319D of the Public Health Service Act (42
U.S.C. 247d-4) is amended--
(1) in subsection (b)--
(A) in paragraph (1)(B), by inserting ``poison
control centers,'' after ``hospitals,'';
(B) in paragraph (2), by inserting before the period
at the end the following: ``, allowing for coordination
to maximize all-hazards medical and public health
preparedness and response and to minimize duplication of
effort''; and
(C) in paragraph (3), by inserting before the period
at the end the following: ``and update such standards as
necessary'';
(2) by striking subsection (c);
(3) by redesignating subsections (d) through (g) as
subsections (c) through (f), respectively;
(4) in subsection (c), as so redesignated--
(A) in the subsection heading, by striking ``Public
Health Situational Awareness'' and inserting
``Modernizing Public Health Situational Awareness and
Biosurveillance'';
(B) in paragraph (1)--
(i) by striking ``Pandemic and All-Hazards
Preparedness Act'' and inserting ``Pandemic and
All-Hazards Preparedness Reauthorization Act of
2013''; and
(ii) by inserting ``, novel emerging
threats,'' after ``disease outbreaks'';
(C) by striking paragraph (2) and inserting the
following:
``(2) <<NOTE: Deadline.>> 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) <<NOTE: Determination. Consultation.>>
utilize applicable interoperability standards as
determined by the Secretary, and in consultation with
the
[[Page 127 STAT. 178]]
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 <<NOTE: Guidance. Recommenda- tions.>> 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) <<NOTE: Coordination.>> 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
[[Page 127 STAT. 179]]
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 <<NOTE: Repeal.>> of the Project Bioshield Act of 2004
(42 U.S.C. 247d-6c) is repealed.
TITLE III--ENHANCING MEDICAL COUNTERMEASURE REVIEW
SEC. 301. SPECIAL PROTOCOL ASSESSMENT.
Section 505(b)(5)(B) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(b)(5)(B)) is amended by striking ``size of clinical trials
intended'' and all that follows through ``. The sponsor or applicant''
and inserting the following: ``size--
``(i)(I) of clinical trials intended to form the primary
basis of an effectiveness claim; or
``(II) in the case where human efficacy studies are not
ethical or feasible, of animal and any associated clinical
trials which, in combination, are intended to form the primary
basis of an effectiveness claim; or
``(ii) with respect to an application for approval of a
biological product under section 351(k) of the Public Health
Service Act, of any necessary clinical study or studies.
The sponsor or applicant''.
SEC. 302. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN
EMERGENCIES.
(a) In General.--Section 564 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb-3) is amended--
(1) in subsection (a)--
(A) in paragraph (1), by striking ``sections 505,
510(k), and 515 of this Act'' and inserting ``any
provision of this Act'';
(B) in paragraph (2)(A), by striking ``under a
provision of law referred to in such paragraph'' and
inserting ``under section 505, 510(k), or 515 of this
Act or section 351 of the Public Health Service Act'';
and
(C) in paragraph (3), by striking ``a provision of
law referred to in such paragraph'' and inserting ``a
section of this Act or the Public Health Service Act
referred to in paragraph (2)(A)'';
(2) in subsection (b)--
(A) in the subsection heading, by striking
``Emergency'' and inserting ``Emergency or Threat
Justifying Emergency Authorized Use'';
(B) in paragraph (1)--
[[Page 127 STAT. 180]]
(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) <<NOTE: Determination.>> 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
[[Page 127 STAT. 181]]
(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) <<NOTE: Waiver. Limitations.>> 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).'';
[[Page 127 STAT. 182]]
(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: <<NOTE: Review.>> ``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: <<NOTE: Web posting.>> ``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) <<NOTE: Determination.>> 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).''.
[[Page 127 STAT. 183]]
(b) Emergency Use of Medical Products.--Subchapter E of chapter V of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is
amended by inserting after section 564 the following:
``SEC. 564A. <<NOTE: 21 USC 360bbb-3a.>> 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
[[Page 127 STAT. 184]]
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) <<NOTE: Definition.>> 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
[[Page 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) <<NOTE: Determination.>> 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. <<NOTE: 21 USC 360bbb-3b.>> PRODUCTS HELD FOR
EMERGENCY USE.
``It is not a violation of any section of this Act or of the Public
Health Service Act for a government entity (including a Federal, State,
local, or tribal government entity), or a person acting on behalf of
such a government entity, to introduce into interstate commerce a
product (as defined in section 564(a)(4)) intended for emergency use, if
that product--
``(1) is intended to be held and not used; and
``(2) is held and not used, unless and until that product--
``(A) is approved, cleared, or licensed under
section 505, 510(k), or 515 of this Act or section 351
of the Public Health Service Act;
``(B) is authorized for investigational use under
section 505 or 520 of this Act or section 351 of the
Public Health Service Act; or
``(C) is authorized for use under section 564.''.
SEC. 303. DEFINITIONS.
Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-4) is amended by striking ``The Secretary, in consultation'' and
inserting the following:
``(a) Definitions.--In this section--
[[Page 127 STAT. 186]]
``(1) the term `countermeasure' means a qualified
countermeasure, a security countermeasure, and a qualified
pandemic or epidemic product;
``(2) the term `qualified countermeasure' has the meaning
given such term in section 319F-1 of the Public Health Service
Act;
``(3) the term `security countermeasure' has the meaning
given such term in section 319F-2 of such Act; and
``(4) the term `qualified pandemic or epidemic product'
means a product that meets the definition given such term in
section 319F-3 of the Public Health Service Act and--
``(A) that has been identified by the Department of
Health and Human Services or the Department of Defense
as receiving funding directly related to addressing
chemical, biological, radiological, or nuclear threats,
including pandemic influenza; or
``(B) is included under this paragraph pursuant to a
determination by the Secretary.
``(b) General Duties.--The Secretary, in consultation''.
SEC. 304. ENHANCING MEDICAL COUNTERMEASURE ACTIVITIES.
Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-4), as amended by section 303, is further amended--
(1) in the section heading, by striking ``technical
assistance'' and inserting ``countermeasure development, review,
and technical assistance'';
(2) in subsection (b), by striking the subsection enumerator
and all that follows through ``shall establish'' and inserting
the following:
``(b) <<NOTE: Consultations.>> 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;
[[Page 127 STAT. 187]]
``(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) <<NOTE: Deadline.>> 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) <<NOTE: Reports.>> 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) <<NOTE: Deadline.>> 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
[[Page 127 STAT. 188]]
``(B) a meeting prior to initiating pivotal animal
studies.
``(2) Pediatric models.--To facilitate the development and
selection of animal models that could translate to pediatric
studies, any meeting conducted under paragraph (1) shall include
discussion of animal models for pediatric populations, as
appropriate.
``(e) Review and Approval of Countermeasures.--
``(1) Material threat.--When evaluating an application or
submission for approval, licensure, or clearance of a
countermeasure, the Secretary shall take into account the
material threat posed by the chemical, biological, radiological,
or nuclear agent or agents identified under section 319F-2 of
the Public Health Service Act for which the countermeasure under
review is intended.
``(2) Review expertise.--When practicable and appropriate,
teams of Food and Drug Administration personnel reviewing
applications or submissions described under paragraph (1) shall
include a reviewer with sufficient training or experience with
countermeasures pursuant to the protocols established under
subsection (b)(3)(D).''.
SEC. 305. REGULATORY MANAGEMENT PLANS.
Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-4), as amended by section 304, is further amended by adding at
the end the following:
``(f) Regulatory Management Plan.--
``(1) Definition.--In this subsection, the term `eligible
countermeasure' means--
``(A) a security countermeasure with respect to
which the Secretary has entered into a procurement
contract under section 319F-2(c) of the Public Health
Service Act; or
``(B) a countermeasure with respect to which the
Biomedical Advanced Research and Development Authority
has provided funding under section 319L of the Public
Health Service Act for advanced research and
development.
``(2) <<NOTE: Consultation.>> 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.
[[Page 127 STAT. 189]]
``(C) <<NOTE: Time period.>> 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. <<NOTE: Determination.>> 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
[[Page 127 STAT. 190]]
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) <<NOTE: Determination.>> 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 <<NOTE: Consultation. Prioritization.>> are
available to establish regulatory management plans for
eligible countermeasures that are not security
countermeasures, and if resources are not available to
establish regulatory management plans for all eligible
countermeasures for which requests have been submitted,
the Director of the Biomedical Advanced Research and
Development Authority, in consultation with the
Commissioner, shall prioritize which eligible
countermeasures may receive regulatory management
plans.''.
SEC. 306. REPORT.
Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-4), as amended by section 305, is further amended by adding at
the end the following:
``(g) <<NOTE: Public information. Web posting.>> 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
[[Page 127 STAT. 191]]
of, type of, and any progress made as a result of consultations
carried out under subsection (b)(4)(A);
``(4) an estimate of resources obligated to countermeasure
development and regulatory assessment, including--
``(A) Center-specific objectives and
accomplishments; and
``(B) the number of full-time equivalent employees
of the Food and Drug Administration who directly support
the review of countermeasures;
``(5) the number of countermeasure applications and
submissions submitted, the number of countermeasures approved,
licensed, or cleared, the status of remaining submitted
applications and submissions, and the number of each type of
authorization issued pursuant to section 564;
``(6) the number of written requests for a regulatory
management plan submitted under subsection (f)(3)(A), the number
of regulatory management plans developed, and the number of such
plans developed for security countermeasures; and
``(7) the number, type, and frequency of meetings between
the Food and Drug Administration and--
``(A) sponsors of a countermeasure as defined in
subsection (a); or
``(B) another agency engaged in development or
management of portfolios for such countermeasures,
including the Centers for Disease Control and
Prevention, the Biomedical Advanced Research and
Development Authority, the National Institutes of
Health, and the appropriate agencies of the Department
of Defense.''.
SEC. 307. PEDIATRIC MEDICAL COUNTERMEASURES.
(a) Pediatric Studies of Drugs.--Section 505A of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355a) is amended--
(1) in subsection (d), by adding at the end the following:
``(5) Consultation.--With respect to a drug that is a
qualified countermeasure (as defined in section 319F-1 of the
Public Health Service Act), a security countermeasure (as
defined in section 319F-2 of the Public Health Service Act), or
a qualified pandemic or epidemic product (as defined in section
319F-3 of the Public Health Service Act), the Secretary shall
solicit input from the Assistant Secretary for Preparedness and
Response regarding the need for and, from the Director of the
Biomedical Advanced Research and Development Authority regarding
the conduct of, pediatric studies under this section.''; and
(2) in subsection (n)(1), by adding at the end the
following:
``(C) <<NOTE: Notification.>> 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
[[Page 127 STAT. 192]]
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) <<NOTE: Consultation.>> 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) <<NOTE: 42 USC 284m-1.>> Advice and Recommendations of the
Pediatric Advisory Committee Regarding Countermeasures for Pediatric
Populations.--Subsection (b)(2) of section 14 of the Best
Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended--
(1) in subparagraph (C), by striking the period and
inserting ``; and''; and
(2) by adding at the end the following:
``(D) the development of countermeasures (as defined
in section 565(a) of the Federal Food, Drug, and
Cosmetic Act) for pediatric populations.''.
TITLE IV--ACCELERATING MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND
DEVELOPMENT
SEC. 401. BIOSHIELD.
(a) Procurement of Countermeasures.--Section 319F-2(c) of the Public
Health Service Act (42 U.S.C. 247d-6b(c)) is amended--
(1) in paragraph (1)(B)(i)(III)(bb), by striking ``eight
years'' and inserting ``10 years'';
(2) in paragraph (2)(C), by striking ``the designated
congressional committees (as defined in paragraph (10))'' and
inserting ``the appropriate committees of Congress'';
[[Page 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.--
[[Page 127 STAT. 194]]
``(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) <<NOTE: Determination. Procurement.>> Report.--Not
later than 30 days after any date on which the Secretary
determines that the amount of funds in the special reserve fund
available for procurement is less than $1,500,000,000, the
Secretary shall submit to the appropriate committees of Congress
a report detailing the amount of such funds available for
procurement and the impact such reduction in funding will have--
``(A) in meeting the security countermeasure needs
identified under this section; and
``(B) on the annual Public Health Emergency Medical
Countermeasures Enterprise and Strategy Implementation
Plan (pursuant to section 2811(d)).
``(h) Definitions.--In this section:
``(1) The term `advanced research and development' has the
meaning given such term in section 319L(a).
``(2) The term `special reserve fund' means the `Biodefense
Countermeasures' appropriations account, any appropriation made
available pursuant to section 521(a) of the Homeland Security
Act of 2002, and any appropriation made available pursuant to
subsection (g)(1).''.
SEC. 402. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.
(a) Duties.--Section 319L(c)(4) of the Public Health Service Act (42
U.S.C. 247d-7e(c)(4)) is amended--
(1) in subparagraph (B)(iii), by inserting ``(which may
include advanced research and development for purposes of
fulfilling requirements under the Federal Food, Drug, and
Cosmetic Act or section 351 of this Act)'' after
``development''; and
(2) in subparagraph (D)(iii), by striking ``and vaccine
manufacturing technologies'' and inserting ``vaccine-
manufacturing
[[Page 127 STAT. 195]]
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 All-
Hazards Preparedness Act (42 U.S.C. 247d-6a note) is amended by
striking ``6-year'' and inserting ``12-year''.
(2) <<NOTE: 42 USC 247d-6a note.>> 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) <<NOTE: Deadline.>> 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). <<NOTE: Review. Assessment.>>
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.--
[[Page 127 STAT. 196]]
(1) Qualified countermeasure.--Section 319F-1(a)(2)(A) of
the Public Health Service Act (42 U.S.C. 247d-6a(a)(2)(A)) is
amended--
(A) in the matter preceding clause (i), by striking
``to--'' and inserting ``--'';
(B) in clause (i)--
(i) by striking ``diagnose'' and inserting
``to diagnose''; and
(ii) by striking ``; or'' and inserting a
semicolon;
(C) in clause (ii)--
(i) by striking ``diagnose'' and inserting
``to diagnose''; and
(ii) by striking the period at the end and
inserting ``; or''; and
(D) by adding at the end the following:
``(iii) is a product or technology intended to
enhance the use or effect of a drug, biological
product, or device described in clause (i) or
(ii).''.
(2) Qualified pandemic or epidemic product.--Section 319F-
3(i)(7)(A) of the Public Health Service Act (42 U.S.C. 247d-
6d(i)(7)(A)) is amended--
(A) in clause (i)(II), by striking ``; or'' and
inserting ``;'';
(B) in clause (ii), by striking ``; and'' and
inserting ``; or''; and
(C) by adding at the end the following:
``(iii) a product or technology intended to
enhance the use or effect of a drug, biological
product, or device described in clause (i) or
(ii); and''.
(3) Technical amendments.--Section 319F-3(i) of the Public
Health Service Act (42 U.S.C. 247d-6d(i)) is amended--
(A) in paragraph (1)(C), by inserting ``, 564A, or
564B'' after ``564''; and
(B) in paragraph (7)(B)(iii), by inserting ``, 564A,
or 564B'' after ``564''.
SEC. 403. STRATEGIC NATIONAL STOCKPILE.
Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b)
is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by inserting ``consistent with section
2811'' before ``by the Secretary to be
appropriate''; and
(ii) by inserting before the period at the end
of the second sentence the
following: <<NOTE: Review. Deadline.>> ``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
[[Page 127 STAT. 197]]
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.''.
Approved March 13, 2013.
LEGISLATIVE HISTORY--H.R. 307:
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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.
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