[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 307 Enrolled Bill (ENR)]
H.R.307
One Hundred Thirteenth Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Thursday,
the third day of January, two thousand and thirteen
An Act
To reauthorize certain programs under the Public Health Service Act and
the Federal Food, Drug, and Cosmetic Act with respect to public health
security and all-hazards preparedness and response, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,

d6de9869aabe4c48f3ab06e389c74b3e26a01ac54a9ac2b4ec7695a0c3f178a8

(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:

41767232e7ea6f1b044eddf27b86b4e65b1862db70229f7b1adc865cf25c9803

c9c9b45bee4bd5dfd308195c2f76dbaf3507552e15f5d3924a9736d7dd9dd633

d6399d87d53f83a766e3c2a3700f37d99bdc6fadf8ab583329fdd24c8ea9309b

TITLE I

-STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE FOR PUBLIC

9eee1f6bcecbea8b00fbd08dd850c1f3e061bc955fac46a2ff5d6e97ad36b92e

TITLE II

-OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS AND

823aa5983cb0e574bdf87d2f4477a431e2542c16ec99594d0463d5aa37022b0a

TITLE III

-ENHANCING MEDICAL COUNTERMEASURE REVIEW

TITLE IV

-ACCELERATING MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND

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

c853886d5e6a01c9cc9e57aec86f82378a2b0fc89e024eab22afbb6ece38b8a5

(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)'';
(B) in paragraph (4), by adding at the end the following:
``(D) Policy coordination and strategic direction.--Provide
integrated policy coordination and strategic direction with
respect to all matters related to Federal public health and
medical preparedness and execution and deployment of the
Federal response for public health emergencies and incidents
covered by the National Response Plan developed pursuant to
section 504(6) of the Homeland Security Act of 2002, or any
successor plan, before, during, and following public health
emergencies.
``(E) Identification of inefficiencies.--Identify and
minimize gaps, duplication, and other inefficiencies in medical
and public health preparedness and response activities and the
actions necessary to overcome these obstacles.
``(F) Coordination of grants and agreements.--Align and
coordinate medical and public health grants and cooperative
agreements as applicable to preparedness and response
activities authorized under this Act, to the extent possible,
including program requirements, timelines, and measurable
goals, and in consultation with the Secretary of Homeland
Security, to--
``(i) optimize and streamline medical and public health
preparedness and response capabilities and the ability of
local communities to respond to public health emergencies;
and
``(ii) gather and disseminate best practices among
grant and cooperative agreement recipients, as appropriate.
``(G) Drill and operational exercises.--Carry out drills
and operational exercises, in consultation with the Department
of Homeland Security, the Department of Defense, the Department
of Veterans Affairs, and other applicable Federal departments
and agencies, as necessary and appropriate, to identify,
inform, and address gaps in and policies related to all-hazards
medical and public health preparedness and response, including
exercises based on--
``(i) identified threats for which countermeasures are
available and for which no countermeasures are available;
and
``(ii) unknown threats for which no countermeasures are
available.
``(H) National security priority.--On a periodic basis
consult with, as applicable and appropriate, the Assistant to
the President for National Security Affairs, to provide an
update on, and discuss, medical and public health preparedness
and response activities pursuant to this Act and the Federal
Food, Drug, and Cosmetic Act, including progress on the
development, approval, clearance, and licensure of medical
countermeasures.''; and
(C) by adding at the end the following:
``(7) Countermeasures budget plan.--Develop, and update on an
annual basis, a coordinated 5-year budget plan based on the medical
countermeasure priorities described in subsection (d). Each such
plan shall--
``(A) include consideration of the entire medical
countermeasures enterprise, including--
``(i) basic research and advanced research and
development;
``(ii) approval, clearance, licensure, and authorized
uses of products; and
``(iii) procurement, stockpiling, maintenance, and
replenishment of all products in the Strategic National
Stockpile;
``(B) inform prioritization of resources and include
measurable outputs and outcomes to allow for the tracking of
the progress made toward identified priorities;
``(C) identify medical countermeasure life-cycle costs to
inform planning, budgeting, and anticipated needs within the
continuum of the medical countermeasure enterprise consistent
with section 319F-2; and
``(D) be made available to the appropriate committees of
Congress upon request.'';
(2) by striking subsection (c) and inserting the following:
``(c) Functions.--The Assistant Secretary for Preparedness and
Response shall--
``(1) have lead responsibility within the Department of Health
and Human Services for emergency preparedness and response policy
coordination and strategic direction;
``(2) have authority over and responsibility for--
``(A) the National Disaster Medical System pursuant to
section 2812;
``(B) the Hospital Preparedness Cooperative Agreement
Program pursuant to section 319C-2;
``(C) the Biomedical Advanced Research and Development
Authority pursuant to section 319L;
``(D) the Medical Reserve Corps pursuant to section 2813;
``(E) the Emergency System for Advance Registration of
Volunteer Health Professionals pursuant to section 319I; and
``(F) administering grants and related authorities related
to trauma care under parts A through C of title XII, such
authority to be transferred by the Secretary from the
Administrator of the Health Resources and Services
Administration to such Assistant Secretary;
``(3) exercise the responsibilities and authorities of the
Secretary with respect to the coordination of--
``(A) the Public Health Emergency Preparedness Cooperative
Agreement Program pursuant to section 319C-1;
``(B) the Strategic National Stockpile pursuant to section
319F-2; and
``(C) the Cities Readiness Initiative; and
``(4) assume other duties as determined appropriate by the
Secretary.''; and
(3) by adding at the end the following:
``(d) Public Health Emergency Medical Countermeasures Enterprise
Strategy and Implementation Plan.--
``(1) In general.--Not later than 180 days after the date of
enactment of this subsection, and every year thereafter, the
Assistant Secretary for Preparedness and Response shall develop and
submit to the appropriate committees of Congress a coordinated
strategy and accompanying implementation plan for medical
countermeasures to address chemical, biological, radiological, and
nuclear threats. In developing such a plan, the Assistant Secretary
for Preparedness and Response shall consult with the Director of
the Biomedical Advanced Research and Development Authority, the
Director of the National Institutes of Health, the Director of the
Centers for Disease Control and Prevention, and the Commissioner of
Food and Drugs. Such strategy and plan shall be known as the
`Public Health Emergency Medical Countermeasures Enterprise
Strategy and Implementation Plan'.
``(2) Requirements.--The plan under paragraph (1) shall--
``(A) describe the chemical, biological, radiological, and
nuclear agent or agents that may present a threat to the Nation
and the corresponding efforts to develop qualified
countermeasures (as defined in section 319F-1), security
countermeasures (as defined in section 319F-2), or qualified
pandemic or epidemic products (as defined in section 319F-3)
for each threat;
``(B) evaluate the progress of all activities with respect
to such countermeasures or products, including research,
advanced research, development, procurement, stockpiling,
deployment, distribution, and utilization;
``(C) identify and prioritize near-, mid-, and long-term
needs with respect to such countermeasures or products to
address a chemical, biological, radiological, and nuclear
threat or threats;
``(D) identify, with respect to each category of threat, a
summary of all awards and contracts, including advanced
research and development and procurement, that includes--
``(i) the time elapsed from the issuance of the initial
solicitation or request for a proposal to the adjudication
(such as the award, denial of award, or solicitation
termination); and
``(ii) an identification of projected timelines,
anticipated funding allocations, benchmarks, and milestones
for each medical countermeasure priority under subparagraph
(C), including projected needs with regard to replenishment
of the Strategic National Stockpile;
``(E) be informed by the recommendations of the National
Biodefense Science Board pursuant to section 319M;
``(F) evaluate progress made in meeting timelines,
allocations, benchmarks, and milestones identified under
subparagraph (D)(ii);
``(G) report on the amount of funds available for
procurement in the special reserve fund as defined in section
319F-2(h) and the impact this funding will have on meeting the
requirements under section 319F-2;
``(H) incorporate input from Federal, State, local, and
tribal stakeholders;
``(I) identify the progress made in meeting the medical
countermeasure priorities for at-risk individuals (as defined
in 2802(b)(4)(B)), as applicable under subparagraph (C),
including with regard to the projected needs for related
stockpiling and replenishment of the Strategic National
Stockpile, including by addressing the needs of pediatric
populations with respect to such countermeasures and products
in the Strategic National Stockpile, including--
``(i) a list of such countermeasures and products
necessary to address the needs of pediatric populations;
``(ii) a description of measures taken to coordinate
with the Office of Pediatric Therapeutics of the Food and
Drug Administration to maximize the labeling, dosages, and
formulations of such countermeasures and products for
pediatric populations;
``(iii) a description of existing gaps in the Strategic
National Stockpile and the development of such
countermeasures and products to address the needs of
pediatric populations; and
``(iv) an evaluation of the progress made in addressing
priorities identified pursuant to subparagraph (C);
``(J) identify the use of authority and activities
undertaken pursuant to sections 319F-1(b)(1), 319F-1(b)(2),
319F-1(b)(3), 319F-1(c), 319F-1(d), 319F-1(e), 319F-
2(c)(7)(C)(iii), 319F-2(c)(7)(C)(iv), and 319F-2(c)(7)(C)(v) of
this Act, and subsections (a)(1), (b)(1), and (e) of section
564 of the Federal Food, Drug, and Cosmetic Act, by
summarizing--
``(i) the particular actions that were taken under the
authorities specified, including, as applicable, the
identification of the threat agent, emergency, or the
biomedical countermeasure with respect to which the
authority was used;
``(ii) the reasons underlying the decision to use such
authorities, including, as applicable, the options that
were considered and rejected with respect to the use of
such authorities;
``(iii) the number of, nature of, and other information
concerning the persons and entities that received a grant,
cooperative agreement, or contract pursuant to the use of
such authorities, and the persons and entities that were
considered and rejected for such a grant, cooperative
agreement, or contract, except that the report need not
disclose the identity of any such person or entity;
``(iv) whether, with respect to each procurement that
is approved by the President under section 319F-2(c)(6), a
contract was entered into within one year after such
approval by the President; and
``(v) with respect to section 319F-1(d), for the one-
year period for which the report is submitted, the number
of persons who were paid amounts totaling $100,000 or
greater and the number of persons who were paid amounts
totaling at least $50,000 but less than $100,000; and
``(K) be made publicly available.
``(3) GAO report.--
``(A) In general.--Not later than 1 year after the date of
the submission to the Congress of the first Public Health
Emergency Medical Countermeasures Enterprise Strategy and
Implementation Plan, the Comptroller General of the United
States shall conduct an independent evaluation, and submit to
the appropriate committees of Congress a report, concerning
such Strategy and Implementation Plan.
``(B) Content.--The report described in subparagraph (A)
shall review and assess--
``(i) the near-term, mid-term, and long-term medical
countermeasure needs and identified priorities of the
Federal Government pursuant to paragraph (2)(C);
``(ii) the activities of the Department of Health and
Human Services with respect to advanced research and
development pursuant to section 319L; and
``(iii) the progress made toward meeting the timelines,
allocations, benchmarks, and milestones identified in the
Public Health Emergency Medical Countermeasures Enterprise
Strategy and Implementation Plan under this subsection.
``(e) Protection of National Security.--In carrying out subsections
(b)(7) and (d), the Secretary shall ensure that information and items
that could compromise national security, contain confidential
commercial information, or contain proprietary information are not
disclosed.''.
(b) Interagency Coordination Plan.--In the first Public Health
Emergency Countermeasures Enterprise Strategy and Implementation Plan
submitted under subsection (d) of section 2811 of the Public Health
Service Act (42 U.S.C. 300hh-10) (as added by subsection (a)(3)), the
Secretary of Health and Human Services, in consultation with the
Secretary of Defense, shall include a description of the manner in
which the Department of Health and Human Services is coordinating with
the Department of Defense regarding countermeasure activities to
address chemical, biological, radiological, and nuclear threats. Such
report shall include information with respect to--
(1) the research, advanced research, development, procurement,
stockpiling, and distribution of countermeasures to meet identified
needs; and
(2) the coordination of efforts between the Department of
Health and Human Services and the Department of Defense to address
countermeasure needs for various segments of the population.

9a243987ce95dbb91302ed21f5ec1b8622a649153f5b398f505ea4385c7f250c

Subtitle B of title XXVIII of the Public Health Service Act (42
U.S.C. 300hh et seq.) is amended by inserting after section 2811 the
following:
``SEC. 2811A. NATIONAL ADVISORY COMMITTEE ON CHILDREN AND DISASTERS.
``(a) Establishment.--The Secretary, in consultation with the
Secretary of Homeland Security, shall establish an advisory committee
to be known as the `National Advisory Committee on Children and
Disasters' (referred to in this section as the `Advisory Committee').
``(b) Duties.--The Advisory Committee shall--
``(1) provide advice and consultation with respect to the
activities carried out pursuant to section 2814, as applicable and
appropriate;
``(2) evaluate and provide input with respect to the medical
and public health needs of children as they relate to preparation
for, response to, and recovery from all-hazards emergencies; and
``(3) provide advice and consultation with respect to State
emergency preparedness and response activities and children,
including related drills and exercises pursuant to the preparedness
goals under section 2802(b).
``(c) Additional Duties.--The Advisory Committee may provide advice
and recommendations to the Secretary with respect to children and the
medical and public health grants and cooperative agreements as
applicable to preparedness and response activities authorized under
this title and title III.
``(d) Membership.--
``(1) In general.--The Secretary, in consultation with such
other Secretaries as may be appropriate, shall appoint not to
exceed 15 members to the Advisory Committee. In appointing such
members, the Secretary shall ensure that the total membership of
the Advisory Committee is an odd number.
``(2) Required members.--The Secretary, in consultation with
such other Secretaries as may be appropriate, may appoint to the
Advisory Committee under paragraph (1) such individuals as may be
appropriate to perform the duties described in subsections (b) and
(c), which may include--
``(A) the Assistant Secretary for Preparedness and
Response;
``(B) the Director of the Biomedical Advanced Research and
Development Authority;
``(C) the Director of the Centers for Disease Control and
Prevention;
``(D) the Commissioner of Food and Drugs;
``(E) the Director of the National Institutes of Health;
``(F) the Assistant Secretary of the Administration for
Children and Families;
``(G) the Administrator of the Federal Emergency Management
Agency;
``(H) at least two non-Federal health care professionals
with expertise in pediatric medical disaster planning,
preparedness, response, or recovery;
``(I) at least two representatives from State, local,
territorial, or tribal agencies with expertise in pediatric
disaster planning, preparedness, response, or recovery; and
``(J) representatives from such Federal agencies (such as
the Department of Education and the Department of Homeland
Security) as determined necessary to fulfill the duties of the
Advisory Committee, as established under subsections (b) and
(c).
``(e) Meetings.--The Advisory Committee shall meet not less than
biannually.
``(f) Sunset.--The Advisory Committee shall terminate on September
30, 2018.''.

a6b5d2ad46252ecdb0ffaa9b0213436c96ce2e31edae21c307cae264753e9a3e

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''.

18a18f75657bda183d890e017ba1217207daa21b5eb0b41248d8bb65ab973010

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''.
RESPONSE

f137c9d492eeea2f5f29a53a6df8dbdef4b1cd8746261bac0516db8aff7418c1

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.
``(2) Activation of emergency reassignment.--
``(A) Public health emergency.--The Secretary may authorize
a temporary reassignment of personnel under paragraph (1) only
during the period of a public health emergency determined
pursuant to subsection (a).
``(B) Contents of request.--To seek authority for a
temporary reassignment of personnel under paragraph (1), the
Governor of a State or a tribal organization shall submit to
the Secretary a request for such reassignment flexibility and
shall include in the request each of the following:
``(i) An assurance that the public health emergency in
the geographic area of the requesting State or Indian tribe
cannot be adequately and appropriately addressed by the
public health workforce otherwise available.
``(ii) An assurance that the public health emergency
would be addressed more efficiently and effectively through
the requested temporary reassignment of State and local
personnel described in paragraph (1).
``(iii) An assurance that the requested temporary
reassignment of personnel is consistent with any applicable
All-Hazards Public Health Emergency Preparedness and
Response Plan under section 319C-1.
``(iv) An identification of--
``(I) each Federal program from which personnel
would be temporarily reassigned pursuant to the
requested authority; and
``(II) the number of personnel who would be so
reassigned from each such program.
``(v) Such other information and assurances upon which
the Secretary and Governor of a State or tribal
organization agree.
``(C) Consideration.--In reviewing a request for temporary
reassignment under paragraph (1), the Secretary shall consider
the degree to which the program or programs funded in whole or
in part by programs authorized under this Act would be
adversely affected by the reassignment.
``(D) Termination and extension.--
``(i) Termination.--A State or Indian tribe's temporary
reassignment of personnel under paragraph (1) shall
terminate upon the earlier of the following:
``(I) The Secretary's determination that the public
health emergency no longer exists.
``(II) Subject to clause (ii), the expiration of
the 30-day period following the date on which the
Secretary approved the State or Indian tribe's request
for such reassignment flexibility.
``(ii) Extension of reassignment flexibility.--The
Secretary may extend reassignment flexibility of personnel
under paragraph (1) beyond the date otherwise applicable
under clause (i)(II) if the public health emergency still
exists as of such date, but only if--
``(I) the State or Indian tribe that submitted the
initial request for a temporary reassignment 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
``(E) recommendations on how medical surge capacity could
be improved in responding to public health emergencies and the
impact of the reassignment flexibility under this section on
such surge capacity.
``(7) Definitions.--In this subsection--
``(A) the terms `Indian tribe' and `tribal organization'
have the meanings given such terms in section 4 of the Indian
Self-Determination and Education Assistance Act; and
``(B) the term `State' includes, in addition to the
entities listed in the definition of such term in section 2,
the Freely Associated States.
``(8) Sunset.--This subsection shall terminate on September 30,
2018.''.

528cb90f8eabc4184835ecf21074745b484f540247aa719d2f289152e7b61624

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

4c08fc513cb0aef318ab909f5adc4b6ff7f31ca50f065a82d5f6f186ad5acc56

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

80cf1c7f690d4ab649ea2f984f1df2c894104f1d64becab9b5abf73400336a5c

(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) Strategy and implementation plan.--Not later than 180
days after the date of enactment of the Pandemic and All-Hazards
Preparedness Reauthorization Act of 2013, the Secretary shall
submit to the appropriate committees of Congress a coordinated
strategy and an accompanying implementation plan that identifies
and demonstrates the measurable steps the Secretary will carry out
to--
``(A) develop, implement, and evaluate the network
described in paragraph (1), utilizing the elements described in
paragraph (3);
``(B) modernize and enhance biosurveillance activities; and
``(C) improve information sharing, coordination, and
communication among disparate biosurveillance systems supported
by the Department of Health and Human Services.'';
(D) in paragraph (3)(D), by inserting ``community health
centers, health centers'' after ``poison control,'';
(E) in paragraph (5), by striking subparagraph (A) and
inserting the following:
``(A) utilize applicable interoperability standards as
determined by the Secretary, and in consultation with the
Office of the National Coordinator for Health Information
Technology, through a joint public and private sector
process;''; and
(F) by adding at the end the following:
``(6) Consultation with the national biodefense science
board.--In carrying out this section and consistent with section
319M, the National Biodefense Science Board shall provide expert
advice and guidance, including recommendations, regarding the
measurable steps the Secretary should take to modernize and enhance
biosurveillance activities pursuant to the efforts of the
Department of Health and Human Services to ensure comprehensive,
real-time, all-hazards biosurveillance capabilities. In complying
with the preceding sentence, the National Biodefense Science Board
shall--
``(A) identify the steps necessary to achieve a national
biosurveillance system for human health, with international
connectivity, where appropriate, that is predicated on State,
regional, and community level capabilities and creates a
networked system to allow for two-way information flow between
and among Federal, State, and local government public health
authorities and clinical health care providers;
``(B) identify any duplicative surveillance programs under
the authority of the Secretary, or changes that are necessary
to existing programs, in order to enhance and modernize such
activities, minimize duplication, strengthen and streamline
such activities under the authority of the Secretary, and
achieve real-time and appropriate data that relate to disease
activity, both human and zoonotic; and
``(C) coordinate with applicable existing advisory
committees of the Director of the Centers for Disease Control
and Prevention, including such advisory committees consisting
of representatives from State, local, and tribal public health
authorities and appropriate public and private sector health
care entities and academic institutions, in order to provide
guidance on public health surveillance activities.'';
(5) in subsection (d), as so redesignated--
(A) in paragraph (1), by striking ``subsection (d)'' and
inserting ``subsection (c)'';
(B) in paragraph (4)(B), by striking ``subsection (d)'' and
inserting ``subsection (c)''; and
(C) in paragraph (5)--
(i) by striking ``4 years after the date of enactment
of the Pandemic and All-Hazards Preparedness Act'' and
inserting ``3 years after the date of enactment of the
Pandemic and All-Hazards Preparedness Reauthorization Act
of 2013''; and
(ii) by striking ``subsection (d)'' and inserting
``subsection (c)'';
(6) in subsection (f), as so redesignated, by striking ``such
sums as may be necessary in each of fiscal years 2007 through
2011'' and inserting ``$138,300,000 for each of fiscal years 2014
through 2018''; and
(7) by adding at the end the following:
``(g) Definition.--For purposes of this section the term
`biosurveillance' means the process of gathering near real-time
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)''.

8464355afdb61707eb75866363546840f6c0f2ff1acf4be798b4b7cd9b31528f

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

2a94681fec07bda49f30ba4d714d065b747f081c1ad034babad6d4a9c19e46ca

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''.

df99d32734b452aed6381bcab09700b0f0569fba2ff2fca5409dfa856b6a2c16

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)--
(i) in the matter preceding subparagraph (A), by
striking ``may declare an emergency'' and inserting ``may
make a declaration that the circumstances exist'';
(ii) in subparagraph (A), by striking ``specified'';
(iii) in subparagraph (B)--
(I) by striking ``specified''; and
(II) by striking ``; or'' and inserting a
semicolon;
(iv) by amending subparagraph (C) to read as follows:
``(C) a determination by the Secretary that there is a
public health emergency, or a significant potential for a
public health emergency, that affects, or has a significant
potential to affect, national security or the health and
security of United States citizens living abroad, and that
involves a biological, chemical, radiological, or nuclear agent
or agents, or a disease or condition that may be attributable
to such agent or agents; or''; and
(v) by adding at the end the following:
``(D) the identification of a material threat pursuant to
section 319F-2 of the Public Health Service Act sufficient to
affect national security or the health and security of United
States citizens living abroad.'';
(C) in paragraph (2)--
(i) in subparagraph (A), by amending clause (ii) to
read as follows:
``(ii) a change in the approval status of the product
such that the circumstances described in subsection (a)(2)
have ceased to exist.'';
(ii) by striking subparagraph (B); and
(iii) by redesignating subparagraph (C) as subparagraph
(B);
(D) in paragraph (4), by striking ``advance notice of
termination, and renewal under this subsection.'' and inserting
``, and advance notice of termination under this subsection.'';
and
(E) by adding at the end the following:
``(5) Explanation by secretary.--If an authorization under this
section with respect to an unapproved product or an unapproved use
of an approved product has been in effect for more than 1 year, the
Secretary shall provide in writing to the sponsor of such product
an explanation of the scientific, regulatory, or other obstacles to
approval, licensure, or clearance of such product or use, including
specific actions to be taken by the Secretary and the sponsor to
overcome such obstacles.'';
(3) in subsection (c)--
(A) in the matter preceding paragraph (1)--
(i) by inserting ``the Assistant Secretary for
Preparedness and Response,'' after ``consultation with'';
(ii) by striking ``Health and'' and inserting ``Health,
and''; and
(iii) by striking ``circumstances of the emergency
involved'' and inserting ``applicable circumstances
described in subsection (b)(1)'';
(B) in paragraph (1), by striking ``specified'' and
inserting ``referred to''; and
(C) in paragraph (2)(B), by inserting ``, taking into
consideration the material threat posed by the agent or agents
identified in a declaration under subsection (b)(1)(D), if
applicable'' after ``risks of the product'';
(4) in subsection (d)(3), by inserting ``, to the extent
practicable given the circumstances of the emergency,'' after
``including'';
(5) in subsection (e)--
(A) in paragraph (1)(A), by striking ``circumstances of the
emergency'' and inserting ``applicable circumstances described
in subsection (b)(1)'';
(B) in paragraph (1)(B), by amending clause (iii) to read
as follows:
``(iii) Appropriate conditions with respect to
collection and analysis of information concerning the
safety and effectiveness of the product with respect to the
use of such product during the period when the
authorization is in effect and a reasonable time following
such period.'';
(C) in paragraph (2)--
(i) in subparagraph (A)--
(I) by striking ``manufacturer of the product'' and
inserting ``person'';
(II) by striking ``circumstances of the emergency''
and inserting ``applicable circumstances described in
subsection (b)(1)''; and
(III) by inserting at the end before the period
``or in paragraph (1)(B)'';
(ii) in subparagraph (B)(i), by inserting before the
period at the end ``, except as provided in section 564A
with respect to authorized changes to the product
expiration date''; and
(iii) by amending subparagraph (C) to read as follows:
``(C) In establishing conditions under this paragraph with
respect to the distribution and administration of the product
for the unapproved use, the Secretary shall not impose
conditions that would restrict distribution or administration
of the product when distributed or administered for the
approved use.''; and
(D) by amending paragraph (3) to read as follows:
``(3) Good manufacturing practice; prescription.--With respect
to the emergency use of a product for which an authorization under
this section is issued (whether an unapproved product or an
unapproved use of an approved product), the Secretary may waive or
limit, to the extent appropriate given the applicable circumstances
described in subsection (b)(1)--
``(A) requirements regarding current good manufacturing
practice otherwise applicable to the manufacture, processing,
packing, or holding of products subject to regulation under
this Act, including such requirements established under section
501 or 520(f)(1), and including relevant conditions prescribed
with respect to the product by an order under section
520(f)(2);
``(B) requirements established under section 503(b); and
``(C) requirements established under section 520(e).'';
(6) in subsection (g)--
(A) in the subsection heading, by inserting ``Review and''
before ``Revocation'';
(B) in paragraph (1), by inserting after the period at the
end the following: ``As part of such review, the Secretary
shall regularly review the progress made with respect to the
approval, licensure, or clearance of--
``(A) an unapproved product for which an authorization was
issued under this section; or
``(B) an unapproved use of an approved product for which an
authorization was issued under this section.''; and
(C) by amending paragraph (2) to read as follows:
``(2) Revision and revocation.--The Secretary may revise or
revoke an authorization under this section if--
``(A) the circumstances described under subsection (b)(1)
no longer exist;
``(B) the criteria under subsection (c) for issuance of
such authorization are no longer met; or
``(C) other circumstances make such revision or revocation
appropriate to protect the public health or safety.'';
(7) in subsection (h)(1), by adding after the period at the end
the following: ``The Secretary shall make any revisions to an
authorization under this section available on the Internet Web site
of the Food and Drug Administration.'';
(8) by adding at the end of subsection (j) the following:
``(4) Nothing in this section shall be construed as authorizing
a delay in the review or other consideration by the Secretary of
any application or submission pending before the Food and Drug
Administration for a product for which an authorization under this
section is issued.''; and
(9) by adding at the end the following:
``(m) Categorization of Laboratory Tests Associated With Devices
Subject to Authorization.--
``(1) In general.--In issuing an authorization under this
section with respect to a device, the Secretary may, subject to the
provisions of this section, determine that a laboratory examination
or procedure associated with such device shall be deemed, for
purposes of section 353 of the Public Health Service Act, to be in
a particular category of examinations and procedures (including the
category described by subsection (d)(3) of such section) if, based
on the totality of scientific evidence available to the Secretary--
``(A) such categorization would be beneficial to protecting
the public health; and
``(B) the known and potential benefits of such
categorization under the circumstances of the authorization
outweigh the known and potential risks of the categorization.
``(2) Conditions of determination.--The Secretary may establish
appropriate conditions on the performance of the examination or
procedure pursuant to such determination.
``(3) Effective period.--A determination under this subsection
shall be effective for purposes of section 353 of the Public Health
Service Act notwithstanding any other provision of that section
during the effective period of the relevant declaration under
subsection (b).''.
(b) Emergency Use of Medical Products.--Subchapter E of chapter V
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.)
is amended by inserting after section 564 the following:
``SEC. 564A. EMERGENCY USE OF MEDICAL PRODUCTS.
``(a) Definitions.--In this section:
``(1) Eligible product.--The term `eligible product' means a
product that--
``(A) is approved or cleared under this chapter or licensed
under section 351 of the Public Health Service Act;
``(B)(i) is intended for use to prevent, diagnose, or treat
a disease or condition involving a biological, chemical,
radiological, or nuclear agent or agents; or
``(ii) is intended for use to prevent, diagnose, or treat a
serious or life-threatening disease or condition caused by a
product described in clause (i); and
``(C) is intended for use during the circumstances under
which--
``(i) a determination described in subparagraph (A),
(B), or (C) of section 564(b)(1) has been made by the
Secretary of Homeland Security, the Secretary of Defense,
or the Secretary, respectively; or
``(ii) the identification of a material threat
described in subparagraph (D) of section 564(b)(1) has been
made pursuant to section 319F-2 of the Public Health
Service Act.
``(2) Product.--The term `product' means a drug, device, or
biological product.
``(b) Expiration Dating.--
``(1) In general.--The Secretary may extend the expiration date
and authorize the introduction or delivery for introduction into
interstate commerce of an eligible product after the expiration
date provided by the manufacturer if--
``(A) the expiration date extension is intended to support
the United States ability to protect--
``(i) the public health; or
``(ii) military preparedness and effectiveness; and
``(B) the expiration date extension is supported by an
appropriate scientific evaluation that is conducted or accepted
by the Secretary.
``(2) Requirements and conditions.--Any extension of an
expiration date under paragraph (1) shall, as part of the
extension, identify--
``(A) each specific lot, batch, or other unit of the
product for which extended expiration is authorized;
``(B) the duration of the extension; and
``(C) any other requirements or conditions as the Secretary
may deem appropriate for the protection of the public health,
which may include requirements for, or conditions on, product
sampling, storage, packaging or repackaging, transport,
labeling, notice to product recipients, recordkeeping, periodic
testing or retesting, or product disposition.
``(3) Effect.--Notwithstanding any other provision of this Act
or the Public Health Service Act, an eligible product shall not be
considered an unapproved product (as defined in section
564(a)(2)(A)) and shall not be deemed adulterated or misbranded
under this Act because, with respect to such product, the Secretary
has, under paragraph (1), extended the expiration date and
authorized the introduction or delivery for introduction into
interstate commerce of such product after the expiration date
provided by the manufacturer.
``(4) Expiration date.--For purposes of this subsection, the
term `expiration date' means the date established through
appropriate stability testing required by the regulations issued by
the Secretary to ensure that the product meets applicable standards
of identity, strength, quality, and purity at the time of use.
``(c) Current Good Manufacturing Practice.--
``(1) In general.--The Secretary may, when the circumstances of
a domestic, military, or public health emergency or material threat
described in subsection (a)(1)(C) so warrant, authorize, with
respect to an eligible product, deviations from current good
manufacturing practice requirements otherwise applicable to the
manufacture, processing, packing, or holding of products subject to
regulation under this Act, including requirements under section 501
or 520(f)(1) or applicable conditions prescribed with respect to
the eligible product by an order under section 520(f)(2).
``(2) Effect.--Notwithstanding any other provision of this Act
or the Public Health Service Act, an eligible product shall not be
considered an unapproved product (as defined in section
564(a)(2)(A)) and shall not be deemed adulterated or misbranded
under this Act because, with respect to such product, the Secretary
has authorized deviations from current good manufacturing practices
under paragraph (1).
``(d) Emergency Dispensing.--The requirements of sections 503(b)
and 520(e) shall not apply to an eligible product, and the product
shall not be considered an unapproved product (as defined in section
564(a)(2)(A)) and shall not be deemed adulterated or misbranded under
this Act because it is dispensed without an individual prescription,
if--
``(1) the product is dispensed during the circumstances
described in subsection (a)(1)(C); and
``(2) such dispensing without an individual prescription
occurs--
``(A) as permitted under the law of the State in which the
product is dispensed; or
``(B) in accordance with an order issued by the Secretary,
for the purposes and duration of the circumstances described in
subsection (a)(1)(C).
``(e) Emergency Use Instructions.--
``(1) In general.--The Secretary, acting through an appropriate
official within the Department of Health and Human Services, may
create and issue emergency use instructions to inform health care
providers or individuals to whom an eligible product is to be
administered concerning such product's approved, licensed, or
cleared conditions of use.
``(2) Effect.--Notwithstanding any other provisions of this Act
or the Public Health Service Act, a product shall not be considered
an unapproved product and shall not be deemed adulterated or
misbranded under this Act because of the issuance of emergency use
instructions under paragraph (1) with respect to such product or
the introduction or delivery for introduction of such product into
interstate commerce accompanied by such instructions--
``(A) during an emergency response to an actual emergency
that is the basis for a determination described in subsection
(a)(1)(C)(i); or
``(B) by a government entity (including a Federal, State,
local, or tribal government entity), or a person acting on
behalf of such a government entity, in preparation for an
emergency response.''.
(c) Risk Evaluation and Mitigation Strategies.--Section 505-1 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1), is
amended--
(1) in subsection (f), by striking paragraph (7); and
(2) by adding at the end the following:
``(k) Waiver in Public Health Emergencies.--The Secretary may waive
any requirement of this section with respect to a qualified
countermeasure (as defined in section 319F-1(a)(2) of the Public Health
Service Act) to which a requirement under this section has been
applied, if the Secretary determines that such waiver is required to
mitigate the effects of, or reduce the severity of, the circumstances
under which--
``(1) a determination described in subparagraph (A), (B), or
(C) of section 564(b)(1) has been made by the Secretary of Homeland
Security, the Secretary of Defense, or the Secretary, respectively;
or
``(2) the identification of a material threat described in
subparagraph (D) of section 564(b)(1) has been made pursuant to
section 319F-2 of the Public Health Service Act.''.
(d) Products Held for Emergency Use.--The Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) is amended by inserting after
section 564A, as added by subsection (b), the following:
``SEC. 564B. PRODUCTS HELD FOR EMERGENCY USE.
``It is not a violation of any section of this Act or of the Public
Health Service Act for a government entity (including a Federal, State,
local, or tribal government entity), or a person acting on behalf of
such a government entity, to introduce into interstate commerce a
product (as defined in section 564(a)(4)) intended for emergency use,
if that product--
``(1) is intended to be held and not used; and
``(2) is held and not used, unless and until that product--
``(A) is approved, cleared, or licensed under section 505,
510(k), or 515 of this Act or section 351 of the Public Health
Service Act;
``(B) is authorized for investigational use under section
505 or 520 of this Act or section 351 of the Public Health
Service Act; or
``(C) is authorized for use under section 564.''.

4fdc8e6d89508e6c8d22a7db0b38705c2d7cf4412c4cb95834ef28bdb1131654

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--
``(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''.

e070247366c0b0d43822d25d4386cf48ec71bc10ce493322802d53c65febf58f

Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-4), as amended by section 303, is further amended--
(1) in the section heading, by striking ``technical
assistance'' and inserting ``countermeasure development, review,
and technical assistance'';
(2) in subsection (b), by striking the subsection enumerator
and all that follows through ``shall establish'' and inserting the
following:
``(b) General Duties.--In order to accelerate the development,
stockpiling, approval, licensure, and clearance of qualified
countermeasures, security countermeasures, and qualified pandemic or
epidemic products, the Secretary, in consultation with the Assistant
Secretary for Preparedness and Response, shall--
``(1) ensure the appropriate involvement of Food and Drug
Administration personnel in interagency activities related to
countermeasure advanced research and development, consistent with
sections 319F, 319F-1, 319F-2, 319F-3, 319L, and 2811 of the Public
Health Service Act;
``(2) ensure the appropriate involvement and consultation of
Food and Drug Administration personnel in any flexible
manufacturing activities carried out under section 319L of the
Public Health Service Act, including with respect to meeting
regulatory requirements set forth in this Act;
``(3) promote countermeasure expertise within the Food and Drug
Administration by--
``(A) ensuring that Food and Drug Administration personnel
involved in reviewing countermeasures for approval, licensure,
or clearance are informed by the Assistant Secretary for
Preparedness and Response on the material threat assessment
conducted under section 319F-2 of the Public Health Service Act
for the agent or agents for which the countermeasure under
review is intended;
``(B) training Food and Drug Administration personnel
regarding review of countermeasures for approval, licensure, or
clearance;
``(C) holding public meetings at least twice annually to
encourage the exchange of scientific ideas; and
``(D) establishing protocols to ensure that countermeasure
reviewers have sufficient training or experience with
countermeasures;
``(4) maintain teams, composed of Food and Drug Administration
personnel with expertise on countermeasures, including specific
countermeasures, populations with special clinical needs (including
children and pregnant women that may use countermeasures, as
applicable and appropriate), classes or groups of countermeasures,
or other countermeasure-related technologies and capabilities, that
shall--
``(A) consult with countermeasure experts, including
countermeasure sponsors and applicants, to identify and help
resolve scientific issues related to the approval, licensure,
or clearance of countermeasures, through workshops or public
meetings; and
``(B) improve and advance the science relating to the
development of new tools, standards, and approaches to
assessing and evaluating countermeasures--
``(i) in order to inform the process for countermeasure
approval, clearance, and licensure; and
``(ii) with respect to the development of
countermeasures for populations with special clinical
needs, including children and pregnant women, in order to
meet the needs of such populations, as necessary and
appropriate; and
``(5) establish''; and
(3) by adding at the end the following:
``(c) Final Guidance on Development of Animal Models.--
``(1) In general.--Not later than 1 year after the date of the
enactment of the Pandemic and All-Hazards Preparedness
Reauthorization Act of 2013, the Secretary shall provide final
guidance to industry regarding the development of animal models to
support approval, clearance, or licensure of countermeasures
referred to in subsection (a) when human efficacy studies are not
ethical or feasible.
``(2) Authority to extend deadline.--The Secretary may extend
the deadline for providing final guidance under paragraph (1) by
not more than 6 months upon submission by the Secretary of a report
on the status of such guidance to the Committee on Energy and
Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate.
``(d) Development and Animal Modeling Procedures.--
``(1) Availability of animal model meetings.--To facilitate the
timely development of animal models and support the development,
stockpiling, licensure, approval, and clearance of countermeasures,
the Secretary shall, not later than 180 days after the enactment of
this subsection, establish a procedure by which a sponsor or
applicant that is developing a countermeasure for which human
efficacy studies are not ethical or practicable, and that has an
approved investigational new drug application or investigational
device exemption, may request and receive--
``(A) a meeting to discuss proposed animal model
development activities; and
``(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).''.

21dd79d3392af95950c8d37acb590478d920a4108851a469fc3621e570e422d3

Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-4), as amended by section 304, is further amended by adding at
the end the following:
``(f) Regulatory Management Plan.--
``(1) Definition.--In this subsection, the term `eligible
countermeasure' means--
``(A) a security countermeasure with respect to which the
Secretary has entered into a procurement contract under section
319F-2(c) of the Public Health Service Act; or
``(B) a countermeasure with respect to which the Biomedical
Advanced Research and Development Authority has provided
funding under section 319L of the Public Health Service Act for
advanced research and development.
``(2) Regulatory management plan process.--The Secretary, in
consultation with the Assistant Secretary for Preparedness and
Response and the Director of the Biomedical Advanced Research and
Development Authority, shall establish a formal process for
obtaining scientific feedback and interactions regarding the
development and regulatory review of eligible countermeasures by
facilitating the development of written regulatory management plans
in accordance with this subsection.
``(3) Submission of request and proposed plan by sponsor or
applicant.--
``(A) In general.--A sponsor or applicant of an eligible
countermeasure may initiate the process described under
paragraph (2) upon submission of a written request to the
Secretary. Such request shall include a proposed regulatory
management plan.
``(B) Timing of submission.--A sponsor or applicant may
submit a written request under subparagraph (A) after the
eligible countermeasure has an investigational new drug or
investigational device exemption in effect.
``(C) Response by secretary.--The Secretary shall direct
the Food and Drug Administration, upon submission of a written
request by a sponsor or applicant under subparagraph (A), to
work with the sponsor or applicant to agree on a regulatory
management plan within a reasonable time not to exceed 90 days.
If the Secretary determines that no plan can be agreed upon,
the Secretary shall provide to the sponsor or applicant, in
writing, the scientific or regulatory rationale why such
agreement cannot be reached.
``(4) Plan.--The content of a regulatory management plan agreed
to by the Secretary and a sponsor or applicant shall include--
``(A) an agreement between the Secretary and the sponsor or
applicant regarding developmental milestones that will trigger
responses by the Secretary as described in subparagraph (B);
``(B) performance targets and goals for timely and
appropriate responses by the Secretary to the triggers
described under subparagraph (A), including meetings between
the Secretary and the sponsor or applicant, written feedback,
decisions by the Secretary, and other activities carried out as
part of the development and review process; and
``(C) an agreement on how the plan shall be modified, if
needed.
``(5) Milestones and performance targets.--The developmental
milestones described in paragraph (4)(A) and the performance
targets and goals described in paragraph (4)(B) shall include--
``(A) feedback from the Secretary regarding the data
required to support the approval, clearance, or licensure of
the eligible countermeasure involved;
``(B) feedback from the Secretary regarding the data
necessary to inform any authorization under section 564;
``(C) feedback from the Secretary regarding the data
necessary to support the positioning and delivery of the
eligible countermeasure, including to the Strategic National
Stockpile;
``(D) feedback from the Secretary regarding the data
necessary to support the submission of protocols for review
under section 505(b)(5)(B);
``(E) feedback from the Secretary regarding any gaps in
scientific knowledge that will need resolution prior to
approval, licensure, or clearance of the eligible
countermeasure and plans for conducting the necessary
scientific research;
``(F) identification of the population for which the
countermeasure sponsor or applicant seeks approval, licensure,
or clearance and the population for which desired labeling
would not be appropriate, if known; and
``(G) as necessary and appropriate, and to the extent
practicable, a plan for demonstrating safety and effectiveness
in pediatric populations, and for developing pediatric dosing,
formulation, and administration with respect to the eligible
countermeasure, provided that such plan would not delay
authorization under section 564, approval, licensure, or
clearance for adults.
``(6) Prioritization.--
``(A) Plans for security countermeasures.--The Secretary
shall establish regulatory management plans for all security
countermeasures for which a request is submitted under
paragraph (3)(A).
``(B) Plans for other eligible countermeasures.--The
Secretary shall determine whether resources are available to
establish regulatory management plans for eligible
countermeasures that are not security countermeasures. If
resources are available to establish regulatory management
plans for eligible countermeasures that are not security
countermeasures, and if resources are not available to
establish regulatory management plans for all eligible
countermeasures for which requests have been submitted, the
Director of the Biomedical Advanced Research and Development
Authority, in consultation with the Commissioner, shall
prioritize which eligible countermeasures may receive
regulatory management plans.''.

980d74af0aeeb73b4d7ddae852f30dcfa0f5a755bc649900f02013bb7b23f732

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

15dc607824406a7f16a1c19516decb4750a9b9617b05fa080bd6b2d35881da9c

(a) Pediatric Studies of Drugs.--Section 505A of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355a) is amended--
(1) in subsection (d), by adding at the end the following:
``(5) Consultation.--With respect to a drug that is a qualified
countermeasure (as defined in section 319F-1 of the Public Health
Service Act), a security countermeasure (as defined in section
319F-2 of the Public Health Service Act), or a qualified pandemic
or epidemic product (as defined in section 319F-3 of the Public
Health Service Act), the Secretary shall solicit input from the
Assistant Secretary for Preparedness and Response regarding the
need for and, from the Director of the Biomedical Advanced Research
and Development Authority regarding the conduct of, pediatric
studies under this section.''; and
(2) in subsection (n)(1), by adding at the end the following:
``(C) For a drug that is a qualified countermeasure (as
defined in section 319F-1 of the Public Health Service Act), a
security countermeasure (as defined in section 319F-2 of the
Public Health Service Act), or a qualified pandemic or epidemic
product (as defined in section 319F-3 of such Act), in addition
to any action with respect to such drug under subparagraph (A)
or (B), the Secretary shall notify the Assistant Secretary for
Preparedness and Response and the Director of the Biomedical
Advanced Research and Development Authority of all pediatric
studies in the written request issued by the Commissioner of
Food and Drugs.''.
(b) Addition to Priority List Considerations.--Section 409I of the
Public Health Service Act (42 U.S.C. 284m) is amended--
(1) by striking subsection (a)(2) and inserting the following:
``(2) Consideration of available information.--In developing
and prioritizing the list under paragraph (1), the Secretary--
``(A) shall consider--
``(i) therapeutic gaps in pediatrics that may include
developmental pharmacology, pharmacogenetic determinants of
drug response, metabolism of drugs and biologics in
children, and pediatric clinical trials;
``(ii) particular pediatric diseases, disorders or
conditions where more complete knowledge and testing of
therapeutics, including drugs and biologics, may be
beneficial in pediatric populations; and
``(iii) the adequacy of necessary infrastructure to
conduct pediatric pharmacological research, including
research networks and trained pediatric investigators; and
``(B) may consider the availability of qualified
countermeasures (as defined in section 319F-1), security
countermeasures (as defined in section 319F-2), and qualified
pandemic or epidemic products (as defined in section 319F-3) to
address the needs of pediatric populations, in consultation
with the Assistant Secretary for Preparedness and Response,
consistent with the purposes of this section.''; and
(2) in subsection (b), by striking ``subsection (a)'' and
inserting ``paragraphs (1) and (2)(A) of subsection (a)''.
(c) Advice and Recommendations of the Pediatric Advisory Committee
Regarding Countermeasures for Pediatric Populations.--Subsection (b)(2)
of section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C.
284m note) is amended--
(1) in subparagraph (C), by striking the period and inserting
``; and''; and
(2) by adding at the end the following:
``(D) the development of countermeasures (as defined in
section 565(a) of the Federal Food, Drug, and Cosmetic Act) for
pediatric populations.''.
DEVELOPMENT

dcd01f4350991d8634a71d68a84da42c41b83167271bacd8b64396912a433326

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

2cb2f66e0bc790f843f5db195faad69ac4d33572f42f739e4610b02c736c4c14

(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
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) Effective date.--This subsection shall take effect as if
enacted on December 17, 2012.
(f) Independent Evaluation.--Section 319L of the Public Health
Service Act (42 U.S.C. 247d-7e) is amended by adding at the end the
following:
``(f) Independent Evaluation.--
``(1) In general.--Not later than 180 days after the date of
enactment of this subsection, the Comptroller General of the United
States shall conduct an independent evaluation of the activities
carried out to facilitate flexible manufacturing capacity pursuant
to this section.
``(2) Report.--Not later than 1 year after the date of
enactment of this subsection, the Comptroller General of the United
States shall submit to the appropriate committees of Congress a
report concerning the results of the evaluation conducted under
paragraph (1). Such report shall review and assess--
``(A) the extent to which flexible manufacturing capacity
under this section is dedicated to chemical, biological,
radiological, and nuclear threats;
``(B) the activities supported by flexible manufacturing
initiatives; and
``(C) the ability of flexible manufacturing activities
carried out under this section to--
``(i) secure and leverage leading technical expertise
with respect to countermeasure advanced research,
development, and manufacturing processes; and
``(ii) meet the surge manufacturing capacity needs
presented by novel and emerging threats, including
chemical, biological, radiological, and nuclear agents.''.
(g) Definitions.--
(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''.

8f2fd3d7a81d6775c2a644eeeeb13a8eec10ace31b3be9e77dd8ce261bbdc236

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

a6f68279f6ec8dd4133469c9bbcb620a5352944ef8ade686b1e02701e19001e8

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

54149cd5061407e6cdba8f8d6f642813a8acc10e6af07d26f3d77a8b96886ce9

Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 — HR. 307

Other Sections

TITLE I

TITLE II

TITLE III

TITLE IV

Want the full experience?