[Congressional Record Volume 159, Number 28 (Wednesday, February 27, 2013)]
[Senate]
[Pages S948-S957]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PANDEMIC AND ALL-HAZARDS PREPAREDNESS REAUTHORIZATION ACT OF 2013
Mr. REID. Mr. President, I ask unanimous consent that the Senate
proceed to Calendar No. 14, H.R. 307.
The PRESIDING OFFICER. The clerk will report the bill by title.
The legislative clerk read as follows:
A bill (H.R. 307) 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.
There being no objection, the Senate proceeded to consider the bill,
which had been reported from the Committee on Health, Education, Labor,
and Pensions, with an amendment to strike all after the enacting clause
and insert in lieu thereof the following:
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Pandemic
and All-Hazards Preparedness Reauthorization Act of 2013''.
(b) Table of Contents.--The table of contents of this Act
is as follows:
Sec. 1. Short title; table of contents.
TITLE I--STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE FOR PUBLIC
HEALTH EMERGENCIES
Sec. 101. National Health Security Strategy.
Sec. 102. Assistant Secretary for Preparedness and Response.
Sec. 103. National Advisory Committee on Children and Disasters.
Sec. 104. Modernization of the National Disaster Medical System.
Sec. 105. Continuing the role of the Department of Veterans Affairs.
TITLE II--OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS AND
RESPONSE
Sec. 201. Temporary reassignment of State and local personnel during a
public health emergency.
Sec. 202. Improving State and local public health security.
Sec. 203. Hospital preparedness and medical surge capacity.
Sec. 204. Enhancing situational awareness and biosurveillance.
Sec. 205. Eliminating duplicative Project Bioshield reports.
TITLE III--ENHANCING MEDICAL COUNTERMEASURE REVIEW
Sec. 301. Special protocol assessment.
Sec. 302. Authorization for medical products for use in emergencies.
Sec. 303. Definitions.
Sec. 304. Enhancing medical countermeasure activities.
Sec. 305. Regulatory management plans.
Sec. 306. Report.
Sec. 307. Pediatric medical countermeasures.
TITLE IV--ACCELERATING MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND
DEVELOPMENT
Sec. 401. BioShield.
Sec. 402. Biomedical Advanced Research and Development Authority.
Sec. 403. Strategic National Stockpile.
Sec. 404. National Biodefense Science Board.
TITLE I--STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE FOR PUBLIC
HEALTH EMERGENCIES
SEC. 101. NATIONAL HEALTH SECURITY STRATEGY.
(a) In General.--Section 2802 of the Public Health Service
Act (42 U.S.C. 300hh-1) is amended--
(1) in subsection (a)(1), by striking ``2009'' and
inserting ``2014''; and
(2) in subsection (b)--
(A) in paragraph (1)(A), by inserting ``, including drills
and exercises to ensure medical surge capacity for events
without notice'' after ``exercises''; and
(B) in paragraph (3)--
(i) in the matter preceding subparagraph (A)--
(I) by striking ``facilities), and trauma care'' and
inserting ``and ambulatory care facilities and which may
include dental health facilities), and trauma care, critical
care,''; and
(II) by inserting ``(including related availability,
accessibility, and coordination)'' after ``public health
emergencies'';
(ii) in subparagraph (A), by inserting ``and trauma'' after
``medical'';
(iii) in subparagraph (B), by striking ``Medical evacuation
and fatality management'' and inserting ``Fatality
management'';
(iv) by redesignating subparagraphs (C), (D), and (E) as
subparagraphs (D), (E), and (F), respectively;
(v) by inserting after subparagraph (B), the following the
new subparagraph:
``(C) Coordinated medical triage and evacuation to
appropriate medical institutions based on patient medical
need, taking into account regionalized systems of care.'';
(vi) in subparagraph (E), as redesignated by clause (iv),
by inserting ``(which may include such dental health
assets)'' after ``medical assets''; and
(vii) by adding at the end the following:
``(G) Optimizing a coordinated and flexible approach to the
medical surge capacity of hospitals, other health care
facilities, critical care, trauma care (which may include
trauma centers), and emergency medical systems.'';
(C) in paragraph (4)--
(i) in subparagraph (A), by inserting ``, including the
unique needs and considerations of individuals with
disabilities,'' after ``medical needs of at-risk
individuals''; and
(ii) in subparagraph (B), by inserting ``the'' before
``purpose of this section''; and
(D) by adding at the end the following:
``(7) Countermeasures.--
``(A) Promoting strategic initiatives to advance
countermeasures to diagnose, mitigate, prevent, or treat harm
from any biological agent or toxin, chemical, radiological,
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.''.
SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.
(a) In General.--Section 2811 of the Public Health Service
Act (42 U.S.C. 300hh-10) is amended--
[[Page S949]]
(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
[[Page S950]]
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.
SEC. 103. NATIONAL ADVISORY COMMITTEE ON CHILDREN AND
DISASTERS.
Subtitle B of title XXVIII of the Public Health Service Act
(42 U.S.C. 300hh et seq.) is amended by inserting after
section 2811 the following:
``SEC. 2811A. 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.''.
SEC. 104. MODERNIZATION OF THE NATIONAL DISASTER MEDICAL
SYSTEM.
Section 2812 of the Public Health Service Act (42 U.S.C.
300hh-11) is amended--
(1) in subsection (a)(3)--
(A) in subparagraph (A), in clause (i) by inserting ``,
including at-risk individuals as applicable'' after ``victims
of a public health emergency'';
(B) by redesignating subparagraph (C) as subparagraph (E);
and
(C) by inserting after subparagraph (B), the following:
``(C) Considerations for at-risk populations.--The
Secretary shall take steps to ensure that an appropriate
specialized and focused range of public health and medical
capabilities are represented in the National Disaster Medical
System, which take into account the needs of at-risk
individuals, in the event of a public health emergency.''.
``(D) Administration.--The Secretary may determine and pay
claims for reimbursement for services under subparagraph (A)
directly or through contracts that provide for payment in
advance or by way of reimbursement.''; and
(2) in subsection (g), by striking ``such sums as may be
necessary for each of the fiscal years 2007 through 2011''
and inserting ``$52,700,000 for each of fiscal years 2014
through 2018''.
SEC. 105. CONTINUING THE ROLE OF THE DEPARTMENT OF VETERANS
AFFAIRS.
Section 8117(g) of title 38, United States Code, is amended
by striking ``such sums as may be necessary to carry out this
section for each of fiscal years 2007 through 2011'' and
inserting ``$155,300,000 for each of fiscal years 2014
through 2018 to carry out this section''.
TITLE II--OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS AND
RESPONSE
SEC. 201. TEMPORARY REASSIGNMENT OF STATE AND LOCAL PERSONNEL
DURING A PUBLIC HEALTH EMERGENCY.
Section 319 of the Public Health Service Act (42 U.S.C.
247d) is amended by adding at the end the following:
``(e) Temporary Reassignment of State and Local Personnel
During a Public Health Emergency.--
``(1) Emergency reassignment of federally funded
personnel.--Notwithstanding any other provision of law, and
subject to paragraph (2), upon request by the Governor of a
State or a tribal organization or such Governor or tribal
organization's designee, the Secretary may authorize the
requesting State or Indian tribe to temporarily reassign, for
purposes of immediately addressing a public health emergency
in the State or Indian tribe, State and local public health
department or agency personnel funded in whole or in part
through programs authorized under this Act, as appropriate.
``(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
[[Page S951]]
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.''.
SEC. 202. IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY.
(a) Cooperative Agreements.--Section 319C-1 of the Public
Health Service Act (42 U.S.C. 247d-3a) is amended--
(1) in subsection (b)(1)(C), by striking ``consortium of
entities described in subparagraph (A)'' and inserting
``consortium of States'';
(2) in subsection (b)(2)--
(A) in subparagraph (A)--
(i) by striking clauses (i) and (ii) and inserting the
following:
``(i) a description of the activities such entity will
carry out under the agreement to meet the goals identified
under section 2802, including with respect to chemical,
biological, radiological, or nuclear threats, whether
naturally occurring, unintentional, or deliberate;
``(ii) a description of the activities such entity will
carry out with respect to pandemic influenza, as a component
of the activities carried out under clause (i), and
consistent with the requirements of paragraphs (2) and (5) of
subsection (g);'';
(ii) in clause (iv), by striking ``and'' at the end; and
(iii) by adding at the end the following:
``(vi) a description of how, as appropriate, the entity may
partner with relevant public and private stakeholders in
public health emergency preparedness and response;
``(vii) a description of how the entity, as applicable and
appropriate, will coordinate with State emergency
preparedness and response plans in public health emergency
preparedness, including State educational agencies (as
defined in section 9101(41) of the Elementary and Secondary
Education Act of 1965) and State child care lead agencies
(designated under section 658D of the Child Care and
Development Block Grant Act of 1990);
``(viii) in the case of entities that operate on the United
States-Mexico border or the United States-Canada border, a
description of the activities such entity will carry out
under the agreement that are specific to the border area
including disease detection, identification, investigation,
and preparedness and 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)''.
SEC. 203. HOSPITAL PREPAREDNESS AND MEDICAL SURGE CAPACITY.
(a) All-Hazards Public Health and Medical Response
Curricula and Training.--Section 319F(a)(5)(B) of the Public
Health Service Act (42 U.S.C. 247d-6(a)(5)(B)) is amended by
striking ``public health or medical'' and inserting ``public
health, medical, or dental''.
(b) Encouraging Health Professional Volunteers.--
(1) Emergency system for advance registration of volunteer
health professionals.--Section 319I(k) of the Public Health
Service Act (42 U.S.C. 247d-7b(k)) is amended by striking
``$2,000,000 for fiscal year 2002, and such sums as may be
necessary for each of the fiscal years 2003 through 2011''
and inserting ``$5,000,000 for each of fiscal years 2014
through 2018''.
(2) Volunteers.--Section 2813 of the Public Health Service
Act (42 U.S.C. 300hh-15) is amended--
(A) in subsection (d)(2), by adding at the end the
following: ``Such training exercises shall, as appropriate
and applicable, incorporate the needs of at-risk individuals
in the event of a public health emergency.''; and
(B) in subsection (i), by striking ``$22,000,000 for fiscal
year 2007, and such sums as may be necessary for each of
fiscal years 2008 through 2011'' and inserting ``$11,200,000
for each of fiscal years 2014 through 2018''.
(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'';
[[Page S952]]
(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).''.
SEC. 204. ENHANCING SITUATIONAL AWARENESS AND
BIOSURVEILLANCE.
(a) In General.--Section 319D of the Public Health Service
Act (42 U.S.C. 247d-4) is amended--
(1) in subsection (b)--
(A) in paragraph (1)(B), by inserting ``poison control
centers,'' after ``hospitals,'';
(B) in paragraph (2), by inserting before the period at the
end the following: ``, allowing for coordination to maximize
all-hazards medical and public health preparedness and
response and to minimize duplication of effort''; and
(C) in paragraph (3), by inserting before the period at the
end the following: ``and update such standards as
necessary'';
(2) by striking subsection (c);
(3) by redesignating subsections (d) through (g) as
subsections (c) through (f), respectively;
(4) in subsection (c), as so redesignated--
(A) in the subsection heading, by striking ``Public Health
Situational Awareness'' and inserting ``Modernizing Public
Health Situational Awareness and Biosurveillance'';
(B) in paragraph (1)--
(i) by striking ``Pandemic and All-Hazards Preparedness
Act'' and inserting ``Pandemic and All-Hazards Preparedness
Reauthorization Act of 2013''; and
(ii) by inserting ``, novel emerging threats,'' after
``disease outbreaks'';
(C) by striking paragraph (2) and inserting the following:
``(2) 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)''.
SEC. 205. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD REPORTS.
Section 5 of the Project Bioshield Act of 2004 (42 U.S.C.
247d-6c) is repealed.
TITLE III--ENHANCING MEDICAL COUNTERMEASURE REVIEW
SEC. 301. SPECIAL PROTOCOL ASSESSMENT.
Section 505(b)(5)(B) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(b)(5)(B)) is amended by striking
``size of clinical trials intended'' and all that follows
through ``. The sponsor or applicant'' and inserting the
following: ``size--
``(i)(I) of clinical trials intended to form the primary
basis of an effectiveness claim; or
``(II) in the case where human efficacy studies are not
ethical or feasible, of animal and any associated clinical
trials which, in combination, are intended to form the
primary basis of an effectiveness claim; or
``(ii) with respect to an application for approval of a
biological product under section 351(k) of the Public Health
Service Act, of any necessary clinical study or studies.
The sponsor or applicant''.
SEC. 302. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN
EMERGENCIES.
(a) In General.--Section 564 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-3) is amended--
(1) in subsection (a)--
(A) in paragraph (1), by striking ``sections 505, 510(k),
and 515 of this Act'' and inserting ``any provision of this
Act'';
(B) in paragraph (2)(A), by striking ``under a provision of
law referred to in such paragraph'' and inserting ``under
section 505, 510(k), or 515 of this Act or section 351 of the
Public Health Service Act''; and
(C) in paragraph (3), by striking ``a provision of law
referred to in such paragraph'' and inserting ``a section of
this Act or the Public Health Service Act referred to in
paragraph (2)(A)'';
(2) in subsection (b)--
(A) in the subsection heading, by striking ``Emergency''
and inserting ``Emergency or Threat Justifying 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:
[[Page S953]]
``(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.
[[Page S954]]
``(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.''.
SEC. 303. DEFINITIONS.
Section 565 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-4) is amended by striking ``The Secretary, in
consultation'' and inserting the following:
``(a) Definitions.--In this section--
``(1) the term `countermeasure' means a qualified
countermeasure, a security countermeasure, and a qualified
pandemic or epidemic product;
``(2) the term `qualified countermeasure' has the meaning
given such term in section 319F-1 of the Public Health
Service Act;
``(3) the term `security countermeasure' has the meaning
given such term in section 319F-2 of such Act; and
``(4) the term `qualified pandemic or epidemic product'
means a product that meets the definition given such term in
section 319F-3 of the Public Health Service Act and--
``(A) that has been identified by the Department of Health
and Human Services or the Department of Defense as receiving
funding directly related to addressing chemical, biological,
radiological, or nuclear threats, including pandemic
influenza; or
``(B) is included under this paragraph pursuant to a
determination by the Secretary.
``(b) General Duties.--The Secretary, in consultation''.
SEC. 304. ENHANCING MEDICAL COUNTERMEASURE ACTIVITIES.
Section 565 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-4), as amended by section 303, is further
amended--
(1) in the section heading, by striking ``TECHNICAL
ASSISTANCE'' and inserting ``COUNTERMEASURE DEVELOPMENT,
REVIEW, AND TECHNICAL ASSISTANCE'';
(2) in subsection (b), by striking the subsection
enumerator and all that follows through ``shall establish''
and inserting the following:
``(b) 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
[[Page S955]]
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).''.
SEC. 305. REGULATORY MANAGEMENT PLANS.
Section 565 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-4), as amended by section 304, is further
amended by adding at the end the following:
``(f) Regulatory Management Plan.--
``(1) Definition.--In this subsection, the term `eligible
countermeasure' means--
``(A) a security countermeasure with respect to which the
Secretary has entered into a procurement contract under
section 319F-2(c) of the Public Health Service Act; or
``(B) a countermeasure with respect to which the Biomedical
Advanced Research and Development Authority has provided
funding under section 319L of the Public Health Service Act
for advanced research and development.
``(2) 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.''.
SEC. 306. REPORT.
Section 565 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-4), as amended by section 305, is further
amended by adding at the end the following:
``(g) Annual Report.--Not later than 180 days after the
date of enactment of this subsection, and annually
thereafter, the 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.''.
SEC. 307. PEDIATRIC MEDICAL COUNTERMEASURES.
(a) Pediatric Studies of Drugs.--Section 505A of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is
amended--
(1) in subsection (d), by adding at the end the following:
``(5) Consultation.--With respect to a drug that is a
qualified countermeasure (as defined in section 319F-1 of the
Public Health Service Act), a security countermeasure (as
defined in section 319F-2 of the Public Health Service Act),
or a qualified pandemic or epidemic product (as defined in
section 319F-3 of the Public Health
[[Page S956]]
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.''.
TITLE IV--ACCELERATING MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND
DEVELOPMENT
SEC. 401. BIOSHIELD.
(a) Procurement of Countermeasures.--Section 319F-2(c) of
the Public Health Service Act (42 U.S.C. 247d-6b(c)) is
amended--
(1) in paragraph (1)(B)(i)(III)(bb), by striking ``eight
years'' and inserting ``10 years'';
(2) in paragraph (2)(C), by striking ``the designated
congressional committees (as defined in paragraph (10))'' and
inserting ``the appropriate committees of Congress'';
(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).''.
SEC. 402. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT
AUTHORITY.
(a) Duties.--Section 319L(c)(4) of the Public Health
Service Act (42 U.S.C. 247d-7e(c)(4)) is amended--
(1) in subparagraph (B)(iii), by inserting ``(which may
include advanced research and development for purposes of
fulfilling requirements under the Federal Food, Drug, and
Cosmetic Act or section 351 of this Act)'' after
``development''; and
(2) in subparagraph (D)(iii), by striking ``and vaccine
manufacturing technologies'' and inserting ``vaccine-
manufacturing 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
[[Page S957]]
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''.
SEC. 403. STRATEGIC NATIONAL STOCKPILE.
Section 319F-2 of the Public Health Service Act (42 U.S.C.
247d-6b) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by inserting ``consistent with section 2811'' before
``by the Secretary to be appropriate''; and
(ii) by inserting before the period at the end of the
second sentence the following: ``and shall submit such review
annually to the appropriate congressional committees of
jurisdiction to the extent that disclosure of such
information does not compromise national 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).''.
SEC. 404. NATIONAL BIODEFENSE SCIENCE BOARD.
Section 319M(a) of the Public Health Service Act (42 U.S.C.
247d-f(a)) is amended--
(1) in paragraph (2)--
(A) in subparagraph (D)--
(i) in clause (i), by striking ``and'' at the end;
(ii) in clause (ii), by striking the period and inserting a
semicolon; and
(iii) by adding at the end the following:
``(iii) one such member shall be an individual with
pediatric subject matter expertise; and
``(iv) one such member shall be a State, tribal,
territorial, or local public health official.''; and
(B) by adding at the end the following flush sentence:
``Nothing in this paragraph shall preclude a member of the
Board from satisfying two or more of the requirements
described in subparagraph (D).''; and
(2) in paragraph (5)--
(A) in subparagraph (B), by striking ``and'' at the end;
(B) in subparagraph (C), by striking the period and
inserting ``; and''; and
(C) by adding at the end the following:
``(D) provide any recommendation, finding, or report
provided to the Secretary under this paragraph to the
appropriate committees of Congress.''.
Mr. REID. Mr. President, I ask unanimous consent that the committee-
reported substitute be agreed to, the bill, as amended, be read a third
time and passed, and the motion to reconsider be made and laid upon the
table with no intervening action or debate.
The PRESIDING OFFICER. Without objection, it is so ordered.
The committee-reported substitute was agreed to.
The amendment was ordered to be engrossed and the bill to be read the
third time and passed.
The bill (H.R. 307), as amended, was read the third time and passed.
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