[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 307 Reported in Senate (RS)]
Calendar No. 14
113th CONGRESS
1st Session
H. R. 307
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
January 23 (legislative day, January 3), 2013
Received; read twice and referred to the Committee on Health,
Education, Labor, and Pensions
February 14, 2013
Reported by Mr. Harkin, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
AN ACT
To reauthorize certain programs under the Public Health Service Act and
the Federal Food, Drug, and Cosmetic Act with respect to public health
security and all-hazards preparedness and response, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE; TABLE OF CONTENTS.</DELETED>
<DELETED> (a) Short Title.--This Act may be cited as the ``Pandemic
and All-Hazards Preparedness Reauthorization Act of 2013''.</DELETED>
<DELETED> (b) Table of Contents.--The table of contents of this Act
is as follows:</DELETED>
<DELETED>Sec. 1. Short title; table of contents.
<DELETED>TITLE I--STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE FOR
PUBLIC HEALTH EMERGENCIES
<DELETED>Sec. 101. National Health Security Strategy.
<DELETED>Sec. 102. Assistant Secretary for Preparedness and Response.
<DELETED>Sec. 103. National Advisory Committee on Children and
Disasters.
<DELETED>Sec. 104. Modernization of the National Disaster Medical
System.
<DELETED>Sec. 105. Continuing the role of the Department of Veterans
Affairs.
<DELETED>TITLE II--OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS
AND RESPONSE
<DELETED>Sec. 201. Temporary redeployment of federally funded personnel
during a public health emergency.
<DELETED>Sec. 202. Improving State and local public health security.
<DELETED>Sec. 203. Hospital preparedness and medical surge capacity.
<DELETED>Sec. 204. Enhancing situational awareness and biosurveillance.
<DELETED>Sec. 205. Eliminating duplicative Project Bioshield reports.
<DELETED>TITLE III--ENHANCING MEDICAL COUNTERMEASURE REVIEW
<DELETED>Sec. 301. Special protocol assessment.
<DELETED>Sec. 302. Authorization for medical products for use in
emergencies.
<DELETED>Sec. 303. Definitions.
<DELETED>Sec. 304. Enhancing medical countermeasure activities.
<DELETED>Sec. 305. Regulatory management plans.
<DELETED>Sec. 306. Report.
<DELETED>Sec. 307. Pediatric medical countermeasures.
<DELETED>TITLE IV--ACCELERATING MEDICAL COUNTERMEASURE ADVANCED
RESEARCH AND DEVELOPMENT
<DELETED>Sec. 401. BioShield.
<DELETED>Sec. 402. Biomedical Advanced Research and Development
Authority.
<DELETED>Sec. 403. Strategic National Stockpile.
<DELETED>Sec. 404. National Biodefense Science Board.
<DELETED>TITLE I--STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE FOR
PUBLIC HEALTH EMERGENCIES</DELETED>
<DELETED>SEC. 101. NATIONAL HEALTH SECURITY STRATEGY.</DELETED>
<DELETED> (a) In General.--Section 2802 of the Public Health Service
Act (42 U.S.C. 300hh-1) is amended--</DELETED>
<DELETED> (1) in subsection (a)(1), by striking ``2009'' and
inserting ``2014''; and</DELETED>
<DELETED> (2) in subsection (b)--</DELETED>
<DELETED> (A) in paragraph (1)(A), by inserting ``,
including drills and exercises to ensure medical surge
capacity for events without notice'' after
``exercises''; and</DELETED>
<DELETED> (B) in paragraph (3)--</DELETED>
<DELETED> (i) in the matter preceding
subparagraph (A)--</DELETED>
<DELETED> (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</DELETED>
<DELETED> (II) by inserting
``(including related availability,
accessibility, and coordination)''
after ``public health
emergencies'';</DELETED>
<DELETED> (ii) in subparagraph (A), by
inserting ``and trauma'' after
``medical'';</DELETED>
<DELETED> (iii) in subparagraph (B), by
striking ``Medical evacuation and fatality
management'' and inserting ``Fatality
management'';</DELETED>
<DELETED> (iv) by redesignating
subparagraphs (C), (D), and (E) as
subparagraphs (D), (E), and (F),
respectively;</DELETED>
<DELETED> (v) by inserting after
subparagraph (B), the following the new
subparagraph:</DELETED>
<DELETED> ``(C) Coordinated medical triage and
evacuation to appropriate medical institutions based on
patient medical need, taking into account regionalized
systems of care.'';</DELETED>
<DELETED> (vi) in subparagraph (E), as
redesignated by clause (iv), by inserting
``(which may include such dental health
assets)'' after ``medical assets'';
and</DELETED>
<DELETED> (vii) by adding at the end the
following:</DELETED>
<DELETED> ``(G) Optimizing a coordinated and
flexible approach to the medical surge capacity of
hospitals, other health care facilities, critical care,
and trauma care (which may include trauma centers) and
emergency medical systems.'';</DELETED>
<DELETED> (C) in paragraph (4)--</DELETED>
<DELETED> (i) in subparagraph (A), by
inserting ``, including the unique needs and
considerations of individuals with
disabilities,'' after ``medical needs of at-
risk individuals''; and</DELETED>
<DELETED> (ii) in subparagraph (B), by
inserting ``the'' before ``purpose of this
section''; and</DELETED>
<DELETED> (D) by adding at the end the
following:</DELETED>
<DELETED> ``(7) Countermeasures.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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--
</DELETED>
<DELETED> ``(A) optimizing alignment and integration
of medical and public health preparedness and response
planning and capabilities with and into routine daily
activities; and</DELETED>
<DELETED> ``(B) promoting familiarity with local
medical and public health systems.''.</DELETED>
<DELETED> (b) At-Risk Individuals.--Section 2814 of the Public
Health Service Act (42 U.S.C. 300hh-16) is amended--</DELETED>
<DELETED> (1) by striking paragraphs (5), (7), and
(8);</DELETED>
<DELETED> (2) in paragraph (4), by striking
``2811(b)(3)(B)'' and inserting ``2802(b)(4)(B)'';</DELETED>
<DELETED> (3) by redesignating paragraphs (1) through (4) as
paragraphs (2) through (5), respectively;</DELETED>
<DELETED> (4) by inserting before paragraph (2) (as so
redesignated), the following:</DELETED>
<DELETED> ``(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;'';</DELETED>
<DELETED> (5) by amending paragraph (2) (as so redesignated)
to read as follows:</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (6) by inserting after paragraph (6), the
following:</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED>SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND
RESPONSE.</DELETED>
<DELETED> (a) In General.--Section 2811 of the Public Health Service
Act (42 U.S.C. 300hh-10) is amended--</DELETED>
<DELETED> (1) in subsection (b)--</DELETED>
<DELETED> (A) in paragraph (3), by inserting ``,
security countermeasures (as defined in section 319F-
2),'' after ``qualified countermeasures (as defined in
section 319F-1)'';</DELETED>
<DELETED> (B) in paragraph (4), by adding at the end
the following:</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(ii) gather and disseminate best
practices among grant and cooperative agreement
recipients, as appropriate.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(i) identified threats for which
countermeasures are available and for which no
countermeasures are available; and</DELETED>
<DELETED> ``(ii) unknown threats for which
no countermeasures are available.</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (C) by adding at the end the
following:</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(A) include consideration of the entire
medical countermeasures enterprise, including--
</DELETED>
<DELETED> ``(i) basic research and advanced
research and development;</DELETED>
<DELETED> ``(ii) approval, clearance,
licensure, and authorized uses of products;
and</DELETED>
<DELETED> ``(iii) procurement, stockpiling,
maintenance, and replenishment of all products
in the Strategic National Stockpile;</DELETED>
<DELETED> ``(B) inform prioritization of resources
and include measurable outputs and outcomes to allow
for the tracking of the progress made toward identified
priorities;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(D) be made available to the appropriate
committees of Congress upon request.'';</DELETED>
<DELETED> (2) by striking subsection (c) and inserting the
following:</DELETED>
<DELETED> ``(c) Functions.--The Assistant Secretary for Preparedness
and Response shall--</DELETED>
<DELETED> ``(1) have lead responsibility within the
Department of Health and Human Services for emergency
preparedness and response policy coordination and strategic
direction;</DELETED>
<DELETED> ``(2) have authority over and responsibility for--
</DELETED>
<DELETED> ``(A) the National Disaster Medical System
pursuant to section 2812;</DELETED>
<DELETED> ``(B) the Hospital Preparedness
Cooperative Agreement Program pursuant to section 319C-
2;</DELETED>
<DELETED> ``(C) the Biomedical Advanced Research and
Development Authority pursuant to section
319L;</DELETED>
<DELETED> ``(D) the Medical Reserve Corps pursuant
to section 2813;</DELETED>
<DELETED> ``(E) the Emergency System for Advance
Registration of Volunteer Health Professionals pursuant
to section 319I; and</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(3) exercise the responsibilities and
authorities of the Secretary with respect to the coordination
of--</DELETED>
<DELETED> ``(A) the Public Health Emergency
Preparedness Cooperative Agreement Program pursuant to
section 319C-1;</DELETED>
<DELETED> ``(B) the Strategic National Stockpile
pursuant to section 319F-2; and</DELETED>
<DELETED> ``(C) the Cities Readiness Initiative;
and</DELETED>
<DELETED> ``(4) assume other duties as determined
appropriate by the Secretary.''; and</DELETED>
<DELETED> (3) by adding at the end the following:</DELETED>
<DELETED> ``(d) Public Health Emergency Medical Countermeasures
Enterprise Strategy and Implementation Plan.--</DELETED>
<DELETED> ``(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'.</DELETED>
<DELETED> ``(2) Requirements.--The plan under paragraph (1)
shall--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(E) be informed by the recommendations
of the National Biodefense Science Board pursuant to
section 319M;</DELETED>
<DELETED> ``(F) evaluate progress made in meeting
timelines, allocations, benchmarks, and milestones
identified under subparagraph (D)(ii);</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(H) incorporate input from Federal,
State, local, and tribal stakeholders;</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(i) a list of such
countermeasures and products necessary to
address the needs of pediatric
populations;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(iv) an evaluation of the
progress made in addressing priorities
identified pursuant to subparagraph
(C);</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(K) be made publicly
available.</DELETED>
<DELETED> ``(3) GAO report.--</DELETED>
<DELETED> ``(A) In general.--Not later than 1 year
after the date of the submission to the Congress of the
first Public Health Emergency Medical Countermeasures
Enterprise Strategy and Implementation Plan, the
Comptroller General of the United States shall conduct
an independent evaluation, and submit to the
appropriate committees of Congress a report, concerning
such Strategy and Implementation Plan.</DELETED>
<DELETED> ``(B) Content.--The report described in
subparagraph (A) shall review and assess--</DELETED>
<DELETED> ``(i) the near-term, mid-term, and
long-term medical countermeasure needs and
identified priorities of the Federal Government
pursuant to paragraph (2)(C);</DELETED>
<DELETED> ``(ii) the activities of the
Department of Health and Human Services with
respect to advanced research and development
pursuant to section 319L; and</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (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--
</DELETED>
<DELETED> (1) the research, advanced research, development,
procurement, stockpiling, and distribution of countermeasures
to meet identified needs; and</DELETED>
<DELETED> (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.</DELETED>
<DELETED>SEC. 103. NATIONAL ADVISORY COMMITTEE ON CHILDREN AND
DISASTERS.</DELETED>
<DELETED> 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:</DELETED>
<DELETED>``SEC. 2811A. NATIONAL ADVISORY COMMITTEE ON CHILDREN AND
DISASTERS.</DELETED>
<DELETED> ``(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').</DELETED>
<DELETED> ``(b) Duties.--The Advisory Committee shall--</DELETED>
<DELETED> ``(1) provide advice and consultation with respect
to the activities carried out pursuant to section 2814, as
applicable and appropriate;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(d) Membership.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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--
</DELETED>
<DELETED> ``(A) the Assistant Secretary for
Preparedness and Response;</DELETED>
<DELETED> ``(B) the Director of the Biomedical
Advanced Research and Development Authority;</DELETED>
<DELETED> ``(C) the Director of the Centers for
Disease Control and Prevention;</DELETED>
<DELETED> ``(D) the Commissioner of Food and
Drugs;</DELETED>
<DELETED> ``(E) the Director of the National
Institutes of Health;</DELETED>
<DELETED> ``(F) the Assistant Secretary of the
Administration for Children and Families;</DELETED>
<DELETED> ``(G) the Administrator of the Federal
Emergency Management Agency;</DELETED>
<DELETED> ``(H) at least two non-Federal health care
professionals with expertise in pediatric medical
disaster planning, preparedness, response, or
recovery;</DELETED>
<DELETED> ``(I) at least two representatives from
State, local, territorial, or tribal agencies with
expertise in pediatric disaster planning, preparedness,
response, or recovery; and</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(e) Meetings.--The Advisory Committee shall meet not
less than biannually.</DELETED>
<DELETED> ``(f) Sunset.--The Advisory Committee shall terminate on
the date that is 5 years after the date of enactment of the Pandemic
and All-Hazards Preparedness Reauthorization Act of 2013.''.</DELETED>
<DELETED>SEC. 104. MODERNIZATION OF THE NATIONAL DISASTER MEDICAL
SYSTEM.</DELETED>
<DELETED> Section 2812 of the Public Health Service Act (42 U.S.C.
300hh-11) is amended--</DELETED>
<DELETED> (1) in subsection (a)(3)--</DELETED>
<DELETED> (A) in subparagraph (A), in clause (i) by
inserting ``, including at-risk individuals as
applicable'' after ``victims of a public health
emergency'';</DELETED>
<DELETED> (B) by redesignating subparagraph (C) as
subparagraph (E); and</DELETED>
<DELETED> (C) by inserting after subparagraph (B),
the following:</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (2) in subsection (g), by striking ``such sums as
may be necessary for each of the fiscal years 2007 through
2011'' and inserting ``$52,700,000 for each of fiscal years
2013 through 2017''.</DELETED>
<DELETED>SEC. 105. CONTINUING THE ROLE OF THE DEPARTMENT OF VETERANS
AFFAIRS.</DELETED>
<DELETED> Section 8117(g) of title 38, United States Code, is
amended by striking ``such sums as may be necessary to carry out this
section for each of fiscal years 2007 through 2011'' and inserting
``$155,300,000 for each of fiscal years 2013 through 2017 to carry out
this section''.</DELETED>
<DELETED>TITLE II--OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS
AND RESPONSE</DELETED>
<DELETED>SEC. 201. TEMPORARY REDEPLOYMENT OF FEDERALLY FUNDED PERSONNEL
DURING A PUBLIC HEALTH EMERGENCY.</DELETED>
<DELETED> Section 319 of the Public Health Service Act (42 U.S.C.
247d) is amended by adding at the end the following:</DELETED>
<DELETED> ``(e) Temporary Redeployment of Federally Funded Personnel
During a Public Health Emergency.--</DELETED>
<DELETED> ``(1) Emergency redeployment of federally funded
personnel.--Notwithstanding any other provision of law, and
subject to paragraph (2), upon request by the Governor of a
State or the chief of a tribe or such Governor or chief's
designee, the Secretary may authorize the requesting State or
tribe to temporarily redeploy, for purposes of immediately
addressing a public health emergency in the State or tribe,
non-Federal personnel funded in whole or in part through, as
appropriate, programs under this Act.</DELETED>
<DELETED> ``(2) Activation of emergency redeployment.--
</DELETED>
<DELETED> ``(A) Public health emergency.--The
Secretary may authorize a temporary redeployment of
personnel under paragraph (1) only during the period of
a public health emergency determined pursuant to
subsection (a).</DELETED>
<DELETED> ``(B) Contents of request.--To seek
authority for a temporary redeployment of personnel
under paragraph (1), the Governor of a State or the
chief of a tribe shall submit to the Secretary a
request for such authority and shall include in the
request each of the following:</DELETED>
<DELETED> ``(i) An assurance that the public
health emergency in the geographic area of the
requesting State or tribe cannot be adequately
and appropriately addressed by the public
health workforce otherwise available.</DELETED>
<DELETED> ``(ii) An assurance that the
public health emergency would be addressed more
efficiently and effectively through the
requested temporary redeployment of
personnel.</DELETED>
<DELETED> ``(iii) An assurance that the
requested temporary redeployment of personnel
is consistent with any applicable All-Hazards
Public Health Emergency Preparedness and
Response Plan under section 319C-1.</DELETED>
<DELETED> ``(iv) An identification of--
</DELETED>
<DELETED> ``(I) each Federal program
from which personnel would be
temporarily redeployed pursuant to the
requested authority; and</DELETED>
<DELETED> ``(II) the number of
personnel who would be so redeployed
from each such program.</DELETED>
<DELETED> ``(v) Such other information and
assurances as the Secretary may
require.</DELETED>
<DELETED> ``(C) Consideration.--In reviewing a
request for temporary redeployment under paragraph (1)
of personnel funded through a Federal program, the
Secretary shall consider the degree to which the
program would be adversely affected by the
redeployment.</DELETED>
<DELETED> ``(D) Termination and extension.--
</DELETED>
<DELETED> ``(i) Termination.--A State or
tribe's authority for a temporary redeployment
of personnel under paragraph (1) shall
terminate upon the earlier of the
following:</DELETED>
<DELETED> ``(I) The Secretary's
determination that the public health
emergency no longer exists.</DELETED>
<DELETED> ``(II) Subject to clause
(ii), the expiration of the 30-day
period following the date on which the
Secretary approved the State or tribe's
request for such authority.</DELETED>
<DELETED> ``(ii) Extension authority.--The
Secretary may extend the authority to authorize
a temporary redeployment 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--</DELETED>
<DELETED> ``(I) the State or tribe
that submitted the initial request for
authority for a temporary redeployment
of personnel submits a request for an
extension of such authority;
and</DELETED>
<DELETED> ``(II) the request for an
extension contains the same type of
information and assurances necessary
for the approval of an initial request
for such authority.</DELETED>
<DELETED> ``(3) Notice to personnel of possibility of
redeployment.--The Secretary shall ensure that, if a State or
tribe receives Federal funds for personnel who are subject to
the Secretary's redeployment authority under this subsection,
the State or tribe gives notice to such personnel of the
possibility of redeployment--</DELETED>
<DELETED> ``(A) at the time of hiring; or</DELETED>
<DELETED> ``(B) in the case of personnel hired
before the date of the enactment of this subsection, as
soon as practicable.</DELETED>
<DELETED> ``(4) Notice to congress.--The Secretary shall
give notice to the Congress in conjunction with the approval
under this subsection of--</DELETED>
<DELETED> ``(A) any initial request for authority
for a temporary redeployment of personnel;
and</DELETED>
<DELETED> ``(B) any request for an extension of such
authority.</DELETED>
<DELETED> ``(5) Guidance.--The Secretary shall--</DELETED>
<DELETED> ``(A) not later than 6 months after the
enactment of this subsection, issue proposed guidance
on the temporary redeployment of personnel under this
subsection; and</DELETED>
<DELETED> ``(B) after providing notice and a 60-day
period for public comment, finalize such
guidance.</DELETED>
<DELETED> ``(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 the Secretary's authority under this
subsection, including--</DELETED>
<DELETED> ``(A) a description of how, and under what
circumstances, such authority has been used by States
and tribes;</DELETED>
<DELETED> ``(B) an analysis of how such authority
has assisted States and tribes in responding to public
health emergencies;</DELETED>
<DELETED> ``(C) an evaluation of how such authority
has improved operational efficiencies in responding to
public health emergencies;</DELETED>
<DELETED> ``(D) an analysis of the extent to which,
if any, Federal programs from which personnel have been
temporarily redeployed pursuant to such authority have
been adversely affected by the redeployment;
and</DELETED>
<DELETED> ``(E) recommendations on how such
authority could be improved to further assist in
responding to public health emergencies.</DELETED>
<DELETED> ``(7) Definition.--In this subsection, the term
`State' includes, in addition to the entities listed in the
definition of such term in section 2, the Freely Associated
States.</DELETED>
<DELETED> ``(8) Sunset.--The authority under this subsection
shall terminate on the date that is 5 years after the date of
enactment of the Pandemic and All-Hazards Preparedness
Reauthorization Act of 2013.''.</DELETED>
<DELETED>SEC. 202. IMPROVING STATE AND LOCAL PUBLIC HEALTH
SECURITY.</DELETED>
<DELETED> (a) Cooperative Agreements.--Section 319C-1 of the Public
Health Service Act (42 U.S.C. 247d-3a) is amended--</DELETED>
<DELETED> (1) in subsection (b)(1)(C), by striking
``consortium of entities described in subparagraph (A)'' and
inserting ``consortium of States'';</DELETED>
<DELETED> (2) in subsection (b)(2)--</DELETED>
<DELETED> (A) in subparagraph (A)--</DELETED>
<DELETED> (i) by striking clauses (i) and
(ii) and inserting the following:</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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);'';</DELETED>
<DELETED> (ii) in clause (iv), by striking
``and'' at the end; and</DELETED>
<DELETED> (iii) by adding at the end the
following:</DELETED>
<DELETED> ``(vi) a description of how, as
appropriate, the entity may partner with
relevant public and private stakeholders in
public health emergency preparedness and
response;</DELETED>
<DELETED> ``(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);</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (B) in subparagraph (C), by inserting ``,
including addressing the needs of at-risk
individuals,'' after ``capabilities of such
entity'';</DELETED>
<DELETED> (3) in subsection (f)--</DELETED>
<DELETED> (A) in paragraph (2), by adding ``and'' at
the end;</DELETED>
<DELETED> (B) in paragraph (3), by striking ``;
and'' and inserting a period; and</DELETED>
<DELETED> (C) by striking paragraph (4);</DELETED>
<DELETED> (4) in subsection (g)--</DELETED>
<DELETED> (A) in paragraph (1), by striking
subparagraph (A) and inserting the following:</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (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).'';</DELETED>
<DELETED> (5) by striking subsection (h);</DELETED>
<DELETED> (6) in subsection (i)--</DELETED>
<DELETED> (A) in paragraph (1)--</DELETED>
<DELETED> (i) in subparagraph (A)--
</DELETED>
<DELETED> (I) by striking
``$824,000,000 for fiscal year 2007, of
which $35,000,000 shall be used to
carry out subsection (h),'' and
inserting ``$641,900,000 for fiscal
year 2013''; and</DELETED>
<DELETED> (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 2014 through
2017'';</DELETED>
<DELETED> (ii) by striking subparagraph
(B);</DELETED>
<DELETED> (iii) by redesignating
subparagraphs (C) and (D) as subparagraphs (B)
and (C), respectively; and</DELETED>
<DELETED> (iv) in subparagraph (C), as so
redesignated, by striking ``subparagraph (C)''
and inserting ``subparagraph (B)'';</DELETED>
<DELETED> (B) in subparagraphs (C) and (D) of
paragraph (3), by striking ``(1)(A)(i)(I)'' each place
it appears and inserting ``(1)(A)'';</DELETED>
<DELETED> (C) in paragraph (4)(B), by striking
``subsection (c)'' and inserting ``subsection (b)'';
and</DELETED>
<DELETED> (D) by adding at the end the
following:</DELETED>
<DELETED> ``(7) Availability of cooperative agreement
funds.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (7) in subsection (j), by striking paragraph
(3).</DELETED>
<DELETED> (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 2013 through
2017''.</DELETED>
<DELETED>SEC. 203. HOSPITAL PREPAREDNESS AND MEDICAL SURGE
CAPACITY.</DELETED>
<DELETED> (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''.</DELETED>
<DELETED> (b) Encouraging Health Professional Volunteers.--
</DELETED>
<DELETED> (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 2013
through 2017''.</DELETED>
<DELETED> (2) Volunteers.--Section 2813 of the Public Health
Service Act (42 U.S.C. 300hh-15) is amended--</DELETED>
<DELETED> (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</DELETED>
<DELETED> (B) in subsection (i), by striking
``$22,000,000 for fiscal year 2007, and such sums as
may be necessary for each of fiscal years 2008 through
2011'' and inserting ``$11,200,000 for each of fiscal
years 2013 through 2017''.</DELETED>
<DELETED> (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--</DELETED>
<DELETED> (1) in subsection (a), by inserting ``, including
capacity and preparedness to address the needs of pediatric and
other at-risk populations'' before the period at the
end;</DELETED>
<DELETED> (2) in subsection (b)(1)(A)(ii), by striking
``centers, primary'' and inserting ``centers, community health
centers, primary'';</DELETED>
<DELETED> (3) by striking subsection (c) and inserting the
following:</DELETED>
<DELETED> ``(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.'';</DELETED>
<DELETED> (4) by striking subsection (g) and inserting the
following:</DELETED>
<DELETED> ``(g) Coordination.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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).'';</DELETED>
<DELETED> (5) in subsection (i)--</DELETED>
<DELETED> (A) by striking ``The requirements of''
and inserting the following:</DELETED>
<DELETED> ``(1) In general.--The requirements of'';
and</DELETED>
<DELETED> (B) by adding at the end the
following:</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (6) in subsection (j)--</DELETED>
<DELETED> (A) by amending paragraph (1) to read as
follows:</DELETED>
<DELETED> ``(1) In general.--For purposes of carrying out
this section, there is authorized to be appropriated
$374,700,000 for each of fiscal years 2013 through 2017.'';
and</DELETED>
<DELETED> (B) by adding at the end the
following:</DELETED>
<DELETED> ``(4) Availability of cooperative agreement
funds.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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).''.</DELETED>
<DELETED>SEC. 204. ENHANCING SITUATIONAL AWARENESS AND
BIOSURVEILLANCE.</DELETED>
<DELETED> Section 319D of the Public Health Service Act (42 U.S.C.
247d-4) is amended--</DELETED>
<DELETED> (1) in subsection (b)--</DELETED>
<DELETED> (A) in paragraph (1)(B), by inserting
``poison control centers,'' after
``hospitals,'';</DELETED>
<DELETED> (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</DELETED>
<DELETED> (C) in paragraph (3), by inserting before
the period at the end the following: ``and update such
standards as necessary'';</DELETED>
<DELETED> (2) by striking subsection (c); and</DELETED>
<DELETED> (3) in subsection (d)--</DELETED>
<DELETED> (A) in the subsection heading, by striking
``Public Health Situational Awareness'' and inserting
``Modernizing Public Health Situational Awareness and
Biosurveillance'';</DELETED>
<DELETED> (B) in paragraph (1)--</DELETED>
<DELETED> (i) by striking ``Pandemic and
All-Hazards Preparedness Act'' and inserting
``Pandemic and All-Hazards Preparedness
Reauthorization Act of 2013''; and</DELETED>
<DELETED> (ii) by inserting ``, novel
emerging threats,'' after ``disease
outbreaks'';</DELETED>
<DELETED> (C) by striking paragraph (2) and
inserting the following:</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(A) develop, implement, and evaluate the
network described in paragraph (1), utilizing the
elements described in paragraph (3);</DELETED>
<DELETED> ``(B) modernize and enhance
biosurveillance activities; and</DELETED>
<DELETED> ``(C) improve information sharing,
coordination, and communication among disparate
biosurveillance systems supported by the Department of
Health and Human Services.'';</DELETED>
<DELETED> (D) in paragraph (3)(D), by inserting
``community health centers, health centers'' after
``poison control,'';</DELETED>
<DELETED> (E) in paragraph (5), by striking
subparagraph (A) and inserting the following:</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (F) by adding at the end the
following:</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.'';</DELETED>
<DELETED> (4) in subsection (e)(5), by striking ``4 years
after the date of enactment of the Pandemic and All-Hazards
Preparedness Act'' and inserting ``3 years after the date of
enactment of the Pandemic and All-Hazards Preparedness
Reauthorization Act of 2013'';</DELETED>
<DELETED> (5) in subsection (g), by striking ``such sums as
may be necessary in each of fiscal years 2007 through 2011''
and inserting ``$138,300,000 for each of fiscal years 2013
through 2017''; and</DELETED>
<DELETED> (6) by adding at the end the following:</DELETED>
<DELETED> ``(h) Definition.--For purposes of this section the term
`biosurveillance' means the process of gathering near real-time
biological data that relates to human and zoonotic disease activity and
threats to human or animal health, in order to achieve early warning
and identification of such health threats, early detection and prompt
ongoing tracking of health events, and overall situational awareness of
disease activity.''.</DELETED>
<DELETED>SEC. 205. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD
REPORTS.</DELETED>
<DELETED> Section 5 of the Project Bioshield Act of 2004 (42 U.S.C.
247d-6c) is repealed.</DELETED>
<DELETED>TITLE III--ENHANCING MEDICAL COUNTERMEASURE REVIEW</DELETED>
<DELETED>SEC. 301. SPECIAL PROTOCOL ASSESSMENT.</DELETED>
<DELETED> 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--</DELETED>
<DELETED> ``(i)(I) of clinical trials intended to form the
primary basis of an effectiveness claim; or</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED>The sponsor or applicant''.</DELETED>
<DELETED>SEC. 302. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN
EMERGENCIES.</DELETED>
<DELETED> (a) In General.--Section 564 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bbb-3) is amended--</DELETED>
<DELETED> (1) in subsection (a)--</DELETED>
<DELETED> (A) in paragraph (1), by striking
``sections 505, 510(k), and 515 of this Act'' and
inserting ``any provision of this Act'';</DELETED>
<DELETED> (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</DELETED>
<DELETED> (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)'';</DELETED>
<DELETED> (2) in subsection (b)--</DELETED>
<DELETED> (A) in the subsection heading, by striking
``Emergency'' and inserting ``Emergency or Threat
Justifying Emergency Authorized Use'';</DELETED>
<DELETED> (B) in paragraph (1)--</DELETED>
<DELETED> (i) in the matter preceding
subparagraph (A), by striking ``may declare an
emergency'' and inserting ``may make a
declaration that the circumstances
exist'';</DELETED>
<DELETED> (ii) in subparagraph (A), by
striking ``specified'';</DELETED>
<DELETED> (iii) in subparagraph (B)--
</DELETED>
<DELETED> (I) by striking
``specified''; and</DELETED>
<DELETED> (II) by striking ``; or''
and inserting a semicolon;</DELETED>
<DELETED> (iv) by amending subparagraph (C)
to read as follows:</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (v) by adding at the end the
following:</DELETED>
<DELETED> ``(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.'';</DELETED>
<DELETED> (C) in paragraph (2)--</DELETED>
<DELETED> (i) in subparagraph (A), by
amending clause (ii) to read as
follows:</DELETED>
<DELETED> ``(ii) a change in the approval
status of the product such that the
circumstances described in subsection (a)(2)
have ceased to exist.'';</DELETED>
<DELETED> (ii) by striking subparagraph (B);
and</DELETED>
<DELETED> (iii) by redesignating
subparagraph (C) as subparagraph (B);</DELETED>
<DELETED> (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</DELETED>
<DELETED> (E) by adding at the end the
following:</DELETED>
<DELETED> ``(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.'';</DELETED>
<DELETED> (3) in subsection (c)--</DELETED>
<DELETED> (A) in the matter preceding paragraph
(1)--</DELETED>
<DELETED> (i) by inserting ``the Assistant
Secretary for Preparedness and Response,''
after ``consultation with'';</DELETED>
<DELETED> (ii) by striking ``Health and''
and inserting ``Health, and''; and</DELETED>
<DELETED> (iii) by striking ``circumstances
of the emergency involved'' and inserting
``applicable circumstances described in
subsection (b)(1)'';</DELETED>
<DELETED> (B) in paragraph (1), by striking
``specified'' and inserting ``referred to'';
and</DELETED>
<DELETED> (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'';</DELETED>
<DELETED> (4) in subsection (d)(3), by inserting ``, to the
extent practicable given the circumstances of the emergency,''
after ``including'';</DELETED>
<DELETED> (5) in subsection (e)--</DELETED>
<DELETED> (A) in paragraph (1)(A), by striking
``circumstances of the emergency'' and inserting
``applicable circumstances described in subsection
(b)(1)'';</DELETED>
<DELETED> (B) in paragraph (1)(B), by amending
clause (iii) to read as follows:</DELETED>
<DELETED> ``(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.'';</DELETED>
<DELETED> (C) in paragraph (2)--</DELETED>
<DELETED> (i) in subparagraph (A)--
</DELETED>
<DELETED> (I) by striking
``manufacturer of the product'' and
inserting ``person'';</DELETED>
<DELETED> (II) by striking
``circumstances of the emergency'' and
inserting ``applicable circumstances
described in subsection (b)(1)'';
and</DELETED>
<DELETED> (III) by inserting at the
end before the period ``or in paragraph
(1)(B)'';</DELETED>
<DELETED> (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</DELETED>
<DELETED> (iii) by amending subparagraph (C)
to read as follows:</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (D) by amending paragraph (3) to read as
follows:</DELETED>
<DELETED> ``(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)--</DELETED>
<DELETED> ``(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);</DELETED>
<DELETED> ``(B) requirements established under
section 503(b); and</DELETED>
<DELETED> ``(C) requirements established under
section 520(e).'';</DELETED>
<DELETED> (6) in subsection (g)--</DELETED>
<DELETED> (A) in the subsection heading, by
inserting ``Review and'' before
``Revocation'';</DELETED>
<DELETED> (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--</DELETED>
<DELETED> ``(A) an unapproved product for which an
authorization was issued under this section;
or</DELETED>
<DELETED> ``(B) an unapproved use of an approved
product for which an authorization was issued under
this section.''; and</DELETED>
<DELETED> (C) by amending paragraph (2) to read as
follows:</DELETED>
<DELETED> ``(2) Revision and revocation.--The Secretary may
revise or revoke an authorization under this section if--
</DELETED>
<DELETED> ``(A) the circumstances described under
subsection (b)(1) no longer exist;</DELETED>
<DELETED> ``(B) the criteria under subsection (c)
for issuance of such authorization are no longer met;
or</DELETED>
<DELETED> ``(C) other circumstances make such
revision or revocation appropriate to protect the
public health or safety.'';</DELETED>
<DELETED> (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.'';</DELETED>
<DELETED> (8) by adding at the end of subsection (j) the
following:</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (9) by adding at the end the following:</DELETED>
<DELETED> ``(m) Categorization of Laboratory Tests Associated With
Devices Subject to Authorization.--</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(A) such categorization would be
beneficial to protecting the public health;
and</DELETED>
<DELETED> ``(B) the known and potential benefits of
such categorization under the circumstances of the
authorization outweigh the known and potential risks of
the categorization.</DELETED>
<DELETED> ``(2) Conditions of determination.--The Secretary
may establish appropriate conditions on the performance of the
examination or procedure pursuant to such
determination.</DELETED>
<DELETED> ``(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).''.</DELETED>
<DELETED> (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:</DELETED>
<DELETED>``SEC. 564A. EMERGENCY USE OF MEDICAL PRODUCTS.</DELETED>
<DELETED> ``(a) Definitions.--In this section:</DELETED>
<DELETED> ``(1) Eligible product.--The term `eligible
product' means a product that--</DELETED>
<DELETED> ``(A) is approved or cleared under this
chapter or licensed under section 351 of the Public
Health Service Act;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(C) is intended for use during the
circumstances under which--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(2) Product.--The term `product' means a drug,
device, or biological product.</DELETED>
<DELETED> ``(b) Expiration Dating.--</DELETED>
<DELETED> ``(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--
</DELETED>
<DELETED> ``(A) the expiration date extension is
intended to support the United States ability to
protect--</DELETED>
<DELETED> ``(i) the public health;
or</DELETED>
<DELETED> ``(ii) military preparedness and
effectiveness; and</DELETED>
<DELETED> ``(B) the expiration date extension is
supported by an appropriate scientific evaluation that
is conducted or accepted by the Secretary.</DELETED>
<DELETED> ``(2) Requirements and conditions.--Any extension
of an expiration date under paragraph (1) shall, as part of the
extension, identify--</DELETED>
<DELETED> ``(A) each specific lot, batch, or other
unit of the product for which extended expiration is
authorized;</DELETED>
<DELETED> ``(B) the duration of the extension;
and</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(c) Current Good Manufacturing Practice.--</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(1) the product is dispensed during the
circumstances described in subsection (a)(1)(C); and</DELETED>
<DELETED> ``(2) such dispensing without an individual
prescription occurs--</DELETED>
<DELETED> ``(A) as permitted under the law of the
State in which the product is dispensed; or</DELETED>
<DELETED> ``(B) in accordance with an order issued
by the Secretary, for the purposes and duration of the
circumstances described in subsection
(a)(1)(C).</DELETED>
<DELETED> ``(e) Emergency Use Instructions.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(A) during an emergency response to an
actual emergency that is the basis for a determination
described in subsection (a)(1)(C)(i); or</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (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--</DELETED>
<DELETED> (1) in subsection (f), by striking paragraph (7);
and</DELETED>
<DELETED> (2) by adding at the end the following:</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (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:</DELETED>
<DELETED>``SEC. 564B. PRODUCTS HELD FOR EMERGENCY USE.</DELETED>
<DELETED> ``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--</DELETED>
<DELETED> ``(1) is intended to be held and not used;
and</DELETED>
<DELETED> ``(2) is held and not used, unless and until that
product--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(B) is authorized for investigational
use under section 505 or 520 of this Act or section 351
of the Public Health Service Act; or</DELETED>
<DELETED> ``(C) is authorized for use under section
564.''.</DELETED>
<DELETED>SEC. 303. DEFINITIONS.</DELETED>
<DELETED> 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:</DELETED>
<DELETED> ``(a) Definitions.--In this section--</DELETED>
<DELETED> ``(1) the term `countermeasure' means a qualified
countermeasure, a security countermeasure, and a qualified
pandemic or epidemic product;</DELETED>
<DELETED> ``(2) the term `qualified countermeasure' has the
meaning given such term in section 319F-1 of the Public Health
Service Act;</DELETED>
<DELETED> ``(3) the term `security countermeasure' has the
meaning given such term in section 319F-2 of such Act;
and</DELETED>
<DELETED> ``(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--
</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(B) is included under this paragraph
pursuant to a determination by the Secretary.</DELETED>
<DELETED> ``(b) General Duties.--The Secretary, in
consultation''.</DELETED>
<DELETED>SEC. 304. ENHANCING MEDICAL COUNTERMEASURE
ACTIVITIES.</DELETED>
<DELETED> Section 565 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bbb-4), as amended by section 303, is further amended--
</DELETED>
<DELETED> (1) in the section heading, by striking
``technical assistance'' and inserting ``countermeasure
development, review, and technical assistance'';</DELETED>
<DELETED> (2) in subsection (b), by striking the subsection
enumerator and all that follows through ``shall establish'' and
inserting the following:</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(3) promote countermeasure expertise within the
Food and Drug Administration by--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(B) training Food and Drug
Administration personnel regarding review of
countermeasures for approval, licensure, or
clearance;</DELETED>
<DELETED> ``(C) holding public meetings at least
twice annually to encourage the exchange of scientific
ideas; and</DELETED>
<DELETED> ``(D) establishing protocols to ensure
that countermeasure reviewers have sufficient training
or experience with countermeasures;</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(B) improve and advance the science
relating to the development of new tools, standards,
and approaches to assessing and evaluating
countermeasures--</DELETED>
<DELETED> ``(i) in order to inform the
process for countermeasure approval, clearance,
and licensure; and</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(5) establish''; and</DELETED>
<DELETED> (3) by adding at the end the following:</DELETED>
<DELETED> ``(c) Final Guidance on Development of Animal Models.--
</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(d) Development and Animal Modeling Procedures.--
</DELETED>
<DELETED> ``(1) Availability of animal model meetings.--To
facilitate the timely development of animal models and support
the development, stockpiling, licensure, approval, and
clearance of countermeasures, the Secretary shall, not later
than 180 days after the enactment of this subsection, establish
a procedure by which a sponsor or applicant that is developing
a countermeasure for which human efficacy studies are not
ethical or practicable, and that has an approved
investigational new drug application or investigational device
exemption, may request and receive--</DELETED>
<DELETED> ``(A) a meeting to discuss proposed animal
model development activities; and</DELETED>
<DELETED> ``(B) a meeting prior to initiating
pivotal animal studies.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(e) Review and Approval of Countermeasures.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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).''.</DELETED>
<DELETED>SEC. 305. REGULATORY MANAGEMENT PLANS.</DELETED>
<DELETED> 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:</DELETED>
<DELETED> ``(f) Regulatory Management Plan.--</DELETED>
<DELETED> ``(1) Definition.--In this subsection, the term
`eligible countermeasure' means--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(3) Submission of request and proposed plan by
sponsor or applicant.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(4) Plan.--The content of a regulatory
management plan agreed to by the Secretary and a sponsor or
applicant shall include--</DELETED>
<DELETED> ``(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);</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(C) an agreement on how the plan shall
be modified, if needed.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(A) feedback from the Secretary
regarding the data required to support the approval,
clearance, or licensure of the eligible countermeasure
involved;</DELETED>
<DELETED> ``(B) feedback from the Secretary
regarding the data necessary to inform any
authorization under section 564;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(D) feedback from the Secretary
regarding the data necessary to support the submission
of protocols for review under section
505(b)(5)(B);</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(6) Prioritization.--</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED>SEC. 306. REPORT.</DELETED>
<DELETED> 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:</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(1) with respect to the development of new
tools, standards, and approaches to assess and evaluate
countermeasures--</DELETED>
<DELETED> ``(A) the identification of the priorities
of the Food and Drug Administration and the progress
made on such priorities; and</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(A) whether the regulatory management
plan was completed within the required timeframe, and
the length of time taken to complete such
plan;</DELETED>
<DELETED> ``(B) whether the Secretary adhered to the
timely and appropriate response times set forth in such
plan; and</DELETED>
<DELETED> ``(C) explanations for any failure to meet
such performance targets and goals;</DELETED>
<DELETED> ``(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);</DELETED>
<DELETED> ``(4) an estimate of resources obligated to
countermeasure development and regulatory assessment,
including--</DELETED>
<DELETED> ``(A) Center-specific objectives and
accomplishments; and</DELETED>
<DELETED> ``(B) the number of full-time equivalent
employees of the Food and Drug Administration who
directly support the review of
countermeasures;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(7) the number, type, and frequency of meetings
between the Food and Drug Administration and--</DELETED>
<DELETED> ``(A) sponsors of a countermeasure as
defined in subsection (a); or</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED>SEC. 307. PEDIATRIC MEDICAL COUNTERMEASURES.</DELETED>
<DELETED> (a) Pediatric Studies of Drugs.--Section 505A of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended--
</DELETED>
<DELETED> (1) in subsection (d), by adding at the end the
following:</DELETED>
<DELETED> ``(5) Consultation.--With respect to a drug that
is a qualified countermeasure (as defined in section 319F-1 of
the Public Health Service Act), a security countermeasure (as
defined in section 319F-2 of the Public Health Service Act), or
a qualified pandemic or epidemic product (as defined in section
319F-3 of the Public Health Service Act), the Secretary shall
solicit input from the Assistant Secretary for Preparedness and
Response regarding the need for and, from the Director of the
Biomedical Advanced Research and Development Authority
regarding the conduct of, pediatric studies under this
section.''; and</DELETED>
<DELETED> (2) in subsection (n)(1), by adding at the end the
following:</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (b) Addition to Priority List Considerations.--Section
409I of the Public Health Service Act (42 U.S.C. 284m) is amended--
</DELETED>
<DELETED> (1) by striking subsection (a)(2) and inserting
the following:</DELETED>
<DELETED> ``(2) Consideration of available information.--In
developing and prioritizing the list under paragraph (1), the
Secretary--</DELETED>
<DELETED> ``(A) shall consider--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(iii) the adequacy of necessary
infrastructure to conduct pediatric
pharmacological research, including research
networks and trained pediatric investigators;
and</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (2) in subsection (b), by striking ``subsection
(a)'' and inserting ``paragraphs (1) and (2)(A) of subsection
(a)''.</DELETED>
<DELETED> (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--</DELETED>
<DELETED> (1) in subparagraph (C), by striking the period
and inserting ``; and''; and</DELETED>
<DELETED> (2) by adding at the end the following:</DELETED>
<DELETED> ``(D) the development of countermeasures
(as defined in section 565(a) of the Federal Food,
Drug, and Cosmetic Act) for pediatric
populations.''.</DELETED>
<DELETED>TITLE IV--ACCELERATING MEDICAL COUNTERMEASURE ADVANCED
RESEARCH AND DEVELOPMENT</DELETED>
<DELETED>SEC. 401. BIOSHIELD.</DELETED>
<DELETED> (a) Procurement of Countermeasures.--Section 319F-2(c) of
the Public Health Service Act (42 U.S.C. 247d-6b(c)) is amended--
</DELETED>
<DELETED> (1) in paragraph (1)(B)(i)(III)(bb), by striking
``eight years'' and inserting ``10 years'';</DELETED>
<DELETED> (2) in paragraph (2)(C), by striking ``the
designated congressional committees (as defined in paragraph
(10))'' and inserting ``the appropriate committees of
Congress'';</DELETED>
<DELETED> (3) in paragraph (5)(B)(ii), by striking ``eight
years'' and inserting ``10 years'';</DELETED>
<DELETED> (4) in subparagraph (C) of paragraph (6)--
</DELETED>
<DELETED> (A) in the subparagraph heading, by
striking ``designated congressional committees'' and
inserting ``appropriate congressional committees'';
and</DELETED>
<DELETED> (B) by striking ``the designated
congressional committees'' and inserting ``the
appropriate congressional committees''; and</DELETED>
<DELETED> (5) in paragraph (7)(C)--</DELETED>
<DELETED> (A) in clause (i)(I), by inserting
``including advanced research and development,'' after
``as may reasonably be required,'';</DELETED>
<DELETED> (B) in clause (ii)--</DELETED>
<DELETED> (i) in subclause (III), by
striking ``eight years'' and inserting ``10
years''; and</DELETED>
<DELETED> (ii) by striking subclause (IX)
and inserting the following:</DELETED>
<DELETED> ``(IX) Contract terms.--
The Secretary, in any contract for
procurement under this section--
</DELETED>
<DELETED> ``(aa) may
specify--</DELETED>
<DELETED> ``(AA) the
dosing and
administration
requirements for the
countermeasure to be
developed and
procured;</DELETED>
<DELETED> ``(BB) the
amount of funding that
will be dedicated by
the Secretary for
advanced research,
development, and
procurement of the
countermeasure;
and</DELETED>
<DELETED> ``(CC) the
specifications the
countermeasure must
meet to qualify for
procurement under a
contract under this
section; and</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (C) by adding at the end the
following:</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (b) Reauthorization of the Special Reserve Fund.--Section
319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) is
amended--</DELETED>
<DELETED> (1) in subsection (c)--</DELETED>
<DELETED> (A) by striking ``special reserve fund
under paragraph (10)'' each place it appears and
inserting ``special reserve fund as defined in
subsection (h)''; and</DELETED>
<DELETED> (B) by striking paragraphs (9) and (10);
and</DELETED>
<DELETED> (2) by adding at the end the following:</DELETED>
<DELETED> ``(g) Special Reserve Fund.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(A) in meeting the security
countermeasure needs identified under this section;
and</DELETED>
<DELETED> ``(B) on the annual Public Health
Emergency Medical Countermeasures Enterprise and
Strategy Implementation Plan (pursuant to section
2811(d)).</DELETED>
<DELETED> ``(h) Definitions.--In this section:</DELETED>
<DELETED> ``(1) The term `advanced research and development'
has the meaning given such term in section 319L(a).</DELETED>
<DELETED> ``(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).''.</DELETED>
<DELETED>SEC. 402. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT
AUTHORITY.</DELETED>
<DELETED> (a) Duties.--Section 319L(c)(4) of the Public Health
Service Act (42 U.S.C. 247d-7e(c)(4)) is amended--</DELETED>
<DELETED> (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</DELETED>
<DELETED> (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''.</DELETED>
<DELETED> (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:</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (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:</DELETED>
<DELETED> ``(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 2013 through 2017, such
amounts to remain available until expended.''.</DELETED>
<DELETED> (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 ``11
years''.</DELETED>
<DELETED> (e) Extension of Limited Antitrust Exemption.--</DELETED>
<DELETED> (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 ``11-
year''.</DELETED>
<DELETED> (2) Effective date.--This subsection shall take
effect as if enacted on December 17, 2012.</DELETED>
<DELETED> (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:</DELETED>
<DELETED> ``(f) Independent Evaluation.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(2) Report.--Not later than 1 year after the
date of enactment of this subsection, the Comptroller General
of the United States shall submit to the appropriate committees
of Congress a report concerning the results of the evaluation
conducted under paragraph (1). Such report shall review and
assess--</DELETED>
<DELETED> ``(A) the extent to which flexible
manufacturing capacity under this section is dedicated
to chemical, biological, radiological, and nuclear
threats;</DELETED>
<DELETED> ``(B) the activities supported by flexible
manufacturing initiatives; and</DELETED>
<DELETED> ``(C) the ability of flexible
manufacturing activities carried out under this section
to--</DELETED>
<DELETED> ``(i) secure and leverage leading
technical expertise with respect to
countermeasure advanced research, development,
and manufacturing processes; and</DELETED>
<DELETED> ``(ii) meet the surge
manufacturing capacity needs presented by novel
and emerging threats, including chemical,
biological, radiological, and nuclear
agents.''.</DELETED>
<DELETED> (g) Definitions.--</DELETED>
<DELETED> (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--</DELETED>
<DELETED> (A) in the matter preceding clause (i), by
striking ``to--'' and inserting ``--'';</DELETED>
<DELETED> (B) in clause (i)--</DELETED>
<DELETED> (i) by striking ``diagnose'' and
inserting ``to diagnose''; and</DELETED>
<DELETED> (ii) by striking ``; or'' and
inserting a semicolon;</DELETED>
<DELETED> (C) in clause (ii)--</DELETED>
<DELETED> (i) by striking ``diagnose'' and
inserting ``to diagnose''; and</DELETED>
<DELETED> (ii) by striking the period at the
end and inserting ``; or''; and</DELETED>
<DELETED> (D) by adding at the end the
following:</DELETED>
<DELETED> ``(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).''.</DELETED>
<DELETED> (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--</DELETED>
<DELETED> (A) in clause (i)(II), by striking ``;
or'' and inserting ``;'';</DELETED>
<DELETED> (B) in clause (ii), by striking ``; and''
and inserting ``; or''; and</DELETED>
<DELETED> (C) by adding at the end the
following:</DELETED>
<DELETED> ``(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''.</DELETED>
<DELETED> (3) Technical amendments.--Section 319F-3(i) of
the Public Health Service Act (42 U.S.C. 247d-6d(i)) is
amended--</DELETED>
<DELETED> (A) in paragraph (1)(C), by inserting ``,
564A, or 564B'' after ``564''; and</DELETED>
<DELETED> (B) in paragraph (7)(B)(iii), by inserting
``, 564A, or 564B'' after ``564''.</DELETED>
<DELETED>SEC. 403. STRATEGIC NATIONAL STOCKPILE.</DELETED>
<DELETED> Section 319F-2 of the Public Health Service Act (42 U.S.C.
247d-6b) is amended--</DELETED>
<DELETED> (1) in subsection (a)--</DELETED>
<DELETED> (A) in paragraph (1)--</DELETED>
<DELETED> (i) by inserting ``consistent with
section 2811'' before ``by the Secretary to be
appropriate''; and</DELETED>
<DELETED> (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</DELETED>
<DELETED> (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</DELETED>
<DELETED> (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 2013 through 2017. Such
authorization is in addition to amounts in the special reserve
fund referred to in subsection (h).''.</DELETED>
<DELETED>SEC. 404. NATIONAL BIODEFENSE SCIENCE BOARD.</DELETED>
<DELETED> Section 319M(a) of the Public Health Service Act (42
U.S.C. 247d-f(a)) is amended--</DELETED>
<DELETED> (1) in paragraph (2)--</DELETED>
<DELETED> (A) in subparagraph (D)--</DELETED>
<DELETED> (i) in clause (i), by striking
``and'' at the end;</DELETED>
<DELETED> (ii) in clause (ii), by striking
the period and inserting a semicolon;
and</DELETED>
<DELETED> (iii) by adding at the end the
following:</DELETED>
<DELETED> ``(iii) one such member shall be
an individual with pediatric subject matter
expertise; and</DELETED>
<DELETED> ``(iv) one such member shall be a
State, tribal, territorial, or local public
health official.''; and</DELETED>
<DELETED> (B) by adding at the end the following
flush sentence:</DELETED>
<DELETED>``Nothing in this paragraph shall preclude a member of
the Board from satisfying two or more of the requirements
described in subparagraph (D).''; and</DELETED>
<DELETED> (2) in paragraph (5)--</DELETED>
<DELETED> (A) in subparagraph (B), by striking
``and'' at the end;</DELETED>
<DELETED> (B) in subparagraph (C), by striking the
period and inserting ``; and''; and</DELETED>
<DELETED> (C) by adding at the end the
following:</DELETED>
<DELETED> ``(D) provide any recommendation, finding,
or report provided to the Secretary under this
paragraph to the appropriate committees of
Congress.''.</DELETED>
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--
(1) in subsection (b)--
(A) in paragraph (3), by inserting ``, security
countermeasures (as defined in section 319F-2),'' after
``qualified countermeasures (as defined in section
319F-1)'';
(B) in paragraph (4), by adding at the end the
following:
``(D) Policy coordination and strategic
direction.--Provide integrated policy coordination and
strategic direction with respect to all matters related
to Federal public health and medical preparedness and
execution and deployment of the Federal response for
public health emergencies and incidents covered by the
National Response Plan developed pursuant to section
504(6) of the Homeland Security Act of 2002, or any
successor plan, before, during, and following public
health emergencies.
``(E) Identification of inefficiencies.--Identify
and minimize gaps, duplication, and other
inefficiencies in medical and public health
preparedness and response activities and the actions
necessary to overcome these obstacles.
``(F) Coordination of grants and agreements.--Align
and coordinate medical and public health grants and
cooperative agreements as applicable to preparedness
and response activities authorized under this Act, to
the extent possible, including program requirements,
timelines, and measurable goals, and in consultation
with the Secretary of Homeland Security, to--
``(i) optimize and streamline medical and
public health preparedness and response
capabilities and the ability of local
communities to respond to public health
emergencies; and
``(ii) gather and disseminate best
practices among grant and cooperative agreement
recipients, as appropriate.
``(G) Drill and operational exercises.--Carry out
drills and operational exercises, in consultation with
the Department of Homeland Security, the Department of
Defense, the Department of Veterans Affairs, and other
applicable Federal departments and agencies, as
necessary and appropriate, to identify, inform, and
address gaps in and policies related to all-hazards
medical and public health preparedness and response,
including exercises based on--
``(i) identified threats for which
countermeasures are available and for which no
countermeasures are available; and
``(ii) unknown threats for which no
countermeasures are available.
``(H) National security priority.--On a periodic
basis consult with, as applicable and appropriate, the
Assistant to the President for National Security
Affairs, to provide an update on, and discuss, medical
and public health preparedness and response activities
pursuant to this Act and the Federal Food, Drug, and
Cosmetic Act, including progress on the development,
approval, clearance, and licensure of medical
countermeasures.''; and
(C) by adding at the end the following:
``(7) Countermeasures budget plan.--Develop, and update on
an annual basis, a coordinated 5-year budget plan based on the
medical countermeasure priorities described in subsection (d).
Each such plan shall--
``(A) include consideration of the entire medical
countermeasures enterprise, including--
``(i) basic research and advanced research
and development;
``(ii) approval, clearance, licensure, and
authorized uses of products; and
``(iii) procurement, stockpiling,
maintenance, and replenishment of all products
in the Strategic National Stockpile;
``(B) inform prioritization of resources and
include measurable outputs and outcomes to allow for
the tracking of the progress made toward identified
priorities;
``(C) identify medical countermeasure life-cycle
costs to inform planning, budgeting, and anticipated
needs within the continuum of the medical
countermeasure enterprise consistent with section 319F-
2; and
``(D) be made available to the appropriate
committees of Congress upon request.'';
(2) by striking subsection (c) and inserting the following:
``(c) Functions.--The Assistant Secretary for Preparedness and
Response shall--
``(1) have lead responsibility within the Department of
Health and Human Services for emergency preparedness and
response policy coordination and strategic direction;
``(2) have authority over and responsibility for--
``(A) the National Disaster Medical System pursuant
to section 2812;
``(B) the Hospital Preparedness Cooperative
Agreement Program pursuant to section 319C-2;
``(C) the Biomedical Advanced Research and
Development Authority pursuant to section 319L;
``(D) the Medical Reserve Corps pursuant to section
2813;
``(E) the Emergency System for Advance Registration
of Volunteer Health Professionals pursuant to section
319I; and
``(F) administering grants and related authorities
related to trauma care under parts A through C of title
XII, such authority to be transferred by the Secretary
from the Administrator of the Health Resources and
Services Administration to such Assistant Secretary;
``(3) exercise the responsibilities and authorities of the
Secretary with respect to the coordination of--
``(A) the Public Health Emergency Preparedness
Cooperative Agreement Program pursuant to section 319C-
1;
``(B) the Strategic National Stockpile pursuant to
section 319F-2; and
``(C) the Cities Readiness Initiative; and
``(4) assume other duties as determined appropriate by the
Secretary.''; and
(3) by adding at the end the following:
``(d) Public Health Emergency Medical Countermeasures Enterprise
Strategy and Implementation Plan.--
``(1) In general.--Not later than 180 days after the date
of enactment of this subsection, and every year thereafter, the
Assistant Secretary for Preparedness and Response shall develop
and submit to the appropriate committees of Congress a
coordinated strategy and accompanying implementation plan for
medical countermeasures to address chemical, biological,
radiological, and nuclear threats. In developing such a plan,
the Assistant Secretary for Preparedness and Response shall
consult with the Director of the Biomedical Advanced Research
and Development Authority, the Director of the National
Institutes of Health, the Director of the Centers for Disease
Control and Prevention, and the Commissioner of Food and Drugs.
Such strategy and plan shall be known as the `Public Health
Emergency Medical Countermeasures Enterprise Strategy and
Implementation Plan'.
``(2) Requirements.--The plan under paragraph (1) shall--
``(A) describe the chemical, biological,
radiological, and nuclear agent or agents that may
present a threat to the Nation and the corresponding
efforts to develop qualified countermeasures (as
defined in section 319F-1), security countermeasures
(as defined in section 319F-2), or qualified pandemic
or epidemic products (as defined in section 319F-3) for
each threat;
``(B) evaluate the progress of all activities with
respect to such countermeasures or products, including
research, advanced research, development, procurement,
stockpiling, deployment, distribution, and utilization;
``(C) identify and prioritize near-, mid-, and
long-term needs with respect to such countermeasures or
products to address a chemical, biological,
radiological, and nuclear threat or threats;
``(D) identify, with respect to each category of
threat, a summary of all awards and contracts,
including advanced research and development and
procurement, that includes--
``(i) the time elapsed from the issuance of
the initial solicitation or request for a
proposal to the adjudication (such as the
award, denial of award, or solicitation
termination); and
``(ii) an identification of projected
timelines, anticipated funding allocations,
benchmarks, and milestones for each medical
countermeasure priority under subparagraph (C),
including projected needs with regard to
replenishment of the Strategic National
Stockpile;
``(E) be informed by the recommendations of the
National Biodefense Science Board pursuant to section
319M;
``(F) evaluate progress made in meeting timelines,
allocations, benchmarks, and milestones identified
under subparagraph (D)(ii);
``(G) report on the amount of funds available for
procurement in the special reserve fund as defined in
section 319F-2(h) and the impact this funding will have
on meeting the requirements under section 319F-2;
``(H) incorporate input from Federal, State, local,
and tribal stakeholders;
``(I) identify the progress made in meeting the
medical countermeasure priorities for at-risk
individuals (as defined in 2802(b)(4)(B)), as
applicable under subparagraph (C), including with
regard to the projected needs for related stockpiling
and replenishment of the Strategic National Stockpile,
including by addressing the needs of pediatric
populations with respect to such countermeasures and
products in the Strategic National Stockpile,
including--
``(i) a list of such countermeasures and
products necessary to address the needs of
pediatric populations;
``(ii) a description of measures taken to
coordinate with the Office of Pediatric
Therapeutics of the Food and Drug
Administration to maximize the labeling,
dosages, and formulations of such
countermeasures and products for pediatric
populations;
``(iii) a description of existing gaps in
the Strategic National Stockpile and the
development of such countermeasures and
products to address the needs of pediatric
populations; and
``(iv) an evaluation of the progress made
in addressing priorities identified pursuant to
subparagraph (C);
``(J) identify the use of authority and activities
undertaken pursuant to sections 319F-1(b)(1), 319F-
1(b)(2), 319F-1(b)(3), 319F-1(c), 319F-1(d), 319F-1(e),
319F-2(c)(7)(C)(iii), 319F-2(c)(7)(C)(iv), and 319F-
2(c)(7)(C)(v) of this Act, and subsections (a)(1),
(b)(1), and (e) of section 564 of the Federal Food,
Drug, and Cosmetic Act, by summarizing--
``(i) the particular actions that were
taken under the authorities specified,
including, as applicable, the identification of
the threat agent, emergency, or the biomedical
countermeasure with respect to which the
authority was used;
``(ii) the reasons underlying the decision
to use such authorities, including, as
applicable, the options that were considered
and rejected with respect to the use of such
authorities;
``(iii) the number of, nature of, and other
information concerning the persons and entities
that received a grant, cooperative agreement,
or contract pursuant to the use of such
authorities, and the persons and entities that
were considered and rejected for such a grant,
cooperative agreement, or contract, except that
the report need not disclose the identity of
any such person or entity;
``(iv) whether, with respect to each
procurement that is approved by the President
under section 319F-2(c)(6), a contract was
entered into within one year after such
approval by the President; and
``(v) with respect to section 319F-1(d),
for the one-year period for which the report is
submitted, the number of persons who were paid
amounts totaling $100,000 or greater and the
number of persons who were paid amounts
totaling at least $50,000 but less than
$100,000; and
``(K) be made publicly available.
``(3) GAO report.--
``(A) In general.--Not later than 1 year after the
date of the submission to the Congress of the first
Public Health Emergency Medical Countermeasures
Enterprise Strategy and Implementation Plan, the
Comptroller General of the United States shall conduct
an independent evaluation, and submit to the
appropriate committees of Congress a report, concerning
such Strategy and Implementation Plan.
``(B) Content.--The report described in
subparagraph (A) shall review and assess--
``(i) the near-term, mid-term, and long-
term medical countermeasure needs and
identified priorities of the Federal Government
pursuant to paragraph (2)(C);
``(ii) the activities of the Department of
Health and Human Services with respect to
advanced research and development pursuant to
section 319L; and
``(iii) the progress made toward meeting
the timelines, allocations, benchmarks, and
milestones identified in the Public Health
Emergency Medical Countermeasures Enterprise
Strategy and Implementation Plan under this
subsection.
``(e) Protection of National Security.--In carrying out subsections
(b)(7) and (d), the Secretary shall ensure that information and items
that could compromise national security, contain confidential
commercial information, or contain proprietary information are not
disclosed.''.
(b) Interagency Coordination Plan.--In the first Public Health
Emergency Countermeasures Enterprise Strategy and Implementation Plan
submitted under subsection (d) of section 2811 of the Public Health
Service Act (42 U.S.C. 300hh-10) (as added by subsection (a)(3)), the
Secretary of Health and Human Services, in consultation with the
Secretary of Defense, shall include a description of the manner in
which the Department of Health and Human Services is coordinating with
the Department of Defense regarding countermeasure activities to
address chemical, biological, radiological, and nuclear threats. Such
report shall include information with respect to--
(1) the research, advanced research, development,
procurement, stockpiling, and distribution of countermeasures
to meet identified needs; and
(2) the coordination of efforts between the Department of
Health and Human Services and the Department of Defense to
address countermeasure needs for various segments of the
population.
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 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'';
(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:
``(C) a determination by the Secretary that there
is a public health emergency, or a significant
potential for a public health emergency, that affects,
or has a significant potential to affect, national
security or the health and security of United States
citizens living abroad, and that involves a biological,
chemical, radiological, or nuclear agent or agents, or
a disease or condition that may be attributable to such
agent or agents; or''; and
(v) by adding at the end the following:
``(D) the identification of a material threat
pursuant to section 319F-2 of the Public Health Service
Act sufficient to affect national security or the
health and security of United States citizens living
abroad.'';
(C) in paragraph (2)--
(i) in subparagraph (A), by amending clause
(ii) to read as follows:
``(ii) a change in the approval status of
the product such that the circumstances
described in subsection (a)(2) have ceased to
exist.'';
(ii) by striking subparagraph (B); and
(iii) by redesignating subparagraph (C) as
subparagraph (B);
(D) in paragraph (4), by striking ``advance notice
of termination, and renewal under this subsection.''
and inserting ``, and advance notice of termination
under this subsection.''; and
(E) by adding at the end the following:
``(5) Explanation by secretary.--If an authorization under
this section with respect to an unapproved product or an
unapproved use of an approved product has been in effect for
more than 1 year, the Secretary shall provide in writing to the
sponsor of such product an explanation of the scientific,
regulatory, or other obstacles to approval, licensure, or
clearance of such product or use, including specific actions to
be taken by the Secretary and the sponsor to overcome such
obstacles.'';
(3) in subsection (c)--
(A) in the matter preceding paragraph (1)--
(i) by inserting ``the Assistant Secretary
for Preparedness and Response,'' after
``consultation with'';
(ii) by striking ``Health and'' and
inserting ``Health, and''; and
(iii) by striking ``circumstances of the
emergency involved'' and inserting ``applicable
circumstances described in subsection (b)(1)'';
(B) in paragraph (1), by striking ``specified'' and
inserting ``referred to''; and
(C) in paragraph (2)(B), by inserting ``, taking
into consideration the material threat posed by the
agent or agents identified in a declaration under
subsection (b)(1)(D), if applicable'' after ``risks of
the product'';
(4) in subsection (d)(3), by inserting ``, to the extent
practicable given the circumstances of the emergency,'' after
``including'';
(5) in subsection (e)--
(A) in paragraph (1)(A), by striking
``circumstances of the emergency'' and inserting
``applicable circumstances described in subsection
(b)(1)'';
(B) in paragraph (1)(B), by amending clause (iii)
to read as follows:
``(iii) Appropriate conditions with respect
to collection and analysis of information
concerning the safety and effectiveness of the
product with respect to the use of such product
during the period when the authorization is in
effect and a reasonable time following such
period.'';
(C) in paragraph (2)--
(i) in subparagraph (A)--
(I) by striking ``manufacturer of
the product'' and inserting ``person'';
(II) by striking ``circumstances of
the emergency'' and inserting
``applicable circumstances described in
subsection (b)(1)''; and
(III) by inserting at the end
before the period ``or in paragraph
(1)(B)'';
(ii) in subparagraph (B)(i), by inserting
before the period at the end ``, except as
provided in section 564A with respect to
authorized changes to the product expiration
date''; and
(iii) by amending subparagraph (C) to read
as follows:
``(C) In establishing conditions under this
paragraph with respect to the distribution and
administration of the product for the unapproved use,
the Secretary shall not impose conditions that would
restrict distribution or administration of the product
when distributed or administered for the approved
use.''; and
(D) by amending paragraph (3) to read as follows:
``(3) Good manufacturing practice; prescription.--With
respect to the emergency use of a product for which an
authorization under this section is issued (whether an
unapproved product or an unapproved use of an approved
product), the Secretary may waive or limit, to the extent
appropriate given the applicable circumstances described in
subsection (b)(1)--
``(A) requirements regarding current good
manufacturing practice otherwise applicable to the
manufacture, processing, packing, or holding of
products subject to regulation under this Act,
including such requirements established under section
501 or 520(f)(1), and including relevant conditions
prescribed with respect to the product by an order
under section 520(f)(2);
``(B) requirements established under section
503(b); and
``(C) requirements established under section
520(e).'';
(6) in subsection (g)--
(A) in the subsection heading, by inserting
``Review and'' before ``Revocation'';
(B) in paragraph (1), by inserting after the period
at the end the following: ``As part of such review, the
Secretary shall regularly review the progress made with
respect to the approval, licensure, or clearance of--
``(A) an unapproved product for which an
authorization was issued under this section; or
``(B) an unapproved use of an approved product for
which an authorization was issued under this
section.''; and
(C) by amending paragraph (2) to read as follows:
``(2) Revision and revocation.--The Secretary may revise or
revoke an authorization under this section if--
``(A) the circumstances described under subsection
(b)(1) no longer exist;
``(B) the criteria under subsection (c) for
issuance of such authorization are no longer met; or
``(C) other circumstances make such revision or
revocation appropriate to protect the public health or
safety.'';
(7) in subsection (h)(1), by adding after the period at the
end the following: ``The Secretary shall make any revisions to
an authorization under this section available on the Internet
Web site of the Food and Drug Administration.'';
(8) by adding at the end of subsection (j) the following:
``(4) Nothing in this section shall be construed as
authorizing a delay in the review or other consideration by the
Secretary of any application or submission pending before the
Food and Drug Administration for a product for which an
authorization under this section is issued.''; and
(9) by adding at the end the following:
``(m) Categorization of Laboratory Tests Associated With Devices
Subject to Authorization.--
``(1) In general.--In issuing an authorization under this
section with respect to a device, the Secretary may, subject to
the provisions of this section, determine that a laboratory
examination or procedure associated with such device shall be
deemed, for purposes of section 353 of the Public Health
Service Act, to be in a particular category of examinations and
procedures (including the category described by subsection
(d)(3) of such section) if, based on the totality of scientific
evidence available to the Secretary--
``(A) such categorization would be beneficial to
protecting the public health; and
``(B) the known and potential benefits of such
categorization under the circumstances of the
authorization outweigh the known and potential risks of
the categorization.
``(2) Conditions of determination.--The Secretary may
establish appropriate conditions on the performance of the
examination or procedure pursuant to such determination.
``(3) Effective period.--A determination under this
subsection shall be effective for purposes of section 353 of
the Public Health Service Act notwithstanding any other
provision of that section during the effective period of the
relevant declaration under subsection (b).''.
(b) Emergency Use of Medical Products.--Subchapter E of chapter V
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.)
is amended by inserting after section 564 the following:
``SEC. 564A. EMERGENCY USE OF MEDICAL PRODUCTS.
``(a) Definitions.--In this section:
``(1) Eligible product.--The term `eligible product' means
a product that--
``(A) is approved or cleared under this chapter or
licensed under section 351 of the Public Health Service
Act;
``(B)(i) is intended for use to prevent, diagnose,
or treat a disease or condition involving a biological,
chemical, radiological, or nuclear agent or agents; or
``(ii) is intended for use to prevent, diagnose, or
treat a serious or life-threatening disease or
condition caused by a product described in clause (i);
and
``(C) is intended for use during the circumstances
under which--
``(i) a determination described in
subparagraph (A), (B), or (C) of section
564(b)(1) has been made by the Secretary of
Homeland Security, the Secretary of Defense, or
the Secretary, respectively; or
``(ii) the identification of a material
threat described in subparagraph (D) of section
564(b)(1) has been made pursuant to section
319F-2 of the Public Health Service Act.
``(2) Product.--The term `product' means a drug, device, or
biological product.
``(b) Expiration Dating.--
``(1) In general.--The Secretary may extend the expiration
date and authorize the introduction or delivery for
introduction into interstate commerce of an eligible product
after the expiration date provided by the manufacturer if--
``(A) the expiration date extension is intended to
support the United States ability to protect--
``(i) the public health; or
``(ii) military preparedness and
effectiveness; and
``(B) the expiration date extension is supported by
an appropriate scientific evaluation that is conducted
or accepted by the Secretary.
``(2) Requirements and conditions.--Any extension of an
expiration date under paragraph (1) shall, as part of the
extension, identify--
``(A) each specific lot, batch, or other unit of
the product for which extended expiration is
authorized;
``(B) the duration of the extension; and
``(C) any other requirements or conditions as the
Secretary may deem appropriate for the protection of
the public health, which may include requirements for,
or conditions on, product sampling, storage, packaging
or repackaging, transport, labeling, notice to product
recipients, recordkeeping, periodic testing or
retesting, or product disposition.
``(3) Effect.--Notwithstanding any other provision of this
Act or the Public Health Service Act, an eligible product shall
not be considered an unapproved product (as defined in section
564(a)(2)(A)) and shall not be deemed adulterated or misbranded
under this Act because, with respect to such product, the
Secretary has, under paragraph (1), extended the expiration
date and authorized the introduction or delivery for
introduction into interstate commerce of such product after the
expiration date provided by the manufacturer.
``(4) Expiration date.--For purposes of this subsection,
the term `expiration date' means the date established through
appropriate stability testing required by the regulations
issued by the Secretary to ensure that the product meets
applicable standards of identity, strength, quality, and purity
at the time of use.
``(c) Current Good Manufacturing Practice.--
``(1) In general.--The Secretary may, when the
circumstances of a domestic, military, or public health
emergency or material threat described in subsection (a)(1)(C)
so warrant, authorize, with respect to an eligible product,
deviations from current good manufacturing practice
requirements otherwise applicable to the manufacture,
processing, packing, or holding of products subject to
regulation under this Act, including requirements under section
501 or 520(f)(1) or applicable conditions prescribed with
respect to the eligible product by an order under section
520(f)(2).
``(2) Effect.--Notwithstanding any other provision of this
Act or the Public Health Service Act, an eligible product shall
not be considered an unapproved product (as defined in section
564(a)(2)(A)) and shall not be deemed adulterated or misbranded
under this Act because, with respect to such product, the
Secretary has authorized deviations from current good
manufacturing practices under paragraph (1).
``(d) Emergency Dispensing.--The requirements of sections 503(b)
and 520(e) shall not apply to an eligible product, and the product
shall not be considered an unapproved product (as defined in section
564(a)(2)(A)) and shall not be deemed adulterated or misbranded under
this Act because it is dispensed without an individual prescription,
if--
``(1) the product is dispensed during the circumstances
described in subsection (a)(1)(C); and
``(2) such dispensing without an individual prescription
occurs--
``(A) as permitted under the law of the State in
which the product is dispensed; or
``(B) in accordance with an order issued by the
Secretary, for the purposes and duration of the
circumstances described in subsection (a)(1)(C).
``(e) Emergency Use Instructions.--
``(1) In general.--The Secretary, acting through an
appropriate official within the Department of Health and Human
Services, may create and issue emergency use instructions to
inform health care providers or individuals to whom an eligible
product is to be administered concerning such product's
approved, licensed, or cleared conditions of use.
``(2) Effect.--Notwithstanding any other provisions of this
Act or the Public Health Service Act, a product shall not be
considered an unapproved product and shall not be deemed
adulterated or misbranded under this Act because of the
issuance of emergency use instructions under paragraph (1) with
respect to such product or the introduction or delivery for
introduction of such product into interstate commerce
accompanied by such instructions--
``(A) during an emergency response to an actual
emergency that is the basis for a determination
described in subsection (a)(1)(C)(i); or
``(B) by a government entity (including a Federal,
State, local, or tribal government entity), or a person
acting on behalf of such a government entity, in
preparation for an emergency response.''.
(c) Risk Evaluation and Mitigation Strategies.--Section 505-1 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1), is
amended--
(1) in subsection (f), by striking paragraph (7); and
(2) by adding at the end the following:
``(k) Waiver in Public Health Emergencies.--The Secretary may waive
any requirement of this section with respect to a qualified
countermeasure (as defined in section 319F-1(a)(2) of the Public Health
Service Act) to which a requirement under this section has been
applied, if the Secretary determines that such waiver is required to
mitigate the effects of, or reduce the severity of, the circumstances
under which--
``(1) a determination described in subparagraph (A), (B),
or (C) of section 564(b)(1) has been made by the Secretary of
Homeland Security, the Secretary of Defense, or the Secretary,
respectively; or
``(2) the identification of a material threat described in
subparagraph (D) of section 564(b)(1) has been made pursuant to
section 319F-2 of the Public Health Service Act.''.
(d) Products Held for Emergency Use.--The Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) is amended by inserting after
section 564A, as added by subsection (b), the following:
``SEC. 564B. PRODUCTS HELD FOR EMERGENCY USE.
``It is not a violation of any section of this Act or of the Public
Health Service Act for a government entity (including a Federal, State,
local, or tribal government entity), or a person acting on behalf of
such a government entity, to introduce into interstate commerce a
product (as defined in section 564(a)(4)) intended for emergency use,
if that product--
``(1) is intended to be held and not used; and
``(2) is held and not used, unless and until that product--
``(A) is approved, cleared, or licensed under
section 505, 510(k), or 515 of this Act or section 351
of the Public Health Service Act;
``(B) is authorized for investigational use under
section 505 or 520 of this Act or section 351 of the
Public Health Service Act; or
``(C) is authorized for use under section 564.''.
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 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 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
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.''.
Calendar No. 14
113th CONGRESS
1st Session
H. R. 307
_______________________________________________________________________
AN ACT
To reauthorize certain programs under the Public Health Service Act and
the Federal Food, Drug, and Cosmetic Act with respect to public health
security and all-hazards preparedness and response, and for other
purposes.
_______________________________________________________________________
February 14, 2013
Reported with an amendment