[Congressional Record Volume 158, Number 37 (Wednesday, March 7, 2012)]
[Senate]
[Pages S1476-S1493]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PANDEMIC AND ALL-HAZARDS PREPAREDNESS ACT REAUTHORIZATION OF 2011
Mr. REID. Mr. President, I ask unanimous consent that the Senate
proceed to the consideration of Calendar No. 263.
The PRESIDING OFFICER. Without objection, it is so ordered.
The clerk will state the bill by title.
The assistant legislative clerk read as follows:
A bill (S. 1855) to amend the Public Health Service Act to
reauthorize various programs under the Pandemic and All-
Hazards Preparedness Act.
There being no objection, the Senate proceeded to consider the bill,
which had been reported from the Committee on Health, Education, Labor,
and Pensions, with an amendment to strike all after the enacting clause
and insert in lieu thereof the following:
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Pandemic
and All-Hazards Preparedness Act Reauthorization of 2011''.
(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. Improving State and local public health security.
Sec. 202. Hospital preparedness and medical surge capacity.
Sec. 203. Enhancing situational awareness and biosurveillance.
TITLE III--ENHANCING MEDICAL COUNTERMEASURE REVIEW
Sec. 301. Special protocol assessment.
Sec. 302. Authorization of 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 (3)--
(i) in the matter preceding subparagraph (A)--
(I) by striking ``facilities), and trauma care'' and
inserting ``facilities and which may include dental health
facilities), and trauma care, critical care,''; and
[[Page S1477]]
(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 (D), by inserting ``(which may
include such dental health assets)'' after ``medical
assets'';
(iv) by adding at the end the following:
``(F) Optimizing a coordinated and flexible approach to the
medical surge capacity of hospitals, other healthcare
facilities, and trauma care (which may include trauma
centers) and emergency medical systems.'';
(B) 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
(C) 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) by redesignating paragraphs (1) through (4) as
paragraphs (2) through (5), respectively;
(3) 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;'';
(4) in paragraph (2) (as so redesignated), by striking
``National Preparedness goal'' and inserting ``preparedness
goals, as described in section 2802(b),''; and
(5) 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.
Section 2811 of the Public Health Service Act (42 U.S.C.
300hh 10) is amended--
(1) in subsection (b)(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 502(6) of the Homeland Security Act of 2002, or any
successor plan, before, during, and following public health
emergencies.'';
(2) by striking subsection (c) and inserting the following:
``(c) Functions.--The Assistant Secretary for Preparedness
and Response shall--
``(1) have authority over and responsibility for--
``(A) the National Disaster Medical System (in accordance
with section 301 of the Pandemic and All-Hazards Preparedness
Act);
``(B) the Hospital Preparedness Cooperative Agreement
Program pursuant to section 319C 2;
``(C) the Medical Reserve Corps pursuant to section 2813;
``(D) the Emergency System for Advance Registration of
Volunteer Health Professionals pursuant to section 319I; and
``(E) 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;
``(2) 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; and
``(C) the Cities Readiness Initiative;
``(3) 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 coordination with the Secretary of
Homeland Security, to--
``(A) optimize and streamline medical and public health
preparedness capabilities and the ability of local
communities to respond to public health emergencies;
``(B) minimize duplication of efforts with regard to
medical and public health preparedness and response programs;
and
``(C) gather and disseminate best practices among grant and
cooperative agreement recipients, as appropriate;
``(4) carry out drills and operational exercises, in
coordination 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, including exercises based on--
``(A) identified threats for which countermeasures are
available and for which no countermeasures are available; and
``(B) unknown threats for which no countermeasures are
available; and
``(5) assume other duties as determined appropriate by the
Secretary.''; and
(3) by adding at the end the following:
``(d) National Security Priority.--The Secretary, acting
through the Assistant Secretary for Preparedness and
Response, shall on a periodic basis conduct meetings, as
applicable and appropriate, with 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.
``(e) 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 other year
thereafter, the Secretary, acting through the Assistant
Secretary for Preparedness and Response and in consultation
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 the Food and
Drug Administration, 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. 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) consider and reflect the full spectrum of medical
countermeasure-related activities, including research,
advanced research, development, procurement, stockpiling,
deployment, and distribution;
``(B) identify and prioritize near-term, mid-term, and
long-term priority qualified and security countermeasure (as
defined in sections 319F 1 and 319F 2) needs and goals of the
Federal Government according to chemical, biological,
radiological, and nuclear threat or threats;
``(C) identify projected timelines, anticipated funding
allocations, benchmarks, and milestones for each medical
countermeasure priority under subparagraph (B), including
projected needs with regard to replenishment of the Strategic
National Stockpile;
``(D) be informed by the recommendations of the National
Biodefense Science Board pursuant to section 319M;
``(E) report on advanced research and development awards
and the date of the issuance of contract awards, including
awards made through the special reserve fund (as defined in
section 319F 2(c)(10));
``(F) identify progress made in meeting the goals,
benchmarks, and milestones identified under subparagraph (C)
in plans submitted subsequent to the initial plan;
``(G) 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
(B), including with regard to the projected needs for related
stockpiling and replenishment of the Strategic National
Stockpile; and
``(H) be made publicly available.
``(3) GAO report.--
``(A) In general.--Not later than 1 year after the date on
which a Public Health Emergency Medical Countermeasures
Enterprise Strategy and Implementation Plan under this
subsection is issued by the Secretary, the Government
Accountability Office 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 subparagraphs (A) and (B) of paragraph
(2);
``(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 goals,
benchmarks, and milestones identified in the Public Health
Emergency Medical Countermeasures Enterprise Strategy and
Implementation Plan under this subsection.
``(f) Internal Multiyear Planning Process.--The Secretary
shall develop, and update on an annual basis, a coordinated
5-year budget plan based on the medical countermeasure
priorities and goals described in subsection (e). Each such
plan shall--
[[Page S1478]]
``(1) include consideration of the entire medical
countermeasures enterprise, including--
``(A) basic research, advanced research and development;
``(B) approval, clearance, licensure, and authorized uses
of products; and
``(C) procurement, stockpiling, maintenance, and
replenishment of all products in the Strategic National
Stockpile;
``(2) include measurable outputs and outcomes to allow for
the tracking of the progress made toward identified goals;
``(3) 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
``(4) be made available to the appropriate committees of
Congress upon request.
``(g) Interagency Coordination Plan.--Not later than 1 year
after the date of enactment of this subsection, the
Secretary, in coordination with the Secretary of Defense,
shall submit to the appropriate committees of Congress a
report concerning 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.
``(h) Protection of National Security.--In carrying out
subsections (e), (f), and (g), the Secretary shall ensure
that information and items that could compromise national
security are not disclosed.''.
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 end 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 needs
of children as they relate to preparation for, response to,
and recovery from all-hazards, including public health
emergencies; and
``(3) provide advice and consultation to States and
territories 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) at least two health care professionals with expertise
in pediatric medical disaster planning, preparedness,
response, or recovery;
``(H) at least two representatives from State, local,
territories, or tribal agencies with expertise in pediatric
disaster planning, preparedness, response, or recovery; and
``(I) 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
the date that is 5 years after the date of enactment of the
Pandemic and All-Hazards Preparedness Act Reauthorization of
2011.''.
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 ``$56,000,000 for each of fiscal years 2012
through 2016''.
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 ``$156,500,000 for each of fiscal years 2012
through 2016 to carry out this section''.
TITLE II--OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS AND
RESPONSE
SEC. 201. 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)(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 (as
defined in section 658D of the Child Care and Development
Block Grant Act); and
``(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, and
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
(B) in subparagraph (C), by inserting ``, including
addressing the needs of at-risk individuals,'' after
``capabilities of such entity'';
(2) 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).'';
(3) in subsection (i)--
(A) in paragraph (1)(A)--
(i) by striking ``$824,000,000 for fiscal year 2007'' and
inserting ``$632,900,000 for fiscal year 2012''; and
(ii) by striking ``such sums as may be necessary for each
of fiscal years 2008 through 2011'' and inserting
``$632,900,000 for each of fiscal years 2013 through 2016'';
and
(B) 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
(4) in subsection (j), by striking paragraph (3).
(b) Vaccine Tracking and Distribution.--Section 319A(e) of
the Public Health Service Act
[[Page S1479]]
(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 2012 through 2016''.
(c) GAO Report.--Section 319C-1 of the Public Health
Service Act (42 U.S.C. 247d 3a) is amended by adding at the
end the following:
``(l) GAO Report.--
``(1) In general.--Not later than 1 year after the date of
enactment of the Pandemic and All-Hazards Preparedness Act
Reauthorization of 2011, the Government Accountability Office
shall conduct an independent evaluation, and submit to the
appropriate committees of Congress a report, concerning
Federal programs at the Department of Health and Human
Services that support medical and public health preparedness
and response programs at the State and local levels.
``(2) Content.--The report described in paragraph (1) shall
review and assess--
``(A) the extent to which grant and cooperative agreement
requirements and goals have been met by recipients;
``(B) the extent to which such grants and cooperative
agreements have supported medical and public health
preparedness and response goals pursuant to section 2802(b),
as appropriate and applicable;
``(C) whether recipients or the Department of Health and
Human Services have identified any factors that may impede a
recipient's ability to achieve programmatic goals and
requirements; and
``(D) instances in which funds may not have been used
appropriately, in accordance with grant and cooperative
agreement requirements, and actions taken to address
inappropriate expenditures.''.
SEC. 202. 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 ``$5,900,000 for each of fiscal years 2012
through 2016''.
(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 ``$11,900,000
for each of fiscal years 2012 through 2016''.
(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 (b)(1)(A)(ii), by striking ``centers,
primary'' and inserting ``centers, community health centers,
primary'';
(2) 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.'';
(3) 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).''; and
(4) in subsection (j)--
(A) in paragraph (1), by striking ``$474,000,000 for fiscal
year 2007, and such sums as may be necessary for each of
fiscal years 2008 through 2011'' and inserting ``$378,000,000
for each of fiscal years 2012 through 2016''; 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. 203. ENHANCING SITUATIONAL AWARENESS AND
BIOSURVEILLANCE.
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 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 the
following: ``and update such standards as necessary'';
(2) in subsection (d)--
(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
Act Reauthorization of 2011''; 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 Act Reauthorization of 2011, 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); and
``(B) modernize and enhance biosurveillance activities.'';
(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 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 Humans 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.'';
(3) 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 Act
Reauthorization of 2011'';
(4) in subsection (g), by striking ``such sums as may be
necessary in each of fiscal years 2007 through 2011'' and
inserting ``$160,121,000 for each of fiscal years 2012
through 2016''; and
(5) by adding at the end the following:
``(h) Definition.--For purposes of this section the term
`biosurveillance' means the process of gathering near real-
time, biological data that relates to disease activity and
threats to human or zoonotic 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.''.
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
[[Page S1480]]
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 a
provision of law in 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 provision
of law 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 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)(A)--
(i) 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. The Secretary shall make any renewal under this
subsection available on the Internet Web site of the Food and
Drug Administration.''; 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 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, 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 (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 done solely for the approved use.''; and
(C) 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.''; and
(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 Food and Drug Administration of any application pending
before the Administration for a countermeasure or product
referred to in subsection (a).''.
(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, including a product
intended to be used to prevent or treat pandemic influenza;
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) Extension of Expiration Date.--
``(1) Authority to extend expiration date.--The Secretary
may extend the expiration date of an eligible product in
accordance with this subsection.
``(2) 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.
``(3) Effect of extension.--Notwithstanding any other
provision of this Act or the Public Health Service Act, if
the expiration date of an eligible product is extended in
accordance with this section, the introduction or delivery
for introduction into interstate commerce of such product
after the expiration date provided by the manufacturer and
within the duration of such extension shall not be deemed to
render the product--
``(A) an unapproved product; or
``(B) adulterated or misbranded under this Act.
``(4) Determinations by secretary.--Before extending the
expiration date of an eligible product under this subsection,
the Secretary shall determine--
``(A) that extension of the expiration date will help
protect public health;
``(B) that any extension of expiration is supported by
scientific evaluation that is conducted or accepted by the
Secretary;
``(C) what changes to the product labeling, if any, are
required or permitted, including whether and how any
additional labeling communicating the extension of the
expiration date
[[Page S1481]]
may alter or obscure the labeling provided by the
manufacturer; and
``(D) that any other conditions that the Secretary deems
appropriate have been met.
``(5) Scope of extension.--With respect to each extension
of an expiration date granted under this subsection, the
Secretary shall determine--
``(A) the batch, lot, or unit to which such extension shall
apply;
``(B) the duration of such extension; and
``(C) any conditions to effectuate such extension that are
necessary and appropriate to protect public health or safety.
``(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 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 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, and 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, and 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 heading
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, and 319L 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;
``(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) 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.
``(d) 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
[[Page S1482]]
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:
``(e) 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 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.--If the Commissioner of Food and
Drugs determines that resources are not available to
establish regulatory management plans under this section for
all eligible countermeasures for which a request is submitted
under paragraph (3)(A), the Director of the Biomedical
Advanced Research and Development Authority, in consultation
with the Commissioner of Food and Drugs, shall prioritize
which eligible countermeasures may receive regulatory
managements plans, and in doing so shall give priority to
eligible countermeasures that are security
countermeasures.''.
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:
``(f) Annual Report.--Not later than 180 days after the
date of enactment of this subsection, and annually
thereafter, the Secretary shall submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives 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 or 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 (e), the extent to which the performance targets
and goals set forth in subsection (e)(4)(B) and the
regulatory management plan has 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 Center
specific objectives and accomplishments;
``(5) the number of countermeasure applications submitted,
the number of countermeasures approved, licensed, or cleared,
the status of remaining submitted applications, and the
number of each type of authorization issued pursuant to
section 564; and
``(6) the number of written requests for a regulatory
management plan submitted under subsection (e)(3)(A), the
number of regulatory management plans developed, and the
number of such plans developed for security
countermeasures.''.
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)''.
[[Page S1483]]
(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) Reauthorization of the Special Reserve Fund.--Section
319F 2(c) of the Public Health Service Act (42 U.S.C. 247d-
6b(c)) is amended by adding at the end the following:
``(11) Reauthorization of the special reserve fund.--In
addition to amounts otherwise appropriated, there are
authorized to be appropriated for the special reserve fund,
$2,800,000,000 for the fiscal years 2014 through 2018.
``(12) 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 biennial Public Health Emergency Medical
Countermeasures Enterprise and Strategy Implementation Plan
(pursuant to section 2811(d)).''.
(b) 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 (5)(B)(ii), by striking ``eight years''
and inserting ``10 years'';
(3) 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.'';
(4) in paragraph (9)(B), by inserting before the period the
following: ``, except that this subparagraph shall not be
construed to prohibit the use of such amounts as otherwise
authorized in this title''; and
(5) in paragraph (10), by adding at the end the following:
``(C) Advanced research and development.--For purposes of
this paragraph, the term `advanced research and development'
shall have the meaning given such term in section 319L(a).''.
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) Strategic Public-private Partnership.--Section
319L(c)(4) of the Public Health Service Act (42 U.S.C. 247d-
7e(c)(4)) is amended by adding at the end the following:
``(E) Strategic investor.--
``(i) In general.--To support the purposes described in
paragraph (2), the Secretary, acting through the Director of
BARDA, may enter into an agreement (including through the use
of grants, contracts, cooperative agreements, or other
transactions as described in paragraph (5)) with an
independent, non-profit entity to--
``(I) foster and accelerate the development and innovation
of medical countermeasures and technologies that may assist
advanced research and development of qualified
countermeasures and qualified pandemic or epidemic products,
including strategic investment through the use of venture
capital practices and methods;
``(II) promote the development of new and promising
technologies that address urgent medical countermeasure
needs, as identified by the Secretary;
``(III) address unmet public health needs that are directly
related to medical countermeasure requirements, such as novel
antimicrobials for multidrug resistant organisms and multiuse
platform technologies for diagnostics, prophylaxis, vaccines,
and therapeutics; and
``(IV) provide expert consultation and advice to foster
viable medical countermeasure innovators, including helping
qualified countermeasure innovators navigate unique industry
challenges with respect to developing chemical, biological,
radiological, and nuclear countermeasure products.
``(ii) Eligibility.--
``(I) In general.--To be eligible to enter into an
agreement under clause (i) an entity shall--
``(aa) be an independent, non-profit entity not otherwise
affiliated with the Department of Health and Human Services;
``(bb) have a demonstrated record of being able to create
linkages between innovators and investors and leverage such
partnerships and resources for the purpose of addressing
identified strategic needs of the Federal Government;
``(cc) have experience in promoting novel technology
innovation;
``(dd) be problem driven and solution focused based on the
needs, requirements, and problems identified by the Secretary
under clause (iv);
``(ee) demonstrate the ability, or the potential ability,
to promote the development of medical countermeasure
products; and
``(ff) demonstrate expertise, or the capacity to develop or
acquire expertise, related to technical and regulatory
considerations with respect to medical countermeasures.
``(II) Partnering experience.--In selecting an entity with
which to enter into an agreement under clause (i), the
Secretary shall place a high value on the demonstrated
experience of the entity in partnering with the Federal
Government to meet identified strategic needs.
``(iii) Not agency.--An entity that enters into an
agreement under clause (i) shall not be deemed to be a
Federal agency for any purpose, including for any purpose
under title 5, United States Code.
``(iv) Direction.--Pursuant to an agreement entered into
under this subparagraph, the Secretary, acting through the
Director of BARDA, shall provide direction to the entity that
enters into an agreement under clause (i). As part of this
agreement the Director of BARDA shall--
``(I) communicate the medical countermeasure needs,
requirements, and problems to be addressed by the entity
under the agreement;
``(II) develop a description of work to be performed by the
entity under the agreement;
``(III) provide technical feedback and appropriate
oversight over work carried out by the entity under the
agreement, including subsequent development and partnerships
consistent with the needs and requirements set forth in this
subparagraph;
``(IV) ensure fair consideration of products developed
under the agreement in order to maintain competition to the
maximum practical extent, as applicable and appropriate under
applicable provisions of this section; and
``(V) ensure, as a condition of the agreement--
``(aa) a comprehensive set of policies that demonstrate a
commitment to transparency and accountability;
``(bb) protection against conflicts of interest through a
comprehensive set of policies that address potential
conflicts of interest, ethics, disclosure, and reporting
requirements;
``(cc) that the entity provides monthly accounting on the
use of funds provided under such agreement; and
``(dd) that the entity provides on a quarterly basis,
reports regarding the progress made toward meeting the
identified needs set forth in the agreement.
``(v) Supplement not supplant.--Activities carried out
under this subparagraph shall supplement, and not supplant,
other activities carried out under this section.
``(vi) No establishment of entity.--To prevent unnecessary
duplication and target resources effectively, nothing in this
subparagraph shall be construed to authorize the Secretary to
establish within the Department of Health and Human Services
a strategic investor entity.
``(vii) Transparency and oversight.--Upon request, the
Secretary shall provide to Congress the information provided
to the Secretary under clause (iv)(V)(dd).
``(viii) Independent evaluation.--Not later than 4 years
after the date of enactment of this subparagraph, the
Government Accountability Office shall conduct an independent
evaluation, and submit to the Secretary and the appropriate
committees of Congress a report, concerning the activities
conducted under this subparagraph. Such report shall include
recommendations with respect to any agreement or activities
carried out pursuant to this subparagraph.
``(ix) Sunset.--This subparagraph shall have no force or
effect after September 30, 2016.''.
(c) 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.''.
(d) 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:
[[Page S1484]]
``(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 2012 through 2016, such
amounts to remain available until expended.''.
(e) 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 ``10 years''.
(f) Extension of Limited Antitrust Exemption.--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 ``10-year''.
(g) 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 Government
Accountability Office 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 Government Accountability
Office 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.''.
(h) 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.
(a) In General.--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 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)--
(i) by redesignating subparagraphs (E) through (H) as
subparagraphs (F) through (I), respectively; and
(ii) by inserting after subparagraph (D), the following:
``(E) identify and address the potential depletion and
ensure appropriate replenishment of medical countermeasures,
including those currently in the stockpile;''; 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'' and inserting
``$522,486,000 for each of fiscal years 2012 through 2016''.
(b) Report on Potassium Iodide.--Not later than 270 days
after the date of enactment of this Act, the Secretary of
Health and Human Services shall submit to the appropriate
Committees of Congress a report regarding the stockpiling of
potassium iodide. Such report shall include--
(1) an assessment of the availability of potassium iodide
at Federal, State, and local levels; and
(2) a description of the extent to which such activities
and policies provide public health protection in the event of
a nuclear incident, whether unintentional or deliberate,
including an act of terrorism.
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 the matter preceding clause (i), by striking
``five'' and inserting ``six'';
(ii) in clause (i), by striking ``and'' at the end;
(iii) in clause (ii), by striking the period and inserting
a semicolon; and
(iv) 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).'';
(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.''; and
(3) in paragraph (8), by adding at the end the following:
``Such chairperson shall serve as the deciding vote in the
event that a deciding vote is necessary with respect to
voting by members of the Board.''.
Mr. REID. Mr. President, I ask unanimous consent that the Harkin
amendment, which is at desk, be agreed to, the committee-reported
substitute, as amended, be agreed to, the bill, as amended, be read the
third time and passed, with no intervening action or debate, and that
any statements relating to the measure be printed in the Record.
The PRESIDING OFFICER. Without objection, it is so ordered.
The amendment (No. 1823) was agreed to, as follows:
(Purpose: To make certain technical corrections)
On page 80, line 18, insert ``medical and public health''
before ``needs of children''.
On page 80, lines 19 and 20, strike ``, including public
health emergencies''.
On page 82, between lines 5 and 6, insert the following:
``(G) the Administrator of the Federal Emergency Management
Agency;''.
On page 82, line 6, strike ``(G) at least two'' and insert
``(H) at least two non-Federal''.
On page 82, line 9, strike ``(H)'' and insert ``(I)''.
On page 82, line 13, strike ``(I)'' and insert ``(J)''.
The committee amendment in the nature of a substitute, as amended,
was agreed to.
The bill (S. 1855), as amended, was ordered to be engrossed for a
third reading, was read the third time, and passed, as follows:
S. 1855
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Pandemic
and All-Hazards Preparedness Act Reauthorization of 2011''.
(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. Improving State and local public health security.
Sec. 202. Hospital preparedness and medical surge capacity.
Sec. 203. Enhancing situational awareness and biosurveillance.
TITLE III--ENHANCING MEDICAL COUNTERMEASURE REVIEW
Sec. 301. Special protocol assessment.
Sec. 302. Authorization of 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.
[[Page S1485]]
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 (3)--
(i) in the matter preceding subparagraph (A)--
(I) by striking ``facilities), and trauma care'' and
inserting ``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 (D), by inserting ``(which may
include such dental health assets)'' after ``medical
assets'';
(iv) by adding at the end the following:
``(F) Optimizing a coordinated and flexible approach to the
medical surge capacity of hospitals, other healthcare
facilities, and trauma care (which may include trauma
centers) and emergency medical systems.'';
(B) 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
(C) 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) by redesignating paragraphs (1) through (4) as
paragraphs (2) through (5), respectively;
(3) 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;'';
(4) in paragraph (2) (as so redesignated), by striking
``National Preparedness goal'' and inserting ``preparedness
goals, as described in section 2802(b),''; and
(5) 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.
Section 2811 of the Public Health Service Act (42 U.S.C.
300hh 10) is amended--
(1) in subsection (b)(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 502(6) of the Homeland Security Act of 2002, or any
successor plan, before, during, and following public health
emergencies.'';
(2) by striking subsection (c) and inserting the following:
``(c) Functions.--The Assistant Secretary for Preparedness
and Response shall--
``(1) have authority over and responsibility for--
``(A) the National Disaster Medical System (in accordance
with section 301 of the Pandemic and All-Hazards Preparedness
Act);
``(B) the Hospital Preparedness Cooperative Agreement
Program pursuant to section 319C 2;
``(C) the Medical Reserve Corps pursuant to section 2813;
``(D) the Emergency System for Advance Registration of
Volunteer Health Professionals pursuant to section 319I; and
``(E) 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;
``(2) 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; and
``(C) the Cities Readiness Initiative;
``(3) 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 coordination with the Secretary of
Homeland Security, to--
``(A) optimize and streamline medical and public health
preparedness capabilities and the ability of local
communities to respond to public health emergencies;
``(B) minimize duplication of efforts with regard to
medical and public health preparedness and response programs;
and
``(C) gather and disseminate best practices among grant and
cooperative agreement recipients, as appropriate;
``(4) carry out drills and operational exercises, in
coordination 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, including exercises based on--
``(A) identified threats for which countermeasures are
available and for which no countermeasures are available; and
``(B) unknown threats for which no countermeasures are
available; and
``(5) assume other duties as determined appropriate by the
Secretary.''; and
(3) by adding at the end the following:
``(d) National Security Priority.--The Secretary, acting
through the Assistant Secretary for Preparedness and
Response, shall on a periodic basis conduct meetings, as
applicable and appropriate, with 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.
``(e) 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 other year
thereafter, the Secretary, acting through the Assistant
Secretary for Preparedness and Response and in consultation
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 the Food and
Drug Administration, 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. 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) consider and reflect the full spectrum of medical
countermeasure-related activities, including research,
advanced research, development, procurement, stockpiling,
deployment, and distribution;
``(B) identify and prioritize near-term, mid-term, and
long-term priority qualified and security countermeasure (as
defined in sections 319F 1 and 319F 2) needs and goals of the
Federal Government according to chemical, biological,
radiological, and nuclear threat or threats;
``(C) identify projected timelines, anticipated funding
allocations, benchmarks, and milestones for each medical
countermeasure priority under subparagraph (B), including
projected needs with regard to replenishment of the Strategic
National Stockpile;
``(D) be informed by the recommendations of the National
Biodefense Science Board pursuant to section 319M;
``(E) report on advanced research and development awards
and the date of the issuance of contract awards, including
awards made through the special reserve fund (as defined in
section 319F 2(c)(10));
``(F) identify progress made in meeting the goals,
benchmarks, and milestones identified under subparagraph (C)
in plans submitted subsequent to the initial plan;
``(G) identify the progress made in meeting the medical
countermeasure priorities for at-risk individuals, (as
defined in
[[Page S1486]]
2802(b)(4)(B)), as applicable under subparagraph (B),
including with regard to the projected needs for related
stockpiling and replenishment of the Strategic National
Stockpile; and
``(H) be made publicly available.
``(3) GAO report.--
``(A) In general.--Not later than 1 year after the date on
which a Public Health Emergency Medical Countermeasures
Enterprise Strategy and Implementation Plan under this
subsection is issued by the Secretary, the Government
Accountability Office 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 subparagraphs (A) and (B) of paragraph
(2);
``(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 goals,
benchmarks, and milestones identified in the Public Health
Emergency Medical Countermeasures Enterprise Strategy and
Implementation Plan under this subsection.
``(f) Internal Multiyear Planning Process.--The Secretary
shall develop, and update on an annual basis, a coordinated
5-year budget plan based on the medical countermeasure
priorities and goals described in subsection (e). Each such
plan shall--
``(1) include consideration of the entire medical
countermeasures enterprise, including--
``(A) basic research, advanced research and development;
``(B) approval, clearance, licensure, and authorized uses
of products; and
``(C) procurement, stockpiling, maintenance, and
replenishment of all products in the Strategic National
Stockpile;
``(2) include measurable outputs and outcomes to allow for
the tracking of the progress made toward identified goals;
``(3) 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
``(4) be made available to the appropriate committees of
Congress upon request.
``(g) Interagency Coordination Plan.--Not later than 1 year
after the date of enactment of this subsection, the
Secretary, in coordination with the Secretary of Defense,
shall submit to the appropriate committees of Congress a
report concerning 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.
``(h) Protection of National Security.--In carrying out
subsections (e), (f), and (g), the Secretary shall ensure
that information and items that could compromise national
security are not disclosed.''.
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 end 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;
and
``(3) provide advice and consultation to States and
territories 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,
territories, 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
the date that is 5 years after the date of enactment of the
Pandemic and All-Hazards Preparedness Act Reauthorization of
2011.''.
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 ``$56,000,000 for each of fiscal years 2012
through 2016''.
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 ``$156,500,000 for each of fiscal years 2012
through 2016 to carry out this section''.
TITLE II--OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS AND
RESPONSE
SEC. 201. 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)(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 (as
defined in section 658D of the Child Care and Development
Block Grant Act); and
``(viii) in the case of entities that operate on the United
States-Mexico border or the
[[Page S1487]]
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, and 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
(B) in subparagraph (C), by inserting ``, including
addressing the needs of at-risk individuals,'' after
``capabilities of such entity'';
(2) 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).'';
(3) in subsection (i)--
(A) in paragraph (1)(A)--
(i) by striking ``$824,000,000 for fiscal year 2007'' and
inserting ``$632,900,000 for fiscal year 2012''; and
(ii) by striking ``such sums as may be necessary for each
of fiscal years 2008 through 2011'' and inserting
``$632,900,000 for each of fiscal years 2013 through 2016'';
and
(B) 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
(4) in subsection (j), 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 2012 through 2016''.
(c) GAO Report.--Section 319C 1 of the Public Health
Service Act (42 U.S.C. 247d 3a) is amended by adding at the
end the following:
``(l) GAO Report.--
``(1) In general.--Not later than 1 year after the date of
enactment of the Pandemic and All-Hazards Preparedness Act
Reauthorization of 2011, the Government Accountability Office
shall conduct an independent evaluation, and submit to the
appropriate committees of Congress a report, concerning
Federal programs at the Department of Health and Human
Services that support medical and public health preparedness
and response programs at the State and local levels.
``(2) Content.--The report described in paragraph (1) shall
review and assess--
``(A) the extent to which grant and cooperative agreement
requirements and goals have been met by recipients;
``(B) the extent to which such grants and cooperative
agreements have supported medical and public health
preparedness and response goals pursuant to section 2802(b),
as appropriate and applicable;
``(C) whether recipients or the Department of Health and
Human Services have identified any factors that may impede a
recipient's ability to achieve programmatic goals and
requirements; and
``(D) instances in which funds may not have been used
appropriately, in accordance with grant and cooperative
agreement requirements, and actions taken to address
inappropriate expenditures.''.
SEC. 202. 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 ``$5,900,000 for each of fiscal years 2012
through 2016''.
(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 ``$11,900,000
for each of fiscal years 2012 through 2016''.
(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 (b)(1)(A)(ii), by striking ``centers,
primary'' and inserting ``centers, community health centers,
primary'';
(2) 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.'';
(3) 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).''; and
(4) in subsection (j)--
(A) in paragraph (1), by striking ``$474,000,000 for fiscal
year 2007, and such sums as may be necessary for each of
fiscal years 2008 through 2011'' and inserting ``$378,000,000
for each of fiscal years 2012 through 2016''; 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. 203. ENHANCING SITUATIONAL AWARENESS AND
BIOSURVEILLANCE.
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 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 the
following: ``and update such standards as necessary'';
(2) in subsection (d)--
(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
Act Reauthorization of 2011''; 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 Act Reauthorization of 2011, 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); and
``(B) modernize and enhance biosurveillance activities.'';
(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 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 Humans Services
to ensure comprehensive, real-time all-hazards
biosurveillance capabilities. In complying with the
[[Page S1488]]
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.'';
(3) 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 Act
Reauthorization of 2011'';
(4) in subsection (g), by striking ``such sums as may be
necessary in each of fiscal years 2007 through 2011'' and
inserting ``$160,121,000 for each of fiscal years 2012
through 2016''; and
(5) by adding at the end the following:
``(h) Definition.--For purposes of this section the term
`biosurveillance' means the process of gathering near real-
time, biological data that relates to disease activity and
threats to human or zoonotic 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.''.
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 a
provision of law in 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 provision
of law 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 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)(A)--
(i) 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. The Secretary shall make any renewal under this
subsection available on the Internet Web site of the Food and
Drug Administration.''; 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 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, 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 (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 done solely for the approved use.''; and
(C) 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.'';
[[Page S1489]]
(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.''; and
(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 Food and Drug Administration of any application pending
before the Administration for a countermeasure or product
referred to in subsection (a).''.
(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, including a product
intended to be used to prevent or treat pandemic influenza;
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) Extension of Expiration Date.--
``(1) Authority to extend expiration date.--The Secretary
may extend the expiration date of an eligible product in
accordance with this subsection.
``(2) 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.
``(3) Effect of extension.--Notwithstanding any other
provision of this Act or the Public Health Service Act, if
the expiration date of an eligible product is extended in
accordance with this section, the introduction or delivery
for introduction into interstate commerce of such product
after the expiration date provided by the manufacturer and
within the duration of such extension shall not be deemed to
render the product--
``(A) an unapproved product; or
``(B) adulterated or misbranded under this Act.
``(4) Determinations by secretary.--Before extending the
expiration date of an eligible product under this subsection,
the Secretary shall determine--
``(A) that extension of the expiration date will help
protect public health;
``(B) that any extension of expiration is supported by
scientific evaluation that is conducted or accepted by the
Secretary;
``(C) what changes to the product labeling, if any, are
required or permitted, including whether and how any
additional labeling communicating the extension of the
expiration date may alter or obscure the labeling provided by
the manufacturer; and
``(D) that any other conditions that the Secretary deems
appropriate have been met.
``(5) Scope of extension.--With respect to each extension
of an expiration date granted under this subsection, the
Secretary shall determine--
``(A) the batch, lot, or unit to which such extension shall
apply;
``(B) the duration of such extension; and
``(C) any conditions to effectuate such extension that are
necessary and appropriate to protect public health or safety.
``(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 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 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, and 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, and 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 heading
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,
[[Page S1490]]
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, and 319L 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;
``(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) 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.
``(d) 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:
``(e) 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 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.--If the Commissioner of Food and
Drugs determines that resources are not available to
establish regulatory management plans under this section for
all eligible countermeasures for which a request is submitted
under paragraph (3)(A), the Director of the Biomedical
Advanced Research and Development Authority, in consultation
with the Commissioner of Food and Drugs, shall prioritize
which eligible countermeasures may receive regulatory
managements plans, and in doing so shall give priority to
eligible countermeasures that are security
countermeasures.''.
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:
``(f) Annual Report.--Not later than 180 days after the
date of enactment of this subsection, and annually
thereafter, the Secretary shall submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives a report that details the countermeasure
development and review activities
[[Page S1491]]
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 or 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 (e), the extent to which the performance targets
and goals set forth in subsection (e)(4)(B) and the
regulatory management plan has 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 Center
specific objectives and accomplishments;
``(5) the number of countermeasure applications submitted,
the number of countermeasures approved, licensed, or cleared,
the status of remaining submitted applications, and the
number of each type of authorization issued pursuant to
section 564; and
``(6) the number of written requests for a regulatory
management plan submitted under subsection (e)(3)(A), the
number of regulatory management plans developed, and the
number of such plans developed for security
countermeasures.''.
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) Reauthorization of the Special Reserve Fund.--Section
319F 2(c) of the Public Health Service Act (42 U.S.C. 247d
6b(c)) is amended by adding at the end the following:
``(11) Reauthorization of the special reserve fund.--In
addition to amounts otherwise appropriated, there are
authorized to be appropriated for the special reserve fund,
$2,800,000,000 for the fiscal years 2014 through 2018.
``(12) 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 biennial Public Health Emergency Medical
Countermeasures Enterprise and Strategy Implementation Plan
(pursuant to section 2811(d)).''.
(b) 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 (5)(B)(ii), by striking ``eight years''
and inserting ``10 years'';
(3) 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.'';
(4) in paragraph (9)(B), by inserting before the period the
following: ``, except that this subparagraph shall not be
construed to prohibit the use of such amounts as otherwise
authorized in this title''; and
(5) in paragraph (10), by adding at the end the following:
``(C) Advanced research and development.--For purposes of
this paragraph, the term `advanced research and development'
shall have the meaning given such term in section 319L(a).''.
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) Strategic Public-private Partnership.--Section
319L(c)(4) of the Public Health Service Act (42 U.S.C. 247d
7e(c)(4)) is amended by adding at the end the following:
``(E) Strategic investor.--
``(i) In general.--To support the purposes described in
paragraph (2), the Secretary, acting through the Director of
BARDA, may enter into an agreement (including through the use
of grants, contracts, cooperative agreements, or other
transactions as described in paragraph (5)) with an
independent, non-profit entity to--
``(I) foster and accelerate the development and innovation
of medical countermeasures
[[Page S1492]]
and technologies that may assist advanced research and
development of qualified countermeasures and qualified
pandemic or epidemic products, including strategic investment
through the use of venture capital practices and methods;
``(II) promote the development of new and promising
technologies that address urgent medical countermeasure
needs, as identified by the Secretary;
``(III) address unmet public health needs that are directly
related to medical countermeasure requirements, such as novel
antimicrobials for multidrug resistant organisms and multiuse
platform technologies for diagnostics, prophylaxis, vaccines,
and therapeutics; and
``(IV) provide expert consultation and advice to foster
viable medical countermeasure innovators, including helping
qualified countermeasure innovators navigate unique industry
challenges with respect to developing chemical, biological,
radiological, and nuclear countermeasure products.
``(ii) Eligibility.--
``(I) In general.--To be eligible to enter into an
agreement under clause (i) an entity shall--
``(aa) be an independent, non-profit entity not otherwise
affiliated with the Department of Health and Human Services;
``(bb) have a demonstrated record of being able to create
linkages between innovators and investors and leverage such
partnerships and resources for the purpose of addressing
identified strategic needs of the Federal Government;
``(cc) have experience in promoting novel technology
innovation;
``(dd) be problem driven and solution focused based on the
needs, requirements, and problems identified by the Secretary
under clause (iv);
``(ee) demonstrate the ability, or the potential ability,
to promote the development of medical countermeasure
products; and
``(ff) demonstrate expertise, or the capacity to develop or
acquire expertise, related to technical and regulatory
considerations with respect to medical countermeasures.
``(II) Partnering experience.--In selecting an entity with
which to enter into an agreement under clause (i), the
Secretary shall place a high value on the demonstrated
experience of the entity in partnering with the Federal
Government to meet identified strategic needs.
``(iii) Not agency.--An entity that enters into an
agreement under clause (i) shall not be deemed to be a
Federal agency for any purpose, including for any purpose
under title 5, United States Code.
``(iv) Direction.--Pursuant to an agreement entered into
under this subparagraph, the Secretary, acting through the
Director of BARDA, shall provide direction to the entity that
enters into an agreement under clause (i). As part of this
agreement the Director of BARDA shall--
``(I) communicate the medical countermeasure needs,
requirements, and problems to be addressed by the entity
under the agreement;
``(II) develop a description of work to be performed by the
entity under the agreement;
``(III) provide technical feedback and appropriate
oversight over work carried out by the entity under the
agreement, including subsequent development and partnerships
consistent with the needs and requirements set forth in this
subparagraph;
``(IV) ensure fair consideration of products developed
under the agreement in order to maintain competition to the
maximum practical extent, as applicable and appropriate under
applicable provisions of this section; and
``(V) ensure, as a condition of the agreement--
``(aa) a comprehensive set of policies that demonstrate a
commitment to transparency and accountability;
``(bb) protection against conflicts of interest through a
comprehensive set of policies that address potential
conflicts of interest, ethics, disclosure, and reporting
requirements;
``(cc) that the entity provides monthly accounting on the
use of funds provided under such agreement; and
``(dd) that the entity provides on a quarterly basis,
reports regarding the progress made toward meeting the
identified needs set forth in the agreement.
``(v) Supplement not supplant.--Activities carried out
under this subparagraph shall supplement, and not supplant,
other activities carried out under this section.
``(vi) No establishment of entity.--To prevent unnecessary
duplication and target resources effectively, nothing in this
subparagraph shall be construed to authorize the Secretary to
establish within the Department of Health and Human Services
a strategic investor entity.
``(vii) Transparency and oversight.--Upon request, the
Secretary shall provide to Congress the information provided
to the Secretary under clause (iv)(V)(dd).
``(viii) Independent evaluation.--Not later than 4 years
after the date of enactment of this subparagraph, the
Government Accountability Office shall conduct an independent
evaluation, and submit to the Secretary and the appropriate
committees of Congress a report, concerning the activities
conducted under this subparagraph. Such report shall include
recommendations with respect to any agreement or activities
carried out pursuant to this subparagraph.
``(ix) Sunset.--This subparagraph shall have no force or
effect after September 30, 2016.''.
(c) 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.''.
(d) 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 2012 through 2016, such
amounts to remain available until expended.''.
(e) 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 ``10 years''.
(f) Extension of Limited Antitrust Exemption.--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 ``10-year''.
(g) 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 Government
Accountability Office 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 Government Accountability
Office 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.''.
(h) 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.
(a) In General.--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 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)--
(i) by redesignating subparagraphs (E) through (H) as
subparagraphs (F) through (I), respectively; and
(ii) by inserting after subparagraph (D), the following:
[[Page S1493]]
``(E) identify and address the potential depletion and
ensure appropriate replenishment of medical countermeasures,
including those currently in the stockpile;''; 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'' and inserting
``$522,486,000 for each of fiscal years 2012 through 2016''.
(b) Report on Potassium Iodide.--Not later than 270 days
after the date of enactment of this Act, the Secretary of
Health and Human Services shall submit to the appropriate
Committees of Congress a report regarding the stockpiling of
potassium iodide. Such report shall include--
(1) an assessment of the availability of potassium iodide
at Federal, State, and local levels; and
(2) a description of the extent to which such activities
and policies provide public health protection in the event of
a nuclear incident, whether unintentional or deliberate,
including an act of terrorism.
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 the matter preceding clause (i), by striking
``five'' and inserting ``six'';
(ii) in clause (i), by striking ``and'' at the end;
(iii) in clause (ii), by striking the period and inserting
a semicolon; and
(iv) 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).'';
(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.''; and
(3) in paragraph (8), by adding at the end the following:
``Such chairperson shall serve as the deciding vote in the
event that a deciding vote is necessary with respect to
voting by members of the Board.''.
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