1.Short title; table of contents
(a)This Act may be cited as the
Pandemic and All-Hazards Preparedness
Act Reauthorization of 2011
.
(b)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.
<enum>I</enum><header display-inline="yes-display-inline">Strengthening national preparedness and
response for public health emergencies</header>
<section commented="no" display-inline="no-display-inline" id="idd4604ab8-07d5-4771-9ceb-8864179e99b4" section-type="subsequent-section"><enum>101.</enum><header display-inline="yes-display-inline">National Health Security Strategy</header>
<subsection commented="no" display-inline="no-display-inline" id="idc261478e-cd05-47ac-9461-3fca15b81daf"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 2802 of the Public Health Service
Act (42 U.S.C. 300hh–1) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id54614566-5c03-485c-9747-569035810e7e"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)(1), by striking
<quote>2009</quote> and inserting <quote>2014</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id87f39a92-2b2a-4172-bd06-8c263e57b31d"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="iddcfa32cc-049f-4f75-ac24-b92a6610a9de"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (3)—</text>
<clause commented="no" display-inline="no-display-inline" id="id8098a44e-6bb4-449e-997d-56b2f74360c5"><enum>(i)</enum><text display-inline="yes-display-inline">in the matter preceding subparagraph
(A)—</text>
<subclause commented="no" display-inline="no-display-inline" id="idB11FACBC3FDA4953A3B104F1721B86D5"><enum>(I)</enum><text display-inline="yes-display-inline">by striking <quote>facilities), and trauma
care</quote> and inserting <quote>facilities and which may include dental
health facilities), and trauma care, critical care,</quote>; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idFD10AF7EEE9A4DAF97E522CE7EFCE05D"><enum>(II)</enum><text display-inline="yes-display-inline">by inserting <quote>(including related
availability, accessibility, and coordination)</quote> after <quote>public
health emergencies</quote>;</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="idD9C7DFA05CAC4CB8AEC7A06996FE0839"><enum>(ii)</enum><text display-inline="yes-display-inline">in subparagraph (A), by inserting
<quote>and trauma</quote> after <quote>medical</quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id7be35ee4-ca71-448f-a100-961b79293766"><enum>(iii)</enum><text display-inline="yes-display-inline">in subparagraph (D), by inserting
<quote>(which may include such dental health assets)</quote> after
<quote>medical assets</quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id41AB328F176444BC90D38C983146C1EF"><enum>(iv)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idCB71A06675FA4CAE8E33EC23DA8C9F19" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="id68635FD5ACFF4AA5BC07351BE5414042"><enum>(F)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idce4b9ff6-2b79-4c48-91fb-5a3955aae316"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (4)—</text>
<clause commented="no" display-inline="no-display-inline" id="idb151a9ad-06fe-4586-9339-0207f0391b31"><enum>(i)</enum><text display-inline="yes-display-inline">in subparagraph (A), by inserting <quote>,
including the unique needs and considerations of individuals with
disabilities,</quote> after <quote>medical needs of at-risk
individuals</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id00ebe438-01e9-494e-9030-f29704cfe11f"><enum>(ii)</enum><text display-inline="yes-display-inline">in subparagraph (B), by inserting
<quote>the</quote> before <quote>purpose of this section</quote>; and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idbcede22a-10ad-48c5-b71f-f12470b15ac0"><enum>(C)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="ida53c9e18-ca55-473d-bf39-784e5d27b83d" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="id58ee1428-bd23-4133-a4c8-b5b2e2ec791a"><enum>(7)</enum><header display-inline="yes-display-inline">Countermeasures</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id084702fe-4242-4fe2-b8c1-acf137e11ad6"><enum>(A)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3e1fe357-bbd0-4112-858d-2ed0d70758b3"><enum>(B)</enum><text display-inline="yes-display-inline">For purposes of this paragraph the term
<term>countermeasures</term> has the same meaning as the terms <quote>qualified
countermeasures</quote> under section 319F–1, <quote>qualified pandemic and
epidemic products</quote> under section 319F–3, and <quote>security
countermeasures</quote> under section 319F–2.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4cee2df3-14af-4994-b646-da495d307913"><enum>(8)</enum><header display-inline="yes-display-inline">Medical and public health community
resiliency</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id8e890bdb-8d02-403e-bde5-d5d18881f820"><enum>(A)</enum><text display-inline="yes-display-inline">optimizing alignment and integration of
medical and public health preparedness and response planning and capabilities
with and into routine daily activities; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idcfefb7bc-8642-4009-99b8-3a456f456d29"><enum>(B)</enum><text display-inline="yes-display-inline">promoting familiarity with local medical
and public health
systems.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id722de859-440b-43a3-be67-f813df99e370"><enum>(b)</enum><header display-inline="yes-display-inline">At-Risk individuals</header><text display-inline="yes-display-inline">Section 2814 of the Public Health Service
Act (42 U.S.C. 300hh–16) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idab99e911-876b-4774-a333-30539c103e6c"><enum>(1)</enum><text display-inline="yes-display-inline">by striking paragraphs (5), (7), and
(8);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idfa960496-d883-4775-b359-77680b890aff"><enum>(2)</enum><text display-inline="yes-display-inline">by redesignating paragraphs (1) through (4)
as paragraphs (2) through (5), respectively;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9e7b00e6-a71a-42df-a9c0-c00c4a0af52d"><enum>(3)</enum><text display-inline="yes-display-inline">by inserting before paragraph (2) (as so
redesignated), the following:</text>
<quoted-block display-inline="no-display-inline" id="idc61711ba-b5cf-49c4-887c-b2e7c53e1d4b" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="id3a9058b5-88fd-4409-a342-87b38907f539"><enum>(1)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idAC63C9C56C254272B2C0D9AEA145FFD0"><enum>(4)</enum><text display-inline="yes-display-inline">in paragraph (2) (as so redesignated), by
striking <quote>National Preparedness goal</quote> and inserting
<quote>preparedness goals, as described in section 2802(b),</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id76dd00e7-5259-479b-9f7e-a897c0bd0a99"><enum>(5)</enum><text display-inline="yes-display-inline">by inserting after paragraph (6), the
following:</text>
<quoted-block display-inline="no-display-inline" id="id7d1d97bd-7960-435a-997c-5f4510dc5f66" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="id14730460-db02-43f0-81ac-5d5b8ceda33e"><enum>(7)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id824d5a38-542c-4f15-9177-02c2a23b46e9"><enum>(8)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="idcd0339ec-34df-4ca3-9c66-27a619cd16db" section-type="subsequent-section"><enum>102.</enum><header display-inline="yes-display-inline">Assistant Secretary for Preparedness and
Response</header><text display-inline="no-display-inline">Section 2811 of the
Public Health Service Act (42 U.S.C. 300hh–10) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idd1924021-56fa-4cf1-80d0-910f46cdb93e"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (b)(4), by adding at the end
the following:</text>
<quoted-block display-inline="no-display-inline" id="id8b65dd7e-90e9-4a3d-bcbc-a5f6a4fa3ed4" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="id20932616-d4b1-4699-b93e-8d9d3818fb55"><enum>(D)</enum><header display-inline="yes-display-inline">Policy coordination and strategic
direction</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6e79076b-6163-4467-aef5-472aea972ed6"><enum>(2)</enum><text display-inline="yes-display-inline">by striking subsection (c) and inserting
the following:</text>
<quoted-block display-inline="no-display-inline" id="id8a37205e-2e70-4b6b-a44b-5b364fa24083" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id7ec7804c-ade4-44aa-ab12-795e6c4c7ea7"><enum>(c)</enum><header display-inline="yes-display-inline">Functions</header><text display-inline="yes-display-inline">The Assistant Secretary for Preparedness
and Response shall—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id1e534e92-95c7-4841-bbf0-42f1e88b2ffa"><enum>(1)</enum><text display-inline="yes-display-inline">have authority over and responsibility
for—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idbc0a99aa-acd1-437f-ad6f-8fda0005bc65"><enum>(A)</enum><text display-inline="yes-display-inline">the National Disaster Medical System (in
accordance with section 301 of the Pandemic and All-Hazards Preparedness
Act);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idcbf4b37a-1d61-45a3-ac3d-002c4023cb0b"><enum>(B)</enum><text display-inline="yes-display-inline">the Hospital Preparedness Cooperative
Agreement Program pursuant to section 319C–2;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id185275bc-5496-4dce-ad33-26c2301dde36"><enum>(C)</enum><text display-inline="yes-display-inline">the Medical Reserve Corps pursuant to
section 2813;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide5891d1f-7c6c-4227-a399-0e08bfdeefb8"><enum>(D)</enum><text display-inline="yes-display-inline">the Emergency System for Advance
Registration of Volunteer Health Professionals pursuant to section 319I;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id66f9b221-1579-46ff-862c-d29c20b8b52c"><enum>(E)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id975349e5-bb9c-44db-b2f6-e25bf77b7dfe"><enum>(2)</enum><text display-inline="yes-display-inline">exercise the responsibilities and
authorities of the Secretary with respect to the coordination of—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idfd4814ab-6be7-408b-a8dd-9eb9ef4b8123"><enum>(A)</enum><text display-inline="yes-display-inline">the Public Health Emergency Preparedness
Cooperative Agreement Program pursuant to section 319C–1;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id73354990-0253-4afa-b630-ea7091fdb1f9"><enum>(B)</enum><text display-inline="yes-display-inline">the Strategic National Stockpile;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idb389da9b-03dd-490c-a52a-5ff13e1d0e65"><enum>(C)</enum><text display-inline="yes-display-inline">the Cities Readiness Initiative;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id497559e8-59c5-402a-9ec4-b66e672dce06"><enum>(3)</enum><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id9774c29e-f459-4ee6-973a-cf2ebf7e46c1"><enum>(A)</enum><text display-inline="yes-display-inline">optimize and streamline medical and public
health preparedness capabilities and the ability of local communities to
respond to public health emergencies;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idac3eaada-ed48-4663-8c8b-d7d3ccd89504"><enum>(B)</enum><text display-inline="yes-display-inline">minimize duplication of efforts with regard
to medical and public health preparedness and response programs; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id357862c3-b1ed-4678-a824-823c48b8b8dc"><enum>(C)</enum><text display-inline="yes-display-inline">gather and disseminate best practices among
grant and cooperative agreement recipients, as appropriate;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idfcbac09d-4ca6-4fd8-98b3-a06af10abbc6"><enum>(4)</enum><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id1c2b0aa6-88d1-4514-a556-c1acae2bcbc9"><enum>(A)</enum><text display-inline="yes-display-inline">identified threats for which
countermeasures are available and for which no countermeasures are available;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idbffa2b8e-ccb6-4c45-b35f-0dd02fb47b09"><enum>(B)</enum><text display-inline="yes-display-inline">unknown threats for which no
countermeasures are available; and</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6d11b03c-abf6-41b4-9e50-036d51c6b447"><enum>(5)</enum><text display-inline="yes-display-inline">assume other duties as determined
appropriate by the Secretary.</text>
</paragraph></subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf5c6e762-1e4f-413e-b5fa-3971933d9796"><enum>(3)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id21e4606b-d28e-4132-b6c7-e35fc1df46fb" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="iddd28fbfd-f9e8-44f8-8f8b-0579fa2cd8a6"><enum>(d)</enum><header display-inline="yes-display-inline">National security priority</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idf8862312-a0c2-4e1a-abf2-721df87a0da4"><enum>(e)</enum><header display-inline="yes-display-inline">Public Health Emergency Medical
Countermeasures Enterprise Strategy and Implementation Plan</header>
<paragraph commented="no" display-inline="no-display-inline" id="id4fb6a5ba-5af5-46aa-a8da-b31022c7c484"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 <quote>Public Health Emergency Medical Countermeasures Enterprise
Strategy and Implementation Plan</quote>.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id5c019fd2-8f10-41cd-950e-60af1d3e023f"><enum>(2)</enum><header display-inline="yes-display-inline">Requirements</header><text display-inline="yes-display-inline">The plan under paragraph (1) shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id6b0a621f-cb77-45ad-9ca8-0f5794ad6f4c"><enum>(A)</enum><text display-inline="yes-display-inline">consider and reflect the full spectrum of
medical countermeasure-related activities, including research, advanced
research, development, procurement, stockpiling, deployment, and
distribution;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id22917a35-4ebd-4ae5-9449-8c70f1048df8"><enum>(B)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide1aad948-b07f-4507-adc7-e112d5cbc0b7"><enum>(C)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ided4eee2b-ce2c-49ab-b117-845eae06d2b8"><enum>(D)</enum><text display-inline="yes-display-inline">be informed by the recommendations of the
National Biodefense Science Board pursuant to section 319M;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idbac7bb4f-5b22-4089-b2a7-762156bfc5a3"><enum>(E)</enum><text display-inline="yes-display-inline">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));</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id82ff4154-5e45-44f3-aaf0-3ecd402705a4"><enum>(F)</enum><text display-inline="yes-display-inline">identify progress made in meeting the
goals, benchmarks, and milestones identified under subparagraph (C) in plans
submitted subsequent to the initial plan;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID464affe79d634e9e9771e09736aba70c"><enum>(G)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id482a989d-3ef8-45af-b5b9-e8b9a31e598e"><enum>(H)</enum><text display-inline="yes-display-inline">be made publicly available.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2fe9a71f-8de0-455f-86b3-0af44f4c3d43"><enum>(3)</enum><header display-inline="yes-display-inline">GAO report</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idbf6b53dc-d71d-48f5-ad65-7a4c24ed4e74"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0628c102-9439-467b-be86-44be6dd2722d"><enum>(B)</enum><header display-inline="yes-display-inline">Content</header><text display-inline="yes-display-inline">The report described in subparagraph (A)
shall review and assess—</text>
<clause commented="no" display-inline="no-display-inline" id="id5649fef1-6f48-42c4-acf5-bf3c1fff7973"><enum>(i)</enum><text display-inline="yes-display-inline">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);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idc4109574-fda3-4aa2-b6fa-cae3ba32319d"><enum>(ii)</enum><text display-inline="yes-display-inline">the activities of the Department of Health
and Human Services with respect to advanced research and development pursuant
to section 319L; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ide6592e02-5cf0-455c-92ad-a3031382d39c"><enum>(iii)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id40b50f0d-451b-44e5-a1f0-f8d85a1437a0"><enum>(f)</enum><header display-inline="yes-display-inline">Internal multiyear planning
process</header><text display-inline="yes-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id397c57dd-21d8-497f-9fda-e1b41f446535"><enum>(1)</enum><text display-inline="yes-display-inline">include consideration of the entire medical
countermeasures enterprise, including—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idadda9666-7f9f-4948-9108-662ca145234a"><enum>(A)</enum><text display-inline="yes-display-inline">basic research, advanced research and
development;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idf246f3b0-6385-45c7-b7ad-844f369a04ea"><enum>(B)</enum><text display-inline="yes-display-inline">approval, clearance, licensure, and
authorized uses of products; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idb5c8d0a3-9679-4c0a-aba8-7acafddee670"><enum>(C)</enum><text display-inline="yes-display-inline">procurement, stockpiling, maintenance, and
replenishment of all products in the Strategic National Stockpile;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ida98ee453-8eca-4ffa-bb7a-3986d22836d6"><enum>(2)</enum><text display-inline="yes-display-inline">include measurable outputs and outcomes to
allow for the tracking of the progress made toward identified goals;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf011494c-503a-4adc-bf8a-c043cf948ede"><enum>(3)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ida81fd74a-7b7f-446e-b1b3-9504ba582f49"><enum>(4)</enum><text display-inline="yes-display-inline">be made available to the appropriate
committees of Congress upon request.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id19b3c702-62ba-460b-ba06-bfefa2adf17b"><enum>(g)</enum><header display-inline="yes-display-inline">Interagency Coordination Plan</header><text display-inline="yes-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id14d48e6a-a738-46ea-9563-d5cd1e90d327"><enum>(1)</enum><text display-inline="yes-display-inline">the research, advanced research,
development, procurement, stockpiling, and distribution of countermeasures to
meet identified needs; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf4a3dcd6-48d2-4374-a1d5-a52765283431"><enum>(2)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id51ad4fb1-3ecf-4d2f-a2f1-d87d8be1eef4"><enum>(h)</enum><header display-inline="yes-display-inline">Protection of national
security</header><text display-inline="yes-display-inline">In carrying out
subsections (e), (f), and (g), the Secretary shall ensure that information and
items that could compromise national security are not
disclosed.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="id73C23CA64E2840CD9929631B8C599581" section-type="subsequent-section"><enum>103.</enum><header display-inline="yes-display-inline">National Advisory Committee on Children and
Disasters</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="id07B4B8DBC8E74E9DB47CF5DB97E496DD" style="OLC">
<section commented="no" display-inline="no-display-inline" id="id7913FCB38E8C43EEA3DB9E862F2A1F9C" section-type="subsequent-section"><enum>2811A.</enum><header display-inline="yes-display-inline">National Advisory Committee on Children and
Disasters</header>
<subsection commented="no" display-inline="no-display-inline" id="IDa5c6242578dd4c4a84de2b9260f29295"><enum>(a)</enum><header display-inline="yes-display-inline">Establishment</header><text display-inline="yes-display-inline">The Secretary, in consultation with the
Secretary of Homeland Security, shall establish an advisory committee to be
known as the <quote>National Advisory Committee on Children and
Disasters</quote> (referred to in this section as the <quote>Advisory
Committee</quote>).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="IDd4b3ec5069e9405dacb5d7811b8a6da7"><enum>(b)</enum><header display-inline="yes-display-inline">Duties</header><text display-inline="yes-display-inline">The Advisory Committee shall—</text>
<paragraph commented="no" display-inline="no-display-inline" id="ID28f72106c4794fa3a10a852c4cafc23a"><enum>(1)</enum><text display-inline="yes-display-inline">provide advice and consultation with
respect to the activities carried out pursuant to section 2814, as applicable
and appropriate;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID818d203ae0874ae680efea8b37dd4fbf"><enum>(2)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID1476119c70714077a884e71d946b169d"><enum>(3)</enum><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idD75C92D8F5A44FF88349AE99794F181C"><enum>(c)</enum><header display-inline="yes-display-inline">Additional duties</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID8b15882503ae44a4a9bc473460f868ce"><enum>(d)</enum><header display-inline="yes-display-inline">Membership</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID47bd73741b7a4cc898feafc8127c0703"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID9a1ab38eb2074751ad2c6e1d0c8cce24"><enum>(2)</enum><header display-inline="yes-display-inline">Required members</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID0fe7d9cb1f3545afad7deafc7b6e7b58"><enum>(A)</enum><text display-inline="yes-display-inline">the Assistant Secretary for Preparedness
and Response;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID946b9a01401a4b1e967bebcb23b0b454"><enum>(B)</enum><text display-inline="yes-display-inline">the Director of the Biomedical Advanced
Research and Development Authority;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDd4df7e806b3241029c6acdcc29d2c236"><enum>(C)</enum><text display-inline="yes-display-inline">the Director of the Centers for Disease
Control and Prevention;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDb74cfc13939d4d69a859a235a7ac943d"><enum>(D)</enum><text display-inline="yes-display-inline">the Commissioner of Food and Drugs;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID2b694700b8e24b6ba66741585a17fa83"><enum>(E)</enum><text display-inline="yes-display-inline">the Director of the National Institutes of
Health;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID2107b9f0bcd6456982a8830a7eb4652d"><enum>(F)</enum><text display-inline="yes-display-inline">the Assistant Secretary of the
Administration for Children and Families;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDcf02f4fdd4fe456d94bf2a07c45ff43a"><enum>(G)</enum><text display-inline="yes-display-inline">the Administrator of the Federal Emergency
Management Agency;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA3D230F4FA494C24B802CC03825D0BC1"><enum>(H)</enum><text display-inline="yes-display-inline">at least two non-Federal health care
professionals with expertise in pediatric medical disaster planning,
preparedness, response, or recovery;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDb59a5e92b9d148d09b1e32c36d09d3bd"><enum>(I)</enum><text display-inline="yes-display-inline">at least two representatives from State,
local, territories, or tribal agencies with expertise in pediatric disaster
planning, preparedness, response, or recovery; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID743758e003a7421c9ea42de5baa06f2f"><enum>(J)</enum><text display-inline="yes-display-inline">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).</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID0b30367b150040d998b8c137c3bd195c"><enum>(e)</enum><header display-inline="yes-display-inline">Meetings</header><text display-inline="yes-display-inline">The Advisory Committee shall meet not less
than biannually.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID21c83d354ac144e0808aba30d8fe6e77"><enum>(f)</enum><header display-inline="yes-display-inline">Sunset</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="id054abb24-c254-44aa-9372-1506ecfcc97f" section-type="subsequent-section"><enum>104.</enum><header display-inline="yes-display-inline">Modernization of the National Disaster
Medical System</header><text display-inline="no-display-inline">Section 2812 of
the Public Health Service Act (42 U.S.C. 300hh–11) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id09ceb2b2-83b4-4010-8f1c-f9fe2669e88e"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)(3)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idd027933e-e42c-473b-ac41-3b8e366091fc"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (A), in clause (i) by
inserting <quote>, including at-risk individuals as applicable</quote> after
<quote>victims of a public health emergency</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idd7020561-99da-4fe8-9765-3c15091057d4"><enum>(B)</enum><text display-inline="yes-display-inline">by redesignating subparagraph (C) as
subparagraph (E); and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id211027da-b12a-4290-b933-9a7d4e26281b"><enum>(C)</enum><text display-inline="yes-display-inline">by inserting after subparagraph (B), the
following:</text>
<quoted-block display-inline="no-display-inline" id="idb9a754ff-2c08-4238-bd14-59e82e9a461f" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="id37764177-9eaf-4a2b-afdb-66c8f1299839"><enum>(C)</enum><header display-inline="yes-display-inline">Considerations for at-risk
populations</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
<quoted-block display-inline="no-display-inline" id="ide89bbb36-dda8-405f-8074-41ad1de78fd4" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="id51b1a42d-0c2a-4357-982f-03c66b5c7b67"><enum>(D)</enum><header display-inline="yes-display-inline">Administration</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idb99e4905-5e87-435d-b56c-c5e053c7ba90"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (g), by striking <quote>such
sums as may be necessary for each of the fiscal years 2007 through 2011</quote>
and inserting <quote>$56,000,000 for each of fiscal years 2012 through
2016</quote>.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="id49887861-a153-47cf-9948-b8160baf8dd4" section-type="subsequent-section"><enum>105.</enum><header display-inline="yes-display-inline">Continuing the role of the Department of
Veterans Affairs</header><text display-inline="no-display-inline">Section
8117(g) of title 38, United States Code, is amended by striking <quote>such
sums as may be necessary to carry out this section for each of fiscal years
2007 through 2011</quote> and inserting <quote>$156,500,000 for each of fiscal
years 2012 through 2016 to carry out this section</quote>.</text>
</section><enum>II</enum><header display-inline="yes-display-inline">Optimizing State and local all-hazards
preparedness and response</header>
<section commented="no" display-inline="no-display-inline" id="id040ff578-3e4b-42a3-abdb-c317f271663c" section-type="subsequent-section"><enum>201.</enum><header display-inline="yes-display-inline">Improving State and local public health
security</header>
<subsection commented="no" display-inline="no-display-inline" id="id43a4b991-1865-4aa4-8744-75523e0c387f"><enum>(a)</enum><header display-inline="yes-display-inline">Cooperative agreements</header><text display-inline="yes-display-inline">Section 319C–1 of the Public Health Service
Act (42 U.S.C. 247d–3a) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id90dd5ae6-1934-46c6-bebd-9cbddb50c7e7"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (b)(2)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id454aa90f-a70b-4983-8a23-4177a838f016"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (A)—</text>
<clause commented="no" display-inline="no-display-inline" id="ide524aedb-572c-4125-a9f2-53d9b967d8f7"><enum>(i)</enum><text display-inline="yes-display-inline">by striking clauses (i) and (ii) and
inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="idd1a71242-6859-449b-be3d-a890a916d270" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="ided4055ae-92ce-4001-97ab-9452f46c3979"><enum>(i)</enum><text display-inline="yes-display-inline">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;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idac15f77a-b86f-4bcf-8b30-c4f2a75a81e0"><enum>(ii)</enum><text display-inline="yes-display-inline">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);</text>
</clause><after-quoted-block>;</after-quoted-block></quoted-block>
</clause><clause commented="no" display-inline="no-display-inline" id="id5ff660b2-2b2e-4250-8d19-fafa6931d543"><enum>(ii)</enum><text display-inline="yes-display-inline">in clause (iv), by striking
<quote>and</quote> at the end; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id33dc2174-041c-4503-b762-699f9df6176f"><enum>(iii)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="ida50a62dc-795c-4f96-ad14-f99161fde178" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="idcf698bb5-2b3a-4185-a12e-320e798b0b40"><enum>(vi)</enum><text display-inline="yes-display-inline">a description of how, as appropriate, the
entity may partner with relevant public and private stakeholders in public
health emergency preparedness and response;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id622590EBE5B5483DBE520B84DFEC8B06"><enum>(vii)</enum><text display-inline="yes-display-inline">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</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDd8be094521c84057a169ef05fe15eea4"><enum>(viii)</enum><text display-inline="yes-display-inline">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;</text>
</clause><after-quoted-block>;
and</after-quoted-block></quoted-block>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="iddde71b57-985d-4181-8e10-ed5584f8c11d"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (C), by inserting <quote>,
including addressing the needs of at-risk individuals,</quote> after
<quote>capabilities of such entity</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1d9b84c9-4571-47f0-8f6b-b729a82153b0"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (g)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id370d9025-e6fa-415d-91de-b87a0ce713b2"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking subparagraph
(A) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="id6640a401-f867-4db8-b0d4-874dceb95753" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="iddc00f032-7cbf-48b9-8ff6-cfe5a40f3d54"><enum>(A)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idee051387-d6d2-4bc4-ac91-9cc541178650"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2)(A), by adding at the end
the following: <quote>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).</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id07e3fdb3-ed33-4ea1-b12a-639e10efa4ae"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (i)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id746cb3d1-c598-4186-93e3-34aa20445e6a"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)(A)—</text>
<clause commented="no" display-inline="no-display-inline" id="id32aa6665-1d9e-4b3d-bc5b-a9c23d394897"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>$824,000,000 for fiscal
year 2007</quote> and inserting <quote>$632,900,000 for fiscal year
2012</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id58ac0750-0717-4caf-b3a7-62be7a37e187"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>such sums as may be
necessary for each of fiscal years 2008 through 2011</quote> and inserting
<quote>$632,900,000 for each of fiscal years 2013 through 2016</quote>;
and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id9b726853-b28e-4197-b9cb-1d670b7cfd22"><enum>(B)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idcc855631-884c-4fce-8a59-947381c89a15" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idf172aa34-d445-44a8-96a2-05b0fe3f00f3"><enum>(7)</enum><header display-inline="yes-display-inline">Availability of cooperative agreement
funds</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id50b0e5ad-700d-4848-84ff-c3711f18d724"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id21f68831-5a10-465d-ba7f-a73990d13491"><enum>(B)</enum><header display-inline="yes-display-inline">Funds contingent on achieving
benchmarks</header><text display-inline="yes-display-inline">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).</text>
</subparagraph></paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idEEE203B9854F460AAF0A9A5C9CEA2AD3"><enum>(4)</enum><text display-inline="yes-display-inline">in subsection (j), by striking paragraph
(3).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id9159a7ba-a707-45b7-828a-c96df8669f05"><enum>(b)</enum><header display-inline="yes-display-inline">Vaccine tracking and
distribution</header><text display-inline="yes-display-inline">Section 319A(e)
of the Public Health Service Act (42 U.S.C. 247d–1(e)) is amended by striking
<quote>such sums for each of fiscal years 2007 through 2011</quote> and
inserting <quote>$30,800,000 for each of fiscal years 2012 through
2016</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id10DD9431AB824014820F1B33741AD2AD"><enum>(c)</enum><header display-inline="yes-display-inline">GAO report</header><text display-inline="yes-display-inline">Section 319C–1 of the Public Health Service
Act (42 U.S.C. 247d–3a) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idE4220CD05DFC4C30AD7F1FEE1AE72F70" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="idDD2AC6C583E74FB5A9B53DF54D90F330"><enum>(l)</enum><header display-inline="yes-display-inline">GAO report</header>
<paragraph commented="no" display-inline="no-display-inline" id="id73722357A18E4D5ABB307B3FEC3548AC"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 1 year after the date of
enactment of the <short-title>Pandemic and All-Hazards
Preparedness Act Reauthorization of 2011</short-title>, 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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id61603409B19349B3833AC5D43B710630"><enum>(2)</enum><header display-inline="yes-display-inline">Content</header><text display-inline="yes-display-inline">The report described in paragraph (1) shall
review and assess—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id2E321417076C414AAAA0CD53BE8F3F5C"><enum>(A)</enum><text display-inline="yes-display-inline">the extent to which grant and cooperative
agreement requirements and goals have been met by recipients;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id100A11E554CC430D825E475608F093F2"><enum>(B)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idAA22156AD97D4327AA55CECE95285945"><enum>(C)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id31ACB1BF38154BFEBDE1992227FE3071"><enum>(D)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" display-inline="no-display-inline" id="id3eccb6e5-c0cb-473d-9286-7b7eec70d6ee" section-type="subsequent-section"><enum>202.</enum><header display-inline="yes-display-inline">Hospital preparedness and medical surge
capacity</header>
<subsection commented="no" display-inline="no-display-inline" id="idfb0a59e5-8027-4692-a031-f037626b899b"><enum>(a)</enum><header display-inline="yes-display-inline">All-Hazards public health and medical
response curricula and training</header><text display-inline="yes-display-inline">Section 319F(a)(5)(B) of the Public Health
Service Act (42 U.S.C. 247d–6(a)(5)(B)) is amended by striking <quote>public
health or medical</quote> and inserting <quote>public health, medical, or
dental</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idbc6696e7-d375-4d46-8006-3aafac6efedd"><enum>(b)</enum><header display-inline="yes-display-inline">Encouraging health professional
volunteers</header>
<paragraph commented="no" display-inline="no-display-inline" id="ide52779d2-dcf4-4191-b589-7f6a9ee9c20a"><enum>(1)</enum><header display-inline="yes-display-inline">Emergency system for advance registration
of volunteer health professionals</header><text display-inline="yes-display-inline">Section 319I(k) of the Public Health
Service Act (42 U.S.C. 247d–7b(k)) is amended by striking <quote>$2,000,000 for
fiscal year 2002, and such sums as may be necessary for each of the fiscal
years 2003 through 2011</quote> and inserting <quote>$5,900,000 for each of
fiscal years 2012 through 2016</quote>.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0a2b8215-a332-4c3e-bc54-526ca68faf86"><enum>(2)</enum><header display-inline="yes-display-inline">Volunteers</header><text display-inline="yes-display-inline">Section 2813 of the Public Health Service
Act (42 U.S.C. 300hh–15) is amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ide0cd9ebf-e142-42fa-a4f0-ba11512a3bf6"><enum>(A)</enum><text display-inline="yes-display-inline">in subsection (d)(2), by adding at the end
the following: <quote>Such training exercises shall, as appropriate and
applicable, incorporate the needs of at-risk individuals in the event of a
public health emergency.</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id196f42d4-bb19-47d7-b6d3-2e7c3f602213"><enum>(B)</enum><text display-inline="yes-display-inline">in subsection (i), by striking
<quote>$22,000,000 for fiscal year 2007, and such sums as may be necessary for
each of fiscal years 2008 through 2011</quote> and inserting <quote>$11,900,000
for each of fiscal years 2012 through 2016</quote>.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idbabd36c8-b774-44d8-b5ae-234fcb5400e3"><enum>(c)</enum><header display-inline="yes-display-inline">Partnerships for State and regional
preparedness To improve surge capacity</header><text display-inline="yes-display-inline">Section 319C–2 of the Public Health Service
Act (42 U.S.C. 247d–3b) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idF8EB4B7EB1984C889E2CD607EBEC9146"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (b)(1)(A)(ii), by striking
<quote>centers, primary</quote> and inserting <quote>centers, community health
centers, primary</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id46448459-2689-4e21-984f-d0f3bc416caf"><enum>(2)</enum><text display-inline="yes-display-inline">by striking subsection (c) and inserting
the following:</text>
<quoted-block display-inline="no-display-inline" id="idcbce64f2-ff37-4834-8637-ed9f720c4d10" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id84823e94-3cdd-480e-8b58-dfc22f75ff46"><enum>(c)</enum><header display-inline="yes-display-inline">Use of funds</header><text display-inline="yes-display-inline">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.</text>
</subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id96e24177-d90f-4de2-99e7-ae128d05d8e3"><enum>(3)</enum><text display-inline="yes-display-inline">by striking subsection (g) and inserting
the following:</text>
<quoted-block display-inline="no-display-inline" id="id201fbc56-4baf-4d19-89f6-2fb0a5c68ea9" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id7d60225e-16af-42d2-9b18-dde3ea0ed4f5"><enum>(g)</enum><header display-inline="yes-display-inline">Coordination</header>
<paragraph commented="no" display-inline="no-display-inline" id="idf8e613c6-05a2-4fda-a913-72fa8c1d2b67"><enum>(1)</enum><header display-inline="yes-display-inline">Local response capabilities</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id742e4d6d-2f6e-41ce-a2a6-5e479f723561"><enum>(2)</enum><header display-inline="yes-display-inline">National collaboration</header><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9f590f9a-0615-43da-a087-74b1236b5d59"><enum>(4)</enum><text display-inline="yes-display-inline">in subsection (j)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id6abbc59d-4585-4f2f-a0af-e3018680043b"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking
<quote>$474,000,000 for fiscal year 2007, and such sums as may be necessary for
each of fiscal years 2008 through 2011</quote> and inserting
<quote>$378,000,000 for each of fiscal years 2012 through 2016</quote>;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id07891023-b95d-4ceb-8c70-78f6c47f3f14"><enum>(B)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id79495e92-871f-4f3a-9a72-2218b7900da3" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="id014da01a-33a0-49fd-9dfb-ae883e3e841b"><enum>(4)</enum><header display-inline="yes-display-inline">Availability of cooperative agreement
funds</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id3ba7947b-969a-4956-8447-fe28204790a4"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0494192c-ad70-4799-9bfd-6ffc3b678e48"><enum>(B)</enum><header display-inline="yes-display-inline">Funds contingent on achieving
benchmarks</header><text display-inline="yes-display-inline">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).</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id6179d3e2-7eca-470e-a33a-039c106f0aca" section-type="subsequent-section"><enum>203.</enum><header display-inline="yes-display-inline">Enhancing situational awareness and
biosurveillance</header><text display-inline="no-display-inline">Section 319D
of the Public Health Service Act (42 U.S.C. 247d–4) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="iddb728049-17dc-40de-a470-c421428e283c"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (b)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idb3dc02b3-4403-4fc6-a112-54bfbb0ccba1"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)(B), by inserting
<quote>poison control centers,</quote> after <quote>hospitals,</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idf76c8c71-0598-4018-8886-509746405ca2"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2), by inserting before the
period the following: <quote>, allowing for coordination to maximize
all-hazards medical and public health preparedness and response and to minimize
duplication of effort</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide39997fa-5397-437c-a4ad-2bceddaf1dab"><enum>(C)</enum><text display-inline="yes-display-inline">in paragraph (3), by inserting before the
period the following: <quote>and update such standards as
necessary</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf838372e-2e96-4800-86f2-c84c7c6b7b6e"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (d)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id4cfbe526-ccdb-4c95-98fd-0f4984ddbe49"><enum>(A)</enum><text display-inline="yes-display-inline">in the subsection heading, by striking
<quote><header-in-text level="subsection" style="OLC">Public Health Situational
Awareness</header-in-text></quote> and inserting <quote><header-in-text level="subsection" style="OLC">Modernizing Public Health Situational Awareness
and BioSurveillance</header-in-text></quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id5c65eaf9-7c7a-4489-8d4b-a525b42d03c7"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<clause commented="no" display-inline="no-display-inline" id="id15d0d422-7ba0-43e6-b746-7e5af988c6a1"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>Pandemic and All-Hazards
Preparedness Act</quote> and inserting <quote>Pandemic and All-Hazards
Preparedness Act Reauthorization of 2011</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id665d3655-07a5-45db-a185-2a8ddb5e5aa9"><enum>(ii)</enum><text display-inline="yes-display-inline">by inserting <quote>, novel emerging
threats,</quote> after <quote>disease outbreaks</quote>;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2cab7498-b671-4e28-90d5-64d41ed219df"><enum>(C)</enum><text display-inline="yes-display-inline">by striking paragraph (2) and inserting the
following:</text>
<quoted-block display-inline="no-display-inline" id="id5a8e10da-0317-4ce7-98a5-74c9e1c4d0c3" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="id13bcd032-5cd9-4069-8279-01398acca68e"><enum>(2)</enum><header display-inline="yes-display-inline">Strategy and implementation
plan</header><text display-inline="yes-display-inline">Not later than 180 days
after the date of enactment of the <short-title>Pandemic
and All-Hazards Preparedness Act Reauthorization of 2011</short-title>, 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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idb619242c-6f20-41ab-af39-b8d895480960"><enum>(A)</enum><text display-inline="yes-display-inline">develop, implement, and evaluate the
network described in paragraph (1), utilizing the elements described in
paragraph (3); and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0ca59588-411e-48d2-8c79-3823d5c507f9"><enum>(B)</enum><text display-inline="yes-display-inline">modernize and enhance biosurveillance
activities.</text>
</subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4B1C7795EC6C49489E0360043DF92A63"><enum>(D)</enum><text display-inline="yes-display-inline">in paragraph (3)(D), by inserting
<quote>community health centers, health centers</quote> after <quote>poison
control,</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idaa0f825f-c658-4649-bc04-0dc850202636"><enum>(E)</enum><text display-inline="yes-display-inline">in paragraph (5), by striking subparagraph
(A) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="id03ee16b8-e512-4d46-a45d-65728a136474" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="ide9d871b1-e89b-48a8-abc9-2ad43e1868c1"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1191fec3-43d1-41a0-937d-a94b7b4541e8"><enum>(F)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id7c3c96e3-13d3-45e1-9709-a78488adebe2" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="ida5a509cf-0a59-4791-8424-7381935adab5"><enum>(6)</enum><header display-inline="yes-display-inline">Consultation with the National Biodefense
Science Board</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id6a2952a0-cf12-45fe-9f56-417934415547"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idcff99303-acf9-474b-90a7-0da60328a6a6"><enum>(B)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id083BADD6390C4248821F38471C6A2FA7"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf2792a57-1005-4cdc-b6e0-12ab53da8a36"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (e)(5), by striking <quote>4
years after the date of enactment of the Pandemic and All-Hazards Preparedness
Act</quote> and inserting <quote>3 years after the date of enactment of the
<short-title>Pandemic and All-Hazards Preparedness Act
Reauthorization of 2011</short-title></quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9038fbf9-5efc-4034-957e-60727d4f67e3"><enum>(4)</enum><text display-inline="yes-display-inline">in subsection (g), by striking <quote>such
sums as may be necessary in each of fiscal years 2007 through 2011</quote> and
inserting <quote>$160,121,000 for each of fiscal years 2012 through
2016</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id791d9863-04b2-437e-a574-2d899fed6dae"><enum>(5)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="ida8fc4817-fd1b-46d0-baad-a49bd71ced71" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="idef9fc94b-c176-4a7a-a291-da1bdb72ffe9"><enum>(h)</enum><header display-inline="yes-display-inline">Definition</header><text display-inline="yes-display-inline">For purposes of this section the term
<term>biosurveillance</term> 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.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><enum>III</enum><header display-inline="yes-display-inline">Enhancing medical countermeasure
review</header>
<section commented="no" display-inline="no-display-inline" id="ida28ff236-47aa-4aff-943b-da9f1a437bbb" section-type="subsequent-section"><enum>301.</enum><header display-inline="yes-display-inline">Special protocol assessment</header><text display-inline="no-display-inline">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
<quote>size of clinical trials intended</quote> and all that follows through
<quote>. The sponsor or applicant</quote> and inserting the following:
“size—</text>
<quoted-block display-inline="no-display-inline" id="id7314cbc0-df15-4a8c-9319-b189a8a7a607" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="ide468eac7-c83c-47ba-a43c-14ad4c824757" indent="up2"><enum>(i)</enum><subclause commented="no" display-inline="yes-display-inline" id="ideb640730-b54b-4607-848c-8325f842c080"><enum>(I)</enum><text display-inline="yes-display-inline">of clinical trials intended to form the
primary basis of an effectiveness claim; or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id0e02a595-76ac-4f51-8f10-29427013192f" indent="up1"><enum>(II)</enum><text display-inline="yes-display-inline">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</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="id6ad8f5b7-eda0-475d-a866-b59a6a07b78e" indent="up2"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause><quoted-block-continuation-text quoted-block-continuation-text-level="subsection">The
sponsor or
applicant</quoted-block-continuation-text><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="idac6e104b-bd90-4a8c-97ab-f97fe0c5edc6" section-type="subsequent-section"><enum>302.</enum><header display-inline="yes-display-inline">Authorization for medical products for use
in emergencies</header>
<subsection commented="no" display-inline="no-display-inline" id="id023CDC23499E4833871556108C667AEC"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 564 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb–3) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id1a55d50c-4c1b-4b8b-9298-14d6a0f739b2"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idf868c776-2047-4d01-8f95-1149bf6b4b51"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking
<quote>sections 505, 510(k), and 515 of this Act</quote> and inserting
<quote>any provision of this Act</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6DE825D69E5442588DB5A048F4EED4F8"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2)(A), by striking
<quote>under a provision of law referred to in such paragraph</quote> and
inserting <quote>under a provision of law in section 505, 510(k), or 515 of
this Act or section 351 of the Public Health Service Act</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idAB0C3415834C420CBE8CA392EE0085BC"><enum>(C)</enum><text display-inline="yes-display-inline">in paragraph (3), by striking <quote>a
provision of law referred to in such paragraph</quote> and inserting <quote>a
provision of law referred to in paragraph (2)(A)</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ide5634622-537e-491f-b2d6-9e194c201ddd"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id7cf3534d-5f90-4c39-9cae-17503aff51c8"><enum>(A)</enum><text display-inline="yes-display-inline">in the subsection heading, by striking
<quote><header-in-text level="subsection" style="OLC">Emergency</header-in-text></quote> and inserting
<quote><header-in-text level="subsection" style="OLC">Emergency or Threat
Justifying Emergency Authorized Use</header-in-text></quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idc870b423-3bda-4645-8746-f644925c7396"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<clause commented="no" display-inline="no-display-inline" id="id96673e42-092b-4647-9cc8-d507e28eb7a6"><enum>(i)</enum><text display-inline="yes-display-inline">in the matter preceding subparagraph (A),
by striking <quote>may declare an emergency</quote> and inserting <quote>may
make a declaration that the circumstances exist</quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id90D7141B35C64043BA8596173CE8C624"><enum>(ii)</enum><text display-inline="yes-display-inline">in subparagraph (A), by striking
<quote>specified</quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idbd91e33e-b3c7-4c45-ae7f-ec4d58133ba9"><enum>(iii)</enum><text display-inline="yes-display-inline">in subparagraph (B)—</text>
<subclause commented="no" display-inline="no-display-inline" id="idEA2E427C0CCA4573BFDB5EFD422F8511"><enum>(I)</enum><text display-inline="yes-display-inline">by striking <quote>specified</quote>;
and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id318C8A1F95CB4ED29BE7C84B942B8A1D"><enum>(II)</enum><text display-inline="yes-display-inline">by striking <quote>; or</quote> and
inserting a semicolon;</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="id108d5017-932e-46a0-8a14-e73cfcc6ef65"><enum>(iv)</enum><text display-inline="yes-display-inline">by amending subparagraph (C) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="idF1A986E27E144CC79AB309DA4BD4146D" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="IDa06c17dbba314da1a07b4988b6e44dbf"><enum>(C)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block>
</clause><clause commented="no" display-inline="no-display-inline" id="id93ef1b86-f902-4e57-bc1b-44fccbee7846"><enum>(v)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id3c3c06fe-3cbe-466c-a3f3-747d9022452e" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="idca5b7279-9ab1-4dd5-8c5f-4214e08f0cf9"><enum>(D)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idd6058143-4760-4d8c-b447-87d5acf3d494"><enum>(C)</enum><text display-inline="yes-display-inline">in paragraph (2)(A)—</text>
<clause commented="no" display-inline="no-display-inline" id="idDA44570383F443D29909EC53E5514CF2"><enum>(i)</enum><text display-inline="yes-display-inline">by amending clause (ii) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="id405A4A2563C7487781B7B06052936DDF" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="idc690a580-dcc0-4f74-8986-142190eeff74"><enum>(ii)</enum><text display-inline="yes-display-inline">a change in the approval status of the
product such that the circumstances described in subsection (a)(2) have ceased
to exist.</text>
</clause><after-quoted-block>;
</after-quoted-block></quoted-block>
</clause><clause commented="no" display-inline="no-display-inline" id="id5944CC4714154AEF8873FA893646899D"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking subparagraph (B); and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id41D2D772302E467B8607201D985A2F28"><enum>(iii)</enum><text display-inline="yes-display-inline">by redesignating subparagraph (C) as
subparagraph (B);</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1DE75A89838645E2A57A055057F0A49D"><enum>(D)</enum><text display-inline="yes-display-inline">in paragraph (4), by striking
<quote>advance notice of termination, and renewal under this
subsection.</quote> and inserting <quote>, 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.</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id023AAD3A615544DB91F50BBE484408E0"><enum>(E)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idE4E40B8390304331B92F86798819D956" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idAC86EF6F747B4AD495FAF79A5427B438"><enum>(5)</enum><header display-inline="yes-display-inline">Explanation by Secretary</header><text display-inline="yes-display-inline">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.</text>
</paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id44c43f7b-89c7-4e20-932c-0811b3ef14b7"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (c)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ide486dcb9-bbf5-48e7-bae7-63856a4135e0"><enum>(A)</enum><text display-inline="yes-display-inline">in the matter preceding paragraph
(1)—</text>
<clause commented="no" display-inline="no-display-inline" id="idf0b373b2-4f8e-445a-b49f-36e8eee7d1e8"><enum>(i)</enum><text display-inline="yes-display-inline">by inserting <quote>the Assistant Secretary
for Preparedness and Response,</quote> after <quote>consultation
with</quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id26765536-47ad-406c-b665-76ac4b64c07c"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>Health and</quote> and
inserting <quote>Health, and</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id413fd39d-0a33-4baf-873b-342335150c7c"><enum>(iii)</enum><text display-inline="yes-display-inline">by striking <quote>circumstances of the
emergency involved</quote> and inserting <quote>applicable circumstances
described in subsection (b)(1)</quote>;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id91AF352A4EBF47BF877AF3A39A0D28DE"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking
<quote>specified</quote> and inserting <quote>referred to</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3d0f1258-e98b-488e-a6d9-c55a8c7b5264"><enum>(C)</enum><text display-inline="yes-display-inline">in paragraph (2)(B), by inserting <quote>,
taking into consideration the material threat posed by the agent or agents
identified in a declaration under subsection (b)(1)(D), if applicable</quote>
after <quote>risks of the product</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1A9881AC610443129FB6875F84B035C5"><enum>(4)</enum><text display-inline="yes-display-inline">in subsection (d)(3), by inserting <quote>,
to the extent practicable given the circumstances of the emergency,</quote>
after <quote>including</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idab578994-7f88-4a0a-9b77-27472c6a9bb8"><enum>(5)</enum><text display-inline="yes-display-inline">in subsection (e)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idE14184BE1DC4430C9580DC00042F60C8"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)(A), by striking
<quote>circumstances of the emergency</quote> and inserting <quote>applicable
circumstances described in subsection (b)(1)</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ida7be6208-06e5-4979-9646-aea959190e36"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text>
<clause commented="no" display-inline="no-display-inline" id="idBBA22882267F438EBDB79B6E49BAF11A"><enum>(i)</enum><text display-inline="yes-display-inline">in subparagraph (A)—</text>
<subclause commented="no" display-inline="no-display-inline" id="id9D5E3B6429A74622B23006734C519505"><enum>(I)</enum><text display-inline="yes-display-inline">by striking <quote>manufacturer of the
product</quote> and inserting <quote>person</quote>;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id703B243E365C4B968DD13C6D3D53B545"><enum>(II)</enum><text display-inline="yes-display-inline">by striking <quote>circumstances of the
emergency</quote> and inserting <quote>applicable circumstances described in
subsection (b)(1)</quote>; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id0F656E8775224B0F88543B76F53DE532"><enum>(III)</enum><text display-inline="yes-display-inline">by inserting at the end before the period
<quote>or in paragraph (1)(B)</quote>;</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="id964587564BE14F79B94EF1B51558F0D8"><enum>(ii)</enum><text display-inline="yes-display-inline">in subparagraph (B)(i), by inserting before
the period at the end <quote>, except as provided in section 564A with respect
to authorized changes to the product expiration date</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idDBEB587F005245D2B8B43294436CAB9C"><enum>(iii)</enum><text display-inline="yes-display-inline">by amending subparagraph (C) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="id7C56D8B35EF14251B920084A52D86888" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="id4E3B7513F57C4F35BAEBBFE65D7CDC57"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id06dce148-9f04-439b-b136-a68135acd0d8"><enum>(C)</enum><text display-inline="yes-display-inline">by amending paragraph (3) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="idC69C2915DD94409F97EBAB716B202AFF" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idEE6972BD9F4740A292F3761A5C205373"><enum>(3)</enum><header display-inline="yes-display-inline">Good manufacturing practice;
prescription</header><text display-inline="yes-display-inline">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)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idFC8D85D0EA104EE7A854972554803332"><enum>(A)</enum><text display-inline="yes-display-inline">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);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idF449677587424B49836A8305DE743170"><enum>(B)</enum><text display-inline="yes-display-inline">requirements established under section
503(b); and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id45075275CC4D449B81D697C3A3677B38"><enum>(C)</enum><text display-inline="yes-display-inline">requirements established under section
520(e).</text>
</subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7f757e3a-ac72-4543-ab42-592ea659d6e5"><enum>(6)</enum><text display-inline="yes-display-inline">in subsection (g)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ida45d193a-c640-4257-b22f-5286dee0c4ce"><enum>(A)</enum><text display-inline="yes-display-inline">in the subsection heading, by inserting
<quote><header-in-text level="subsection" style="OLC">Review
and</header-in-text></quote> before <quote><header-in-text level="subsection" style="OLC">Revocation</header-in-text></quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idab17bc99-7bb9-4fd2-bd47-5292675251ba"><enum>(B)</enum><text display-inline="yes-display-inline">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—</text>
<quoted-block display-inline="no-display-inline" id="id89883747-2e51-460e-8248-1709501f4f54" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="id0bfb1957-31ab-43dc-a6a6-15a0951c8623"><enum>(A)</enum><text display-inline="yes-display-inline">an unapproved product for which an
authorization was issued under this section; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id17cd05af-c29c-44c2-9f33-0ff2382fb851"><enum>(B)</enum><text display-inline="yes-display-inline">an unapproved use of an approved product
for which an authorization was issued under this
section.</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3dd564ed-2a2b-4bfd-8d51-cafd06c6bf44"><enum>(C)</enum><text display-inline="yes-display-inline">by amending paragraph (2) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="idef8c73e6-4802-4c08-91ec-88574731967a" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="id9cb164ff-1bec-4608-a9c7-611a97e7b56e"><enum>(2)</enum><header display-inline="yes-display-inline">Revision and revocation</header><text display-inline="yes-display-inline">The Secretary may revise or revoke an
authorization under this section if—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="iddb243800-d698-4cdc-8699-d55318315b58"><enum>(A)</enum><text display-inline="yes-display-inline">the circumstances described under
subsection (b)(1) no longer exist;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3cb077f0-544c-4226-aa1e-a846deb1e2e5"><enum>(B)</enum><text display-inline="yes-display-inline">the criteria under subsection (c) for
issuance of such authorization are no longer met; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id380c3d82-9b97-48c9-a56f-754b4980879b"><enum>(C)</enum><text display-inline="yes-display-inline">other circumstances make such revision or
revocation appropriate to protect the public health or
safety.</text>
</subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0ab5fc1b-fb7f-4bb7-9936-84f63241fabf"><enum>(7)</enum><text display-inline="yes-display-inline">in subsection (h)(1), by adding after the
period at the end the following: <quote>The Secretary shall make any revisions
to an authorization under this section available on the Internet Web site of
the Food and Drug Administration.</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9EABDEA7E8784BE7AD4644DF45C2E2B8"><enum>(8)</enum><text display-inline="yes-display-inline">by adding at the end of subsection (j) the
following:</text>
<quoted-block display-inline="no-display-inline" id="idD5579AB52FF34895ABA82669DA7CCDBA" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idD971C9D66EBB4E26A5F376BC12FC27D8"><enum>(4)</enum><text display-inline="yes-display-inline">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).</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idFA18ECF49566477B81A3828B7080221E"><enum>(b)</enum><header display-inline="yes-display-inline">Emergency use of medical
products</header><text display-inline="yes-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="idfbcadd31-cbb2-40d0-be3a-2ac4c8fb1912" style="OLC">
<section commented="no" display-inline="no-display-inline" id="id11a6c0e2-8fae-4d47-9134-fe373a5fd97b" section-type="subsequent-section"><enum>564A.</enum><header display-inline="yes-display-inline">Emergency use of medical products</header>
<subsection commented="no" display-inline="no-display-inline" id="id80F61C007A264A2EBE1FAED4642B39D8"><enum>(a)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this section:</text>
<paragraph commented="no" display-inline="no-display-inline" id="idCE1661B310E54DB88AC14DFF683446C4"><enum>(1)</enum><header display-inline="yes-display-inline">Eligible product</header><text display-inline="yes-display-inline">The term <term>eligible product</term>
means a product that—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDd1f01fb8fd9847e6b99cbacc800da0d3"><enum>(A)</enum><text display-inline="yes-display-inline">is approved or cleared under this chapter
or licensed under section 351 of the Public Health Service Act;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idC85BA02AA5B44F89946AC2D9A1EF2353"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="id757FFF236D45437494F815F5E17E2CBB"><enum>(i)</enum><text display-inline="yes-display-inline">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</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id367272075D8A459E99475D8192CA07D1" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">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</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idE612AF5840884CEBAF515AF90F648F18"><enum>(C)</enum><text display-inline="yes-display-inline">is intended for use during the
circumstances under which—</text>
<clause commented="no" display-inline="no-display-inline" id="id84DC7BE84B4241CB8893958BED18B113"><enum>(i)</enum><text display-inline="yes-display-inline">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</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idEC5F7328F61C43FE95039AD8F9F272A8"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id736F0CA1DBD94002AD2C6C8CED406F92"><enum>(2)</enum><header display-inline="yes-display-inline">Product</header><text display-inline="yes-display-inline">The term <term>product</term> means a drug,
device, or biological product.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idE59F91D54DDE46D6BE3338275ADAFF90"><enum>(b)</enum><header display-inline="yes-display-inline">Extension of expiration date</header>
<paragraph commented="no" display-inline="no-display-inline" id="id89acbbe9-58c8-4372-b159-5757d63bd3b2"><enum>(1)</enum><header display-inline="yes-display-inline">Authority to extend expiration
date</header><text display-inline="yes-display-inline">The Secretary may extend
the expiration date of an eligible product in accordance with this
subsection.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id374e5443-fc1d-4d8f-a937-2a3b7d8cf89c"><enum>(2)</enum><header display-inline="yes-display-inline">Expiration date</header><text display-inline="yes-display-inline">For purposes of this subsection, the term
<term>expiration date</term> 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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3522ed5c-b46e-4874-932f-5665bd721439"><enum>(3)</enum><header display-inline="yes-display-inline">Effect of extension</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idAEC0A9A343E743ADBCC2E9E206E5A40C"><enum>(A)</enum><text display-inline="yes-display-inline">an unapproved product; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4EC6F78F1DA94012863197B9515B20B6"><enum>(B)</enum><text display-inline="yes-display-inline">adulterated or misbranded under this
Act.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id10195a1d-df50-4304-bcea-3dd081a59d1b"><enum>(4)</enum><header display-inline="yes-display-inline">Determinations by Secretary</header><text display-inline="yes-display-inline">Before extending the expiration date of an
eligible product under this subsection, the Secretary shall determine—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id0f71d38b-1170-421e-8ec4-7d715f4edddc"><enum>(A)</enum><text display-inline="yes-display-inline">that extension of the expiration date will
help protect public health;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id00992956-7078-48ee-b9c4-0bc07e952c21"><enum>(B)</enum><text display-inline="yes-display-inline">that any extension of expiration is
supported by scientific evaluation that is conducted or accepted by the
Secretary;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id8e24a1cf-5bb4-41a2-8b39-8f607af140f2"><enum>(C)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idFF6BE662EC834AD79BE99E00CB822BAC"><enum>(D)</enum><text display-inline="yes-display-inline">that any other conditions that the
Secretary deems appropriate have been met.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id542e906c-0a80-423f-ad98-9d4654ece7f2"><enum>(5)</enum><header display-inline="yes-display-inline">Scope of extension</header><text display-inline="yes-display-inline">With respect to each extension of an
expiration date granted under this subsection, the Secretary shall
determine—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id7223efb8-60a8-4358-8dfa-4b7cb4d3b1fd"><enum>(A)</enum><text display-inline="yes-display-inline">the batch, lot, or unit to which such
extension shall apply;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id84906561-57ab-47f6-8b60-e53a6a9de9e5"><enum>(B)</enum><text display-inline="yes-display-inline">the duration of such extension; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id13c63c78-1514-4ef0-873b-4942eed55e8d"><enum>(C)</enum><text display-inline="yes-display-inline">any conditions to effectuate such extension
that are necessary and appropriate to protect public health or safety.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idBC7E65EB621C40758F506847ECE50973"><enum>(c)</enum><header display-inline="yes-display-inline">Current good manufacturing
practice</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID00cc92f38678457ebbaf27f559dde01f"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID97a8264c2cd64d96ac4cf7edf99d0e25"><enum>(2)</enum><header display-inline="yes-display-inline">Effect</header><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id033C3CFF78454D53BEAA67377F1DE50C"><enum>(d)</enum><header display-inline="yes-display-inline">Emergency use instructions</header>
<paragraph commented="no" display-inline="no-display-inline" id="IDa3a9e83bafd942af815f4fa35a1fd423"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDd06e3be6dd39499084d4c2ae57aac0ae"><enum>(2)</enum><header display-inline="yes-display-inline">Effect</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID2449957717b04486b9aa366435681744"><enum>(A)</enum><text display-inline="yes-display-inline">during an emergency response to an actual
emergency that is the basis for a determination described in subsection
(a)(1)(C)(i); or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idDCF5957D075D4EACA19028ACDD912C13"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id60D99CE99EB44B41AEC9364C95B372AE"><enum>(c)</enum><header display-inline="yes-display-inline">Risk evaluation and mitigation
strategies</header><text display-inline="yes-display-inline">Section 505–1 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1), is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDd8f3b17f6a5f44a29c7938a9ccd37697"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (f), by striking paragraph
(7); and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID463bca1376b74caa8d5c101e604ed0ef"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idCD6FE615616340A8AC012B6F870E81E1" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="idE88EBF8E8C8C46608009CC87B232EB17"><enum>(k)</enum><header display-inline="yes-display-inline">Waiver in public health
emergencies</header><text display-inline="yes-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idDF7045FA855C4B44AF4B9441C7D912A5"><enum>(1)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id21945367159A4893806E980132DE0371"><enum>(2)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID68bde34599b44e45b5d71867052e6411"><enum>(d)</enum><header display-inline="yes-display-inline">Products held for emergency
use</header><text display-inline="yes-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="idB79773350D19404AA746E5F5F2DC7149" style="OLC">
<section commented="no" display-inline="no-display-inline" id="ID39580762d23d4edcbe6517e7e30574e9" section-type="subsequent-section"><enum>564B.</enum><header display-inline="yes-display-inline">Products held for emergency
use</header><text display-inline="no-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="ID9af18e5cbe9844149592b3ca60a72e62"><enum>(1)</enum><text display-inline="yes-display-inline">is intended to be held and not used;
and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDec849d539b5a4af3af82b6bc5b87f8af"><enum>(2)</enum><text display-inline="yes-display-inline">is held and not used, unless and until that
product—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID939d5cad76924af589e91630b4663c46"><enum>(A)</enum><text display-inline="yes-display-inline">is approved, cleared, or licensed under
section 505, 510(k), or 515 of this Act or section 351 of the Public Health
Service Act;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID868b49d6d80b4705bd52c9fee914131e"><enum>(B)</enum><text display-inline="yes-display-inline">is authorized for investigational use under
section 505 or 520 of this Act or section 351 of the Public Health Service Act;
or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID6756577000464654af37c895ccd48d11"><enum>(C)</enum><text display-inline="yes-display-inline">is authorized for use under section
564.</text>
</subparagraph></paragraph></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" display-inline="no-display-inline" id="ida4ea2833-17d0-4373-a7bf-39d29d068534" section-type="subsequent-section"><enum>303.</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="no-display-inline">Section 565 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb–4) is amended by striking <quote>The Secretary,
in consultation</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="id9ee8a67d-81f3-48ae-8faf-4800989e97d3" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id51944f98-2ae2-498b-868c-183bd4602b54"><enum>(a)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this section—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id5e452ac3-7fb6-4f50-88f8-5664e3bb7d08"><enum>(1)</enum><text display-inline="yes-display-inline">the term <term>countermeasure</term> means
a qualified countermeasure, a security countermeasure, and a qualified pandemic
or epidemic product;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ide342f336-66a5-409f-a06d-fbce77904c66"><enum>(2)</enum><text display-inline="yes-display-inline">the term <term>qualified
countermeasure</term> has the meaning given such term in section 319F–1 of the
Public Health Service Act;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idc12c88be-490a-4c44-a3b5-afd8e66a82a3"><enum>(3)</enum><text display-inline="yes-display-inline">the term <term>security
countermeasure</term> has the meaning given such term in section 319F–2 of such
Act; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf84725a5-d859-43b9-9383-2235ec42771d"><enum>(4)</enum><text display-inline="yes-display-inline">the term <term>qualified pandemic or
epidemic product</term> means a product that meets the definition given such
term in section 319F–3 of the Public Health Service Act and—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id3AAD1292F6C142B18AD7EB95267A6A72"><enum>(A)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA1060B6ED89E4DA59323683EA6C2CFFC"><enum>(B)</enum><text display-inline="yes-display-inline">is included under this paragraph pursuant
to a determination by the Secretary.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idbb32286b-8c07-460e-933c-ed6a3dd59745"><enum>(b)</enum><header display-inline="yes-display-inline">General
duties</header><text display-inline="yes-display-inline">The Secretary, in
consultation</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="id834004ea-da63-4b55-9489-ee970e842f4b" section-type="subsequent-section"><enum>304.</enum><header display-inline="yes-display-inline">Enhancing medical countermeasure
activities</header><text display-inline="no-display-inline">Section 565 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4), as amended by
section 303, is further amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idb17463ec-5a7d-4baf-ab0d-edf9ff31b3ff"><enum>(1)</enum><text display-inline="yes-display-inline">in the section heading, by striking
<quote><header-in-text level="section" style="OLC">Technical
Assistance</header-in-text></quote> and inserting <quote><header-in-text level="section" style="OLC">Countermeasure Development, Review, and Technical
Assistance</header-in-text></quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf96399e6-af4a-4b65-ae38-854ab39ac84f"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b), by striking the
subsection heading and all that follows through <quote>shall establish</quote>
and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="idd4743f52-c87d-4333-81d0-204a15614edb" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id511cc603-14b4-493f-935b-a6dcb3d11414"><enum>(b)</enum><header display-inline="yes-display-inline">General
duties</header><text display-inline="yes-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id3bc35290-3eeb-4278-b73c-16bf4856d5bc"><enum>(1)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idcc7daf02-aa82-40ad-ac14-a23a9910bfc0"><enum>(2)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idcd20197a-5a0c-41a9-a99a-37f17209a5aa"><enum>(3)</enum><text display-inline="yes-display-inline">promote countermeasure expertise within the
Food and Drug Administration by—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id4e20b85b-feb4-439e-9e1b-5fa7904676cb"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ida4ec7a8e-5242-4e1d-af6d-9dac2ec58ff5"><enum>(B)</enum><text display-inline="yes-display-inline">training Food and Drug Administration
personnel regarding review of countermeasures for approval, licensure, or
clearance;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id14e6e83e-1eda-4e7a-bd2e-8e8b472569f9"><enum>(C)</enum><text display-inline="yes-display-inline">holding public meetings at least twice
annually to encourage the exchange of scientific ideas; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id790b35ea-1567-4296-a5c8-151756856e3f"><enum>(D)</enum><text display-inline="yes-display-inline">establishing protocols to ensure that
countermeasure reviewers have sufficient training or experience with
countermeasures;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id73ba6478-98ac-45e5-aaad-a39a03517b64"><enum>(4)</enum><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ide0caaf3f-da4f-444f-b4aa-cf47c200e053"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2ce975fd-9d15-48f1-9d0f-36da764c3be4"><enum>(B)</enum><text display-inline="yes-display-inline">improve and advance the science relating to
the development of new tools, standards, and approaches to assessing and
evaluating countermeasures—</text>
<clause commented="no" display-inline="no-display-inline" id="id02a2a0c5-9f7c-4ebb-82e4-65870911db45"><enum>(i)</enum><text display-inline="yes-display-inline">in order to inform the process for
countermeasure approval, clearance, and licensure; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idd301fc2c-fdf5-47ff-936f-17bfa18da409"><enum>(ii)</enum><text display-inline="yes-display-inline">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</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ide939f4b4-9f7e-468a-9a80-3842ade767bc"><enum>(5)</enum><text display-inline="yes-display-inline">establish</text>
</paragraph></subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf4416e3d-2a89-4f5d-bc71-3efbaeba2a76"><enum>(3)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id2d99401f-8e7a-45ab-bde4-00eab7cc5726" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id5a1ee887-3cde-4e12-95da-b17e3f8aaf21"><enum>(c)</enum><header display-inline="yes-display-inline">Development and animal modeling
procedures</header>
<paragraph commented="no" display-inline="no-display-inline" id="idb02f1ea4-38df-4025-9b33-5a17d8f2425d"><enum>(1)</enum><header display-inline="yes-display-inline">Availability of animal model
meetings</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id4b25a08f-4812-49a3-993b-7a6e03c0780a"><enum>(A)</enum><text display-inline="yes-display-inline">a meeting to discuss proposed animal model
development activities; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0a77c414-a873-48ad-b38c-4322508349bb"><enum>(B)</enum><text display-inline="yes-display-inline">a meeting prior to initiating pivotal
animal studies.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id90adbb29-5321-49cd-9b16-d4dc05ba5760"><enum>(2)</enum><header display-inline="yes-display-inline">Pediatric models</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id44a7f453-8123-4122-8ecf-19bcb85f4dd5"><enum>(d)</enum><header display-inline="yes-display-inline">Review and approval of
countermeasures</header>
<paragraph commented="no" display-inline="no-display-inline" id="id8c8f5750-a34f-44ea-87b4-df9daed8ff82"><enum>(1)</enum><header display-inline="yes-display-inline">Material threat</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id247e00bb-98de-4306-82a2-8baaa3fa1305"><enum>(2)</enum><header display-inline="yes-display-inline">Review expertise</header><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="idfaa6a7c0-ddf5-44b3-b84b-b6a705f905b9" section-type="subsequent-section"><enum>305.</enum><header display-inline="yes-display-inline">Regulatory management plans</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="id3cba3b04-30a9-4e2d-a607-b572b697421e" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id7786988a-dc69-4989-bd49-da009cd28499"><enum>(e)</enum><header display-inline="yes-display-inline">Regulatory management plan</header>
<paragraph commented="no" display-inline="no-display-inline" id="idB4D61644F3D344D4A9C1FA30571A84CE"><enum>(1)</enum><header display-inline="yes-display-inline">Definition</header><text display-inline="yes-display-inline">In this subsection, the term <term>eligible
countermeasure</term> means—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idCB63841648A04C7390BE3009CBAFBF2A"><enum>(A)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idE80FBEBD24D74E42BEF4476569FC3F5F"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id013e03e7-3484-4335-8fd7-1248cf18d665"><enum>(2)</enum><header display-inline="yes-display-inline">Regulatory management plan
process</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idE195F4BA996D41CD948F1D1531DBF8D0"><enum>(3)</enum><header display-inline="yes-display-inline">Submission of request and proposed plan by
sponsor or applicant</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idE3C23E1DC4644445A1F5308E4ECD76D3"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idCCB68D47BD05477A874A2BC9C4E5C5B5"><enum>(B)</enum><header display-inline="yes-display-inline">Timing of submission</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7D33064496EC41AD9B9F9F7BCFF45019"><enum>(C)</enum><header display-inline="yes-display-inline">Response by Secretary</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idfdc6e05a-6669-4705-875c-2b372df151e0"><enum>(4)</enum><header display-inline="yes-display-inline">Plan</header><text display-inline="yes-display-inline">The content of a regulatory management plan
agreed to by the Secretary and a sponsor or applicant shall include—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id5e6f7f2a-b82c-4e0b-944e-649363917e5b"><enum>(A)</enum><text display-inline="yes-display-inline">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);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide8368f22-fbe9-47bb-97c2-844c127fbb65"><enum>(B)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id86727B80129D4C188C793C29712CA137"><enum>(C)</enum><text display-inline="yes-display-inline">an agreement on how the plan shall be
modified, if needed.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD0AD97F55B374E10ACFFE0794917CBB1"><enum>(5)</enum><header display-inline="yes-display-inline">Milestones and performance
targets</header><text display-inline="yes-display-inline">The developmental
milestones described in paragraph (4)(A) and the performance targets and goals
described in paragraph (4)(B) shall include—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idbff82344-8dab-4b40-af80-812c30382e4d"><enum>(A)</enum><text display-inline="yes-display-inline">feedback from the Secretary regarding the
data required to support the approval, clearance, or licensure of the eligible
countermeasure involved;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id687f5b68-16a8-4c9c-aae2-0f5e830fe29c"><enum>(B)</enum><text display-inline="yes-display-inline">feedback from the Secretary regarding the
data necessary to inform any authorization under section 564;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id012303a5-9765-4b16-a719-014f1da92b3f"><enum>(C)</enum><text display-inline="yes-display-inline">feedback from the Secretary regarding the
data necessary to support the positioning and delivery of the eligible
countermeasure, including to the Strategic National Stockpile;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id10efb51a-799c-4e55-b782-ad16bcb36ba0"><enum>(D)</enum><text display-inline="yes-display-inline">feedback from the Secretary regarding the
data necessary to support the submission of protocols for review under section
505(b)(5)(B);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id59563041-ce43-47aa-95fd-2b8e8b0cc79d"><enum>(E)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idc6b7fbe7-9458-4d78-9613-bc457b979486"><enum>(F)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idce1991a5-d148-4f1a-80e0-19e19c957478"><enum>(G)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id26817A58A9E447919DF3B45544517189"><enum>(6)</enum><header display-inline="yes-display-inline">Prioritization</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="idfed9edc4-f439-4da3-ae46-f795ce261b3a" section-type="subsequent-section"><enum>306.</enum><header display-inline="yes-display-inline">Report</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="idab985598-a11a-4a02-8aa2-9a04eb256915" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="iddad01f0e-0659-4cb7-af90-474cd3f786b0"><enum>(f)</enum><header display-inline="yes-display-inline">Annual report</header><text display-inline="yes-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idc316d9be-9b5f-4366-a9ee-a539de3ec451"><enum>(1)</enum><text display-inline="yes-display-inline">with respect to the development of new
tools, standards, and approaches to assess and evaluate countermeasures—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ida4c3dbcd-d5c5-44d1-8943-e9c6abde81fc"><enum>(A)</enum><text display-inline="yes-display-inline">the identification of the priorities of the
Food and Drug Administration and the progress made on such priorities;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ida65d4701-99ef-4262-8aa6-9a3bf33d371f"><enum>(B)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7f1cac08-1040-43f7-be62-42938f39e1fc"><enum>(2)</enum><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id24b1c27e-bf65-4b63-9bf6-911e3a7052d6"><enum>(A)</enum><text display-inline="yes-display-inline">whether the regulatory management plan was
completed within the required timeframe, and the length of time taken to
complete such plan;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id96328c80-e8fa-4fe0-a20b-318fcc16442d"><enum>(B)</enum><text display-inline="yes-display-inline">whether the Secretary adhered to the timely
and appropriate response times set forth in such plan; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id81e2a52d-154b-41db-8339-b1b8ae807541"><enum>(C)</enum><text display-inline="yes-display-inline">explanations for any failure to meet such
performance targets and goals;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3c6a6d60-b5e3-4833-be42-26f85245844c"><enum>(3)</enum><text display-inline="yes-display-inline">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);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ide13f6704-564d-4ada-8780-213c88806def"><enum>(4)</enum><text display-inline="yes-display-inline">an estimate of resources obligated to
countermeasure development and regulatory assessment, including Center specific
objectives and accomplishments;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6b98eb9a-fb14-4bb8-a871-98ada91236d7"><enum>(5)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID3b8753ce864a44e5bd2598acb2f87f78"><enum>(6)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="id312cefd9-37d1-4a61-b2c2-70a609bcbbb5" section-type="subsequent-section"><enum>307.</enum><header display-inline="yes-display-inline">Pediatric medical countermeasures</header>
<subsection commented="no" display-inline="no-display-inline" id="id8da95f1a-3494-4510-8790-43c37de899f2"><enum>(a)</enum><header display-inline="yes-display-inline">Pediatric studies of drugs</header><text display-inline="yes-display-inline">Section 505A of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355a) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id4a72165a-49b5-4191-aa4f-4a433a92e78b"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (d), by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="idf9709281-f3dc-432b-a503-9a6486509f92" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="id2d286ec9-c6ba-49cf-97ed-eaacf7a1ee6c"><enum>(5)</enum><header display-inline="yes-display-inline">Consultation</header><text display-inline="yes-display-inline">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.</text>
</paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ida3c1d4c0-ff2c-4cbf-b362-c5af483e42dc"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (n)(1), by adding at the end
the following:</text>
<quoted-block display-inline="no-display-inline" id="id52f8d8fd-907c-4bed-ae68-ff63dd990292" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="id32d7327a-61a1-4183-86b5-6dbe0e7ab940"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idf187ad88-84d7-4d4a-8892-3acf004f1bce"><enum>(b)</enum><header display-inline="yes-display-inline">Addition to priority list
considerations</header><text display-inline="yes-display-inline">Section 409I
of the Public Health Service Act (42 U.S.C. 284m) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id8c0ccff4-1152-446a-a6c1-ce415881906c"><enum>(1)</enum><text display-inline="yes-display-inline">by striking subsection (a)(2) and inserting
the following:</text>
<quoted-block display-inline="no-display-inline" id="id0e2bf9d7-04c8-4bcb-a21a-f2ecf2335bc9" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="id1219abc0-06c9-4ecc-9660-28c3b2c30b8f"><enum>(2)</enum><header display-inline="yes-display-inline">Consideration of available
information</header><text display-inline="yes-display-inline">In developing and
prioritizing the list under paragraph (1), the Secretary—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ida2913b8c-9f40-47f6-b385-a2ead6e24d4d"><enum>(A)</enum><text display-inline="yes-display-inline">shall consider—</text>
<clause commented="no" display-inline="no-display-inline" id="id83949d16-25ec-4b5f-9532-6fe6f47b1abd"><enum>(i)</enum><text display-inline="yes-display-inline">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;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id3ca45a2c-cea0-4598-89f9-006e1c8e4f94"><enum>(ii)</enum><text display-inline="yes-display-inline">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</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id0c9a0cb7-16d5-4d03-ad32-1f455e758b96"><enum>(iii)</enum><text display-inline="yes-display-inline">the adequacy of necessary infrastructure to
conduct pediatric pharmacological research, including research networks and
trained pediatric investigators; and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6a13edbd-f43e-4161-ae50-5b152a8a5cdd"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><after-quoted-block>; and
</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idcc5f47bd-29ac-471c-8306-3af9d0e20c43"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b), by striking
<quote>subsection (a)</quote> and inserting <quote>paragraphs (1) and (2)(A) of
subsection (a)</quote>.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id8fb5b6aa-d04d-45c7-8192-2c65b3940820"><enum>(c)</enum><header display-inline="yes-display-inline">Advice and recommendations of the pediatric
advisory committee regarding countermeasures for pediatric
populations</header><text display-inline="yes-display-inline">Subsection (b)(2)
of section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m
note) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id4126af1a-f5bb-4542-a1b5-eeed733073d2"><enum>(1)</enum><text display-inline="yes-display-inline">in subparagraph (C), by striking the period
and inserting <quote>; and</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id47791b77-19fe-41bb-9a42-d30b80a97d57"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idc9b972eb-d76b-4e47-a808-778ddea7e0c4" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="id00e88b3e-16e4-4187-a106-415ae7bf7849"><enum>(D)</enum><text display-inline="yes-display-inline">the development of countermeasures (as
defined in section 565(a) of the Federal Food, Drug, and Cosmetic Act) for
pediatric
populations.</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection></section><enum>IV</enum><header display-inline="yes-display-inline">Accelerating medical countermeasure
advanced research and development</header>
<section commented="no" display-inline="no-display-inline" id="id6309a68f-0f00-45fd-9866-b8c9b85efddc" section-type="subsequent-section"><enum>401.</enum><header display-inline="yes-display-inline">BioShield</header>
<subsection commented="no" display-inline="no-display-inline" id="id6276ea7c-61f4-4eca-a4cb-534d690aff8e"><enum>(a)</enum><header display-inline="yes-display-inline">Reauthorization of the special reserve
fund</header><text display-inline="yes-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="idd796f855-3ca1-4fea-b2be-f26efcca8d0f" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idc338c806-4a1a-4dfd-aa7c-53a56538c4ae"><enum>(11)</enum><header display-inline="yes-display-inline">Reauthorization of the special reserve
fund</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf36e714d-1600-49f9-bee5-4f33545130f7"><enum>(12)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id76a79e10-159d-4970-86e5-cf8d7ba0308d"><enum>(A)</enum><text display-inline="yes-display-inline">in meeting the security countermeasure
needs identified under this section; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3002c7d9-4c84-46cf-af8d-3f564189cb76"><enum>(B)</enum><text display-inline="yes-display-inline">on the biennial Public Health Emergency
Medical Countermeasures Enterprise and Strategy Implementation Plan (pursuant
to section
2811(d)).</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idd2226b38-c2bc-4785-87e1-86652e8b5c57"><enum>(b)</enum><header display-inline="yes-display-inline">Procurement of
countermeasures</header><text display-inline="yes-display-inline">Section
319F–2(c) of the Public Health Service Act (42 U.S.C. 247d–6b(c)) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idd11e6844-a153-4e36-9840-399a041c116f"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1)(B)(i)(III)(bb), by
striking <quote>eight years</quote> and inserting <quote>10
years</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0d5e693a-e2ff-42e7-8832-d9220f3ae120"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (5)(B)(ii), by striking
<quote>eight years</quote> and inserting <quote>10 years</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idd903fee9-6446-46ec-806a-af8bc02d6f5f"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (7)(C)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id6b05ef56-be30-4910-a1b8-ab385f7a1375"><enum>(A)</enum><text display-inline="yes-display-inline">in clause (i)(I), by inserting
<quote>including advanced research and development,</quote> after <quote>as may
reasonably be required,</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id81862d7a-e4af-47af-9253-d5332e6b94f2"><enum>(B)</enum><text display-inline="yes-display-inline">in clause (ii)—</text>
<clause commented="no" display-inline="no-display-inline" id="id338d4e69-8bf2-42ea-a1a7-f90dd746f404"><enum>(i)</enum><text display-inline="yes-display-inline">in subclause (III), by striking
<quote>eight years</quote> and inserting <quote>10 years</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id02b487cd-91b5-4a57-a5e4-b849f93767af"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking subclause (IX) and inserting
the following:</text>
<quoted-block display-inline="no-display-inline" id="id54baf3c8-96c0-42a3-bb4f-7f600879b441" style="OLC">
<subclause commented="no" display-inline="no-display-inline" id="id6b54d725-a36a-4f03-9230-4569a8f7f2fd"><enum>(IX)</enum><header display-inline="yes-display-inline">Contract
terms</header><text display-inline="yes-display-inline">The Secretary, in any
contract for procurement under this section—</text>
<item commented="no" display-inline="no-display-inline" id="idcc614e86-76f9-42bc-b86a-bc1f59f8f265"><enum>(aa)</enum><text display-inline="yes-display-inline">may specify—</text>
<subitem commented="no" display-inline="no-display-inline" id="id8a363121-9a64-4118-9eb1-44ee9d7c22f4"><enum>(AA)</enum><text display-inline="yes-display-inline">the dosing and administration requirements
for the countermeasure to be developed and procured;</text>
</subitem><subitem commented="no" display-inline="no-display-inline" id="idff5889ae-ee4f-4f08-981f-31fa77eaafb9"><enum>(BB)</enum><text display-inline="yes-display-inline">the amount of funding that will be
dedicated by the Secretary for advanced research, development, and procurement
of the countermeasure; and</text>
</subitem><subitem commented="no" display-inline="no-display-inline" id="id0b11c893-edf5-45aa-9ce0-0a869fdddcf2"><enum>(CC)</enum><text display-inline="yes-display-inline">the specifications the countermeasure must
meet to qualify for procurement under a contract under this section; and</text>
</subitem></item><item commented="no" display-inline="no-display-inline" id="idacfe7e48-c7ec-4355-9191-b3bfa71fd5f6"><enum>(bb)</enum><text display-inline="yes-display-inline">shall provide a clear statement of defined
Government purpose limited to uses related to a security countermeasure, as
defined in paragraph (1)(B).</text>
</item></subclause><after-quoted-block>;
and</after-quoted-block></quoted-block>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4f5553f9-6d9a-48d9-9440-4a479b0eea46"><enum>(C)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id7c64b471-f236-4b04-92be-90aec1a2d557" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="idcc0b194e-a9bd-4f2f-9758-d40032cce9bf"><enum>(viii)</enum><header display-inline="yes-display-inline">Flexibility</header><text display-inline="yes-display-inline">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.</text>
</clause><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idefabf4bf-50c8-4d21-aa51-5d12a909ca3d"><enum>(4)</enum><text display-inline="yes-display-inline">in paragraph (9)(B), by inserting before
the period the following: <quote>, except that this subparagraph shall not be
construed to prohibit the use of such amounts as otherwise authorized in this
title</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id11c33f18-66f1-4ea4-96b8-15485bb39d03"><enum>(5)</enum><text display-inline="yes-display-inline">in paragraph (10), by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="id219dd2f7-65ec-4183-9422-d253d15328cb" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="idec07ebd8-504f-4098-9c0d-44e714b21fc1"><enum>(C)</enum><header display-inline="yes-display-inline">Advanced research and
development</header><text display-inline="yes-display-inline">For purposes of
this paragraph, the term <term>advanced research and development</term> shall
have the meaning given such term in section
319L(a).</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="idf31301de-3f5c-45f9-86f4-e369b9035a0b" section-type="subsequent-section"><enum>402.</enum><header display-inline="yes-display-inline">Biomedical Advanced Research and
Development Authority</header>
<subsection commented="no" display-inline="no-display-inline" id="idd6fc6fb2-1138-41db-9c98-26603b89f031"><enum>(a)</enum><header display-inline="yes-display-inline">Duties</header><text display-inline="yes-display-inline">Section 319L(c)(4) of the Public Health
Service Act (42 U.S.C. 247d–7e(c)(4)) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id8f7895ca-7e2f-4b61-b676-64aae758227b"><enum>(1)</enum><text display-inline="yes-display-inline">in subparagraph (B)(iii), by inserting
<quote>(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)</quote> after <quote>development</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id117c7c43-338d-4f66-8bd8-6e157dc65921"><enum>(2)</enum><text display-inline="yes-display-inline">in subparagraph (D)(iii), by striking
<quote>and vaccine manufacturing technologies</quote> and inserting
<quote>vaccine manufacturing technologies, dose sparing technologies, efficacy
increasing technologies, and platform technologies</quote>.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id91CC328F49C34EF3974DE4E6713E64C9"><enum>(b)</enum><header display-inline="yes-display-inline">Strategic public-private
partnership</header><text display-inline="yes-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="id04086B89C3444F179CC083FDF5B233E2" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="id3FB55C0B31084C929C54247A4F09F54D"><enum>(E)</enum><header display-inline="yes-display-inline">Strategic investor</header>
<clause commented="no" display-inline="no-display-inline" id="ID27ffdebffe3a491b85649b0775a630bf"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID9c3177e0bfe74e11bb4ea82b6b6c516f"><enum>(I)</enum><text display-inline="yes-display-inline">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;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDf52e7cc0d0eb4b4ab2495cc5dc3314f1"><enum>(II)</enum><text display-inline="yes-display-inline">promote the development of new and
promising technologies that address urgent medical countermeasure needs, as
identified by the Secretary;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDa9bcb4c9f9b34b28ba392a4124ad2f25"><enum>(III)</enum><text display-inline="yes-display-inline">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</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id51AF0FC22A3B41D0A279C08981731ACF"><enum>(IV)</enum><text display-inline="yes-display-inline">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.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID4abcf26336de44ab888459e90855f547"><enum>(ii)</enum><header display-inline="yes-display-inline">Eligibility</header>
<subclause commented="no" display-inline="no-display-inline" id="idF8463EBF46224563B629FCBC6A5CD58A"><enum>(I)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">To be eligible to enter into an agreement
under clause (i) an entity shall—</text>
<item commented="no" display-inline="no-display-inline" id="ID4fd23302f1074d1e85c02676df7a3a75"><enum>(aa)</enum><text display-inline="yes-display-inline">be an independent, non-profit entity not
otherwise affiliated with the Department of Health and Human Services;</text>
</item><item commented="no" display-inline="no-display-inline" id="IDa648a5a0e9b24a1581fa55676588e776"><enum>(bb)</enum><text display-inline="yes-display-inline">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;</text>
</item><item commented="no" display-inline="no-display-inline" id="IDbb3d0405c1534f2e943aad07e926ed33"><enum>(cc)</enum><text display-inline="yes-display-inline">have experience in promoting novel
technology innovation;</text>
</item><item commented="no" display-inline="no-display-inline" id="IDf3755e08a8c64f2bb74768043f18bf9e"><enum>(dd)</enum><text display-inline="yes-display-inline">be problem driven and solution focused
based on the needs, requirements, and problems identified by the Secretary
under clause (iv);</text>
</item><item commented="no" display-inline="no-display-inline" id="IDc774a32dafe440ff933fe3642e159bb3"><enum>(ee)</enum><text display-inline="yes-display-inline">demonstrate the ability, or the potential
ability, to promote the development of medical countermeasure products;
and</text>
</item><item commented="no" display-inline="no-display-inline" id="ID0c14da39f80943d0a66b26e3443600a6"><enum>(ff)</enum><text display-inline="yes-display-inline">demonstrate expertise, or the capacity to
develop or acquire expertise, related to technical and regulatory
considerations with respect to medical countermeasures.</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="id6425B1DF048242DDB272EA9D6E6B000A"><enum>(II)</enum><header display-inline="yes-display-inline">Partnering experience</header><text display-inline="yes-display-inline">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.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDc7a9d4fd023b46949d4457485673ed32"><enum>(iii)</enum><header display-inline="yes-display-inline">Not agency</header><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID4081bbee6cff4e5eaa1ceb72d780b3a2"><enum>(iv)</enum><header display-inline="yes-display-inline">Direction</header><text display-inline="yes-display-inline">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—</text>
<subclause commented="no" display-inline="no-display-inline" id="IDa9d8664d40b44a5f825c44b968ad6db8"><enum>(I)</enum><text display-inline="yes-display-inline">communicate the medical countermeasure
needs, requirements, and problems to be addressed by the entity under the
agreement;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDeb86a3ef3807443b95f9c582b988ee10"><enum>(II)</enum><text display-inline="yes-display-inline">develop a description of work to be
performed by the entity under the agreement;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID1524433c01a54ee4a36e6594db465062"><enum>(III)</enum><text display-inline="yes-display-inline">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;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDd25217baa9ae49bf8f9111826ffeb9ba"><enum>(IV)</enum><text display-inline="yes-display-inline">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</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDe2b8f30d3866428cacb429688655fcea"><enum>(V)</enum><text display-inline="yes-display-inline">ensure, as a condition of the
agreement—</text>
<item commented="no" display-inline="no-display-inline" id="IDb8a62b1c168e4c4db49ae4c3a1a1d7b1"><enum>(aa)</enum><text display-inline="yes-display-inline">a comprehensive set of policies that
demonstrate a commitment to transparency and accountability;</text>
</item><item commented="no" display-inline="no-display-inline" id="ID19ddf5c99f9f4d59bfe3ab22b8f94816"><enum>(bb)</enum><text display-inline="yes-display-inline">protection against conflicts of interest
through a comprehensive set of policies that address potential conflicts of
interest, ethics, disclosure, and reporting requirements;</text>
</item><item commented="no" display-inline="no-display-inline" id="ID5196560c8e8d46dfadcfd3bf308aacc7"><enum>(cc)</enum><text display-inline="yes-display-inline">that the entity provides monthly accounting
on the use of funds provided under such agreement; and</text>
</item><item commented="no" display-inline="no-display-inline" id="ID9e1fcf54b57d4d3e8536b36651ddf299"><enum>(dd)</enum><text display-inline="yes-display-inline">that the entity provides on a quarterly
basis, reports regarding the progress made toward meeting the identified needs
set forth in the agreement.</text>
</item></subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID965db80927ff467d8116c4e04bb24105"><enum>(v)</enum><header display-inline="yes-display-inline">Supplement not supplant</header><text display-inline="yes-display-inline">Activities carried out under this
subparagraph shall supplement, and not supplant, other activities carried out
under this section.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID489ec1e23d9540bda1b266872755f1c4"><enum>(vi)</enum><header display-inline="yes-display-inline">No establishment of entity</header><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID67886908661c4acc854a56cae389ada7"><enum>(vii)</enum><header display-inline="yes-display-inline">Transparency and oversight</header><text display-inline="yes-display-inline">Upon request, the Secretary shall provide
to Congress the information provided to the Secretary under clause
(iv)(V)(dd).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID0623b4e64de54f64832f7c22ec4b4451"><enum>(viii)</enum><header display-inline="yes-display-inline">Independent evaluation</header><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDe791648b7493400fb8539aeb465a64a9"><enum>(ix)</enum><header display-inline="yes-display-inline">Sunset</header><text display-inline="yes-display-inline">This subparagraph shall have no force or
effect after September 30,
2016.</text>
</clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id3234ab07-33d9-4ade-beb6-e744091128fe"><enum>(c)</enum><header display-inline="yes-display-inline">Transaction authorities</header><text display-inline="yes-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="id87a0f904-95a0-4a91-b064-66324d6f1b5e" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="id356f8573-9257-4aef-9dea-1905b8e98250"><enum>(G)</enum><header display-inline="yes-display-inline">Government purpose</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id49e02596-78e9-448b-91a5-0f1d759b1956"><enum>(d)</enum><header display-inline="yes-display-inline">Fund</header><text display-inline="yes-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="id3fbb8c5c-85f2-4750-a666-4ba608caea4a" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idb0590125-dd81-4c9a-a108-b147c22a9223"><enum>(2)</enum><header display-inline="yes-display-inline">Funding</header><text display-inline="yes-display-inline">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.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ida2472223-48bb-4890-97e0-954666590395"><enum>(e)</enum><header display-inline="yes-display-inline">Continued Inapplicability of Certain
Provisions</header><text display-inline="yes-display-inline">Section
319L(e)(1)(C) of the Public Health Service Act (42 U.S.C. 247d–7e(e)(1)(C)) is
amended by striking <quote>7 years</quote> and inserting <quote>10
years</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id3c172fd1-95d0-4f39-b39f-9be382b2f5ab"><enum>(f)</enum><header display-inline="yes-display-inline">Extension of limited antitrust
exemption</header><text display-inline="yes-display-inline">Section 405(b) of
the Pandemic and All-Hazards Preparedness Act (42 U.S.C. 247d–6a note) is
amended by striking <quote>6-year</quote> and inserting
<quote>10-year</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idc8fe5fc5-8703-4c15-be76-9b435efe73a8"><enum>(g)</enum><header display-inline="yes-display-inline">Independent evaluation</header><text display-inline="yes-display-inline">Section 319L of the Public Health Service
Act (42 U.S.C. 247d–7e) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idc542bfcf-e96c-4584-96bd-b6b4688a207e" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id8b8d0885-c122-4f56-83a6-ec2dbd498e37"><enum>(f)</enum><header display-inline="yes-display-inline">Independent evaluation</header>
<paragraph commented="no" display-inline="no-display-inline" id="ide1cfb3f8-9114-4666-a402-8b84546f9e44"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idbac9600c-4730-4442-8494-6aca4ade54d5"><enum>(2)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id986b8f36-396b-40de-ac6b-7e94e6bae918"><enum>(A)</enum><text display-inline="yes-display-inline">the extent to which flexible manufacturing
capacity under this section is dedicated to chemical, biological, radiological,
and nuclear threats;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idf0d6f3fc-f513-4659-924f-a8c33497ff39"><enum>(B)</enum><text display-inline="yes-display-inline">the activities supported by flexible
manufacturing initiatives; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idf0ef1ed0-54cf-4b25-b28c-7fc089c50840"><enum>(C)</enum><text display-inline="yes-display-inline">the ability of flexible manufacturing
activities carried out under this section to—</text>
<clause commented="no" display-inline="no-display-inline" id="id7f4c9568-c15e-4354-b88e-d6bbc1b884c7"><enum>(i)</enum><text display-inline="yes-display-inline">secure and leverage leading technical
expertise with respect to countermeasure advanced research, development, and
manufacturing processes; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idc6118a82-e713-4b21-9b70-0d28c998712c"><enum>(ii)</enum><text display-inline="yes-display-inline">meet the surge manufacturing capacity needs
presented by novel and emerging threats, including chemical, biological,
radiological and nuclear
agents.</text>
</clause></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ida3649fbf-ab07-44bd-b1e0-ac753274da82"><enum>(h)</enum><header display-inline="yes-display-inline">Definitions</header>
<paragraph commented="no" display-inline="no-display-inline" id="id54e092d9-e0be-4b5c-a521-6599bed485fd"><enum>(1)</enum><header display-inline="yes-display-inline">Qualified countermeasure</header><text display-inline="yes-display-inline">Section 319F–1(a)(2)(A) of the Public
Health Service Act (42 U.S.C. 247d–6a(a)(2)(A)) is amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idf1d84807-68f8-47e0-886f-ce67242865d9"><enum>(A)</enum><text display-inline="yes-display-inline">in the matter preceding clause (i), by
striking <quote>to—</quote> and inserting <quote>—</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id9652f39c-d0d6-4beb-ad45-05c4860551b8"><enum>(B)</enum><text display-inline="yes-display-inline">in clause (i)—</text>
<clause commented="no" display-inline="no-display-inline" id="id7f4e9def-fe6c-4bbb-8555-0c201741a68b"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>diagnose</quote> and
inserting <quote>to diagnose</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id818ffa6e-cad5-4726-9b51-c6ccf99084e9"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>; or</quote> and
inserting a semicolon;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id07b79eb4-8211-44cb-96c2-43ab5ec7c54b"><enum>(C)</enum><text display-inline="yes-display-inline">in clause (ii)—</text>
<clause commented="no" display-inline="no-display-inline" id="idca55924e-8724-4f35-ad26-9bad9c209694"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>diagnose</quote> and
inserting <quote>to diagnose</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idbbc11057-f97d-4995-a7d4-96a29ccab8f9"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking the period at the end and
inserting <quote>; or</quote>; and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id058126ce-0059-4683-9666-fc625af91ed7"><enum>(D)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id3dea989d-96af-480b-8bde-819ea4022011" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="id1ee2dae4-fce6-4a28-8702-f62a70e47cc5"><enum>(iii)</enum><text display-inline="yes-display-inline">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).</text>
</clause><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2d2a8883-833c-4310-b44b-8f6fe0a4ed10"><enum>(2)</enum><header display-inline="yes-display-inline">Qualified pandemic or epidemic
product</header><text display-inline="yes-display-inline">Section
319F–3(i)(7)(A) of the Public Health Service Act (42 U.S.C. 247d–6d(i)(7)(A))
is amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id786b5c62-887d-4e7b-8b65-68d91bcfc224"><enum>(A)</enum><text display-inline="yes-display-inline">in clause (i)(II), by striking <quote>;
or</quote> and inserting <quote>;</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id5d8509f7-ccfa-449e-a5e0-6ccb5e485c70"><enum>(B)</enum><text display-inline="yes-display-inline">in clause (ii), by striking <quote>;
and</quote> and inserting <quote>; or</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id01d69313-2369-4f73-919b-e291eac65fad"><enum>(C)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id0c8c52b8-04b8-4fed-a33a-377ae60298d6" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="id4f4ebe91-502c-40c5-955b-0a869eaa314e"><enum>(iii)</enum><text display-inline="yes-display-inline">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</text>
</clause><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id93F2AF39FE2249C49450BAE426A76A7E"><enum>(3)</enum><header display-inline="yes-display-inline">Technical amendments</header><text display-inline="yes-display-inline">Section 319F–3(i) of the Public Health
Service Act (42 U.S.C. 247d–6d(i)) is amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idEF6DF1BF511E406FBB6233C3C382BC01"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)(C), by inserting <quote>,
564A, or 564B</quote> after <quote>564</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3F26AD0335D946698B0B11D44A84B9DD"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (7)(B)(iii), by inserting
<quote>, 564A, or 564B</quote> after <quote>564</quote>.</text>
</subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="idde32dc73-fa12-40d5-982e-a32e02bf5476" section-type="subsequent-section"><enum>403.</enum><header display-inline="yes-display-inline">Strategic National Stockpile</header>
<subsection commented="no" display-inline="no-display-inline" id="id0F5BAD7BE63D43998E2652C7AC9CD492"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 319F–2 of the Public Health Service
Act (42 U.S.C. 247d–6b) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id1bb82418-589f-4ec6-a2fb-faf6df970ed5"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id54727058-7712-48c6-af2e-0b5fd435624b"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<clause commented="no" display-inline="no-display-inline" id="id001a6448-d43d-4530-8f5f-68b68a2df739"><enum>(i)</enum><text display-inline="yes-display-inline">by inserting <quote>consistent with section
2811</quote> before <quote>by the Secretary to be appropriate</quote>;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idbbda12da-b812-46a3-b0ca-86c2d5d02406"><enum>(ii)</enum><text display-inline="yes-display-inline">by inserting before the period at the end
the following: <quote>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</quote>; and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ida5738012-c55d-4e5a-ad9c-755cbfee8390"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text>
<clause commented="no" display-inline="no-display-inline" id="id3ea0ee7b-c2c1-4b31-9ba1-532c21c91fca"><enum>(i)</enum><text display-inline="yes-display-inline">by redesignating subparagraphs (E) through
(H) as subparagraphs (F) through (I), respectively; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idaba0cf69-1675-480a-88eb-7f06651bab8c"><enum>(ii)</enum><text display-inline="yes-display-inline">by inserting after subparagraph (D), the
following:</text>
<quoted-block display-inline="no-display-inline" id="id33aaa41c-b60b-4b19-9272-97d78c3d9332" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="iddabd09c2-6b26-46b2-b7a3-b4c04be81bce"><enum>(E)</enum><text display-inline="yes-display-inline">identify and address the potential
depletion and ensure appropriate replenishment of medical countermeasures,
including those currently in the
stockpile;</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf95abb0e-537f-4f04-b3b3-21b170f3e93e"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (f)(1), by striking
<quote>$640,000,000 for fiscal year 2002, and such sums as may be necessary for
each of fiscal years 2003 through 2006</quote> and inserting
<quote>$522,486,000 for each of fiscal years 2012 through 2016</quote>.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idEF16D53A48A943A588B0FBB796D46CCF"><enum>(b)</enum><header display-inline="yes-display-inline">Report on potassium iodide</header><text display-inline="yes-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id40890E99D1CB4374B118EEF970318A8B"><enum>(1)</enum><text display-inline="yes-display-inline">an assessment of the availability of
potassium iodide at Federal, State, and local levels; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB97DCF42E35C4813A2A1F6FBAC1AB3BF"><enum>(2)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="idfd810c92-7b0c-4c04-9920-0a408064a870" section-type="subsequent-section"><enum>404.</enum><header display-inline="yes-display-inline">National Biodefense Science
Board</header><text display-inline="no-display-inline">Section 319M(a) of the
Public Health Service Act (42 U.S.C. 247d–f(a)) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="ida0293761-e0b9-4713-930b-d1c60ca93821"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id98b8012e-1b7e-4a4c-95e0-09a2cb9f99c4"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (D)—</text>
<clause commented="no" display-inline="no-display-inline" id="ida2582a97-a4dc-4c31-9174-2c1c57d8acfd"><enum>(i)</enum><text display-inline="yes-display-inline">in the matter preceding clause (i), by
striking <quote>five</quote> and inserting <quote>six</quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id380bb926-d135-421d-a2ac-721312490ce4"><enum>(ii)</enum><text display-inline="yes-display-inline">in clause (i), by striking
<quote>and</quote> at the end;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id49acec04-64e8-49f0-8b9a-9514888bd4f2"><enum>(iii)</enum><text display-inline="yes-display-inline">in clause (ii), by striking the period and
inserting a semicolon; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id92671e99-9df6-4593-bde4-62302704c324"><enum>(iv)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id3091d41c-bf48-4879-ae97-98582709fe8e" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="ide0fcc5a4-5ece-4a20-80b4-9187221629d5"><enum>(iii)</enum><text display-inline="yes-display-inline">one such member shall be an individual with
pediatric subject matter expertise; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idf3da3ae5-624f-4dea-bf6d-0e9c9833d748"><enum>(iv)</enum><text display-inline="yes-display-inline">one such member shall be a State, tribal,
territorial, or local public health
official.</text>
</clause><after-quoted-block>;
and</after-quoted-block></quoted-block>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7cc91805-0af1-4f07-a0c0-e9770c6670ee"><enum>(B)</enum><text display-inline="yes-display-inline">by adding at the end the following flush
sentence:</text>
</subparagraph><continuation-text commented="no" continuation-text-level="paragraph"><quote>Nothing in this paragraph
shall preclude a member of the Board from satisfying two or more of the
requirements described in subparagraph (D).</quote>;</continuation-text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id66c25c9b-bc28-4123-b862-bed0636fe9df"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (5)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idf70a01f1-0554-478c-a2c0-8d3d38dbd569"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (B), by striking
<quote>and</quote> at the end;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id95e88589-6cfd-40e3-a877-87911c3a6dd8"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (C), by striking the period
and inserting <quote>; and</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id318a3377-5ffc-4112-8291-c5e457e87881"><enum>(C)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id7fb85ace-2e24-4057-997d-c50ebe3ab37c" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="idb553a745-8c3f-4632-be4f-1ce3cba38566"><enum>(D)</enum><text display-inline="yes-display-inline">provide any recommendation, finding, or
report provided to the Secretary under this paragraph to the appropriate
committees of Congress.</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idfd1070a4-f62c-428b-94c5-fd250c39bbb6"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (8), by adding at the end the
following: <quote>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.</quote>.</text>
</paragraph></section>
Passed the Senate
March 7, 2012.
Secretary