[House Report 112-286]
[From the U.S. Government Publishing Office]
112th Congress Report
HOUSE OF REPRESENTATIVES
1st Session 112-286
======================================================================
PANDEMIC AND ALL-HAZARDS PREPAREDNESS REAUTHORIZATION ACT OF 2011
_______
November 16, 2011.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mr. Upton, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 2405]
[Including cost estimate of the Congressional Budget Office]
The Committee on on Energy and Commerce, to whom was
referred the bill (H.R. 2405) to reauthorize certain provisions
of the Public Health Service Act and the Federal Food, Drug,
and Cosmetic Act relating to public health preparedness and
countermeasure development, and for other purposes, having
considered the same, report favorably thereon with an amendment
and recommend that the bill as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 12
Background and Need for Legislation.............................. 13
Hearings......................................................... 14
Committee Consideration.......................................... 14
Committee Votes.................................................. 15
Committee Oversight Findings..................................... 15
Statement of General Performance Goals and Objectives............ 15
New Budget Authority, Entitlement Authority, and Tax Expenditures 15
Earmarks......................................................... 15
Committee Cost Estimate.......................................... 15
Congressional Budget Office Estimate............................. 15
Federal Mandates Statement....................................... 20
Advisory Committee Statement..................................... 20
Applicability to Legislative Branch.............................. 20
Section-by-Section Analysis of the Legislation................... 20
Changes in Existing Law Made by the Bill......................... 27
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Pandemic and All-
Hazards Preparedness Reauthorization Act of 2011''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Reauthorization of certain provisions relating to public health
preparedness.
Sec. 3. Temporary redeployment of personnel during a public health
emergency.
Sec. 4. Coordination by Assistant Secretary for Preparedness and
Response.
Sec. 5. Eliminating duplicative Project Bioshield reports.
Sec. 6. Authorization for medical products for use in emergencies.
Sec. 7. Additional provisions related to medical products for emergency
use.
Sec. 8. Products held for emergency use.
Sec. 9. Accelerate countermeasure development by strengthening FDA's
role in reviewing products for national security priorities.
SEC. 2. REAUTHORIZATION OF CERTAIN PROVISIONS RELATING TO PUBLIC HEALTH
PREPAREDNESS.
(a) Vaccine Tracking and Distribution.--Subsection (e) of section
319A of the Public Health Service Act (42 U.S.C. 247d-1) is amended by
striking ``such sums for each of fiscal years 2007 through 2011'' and
inserting ``$30,800,000 for each of fiscal years 2012 through 2016''.
(b) Improving State and Local Public Health Security.--Effective on
October 1, 2011, section 319C-1 of the Public Health Service Act (42
U.S.C. 247d-3a) is amended--
(1) in subsection (b)(2)(A)--
(A) in clause (iv), by striking ``and'' at the end;
(B) in clause (v), by adding ``and'' at the end; and
(C) by adding at the end the following:
``(vi) a description of any activities that
such entity will use to analyze real-time
clinical specimens for pathogens of public
health or bioterrorism significance, including
any utilization of poison control centers;'';
(2) in subsection (f)--
(A) in paragraph (2), by inserting ``and'' at the
end;
(B) in paragraph (3), by striking ``; and'' and
inserting a period; and
(C) by striking paragraph (4);
(3) by striking subsection (h); and
(4) in subsection (i)--
(A) in paragraph (1)--
(i) by amending subparagraph (A) to read as
follows:
``(A) In general.--For the purpose of carrying out
this section, there is authorized to be appropriated
$632,900,000 for each of fiscal years 2012 through
2016.''; and
(ii) by striking subparagraph (B); and
(B) in subparagraphs (C) and (D) of paragraph (3), by
striking ``(1)(A)(i)(I)'' each place it appears and
inserting ``(1)(A)''.
(c) Partnerships for State and Regional Hospital Preparedness To
Improve Surge Capacity.--Section 319C-2 of the Public Health Service
Act (42 U.S.C. 247d-3b) is amended--
(1) in subsection (a), by inserting ``, including capacity
and preparedness to address the needs of pediatric and other
at-risk populations'' before the period at the end;
(2) in subsection (i)--
(A) by striking ``The requirements of'' and inserting
the following:
``(1) In general.--The requirements of''; and
(B) by adding at the end the following:
``(2) Meeting goals of national health security strategy.--
The Secretary shall implement objective, evidence-based metrics
to ensure that entities receiving awards under this section are
meeting, to the extent practicable, the goals of the National
Health Security Strategy under section 2802.''; and
(3) by amending subsection (j)(1) to read as follows:
``(1) In general.--For purposes of carrying out this section,
there is authorized to be appropriated $378,000,000 for each of
fiscal years 2012 through 2016.''.
(d) CDC Programs for Combating Public Health Threats.--Section 319D
of the Public Health Service Act (42 U.S.C. 247d-4) is amended--
(1) by striking subsection (c); and
(2) in subsection (g), by striking ``such sums as may be
necessary in each of fiscal years 2007 through 2011'' and
inserting ``$160,121,000 for each of fiscal years 2012 through
2016''.
(e) Dental Emergency Responders: Public Health and Medical
Response.--
(1) All-hazards public health and medical response curricula
and training.--Section 319F(a)(5)(B) of the Public Health
Service Act (42 U.S.C. 247d-6(a)(5)(B)) is amended by striking
``public health or medical'' and inserting ``public health,
medical, or dental''.
(2) National health security strategy.--Section 2802(b)(3) of
the Public Health Service Act (42 U.S.C. 300hh-1(b)(3)) is
amended--
(A) in the matter preceding subparagraph (A), by
inserting ``and which may include dental health
facilities'' after ``mental health facilities''; and
(B) in subparagraph (D), by inserting ``(which may
include dental health assets)'' after ``medical
assets''.
(f) Procurement of Countermeasures.--
(1) Contract terms.--Subclause (IX) of section 319F-
2(c)(7)(C)(ii) of the Public Health Service Act (42 U.S.C.
247d-6b(c)(7)(C)(ii)) is amended to read as follows:
``(IX) Contract terms.--The
Secretary, in any contract for
procurement under this section--
``(aa) may specify--
``(AA) the dosing and
administration
requirements for
countermeasures to be
developed and procured;
``(BB) the amount of
funding that will be
dedicated by the
Secretary for
development and
acquisition of the
countermeasure; and
``(CC) the
specifications the
countermeasure must
meet to qualify for
procurement under a
contract under this
section; and
``(bb) shall provide a clear
statement of defined Government
purpose limited to uses related
to a security countermeasure,
as defined in paragraph
(1)(B).''.
(2) Reauthorization of the special reserve fund.--Section
319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) is
amended--
(A) in subsection (c)--
(i) by striking ``special reserve fund under
paragraph (10)'' each place it appears and
inserting ``special reserve fund as defined in
subsection (g)(5)''; and
(ii) by striking paragraphs (9) and (10); and
(B) by adding at the end the following:
``(g) Special Reserve Fund.--
``(1) Authorization of appropriations.--In addition to
amounts appropriated to the special reserve fund prior to the
date of the enactment of this subsection, there is authorized
to be appropriated, for the procurement of security
countermeasures under subsection (c) and for carrying out
section 319L (relating to the Biomedical Advanced Research and
Development Authority), $2,800,000,000 for the period of fiscal
years 2014 through 2018. Amounts appropriated pursuant to the
preceding sentence are authorized to remain available until
September 30, 2019.
``(2) Notice of insufficient funds.--Not later than 15 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 Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate a report detailing the amount of
such funds available for procurement and the impact such
funding will have--
``(A) in meeting the security countermeasure needs
identified under this section; and
``(B) on the annual Countermeasure Implementation
Plan under section 2811(d).
``(3) Use of special reserve fund for advanced research and
development.--The Secretary may utilize not more than 30
percent of the amounts authorized to be appropriated under
paragraph (1) to carry out section 319L (related to the
Biomedical Advanced Research and Development Authority).
Amounts authorized to be appropriated under this subsection to
carry out section 319L are in addition to amounts otherwise
authorized to be appropriated to carry out such section.
``(4) Restrictions on use of funds.--Amounts in the special
reserve fund shall not be used to pay--
``(A) costs other than payments made by the Secretary
to a vendor for advanced development (under section
319L) or for procurement of a security countermeasure
under subsection (c)(7); and
``(B) any administrative expenses, including
salaries.
``(5) Definition.--In this section, the term `special reserve
fund' means the `Biodefense Countermeasures' appropriations
account, any appropriation made available pursuant to section
521(a) of the Homeland Security Act of 2002, and any
appropriation made available pursuant to paragraph (1) of this
paragraph.''.
(g) Emergency System for Advance Registration of Volunteer Health
Professionals.--Section 319I(k) of the Public Health Service Act (42
U.S.C. 247d-7b(k)) is amended by striking ``are authorized to be
appropriated $2,000,000 for fiscal year 2002, and such sums as may be
necessary for each of the fiscal years 2003 through 2011'' and
inserting ``is authorized to be appropriated $5,900,000 for each of
fiscal years 2012 through 2016''.
(h) Biomedical Advanced Research and Development Authority.--
(1) Transaction authorities.--Section 319L(c)(5) of the
Public Health Service Act (42 U.S.C. 247d-7e(c)(5)) is amended
by adding at the end the following:
``(G) Government purpose.--In awarding contracts,
grants, and cooperative agreements under this section,
the Secretary shall provide a clear statement of
defined Government purpose related to activities
included in subsection (a)(6)(B) for a qualified
countermeasure or qualified pandemic or epidemic
product.''.
(2) Biodefense medical countermeasure development fund.--
Paragraph (2) of section 319L(d) of the Public Health Service
Act (42 U.S.C. 247d-7e(d)) is amended to read as follows:
``(2) Funding.--To carry out the purposes of this section,
there is authorized to be appropriated to the Fund $415,000,000
for each of fiscal years 2012 through 2016, the amounts to
remain available until expended.''.
(3) Continued inapplicability of certain provisions.--Section
319L(e)(1)(C) of the Public Health Service Act (42 U.S.C. 247d-
7e(e)(1)(C)) is amended by striking ``the date that is 7 years
after the date of enactment of the Pandemic and All-Hazards
Preparedness Act'' and inserting ``September 30, 2016''.
(i) National Disaster Medical System.--Section 2812 of the Public
Health Service Act (42 U.S.C. 300hh-11) is amended--
(1) in subsection (a)(3), by adding at the end the following:
``(D) Administration.--The Secretary may determine
and pay claims for reimbursement for services under
subparagraph (A) directly or by contract providing for
payment in advance or by way of reimbursement.''; and
(2) in subsection (g), by striking ``such sums as may be
necessary for each of the fiscal years 2007 through 2011'' and
inserting ``$56,000,000 for each of fiscal years 2012 through
2016''.
(j) National Health Security Strategy Timeline.--Section 2802(a)(1)
of the Public Health Service Act (42 U.S.C. 300hh-1(a)(1)) is amended
by striking ``2009'' and inserting ``2014''.
(k) Enhancing Surge Capacity.--Section 2802(b) of the Public Health
Service Act (42 U.S.C. 300hh-1(b)(3)) is amended--
(1) in paragraph (1)(A), by inserting ``, including drills
and exercises to ensure medical surge capacity for events
without notice'' after ``exercises''; and
(2) in paragraph (3)--
(A) in the matter preceding subparagraph (A), as
amended by subsection (e)(2) of this section--
(i) by inserting ``availability,
coordination, accessibility,'' after ``response
capabilities,'';
(ii) by striking ``including mental health
facilities'' and inserting ``including mental
health and ambulatory care facilities''; and
(iii) by striking ``trauma care and emergency
medical service systems'' and inserting
``trauma care, critical care, and emergency
medical service systems''; and
(B) in subparagraph (B), by striking ``Medical
evacuation and fatality management'' and inserting
``Fatality management, and coordinated medical triage
and evacuation to the appropriate medical institution
based on patient medical need as part of regional
systems''.
(l) Volunteer Medical Reserve Corps.--Section 2813(i) of the Public
Health Service Act (42 U.S.C. 300hh-15(i)) is amended by striking
``$22,000,000 for fiscal year 2007, and such sums as may be necessary
for each of fiscal years 2008 through 2011'' and inserting
``$11,900,000 for each of fiscal years 2012 through 2016''.
(m) Extension of Limited Antitrust Exemption.--Section 405(b) of the
Pandemic and All-Hazard Preparedness Act (42 U.S.C. 247d-6a note) is
amended by striking ``at the end of the 6-year period that begins on
the date of enactment of this Act'' and inserting ``on September 30,
2016''.
SEC. 3. TEMPORARY REDEPLOYMENT OF PERSONNEL DURING A PUBLIC HEALTH
EMERGENCY.
Section 319 of the Public Health Service Act (42 U.S.C. 247d) is
amended by adding at the end the following:
``(e) Temporary Redeployment of Personnel During a Public Health
Emergency.--
``(1) Emergency redeployment of federally funded personnel.--
Notwithstanding any other provision of law, and subject to
paragraph (2), upon a request that is from a State, locality,
territory, tribe, or the Freely Associated States and that
includes such information and assurances as the Secretary may
require, the Secretary may authorize the requesting entity to
temporarily redeploy to immediately address a public health
emergency non-Federal personnel funded in whole or in part
through--
``(A) any program under this Act; or
``(B) at the discretion of the Secretary, any other
program funded in whole or in part by the Department of
Health and Human Services.
``(2) Activation of emergency redeployment.--
``(A) Public health emergency.--The Secretary may
exercise the authority vested by paragraph (1) only
during the period of a public health emergency
determined pursuant to subsection (a).
``(B) Considerations.--In authorizing a temporary
redeployment under paragraph (1), the Secretary shall
consider each of the following:
``(i) The degree to which the emergency
cannot be adequately and appropriately
addressed by the public health workforce.
``(ii) The degree to which the emergency
requires or would otherwise benefit from
supplemental staffing from those funded through
nonpreparedness Federal programs.
``(iii) The degree to which such programs
would be adversely affected by the
redeployment.
``(iv) Such other factors as the Secretary
may deem appropriate.
``(C) Termination and extension.--
``(i) Termination.--The authority to
authorize a temporary redeployment of personnel
under paragraph (1) shall terminate upon the
earlier of the following:
``(I) The Secretary's determination
that the public health emergency no
longer exists.
``(II) Subject to clause (ii), 30
days after the activation of the
Secretary's authority pursuant to
subparagraph (A).
``(ii) Extension authority.--The Secretary
may extend the authority to authorize a
temporary redeployment of personnel under
paragraph (1) beyond the date otherwise
applicable under clause (i)(II) if the public
health emergency still exists, but only if--
``(I) the extension is requested by
the entity that requested authority to
authorize a temporary redeployment; and
``(II) the Secretary gives notice to
the Congress in conjunction with the
extension.''.
SEC. 4. COORDINATION BY ASSISTANT SECRETARY FOR PREPAREDNESS AND
RESPONSE.
(a) In General.--Section 2811 of the Public Health Service Act (42
U.S.C. 300hh-10) is amended--
(1) in subsection (b)(3)--
(A) by inserting ``stockpiling, distribution,''
before ``and procurement''; and
(B) by inserting ``, security measures (as defined in
section 319F-2,'' after ``qualified countermeasures (as
defined in section 319F-1)'';
(2) in subsection (b)(4), by adding at the end the following:
``(D) Identification of inefficiencies.--Identify
gaps, duplication, and other inefficiencies in public
health preparedness activities and the actions
necessary to overcome these obstacles.
``(E) Development of countermeasure implementation
plan.--Lead the development of a coordinated
Countermeasure Implementation Plan under subsection
(d).
``(F) Countermeasures budget analysis.--Oversee the
development of a comprehensive, cross-cutting 5-year
budget analysis with respect to activities described in
paragraph (3)--
``(i) to inform prioritization of resources;
and
``(ii) to ensure that challenges to such
activities are adequately addressed.
``(G) Grant programs for medical and public health
preparedness capabilities.--Coordinate, in consultation
with the Secretary of Homeland Security, grant programs
of the Department of Health and Human Services relating
to medical and public health preparedness capabilities
and the activities of local communities to respond to
public health emergencies, including the--
``(i) coordination of relevant program
requirements, timelines, and measurable goals
of such grant programs; and
``(ii) establishment of a system for
gathering and disseminating best practices
among grant recipients.'';
(3) by amending subsection (c) to read as follows:
``(c) Functions.--The Assistant Secretary for Preparedness and
Response shall--
``(1) have lead responsibility within the Department of
Health and Human Services for emergency preparedness and
response policy and coordination;
``(2) have authority over and responsibility for--
``(A) the National Disaster Medical System (in
accordance with section 301 of the Pandemic and All-
Hazards Preparedness Act);
``(B) the Hospital Preparedness Cooperative Agreement
Program pursuant to section 319C-2;
``(C) the Biomedical Advanced Research and
Development Authority under section 319L; and
``(D) the Emergency System for Advance Registration
of Volunteer Health Professionals pursuant to section
319I;
``(3) provide policy coordination and oversight of--
``(A) the Strategic National Stockpile under section
319F-2;
``(B) the Cities Readiness Initiative; and
``(C) the Medical Reserve Corps pursuant to section
2813; and
``(4) assume other duties as determined appropriate by the
Secretary.''; and
(4) by adding at the end the following:
``(d) Countermeasure Implementation Plan.--Not later than 6 months
after the date of enactment of this subsection, and annually
thereafter, the Assistant Secretary for Preparedness and Response shall
submit through the Secretary to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate a Countermeasure Implementation Plan
that--
``(1) describes the chemical, biological, radiological, and
nuclear threats facing the Nation and the corresponding efforts
to develop qualified countermeasures (as defined in section
319F-1), security countermeasures (as defined in section 319F-
2), or qualified pandemic or epidemic products (as defined in
section 319F-3) for each threat;
``(2) evaluates the progress of all activities with respect
to such countermeasures or products, including research,
advanced research, development, procurement, stockpiling,
deployment, and utilization;
``(3) identifies and prioritizes near-, mid-, and long-term
needs with respect to such countermeasures or products to
address chemical, biological, radiological, and nuclear
threats;
``(4) identifies, with respect to each category of threat, a
summary of all advanced development and procurement awards,
including--
``(A) the time elapsed from the issuance of the
initial solicitation or request for a proposal to the
adjudication (such as the award, denial of award, or
solicitation termination);
``(B) projected timelines for development and
procurement of such countermeasures or products;
``(C) clearly defined goals, benchmarks, and
milestones for each such countermeasure or product,
including information on the number of doses required,
the intended use of the countermeasure or product, and
the required countermeasure or product characteristics;
and
``(D) projected needs with regard to the
replenishment of the Strategic National Stockpile;
``(5) evaluates progress made in meeting the goals,
benchmarks, and milestones identified under paragraph (4)(C);
``(6) reports on the amount of funds available for
procurement in the special reserve fund as defined in section
319F-2(g)(5) and the impact this funding will have on meeting
the requirements under section 319F-2;
``(7) incorporates input from Federal, State, local, and
tribal stakeholders; and
``(8) addresses the needs of pediatric populations with
respect to such countermeasures and products in the Strategic
National Stockpile and includes--
``(A) a list of such countermeasures and products
necessary to address the needs of pediatric
populations;
``(B) a description of measures taken to coordinate
with Office of Pediatric Therapeutics of the Food and
Drug Administration to maximize the labeling, dosages,
and formulations of such countermeasures and products
for pediatric populations;
``(C) a description of existing gaps in the Strategic
National Stockpile and the development of such
countermeasures and products to address the needs of
pediatric populations; and
``(D) an evaluation of the progress made in
addressing gaps identified pursuant to subparagraph
(C).
Notwithstanding any other provision of this subsection, the Plan shall
not include any confidential commercial information, proprietary
information, or information that could reveal vulnerabilities of the
Nation in the preparation for or ability to respond to chemical,
biological, radiological, or nuclear threats.''.
(b) Consultation in Authorizing Medical Products for Use in
Emergencies.--Subsection (c) of section 564 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bbb-3) is amended by striking
``consultation with the Director of the National Institutes of Health''
and inserting ``consultation with the Assistant Secretary for
Preparedness and Response, the Director of the National Institutes of
Health,''.
(c) Biosurveillance Plan.--Not later than one year after the date of
the enactment of this Act, the Secretary of Health and Human Services
shall prepare and submit to the Committee on Energy and Commerce of the
House of Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate a plan to improve information sharing,
coordination, and communications among disparate biosurveillance
systems supported by the Department of Health and Human Services.
SEC. 5. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD REPORTS.
Section 5 of the Project Bioshield Act of 2004 (42 U.S.C. 247d-6c) is
repealed.
SEC. 6. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.
Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-3) is amended--
(1) in subsection (a)--
(A) in paragraph (1), by striking ``sections 505,
510(k), and 515 of this Act'' and inserting ``any
provision of this Act'';
(B) in paragraph (2)(A), by striking ``under a
provision of law referred to in such paragraph'' and
inserting ``under a provision of law in section 505,
510(k), or 515 of this Act or section 351 of the Public
Health Service Act''; and
(C) in paragraph (3), by striking ``a provision of
law referred to in such paragraph'' and inserting ``a
provision of law referred to in paragraph (2)(A)'';
(2) in subsection (b)--
(A) in the subsection heading, by striking
``Declaration of Emergency'' and inserting
``Declaration Supporting Emergency Use Authorization'';
(B) in paragraph (1)--
(i) in the matter preceding subparagraph (A),
by striking ``an emergency justifying'' and
inserting ``that circumstances exist
justifying'';
(ii) in subparagraph (A), by striking
``specified'';
(iii) in subparagraph (B), by striking
``specified''; and
(iv) by amending subparagraph (C) to read as
follows:
``(C) a determination by the Secretary that there is
a public health emergency, or a significant potential
for a public health emergency, involving a heightened
risk to national security or the health and security of
United States citizens abroad, and involving a
biological, chemical, radiological, or nuclear agent or
agents, or a disease or condition that may be
attributable to such agent or agents.'';
(C) in paragraph (2)--
(i) by amending subparagraph (A) to read as
follows:
``(A) In general.--A declaration under this
subsection shall terminate upon a determination by the
Secretary, in consultation with, as appropriate, the
Secretary of Homeland Security or the Secretary of
Defense, that the circumstances described in paragraph
(1) have ceased to exist.'';
(ii) by striking subparagraph (B); and
(iii) by redesignating subparagraph (C) as
subparagraph (B); and
(D) in paragraph (4), by striking ``advance notice of
termination, and renewal'' and inserting ``and advance
notice of termination'';
(3) in subsection (c)(1), by striking ``specified in'' and
insert ``covered by'';
(4) in subsection (d)(3), by inserting ``, to the extent
practicable given the circumstances of the emergency,'' after
``including'';
(5) in subsection (e)--
(A) in paragraph (1)(B), by amending clause (iii) to
read as follows:
``(iii) Appropriate conditions with respect
to the collection and analysis of information
concerning the safety and effectiveness of the
product with respect to the actual use of such
product pursuant to an authorization under this
section.'';
(B) in paragraph (2)--
(i) in subparagraph (A)--
(I) by striking ``manufacturer of the
product'' and inserting ``person''; and
(II) by inserting ``or in paragraph
(1)(B)'' before the period at the end;
(ii) in subparagraph (B)(i), by inserting ``,
with the exception of extensions of a product's
expiration date authorized under section
564A(b)'' before the period at the end; and
(iii) by amending subparagraph (C) to read as
follows:
``(C) In establishing conditions under this paragraph
with respect to the distribution and administration of
a product, the Secretary shall not impose conditions
that would restrict distribution or administration of
the product that is solely for the approved uses.'';
(C) by amending paragraph (3) to read as follows:
``(3) Good manufacturing practice; prescription;
practitioner's authorization.--With respect to the emergency
use of a product for which an authorization under this section
is issued (whether for an unapproved product or an unapproved
use of an approved product), the Secretary may waive or limit,
to the extent appropriate given the circumstances of the
emergency--
``(A) requirements regarding current good
manufacturing practice otherwise applicable to the
manufacture, processing, packing, or holding of
products subject to regulation under this Act,
including such requirements established under section
501 or 520(f)(1), and including relevant conditions
prescribed with respect to the product by an order
under section 520(f)(2);
``(B) requirements established under section 503(b);
and
``(C) requirements established under section
520(e).''; and
(D) by adding at the end the following:
``(5) Existing authorities.--Nothing in this section
restricts any authority vested in the Secretary by any other
provision of this Act or the Public Health Service Act for
establishing conditions of authorization for a product.''; and
(6) in subsection (g)--
(A) in the heading, by striking ``Revocation of
Authorization'' and inserting ``Review, Modification,
and Revocation of Authorization'';
(B) in paragraph (1), by striking ``periodically
review'' and inserting ``review not less than every
three years''; and
(C) by adding at the end the following:
``(3) Modification.--The Secretary may modify an
authorization under this section or the conditions of such an
authorization, at any time, based on a review of the
authorization or new information that is otherwise obtained,
including information obtained during an emergency.''.
SEC. 7. ADDITIONAL PROVISIONS RELATED TO MEDICAL PRODUCTS FOR EMERGENCY
USE.
(a) In General.--The Federal Food, Drug, and Cosmetic Act is amended
by inserting after section 564 (21 U.S.C. 360bbb-3) the following:
``SEC. 564A. ADDITIONAL PROVISIONS RELATED TO MEDICAL PRODUCTS FOR
EMERGENCY USE.
``(a) Definitions.--For purposes of this section:
``(1) The term `product' means a drug, device, or biological
product.
``(2) The term `eligible product' means a product that is--
``(A) approved or cleared under this chapter or
licensed under section 351 of the Public Health Service
Act; and
``(B) intended to be used to diagnose, prevent, or
treat a disease or condition involving a biological,
chemical, radiological, or nuclear agent or agents
during--
``(i) a domestic emergency or military
emergency involving heightened risk of attack
with such an agent or agents; or
``(ii) a public health emergency affecting
national security or the health and security of
United States citizens abroad.
``(b) Expiration Dating.--
``(1) In general.--The Secretary may extend the expiration
date and authorize the introduction or delivery for
introduction into interstate commerce of an eligible product
after the expiration date provided by the manufacturer if--
``(A) the eligible product is intended to be held for
use for a domestic, military, or public health
emergency described in subsection (a)(2)(B);
``(B) the expiration date extension is intended to
support the United States' ability to protect--
``(i) the public health; or
``(ii) military preparedness and
effectiveness; and
``(C) the expiration date extension is supported by
an appropriate scientific evaluation that is conducted
or accepted by the Secretary.
``(2) Requirements and conditions.--Any extension of an
expiration date under paragraph (1) shall, as part of the
extension, identify--
``(A) each specific lot, batch, or other unit of the
product for which extended expiration is authorized;
``(B) the duration of the extension; and
``(C) any other requirements or conditions as the
Secretary may deem appropriate for the protection of
the public health, which may include requirements for,
or conditions on, product sampling, storage, packaging
or repackaging, transport, labeling, notice to product
recipients, recordkeeping, periodic testing or
retesting, or product disposition.
``(3) Effect.--Notwithstanding any other provision of this
Act or the Public Health Service Act, an eligible product shall
not be considered an unapproved product (as defined in section
564(a)(2)(A)) and shall not be deemed adulterated or misbranded
under this Act because, with respect to such product, the
Secretary has, under paragraph (1), extended the expiration
date and authorized the introduction or delivery for
introduction into interstate commerce of such product after the
expiration date provided by the manufacturer.
``(c) Current Good Manufacturing Practices.--
``(1) In general.--The Secretary may, when the circumstances
of a domestic, military, or public health emergency described
in subsection (a)(2)(B) so warrant, authorize, with respect to
an eligible product, deviations from current good manufacturing
practice requirements otherwise applicable to the manufacture,
processing, packing, or holding of products subject to
regulation under this Act, including requirements under section
501 or 520(f)(1) or applicable conditions prescribed with
respect to the eligible product by an order under section
520(f)(2).
``(2) Effect.--Notwithstanding any other provision of this
Act or the Public Health Service Act, an eligible product shall
not be considered an unapproved product (as defined in section
564(a)(2)(A)) and shall not be deemed adulterated or misbranded
under this Act because, with respect to such product, the
Secretary has authorized deviations from current good
manufacturing practices under paragraph (1).
``(d) Mass Dispensing.--The requirements of section 503(b) and 520(e)
shall not apply to an eligible product, and the product shall not be
considered an unapproved product (as defined in section 564(a)(2)(A))
and shall not be deemed adulterated or misbranded under this Act
because it is dispensed without an individual prescription, if--
``(1) the product is dispensed during an actual emergency
described in subsection (a)(2)(B); and
``(2) such dispensing without an individual prescription
occurs--
``(A) as permitted under the law of the State in
which the product is dispensed; or
``(B) in accordance with an order issued by the
Secretary.
``(e) Emergency Use Instructions.--
``(1) In general.--The Secretary, acting through an
appropriate official within the Department of Health and Human
Services, may create and issue emergency use instructions to
inform health care providers or individuals to whom an eligible
product is to be administered concerning such product's
approved, licensed, or cleared conditions of use.
``(2) Effect.--Notwithstanding any other provisions of this
Act or the Public Health Service Act, a product shall not be
considered an unapproved product (as defined in section
564(a)(2)(A)) and shall not be deemed adulterated or misbranded
under this Act because of--
``(A) the issuance of emergency use instructions
under paragraph (1) with respect to such product; or
``(B) the introduction or delivery for introduction
of such product into interstate commerce accompanied by
such instructions during an emergency response to an
actual emergency described in subsection (a)(2)(B).''.
(b) Risk Evaluation and Mitigation Strategies.--Section 505-1 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1), is amended--
(1) in subsection (f), by striking paragraph (7); and
(2) by adding at the end the following:
``(k) Waiver in Public Health Emergencies.--The Secretary may waive
any requirement of this section with respect to a qualified
countermeasure (as defined in section 319F-1(a)(2) of the Public Health
Service Act) to which a requirement under this section has been
applied, if the Secretary determines that such waiver is required to
mitigate the effects of, or reduce the severity of, an actual or
potential domestic emergency or military emergency involving heightened
risk of attack with a biological, chemical, radiological, or nuclear
agent, or an actual or potential public health emergency affecting
national security or the health and security of United States citizens
abroad.''.
SEC. 8. PRODUCTS HELD FOR EMERGENCY USE.
The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is
amended by inserting after section 564A, as added by section 7, the
following:
``SEC. 564B. PRODUCTS HELD FOR EMERGENCY USE.
``It is not a violation of any section of this Act or of the Public
Health Service Act for a government entity (including a Federal, State,
local, and tribal government entity), or a person acting on behalf of
such a government entity, to introduce into interstate commerce a
product (as defined in section 564(a)(4)) intended for emergency use,
if that product--
``(1) is intended to be held and not used; and
``(2) is held and not used, unless and until that product--
``(A) is approved, cleared, or licensed under section
505, 510(k), or 515 of this Act or section 351 of the
Public Health Service Act;
``(B) is authorized for investigational use under
section 505 or 520 of this Act or section 351 of the
Public Health Service Act; or
``(C) is authorized for use under section 564.''.
SEC. 9. ACCELERATE COUNTERMEASURE DEVELOPMENT BY STRENGTHENING FDA'S
ROLE IN REVIEWING PRODUCTS FOR NATIONAL SECURITY
PRIORITIES.
(a) In General.--Section 565 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb-4) is amended to read as follows:
``SEC. 565. COUNTERMEASURE DEVELOPMENT AND REVIEW.
``(a) Countermeasures and Products.--The countermeasures and products
referred to in this subsection are--
``(1) qualified countermeasures (as defined in section 319F-1
of the Public Health Service Act);
``(2) security countermeasures (as defined in section 319F-2
of such Act); and
``(3) qualified pandemic or epidemic products (as defined in
section 319F-3 of such Act) that the Secretary determines to be
a priority.
``(b) In General.--
``(1) Involvement of fda personnel in interagency
activities.--For the purpose of accelerating the development,
stockpiling, approval, clearance, and licensure of
countermeasures and products referred to in subsection (a), the
Secretary shall expand the involvement of Food and Drug
Administration personnel in interagency activities with the
Assistant Secretary for Preparedness and Response (including
the Biomedical Advanced Research and Development Authority),
the Centers for Disease Control and Prevention, the National
Institutes of Health, and the Department of Defense.
``(2) Technical assistance.--The Secretary shall establish
within the Food and Drug Administration a team of experts on
manufacturing and regulatory activities (including compliance
with current Good Manufacturing Practices) to provide both off-
site and on-site technical assistance to the manufacturers of
countermeasures and products referred to in subsection (a). On-
site technical assistance shall be provided upon the request of
the manufacturer and at the discretion of the Secretary if the
Secretary determines that the provision of such assistance
would accelerate the development, manufacturing, or approval,
clearance, or licensure of countermeasures and products
referred to in subsection (a).
``(c) Agency Interaction With Security Countermeasure Sponsors.--
``(1) In general.--For security countermeasures (as defined
in section 319F-2 of the Public Health Service Act) that are
procured under such section 319F-2--
``(A) the Secretary shall establish a process for
frequent scientific feedback and interactions between
the Food and Drug Administration and the security
countermeasure sponsor (referred to in this subsection
as the `sponsor'), designed to facilitate the approval,
clearance, and licensure of the security
countermeasures;
``(B) such feedback and interactions shall include
meetings and, in accordance with subsection (b)(2), on-
site technical assistance; and
``(C) at the request of the Secretary, the process
under this paragraph shall include participation by the
Food and Drug Administration in meetings between the
Biomedical Advanced Research and Development Authority
and sponsors on the development of such
countermeasures.
``(2) Regulatory management plan.--
``(A) In general.--The process established under
paragraph (1) shall allow for the development of a
written regulatory management plan (in this paragraph
referred to as the `plan') for a security
countermeasure (as defined in paragraph (1)) in
accordance with this paragraph.
``(B) Proposal and finalization of plan.--In carrying
out the process under paragraph (1), the Secretary
shall direct the Food and Drug Administration, upon
submission of a written request by the sponsor that
includes a proposed plan and relevant data and future
planning detail to support such a plan, to work with
the sponsor to agree on a final plan within a
reasonable time not to exceed 90 days. The basis for
this agreement shall be the proposed plan submitted by
the sponsor. Notwithstanding the preceding sentence,
the Secretary shall retain full discretion to determine
the contents of the final plan or to determine that no
such plan can be agreed upon. If the Secretary
determines that no final plan can be agreed upon, the
Secretary shall provide to the sponsor, in writing, the
scientific or regulatory rationale why such agreement
cannot be reached. If a final plan is agreed upon, it
shall be shared with the sponsor in writing.
``(C) Contents.--The plan shall include an agreement
on the nature of, and timelines for, feedback and
interactions between the sponsor and the Food and Drug
Administration, shall provide reasonable flexibility in
implementing and adjusting the agreement under this
paragraph as warranted during the countermeasure
development process, and shall identify--
``(i) the current regulatory status of the
countermeasure, an assessment of known
scientific gaps relevant to approval,
clearance, or licensure of the countermeasure,
and a proposed pathway to approval, clearance,
or licensure of the countermeasure;
``(ii) developmental milestones whose
completion will result in meetings to be
scheduled within a reasonable time between the
applicable review division of the Food and Drug
Administration and the sponsor;
``(iii) sponsor submissions that will result
in written feedback from the review division
within a reasonable time;
``(iv) feedback by the Food and Drug
Administration regarding the data required to
support delivery of the countermeasure to the
Strategic National Stockpile under section
319F-2 of the Public Health Service Act;
``(v) feedback by the Food and Drug
Administration regarding data required to
support submission of a proposed agreement on
the design and size of clinical trials for
review under section 505(b)(5)(B); and
``(vi) other issues that have the potential
to delay approval, clearance, or licensure.
``(D) Changes.--Changes to the plan shall be made by
subsequent agreement between the Secretary and the
sponsor. If after reasonable attempts to negotiate
changes to the plan the Secretary and the sponsor are
unable to finalize such changes, the Secretary shall
provide to the sponsor, in writing, the scientific or
regulatory rationale why such changes are required or
cannot be included in the plan.
``(3) Applicability to certain qualified pandemic or epidemic
products.--The Secretary may, with respect to qualified
pandemic or epidemic products (as defined in section 319F-3 of
the Public Health Service Act) for which a contract for
advanced research and development is entered into under section
319L of such Act, choose to apply the provisions of paragraphs
(1) and (2) to the same extent and in the same manner as such
provisions apply with respect to security countermeasures.
``(d) Final Guidance on Development of Animal Models.--
``(1) In general.--Not later than 1 year after the date of
the enactment of the Pandemic and All-Hazards Preparedness
Reauthorization Act of 2011, the Secretary shall provide final
guidance to industry regarding the development of animal models
to support approval, clearance, or licensure of countermeasures
and products referred to in subsection (a) when human efficacy
studies are not ethical or feasible.
``(2) Authority to extend deadline.--The Secretary may extend
the deadline for providing final guidance under paragraph (1)
by not more than 6 months upon submission by the Secretary of a
report on the status of such guidance to the Committee on
Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate.
``(e) Biennial Report.--Not later than January 1, 2013, and every 2
years thereafter, the Secretary shall submit a report to the Committee
on Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the Senate,
that, with respect to the preceding 2 fiscal years, includes--
``(1) the number of full-time equivalent employees of the
Food and Drug Administration who directly support the review of
countermeasures and products referred to in subsection (a);
``(2) estimates of funds obligated by the Food and Drug
Administration for review of such countermeasures and products;
``(3) the number of regulatory teams at the Food and Drug
Administration specific to such countermeasures and products
and, for each such team, the assigned products, classes of
products, or technologies;
``(4) the length of time between each request by the sponsor
of such a countermeasure or product for information and the
provision of such information by the Food and Drug
Administration;
``(5) the number, type, and frequency of official
interactions between the Food and Drug Administration and--
``(A) sponsors of a countermeasure or product
referred to in subsection (a); or
``(B) another agency engaged in development or
management of portfolios for such countermeasures or
products, including the Centers for Disease Control and
Prevention, the Biomedical Advanced Research and
Development Authority, the National Institutes of
Health, and the appropriate agencies of the Department
of Defense;
``(6) a description of other measures that, as determined by
the Secretary, are appropriate to determine the efficiency of
the regulatory teams described in paragraph (3); and
``(7) the regulatory science priorities that relate to
countermeasures or products referred to in subsection (a) and
which the Food and Drug Administration is addressing and the
progress made on these priorities.''.
(b) Special Protocol Assessment.--Subparagraph (B) of section
505(b)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(b)(5)) is amended to read as follows:
``(B)(i) The Secretary shall meet with a sponsor of an investigation
or an applicant for approval for a drug under this subsection or
section 351 of the Public Health Service Act if the sponsor or
applicant makes a reasonable written request for a meeting for the
purpose of reaching agreement on the design and size of--
``(I) clinical trials intended to form the primary basis of
an effectiveness claim; or
``(II) animal efficacy trials and any associated clinical
trials that in combination are intended to form the primary
basis of an effectiveness claim for a countermeasure or product
referred to in section 565(a) when human efficacy studies are
not ethical or feasible.
``(ii) The sponsor or applicant shall provide information necessary
for discussion and agreement on the design and size of the clinical
trials. Minutes of any such meeting shall be prepared by the Secretary
and made available to the sponsor or applicant upon request.''.
Purpose and Summary
H.R. 2405, the ``Pandemic and All-Hazards Preparedness
Reauthorization Act of 2011,'' was introduced on June 28, 2011,
by Representative Mike Rogers (R-MI) and referred to the
Committee on Energy and Commerce.
The legislation would facilitate the development of
chemical, biological, radioactive, and nuclear (CBRN) medical
countermeasures (MCMs) and bolster the nation's public health
preparedness infrastructure so the Nation can better respond to
public health emergencies and disasters, including those caused
by CBRN attack.
Background and Need for Legislation
In the wake of the September 11th terrorist attacks,
Congress took important steps to build the Nation's health
infrastructure and foster the development of CBRN MCMs to
enable the Nation to better respond to CBRN attacks. As part of
these steps, Congress enacted two key pieces of legislation,
the ``Project BioShield Act of 2004'' (Project BioShield) (P.L.
108-276) and the ``Pandemic and All-Hazards Preparedness Act of
2006'' (PAHPA) (P.L. 109-417), and they have dramatically
improved our nation's ability to respond to public health
emergencies and disasters, including those caused by terrorism.
As described in this report, the ``Pandemic and All-Hazards
Preparedness Reauthorization Act of 2011'' would reauthorize
and improve certain provisions of Project BioShield and PAHPA
in order to increase certainty and predictability, clarify the
role of the Assistant Secretary for Preparedness and Response
(ASPR) as the leader of preparedness and response, and
strengthen our nation's preparedness infrastructure.
The 108th Congress passed Project BioShield to encourage
the private sector to develop MCMs against CBRN agents that
would not otherwise have a commercial market and bring
certainty and predictability to the MCM development space.
Project BioShield included provisions that, among other things,
authorized funds for the purchase of MCMs through the Special
Reserve Fund (SRF) and enabled the Secretary of the Department
of Health and Human Services (HHS) to authorize the emergency
use of medical products. The SRF was intended to be a secure
funding source for the procurement of critical MCMs; it is
critical because it clearly demonstrates the Federal
government's commitment to MCM procurement. By increasing
certainty and predictability, which this legislation seeks to
do through the reauthorization of the Special Reserve Fund and
the Biodefense Advanced Research and Development Authority
(BARDA) as well as the establishment of the Regulatory
Management Plan process, among other provisions, H.R. 2405
would build on the provisions of Project BioShield to encourage
investment, research, and development and increase the
likelihood of securing the MCMs necessary to protect our
citizens during health emergencies and disasters, including
those caused by terrorism.
Shortly after the enactment of Project BioShield, the 109th
Congress passed PAHPA, which reauthorized a number of expiring
preparedness and response programs in the Public Health Service
Act and established several new authorities. For instance,
PAHPA established BARDA, a new authority within HHS, to foster
advanced MCM development and facilitate interactions between
HHS and MCM developers. PAHPA also established a crucial new
position at HHS, the Assistant Secretary for Preparedness and
Response, to lead the Federal government's efforts and
coordination for CBRN preparedness and response. H.R. 2405
includes provisions to clarify that the ASPR has lead
responsibility within HHS for emergency preparedness and
response policy and coordination. Finally, PAHPA included
provisions to build the nation's public health infrastructure.
The provisions of H.R. 2405 would reauthorize many of these
PAHPA provisions to continue the effort to strengthen our
Nation's preparedness infrastructure.
Hearings
On July 21, 2011, the Subcommittee on Health held a hearing
entitled ``Legislative Hearing to Address Bioterrorism,
Controlled Substances and Public Health Issues.'' H.R. 2405,
the ``Pandemic and All-Hazards Preparedness Reauthorization Act
of 2011,'' was one of three bills considered at this hearing.
The Subcommittee received testimony from: Representative
Charlie Dent (PA-15); Nicole Lurie, M.D., M.S.P.H, Assistant
Secretary for Preparedness and Response, U.S. Department of
Health and Human Services; and Howard K. Koh, M.D., M.P.H,
Assistant Secretary for Health, U.S. Department of Health and
Human Services.
Committee Consideration
H.R. 2405, the ``Pandemic and All-Hazards Preparedness
Reauthorization Act of 2011,'' was introduced on June 28, 2011,
by Representative Mike Rogers (R-MI) and referred to the
Committee on Energy and Commerce.
The Subcommittee on Health held a legislative hearing on
July 21, 2011, entitled, ``Legislative Hearing to Address
Bioterrorism, Controlled Substances and Public Health Issues,''
during which it considered H.R. 2405. On July 26, 2011, the
Subcommittee met in open markup session to consider H.R. 2405.
The Subcommittee favorably reported an Amendment in the Nature
of a Substitute, which included technical changes recommended
by the Administration and the reauthorization of two programs
from the original PAHPA law passed in 2006: the Medical Reserve
Corps and the Emergency System for Advance Registration of
Health Professional Volunteers. Thereafter, the Subcommittee
ordered that H.R. 2405 be favorably forwarded to the full
Committee for consideration.
On July 28, 2011, the Committee on Energy and Commerce met
in open markup session to consider H.R. 2405, as approved by
the Subcommittee on Health. The Committee considered an
Amendment in the Nature of a Substitute, which included
provisions to improve the accountability of the Hospital
Preparedness Cooperative Agreement Program, enhance surge
capacity as part of the National Health Security Strategy,
allow the temporary reassignment of federally funded personnel
at the request of states or localities, and enhance reporting
on biosurveillance efforts. It also further clarified that the
ASPR would lead emergency response efforts across the various
HHS agencies and among federal interagency partners. The
Committee also considered an amendment to the Amendment in the
Nature of a Substitute. In addition to a number of technical
and conforming changes, the amendment to the Amendment in the
Nature of a Substitute included provisions that would provide
increased clarity and flexibility to enhance our nation's
ability to pre-position and deploy medical countermeasures. In
addition, it included provisions that would enable the federal
government to extend the shelf-life of current countermeasures
in the Strategic National Stockpile and to dispense medical
countermeasures requiring prescriptions on a mass-level during
emergencies.
The full Committee approved both the amendment to the
Amendment in the Nature of a Substitute and the Amendment in
the Nature of a Substitute by voice vote, and ordered that H.R.
2405 be favorably reported to the House by voice vote.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the recorded
votes on the motion to report legislation and amendments
thereto. There were no recorded votes taken in connection with
ordering H.R. 2405 reported. A motion to order H.R. 2405 be
reported to the House, as amended, was agreed to by voice vote.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the oversight findings and
recommendations of the Committee are reflected in the
descriptive portions of this report, including the finding that
the nation must facilitate development of CBRN MCMs and bolster
our public health preparedness infrastructure so the nation can
better respond to public health emergencies and disasters,
including those caused by CBRN attack.
Statement of General Performance Goals and Objectives
In accordance with clause 3(c)(4) of rule XIII of the Rules
of the House of Representatives, the performance goals and
objectives of the Committee are reflected in the descriptive
portions of this report, including the goal that the nation
facilitate the development of CBRN MCMs and bolster our public
health preparedness infrastructure so the nation can better
respond to public health emergencies and disasters, including
those caused by CBRN attack.
New Budget Authority, Entitlement Authority, and
Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
2405, the ``Pandemic and All-Hazards Preparedness
Reauthorization Act of 2011,'' would result in no new or
increased budget authority, entitlement authority, or tax
expenditures or revenues.
Earmarks
In compliance with clause 9(e), 9(f), and 9(g) of rule XXI,
the Committee finds that H.R. 2405, the ``Pandemic and All-
Hazards Preparedness Reauthorization Act of 2011,'' contains no
earmarks, limited tax benefits, or limited tariff benefits.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, September 26, 2011.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 2405, the Pandemic
and All-Hazards Preparedness Reauthorization Act of 2011.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Andrea Noda.
Sincerely,
Douglas W. Elmendorf.
Enclosure.
H.R. 2405--Pandemic and All-Hazards Preparedness Reauthorization Act of
2011
Summary: H.R. 2405 would amend the Public Health Service
Act to authorize funding for certain activities carried out by
various agencies and offices within the Department of Health
and Human Services (HHS) that would support the readiness of
the public health system to address public health and medical
emergencies. Those activities are conducted by the Centers for
Disease Control and Prevention (CDC), the Food and Drug
Administration (FDA), and several offices within the HHS Office
of the Secretary.
CBO estimates that implementing the bill would cost $395
million in 2012 and $7.9 billion over the 2012-2016 period,
assuming the appropriation of the authorized amounts. The
funding authorized by H.R. 2405 is similar to the appropriation
amounts enacted in recent years for the same activities. Pay-
as-you-go procedures do not apply to this legislation because
it would not affect direct spending or revenues.
H.R. 2405 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA).
Estimated cost to the Federal Government: The estimated
budgetary impact of H.R. 2405 is shown in the following table.
The costs of this legislation fall within budget function 550
(health).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-------------------------------------------------------
2012 2013 2014 2015 2016 2012-2016
----------------------------------------------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
Centers for Disease Control and Prevention:
State and Local Public Health Security:
Authorization Level............................. 633 633 633 633 633 3,165
Estimated Outlays............................... 130 440 540 600 615 2,325
Public Health Threats:
Authorization Level............................. 160 160 160 160 160 800
Estimated Outlays............................... 55 120 145 150 155 625
Vaccine Tracking and Distribution:
Authorization Level............................. 31 31 31 31 31 155
Estimated Outlays............................... 15 25 30 30 30 130
Food and Drug Administration:
Estimated Authorization............................. 15 30 35 40 40 160
Estimated Outlays................................... 15 25 35 35 40 150
Office of the Assistant Secretary for Health:
Authorization Level................................. 12 12 12 12 12 60
Estimated Outlays................................... 5 10 10 10 10 45
Office of the Assistant Secretary for Preparedness and
Response:
Procurement of Countermeasures:
Authorization Level............................. 2,800 0 0 0 0 2,800
Estimated Outlays............................... 0 0 365 665 330 1,360
Advance Development of Countermeasures:
Authorization Level............................. 415 415 415 415 415 2,075
Estimated Outlays............................... 85 315 380 405 415 1,600
Hospital Preparedness:
Authorization Level............................. 378 378 378 378 378 1,890
Estimated Outlays............................... 75 265 320 360 365 1,385
National Disaster Medical System:
Authorization Level............................. 56 56 56 56 56 280
Estimated Outlays............................... 10 45 50 55 55 215
Emergency Volunteer Registration:
Authorization Level............................. 6 6 6 6 6 30
Estimated Outlays............................... 5 5 5 5 5 25
Total Changes:
Authorization Level................................. 4,506 1,721 1,726 1,731 1,731 11,415
Estimated Outlays................................... 395 1,250 1,880 2,315 2,020 7,860
----------------------------------------------------------------------------------------------------------------
Basis of estimate: For this estimate, CBO assumes that H.R.
2405 will be enacted near the start of fiscal year 2012 and
that the authorized amounts will be appropriated for each year.
The bill contains provisions that would authorize funding
for activities administered by CDC, FDA, the Office of the
Assistant Secretary of Health (ASH), and the Office of the
Assistant Secretary for Preparedness and Response (ASPR) to
improve the coordination of preparedness activities and to
increase medical system capacity in the event of a public
health emergency.
Centers for Disease Control and Prevention
H.R. 2405 would authorize funding through 2016 for
activities related to preparing for a public health emergency
at levels similar to the appropriations for recent years.
State and Local Public Health Security. H.R. 2405 would
allow CDC to continue to administer cooperative agreements with
state and local governments to help prepare for public health
emergencies. Entities receiving funding through those
cooperative agreements must submit plans for responding to an
outbreak of pandemic influenza and contribute matching funds.
This bill would authorize the appropriation of $633 million
each fiscal year for 2012 through 2016 for CDC to administer
those cooperative agreements. Based on historical spending
patterns of similar programs, CBO estimates that implementing
that provision would cost $130 million in 2012 and $2.3 billion
over the 2012-2016 period, assuming appropriation of the
authorized amounts.
Public Health Threats. H.R. 2405 would authorize funding
for the Secretary to continue to expand, enhance, and improve
the capacity for CDC to respond effectively to bioterrorism and
other public health emergencies. H.R. 2405 would also authorize
funding to establish and maintain surveillance programs and
networks that enhance coordinated efforts in response to
outbreaks of infectious diseases and public health emergencies.
The bill would authorize the appropriation of $160 million a
year for fiscal years 2012 through 2016. Based on historical
spending patterns for similar programs, CBO estimates that
implementing that provision would cost $55 million in 2012 and
$625 million over the 2012-2016 period, assuming appropriation
of the authorized amounts.
Vaccine Tracking and Distribution. CDC collaborates with
officials in state, local, and tribal governments as well as
private entities, such as vaccine manufacturers, wholesalers,
and distributors, to track the distribution of vaccines for
pandemic flu and to promote effective distribution of vaccines
for the seasonal flu. H.R. 2405 would authorize the Secretary
to continue those activities and would authorize the
appropriation $31 million for each fiscal year over the 2012-
2016 period. Assuming appropriation of authorized amounts, CBO
estimates that implementing that provision would cost $15
million in 2012 and $130 million over the 2012-2016 period,
based on historical spending patterns for similar programs.
Food and Drug Administration
H.R. 2405 would expand the role of FDA personnel in
supporting the development, stockpiling, approval and licensure
of medical countermeasures (such as diagnostic tests, drugs,
vaccines and other treatments for response to chemical,
biological, radiological and nuclear threats) as well as
medical responses to pandemics and epidemics. The bill would
require the formation of a team of experts on manufacturing and
regulatory activities within the FDA to provide both off-site
and on-site technical assistance to manufacturers of those
products. CBO estimates that the FDA would require the
appropriation of an additional $15 million in 2012 and $160
million for the 2012-2016 period for such activities. Assuming
the appropriation of those amounts, CBO estimates those
provisions would cost $150 million over the 2012-2016 period.
Office of the Assistant Secretary of Health
The Medical Reserve Corps (MRC) is a community-based
program that coordinates medical and public health volunteers
to support public health activities, including emergency
preparedness and response efforts. The bill would authorize
funding for the MRC, which is operated by the HHS Office of the
Surgeon General within the ASH. The MRC received an
appropriation of just under $12 million for fiscal year 2011.
The bill would authorize the same amount for each fiscal year
over the 2012-2016 period. Based on historical spending
patterns for similar programs, CBO estimates that implementing
that provision would cost $5 million in 2012 and $45 million
over the 2012-2016 period, assuming appropriation of authorized
amounts.
Office of the Assistant Secretary for Preparedness and Response
H.R. 2405 would authorize funding for the following
activities administered by ASPR related to medical system
capacity and countermeasure development and procurement.
Procurement of Countermeasures. Project Bioshield, a
special reserve fund established for the procurement of
biodefense countermeasures, is funded by an appropriation of
approximately $5.6 billion for fiscal years 2004-2013. H.R.
2405 would authorize an additional appropriation of $2.8
billion for fiscal years 2014-2018 to the fund for continuing
those activities. H.R. 2405 would allow up to 30 percent of the
$2.8 billion to be used for advance research and development of
countermeasures. Based on historical spending patterns, CBO
estimates that implementing the provision would cost $1.4
billion over the 2012-2016 period, assuming appropriation of
the authorized amount.
Advance Development of Countermeasures. The Biomedical
Advance Research and Development Authority (BARDA) office
within ASPR supports the advance development of medical
countermeasures to respond to bioterrorism and other public
health emergencies. BARDA is funded by the Biodefense Medical
Countermeasure Development Fund. H.R. 2405 would authorize $415
million for the fund in each year for fiscal years 2012 through
2016. Based on historical spending patterns, CBO estimates that
implementing that provision would cost $85 million in 2012 and
$1.6 billion over the 2012-2016 period, assuming appropriation
of the authorized amounts.
Hospital Preparedness. The bill would authorize a grant
program that provides funding to entities such as states,
localities, or health care facilities to enhance hospital
capacity to handle a surge of patients in the event of a public
health emergency. The grant program received an appropriation
of $378 million in fiscal year 2011. The bill would authorize
the same amount in each fiscal year over the 2012-2016 period.
Assuming appropriation of authorized amounts, CBO estimates
that implementing that provision would cost $75 million in 2012
and $1.4 billion over the 2012-2016 period, based on historical
spending patterns of similar programs.
National Disaster Medical System (NDMS). The bill would
authorize funding for the NDMS, which is a partnership between
HHS, the Departments of Defense, Homeland Security, and
Veterans Affairs. It provides for medical assistance to states
and localities when responding to a large-scale public health
emergency. In fiscal year 2011, the NDMS received an
appropriation of $56 million. The bill would authorize the same
amount in each fiscal year over the 2012-2016 period. Based on
historical spending patterns of similar programs, CBO estimates
that implementing that provision would cost $215 million over
the 2012-2016 period, assuming appropriation of authorized
amounts.
Emergency Volunteer Registration. The Emergency System for
Advance Registration of Volunteer Health Professionals (ESAR-
VHP) is a national database that links state credential
verification systems in order to streamline the pre-
registration of volunteer health professionals who are willing
to respond in the event of a public health emergency. The ESAR-
VHP received an appropriation of about $6 million in fiscal
year 2011. The bill would authorize the same amount in each
fiscal year over the 2012-2016 period. Assuming appropriation
of authorized amounts, CBO estimates that implementing that
provision would cost $25 million over the 2012-2016 period,
based on historical spending patterns of similar programs.
Pay-As-You-Go considerations: None.
Intergovernmental and private-sector impact: H.R. 2405
contains no intergovernmental or private-sector mandates as
defined in UMRA. Programs and activities authorized in the bill
would benefit state, local, and tribal agencies that prepare
for and respond to public health emergencies.
Estimate prepared by: Federal costs: Stephanie Cameron,
Andrea Noda, Ellen Werble; Impact on state, local, and tribal
governments: Lisa Ramirez-Branum; Impact on the private sector:
Jimmy Jin.
Estimate approved by: Holly Harvey, Deputy Assistant
Director for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1--Short title and table of contents
This section includes the name of the bill: ``Pandemic and
All-Hazards Preparedness Reauthorization Act of 2011.''
Section 2--Reauthorization of certain provisions relating to public
health preparedness
This section includes the following provisions:
Section 2(a)--Vaccine tracking and distribution.
This provision would reauthorize the vaccine tracking and
distribution program used during an influenza pandemic. The
bill would authorize the program at $30.8 million each year for
five years (FY 2012-2016). This level of funding is equal to
the program's FY 2011 appropriated level.
Section 2(b)--Public health preparedness grants.
This provision would reauthorize the Public Health Emergency
Preparedness Cooperative Agreement (PHEP) administered by the
Centers for Disease Control and Prevention (CDC). These grants
to state and local health departments have greatly improved the
Nation's ability to respond to many public health hazards. The
bill would require those applying for the grants to describe
any activities they will use to analyze clinical specimens,
including any utilization of poison control centers, which the
Committee believes are vital components to our nation's
preparedness infrastructure and therefore should be utilized.
Poison Control Centers possess the capacity and expertise to
assist in responding to a public health emergency. The bill
would authorize the program at $632.9 million each year for
five years (FY 2012-2016). This level of funding is equal to
the program's FY 2011 appropriated level.
Section 2(c)--Health system preparedness grants.
This provision would reauthorize the Hospital Preparedness
Program Cooperative Agreement administered by the ASPR. These
grants to states and hospitals have greatly improved our
Nation's preparedness for disasters that would result in a
surge in the need for medical care. The bill includes language
that would require the awards to take into account the needs of
pediatric and other at-risk populations. The bill also would
require the HHS Secretary to implement evidence-based metrics
to ensure that those receiving awards meet the goals of the
National Health Security Strategy. The bill would authorize the
program at $378 million each year for five years (FY 2012-
2016). This level of funding is equal to the program's FY 2011
appropriated level.
Section 2(d)--CDC surveillance and capacity. The
provision would reauthorize the Federal, state, and local
surveillance and situational awareness capacity program. The
bill would authorize the program at $160.1 million each year
for five years (FY 2012-2016). This level of funding is equal
to the program's FY 2011 appropriated level.
Section 2(e)--Dental emergency responders. This
provision would incorporate dentists by name into Federal and
state disaster response frameworks, allowing dentists to be
deployed during a natural or man-made disaster. This provision
is based on H.R. 570, the ``Dental Emergency Responder Act of
2011'', which was introduced by Rep. Michael Burgess (R-TX) on
February 9, 2011, and reported favorably by the Committee
earlier this Congress. Recent disasters have made clear the
critical need for a prepared, robust national medical response
framework. Currently, dentists, allied dental personnel, and
dental facilities are not part of that framework. These
individuals and offices are both eager and willing to
participate and otherwise assist in supporting medical and
public health responses to disasters. The legislation would
allow but not require these health care professionals to assist
in public health emergencies.
Section 2(f)--BioShield Special Reserve Fund. This
provision would reauthorize the Project BioShield Special
Reserve Fund, originally created in 2004. The SRF was intended
to be used solely for procuring medical countermeasures in
response to chemical, biological, radiological, or nuclear
threats against the nation. Since 2004, the SRF has
successfully procured medical countermeasures for the Strategic
National Stockpile, protecting against threats such as anthrax
and smallpox.
The Committee believes stable funding for MCM development
and procurement is vital to create producer interest in and
willingness to enter this space. The SRF is intended to be a
secure funding source for the procurement of critical MCMs; it
is critical because it clearly demonstrates the Federal
government's commitment to MCM procurement. As such, the
Committee believes these funds for development and procurement
of MCMs should go to these specific activities and not be
diverted. Because substantial funds have, in fact, been
diverted to non-MCM activities, causing significant fear that
there are or will soon be insufficient funds to support MCM
development and procurement, H.R. 2405 would prohibit SRF funds
from being used for anything other than MCM development and
procurement, as defined under sections 319L and 319F-2 of the
Public Health Service Act.
This legislation would reauthorize the SRF at $2.8 billion
over five years (FY 2014-2018). This level of funding is
consistent with the SRF's original, 10-year appropriation of
$5.6 billion for FY 2004-2013. In addition to reauthorizing the
SRF, the provision also would:
Require the Federal government to clearly
define the purpose of a particular contract as it
relates to the medical countermeasure being procured.
Require the HHS Secretary to provide a
report to Congress when funds available in the SRF go
below $1.5 billion. The report would detail how the
level of funding in the SRF would affect our nation's
ability to develop medical countermeasures for public
health threats.
Allow the HHS Secretary to use up to 30
percent of funds available in the SRF for advanced
research and development of medical countermeasures at
BARDA. These funds would supplement, not supplant,
BARDA's funding through the annual appropriations
process.
Section 2(g)--Emergency System for Advance
Registration of Health Professions Volunteers (ESAR-VHP). This
provision would reauthorize the ESAR-VHP program, which
supports state and territories in establishing standardized
volunteer registration programs for disasters and public health
and medical emergencies. The program is funded at $5.9 million
each year for five years (FY 2012-2016). This level of funding
is equal to the program's FY 2011 appropriated level.
Section 2(h)--Biomedical Advanced Research and
Development Authority. This provision would reauthorize BARDA,
which was created in 2006 to help bridge the ``valley of
death'' between medical countermeasure development and
procurement. BARDA has been successful in getting many early-
stage medical countermeasures through the expensive, time
consuming development process so that these products can be
procured for the Strategic National Stockpile. The bill would
reauthorize BARDA at $415 million each year for five years (FY
2012-2016). This level of funding is equal to the program's FY
2011 appropriated level. The bill also would extend the
requirement that the HHS Secretary withhold from FOIA
disclosure specific technical data or scientific information
created during the advanced research and development of a
medical countermeasure that would reveal vulnerabilities of
existing medical or public health defenses against CBRN
threats. Finally, the bill would require the Federal government
to clearly define the purpose of a particular advanced research
and development contract as it relates to the medical
countermeasure under contract.
Section 2(i)--National Disaster Medical System
(NDMS). The bill would reauthorize the NDMS, which assists in
managing the Federal government's medical response to major
emergencies and disasters. The bill would reauthorize the
program at $56 million each year for five years (FY 2012-2016).
This level of funding is equal to the program's FY 2011
appropriated level. Under this provision, the HHS Secretary
could pay third party vendors to assist in the Federal response
to emergencies and disasters.
Section 2(j)--National Health Security Strategy
Timeline. This provision would change the submission date of
the National Health Security Strategy to 2014.
Section 2(k)--Enhancing Surge Capacity. This
provision would modify the goals in the National Health
Security Strategy to ensure that periodic evaluation of
Federal, State, local, and tribal preparedness will include
drills and exercises to ensure medical surge capacity,
particularly for events without notice. The goals for medical
preparedness capacity would be expanded to include
availability, coordination, and accessibility of resources. The
provision also would change the definition of the components of
medical preparedness under the strategy to include both
ambulatory care and critical care. Finally, the provision would
ensure that medical evacuation goals include triage and
evacuation to the appropriate medical institution based on the
medical needs of the patient, as part of regional systems.
Section 2(l)--Volunteer Medical Reserve Corps.
This provision would reauthorize the Medical Reserve Corps,
which engages local volunteers to strengthen public health,
emergency response and community resiliency. The bill would
reauthorize the program at $11.9 million each year for five
years (FY 2012-2016). This level of funding is equal to the
program's FY 2011 appropriated level.
Section 2(m)--Extension of anti-trust exemptions.
This provision would extend limited anti-trust exemptions for
meetings regarding medical countermeasure development that
include national security information.
Section 3--Temporary redeployment of personnel during a public health
emergency
The section would allow the HHS Secretary to redeploy
nonFederal personnel (funded through the Public Health Service
Act or programs funded through HHS) to assist in public health
emergencies and disasters, but only at the request of the state
or locality.
Section 4--Improving coordination by the Assistant Secretary for
Preparedness and Response
The ASPR serves as the principal advisor to the HHS
Secretary on all matters related to bioterrorism and other
public health emergencies. Additionally, the ASPR plays a vital
role in coordinating emergency response efforts across the
various HHS agencies and among HHS; other Federal departments,
agencies, and offices; and state and local officials. The
Committee believes that it is clear that the successful
execution of the ASPR's mission, which, according to the ASPR,
is to ``lead the nation in preventing, responding to and
recovering from the adverse health effects of public health
emergencies and disasters,'' is vital to ensuring that our
Nation is prepared to effectively respond to a CBRN threat or
emergency.\1\ While centralizing significant coordination
authority with the ASPR is necessary, the Federal response to
recent emergencies has not always clearly demonstrated which
office or agency leads our nation's efforts on preparedness and
response.
---------------------------------------------------------------------------
\1\http://www.hhs.gov/open/contacts/aspr.html.
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The section would amend Section 2811 of the Public Health
Service Act to clarify that the ASPR has lead responsibility
within HHS for emergency preparedness and response policy and
coordination. The Committee believes this clarification is
essential, not only to better coordinate our nation's
preparedness efforts, but also to ensure that, if there is a
public health emergency or disaster, the public, and those
involved in responding to such an emergency or disaster,
understand the division of responsibilities. To this end, the
bill includes the following provisions that would require the
ASPR to:
Streamline and better coordinate HHS
preparedness grants in order to avoid duplication, as
well as to disseminate best practices.
Conduct a comprehensive five-year budget
analysis of the entire medical countermeasure
enterprise to ensure prioritization of limited
resources.
Identify gaps, duplication, and other
inefficiencies in public health preparedness activities
and the actions necessary to overcome these obstacles.
Conduct a Countermeasure Implementation Plan
(CIP) in order to improve transparency, accountability,
and success of the entire medical countermeasure
enterprise. The CIP would require ASPR to identify
threats against the nation, create measurable goals to
address these threats, report on progress of meeting
these goals, identify budget and funding needs, and
identify specific timelines for medical countermeasure
development. The CIP would be presented to Congress 6
months after the date of enactment of H.R. 2405 and
annually thereafter.
In the CIP, the Committee believes that the ASPR
would have to address the needs of pediatric
populations with respect to countermeasures and
products in the Strategic National Stockpile, as there
have been a number of concerns raised in this area.
Specifically, the ASPR would have to include a list of
qualified countermeasures and products necessary to
address the needs of pediatric populations and a plan
for addressing these needs. Through this process, the
ASPR should remedy gaps in the pediatric countermeasure
enterprise in addition to ensuring that countermeasures
developed and approved in the future have pediatric
labeling, dosages, and formulations, where feasible.
Finally, with respect to pediatric populations, the
ASPR would be required to advise the HHS Secretary on
issues pertaining to pediatric qualified
countermeasures and products.
Be consulted when the HHS Secretary
authorizes medical products for use during emergencies.
Submit a plan on improving coordination of
the biosurveillance systems of HHS.
The Committee underscores that it is not its intent to move
the day-to-day operations of the Cities Readiness Initiative
(CRI), the Medical Reserve Corps or the SNS. Rather, the
legislation is designed to ensure that the ASPR has policy
oversight and coordination authority over these preparedness
programs.
Section 5--Eliminating duplicative Project Bioshield reports
This section would repeal a report included under Project
Bioshield that is duplicative of parts of the new
Countermeasure Implementation Plan created in Section 4.
Section 6--Authorization for medical products for use in emergencies
This section would amend FDA's current Emergency Use
Authority (EUA) authority to enable FDA to authorize the
distribution, stockpiling, and use of products before an actual
emergency. Specifically, the provisions would:
Enable the HHS Secretary to make a threat
determination of a significant potential for a public
health emergency (as opposed to an actual emergency)
justifying issuance of an EUA and thus allowing FDA to
take important, life-saving steps before the emergency
actually occurs.
Permit FDA to collect and analyze
information about safety and effectiveness beyond the
effective period of the EUA, but only for products
actually used in an emergency.
Allow FDA to issue an EUA for products or
uses that otherwise may violate provisions of Federal
Food, Drug, and Cosmetic Act (i.e. adulteration and
misbranding provisions), but are important to
protecting Americans.
The Committee notes that it intends the provisions applying
to emergency use authority to include countermeasures and
products for pediatric populations.
Section 7--Additional provisions related to medical products for
emergency use
This section would provide added flexibility for emergency
dispensing and use of eligible, FDA-approved medical
countermeasure products. Specifically, the provisions would:
Enable FDA to extend the expiration date for
medical countermeasures intended to be used for
emergency responses.
Allow waivers of current Good Manufacturing
Practices (cGMP) without rendering a product
adulterated or misbranded.
Authorize mass dispensing of medical
countermeasures during an actual emergency without an
individual prescription if permitted under state law or
permitted by an order of the HHS Secretary.
Authorize the HHS Secretary to create and
issue emergency use instructions concerning a product's
conditions of use.
Authorize the HHS Secretary to waive a Risk
Evaluation and Mitigation Strategy if the Secretary determines
that a waiver is required to mitigate the effects or reduce the
severity of emergencies.
Section 8--Product held for emergency use
This section would authorize pre-positioning of medical
countermeasure by federal, state or local governments in
anticipation of emergencies, allowing faster response during an
actual emergency.
Section 9--Accelerating medical countermeasure development by
strengthening FDA's role in reviewing products for national
security priorities
Transparency, certainty, and predictability are
particularly important in the context of MCM research and
development because the stakes are so high for MCM sponsors and
the American public. Because in some instances sponsors can
rely only on the Federal government to purchase their MCM
products, risk associated with investing the time and resources
necessary to enter the countermeasure space is significant. By
increasing transparency, accountability, and predictability in
this area, which this legislation seeks to do, the Committee
believes the bill will encourage investment, research, and
development in the space and increase the likelihood of
securing the MCMs necessary for public health emergencies and
disasters, including those caused by terrorism.
This section includes provisions aimed at providing greater
transparency, predictability, and certainty for medical
countermeasure sponsors by increasing FDA's interaction with
sponsors and requiring FDA to provide additional clarity around
the requirements of the approval, clearance, and licensure
processes. Specifically, the section would:
Increase the involvement of FDA personnel in
interagency, countermeasure-related activities.
Permit FDA to provide on-site and off-site
technical assistance to countermeasure manufacturers.
Require FDA to establish a process for
frequent scientific feedback and interaction with those
sponsors whose countermeasures have been procured under
Project BioShield, in order to facilitate the approval,
clearance, and licensure of the countermeasures. As
part of this process, the bill would allow for the
development of regulatory management plans (RMPs)
through which eligible sponsors can create an agreement
with the FDA to have scientific exchanges throughout
the product development process. The Committee believes
the use of RMPs will reduce the uncertainty and risk
experienced by countermeasure sponsors. Under the bill,
these plans would be developed by the sponsors and
include information on the following: current
regulatory status of the countermeasure; proposed
pathway to approval, clearance or licensure of the
countermeasure including the data, clinical trials and
any other information required for such approval,
clearance or licensure; developmental milestones which
will result in meetings between the sponsor and FDA;
sponsor submissions which will result in written
feedback and any other information; or issues that
would facilitate or delay approval. FDA, upon receipt
of a proposal with relevant data from a sponsor, would
have 90 days to work with the sponsor to agree on a
Regulatory Management Plan. FDA retains full discretion
to determine the contents of the final plan, or to
determine that no final plan can be agreed upon. In the
latter case, FDA will provide the sponsor with the
scientific or regulatory rationale why such agreement
cannot be reached. Under the bill, the HHS would have
the authority to apply this process to other qualified
pandemic or epidemic products.
Set forth a timeline for FDA's issuance of a
final guidance on development of animal models. FDA
would have one year to provide the final guidance, but
the deadline could be extended by six months if the HHS
Secretary submits a report to Congress on the status of
the guidance.
Expand the use of Special Protocol
Assessments to the use of animal trials and any
associated clinical trials necessary to support
licensure of countermeasures referenced in Section
565(a) of the Federal Food, Drug, and Cosmetic Act when
human efficacy studies are not ethical or feasible.
Require FDA to report on countermeasure
development and review activities on a biennial basis,
starting on January 1, 2013.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, existing law in which no change is
proposed is shown in roman):
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
* * * * * * *
Part B--Federal-State Cooperation
* * * * * * *
SEC. 319. PUBLIC HEALTH EMERGENCIES.
(a) * * *
* * * * * * *
(e) Temporary Redeployment of Personnel During a Public
Health Emergency.--
(1) Emergency redeployment of federally funded
personnel.--Notwithstanding any other provision of law,
and subject to paragraph (2), upon a request that is
from a State, locality, territory, tribe, or the Freely
Associated States and that includes such information
and assurances as the Secretary may require, the
Secretary may authorize the requesting entity to
temporarily redeploy to immediately address a public
health emergency non-Federal personnel funded in whole
or in part through--
(A) any program under this Act; or
(B) at the discretion of the Secretary, any
other program funded in whole or in part by the
Department of Health and Human Services.
(2) Activation of emergency redeployment.--
(A) Public health emergency.--The Secretary
may exercise the authority vested by paragraph
(1) only during the period of a public health
emergency determined pursuant to subsection
(a).
(B) Considerations.--In authorizing a
temporary redeployment under paragraph (1), the
Secretary shall consider each of the following:
(i) The degree to which the emergency
cannot be adequately and appropriately
addressed by the public health
workforce.
(ii) The degree to which the
emergency requires or would otherwise
benefit from supplemental staffing from
those funded through nonpreparedness
Federal programs.
(iii) The degree to which such
programs would be adversely affected by
the redeployment.
(iv) Such other factors as the
Secretary may deem appropriate.
(C) Termination and extension.--
(i) Termination.--The authority to
authorize a temporary redeployment of
personnel under paragraph (1) shall
terminate upon the earlier of the
following:
(I) The Secretary's
determination that the public
health emergency no longer
exists.
(II) Subject to clause (ii),
30 days after the activation of
the Secretary's authority
pursuant to subparagraph (A).
(ii) Extension authority.--The
Secretary may extend the authority to
authorize a temporary redeployment of
personnel under paragraph (1) beyond
the date otherwise applicable under
clause (i)(II) if the public health
emergency still exists, but only if--
(I) the extension is
requested by the entity that
requested authority to
authorize a temporary
redeployment; and
(II) the Secretary gives
notice to the Congress in
conjunction with the extension.
SEC. 319A. VACCINE TRACKING AND DISTRIBUTION.
(a) * * *
* * * * * * *
(e) Authorization of Appropriations.--There are authorized to
be appropriated to carry out this section, [such sums for each
of fiscal years 2007 through 2011] $30,800,000 for each of
fiscal years 2012 through 2016.
* * * * * * *
SEC. 319C-1. IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY.
(a) * * *
(b) Eligible Entities.--To be eligible to receive an award
under subsection (a), an entity shall--
(1) * * *
(2) prepare and submit to the Secretary an
application at such time, and in such manner, and
containing such information as the Secretary may
require, including--
(A) an All-Hazards Public Health Emergency
Preparedness and Response Plan which shall
include--
(i) * * *
* * * * * * *
(iv) a description of the mechanism
the entity will implement to utilize
the Emergency Management Assistance
Compact or other mutual aid agreements
for medical and public health mutual
aid; [and]
(v) a description of how the entity
will include the State Unit on Aging in
public health emergency preparedness;
and
(vi) a description of any activities
that such entity will use to analyze
real-time clinical specimens for
pathogens of public health or
bioterrorism significance, including
any utilization of poison control
centers;
* * * * * * *
(f) Consultation With Homeland Security.--In making awards
under subsection (a), the Secretary shall consult with the
Secretary of Homeland Security to--
(1) * * *
(2) minimize duplicative funding of programs and
activities; and
(3) analyze activities, including exercises and
drills, conducted under this section to develop
recommendations and guidance on best practices for such
activities[; and] .
[(4) disseminate such recommendations and guidance,
including through expanding existing lessons learned
information systems to create a single Internet-based
point of access for sharing and distributing medical
and public health best practices and lessons learned
from drills, exercises, disasters, and other
emergencies.]
* * * * * * *
[(h) Grants for Real-Time Disease Detection Improvement.--
[(1) In general.--The Secretary may award grants to
eligible entities to carry out projects described under
paragraph (4).
[(2) Eligible entity.--For purposes of this section,
the term ``eligible entity'' means an entity that is--
[(A)(i)a hospital, clinical laboratory,
university; or
[(ii) a poison control center or professional
organization in the field of poison control;
and
[(B) a participant in the network established
under subsection 319D(d).
[(3) Application.--Each eligible entity desiring a
grant under this subsection shall submit to the
Secretary an application at such time, in such manner,
and containing such information as the Secretary may
require.
[(4) Use of funds.--
[(A) In general.--An eligible entity
described in paragraph (2)(A)(i) that receives
a grant under this subsection shall use the
funds awarded pursuant to such grant to carry
out a pilot demonstration project to purchase
and implement the use of advanced diagnostic
medical equipment to analyze real-time clinical
specimens for pathogens of public health or
bioterrorism significance and report any
results from such project to State, local, and
tribal public health entities and the network
established under section 319D(d).
[(B) Other entities.--An eligible entity
described in paragraph (2)(A)(ii) that receives
a grant under this section shall use the funds
awarded pursuant to such grant to--
[(i) improve the early detection,
surveillance, and investigative
capabilities of poison control centers
for chemical, biological, radiological,
and nuclear events by training poison
information personnel to improve the
accuracy of surveillance data,
improving the definitions used by the
poison control centers for
surveillance, and enhancing timely and
efficient investigation of data
anomalies;
[(ii) improve the capabilities of
poison control centers to provide
information to health care providers
and the public with regard to chemical,
biological, radiological, or nuclear
threats or exposures, in consultation
with the appropriate State, local, and
tribal public health entities; or
[(iii) provide surge capacity in the
event of a chemical, biological,
radiological, or nuclear event through
the establishment of alternative poison
control center worksites and the
training of nontraditional personnel.]
(i) Funding.--
(1) Authorization of appropriations.--
[(A) In general.--For the purpose of carrying
out this section, there is authorized to be
appropriated $824,000,000 for fiscal year 2007,
of which $35,000,000 shall be used to carry out
subsection (h), for awards pursuant to
paragraph (3) (subject to the authority of the
Secretary to make awards pursuant to paragraphs
(4) and (5)), and such sums as may be necessary
for each of fiscal years 2008 through 2011.
[(B) Coordination.--There are authorized to
be appropriated, $10,000,000 for fiscal year
2007 to carry out subsection (f)(4) of this
section and section 2814.]
(A) In general.--For the purpose of carrying
out this section, there is authorized to be
appropriated $632,900,000 for each of fiscal
years 2012 through 2016.
* * * * * * *
(3) Determination of amount.--
(A) * * *
* * * * * * *
(C) Increase on basis of population.--After
determining the base amount for a State under
subparagraph (B), the Secretary shall increase
the base amount by an amount equal to the
product of--
(i) the amount appropriated under
paragraph [(1)(A)(i)(I)] (1)(A) for the
fiscal year, less an amount equal to
the sum of all base amounts determined
for the States under subparagraph (B),
and less the amount, if any, reserved
by the Secretary under paragraphs (4)
and (5); and
* * * * * * *
(D) Minimum amount.--Subject to the amount
appropriated under paragraph [(1)(A)(i)(I)]
(1)(A), an award pursuant to subparagraph (A)
for a State shall be the greater of the base
amount as increased under subparagraph (C), or
the minimum amount under this subparagraph. The
minimum amount under this subparagraph is--
(i) in the case of each of the
several States, the District of
Columbia, and the Commonwealth of
Puerto Rico, an amount equal to the
lesser of--
(I) * * *
(II) if the amount
appropriated under paragraph
[(1)(A)(i)(I)] (1)(A) is less
than $667,000,000, an amount
equal to 0.75 percent of the
amount appropriated under such
paragraph, less the amount, if
any, reserved by the Secretary
under paragraphs (4) and (5);
or
* * * * * * *
SEC. 319C-2. PARTNERSHIPS FOR STATE AND REGIONAL HOSPITAL PREPAREDNESS
TO IMPROVE SURGE CAPACITY.
(a) In General.--The Secretary shall award competitive grants
or cooperative agreements to eligible entities to enable such
entities to improve surge capacity and enhance community and
hospital preparedness for public health emergencies, including
capacity and preparedness to address the needs of pediatric and
other at-risk populations.
* * * * * * *
(i) Performance and Accountability.--[The requirements of]
(1) In general.--The requirements of section 319C-
1(g), (j), and (k) shall apply to entities receiving
awards under this section (regardless of whether such
entities are described under subsection (b)(1)(A) or
(b)(2)(A)) in the same manner as such requirements
apply to entities under section 319C-1. An entity
described in subsection (b)(1)(A) shall make such
reports available to the lead health official of the
State in which such partnership is located.
(2) Meeting goals of national health security
strategy.--The Secretary shall implement objective,
evidence-based metrics to ensure that entities
receiving awards under this section are meeting, to the
extent practicable, the goals of the National Health
Security Strategy under section 2802.
(j) Authorization of Appropriations.--
[(1) In general.--For the purpose of carrying out
this section, there is authorized to be appropriated
$474,000,000 for fiscal year 2007, and such sums as may
be necessary for each of fiscal years 2008 through
2011.]
(1) In general.--For purposes of carrying out this
section, there is authorized to be appropriated
$378,000,000 for each of fiscal years 2012 through
2016.
* * * * * * *
SEC. 319D. REVITALIZING THE CENTERS FOR DISEASE CONTROL AND PREVENTION.
(a) * * *
* * * * * * *
[(c) Authorization of Appropriations.--
[(1) Facilities; capacities.--
[(A) Facilities.--For the purpose of carrying
out subsection (a)(2), there are authorized to
be appropriated $300,000,000 for each of the
fiscal years 2002 and 2003, and such sums as
may be necessary for each of the fiscal years
2004 through 2006.
[(B) Mission; Improving capacities.--For the
purposes of achieving the mission of the
Centers for Disease Control and Prevention
described in subsection (a)(1), for carrying
out subsection (a)(3), for better conducting
the capacities described in section 319A, and
for supporting public health activities, there
are authorized to be appropriated such sums as
may be necessary for each of the fiscal years
2002 through 2006.
[(2) National communications and surveillance
networks.--For the purpose of carrying out subsection
(b), there are authorized to be appropriated such sums
as may be necessary for each of the fiscal years 2002
through 2006.]
* * * * * * *
(g) Authorization of Appropriations.--There are authorized to
be appropriated to carry out this section, [such sums as may be
necessary in each of fiscal years 2007 through 2011]
$160,121,000 for each of fiscal years 2012 through 2016.
* * * * * * *
SEC. 319F. PUBLIC HEALTH COUNTERMEASURES TO A BIOTERRORIST ATTACK.
(a) All-Hazards Public Health and Medical Response Curricula
and Training.--
(1) * * *
* * * * * * *
(5) Dissemination and training.--
(A) * * *
(B) Certain entities.--The education and
training activities described in subparagraph
(A) may be carried out by Federal [public
health or medical] public health, medical, or
dental entities, appropriate educational
entities, professional organizations and
societies, private accrediting organizations,
and other nonprofit institutions or entities
meeting criteria established by the Secretary.
* * * * * * *
SEC. 319F-2. STRATEGIC NATIONAL STOCKPILE AND SECURITY COUNTERMEASURE
PROCUREMENTS.
(a) * * *
* * * * * * *
(c) Additional Authority Regarding Procurement of Certain
Countermeasures; Availability of Special Reserve Fund.--
(1) In general.--
(A) Use of fund.--A security countermeasure
may, in accordance with this subsection, be
procured with amounts in the [special reserve
fund under paragraph (10)] special reserve fund
as defined in subsection (g)(5).
* * * * * * *
(4) Call for development of countermeasures;
commitment for recommendation for procurement.--
(A) Proposal to the president.--If, pursuant
to an assessment under paragraph (3), the
Homeland Security Secretary and the Secretary
make a determination that a countermeasure
would be appropriate but is either currently
not developed or unavailable for procurement as
a security countermeasure or is approved,
licensed, or cleared only for alternative uses,
such Secretaries may jointly submit to the
President a proposal to--
(i) * * *
(ii) make a commitment that, upon the
first development of such
countermeasure that meets the
conditions for procurement under
paragraph (5), the Secretaries will,
based in part on information obtained
pursuant to such call, make a
recommendation under paragraph (6) that
the [special reserve fund under
paragraph (10)] special reserve fund as
defined in subsection (g)(5) be made
available for the procurement of such
countermeasure.
* * * * * * *
(5) Secretary's determination of countermeasures
appropriate for funding from special reserve fund.--
(A) In general.--The Secretary, in accordance
with the provisions of this paragraph, shall
identify specific security countermeasures that
the Secretary determines, in consultation with
the Homeland Security Secretary, to be
appropriate for inclusion in the stockpile
under subsection (a) pursuant to procurements
made with amounts in the [special reserve fund
under paragraph (10)] special reserve fund as
defined in subsection (g)(5) (referred to in
this subsection individually as a ``procurement
under this subsection'').
* * * * * * *
(6) Recommendation for president's approval.--
(A) Recommendation for procurement.--In the
case of a security countermeasure that the
Secretary has, in accordance with paragraphs
(3) and (5), determined to be appropriate for
procurement under this subsection, the Homeland
Security Secretary and the Secretary shall
jointly submit to the President, in
coordination with the Director of the Office of
Management and Budget, a recommendation that
the [special reserve fund under paragraph (10)]
special reserve fund as defined in subsection
(g)(5) be made available for the procurement of
such countermeasure.
(B) Presidential approval.--The [special
reserve fund under paragraph (10)] special
reserve fund as defined in subsection (g)(5) is
available for a procurement of a security
countermeasure only if the President has
approved a recommendation under subparagraph
(A) regarding the countermeasure.
(C) Notice to designated congressional
committees.--The Secretary and the Homeland
Security Secretary shall notify the designated
congressional committees of each decision of
the President to approve a recommendation under
subparagraph (A). Such notice shall include an
explanation of the decision to make available
the [special reserve fund under paragraph (10)]
special reserve fund as defined in subsection
(g)(5) for procurement of such a
countermeasure, including, where available, the
number of, nature of, and other information
concerning potential suppliers of such
countermeasure, and whether other potential
suppliers of the same or similar
countermeasures were considered and rejected
for procurement under this section and the
reasons therefor.
* * * * * * *
(E) Rule of construction.--Recommendations
and approvals under this paragraph apply solely
to determinations that the [special reserve
fund under paragraph (10)] special reserve fund
as defined in subsection (g)(5) will be made
available for a procurement of a security
countermeasure, and not to the substance of
contracts for such procurement or other matters
relating to awards of such contracts.
(7) Procurement.--
(A) * * *
(B) Interagency agreement; cost.--The
Homeland Security Secretary shall enter into an
agreement with the Secretary for procurement of
a security countermeasure in accordance with
the provisions of this paragraph. The [special
reserve fund under paragraph (10)] special
reserve fund as defined in subsection (g)(5)
shall be available for payments made by the
Secretary to a vendor for such procurement.
(C) Procurement.--
(i) * * *
(ii) Contract terms.--A contract for
procurements under this subsection
shall (or, as specified below, may)
include the following terms:
(I) * * *
* * * * * * *
(IV) Storage by vendor.--The
contract may provide that the
vendor will provide storage for
stocks of a product delivered
to the ownership of the Federal
Government under the contract,
for such period and under such
terms and conditions as the
Secretary may specify, and in
such case amounts from the
[special reserve fund under
paragraph (10)] special reserve
fund as defined in subsection
(g)(5) shall be available for
costs of shipping, handling,
storage, and related costs for
such product.
* * * * * * *
[(IX) Contract terms.--The
Secretary, in any contract for
procurement under this section,
may specify--
[(aa) the dosing and
administration
requirements for
countermeasures to be
developed and procured;
[(bb) the amount of
funding that will be
dedicated by the
Secretary for
development and
acquisition of the
countermeasure; and
[(cc) the
specifications the
countermeasure must
meet to qualify for
procurement under a
contract under this
section.]
(IX) Contract terms.--The
Secretary, in any contract for
procurement under this
section--
(aa) may specify--
(AA) the
dosing and
administration
requirements
for
countermeasures
to be developed
and procured;
(BB) the
amount of
funding that
will be
dedicated by
the Secretary
for development
and acquisition
of the
countermeasure;
and
(CC) the
specifications
the
countermeasure
must meet to
qualify for
procurement
under a
contract under
this section;
and
(bb) shall provide a
clear statement of
defined Government
purpose limited to uses
related to a security
countermeasure, as
defined in paragraph
(1)(B).
* * * * * * *
[(9) Restrictions on use of funds.--Amounts in the
special reserve fund as defined in subsection (g)(5)
shall not be used to pay--
[(A) costs for the purchase of vaccines under
procurement contracts entered into before the
date of the enactment of the Project BioShield
Act of 2004; or
[(B) costs other than payments made by the
Secretary to a vendor for a procurement of a
security countermeasure under paragraph (7).
[(10) Definitions.--
[(A) Special reserve fund.--For purposes of
this subsection, the term ``special reserve
fund'' has the meaning given such term in
section 510 of the Homeland Security Act of
2002.
[(B) Designated congressional committees.--
For purposes of this section, the term
``designated congressional committees'' means
the following committees of the Congress:
[(i) In the House of Representatives:
the Committee on Energy and Commerce,
the Committee on Appropriations, the
Committee on Government Reform, and the
Select Committee on Homeland Security
(or any successor to the Select
Committee).
[(ii) In the Senate: the appropriate
committees.]
* * * * * * *
(g) Special Reserve Fund.--
(1) Authorization of appropriations.--In addition to
amounts appropriated to the special reserve fund prior
to the date of the enactment of this subsection, there
is authorized to be appropriated, for the procurement
of security countermeasures under subsection (c) and
for carrying out section 319L (relating to the
Biomedical Advanced Research and Development
Authority), $2,800,000,000 for the period of fiscal
years 2014 through 2018. Amounts appropriated pursuant
to the preceding sentence are authorized to remain
available until September 30, 2019.
(2) Notice of insufficient funds.--Not later than 15
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 Committee on Energy
and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of
the Senate a report detailing the amount of such funds
available for procurement and the impact such funding
will have--
(A) in meeting the security countermeasure
needs identified under this section; and
(B) on the annual Countermeasure
Implementation Plan under section 2811(d).
(3) Use of special reserve fund for advanced research
and development.--The Secretary may utilize not more
than 30 percent of the amounts authorized to be
appropriated under paragraph (1) to carry out section
319L (related to the Biomedical Advanced Research and
Development Authority). Amounts authorized to be
appropriated under this subsection to carry out section
319L are in addition to amounts otherwise authorized to
be appropriated to carry out such section.
(4) Restrictions on use of funds.--Amounts in the
special reserve fund shall not be used to pay--
(A) costs other than payments made by the
Secretary to a vendor for advanced development
(under section 319L) or for procurement of a
security countermeasure under subsection
(c)(7); and
(B) any administrative expenses, including
salaries.
(5) Definition.--In this section, the term ``special
reserve fund'' means the ``Biodefense Countermeasures''
appropriations account, any appropriation made
available pursuant to section 521(a) of the Homeland
Security Act of 2002, and any appropriation made
available pursuant to paragraph (1) of this paragraph.
* * * * * * *
SEC. 319I. EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF HEALTH
PROFESSIONS VOLUNTEERS.
(a) * * *
* * * * * * *
(k) Authorization of Appropriations.--For the purpose of
carrying out this section, there [are authorized to be
appropriated $2,000,000 for fiscal year 2002, and such sums as
may be necessary for each of the fiscal years 2003 through
2011] is authorized to be appropriated $5,900,000 for each of
fiscal years 2012 through 2016.
* * * * * * *
SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.
(a) * * *
* * * * * * *
(c) Biomedical Advanced Research and Development Authority.--
(1) * * *
* * * * * * *
(5) Transaction authorities.--
(A) * * *
* * * * * * *
(G) Government purpose.--In awarding
contracts, grants, and cooperative agreements
under this section, the Secretary shall provide
a clear statement of defined Government purpose
related to activities included in subsection
(a)(6)(B) for a qualified countermeasure or
qualified pandemic or epidemic product.
* * * * * * *
(d) Fund.--
(1) * * *
[(2) Funding.--To carry out the purposes of this
section, there are authorized to be appropriated to the
Fund--
[(A) $1,070,000,000 for fiscal years 2006
through 2008, the amounts to remain available
until expended; and
[(B) such sums as may be necessary for
subsequent fiscal years, the amounts to remain
available until expended.]
(2) Funding.--To carry out the purposes of this
section, there is authorized to be appropriated to the
Fund $415,000,000 for each of fiscal years 2012 through
2016, the amounts to remain available until expended.
(e) Inapplicability of Certain Provisions.--
(1) Disclosure.--
(A) * * *
* * * * * * *
(C) Sunset.--This paragraph shall cease to
have force or effect on [the date that is 7
years after the date of enactment of the
Pandemic and All-Hazards Preparedness Act]
September 30, 2016.
* * * * * * *
TITLE XXVIII--NATIONAL ALL-HAZARDS PREPAREDNESS FOR PUBLIC HEALTH
EMERGENCIES
Subtitle A--National All-Hazards Preparedness and Response Planning,
Coordinating, and Reporting
* * * * * * *
SEC. 2802. NATIONAL HEALTH SECURITY STRATEGY.
(a) In General.--
(1) Preparedness and response regarding public health
emergencies.--Beginning in [2009] 2014 and every four
years thereafter, the Secretary shall prepare and
submit to the relevant committees of Congress a
coordinated strategy (to be known as the National
Health Security Strategy) and any revisions thereof,
and an accompanying implementation plan for public
health emergency preparedness and response. Such
National Health Security Strategy shall identify the
process for achieving the preparedness goals described
in subsection (b) and shall be consistent with the
National Preparedness Goal, the National Incident
Management System, and the National Response Plan
developed pursuant to section 502(6) of the Homeland
Security Act of 2002, or any successor plan.
* * * * * * *
(b) Preparedness Goals.--The National Health Security
Strategy shall include provisions in furtherance of the
following:
(1) Integration.--Integrating public health and
public and private medical capabilities with other
first responder systems, including through--
(A) the periodic evaluation of Federal,
State, local, and tribal preparedness and
response capabilities through drills and
exercises, including drills and exercises to
ensure medical surge capacity for events
without notice; and
* * * * * * *
(3) Medical.--Increasing the preparedness, response
capabilities, availability, coordination,
accessibility, and surge capacity of hospitals, other
health care facilities ([including mental health
facilities] including mental health and ambulatory care
facilities and which may include dental health
facilities), and [trauma care and emergency medical
service systems] trauma care, critical care, and
emergency medical service systems, with respect to
public health emergencies, which shall include
developing plans for the following:
(A) * * *
(B) [Medical evacuation and fatality
management] Fatality management, and
coordinated medical triage and evacuation to
the appropriate medical institution based on
patient medical need as part of regional
systems.
* * * * * * *
(D) Effective utilization of any available
public and private mobile medical assets (which
may include dental health assets) and
integration of other Federal assets.
* * * * * * *
Subtitle B--All-Hazards Emergency Preparedness and Response
SEC. 2811. COORDINATION OF PREPAREDNESS FOR AND RESPONSE TO ALL-HAZARDS
PUBLIC HEALTH EMERGENCIES.
(a) * * *
(b) Duties.--Subject to the authority of the Secretary, the
Assistant Secretary for Preparedness and Response shall carry
out the following functions:
(1) * * *
* * * * * * *
(3) Countermeasures.--Oversee advanced research,
development, stockpiling, distribution, and procurement
of qualified countermeasures (as defined in section
319F-1), security measures (as defined in section 319F-
2), and qualified pandemic or epidemic products (as
defined in section 319F-3).
(4) Coordination.--
(A) * * *
* * * * * * *
(D) Identification of inefficiencies.--
Identify gaps, duplication, and other
inefficiencies in public health preparedness
activities and the actions necessary to
overcome these obstacles.
(E) Development of countermeasure
implementation plan.--Lead the development of a
coordinated Countermeasure Implementation Plan
under subsection (d).
(F) Countermeasures budget analysis.--Oversee
the development of a comprehensive, cross-
cutting 5-year budget analysis with respect to
activities described in paragraph (3)--
(i) to inform prioritization of
resources; and
(ii) to ensure that challenges to
such activities are adequately
addressed.
(G) Grant programs for medical and public
health preparedness capabilities.--Coordinate,
in consultation with the Secretary of Homeland
Security, grant programs of the Department of
Health and Human Services relating to medical
and public health preparedness capabilities and
the activities of local communities to respond
to public health emergencies, including the--
(i) coordination of relevant program
requirements, timelines, and measurable
goals of such grant programs; and
(ii) establishment of a system for
gathering and disseminating best
practices among grant recipients.
* * * * * * *
[(c) Functions.--The Assistant Secretary for Preparedness and
Response shall--
[(1) have authority over and responsibility for--
[(A) the National Disaster Medical System (in
accordance with section 301 of the Pandemic and
All-Hazards Preparedness Act); and
[(B) the Hospital Preparedness Cooperative
Agreement Program pursuant to section 319C-2;
[(2) exercise the responsibilities and authorities of
the Secretary with respect to the coordination of--
[(A) the Medical Reserve Corps pursuant to
section 2813;
[(B) the Emergency System for Advance
Registration of Volunteer Health Professionals
pursuant to section 319I;
[(C) the Strategic National Stockpile; and
[(D) the Cities Readiness Initiative; and
[(3) assume other duties as determined appropriate by
the Secretary.]
(c) Functions.--The Assistant Secretary for Preparedness and
Response shall--
(1) have lead responsibility within the Department of
Health and Human Services for emergency preparedness
and response policy and coordination;
(2) have authority over and responsibility for--
(A) the National Disaster Medical System (in
accordance with section 301 of the Pandemic and
All-Hazards Preparedness Act);
(B) the Hospital Preparedness Cooperative
Agreement Program pursuant to section 319C-2;
(C) the Biomedical Advanced Research and
Development Authority under section 319L; and
(D) the Emergency System for Advance
Registration of Volunteer Health Professionals
pursuant to section 319I;
(3) provide policy coordination and oversight of--
(A) the Strategic National Stockpile under
section 319F-2;
(B) the Cities Readiness Initiative; and
(C) the Medical Reserve Corps pursuant to
section 2813; and
(4) assume other duties as determined appropriate by
the Secretary.
(d) Countermeasure Implementation Plan.--Not later than 6
months after the date of enactment of this subsection, and
annually thereafter, the Assistant Secretary for Preparedness
and Response shall submit through the Secretary to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate a Countermeasure Implementation Plan
that--
(1) describes the chemical, biological, radiological,
and nuclear threats facing the Nation and the
corresponding efforts to develop qualified
countermeasures (as defined in section 319F-1),
security countermeasures (as defined in section 319F-
2), or qualified pandemic or epidemic products (as
defined in section 319F-3) for each threat;
(2) evaluates the progress of all activities with
respect to such countermeasures or products, including
research, advanced research, development, procurement,
stockpiling, deployment, and utilization;
(3) identifies and prioritizes near-, mid-, and long-
term needs with respect to such countermeasures or
products to address chemical, biological, radiological,
and nuclear threats;
(4) identifies, with respect to each category of
threat, a summary of all advanced development and
procurement awards, including--
(A) the time elapsed from the issuance of the
initial solicitation or request for a proposal
to the adjudication (such as the award, denial
of award, or solicitation termination);
(B) projected timelines for development and
procurement of such countermeasures or
products;
(C) clearly defined goals, benchmarks, and
milestones for each such countermeasure or
product, including information on the number of
doses required, the intended use of the
countermeasure or product, and the required
countermeasure or product characteristics; and
(D) projected needs with regard to the
replenishment of the Strategic National
Stockpile;
(5) evaluates progress made in meeting the goals,
benchmarks, and milestones identified under paragraph
(4)(C);
(6) reports on the amount of funds available for
procurement in the special reserve fund as defined in
section 319F-2(g)(5) and the impact this funding will
have on meeting the requirements under section 319F-2;
(7) incorporates input from Federal, State, local,
and tribal stakeholders; and
(8) addresses the needs of pediatric populations with
respect to such countermeasures and products in the
Strategic National Stockpile and includes--
(A) a list of such countermeasures and
products necessary to address the needs of
pediatric populations;
(B) a description of measures taken to
coordinate with Office of Pediatric
Therapeutics of the Food and Drug
Administration to maximize the labeling,
dosages, and formulations of such
countermeasures and products for pediatric
populations;
(C) a description of existing gaps in the
Strategic National Stockpile and the
development of such countermeasures and
products to address the needs of pediatric
populations; and
(D) an evaluation of the progress made in
addressing gaps identified pursuant to
subparagraph (C).
Notwithstanding any other provision of this subsection, the
Plan shall not include any confidential commercial information,
proprietary information, or information that could reveal
vulnerabilities of the Nation in the preparation for or ability
to respond to chemical, biological, radiological, or nuclear
threats.
SEC. 2812. NATIONAL DISASTER MEDICAL SYSTEM.
(a) National Disaster Medical System.--
(1) * * *
* * * * * * *
(3) Purpose of system.--
(A) * * *
* * * * * * *
(D) Administration.--The Secretary may
determine and pay claims for reimbursement for
services under subparagraph (A) directly or by
contract providing for payment in advance or by
way of reimbursement.
* * * * * * *
(g) Authorization of Appropriations.--For the purpose of
providing for the Assistant Secretary for Preparedness and
Response and the operations of the National Disaster Medical
System, other than purposes for which amounts in the Public
Health Emergency Fund under section 319 are available, there
are authorized to be appropriated [such sums as may be
necessary for each of the fiscal years 2007 through 2011]
$56,000,000 for each of fiscal years 2012 through 2016.
SEC. 2813. VOLUNTEER MEDICAL RESERVE CORPS.
(a) * * *
* * * * * * *
(i) Authorization of Appropriations.--There is authorized to
be appropriated to carry out this section, [$22,000,000 for
fiscal year 2007, and such sums as may be necessary for each of
fiscal years 2008 through 2011] $11,900,000 for each of fiscal
years 2012 through 2016.
* * * * * * *
----------
SECTION 405 OF THE PANDEMIC AND ALL-HAZARD PREPAREDNESS ACT
SEC. 405. COLLABORATION AND COORDINATION.
(a) * * *
(b) Sunset..--The applicability of this section shall expire
[at the end of the 6-year period that begins on the date of
enactment of this Act] on September 30, 2016.
----------
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER V--DRUGS AND DEVICES
Subchapter A--Drugs and Devices
* * * * * * *
NEW DRUGS
Sec. 505. (a) * * *
(b)(1) * * *
* * * * * * *
(5)(A) * * *
[(B) The Secretary shall meet with a sponsor of an
investigation or an applicant for approval for a drug under
this subsection or section 351 of the Public Health Service Act
if the sponsor or applicant makes a reasonable written request
for a meeting for the purpose of reaching agreement on the
design and size of clinical trials intended to form the primary
basis of an effectiveness claim or, with respect to an
applicant for approval of a biological product under section
351(k) of the Public Health Service Act, any necessary clinical
study or studies. The sponsor or applicant shall provide
information necessary for discussion and agreement on the
design and size of the clinical trials. Minutes of any such
meeting shall be prepared by the Secretary and made available
to the sponsor or applicant upon request.]
(B)(i) The Secretary shall meet with a sponsor of an
investigation or an applicant for approval for a drug under
this subsection or section 351 of the Public Health Service Act
if the sponsor or applicant makes a reasonable written request
for a meeting for the purpose of reaching agreement on the
design and size of--
(I) clinical trials intended to form the primary
basis of an effectiveness claim; or
(II) animal efficacy trials and any associated
clinical trials that in combination are intended to
form the primary basis of an effectiveness claim for a
countermeasure or product referred to in section 565(a)
when human efficacy studies are not ethical or
feasible.
(ii) The sponsor or applicant shall provide information
necessary for discussion and agreement on the design and size
of the clinical trials. Minutes of any such meeting shall be
prepared by the Secretary and made available to the sponsor or
applicant upon request.
* * * * * * *
SEC. 505-1. RISK EVALUATION AND MITIGATION STRATEGIES.
(a) * * *
* * * * * * *
(f) Providing Safe Access for Patients to Drugs With Known
Serious Risks That Would Otherwise Be Unavailable.--
(1) * * *
* * * * * * *
[(7) Waiver in public health emergencies.--The
Secretary may waive any requirement of this subsection
during the period described in section 319(a) of the
Public Health Service Act with respect to a qualified
countermeasure described under section 319F-1(a)(2) of
such Act, to which a requirement under this subsection
has been applied, if the Secretary has--
[(A) declared a public health emergency under
such section 319; and
[(B) determined that such waiver is required
to mitigate the effects of, or reduce the
severity of, such public health emergency.]
* * * * * * *
(k) Waiver in Public Health Emergencies.--The Secretary may
waive any requirement of this section with respect to a
qualified countermeasure (as defined in section 319F-1(a)(2) of
the Public Health Service Act) to which a requirement under
this section has been applied, if the Secretary determines that
such waiver is required to mitigate the effects of, or reduce
the severity of, an actual or potential domestic emergency or
military emergency involving heightened risk of attack with a
biological, chemical, radiological, or nuclear agent, or an
actual or potential public health emergency affecting national
security or the health and security of United States citizens
abroad.
* * * * * * *
Subchapter E--General Provisions Relating to Drugs and Devices
* * * * * * *
SEC. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.
(a) In General.--
(1) Emergency uses.--Notwithstanding [sections 505,
510(k), and 515 of this Act] any provision of this Act
and section 351 of the Public Health Service Act, and
subject to the provisions of this section, the
Secretary may authorize the introduction into
interstate commerce, during the effective period of a
declaration under subsection (b), of a drug, device, or
biological product intended for use in an actual or
potential emergency (referred to in this section as an
``emergency use'').
(2) Approval status of product.--An authorization
under paragraph (1) may authorize an emergency use of a
product that--
(A) is not approved, licensed, or cleared for
commercial distribution [under a provision of
law referred to in such paragraph] under a
provision of law in section 505, 510(k), or 515
of this Act or section 351 of the Public Health
Service Act (referred to in this section as an
``unapproved product''); or
* * * * * * *
(3) Relation to other uses.--An emergency use
authorized under paragraph (1) for a product is in
addition to any other use that is authorized for the
product under [a provision of law referred to in such
paragraph] a provision of law referred to in paragraph
(2)(A).
* * * * * * *
(b) [Declaration of Emergency] Declaration Supporting
Emergency Use Authorization.--
(1) In general.--The Secretary may declare [an
emergency justifying] that circumstances exist
justifying the authorization under this subsection for
a product on the basis of--
(A) a determination by the Secretary of
Homeland Security that there is a domestic
emergency, or a significant potential for a
domestic emergency, involving a heightened risk
of attack with a [specified] biological,
chemical, radiological, or nuclear agent or
agents;
(B) a determination by the Secretary of
Defense that there is a military emergency, or
a significant potential for a military
emergency, involving a heightened risk to
United States military forces of attack with a
[specified] biological, chemical, radiological,
or nuclear agent or agents; or
[(C) a determination by the Secretary of a
public health emergency under section 319 of
the Public Health Service Act that affects, or
has a significant potential to affect, national
security, and that involves a specified
biological, chemical, radiological, or nuclear
agent or agents, or a specified disease or
condition that may be attributable to such
agent or agents.]
(C) a determination by the Secretary that
there is a public health emergency, or a
significant potential for a public health
emergency, involving a heightened risk to
national security or the health and security of
United States citizens abroad, and involving a
biological, chemical, radiological, or nuclear
agent or agents, or a disease or condition that
may be attributable to such agent or agents.
(2) Termination of declaration.--
[(A) In general.--A declaration under this
subsection shall terminate upon the earlier
of--
[(i) a determination by the
Secretary, in consultation as
appropriate with the Secretary of
Homeland Security or the Secretary of
Defense, that the circumstances
described in paragraph (1) have ceased
to exist; or
[(ii) the expiration of the one-year
period beginning on the date on which
the declaration is made.
[(B) Renewal.--Notwithstanding subparagraph
(A), the Secretary may renew a declaration
under this subsection, and this paragraph shall
apply to any such renewal.]
(A) In general.--A declaration under this
subsection shall terminate upon a determination
by the Secretary, in consultation with, as
appropriate, the Secretary of Homeland Security
or the Secretary of Defense, that the
circumstances described in paragraph (1) have
ceased to exist.
[(C)] (B) Disposition of product.--If an
authorization under this section with respect
to an unapproved product ceases to be effective
as a result of a termination under subparagraph
(A) of this paragraph, the Secretary shall
consult with the manufacturer of such product
with respect to the appropriate disposition of
the product.
* * * * * * *
(4) Publication.--The Secretary shall promptly
publish in the Federal Register each declaration,
determination, [advance notice of termination, and
renewal] and advance notice of termination under this
subsection.
(c) Criteria for Issuance of Authorization.--The Secretary
may issue an authorization under this section with respect to
the emergency use of a product only if, after [consultation
with the Director of the National Institutes of Health]
consultation with the Assistant Secretary for Preparedness and
Response, the Director of the National Institutes of Health,
and the Director of the Centers for Disease Control and
Prevention (to the extent feasible and appropriate given the
circumstances of the emergency involved), the Secretary
concludes--
(1) that an agent [specified in] covered by a
declaration under subsection (b) can cause a serious or
life-threatening disease or condition;
* * * * * * *
(d) Scope of Authorization.--An authorization of a product
under this section shall state--
(1) * * *
* * * * * * *
(3) the Secretary's conclusions, made under
subsection (c), concerning the safety and potential
effectiveness of the product in diagnosing, preventing,
or treating such diseases or conditions, including, to
the extent practicable given the circumstances of the
emergency, an assessment of the available scientific
evidence.
(e) Conditions of Authorization.--
(1) Unapproved product.--
(A) * * *
(B) Authority for additional conditions.--
With respect to the emergency use of an
unapproved product, the Secretary may, for a
person who carries out any activity for which
the authorization is issued, establish such
conditions on an authorization under this
section as the Secretary finds necessary or
appropriate to protect the public health,
including the following:
(i) * * *
* * * * * * *
[(iii) Appropriate conditions with
respect to the collection and analysis
of information, during the period when
the authorization is in effect,
concerning the safety and effectiveness
of the product with respect to the
emergency use of such product.]
(iii) Appropriate conditions with
respect to the collection and analysis
of information concerning the safety
and effectiveness of the product with
respect to the actual use of such
product pursuant to an authorization
under this section.
* * * * * * *
(2) Unapproved use.--With respect to the emergency
use of a product that is an unapproved use of an
approved product:
(A) For a [manufacturer of the product]
person who carries out any activity for which
the authorization is issued, the Secretary
shall, to the extent practicable given the
circumstances of the emergency, establish
conditions described in clauses (i) and (ii) of
paragraph (1)(A), and may establish conditions
described in clauses (iii) and (iv) of such
paragraph or in paragraph (1)(B).
(B)(i) If the authorization under this
section regarding the emergency use authorizes
a change in the labeling of the product, but
the manufacturer of the product chooses not to
make such change, such authorization may not
authorize distributors of the product or any
other person to alter or obscure the labeling
provided by the manufacturer, with the
exception of extensions of a product's
expiration date authorized under section
564A(b).
* * * * * * *
[(C) The Secretary may establish with respect
to the distribution and administration of the
product for the unapproved use conditions no
more restrictive than those established by the
Secretary with respect to the distribution and
administration of the product for the approved
use.]
(C) In establishing conditions under this
paragraph with respect to the distribution and
administration of a product, the Secretary
shall not impose conditions that would restrict
distribution or administration of the product
that is solely for the approved uses.
[(3) Good manufacturing practice.--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 circumstances of the
emergency, 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.]
(3) Good manufacturing practice; prescription;
practitioner's authorization.--With respect to the
emergency use of a product for which an authorization
under this section is issued (whether for an unapproved
product or an unapproved use of an approved product),
the Secretary may waive or limit, to the extent
appropriate given the circumstances of the emergency--
(A) requirements regarding current good
manufacturing practice otherwise applicable to
the manufacture, processing, packing, or
holding of products subject to regulation under
this Act, including such requirements
established under section 501 or 520(f)(1), and
including relevant conditions prescribed with
respect to the product by an order under
section 520(f)(2);
(B) requirements established under section
503(b); and
(C) requirements established under section
520(e).
* * * * * * *
(5) Existing authorities.--Nothing in this section
restricts any authority vested in the Secretary by any
other provision of this Act or the Public Health
Service Act for establishing conditions of
authorization for a product.
* * * * * * *
(g) [Revocation of Authorization] Review, Modification, and
Revocation of Authorization.--
(1) Review.--The Secretary shall [periodically
review] review not less than every three years the
circumstances and the appropriateness of an
authorization under this section.
* * * * * * *
(3) Modification.--The Secretary may modify an
authorization under this section or the conditions of
such an authorization, at any time, based on a review
of the authorization or new information that is
otherwise obtained, including information obtained
during an emergency.
* * * * * * *
SEC. 564A. ADDITIONAL PROVISIONS RELATED TO MEDICAL PRODUCTS FOR
EMERGENCY USE.
(a) Definitions.--For purposes of this section:
(1) The term ``product'' means a drug, device, or
biological product.
(2) The term ``eligible product'' means a product
that is--
(A) approved or cleared under this chapter or
licensed under section 351 of the Public Health
Service Act; and
(B) intended to be used to diagnose, prevent,
or treat a disease or condition involving a
biological, chemical, radiological, or nuclear
agent or agents during--
(i) a domestic emergency or military
emergency involving heightened risk of
attack with such an agent or agents; or
(ii) a public health emergency
affecting national security or the
health and security of United States
citizens abroad.
(b) Expiration Dating.--
(1) In general.--The Secretary may extend the
expiration date and authorize the introduction or
delivery for introduction into interstate commerce of
an eligible product after the expiration date provided
by the manufacturer if--
(A) the eligible product is intended to be
held for use for a domestic, military, or
public health emergency described in subsection
(a)(2)(B);
(B) the expiration date extension is intended
to support the United States' ability to
protect--
(i) the public health; or
(ii) military preparedness and
effectiveness; and
(C) the expiration date extension is
supported by an appropriate scientific
evaluation that is conducted or accepted by the
Secretary.
(2) Requirements and conditions.--Any extension of an
expiration date under paragraph (1) shall, as part of
the extension, identify--
(A) each specific lot, batch, or other unit
of the product for which extended expiration is
authorized;
(B) the duration of the extension; and
(C) any other requirements or conditions as
the Secretary may deem appropriate for the
protection of the public health, which may
include requirements for, or conditions on,
product sampling, storage, packaging or
repackaging, transport, labeling, notice to
product recipients, recordkeeping, periodic
testing or retesting, or product disposition.
(3) Effect.--Notwithstanding any other provision of
this Act or the Public Health Service Act, an eligible
product shall not be considered an unapproved product
(as defined in section 564(a)(2)(A)) and shall not be
deemed adulterated or misbranded under this Act
because, with respect to such product, the Secretary
has, under paragraph (1), extended the expiration date
and authorized the introduction or delivery for
introduction into interstate commerce of such product
after the expiration date provided by the manufacturer.
(c) Current Good Manufacturing Practices.--
(1) In general.--The Secretary may, when the
circumstances of a domestic, military, or public health
emergency described in subsection (a)(2)(B) so warrant,
authorize, with respect to an eligible product,
deviations from current good manufacturing practice
requirements otherwise applicable to the manufacture,
processing, packing, or holding of products subject to
regulation under this Act, including requirements under
section 501 or 520(f)(1) or applicable conditions
prescribed with respect to the eligible product by an
order under section 520(f)(2).
(2) Effect.--Notwithstanding any other provision of
this Act or the Public Health Service Act, an eligible
product shall not be considered an unapproved product
(as defined in section 564(a)(2)(A)) and shall not be
deemed adulterated or misbranded under this Act
because, with respect to such product, the Secretary
has authorized deviations from current good
manufacturing practices under paragraph (1).
(d) Mass Dispensing.--The requirements of section 503(b) and
520(e) shall not apply to an eligible product, and the product
shall not be considered an unapproved product (as defined in
section 564(a)(2)(A)) and shall not be deemed adulterated or
misbranded under this Act because it is dispensed without an
individual prescription, if--
(1) the product is dispensed during an actual
emergency described in subsection (a)(2)(B); and
(2) such dispensing without an individual
prescription occurs--
(A) as permitted under the law of the State
in which the product is dispensed; or
(B) in accordance with an order issued by the
Secretary.
(e) Emergency Use Instructions.--
(1) In general.--The Secretary, acting through an
appropriate official within the Department of Health
and Human Services, may create and issue emergency use
instructions to inform health care providers or
individuals to whom an eligible product is to be
administered concerning such product's approved,
licensed, or cleared conditions of use.
(2) Effect.--Notwithstanding any other provisions of
this Act or the Public Health Service Act, a product
shall not be considered an unapproved product (as
defined in section 564(a)(2)(A)) and shall not be
deemed adulterated or misbranded under this Act because
of--
(A) the issuance of emergency use
instructions under paragraph (1) with respect
to such product; or
(B) the introduction or delivery for
introduction of such product into interstate
commerce accompanied by such instructions
during an emergency response to an actual
emergency described in subsection (a)(2)(B).
SEC. 564B. PRODUCTS HELD FOR EMERGENCY USE.
It is not a violation of any section of this Act or of the
Public Health Service Act for a government entity (including a
Federal, State, local, and tribal government entity), or a
person acting on behalf of such a government entity, to
introduce into interstate commerce a product (as defined in
section 564(a)(4)) intended for emergency use, if that
product--
(1) is intended to be held and not used; and
(2) is held and not used, unless and until that
product--
(A) is approved, cleared, or licensed under
section 505, 510(k), or 515 of this Act or
section 351 of the Public Health Service Act;
(B) is authorized for investigational use
under section 505 or 520 of this Act or section
351 of the Public Health Service Act; or
(C) is authorized for use under section 564.
[SEC. 565. TECHNICAL ASSISTANCE.
[The Secretary, in consultation with the Commissioner of Food
and Drugs, shall establish within the Food and Drug
Administration a team of experts on manufacturing and
regulatory activities (including compliance with current Good
Manufacturing Practice) to provide both off-site and on-site
technical assistance to the manufacturers of qualified
countermeasures (as defined in section 319F-1 of the Public
Health Service Act), security countermeasures (as defined in
section 319F-2 of such Act), or vaccines, at the request of
such a manufacturer and at the discretion of the Secretary, if
the Secretary determines that a shortage or potential shortage
may occur in the United States in the supply of such vaccines
or countermeasures and that the provision of such assistance
would be beneficial in helping alleviate or avert such
shortage.]
SEC. 565. COUNTERMEASURE DEVELOPMENT AND REVIEW.
(a) Countermeasures and Products.--The countermeasures and
products referred to in this subsection are--
(1) qualified countermeasures (as defined in section
319F-1 of the Public Health Service Act);
(2) security countermeasures (as defined in section
319F-2 of such Act); and
(3) qualified pandemic or epidemic products (as
defined in section 319F-3 of such Act) that the
Secretary determines to be a priority.
(b) In General.--
(1) Involvement of fda personnel in interagency
activities.--For the purpose of accelerating the
development, stockpiling, approval, clearance, and
licensure of countermeasures and products referred to
in subsection (a), the Secretary shall expand the
involvement of Food and Drug Administration personnel
in interagency activities with the Assistant Secretary
for Preparedness and Response (including the Biomedical
Advanced Research and Development Authority), the
Centers for Disease Control and Prevention, the
National Institutes of Health, and the Department of
Defense.
(2) Technical assistance.--The Secretary shall
establish within the Food and Drug Administration a
team of experts on manufacturing and regulatory
activities (including compliance with current Good
Manufacturing Practices) to provide both off-site and
on-site technical assistance to the manufacturers of
countermeasures and products referred to in subsection
(a). On-site technical assistance shall be provided
upon the request of the manufacturer and at the
discretion of the Secretary if the Secretary determines
that the provision of such assistance would accelerate
the development, manufacturing, or approval, clearance,
or licensure of countermeasures and products referred
to in subsection (a).
(c) Agency Interaction With Security Countermeasure
Sponsors.--
(1) In general.--For security countermeasures (as
defined in section 319F-2 of the Public Health Service
Act) that are procured under such section 319F-2--
(A) the Secretary shall establish a process
for frequent scientific feedback and
interactions between the Food and Drug
Administration and the security countermeasure
sponsor (referred to in this subsection as the
``sponsor''), designed to facilitate the
approval, clearance, and licensure of the
security countermeasures;
(B) such feedback and interactions shall
include meetings and, in accordance with
subsection (b)(2), on-site technical
assistance; and
(C) at the request of the Secretary, the
process under this paragraph shall include
participation by the Food and Drug
Administration in meetings between the
Biomedical Advanced Research and Development
Authority and sponsors on the development of
such countermeasures.
(2) Regulatory management plan.--
(A) In general.--The process established
under paragraph (1) shall allow for the
development of a written regulatory management
plan (in this paragraph referred to as the
``plan'') for a security countermeasure (as
defined in paragraph (1)) in accordance with
this paragraph.
(B) Proposal and finalization of plan.--In
carrying out the process under paragraph (1),
the Secretary shall direct the Food and Drug
Administration, upon submission of a written
request by the sponsor that includes a proposed
plan and relevant data and future planning
detail to support such a plan, to work with the
sponsor to agree on a final plan within a
reasonable time not to exceed 90 days. The
basis for this agreement shall be the proposed
plan submitted by the sponsor. Notwithstanding
the preceding sentence, the Secretary shall
retain full discretion to determine the
contents of the final plan or to determine that
no such plan can be agreed upon. If the
Secretary determines that no final plan can be
agreed upon, the Secretary shall provide to the
sponsor, in writing, the scientific or
regulatory rationale why such agreement cannot
be reached. If a final plan is agreed upon, it
shall be shared with the sponsor in writing.
(C) Contents.--The plan shall include an
agreement on the nature of, and timelines for,
feedback and interactions between the sponsor
and the Food and Drug Administration, shall
provide reasonable flexibility in implementing
and adjusting the agreement under this
paragraph as warranted during the
countermeasure development process, and shall
identify--
(i) the current regulatory status of
the countermeasure, an assessment of
known scientific gaps relevant to
approval, clearance, or licensure of
the countermeasure, and a proposed
pathway to approval, clearance, or
licensure of the countermeasure;
(ii) developmental milestones whose
completion will result in meetings to
be scheduled within a reasonable time
between the applicable review division
of the Food and Drug Administration and
the sponsor;
(iii) sponsor submissions that will
result in written feedback from the
review division within a reasonable
time;
(iv) feedback by the Food and Drug
Administration regarding the data
required to support delivery of the
countermeasure to the Strategic
National Stockpile under section 319F-2
of the Public Health Service Act;
(v) feedback by the Food and Drug
Administration regarding data required
to support submission of a proposed
agreement on the design and size of
clinical trials for review under
section 505(b)(5)(B); and
(vi) other issues that have the
potential to delay approval, clearance,
or licensure.
(D) Changes.--Changes to the plan shall be
made by subsequent agreement between the
Secretary and the sponsor. If after reasonable
attempts to negotiate changes to the plan the
Secretary and the sponsor are unable to
finalize such changes, the Secretary shall
provide to the sponsor, in writing, the
scientific or regulatory rationale why such
changes are required or cannot be included in
the plan.
(3) Applicability to certain qualified pandemic or
epidemic products.--The Secretary may, with respect to
qualified pandemic or epidemic products (as defined in
section 319F-3 of the Public Health Service Act) for
which a contract for advanced research and development
is entered into under section 319L of such Act, choose
to apply the provisions of paragraphs (1) and (2) to
the same extent and in the same manner as such
provisions apply with respect to security
countermeasures.
(d) Final Guidance on Development of Animal Models.--
(1) In general.--Not later than 1 year after the date
of the enactment of the Pandemic and All-Hazards
Preparedness Reauthorization Act of 2011, the Secretary
shall provide final guidance to industry regarding the
development of animal models to support approval,
clearance, or licensure of countermeasures and products
referred to in subsection (a) when human efficacy
studies are not ethical or feasible.
(2) Authority to extend deadline.--The Secretary may
extend the deadline for providing final guidance under
paragraph (1) by not more than 6 months upon submission
by the Secretary of a report on the status of such
guidance to the Committee on Energy and Commerce of the
House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate.
(e) Biennial Report.--Not later than January 1, 2013, and
every 2 years thereafter, the Secretary shall submit a report
to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate, that, with respect to the preceding
2 fiscal years, includes--
(1) the number of full-time equivalent employees of
the Food and Drug Administration who directly support
the review of countermeasures and products referred to
in subsection (a);
(2) estimates of funds obligated by the Food and Drug
Administration for review of such countermeasures and
products;
(3) the number of regulatory teams at the Food and
Drug Administration specific to such countermeasures
and products and, for each such team, the assigned
products, classes of products, or technologies;
(4) the length of time between each request by the
sponsor of such a countermeasure or product for
information and the provision of such information by
the Food and Drug Administration;
(5) the number, type, and frequency of official
interactions between the Food and Drug Administration
and--
(A) sponsors of a countermeasure or product
referred to in subsection (a); or
(B) another agency engaged in development or
management of portfolios for such
countermeasures or products, including the
Centers for Disease Control and Prevention, the
Biomedical Advanced Research and Development
Authority, the National Institutes of Health,
and the appropriate agencies of the Department
of Defense;
(6) a description of other measures that, as
determined by the Secretary, are appropriate to
determine the efficiency of the regulatory teams
described in paragraph (3); and
(7) the regulatory science priorities that relate to
countermeasures or products referred to in subsection
(a) and which the Food and Drug Administration is
addressing and the progress made on these priorities.
* * * * * * *
----------
PROJECT BIOSHIELD ACT OF 2004
[SEC. 5. REPORTS REGARDING AUTHORITIES UNDER THIS ACT.
[(a) Secretary of Health and Human Services.--
[(1) Annual reports on particular exercises of
authority.--
[(A) Relevant authorities.--The Secretary of
Health and Human Services (referred to in this
subsection as the ``Secretary'') shall submit
reports in accordance with subparagraph (B)
regarding the exercise of authority under the
following provisions of law:
[(i) With respect to section 319F-1
of the Public Health Service Act (as
added by section 2 of this Act):
[(I) Subsection (b)(1)
(relating to increased
simplified acquisition
threshold).
[(II) Subsection (b)(2)
(relating to procedures other
than full and open
competition).
[(III) Subsection (c)
(relating to expedited peer
review procedures).
[(ii) With respect to section 319F-2
of the Public Health Service Act (as
added by section 3 of this Act):
[(I) Subsection
(c)(7)(C)(iii) (relating to
simplified acquisition
procedures).
[(II) Subsection
(c)(7)(C)(iv) (relating to
procedures other than full and
open competition).
[(III) Subsection
(c)(7)(C)(v) (relating to
premium provision in multiple-
award contracts).
[(iii) With respect to section 564 of
the Federal Food, Drug, and Cosmetic
Act (as added by section 4 of this
Act):
[(I) Subsection (a)(1)
(relating to emergency uses of
certain drugs and devices).
[(II) Subsection (b)(1)
(relating to a declaration of
an emergency).
[(III) Subsection (e)
(relating to conditions on
authorization).
[(B) Contents of reports.--The Secretary
shall annually submit to the designated
congressional committees a report that
summarizes--
[(i) the particular actions that were
taken under the authorities specified
in subparagraph (A), including, as
applicable, the identification of the
threat agent, emergency, or the
biomedical countermeasure with respect
to which the authority was used;
[(ii) the reasons underlying the
decision to use such authorities,
including, as applicable, the options
that were considered and rejected with
respect to the use of such authorities;
[(iii) the number of, nature of, and
other information concerning the
persons and entities that received a
grant, cooperative agreement, or
contract pursuant to the use of such
authorities, and the persons and
entities that were considered and
rejected for such a grant, cooperative
agreement, or contract, except that the
report need not disclose the identity
of any such person or entity; and
[(iv) whether, with respect to each
procurement that is approved by the
President under section 319F-2(c)(6) of
the Public Health Service Act (as added
by section 3 of this Act), a contract
was entered into within one year after
such approval by the President.
[(2) Annual summaries regarding certain activity.--
The Secretary shall annually submit to the designated
congressional committees a report that summarizes the
activity undertaken pursuant to the following
authorities under section 319F-1 of the Public Health
Service Act (as added by section 2 of this Act):
[(A) Subsection (b)(3) (relating to increased
micropurchase threshold).
[(B) Subsection (d) (relating to authority
for personal services contracts).
[(C) Subsection (e) (relating to streamlined
personnel authority).
With respect to subparagraph (B), the report shall
include a provision specifying, for the one-year period
for which the report is submitted, the number of
persons who were paid amounts greater than $100,000 and
the number of persons who were paid amounts between
$50,000 and $100,000.
[(3) Report on additional barriers to procurement of
security countermeasures.--Not later than one year
after the date of the enactment of this Act, the
Secretary, in consultation with the Secretary of
Homeland Security, shall report to the designated
congressional committees any potential barriers to the
procurement of security countermeasures that have not
been addressed by this Act.
[(b) General Accounting Office Review.--
[(1) In general.--Four years after the date of the
enactment of this Act, the Comptroller General of the
United States shall initiate a study--
[(A)(i)to review the Secretary of Health and
Human Services' utilization of the authorities
granted under this Act with respect to
simplified acquisition procedures, procedures
other than full and open competition, increased
micropurchase thresholds, personal services
contracts, streamlined personnel authority, and
the purchase of security countermeasures under
the special reserve fund; and
[(ii) to make recommendations to improve the
utilization or effectiveness of such
authorities in the future;
[(B)(i)to review and assess the adequacy of
the internal controls instituted by such
Secretary with respect to such authorities,
where required by this Act; and
[(ii) to make recommendations to improve the
effectiveness of such controls;
[(C)(i)to review such Secretary's utilization
of the authority granted under this Act to
authorize an emergency use of a biomedical
countermeasure, including the means by which
the Secretary determines whether and under what
conditions any such authorizations should be
granted and the benefits and adverse impacts,
if any, resulting from the use of such
authority; and
[(ii) to make recommendations to improve the
utilization or effectiveness of such authority
and to enhance protection of the public health;
[(D) to identify any purchases or
procurements that would not have been made or
would have been significantly delayed except
for the authorities described in subparagraph
(A)(i); and
[(E)(i)to determine whether and to what
extent activities undertaken pursuant to the
biomedical countermeasure research and
development authorities established in this Act
have enhanced the development of biomedical
countermeasures affecting national security;
and
[(ii) to make recommendations to improve the
ability of the Secretary to carry out these
activities in the future.
[(2) Additional provisions regarding determination on
development of biomedical countermeasures affecting
national security.--In the report under paragraph (1),
the determination under subparagraph (E) of such
paragraph shall include--
[(A) the Comptroller General's assessment of
the current availability of countermeasures to
address threats identified by the Secretary of
Homeland Security;
[(B) the Comptroller General's assessment of
the extent to which programs and activities
under this Act will reduce any gap between the
threat and the availability of countermeasures
to an acceptable level of risk; and
[(C)(i)the Comptroller General's assessment
of threats to national security that are posed
by technology that will enable, during the 10-
year period beginning on the date of the
enactment of this Act, the development of
antibiotic resistant, mutated, or bioengineered
strains of biological agents; and
[(ii) recommendations on short-term and long-
term governmental strategies for addressing
such threats, including recommendations for
Federal policies regarding research priorities,
the development of countermeasures, and
investments in technology.
[(3) Report.--A report providing the results of the
study under paragraph (1) shall be submitted to the
designated congressional committees not later than five
years after the date of the enactment of this Act.
[(c) Report Regarding Biocontainment Facilities.--Not later
than 120 days after the date of the enactment of this Act, the
Secretary of Homeland Security and the Secretary of Health and
Human Services shall jointly report to the designated
congressional committees whether there is a lack of adequate
large-scale biocontainment facilities necessary for the testing
of security countermeasures in accordance with Food and Drug
Administration requirements.
[(d) Designated Congressional Committees.--For purposes of
this section, the term ``designated congressional committees''
means the following committees of the Congress:
[(1) In the House of Representatives: the Committee
on Energy and Commerce, the Committee on
Appropriations, the Committee on Government Reform, and
the Select Committee on Homeland Security (or any
successor to the Select Committee).
[(2) In the Senate: the appropriate committees.]
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