[Congressional Record Volume 157, Number 186 (Tuesday, December 6, 2011)]
[House]
[Pages H8153-H8159]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PANDEMIC AND ALL-HAZARDS PREPAREDNESS REAUTHORIZATION ACT OF 2011
Mr. PITTS. Mr. Speaker, I move to suspend the rules and pass 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, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 2405
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Pandemic
and All-Hazards Preparedness 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
[[Page H8154]]
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;
[[Page H8155]]
``(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).
[[Page H8156]]
``(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
[[Page H8157]]
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.''.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Pennsylvania (Mr. Pitts) and the gentleman from New Jersey (Mr.
Pallone) each will control 20 minutes.
The Chair recognizes the gentleman from Pennsylvania.
General Leave
Mr. PITTS. Mr. Speaker, I ask unanimous consent that all Members may
have 5 legislative days in which to revise and extend their remarks and
insert extraneous materials into the Record.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Pennsylvania?
There was no objection.
Mr. PITTS. Mr. Speaker, I yield myself such time as I may consume.
H.R. 2405, introduced by my colleague Mike Rogers from Michigan,
would reauthorize certain provisions of the Project Bioshield Act of
2004 and the Pandemic and All-Hazards Preparedness Act of 2006. These
two laws help protect the United States against attacks from chemical,
biological, radiological, and nuclear weapons.
Project Bioshield authorized funds for the purchase of medical
countermeasures through the Special Reserve Fund and enabled the
Secretary of Health and Human Services to authorize the emergency use
of medical products. PAHPA created the Biodefense Advanced Research and
Development Authority within HHS to help with the development of
medical countermeasures and to ensure the communication between HHS and
the developers of the medical countermeasures. PAHPA also created a
position at HHS to lead the government's efforts on the chemical,
biological, radiological, and nuclear weapons preparedness and
response, the Assistant Secretary for Preparedness and Response.
Some of these key provisions expired at the end of FY 2011. Since the
terrorist attacks of 9/11, we have become more aware of the dangers our
country faces and of the lengths to which some may go to inflict harm
on us. These provisions must be reauthorized, so I would urge all
Members to support this critical piece of legislation.
I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
I am pleased to rise in support of H.R. 2405, the Pandemic and All-
Hazards Preparedness Reauthorization Act of 2011. This bill is an
opportunity to build a more prepared and resilient public health
infrastructure. We all know very well that our Nation continues to face
threats that require an ongoing commitment to public health and
emergency preparedness, which is why, over the past 10 years, this
Congress has placed a high priority on biodefense.
In 2004, with tremendous bipartisan support, we passed the Project
Bioshield Act. Democrats and Republicans worked together to establish a
process that would help our Nation respond to bioterrorism threats and
attacks. We then identified some shortfalls and, in 2006, worked to
amend the program by passing the Pandemic and All-Hazards Preparedness
Act, also known as PAHPA. Specifically, PAHPA provided the Department
of Health and Human Services with the additional authorities and
resources necessary to rapidly develop drugs and vaccines to protect
citizens from various medical incidents, whether accidental, such as
H1N1 outbreaks, or those that are deliberate, such as anthrax attacks.
The programs and activities first established in both the 2004
Project Bioshield Act and the 2006 PAHPA codified and expanded the
Federal Government's support for public health preparedness. As a
result of these bills and the investments that followed, our Nation is
better equipped to respond to bioterrorism threats and attacks.
H.R. 2405 will now help to build on that progress. The bill further
facilitates the development of medical countermeasures, and it bolsters
the Nation's public health preparedness infrastructure. It strengthens
and clarifies the position of Assistant Secretary for Preparedness and
Response, who has led the Federal Government's efforts and attempts to
improve coordination and accountability.
I was especially supportive of the bill's provisions to identify and
dedicate the FDA's role in hazardous events. H.R. 2405 enhances the
flexibility of FDA while strengthening their emergency use
administrative functions.
{time} 1330
These revisions are a significant step forward on a framework for FDA
to develop better policies and guidance in emergency situations.
In addition, I was appreciative of the bipartisan effort to address
the special needs of pediatric populations in emergency situations. It
was clear that there were some gaps in our Nation's public health
emergency strategy for children, and I'm confident we took an
appropriate approach for filling in these gaps.
So I really want to thank Representative Mike Rogers and
Representative Gene Green and their staffs, who authored the base bill
and have continued to work to strengthen its provisions.
I would also like to thank the staff of the Energy and Commerce
Committee and, of course, my chairman, Mr. Pitts, who collaborated in a
bipartisan manner to further enhance the bill. They have worked hard to
accomplish the goals of our Members, as well as stakeholders, and to
strengthen its provisions. It's been a good bipartisan process and one
that I think should be emulated in our subcommittee and full committee
in the future.
I would urge all Members to support H.R. 2405.
I reserve the balance of my time.
Mr. PITTS. Mr. Speaker, I yield such time as he may consume to the
gentleman from Michigan (Mr. Rogers), the prime sponsor of the
legislation.
Mr. ROGERS of Michigan. Thank you, Mr. Pitts, and thank you for your
leadership on the committee to allow this bill to come to the floor
today. Good news, Mr. Speaker: this bill is bipartisan, it's fiscally
responsible, and it will make a positive impact on our Nation's
national security.
[[Page H8158]]
It's been more than 10 years since 9/11 and the anthrax attacks that
followed. And while we haven't had a successful terrorist attack on
U.S. soil, our enemies are still working every day to kill innocent
Americans. Today the threat of bioterrorism remains very real.
Earlier this year, the bipartisan Graham-Talent Commission warned
that the United States it is still ``vulnerable to a large-scale
biological attack.''
Thankfully, we have spent the last decade preparing for chemical,
biological, radiological, and nuclear threats by developing and
stockpiling numerous medical countermeasures to protect American
citizens in case of such an attack. Because of these efforts, we now
have numerous vaccines and treatments in the Strategic National
Stockpile that will save lives, and thousands of lives, in the event of
such an attack.
But we have more work to do to be prepared. H.R. 2405 is a
bipartisan, fiscally responsible bill that will reauthorize successful
biodefense programs at the Department of Health and Human Services
while also making some key changes to our Nation's biodefense strategy.
In 2004 Congress passed Project BioShield, which created a market
guarantee that prompted the private sector to develop countermeasures
for the Federal Government. Because the government is the only
purchaser of these countermeasures, it was important to show the
private sector we were committed to developing and eventually
purchasing these products for stockpile.
Project BioShield Special Reserve Fund has been a critical tool to
protect our country against an attack, and this legislation will
reauthorize the fund for 5 additional years to continue the Federal
Government's commitment to procurement of medical countermeasures.
Importantly, this legislation reaffirms that the Special Reserve Fund
should only be used for chemical, biological, radiological, and nuclear
countermeasure procurement. This is a national security priority, and
these funds should never be diverted for other purposes.
In 2006, Congress created a Biomedical Advanced Research and
Development Authority, called BARDA, which helped bridge what many
termed the ``valley of death'' that had prevented many countermeasure
developers from being successful. BARDA was created because we
recognize that most of the CBRN countermeasures do not yet exist and
medical development countermeasure is a risky, expensive and lengthy
process.
BARDA bridges the funding gap between early-stage research and the
ultimate procurement of products from the SRF fund from the national
stockpile. H.R. 2405 reauthorizes BARDA for 5 years.
In 2006, we also created a unique set of public health programs to
assist hospitals, local public health departments, and first responders
in their preparedness efforts. Under H.R. 2405, these programs have
been reauthorized for an additional 5 years so that we can continue to
strengthen our preparedness infrastructure so critical for prevention
and dealing with any possible attack.
H.R. 2405 also strengthens the role of the HHS Assistant Secretary of
Preparedness and Response. We need to have one leader at HHS that
coordinates countermeasure development and stockpiling across all
agencies. This bill does that.
Finally, this bill includes important reforms to the Food and Drug
Administration, the FDA. The bill strengthens FDA's role in reviewing
medical products for national security priorities.
I believe that we've identified biological threats and spent millions
in taxpayers' funds to develop countermeasures. The FDA must take a
lead role in getting these countermeasures approved.
While we can use many of these products without FDA approval through
an emergency-use authorization, the FDA licensure is hugely important
and sends an important signal to developers of these new hopeful
technologies and immunizations working on next-generation medical
countermeasures.
Simply put, medical countermeasures for national security priorities
cannot continue to be treated the same way as the next Viagra or
Lipitor. FDA must accelerate their review and approval.
It's important for Members to know that this legislation, again, is
fiscally responsible. H.R. 2405 does not create any new Federal
programs or increase spending in any existing programs. I am pleased
CBO has confirmed this in their score. H.R. 2405 creates a 5-year
reauthorization of the biodefense programs we know are working while
making critical policy changes at HHS to strengthen countermeasure
development and public health preparedness.
I would like to thank my colleagues on the Energy and Commerce
Committee for their hard work on this bipartisan legislation. Mr.
Upton, Mr. Pitts, Mr. Waxman, Mr. Pallone, and their staffs have spent
several months helping us develop a bipartisan bill that can be signed
into law. I want to especially thank my friends, Gene Green, Sue
Myrick, and Anna Eshoo for their work to advance this legislation; and
I appreciate your work and counsel along the way, Mr. Green.
I hope we never have to use these countermeasures, Mr. Speaker; but
they are critical to the assurance that the public will be protected
from an attack, and we must continue to speed development and
strengthen our national stockpile. Simply put, we must always be
prepared.
I would urge the strong support of H.R. 2405.
Mr. PALLONE. Mr. Speaker, I yield such time as he may consume to one
of the authors of the bill, the gentleman from Texas (Mr. Gene Green).
Mr. GENE GREEN of Texas. Mr. Speaker, as a personal aside, this
probably won't be the headline on the 6 o'clock news tonight around the
country because we're actually agreeing on something, and I think I can
associate myself with the remarks of my colleague, the primary sponsor
of this bill, as well as he could associate with mine, Mr. Pallone, and
Mr. Pitts.
But I rise today in strong support of H.R. 2405, the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2011, which will
reauthorize certain provisions of the Project BioShield Act of 2004 and
the Pandemic and All-Hazards Preparedness Act of 2006, and I'm proud to
be an original cosponsor of this legislation.
This legislation was initially passed by Congress to help the U.S.
develop medical countermeasures against chemical, biological,
radiological, and nuclear terrorism agents to provide a mechanism for
Federal acquisition of these newly developed countermeasures.
Our Nation remains vulnerable to these threats because many of the
vaccines and medicines that are needed to protect our citizens do not
exist. Developing and stockpiling these medical countermeasures require
time, resources and research, all of which will be provided under this
legislation before us today.
As my colleague from Michigan said, it may not be the bestseller on
the market, like so many other pharmaceuticals, but this is something
that our country needs.
H.R. 2405 is important to me because the University of Texas Medical
Branch-Galveston National Laboratory is literally in the backyard of
our congressional district. The Galveston National Lab is the only BSL-
4 lab located on a university campus.
At the lab, the scientists conduct research and develop therapies,
vaccines, and diagnostic tests for naturally-occurring emerging
diseases such as SARS and avian influenza, as well as for microbes that
may be employed by terrorists.
This is exactly the type of research we hope to encourage under the
Pandemic and All-Hazards Preparedness Reauthorization Act. As an
original cosponsor of H.R. 2405 with Mr. Rogers, I'm really pleased
with how quickly we moved this rare bipartisan piece of legislation. I
want to thank Mr. Rogers, Chairman Upton, Ranking Member Waxman and
Ranking Member Pallone, along with the chair of our Health
Subcommittee, Mr. Pitts, Mrs. Myrick, Ms. Eshoo, and Mr. Markey for
their work on H.R. 2405.
I strongly urge my colleagues to vote ``yes.''
{time} 1340
Mr. PITTS. I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentlewoman from
California (Mrs. Capps).
[[Page H8159]]
Mrs. CAPPS. Mr. Speaker, I rise in support of H.R. 2405, the Pandemic
and All-Hazards Preparedness Reauthorization Act. But I want to take
this time to discuss a critical health issue that Congress must address
before the year is out--fixing the sustainable growth rate issue.
Medicare physicians are facing steep reimbursement cuts of nearly 30
percent. And to let these cuts go into effect will harm not only them
and their employees, but our seniors as well. That's why I have been a
longtime supporter of efforts to postpone SGR cuts and continue to work
on a permanent fix.
We here in the House passed legislation to do just that through our
version of health care reform. And here we are again, just weeks from
the next scheduled cut with an opportunity to craft a bipartisan
solution to an issue that both sides of the aisle say they care about.
But there is no workable plan in sight.
Instead, it is reported that any fix on the House side will come with
indefensible strings attached, pitting doctors' salaries against
seniors' benefits, Federal workers, and important cost-saving
prevention programs. To be clear, SGR must be fixed permanently, but
the idea of stripping other critical health care funding to pay for it,
ideas that will not see the light of day in the Senate, is like robbing
Peter to pay Paul. It is disingenuous to our Nation's doctors, and it
is an indefensible action which will harm our seniors.
So I urge the majority to stop playing politics with the health and
well-being of our seniors and to work together to achieve a meaningful
and realistic fix.
Mr. PITTS. Mr. Speaker, I would tell the gentleman from New Jersey
that I have no other speakers.
Mr. PALLONE. I have no additional speakers. I urge support for this
legislation. It is truly bipartisan.
I yield back the balance of my time.
Mr. PITTS. Mr. Speaker, this is good, bipartisan legislation. I would
like to thank Mr. Pallone, Mr. Green, Mr. Waxman, along with our side
of the aisle, for developing and helping move this bipartisan
legislation. I urge my colleagues to support it, and I yield back the
balance of my time.
Mr. PAULSEN. Mr. Speaker, I rise in support of the Pandemic and All-
Hazards Preparedness Reauthorization Act that aims to bolster the
nation's public health preparedness infrastructure.
In particular, I want to thank Congressman Rogers for including key
provisions that enhance the nation's ability to care for the critically
ill and injured in the aftermath of a public health emergency. This
includes section two that adds the critical care system to the National
Health Security Strategy's medical preparedness goals, to ensure that
critical care is prioritized in planning efforts to increase
preparedness in respect to public health emergencies.
We must understand the significant role critical care medicine plays
in providing high quality health care for the critically ill and
injured in the context of public health preparedness.
The 2009 H1N1 pandemic highlighted some of the deficiencies in
current federal critical care preparedness efforts, as hospitals and
intensive care units faced very real shortages of ventilators and
federal officials scrambled to identify solutions to mitigate this
potential life threatening situation.
In order to ensure that the nation's critical care system is
structured to provide the highest quality and most efficient health
care, including during a national health emergency, I joined with
Congresswoman Baldwin earlier this year to introduce the Critical Care
Assessment and Improvement Act (H.R. 971). This legislation is designed
to identify gaps in the current critical care delivery model and
bolster capabilities to meet future demand. Today's bill includes
provisions that reflect some of the national preparedness priorities
from in H.R. 971.
We must ensure that critical care medicine is given sufficient
consideration by the Administration in respect to disaster preparedness
efforts.
Ms. BALDWIN. Mr. Speaker, I rise in support of the Pandemic and All-
Hazards Preparedness Reauthorization Act, H.R. 2405, a measure that
will improve our nation's medical preparedness and response
capabilities.
I am especially pleased to see that this bill takes important steps
to ensure that our medical response systems are prepared to care for
the critically ill and injured in the aftermath of a public health
emergency.
As you can imagine, when we face a health emergency such as a flu
pandemic, the critical care delivery system is an integral component of
our nation's medical response. Yet, up to this point, critical care
medicine has been largely under-contemplated in our national health
policy.
Earlier this year, I introduced the bipartisan Critical Care
Assessment Act, H.R. 971, with my colleague from Minnesota, Erik
Paulsen. This measure seeks to identify gaps in the current critical
care delivery model and bolster our capabilities to meet future
demands.
I am pleased that the measure before us today includes two important
provisions from my bill to improve federal disaster preparedness
efforts to care for the critically ill and injured.
Notably, the reauthorization bill adds critical care to the
priorities within the nation's medical preparedness goals. When a
natural disaster strikes or a pandemic sweeps the nation, the demands
on critical care increase exponentially, and I am pleased to see this
language that recognizes the importance of treating the critically ill
and injured in a public health emergency.
Additionally, the reauthorization bill improves efforts to ensure
that the systems we have in place to address surge capacity will work
effectively and efficiently during an emergency. Specifically, the bill
includes language to provide for periodic evaluation and testing of the
databases intended to ensure medical surge capacity.
As we learned during Hurricane Katrina and the 2009 H1N1 pandemic,
having a system in place for the effective deployment of needed medical
personnel and supplies is vital for the care of the critically ill and
injured.
I would like to thank Chairman Upton, Chairman Pitts, and my
colleagues on both sides of the aisle for working with me to recognize
the importance of critical care preparedness by including these
important provisions. I look forward to continuing to work to ensure we
have a robust critical care infrastructure.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Pennsylvania (Mr. Pitts) that the House suspend the
rules and pass the bill, H.R. 2405, as amended.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill, as amended, was passed.
A motion to reconsider was laid on the table.
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