[Congressional Record Volume 150, Number 97 (Wednesday, July 14, 2004)]
[House]
[Pages H5721-H5741]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PROJECT BIOSHIELD ACT OF 2004
Mr. BARTON of Texas. Mr. Speaker, pursuant to the order of the House
of Tuesday, July 13, 2004, I call up the Senate bill (S. 15) to amend
the Public Health Service Act to provide protections and
countermeasures against chemical, radiological, or nuclear agents that
may be used in a terrorist attack against the United States by giving
the National Institutes of Health contracting flexibility,
infrastructure improvements, and expediting the scientific peer review
process, and streamlining the Food and Drug Administration approval
process of countermeasures, and ask for its immediate consideration.
The Clerk read the title of the bill.
The text of S. 15 is as follows:
S. 15
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Project BioShield Act of
2004''.
SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT---
AUTHORITIES.
(a) In General.--Part B of title III of the Public Health
Service Act (42 U.S.C. 243 et seq.) is amended by inserting
after section 319F the following section:
``SEC. 319F-1. AUTHORITY FOR USE OF CERTAIN PROCEDURES
REGARDING QUALIFIED COUNTERMEASURE RESEARCH AND
DEVELOPMENT ACTIVITIES.
``(a) In General.--
``(1) Authority.--In conducting and supporting research and
development activities regarding countermeasures under
section 319F(h), the Secretary may conduct and support such
activities in accordance with this section and, in
consultation with the Director of the National Institutes of
Health, as part of the program under section 446, if the
activities concern qualified countermeasures.
``(2) Qualified countermeasure.--For purposes of this
section, the term `qualified countermeasure' means a drug (as
that term is defined by section 201(g)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))),
biological product (as that term is defined by section 351(i)
of this Act (42 U.S.C. 262(i))), or device (as that term is
defined by section 201(h) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(h))) that the Secretary
determines to be a priority (consistent with sections 302(2)
and 304(a) of the Homeland Security Act of 2002) to--
``(A) treat, identify, or prevent harm from any biological,
chemical, radiological, or nuclear agent that may cause a
public health emergency affecting national security; or
``(B) treat, identify, or prevent harm from a condition
that may result in adverse health consequences or death and
may be caused by administering a drug, biological product, or
device that is used as described in subparagraph (A).
``(3) Interagency cooperation.--
``(A) In general.--In carrying out activities under this
section, the Secretary is authorized, subject to subparagraph
(B), to enter into interagency agreements and other
collaborative undertakings with other agencies of the United
States Government.
``(B) Limitation.--An agreement or undertaking under this
paragraph shall not authorize another agency to exercise the
authorities provided by this section.
``(4) Availability of facilities to the secretary.--In any
grant, contract, or cooperative agreement entered into under
the authority provided in this section with respect to a
biocontainment laboratory or other related or ancillary
specialized research facility that the Secretary determines
necessary for the purpose of performing, administering, or
supporting qualified countermeasure research and development,
the Secretary may provide that the facility that is the
object of such grant, contract, or cooperative agreement
shall be available as needed to the Secretary to respond to
public health emergencies affecting national security.
``(5) Transfers of qualified countermeasures.--Each
agreement for an award of a grant, contract, or cooperative
agreement under section 319F(h) for the development of a
qualified countermeasure shall provide that the recipient of
the award will comply with all applicable export-related
controls with respect to such countermeasure.
``(b) Expedited Procurement Authority.--
``(1) Increased simplified acquisition threshold for
qualified countermeasure procurements.--
``(A) In general.--For any procurement by the Secretary of
property or services for use (as determined by the Secretary)
in performing, administering, or supporting qualified
countermeasure research or development activities under this
section that the Secretary determines necessary to respond to
pressing research and development needs under this section,
the amount specified in section 4(11) of the Office of
Federal Procurement Policy Act (41 U.S.C. 403(11)), as
applicable pursuant to section 302A(a) of the Federal
Property and Administrative Services Act of 1949 (41 U.S.C.
252a(a)), shall be deemed to be $25,000,000 in the
administration, with respect to such procurement, of--
``(i) section 303(g)(1)(A) of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C. 253(g)(1)(A))
and its implementing regulations; and
``(ii) section 302A(b) of such Act (41 U.S.C. 252a(b)) and
its implementing regulations.
``(B) Application of certain provisions.--Notwithstanding
subparagraph (A) and the provision of law and regulations
referred to in such subparagraph, each of the following
provisions shall apply to procurements described in this
paragraph to the same extent that such provisions would apply
to such procurements in the absence of subparagraph (A):
``(i) Chapter 37 of title 40, United States Code (relating
to contract work hours and safety standards).
``(ii) Subsections (a) and (b) of section 7 of the Anti-
Kickback Act of 1986 (41 U.S.C. 57(a) and (b)).
``(iii) Section 304C of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C. 254d)
(relating to the examination of contractor records).
``(iv) Section 3131 of title 40, United States Code
(relating to bonds of contractors of public buildings or
works).
``(v) Subsection (a) of section 304 of the Federal Property
and Administrative Services Act of 1949 (41 U.S.C. 254(a))
(relating to contingent fees to middlemen).
``(vi) Section 6002 of the Solid Waste Disposal Act (42
U.S.C. 6962).
``(vii) Section 1354 of title 31, United States Code
(relating to the limitation on the use of appropriated funds
for contracts with entities not meeting veterans employment
reporting requirements).
``(C) Internal controls to be instituted.--The Secretary
shall institute appropriate internal controls for
procurements that are under this paragraph, including
requirements with regard to documenting the justification for
use of the authority in this paragraph with respect to the
procurement involved.
``(D) Authority to limit competition.--In conducting a
procurement under this paragraph, the Secretary may not use
the authority provided for under subparagraph (A) to conduct
a procurement on a basis other than full and open competition
unless the Secretary determines that the mission of the
BioShield Program under the Project BioShield Act of 2004
would be seriously impaired without such a limitation.
``(2) Procedures other than full and open competition.--
``(A) In general.--In using the authority provided in
section 303(c)(1) of title III of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C. 253(c)(1)) to
use procedures other than competitive procedures in the case
of a procurement described in paragraph (1) of this
subsection, the phrase `available from only one responsible
source' in such section 303(c)(1) shall be deemed to mean
`available from only one responsible source or only from a
limited number of responsible sources'.
``(B) Relation to other authorities.--The authority under
subparagraph (A) is in addition to any other authority to use
procedures other than competitive procedures.
``(C) Applicable government-wide regulations.--The
Secretary shall implement this paragraph in accordance with
government-wide regulations implementing such section
303(c)(1) (including requirements that offers be solicited
from as many potential
[[Page H5722]]
sources as is practicable under the circumstances, that
required notices be published, and that submitted offers be
considered), as such regulations apply to procurements for
which an agency has authority to use procedures other than
competitive procedures when the property or services needed
by the agency are available from only one responsible source
or only from a limited number of responsible sources and no
other type of property or services will satisfy the needs of
the agency.
``(3) Increased micropurchase threshold.--
``(A) In general.--For a procurement described by paragraph
(1), the amount specified in subsections (c), (d), and (f) of
section 32 of the Office of Federal Procurement Policy Act
(41 U.S.C. 428) shall be deemed to be $15,000 in the
administration of that section with respect to such
procurement.
``(B) Internal controls to be instituted.--The Secretary
shall institute appropriate internal controls for purchases
that are under this paragraph and that are greater than
$2,500.
``(C) Exception to preference for purchase card
mechanism.--No provision of law establishing a preference for
using a Government purchase card method for purchases shall
apply to purchases that are under this paragraph and that are
greater than $2,500.
``(4) Review.--
``(A) Review allowed.--Notwithstanding subsection (f),
section 1491 of title 28, United States Code, and section
3556 of title 31 of such Code, review of a contracting agency
decision relating to a procurement described in paragraph (1)
may be had only by filing a protest--
``(i) with a contracting agency; or
``(ii) with the Comptroller General under subchapter V of
chapter 35 of title 31, United States Code.
``(B) Override of stay of contract award or performance
committed to agency discretion.--Notwithstanding section 1491
of title 28, United States Code, and section 3553 of title 31
of such Code, the following authorizations by the head of a
procuring activity are committed to agency discretion:
``(i) An authorization under section 3553(c)(2) of title
31, United States Code, to award a contract for a procurement
described in paragraph (1) of this subsection.
``(ii) An authorization under section 3553(d)(3)(C) of such
title to perform a contract for a procurement described in
paragraph (1) of this subsection.
``(c) Authority To Expedite Peer Review.--
``(1) In general.--The Secretary may, as the Secretary
determines necessary to respond to pressing qualified
countermeasure research and development needs under this
section, employ such expedited peer review procedures
(including consultation with appropriate scientific experts)
as the Secretary, in consultation with the Director of NIH,
deems appropriate to obtain assessment of scientific and
technical merit and likely contribution to the field of
qualified countermeasure research, in place of the peer
review and advisory council review procedures that would be
required under sections 301(a)(3), 405(b)(1)(B), 405(b)(2),
406(a)(3)(A), 492, and 494, as applicable to a grant,
contract, or cooperative agreement--
``(A) that is for performing, administering, or supporting
qualified countermeasure research and development activities;
and
``(B) the amount of which is not greater than $1,500,000.
``(2) Subsequent phases of research.--The Secretary's
determination of whether to employ expedited peer review with
respect to any subsequent phases of a research grant,
contract, or cooperative agreement under this section shall
be determined without regard to the peer review procedures
used for any prior peer review of that same grant, contract,
or cooperative agreement. Nothing in the preceding sentence
may be construed to impose any requirement with respect to
peer review not otherwise required under any other law or
regulation.
``(d) Authority for Personal Services Contracts.--
``(1) In general.--For the purpose of performing,
administering, or supporting qualified countermeasure
research and development activities, the Secretary may, as
the Secretary determines necessary to respond to pressing
qualified countermeasure research and development needs under
this section, obtain by contract (in accordance with section
3109 of title 5, United States Code, but without regard to
the limitations in such section on the period of service and
on pay) the personal services of experts or consultants who
have scientific or other professional qualifications, except
that in no case shall the compensation provided to any such
expert or consultant exceed the daily equivalent of the
annual rate of compensation for the President.
``(2) Federal tort claims act coverage.--
``(A) In general.--A person carrying out a contract under
paragraph (1), and an officer, employee, or governing board
member of such person, shall, subject to a determination by
the Secretary, be deemed to be an employee of the Department
of Health and Human Services for purposes of claims under
sections 1346(b) and 2672 of title 28, United States Code,
for money damages for personal injury, including death,
resulting from performance of functions under such contract.
``(B) Exclusivity of remedy.--The remedy provided by
subparagraph (A) shall be exclusive of any other civil action
or proceeding by reason of the same subject matter against
the entity involved (person, officer, employee, or governing
board member) for any act or omission within the scope of the
Federal Tort Claims Act.
``(C) Recourse in case of gross misconduct or contract
violation.--
``(i) In general.--Should payment be made by the United
States to any claimant bringing a claim under this paragraph,
either by way of administrative determination, settlement, or
court judgment, the United States shall have, notwithstanding
any provision of State law, the right to recover against any
entity identified in subparagraph (B) for that portion of the
damages so awarded or paid, as well as interest and any costs
of litigation, resulting from the failure of any such entity
to carry out any obligation or responsibility assumed by such
entity under a contract with the United States or from any
grossly negligent or reckless conduct or intentional or
willful misconduct on the part of such entity.
``(ii) Venue.--The United States may maintain an action
under this subparagraph against such entity in the district
court of the United States in which such entity resides or
has its principal place of business.
``(3) Internal controls to be instituted.--
``(A) In general.--The Secretary shall institute
appropriate internal controls for contracts under this
subsection, including procedures for the Secretary to make a
determination of whether a person, or an officer, employee,
or governing board member of a person, is deemed to be an
employee of the Department of Health and Human Services
pursuant to paragraph (2).
``(B) Determination of employee status to be final.--A
determination by the Secretary under subparagraph (A) that a
person, or an officer, employee, or governing board member of
a person, is or is not deemed to be an employee of the
Department of Health and Human Services shall be final and
binding on the Secretary and the Attorney General and other
parties to any civil action or proceeding.
``(4) Number of personal services contracts limited.--The
number of experts and consultants whose personal services are
obtained under paragraph (1) shall not exceed 30 at any time.
``(e) Streamlined Personnel Authority.--
``(1) In general.--In addition to any other personnel
authorities, the Secretary may, as the Secretary determines
necessary to respond to pressing qualified countermeasure
research and development needs under this section, without
regard to those provisions of title 5, United States Code,
governing appointments in the competitive service, and
without regard to the provisions of chapter 51 and subchapter
III of chapter 53 of such title relating to classification
and General Schedule pay rates, appoint professional and
technical employees, not to exceed 30 such employees at any
time, to positions in the National Institutes of Health to
perform, administer, or support qualified countermeasure
research and development activities in carrying out this
section.
``(2) Limitations.--The authority provided for under
paragraph (1) shall be exercised in a manner that--
``(A) recruits and appoints individuals based solely on
their abilities, knowledge, and skills;
``(B) does not discriminate for or against any applicant
for employment on any basis described in section 2302(b)(1)
of title 5, United States Code;
``(C) does not allow an official to appoint an individual
who is a relative (as defined in section 3110(a)(3) of such
title) of such official;
``(D) does not discriminate for or against an individual
because of the exercise of any activity described in
paragraph (9) or (10) of section 2302(b) of such title; and
``(E) accords a preference, among equally qualified
persons, to persons who are preference eligibles (as defined
in section 2108(3) of such title).
``(3) Internal controls to be instituted.--The Secretary
shall institute appropriate internal controls for
appointments under this subsection.
``(f) Actions Committed to Agency Discretion.--Actions by
the Secretary under the authority of this section are
committed to agency discretion.''.
(b) Technical Amendment.--Section 481A of the Public Health
Service Act (42 U.S.C. 287a-2) is amended--
(1) in subsection (a)(1), by inserting ``or the Director of
the National Institute of Allergy and Infectious Diseases''
after ``Director of the Center'';
(2) in subsection (c)--
(A) in paragraph (1), by inserting ``or the Director of the
National Institute of Allergy and Infectious Diseases'' after
``Director of the Center''; and
(B) in paragraph (2), in the matter preceding subparagraph
(A), by striking ``subsection (i)'' and inserting
``subsection (i)(1)'';
(3) in subsection (d), by inserting ``or the Director of
the National Institute of Allergy and Infectious Diseases''
after ``Director of the Center'';
(4) in subsection (e)--
(A) in paragraph (1)--
(i) in the matter preceding subparagraph (A), by inserting
``or the Director of the National Institute of Allergy and
Infectious Diseases'' after ``Director of the Center'';
(ii) in subparagraph (A), by inserting ``(or, in the case
of the Institute, 75 percent)'' after ``50 percent''; and
[[Page H5723]]
(iii) in subparagraph (B), by inserting ``(or, in the case
of the Institute, 75 percent)'' after ``40 percent'';
(B) in paragraph (2), by inserting ``or the Director of the
National Institute of Allergy and Infectious Diseases'' after
``Director of the Center''; and
(C) in paragraph (4), by inserting ``of the Center or the
Director of the National Institute of Allergy and Infectious
Diseases'' after ``Director'';
(5) in subsection (f)--
(A) in paragraph (1), by inserting ``in the case of an
award by the Director of the Center,'' before ``the
applicant''; and
(B) in paragraph (2), by inserting ``of the Center or the
Director of the National Institute of Allergy and Infectious
Diseases'' after ``Director''; and
(6) in subsection (i)--
(A) by striking ``Appropriations.--For the purpose of
carrying out this section,'' and inserting the following:
``Appropriations.--
``(1) Center.--For the purpose of carrying out this section
with respect to the Center,''; and
(B) by adding at the end the following:
``(2) National institute of allergy and infectious
diseases.--For the purpose of carrying out this section with
respect to the National Institute of Allergy and Infectious
Diseases, there are authorized to be appropriated such sums
as may be necessary for each of the fiscal years 2004 and
2005.''.
(c) Additional Authorizations of Appropriations.--Section
2106 of the Public Health Service Act (42 U.S.C. 300aa-6) is
amended--
(1) in subsection (a), by striking ``authorized to be
appropriated'' and all that follows and inserting the
following: ``authorized to be appropriated such sums as may
be necessary for each of the fiscal years 2004 and 2005.'';
and
(2) in subsection (b), by striking ``authorized to be
appropriated'' and all that follows and inserting the
following: ``authorized to be appropriated such sums as may
be necessary for each of the fiscal years 2004 and 2005.''.
(d) Technical Amendments.--Section 319F of the Public
Health Service Act (42 U.S.C. 247d-6) is amended--
(1) in subsection (a), by inserting ``the Secretary of
Homeland Security,'' after ``Management Agency,''; and
(2) in subsection (h)(4)(B), by striking ``to diagnose
conditions'' and inserting ``to treat, identify, or prevent
conditions''.
(e) Rule of Construction.--Nothing in this section has any
legal effect on sections 302(2), 302(4), 304(a), or 304(b) of
the Homeland Security Act of 2002.
SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT.
(a) Additional Authority Regarding Strategic National
Stockpile.--
(1) Transfer of program.--Section 121 of the Public Health
Security and Bioterrorism Preparedness and Response Act of
2002 (116 Stat. 611; 42 U.S.C. 300hh-12) is transferred from
such Act to the Public Health Service Act, is redesignated as
section 319F-2, and is inserted after section 319F-1 of the
Public Health Service Act (as added by section 2 of this
Act).
(2) Additional authority.--Section 319F-2 of the Public
Health Service Act, as added by paragraph (1), is amended to
read as follows:
``SEC. 319F-2. STRATEGIC NATIONAL STOCKPILE.
``(a) Strategic National Stockpile.--
``(1) In general.--The Secretary, in coordination with the
Secretary of Homeland Security (referred to in this section
as the `Homeland Security Secretary'), shall maintain a
stockpile or stockpiles of drugs, vaccines and other
biological products, medical devices, and other supplies in
such numbers, types, and amounts as are determined by the
Secretary to be appropriate and practicable, taking into
account other available sources, to provide for the emergency
health security of the United States, including the emergency
health security of children and other vulnerable populations,
in the event of a bioterrorist attack or other public health
emergency.
``(2) Procedures.--The Secretary, in managing the stockpile
under paragraph (1), shall--
``(A) consult with the working group under section 319F(a);
``(B) ensure that adequate procedures are followed with
respect to such stockpile for inventory management and
accounting, and for the physical security of the stockpile;
``(C) in consultation with Federal, State, and local
officials, take into consideration the timing and location of
special events;
``(D) review and revise, as appropriate, the contents of
the stockpile on a regular basis to ensure that emerging
threats, advanced technologies, and new countermeasures are
adequately considered;
``(E) devise plans for the effective and timely supply-
chain management of the stockpile, in consultation with
appropriate Federal, State and local agencies, and the public
and private health care infrastructure;
``(F) deploy the stockpile as required by the Secretary of
Homeland Security to respond to an actual or potential
emergency;
``(G) deploy the stockpile at the discretion of the
Secretary to respond to an actual or potential public health
emergency or other situation in which deployment is necessary
to protect the public health or safety; and
``(H) ensure the adequate physical security of the
stockpile.
``(b) Smallpox Vaccine Development.--
``(1) In general.--The Secretary shall award contracts,
enter into cooperative agreements, or carry out such other
activities as may reasonably be required in order to ensure
that the stockpile under subsection (a) includes an amount of
vaccine against smallpox as determined by such Secretary to
be sufficient to meet the health security needs of the United
States.
``(2) Rule of construction.--Nothing in this section shall
be construed to limit the private distribution, purchase, or
sale of vaccines from sources other than the stockpile
described in subsection (a).
``(c) Additional Authority Regarding Procurement of Certain
Biomedical 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).
``(B) Security countermeasure.--For purposes of this
subsection, the term `security countermeasure' means a drug
(as that term is defined by section 201(g)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))),
biological product (as that term is defined by section 351(i)
of this Act (42 U.S.C. 262(i))), or device (as that term is
defined by section 201(h) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(h))) that--
``(i)(I) -the Secretary determines to be a priority
(consistent with sections 302(2) and 304(a) of the Homeland
Security Act of 2002) to treat, identify, or prevent harm
from any biological, chemical, radiological, or nuclear agent
identified as a material threat under paragraph (2)(A)(ii),
or to treat, identify, or prevent harm from a condition that
may result in adverse health consequences or death and may be
caused by administering a drug, biological product, or device
against such an agent;
``(II) the Secretary determines under paragraph (2)(B)(ii)
to be a necessary countermeasure; and
``(III)(aa) is approved or cleared under chapter V of the
Federal Food, Drug, and Cosmetic Act or licensed under
section 351 of this Act; or
``(bb) is a countermeasure for which the Secretary
determines that sufficient and satisfactory clinical
experience or research data (including data, if available,
from pre-clinical and clinical trials) support a reasonable
conclusion that the countermeasure will qualify for approval
or licensing within eight years after the date of a
determination under paragraph (5); or
``(ii) is authorized for emergency use under section 564 of
the Federal Food, Drug, and Cosmetic Act.
``(2) Determination of material threats.--
``(A) Material threat.--The Homeland Security Secretary, in
consultation with the Secretary and the heads of other
agencies as appropriate, shall on an ongoing basis--
``(i) assess current and emerging threats of chemical,
biological, radiological, and nuclear agents; and
``(ii) determine which of such agents present a material
threat against the United States population sufficient to
affect national security.
``(B) Public health impact; necessary countermeasures.--The
Secretary shall on an ongoing basis--
``(i) assess the potential public health consequences for
the United States population of exposure to agents identified
under subparagraph (A)(ii); and
``(ii) determine, on the basis of such assessment, the
agents identified under subparagraph (A)(ii) for which
countermeasures are necessary to protect the public health.
``(C) Notice to congress.--The Secretary and the Homeland
Security Secretary shall promptly notify the designated
congressional committees (as defined in paragraph (10)) that
a determination has been made pursuant to subparagraph (A) or
(B).
``(D) Assuring access to threat information.--In making the
assessment and determination required under subparagraph (A),
the Homeland Security Secretary shall use all relevant
information to which such Secretary is entitled under section
202 of the Homeland Security Act of 2002, including but not
limited to information, regardless of its level of
classification, relating to current and emerging threats of
chemical, biological, radiological, and nuclear agents.
``(3) Assessment of availability and appropriateness of
countermeasures.--The Secretary, in consultation with the
Homeland Security Secretary, shall assess on an ongoing basis
the availability and appropriateness of specific
countermeasures to address specific threats identified under
paragraph (2).
``(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
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) issue a call for the development of such
countermeasure; and
``(ii) make a commitment that, upon the first development
of such countermeasure that meets the conditions for
procurement under paragraph (5), the Secretaries will,
[[Page H5724]]
based in part on information obtained pursuant to such call,
make a recommendation under paragraph (6) that the special
reserve fund under paragraph (10) be made available for the
procurement of such countermeasure.
``(B) Countermeasure specifications.--The Homeland Security
Secretary and the Secretary shall, to the extent practicable,
include in the proposal under subparagraph (A)--
``(i) estimated quantity of purchase (in the form of number
of doses or number of effective courses of treatments
regardless of dosage form);
``(ii) necessary measures of minimum safety and
effectiveness;
``(iii) estimated price for each dose or effective course
of treatment regardless of dosage form; and
``(iv) other information that may be necessary to encourage
and facilitate research, development, and manufacture of the
countermeasure or to provide specifications for the
countermeasure.
``(C) Presidential approval.--If the President approves a
proposal under subparagraph (A), the Homeland Security
Secretary and the Secretary shall make known to persons who
may respond to a call for the countermeasure involved--
``(i) the call for the countermeasure;
``(ii) specifications for the countermeasure under
subparagraph (B); and
``(iii) the commitment described in subparagraph (A)(ii).
``(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) (referred to in this
subsection individually as a `procurement under this
subsection').
``(B) Requirements.--In making a determination under
subparagraph (A) with respect to a security countermeasure,
the Secretary shall determine and consider the following:
``(i) The quantities of the product that will be needed to
meet the needs of the stockpile.
``(ii) The feasibility of production and delivery within
eight years of sufficient quantities of the product.
``(iii) Whether there is a lack of a significant commercial
market for the product at the time of procurement, other than
as a security countermeasure.
``(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) be made available for the
procurement of such countermeasure.
``(B) Presidential approval.--The special reserve fund
under paragraph (10) 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) 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.
``(D) Subsequent specific countermeasures.--Procurement
under this subsection of a security countermeasure for a
particular purpose does not preclude the subsequent
procurement under this subsection of any other security
countermeasure for such purpose if the Secretary has
determined under paragraph (5)(A) that such countermeasure is
appropriate for inclusion in the stockpile and if, as
determined by the Secretary, such countermeasure provides
improved safety or effectiveness, or for other reasons
enhances preparedness to respond to threats of use of a
biological, chemical, radiological, or nuclear agent. Such a
determination by the Secretary is committed to agency
discretion.
``(E) Rule of construction.--Recommendations and approvals
under this paragraph apply solely to determinations that the
special reserve fund under paragraph (10) 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) In general.--For purposes of a procurement under this
subsection that is approved by the President under paragraph
(6), the Homeland Security Secretary and the Secretary shall
have responsibilities in accordance with subparagraphs (B)
and (C).
``(B) Interagency agreement; costs.--
``(i) Interagency agreement.--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) shall be available for payments
made by the Secretary to a vendor for such procurement.
``(ii) Other costs.--The actual costs to the Secretary
under this section, other than the costs described in clause
(i), shall be paid from the appropriation provided for under
subsection (f)(1).
``(C) Procurement.--
``(i) In general.--The Secretary shall be responsible for--
``(I) arranging for procurement of a security
countermeasure, including negotiating terms (including
quantity, production schedule, and price) of, and entering
into, contracts and cooperative agreements, and for carrying
out such other activities as may reasonably be required, in
accordance with the provisions of this subparagraph; and
``(II) promulgating such regulations as the Secretary
determines necessary to implement the provisions of this
subsection.
``(ii) Contract terms.--A contract for procurements under
this subsection shall (or, as specified below, may) include
the following terms:
``(I) Payment conditioned on delivery.--The contract shall
provide that no payment may be made until delivery has been
made of a portion, acceptable to the Secretary, of the total
number of units contracted for, except that, notwithstanding
any other provision of law, the contract may provide that, if
the Secretary determines (in the Secretary's discretion) that
an advance payment is necessary to ensure success of a
project, the Secretary may pay an amount, not to exceed 10
percent of the contract amount, in advance of delivery. The
contract shall provide that such advance payment is required
to be repaid if there is a failure to perform by the vendor
under the contract. Nothing in this subclause may be
construed as affecting rights of vendors under provisions of
law or regulation (including the Federal Acquisition
Regulation) relating to termination of contracts for the
convenience of the Government.
``(II) Discounted payment.--The contract may provide for a
discounted price per unit of a product that is not licensed,
cleared, or approved as described in paragraph
(1)(B)(i)(III)(aa) at the time of delivery, and may provide
for payment of an additional amount per unit if the product
becomes so licensed, cleared, or approved before the
expiration date of the contract (including an additional
amount per unit of product delivered before the effective
date of such licensing, clearance, or approval).
``(III) Contract duration.--The contract shall be for a
period not to exceed five years, except that, in first
awarding the contract, the Secretary may provide for a longer
duration, not exceeding eight years, if the Secretary
determines that complexities or other difficulties in
performance under the contract justify such a period. The
contract shall be renewable for additional periods, none of
which shall exceed five years.
``(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)
shall be available for costs of shipping, handling, storage,
and related costs for such product.
``(V) Product approval.--The contract shall provide that
the vendor seek approval, clearance, or licensing of the
product from the Secretary; for a timetable for the
development of data and other information to support such
approval, clearance, or licensing; and that the Secretary may
waive part or all of this contract term on request of the
vendor or on the initiative of the Secretary.
``(VI) Non-stockpile transfers of security
countermeasures.--The contract shall provide that the vendor
will comply with all applicable export-related controls with
respect to such countermeasure.
``(iii) Availability of simplified acquisition
procedures.--
``(I) In general.--If the Secretary determines that there
is a pressing need for a procurement of a specific
countermeasure, the amount of the procurement under this
subsection shall be deemed to be below the threshold amount
specified in section 4(11) of the Office of Federal
Procurement Policy Act (41 U.S.C. 403(11)), for purposes of
application to such procurement, pursuant to section 302A(a)
of the Federal Property and Administrative Services Act of
1949 (41 U.S.C. 252a(a)), of--
``(aa) section 303(g)(1)(A) of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C. 253(g)(1)(A))
and its implementing regulations; and
``(bb) section 302A(b) of such Act (41 U.S.C. 252a(b)) and
its implementing regulations.
``(II) Application of certain provisions.--Notwithstanding
subclause (I) and the provision of law and regulations
referred to in such clause, each of the following provisions
shall apply to procurements described in this clause to the
same extent that such provisions would apply to such
procurements in the absence of subclause (I):
[[Page H5725]]
``(aa) Chapter 37 of title 40, United States Code (relating
to contract work hours and safety standards).
``(bb) Subsections (a) and (b) of section 7 of the Anti-
Kickback Act of 1986 (41 U.S.C. 57(a) and (b)).
``(cc) Section 304C of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C. 254d)
(relating to the examination of contractor records).
``(dd) Section 3131 of title 40, United States Code
(relating to bonds of contractors of public buildings or
works).
``(ee) Subsection (a) of section 304 of the Federal
Property and Administrative Services Act of 1949 (41 U.S.C.
254(a)) (relating to contingent fees to middlemen).
``(ff) Section 6002 of the Solid Waste Disposal Act (42
U.S.C. 6962).
``(gg) Section 1354 of title 31, United States Code
(relating to the limitation on the use of appropriated funds
for contracts with entities not meeting veterans employment
reporting requirements).
``(III) Internal controls to be established.--The Secretary
shall establish appropriate internal controls for
procurements made under this clause, including requirements
with respect to documentation of the justification for the
use of the authority provided under this paragraph with
respect to the procurement involved.
``(IV) Authority to limit competition.--In conducting a
procurement under this subparagraph, the Secretary may not
use the authority provided for under subclause (I) to conduct
a procurement on a basis other than full and open competition
unless the Secretary determines that the mission of the
BioShield Program under the Project BioShield Act of 2004
would be seriously impaired without such a limitation.
``(iv) Procedures other than full and open competition.--
``(I) In general.--In using the authority provided in
section 303(c)(1) of title III of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C. 253(c)(1)) to
use procedures other than competitive procedures in the case
of a procurement under this subsection, the phrase `available
from only one responsible source' in such section 303(c)(1)
shall be deemed to mean `available from only one responsible
source or only from a limited number of responsible sources'.
``(II) Relation to other authorities.--The authority under
subclause (I) is in addition to any other authority to use
procedures other than competitive procedures.
``(III) Applicable government-wide regulations.--The
Secretary shall implement this clause in accordance with
government-wide regulations implementing such section
303(c)(1) (including requirements that offers be solicited
from as many potential sources as is practicable under the
circumstances, that required notices be published, and that
submitted offers be considered), as such regulations apply to
procurements for which an agency has authority to use
procedures other than competitive procedures when the
property or services needed by the agency are available from
only one responsible source or only from a limited number of
responsible sources and no other type of property or services
will satisfy the needs of the agency.
``(v) Premium provision in multiple award contracts.--
``(I) In general.--If, under this subsection, the Secretary
enters into contracts with more than one vendor to procure a
security countermeasure, such Secretary may, notwithstanding
any other provision of law, include in each of such contracts
a provision that--
``(aa) identifies an increment of the total quantity of
security countermeasure required, whether by percentage or by
numbers of units; and
``(bb) promises to pay one or more specified premiums based
on the priority of such vendors' production and delivery of
the increment identified under item (aa), in accordance with
the terms and conditions of the contract.
``(II) Determination of government's requirement not
reviewable.--If the Secretary includes in each of a set of
contracts a provision as described in subclause (I), such
Secretary's determination of the total quantity of security
countermeasure required, and any amendment of such
determination, is committed to agency discretion.
``(vi) Extension of closing date for receipt of proposals
not reviewable.--A decision by the Secretary to extend the
closing date for receipt of proposals for a procurement under
this subsection is committed to agency discretion.
``(vii) Limiting competition to sources responding to
request for information.--In conducting a procurement under
this subsection, the Secretary may exclude a source that has
not responded to a request for information under section
303A(a)(1)(B) of the Federal Property and Administrative
Services Act of 1949 (41 U.S.C. 253a(a)(1)(B)) if such
request has given notice that the Secretary may so exclude
such a source.
``(8) Interagency cooperation.--
``(A) In general.--In carrying out activities under this
section, the Homeland Security Secretary and the Secretary
are authorized, subject to subparagraph (B), to enter into
interagency agreements and other collaborative undertakings
with other agencies of the United States Government.
``(B) Limitation.--An agreement or undertaking under this
paragraph shall not authorize another agency to exercise the
authorities provided by this section to the Homeland Security
Secretary or to the Secretary.
``(9) Restrictions on use of funds.--Amounts in the special
reserve fund under paragraph (10) 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.
``(d) Disclosures.--No Federal agency shall disclose under
section 552 of title 5, United States Code, any information
identifying the location at which materials in the stockpile
under subsection (a) are stored.
``(e) Definition.--For purposes of subsection (a), the term
`stockpile' includes--
``(1) a physical accumulation (at one or more locations) of
the supplies described in subsection (a); or
``(2) a contractual agreement between the Secretary and a
vendor or vendors under which such vendor or vendors agree to
provide to such Secretary supplies described in subsection
(a).
``(f) Authorization of Appropriations.--
``(1) Strategic national stockpile.--For the purpose of
carrying out subsection (a), there are authorized to be
appropriated $640,000,000 for fiscal year 2002, and such sums
as may be necessary for each of fiscal years 2003 through
2006. Such authorization is in addition to amounts in the
special reserve fund referred to in subsection (c)(10)(A).
``(2) Smallpox vaccine development.--For the purpose of
carrying out subsection (b), there are authorized to be
appropriated $509,000,000 for fiscal year 2002, and such sums
as may be necessary for each of fiscal years 2003 through
2006.''.
(b) Amendments to Homeland Security Act of 2002.--Title V
of the Homeland Security Act of 2002 (116 Stat. 2212; 6
U.S.C. 311 et seq.) is amended--
(1) in section 502(3) (6 U.S.C. 312(3))--
(A) in subparagraph (B), by striking ``the Strategic
National Stockpile,''; and
(B) in subparagraph (D), by inserting ``, including
requiring deployment of the Strategic National Stockpile,''
after ``resources''; and
(2) by adding at the end the following:
``SEC. 510. PROCUREMENT OF SECURITY COUNTERMEASURES FOR
STRATEGIC NATIONAL STOCKPILE.
``(a) Authorization of Appropriations.--For the procurement
of security countermeasures under section 319F-2(c) of the
Public Health Service Act (referred to in this section as the
`security countermeasures program'), there is authorized to
be appropriated up to $5,593,000,000 for the fiscal years
2004 through 2013. Of the amounts appropriated under the
preceding sentence, not to exceed $3,418,000,000 may be
obligated during the fiscal years 2004 through 2008, of which
not to exceed $890,000,000 may be obligated during fiscal
year 2004.
``(b) Special Reserve Fund.--For purposes of the security
countermeasures program, the term `special reserve fund'
means the `Biodefense Countermeasures' appropriations account
or any other appropriation made under subsection (a).
``(c) Availability.--Amounts appropriated under subsection
(a) become available for a procurement under the security
countermeasures program only upon the approval by the
President of such availability for the procurement in
accordance with paragraph (6)(B) of such program.
``(d) Related Authorizations of Appropriations.--
``(1) Threat assessment capabilities.--For the purpose of
carrying out the responsibilities of the Secretary for terror
threat assessment under the security countermeasures program,
there are authorized to be appropriated such sums as may be
necessary for each of the fiscal years 2004 through 2006, for
the hiring of professional personnel within the Directorate
for Information Analysis and Infrastructure Protection, who
shall be analysts responsible for chemical, biological,
radiological, and nuclear threat assessment (including but
not limited to analysis of chemical, biological,
radiological, and nuclear agents, the means by which such
agents could be weaponized or used in a terrorist attack, and
the capabilities, plans, and intentions of terrorists and
other non-state actors who may have or acquire such agents).
All such analysts shall meet the applicable standards and
qualifications for the performance of intelligence activities
promulgated by the Director of Central Intelligence pursuant
to section 104 of the National Security Act of 1947.
``(2) Intelligence sharing infrastructure.--For the purpose
of carrying out the
[[Page H5726]]
acquisition and deployment of secure facilities (including
information technology and physical infrastructure, whether
mobile and temporary, or permanent) sufficient to permit the
Secretary to receive, not later than 180 days after the date
of enactment of the Project BioShield Act of 2004, all
classified information and products to which the Under
Secretary for Information Analysis and Infrastructure
Protection is entitled under subtitle A of title II, there
are authorized to be appropriated such sums as may be
necessary for each of the fiscal years 2004 through 2006.''.
(c) Stockpile Functions Transferred.--
(1) In general.--Except as provided in paragraph (2), there
shall be transferred to the Secretary of Health and Human
Services the functions, personnel, assets, unexpended
balances, and liabilities of the Strategic National
Stockpile, including the functions of the Secretary of
Homeland Security relating thereto.
(2) Exceptions.--
(A) Functions.--The transfer of functions pursuant to
paragraph (1) shall not include such functions as are
explicitly assigned to the Secretary of Homeland Security by
this Act (including the amendments made by this Act).
(B) Assets and unexpended balances.--The transfer of assets
and unexpended balances pursuant to paragraph (1) shall not
include the funds appropriated under the heading ``biodefense
countermeasures'' in the Department of Homeland Security
Appropriations Act, 2004 (Public law 108-90).
(3) Conforming amendment.--Section 503 of the Homeland
Security Act of 2002 (6 U.S.C. 313) is amended by striking
paragraph (6).
SEC. 4. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN
EMERGENCIES.
(a) In General.--Section 564 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-3) is amended to read as
follows:
``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 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 (referred to in this section as an `unapproved
product'); or
``(B) is approved, licensed, or cleared under such a
provision, but which use is not under such provision an
approved, licensed, or cleared use of the product (referred
to in this section as an `unapproved use of an approved
product').
``(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.
``(4) Definitions.--For purposes of this section:
``(A) The term `biological product' has the meaning given
such term in section 351 of the Public Health Service Act.
``(B) The term `emergency use' has the meaning indicated
for such term in paragraph (1).
``(C) The term `product' means a drug, device, or
biological product.
``(D) The term `unapproved product' has the meaning
indicated for such term in paragraph (2)(A).
``(E) The term `unapproved use of an approved product' has
the meaning indicated for such term in paragraph (2)(B).
``(b) Declaration of Emergency.--
``(1) In general.--The Secretary may declare an emergency
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.
``(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.
``(C) 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.
``(3) Advance notice of termination.--The Secretary shall
provide advance notice that a declaration under this
subsection will be terminated. The period of advance notice
shall be a period reasonably determined to provide--
``(A) in the case of an unapproved product, a sufficient
period for disposition of the product, including the return
of such product (except such quantities of product as are
necessary to provide for continued use consistent with
subsection (f)(2)) to the manufacturer (in the case of a
manufacturer that chooses to have such product returned); and
``(B) in the case of an unapproved use of an approved
product, a sufficient period for the disposition of any
labeling, or any information under subsection (e)(2)(B)(ii),
as the case may be, that was provided with respect to the
emergency use involved.
``(4) Publication.--The Secretary shall promptly publish in
the Federal Register each declaration, determination, advance
notice of termination, and renewal 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 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 a declaration under
subsection (b) can cause a serious or life-threatening
disease or condition;
``(2) that, based on the totality of scientific evidence
available to the Secretary, including data from adequate and
well-controlled clinical trials, if available, it is
reasonable to believe that--
``(A) the product may be effective in diagnosing, treating,
or preventing--
``(i) such disease or condition; or
``(ii) a serious or life-threatening disease or condition
caused by a product authorized under this section, approved
or cleared under this Act, or licensed under section 351 of
the Public Health Service Act, for diagnosing, treating, or
preventing such a disease or condition caused by such an
agent; and
``(B) the known and potential benefits of the product, when
used to diagnose, prevent, or treat such disease or
condition, outweigh the known and potential risks of the
product;
``(3) that there is no adequate, approved, and available
alternative to the product for diagnosing, preventing, or
treating such disease or condition; and
``(4) that such other criteria as the Secretary may by
regulation prescribe are satisfied.
``(d) Scope of Authorization.--An authorization of a
product under this section shall state--
``(1) each disease or condition that the product may be
used to diagnose, prevent, or treat within the scope of the
authorization;
``(2) the Secretary's conclusions, made under subsection
(c)(2)(B), that the known and potential benefits of the
product, when used to diagnose, prevent, or treat such
disease or condition, outweigh the known and potential risks
of the product; and
``(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 an assessment of the available
scientific evidence.
``(e) Conditions of Authorization.--
``(1) Unapproved product.--
``(A) Required conditions.--With respect to the emergency
use of an unapproved product, the Secretary, to the extent
practicable given the circumstances of the emergency, shall,
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) Appropriate conditions designed to ensure that health
care professionals administering the product are informed--
``(I) that the Secretary has authorized the emergency use
of the product;
``(II) of the significant known and potential benefits and
risks of the emergency use of the product, and of the extent
to which such benefits and risks are unknown; and
``(III) of the alternatives to the product that are
available, and of their benefits and risks.
``(ii) Appropriate conditions designed to ensure that
individuals to whom the product is administered are
informed--
``(I) that the Secretary has authorized the emergency use
of the product;
``(II) of the significant known and potential benefits and
risks of such use, and of the
[[Page H5727]]
extent to which such benefits and risks are unknown; and
``(III) of the option to accept or refuse administration of
the product, of the consequences, if any, of refusing
administration of the product, and of the alternatives to the
product that are available and of their benefits and risks.
``(iii) Appropriate conditions for the monitoring and
reporting of adverse events associated with the emergency use
of the product.
``(iv) For manufacturers of the product, appropriate
conditions concerning recordkeeping and reporting, including
records access by the Secretary, with respect to the
emergency use of the product.
``(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) Appropriate conditions on which entities may
distribute the product with respect to the emergency use of
the product (including limitation to distribution by
government entities), and on how distribution is to be
performed.
``(ii) Appropriate conditions on who may administer the
product with respect to the emergency use of the product, and
on the categories of individuals to whom, and the
circumstances under which, the product may be administered
with respect to such use.
``(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.
``(iv) For persons other than manufacturers of the product,
appropriate conditions concerning recordkeeping and
reporting, including records access by the Secretary, with
respect to the emergency use of the product.
``(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 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.
``(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.
``(ii) In the circumstances described in clause (i), for a
person who does not manufacture the product and who chooses
to act under this clause, an authorization under this section
regarding the emergency use shall, to the extent practicable
given the circumstances of the emergency, authorize such
person to provide appropriate information with respect to
such product in addition to the labeling provided by the
manufacturer, subject to compliance with clause (i). While
the authorization under this section is effective, such
additional information shall not be considered labeling for
purposes of section 502.
``(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.
``(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.
``(4) Advertising.--The Secretary may establish conditions
on advertisements and other promotional descriptive printed
matter that relate 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), including, as appropriate--
``(A) with respect to drugs and biological products,
requirements applicable to prescription drugs pursuant to
section 502(n); or
``(B) with respect to devices, requirements applicable to
restricted devices pursuant to section 502(r).
``(f) Duration of Authorization.--
``(1) In general.--Except as provided in paragraph (2), an
authorization under this section shall be effective until the
earlier of the termination of the declaration under
subsection (b) or a revocation under subsection (g).
``(2) Continued use after end of effective period.--
Notwithstanding the termination of the declaration under
subsection (b) or a revocation under subsection (g), an
authorization shall continue to be effective to provide for
continued use of an unapproved product with respect to a
patient to whom it was administered during the period
described by paragraph (1), to the extent found necessary by
such patient's attending physician.
``(g) Revocation of Authorization.--
``(1) Review.--The Secretary shall periodically review the
circumstances and the appropriateness of an authorization
under this section.
``(2) Revocation.--The Secretary may revoke an
authorization under this section if the criteria under
subsection (c) for issuance of such authorization are no
longer met or other circumstances make such revocation
appropriate to protect the public health or safety.
``(h) Publication; Confidential Information.--
``(1) Publication.--The Secretary shall promptly publish in
the Federal Register a notice of each authorization, and each
termination or revocation of an authorization under this
section, and an explanation of the reasons therefor (which
may include a summary of data or information that has been
submitted to the Secretary in an application under section
505(i) or section 520(g), even if such summary may indirectly
reveal the existence of such application).
``(2) Confidential information.--Nothing in this section
alters or amends section 1905 of title 18, United States
Code, or section 552(b)(4) of title 5 of such Code.
``(i) Actions Committed to Agency Discretion.--Actions
under the authority of this section by the Secretary, by the
Secretary of Defense, or by the Secretary of Homeland
Security are committed to agency discretion.
``(j) Rules of Construction.--The following applies with
respect to this section:
``(1) Nothing in this section impairs the authority of the
President as Commander in Chief of the Armed Forces of the
United States under article II, section 2 of the United
States Constitution.
``(2) Nothing in this section impairs the authority of the
Secretary of Defense with respect to the Department of
Defense, including the armed forces, under other provisions
of Federal law.
``(3) Nothing in this section (including any exercise of
authority by a manufacturer under subsection (e)(2)) impairs
the authority of the United States to use or manage
quantities of a product that are owned or controlled by the
United States (including quantities in the stockpile
maintained under section 319F-2 of the Public Health Service
Act).
``(k) Relation to Other Provisions.--If a product is the
subject of an authorization under this section, the use of
such product within the scope of the authorization shall not
be considered to constitute a clinical investigation for
purposes of section 505(i), section 520(g), or any other
provision of this Act or section 351 of the Public Health
Service Act.
``(l) Option to Carry Out Authorized Activities.--Nothing
in this section provides the Secretary any authority to
require any person to carry out any activity that becomes
lawful pursuant to an authorization under this section, and
no person is required to inform the Secretary that the person
will not be carrying out such activity, except that a
manufacturer of a sole-source unapproved product authorized
for emergency use shall report to the Secretary within a
reasonable period of time after the issuance by the Secretary
of such authorization if such manufacturer does not intend to
carry out any activity under the authorization. This section
only has legal effect on a person who carries out an activity
for which an authorization under this section is issued. This
section does not modify or affect activities carried out
pursuant to other provisions of this Act or section 351 of
the Public Health Service Act. Nothing in this subsection may
be construed as restricting the Secretary from imposing
conditions on persons who carry out any activity pursuant to
an authorization under this section.''.
(b) Repeal of Termination Provision.--Subsection (d) of
section 1603 of the National Defense Authorization Act for
Fiscal Year 2004 (10 U.S.C. 1107a note) is repealed.
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).
[[Page H5728]]
(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.
SEC. 6. OUTREACH.
The Secretary of Health and Human Services shall develop
outreach measures to ensure to the extent practicable that
diverse institutions, including Historically Black Colleges
and Universities and those serving large proportions of Black
or African Americans, American Indians, Appalachian
Americans, Alaska Natives, Asians, Native Hawaiians, other
Pacific Islanders, Hispanics or Latinos, or other
underrepresented populations, are meaningfully aware of
available research and development grants, contracts,
cooperative agreements, and procurements conducted under
sections 2 and 3 of this Act.
SEC. 7. RECOMMENDATION FOR EXPORT CONTROLS ON CERTAIN
BIOMEDICAL COUNTERMEASURES.
Upon the award of any grant, contract, or cooperative
agreement under section 2 or 3 of this Act for the research,
development, or procurement of a qualified countermeasure or
a security countermeasure (as those terms are defined in this
Act), the Secretary of Health and Human Services shall, in
consultation with the heads of other appropriate Federal
agencies, determine whether the countermeasure involved in
such grant, contract, or cooperative agreement is subject to
existing export-related controls and, if not, may make a
recommendation to the appropriate Federal agency or agencies
that such countermeasure should be included on the list of
controlled items subject to such controls.
SEC. 8. ENSURING COORDINATION, COOPERATION AND THE
ELIMINATION OF UNNECESSARY DUPLICATION IN
PROGRAMS DESIGNED TO PROTECT THE HOMELAND FROM
BIOLOGICAL, CHEMICAL, RADIOLOGICAL, AND NUCLEAR
AGENTS.
(a) Ensuring Coordination of Programs.--The Secretary of
Health and Human Services, the Secretary of Homeland
Security, and the Secretary of Defense shall ensure that the
activities of their respective Departments coordinate,
complement, and do not unnecessarily duplicate programs to
identify potential domestic threats from biological,
chemical, radiological or nuclear agents, detect domestic
incidents involving such agents, analyze such incidents, and
develop necessary countermeasures. The aforementioned
Secretaries shall further ensure that information and
technology possessed by the Departments relevant to these
activities are shared with the other Departments.
(b) Designation of Agency Coordination Officer.--The
Secretary of Health and Human Services, the Secretary of
Homeland Security, and the Secretary of Defense shall each
designate an officer or employee of their respective
Departments who shall coordinate, through regular meetings
and communications, with the other aforementioned Departments
such programs and activities carried out by their
Departments.
SEC. 9. AUTHORITY OF THE SECRETARY OF HEALTH AND HUMAN
SERVICES DURING NATIONAL EMERGENCIES.
Section 1135(b) of the Social Security Act (42 U.S.C.
1320b-5(b)) is amended--
(1) by striking paragraph (3) and inserting the following:
``(3) actions under section 1867 (relating to examination
and treatment for emergency medical conditions and women in
labor) for--
``(A) a transfer of an individual who has not been
stabilized in violation of subsection
[[Page H5729]]
(c) of such section if the transfer is necessitated by the
circumstances of the declared emergency in the emergency area
during the emergency period; or
``(B) the direction or relocation of an individual to
receive medical screening in an alternate location pursuant
to an appropriate State emergency preparedness plan;'';
(2) in paragraph (5), by striking ``and'' at the end;
(3) in paragraph (6), by striking the period and inserting
``; and'';
(4) by inserting after paragraph (6), the following:
``(7) sanctions and penalties that arise from noncompliance
with the following requirements (as promulgated under the
authority of section 264(c) of the Health Insurance
Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2
note)--
``(A) section 164.510 of title 45, Code of Federal
Regulations, relating to--
``(i) requirements to obtain a patient's agreement to speak
with family members or friends; and
``(ii) the requirement to honor a request to opt out of the
facility directory;
``(B) section 164.520 of such title, relating to the
requirement to distribute a notice; or
``(C) section 164.522 of such title, relating to--
``(i) the patient's right to request privacy restrictions;
and
``(ii) the patient's right to request confidential
communications.''; and
(5) by adding at the end the following: ``A waiver or
modification provided for under paragraph (3) or (7) shall
only be in effect if such actions are taken in a manner that
does not discriminate among individuals on the basis of their
source of payment or of their ability to pay, and shall be
limited to a 72-hour period beginning upon implementation of
a hospital disaster protocol. A waiver or modification under
such paragraph (7) shall be withdrawn after such period and
the provider shall comply with the requirements under such
paragraph for any patient still under the care of the
provider.''.
The SPEAKER pro tempore. Pursuant to the order of the House of
Tuesday, July 13, 2004, the gentleman from Texas (Mr. Barton) and the
gentleman from Ohio (Mr. Brown) each will control 30 minutes. The
gentleman from Virginia (Mr. Tom Davis), the gentleman from California
(Mr. Waxman), the gentlewoman from Washington (Ms. Dunn), and the
gentleman from Texas (Mr. Turner) each will control 7\1/2\ minutes.
The Chair recognizes the gentleman from Texas (Mr. Barton).
General Leave
Mr. BARTON of Texas. Mr. Speaker, I ask unanimous consent that all
Members may have 5 legislative days within which to revise and extend
their remarks and include extraneous material on S. 15.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Texas?
There was no objection.
Mr. BARTON of Texas. Mr. Speaker, I yield myself such time as I may
consume.
(Mr. BARTON of Texas asked and was given permission to revise and
extend his remarks, and include extraneous material.)
Mr. BARTON of Texas. Mr. Speaker, the Senate recently joined the
House in passing one of President Bush's top legislative initiatives
for this Congress, Project Bioshield. The House passed a similar bill
in July 2003 by a strong bipartisan vote of 421 to 2. I want to commend
our colleagues in the Senate for working with us after the House passed
its legislation to provide a bill that will be acceptable to both
bodies.
The bill largely reflects H.R. 2122, the bill that passed the House
last year. Revisions in the Senate were made in close consultation with
the House committees of jurisdiction. This is a bicameral and
bipartisan product.
On the House side, I want to thank the gentleman from Louisiana (Mr.
Tauzin), my predecessor as chairman of the committee, who is on the
floor this evening, for his strong leadership; and I would also like to
thank the gentleman from California (Mr. Cox), the gentleman from
Virginia (Mr. Tom Davis), the gentleman from Michigan (Mr. Dingell),
the gentleman from Texas (Mr. Turner), and the gentleman from
California (Mr. Waxman) for their cooperation and hard work on this
bill.
The bipartisan spirit reflected in this legislation is similar to the
effort of the last Congress on the Public Health Security and
Bioterrorism Preparedness and Response Act and also on the Homeland
Security Act. We can be proud of this product, and America can be
confident in our commitment to make the right investments and smart
policy choices to meet the challenges and to protect our Nation's
public health.
Project Bioshield will spur the research and development of new
vaccines, new drugs and other countermeasures to deal with those
biological, chemical, nuclear, or radiological agents that pose a
material threat to our national security. This list includes anthrax,
the plague, ebola and other similar viruses, many of which lack any
effective treatment or antidote today.
The bill provides increased flexibility in a range of areas, from
government contracting rules and peer review to personnel matters, in
order to speed up government-sponsored research and development into
these deadly agents.
It would also authorize a special reserve fund of money, authorized
in advance, for the government's purchase of those countermeasures that
ultimately are developed in response to the President's call. This
latter feature is the most important because, without this clear
commitment of funding in future years, private sector companies that
are capable of such development will not undertake the heavy investment
and risk associated with developing products that deal with agents that
do not affect significant populations today and hopefully never will.
Congress has already provided the advance appropriation of $5.6 billion
over the next 10 years for this purpose, consistent with our
authorization in the House budget resolution.
The bill before us also provides new authority to the Secretary of
Health and Human Services to authorize, in times of emergency, the use
of unapproved products whose benefits in treating or preventing
infection outweigh the risk of using those products. Under current law,
the only way an individual can receive an unapproved product is
pursuant to a clinical investigation. In a time of national emergency,
however, it may be necessary to give such investigational drugs on a
large-scale basis to millions of Americans. The bill before us today
says that if there is such an emergency, if no adequate alternative
therapy is available, then and only then the Secretary can authorize
the use of such a drug, device, or vaccine in a flexible manner.
I applaud the leadership of President Bush and the truly bipartisan
work of both bodies across multiple committees of jurisdiction to
protect our country and to promote public health security from the many
new dangers that we face today.
I would urge my colleagues to support the bill and look forward to
President Bush signing into law another of his major homeland security
initiatives.
At this point in the Record, I will insert an exchange of letters
between the gentleman from California (Mr. Thomas) and myself on this
subject.
House of Representatives,
Committee on Ways and Means
Washington, DC, July 13, 2004.
The Hon. Joe Barton,
Chairman, Committee on Energy and Commerce, 2125 Rayburn
House Office Building, Washington, DC.
Dear Chairman Barton: I am writing concerning S. 15, the
``Project Bioshield Act of 2004,'' which is scheduled for
floor consideration on Wednesday, July 14, 2004.
As you know, the Committee on Ways and Means has
jurisdiction over matters concerning health issues.
Specifically, Section 9 of the bill provides a waiver for
application of Section 1867 of the Social Security Act, known
as the Examination and Treatment for Emergency Medical
Conditions and Women in Labor Act. Section 9 allows hospitals
and other providers to transfer unstable patients during a
declared emergency period or pursuant to a state emergency
preparedness plan by waiving hospital requirements under
Medicare, and thus falls within the jurisdiction of the
Committee on Ways and Means.
However, in order to expedite this legislation for floor
consideration, the Committee will forego action on this bill.
This is being done with the understanding that it does not in
any way prejudice the Committee with respect to exercising
its jurisdictional prerogatives on this or similar
legislation.
I would appreciate your response to this letter, confirming
this understanding with respect to S. 15 and would ask that a
copy of our exchange of letters on this matter be included in
the Congressional Record during floor consideration.
Best regards,
Bill Thomas,
Chairman.
[[Page H5730]]
____
House of Representatives,
Committee on Energy and Commerce,
Washington, DC, July 14, 2004.
Hon. Bill Thomas,
Chairman, Committee on Ways and Means, Longworth House Office
Building, Washington, DC.
Dear Chairman Thomas: Thank you for your letter regarding
S. 15, the `` Project BioShield Act of 2004.'' As you noted,
the bill contains provisions that fall within the Rule X
jurisdiction of the Committee on Ways and Means.
I appreciate your willingness not to seek a referral on S.
15. I agree that your decision to forego action on the bill
will not prejudice the Committee on Ways and Means with
respect to its jurisdictional prerogatives on this or similar
legislation.
I will include a copy of your letter and this response in
the Congressional Record during consideration of S. 15 on the
House floor.
Sincerely,
Joe Barton,
Chairman.
Mr. Speaker, I reserve the balance of my time.
Mr. BROWN of Ohio. Mr. Speaker, I yield myself as much time as I may
consume.
The United States, and the global community, can only benefit from
the development of bioterrorism countermeasures.
By rendering biological attacks less lethal and, therefore, less
attractive to would-be terrorists, new countermeasures serve a dual
purpose. They are both an antidote and a deterrent to future attacks.
For the sake of national and international security, it makes sense
to invest in both basic and advanced research aimed at producing new
bioterrorism countermeasures. When an opportunity to produce one of
these countermeasures presents itself, it makes sense to capitalize on
that opportunity quickly.
That is the logic behind this legislation. It establishes an
expedited process for Federal support of countermeasure research and a
procurement process to encourage private sector investment.
But Project Bioshield is not a blank check. Congress has a
responsibility to weigh competing priorities and set funding levels
appropriately. In that context, Congress cannot rest easy once we have
passed this bill.
Bioterrorism funding is certainly important, the legislation before
us today is certainly important, but our investment in bioterrorism
must not come at the expense of research on cancer and research on
Alzheimer's and muscular dystrophy and AIDS and other significant
health threats.
If investing in Bioshield means diverting from other promising
medical research, TB, multiple sclerosis, all other kinds of medical
research, we are not making progress. We are, in fact, making trade-
offs; trade-offs that set back the clock on cures for deadly and
disabling diseases; trade-offs the public did not bargain for and
should not abide.
The last thing Congress or the President should do is assure the
public that we are doing everything we can more than ever to find cures
for major illnesses like cancer and Parkinson's when actually we are
choking off funding for medical research.
During his 2000 election campaign, President Bush said, ``As
President, I will fund and lead a medical moonshot to reach far beyond
what seems possible today.'' Apparently it was a short trip.
According to a White House budget memo recently leaked to the press,
if President Bush wins the election this fall, one of his first actions
will be to propose a $587 million cut in funding for the National
Institutes of Health.
Medical researchers tell us that just to sustain the pace of medical
progress that NIH has fostered, the agency's budget must increase 10
percent annually, something I hope everyone here would agree with, even
though the President does not. Compared to annual, double-digit
increases in the NIH budget, a cut in funding is a major step backward
that would undermine promising medical research.
Finding ways to prevent, to treat, and to cure disease is an enduring
national priority. Interest in that should not wax and wane. That is
why we do not double NIH funding, which we did bipartisanly between
1999 under President Clinton, into 2003 still supported by President
Bush, but then reduced that increase and then proposed a cut in
funding. Our investment must remain constant.
We have a responsibility to prepare the country for a possible
bioterrorist attack, but we also have a responsibility to maintain
strong support for other medical research priorities.
I urge my colleagues to support this legislation. In creating Project
Bioshield, it gives America a promising weapon in the battle against
terrorism.
But bioterrorism, as I have said, is just one enemy in a much broader
war against disease and disability. If we fund Project Bioshield, as we
should, at the expense of life-saving and life-improving NIH research,
we risk winning the battle and losing the war.
Mr. Speaker, I reserve the balance of my time.
Mr. BARTON of Texas. Mr. Speaker, I yield such time as he may consume
to the gentleman from Louisiana (Mr. Tauzin), the distinguished former
chairman of the Committee on Energy and Commerce, who in a very true
sense is a principal author of this piece of legislation and who has
toiled tirelessly for the last several years to have it passed.
{time} 1730
Mr. TAUZIN. Mr. Speaker, I thank the gentleman for yielding me this
time; and, on a very bipartisan note, let me first thank the Members of
this House and of the Senate, and particularly my friend from
Massachusetts, Mr. Kennedy, for the great success we had in passing the
Public Health Security Act and the Bioterrorism Preparedness and
Response Act.
As my colleagues will recall, right after 9-11 it became clear to us
as a Nation that we were under serious threat of attacks from agents
like anthrax or perhaps even such horrible agents as botulism toxin or
ebola or other similar viruses and that we were so unprepared in this
country for that kind of attack that we got together, in a bipartisan
fashion, and immediately passed an act to bolster the competence and
the ability of the Center for Disease Control and of agents across the
country to better respond to an attack of that nature.
Since the passage of those two very important actions that have
better armed our country for this danger that we face perhaps even more
increasingly as years go by, it has come to our attention that there
were some holes even in that great act. The most important hole which
this act seeks to fill is the concern we have that when it comes to
some of these agents, whether they be a botulism toxin agent, ebola, or
whether it is a radioactive type of attack we have to deal with in this
country, that we have not done enough research and development into the
antidotes, the vaccines, the treatments that victims of these attacks
might find are critically necessary to save lives and prevent injury.
I do not have to tell my colleagues that this House and the Senate
recently received another briefing on national security threats. The
concern levels are up about an attack that might occur in this country
from al Qaeda or other enemies of this country. As we fight them
overseas, they are thinking about planning an attack on us here at home
again. We know that. We know the attack may come in a place we do not
know, in a place we are unprepared for, and it might involve
radiological materials or it might involve some horrible virus or some
agent the likes of which we are unprepared to deal with.
This bill seeks to make sure that the private sector does the work
along with government to find the antidotes, the treatment for these
kinds of agents that might be used in such an attack which might not
otherwise be developed in the private sector.
What is the incentive today to develop a vaccine for ebola or for the
plague when there is no real market for such a vaccine in this country?
This bill and the appropriations we have already provided in the
advance funds, some $5.6 billion, is designed to make sure that that
research and development occurs and that those vaccines and those
treatments are indeed available to our country in case the worst
happens and we are subject to that kind of an attack by al Qaeda or
other enemies of this country within our borders as we saw on 9-11.
Secondly, the bill tries to do something else, and that is to say we
are going to change our law a little bit when it comes to the
government's approval of treatment and/or it might be
[[Page H5731]]
a vaccine or some treatment that has not yet been approved by the Food
and Drug Administration but yet has a greater ability to cure and help
people than the risk involved with allowing it to be used. In other
words, we are streamlining the law to make sure, if we do come under
attack, if there is some vaccine, some treatment under study that has a
lot of promise but has not yet been approved, that we are not forbidden
to use it to help people who might be hurt or in need of that kind of
treatment.
In short, this Bioshield Act, an incredibly important new step in
protecting our country at a time when we are increasingly learning of
the hatred and evil that exists out there that wants to inflict more
damage on our country, this new act, passed again in, I hope, a very
strong bipartisan way, reaching the President's desk for his signature
very soon, I hope, will add this new element of protection for our
country that Senator Kennedy and I tried to provide in the first
bioterrorism act for our Nation following 9-11.
This is an important step in protecting our country at a time when we
are under, as you know, this increasing warning that these evil
individuals are thinking about planning and trying to figure out how
they might hurt us again. It is a critical two-step process in making
sure that we have the protective vaccines and treatments in place when
the worst might happen to our people. So I urge its adoption.
I want to congratulate all of those who have worked on completing the
conference on this bill with the Senate. I want to thank the other body
for its cooperation. The sooner this reaches the President's desk, the
sooner all of us can feel a little better this country is becoming
safer as fast as we can from the threat of these kind of agents, and I
urge its final approval by this House.
The SPEAKER pro tempore (Mr. Foley). The gentlewoman from New York
(Mrs. Maloney) is recognized on behalf of the Committee on Government
Reform.
Mrs. MALONEY. Mr. Speaker, I do claim the time on behalf of the
Committee on Government Reform, and I yield myself such time as I may
consume.
Mr. Speaker, we have before us today S. 15, the Project Bioshield
Act. This bill is substantially the same as H.R. 2122, which passed
this House on July 16 of last year by a vote of 421 to 2. This bill is,
in essence, the conference report on the bill and includes some minor
improvements made by the Senate. I urge Members to support this measure
as well.
Given the serious threat of bioterrorism, the development of
effective countermeasures to biological agents is vital to our national
security. The goal of Project Bioshield is to encourage the development
of these projects. I fully support the intent of this legislation. I
also agree with its premise, that when the market cannot foster the
development of critical products by itself, the government must rise to
the challenge.
The bill before us today includes several significant improvements
from earlier proposals. For example, it includes important protections
against waste and abuse that are standard for government contracts,
such as preserving the government's right to review contractors' books
and records.
The bill also permits the use of certain streamlined procurement
procedures, but only if the Secretary of Health and Human Services
determines that there is a pressing need to do so.
The Senate bill appropriately strengthens some of these provisions
and also allows for recovery by the government in the event of grossly
negligent or reckless conduct on the part of a contractor.
In emergency situations, we should not impede the development of
necessary products. However, any exceptions from standard procurement
procedures should be made only when necessary and should be subject to
review. This proposal preserves that important standard.
The provisions of Bioshield authorizing the emergency distribution of
unapproved drugs and devices, whose risks and benefits are not fully
tested, impose an unprecedented responsibility on the government. FDA
must be vigilant in protecting the public against unnecessary risks
from these products. In part because of these concerns, the bill
requires that health care providers and patients be informed that the
products have not been approved and be informed of their risks.
The bill also requires that manufacturers monitor and report adverse
reactions to the products and keep other appropriate records about the
use of the products. These conditions are essential for the safe use of
unapproved products, and they should be imposed in all cases except in
truly extraordinary circumstances.
In addition, the HHS secretary is authorized to limit the
distribution of the products, to limit who may administer the products,
to waive good manufacturing practice requirements only when absolutely
necessary, and to require recordkeeping by others in the chain of
distribution. We expect the Secretary to consider the needs for these
additional conditions in each case and to impose them to the full
extent necessary to protect the public from the risk of these products.
The bill before us today is an improvement over the original proposal
and represents a bipartisan consensus of the House and the Senate and
the White House. It deserves our support.
Mr. Speaker, I ask unanimous consent to yield the balance of my time
to the gentleman from Texas (Mr. Turner) as the ranking minority member
of the Select Committee on Homeland Security and that he be allowed to
control that time.
The SPEAKER pro tempore. Without objection, the Chair will recognize
the gentleman from Texas (Mr. Turner) for the time remaining to the
representative from the Committee on Government Reform.
There was no objection.
Mr. BROWN of Ohio. Mr. Speaker, I also ask unanimous consent to yield
the remainder of my time to the ranking member of the Select Committee
on Homeland Security, the gentleman from Texas (Mr. Turner), and that
he be allowed to control that time.
The SPEAKER pro tempore. Without objection, the Chair will recognize
the gentleman from Texas (Mr. Turner) for the balance of the time
allocated to the minority on the Committee on Energy and Commerce.
There was no objection.
Mr. BARTON of Texas. Mr. Speaker, could I inquire as to how much time
remains that I am controlling?
The SPEAKER pro tempore. The gentleman from Texas (Mr. Barton) has 20
minutes, and the gentleman from Texas (Mr. Turner), for the minority,
has 37 minutes.
Mr. BARTON of Texas. Mr. Speaker, I yield 2 minutes to the
distinguished gentleman from Michigan (Mr. Rogers), a member of the
committee.
Mr. ROGERS of Michigan. Mr. Speaker, I thank the gentleman for
yielding me this time; and I want to also thank Members on both sides
of the aisle on this very, very important issue.
This legislation will greatly strengthen our Nation's capability to
protect our military, first responders, and U.S. citizens from the real
threat of biological, chemical, radiological, and nuclear weapons of
mass destruction.
I am very pleased that this expands the definition of eligible
countermeasures and would permit funding and procurement for certain
FDA-licensed vaccines as well as experimental products for inclusion in
the Strategic National Stockpile. I cannot say how important that is.
We find heroes and patriots both abroad and at home risking their
lives in defense of freedom in this war on terror, but there are
patriots and unsung heroes in my community who, under withering
criticism, toiled to make their product better and get it into the
hands of those who needed it most. Thanks to the employees of Bioport
in Lansing, Michigan, since 1998, more than 1.1 million military and
civilian personnel have been safely vaccinated with more than 4 million
doses of the vaccine, including both pre- and post-exposure
vaccinations of many of our own congressional colleagues and staff
members after the October, 2001, anthrax attacks.
These existing products, like BioThrax vaccine, will provide our
Nation with the insurance policy to strengthen its immediate
bioterrorism preparedness capability in conjunction with working on new
experimental vaccines.
[[Page H5732]]
Mr. Speaker, I would even go further and urge the Departments of
Homeland Security and Health and Human Services to consider the
immediate procurement of millions of additional doses of the FDA-
licensed anthrax vaccines, as well as additional doses of antibiotics
for the Strategic National Stockpile. These doses are essential to
improving our capability and responding to another potential anthrax
attack.
I want to again thank the President of the United States for making
this a priority and sending a very clear and strong message that our
Nation is serious about protecting the citizens and first responders
from deadly terrorist threats with proven countermeasures.
The SPEAKER pro tempore. The Chair will clarify the time allotments.
The gentleman from Texas (Mr. Barton) has 18 minutes remaining, and
the gentleman from Texas (Mr. Turner) has 37 minutes. We also have a
15-minute allocation to the majority, 7\1/2\ minutes to the gentlewoman
from Washington (Ms. Dunn) on the Select Committee on Homeland
Security, and 7\1/2\ minutes to the gentleman from Virginia (Mr. Tom
Davis), chairman of the Committee on Government Reform.
Mr. TURNER of Texas. Mr. Speaker, I yield myself such time as I may
consume.
I think we all understand that to win the war on terror we have to be
much more aggressive about going after the terrorists wherever they
are. Breaking up international terrorist cells is project number one
for the national defense of this country.
We also know that we have to strengthen our homeland defenses and
protect our vulnerabilities and protect our population from threats
posed by challenges as the one addressed in this bill today,
bioterrorism.
Finally, I hope we will soon learn that in order to win the war on
terror we have to start addressing the policies that we need to pursue
to prevent the rise of future terrorists so that someday we can stand
on this floor and announce, as we did at the end of the Cold War, that
we have won, that we have prevailed.
{time} 1745
To win this war on terror, we must address the threat that is
addressed by Project Bioshield, the threat of mass destruction through
the use of bioweapons. Perhaps the most devastating weapon is a
bioweapon of mass destruction. The anthrax attacks of 2001 woke this
Nation up to the very real threat of bioterrorism. We know that al
Qaeda intends to engage in bioterrorism, and we know that Osama bin
Laden has called for the use of weapons of mass destruction against the
American public. In fact, he has called it a religious duty.
In spite of this dire and clear warning, our biodefenses are no
better than they were in September of 2001. No new medical treatments,
vaccines, or lifesaving drugs have been approved for use. There is no
antitoxin for ricin poisoning, no vaccine to protect against the
plague, and no treatments of any kind against the deadly ebola virus.
Mr. Speaker, we must regain the sense of urgency that we all felt in
this Chamber in the aftermath of September 11, and I hope that the
passage of this bill will mark a renewed sense of urgency regarding the
bioterror threat. Because this bill marks but the beginning, not the
end, of a long road we must travel, I hope that the passage of this
legislation will renew our urgency about the threat of bioterrorism. I
support the Bioshield legislation because it is a good first step to
addressing the challenge.
From the beginning of this process, I and many of my colleagues on
the Democratic side have been concerned that this legislation is not
enough to address the threats that we face. Whether Bioshield will be a
success is yet to be determined. Bioshield is, in fact, an experiment.
We do not know if the incentives in this bill will drive our
pharmaceutical industry to develop medicines for biodefense when we all
know they can make much more money developing and putting on the market
other types of products. Many experts in the field believe that the
best we can hope for is that in 10 years we may have a few new
countermeasures that will plug some of the holes in our biodefenses.
The longer it takes for companies to step forward to fill these gaps,
the longer we will remain vulnerable. Our terrorist enemies will not
wait while we experiment and our national security is at stake. We must
protect our population. That is our responsibility. If the private
sector does not step up to address and accept the challenge presented
in this bill, then our government needs to have the authority to do the
job itself directly.
One example of a capability that we clearly need and that Project
Bioshield does not address is the ability to respond rapidly to a
previously unknown or engineered pathogen. Terrorists may soon be able
to genetically manipulate biological agents so they are resistant to
our current stockpile of countermeasures and perhaps to those we
develop in the future. That is why I, along with 35 of my Democratic
colleagues, introduced H.R. 4258, the Rapid Cures Act. This legislation
recognizes the fact that the growing power of biotechnology can render
a pathogen like anthrax or smallpox immune to the vaccines and drugs we
may develop through Project Bioshield. We need to develop the mechanism
to go from bug to drug, that is from the identification of a pathogen
to the development of a countermeasure to combat it in a matter of a
few months or even weeks.
Today the average development period for a vaccine is 8 years. That
is too long to address the threat that our terrorist enemies of the
future may present us. Personally, I cannot think of another research
goal that would bring more benefits to the security and the health of
this Nation than shortening the period of drug and vaccine development.
It is that kind of capability that we need legislation to bring about
today.
Finally, it is incumbent on this Congress to exercise vigorous
oversight in the implementation of this law and to ensure that the
investment in resources which could be as much as $6 billion over 10
years produces the results that we intend. We have had biodefense
failures before. The national smallpox vaccine program which was
announced by the President with much fanfare at the end of 2002 has
fallen far short of its goal of vaccinating 500,000 health care workers
with, in fact, less than 10 percent of that number actually vaccinated
today.
Forty percent of our States report that they are unable to vaccinate
their populations within 10 days, that critical period, 10 days of an
outbreak of smallpox. As soon as next month, we are likely to hear of
the award of the first-ever Bioshield contract for 75 million doses of
new anthrax vaccine. We need to be asking now before the ink dries on
this multimillion-dollar contract, what is the plan? How does this
vaccine fit into our biodefenses? Given the failure of our smallpox
vaccine program, do we really expect our citizens to be any more
receptive to the anthrax vaccine than they were to the smallpox
vaccine? And if the old anthrax vaccine, as some have told us, is now
safe and effective for our troops, why in fact do we need a new one?
And if as is the case and we already have a vaccine but we lack good
treatments for an anthrax infection, perhaps we need to be investing in
the treatment for those who may contract anthrax and need a drug to
cure that dread condition. And if anthrax is not a contagious disease
and we know it is not and if this vaccine will only work after three
injections over 3 weeks, as I understand the proposed new anthrax
vaccine requires, how will that protect us in the event of an actual
anthrax attack?
So before the Secretary of Homeland Security and the Secretary of
Health and Human Services decide to spend a billion dollars on a new
vaccine, we in this Congress have a responsibility to get the answers
to those questions.
For this Nation, Project Bioshield is an important first step, but
much more work remains to be done, and we must take even stronger steps
as soon as possible to protect us and to secure us in the days ahead.
Mr. Speaker, I reserve the balance of my time.
Mr. BARTON of Texas. Mr. Speaker, I yield 3 minutes to the gentleman
from Arizona (Mr. Shadegg), the distinguished whip of the Committee on
Energy and Commerce.
Mr. SHADEGG. Mr. Speaker, I thank the gentleman for yielding me this
[[Page H5733]]
time. I rise in strong support of the Project Bioshield Act. Is the act
perfect? Does it solve all problems in this area? No. But I do not
think we will hear anyone take to the floor and say that this is not a
bicameral, bipartisan proposal to address a serious threat to this
Nation.
I want to thank the chairman of the Committee on Energy and Commerce
and the previous chairman, the gentleman from Louisiana (Mr. Tauzin),
both of whom have worked very hard on this legislation, as well as the
chairman of the Select Committee on Homeland Security in bringing this
initiative forward and moving it as rapidly as possible through the
United States Congress. I also want to thank President Bush for putting
this initiative on our agenda.
Thirty years ago, perhaps 20 years ago, we had never even heard of
biotechnology or genomics; but today, along with our country's
unparalleled leadership in semiconductors and computing power, we are
making breathtaking breakthroughs in the field of bioscience. And as my
colleague from Texas just outlined, there is much more that can be
done. This legislation goes at a serious vulnerability for our Nation.
As has been referred to in this debate, we are aware by the briefings
we get and by the press we read that we face a threat from al Qaeda and
others who would seek to use these agents against us, chemical,
biological, radiological, and even nuclear, weapons. They would like to
use dangerous agents like anthrax, botulinum toxin, the plague, ebola
and other similar viruses, as have just been noted, even some we are
not even aware of. And of course as was well explained by my colleague,
the former chairman of the Committee on Energy and Commerce, the
gentleman from Louisiana, in the absence of this legislation, it is
very clear that there is no incentive for anyone, not the government,
not the private sector, not anyone, to develop and do the research to
develop the countermeasures we need for these serious threats to the
American people.
This is critically important first-step legislation. It not only will
encourage the research but it also encourages the development of those
countermeasures and the stockpiling of them so that they are readily
available. The American people expect that of us and both committees in
both bodies have worked hard on this kind of legislation.
I want to point out that I chair the Subcommittee on Emergency
Preparedness and Response of the Select Committee on Homeland Security
as well as serving on the Committee on Energy and Commerce; and I
chaired hearings on the House parallel to this legislation, H.R. 2122.
In those hearings we discovered a fact that has not been mentioned in
this debate, and that is that the mere development of these
countermeasures for such a biological attack will deter the attack.
Think of that point. The reality is if al Qaeda knows that we are
unprepared for a chemical, a biological or a radiological attack, then
they are incentivized to make that kind of attack. On the other hand if
they know that we have invested the money and done the research and we
have developed countermeasures so that a biological attack or an
anthrax attack, an attack of ebola or of the plague is something we are
prepared for, then they are discouraged to even make that kind of
attack.
The American people expect us to do everything humanly possible to
prepare for the event of an attack; but even more importantly they want
us to deter any attacks. They want us to protect the American people
from an attack. This legislation, Project Bioshield, by not only
encouraging the research of these antitoxins but also encouraging their
development and their stockpiling will indeed deter such attacks.
I strongly urge my colleagues to support this legislation.
Mr. TURNER of Texas. Mr. Speaker, I yield 5 minutes to the
distinguished gentleman from New Jersey (Mr. Andrews), who has spent a
great deal of time and energy working on this important issue.
(Mr. ANDREWS asked and was given permission to revise and extend his
remarks.)
Mr. ANDREWS. Mr. Speaker, I thank my friend from Texas for his
leadership and hard work on this bill. I congratulate him, the
gentleman from Ohio (Mr. Brown), the gentleman from Michigan (Mr.
Dingell), the gentlewoman from New York (Mrs. Maloney), the gentleman
from Texas (Mr. Barton), the gentleman from Louisiana (Mr. Tauzin), the
gentleman from California (Mr. Cox), and all those responsible for the
passage of this very important bill.
One of the most frustrating failures of local government is when
there is a traffic fatality at an intersection and the residents of the
community say, for years we have been warning that there was going to
be a fatality at this intersection. How come you did not put a traffic
light or a stop sign up before? Why did it take a fatality to get
government to pay attention?
This is a massive and serious equivalent at the national level of
whether we should prevent the traffic accident by putting up the signal
ahead of time. Although this bill is not perfect, it recognizes an
issue that is not much talked about today but is very much looming on
the horizon as a potential catastrophe for the country. As the
gentleman from Texas said very eloquently just a few minutes ago,
perhaps the most ominous and destructive terrorist attack that could
occur on this country would be a terrorist attack using a biological
weapon. Unlike chemical weapons, unlike radiological weapons, even
unlike nuclear weapons, the threat of a bioweapon is not localized
because very often a bioweapon uses as its carrier a human being. So
the spread of a bioweapon attack will not be limited to a discrete
local area. It will likely be spread throughout the country and
throughout the world. This makes it even more urgent that antidotes
that could cure those exposed to the attack or prevent people from
being sickened or killed by the attack, that these antidotes be
developed as rapidly as possible.
I am particularly pleased that the committees involved worked with us
to include in this bill language that will protect the interests of
companies that begin the process of developing an antidote and then
have their contract terminated for convenience because a better idea
comes along from another vendor. It is a very important provision that
will permit these investors in research to recover the funds that they
put into the contract.
Let me express three concerns about the bill, and I hope that we
return once this is made law to improve these areas. One is what the
gentleman from Texas talks about, particularly with respect to mutant
or new strains of bioweapons that would not be handled by the antidotes
developed under this bill. We need a much more rapid and focused effort
to deal with those mutant or new strains.
Second, I am very concerned that the liability provisions in this
bill are not sufficiently protective of the companies that would step
forward to address the need to create these Bioshield defenses. I am
not at all convinced that the immunity is broad enough or dependable
enough. Time will tell.
{time} 1800
If the immunity is not broad or dependable enough, we are going to
have to revisit that issue.
Finally, I am concerned, to the extent that funding under this bill
is discretionary and not mandatory, the financial rewards that are
necessary to induce a company to step forward and participate in this
process may not be certain enough. An investor is not going to take a
risk unless there is a guaranteed return. I think this bill takes a
step in the right direction, but I am concerned it does not go far
enough.
I wholeheartedly support this bill. I am honored to have been a part
of writing and pursuing the bill. I hope that the products produced as
a result of this bill are never used. That would be the real measure of
success. But, God forbid, if the day comes when they need to be used,
let us be prepared. Let us not look upon ourselves and say, why did we
not take action in the peaceful days before the attack when we had a
chance to do so?
This legislation is long overdue. I enthusiastically support it. I
would ask colleagues on both the Republican and Democratic side to vote
``yes.''
Mr. BARTON of Texas. Mr. Speaker, I yield 3 minutes to the
distinguished gentlewoman from Florida (Ms. Ginny Brown-Waite), a
former president pro
[[Page H5734]]
tempore with the Florida Senate who chaired the Homeland Security
Select Committee in the Florida Senate.
Ms. GINNY BROWN-WAITE of Florida. Mr. Speaker, I rise today in
support of this legislation and certainly to congratulate both the
former and current chairmen of the Committee on Energy and Commerce for
their perseverance in bringing this bill to fruition today.
Since the attacks of 9-11, America has been under siege. We are
fighting a war against terror and must not waver in our commitment to
combating this evil. This war knows no set battleground, and the
terrorists' arsenal of weapons is limitless. From using a cell phone as
a bomb detonator to contemplating a crop-duster, as we found in
Florida, as a vessel of pestilence, these thugs have proven both their
resourcefulness and also their boldness and audacity.
For this reason, America must be prepared and must do everything in
its power to protect its citizens. This legislation does exactly that.
Among other things, the bill gives the Secretary of HHS the authority
to conduct research and development for new vaccines that will offer
protection from the possible chemical and biological agents that these
arrogant fanatics conspire to exploit. Congress will provide the
advance appropriation of $5.6 billion over the next 10 years to
purchase these vital countermeasures.
S. 15 adds to America's security and offers us the piece of mind in
knowing that if terror strikes America will be ready and we will be a
whole lot safer. The tragedies of 9-11 taught us that we must do much
more to protect our Nation and that the unrest around the world can
have a disastrous impact on us here at home. Terrorism knows no
boundaries, and neither should our efforts to prevent it.
This is a well-thought-out bill, and I encourage my colleagues on
both sides of the aisle to support this proposal this evening.
Mr. TURNER of Texas. Mr. Speaker, I yield 6 minutes to the
distinguished gentlewoman from Texas (Ms. Jackson-Lee), who has worked
very hard in the area of trying to improve our bioterror defenses.
(Ms. JACKSON-LEE of Texas asked and was given permission to revise
and extend her remarks.)
Ms. JACKSON-LEE of Texas. Mr. Speaker, I thank my friend and
colleague from Texas for yielding me this time. I listened to him as he
was outlining some of the positives and, of course, some of the
challenges that we still have before us. We cannot thank him enough for
the studious and deliberate approach that he has taken to protecting
the homeland.
It is important to note as well, since there are two Texans on the
floor, now three, that this is a bipartisan bill; and we thank the
distinguished chairman and the number of other Members who have worked
so hard on this legislation. So my remarks should not be taken out of
context to the extent that I disregard the hard work and the very
valuable aspects of this legislation.
Frankly, I think, in order to make it more understandable, it is
simply the government doing what it should do. It is the big umbrella.
It is the responsibility of this government to secure the homeland. And
when the private sector has not yet reached the point when it can move
with all due and deliberate speed and even faster, it is imperative
that we, the government, move in to protect the American people.
But there lies, I believe, the core of my criticism or my critique,
because I am concerned that the American people do not believe that
they are more safe today than they were 4 years ago or more safe today
in light of the horrific tragedy of 9-11. I think we should be very
frank about questions being asked that if there was a tragedy, whether
it would be by some form of nuclear reaction or activity or whether it
would be bioterrorism or whether it be acts of terrorists, the question
is who is in charge? All of these elements that we are now discussing,
in this instance, bioterrorism, all need to relate to an orderly focus
on securing the homeland; and I believe it is extremely important that
we find ourselves organizing this whole effort of the war against
terrorism in a methodical way.
We are very delighted that a number of us Democrats are putting
forward a number of initiatives that deal step by step with securing
the homeland in an orderly fashion. I believe the bioterrorism in the
Project Bioshield Act of 2004 is a positive first step. It is important
to note that even as recently as April we were faced with challenges
dealing with the question of bioterrorism.
I am reminded of a couple of days after 9-11 when I gathered a number
of our first responders from all over the county in a meeting held by
my congressional district. In the midst of that meeting, just 3 days
after 9-11, a number of my firefighters had to immediately leave in an
emergency as some white powder was discovered at a major hospital in my
community. We have not had a series of these lately, but they are
occurring on a rapid basis or regularly, even though we do not see them
in the news.
As recently as April 22 of this year in Tacoma, Washington, we had a
bioterrorism scare. A white powder was found in two envelopes, and 94
people had been evacuated from a mail distribution facility. Initial
tests of the powder tested positive for biotoxins that cause bubonic
plague or botulism. Four people at the facility had to be
decontaminated.
The same day, a suspicious powder was found in a Federal Express
cargo area at Southwest Florida International Airport in Fort Myers,
Florida. Six people were taken to a hospital for possible
decontamination, including one who suffered burning eyes and nose.
We are presently faced with the threat of a worldwide SARS outbreak.
The inability of many foreign countries to adequately deal with that
outbreak raises questions about our own preparedness.
What about other infectious diseases like tuberculosis? There are
many ailments that our medical professionals are struggling to control,
and we must do better in the area of biological weapons.
Might I say also that we are confronting and fighting the devastation
of HIV/AIDS. We have found in this country that sometimes the infected
person has used it in a criminal manner. Who is to say that it could
not also be engaged in some act of bioterrorism?
So I do support the Project Bioshield Act of 2004. But, frankly, I
believe that one of the things that we should get out of these
legislative initiatives is to find an orderly way of putting all of
these ways of protecting the homeland in a way that we know who is in
charge, why they are in charge, and how they can intermesh with
protecting the homeland. I will raise that question over and over
again.
Might I also acknowledge that, as we put forward Project Bioshield
that will take now some $5.6 billion, we should not forget, as our
friends and colleagues on the Committee on Energy and Commerce have
noted, the other preventable diseases or other contagious diseases and
the other work of NIH so that we are assured that we are protecting the
homeland in many ways. We must seek to balance the fear of the American
people with the health needs of the American people. Again, we must
have an orderly process of protection.
Let me make note of an amendment that I offered and added to this,
because I am always concerned that protecting the homeland reaches the
neighborhoods, reaches the families, the schools. In fact, I am a
supporter of finding safe places in communities such as public
buildings like schools and fire stations. But, Mr. Speaker, we added to
this legislation that the Secretary of Health and Human Services reach
out to Historically Black Colleges and Universities, those serving
Black or African Americans, American Indians, Appalachian Americans,
Alaska Natives, Asians, Native Hawaiians, other Pacific Islanders,
Hispanics or Latinos, in order to reach out to provide resources for
those institutions to be utilized in available research and development
grants, contracts, cooperative agreements, and procurements under this
particular legislation. If we secure the homeland, we must secure the
rural homeland, the urban homeland, and all segments of our population.
We must secure the neighborhoods.
So I support this legislation, but I also believe that we still have
work undone to complete our task of assuring the American people that
the homeland is securely secure.
[[Page H5735]]
Mr. Speaker, I rise today in support of S. 15, the ``Project
Bioshield Act of 2004.'' I supported the predecessor of this bill, H.R.
2122 as it passed previously. This is important legislation because it
takes America one-step closer to being prepared to deal with a
biochemical terrorist attack. As we consider this legislation, Mr.
Speaker, America is still not safe. We remain vulnerable. Our ports are
not secure. Our critical infrastructure is not secure. our communities
are not protected from biochemical agents. S. 15, will help to make
America safer.
The purpose of the Project BioShield Act of 2004 is to ``enhance the
research, development, procurement, and use of biomedical
countermeasures to respond to public health threats affecting national
security, and for other purposes.'' The stated purpose of H.R. 2122 and
now of S. 15 are noble given the danger posed by biochemical weapons.
The threat of bioterrorism is substantial, and protecting America
from biochemical agents and terrorist attacks must be one of our chief
concerns as we continue our work of protecting our homelands.
Biological weapons pose a particularly dangerous threat. Biological
weapons are highly portable and difficult to detect.
Bioterrorism attacks not only pose a danger to human lives, they also
have the ability to cripple the operation of our society and severely
harm our economy. We all recall the primary and secondary impact of the
anthrax attacks in 2001. The attacks involved a series of letters
mailed in prestamped envelopes to media outlets in Florida and New York
and to the offices of Senators Thomas Daschle and Patrick J. Leahy (D-
Vt.). The anthrax attacks killed 5 Americans and left 13 others
severely ill. The five people who died from inhalation anthrax included
two postal workers at the Brentwood postal facility in Washington, a
Florida photojournalist, a New York hospital worker, and a 94-year-old
woman in Connecticut. Thousands more were exposed to the lethal
bacteria. The letters passed through various post offices and postal
distribution centers along the east coast leaving a trail of
contamination. Buildings from the Brentwood mail facility, to the
congressional office buildings, to NBC headquarters had to cease
operations.
The threat of bioterrorism did not end in September 2001. As recently
as April 22 of this year in Tacoma, WA, we had a bioterrorism scare. A
white powder was found in two envelopes, and 94 people had to be
evacuated from a mail distribution facility. Initial tests of the
powder tested positive for biotoxins that cause bubonic plague or
botulism. Four people at the facility had to be decontaminated. The
same day, a suspicious powder was found in a Federal Express cargo area
at Southwest Florida International Airport, in Fort Myers, FL. Six
people were taken to a hospital for possible decontamination, including
one who suffered burning eyes and nose.
We are presently faced with the threat of a worldwide SARS outbreak.
The inability of many foreign countries to adequately deal with that
outbreak raises questions about our own preparedness. What about other
infectious disease like tuberculosis? There are many ailments that our
medical professionals are struggling to control. We must do better in
the area of biological weapons.
The ease with which biological weapons can be manufactured is also a
danger. The equipment and ingredients needed to manufacture many
biological agents can be purchased over the Internet. Additionally, as
our failure to apprehend those responsible for the 2001 anthrax attacks
illustrates, biological terrorists can operate with more secrecy than
traditional terrorists.
Positive strides have been made in the various biochemical fields. We
have improved our ability to secure our borders and prevent deadly
materials from entering our country. However, it is unrealistic to
expect no biological weapons to enter the United States. Last year
alone 30 million tons of cocaine was smuggled into the United States.
If we can't stop 30 million tons of cocaine from crossing our borders,
how can we expect to stop a vile filled with anthrax, botulism, or
small pox? A vile that could kill hundreds or possibly thousands.
To adequately protect our homeland from bioterrorist attacks we must
address these and many other concerns in the Project Bioshield bill.
The provisions of Project Bioshield provide a good start to protecting
Americans from a bioterrorist attack but work remains. Presently
Project Bioshield's provisions grant the National Institute of Health
new powers, through grants and contract awards, to speed effective
research and development efforts on bioterrorism countermeasures.
Project Bioshield also creates a long-term funding mechanism for the
development of medical counter measures, and empowers the government to
purchase safe and effective vaccines. Finally, Project Bioshield
authorizes the Food and Drug Administration to use promising, yet
uncertified, biological treatments in the case of emergencies.
The research, development, and procurement provisions of the Project
Bioshield bill are instrumental to the development of countermeasures
for protecting our communities. The development of effective vaccines
will mean the difference between life and death. There needs to be
research and development participation from diverse institutions
nationwide, so that the expertise of as many biological and chemical
industry leaders can be utilized. During markup of the House version of
this legislation, H.R. 2212 in the Select Committee on Homeland
Security, I negotiated the inclusion of language to ensure that
Historically Black Colleges and Universities, and institutions serving
large populations of Native Americans, Hispanic Americans, and Asian
Pacific Americans are meaningfully aware of research and development
grants. Provisions such as this not only include diverse scientists in
the research and development process, they facilitate dispersal of
information to all communities. I am very pleased to see the retention
of this provision as ``Section 6, Outreach'' in the bill before us
today, and I wholeheartedly support its passage.
Protecting our communities is the most challenging and most important
responsibility of the Federal Department of Homeland Security, the
House and Senate Select Committees on Homeland Security, and all
members of this Congress. An ongoing failure of all agencies
responsible for homeland security is our inability to equip our local
communities with the funds and supplies needed to counter a terrorist
attack now. During recent on-site reviews in Colorado and California, I
spoke with first responders and individuals responsible for securing
our ports. I also organized a briefing with testimony on the issue of
homeland security in Houston, TX, in April. During each of these
events, America's first responders echoed the same sentiment: They lack
the funding and equipment to deal with a terrorist attack.
The Project Bioshield bill is an opportunity to correct this
continuing failure. It is insufficient to simply research and develop
bioterrorism countermeasures. We must also get those countermeasures
into the hands of the health professionals and other first responders
responsible for administering vaccines to the victims of bioterror
attacks. We must not delay. First responders need these supplies
immediately.
Mr. Speaker, I believe the provisions of S. 15, the Project Bioshield
bill, are good first steps in protecting Americans from biological
attacks. However, I feel that our country is still not safe and that
many protections need to be established to fully protect our
communities from biochemical attacks.
SEC. 6. OUTREACH.
The Secretary of Health and Human Services shall develop
outreach measures to ensure to the extent practicable that
diverse institutions, including Historically Black Colleges
and Universities and those serving large proportions of Black
or African Americans, American Indians, Appalachian
Americans, Alaska Natives, Asians, Native Hawaiians, other
Pacific Islanders, Hispanics or Latinos, or other
underrepresented populations, are meaningfully aware of
available research and development grants, contracts,
cooperative agreements, and procurements conducted under
section 2 and 3 of this Act.
Mr. BARTON of Texas. Mr. Speaker, I yield such time as he may consume
to the gentleman from California (Mr. Cox), the distinguished chairman
of the Select Committee on Homeland Security.
Mr. COX. Mr. Speaker, I thank the chairman for yielding me this time.
This has been an extraordinary collaborative effort. I want to
congratulate the gentleman from Texas (Mr. Turner), my ranking member,
who is on the floor and who has been on his feet for much of this
debate. I want to thank the gentleman from Texas (Mr. Barton), the
chairman of the Committee on Energy and Commerce; and the gentleman
from Michigan (Mr. Dingell), ranking Democrat on that committee.
In the same way that this was a collaboration between the Committee
on Energy and Commerce and the Select Committee on Homeland Security in
the Congress and the Committee on Government Reform in the House of
Representatives, chaired by the gentleman from Virginia (Mr. Tom
Davis), who will speak shortly; likewise, it was a collaborative effort
in the Senate, including their Government Affairs Committee. It is a
collaborative effort within the administration that we are setting up.
The Department of Homeland Security and the Department of Health and
Human Services will partner in this first responder effort of
unprecedented magnitude.
And I should say, Mr. Speaker, that this is the largest first
responder program ever enacted in American history. The purpose, of
course, is to protect Americans, to protect Americans
[[Page H5736]]
in the event of an attack. That puts this squarely in the orbit of what
we consider to be first response. But we need to make sure that our
first responders have the tools that they need to arrest the spread of
a biological attack and to protect Americans before it is too late.
Every second, every moment really does count in the event of a terror
attack, as the Senate Majority Leader Dr. Frist has so ably pointed out
in his book on this topic.
It was 18 months ago that President Bush called on Congress to enact
a bill to speed the development of antidotes, vaccines, against
biological warfare and against chemical weapons. We need to have drugs,
vaccines, and antidotes to combat these weapons if they are used
against us, as we now expect they might be.
We know, for example, that Mr. Zarqawi, when he was in Afghanistan,
was working on biological and chemical weapons development. He is now
attacking Americans and leading the terrorist attacks on Americans in
Iraq. We know that Osama bin Laden at various times expressed interest
in and may have acquired precursors of these same kinds of weapons.
We cannot take these kinds of threats lightly, and we are not. The
bill that we are passing today reflects a model for future legislation
because it is so collaborative. Homeland security requires us to knit
together different responsibilities, different authorities, the
responsibilities of different agencies of government, of law
enforcement, different levels of government, Federal, State, and local,
as never before.
{time} 1815
That is going to happen under this bill as well.
In the first instance, it will be the responsibility of the
Department of Homeland Security to assess the global threat, to tell us
what are the most likely and most threatening agents that could be used
against us. Then we will hand off to the Department of Health and Human
Services, which will help, after the priorities are set for this
research jointly with DHS, implement this program. The research
priorities will be implemented based on the information that has been
provided by the Department of Homeland Security.
By properly understanding the threats that confront us based on our
country's best intelligence, we can allocate our resources and focus
our efforts where they are most needed, on the biological, chemical and
radiological agents for which the risks and potential consequences of
attacks are greatest.
Another genius of this program is that it is not a government-run
program. The government is putting significant resources at the ready
to provide an incentive and a market to purchase any successful
products that are developed as a result of our call to action, but we
are unleashing the creative genius of the private sector.
Under the President's new national biodefense directive issued on
April 28, 2004, all bioterrorism projects and programs will fall under
a coordinated and focused strategic plan. This will help maximize these
resources that we are putting to work here, and it will ensure a
unified effort across all the Federal agencies.
Bioshield is an integral part of this strategic plan. It will draw
upon the expertise and resources of the private sector, as almost no
other government program that is part of the strategic plan, in order
to produce more quickly those countermeasures necessary to make our
Nation safer.
It is important to recognize the visionary leadership of the
President in this regard. It is without exaggeration or embellishment
that I can say that this President, President Bush, and his
administration, and in particular Vice President Cheney, have devoted
more attention and more resources to the fight against bioterror than
any administration in history.
Prior to 2001, our investments in research and development and other
public health preparedness activities were minimal. They are now
profound. The President and this Congress are allocating annually
billions of dollars to this fight, and under Project Bioshield alone we
will spend $5.6 billion over the next 10 years. The President is
clearly leading the way.
Project Bioshield was not dreamed up here in the halls of Congress,
but with big obstacles to addressing that need we have acted. So it is
with both bipartisan pride, I think, and also with collaboration in
mind between the executive branch and the legislative branch that we
can say that we have enacted into law, we very shortly will be able to
do this, next week we will be able to say this, the most significant
first responder program in our Nation's history.
The Select Committee looks forward to working with President Bush,
Secretary Ridge, Secretary Thompson, and the other committees in the
House and Senate to make sure we leverage the resources provided by
Project Bioshield to build a sustained countermeasure capacity to
protect our Nation and our citizens from the ever-evolving threat of
weapons of mass destruction.
Mr. Speaker, I reserve the balance of my time.
Mr. TURNER of Texas. Mr. Speaker, I reserve the balance of my time.
Mr. BARTON of Texas. Mr. Speaker, I yield 3 minutes to the great
volunteer, the gentleman from Tennessee (Mr. Wamp).
(Mr. WAMP asked and was given permission to revise and extend his
remarks.)
Mr. WAMP. Mr. Speaker, I thank the chairman for yielding me time, and
I thank all of those involved for bringing this legislation to the
floor in the form of a conference report.
I have to come to the floor, though, saying it is frustrating for me
as a Member of the Subcommittee on Homeland Security of the Committee
on Appropriations that it took a year to get the bill from the House
floor back to the House floor in the form of a conference agreement,
since time is very much of the essence.
Also I want to tell a story. About a year ago, when I brought ``Buy
America'' provisions to the floor trying to insert them in this
legislation, received assurances from Secretary Thompson and the
gentleman from Louisiana (Chairman Tauzin) that every effort would be
made to buy America where possible in all of the implementation of not
just Bioshield, but all of the different treatments and antidotes that
fall under Bioshield or not. Then later in the fall I had an Assistant
Secretary of Health and Human Services in my office, and I spoke about
the treatment for a radiation event and how that was going to be
procured. It is called Prussian Blue, and I was told that that was
still in the process of being competed.
Little did anyone know in the room under this interagency working
group that a month earlier, an exclusive contract had already been
committed to procure Prussian Blue and fill up our stockpiles to a
German company.
I have got to tell you, in Tennessee that does not go over very well,
when there are U.S. manufacturers prepared to do this and time is of
the essence. The FDA, HHS, DHS, we need to coordinate better. I am very
concerned about ceding the responsibility to interagency working groups
and not having an accountable person.
This is billions of dollars. It is, frankly, late. We have been
appropriating the money. It cannot go forward, and time is of the
essence. We are going to the conventions, and the threats are real, and
we do not have the stockpiles full.
I commend the authorizers; but, darn, everybody involved needs to
move quicker because we do not have the stockpiles full of these
treatments, and many of them are available and on the shelf by U.S.
manufacturers. I was in Tampa, Florida, a week ago Monday; and I saw
those treatments, and they are not on the streets of New York or Boston
or across the country, or in Athens, Greece; and U.S. manufacturers can
export them.
We have the best technology in the world. We do not have to lean on
the French or the Germans to fill up our stockpiles for treatments in
the event of more terrorism. It is not just Bioshield, it is Chemshield
and Nukeshield. It is all of the major threats.
So, yes, vote for this. It is long overdue. Move it quickly to the
President's desk. And then get the administration to coordinate better
together.
I called Assistant Secretary Simonson today. I said, I need to talk
to you. I am still waiting for the phone call. The legislation is on
the floor. I am on the subcommittee. I am waiting
[[Page H5737]]
for the phone to ring. We need action. The American people demand no
less. This is the most target-rich environment in the next 4 months
that we have ever faced in the history of this country. Let us get it
on.
Mr. BARTON of Texas. Mr. Speaker, I believe I have 4 minutes
remaining. I yield that time to the gentleman from Virginia (Mr. Tom
Davis), the chairman of the Committee on Government Reform, and ask
that he control the balance of the Committee on Energy and Commerce
time.
The SPEAKER pro tempore (Mr. Foley). Is there objection to the
request of the gentleman from Texas?
There was no objection.
The SPEAKER pro tempore. The gentleman from Virginia (Mr. Tom Davis)
has 11\1/2\ minutes remaining, the gentlewoman from Washington (Ms.
Dunn) has 7\1/2\ minutes remaining, and the gentleman from Texas (Mr.
Turner) has 17 minutes remaining.
Mr. TOM DAVIS of Virginia. Mr. Speaker, I yield myself such time as I
may consume.
Mr. Speaker, I rise in support of S. 15, the Project Bioshield Act of
2004. The bill provides the government with the necessary tools to
develop and purchase vaccines and other drugs to protect Americans in
the event of a bioterrorist attack. The President first announced this
proposal during his 2003 State of the Union address, and it serves as
the cornerstone of the administration's strategy to prepare our Nation
against the possibility of bioterrorism.
A few minutes ago, we were privileged to hear from the chairman of
the Select Committee on Homeland Security, the gentleman from
California (Mr. Cox); and I will include for the Record an editorial
written by the gentleman from California that appeared in the
Washington Times and published July 12, 2004.
[From the Washington Times, July 12, 2004]
Intercepting Bioterrorism
(By Christopher Cox)
America is at a very dangerous crossroads. Not only al
Qaeda but also terrorist groups such as Jemaah Islamiah are
working on acquiring or developing new terrorism
capabilities, including bioweapons. Will we be prepared?
Evidence in an Egyptian terrorism trial two years ago
indicated Osama bin Laden may already have access to
dangerous biological agents. Meanwhile, the risk of
proliferation to terrorists continues growing, with at least
eight nations running bioweapons programs, including genetic
engineering of pathogens and developmental programs for new
production and delivery methods.
Winning the war on terrorism will require our nation not
only to defeat attacks with explosives and military-style
weapons, but also to be prepared to overcome potential
assaults with weaponized anthrax, ricin, smallpox, plague,
tularemia, botulism toxin and viral hemmorhagic fevers (such
as the Ebola virus).
Just how vulnerable are we to such attacks today? The
United States now can fully meet only a handful of the 57
``top echelon'' bioterror threats. That's not an acceptable
level of preparedness for the greatest power on Earth. We can
launch a Tomahawk cruise missile and thread it down the
smokestack of a munitions factory from 1,000 miles away--once
thought to be a million-to-one shot at best--yet we aren't
prepared to deal with the frightening prospect of an anthrax
or sarin gas attack against our civilian population.
It's vital that we put our best minds to work round-the-
clock on new ways to prepare for a biological or chemical
attack here at home. But according to a study published in
the May 2004 issue of the journal Clinical Infectious
Diseases, only six of 506 drugs currently in development are
antibioltics--even though drug-resistant bacteria are a
growing threat.
This is only because the proper incentives and funding
aren't there, not because the scientific challenge is too
great. Indeed, the germs that cause anthrax and plague are
not nearly as difficult to analyze as a virus such as HIV.
Vaccines and treatments for biological weapons such as these
can be developed.
Certainly, America has made some progress in preparing for
possible germ warfare on our own soil, but we're not ready to
combat a major bioterror assault at this time and our enemies
know it. Worse, they're looking for ways to exploit our
weaknesses.
We are now on the threshold of changing that. Project
Bioshield, expected to receive final legislative approval
tomorrow and then be sent to the president for his signature,
will shortly unleash the greatest force in world history:
American ingenuity.
By guaranteeing a market for successful vaccines and
antidotes, Project BioShield will provide incentives for
private-sector scientists, physicians, and researchers to
develop lifesaving treatments. Congress has made available
$5.6 billion over 10 years to purchase and stockpile a
national supply of drugs and vaccines for use if a biological
weapon is set loose by terrorists on an unsuspecting American
public.
BioShield will speed research and development on new drugs
and antidotes at the National Institutes of Health and in our
national laboratories. And it will allow, if germ warfare
breaks out, distribution of developmental lifesaving drugs on
a fast-track approval basis to save innocent lives, so long
as the benefits outweigh potential risks.
President Bush asked Congress to move immediately on his
plans for Project BioShields in the 2003 State of the Union
address. The House quickly responded. Last July, the
Homeland Security Committee, which I chair, worked closely
with other House committees to turn the president's vision
into legislation. Unfortunately, after our bipartisan bill
passed the House by a wide margin, it languished in the
Senate nearly a year before being rescued by Majority
Leader Bill Frist, Tennessee Republican.
But now that both chambers have worked out their
differences, America finally is ready to prepare in earnest
for a potential terrorist attack that won't yield to bullets
or bombs. Now, we'll be using the very best weapon in our
defensive arsenal--our brainpower.
By approving Project BioShield, Congress is saying: ``Let
the race to find lifesaving countermeasures begin.''
America's leaders have heeded the advice of experts who have
estimated that without BioShield it could take 10 years, and
cost up to $800 million or more, to bring a single new
vaccine from development through clinical trials to market.
The war won't wait that long, of course: Terrorists could
strike us at any minute. And once a bioweapon is released,
every second will count.
In many ways, the war on terrorism is like a chess game. We
must anticipate our enemy's moves, and mount an impenetrable
defense. In their pursuit of bioweapons, the terrorists have
revealed some of their game plan. Project BioShield will
ensure we stay one move ahead of them.
Someday soon, when it comes to bioterrorism, Americans will
be able to say: Checkmate.
Mr. Speaker, the bipartisan bill we are considering today is similar
to H.R. 2122, which was passed by the House on July 16, 2003. S. 15 is
a good bill that serves a compelling national interest.
Over the past few decades, we have seen rapid progress in the
development of treatments for many serious, naturally occurring
diseases. Pharmaceutical and biotech companies are highly capable of
producing diagnostics and therapeutics when consumer demand exists.
However, there has been little progress in treatments for deadly
diseases like smallpox, anthrax, ebola, and plague that affect today
few Americans. There is little manufacturer interest in developing
treatments for these diseases since there is no significant market,
other than the government.
Drug companies have little incentive for the substantial investment
required to bring treatments to these deadly diseases to market.
Moreover, the potential liability for an adverse reaction by a patient
far outweighs any potential financial benefit in some of these cases.
Should the United States be attacked with these deadly pathogens,
however, the need for vaccines, tests and treatments would be great and
immediate. S. 15 is designed to ensure that our country is prepared.
The bill provides the Secretary of Health and Human Services with a
number of flexible acquisition tools based on existing streamlined
procedures to promote research and development and procure necessary
drugs and vaccines. These tools are instrumental to the success of the
Bioshield program.
S. 15 gives the Secretary of Health and Human Services streamlined
authorities to promote the research and development of drugs and other
products needed to protect Americans in the event of a public health
emergency affecting national security. The Secretary will be armed with
flexible acquisition tools for research and development projects and
would also have expedited authorities to award research grants and to
hire technical experts and consultants. It would not be burdened with
the existing procurement processes that could take months.
The bill authorizes the procurement of biomedical countermeasures for
the Nation's stockpile, using a special reserve fund. The Secretary of
Health and Human Services and the Secretary of the Department of
Homeland Security would be required to work together to recommend the
countermeasures that are needed for the stockpile. Acquisition of
countermeasures
[[Page H5738]]
using the special reserve fund could only be made with the approval of
the President of the United States.
This bill would permit the use of simplified acquisition procedures
only when the Secretary of Health and Human Services determines that
the mission of the Bioshield program would be seriously impaired
without the use of such special procedures.
Finally, during national emergencies, the bill would permit the
government to make available new and promising treatments prior to
approval by the Food and Drug Administration.
I especially want to thank my ranking member, the gentleman from
California (Mr. Waxman), and his staff for working with us on this
important legislation. I urge my colleagues to support it.
Mr. Speaker, I reserve the balance of my time.
Mr. TURNER of Texas. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, first of all, let me thank all of the Members on both
sides who have worked to bring us to this point in the passage of the
legislation. I must say I have a great deal of agreement and sympathy
for the remarks made by the gentleman from Tennessee (Mr. Wamp) a few
moments ago, because the urgency of this matter certainly dictates that
we move much more quickly than we have been able to move on this
legislation.
The President proposed this project in his State of the Union address
in 2003. The House passed the bill in July of 2003, the Senate passed
the bill 2 months ago, and we are just now bringing this conference
report to the floor. So there is no question that in these times of
terrorist threat the stakes are very high. The risks that we face are
very great, and failure to close the security gaps in the area of
bioterrorism or in a host of other areas where we have serious threats
is not an option for this country.
We also know that in Project Bioshield and its implementation, we
face great risk; and it is my hope that the three committees who worked
so well together in crafting this bill will also each in their own way
vigorously exercise the oversight that is necessary to ensure that
Project Bioshield is successful.
When we know that we may be hearing of a decision in the near future
by Secretary Ridge and Secretary Thompson to begin to acquire a new
anthrax vaccine, I think it is incumbent upon each of us in our
committees, in our oversight responsibilities to ask the tough
questions about whether or not we are moving in the right direction;
for that first contract could be in the neighborhood of a $1 billion
Federal contract.
{time} 1830
Failure in making that decision in the appropriate and proper way to
ensure that it is successful is an essential oversight responsibility
that each of us have.
So it is my hope that the good work and the good cooperation that
occurred between the Committee on Commerce and the Committee on
Homeland Security and the Committee on Government Reform will be
carried forward as we provide the necessary oversight to ensure the
success of this important piece of legislation.
Again, Mr. Speaker, this is an important bill, and I urge every
Member of the House to vote aye.
Mr. Speaker, I yield back the balance of my time.
Mr. TOM DAVIS of Virginia. Mr. Speaker, I thank the gentleman from
Texas and others who have been involved in getting this legislation
before us.
Let me just say I share the frustration that many Members of this
body feel at the time it has taken to get this measure to this floor,
in a conference report form, and then send it on to the President's
desk for signature. We passed this legislation with bipartisan support
a year ago, and it languished over in the other body until it was
rescued by Senator Frist.
The time is late, but the time is now. I urge my colleagues to adopt
and support this legislation.
Announcement by the Speaker Pro Tempore
The SPEAKER pro tempore (Mr. Foley). The gentleman will refrain from
improper references to the Senate.
Ms. McCARTHY of Missouri. Mr. Speaker, I rise today in strong support
of S. 15, legislation to protect our Nation from future biological and
chemical terrorist attacks. The House passed H.R. 2122, similar
legislation, last year by an overwhelming margin of 421 to 2. As a
member of both the Homeland Security Committee and the Energy and
Commerce Committee, I have been proud of the bipartisan work that has
gone into this legislation which will add to our effort to protect the
Nation from biochemical attack.
Mr. Speaker, although five people were killed in the anthrax attacks
of 2001, the death toll was kept relatively low because effective
medical countermeasures were available. After the outbreak, strong
antibiotics were immediately prescribed to deal with the crisis. In
2002, Congress further enhanced our ability to respond by enacting the
Public Health Security and Bioterrorism Preparedness Response Act (PL
107-188), which authorized funds to increase the Nation's stockpile of
medicines and vaccines--particularly for smallpox--and provided aid to
state and local governments and health facilities to help them prepare
for possible attacks.
Unfortunately, effective vaccines or treatments do not exist for many
biological threats deemed by the U.S. government to be most dangerous,
including botulinum toxin, plague, and viral hemorrhagic fevers such as
the Ebola virus.
The development of effective countermeasures has been hindered by the
lack of a significant commercial market. Currently, companies have
little financial incentive to invest the funds needed to research,
develop or produce vaccines or other countermeasures because there is
little or no market.
Despite these challenges, in my district, the Stowers Institute and
the Kansas City Life Sciences Institute are both trailblazers in the
field of research. The Stowers Institute's new research facility in
Kansas City incorporates the best that present technology can offer. In
my community, the best and the brightest are working to broaden the
base of knowledge in hopes of discovering cures and vaccines for
today's diseases and future threats.
Today's legislation will encourage and support these efforts by
providing additional funding for research and development of new
countermeasures and vaccines. The bill will also provide for an
expedited approval process to ensure that the fruits of our research
can protect the public as soon as possible.
Mr. Speaker, all over this Nation, our first responders serve on the
front lines when disasters occur and continue to be the eyes and ears
of our Nation. They are a significant part of the effort to protect our
homeland and guard against the invisible threat of a chemical and
biological attack. Today's legislation is an important step in that
process and I support it.
Mrs. CHRISTENSEN. Mr. Speaker, I want to begin by first thanking our
Chairman, Mr. Cox from California and Ranking member, from Texas, Mr.
Turner, for their leadership on the select committee and for this
opportunity to offer my support for S. 15, Project Bioshield, and to
draw attention to the critical issues of homeland security. And I also
want to take the opportunity to again thank the minority leader, the
gentlewoman from California, Ms. Pelosi, for the honor of serving on
this important committee.
In this post 9/11 world, it has been said that bioterrorism may
represent our greatest threat. Project Bioshield is important because
it will help to ensure that we can spur the development of vaccines and
other countermeasures that will be needed to counteract or treat an
infectious, radiological or chemical attack. But it can only go so far,
because we have no idea what the agent might be or how a known one
might be altered. Not only is it possible that hundreds of millions of
dollars could be spent to develop a medicine or vaccine and it be
totally useless, but the very best of medicines, vaccines or other
agents will be worthless to you, me and the people we serve without an
intact public health system.
A recent bipartisan commission's report, ``First Responders
Underfunded and Unprepared,'' documents the dire need of our public
health and other responders in stark and frightening terms. I am still
waiting for a formal hearing on their findings, and we should not be
afraid to have the report aired. We should really be more afraid not to
pay attention to its findings and its recommendations.
Particular when we think about the health care disparities in
minorities and in our rural areas that I have come to this floor to
bring to the attention of our colleagues on many occasions did not just
come about by chance. They exist because of the poor public health
systems in these communities. The last 3 years of cuts to health
budgets have been devastating. The lack of emphasis on minority and
rural health and the even bigger cuts that the President is insisting
on this year, so that those who already have the best of health care
can get a tax cut and other perks, have sent States into a free fall of
budget deficits, and local public health safety nets, like those in Los
Angeles, and Detroit, to near collapse.
[[Page H5739]]
Mr. Speaker, we cannot just throw money at the problem of terrorism,
as this administration has a tendency to do, without adequate planning.
In this case, we must first and foremost insist that our public health
system is intact and that it can ensure that people are healthy and our
bodies are in a better condition to fight off infections and the other
biological assaults that may come from a bioterrorism attack.
The anthrax scare taught us that lesson. The breakdowns were
fundamental ones. Project Bioshield, the administration's centerpiece
for public health preparedness and biological countermeasures, would
not have saved the two postal workers just down the street from here
who died because the public health system failed to respond. It
happened here, but it could happen anywhere.
Confronting the danger posed by these advanced biological weapons is
a challenge we must begin today. Thus, we must ensure that
biotechnology is fundamentally ``dual-use,'' that is it can be used
both for peaceful and destructive purposes. Because of its potential
for misuse, balanced biodefense policies must be developed and adopted
to ensure our safety and security. These should include reasonable
steps to prevent the spread of dangerous pathogens and the technology
to enhance them. Preparedness of our health infrastructure must also be
enhanced and maintained. Finally, protections, including drugs and
vaccines, to counter potential weaponized pathogens need to be
available during a crisis.
It is in the area of protections for tomorrow's biological weapons
threat that we are particularly weak. The primary proposal advanced to
boost our protection capacities, Project Bioshield, will not address
this threat because it is targeted to addressing classical agents. In
addition, it relies on the current base of science and technology in
drug and vaccine development, which takes an average of 14 years to
develop and introduce a new medicine. As a consequence, our protective
biodefenses are essentially static and unmoving in the face of a threat
that is highly variable and unpredictable. The recent experience with
SARS and the danger of a new flu pandemic demonstrate the dangers of a
lack of effective countermeasures and a nimble ability to develop and
field them.
Recently, Ranking member Turner and I introduced H.R. 4258 The RAPID
Cures Act. This bill seeks to commission the development of a strategy
to achieve a dramatic reduction in the timeframe required today for the
delivery of drugs and vaccines to counter pathogen threats for which we
have no existing countermeasures. The achievement of reductions and the
institution of a national rapid response ``Bug-to-Drug'' capability
will be a significant boost to our biodefenses against the emerging and
future threat of bioengineered biological weapons, as well as naturally
occurring novel threats, such as SARS or pandemic flu.
In addition to improving antimicrobial and vaccine development
capabilities, an area currently neglected by the private sector, the
technical spin-offs of such an endeavor are also likely to benefit the
domestic pharmaceutical and biotechnology industries more generally.
Broad public health benefits will also be forthcoming. Extensive
literature exists to show that the long timeframes (14 years) and high
failure rates typical of drug development processes today are a
significant cause of high R&D costs, and thus high prescription drug
costs.
Mr. Speaker, today I know that we will pass this bill, but what I and
other health providers, public health experts and officials and the
people of this country want to know is that we will always move just as
determinedly and expeditiously to fully fund the strengthening of our
public health system, the training of our first responders and provide
them with the tools and facilities they need to protect us in those
first critical hours where lives can and must be saved.
I again want to take this opportunity to thank and commend Chairman
Cox and Ranking Member Turner for their leadership in moving this bill
through Congress.
Mr. SHAYS. Mr. Speaker, I rise today in strong support of this
bipartisan legislation, the Project BioShield Act. The anthrax attacks
in the fall of 2001 brought the once distant threat of biological
weapons into these very buildings. It is not a question of if, but when
terrorists will strike again. Project BioShield marks an important step
toward preparedness to deter or defeat the next terrorist attack using
deadly pathogens.
I am particularly pleased that the legislation clarified some
ambiguity that I had raised during the bill's initial consideration
regarding safeguards for the application of medical products during
emergencies for military personnel. Initially, the legislation appeared
to allow the President or Secretary of HHS to remove safeguards for
military personnel that were available to the general population. This
legislation addressed those concerns.
This legislation will provide $5.6 billion over 10 years to develop
and procure effective countermeasures against biological, chemical and
radiological weapons. To counter the grave and changing threat, the
bill gives the Secretary of HHS new, flexible authorities to conduct
and support research and development for new vaccines and drugs. Most
importantly, Project BioShield removes barriers and provides important
incentives to the private sector to spur the advance of
biotechnologies. If used aggressively and wisely, the authorities in
this legislation will result in significantly strengthened defenses
against bioterrorism.
Two words of caution: First, implementation of BioShield must be
linked to the threat. Vaccines and antidotes against exotic agents may
present easier, near-term opportunities for quick successes. But the
Center for Disease Control and the intelligence community maintain a
threat list of pathogens, and that list should focus and guide
BioShield investments. Botulinum toxin ranks right behind anthrax as a
known biological threat. But testimony before the Select Committee on
Homeland Security concluded development of botulinum anti-toxin stocks
could take up to 10 years. If Project BioShield is going to provide
anything more than a symbolic barrier against biological attack, that
estimate has to change.
And, the success of BioShield also depends upon broader bio-
preparedness priorities. The Government Reform National Security
Subcommittee, which I chair, has held several hearings on bioterrorism
preparedness. We learned that massive caches of stockpiled vaccines,
antibiotics and drugs will protect no one if they cannot be
administered quickly and safely. Public health capacity is a critical
enabler to BioShield success. Surveillance systems, diagnostic tools
and trained medical personnel are prerequisites to any effective
defense against natural and man-made biological outbreaks.
Terrorism thrives on uncertainty. We cannot expect to vaccinate
everyone against every possible pathogen. Instead, we need a well-
equipped, well-trained public health system that can rapidly respond to
health emergencies.
Mr. Speaker, Project Bioshield is a much needed initiative, and I
would urge all of my colleagues to support for this legislation.
Mr. DINGELL. Mr. Speaker, I rise in support of S. 15, the ``Project
Bioshield Act of 2004.'' This legislation reflects bipartisan bicameral
negotiations that have made minor modifications to the language of H.R.
2122 which was passed by the House on July 16, 2003. I commend the hard
work and dedication of all who participated in this endeavor.
In this era of heightened threats to our national security and the
increased risk of harm to Americans, Project Bioshield is an
unfortunate but necessary measure. There are no effective therapies for
many of the ``select agents'' that have been identified as potential
instrumentalities of terrorism. The basic purpose of Project Bioshield
is to support research that will lead to the development and
availability in the Strategic National Stockpile of ``countermeasures''
to combat public health emergencies that threaten our national
security.
The bill has three basic features: enhanced countermeasure research;
procurement of countermeasures; and emergency regulatory authority for
approval and use of drugs, biologics, and devices that are qualified
countermeasures. The Committees' work clarified, modified, and
otherwise improved on the Administration's proposal in each of these
areas. The bill before us reflects further refinements and does not
contain major policy changes from last year's bill.
Among the significant measures in this bill are provisions aimed at
enhancing accountability for actions taken pursuant to Project
Bioshield. Congress will receive comprehensive information, not less
than annually, on the major activities authorized by this Act. In
addition, the Government Accountability Office (GAO) will provide
reports on key economic and scientific elements of this program after
it has been in effect for several years.
Finally, I am pleased to note that this bill maintains the approach
of H.R. 2122 that funding be authorized, rather than a permanent,
unlimited appropriation sought by the Administration. Bioshield should
not automatically be given a higher priority over other national
security or public health matters.
This is a good bill, and is a worthy continuation of our important
and bipartisan work on bioterrorism preparedness. I urge all of my
colleagues to support it.
Mr. WAXMAN. Mr. Speaker, we have before us today S. 15, the Project
BioShield Act. This bill is substantially the same as H.R. 2122, which
passed the House on July 16, of last year by a vote of 421 to 2. This
bill is in essence the conference report on the bill, and includes some
minor improvements made by the Senate. I urge members to support this
measure as well.
Given the serious threat of bioterrorism, the development of
effective countermeasures to biological agents is vital to our national
security. The goal of Project BioShield is to encourage the development
of these products. I fully
[[Page H5740]]
support the intent of this legislation. I also agree with its premise--
that when the market cannot foster the development of critical products
by itself, the government must rise to the challenge.
The bill before us today includes several significant improvements
from earlier proposals. For example, it includes important protections
against waste and abuse that are standard for government contracts,
such as preserving the government's rights to review contractor's books
and records. The bill also permits the use of certain streamlined
procurement procedures, but only if the Secretary of Health and Human
Services determines that there is a pressing need to do so.
The Senate bill appropriately strengthens some of these provisions
and also allows for recovery by the government in the event of grossly
negligent or reckless conduct on the part a contractor.
In emergency situations we should not impede the development of
necessary products. However, any exceptions from standard procurement
procedures should be made only when necessary and should be subject to
review. This proposal preserves that standard.
The provisions of Bioshield authorizing the emergency distribution of
unapproved drugs and devices, whose risks and benefits are not fully
tested, impose an unprecedented responsibility on the government. FDA
must be vigilant in protecting the public against unnecessary risks
from these products.
In part because of these concerns, the bill requires that health care
providers and patients be informed that the products have not been
approved and of their risks. The bill also requires that manufacturers
monitor and report adverse reactions to the products and keep other
appropriate records about the use of the products.
These conditions are essential for the safe use of unapproved
products, and they should be imposed in all cases, except in truly
extraordinary circumstances. In addition, the HHS Secretary is
authorized to limit the distribution of the products, to limit who may
administer the products, to waive good manufacturing practice
requirements only when absolutely necessary, and to require record
keeping by others in the chain of distribution.
We expect the Secretary to consider the need for these additional
conditions in each case and to impose them to the full extent necessary
to protect the public from the risks of these products.
The bill before us today is an improvement over the original
proposal, and represents a bipartisan consensus of the House, the
Senate, and the White House. It deserves our support.
Mr. LANGEVIN. Mr. Speaker, I rise today in support of the Project
Bioshield Act of 2004. Bioterrorism is a major threat to our national
security, and I believe it is our job as members of Congress to instill
confidence in the American people that a coordinated, concerted effort
is being made to combat this threat. While Project Bioshield is not the
only answer, it is certainly an important step towards that goal, and I
hope Congress will continue to provide the funding and oversight the
project needs to be effective.
This bill, much like H.R. 2212 passed by the House a year ago,
authorizes the Project Bioshield initiative and will set in motion
crucial efforts to develop new countermeasures to treat diseases and
conditions caused by bioterror attacks and chemical, radiological and
nuclear agents. Under this program, the Federal government will be able
to enhance the Strategic National Stockpile, promote research and
development of countermeasures, and, in an emergency, move forward with
public distribution of certain drugs and treatments that may not yet
have FDA approval. It is never pleasant to imagine a scenario where
this kind of preparation and flexibility will be necessary, but the
threat is indeed there. Project Bioshield will help lay the groundwork
to respond to that threat quickly and effectively.
However, I must also mention my ongoing concern that until the
Department of Homeland Security's Information Analysis and
Infrastructure Protection Directorate is fully staffed and meeting
expectations, the rest of DHS is at a tremendous disadvantage in
determining how to allocate resources and focus energies. The proper
implementation of Project Bioshield requires a reliable and
comprehensive threat assessment from the Information Analysis team, a
team that should include bioterror experts working closely with their
peers at agencies like CDC and NIH to identify the most pressing
dangers and develop a plan to combat them.
So, Mr. Speaker, I urge my colleagues to support this legislation and
hope that DHS will do its part to make Project Bioshield as effective
as possible.
Ms. ESHOO. Mr. Speaker, I'm pleased to support the Project Bioshield
Act which encourages the development of new countermeasures to deal
with diseases and conditions caused by bioterrorism attacks. It
authorizes $5.6 billion over 10 years for purchasing countermeasures,
such as vaccines and treatments, to bioterrorist attacks. The bill also
allows the government, in the event of a national emergency involving a
bioterrorism or similar attack, to distribute to the public certain
drugs and treatments that have not yet been approved by the Federal
Drug Administration (FDA).
The Project Bioshield Act is an important part of our mission to
secure and protect our homeland and hometowns. The threat of chemical,
biological and radiological attacks is too great and this bill provides
necessary regulatory flexibility to the Department of Homeland Security
and the Department of Health and Human Services so they can speed and
promote research and development of needed countermeasures.
The September 11th tragedies and subsequent anthrax attacks made the
Nation aware that the public health system is ill-prepared to mange a
large scale emergency. Since then, our public health system has
continued to respond to high profile threats like severe acute
respiratory syndromes (SARS) and West Nile Virus which illustrate how
quickly infections can spread among populations and across the globe.
Over the last 3 years, our eyes have been opened to the threats we
face on our own soil. We've discovered serious vulnerabilities and I'm
proud of what we've done in this bill to address them. I urge the
entire House to vote for this important legislation.
Mr. SENSENBRENNER. Mr. Speaker, I rise in support of S. 15, the
``Project BioShield Act of 2004.'' This important legislation will help
us to be better prepared against bioterrorism and other forms of
terrorism. I just want to briefly note the jurisdictional interest of
the Committee on the Judiciary in the Federal Tort Claims Act provision
contained in the new Sec. 319F-1(d)(2) which is contained in 2(a) of
the bill. I support the inclusion of this provision. However, I want to
note that by allowing this provision to be included in the bill, the
Committee on the Judiciary does not waive its jurisdiction over the
provision. With that, I urge my colleagues to support the bill.
Mr. TOM DAVIS of Virginia Mr. Speaker, I yield back the balance of my
time.
The SPEAKER pro tempore. All time having been yielded back, pursuant
to the order of the House of Tuesday, July 13, 2004, the Senate bill is
considered read for amendment, and the previous question is ordered.
The question is on third reading of the Senate bill.
The Senate bill was ordered to be read a third time, and was read the
third time.
The SPEAKER pro tempore. The question is on the passage of the Senate
bill.
The question was taken; and the Speaker pro tempore announced that
the ayes appeared to have it.
Mr. TOM DAVIS of Virginia. Mr. Speaker, on that I demand the yeas and
nays.
The yeas and nays were ordered.
The vote was taken by electronic device, and there were--yeas 414,
nays 2, not voting 17, as follows:
[Roll No. 376]
YEAS--414
Abercrombie
Ackerman
Aderholt
Akin
Alexander
Allen
Andrews
Baca
Bachus
Baird
Baker
Baldwin
Ballenger
Barrett (SC)
Bartlett (MD)
Barton (TX)
Bass
Beauprez
Becerra
Bell
Bereuter
Berkley
Berman
Berry
Biggert
Bilirakis
Bishop (GA)
Bishop (NY)
Bishop (UT)
Blackburn
Blumenauer
Blunt
Boehlert
Boehner
Bonilla
Bonner
Bono
Boozman
Boswell
Boucher
Boyd
Bradley (NH)
Brady (PA)
Brady (TX)
Brown (OH)
Brown (SC)
Brown, Corrine
Brown-Waite, Ginny
Burgess
Burns
Burr
Burton (IN)
Buyer
Calvert
Camp
Cannon
Cantor
Capito
Capps
Capuano
Cardoza
Carson (OK)
Carter
Case
Castle
Chabot
Chandler
Chocola
Clay
Clyburn
Coble
Cole
Cooper
Costello
Cox
Cramer
Crane
Crenshaw
Crowley
Cubin
Culberson
Cummings
Cunningham
Davis (AL)
Davis (CA)
Davis (FL)
Davis (IL)
Davis (TN)
Davis, Jo Ann
Davis, Tom
Deal (GA)
DeFazio
DeGette
Delahunt
DeLauro
DeLay
DeMint
Diaz-Balart, L.
Diaz-Balart, M.
Dicks
Doggett
Doolittle
Doyle
Dreier
Duncan
Dunn
Edwards
Ehlers
Emanuel
Emerson
Engel
English
Eshoo
Etheridge
Evans
Everett
Farr
Fattah
Feeney
Ferguson
Filner
Foley
Forbes
Fossella
Franks (AZ)
Frelinghuysen
Frost
Gallegly
Garrett (NJ)
Gerlach
Gibbons
Gilchrest
Gillmor
Gingrey
Gonzalez
Goode
Goodlatte
Gordon
Goss
Granger
Graves
Green (TX)
[[Page H5741]]
Green (WI)
Greenwood
Grijalva
Gutierrez
Gutknecht
Hall
Harman
Harris
Hart
Hastings (FL)
Hastings (WA)
Hayes
Hayworth
Hefley
Hensarling
Herger
Herseth
Hill
Hinchey
Hinojosa
Hobson
Hoekstra
Holden
Holt
Honda
Hooley (OR)
Hostettler
Hoyer
Hulshof
Hunter
Hyde
Inslee
Israel
Issa
Istook
Jackson (IL)
Jackson-Lee (TX)
Jefferson
Jenkins
John
Johnson (CT)
Johnson (IL)
Johnson, E. B.
Johnson, Sam
Jones (NC)
Jones (OH)
Kanjorski
Kaptur
Keller
Kelly
Kennedy (MN)
Kennedy (RI)
Kildee
Kilpatrick
King (IA)
King (NY)
Kingston
Kirk
Kline
Knollenberg
Kolbe
Kucinich
LaHood
Lampson
Langevin
Lantos
Larsen (WA)
Larson (CT)
Latham
LaTourette
Leach
Lee
Levin
Lewis (CA)
Lewis (GA)
Lewis (KY)
Linder
Lipinski
LoBiondo
Lofgren
Lowey
Lucas (KY)
Lucas (OK)
Lynch
Maloney
Manzullo
Markey
Marshall
Matheson
Matsui
McCarthy (MO)
McCarthy (NY)
McCollum
McCotter
McCrery
McDermott
McGovern
McHugh
McInnis
McIntyre
McKeon
McNulty
Meehan
Meek (FL)
Meeks (NY)
Menendez
Mica
Michaud
Millender-McDonald
Miller (FL)
Miller (MI)
Miller (NC)
Miller, Gary
Miller, George
Mollohan
Moore
Moran (KS)
Moran (VA)
Murphy
Murtha
Musgrave
Myrick
Nadler
Napolitano
Neal (MA)
Nethercutt
Neugebauer
Ney
Northup
Norwood
Nunes
Nussle
Oberstar
Obey
Olver
Ortiz
Osborne
Ose
Otter
Owens
Oxley
Pallone
Pascrell
Pastor
Payne
Pearce
Pelosi
Pence
Peterson (MN)
Peterson (PA)
Petri
Pickering
Pitts
Platts
Pombo
Pomeroy
Porter
Portman
Price (NC)
Pryce (OH)
Putnam
Quinn
Radanovich
Rahall
Ramstad
Regula
Rehberg
Renzi
Reyes
Reynolds
Rodriguez
Rogers (AL)
Rogers (KY)
Rogers (MI)
Rohrabacher
Ros-Lehtinen
Ross
Rothman
Roybal-Allard
Royce
Ruppersberger
Rush
Ryan (OH)
Ryan (WI)
Ryun (KS)
Sabo
Sanchez, Linda T.
Sanchez, Loretta
Sanders
Sandlin
Saxton
Schakowsky
Schiff
Schrock
Scott (GA)
Scott (VA)
Sensenbrenner
Serrano
Sessions
Shadegg
Shaw
Shays
Sherman
Sherwood
Shimkus
Shuster
Simmons
Simpson
Skelton
Slaughter
Smith (MI)
Smith (NJ)
Smith (TX)
Smith (WA)
Snyder
Solis
Souder
Spratt
Stark
Stearns
Stenholm
Strickland
Stupak
Sullivan
Sweeney
Tancredo
Tanner
Tauscher
Tauzin
Taylor (MS)
Taylor (NC)
Terry
Thomas
Thompson (CA)
Thompson (MS)
Thornberry
Tiahrt
Tiberi
Tierney
Toomey
Towns
Turner (OH)
Turner (TX)
Udall (CO)
Udall (NM)
Upton
Van Hollen
Velazquez
Visclosky
Vitter
Walden (OR)
Walsh
Wamp
Waters
Watson
Watt
Waxman
Weiner
Weldon (FL)
Weldon (PA)
Weller
Wexler
Whitfield
Wicker
Wilson (NM)
Wilson (SC)
Wolf
Woolsey
Wu
Wynn
Young (AK)
Young (FL)
NAYS--2
Flake
Paul
NOT VOTING--17
Cardin
Carson (IN)
Collins
Conyers
Deutsch
Dingell
Dooley (CA)
Ford
Frank (MA)
Gephardt
Hoeffel
Houghton
Isakson
Kind
Kleczka
Majette
Rangel
Announcement by the Speaker Pro Tempore
The SPEAKER pro tempore (Mr. Foley) (during the vote). Members are
advised 2 minutes remain in this vote.
{time} 1900
Mr. FLAKE changed his vote from ``yea'' to ``nay.''
Mr. WAXMAN changed his vote from ``nay'' to ``yea.''
So the Senate bill was passed.
The result of the vote was announced as above recorded.
A motion to reconsider was laid on the table.
____________________