Congressional Record, Volume 149 Issue 105 (Wednesday, July 16, 2003)

[Congressional Record Volume 149, Number 105 (Wednesday, July 16, 2003)]
[House]
[Pages H6908-H6941]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

{time} 1400
PROJECT BIOSHIELD ACT OF 2003

Mr. TAUZIN. Mr. Speaker, pursuant to the order of the House of
Tuesday, July 15, 2003, I call up the bill (H.R. 2122) to enhance
research, development, procurement, and use of biomedical
countermeasures to respond to public health threats affecting national
security, and for other purposes, and ask for its immediate
consideration.
The Clerk read the title of the bill.
The SPEAKER pro tempore (Mr. Jenkins). Pursuant to the order of the
House of Tuesday, July 15, 2003, the bill is considered read for
amendment.
The text of H.R. 2122 is as follows:

H.R. 2122

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Project BioShield Act of
2003''.

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 BIOMEDICAL COUNTERMEASURE RESEARCH
AND DEVELOPMENT ACTIVITIES.

``(a) In General.--
``(1) Authority.--In conducting and supporting research and
development activities regarding biomedical countermeasures
under section 319F(h), the Secretary may conduct and support
such activities in accordance with this section if the
activities concern qualified countermeasures.
``(2) Qualified countermeasure.--For purposes of this
section, the term `qualified countermeasure' means a priority
countermeasure (as defined in section 319F(h)) that affects
national security.
``(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 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, and
supporting qualified countermeasure research and development,
the Secretary may provide that the facility that is the
object of such grant or cooperative agreement shall be
available as needed to the Secretary to respond to public
health emergencies affecting national security.
``(b) Expedited Procurement Authority.--
``(1) Increased simplified acquisition threshold for
biomedical 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).
``(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.
``(2) Other than full and open competition.--(A) 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) The authority under subparagraph (A) is in addition
to any other authority to use procedures other than
competitive procedures.
``(C) The Secretary shall implement this paragraph in
accordance with applicable government-wide regulations,
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.
``(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.
``(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

[[Page H6909]]

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 subsequent phases of a research grant 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 or cooperative
agreement.
``(d) Authority for Personal Services Contracts.--
``(1) In general.--For the purpose of performing,
administering, and 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 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 person, officer, employee, or governing board member.
``(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 such 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) 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.
``(g) Effect on Right To File Protest.--Nothing in this
section shall affect the right of an interested party to file
a protest with the contracting agency, to file a protest with
the Comptroller General under subchapter V of chapter 35 of
title 31, United States Code, or to file an action in the
United States Court of Federal Claims under section 1491(b)
of title 28, United States Code.''.
(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
(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 fiscal year 2003.''.

SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT.

(a) In General.--Part B of title III of the Public Health
Service Act, as amended by section 2 of this Act, is amended
by inserting after section 319F-1 the following section:

``SEC. 319F-2. STRATEGIC NATIONAL STOCKPILE.

``(a) Strategic National Stockpile.--
``(1) In general.--The Secretary of Homeland Security
(referred to in this section as the `Homeland Security
Secretary'), in coordination with the Secretary and the
Secretary of Veterans Affairs, 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; and
``(F) 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
priority countermeasure (as defined in section 319F(h))--
``(i) that affects national security;
``(ii) that is determined under paragraph (2)(B)(ii) to be
a necessary countermeasure; and
``(iii)(I) that is approved or cleared under chapter V of
the Federal Food, Drug, and Cosmetic Act, or licensed under
section 351 of this Act, for use as a countermeasure to a
chemical, biological, radiological, or nuclear agent
identified as a material threat under paragraph (2)(A)(ii);
or
``(II) 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

[[Page H6910]]

qualify for approval or licensing after the date of a
determination under paragraph (5).
``(2) Determination of material threats.--
``(A) Material threat.--The Homeland Security Secretary, in
consultation with 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.
``(B) Public health impact; necessary countermeasures.--The
Secretary shall on an ongoing basis--
``(i) assess the potential public health consequences of
use against the United States population of agents identified
under subparagraph (A)(ii); and
``(ii) determine, on the basis of such assessment, the
agents for which priority countermeasures are necessary to
protect the public health from a material threat.
``(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 security 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
security countermeasure would be appropriate, such
Secretaries may jointly submit to the President a proposal
to--
``(i) issue a call for the development of such security
countermeasure; and
``(ii) make a commitment that, upon the first development
of such security countermeasure that meets the conditions for
procurement under paragraph (5), the Secretaries will, based
in part on information obtained pursuant to such call, make a
recommendation under paragraph (6) that the special reserve
fund under paragraph (10) be made available for the
procurement of such security 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 security countermeasure
involved--
``(i) the call for the countermeasure;
``(ii) specifications for the countermeasure under
subparagraph (B); and
``(iii) a 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
five 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 (2), (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 congress.--The Secretary and the Homeland
Security Secretary shall notify the Congress 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 identification of the
potential supplier or 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 agreements.--
``(i) For procurement.--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 the Secretary's
costs of such procurement, other than as provided in clause
(ii).
``(ii) For administrative costs.--The agreement entered
into between the Homeland Security Secretary and the
Secretary for managing the stockpile under subsection (a)
shall provide for reimbursement of the Secretary's
administrative costs relating to procurements under this
subsection.
``(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 regulations to implement clauses (v),
(vi), and (vii), and any other provisions of this subsection.

``(ii) Contract terms.--A contract for procurements under
this subsection shall (or, as specified below, may) include
the following terms:

``(III) 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.

``(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

[[Page H6911]]

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):

``(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).
``(iv) Other than full and open competition.--(I) 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) The authority under subclause (I) is in addition to
any other authority to use procedures other than competitive
procedures.
``(III) The Secretary shall implement this clause in
accordance with applicable government-wide regulations,
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.
``(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 2003; or
``(B) administrative costs.
``(10) 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.
``(d) Disclosures.--No Federal agency shall disclose under
section 552, 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 Homeland Security
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 under subsection (c)(10).
``(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) Amendment 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 by adding at the end the following:

``SEC. 510. PROCUREMENT OF SECURITY COUNTERMEASURES FOR
STRATEGIC NATIONAL STOCKPILE.

``(a) Authorization of Appropriations.--For 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 appropriations account established as a result of
any appropriations made under subsection (a).
``(c) Availability.--
``(1) Duration of availability for obligation.--Subject to
paragraph (2), all amounts appropriated under subsection (a)
are available for obligation through the end of fiscal year
2013, provided that any portion of such amount that remains
unobligated for such purposes on the expiration of such term
shall be returned to the United States Treasury and shall not
be available for subsequent obligation for any purpose.
``(2) Initial availability for particular procurements.--
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.''.
(c) Conforming Amendments.--(1) 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
repealed.
(2) The item relating to section 121 in the table of
contents (contained in section 1(b)) of such Act is repealed.
(3) With respect to the program established under former
section 121 of such Act, the repeal of such section under
paragraph (1) applies as a modification of the program in
accordance with the amendment made by subsection (a) of this
section, and not as the termination of the program and the
establishment of a different program.

SEC. 4. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN
EMERGENCIES.

Subchapter E of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding
at the end the following section:

``SEC. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN
EMERGENCIES.

[[Page H6912]]

``(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.
``(3) Advance notice of termination.--In terminating a
declaration under this section, the Secretary shall provide
advance notice that the declaration 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 shipments of the product, including
the return of such shipments to the manufacturer (in the case
of a manufacturer that chooses to have the shipments
returned); and
``(B) in the case of unapproved uses of approved products,
a sufficient period for the disposition of any labeling that
was provided with respect to the emergency use involved.
``(4) Publication.--The Secretary shall promptly publish in
the Federal Register each declaration, determination, 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 detecting,
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 or approved
under this Act or the Public Health Service Act, for
detecting, 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 detect, 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 detecting, 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.--
``(1) In general.--An authorization of a product under this
section shall state--
``(A) each disease or condition that the product may be
used to detect, diagnose, prevent, or treat within the scope
of the authorization;
``(B) the Secretary's conclusions, made under subsection
(c)(2)(B), that the known and potential benefits of the
product, when used to detect, diagnose, prevent, or treat
such disease or condition, outweigh the known and potential
risks of the product; and
``(C) the Secretary's conclusions, made under subsection
(c), concerning the safety and potential effectiveness of the
product in detecting, diagnosing, preventing, or treating
such diseases or conditions, including an assessment of the
available scientific evidence.
``(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.
``(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
feasible given the circumstances of the emergency, shall, for
persons who choose to carry out one or more activities 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, to
the extent feasible given the circumstances of the emergency,
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, to
the extent feasible given the circumstances of the emergency,
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 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, to
the extent feasible given the circumstances of the emergency,
may, for persons who choose to carry out one or more
activities 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) 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.
``(iv) With respect to the emergency use of the product,
waive or limit, to the extent appropriate given the
circumstances of the emergency, conditions 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 in section 501.
``(2) Unapproved use.--With respect to the emergency use of
a product that is an unapproved use of an approved product:
``(A) The Secretary may, for manufacturers of the product
who choose to carry out one or more activities for which the
authorization is issued, establish any of the conditions
described in clauses (i) through (iv) of paragraph (1)(A).
``(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), an
authorization under this section regarding the emergency use
may, for persons who do not manufacture the product and who
choose to act under this clause, authorize such persons to
provide information on the product in addition to the
labeling provided by the manufacturer, subject to compliance
with clause (i). Such additional information shall not be
considered labeling for purposes of section 502.
``(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.--An
authorization shall continue to be effective for continued
use with respect to patients to whom it was administered
during the period described by paragraph (1), to the extent
found necessary by such patients' attending physicians.
``(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, in the Secretary's
unreviewable discretion, the criteria under subsection (c)
for issuance of such authorization are no longer met.
``(h) Publication.--The Secretary shall promptly publish in
the Federal Register a notice of each authorization, and each
termination or revocation of an authorization, and an
explanation of the reasons therefor, under this section.
``(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.--Nothing in this section shall
be construed to impair or otherwise affect--
``(1) 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) the authority of the Secretary of Defense with
respect to the Department of Defense, including the armed
forces, under other provisions of Federal law; or
``(3) the authority of the Secretary under section 319F-2
to manage the stockpile under such section.
``(k) Application to Members of Armed Forces.--
``(1) Waiver of requirement relating to option to refuse.--
In the case of administration of a countermeasure to members
of the armed forces, a requirement, under subsection
(e)(1)(A)(ii)(III), designed to ensure that individuals are
informed of an option to accept or refuse administration of a
product, may be waived by the President if the President
determines, in writing, that complying with such requirement
is not feasible, is contrary to the best interests of the
members affected, or is not in the interests of national
security.
``(2) Provision of information to member of the armed
forces.--If the Secretary makes a determination that it is
not feasible for the information required by subsection
(e)(1)(A)(ii) to

[[Page H6913]]

be provided to a member of the armed forces prior to the
administration of the product, such information shall be
provided to such member of the armed forces (or next-of-kin
in the case of the death of a member) to whom the product was
administered as soon as possible, but not later than 30 days,
after such administration. Information concerning the
administration of the product shall be recorded in the
medical record of the member.
``(3) Effect on statute pertaining to investigational new
drugs.--In the case of an authorization based on a
determination by the Secretary of Defense under subsection
(b)(1)(B), section 1107 of title 10, United States Code,
shall not apply to use of a product that is the subject of
such authorization, within the scope of such authorization
and while such authorization is effective.
``(l) 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--
``(1) shall not be subject to any requirements pursuant to
section 505(i) or 520(g); and
``(2) shall not be subject to any requirements otherwise
applicable to clinical investigations pursuant to other
provisions of this Act.
``(m) Discretion Regarding Use of Authorization.--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 notify 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 an activity or activities under the authorization.
This section does not have any legal effect on a person who
does not carry out any activity for which an authorization
under this section is issued, or who carries out such an
activity pursuant to other provisions of this Act or section
351 of the Public Health Service Act.
``(n) Enforcement.--A person who carries out an activity
pursuant to an authorization under this section, but who
fails to comply with applicable conditions under subsection
(e), is with respect to that act of noncompliance subject to
the provisions of law specified in subsection (a) and to the
enforcement of such provisions under section 301.''.

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 use of noncompetitive
procedures).
(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 use of
noncompetitive procedures).
(III) Subsection (c)(7)(C)(v) (relating to premium
provision in multiple-award contracts).

(iii) With respect to section 564 of the Federal Food,
Drug, and Cosmetic Act (as added by section 4 of this Act):

(I) Subsection (a)(1) (relating to emergency uses of
certain drugs and devices).
(II) Subsection (b)(1) (relating to a declaration of an
emergency).
(III) Subsection (e) (relating to conditions on
authorization).

(B) Contents of reports.--The Secretary shall annually
submit to the Congress 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; and
(iii) the identification of each person or entity that
received, or was considered and rejected for, grants,
cooperative agreements, or contracts pursuant to the use of
such authorities.
(2) Annual summaries regarding certain activity.--The
Secretary shall annually submit to the Congress 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.
(b) National Academy of Sciences Review.--Not later than
three years after the date of the enactment of this Act, the
Secretary of Health and Human Services shall request the
National Academy of Sciences to enter into an agreement for a
review of the biomedical countermeasure research and
development authorities established in this Act to determine
whether and to what extent activities undertaken pursuant to
such authorities have enhanced the development of biomedical
countermeasures affecting national security, and to recommend
any legislative or administrative changes necessary to
improve the ability of the Secretary to carry out these
activities in the future. The Secretary shall ensure that the
results of the study are submitted to the Congress not later
than five years after such date of enactment.
(c) General Accounting Office Review.--Four years after the
date of the enactment of this Act, the Comptroller General of
the United States shall initiate a study--
(1)(A) to review the Secretary of Health and Human
Services' utilization of the authorities granted under this
Act with respect to simplified acquisition procedures, use of
noncompetitive procedures, increased micropurchase
thresholds, personal services contracts, streamlined
personnel authority, and the purchase of security
countermeasures under the special reserve fund; and
(B) to recommend any legislative or administrative changes
necessary to improve the utilization or effectiveness of such
authorities in the future;
(2)(A) to review the internal controls instituted by such
Secretary with respect to such authorities, where required by
this Act; and
(B) to recommend any legislative or administrative changes
necessary to improve the effectiveness of such controls; and
(3)(A) 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
(B) to recommend any legislative or administrative changes
necessary to improve the utilization or effectiveness of such
authority and to enhance protection of the public health.
The results of the study shall be submitted to the Congress
not later than five years after the date of the enactment of
this Act.

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Project BioShield Act of
2003''.

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 BIOMEDICAL COUNTERMEASURE RESEARCH
AND DEVELOPMENT ACTIVITIES.

[[Page H6914]]

(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).
``(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.
``(2) Use of noncompetitive procedures.--In addition to any
other authority to use procedures other than competitive
procedures, the Secretary may use such other procedures
when--
``(A) the procurement is as described by paragraph (1); and
``(B) the property or services needed by the Secretary 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 Secretary's needs.
``(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.
``(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 subsequent phases of a research grant 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 or cooperative
agreement.
``(d) Authority for Personal Services Contracts.--
``(1) In general.--For the purpose of performing,
administering, and 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 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 person, officer, employee, or governing board member.
``(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 such 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) 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
(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 fiscal year 2003.''.

SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT.

(a) In General.--Part B of title III of the Public Health
Service Act, as amended by section 2 of this Act, is amended
by inserting after section 319F-1 the following section:

``SEC. 319F-2. STRATEGIC NATIONAL STOCKPILE.

[[Page H6915]]

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; and
``(F) 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
priority countermeasure (as defined in section 319F(h))--
``(i) against a chemical, biological, radiological, or
nuclear agent identified as a material threat under paragraph
(2)(A)(ii);
``(ii) that is determined under paragraph (2)(B)(ii) to be
a necessary countermeasure;
``(iii) that is designed, developed, modified, or procured
for the specific purpose of preventing, detecting,
identifying, deterring, or mitigating actual or potential
acts of chemical, biological, radiological, or nuclear
catastrophe;
``(iv)(I) that is approved or cleared under chapter V of
the Federal Food, Drug, and Cosmetic Act, or licensed under
section 351 of this Act, for use as a countermeasure to a
chemical, biological, radiological, or nuclear agent
identified as a material threat under paragraph (2)(A)(ii);
or
``(II) 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 after
the date of a determination under paragraph (5); and
``(v) that relates to an actual or potential act of
terrorism or catastrophic event or to actual or potential
warfare.
``(2) Determination of material threats.--
``(A) Material threat.--The Homeland Security Secretary, in
consultation with 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.
``(B) Public health impact; necessary countermeasures.--The
Secretary shall on an ongoing basis--
``(i) assess the potential public health consequences of
use against the United States population of agents identified
under subparagraph (A)(ii); and
``(ii) determine, on the basis of such assessment, the
agents for which priority countermeasures are necessary to
protect the public health from a material threat.
``(C) Notice to congress.--The Secretary and the Homeland
Security Secretary shall promptly notify the designated
congressional committees (as defined in paragraph (10)) of
any determination made pursuant to subparagraph (A) or (B).
Such notice shall be in unclassified and, if necessary,
classified form.
``(D) Assuring access to threat information.--In making the
assessment and determination required under subparagraph (A),
the Homeland Security Secretary shall use all 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 or available under unsuitable
conditions, 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, 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) a 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
five 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 (2), (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 congress.--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
identification of the potential supplier or 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

[[Page H6916]]

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 agreements.--
``(i) For procurement.--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 the Secretary's
costs of such procurement, other than as provided in clause
(ii).
``(ii) For administrative costs.--The agreement entered
into between the Homeland Security Secretary and the
Secretary for managing the stockpile under subsection (a)
shall provide for reimbursement of the Secretary's
administrative costs relating to procurements under this
subsection.
``(C) Procurement.--
``(i) In general.--The Secretary shall be responsible for--

``(ii) Contract terms.--A contract for procurements under
this subsection shall (or, as specified below, may) include
the following terms:

``(II) 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.
``(III) 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.
``(IV) Non-stockpile sales of security countermeasures.--
The contract may provide that the vendor will not at any time
(including after performance under the contract is otherwise
completed) sell or otherwise provide such countermeasure to
any domestic or foreign person, or transfer to any such
person any quantity of such security countermeasure, or any
intellectual property relating thereto that would enable the
development or production of the countermeasure, without
certification by the Secretary, in consultation with the
Homeland Security Secretary, the Secretary of Defense, and
the Secretary of State, that such sale or transfer, or
category of sales or transfers, would not adversely affect
the national security; and that, for each violation of this
provision of the contract, the United States is entitled to
recover from the person as liquidated damages an amount equal
to three times the sum of the payments made to the vendor
under the contract.

``(iii) Availability of simplified acquisition
procedures.--

``(I) In general.--The amount of any 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--

``(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):

``(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).
``(iv) Use of noncompetitive procedures.--In addition to
any other authority to use procedures other than competitive
procedures, the Secretary may use such other procedures for a
procurement under this subsection if the product is available
from only one responsible source or only from a limited
number of responsible sources, and no other type of product
will satisfy the Secretary's needs.
``(v) Premium provision in multiple award contracts.--

``(aa) identifies an increment of the total quantity of
security countermeasure required, whether by percentage or by
numbers of units; and
``(bb) promises to pays 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.

``(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 2003; or
``(B) administrative costs.
``(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 Committee on Health, Education,
Labor, and Pensions, the Committee on Appropriations, and the
Committee on Government Affairs.
``(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 Homeland Security
Secretary and a vendor

[[Page H6917]]

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 under subsection (c)(10).
``(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) Amendment 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 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 appropriations account established as a result of
any appropriations made under subsection (a).
``(c) Availability.--
``(1) Integrity of special reserve fund; limitation of
obligational authority to fund purposes; intent of congress
against reprogramming.--Subject to paragraph (2), all amounts
appropriated under subsection (a) are available for
obligation through the end of fiscal year 2013 and only for
the specific purposes set forth in the security
countermeasures program. It is the intent of the Congress
that no portion of such amount that remains unobligated for
such purposes shall be applied, through reprogramming or
otherwise, to any other purpose.
``(2) Initial availability for particular procurements.--
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 $5,000,000 for fiscal
year 2004, and such sums as may be necessary for each of the
fiscal years 2005 and 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 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
December 31, 2003, 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 2003 through
2006.
``(e) Emergency Development of Security Countermeasures.--
If the Secretary of Homeland Security and the Secretary of
Health and Human Services jointly determine that procurement
of a security countermeasure that has been approved for
procurement using the special reserve fund under subsection
(a)--
``(1) is not proceeding at a sufficiently rapid pace under
319F-2 of the Public Health Service Act to protect the
national security; or
``(2) could be produced significantly less expensively by
the government directly than through procurements under such
section;
then amounts in the special reserve fund may be used by the
Secretary of Health and Human Services to produce security
countermeasures for placement in the stockpile under
subsection (a) of section 319F-2 of such Act if the joint
determination is submitted to the President and the President
approves such use of the special reserve fund. Amounts made
available for such use in accordance with the preceding
sentence are available for obligation as of the date on which
the presidential approval is made, subject to applicable law
regarding the apportionment of appropriations. This
subsection applies notwithstanding other provisions of this
section, and notwithstanding section 319F-2 of the Public
Health Service Act. This subsection may not be construed as
affecting the amounts specified in subsection (a) as
authorizations of appropriations or the obligation limits
contained therein.''.
(c) Conforming Amendment.--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 repealed. With
respect to the program established under former section 121
of such Act, the repeal of such section under the preceding
sentence applies as a modification of the program in
accordance with the amendment made by subsection (a) of this
section, and not as the termination of the program and the
establishment of a different program.

SEC. 4. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN
EMERGENCIES.

Subchapter E of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding
at the end the following section:

``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 or device
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 `emergency use' has the meaning indicated
for such term in paragraph (1).
``(B) The term `product' means a drug or device.
``(C) The term `unapproved product' has the meaning
indicated for such term in paragraph (2)(A).
``(D) 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 national emergency, or a significant
potential for a national 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 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,
affecting national security and involving 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.
``(3) Advance notice of termination.--In terminating a
declaration under this section, the Secretary shall provide
advance notice that the declaration 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 shipments of the product, including
the return of such shipments to the manufacturer (in the case
of a manufacturer that chooses to have the shipments
returned); and

[[Page H6918]]

``(B) in the case of unapproved uses of approved products,
a sufficient period for the disposition of any labeling that
was provided with respect to the emergency use involved.
``(4) Publication.--The Secretary shall promptly publish in
the Federal Register each declaration, determination, 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 detecting,
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 or approved
under this Act or the Public Health Service Act, for
detecting, 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 detect, 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 detecting, 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.--
``(1) In general.--An authorization of a product under this
section shall state--
``(A) each disease or condition that the product may be
used to detect, diagnose, prevent, or treat within the scope
of the authorization;
``(B) the Secretary's conclusions, made under subsection
(c)(2)(B), that the known and potential benefits of the
product, when used to detect, diagnose, prevent, or treat
such disease or condition, outweigh the known and potential
risks of the product; and
``(C) the Secretary's conclusions, made under subsection
(c), concerning the safety and potential effectiveness of the
product in detecting, diagnosing, preventing, or treating
such diseases or conditions, including an assessment of the
available scientific evidence.
``(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.
``(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
feasible given the circumstances of the emergency, shall, for
persons who choose to carry out one or more activities 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, to
the extent feasible given the circumstances of the emergency,
health care professionals administering the product are
informed--

``(ii) Appropriate conditions designed to ensure that, to
the extent feasible given the circumstances of the emergency,
individuals to whom the product is administered are
informed--

[[Page H6919]]

days, after such administration. Information concerning the
administration of the product shall be recorded in the
medical record of the member.
``(3) Effect on statute pertaining to investigational new
drugs.--In the case of an authorization based on a
determination by the Secretary of Defense under subsection
(b)(1)(B), section 1107 of title 10, United States Code,
shall not apply to use of a product that is the subject of
such authorization, within the scope of such authorization
and while such authorization is effective.
``(l) 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--
``(1) shall not be subject to any requirements pursuant to
section 505(i) or 520(g); and
``(2) shall not be subject to any requirements otherwise
applicable to clinical investigations pursuant to other
provisions of this Act.
``(m) Discretion Regarding Use of Authorization.--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 notify 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 an activity or activities under the authorization.
This section does not have any legal effect on a person who
does not carry out any activity for which an authorization
under this section is issued, or who carries out such an
activity pursuant to other provisions of this Act or section
351 of the Public Health Service Act.
``(n) Enforcement.--A person who carries out an activity
pursuant to an authorization under this section, but who
fails to comply with applicable conditions under subsection
(e), is with respect to that act of noncompliance subject to
the provisions of law specified in subsection (a) and to the
enforcement of such provisions under section 301.''.

SEC. 5. REPORTS REGARDING AUTHORITIES UNDER THIS ACT.

(ii) With respect to section 319F-2 of the Public Health
Service Act (as added by section 3 of this Act):

(iii) With respect to section 564 of the Federal Food,
Drug, and Cosmetic Act (as added by section 4 of this Act):

(B) Contents of reports.--The Secretary shall annually
submit to the designated congressional committees (as defined
in subsection (e)) 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 identification of each person or entity that
received, or was considered and rejected for, grants,
cooperative agreements, or contracts pursuant to the use of
such authorities; 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 not 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.
(b) National Academy of Sciences Review.--
(1) In general.--Not later than four years after the date
of the enactment of this Act, the Secretary of Health and
Human Services shall request the National Academy of Sciences
to enter into an agreement for a review of the biomedical
countermeasure research and development authorities
established in this Act to determine whether and to what
extent activities undertaken pursuant to such authorities
have enhanced the development of biomedical countermeasures
affecting national security, and to recommend any legislative
or administrative changes necessary to improve the ability of
the Secretary to carry out these activities in the future.
The Secretary shall ensure that the results of the study are
submitted to the designated congressional committees not
later than five years after such date of enactment.
(2) Certain contents.--The report under paragraph (1) shall
include--
(A) a summary of the most recent analysis by the Department
of Homeland Security and the intelligence community of the
domestic threat from chemical, biological, radiological, and
nuclear agents;
(B) the Academy's assessment of the current availability of
countermeasures to address such threats;
(C) the Academy'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
(D)(i) the Academy'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, and 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.
(c) General Accounting Office Review.--Four years after the
date of the enactment of this Act, the Comptroller General of
the United States shall initiate a study--
(1)(A) to review the Secretary of Health and Human
Services' utilization of the authorities granted under this
Act with respect to simplified acquisition procedures, use of
noncompetitive procedures, increased micropurchase
thresholds, personal services contracts, streamlined
personnel authority, and the purchase of security
countermeasures under the special reserve fund; and
(B) to recommend any legislative or administrative changes
necessary to improve the utilization or effectiveness of such
authorities in the future;
(2)(A) to review the internal controls instituted by such
Secretary with respect to such authorities, where required by
this Act; and
(B) to recommend any legislative or administrative changes
necessary to improve the effectiveness of such controls; and
(3)(A) 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
(B) to recommend any legislative or administrative changes
necessary to improve the utilization or effectiveness of such
authority and to enhance protection of the public health.
The results of the study shall be submitted to the designated
congressional committees not later than five years after the
date of the enactment of this Act.
(d) Report Regarding Additional Barriers to Procurement of
Security Countermeasures.--Not later than 180 days after the
date of the enactment of this Act, the Secretary of Homeland
Security and the Secretary of Health and Human Services shall
report to the designated congressional committees any
barriers to the procurement of security countermeasures that
have not been addressed by this Act.
(e) Status of Program for Chemical Terrorism
Preparedness.--Not later than 180 days after the date of the
enactment of this Act, the Secretary of Homeland Security
shall submit to the designated congressional committees a
report describing the status of the program carried out by
the Secretary to enhance the preparedness of the United
States to respond to terrorist attacks involving chemical
agents.
(f) 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).

[[Page H6920]]

(2) In the Senate: the Committee on Health, Education,
Labor, and Pensions, the Committee on Appropriations, and the
Committee on Government Affairs.

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
Hispanics, Native Americans, Asian-Pacific Americans, or
other underrepresented populations, are meaningfully aware of
available research and development grants and procurements
conducted under sections 2 and 3 of this Act.

SEC. 7. 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 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 such
domestic incidents, 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.

The SPEAKER pro tempore. In lieu of the amendments recommended by the
Committee on Government Reform and the Select Committee on Homeland
Security printed in the bill, the amendment in the nature of a
substitute designate in the previous order of the House is adopted.
The text of the amendment in the nature of a substitute is as
follows:

Strike all after the enacting clause and insert the
following:

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Project BioShield Act of
2003''.

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 biomedical countermeasures
under section 319F(h), the Secretary may conduct and support
such activities in accordance with this section if the
activities concern qualified countermeasures.
``(2) Qualified countermeasure.--For purposes of this
section, the term `qualified countermeasure' means a priority
countermeasure (as defined in section 319F(h) and as
determined by the Secretary in accordance with such section
and consistent with sections 302(2) and 304(a) of the
Homeland Security Act of 2002) against a chemical,
biological, radiological, or nuclear agent that may cause a
public health emergency affecting national security.
``(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) Tranfers of qualifed 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).
``(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.
``(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
applicable government-wide regulations, 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.
``(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 any other provision
of law, including subsection (f), 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 any other
provision of law, 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

[[Page H6921]]

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 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.
``(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 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 person, officer, employee, or governing board member.
``(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 such 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) 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)--
(A) by inserting ``or the Director of the National
Institute of Allergy and Infectious Diseases'' after
"Director of the Center''; and
(B) by inserting ``, or in the case of the Institute, to
any qualified public or private entity,'' after ``private
entities'';
(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
(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 2003 and
2004.''.
(c) Additional Authority.--Section 319F of the Public
Health Service Act (42 U.S.C. 247d-6) is amended--
(1) by redesignating subsections (i) and (j) as subsections
(j) and (k), respectively; and
(2) by inserting after subsection (h) the following
subsection:
``(i) Priority Countermeasures for Strategic National
Stockpile.--
``(1) In general.--The Secretary, taking into consideration
any recommendations of the working group under subsection
(a), may initiate and sustain a program that results in the
delivery of priority countermeasures for placement in the
stockpile under section 319F-2.
``(2) Authorization of appropriations.--For the purpose of
carrying out paragraph (1), there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2004 through 2013.''.
(d) 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 through
2013.''; 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 through
2013.''.
(e) 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''.
(f) 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.

[[Page H6922]]

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; and
``(F) 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
priority countermeasure (as defined in section 319F(h) and as
determined by the Secretary in accordance with such section
and consistent with sections 302(2) and 304(a) of the
Homeland Security Act of 2002) that--
``(i)(I) is against a chemical, biological, radiological,
or nuclear agent identified as a material threat under
paragraph (2)(A)(ii);
``(II) is determined 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, for use as a countermeasure to a
chemical, biological, radiological, or nuclear agent
identified as a material threat under paragraph (2)(A)(ii);
or
``(bb) is a priority 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 after the date of a determination under
paragraph (5); or
``(ii) is authorized under section 564 of the Federal Food,
Drug, and Cosmetic Act for emergency use.
``(2) Determination of material threats.--
``(A) Material threat.--The Homeland Security Secretary, in
consultation with 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.
``(B) Public health impact; necessary countermeasures.--The
Secretary shall on an ongoing basis--
``(i) assess the potential public health consequences of
use against the United States population of agents identified
under subparagraph (A)(ii); and
``(ii) determine, on the basis of such assessment, the
agents for which priority countermeasures are necessary to
protect the public health from a material threat.
``(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). Such notice shall be in unclassified or, if necessary,
classified form.
``(D) Assuring access to threat information.--In making the
assessment and determination required under subparagraph (A),
the Homeland Security Secretary shall use all 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, 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
five 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 identification of the potential supplier
or 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

[[Page H6923]]

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 agreements.--
``(i) For procurement.--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 the Secretary's
costs of such procurement, other than as provided in clause
(ii).
``(ii) For administrative costs.--The agreement entered
into between the Homeland Security Secretary and the
Secretary for managing the stockpile under subsection (a)
shall provide for reimbursement of the Secretary's
administrative costs relating to procurements under this
subsection.
``(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 substantial delivery.--The
contract shall provide that no payment may be made until
delivery has been made of a substantial portion (as
determined by 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 under the contract,
except in special circumstances as determined by the
Secretary on a contract by contract basis. 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) 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.
``(III) 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.
``(IV) 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.--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
applicable government-wide regulations, 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.

``(v) Premium provision in multiple award contracts.--

``(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 2003; or
``(B) administrative costs.
``(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 Committee on Health, Education,
Labor, and Pensions, the Committee on Appropriations, and the
Committee on Government Affairs.
``(d) Disclosures.--No Federal agency shall disclose under
section 552 of title 5,

[[Page H6924]]

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 under subsection (c)(10).
``(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) Amendment 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 by adding at the end the following:

``SEC. 510. PROCUREMENT OF SECURITY COUNTERMEASURES FOR
STRATEGIC NATIONAL STOCKPILE.

SEC. 4. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN
EMERGENCIES.

Subchapter E of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding
at the end the following section:

``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 national emergency, or a significant
potential for a national 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 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,
affecting national security and involving 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.
``(3) Advance notice of termination.--In terminating a
declaration under this section, the Secretary shall provide
advance notice that the declaration 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 shipments of the product, including
the return of such shipments to the manufacturer (in the case
of a manufacturer that chooses to have the shipments
returned); and
``(B) in the case of unapproved uses of approved products,
a sufficient period for the disposition of any labeling that
was provided with respect to the emergency use involved.
``(4) Publication.--The Secretary shall promptly publish in
the Federal Register each declaration, determination, 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 detecting,
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 or approved
under this

[[Page H6925]]

Act or the Public Health Service Act, for detecting,
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 detect, 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 detecting, 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.--
``(1) In general.--An authorization of a product under this
section shall state--
``(A) each disease or condition that the product may be
used to detect, diagnose, prevent, or treat within the scope
of the authorization;
``(B) the Secretary's conclusions, made under subsection
(c)(2)(B), that the known and potential benefits of the
product, when used to detect, diagnose, prevent, or treat
such disease or condition, outweigh the known and potential
risks of the product; and
``(C) the Secretary's conclusions, made under subsection
(c), concerning the safety and potential effectiveness of the
product in detecting, diagnosing, preventing, or treating
such diseases or conditions, including an assessment of the
available scientific evidence.
``(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.
``(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
feasible given the circumstances of the emergency, shall, for
persons who choose to carry out one or more activities 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, to
the extent feasible given the circumstances of the emergency,
health care professionals administering the product are
informed--

``(ii) Appropriate conditions designed to ensure that, to
the extent feasible given the circumstances of the emergency,
individuals to whom the product is administered are
informed--

``(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, to
the extent feasible given the circumstances of the emergency,
may, for persons who choose to carry out one or more
activities 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) 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.
``(iv) With respect to the emergency use of the product,
waive or limit, to the extent appropriate given the
circumstances of the emergency, conditions 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 in section 501.
``(2) Unapproved use.--With respect to the emergency use of
a product that is an unapproved use of an approved product:
``(A) The Secretary may, for manufacturers of the product
who choose to carry out one or more activities for which the
authorization is issued, establish any of the conditions
described in clauses (i) through (iv) of paragraph (1)(A).
``(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), an
authorization under this section regarding the emergency use
may, for persons who do not manufacture the product and who
choose to act under this clause, authorize such persons to
provide information on the product in addition to the
labeling provided by the manufacturer, subject to compliance
with clause (i). Such additional information shall not be
considered labeling for purposes of section 502.
``(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.--
Notwitstanding the termination of the declaration under
subsection (b) or a revocation under subsection (g), an
authorization shall continue to be effective for continued
use with respect to patients to whom it was administered
during the period described by paragraph (1), to the extent
found necessary by such patients' attending physicians.
``(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, in the Secretary's
unreviewable discretion, the criteria under subsection (c)
for issuance of such authorization are no longer met.
``(h) Publication.--The Secretary shall promptly publish in
the Federal Register a notice of each authorization, and each
termination or revocation of an authorization, and an
explanation of the reasons therefor, under this section.
``(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.--Nothing in this section shall
be construed to impair or otherwise affect--
``(1) 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) the authority of the Secretary of Defense with
respect to the Department of Defense, including the armed
forces, under other provisions of Federal law; or
``(3) the authority of the Secretary under section 319F-2
to manage the stockpile under such section.
``(k) Application to Members of Armed Forces.--
``(1) Waiver of requirement relating to option to refuse.--
In the case of administration of a countermeasure to members
of the armed forces, a requirement, under subsection
(e)(1)(A)(ii)(III), designed to ensure that individuals are
informed of an option to accept or refuse administration of a
product, may be waived by the President if the President
determines, in writing, that complying with such requirement
is not feasible, is contrary to the best interests of the
members affected, or is not in the interests of national
security.
``(2) Provision of information to member of the armed
forces.--If the Secretary makes a determination that it is
not feasible for the information required by subsection
(e)(1)(A)(ii) to be provided to a member of the armed forces
prior to the administration of the product, such information
shall be provided to such member of the armed forces (or
next-of-kin in the case of the death of a member) to whom the
product was administered as soon as possible, but not later
than 30 days, after such administration. Information
concerning the administration of the product shall be
recorded in the medical record of the member.
``(3) Effect on statute pertaining to investigational new
drugs.--In the case of an authorization based on a
determination by the Secretary of Defense under subsection
(b)(1)(B), section 1107 of title 10, United States Code,
shall not apply to use of a product that is the subject of
such authorization, within the scope of such authorization
and while such authorization is effective.
``(l) 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 --
``(1) shall not be subject to any requirements pursuant to
section 505(i) or 520(g); and
``(2) shall not be subject to any requirements otherwise
applicable to clinical investigations pursuant to other
provisions of this Act.

[[Page H6926]]

``(m) Discretion Regarding Use of Authorization.--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 notify 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 an activity or activities under the authorization.
This section does not have any legal effect on a person who
does not carry out any activity for which an authorization
under this section is issued, or who carries out such an
activity pursuant to other provisions of this Act or section
351 of the Public Health Service Act.
``(n) Enforcement.--A person who carries out an activity
pursuant to an authorization under this section, but who
fails to comply with applicable conditions under subsection
(e), is with respect to that act of noncompliance subject to
the provisions of law specified in subsection (a) and to the
enforcement of such provisions under section 301.''.

SEC. 5. REPORTS REGARDING AUTHORITIES UNDER THIS ACT.

(I) Subsection (b)(1) (relating to increased simplified
acquisition threshold).
(II) Subsection (b)(2) (relating to procedures other than
full and open competition).
(III) Subsection (c) (relating to expedited peer review
procedures).

(ii) With respect to section 319F-2 of the Public Health
Service Act (as added by section 3 of this Act):

(I) Subsection (c)(7)(C)(iii) (relating to simplified
acquisition procedures).
(II) Subsection (c)(7)(C)(iv) (relating to procedures other
than full and open competition).
(III) Subsection (c)(7)(C)(v) (relating to premium
provision in multiple-award contracts).

(iii) With respect to section 564 of the Federal Food,
Drug, and Cosmetic Act (as added by section 4 of this Act):

(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 identification of each person or entity that
received, or was considered and rejected for, grants,
cooperative agreements, or contracts pursuant to the use of
such authorities; 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.
(b) National Academy of Sciences Review.--
(1) In general.--Not later than four years after the date
of the enactment of this Act, the Secretary of Health and
Human Services shall request the National Academy of Sciences
to enter into an agreement for a review of the biomedical
countermeasure research and development authorities
established in this Act to determine whether and to what
extent activities undertaken pursuant to such authorities
have enhanced the development of biomedical countermeasures
affecting national security, and to recommend any legislative
or administrative changes necessary to improve the ability of
the Secretary to carry out these activities in the future.
The Secretary shall ensure that the results of the study are
submitted to the designated congressional committees not
later than five years after such date of enactment.
(2) Certain contents.--The report under paragraph (1) shall
include--
(A) a summary of the most recent analysis by the Department
of Homeland Security and the intelligence community of the
domestic threat from chemical, biological, radiological, and
nuclear agents;
(B) the Academy's assessment of the current availability of
countermeasures to address such threats;
(C) the Academy'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
(D)(i) the Academy'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.
(c) General Accounting Office Review.--Four years after the
date of the enactment of this Act, the Comptroller General of
the United States shall initiate a study--
(1)(A) 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
(B) to recommend any legislative or administrative changes
necessary to improve the utilization or effectiveness of such
authorities in the future;
(2)(A) to review the internal controls instituted by such
Secretary with respect to such authorities, where required by
this Act; and
(B) to recommend any legislative or administrative changes
necessary to improve the effectiveness of such controls; and
(3)(A) 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
(B) to recommend any legislative or administrative changes
necessary to improve the utilization or effectiveness of such
authority and to enhance protection of the public health.

The results of the study shall be submitted to the designated
congressional committees not later than five years after the
date of the enactment of this Act.
(d) Report Regarding Barriers to Procurement of Security
Countermeasures.--
(1) 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.
(2) Additional barriers.--Not later than one year after the
date of enactment of this Act, such Secretaries shall jointly
report to the designated congressional committees any other
potential barriers to the procurement of security
countermeasures that have not been addressed by this Act.
(e) Status of Program for Chemical Terrorism
Preparedness.--Not later than 270 days after the date of the
enactment of this Act, the Secretary of Homeland Security
shall submit to the designated congressional committees a
report describing the status of the program carried out by
the Secretary to enhance the preparedness of the United
States to respond to terrorist attacks involving chemical
agents.
(f) 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 Committee on Health, Education,
Labor, and Pensions, the Committee on Appropriations, and the
Committee on Government Affairs.

SEC. 6. OUTREACH.

[[Page H6927]]

large proportions of Hispanics, Native Americans, Asian-
Pacific Americans, 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.

The SPEAKER pro tempore. The gentleman from Louisiana (Mr. Tauzin)
and the gentleman from Ohio (Mr. Brown) each will control 30 minutes.
The gentleman from Virginia (Mr. Tom Davis) and the gentleman from
California (Mr. Waxman) each will control 7\1/2\ minutes. The gentleman
from California (Mr. Cox) and the gentleman from Texas (Mr. Turner)
each will control 7\1/2\ minutes.
The Chair recognize the gentleman from Louisiana (Mr. Tauzin).

General Leave

Mr. TAUZIN. 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 H.R. 2122.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Louisiana?
There was no objection.
Mr. TAUZIN. Mr. Speaker, I yield myself 4 minutes.
Today, Mr. Speaker, the House will address one of President Bush's
top initiatives in the war against terror, Project Bioshield.
Mr. Speaker, it is absolutely critical that America's public health
emergency system be prepared to respond to new and emerging threats,
and we are here today to take care of that job. This bipartisan
legislation is about the safety and security of American families and
of our country. America is stepping up to the profound threat of
terrorism and other public health emergencies, and I am proud to report
that H.R. 2122 combines smart policy and provides additional resources
to prepare the Nation for bioterrorism threats and for other public
health emergencies.
The chairman and ranking member of both the committees of
jurisdiction and the Select Committee of Homeland Security have arrived
at this consensus product that is before us today. I would like to
thank the gentleman from Michigan (Mr. Dingell), the gentleman from
Virginia (Mr. Tom Davis), the gentleman from California (Mr. Waxman),
the gentleman from California (Mr. Cox), the gentleman from Texas (Mr.
Turner) for their cooperation and hard work on this bill. This
bipartisan spirit is similar to last year's effort on the Public Health
Security and Bioterrorism Preparedness and Response Act that Senator
Kennedy and I had the privilege to move through the Congress last year.
Project Bioshield will spur the research and development of new
vaccines, drugs, and other countermeasures to deal with these
biological, chemical, nuclear or radiological agents that pose a
material threat to our Nation's security. The list includes, among
other dangerous agents, such things as anthrax, botulinum toxin, the
plague, ebola, and other similar viruses, many of which lack any
effective treatment or antidote today.
The bill before us accomplishes this goal by doing two important
things. First, it provides the needed flexibility in a range of areas
from government contracting rules to peer review to personnel matters
in order to speed up government-sponsored research and development into
these deadly agents. Second, it creates a special reserve fund of money
for the government to purchase these countermeasures that may
ultimately be developed in response to the President's call. Without
this clear commitment of funding in future years, private sector
companies that are capable of such development simply will not
undertake the heavy investment and risk associated with developing
products to deal with agents that do not affect significant populations
today and hopefully never will.
At our urging, the House has already provided an advanced
appropriations of $5.6 billion over the next 10 years for this purpose,
and this is all consistent with our authorization in the House budget
resolution.
The bill 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. Under current law, the only way an individual can receive an
unapproved product is pursuant to a clinical investigation. But in time
of national emergency, when this Nation is under attack, it may be
necessary to give such investigational drugs on a large scale basis to
millions of Americans. H.R. 2122 provides that if there is such an
emergency, and if no adequate alternative therapy is available, the
Secretary can authorize the use of a drug, device, or vaccine in such a
flexible manner.
While we have made improvements to the administration's initial
proposal in certain areas, our bill stays close to that original
proposal, granting all the additional flexibilities and authorities
requested by the President and even expanding them in some cases to
further encourage companies to heed our call for innovation.
Once again, I want to applaud the leadership of President Bush and
the truly bipartisan work of this body across multiple committees of
jurisdiction to protect our country and to promote public health
security from the many new dangers that we face today.
Mr. Speaker, I reserve the balance of my time.
Mr. BROWN of Ohio. Mr. Speaker, I yield myself 3\1/2\ minutes.
Mr. Speaker, this legislation is the product of a good-faith
bipartisan process. I want to thank the gentleman from Louisiana (Mr.
Tauzin), the gentleman from Florida (Mr. Bilirakis), as well as the
ranking member, the gentleman from Michigan (Mr. Dingell), for their
work on this bill.
The United States and the global community of which we are part can
only benefit from the development of bioterrorism countermeasures.
Because the very existence of countermeasures renders bioterrorism less
lethal and, therefore, less attractive to would-be terrorists, new
countermeasures, therefore, 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
quickly on that opportunity. That is the logic behind this legislation.
The bill establishes an expedited process for Federal support of
countermeasure research and a procurement process to encourage private
sector investment in this research. At the same time, Mr. Speaker, the
legislation is

[[Page H6928]]

not a blank check. Congress has a responsibility to weigh competing
funding priorities and set funding levels appropriately.
In that context, it is appropriate to reiterate a concern that I
raised last week while we debated the Labor, Health and Human Services
appropriations bill. Bioterrorism funding is essential and important.
The legislation before us is essential and important, but our
investment in bioterrorism should not and must not come at the expense
of research focusing on cancer and other health threats.
Let me repeat that. Our investment in bioterrorism should not and
must not come at the expense of research focusing on cancer and other
health threats. The appropriations bill we passed last week here funds
the National Institutes of Health at a level barely sufficient to
support existing research projects, much less new research. That is a
direct outgrowth from the tax cut that this Congress passed recently
and the tax cuts for the wealthiest, most privileged citizens this
Congress passed 2 years ago. It means we have not had enough money to
appropriate for basic research, for medical research for the National
Institutes of Health. It means it may be difficult for us in the future
to deal with bioterrorism funding as fully as we should.
This Congress has made choices by giving tax cuts to the wealthiest,
most privileged citizens, and as a result has made far too many cuts in
health care; and health care is clearly inadequately funded, as our
committee has discussed over and over again.
Mr. Speaker, finding ways to prevent and to treat and to cure disease
is an enduring national priority. Interest in it does not wax, does not
wane. Our investment in it should not either. We need to make these
decisions in a way that serves the public and serves the interest of
more medical research. We have a responsibility to balance priorities
to provide adequate resources to prepare the country for a possible
bioterrorist attack while maintaining strong support for other medical
research priorities.
Mr. Speaker, I hope we can work on a bipartisan basis to restore the
momentum that we once had behind groundbreaking medical research while
continuing to move forward in the area of bioterrorism preparedness.
This legislation before us today promotes the latter goal, and I urge
my colleagues to support it. I thank the gentleman from Louisiana (Mr.
Tauzin), the gentleman from Florida (Mr. Bilirakis), the gentleman from
Michigan (Mr. Dingell), the gentleman from Massachusetts (Mr. Markey),
and others who worked on this legislation.
Mr. Speaker, I yield 5 minutes to the gentleman from Massachusetts
(Mr. Markey), my good friend.
Mr. MARKEY. Mr. Speaker, I thank the gentleman from Ohio (Mr. Brown)
for yielding me time.
I rise for the purpose of entering into a colloquy with the gentleman
from Louisiana (Mr. Tauzin).
I want to commend the chairman and his staff along with the gentleman
from California (Mr. Cox); the ranking member, the gentleman from
Michigan (Mr. Dingell); and the gentleman from Ohio (Mr. Brown); and
the ranking member, the gentleman from Texas (Mr. Turner) for all of
their hard work and for working with me and my staff in a bipartisan
fashion that ultimately led to a resolution of all of the concerns
which I raised with the legislation.
I do have, however, two outstanding issues that I wish to clarify at
this time. Mr. Speaker, I have concerns that relate to the emergency
use section of Project Bioshield. Specifically, I want to be sure that
once a declaration of an emergency is terminated or revoked, that
current law applies and it will then be impermissible for anyone to
move such drugs, devices or biologics in interstate commerce without
going through the proper approval process. Is this the case under the
legislation?
Mr. TAUZIN. Mr. Speaker, will the gentleman yield?
Mr. MARKEY. I yield to the gentleman from Louisiana.
Mr. TAUZIN. The gentleman is correct. Like you, I too want to ensure
that unapproved products are available in times of emergency. And while
we allow the FDA to make products available during such time of
emergency, absent such emergency, current law applies. We do allow for
the shipments of such therapies in limited circumstances, namely, where
a physician authorizes the continued treatment of an individual who
initially received the drug during an emergency. However, this is the
only exception. Absent that, present law applies to these unapproved
products.
Mr. MARKEY. I thank the gentleman.
Secondly, I very much appreciate the gentleman's work on crafting
language to ensure that the countermeasures developed under this
legislation are, where necessary, subject to the same export control
laws and regulations as other chemical and biological agents and their
associated countermeasures. One of the new responsibilities the
Secretary of HHS is directed to assume is to review new countermeasures
both in the R&D phase as well as in the procurement phase of the
Bioshield Program. The Secretary is encouraged to consult with other
Federal agencies who play a role in setting export control policy and
to recommend whether the new countermeasure or countermeasure R&D
should be added to the various lists of controlled technologies that
cannot be transferred to other countries without prior permission.
Is it your understanding that the Secretary should do this as
expeditiously as possible, and that each beneficiary of Bioshield funds
be directed as part of the contract or grant to abide by all applicable
U.S. export laws governing the transfer of technology and R&D?
Mr. TAUZIN. The gentleman is absolutely correct. The Secretary should
perform these reviews as expeditiously as possible once the R&D or
procurement has started so as to prevent any exports of countermeasures
or countermeasure R&D that could harm our U.S. national security.
Mr. MARKEY. I just want to thank the chairman. He has worked very
hard and long on this legislation. I want to thank the gentleman's
staff and Kendra Bodner from my staff for working out this language.
Mr. TAUZIN. Let me thank the gentleman from Massachusetts (Mr.
Markey). He raised a great number of concerns as we went true this
process. I want to thank the gentleman for the way in which he worked
with Members on both sides of the aisle so we cannot only take care of
those concerns but produce a great product for the security of our
country, and he has added immeasurably to that effort.
Mr. MARKEY. Good job, Mr. Chairman, and good job to everyone who has
worked on this bill on both sides of the aisle.
Mr. TAUZIN. Mr. Speaker, I yield 3 minutes to the gentleman from Ohio
(Mr. LaTourette).
Mr. LaTOURETTE. Mr. Speaker, I thank the chairman for yielding to me
for the purpose of a colloquy in order to clarify the intent of two
provisions.
This legislation authorizes the director of the National Institute of
Allergies and Infectious Diseases to issue grants to non-Federal
entities for the construction and operation of specialized research
facilities. A second provision of the bill authorizes the Secretary of
HHS to take control of these facilities in the event or threat of
bioterror emergency.
As you know, the Public Buildings Act of 1959, which is under the
exclusive jurisdiction of the Committee on Transportation and
Infrastructure, governs the construction, acquisitions, repair and
alteration of public buildings, including many laboratories and
research facilities.
Mr. Chairman, am I correct that nothing in this legislation exempts
the Secretary of HHS or the director of the institute from the
requirements of the Public Buildings Act?
Mr. TAUZIN. Mr. Speaker, will the gentleman yield?
Mr. LaTOURETTE. I yield to the gentleman from Louisiana.
Mr. TAUZIN. The gentleman is absolutely correct. These provisions do
not preempt the Public Buildings Act to the extent that it would
otherwise apply to such activities.

{time} 1415

Mr. LaTOURETTE. Mr. Speaker, it is also my understanding that the
facilities authority granted to the Secretary of HHS and the Director
of the Institute of Diseases is intended only for

[[Page H6929]]

special use facilities, which do not meet the definition of a public
building under the Public Buildings Act. Is that also correct?
Mr. TAUZIN. Mr. Speaker, if the gentleman will continue to yield,
that is also correct. The Project Bioshield Act authorizes the
construction of highly specialized laboratories, all of which I would
expect to be biosafety level 3 or 4 laboratories unsuitable for general
purpose use. Project Bioshield does not authorize the construction of
``public buildings'' as defined by the Public Buildings Act of 1959.
Mr. LaTOURETTE. Mr. Speaker, lastly, it is my understanding that the
march in authority granted the Secretary of HHS is intended to give the
Secretary control of these facilities for a limited period of time
only. Is that also correct?
Mr. TAUZIN. If the gentleman would continue to yield, that is also
correct. The authority allows the Secretary to take control of these
facilities only during, and as necessary to respond to, public health
emergencies affecting national security. Under the Bioterrorism
Response Act passed last year, a public health emergency can be
declared by the Secretary for up to 90 days at a time; and although the
Secretary may extend the designation for multiple 90-day periods, it is
not the intention of this legislation to allow the Secretary to control
a facility for the useful life of that facility.
Mr. LaTOURETTE. Mr. Speaker, I thank the chairman for the
clarification.
Mr. BROWN of Ohio. Mr. Speaker, I reserve the balance of my time.
Mr. TAUZIN. Mr. Speaker, I yield myself such time as I may consume.
(Mr. TAUZIN asked and was given permission to revise and extend his
remarks, and include extraneous material.)
Mr. TAUZIN. Mr. Speaker, I think we have a couple of other Members
who need to do colloquies.
While we are waiting, I wanted to take this time, Mr. Speaker, to
refer to a letter received today from the Secretary of Health and Human
Services, Secretary Tommy Thompson, dated July 16, 2003; and I want to
place the letter in the Record at this point.

The Secretary of Health

and Human Services,

Washington, DC, July 16, 2003.
Hon. Billy Tauzin,
Chairman, Committee on Energy and Commerce, House of
Representatives, Washington, DC.
Dear Chairman Tauzin: Thank you for your leadership on H.R.
2122, the Project BioShield Act of 2003. This legislation is
a critical step toward strengthening our ability to protect
Americans against chemical, biological, radiological and
nuclear threats.
H.R. 2122 would: (1) speed the Government's ability to turn
promising scientific discoveries into necessary
countermeasures by one-third or more; (2) authorize funding
to purchase critical new countermeasures targeted against the
most worrisome threats; and (3) allow the Food and Drug
Administration to make promising treatments quickly available
to Americans in emergency situations.
I would like to address two issues that have arisen as the
House takes up this vital priority. First, I share
Representative Wamp's interest in building domestic capacity
to produce countermeasures. In implementing Project
BioShield, I will do everything in my power to purchase from
domestic sources. To have a secure supply, we must build
capacity within the United States and my department is
committed to achieving that objective. The essential purpose
of Project BioShield is to ensure we have necessary and
timely countermeasures. We cannot achieve this goal by
relying on foreign sources. Building a robust domestic
capacity to produce countermeasures is, therefore, at the
very heart of Project BioShield.
Second, I agree with Representative Jackson-Lee that the
Strategic National Stockpile must serve all areas of the
Nation, including rural areas. The Centers for Disease
Control and Prevention has positioned stockpile assets to
deliver needed medical supplies anywhere in the country
within 12 hours. I have a personal understanding of the
challenges that rural areas face and share Representative
Jackson-Lee's interest in rural America. My department is
pro-actively working with state and local health departments
to ensure the effective and timely delivery of stockpile
assets to both rural and urban parts our Nation.
If I can provide you or the members of the Committee with
any further information or if I can otherwise be of
assistance, please do not hesitate to contact me.
Sincerely,
Tommy G. Thompson.

Mr. Speaker, I wanted to refer to it because the Secretary refers to
several concerns raised by other Members of the House, of which I also
share with him, and I think we will have a colloquy on one of those.
The first is a concern by the gentleman from Tennessee (Mr. Wamp)
whose interest is in building domestic capacity to produce
countermeasures; and, indeed, the Secretary indicates in his letter
that it is indeed his desire to make sure those countermeasures are
developed within this country. We cannot achieve the goal of securing
our country if indeed we rely upon foreign sources for these measures;
and, therefore, the building of robust domestic capacity to produce
these countermeasures is at the very heart of the Bioshield Project.
I wanted to assure my friend, the gentleman from Tennessee (Mr.
Wamp), that I share the Secretary's comments and his intentions in that
regard.
Secondly, the gentlewoman from Texas (Ms. Jackson-Lee) was concerned
that strategic national stockpile must be developed in such a way as to
serve rural areas of the country, not simply the urban areas of our
country, because rural areas can be affected by these bioterrorism
threats just as easily, obviously, as urban areas. The Secretary
indicates that the Centers for Disease Control and Prevention has
positioned stockpile assets anywhere in the country, delivery within 12
hours, in effect making sure that rural areas are not left out of the
protection of this bill and the other bioterrorism bills that have
passed the House and are part of the Centers for Disease Control
stockpiles and distribution system.
So that those two concerns by our colleagues are addressed in this
letter, and I wanted to share with those colleagues my agreement with
the Secretary on both of those points.
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.
Mr. Speaker, I share the comments both of the chairman of the
committee and Secretary Thompson in his letter that the chairman just
mentioned.
I applaud the gentleman from Tennessee's (Mr. Wamp) interest in
building domestic capacity; and in terms of purchasing from domestic
sources, I think that is an important thing that this Congress too
often forgets. When we look at our trade policy, often that tends to
favor investors and tends often to hurt workers, both in this country
and internationally, whether it is the Singapore-Chile agreement coming
up or whether it is the fast track authority that this Congress I think
wrongly gave the President fairly recently.
I also support the efforts of the gentlewoman from Texas (Ms.
Jackson-Lee) from Houston in terms of serving all the Nation, including
rural areas. I think that our ability to deliver all kinds of health
care, all kinds of public health care, especially in rural areas and
urban areas alike, is especially important.
And I want to reiterate from my opening comments, Mr. Speaker, that
while Bioshield is so very, very, very important and it gives us great
opportunity to further develop our public health system, it is
important that we keep in mind our long-standing, day-to-day public
health system.
Bioshield can serve some synergism with the public health system as
long as we keep focussed on the Centers for Disease Control, as long as
we keep focused on local public health departments, because that has
served the public very well, this public health system. It is too often
starved, too often woefully, inadequately funded. I would hope that the
synergism we can create with Bioshield and with public health will
serve this country well, both in terms of deterring as an antidote and
as a deterrence for bioterrorism attacks and in terms of the day-to-day
issue of public health, whether it is lead-based paints, whether it is
eliminating the discrepancy between rich and poor and the health care
they get, whether it is providing safe drinking water and clean air and
all the things that public health provide to us.
Mr. Speaker, I reserve the balance of my time.
Mr. TAUZIN. Mr. Speaker, I yield myself such time again as I may
consume.
(Mr. TAUZIN asked and was given permission to revise and extend his
remarks, and include extraneous material.)

[[Page H6930]]

Mr. TAUZIN. Mr. Speaker, I insert at this point into the Record of
these proceedings a statement of administration policy in strong
support of this bill.

Executive Office of the President, Office of Management
and Budget,
Washington, DC, July 16, 2003.

Statement of Administration Policy

The Administration supports House passage of H.R. 2122,
Project BioShield Act of 2003. This bill would implement a
Presidential initiative to help spur the development and
availability of next generation countermeasures against
biological, chemical, nuclear, and radiological weapons.
Specifically, H.R. 2122 would: (1) speed the Government's
ability to turn promising scientific discoveries into
necessary countermeasures by one-third or more; (2) authorize
funding to purchase critical new countermeasures targeted
against the most worrisome threats; and (3) allow the Food
and Drug Administration to make promising treatments quickly
available to Americans in emergency situations. Project
BioShield is critical for strengthening our ability to
protect Americans against biological, chemical, radiological,
and nuclear terrorist threats.
The Administration notes that provisions on submission of
legislative proposals, and of reports on options considered
and rejected, should reflect Constitutional principles
regarding Executive-originated legislative proposals and
protecting Executive deliberations.

Mr. Speaker, I again center Congress' attention on the concerns that
our colleague from Tennessee (Mr. Wamp) raises regarding the lack of
domestic capacity to develop and produce new vaccines and
countermeasures, indeed the concern he has that we might end up relying
upon foreign sources for these critical supplies.
Let me first say that I share that concern about our lack of a robust
domestic vaccine industry. I know that the Secretary of Health and
Human Services shares that concern.
I also know that one of the primary purposes behind Project Bioshield
is to help the Nation address this important problem by giving
incentives to all companies, but especially our domestic pharmaceutical
companies, to invest in this capacity, in this vaccine antidote
producing capacity so that we have domestic supplies and domestic
countermeasures available without relying upon foreign sources to
protect this country in case of a domestic attack.
I just read from the Secretary's letter his commitment to do exactly
that, to use this Act to make sure that we incentivize the capacity of
our country to produce those vaccines and those countermeasures, those
antidotes, whatever may be required, in case of the unbelievable attack
upon our country with some of these awful agents, and I am confident
the Secretary will implement the Act with that goal in mind.
We obviously on the Committee on Energy and Commerce will
aggressively oversight the implementation of this Act so that we are
satisfied that we are, in fact, encouraging domestic corporations to
compete for these contracts.
Mr. Speaker, I reserve the balance of my time.
Mr. BROWN of Ohio. Mr. Speaker, I have no other speakers, and I am
willing to yield back if the gentleman from Louisiana (Mr. Tauzin) is.
Mr. TAUZIN. Mr. Speaker, I am pleased to yield 2 minutes to the
gentleman from Georgia (Mr. Norwood), a distinguished member of our
committee.
Mr. NORWOOD. Mr. Speaker, I rise out of breath simply to urge my
colleagues to vote for this. This is an enormous undertaking. The
Secretary has done a great job for us. I think all Americans I know are
as concerned about bioterrorism as any part of terrorism out there.
I thank the chairman for bringing this bill, and hopefully everybody
here will help him and help the Secretary move this thing forward.
Mr. BROWN of Ohio. Mr. Speaker, I yield 3 minutes to the gentleman
from California (Mr. Waxman).
Mr. WAXMAN. Mr. Speaker, I thank the gentleman for yielding time to
me.
I have had the opportunity to review this legislation from the
prospect of two committees, as a member of the Committee on Energy and
Commerce, which looks at the health impact of the threat of
bioterrorism, as well as the Committee on Government Reform; and given
the serious threat of bioterrorism, the development of effective
countermeasures is vital to our national security.
Project Bioshield represents the administration's proposal to
encourage the development of these products, and 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.
This bill is the product of collaboration between the majority and
minority of three separate committees. Although the final bill may not
be perfect, I believe the end product is one that all Members should
support.
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 contractors' books
and records.
The bill also permits the use of certain streamlined procurement
procedures but only if the Secretary determines that there is a
pressing need to do so. In emergency situations, we should not impede
the development of necessary products. However, any exception from the
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. The
FDA must be vigilant in protecting the public against unnecessary risks
from these products.
In part because of these concerns, the bill has been modified to
require that health care providers and patients be informed that the
products have not been approved and of their risks. The bill also has
been modified to require 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 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 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 it deserves our support.
Mr. TAUZIN. Mr. Speaker, I am pleased to yield 2 minutes to the
gentleman from Florida (Mr. Bilirakis), the distinguished chairman of
the Subcommittee on Health of the Committee on Energy and Commerce, who
celebrates his birthday today.
Mr. BILIRAKIS. Mr. Speaker, I appreciate the gentleman, my good
friend, the chairman for recognizing me, and I speak in support of the
Project Bioshield Act of 2003.
Mr. Speaker, in 2001, we really learned about the real threat of
terrorism and the importance of being adequately prepared for an
attack. The possibility that our enemies might attack us with
biological, chemical or radiological weapons still remains,
unfortunately, a significant threat.
During the last Congress, the Committee on Energy and Commerce worked
together in a bipartisan fashion to produce the Public Health Security
and Bioterrorism Response Act which became law in June of 2002. I was
proud to have been a small part of this important effort. However,
while our legislation has helped get critical resources out to the
States and moved us closer to the reality of a more comprehensive
strategic national stockpile, more still needs to be done.
I am pleased to have worked with my colleagues and the Bush
administration to develop legislation that would help make the vision
of Project Bioshield a reality. As we have heard, this initiative is
designed to speed the development and availability of medical
countermeasures that will help us respond to any future terrorist
attacks.

[[Page H6931]]

The bill will also provide the Federal Government with tools to help
encourage our research-driven pharmaceutical, biotechnology and medical
technology to develop new countermeasures where none exists today.
It remains our responsibility to do what we can to ensure that the
United States is ready for whatever biological, chemical or
radiological threat we might face.

{time} 1430

It is for that reason that I join the others in urging my colleagues
to join us in supporting the Project BioShield Act of 2003.
Mr. WAXMAN. Mr. Speaker, I control the time on behalf of the
Democrats on the Committee on Government Reform, and I ask unanimous
consent to yield the time that we have to the gentleman from Ohio (Mr.
Brown) to control that time.
The SPEAKER pro tempore (Mr. Gilchrest). Is there objection to the
request of the gentleman from California?
There was no objection.
The SPEAKER pro tempore. The gentleman from Ohio (Mr. Brown) will be
recognized for an additional 7\1/2\ minutes.
Mr. BROWN of Ohio. Mr. Speaker, could you tell us how much time I
have, the Committee on Energy and Commerce and the Committee on
Government Reform, and how much time the gentleman from Louisiana (Mr.
Tauzin) has?
The SPEAKER pro tempore. The gentleman from Ohio (Mr. Brown) has
24\1/2\ minutes remaining, and the gentleman from Louisiana (Mr.
Tauzin) has 16\1/2\ minutes remaining.
Mr. TAUZIN. Mr. Speaker, I yield 3 minutes to the gentleman from
Connecticut (Mr. Shays).
Mr. SHAYS. Mr. Speaker, I rise to engage the chairman of the
Committee on Energy and Commerce, the gentleman from Louisiana (Mr.
Tauzin), in a colloquy.
Mr. Speaker, I am concerned that certain provisions of section 4 of
the bill will unfairly treat the men and women of our armed services.
Specifically, the bill would create a new section 564 of the Federal
Food, Drug and Cosmetic Act that would allow the application of medical
products to the general population in emergencies, but only with
appropriate safeguards. New subsection (k) of the act, however, seems
to allow the President to waive or the Secretary of HHS to modify the
application of these safeguards for military personnel. Can the
chairman enlighten me as to his intent in this provision?
Mr. TAUZIN. Mr. Speaker, will the gentleman yield?
Mr. SHAYS. I yield to the gentleman from Louisiana.
Mr. TAUZIN. Mr. Speaker, I will be happy to speak to that.
New subsection (k) permits the President to waive, in writing, only
the consent portion of the conditions of authorization set forth in
section 564(e) with respect to armed services personnel, and only to
the extent that complying with the requirement is not feasible, is
contrary to the best interests of the personnel, or is not in the
interest of national security.
It is not my intent that the President may ever waive pursuant to
subsection (k) the other conditions. They are that the individual to
whom the product is to be administered is informed, one, that the
Secretary has authorized the emergency use of a product, and, two,
about the significant known and potential benefits and risks of the use
of the product. The committee intends, absent extraordinary
circumstances, that such information be provided to individuals prior
to receiving the unapproved product.
After the gentleman raised these issues with us, we took a closer
look at the language, and I acknowledge that there is a crossreference
in new section 564(k)(2) that could be confusing. I want to continue to
work with the gentleman and the gentleman from New York (Mr. Towns),
who I know cares deeply about this issue, along with you and many of
us, to make sure that the final version of this bill from the
conference that we will have with the Senate, I am sure, provides that
our military are informed of the drugs that are given before these
drugs are administered.
Let me also assure the gentleman from Connecticut that we understand
the importance of the protections for military personnel receiving
unapproved countermeasures contained in current law, title X, section
1107; and we intend the waiver authority in this bill to be used only
in the very extraordinary circumstances that we describe in the bill.
Mr. SHAYS. Mr. Speaker, reclaiming my time, I thank the gentleman for
his explanation, and I look forward to working with him to make sure
that we clear this matter up in conference with the Senate.
Mr. TAUZIN. Mr. Speaker, if the gentleman will continue to yield, I
thank my friend and give him that assurance.
Mr. BROWN of Ohio. Mr. Speaker, I reserve the balance of my time.
Mr. TAUZIN. Mr. Speaker, I yield 2 minutes to the gentleman from
Nevada (Mr. Gibbons).
Mr. GIBBONS. Mr. Speaker, I want to thank my friend, the chairman,
for yielding me this time. I rise in support of Project BioShield. It
is a very important step for the Department of Homeland Security.
Project BioShield aims to rapidly transfer technology into products
that can be used to protect individuals against biological and chemical
agents used as weapons of terrorism or mass destruction. The emphasis
is on rapid introduction of new countermeasures into actual use, as
many technologies currently under development need to be transitioned
through regulatory commercial or regulatory cycles.
The Homeland Security Act gave the Department of Homeland Security
responsibility for integrating intelligence information and assessing
terrorist threats and vulnerabilities. This information makes full use
of the Department's capabilities. Identifying the most urgent threats
and setting research priorities will be vital to meeting the bioterror
threat.
Obtaining the best intelligence and performing accurate threat
assessment is absolutely critical. By properly understanding the
threats that confront us, we can allocate our resources and focus our
efforts where they are most needed, on agents for which the risk and
potential consequence of attack are greatest.
BioShield tasks the Secretary of the Department of Homeland Security
with using the best information available to identify the greatest
threats to the national security. Incorporated into the bill are
several provisions that will strengthen the Secretary's threat
assessment capabilities.
This legislation, Mr. Speaker, provides the Secretary of the
Department of Homeland Security the authority and resources needed to
quickly hire the necessary bioterror analysts and rapidly build a
bioterror intelligence infrastructure.
I urge all my colleagues to support H.R. 2122, the Project BioShield
Act of 2003.
Mr. BROWN of Ohio. Mr. Speaker, I rise again in support of this bill,
and I ask unanimous consent that I be allowed to yield my remaining
24\1/2\ minutes to the gentleman from New Jersey (Mr. Andrews) with
permission that he be allowed to yield said time.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Ohio?
There was no objection.
The SPEAKER pro tempore. The gentleman from New Jersey (Mr. Andrews)
is recognized for the remaining time.
Mr. ANDREWS. Mr. Speaker, I yield myself such time as I may consume;
and I thank my friend, the gentleman from Ohio (Mr. Brown), for
yielding me this time. I assure my colleagues I will not personally
take all 24 minutes; I will reserve the right to yield to other
Members, and the gentleman from Texas (Mr. Turner) should be here
forthrightly and he will be yielding.
Mr. Speaker, I want to thank the gentleman from Louisiana (Mr.
Tauzin) and the leadership of the gentleman from Michigan (Mr. Dingell)
on our side of the aisle, the other committees of jurisdiction, the
gentleman from California (Mr. Cox), and the gentleman from Texas (Mr.
Turner) for bringing this very important legislation to the floor.
Mr. Speaker, I think that history will reflect that this is our
generation's version of the Manhattan Project. These are uncharted
scientific waters. It is a world that we have not yet become accustomed
to navigating.

[[Page H6932]]

It is the world of massive biological attack against the United States
of America. I have supreme confidence that we will be able to meet and
deter such an attack, but only if we are able to engage the machinery
of the best minds in our universities and our companies, in our
government, and throughout society.
I believe that is exactly what this legislation does. It brings to
the forefront the abilities of our researchers, of our scientists, of
our entrepreneurs, of our public officials to systematically identify
the biological risks that our country faces, to methodically analyze
the best opportunities for addressing those biological risks, and to
use a process that will effectively meet those risks.
I commend the authors for properly balancing the mechanisms of money,
market, and exclusivity. It is very important there be adequate
resources for the companies who we are asking to engage in this so that
they will in fact engage in it. It is important that we create a
market, because it is our fervent wish that there will never be a
market for these products. We hope they are never needed. But in the
absence of that market, it is important the law contain a specific
guarantee to move forward.
Finally, with respect to exclusivity and insulation from antitrust
considerations, it is very important that those who are willing to risk
their capital and their energy to come up with these agents are
afforded the protection of the law.
Mr. TAUZIN. Mr. Speaker, will the gentleman yield?
Mr. ANDREWS. I yield to the gentleman from Louisiana.
Mr. TAUZIN. Mr. Speaker, I thank the gentleman and will be happy to
enter into a discussion with him.
Let me first thank him for the excellent statement he has made. I
think the gentleman is correct. I think it is as important to our
country as perhaps the Manhattan Project was. I remember when Speaker
O'Neill used to remind this House that partisanship ended at the
water's edge. He meant to tell us that when it came to protecting our
country, we were not Democrats or Republicans, we were Americans. And
where the water's edge used to be the boundary of the threats against
our country, because of 9-11, we now understand the water's edge is no
longer the boundary. Within our country we now face these potential
threats.
So I thank the gentleman. And, indeed, the bill is designed to do
exactly that, to balance those important elements of the equation and
to make sure we incentivize the private marketplace, but also provide
the public monies, $5.6 billion over 10 years, to make sure we have the
available money in a trust fund, through our budget resolution,
appropriated through our process, to make sure we can acquire those
countermeasures, stockpile them, distribute them around the country, as
the Secretary is prepared to do, to make sure that those
countermeasures are available.
It also balances the need to build in our own country the capability
of building those vaccines and countermeasures that otherwise would
never be built. Because who would, in the private sector, want to build
a vaccine for the plague today, without this particular legislation? So
I thank the gentleman.
Mr. ANDREWS. Mr. Speaker, reclaiming my time, I agree with the
chairman. I think he is correct that bipartisanship cannot simply begin
at the water's edge in a world where the battlefield is here. And there
is a virtual battlefield that we are all, unfortunately, living in.
I would like to make two other points before I stop. The first is
that I very much appreciate the inclusion into this bill, with the help
of the gentleman from California (Mr. Cox), language that I suggested
with respect to making it clear that when there is a termination for
reason of convenience by the government, that all of the normal cost
recovery rights that would accrue to the vendor in fact accrue under
this bill. I very much appreciate that inclusion.
Mr. TAUZIN. Mr. Speaker, will the gentleman yield?
Mr. ANDREWS. I yield to the gentleman from Louisiana.
Mr. TAUZIN. Mr. Speaker, I want to thank the gentleman for that
language. The neat thing about the way this bill has been processed is
that all through the process Democrats and Republicans have assisted in
building it into a much better bill. And the language the gentleman has
added to the bill is an extraordinary addition to the bill, and I thank
him for it.
Mr. ANDREWS. Reclaiming my time once again, Mr. Speaker, I appreciate
the chairman's cooperation in that regard.
Second, I would like to say it is very important that the chairman
has very skillfully, along with the ranking member, assured that there
will be continuing oversight by the Congress of the activities under
this bill. We had to strike the proper balance here between a
guaranteed funding stream so that the companies involved in this would
know that their investment would in fact be recovered, but at the same
time not yielding the important oversight function that this Congress
should exercise. And I commend the chairman and the ranking member and
all the authors for making that the case.
Mr. Speaker, I reserve the balance of my time.
Mr. TAUZIN. Mr. Speaker, I would ask how much time is available on
both sides at this point.
The SPEAKER pro tempore. The gentleman from Louisiana (Mr. Tauzin)
has 11\1/2\ minutes remaining, and the gentleman from New Jersey (Mr.
Andrews) has 19\1/2\ minutes remaining.
Mr. TAUZIN. Mr. Speaker, I commended the gentleman from Virginia (Mr.
Tom Davis) and the gentleman from California (Mr. Cox) previously,
along with the ranking members for their extraordinary work we did
together; and I now ask unanimous consent to yield the balance of my
time to the gentleman from Virginia (Mr. Tom Davis) so that Chairman
Davis can control the balance of that time.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Louisiana?
There was no objection.
Mr. TOM DAVIS of Virginia. Mr. Speaker, as I understand it, I would
have the time yielded to the Committee on Government Reform in addition
to the time yielded to me by the Committee on Energy and Commerce?
The SPEAKER pro tempore. The gentleman is correct.
Mr. TOM DAVIS of Virginia. Mr. Speaker, I yield 3 minutes to the
gentleman from New York (Mr. Boehlert).
(Mr. Boehlert asked and was given permission to revise and extend his
remarks.)
Mr. BOEHLERT. Mr. Speaker, we live in a different world than we did 2
years ago, a world where the threat of attack from biological and
chemical agents remains high. Here on Capitol Hill we know this all too
well. We were all victims of a vicious attack using anthrax and
poisoning our own postal system. The attack shut down half of an entire
branch of our government and lives were lost. A very real threat became
a sad reality.
Project BioShield will take the necessary steps to provide greater
protection for Americans from those malicious attacks, to research,
develop, manufacture and stockpile effective drugs and vaccines. In
order to make this plan a reality, the Department of Health and Human
Services and the National Institutes of Health must have a strong
infrastructure of laboratories and facilities designed for research on
the most dangerous of pathogens.
The research stage of this process is the most important part of
developing a broad and effective basis for this project. In my own
district, there is an effort underway to build a national
biocontainment laboratory to be administered by the National Institute
of Allergy and Infectious Diseases. This state-of-the-art facility
would take on the daunting task of testing these dangerous agents that
could threaten our communities, and they have got the charge to come up
with the vaccines and drugs necessary to effectively deal with them. I
am fully supportive of this plan and hope this critical facility will
soon call upstate New York home.
Development of these vital medical countermeasures to biological and
chemical agents can take years. With the building of new facilities to
do the research and expedite the development of vaccines, more diseases
may one day

[[Page H6933]]

be eradicated or at least treatable to avoid mass casualty from any
type of attack.
I am pleased that Project BioShield may offer assistance to
enterprising companies like Viral Therapeutics of Ithaca, New York,
that are currently producing needed vaccines and is interested in
answering the call to expand research and development as well as
production.

{time} 1445

Mr. Speaker, I am proud of my service on the Select Committee on
Homeland Security and our determined effort to give the American people
what they desire and deserve, a comprehensive and balanced effort to
protect them from the evils of biological and chemical weapons. This
legislation is designed to do exactly that. I commend all those
involved with the formulation of this bipartisan product for the
American good.
Mr. ANDREWS. Mr. Speaker, I yield 4 minutes to the gentleman from
Rhode Island (Mr. Langevin), who has had experience in State government
with homeland security, who has had experience here on the Committee on
Armed Services and now on the Select Committee on Homeland Security.
Mr. LANGEVIN. Mr. Speaker, I thank the gentleman for yielding me this
time on this incredibly important issue.
Mr. Speaker, I rise today in strong support of the Project BioShield
Act. Bioterrorism is a national threat to our national security, and I
believe it is our job as the Members of the United States Congress to
instill confidence in the American people that a coordinated, concerted
effort is being made to combat this threat.
We have some incredibly talented people in this country in the public
and in the private sector, and this joint partnership will ensure that
we are moving ahead to effectively protect the American people from the
potential of a bioterrorism attack.
While Project BioShield is not the only answer, it is certainly an
important step toward that goal, and I hope Congress will continue to
provide the funding and the oversight that the project needs to be
effective.
However, I must mention my ongoing concern with the operation of
Department of Homeland Security's information analysis and
infrastructure protection directorate. This is truly a life-and-death
issue. If this unit is not running effectively, then the rest of DHS is
at a tremendous disadvantage in determining how to allocate resources
and where to 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, while working closely
with their peers at CDC and NIH to identify the most pressing dangers.
Mr. ANDREWS. Mr. Speaker, will the gentleman yield?
Mr. LANGEVIN. I yield to the gentleman from New Jersey.
Mr. ANDREWS. Mr. Speaker, I very much appreciate the point the
gentleman is making. The BioShield Project is built on a foundation of
accurate assessment of the threats that we face. For example, if there
is an assessment that we face a significant threat from botulism, the
full resources of this bill are applied to finding an antidote to
botulism.
The gentleman's point is very well taken. If the threat assessment is
flawed, then we run the risk of either spending money on a threat that
is not very viable, or failing to spend energy and money on a threat
that is viable that we have failed to detect.
So we can employ the very best resources of our scientists, our
engineers, our researchers, our entrepreneurs, but have them working on
the wrong problem if there is not an adequate intelligence-gathering
capability and then an adequate response to that intelligence-gathering
capability shared with the Department of Homeland Security. I think the
gentleman's point is very well taken.
Mr. LANGEVIN. Mr. Speaker, I thank the gentleman from New Jersey (Mr.
Andrews) for interjecting that point, and I wholeheartedly concur.
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.
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.
Mr. TOM DAVIS of Virginia. Mr. Speaker, I yield myself such time as I
may consume.
Mr. Speaker, I rise in support of H.R. 2122, the Project BioShield
Act. This 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. It is the cornerstone of the administration's
strategy to prepare our Nation against the possibility of a
bioterrorist attack. The bill we are considering today was introduced
by the gentleman from Louisiana (Mr. Tauzin), chairman of the Committee
on Energy and Commerce, and was referred to the committee, as well as
the Committee on Government Reform which I chair, and the Select
Committee on Homeland Security. It is a good bill which serves a
compelling national interest.
As we tragically learned during the fall of 2001, our Nation is
vulnerable to biological terrorism. Letters laced with anthrax caused
the deaths of five individuals and thousands more had to be treated.
The death toll could have been higher if there had not been an
effective countermeasure to treat that form of anthrax. Unfortunately,
there has been little progress in treatment for other deadly diseases,
like smallpox, Ebola and plague, which effect few, if any, Americans.
The reality is that there is little manufacturer interest in
developing necessary treatments for these diseases because there is no
significant commercial market existing outside of government. The
absence of financial incentives has provided drug companies with little
reason to make the substantial investment that would be required to
develop treatments for these deadly diseases.
Should the United States be attacked with any of these deadly
pathogens, the needs for vaccines, tests and treatments would be great,
and it would be immediate. H.R. 2122 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
procurement of necessary drugs and vaccines. These tools are
instrumental to the success of the BioShield program.
For example, the bill increases the simplified acquisition threshold
for research and development projects from the current level of
$100,000 to $25 million. This increase will help the Secretary promote
sophisticated research and development projects by streamlining the
acquisition process. The bill also authorizes the procurement of
biomedical countermeasures, again using tailored, flexible acquisition
tools for inclusion in the Nation's stockpile using a special reserve
fund.
The Secretary would also have expedited authorities to award research
grants and hire technical experts and consultants. 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. The Committee on Government Reform, which I chair, held
a hearing to examine the BioShield proposal on April 4, 2003. Witnesses
from the government, academia, and pharmaceutical and biotech companies
were supportive of the bill. They all recognize the need to create
incentives for manufacturers to develop biomedical countermeasures.
Our committee favorably reported the bill on May 22. Working in a
bipartisan fashion with the gentleman from California (Mr. Waxman), we
unanimously adopted some amendments to ensure greater accountability in
the acquisition process and to clarify the circumstances when
biocountermeasures can be processed.
Specifically, the amendments we approved permit the use of simplified
acquisition procedures only when the Secretary of Health and Human
Services determines there is a pressing need

[[Page H6934]]

for the procurement of specific countermeasures. The bill commits
decisions about research and development projects to the discretion of
the Secretary of Health and Human Services. However, we approved an
amendment which preserves a limited right for companies to appeal to
the General Accounting Office contracting decisions made by the
Secretary, but appeals could not be used to stall the research and
development procurement process.
We also made some technical changes that seek to clarify the
circumstances when the Secretary could use other than fully competitive
procedures for research and development and production contracts.
Mr. ANDREWS. Mr. Speaker, will the gentleman yield?
Mr. TOM DAVIS of Virginia. I yield to the gentleman from New Jersey.
Mr. ANDREWS. Mr. Speaker, I would like to thank the chairman for
working with the gentleman from California (Mr. Cox) and the gentleman
from Texas (Mr. Turner) on the issue of termination for convenience. We
think it is a very important clarification that if there is a
termination by the government for reasons of convenience, the companies
involved in the project can recover their costs under the normal rules
for that. I know that the gentleman's committee was involved in making
that possible, and I wanted to thank him for his cooperation.
Mr. TOM DAVIS of Virginia. Mr. Speaker, the gentleman is correct, and
it makes them more likely to be involved in this process.
We think that all of these amendments, and I thank the gentleman from
California (Mr. Waxman) for working with us as well, have been agreed
to by the majority and the minority on the various committees; and they
are part of the bill that we are considering today.
Since our markup, we have continued to work on this bill in a
bipartisan fashion. This issue is really too important to play party
politics with. We have worked out language to ensure that the rights of
contractors with respect to payment are protected in the event they are
terminated for convenience. This is a good bill and deserves our
support.
Mr. Speaker, I reserve the balance of my time.
Mr. ANDREWS. Mr. Speaker, I ask unanimous consent to yield the
balance of my time to the gentleman from Texas (Mr. Turner) and that he
may further allocate that time.
The SPEAKER pro tempore (Mr. Gilchrest). Is there objection to the
request of the gentleman from New Jersey?
There was no objection.
Mr. TURNER of Texas. Mr. Speaker, I yield myself such time as I may
consume.
To win the war on terror, we must do everything we can to protect the
American people from the threat posed by terrorists using weapons of
mass destruction. We know that our forces in Afghanistan uncovered
plans by al Qaeda to engage in bioterrorism. We know from recent
arrests in Europe that terrorist groups have the means and the will to
carry out such attacks. It is without question that bioterrorism is a
clear and present danger to the American people, perhaps one of our
greatest threats.
In response to this threat, the administration is proposing this
legislation, commonly known as Project BioShield. This bill is a first
step toward ensuring that we protect Americans from the horror of
bioterrorism. The purpose of the BioShield legislation is to provide
incentives to private companies to produce the medicines, the vaccines,
the antidotes we need to counter a biological attack.
Quite frankly, this concept is an experiment, a grand experiment, but
no less an experiment. We do not know if the incentives will drive our
pharmaceutical industry to invest the resources needed to truly prepare
our country for the full range of possible biological attacks. If we
do, we will have been successful and our country will be better off. If
they do not, our country will remain dangerously vulnerable.
I support Project BioShield because I believe this is an experiment
worth conducting; but from the beginning of this process, I have been
working to build mechanisms into the legislation that would monitor
whether the legislation is truly making our Nation safer.
For example, the Select Committee on Homeland Security added a
requirement that the Secretary of Health and Human Services report
annually if the President has identified biological agents that are
threats to the United States, but no private company has contracted to
produce a countermeasure. Thus, if there is a bioterrorist threat to
the American people and private industry will not rise to the challenge
of searching for a cure, we have the right to know about it.
These concerns were shared by the gentleman from California (Mr.
Cox), chairman of the Select Committee on Homeland Security. They were
also shared by the gentleman from Louisiana (Chairman Tauzin) of the
Committee on Energy and Commerce and the ranking member, the gentleman
from Michigan (Mr. Dingell).
If BioShield does not work as we hope it will, we will need plan B.
Thus, I am very pleased that the legislation contains clear authority
that allows the government to operate an emergency program to develop
and produce vaccines. In my view, this is so very important because
protecting our population is our first responsibility. If the private
sector is not producing the medicines we need and we find ourselves
under the threat of biological attack, then the government needs to
have the authority to do the job directly.
The language that has been inserted in the legislation gives the
President, the Secretary of Health and Human Services, the Secretary of
Homeland Security the necessary authority to take action in the event
that this experiment with the private sector fails to produce the
results we all hope it will produce.

{time} 1500

My final concern, Mr. Speaker, is that Project BioShield, despite its
creative name, is really a fairly modest proposal. If we are lucky at
the end of 10 years, we will have some vaccines to address a few of the
possible pathogens that terrorists could use during a bioterror attack.
But the potential problems are much more expansive. Terrorists may soon
be able to genetically manipulate biological agents so they are
resistant to our current stockpile of antibodies and perhaps to the
vaccines we develop.
This possibility presents a daunting threat to our Nation. That is
why I would like to see a much more robust proposal than the one before
us today, an approach that moves us faster and stronger toward creating
a comprehensive defense to the full range of threats we face from
bioterrorism. Based on the information that we all know about, we
clearly need a Manhattan Project to prepare this country to deal with
the vast array and the diverse types of biological threats that we may
face in the years ahead.
Time and time again when faced with such a great challenge, the
government has played a central role in organizing a massive response.
When war threatened to consume the world, we put an end to it through
the success of the original Manhattan Project. When we raced the
Russians to the stars, the Apollo Project put a man on the Moon. It
will take these kinds of bold actions, this kind of bold leadership and
deep resolve to prevail in the war on terror.
Mr. Speaker, I wholeheartedly support this current legislation, but I
also believe that our Nation must take even stronger steps much sooner
in order to protect us and to secure us in the days ahead.
Mr. Speaker, I reserve the balance of my time.
Mr. TOM DAVIS of Virginia. Mr. Speaker, I yield 4 minutes to the
gentleman from Connecticut (Mr. Shays), the distinguished vice chairman
of the Committee on Government Reform.
Mr. SHAYS. Mr. Speaker, I appreciate my chairman yielding me this
time.
Throughout committee consideration of H.R. 2122, I expressed some
skepticism about both the short- and long-term impact of the proposed
approach on our ability to develop, procure and use new medical
countermeasures against chemical, biological or radiological weapons.
Thanks to the work of the Committee on Energy and Commerce, the
Committee on Government Reform and the Select Committee on

[[Page H6935]]

Homeland Security, the bill before us today represents a substantial
improvement over the original proposal. This bill would create agile,
proactive capabilities in meeting the threat of unconventional weapons,
capabilities we do not have today.
Part of the value of Project BioShield would be purely deterrent.
Just having the ability to develop and stockpile vaccines and antidotes
decreases the likelihood, or the lethality, of a biological attack.
However, as I indicated in my earlier colloquy with Chairman Tauzin,
any authority to actually use experimental drugs or medical devices in
emergency situations has to be defined and wielded with nothing less
than surgical precision. Prior informed consent in connection with the
administration of experimental therapy is a basic human right, a right
no one should be asked to surrender except under the most extraordinary
of circumstances. For example, if a patient is unconscious and cannot
give consent or be informed before onset of a life-threatening disease
or event, medical ethics allow use of an experimental therapy.
Mere military inconvenience can never justify waiving consent or
failing to inform service members about medical countermeasures. No
loosely defined concept of feasibility should allow the Secretary of
HHS to waive or delay the requirement to provide essential information
on medical risks and benefits prior to administration of a drug or
vaccine, as could happen under the language in this bill Chairman
Tauzin has agreed to revisit. If the medicine can get to the front,
there should always be room in the transport for the leaflet describing
its dosage, interactions and contraindications.
In the 1991 Persian Gulf War, soldiers, sailors, aircrews and Marines
were ordered to take experimental drugs and vaccines. Despite Pentagon
promises to provide critical medical information and keep accurate
medical records, very little information was provided and very few
records survived the trip home. That cannot happen again. In the course
of 14 hearings on the subsequent health problems of Gulf War veterans,
the Government Reform subcommittee I chair reached this stark
conclusion: ``Unless providing medical information to service members
is mandatory, it's just too easy for the military, in the heat of
battle, to decide it's just not feasible.''
In the war against terrorism, we are all on the front lines. The
citizen-soldiers of our all-voluntary Armed Forces fight and die to
protect our rights and freedoms. They should not be asked to surrender
those fundamental rights under different, less rigorous, circumstances
than those they left behind.
Again, I appreciate the very good work of Chairman Tauzin, Chairman
Davis and Chairman Cox and their respective ranking members; and I look
forward to a conference agreement that relies on the protections of
current law and requires prior notification of service members whenever
an unapproved drug or device has to be used.
Mr. TURNER of Texas. Mr. Speaker, I yield 4 minutes to the
distinguished gentlewoman from the Virgin Islands (Mrs. Christensen).
Mrs. CHRISTENSEN. Mr. Speaker, I rise today as a member of the Select
Committee on Homeland Security and also of the Subcommittee on
Emergency Preparedness and Response in qualified support of the Project
BioShield Act of 2003, the purpose of which is to increase the
development of countermeasures to bioterrorism and facilitate their
approval for use in mass production so that they would be readily
available when needed.
While research and development of such products is extremely
important, I remain very concerned that a commensurate amount of time
and effort has not been devoted to furthering our public health
security, a broader, more basic and more immediate issue.
Through the four or five hearings on Project BioShield, I joined
several other of my colleagues in calling attention to the inadequacies
and deficiencies that exist throughout the public health system in this
country, especially in rural and minority communities.
With the focus on cost containment rather than care, our lack of
focus on prevention and our failure to insure everyone's equal access
to quality health care, added to the system's continued deterioration
because of repeated funding cuts and misguided departmental policies,
our Nation's public health infrastructure today is in worse shape than
ever.
Project BioShield, though, is important because it will help to make
sure that we have the vaccines and other countermeasures as quickly as
possible in the case of a bioterrorism attack. But all of those fancy
medicines and other agents will be worthless to you and me and to the
people we serve without an intact public health system.
The 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.
Mr. Speaker, I am happy that the gentlewoman from Texas (Ms. Jackson-
Lee) and I were able to amend the bill in committee to ensure that the
historically black colleges and universities and other minority-serving
institutions of higher learning will be provided with special outreach
to ensure their participation in this program to the fullest extent
possible. This is an extremely important provision, and I thank our
chair and ranking member and Chairman Tauzin for working with us to
include it in the bill.
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 want to take this opportunity to thank and commend Chairman Cox and
Ranking Member Turner for their guiding what is often not an easy
committee to guide and for their shepherding of this bill through that
committee.
I ask the support of my colleagues for Project BioShield, but I also
ask that when this is passed that we move on from here to soon pass
``Project Public Health.''
Mr. TOM DAVIS of Virginia. Mr. Speaker, I yield the balance of my
time to the gentleman from California (Mr. Cox).
Mr. COX. Mr. Speaker, I want to thank the chairman not only for
yielding time but for the exceptional work that the Committee on
Government Reform has done both on the majority and minority sides to
bring us to this point; likewise, the Committee on Energy and Commerce,
of which I am a member, and Chairman Tauzin and Chairman Dingell for
their extraordinary leadership and commitment to bringing this bill to
the floor; and my ranking member on the Select Committee on Homeland
Security, which I chair, the gentleman from Texas (Mr. Turner), who is
with me on the floor now.
This has been a bipartisan effort for one simple reason. The
terrorists do not discriminate between Democrats and Republicans. They
certainly are not going to protect us because we are on one or another
side of this debate. We are all in their sights. The committees of
jurisdiction working closely together have managed to create a process
in bringing this bill to the floor that has been focused on producing
the best possible policy and thus the best possible security for our
country. It is not focused on Capitol Hill turf battles. This type of
cooperation serves as a model for our efforts to make America more
secure against terrorist attack.
In the fall of 2001, we caught a glimpse of the terrible potential of
a bioterror attack when anthrax attacks were loosed on the Nation's
capital. A broader attack on the American population, on our armed
services involving one of the many biologic agents for which we have no
antidote could be devastating. The potential toll in lives would far
exceed what happened on September 11, 2001. We must, of course, do all
we can to prevent such attacks, but ultimately we must be prepared.

[[Page H6936]]

Because no scheme of prevention, no matter how expert and reliable our
intelligence collection and analysis, is going to be perfect. We must
be prepared.
This legislation, the BioShield Project launched in this bill, will
provide the resources and authorities we need to develop the next
generation of biological countermeasures. It will help to ensure that
we avoid the kind of catastrophe we are contemplating here on the floor
today in the future.
The ability of the Secretary of Homeland Security to identify from
around the world the most serious potential biological threats to our
population is key to making Project BioShield effective, and it is key
to the vital task that we have of meeting this threat. To do that,
Secretary Ridge will have to get the very best intelligence available.
By learning everything we can about the biological weapon threats that
confront us, we can allocate our resources and focus our efforts where
they will be most effective. By identifying the bioterror agents for
which the risks and potential consequences of attacks are greatest, we
can use these substantial new first responder resources most wisely.
That brings us, therefore, to the creation of Project BioShield in
fulfillment of President Bush's charge to this Congress in his State of
the Union message. Both President Bush and Vice President Cheney have
made this a priority, and we are responding in this Congress.
The BioShield Project is by far the most expansive, broadest, largest
first responder program initiated in the history of our country. It is
budgeted for $5.6 billion, but we have made it very plain that, through
the appropriations process and through the budget process, we will put
the resources behind this program that are needed to develop the
antidotes and, if a presidential decision on a recommendation of both
the Secretary of Health and Human Services and the Secretary of
Homeland Security is made, if the President decides to stockpile enough
antidotes, vaccines to immunize the entire American population in the
event of a catastrophe.
The Secretary of Homeland Security as part of this process is charged
with identifying the most significant biological, chemical and nuclear
agents that threaten the American population. Because our ability to
collect, analyze and put to use timely and accurate intelligence
information is at the very heart of doing this job, certainly in
preventing a biological attack but also of being prepared to respond to
it, in this legislation we have given the Secretary of Homeland
Security the information analysis tools that he needs.

{time} 1515

This bill is very important to the Select Committee on Homeland
Security. We worked hard to get it right. We have held extensive
hearings and nearly 3 months of work in three of our subcommittees and
twice in the full committee. We conducted a series of oversight
hearings which examined the new Department's ability to carry out its
threat assessment function; and as a result, we have incorporated into
the bill several provisions designed to strengthen the Secretary's
threat assessment capabilities. We have given the Secretary the
authority and the resources he needs to quickly hire the necessary
bioterror analysts and to rapidly build a bioterror intelligence
infrastructure. The Select Committee on Homeland Security added these
provisions to this bill.
This legislation greatly increases our ability to conduct bioterror
research against the most urgent threats identified by the Department
of Homeland Security. But most importantly, rather than trying to
create a parallel government bioterror industry, or I should say
bioterror response industry, BioShield will draw on the expertise and
resources of the private sector.
Our American industries lead the world in these categories. And our
health care innovation, our free markets, our strong patent protections
have led American industry to spend more on research and development on
new products and treatments than all of Europe and Japan combined. To
make the progress that is necessary in these noncommercial areas that
are so essential to national security, it is essential we tap into this
strength in the private sector. To accomplish this, the legislation
establishes a reserve fund that will be available to stockpile security
countermeasures that are produced against government requirements, even
though these countermeasures do not presently exist.
We want to stimulate the invention, the productivity, the research
that is necessary to find these antidotes, these vaccines to bioweapons
that exist but for which countermeasures do not presently exist. The
gentleman from Louisiana (Chairman Tauzin) and I worked with the
gentleman from Kentucky (Chairman Rogers) of the new Appropriations
Homeland Security Subcommittee to provide this funding in a 10-year
advance appropriation. This money will remain available for a full
decade, creating, in essence, a homeland security market for the
development of critical security countermeasures for which no
commercial market exists. The knowledge that funding will be available
for a full decade and not be subject to the annual appropriations
process will encourage the biotech industry to devote resources to
develop and produce the next generation of treatments for bioterror
agents.
So once again I want to thank the Members on both sides who have
worked so hard on this legislation for their spirit of cooperation, of
bipartisan cooperation; and I strongly urge my colleagues to support
this very important legislation.
Mr. Speaker, I reserve the balance of my time.
I inquire how much time I have remaining.
The SPEAKER pro tempore (Mr. Gilchrest). The gentleman from
California (Mr. Cox) has 6 minutes remaining.
Mr. COX. Mr. Speaker, is that 6 minutes the time that was earlier
yielded to me by the gentleman from Virginia (Mr. Tom Davis)?
The SPEAKER pro tempore. The gentleman from Virginia (Mr. Tom Davis)
yielded 7 minutes, with a total of 14\1/2\ minutes.
Mr. COX. So the time that we are speaking of, Mr. Speaker, comprises
also the time allotted for purposes of debate to the Select Committee
on Homeland Security?
The SPEAKER pro tempore. That is correct.
Mr. TURNER of Texas. Mr. Speaker, I yield 6 minutes to the gentleman
from New Jersey (Mr. Pascrell), one of the most vigorous advocates for
equipping and training first responders to protect America.
Mr. PASCRELL. Mr. Speaker, the tragic events of September 11, and the
anthrax attacks shortly thereafter, reinforced the possibility of a
widespread bioterrorist strike on America; and that is very real. There
was a report submitted to us by Warren Rudman, who was the chairman of
the Independent Task Force on Emergency Responders dealing with this
subject very recently, and in that report it says the following: public
health labs in most States still lack basic equipment and expertise to
adequately respond to a chemical or a biological attack, and 75 percent
of State laboratories report being overwhelmed by too many testing
requests.
In fact, Mr. Speaker, we were told of this threat well before 9-11.
In January of 2001, a report submitted by the National Intelligence
Council stated that the number of players, that is, state players and
nonstate players, bioterrorism sponsored by state governments,
bioterrorism sponsored by nonstate terrorist organizations throughout
the world possessing or seeking to acquire a biological weapon, that
group is growing despite the fact that biological weapons are banned by
international treaty.
We were warned of this in January, 2001. While Congress has made
progress over the last 18 months on expanding our vaccine stockpile, an
enormous amount of work still remains. The Project BioShield Act of
2003 is so important because it encourages the development for new
countermeasures against a bioterror attack in a comprehensive manner.
This committee, the Select Committee on Homeland Security, was given a
rude awakening upon hearing the testimony of Mr. Paul Redmond, the
assistant secretary for information analysis at the Department of
Homeland Security. We learned that Mr. Redmond's office had

[[Page H6937]]

only one person working under him on the bioterror threat and that Mr.
Redmond had limited access to the intelligence himself. Imagine, we are
asking two people to protect 290 million Americans about a possible
biological threat they do not know about.
The Cox-Turner amendment, approved by our committee, correctly
concentrates on increasing not only access to intelligence but an
increase in the staff of those folks who collect intelligence.
Specifically, it requires that the Secretary of the Department of
Health and Human Services be provided all intelligence information from
all other agencies relating to the threats regardless of classification
and regardless of whether the Secretary has requested the information.
This bill is not just about creating a significant stockpile of
vaccines and medical devices. It is about making sure that our first
responders do have the tools to effectively operate their attack. Mr.
Speaker, they will be the first ones there, be it a firefighter, be it
a cop, be it someone working in emergency services. They will be the
first one there; and if they do not know what they are doing, if we do
not train them, if we do not provide the training, we are doing a
disservice to them and we are certainly putting them in harm's way. A
nurse or a doctor will be able to immediately provide a vaccine and
prevent the spread. A fireman will have a mask to breathe purified air
while a building with biological agents burns.
This bill will make those and other lifesaving tools available so we
can begin to protect ourselves, protect our children and our
grandchildren from the threats of today and the unfathomable biological
threat of tomorrow. This is just the beginning, Mr. Speaker. There is a
great deal that we still do not know. When one reads the report of the
National Intelligence Council on biological warfare, one understands
what scale we are talking about and what a delayed onset is and what a
delayed response will lead to. Most biological agents cause symptoms
that have a delayed onset ranging from a few hours to many days. This
is serious business. The fact that an attack has taken place can be
masked, and the identification of the perpetrators would be extremely
difficult to find out. I am confident, Mr. Speaker, that H.R. 2122 will
help, will help protect every American against the unimaginable.
The importance of Project BioShield cannot be overstated, and I
congratulate the leadership of both parties for bringing it to the
floor today.
Mr. COX. Mr. Speaker, I yield 3 minutes to the distinguished
gentlewoman from the State of Washington (Ms. Dunn), the vice chairman
of the full Select Committee on Homeland Security.
Ms. DUNN. Mr. Speaker, I rise today in support of the Project
BioShield Act of 2003. As the Members have heard today, Mr. Speaker,
from the debate we have had on the floor, this is truly bipartisan
legislation. It is also a major step towards giving Americans necessary
protections to address the biological and the chemical threats that
exist today. H.R. 2122 will provide for private companies the
incentives they need to develop vaccines for biological agents. It also
will increase our national pharmaceutical stockpile, and it will
provide DHS, the Department of Homeland Security, better intelligence
capabilities so that they can protect against biological and chemical
attacks.
Earlier this year, President Bush announced his intentions to develop
a vaccination program that would protect against an attack involving
biological and chemical weapons. For months, three committees,
including my committee, the Select Committee on Homeland Security, have
held numerous hearings to consider the best ways to protect our
constituents. I believe it is time to pass this legislation. Mr.
Speaker, this bill will provide $5.6 billion over a 10-year period to
develop vaccines to protect against some of the most dangerous
biological agents that this country and this world has ever known.
These funds are necessary to create an incentive for private companies
to do research and development on drugs that might not normally be in
demand in the marketplace. I believe this investment is worthwhile,
considering the possible effects of a large-scale biological attack.
In addition to authorizing funds for this program, the BioShield
program also addresses the sharing of intelligence. In order to develop
an effective vaccination program, the Department of Homeland Security
must have the intelligence capabilities to predict what the real
threats are thought to be. By understanding the threats, DHS can focus
its resources on those areas of highest vulnerability to the people who
live in this country.
This legislation will authorize specific funds to be used by DHS for
terror threat assessment. In addition, it will require other
intelligence agencies such as the CIA to share timely information and
threat analyses with the Department of Homeland Security.
One of the lessons we learned from the anthrax attacks during the
fall of 2001 is the importance of responding to a biological attack
quickly in order to minimize the damage it causes. While it is indeed
tragic that during those attacks five people died, we all have to
appreciate that. It could have been far worse if the vaccine had not
immediately been available. H.R. 2122 will help us be prepared to
respond quickly to agents such as ebola, plague and smallpox. I ask
that we answer the President's call to develop the BioShield Project
and that people support and that we pass H.R. 2122.
Mr. TURNER of Texas. Mr. Speaker, I yield 5 minutes to the
gentlewoman from Texas (Ms. Jackson-Lee), one of the foremost leaders
in trying to prepare her city and this country to protect us against
the threat of bioterrorism.
(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 the distinguished
gentleman from Texas for yielding me this time.
This is an important statement, if you will, an actuality of the work
that the Select Committee on Homeland Security has done along with
collaborative efforts of our respective committees of jurisdiction.

{time} 1530

Let me again thank the gentleman from Texas (Mr. Turner) for his work
and the chairman for his work and realize that, as we begin this debate
or as we engage in this debate, we need to do much more.
I rise to support this legislation because it takes America one step
closer to being prepared in dealing with a biochemical terrorist
attack. But as we consider this legislation, Mr. Speaker, I think it is
important to note that, while America is on the trail, on the pathway,
on the journey toward being safe, we are still not safe. We remain
vulnerable. Our ports are not secure, our critical infrastructures are
not secure, our communities are not protected from biochemical agents,
but H.R. 2122 will help to make America safer.
The purpose of this Act is to enhance research, development,
procurement, and use of biomedical countermeasures to respond to public
health threats affecting national security and for other purposes. What
it begins to do, Mr. Speaker, is to focus our attention narrowly on the
question of what do we do if we are subjected to a bioterrorist attack.
What kind of chemicals, if you will, will thwart the attack? What kind
of research needs to be done in advance of the diabolical thoughts of
anyone who would want to perpetrate a terrorist act with some chemical
yet unknown?
We already have had the experience of the fear and the intimidation
of anthrax. We have already had the terrible situation of people who
had nothing better to do or wanted to intimidate or scare or frighten,
use anything from salt to sugar to powder to suggest that they were
utilizing anthrax. We know what can be done through a bioterrorist
attack or the suggestion that there would be an attack by some sort of
chemical.
Biological weapons pose a particularly dangerous threat. Biological
weapons are highly portable and difficult to detect. So this concept of
BioShield is more than overdue. Its time has come. 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.

[[Page H6938]]

After 9/11, when we were allowed to fly home from Washington, I held
one of the first town hall meetings with over 400 people on September
14, 2001, on a Sunday, in fact, to be able to bring some sort of order
to people's thoughts, the fear that was going on, the actual
intimidation as far away as Houston. There were all kinds of
suggestions that Houston was next in line, that Houston was about to be
attacked.
But, shortly thereafter, I also held a meeting with my first
responders. As we were having a meeting, my hazardous materials team
had to run out to a hospital about 50 miles down from where our meeting
was being held because a woman drove to the hospital saying that she
had anthrax; someone had put anthrax in her apartment or in her home.
And without the understanding of what anthrax represents and the
hospital officials not yet experienced, took whatever she had through
the hospital, up the stairs, or wherever, up the elevator and, by its
very exposure, caused the hazardous materials team to have to run out
and shut down the hospital. A crippling effect, maybe just one
hospital, but it shows the magnitude of what can happen if we are
dealing with bioterrorism.
We all recall the primary and secondary impact of the anthrax attacks
in 2001. The attacks involved a series of letters mailed in pre-stamped
envelopes to places like Florida and New York and to the offices of
Senator Tom Daschle and Patrick Leahy. Those kinds of incidences prove
that it is vital that we focus on the research aspect. I am gratified
that my colleagues saw the importance of spreading the knowledge, the
research, the input, the collaboration throughout our Nation.
Therefore, we have included language to make sure that we include
historically black, Hispanic-serving, Native American, and Pacific
Islander institutions, that they are able to be exposed, if you will,
to the various opportunities to engage in high-level research so that,
as they are able to relate to different cultures and different
communities, they, too, can be a part of securing the homeland.
It is important as well, as I noted in an amendment that I was going
to propose, that the stockpiles of chemicals that will thwart
bioterrorist attacks that are in this country should be strategically
placed, that they can reach any urban center and any rural area, any
hamlet, any town, any village. I am glad to note by a letter that has
been submitted into the Record dated July 16, 2003, that the Secretary
of Health and Human Services recognizes that my letter had merit and
that he will continue to monitor and be astutely aware of whether or
not the stockpiles we have are sufficient, whether they are within the
sufficient depth, and whether they will be able to protect all of
America.
Let me conclude, Mr. Speaker, by simply saying that I rise to support
this legislation with the knowledge that we will be inclusive and that
the idea is not only to secure the places we know and that are renowned
but to secure the places where people live and to make sure that the
home front and the home neighborhoods are secure in our country.
I ask my colleagues to support this legislation.
Mr. Speaker, I rise today in support of H.R. 2122, the ``Project
Bioshield Act of 2003.'' I support this 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. H.R. 2122, will help to make
America safer.
The purpose of the Project BioShield Act of 2003 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 is
a noble one 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 pre-stamped 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 five 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 of 2001. As
recently as April 22nd 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 diseases like tuberculosis? There are many ailments that our
medical professionals are struggling to control. We must do better in
the ares 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 vial filled with anthrax, botulism, or
smallpox? A vial 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 Institutes 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 countermeasures, and empowers the government to
purchase safe and effective vaccines. Finally, Project Bioshield
authorizes the Food and Drug Administration 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 this legislation 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.
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

[[Page H6939]]

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. If 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 provision of H.R. 2122, 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.
Mr. COX. Mr. Speaker, I yield 2 minutes to the gentleman from Arizona
(Mr. Shadegg), the chairman of the Subcommittee on Emergency
Preparedness and Response.
Mr. SHADEGG. Mr. Speaker, I thank the gentleman for yielding me this
time.
As a member of both the Select Committee on Homeland Security and the
Committee on Energy Commerce, I rise in strong support of H.R. 2122,
the Project BioShield Act.
Mr. Speaker, today, the House takes an important step toward
preparing our Nation for the threat of bioterrorism. Clearly, we are
living in a transformational era. Thirty years ago, none of us knew
what biotechnology or genomics were, but, today, combined with our
country's unparalleled leadership in semiconductors and computing
power, we are on the verge of breathtaking breakthroughs in the field
of bioscience.
Congress has played an important role not only by doubling the
funding for the National Institutes of Health, but also by committing
$6 billion in fiscal year 2003 to develop strategies and
countermeasures to protect the American public from bioterror attacks.
Even though we are in a better position in terms of preparedness than
we were just a few months ago prior to the anthrax attacks here on
Capitol Hill, we have much more to do. Project BioShield is a
critically important step in that process. In many ways, it will serve
as our Nation's primary response to bioterror.
Mr. Speaker, the Subcommittee on Emergency Preparedness and Response
of the Select Committee on Homeland Security, which I chair, held
several hearings on this issue; and, during that process, we learned
that having measures to counter bioterror threats will actually serve
as a deterrent to those threats, as would-be terrorists see that
America can be protected against bioagents which al Qaeda or other
terrorists would use against us.
By providing a steady stream of funding for countermeasures,
increased research capability at NIH, and expedited distribution during
emergencies, project BioShield is a forward-thinking solution to
bioterrorism.
Mr. Speaker, our subcommittee worked hard on this legislation. I
believe it takes an important step in the right direction. I commend
the full committee chairman and the other committees for their work on
it, and I urge my colleagues to support the Project BioShield Act and
to support H.R. 2122.
Mr. COX. Mr. Speaker, I yield 1 minute to the gentleman from Florida
(Mr. Lincoln Diaz-Balart), the chairman of the Select Committee on
Homeland Security Subcommittee on Rules.
Mr. LINCOLN DIAZ-BALART of Florida. Mr. Speaker, I thank the
gentleman for yielding me this time.
For years the National Institutes of Health have served as our
Pentagon in the war against disease. I think Americans, as well as
people around the world, have benefited. Now, we must call upon, and we
do so in this important piece of legislation, for the NIH to utilize
its expertise and innovation, the expertise and innovation of all of
its scientists to guard this Nation against the horrors that a serious
biological attack would mean.
We have already seen, Mr. Speaker, a biological attack on this
country. We know the great damage that it can cause. So what this
legislation is doing is taking another important step, taking another
important step by this Congress to protect the Nation from the great
damage that a biological attack would cause.
I thank the gentleman from California (Chairman Cox) and the entire
committee for its hard work in bringing forth this important piece of
legislation today.
Mr. TURNER of Texas. Mr. Speaker, may I inquire of the time remaining
on both sides?
The SPEAKER pro tempore (Mr. Gilchrest). The gentleman from Texas
(Mr. Turner) has 3 minutes remaining. The time of the gentleman from
California (Mr. Cox) has expired.
Mr. TURNER of Texas. Mr. Speaker, I yield myself 1\1/2\ minutes.
Mr. Speaker, let me first commend the gentleman from California
(Chairman Cox), along with the gentleman from Michigan (Mr. Dingell),
the ranking member, and the gentleman from Louisiana (Chairman Tauzin),
the gentleman from Virginia (Chairman Davis), and the gentleman from
California (Mr. Waxman) for their excellent work on putting together
this legislation in a bipartisan way. I know we all appreciate the work
that Secretary Thompson and Secretary Ridge did on behalf of the
President on this very important initiative.
I hope that we are successful with this legislation, and I hope that
the desired result can be accomplished. But I also want to end with a
caution that the ability of our enemies in the years ahead to develop,
alter, and modify biological pathogens will be at a level unknown to us
today. I urge all of us to commit ourselves to the task of developing
the agility and the responsiveness that we need to address those
threats that we inevitably will face in the future.
The Washington Post today spoke in an editorial entitled ``New Bugs''
that it is important for us to shorten the time frame from the
identification of a dangerous pathogen to the development of a drug or
antidote. The shortening of this time span will require a tremendous
commitment on the part of the American people and our government, and I
hope this step that we take today will be but a first step in ensuring
that we can adequately meet the biological threat that this Nation will
face in the future.
Mr. Speaker, I yield the balance of my time to the distinguished
gentleman from California (Mr. Cox), the chairman of the Select
Committee on Homeland Security.
Mr. COX. Mr. Speaker, I thank the gentleman from Texas for yielding
me the remaining time.
I want to take a moment to say not only how productive it was to work
with the gentleman from Texas but what a pleasure it has been, because
both sides of the aisle, the Republicans and the Democrats, have worked
together, as we should, after September 11 to put our Nation's security
first.
I hope that our Nation never sees the kind of bioterror attack that
we have been discussing on the floor here today. It is our job to be
prepared against that eventuality. The legislative steps that we are
taking today, the resources that we are providing, the intelligence
infrastructure that we are building, the stockpile of vaccines and
antidotes that we may requisition under Project BioShield are all
intended to protect against mass casualties that would result in the
event of a terrorist attack that we hope to prevent and we hope never
to see in this country.
After September 11, I daresay every Member of this body determined
that we will win this war against these terrorists. They are not
superhuman. They are individuals. They do not have infinite
capabilities. They have finite resources. We can find them, we can
defeat them, and we shall. And we will be prepared. That is the purpose
of this legislation today. I strongly urge a vote in support.
Mrs. LOWEY. Mr. Speaker, I support Project BioShield.
Over the last few months. I have been having meetings with local
officials, first responders, hospitals, and school superintendents, to
talk about how we can better prepare for the unimaginable, improve
emergency planning, implement 21st century communication systems, and
foster better cooperation among local, state, and federal public health
and safety officials.

[[Page H6940]]

But all of these efforts won't amount to much if we do not have the
right tools to counteract biological, chemical, radiological, or
nuclear agents, and the diseases caused by such agents. And that's the
crux of this legislation.
With that said, I continue to have some concerns about whether this
bill will be enough of an engine to spur research within the
pharmaceutical industry and if our public health system is prepared and
ready to assume the new products developed by BioShield.
During the drafting process of this bill, a number of expert
witnesses stated that Project BioShield might not be tempting enough
bait to entice the pharmaceutical industry to bite. These fears are
legitimate. And that is why I am pleased that the bill includes a
provision allowing the federal government to assume this work in-hours
if private industry does not or cannot produce countermeasures fast
enough.
On the other hand, if BioShield is successful, which I know we all
hope it will be, and new countermeasures are developed, the success of
these products depend on our public health systems' ability to
distribute and deliver these serums to the general public in a timely,
safe, and orderly fashion. In the case of smallpox, the cost of
vaccinating--roughly $200 per vaccination because of screening,
testing, post vaccination surveillance, and treatment of adverse
reactions--has been a significant impediment to the program. Thus, the
key to effective countermeasures depends on a lot of factors and costs
other than buying countermeasures and putting them in the Strategic
National Stockpile.
As I have discussed with my colleagues and Administration officials
during both Homeland Security Committee and Labor HHS Appropriations
Subcommittee hearings, the bioterrorism grants provided through the
Centers for Disease Control and Prevention and Health Resources
Services Administration have not been adequate, particularly in the
context of the current economy and failing state budgets. Basic health
care programs are starved for cash for their core public health
missions while also trying to take on treater responsibilities in the
terrorism preparedness arena.
So today, I want to go on record with my colleagues that we must be
prepared to better invest in our public health network if we truly want
a sound and secure homeland.
Despite these criticisms, the BioShield proposal is a well-intended
one, and a vitally important component in the fight agaisnt terrorism.
The reality is: the more countermeasures we have, the less capable
terrorists will be. And one way or another Project BioShield is going
to make that happen.
Mr. KENNEDY of Rhode Island. Mr. Speaker, I rise in support of the
BioShield legislation, and commend the committees for their diligence
in meeting the challenge of bioterrorism.
While this bill is an important step in ensuring our nation's
preparedness for bioterrorism, I am concerned that it does not fully
meet our needs. This act does well in raising our defenses against the
``bio,'' but does nothing to defend against the ``terror.''
Mr. Speaker, the point of all terrorism, including bioterrorism, is
not primarily to inflict physical damage, but to undermine our social,
political, and economic vibrancy. Whether terrorists succeed depends
not only on our ability to prevent or mitigate the physical impact of
their acts, but whether we can prevent or mitigate the paralysis,
panic, and demoralization they seek to create.
Tom Kean, Rudolph Giuliani, the National Academy of Sciences, first
responders, and others have talked about the need to build resilience
in our communities. Our preparedness efforts must include plans to
ensure that officials' communications calm instead of panic. We need to
make sure that the public, first responders, teachers, and others have
the proper information delivered in an appropriate way about threats,
safety measures, and emergency plans. If we do not specifically address
the social and behavioral impacts of terrorism and the threat of
terrorism, the measure we debate today and our other preparations will
not be as effective as they could be.
I support this bill as component of our defense against biological
terrorism, and hope that we can take the important next step as well.
Mr. DINGELL. Mr. Speaker, I rise in support of the Project Bioshield
Act of 2003. This legislation reflects bipartisan negotiations that
have significantly improved the language submitted to us by the
Administration. That is a credit to the Committee on Energy and
Commerce and to other committees and colleagues. I commend the good
work of all who participated in this endeavor.
Project Bioshield is unfortunately a necessary measure in view of the
increased risk of harm to Americans in this era of heightened threats
to our national security. 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
counter-measures. The Committees' work clarified, modified, and
otherwise improved on the Administration's proposal in each of these
areas.
Significantly, the bill before us contains an additional section that
enhances 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 General Accounting Office and the National Academy of
Sciences will provide reports on key economic and scientific elements
of this program after it has been in effect for several years.
Finally, I commend Chairman Tauzin of the Committee on Energy and
Commerce and my other colleagues for deciding to proceed with an
authorization for funding, rather than with the mandatory 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 vote for this bill.
Mr. NUSSLE. Mr. Speaker, I rise today to speak on H.R. 2122, the
Project BioShield Act of 2003. This Act would amend the Public Health
Service Act to authorize appropriations to procure security
countermeasures to treat, identify, and prevent the public health
consequences of bio-terrorism.
Project BioShield has been described by President Bush as ``a key
part of our all-out effort to prepare for the threat of bio-terror.''
So I am pleased that the Project BioShield Act of 2003 will be voted on
today in this House.
The framework for this bill was initially established in the FY 04
Budget Resolution that was adopted in April. The budget resolution set
aside $5.593 billion over ten years to establish a program to
accelerate the research, development and acquisition of biomedical
threat countermeasures. Recognizing the importance of this legislation,
it took the somewhat usual step of establishing firewalls around these
funds to ensure they are not used for any other purpose.
I am very pleased that the bill we are considering today is
consistent with the budget resolution. It would authorize
appropriations of $5.6 billion for fiscal years 2004 through 2013. As
some of my colleagues may be aware, the House already passed
appropriations for this bill as part of the Appropriations bill for
Energy and Water. Accordingly, as provided by the budget resolution, I
adjusted the 302(a) allocation to the Appropriations Committee to
accommodate the appropriations for this important bill.
I would also like to comment on the funding mechanism for BioShield.
At the time the budget resolution was adopted, it was unclear whether
this program would be funded through annual appropriations or with a
permanent indefinite appropriation. Both the Budget and Appropriations
Committees expressed a preference for subjecting the program to
periodic review of the annual appropriation process. The Administration
preferred a new entitlement that would be automatically funded without
further legislative action.
I believe the funding mechanism in this bill strikes the right
balance. It would fund Project BioShield through what is effectively a
multi-year appropriation that would give the Administration flexibility
in the amount that is obligated in each year. It subjects the program
to periodic Congressional review through the appropriations process but
provides the pharmaceutical companies that develop the countermeasures
the assurance of future funding.
In conclusion, speaking for myself, and my colleagues, H.R. 2122
reflects our strongest support for those necessary efforts to protect
our people and our way of life.
Mr. VAN HOLLEN. Mr. Speaker, I rise today as the Representative of
the Congressional District that is the intended home of a key component
of the Project Bioshield Act, a $186 million bio-defense laboratory
that is planned to be built on the northeast corner of the National
Institutes of Health campus in Bethesda, Maryland. While I support the
Bioshield initiative, I have serious concerns about the proposed
location of the bio-defense laboratory.
Many of my constituents have expressed to me their concerns about the
potential safety risks that the location of this laboratory poses to
our community, and the possibility that it could become a target for
terrorist attacks. Given that our government determined--even before
this new laboratory was proposed--that a perimeter fence is required to
safeguard the

[[Page H6941]]

buildings and employees at the National Institutes of Health. I believe
a number of questions must be answered before we proceed further with
the plan to locate the laboratory on the NIH campus.
I have written to the Director of the National Institutes of Health
and asked him to address the following issues:
(1) The property of locating this laboratory in an urban setting like
Bethesda, as opposed to at Fort Detrick, where a bio-safety level 3
laboratory is already under construction;
(2) if located on the Bethesda campus, whether it can be located
centrally on the campus, either in a new building or by renovating an
existing building and relocating the offices and laboratories of that
building to a building in the location chosen for Building 33; and
(3) the precautions that will be taken to ensure that, in the event
of a terrorist attack or human error, that any potential risk to our
community presented by the presence of this laboratory on the Bethesda
campus is minimized or eliminated.
Mr. Speaker, I know that all of my colleagues in this House are
united in our common effort to combat terrorism. But we owe it to our
constituents to approach this endeavor carefully. I urge my colleagues
and the Administration to consider all options so that we do right by
all Americans.
Mr. COX. Mr. Speaker, I yield back the balance of my time.
The SPEAKER pro tempore. Pursuant to the order of the House of
Tuesday, July 15, 2003, the previous question is ordered on the bill,
as amended.
The question is on the engrossment and third reading of the bill.
The bill was ordered to be engrossed and read a third time, was read
the third time.
The SPEAKER pro tempore. The question is on the passage of the bill.
The question was taken; and the Speaker pro tempore announced that
the ayes appeared to have it.
Mr. COX. Mr. Speaker, on that I demand the yeas and nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further
proceedings on this question will be postponed.

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