[House Report 108-147]
[From the U.S. Government Publishing Office]
108th Congress Rept. 108-147
HOUSE OF REPRESENTATIVES
1st Session Part 3
======================================================================
PROJECT BIOSHIELD ACT OF 2003
_______
July 8, 2003.--Ordered to be printed
_______
Mr. Cox, from the Select Committee on Homeland Security, submitted the
following
R E P O R T
together with
ADDITIONAL VIEWS
[To accompany H.R. 2122]
The Select Committee on Homeland Security, to whom was
referred 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, having considered the same, report favorably
thereon with an amendment and recommend that the bill as
amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 17
Background and Need for Legislation.............................. 17
Hearings......................................................... 18
Committee Consideration.......................................... 19
Committee Votes.................................................. 19
Committee Oversight Findings..................................... 27
Statement of General Performance Goals and Objectives............ 27
New Budget Authority, Entitlement Authority, and Tax Expenditures 27
Congressional Budget Office Estimate............................. 27
Federal Mandates Statement....................................... 27
Advisory Committee Statement..................................... 27
Constitutional Authority Statement............................... 28
Applicability to Legislative Branch.............................. 28
Section-by-Section Analysis of the Legislation................... 28
Changes in Existing Law Made by the Bill, as Reported............ 35
The amendment 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
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) 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.
``(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) 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 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:
``(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.
``(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--
``(aa) section 303(g)(1)(A)
of the Federal Property and
Administrative Services Act of
1949 (41 U.S.C. 253(g)(1)(A))
and its implementing
regulations; and
``(bb) section 302A(b) of
such Act (41 U.S.C. 252a(b))
and its implementing
regulations.
``(II) Application of certain
provisions.--Notwithstanding subclause
(I) and the provision of law and
regulations referred to in such clause,
each of the following provisions shall
apply to procurements described in this
clause to the same extent that such
provisions would apply to such
procurements in the absence of
subclause (I):
``(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.--
``(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) 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 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
``(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 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 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).
(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.
Purpose and Summary
The purpose of the Project BioShield Act of 2003 is to
provide the Secretary of Health and Human Services with greater
authority and flexibility to facilitate the research and
development of biomedical countermeasures; to authorize the
appropriation of funding for the procurement of security
countermeasures through the creation of a special reserve fund;
and to authorize the emergency use of unapproved drugs,
devices, and biologics and the emergency unapproved use of
approved drugs, devices, and biologics.
Background and Need for Legislation
During times of national, military, or public health
emergency, the American people may be placed at risk of
exposure to biological, chemical, radiological, or nuclear
agents, and the diseases caused by such agents. Unfortunately,
there are not approved or available countermeasures to treat
many diseases or conditions that may be caused by such agents.
Currently, companies have little incentive to research,
develop, or produce vaccines or other drugs simply for a
possible one-time purchase by the Federal government for the
Strategic National Stockpile. Most current private sector
research and development dollars go for drugs or devices that
will have continuous commercial application. In addition, some
of the current generation of drugs or devices may have special
uses as countermeasures to biological agents like Ebola, but
there is little incentive to perform the research or
development or production activities that might tailor the drug
or drug approvals for such a purpose.
Even if a product has been developed to treat such diseases
or conditions, if the product has not yet been approved by the
Food and Drug Administration (FDA), access to the therapy is
greatly limited. Nothing in the Food and Drug Act allows the
Secretary to suspend the approval requirements to ensure access
to unapproved drugs and devices on a large-scale basis in times
of emergency.
Under present law, if a product is not approved by the FDA,
then it is unlawful to provide that product to an individual,
unless the product has been authorized for distribution under
an investigational new drug (IND) application (for a drug and
biologic) or an investigational device exemption (IDE). When a
drug or device is available under such procedures, a number of
conditions apply that make the use of an IND or IDE infeasible
in times of national emergency, where drugs and devices may
need to be deployed at rapid rates. Even if a drug, biologic,
or device is highly promising in treating a disease or
condition associated with biological, chemical, radiological,
or nuclear agents, and even if it is the only therapy
available, current FDA law does not allow for rapid deployment
of the product.
The Project Bioshield Act is designed to help resolve these
problems and make our nation more secure. Like the Public
Health Security and Bioterrorism Preparedness and Response Act,
the Project Bioshield Act is designed to help the
administration and the nation in public health emergency
preparedness, but relies on the ingenuity and hard work of
Americans in the private and public sector to achieve these
goals.
Hearings
The Subcommittee on Emergency Preparedness and Response
held a joint hearing with the Subcommittee on Health of the
Committee on Energy and Commerce on ``Furthering Public Health
Security: Project Bioshield'' on March 27, 2003. The
Subcommittee received testimony from: The Honorable Tommy
Thompson, Secretary, U.S. Department of Health and Human
Services; Mr. Leighton Read M.D., General Partner, Alloy
Ventures, on behalf of Biotechnology Industry Organization; Mr.
Michael Friedman M.D., Chief Medical Officer for Biomedical
Preparedness, PhRMA; Mr. James Baker Jr., Ruth Dow Doan
Professor, Center for Biological Nanotechnology; and, Mr. Gary
Noble M.D., Vice President of Medical and Public Affairs,
Johnson & Johnson, on behalf of AdvaMed.
The Full Committee held a hearing on ``Bioshield:
Countering the Bioterrorist Threat'' on May 15, 2003. The
Committee received testimony from: Dr. Anthony Fauci, Director,
National Institute of Allergy and Infectious Diseases; Dr. L.
Garry Adams, Associate Dean for Research, Biodefense &
Infectious Diseases, College of Veterinary Medicine, Texas A&M
University; Dr. Clarence James Peters, Director for Biodefense,
Center for Biodefense and Emerging Infectious Diseases,
University of Texas Medical Branch; Dr. Ronald Crystal,
Professor and Chairman, Department of Genetic Medicine, Weill
Medical College of Cornell University; William A. Haseltine,
Ph.D., Chairman and Chief Executive Officer, Human Genome
Sciences, Inc.; Alan Pemberton, Pharmaceutical Research and
Manufacturers of America; Robert J. Sutcliffe, Director,
President and Chief Executive Officer, Digital Gene
Technologies, Inc.; and, Frank M. Rapoport, Partner, McKenna
Long & Aldridge LLP.
The Subcommittee on Emergency Preparedness and Response and
The Subcommittee on Intelligence and Counterterrorism held a
joint hearing on ``Does the Homeland Security Act of 2002 give
the Department the Tools it Needs to Determine Which Bio-
Warfare Threats are Most Serious?'' on June 5, 2003. The
Committee received testimony from: Paul J. Redmond, Assistant
Secretary, Information Analysis, Department of Homeland
Security; and, Eric Tolbert, Director of the Response Division,
Emergency Preparedness and Response Directorate, Department of
Homeland Security.
The Full Committee held a hearing on ``Bioshield: Lessons
from Current Efforts to Develop Bio-Warfare Countermeasures''
on June 6, 2003. The Committee received testimony from: Dr.
John Ring La Montagne, Deputy Director, National Institute of
Allergy and Infectious Diseases, National Institutes of Health,
Department of Health and Human Services; and, Dr. Ali Khan,
Chief Science Officer, Parasitic Diseases, National Center for
Infectious Diseases, Center for Disease Control and Prevention,
Department of Health and Human Services.
Committee Consideration
On Thursday, June 27, 2003, the Full Committee met in open
markup session and ordered H.R. 2122 reported to the House, as
amended, by a record vote of 29 yeas and 0 nays.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
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; was ordered favorably reported to the House, amended,
by a recorded vote of 29 yeas and 0 nays (Roll Call Vote No. 4)
as follows:
The following amendments were offered:
An Amendment in the Nature of a Substitute offered by Mr.
Cox (#1), was AGREED TO by voice vote, as amended.
An amendment offered by Mr. Hunter to the Amendment in the
Nature of a Substitute offered by Mr. Cox (#1A), Page 17,
beginning on line 23, strike ``Homeland Security Secretary''
and insert ``Homeland Security Secretary, Secretary of Defense
and Secretary of State.'' was AGREED TO by a recorded vote of
25 yeas and 0 nays (Roll Call Vote No. 1) as follows:
An amendment offered by Mr. Hunter to the Amendment in the
Nature of a Substitute offered by Mr. Cox (#1B), Page 52, line
24, insert a new section entitled ``Ensuring coordination,
cooperation and the elimination of unnecessary duplication in
programs designed to protect the homeland from biological,
chemical, radiological, and nuclear agents'' was AGREED TO by
voice vote.
An amendment offered by Mr. DeFazio to the Amendment in the
Nature of a Substitute offered by Mr. Cox (#1C), to insert a
new subsection entitled ``Status of Program for Chemical
Terrorism Preparedness'' was AGREED TO by voice vote.
An amendment offered by Ms. Slaughter to the Amendment in
the Nature of a Substitute offered by Mr. Cox (#1D), to insert
a new section entitled ``Expatriate Corporations'' was NOT
AGREED TO by a recorded vote of 17 yeas and 18 nays (Roll Call
Vote No. 2) as follows:
An amendment offered by Mr. Markey to the Amendment in the
Nature of a Substitute offered by Mr. Cox (#1E), Page 37, line
9, add the following: ``If an authorization under the preceding
sentence for a product is revoked under subsection (g), or if
the declaration of an emergency under subsection (b) ceases to
be in effect, the product may not be introduced into interstate
commerce except in accordance with section 505, 510(k), or 515,
or section 351 of the Public Health Service Act, as
applicable.'' was WITHDRAWN.
An amendment offered by Ms. Jackson-Lee to the Amendment in
the Nature of a Substitute offered by Mr. Cox (#1F), to insert
a new section at the end of the bill entitled ``Sec. 6.
Inclusion of Certain Populations in Research, Development, and
Procurement Projects.'' was WITHDRAWN.
An amendment offered by Mr. Tauzin to the Amendment in the
Nature of a Substitute offered by Mr. Cox (#1G), Page 28,
strike line 16 and all that follows through page 29, line 19
was NOT AGREED TO by a recorded vote of 19 yeas and 19 nays
(Roll Call Vote No. 3). As follows:
An amendment offered by Mr. Andrews to the Amendment in the
Nature of a Substitute offered by Mr. Cox (#1H), on page 16,
line 4 of the Cox-Turner Substitute amendment: add the
following: ``notwithstanding the preceding provisions of this
subclause, nothing in this section shall alter the rights of
the parties afforded by the Federal Acquisition Regulation or
other applicable laws or regulations regarding a termination
for the convenience of the government.'' was WITHDRAWN.
An amendment offered by Ms. Jackson-Lee to the Amendment in
the Nature of a Substitute offered by Mr. Cox (#1I), to insert
at the end of the substitute the following section: ``Sec. 6.
Outreach.'' was AGREED TO by voice vote.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee has held oversight
hearings and made findings that are reflected in this report.
Statement of General Performance Goals and Objectives
The purpose of the Project BioShield Act of 2003 is to
provide the Secretary of Health and Human Services and the
Secretary of Homeland Security greater authority and
flexibility to facilitate the research, development, and
procurement of biomedical countermeasures.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
2122, the Project Bioshield Act of 2003, would result in no new
or increased budget authority, entitlement authority, or tax
expenditures or revenues.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, a cost estimate provided by the
Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974 was not made available to the
Committee in time for the filing of this report. The Chairman
of the Committee shall cause such estimate to be printed in the
Congressional Record upon its receipt by the Committee.
Federal Mandates Statement
An estimate of Federal mandates prepared by the Director of
the Congressional Budget Office pursuant to section 423 of the
Unfunded Mandates Reform Act was not made available to the
Committee in time for the filing of this report. The Chairman
of the Committee shall cause such estimate to be printed in the
Congressional Record upon its receipt by the Committee.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
Constitutional authority for this legislation is provided in
Article I, section 8, clause 1, which grants Congress the power
to provide for the common Defense of the United States.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 establishes the short title of the Act as the
``Project BioShield Act of 2003.''
Section 2. Biomedical countermeasure research and development
authorities
Section 2(a) of the Project BioShield Act of 2003 amends
the Public Health Service Act to add a new section 319F-1. The
section grants the Secretary of the Department of Health and
Human Services (HHS) additional flexibility and authority in
conducting research and development with respect to biomedical
countermeasures against biological, chemical, nuclear and
radiological agents that may affect national security.
New subsection 319F-1(a) provides general authority.
Proposed subparagraph 319F-1(a)(4) makes the facilities of
entities that enter into a grant or cooperative agreement with
the Secretary of HHS under this section available as needed to
such Secretary of HHS to respond to public health emergencies
affecting national security.
New subsection 319F-1(b) provides expedited authority for
governmental procurements used to perform, administer, or
support pressing research and development activities under this
section, by (1) increasing the simplified acquisition threshold
from $100,000 to $25 million; (2) authorizing the use of
procedures providing for less than full and open competition
when there are only a limited number of responsible sources and
no other type of services will satisfy the Secretary of HHS
needs; and (3) increasing the micropurchase threshold for such
procurements to $15,000.
New subsection 319F-1(c) authorizes the Secretary of HHS to
use expedited peer-review procedures in lieu of otherwise
applicable peer-review procedures in the case of grants and
contracts for biomedical countermeasure research and
development activity, if such grants and contracts do not
exceed $1,500,000 and are necessary to respond to pressing
research needs.
New subsection 319F-1(d) provides additional flexibility to
the Secretary of HHS with respect to the hiring of experts and
consultants when necessary to respond to pressing qualified
countermeasure research and development needs. Under paragraph
319F-1(d)(2), such experts and consultants are deemed to be
employees of HHS for purposes of the Federal Torts Claims Act,
which provides the exclusive remedy against such personnel for
claims relating to the performance of covered duties.
New subsection 319F-1(e) provides streamlined personnel
authority for the Secretary of HHS to appoint up to 30 people
to positions in the National Institutes of Health without
regard to ordinary classification criteria, when necessary to
respond to pressing qualified countermeasure research and
development needs.
New subsection 319F-1(f) provides that actions by the
Secretary of HHS under the section are committed to agency
discretion.
Section 2(b) of the Project BioShield Act of 2003 amends
section 481A of the Public Health Service Act to add the
Director of the National Institute of Allergy and Infectious
Diseases to that section, and thus provide to that Director
certain authorities concerning modernization and construction
of research facilities. Section 2(b) further authorizes such
sums as may be necessary for such purposes.
Section 3. Biomedical countermeasures procurement
Section 3(a) of the Project BioShield Act of 2003 adds a
new section 319F-2 to the Public Health Service Act. Several
provisions of new section 319F-2 simply transfer existing
provisions of law from the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002, as amended
by the Homeland Security Act of 2002. Proposed Subsection 319F-
2(a) contains language from existing law establishing the
Strategic National Stockpile. New section 319F-2(b) contains
language from existing law concerning authorizing procurement
of smallpox vaccine for the National Strategic Stockpile.
New section 319F-2(c) requires the Secretary of the
Department of Homeland Security (DHS) to assess threats that
may be posed by chemical, biological, radiological, and nuclear
agents, and requires the HHS Secretary to assess the public
health consequences of such agents and the availability and
appropriateness of countermeasures for the threats identified.
After these steps, the Secretaries jointly may determine and
recommend to the President that funding for procurement of such
a countermeasure for the nation's stockpile is appropriate from
the special reserve fund established by this Act.
Under section 319F-2(c)(4), the Secretaries of HHS and DHS
may recommend to the President a proposal to issue a call for
the development of countermeasures. Such a call includes a
commitment from the Secretaries to make a recommendation for
funding procurement of such a countermeasure from the special
reserve fund, if government specifications for the product are
achieved. The Secretaries also may secure a Presidential
approval for funding prior to, or without, conducting a call.
New section 319F-2(c)(4)(B) provides that the Secretaries
should include in any call for proposals for countermeasure
production information that may be necessary to encourage or
facilitate research and development into such countermeasures.
The Committee recognizes that an important factor companies
will consider in determining whether to invest scarce research
and development dollars into security countermeasures is
whether and to what extent they may face liability relating to
the development or production of such countermeasures. The
Committee thus encourages the Secretaries to indicate in any
call for proposals the potential availability of
indemnification or liability protections under other laws. The
Secretary of Homeland Security is further encouraged to
designate such countermeasures as ``qualified anti-terrorism
technologies'' as defined in section 862 of the Homeland
Security Act.
Under section 319F-2(c)(7), if the President approves a
recommendation for funding from the special reserve fund, DHS
would then enter into an agreement with HHS under which HHS may
procure the countermeasure for the stockpile using the DHS
special reserve fund. Contracts under this paragraph are
subject to certain conditions, including the condition that
payment shall only be made upon ``substantial delivery,''
unless the Secretary of HHS determines an advance of up to 10
percent of the contract amount is necessary to ensure success
of the project. This provision does not alter the rights of
contracting parties under the Federal Acquisition Regulation or
other applicable laws or regulations regarding a termination
for the convenience of the government. The Secretary of HHS is
authorized to include contract provisions limiting or
forbidding non-stockpile sales of a security countermeasure.
The Secretary is strongly encouraged to include such provisions
when it is necessary or desirable in order to protect United
States national security interests with respect to the transfer
of highly specialized countermeasures or enabling intellectual
property, and particularly to guard against the transfer of
such countermeasures or intellectual property to specific
foreign entities when the Secretary, in consultation with the
Secretaries of the Departments of Homeland Security, State, and
Defense, believes that the transfer would have undesirable
national security implications or pose an unacceptable risk to
the national security.
Section 319F-2(d) contains prohibitions on disclosure of
information transferred from existing law. Section 319F-2(e)
contains definitions transferred from existing law.
Section 319F-2(f) contains authorization of appropriations
for the Strategic National Stockpile and smallpox vaccine
development transferred from existing law with one addition.
The new paragraph makes clear that such existing authorizations
are in addition to amounts authorized under the special reserve
fund. Nothing in the Act would restrict or alter the
Secretaries' existing authority to purchase items for the
stockpile using existing discretionary appropriations for such
purpose.
Section 3(b) of the Project BioShield Act of 2003 adds a
new section 510 to the Homeland Security Act of 2002. This new
section authorizes appropriations for the special reserve fund
referenced in the new section 319F-2(c) of the Public Health
Service Act. The bill authorizes $890 million in FY 04 for such
procurements, and aggregate amounts of $3.4 billion and $5.6
billion over the next five and ten fiscal years respectively.
All amounts appropriated under this authorization would be
available for obligation through the end of FY 2013.
The new section 510 of the Homeland Security Act also
authorizes $5 million in FY 04 for the hiring of professional
biological, chemical, radiological, and nuclear threat analysts
at DHS, and such sums as are necessary to construct secure
facilities for the receipt of classifiedinformation necessary
to allow the Secretary of DHS to carry out his threat assessment
responsibilities under this Act. The Committee expects that the
Secretary of DHS will receive the full cooperation of other agencies in
the federal government in getting up-to-date intelligence and other
information, as required by the Homeland Security Act.
Subsection 510(e) allows the Secretaries of DHS and HHS to
use the special reserve fund to produce security
countermeasures directly, if they jointly determine, and the
President approves, that procurement is not proceeding rapidly
enough.
The Act defines the scope of the new authorities set forth
in this section as applying to countermeasures against agents
that the Secretary of DHS believes present ``a material threat
against the United States population'' and about which the HHS
and DHS Secretaries make certain additional findings. The
Committee expects that both Secretaries will consider the
threat of use of such agents by terrorists against the U.S.
population to be a significant factor in making their
respective scope determinations under these provisions.
However, the Committee also recognizes and encourages the
Secretaries to consider the emerging threats to public health
and national security that may be caused by the spread of
antibiotic resistant organisms or dangerous viruses that may
spread rapidly and lack effective countermeasures today. These
threats may affect national security whether by terrorists or
through natural conditions. The Secretaries should consider
such factors in determining whether to use these new
authorities to promote research, development, and production of
security countermeasures, such as broad-spectrum antibiotics,
that could be useful against a range of potential threat
agents.
Section 4. Authorization for medical products for use in emergencies
Section 4 adds a new section 564 to the Federal Food, Drug,
and Cosmetic Act. New section 564(a) allows the Secretary of
Health and Human Services to authorize for introduction into
interstate commerce unapproved drugs, devices, and biological
products or unapproved uses of approved drugs, approved/cleared
devices, and biological products intended for use in an actual
or potential emergency during the effective period of a
declaration.
New section 564(b) allows the Secretary of HHS to declare
an emergency justifying an emergency use authorization based
upon a determination by the Secretary of Homeland Security that
there is a national emergency or the significant potential of
one, or by a determination of the Secretary of Defense that
there is a military emergency, or a significant potential of
one. Such emergencies must involve a heightened risk of attack
with biological, chemical, radiological, or nuclear agents.
Similarly, an emergency use authorization can be based upon a
determination of the Secretary of HHS that there is a public
health emergency affecting national security and involving
biological, chemical, radiological, or nuclear agents. In
making a determination about whether a public health emergency
under section 319 of the Public Health Service Act affects
national security, the Secretary may consider all information
he deems pertinent and appropriate, and nothing in this Act
requires that the Secretary consult with other executive branch
officials prior to making such a determination.
Under this section, any declaration of emergency will last
for one year, unless the Secretary of HHS terminates it at an
earlier time. The Secretary of HHS may renew a declaration. The
Secretary of HHS must publish all declarations, determinations,
and renewals in the Federal Register, and the Secretary must
provide reasonable advanced notice that declarations are to be
terminated under this section. The Committee intends that,
after a declaration is terminated, final disposition of
labeling or intrastate disposition of a product may occur.
Further, the Committee believes that the Commissioner of the
Food and Drug Administration (Commissioner) may exercise
enforcement discretion not to object to interstate shipment of
an unapproved product for return to a manufacturer. A
determination of what is a ``reasonable'' period for advanced
notice of termination should consider all factors, so in some
cases notice immediately preceding termination may be
reasonable, while in other circumstances it may not.
Section 564(c) details the criteria for issuance of an
emergency use authorization. Under this new section, the
Secretary of HHS, acting through the Commissioner, may issue an
authorization upon concluding (1) that a biological, chemical,
radiological, or nuclear agent or agents can cause a serious or
life-threatening disease or condition; (2) that the drug,
device or biological product may be effective in detecting,
diagnosing, treating, or preventing such disease or condition
(or a serious disease or condition caused by taking a product
already approved, licensed or cleared by FDA for treating or
preventing such disease or condition), and the benefits of the
product outweigh risks; (3) that there is no adequate,
approved, and available alternative to the product; and, (4)
other criteria the Secretary may by regulation specify. The
Commissioner should consult with the Directors of the National
Institutes of Health and the Centers for Disease Control and
Prevention prior to issuing an authorization, but such
consultation is limited by considerations of feasibility and
appropriateness given the circumstances of the emergency.
Section 564(d) concerns the scope of an emergency use
authorization. Under this section, the authorization shall
state the disease or condition that the product may be used to
detect, diagnose, prevent, or treat, as well as the
Commissioner's conclusions about known benefits and risks of
the product and conclusions concerning safety and potential
effectiveness. The Committee intends that before issuing an
authorization under this section, the Commissioner will, where
feasible given the nature and the extent of the emergency,
notify the holder of any relevant application under this
chapter or under section 351 of the Public Health Service Act.
The purpose of such notification is to allow for discussion of
the conditions of this authorization as required by subsection
(e), as well as discussion of whether such product should be
delivered pursuant to section 319F-2(c) of the Public Health
Service Act.
Section 564(e) pertains to products that have never been
approved, licensed, or cleared by FDA. Under this subsection,
conditions shall, to the extent feasible given the
circumstances of the emergency, be applied to persons who
choose to carry out an activity for which the authorization is
issued. Such mandatory conditions include information to
providers about the emergency use of the product as well as
significant known potential risks and benefits, as well as
appropriate conditions designed to ensure that to the maximum
extent feasible given the circumstances of the emergency,
individuals to whom the product is administered are informed of
the emergency use of the product, risks and benefits of the
product, and of the option to accept or refuse the product.
Further, the Commissioner is given the authority to impose
other conditions on those who carry out activities for which
the authorization is issued. Such conditions imposed by the
Commissioner should be designed to provide maximum flexibility
to ensure that those who wish to take the product can indeed
take the product, if made available by the manufacturer.
Section 564(e) also applies to unapproved uses of approved
products and the Commissioner may, for manufacturers who choose
to carry out one or more activities pursuant to an emergency
use authorization, apply certain conditions. This subsection
makes clear that manufacturers do not have to avail themselves
of the emergency use authorization for unapproved uses of
approved products, and it makes clear that no individual may
alter or obscure the labeling ofalready approved products. It
does authorize, however, persons other than the manufacturer to provide
information about the product concerning the emergency use of the
product.
Under section 564(e), the Commissioner may establish
conditions regarding product labeling and information
conveyance concerning unapproved products. Further, the
Committee intends that the Commissioner may establish
conditions regarding product labeling and information
conveyance on manufacturers that carry out one or more
activities pursuant to an emergency use authorization with
respect to the emergency use of that product that is an
unapproved use of an approved product.
Subsection (f) makes clear that an emergency use
authorization is effective until the declaration is terminated
or revoked, but allows patients to continue using such products
in certain instances. Nothing in this subsection is intended to
require manufacturers or others to provide such products to
patients.
Subsection (g) makes clear that the Commissioner shall
periodically review the appropriateness of an authorization,
and it provides the Commissioner needed flexibility to revoke
an authorization if the criteria justifying the authorization
are no longer met.
Subsection (h) ensures that the Commissioner shall promptly
publish in the Federal Register notices of all authorizations,
terminations, and revocations. Subsection (i) makes clear that
all determinations under this new section are committed to
agency discretion. Subsection (j) is a rule of construction
noting that this new section does not impair or otherwise
affect certain existing authorities.
New section 564(k) pertains to members of the Armed Forces
and, among other things, it specifies that the President may
waive requirements designed to ensure that such members are
informed of the option to accept or refuse administration of an
emergency use product, upon certain findings (which are
identical to the findings found in section 1107 of Title 10).
Further, the subsection requires that if certain information is
not provided to members of the Armed Forces prior to an
emergency use product being administered to them, then
information concerning the administration of the product shall
be placed in the medical record of the member.
Subsection (l) makes clear that if a product is authorized
for emergency use under this new section, the investigational
sections of the Act shall not apply to the products.
Subsection (m) ensures that no authority in new section 564
can require a manufacturer of a drug, device, or biological
product to perform any activity that becomes lawful pursuant to
the new section. That is, the Commissioner in no way is given
the authority to, among other things, require a manufacturer to
introduce into interstate commerce or deliver for introduction
into interstate commerce any unapproved product or an approved
product for an unapproved use under this section. Further, even
if the Commissioner authorizes the emergency use of an already-
approved, licensed or cleared product, a manufacturer can
refuse to avail themselves of such emergency use authorization
and continue introducing into interstate commerce its approved
or cleared product under the Federal Food, Drug and Cosmetic
Act, or licensed product pursuant to the Public Health Service
Act. The only obligation in subsection (m) is that if the
Commissioner authorizes the emergency use of a sole-source
unapproved product, then the manufacturer of such product must
inform the Commissioner of its intention not to carry out any
activity under the authorization within a reasonable period of
time. Nothing in this section shall be construed as authorizing
the Commissioner to establish conditions on the distribution,
administration, or labeling of any other product in any other
circumstance.
Subsection (n) ensures that the present enforcement regime
of the Federal Food, Drug, and Cosmetic Act will apply to
individuals who carry out an activity or activities pursuant to
an authorization, but fail to comply with applicable
conditions. If any person carries out an activity pursuant to
section 564, but violates a condition imposed by the
Commissioner, then that person will be subject to Chapter III
of the Act, where the ``prohibited acts'' are found. If a
person is found to be in violation of a prohibited act found in
section 301, then the Committee intends for that person to be
subject to the enforcement provisions found in sections 302,
303, and 304. A violation of any condition applied to an
emergency use product in no way alters or affects the emergency
use status of the underlying product.
Section 5. Reports
Section 5(a) requires the Secretary of HHS to submit annual
reports to Congress concerning the exercise of many of the new
authorities under the Act. Section 5(b) requires a report from
the National Academy of Sciences concerning whether and to what
extent the research authorities granted under the Act have
enhanced the development of biomedical countermeasures
affecting national security. Section 5(c) requires the General
Accounting Office to issue a report concerning the Secretary of
HHS utilization of these new authorities. Section 5(d) requires
the Secretaries of HHS and DHS to report any additional
barriers to procurement of security countermeasures which have
not been addressed by Bioshield. The Secretaries should include
in this report information as to whether there is a shortage of
adequate biocontainment facilities or other resources for
carrying out necessary research and development and testing.
Section 5(e) requires the Secretary of DHS to report on the
status of chemical preparedness.
Section 6. Ensuring coordination, cooperation and the elimination of
unnecessary duplication in programs designed to protect the
homeland from biological, chemical, radiological, and nuclear
agents
Section 6 requires the Secretaries of the HHS, DHS, and DOD
to coordinate their efforts to identify and develop
countermeasures to biological, chemical, radiological, and
nuclear threats. These Departments are instructed to designate
agency coordination officers for this purpose.
Section 7. Outreach
Section 7 instructs the Secretary of HHS to ensure that, to
the extent practicable, Historically Black Colleges and
Universities and other minority research institutions are made
aware of research and development grants and procurements under
Bioshield.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italics, existing law in which no change
is proposed is shown in roman):
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
* * * * * * *
Part B--Federal-State Cooperation
* * * * * * *
SEC. 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) 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.
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) 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 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:
(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.
(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--
(aa) section
303(g)(1)(A) of the
Federal Property and
Administrative Services
Act of 1949 (41 U.S.C.
253(g)(1)(A)) and its
implementing
regulations; and
(bb) section 302A(b)
of such Act (41 U.S.C.
252a(b)) and its
implementing
regulations.
(II) Application of certain
provisions.--Notwithstanding
subclause (I) and the provision
of law and regulations referred
to in such clause, each of the
following provisions shall
apply to procurements described
in this clause to the same
extent that such provisions
would apply to such
procurements in the absence of
subclause (I):
(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.--
(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) 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 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.
* * * * * * *
TITLE IV--NATIONAL RESEARCH INSTITUTES
* * * * * * *
Part E--Other Agencies of NIH
* * * * * * *
SEC. 481A. BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES.
(a) Modernization and Construction of Facilities.--
(1) In general.--The Director of NIH, acting through
the Director of the Center or the Director of the
National Institute of Allergy and Infectious Diseases,
may make grants or contracts to public and nonprofit
private entities to expand, remodel, renovate, or alter
existing research facilities or construct new research
facilities, subject to the provisions of this section.
* * * * * * *
(c) Requirements for Grants.--
(1) In general.--The Director of the Center or the
Director of the National Institute of Allergy and
Infectious Diseases may make a grant under subsection
(a) only if the applicant for the grant meets the
following conditions:
(A) * * *
* * * * * * *
(2) Institutions of emerging excellence.--From the
amount appropriated under [subsection (i)] subsection
(i)(1) for a fiscal year up to $50,000,000, the
Director of the Center shall make available 25 percent
of such amount, and from the amount appropriated under
such subsection for a fiscal year that is over
$50,000,000, the Director of the Center shall make
available up to 25 percent of such amount, for grants
under subsection (a) to applicants that in addition to
meeting the requirements established in paragraph (1),
have demonstrated emerging excellence in biomedical or
behavioral research, as follows:
(A) * * *
* * * * * * *
(d) Requirement of Application.--The Director of the Center
or the Director of the National Institute of Allergy and
Infectious Diseases may make a grant under subsection (a) only
if an application for the grant is submitted to the Director
and the application is in such form, is made in such manner,
and contains such agreements, assurances, and information as
the Director determines to be necessary to carry out this
section.
(e) Amount of Grant; Payments.--
(1) Amount.--The amount of any grant awarded under
subsection (a) shall be determined by the Director of
the Center or the Director of the National Institute of
Allergy and Infectious Diseases, except that such
amount shall not exceed--
(A) 50 percent (or, in the case of the
Institute, 75 percent) of the necessary cost of
the construction of a proposed facility as
determined by the Director; or
(B) in the case of a multipurpose facility,
40 percent (or, in the case of the Institute,
75 percent) of that part of the necessary cost
of construction that the Director determines to
be proportionate to the contemplated use of the
facility.
(2) Reservation of amounts.--On the approval of any
application for a grant under subsection (a), the
Director of the Center or the Director of the National
Institute of Allergy and Infectious Diseases shall
reserve, from any appropriation available for such
grants, the amount of such grant, and shall pay such
amount, in advance or by way of reimbursement, and in
such installments consistent with the construction
progress, as the Director may determine appropriate.
The reservation of any amount by the Director under
this paragraph may be amended by the Director, either
on the approval of an amendment of the application or
on the revision of the estimated cost of construction
of the facility.
* * * * * * *
(4) Waiver of limitations.--The limitations imposed
under paragraph (1) may be waived at the discretion of
the Director of the Center or the Director of the
National Institute of Allergy and Infectious Diseases
for applicants meeting the conditions described in
subsection (c).
(f ) Recapture of Payments.--If, not later than 20 years
after the completion of construction for which a grant has been
awarded under subsection (a)--
(1) in the case of an award by the Director of the
Center, the applicant or other owner of the facility
shall cease to be a public or non profit private
entity; or
(2) the facility shall cease to be used for the
research purposes for which it was constructed (unless
the Director of the Center or the Director of the
National Institute of Allergy and Infectious Diseases
determines, in accordance with regulations, that there
is good cause for releasing the applicant or other
owner from obligation to do so),
the United States shall be entitled to recover from the
applicant or other owner of the facility the amount bearing the
same ratio to the current value (as determined by an agreement
between the parties or by action brought in the United States
District Court for the district in which such facility is
situated) of the facility as the amount of the Federal
participation bore to the cost of the construction of such
facility.
* * * * * * *
(i) Authorization of [Appropriations.--For the purpose of
carrying out this section,] Appropriations.--
(1) Center.--For the purpose of carrying out this
section with respect to the Center, there are
authorized to be appropriated $250,000,000 for fiscal
year 2001, and such sums as may be necessary for each
of the fiscal years 2002 and 2003.
(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.
----------
SECTION 510 OF THE HOMELAND SECURITY ACT OF 2002
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.
----------
SECTION 121 OF THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS
AND RESPONSE ACT OF 2002
[SEC. 121. STRATEGIC NATIONAL STOCKPILE.
[(a) Strategic National Stockpile.--
[(1) In general.--The Secretary of Health and Human
Services (referred to in this section as the
``Secretary''), in coordination with 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) of the Public Health Service
Act;
[(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 the 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) 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.
[(d) 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 the Secretary supplies
described in subsection (a).
[(e) 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.
[(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.]
----------
SECTION 564 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
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
(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 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.