[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 15 Enrolled Bill (ENR)]
S.15
One Hundred Eighth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Tuesday,
the twentieth day of January, two thousand and four
An Act
To amend the Public Health Service Act to provide protections and
countermeasures against chemical, radiological, or nuclear agents that
may be used in a terrorist attack against the United States by giving
the National Institutes of Health contracting flexibility,
infrastructure improvements, and expediting the scientific peer review
process, and streamlining the Food and Drug Administration approval
process of countermeasures.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Project BioShield Act of 2004''.
SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT--
AUTHORITIES.
(a) In General.--Part B of title III of the Public Health Service
Act (42 U.S.C. 243 et seq.) is amended by inserting after section 319F
the following section:
``SEC. 319F-1. AUTHORITY FOR USE OF CERTAIN PROCEDURES REGARDING
QUALIFIED COUNTERMEASURE RESEARCH AND DEVELOPMENT
ACTIVITIES.
``(a) In General.--
``(1) Authority.--In conducting and supporting research and
development activities regarding countermeasures under section
319F(h), the Secretary may conduct and support such activities in
accordance with this section and, in consultation with the Director
of the National Institutes of Health, as part of the program under
section 446, if the activities concern qualified countermeasures.
``(2) Qualified countermeasure.--For purposes of this section,
the term `qualified countermeasure' means a drug (as that term is
defined by section 201(g)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as that
term is defined by section 351(i) of this Act (42 U.S.C. 262(i))),
or device (as that term is defined by section 201(h) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))) that the Secretary
determines to be a priority (consistent with sections 302(2) and
304(a) of the Homeland Security Act of 2002) to--
``(A) treat, identify, or prevent harm from any biological,
chemical, radiological, or nuclear agent that may cause a
public health emergency affecting national security; or
``(B) treat, identify, or prevent harm from a condition
that may result in adverse health consequences or death and may
be caused by administering a drug, biological product, or
device that is used as described in subparagraph (A).
``(3) Interagency cooperation.--
``(A) In general.--In carrying out activities under this
section, the Secretary is authorized, subject to subparagraph
(B), to enter into interagency agreements and other
collaborative undertakings with other agencies of the United
States Government.
``(B) Limitation.--An agreement or undertaking under this
paragraph shall not authorize another agency to exercise the
authorities provided by this section.
``(4) Availability of facilities to the secretary.--In any
grant, contract, or cooperative agreement entered into under the
authority provided in this section with respect to a biocontainment
laboratory or other related or ancillary specialized research
facility that the Secretary determines necessary for the purpose of
performing, administering, or supporting qualified countermeasure
research and development, the Secretary may provide that the
facility that is the object of such grant, contract, or cooperative
agreement shall be available as needed to the Secretary to respond
to public health emergencies affecting national security.
``(5) Transfers of qualified countermeasures.--Each agreement
for an award of a grant, contract, or cooperative agreement under
section 319F(h) for the development of a qualified countermeasure
shall provide that the recipient of the award will comply with all
applicable export-related controls with respect to such
countermeasure.
``(b) Expedited Procurement Authority.--
``(1) Increased simplified acquisition threshold for qualified
countermeasure procurements.--
``(A) In general.--For any procurement by the Secretary of
property or services for use (as determined by the Secretary)
in performing, administering, or supporting qualified
countermeasure research or development activities under this
section that the Secretary determines necessary to respond to
pressing research and development needs under this section, the
amount specified in section 4(11) of the Office of Federal
Procurement Policy Act (41 U.S.C. 403(11)), as applicable
pursuant to section 302A(a) of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C. 252a(a)), shall
be deemed to be $25,000,000 in the administration, with respect
to such procurement, of--
``(i) section 303(g)(1)(A) of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C.
253(g)(1)(A)) and its implementing regulations; and
``(ii) section 302A(b) of such Act (41 U.S.C. 252a(b))
and its implementing regulations.
``(B) Application of certain provisions.--Notwithstanding
subparagraph (A) and the provision of law and regulations
referred to in such subparagraph, each of the following
provisions shall apply to procurements described in this
paragraph to the same extent that such provisions would apply
to such procurements in the absence of subparagraph (A):
``(i) Chapter 37 of title 40, United States Code
(relating to contract work hours and safety standards).
``(ii) Subsections (a) and (b) of section 7 of the
Anti-Kickback Act of 1986 (41 U.S.C. 57(a) and (b)).
``(iii) Section 304C of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C. 254d)
(relating to the examination of contractor records).
``(iv) Section 3131 of title 40, United States Code
(relating to bonds of contractors of public buildings or
works).
``(v) Subsection (a) of section 304 of the Federal
Property and Administrative Services Act of 1949 (41 U.S.C.
254(a)) (relating to contingent fees to middlemen).
``(vi) Section 6002 of the Solid Waste Disposal Act (42
U.S.C. 6962).
``(vii) Section 1354 of title 31, United States Code
(relating to the limitation on the use of appropriated
funds for contracts with entities not meeting veterans
employment reporting requirements).
``(C) Internal controls to be instituted.--The Secretary
shall institute appropriate internal controls for procurements
that are under this paragraph, including requirements with
regard to documenting the justification for use of the
authority in this paragraph with respect to the procurement
involved.
``(D) Authority to limit competition.--In conducting a
procurement under this paragraph, the Secretary may not use the
authority provided for under subparagraph (A) to conduct a
procurement on a basis other than full and open competition
unless the Secretary determines that the mission of the
BioShield Program under the Project BioShield Act of 2004 would
be seriously impaired without such a limitation.
``(2) Procedures other than full and open competition.--
``(A) In general.--In using the authority provided in
section 303(c)(1) of title III of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C. 253(c)(1)) to
use procedures other than competitive procedures in the case of
a procurement described in paragraph (1) of this subsection,
the phrase `available from only one responsible source' in such
section 303(c)(1) shall be deemed to mean `available from only
one responsible source or only from a limited number of
responsible sources'.
``(B) Relation to other authorities.--The authority under
subparagraph (A) is in addition to any other authority to use
procedures other than competitive procedures.
``(C) Applicable government-wide regulations.--The
Secretary shall implement this paragraph in accordance with
government-wide regulations implementing such section 303(c)(1)
(including requirements that offers be solicited from as many
potential sources as is practicable under the circumstances,
that required notices be published, and that submitted offers
be considered), as such regulations apply to procurements for
which an agency has authority to use procedures other than
competitive procedures when the property or services needed by
the agency are available from only one responsible source or
only from a limited number of responsible sources and no other
type of property or services will satisfy the needs of the
agency.
``(3) Increased micropurchase threshold.--
``(A) In general.--For a procurement described by paragraph
(1), the amount specified in subsections (c), (d), and (f) of
section 32 of the Office of Federal Procurement Policy Act (41
U.S.C. 428) shall be deemed to be $15,000 in the administration
of that section with respect to such procurement.
``(B) Internal controls to be instituted.--The Secretary
shall institute appropriate internal controls for purchases
that are under this paragraph and that are greater than $2,500.
``(C) Exception to preference for purchase card
mechanism.--No provision of law establishing a preference for
using a Government purchase card method for purchases shall
apply to purchases that are under this paragraph and that are
greater than $2,500.
``(4) Review.--
``(A) Review allowed.--Notwithstanding subsection (f),
section 1491 of title 28, United States Code, and section 3556
of title 31 of such Code, review of a contracting agency
decision relating to a procurement described in paragraph (1)
may be had only by filing a protest--
``(i) with a contracting agency; or
``(ii) with the Comptroller General under subchapter V
of chapter 35 of title 31, United States Code.
``(B) Override of stay of contract award or performance
committed to agency discretion.--Notwithstanding section 1491
of title 28, United States Code, and section 3553 of title 31
of such Code, the following authorizations by the head of a
procuring activity are committed to agency discretion:
``(i) An authorization under section 3553(c)(2) of
title 31, United States Code, to award a contract for a
procurement described in paragraph (1) of this subsection.
``(ii) An authorization under section 3553(d)(3)(C) of
such title to perform a contract for a procurement
described in paragraph (1) of this subsection.
``(c) Authority to Expedite Peer Review.--
``(1) In general.--The Secretary may, as the Secretary
determines necessary to respond to pressing qualified
countermeasure research and development needs under this section,
employ such expedited peer review procedures (including
consultation with appropriate scientific experts) as the Secretary,
in consultation with the Director of NIH, deems appropriate to
obtain assessment of scientific and technical merit and likely
contribution to the field of qualified countermeasure research, in
place of the peer review and advisory council review procedures
that would be required under sections 301(a)(3), 405(b)(1)(B),
405(b)(2), 406(a)(3)(A), 492, and 494, as applicable to a grant,
contract, or cooperative agreement--
``(A) that is for performing, administering, or supporting
qualified countermeasure research and development activities;
and
``(B) the amount of which is not greater than $1,500,000.
``(2) Subsequent phases of research.--The Secretary's
determination of whether to employ expedited peer review with
respect to any subsequent phases of a research grant, contract, or
cooperative agreement under this section shall be determined
without regard to the peer review procedures used for any prior
peer review of that same grant, contract, or cooperative agreement.
Nothing in the preceding sentence may be construed to impose any
requirement with respect to peer review not otherwise required
under any other law or regulation.
``(d) Authority for Personal Services Contracts.--
``(1) In general.--For the purpose of performing,
administering, or supporting qualified countermeasure research and
development activities, the Secretary may, as the Secretary
determines necessary to respond to pressing qualified
countermeasure research and development needs under this section,
obtain by contract (in accordance with section 3109 of title 5,
United States Code, but without regard to the limitations in such
section on the period of service and on pay) the personal services
of experts or consultants who have scientific or other professional
qualifications, except that in no case shall the compensation
provided to any such expert or consultant exceed the daily
equivalent of the annual rate of compensation for the President.
``(2) Federal tort claims act coverage.--
``(A) In general.--A person carrying out a contract under
paragraph (1), and an officer, employee, or governing board
member of such person, shall, subject to a determination by the
Secretary, be deemed to be an employee of the Department of
Health and Human Services for purposes of claims under sections
1346(b) and 2672 of title 28, United States Code, for money
damages for personal injury, including death, resulting from
performance of functions under such contract.
``(B) Exclusivity of remedy.--The remedy provided by
subparagraph (A) shall be exclusive of any other civil action
or proceeding by reason of the same subject matter against the
entity involved (person, officer, employee, or governing board
member) for any act or omission within the scope of the Federal
Tort Claims Act.
``(C) Recourse in case of gross misconduct or contract
violation.--
``(i) In general.--Should payment be made by the United
States to any claimant bringing a claim under this
paragraph, either by way of administrative determination,
settlement, or court judgment, the United States shall
have, notwithstanding any provision of State law, the right
to recover against any entity identified in subparagraph
(B) for that portion of the damages so awarded or paid, as
well as interest and any costs of litigation, resulting
from the failure of any such entity to carry out any
obligation or responsibility assumed by such entity under a
contract with the United States or from any grossly
negligent or reckless conduct or intentional or willful
misconduct on the part of such entity.
``(ii) Venue.--The United States may maintain an action
under this subparagraph against such entity in the district
court of the United States in which such entity resides or
has its principal place of business.
``(3) Internal controls to be instituted.--
``(A) In general.--The Secretary shall institute
appropriate internal controls for contracts under this
subsection, including procedures for the Secretary to make a
determination of whether a person, or an officer, employee, or
governing board member of a person, is deemed to be an employee
of the Department of Health and Human Services pursuant to
paragraph (2).
``(B) Determination of employee status to be final.--A
determination by the Secretary under subparagraph (A) that a
person, or an officer, employee, or governing board member of a
person, is or is not deemed to be an employee of the Department
of Health and Human Services shall be final and binding on the
Secretary and the Attorney General and other parties to any
civil action or proceeding.
``(4) Number of personal services contracts limited.--The
number of experts and consultants whose personal services are
obtained under paragraph (1) shall not exceed 30 at any time.
``(e) Streamlined Personnel Authority.--
``(1) In general.--In addition to any other personnel
authorities, the Secretary may, as the Secretary determines
necessary to respond to pressing qualified countermeasure research
and development needs under this section, without regard to those
provisions of title 5, United States Code, governing appointments
in the competitive service, and without regard to the provisions of
chapter 51 and subchapter III of chapter 53 of such title relating
to classification and General Schedule pay rates, appoint
professional and technical employees, not to exceed 30 such
employees at any time, to positions in the National Institutes of
Health to perform, administer, or support qualified countermeasure
research and development activities in carrying out this section.
``(2) Limitations.--The authority provided for under paragraph
(1) shall be exercised in a manner that--
``(A) recruits and appoints individuals based solely on
their abilities, knowledge, and skills;
``(B) does not discriminate for or against any applicant
for employment on any basis described in section 2302(b)(1) of
title 5, United States Code;
``(C) does not allow an official to appoint an individual
who is a relative (as defined in section 3110(a)(3) of such
title) of such official;
``(D) does not discriminate for or against an individual
because of the exercise of any activity described in paragraph
(9) or (10) of section 2302(b) of such title; and
``(E) accords a preference, among equally qualified
persons, to persons who are preference eligibles (as defined in
section 2108(3) of such title).
``(3) Internal controls to be instituted.--The Secretary shall
institute appropriate internal controls for appointments under this
subsection.
``(f) Actions Committed to Agency Discretion.--Actions by the
Secretary under the authority of this section are committed to agency
discretion.''.
(b) Technical Amendment.--Section 481A of the Public Health Service
Act (42 U.S.C. 287a-2) is amended--
(1) in subsection (a)(1), by inserting ``or the Director of the
National Institute of Allergy and Infectious Diseases'' after
``Director of the Center'';
(2) in subsection (c)--
(A) in paragraph (1), by inserting ``or the Director of the
National Institute of Allergy and Infectious Diseases'' after
``Director of the Center''; and
(B) in paragraph (2), in the matter preceding subparagraph
(A), by striking ``subsection (i)'' and inserting ``subsection
(i)(1)'';
(3) in subsection (d), by inserting ``or the Director of the
National Institute of Allergy and Infectious Diseases'' after
``Director of the Center'';
(4) in subsection (e)--
(A) in paragraph (1)--
(i) in the matter preceding subparagraph (A), by
inserting ``or the Director of the National Institute of
Allergy and Infectious Diseases'' after ``Director of the
Center'';
(ii) in subparagraph (A), by inserting ``(or, in the
case of the Institute, 75 percent)'' after ``50 percent'';
and
(iii) in subparagraph (B), by inserting ``(or, in the
case of the Institute, 75 percent)'' after ``40 percent'';
(B) in paragraph (2), by inserting ``or the Director of the
National Institute of Allergy and Infectious Diseases'' after
``Director of the Center''; and
(C) in paragraph (4), by inserting ``of the Center or the
Director of the National Institute of Allergy and Infectious
Diseases'' after ``Director'';
(5) in subsection (f)--
(A) in paragraph (1), by inserting ``in the case of an
award by the Director of the Center,'' before ``the
applicant''; and
(B) in paragraph (2), by inserting ``of the Center or the
Director of the National Institute of Allergy and Infectious
Diseases'' after ``Director''; and
(6) in subsection (i)--
(A) by striking ``Appropriations.--For the purpose of
carrying out this section,'' and inserting the following:
``Appropriations.--
``(1) Center.--For the purpose of carrying out this section
with respect to the Center,''; and
(B) by adding at the end the following:
``(2) National institute of allergy and infectious diseases.--
For the purpose of carrying out this section with respect to the
National Institute of Allergy and Infectious Diseases, there are
authorized to be appropriated such sums as may be necessary for
each of the fiscal years 2004 and 2005.''.
(c) Additional Authorizations of Appropriations.--Section 2106 of
the Public Health Service Act (42 U.S.C. 300aa-6) is amended--
(1) in subsection (a), by striking ``authorized to be
appropriated'' and all that follows and inserting the following:
``authorized to be appropriated such sums as may be necessary for
each of the fiscal years 2004 and 2005.''; and
(2) in subsection (b), by striking ``authorized to be
appropriated'' and all that follows and inserting the following:
``authorized to be appropriated such sums as may be necessary for
each of the fiscal years 2004 and 2005.''.
(d) Technical Amendments.--Section 319F of the Public Health
Service Act (42 U.S.C. 247d-6) is amended--
(1) in subsection (a), by inserting ``the Secretary of Homeland
Security,'' after ``Management Agency,''; and
(2) in subsection (h)(4)(B), by striking ``to diagnose
conditions'' and inserting ``to treat, identify, or prevent
conditions''.
(e) Rule of Construction.--Nothing in this section has any legal
effect on sections 302(2), 302(4), 304(a), or 304(b) of the Homeland
Security Act of 2002.
SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT.
(a) Additional Authority Regarding Strategic National Stockpile.--
(1) Transfer of program.--Section 121 of the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002
(116 Stat. 611; 42 U.S.C. 300hh-12) is transferred from such Act to
the Public Health Service Act, is redesignated as section 319F-2,
and is inserted after section 319F-1 of the Public Health Service
Act (as added by section 2 of this Act).
(2) Additional authority.--Section 319F-2 of the Public Health
Service Act, as added by paragraph (1), is amended to read as
follows:
``SEC. 319F-2. STRATEGIC NATIONAL STOCKPILE.
``(a) Strategic National Stockpile.--
``(1) In general.--The Secretary, in coordination with the
Secretary of Homeland Security (referred to in this section as the
`Homeland Security Secretary'), shall maintain a stockpile or
stockpiles of drugs, vaccines and other biological products,
medical devices, and other supplies in such numbers, types, and
amounts as are determined by the Secretary to be appropriate and
practicable, taking into account other available sources, to
provide for the emergency health security of the United States,
including the emergency health security of children and other
vulnerable populations, in the event of a bioterrorist attack or
other public health emergency.
``(2) Procedures.--The Secretary, in managing the stockpile
under paragraph (1), shall--
``(A) consult with the working group under section 319F(a);
``(B) ensure that adequate procedures are followed with
respect to such stockpile for inventory management and
accounting, and for the physical security of the stockpile;
``(C) in consultation with Federal, State, and local
officials, take into consideration the timing and location of
special events;
``(D) review and revise, as appropriate, the contents of
the stockpile on a regular basis to ensure that emerging
threats, advanced technologies, and new countermeasures are
adequately considered;
``(E) devise plans for the effective and timely supply-
chain management of the stockpile, in consultation with
appropriate Federal, State and local agencies, and the public
and private health care infrastructure;
``(F) deploy the stockpile as required by the Secretary of
Homeland Security to respond to an actual or potential
emergency;
``(G) deploy the stockpile at the discretion of the
Secretary to respond to an actual or potential public health
emergency or other situation in which deployment is necessary
to protect the public health or safety; and
``(H) ensure the adequate physical security of the
stockpile.
``(b) Smallpox Vaccine Development.--
``(1) In general.--The Secretary shall award contracts, enter
into cooperative agreements, or carry out such other activities as
may reasonably be required in order to ensure that the stockpile
under subsection (a) includes an amount of vaccine against smallpox
as determined by such Secretary to be sufficient to meet the health
security needs of the United States.
``(2) Rule of construction.--Nothing in this section shall be
construed to limit the private distribution, purchase, or sale of
vaccines from sources other than the stockpile described in
subsection (a).
``(c) Additional Authority Regarding Procurement of Certain
Biomedical Countermeasures; Availability of Special Reserve Fund.--
``(1) In general.--
``(A) Use of fund.--A security countermeasure may, in
accordance with this subsection, be procured with amounts in
the special reserve fund under paragraph (10).
``(B) Security countermeasure.--For purposes of this
subsection, the term `security countermeasure' means a drug (as
that term is defined by section 201(g)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological
product (as that term is defined by section 351(i) of this Act
(42 U.S.C. 262(i))), or device (as that term is defined by
section 201(h) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321(h))) that--
``(i)(I) the Secretary determines to be a priority
(consistent with sections 302(2) and 304(a) of the Homeland
Security Act of 2002) to treat, identify, or prevent harm
from any biological, chemical, radiological, or nuclear
agent identified as a material threat under paragraph
(2)(A)(ii), or to treat, identify, or prevent harm from a
condition that may result in adverse health consequences or
death and may be caused by administering a drug, biological
product, or device against such an agent;
``(II) the Secretary determines under paragraph
(2)(B)(ii) to be a necessary countermeasure; and
``(III)(aa) is approved or cleared under chapter V of
the Federal Food, Drug, and Cosmetic Act or licensed under
section 351 of this Act; or
``(bb) is a countermeasure for which the Secretary
determines that sufficient and satisfactory clinical
experience or research data (including data, if available,
from pre-clinical and clinical trials) support a reasonable
conclusion that the countermeasure will qualify for
approval or licensing within eight years after the date of
a determination under paragraph (5); or
``(ii) is authorized for emergency use under section
564 of the Federal Food, Drug, and Cosmetic Act.
``(2) Determination of material threats.--
``(A) Material threat.--The Homeland Security Secretary, in
consultation with the Secretary and the heads of other agencies
as appropriate, shall on an ongoing basis--
``(i) assess current and emerging threats of chemical,
biological, radiological, and nuclear agents; and
``(ii) determine which of such agents present a
material threat against the United States population
sufficient to affect national security.
``(B) Public health impact; necessary countermeasures.--The
Secretary shall on an ongoing basis--
``(i) assess the potential public health consequences
for the United States population of exposure to agents
identified under subparagraph (A)(ii); and
``(ii) determine, on the basis of such assessment, the
agents identified under subparagraph (A)(ii) for which
countermeasures are necessary to protect the public health.
``(C) Notice to congress.--The Secretary and the Homeland
Security Secretary shall promptly notify the designated
congressional committees (as defined in paragraph (10)) that a
determination has been made pursuant to subparagraph (A) or
(B).
``(D) Assuring access to threat information.--In making the
assessment and determination required under subparagraph (A),
the Homeland Security Secretary shall use all relevant
information to which such Secretary is entitled under section
202 of the Homeland Security Act of 2002, including but not
limited to information, regardless of its level of
classification, relating to current and emerging threats of
chemical, biological, radiological, and nuclear agents.
``(3) Assessment of availability and appropriateness of
countermeasures.--The Secretary, in consultation with the Homeland
Security Secretary, shall assess on an ongoing basis the
availability and appropriateness of specific countermeasures to
address specific threats identified under paragraph (2).
``(4) Call for development of countermeasures; commitment for
recommendation for procurement.--
``(A) Proposal to the president.--If, pursuant to an
assessment under paragraph (3), the Homeland Security Secretary
and the Secretary make a determination that a countermeasure
would be appropriate but is either
currently unavailable for procurement as a security
countermeasure or is approved, licensed, or cleared only for
alternative uses, such Secretaries may jointly submit to the
President a proposal to--
``(i) issue a call for the development of such
countermeasure; and
``(ii) make a commitment that, upon the first
development of such countermeasure that meets the
conditions for procurement under paragraph (5), the
Secretaries will, based in part on information obtained
pursuant to such call, make a recommendation under
paragraph (6) that the special reserve fund under paragraph
(10) be made available for the procurement of such
countermeasure.
``(B) Countermeasure specifications.--The Homeland Security
Secretary and the Secretary shall, to the extent practicable,
include in the proposal under subparagraph (A)--
``(i) estimated quantity of purchase (in the form of
number of doses or number of effective courses of
treatments regardless of dosage form);
``(ii) necessary measures of minimum safety and
effectiveness;
``(iii) estimated price for each dose or effective
course of treatment regardless of dosage form; and
``(iv) other information that may be necessary to
encourage and facilitate research, development, and
manufacture of the countermeasure or to provide
specifications for the countermeasure.
``(C) Presidential approval.--If the President approves a
proposal under subparagraph (A), the Homeland Security
Secretary and the Secretary shall make known to persons who may
respond to a call for the countermeasure involved--
``(i) the call for the countermeasure;
``(ii) specifications for the countermeasure under
subparagraph (B); and
``(iii) the commitment described in subparagraph
(A)(ii).
``(5) Secretary's determination of countermeasures appropriate
for funding from special reserve fund.--
``(A) In general.--The Secretary, in accordance with the
provisions of this paragraph, shall identify specific security
countermeasures that the Secretary determines, in consultation
with the Homeland Security Secretary, to be appropriate for
inclusion in the stockpile under subsection (a) pursuant to
procurements made with amounts in the special reserve fund
under paragraph (10) (referred to in this subsection
individually as a `procurement under this subsection').
``(B) Requirements.--In making a determination under
subparagraph (A) with respect to a security countermeasure, the
Secretary shall determine and consider the following:
``(i) The quantities of the product that will be needed
to meet the needs of the stockpile.
``(ii) The feasibility of production and delivery
within eight years of sufficient quantities of the product.
``(iii) Whether there is a lack of a significant
commercial market for the product at the time of
procurement, other than as a security countermeasure.
``(6) Recommendation for president's approval.--
``(A) Recommendation for procurement.--In the case of a
security countermeasure that the Secretary has, in accordance
with paragraphs (3) and (5), determined to be appropriate for
procurement under this subsection, the Homeland Security
Secretary and the Secretary shall jointly submit to the
President, in coordination with the Director of the Office of
Management and Budget, a recommendation that the special
reserve fund under paragraph (10) be made available for the
procurement of such countermeasure.
``(B) Presidential approval.--The special reserve fund
under paragraph (10) is available for a procurement of a
security countermeasure only if the President has approved a
recommendation under subparagraph (A) regarding the
countermeasure.
``(C) Notice to designated congressional committees.--The
Secretary and the Homeland Security Secretary shall notify the
designated congressional committees of each decision of the
President to approve a recommendation under subparagraph (A).
Such notice shall include an explanation of the decision to
make available the special reserve fund under paragraph (10)
for procurement of such a countermeasure, including, where
available, the number of, nature of, and other information
concerning potential suppliers of such countermeasure, and
whether other potential suppliers of the same or similar
countermeasures were considered and rejected for procurement
under this section and the reasons therefor.
``(D) Subsequent specific countermeasures.--Procurement
under this subsection of a security countermeasure for a
particular purpose does not preclude the subsequent procurement
under this subsection of any other security countermeasure for
such purpose if the Secretary has determined under paragraph
(5)(A) that such countermeasure is appropriate for inclusion in
the stockpile and if, as determined by the Secretary, such
countermeasure provides improved safety or effectiveness, or
for other reasons enhances preparedness to respond to threats
of use of a biological, chemical, radiological, or nuclear
agent. Such a determination by the Secretary is committed to
agency discretion.
``(E) Rule of construction.--Recommendations and approvals
under this paragraph apply solely to determinations that the
special reserve fund under paragraph (10) will be made
available for a procurement of a security countermeasure, and
not to the substance of contracts for such procurement or other
matters relating to awards of such contracts.
``(7) Procurement.--
``(A) In general.--For purposes of a procurement under this
subsection that is approved by the President under paragraph
(6), the Homeland Security Secretary and the Secretary shall
have responsibilities in accordance with subparagraphs (B) and
(C).
``(B) Interagency agreement; costs.--
``(i) Interagency agreement.--The Homeland Security
Secretary shall enter into an agreement with the Secretary
for procurement of a security countermeasure in accordance
with the provisions of this paragraph. The special reserve
fund under paragraph (10) shall be available for payments
made by the Secretary to a vendor for such procurement.
``(ii) Other costs.--The actual costs to the Secretary
under this section, other than the costs described in
clause (i), shall be paid from the appropriation provided
for under subsection (f)(1).
``(C) Procurement.--
``(i) In general.--The Secretary shall be responsible
for--
``(I) arranging for procurement of a security
countermeasure, including negotiating terms (including
quantity, production schedule, and price) of, and
entering into, contracts and cooperative agreements,
and for carrying out such other activities as may
reasonably be required, in accordance with the
provisions of this subparagraph; and
``(II) promulgating such regulations as the
Secretary determines necessary to implement the
provisions of this subsection.
``(ii) Contract terms.--A contract for procurements
under this subsection shall (or, as specified below, may)
include the following terms:
``(I) Payment conditioned on delivery.--The
contract shall provide that no payment may be made
until delivery has been made of a portion, acceptable
to the Secretary, of the total number of units
contracted for, except that, notwithstanding any other
provision of law, the contract may provide that, if the
Secretary determines (in the Secretary's discretion)
that an advance payment is necessary to ensure success
of a project, the Secretary may pay an amount, not to
exceed 10 percent of the contract amount, in advance of
delivery. The contract shall provide that such advance
payment is required to be repaid if there is a failure
to perform by the vendor under the contract. Nothing in
this subclause may be construed as affecting rights of
vendors under provisions of law or regulation
(including the Federal Acquisition Regulation) relating
to termination of contracts for the convenience of the
Government.
``(II) Discounted payment.--The contract may
provide for a discounted price per unit of a product
that is not licensed, cleared, or approved as described
in paragraph (1)(B)(i)(III)(aa) at the time of
delivery, and may provide for payment of an additional
amount per unit if the product becomes so licensed,
cleared, or approved before the expiration date of the
contract (including an additional amount per unit of
product delivered before the effective date of such
licensing, clearance, or approval).
``(III) Contract duration.--The contract shall be
for a period not to exceed five years, except that, in
first awarding the contract, the Secretary may provide
for a longer duration, not exceeding eight years, if
the Secretary determines that complexities or other
difficulties in performance under the contract justify
such a period. The contract shall be renewable for
additional periods, none of which shall exceed five
years.
``(IV) Storage by vendor.--The contract may provide
that the vendor will provide storage for stocks of a
product delivered to the ownership of the Federal
Government under the contract, for such period and
under such terms and conditions as the Secretary may
specify, and in such case amounts from the special
reserve fund under paragraph (10) shall be available
for costs of shipping, handling, storage, and related
costs for such product.
``(V) Product approval.--The contract shall provide
that the vendor seek approval, clearance, or licensing
of the product from the Secretary; for a timetable for
the development of data and other information to
support such approval, clearance, or licensing; and
that the Secretary may waive part or all of this
contract term on request of the vendor or on the
initiative of the Secretary.
``(VI) Non-stockpile transfers of security
countermeasures.--The contract shall provide that the
vendor will comply with all applicable export-related
controls with respect to such countermeasure.
``(iii) Availability of simplified acquisition
procedures.--
``(I) In general.--If the Secretary determines that
there is a pressing need for a procurement of a
specific countermeasure, the amount of the procurement
under this subsection shall be deemed to be below the
threshold amount specified in section 4(11) of the
Office of Federal Procurement Policy Act (41 U.S.C.
403(11)), for purposes of application to such
procurement, pursuant to section 302A(a) of the Federal
Property and Administrative Services Act of 1949 (41
U.S.C. 252a(a)), of--
``(aa) section 303(g)(1)(A) of the Federal
Property and Administrative Services Act of 1949
(41 U.S.C. 253(g)(1)(A)) and its implementing
regulations; and
``(bb) section 302A(b) of such Act (41 U.S.C.
252a(b)) and its implementing regulations.
``(II) Application of certain provisions.--
Notwithstanding subclause (I) and the provision of law
and regulations referred to in such clause, each of the
following provisions shall apply to procurements
described in this clause to the same extent that such
provisions would apply to such procurements in the
absence of subclause (I):
``(aa) Chapter 37 of title 40, United States
Code (relating to contract work hours and safety
standards).
``(bb) Subsections (a) and (b) of section 7 of
the Anti-Kickback Act of 1986 (41 U.S.C. 57(a) and
(b)).
``(cc) Section 304C of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C.
254d) (relating to the examination of contractor
records).
``(dd) Section 3131 of title 40, United States
Code (relating to bonds of contractors of public
buildings or works).
``(ee) Subsection (a) of section 304 of the
Federal Property and Administrative Services Act of
1949 (41 U.S.C. 254(a)) (relating to contingent
fees to middlemen).
``(ff) Section 6002 of the Solid Waste Disposal
Act (42 U.S.C. 6962).
``(gg) Section 1354 of title 31, United States
Code (relating to the limitation on the use of
appropriated funds for contracts with entities not
meeting veterans employment reporting
requirements).
``(III) Internal controls to be established.--The
Secretary shall establish appropriate internal controls
for procurements made under this clause, including
requirements with respect to documentation of the
justification for the use of the authority provided
under this paragraph with respect to the procurement
involved.
``(IV) Authority to limit competition.--In
conducting a procurement under this subparagraph, the
Secretary may not use the authority provided for under
subclause (I) to conduct a procurement on a basis other
than full and open competition unless the Secretary
determines that the mission of the BioShield Program
under the Project BioShield Act of 2004 would be
seriously impaired without such a limitation.
``(iv) Procedures other than full and open
competition.--
``(I) In general.--In using the authority provided
in section 303(c)(1) of title III of the Federal
Property and Administrative Services Act of 1949 (41
U.S.C. 253(c)(1)) to use procedures other than
competitive procedures in the case of a procurement
under this subsection, the phrase `available from only
one responsible source' in such section 303(c)(1) shall
be deemed to mean `available from only one responsible
source or only from a limited number of responsible
sources'.
``(II) Relation to other authorities.--The
authority under subclause (I) is in addition to any
other authority to use procedures other than
competitive procedures.
``(III) Applicable government-wide regulations.--
The Secretary shall implement this clause in accordance
with government-wide regulations implementing such
section 303(c)(1) (including requirements that offers
be solicited from as many potential sources as is
practicable under the circumstances, that required
notices be published, and that submitted offers be
considered), as such regulations apply to procurements
for which an agency has authority to use procedures
other than competitive procedures when the property or
services needed by the agency are available from only
one responsible source or only from a limited number of
responsible sources and no other type of property or
services will satisfy the needs of the agency.
``(v) Premium provision in multiple award contracts.--
``(I) In general.--If, under this subsection, the
Secretary enters into contracts with more than one
vendor to procure a security countermeasure, such
Secretary may, notwithstanding any other provision of
law, include in each of such contracts a provision
that--
``(aa) identifies an increment of the total
quantity of security countermeasure required,
whether by percentage or by numbers of units; and
``(bb) promises to pay one or more specified
premiums based on the priority of such vendors'
production and delivery of the increment identified
under item (aa), in accordance with the terms and
conditions of the contract.
``(II) Determination of government's requirement
not reviewable.--If the Secretary includes in each of a
set of contracts a provision as described in subclause
(I), such Secretary's determination of the total
quantity of security countermeasure required, and any
amendment of such determination, is committed to agency
discretion.
``(vi) Extension of closing date for receipt of
proposals not reviewable.--A decision by the Secretary to
extend the closing date for receipt of proposals for a
procurement under this subsection is committed to agency
discretion.
``(vii) Limiting competition to sources responding to
request for information.--In conducting a procurement under
this subsection, the Secretary may exclude a source that
has not responded to a request for information under
section 303A(a)(1)(B) of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C.
253a(a)(1)(B)) if such request has given notice that the
Secretary may so exclude such a source.
``(8) Interagency cooperation.--
``(A) In general.--In carrying out activities under this
section, the Homeland Security Secretary and the Secretary are
authorized, subject to subparagraph (B), to enter into
interagency agreements and other collaborative undertakings
with other agencies of the United States Government.
``(B) Limitation.--An agreement or undertaking under this
paragraph shall not authorize another agency to exercise the
authorities provided by this section to the Homeland Security
Secretary or to the Secretary.
``(9) Restrictions on use of funds.--Amounts in the special
reserve fund under paragraph (10) shall not be used to pay--
``(A) costs for the purchase of vaccines under procurement
contracts entered into before the date of the enactment of the
Project BioShield Act of 2004; or
``(B) costs other than payments made by the Secretary to a
vendor for a procurement of a security countermeasure under
paragraph (7).
``(10) Definitions.--
``(A) Special reserve fund.--For purposes of this
subsection, the term `special reserve fund' has the meaning
given such term in section 510 of the Homeland Security Act of
2002.
``(B) Designated congressional committees.--For purposes of
this section, the term `designated congressional committees'
means the following committees of the Congress:
``(i) In the House of Representatives: the Committee on
Energy and Commerce, the Committee on Appropriations, the
Committee on Government Reform, and the Select Committee on
Homeland Security (or any successor to the Select
Committee).
``(ii) In the Senate: the appropriate committees.
``(d) Disclosures.--No Federal agency shall disclose under section
552 of title 5, United States Code, any information identifying the
location at which materials in the stockpile under subsection (a) are
stored.
``(e) Definition.--For purposes of subsection (a), the term
`stockpile' includes--
``(1) a physical accumulation (at one or more locations) of the
supplies described in subsection (a); or
``(2) a contractual agreement between the Secretary and a
vendor or vendors under which such vendor or vendors agree to
provide to such Secretary supplies described in subsection (a).
``(f) Authorization of Appropriations.--
``(1) Strategic national stockpile.--For the purpose of
carrying out subsection (a), there are authorized to be
appropriated $640,000,000 for fiscal year 2002, and such sums as
may be necessary for each of fiscal years 2003 through 2006. Such
authorization is in addition to amounts in the special reserve fund
referred to in subsection (c)(10)(A).
``(2) Smallpox vaccine development.--For the purpose of
carrying out subsection (b), there are authorized to be
appropriated $509,000,000 for fiscal year 2002, and such sums as
may be necessary for each of fiscal years 2003 through 2006.''.
(b) Amendments to Homeland Security Act of 2002.--Title V of the
Homeland Security Act of 2002 (116 Stat. 2212; 6 U.S.C. 311 et seq.) is
amended--
(1) in section 502(3) (6 U.S.C. 312(3))--
(A) in subparagraph (B), by striking ``the Strategic
National Stockpile,''; and
(B) in subparagraph (D), by inserting ``, including
requiring deployment of the Strategic National Stockpile,''
after ``resources''; and
(2) by adding at the end the following:
``SEC. 510. PROCUREMENT OF SECURITY COUNTERMEASURES FOR STRATEGIC
NATIONAL STOCKPILE.
``(a) Authorization of Appropriations.--For the procurement of
security countermeasures under section 319F-2(c) of the Public Health
Service Act (referred to in this section as the `security
countermeasures program'), there is authorized to be appropriated up to
$5,593,000,000 for the fiscal years 2004 through 2013. Of the amounts
appropriated under the preceding sentence, not to exceed $3,418,000,000
may be obligated during the fiscal years 2004 through 2008, of which
not to exceed $890,000,000 may be obligated during fiscal year 2004.
``(b) Special Reserve Fund.--For purposes of the security
countermeasures program, the term `special reserve fund' means the
`Biodefense Countermeasures' appropriations account or any other
appropriation made under subsection (a).
``(c) Availability.--Amounts appropriated under subsection (a)
become available for a procurement under the security countermeasures
program only upon the approval by the President of such availability
for the procurement in accordance with paragraph (6)(B) of such
program.
``(d) Related Authorizations of Appropriations.--
``(1) Threat assessment capabilities.--For the purpose of
carrying out the responsibilities of the Secretary for terror
threat assessment under the security countermeasures program, there
are authorized to be appropriated such sums as may be necessary for
each of the fiscal years 2004 through 2006, for the hiring of
professional personnel within the Directorate for Information
Analysis and Infrastructure Protection, who shall be analysts
responsible for chemical, biological, radiological, and nuclear
threat assessment (including but not limited to analysis of
chemical, biological, radiological, and nuclear agents, the means
by which such agents could be weaponized or used in a terrorist
attack, and the capabilities, plans, and intentions of terrorists
and other non-state actors who may have or acquire such agents).
All such analysts shall meet the applicable standards and
qualifications for the performance of intelligence activities
promulgated by the Director of Central Intelligence pursuant to
section 104 of the National Security Act of 1947.
``(2) Intelligence sharing infrastructure.--For the purpose of
carrying out the acquisition and deployment of secure facilities
(including information technology and physical infrastructure,
whether mobile and temporary, or permanent) sufficient to permit
the Secretary to receive, not later than 180 days after the date of
enactment of the Project BioShield Act of 2004, all classified
information and products to which the Under Secretary for
Information Analysis and Infrastructure Protection is entitled
under subtitle A of title II, there are authorized to be
appropriated such sums as may be necessary for each of the fiscal
years 2004 through 2006.''.
(c) Stockpile Functions Transferred.--
(1) In general.--Except as provided in paragraph (2), there
shall be transferred to the Secretary of Health and Human Services
the functions, personnel, assets, unexpended balances, and
liabilities of the Strategic National Stockpile, including the
functions of the Secretary of Homeland Security relating thereto.
(2) Exceptions.--
(A) Functions.--The transfer of functions pursuant to
paragraph (1) shall not include such functions as are
explicitly assigned to the Secretary of Homeland Security by
this Act (including the amendments made by this Act).
(B) Assets and unexpended balances.--The transfer of assets
and unexpended balances pursuant to paragraph (1) shall not
include the funds appropriated under the heading ``biodefense
countermeasures'' in the Department of Homeland Security
Appropriations Act, 2004 (Public Law 108-90).
(3) Conforming amendment.--Section 503 of the Homeland Security
Act of 2002 (6 U.S.C. 313) is amended by striking paragraph (6).
SEC. 4. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.
(a) In General.--Section 564 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-3) is amended to read as follows:
``SEC. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.
``(a) In General.--
``(1) Emergency uses.--Notwithstanding sections 505, 510(k),
and 515 of this Act and section 351 of the Public Health Service
Act, and subject to the provisions of this section, the Secretary
may authorize the introduction into interstate commerce, during the
effective period of a declaration under subsection (b), of a drug,
device, or biological product intended for use in an actual or
potential emergency (referred to in this section as an `emergency
use').
``(2) Approval status of product.--An authorization under
paragraph (1) may authorize an emergency use of a product that--
``(A) is not approved, licensed, or cleared for commercial
distribution under a provision of law referred to in such
paragraph (referred to in this section as an `unapproved
product'); or
``(B) is approved, licensed, or cleared under such a
provision, but which use is not under such provision an
approved, licensed, or cleared use of the product (referred to
in this section as an `unapproved use of an approved product').
``(3) Relation to other uses.--An emergency use authorized
under paragraph (1) for a product is in addition to any other use
that is authorized for the product under a provision of law
referred to in such paragraph.
``(4) Definitions.--For purposes of this section:
``(A) The term `biological product' has the meaning given
such term in section 351 of the Public Health Service Act.
``(B) The term `emergency use' has the meaning indicated
for such term in paragraph (1).
``(C) The term `product' means a drug, device, or
biological product.
``(D) The term `unapproved product' has the meaning
indicated for such term in paragraph (2)(A).
``(E) The term `unapproved use of an approved product' has
the meaning indicated for such term in paragraph (2)(B).
``(b) Declaration of Emergency.--
``(1) In general.--The Secretary may declare an emergency
justifying the authorization under this subsection for a product on
the basis of--
``(A) a determination by the Secretary of Homeland Security
that there is a domestic emergency, or a significant potential
for a domestic emergency, involving a heightened risk of attack
with a specified biological, chemical, radiological, or nuclear
agent or agents;
``(B) a determination by the Secretary of Defense that
there is a military emergency, or a significant potential for a
military emergency, involving a heightened risk to United
States military forces of attack with a specified biological,
chemical, radiological, or nuclear agent or agents; or
``(C) a determination by the Secretary of a public health
emergency under section 319 of the Public Health Service Act
that affects, or has a significant potential to affect,
national security, and that involves a specified biological,
chemical, radiological, or nuclear agent or agents, or a
specified disease or condition that may be attributable to such
agent or agents.
``(2) Termination of declaration.--
``(A) In general.--A declaration under this subsection
shall terminate upon the earlier of--
``(i) a determination by the Secretary, in consultation
as appropriate with the Secretary of Homeland Security or
the Secretary of Defense, that the circumstances described
in paragraph (1) have ceased to exist; or
``(ii) the expiration of the one-year period beginning
on the date on which the declaration is made.
``(B) Renewal.--Notwithstanding subparagraph (A), the
Secretary may renew a declaration under this subsection, and
this paragraph shall apply to any such renewal.
``(C) Disposition of product.--If an authorization under
this section with respect to an unapproved product ceases to be
effective as a result of a termination under subparagraph (A)
of this paragraph, the Secretary shall consult with the
manufacturer of such product with respect to the appropriate
disposition of the product.
``(3) Advance notice of termination.--The Secretary shall
provide advance notice that a declaration under this subsection
will be terminated. The period of advance notice shall be a period
reasonably determined to provide--
``(A) in the case of an unapproved product, a sufficient
period for disposition of the product, including the return of
such product (except such quantities of product as are
necessary to provide for continued use consistent with
subsection (f)(2)) to the manufacturer (in the case of a
manufacturer that chooses to have such product returned); and
``(B) in the case of an unapproved use of an approved
product, a sufficient period for the disposition of any
labeling, or any information under subsection (e)(2)(B)(ii), as
the case may be, that was provided with respect to the
emergency use involved.
``(4) Publication.--The Secretary shall promptly publish in the
Federal Register each declaration, determination, advance notice of
termination, and renewal under this subsection.
``(c) Criteria for Issuance of Authorization.--The Secretary may
issue an authorization under this section with respect to the emergency
use of a product only if, after consultation with the Director of the
National Institutes of Health and the Director of the Centers for
Disease Control and Prevention (to the extent feasible and appropriate
given the circumstances of the emergency involved), the Secretary
concludes--
``(1) that an agent specified in a declaration under subsection
(b) can cause a serious or life-threatening disease or condition;
``(2) that, based on the totality of scientific evidence
available to the Secretary, including data from adequate and well-
controlled clinical trials, if available, it is reasonable to
believe that--
``(A) the product may be effective in diagnosing, treating,
or preventing--
``(i) such disease or condition; or
``(ii) a serious or life-threatening disease or
condition caused by a product authorized under this
section, approved or cleared under this Act, or licensed
under section 351 of the Public Health Service Act, for
diagnosing, treating, or preventing such a disease or
condition caused by such an agent; and
``(B) the known and potential benefits of the product, when
used to diagnose, prevent, or treat such disease or condition,
outweigh the known and potential risks of the product;
``(3) that there is no adequate, approved, and available
alternative to the product for diagnosing, preventing, or treating
such disease or condition; and
``(4) that such other criteria as the Secretary may by
regulation prescribe are satisfied.
``(d) Scope of Authorization.--An authorization of a product under
this section shall state--
``(1) each disease or condition that the product may be used to
diagnose, prevent, or treat within the scope of the authorization;
``(2) the Secretary's conclusions, made under subsection
(c)(2)(B), that the known and potential benefits of the product,
when used to diagnose, prevent, or treat such disease or condition,
outweigh the known and potential risks of the product; and
``(3) the Secretary's conclusions, made under subsection (c),
concerning the safety and potential effectiveness of the product in
diagnosing, preventing, or treating such diseases or conditions,
including an assessment of the available scientific evidence.
``(e) Conditions of Authorization.--
``(1) Unapproved product.--
``(A) Required conditions.--With respect to the emergency
use of an unapproved product, the Secretary, to the extent
practicable given the circumstances of the emergency, shall,
for a person who carries out any activity for which the
authorization is issued, establish such conditions on an
authorization under this section as the Secretary finds
necessary or appropriate to protect the public health,
including the following:
``(i) Appropriate conditions designed to ensure that
health care professionals administering the product are
informed--
``(I) that the Secretary has authorized the
emergency use of the product;
``(II) of the significant known and potential
benefits and risks of the emergency use of the product,
and of the extent to which such benefits and risks are
unknown; and
``(III) of the alternatives to the product that are
available, and of their benefits and risks.
``(ii) Appropriate conditions designed to ensure that
individuals to whom the product is administered are
informed--
``(I) that the Secretary has authorized the
emergency use of the product;
``(II) of the significant known and potential
benefits and risks of such use, and of the extent to
which such benefits and risks are unknown; and
``(III) of the option to accept or refuse
administration of the product, of the consequences, if
any, of refusing administration of the product, and of
the alternatives to the product that are available and
of their benefits and risks.
``(iii) Appropriate conditions for the monitoring and
reporting of adverse events associated with the emergency
use of the product.
``(iv) For manufacturers of the product, appropriate
conditions concerning recordkeeping and reporting,
including records access by the Secretary, with respect to
the emergency use of the product.
``(B) Authority for additional conditions.--With respect to
the emergency use of an unapproved product, the Secretary may,
for a person who carries out any activity for which the
authorization is issued, establish such conditions on an
authorization under this section as the Secretary finds
necessary or appropriate to protect the public health,
including the following:
``(i) Appropriate conditions on which entities may
distribute the product with respect to the emergency use of
the product (including limitation to distribution by
government entities), and on how distribution is to be
performed.
``(ii) Appropriate conditions on who may administer the
product with respect to the emergency use of the product,
and on the categories of individuals to whom, and the
circumstances under which, the product may be administered
with respect to such use.
``(iii) Appropriate conditions with respect to the
collection and analysis of information, during the period
when the authorization is in effect, concerning the safety
and effectiveness of the product with respect to the
emergency use of such product.
``(iv) For persons other than manufacturers of the
product, appropriate conditions concerning recordkeeping
and reporting, including records access by the Secretary,
with respect to the emergency use of the product.
``(2) Unapproved use.--With respect to the emergency use of a
product that is an unapproved use of an approved product:
``(A) For a manufacturer of the product who carries out any
activity for which the authorization is issued, the Secretary
shall, to the extent practicable given the circumstances of the
emergency, establish conditions described in clauses (i) and
(ii) of paragraph (1)(A), and may establish conditions
described in clauses (iii) and (iv) of such paragraph.
``(B)(i) If the authorization under this section regarding
the emergency use authorizes a change in the labeling of the
product, but the manufacturer of the product chooses not to
make such change, such authorization may not authorize
distributors of the product or any other person to alter or
obscure the labeling provided by the manufacturer.
``(ii) In the circumstances described in clause (i), for a
person who does not manufacture the product and who chooses to
act under this clause, an authorization under this section
regarding the emergency use shall, to the extent practicable
given the circumstances of the emergency, authorize such person
to provide appropriate information with respect to such product
in addition to the labeling provided by the manufacturer,
subject to compliance with clause (i). While the authorization
under this section is effective, such additional information
shall not be considered labeling for purposes of section 502.
``(C) The Secretary may establish with respect to the
distribution and administration of the product for the
unapproved use conditions no more restrictive than those
established by the Secretary with respect to the distribution
and administration of the product for the approved use.
``(3) Good manufacturing practice.--With respect to the
emergency use of a product for which an authorization under this
section is issued (whether an unapproved product or an unapproved
use of an approved product), the Secretary may waive or limit, to
the extent appropriate given the circumstances of the emergency,
requirements regarding current good manufacturing practice
otherwise applicable to the manufacture, processing, packing, or
holding of products subject to regulation under this Act, including
such requirements established under section 501.
``(4) Advertising.--The Secretary may establish conditions on
advertisements and other promotional descriptive printed matter
that relate to the emergency use of a product for which an
authorization under this section is issued (whether an unapproved
product or an unapproved use of an approved product), including, as
appropriate--
``(A) with respect to drugs and biological products,
requirements applicable to prescription drugs pursuant to
section 502(n); or
``(B) with respect to devices, requirements applicable to
restricted devices pursuant to section 502(r).
``(f) Duration of Authorization.--
``(1) In general.--Except as provided in paragraph (2), an
authorization under this section shall be effective until the
earlier of the termination of the declaration under subsection (b)
or a revocation under subsection (g).
``(2) Continued use after end of effective period.--
Notwithstanding the termination of the declaration under subsection
(b) or a revocation under subsection (g), an authorization shall
continue to be effective to provide for continued use of an
unapproved product with respect to a patient to whom it was
administered during the period described by paragraph (1), to the
extent found necessary by such patient's attending physician.
``(g) Revocation of Authorization.--
``(1) Review.--The Secretary shall periodically review the
circumstances and the appropriateness of an authorization under
this section.
``(2) Revocation.--The Secretary may revoke an authorization
under this section if the criteria under subsection (c) for
issuance of such authorization are no longer met or other
circumstances make such revocation appropriate to protect the
public health or safety.
``(h) Publication; Confidential Information.--
``(1) Publication.--The Secretary shall promptly publish in the
Federal Register a notice of each authorization, and each
termination or revocation of an authorization under this section,
and an explanation of the reasons therefor (which may include a
summary of data or information that has been submitted to the
Secretary in an application under section 505(i) or section 520(g),
even if such summary may indirectly reveal the existence of such
application).
``(2) Confidential information.--Nothing in this section alters
or amends section 1905 of title 18, United States Code, or section
552(b)(4) of title 5 of such Code.
``(i) Actions Committed to Agency Discretion.--Actions under the
authority of this section by the Secretary, by the Secretary of
Defense, or by the Secretary of Homeland Security are committed to
agency discretion.
``(j) Rules of Construction.--The following applies with respect to
this section:
``(1) Nothing in this section impairs the authority of the
President as Commander in Chief of the Armed Forces of the United
States under article II, section 2 of the United States
Constitution.
``(2) Nothing in this section impairs the authority of the
Secretary of Defense with respect to the Department of Defense,
including the armed forces, under other provisions of Federal law.
``(3) Nothing in this section (including any exercise of
authority by a manufacturer under subsection (e)(2)) impairs the
authority of the United States to use or manage quantities of a
product that are owned or controlled by the United States
(including quantities in the stockpile maintained under section
319F-2 of the Public Health Service Act).
``(k) Relation to Other Provisions.--If a product is the subject of
an authorization under this section, the use of such product within the
scope of the authorization shall not be considered to constitute a
clinical investigation for purposes of section 505(i), section 520(g),
or any other provision of this Act or section 351 of the Public Health
Service Act.
``(l) Option to Carry Out Authorized Activities.--Nothing in this
section provides the Secretary any authority to require any person to
carry out any activity that becomes lawful pursuant to an authorization
under this section, and no person is required to inform the Secretary
that the person will not be carrying out such activity, except that a
manufacturer of a sole-source unapproved product authorized for
emergency use shall report to the Secretary within a reasonable period
of time after the issuance by the Secretary of such authorization if
such manufacturer does not intend to carry out any activity under the
authorization. This section only has legal effect on a person who
carries out an activity for which an authorization under this section
is issued. This section does not modify or affect activities carried
out pursuant to other provisions of this Act or section 351 of the
Public Health Service Act. Nothing in this subsection may be construed
as restricting the Secretary from imposing conditions on persons who
carry out any activity pursuant to an authorization under this
section.''.
(b) Repeal of Termination Provision.--Subsection (d) of section
1603 of the National Defense Authorization Act for Fiscal Year 2004 (10
U.S.C. 1107a note) is repealed.
SEC. 5. REPORTS REGARDING AUTHORITIES UNDER THIS ACT.
(a) Secretary of Health and Human Services.--
(1) Annual reports on particular exercises of authority.--
(A) Relevant authorities.--The Secretary of Health and
Human Services (referred to in this subsection as the
``Secretary'') shall submit reports in accordance with
subparagraph (B) regarding the exercise of authority under the
following provisions of law:
(i) With respect to section 319F-1 of the Public Health
Service Act (as added by section 2 of this Act):
(I) Subsection (b)(1) (relating to increased
simplified acquisition threshold).
(II) Subsection (b)(2) (relating to procedures
other than full and open competition).
(III) Subsection (c) (relating to expedited peer
review procedures).
(ii) With respect to section 319F-2 of the Public
Health Service Act (as added by section 3 of this Act):
(I) Subsection (c)(7)(C)(iii) (relating to
simplified acquisition procedures).
(II) Subsection (c)(7)(C)(iv) (relating to
procedures other than full and open competition).
(III) Subsection (c)(7)(C)(v) (relating to premium
provision in multiple-award contracts).
(iii) With respect to section 564 of the Federal Food,
Drug, and Cosmetic Act (as added by section 4 of this Act):
(I) Subsection (a)(1) (relating to emergency uses
of certain drugs and devices).
(II) Subsection (b)(1) (relating to a declaration
of an emergency).
(III) Subsection (e) (relating to conditions on
authorization).
(B) Contents of reports.--The Secretary shall annually
submit to the designated congressional committees a report that
summarizes--
(i) the particular actions that were taken under the
authorities specified in subparagraph (A), including, as
applicable, the identification of the threat agent,
emergency, or the biomedical countermeasure with respect to
which the authority was used;
(ii) the reasons underlying the decision to use such
authorities, including, as applicable, the options that
were considered and rejected with respect to the use of
such authorities;
(iii) the number of, nature of, and other information
concerning the persons and entities that received a grant,
cooperative agreement, or contract pursuant to the use of
such authorities, and the persons and entities that were
considered and rejected for such a grant, cooperative
agreement, or contract, except that the report need not
disclose the identity of any such person or entity; and
(iv) whether, with respect to each procurement that is
approved by the President under section 319F-2(c)(6) of the
Public Health Service Act (as added by section 3 of this
Act), a contract was entered into within one year after
such approval by the President.
(2) Annual summaries regarding certain activity.--The Secretary
shall annually submit to the designated congressional committees a
report that summarizes the activity undertaken pursuant to the
following authorities under section 319F-1 of the Public Health
Service Act (as added by section 2 of this Act):
(A) Subsection (b)(3) (relating to increased micropurchase
threshold).
(B) Subsection (d) (relating to authority for personal
services contracts).
(C) Subsection (e) (relating to streamlined personnel
authority).
With respect to subparagraph (B), the report shall include a
provision specifying, for the one-year period for which the report
is submitted, the number of persons who were paid amounts greater
than $100,000 and the number of persons who were paid amounts
between $50,000 and $100,000.
(3) Report on additional barriers to procurement of security
countermeasures.--Not later than one year after the date of the
enactment of this Act, the Secretary, in consultation with the
Secretary of Homeland Security, shall report to the designated
congressional committees any potential barriers to the procurement
of security countermeasures that have not been addressed by this
Act.
(b) General Accounting Office Review.--
(1) In general.--Four years after the date of the enactment of
this Act, the Comptroller General of the United States shall
initiate a study--
(A)(i) to review the Secretary of Health and Human
Services' utilization of the authorities granted under this Act
with respect to simplified acquisition procedures, procedures
other than full and open competition, increased micropurchase
thresholds, personal services contracts, streamlined personnel
authority, and the purchase of security countermeasures under
the special reserve fund; and
(ii) to make recommendations to improve the utilization or
effectiveness of such authorities in the future;
(B)(i) to review and assess the adequacy of the internal
controls instituted by such Secretary with respect to such
authorities, where required by this Act; and
(ii) to make recommendations to improve the effectiveness
of such controls;
(C)(i) to review such Secretary's utilization of the
authority granted under this Act to authorize an emergency use
of a biomedical countermeasure, including the means by which
the Secretary determines whether and under what conditions any
such authorizations should be granted and the benefits and
adverse impacts, if any, resulting from the use of such
authority; and
(ii) to make recommendations to improve the utilization or
effectiveness of such authority and to enhance protection of
the public health;
(D) to identify any purchases or procurements that would
not have been made or would have been significantly delayed
except for the authorities described in subparagraph (A)(i);
and
(E)(i) to determine whether and to what extent activities
undertaken pursuant to the biomedical countermeasure research
and development authorities established in this Act have
enhanced the development of biomedical countermeasures
affecting national security; and
(ii) to make recommendations to improve the ability of the
Secretary to carry out these activities in the future.
(2) Additional provisions regarding determination on
development of biomedical countermeasures affecting national
security.--In the report under paragraph (1), the determination
under subparagraph (E) of such paragraph shall include--
(A) the Comptroller General's assessment of the current
availability of countermeasures to address threats identified
by the Secretary of Homeland Security;
(B) the Comptroller General's assessment of the extent to
which programs and activities under this Act will reduce any
gap between the threat and the availability of countermeasures
to an acceptable level of risk; and
(C)(i) the Comptroller General's assessment of threats to
national security that are posed by technology that will
enable, during the 10-year period beginning on the date of the
enactment of this Act, the development of antibiotic resistant,
mutated, or bioengineered strains of biological agents; and
(ii) recommendations on short-term and long-term
governmental strategies for addressing such threats, including
recommendations for Federal policies regarding research
priorities, the development of countermeasures, and investments
in technology.
(3) Report.--A report providing the results of the study under
paragraph (1) shall be submitted to the designated congressional
committees not later than five years after the date of the
enactment of this Act.
(c) Report Regarding Biocontainment Facilities.--Not later than 120
days after the date of the enactment of this Act, the Secretary of
Homeland Security and the Secretary of Health and Human Services shall
jointly report to the designated congressional committees whether there
is a lack of adequate large-scale biocontainment facilities necessary
for the testing of security countermeasures in accordance with Food and
Drug Administration requirements.
(d) Designated Congressional Committees.--For purposes of this
section, the term ``designated congressional committees'' means the
following committees of the Congress:
(1) In the House of Representatives: the Committee on Energy
and Commerce, the Committee on Appropriations, the Committee on
Government Reform, and the Select Committee on Homeland Security
(or any successor to the Select Committee).
(2) In the Senate: the appropriate committees.
SEC. 6. OUTREACH.
The Secretary of Health and Human Services shall develop outreach
measures to ensure to the extent practicable that diverse institutions,
including Historically Black Colleges and Universities and those
serving large proportions of Black or African Americans, American
Indians, Appalachian Americans, Alaska Natives, Asians, Native
Hawaiians, other Pacific Islanders, Hispanics or Latinos, or other
underrepresented populations, are meaningfully aware of available
research and development grants, contracts, cooperative agreements, and
procurements conducted under sections 2 and 3 of this Act.
SEC. 7. RECOMMENDATION FOR EXPORT CONTROLS ON CERTAIN BIOMEDICAL
COUNTERMEASURES.
Upon the award of any grant, contract, or cooperative agreement
under section 2 or 3 of this Act for the research, development, or
procurement of a qualified countermeasure or a security countermeasure
(as those terms are defined in this Act), the Secretary of Health and
Human Services shall, in consultation with the heads of other
appropriate Federal agencies, determine whether the countermeasure
involved in such grant, contract, or cooperative agreement is subject
to existing export-related controls and, if not, may make a
recommendation to the appropriate Federal agency or agencies that such
countermeasure should be included on the list of controlled items
subject to such controls.
SEC. 8. ENSURING COORDINATION, COOPERATION AND THE ELIMINATION OF
UNNECESSARY DUPLICATION IN PROGRAMS DESIGNED TO PROTECT THE HOMELAND
FROM BIOLOGICAL, CHEMICAL, RADIOLOGICAL, AND NUCLEAR AGENTS.
(a) Ensuring Coordination of Programs.--The Secretary of Health and
Human Services, the Secretary of Homeland Security, and the Secretary
of Defense shall ensure that the activities of their respective
Departments coordinate, complement, and do not unnecessarily duplicate
programs to identify potential domestic threats from biological,
chemical, radiological or nuclear agents, detect domestic incidents
involving such agents, analyze such incidents, and develop necessary
countermeasures. The aforementioned Secretaries shall further ensure
that information and technology possessed by the Departments relevant
to these activities are shared with the other Departments.
(b) Designation of Agency Coordination Officer.--The Secretary of
Health and Human Services, the Secretary of Homeland Security, and the
Secretary of Defense shall each designate an officer or employee of
their respective Departments who shall coordinate, through regular
meetings and communications, with the other aforementioned Departments
such programs and activities carried out by their Departments.
SEC. 9. AUTHORITY OF THE SECRETARY OF HEALTH AND HUMAN SERVICES DURING
NATIONAL EMERGENCIES.
Section 1135(b) of the Social Security Act (42 U.S.C. 1320b-5(b))
is amended--
(1) by striking paragraph (3) and inserting the following:
``(3) actions under section 1867 (relating to examination and
treatment for emergency medical conditions and women in labor)
for--
``(A) a transfer of an individual who has not been
stabilized in violation of subsection (c) of such section if
the transfer is necessitated by the circumstances of the
declared emergency in the emergency area during the emergency
period; or
``(B) the direction or relocation of an individual to
receive medical screening in an alternate location pursuant to
an appropriate State emergency preparedness plan;'';
(2) in paragraph (5), by striking ``and'' at the end;
(3) in paragraph (6), by striking the period and inserting ``;
and'';
(4) by inserting after paragraph (6), the following:
``(7) sanctions and penalties that arise from noncompliance
with the following requirements (as promulgated under the authority
of section 264(c) of the Health Insurance Portability and
Accountability Act of 1996 (42 U.S.C. 1320d-2 note)--
``(A) section 164.510 of title 45, Code of Federal
Regulations, relating to--
``(i) requirements to obtain a patient's agreement to
speak with family members or friends; and
``(ii) the requirement to honor a request to opt out of
the facility directory;
``(B) section 164.520 of such title, relating to the
requirement to distribute a notice; or
``(C) section 164.522 of such title, relating to--
``(i) the patient's right to request privacy
restrictions; and
``(ii) the patient's right to request confidential
communications.''; and
(5) by adding at the end the following: ``A waiver or
modification provided for under paragraph (3) or (7) shall only be
in effect if such actions are taken in a manner that does not
discriminate among individuals on the basis of their source of
payment or of their ability to pay, and shall be limited to a 72-
hour period beginning upon implementation of a hospital disaster
protocol. A waiver or modification under such paragraph (7) shall
be withdrawn after such period and the provider shall comply with
the requirements under such paragraph for any patient still under
the care of the provider.''.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.