[DOCID: f:publ276.108]
[[Page 118 STAT. 835]]
Public Law 108-276
108th Congress
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. <<NOTE: July 21, 2004 - [S. 15]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Project
BioShield Act of 2004. 42 USC 201 note.>>
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. <<NOTE: 42 USC 247d-6a.>> 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
[[Page 118 STAT. 836]]
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):
[[Page 118 STAT. 837]]
``(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
[[Page 118 STAT. 838]]
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),
[[Page 118 STAT. 839]]
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
[[Page 118 STAT. 840]]
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) <<NOTE: Procedures.>> 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
[[Page 118 STAT. 841]]
``(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
[[Page 118 STAT. 842]]
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) <<NOTE: 42 USC 247d-6a note.>> 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 <<NOTE: 42 USC 247d-
6b.>> 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;
[[Page 118 STAT. 843]]
``(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;
[[Page 118 STAT. 844]]
``(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.--
[[Page 118 STAT. 845]]
``(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').
[[Page 118 STAT. 846]]
``(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) <<NOTE: Applicability.>> Rule of
construction.--Recommendations and approvals under this
paragraph apply solely to determinations that the
special reserve fund under paragraph (10)
[[Page 118 STAT. 847]]
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) <<NOTE: Regulations.>> promulgatin
g 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.
[[Page 118 STAT. 848]]
``(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--
[[Page 118 STAT. 849]]
``(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.--
[[Page 118 STAT. 850]]
``(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.
[[Page 118 STAT. 851]]
``(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
[[Page 118 STAT. 852]]
``(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. <<NOTE: 6 USC 320.>> 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
[[Page 118 STAT. 853]]
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) <<NOTE: Deadline. Classified
information.>> 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) <<NOTE: Government organization. 42 USC 247d-6b
note.>> 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').
[[Page 118 STAT. 854]]
``(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
[[Page 118 STAT. 855]]
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) <<NOTE: Applicability.>> 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) <<NOTE: Federal
Register, publication.>> 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
[[Page 118 STAT. 856]]
``(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
[[Page 118 STAT. 857]]
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
[[Page 118 STAT. 858]]
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.--
[[Page 118 STAT. 859]]
``(1) <<NOTE: Federal
Register, publication.>> 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) <<NOTE: Applicability.>> 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.
[[Page 118 STAT. 860]]
SEC. 5. REPORTS <<NOTE: 42 USC 247d-6c.>> 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
[[Page 118 STAT. 861]]
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) <<NOTE: Deadline.>> 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
[[Page 118 STAT. 862]]
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. <<NOTE: 42 USC 247d-6a note.>>
The Secretary of Health and Human Services shall develop outreach
measures to ensure to the extent practicable that diverse
[[Page 118 STAT. 863]]
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 <<NOTE: 42 USC 247d-6a note.>> 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 <<NOTE: 42 USC 247d-6a note.>> 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
[[Page 118 STAT. 864]]
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.''.
Approved July 21, 2004.
LEGISLATIVE HISTORY--S. 15:
---------------------------------------------------------------------------
CONGRESSIONAL RECORD, Vol. 150 (2004):
May 19, considered and passed Senate.
July 14, considered and passed House.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 40 (2004):
July 21, Presidential remarks.
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