Project BioShield Act of 2004
PL 108-276 (S.15), enacted 07/21/2004

118 STAT. 835
PUBLIC LAW 108–276—JULY 21, 2004
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.
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 DEVELOP-
MENT—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
42 USC 247d–6a.
Project BioShield
Act of 2004.
42 USC 201 note.
July 21, 2004
[S. 15]
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118 STAT. 836
PUBLIC LAW 108–276—JULY 21, 2004
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 subpara-
graph (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 exer-
cise 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 nec-
essary for the purpose of performing, administering, or sup-
porting 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 avail-
able 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 Sec-
retary of property or services for use (as determined by
the Secretary) in performing, administering, or supporting
qualified countermeasure research or development activi-
ties under this section that the Secretary determines nec-
essary 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.—Notwith-
standing 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):
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118 STAT. 837
PUBLIC LAW 108–276—JULY 21, 2004
‘‘(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 middle-
men).
‘‘(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 Sec-
retary 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 COMPETI-
TION.—
‘‘(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 respon-
sible 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 proce-
dures.
‘‘(C) APPLICABLE
GOVERNMENT-WIDE
REGULATIONS.—
The Secretary shall implement this paragraph in accord-
ance 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 pub-
lished, and that submitted offers be considered), as such
regulations apply to procurements for which an agency
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118 STAT. 838
PUBLIC LAW 108–276—JULY 21, 2004
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 Sec-
retary shall institute appropriate internal controls for pur-
chases 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 pur-
chases shall apply to purchases that are under this para-
graph 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 sub-
chapter V of chapter 35 of title 31, United States
Code.
‘‘(B) OVERRIDE
OF
STAY
OF
CONTRACT
AWARD
OR
PERFORMANCE
COMMITTED
TO
AGENCY
DISCRETION.—Not-
withstanding 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 com-
mitted 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 sub-
section.
‘‘(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 counter-
measure research and development needs under this section,
employ such expedited peer review procedures (including con-
sultation 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 proce-
dures that would be required under sections 301(a)(3),
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118 STAT. 839
PUBLIC LAW 108–276—JULY 21, 2004
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 sup-
porting qualified countermeasure research and develop-
ment 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, admin-
istering, or supporting qualified countermeasure research and
development activities, the Secretary may, as the Secretary
determines necessary to respond to pressing qualified counter-
measure 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 determina-
tion by the Secretary, be deemed to be an employee of
the Department of Health and Human Services for pur-
poses 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 func-
tions 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 CON-
TRACT 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 deter-
mination, 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
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118 STAT. 840
PUBLIC LAW 108–276—JULY 21, 2004
any such entity to carry out any obligation or responsi-
bility 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 busi-
ness.
‘‘(3) INTERNAL CONTROLS TO BE INSTITUTED.—
‘‘(A) IN GENERAL.—The Secretary shall institute appro-
priate internal controls for contracts under this subsection,
including procedures for the Secretary to make a deter-
mination 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 subpara-
graph (A) that a person, or an officer, employee, or gov-
erning 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, gov-
erning 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, admin-
ister, or support qualified countermeasure research and
development activities in carrying out this section.
‘‘(2) LIMITATIONS.—The authority provided for under para-
graph (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 para-
graph (9) or (10) of section 2302(b) of such title; and
Procedures.
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118 STAT. 841
PUBLIC LAW 108–276—JULY 21, 2004
‘‘(E) accords a preference, among equally qualified per-
sons, 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 subpara-
graph (A), by striking ‘‘subsection (i)’’ and inserting ‘‘sub-
section (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 Infec-
tious 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 Infec-
tious 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 DIS-
EASES.—For the purpose of carrying out this section with
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118 STAT. 842
PUBLIC LAW 108–276—JULY 21, 2004
respect to the National Institute of Allergy and Infectious Dis-
eases, 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 appro-
priated’’ 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 appro-
priated’’ 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 Home-
land Security,’’ after ‘‘Management Agency,’’; and
(2) in subsection (h)(4)(B), by striking ‘‘to diagnose condi-
tions’’ 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 Home-
land 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 stock-
pile or stockpiles of drugs, vaccines and other biological prod-
ucts, 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 avail-
able 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 stock-
pile 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;
42 USC 247d–6b.
42 USC 247d–6a
note.
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118 STAT. 843
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‘‘(C) in consultation with Federal, State, and local offi-
cials, 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 Sec-
retary to respond to an actual or potential public health
emergency or other situation in which deployment is nec-
essary to protect the public health or safety; and
‘‘(H) ensure the adequate physical security of the stock-
pile.
‘‘(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 CER-
TAIN 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, radio-
logical, or nuclear agent identified as a material threat
under paragraph (2)(A)(ii), or to treat, identify, or pre-
vent 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;
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118 STAT. 844
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‘‘(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 avail-
able, 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 Sec-
retary, 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 chem-
ical, 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
COUNTER-
MEASURES.—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 des-
ignated 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 counter-
measures to address specific threats identified under paragraph
(2).
‘‘(4) CALL
FOR
DEVELOPMENT
OF
COUNTERMEASURES;
COMMITMENT FOR RECOMMENDATION FOR PROCUREMENT.—
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‘‘(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 para-
graph (10) be made available for the procurement of
such countermeasure.
‘‘(B) COUNTERMEASURE
SPECIFICATIONS.—The Home-
land Security Secretary and the Secretary shall, to the
extent practicable, include in the proposal under subpara-
graph (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 speci-
fications 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 counter-
measure 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 sub-
section (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’).
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118 STAT. 846
PUBLIC LAW 108–276—JULY 21, 2004
‘‘(B) REQUIREMENTS.—In making a determination
under subparagraph (A) with respect to a security counter-
measure, 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 rec-
ommendation that the special reserve fund under para-
graph (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 COMMIT-
TEES.—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 expla-
nation 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 poten-
tial 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 counter-
measure 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 counter-
measure is appropriate for inclusion in the stockpile and
if, as determined by the Secretary, such countermeasure
provides improved safety or effectiveness, or for other rea-
sons 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 determina-
tions that the special reserve fund under paragraph (10)
Applicability.
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118 STAT. 847
PUBLIC LAW 108–276—JULY 21, 2004
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 counter-
measure in accordance with the provisions of this para-
graph. 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 Sec-
retary under this section, other than the costs
described in clause (i), shall be paid from the appropria-
tion provided for under subsection (f)(1).
‘‘(C) PROCUREMENT.—
‘‘(i) IN GENERAL.—The Secretary shall be respon-
sible for—
‘‘(I) arranging for procurement of a security
countermeasure, 
including 
negotiating 
terms
(including quantity, production schedule, and
price) of, and entering into, contracts and coopera-
tive agreements, and for carrying out such other
activities as may reasonably be required, in accord-
ance with the provisions of this subparagraph; and
‘‘(II) promulgating such regulations as the Sec-
retary determines necessary to implement the
provisions of this subsection.
‘‘(ii) CONTRACT
TERMS.—A contract for procure-
ments 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, notwith-
standing any other provision of law, the contract
may provide that, if the Secretary determines (in
the Secretary’s discretion) that an advance pay-
ment 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 con-
strued as affecting rights of vendors under provi-
sions of law or regulation (including the Federal
Acquisition Regulation) relating to termination of
contracts for the convenience of the Government.
Regulations.
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118 STAT. 848
PUBLIC LAW 108–276—JULY 21, 2004
‘‘(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, clear-
ance, 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 perform-
ance 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 condi-
tions as the Secretary may specify, and in such
case amounts from the special reserve fund under
paragraph (10) shall be available for costs of ship-
ping, 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, clear-
ance, 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 sec-
tion 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 sec-
tion 302A(a) of the Federal Property and Adminis-
trative Services Act of 1949 (41 U.S.C. 252a(a)),
of—
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118 STAT. 849
PUBLIC LAW 108–276—JULY 21, 2004
‘‘(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 imple-
menting regulations; and
‘‘(bb) section 302A(b) of such Act (41
U.S.C. 252a(b)) and its implementing regula-
tions.
‘‘(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 Dis-
posal 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
ESTAB-
LISHED.—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 subpara-
graph, 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.—
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118 STAT. 850
PUBLIC LAW 108–276—JULY 21, 2004
‘‘(I) IN GENERAL.—In using the authority pro-
vided 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 procure-
ment 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 REGULA-
TIONS.—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 cir-
cumstances, 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 serv-
ices 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 CON-
TRACTS.—
‘‘(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 ven-
dors’ 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 discre-
tion.
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118 STAT. 851
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‘‘(vi) EXTENSION OF CLOSING DATE FOR RECEIPT OF
PROPOSALS NOT REVIEWABLE.—A decision by the Sec-
retary 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 con-
ducting a procurement under this subsection, the Sec-
retary 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 under-
takings with other agencies of the United States Govern-
ment.
‘‘(B) LIMITATION.—An agreement or undertaking under
this paragraph shall not authorize another agency to exer-
cise the authorities provided by this section to the Home-
land Security Secretary or to the Secretary.
‘‘(9) RESTRICTIONS ON USE OF FUNDS.—Amounts in the spe-
cial reserve fund under paragraph (10) shall not be used to
pay—
‘‘(A) costs for the purchase of vaccines under procure-
ment contracts entered into before the date of the enact-
ment 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 sub-
section, 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 Con-
gress:
‘‘(i) In the House of Representatives: the Com-
mittee 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 sec-
tion 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
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118 STAT. 852
PUBLIC LAW 108–276—JULY 21, 2004
‘‘(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 appro-
priated $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 appro-
priated $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 counter-
measures 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 pro-
gram, 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 Direc-
torate for Information Analysis and Infrastructure Protection,
who shall be analysts responsible for chemical, biological, radio-
logical, and nuclear threat assessment (including but not lim-
ited to analysis of chemical, biological, radiological, and nuclear
6 USC 320.
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118 STAT. 853
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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 pur-
pose of carrying out the acquisition and deployment of secure
facilities (including information technology and physical infra-
structure, whether mobile and temporary, or permanent) suffi-
cient 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 Depart-
ment of Homeland Security Appropriations Act, 2004
(Public Law 108–90).
(3) CONFORMING AMENDMENT.—Section 503 of the Home-
land Security Act of 2002 (6 U.S.C. 313) is amended by striking
paragraph (6).
SEC. 4. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMER-
GENCIES.
(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’).
Government
organization.
42 USC 247d–6b
note.
Deadline.
Classified
information.
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‘‘(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 author-
ized 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, radio-
logical, 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 consulta-
tion as appropriate with the Secretary of Homeland
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118 STAT. 855
PUBLIC LAW 108–276—JULY 21, 2004
Security or the Secretary of Defense, that the cir-
cumstances 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 sub-
section, 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 sub-
section 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 sub-
section (f)(2)) to the manufacturer (in the case of a manufac-
turer 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 sub-
section.
‘‘(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 sub-
section (b) can cause a serious or life-threatening disease or
condition;
‘‘(2) that, based on the totality of scientific evidence avail-
able 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 condi-
tion 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 diag-
nosing, treating, or preventing such a disease or condi-
tion caused by such an agent; and
Federal Register,
publication.
Applicability.
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118 STAT. 856
PUBLIC LAW 108–276—JULY 21, 2004
‘‘(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 regula-
tion 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 condi-
tion, 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 emer-
gency use of an unapproved product, the Secretary, to
the extent practicable given the circumstances of the emer-
gency, shall, for a person who carries out any activity
for which the authorization is issued, establish such condi-
tions on an authorization under this section as the Sec-
retary 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 adminis-
tration of the product, of the consequences, if any,
of refusing administration of the product, and of
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118 STAT. 857
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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 emer-
gency 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 condi-
tions on an authorization under this section as the Sec-
retary 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 record-
keeping 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 cir-
cumstances 
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 manufac-
turer.
‘‘(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
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118 STAT. 858
PUBLIC LAW 108–276—JULY 21, 2004
extent practicable given the circumstances of the emer-
gency, 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 cir-
cumstances of the emergency, requirements regarding current
good manufacturing practice otherwise applicable to the manu-
facture, processing, packing, or holding of products subject to
regulation under this Act, including such requirements estab-
lished 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 sub-
section (b) or a revocation under subsection (g).
‘‘(2) CONTINUED USE AFTER END OF EFFECTIVE PERIOD.—
Notwithstanding the termination of the declaration under sub-
section (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 authoriza-
tion 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.—
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118 STAT. 859
PUBLIC LAW 108–276—JULY 21, 2004
‘‘(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 sub-
ject 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 sec-
tion 1603 of the National Defense Authorization Act for Fiscal
Year 2004 (10 U.S.C. 1107a note) is repealed.
Applicability.
Federal Register,
publication.
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118 STAT. 860
PUBLIC LAW 108–276—JULY 21, 2004
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 sim-
plified 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 sim-
plified acquisition procedures).
(II) Subsection (c)(7)(C)(iv) (relating to proce-
dures other than full and open competition).
(III) Subsection (c)(7)(C)(v) (relating to pre-
mium 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 commit-
tees 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 informa-
tion 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
42 USC 247d–6c.
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118 STAT. 861
PUBLIC LAW 108–276—JULY 21, 2004
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 congres-
sional committees a report that summarizes the activity under-
taken 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 micropur-
chase 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 consulta-
tion with the Secretary of Homeland Security, shall report
to the designated congressional committees any potential bar-
riers 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 enact-
ment 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, proce-
dures other than full and open competition, increased
micropurchase thresholds, personal services contracts,
streamlined personnel authority, and the purchase of secu-
rity 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 effective-
ness 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
Deadline.
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118 STAT. 862
PUBLIC LAW 108–276—JULY 21, 2004
delayed except for the authorities described in subpara-
graph (A)(i); and
(E)(i) to determine whether and to what extent activi-
ties undertaken pursuant to the biomedical countermeasure
research and development authorities established in this
Act have enhanced the development of biomedical counter-
measures 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 cur-
rent 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 counter-
measures 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 bio-
containment facilities necessary for the testing of security counter-
measures 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 Com-
mittee).
(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
42 USC 247d–6a
note.
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118 STAT. 863
PUBLIC LAW 108–276—JULY 21, 2004
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 BIO-
MEDICAL COUNTERMEASURES.
Upon the award of any grant, contract, or cooperative agree-
ment under section 2 or 3 of this Act for the research, development,
or procurement of a qualified countermeasure or a security counter-
measure (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 ELIMI-
NATION 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 aforemen-
tioned Secretaries shall further ensure that information and tech-
nology possessed by the Departments relevant to these activities
are shared with the other Departments.
(b) DESIGNATION OF AGENCY COORDINATION OFFICER.—The Sec-
retary 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 coordi-
nate, 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
42 USC 247d–6a
note.
42 USC 247d–6a
note.
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118 STAT. 864
PUBLIC LAW 108–276—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.
declared emergency in the emergency area during the emer-
gency 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 Regula-
tions, 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 restric-
tions; and
‘‘(ii) the patient’s right to request confidential
communications.’’; and
(5) by adding at the end the following: ‘‘A waiver or modi-
fication 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 para-
graph (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.
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