SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Project BioShield Act
of 2003’’.
SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND
DEVELOPMENT AUTHORITIES.
(a) IN GENERAL.—Part B of title III of the Public
Health Service Act (42 U.S.C. 243 et seq.) is amended
by inserting after section 319F the following section:
‘‘SEC. 319F–1. AUTHORITY FOR USE OF CERTAIN PROCE-
DURES REGARDING QUALIFIED COUNTER-
MEASURE RESEARCH AND DEVELOPMENT
ACTIVITIES.
‘‘(a) IN GENERAL.—
‘‘(1) AUTHORITY.—In conducting and sup-
porting research and development activities regard-
ing 
biomedical 
countermeasures 
under 
section
319F(h), the Secretary may conduct and support
such activities in accordance with this section if the
activities concern qualified countermeasures.
‘‘(2) QUALIFIED COUNTERMEASURE.—For pur-
poses of this section, the term ‘qualified counter-
measure’ means a priority countermeasure (as de-
fined in section 319F(h) and as determined by the
Secretary in accordance with such section and con-
sistent with sections 302(2) and 304(a) of the
Homeland Security Act of 2002) against a chemical,
biological, radiological, or nuclear agent that may
cause a public health emergency affecting national
security.
‘‘(3) INTERAGENCY COOPERATION.—
‘‘(A) IN GENERAL.—In carrying out activi-
ties under this section, the Secretary is author-
ized, 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 un-
dertaking under this paragraph shall not au-
thorize another agency to exercise the authori-
ties provided by this section.
‘‘(4) AVAILABILITY OF FACILITIES TO THE SEC-
RETARY.—In any grant, contract, or cooperative
agreement entered into under the authority provided
in this section with respect to a biocontainment lab-
oratory or other related or ancillary specialized re-
search facility that the Secretary determines nec-
essary for the purpose of performing, administering,
or supporting qualified countermeasure research and
development, the Secretary may provide that the fa-
cility that is the object of such grant, contract, or
cooperative agreement shall be available as needed to
the Secretary to respond to public health emer-
gencies affecting national security.
‘‘(5) TRANSFERS
OF
QUALIFIED
COUNTER-
MEASURES.—Each agreement for an award of a
grant, contract, or cooperative agreement under sec-
tion 319F(h) for the development of a qualified
countermeasure shall provide that the recipient of
the award will comply with all applicable export-re-
lated 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 counter-
measure research or development activities
under this section that the Secretary deter-
mines 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 Adminis-
trative 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 pro-
curement, of—
‘‘(i) section 303(g)(1)(A) of the Fed-
eral 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 reg-
ulations.
‘‘(B) APPLICATION
OF
CERTAIN
PROVI-
SIONS.—Notwithstanding 
subparagraph 
(A)
and the provision of law and regulations re-
ferred to in such subparagraph, each of the fol-
lowing provisions shall apply to procurements
described in this paragraph to the same extent
that such provisions would apply to such pro-
curements in the absence of subparagraph (A):
‘‘(i) Chapter 37 of title 40, United
States Code (relating to contract work
hours and safety standards).
‘‘(ii) Subsections (a) and (b) of sec-
tion 7 of the Anti-Kickback Act of 1986
(41 U.S.C. 57(a) and (b)).
‘‘(iii) Section 304C of the Federal
Property and Administrative Services Act
of 1949 (41 U.S.C. 254d) (relating to the
examination of contractor records).
‘‘(C) INTERNAL CONTROLS TO BE INSTI-
TUTED.—The Secretary shall institute appro-
priate internal controls for procurements that
are under this paragraph, including require-
ments with regard to documenting the justifica-
tion for use of the authority in this paragraph.
‘‘(2) PROCEDURES
OTHER
THAN
FULL
AND
OPEN COMPETITION.—
‘‘(A) IN GENERAL.—In using the authority
provided in section 303(c)(1) of title III of the
Federal Property and Administrative Services
Act of 1949 (41 U.S.C. 253(c)(1)) to use proce-
dures 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 sec-
tion 303(c)(1) shall be deemed to mean ‘avail-
able from only one responsible source or only
from a limited number of responsible sources’.
‘‘(B) RELATION
TO
OTHER
AUTHORI-
TIES.—The authority under subparagraph (A)
is in addition to any other authority to use pro-
cedures other than competitive procedures.
‘‘(C) 
APPLICABLE
GOVERNMENT-WIDE
REGULATIONS.—The Secretary shall implement
this paragraph in accordance with applicable
government-wide regulations, including require-
ments that offers be solicited from as many po-
tential sources as is practicable under the cir-
cumstances, that required notices be published,
and that submitted offers be considered.
‘‘(3) INCREASED
MICROPURCHASE
THRESH-
OLD.—
‘‘(A) IN
GENERAL.—For a procurement
described by paragraph (1), the amount speci-
fied 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 re-
spect to such procurement.
‘‘(B) INTERNAL CONTROLS TO BE INSTI-
TUTED.—The Secretary shall institute appro-
priate internal controls for purchases that are
under this paragraph and that are greater than
$2,500.
to award a contract for a procurement de-
scribed 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 press-
ing qualified countermeasure research and develop-
ment needs under this section, employ such expe-
dited peer review procedures (including consultation
with appropriate scientific experts) as the Secretary,
in consultation with the Director of NIH, deems ap-
propriate to obtain assessment of scientific and tech-
nical merit and likely contribution to the field of
qualified countermeasure research, in place of the
peer review and advisory council review procedures
that would be required under sections 301(a)(3),
405(b)(1)(B), 405(b)(2), 406(a)(3)(A), 492, and
494, as applicable to a grant, contract, or coopera-
tive agreement—
‘‘(A) that is for performing, administering,
or supporting qualified countermeasure research
and development activities; and
‘‘(B) the amount of which is not greater
than $1,500,000.
‘‘(2) SUBSEQUENT
PHASES
OF
RESEARCH.—
The Secretary’s determination of whether to employ
expedited peer review with respect to subsequent
phases of a research grant, contract, or cooperative
agreement under this section shall be determined
without regard to the peer review procedures used
for any prior peer review of that same grant, con-
tract, or cooperative agreement.
‘‘(d) AUTHORITY
FOR PERSONAL SERVICES CON-
TRACTS.—
‘‘(1) IN GENERAL.—For the purpose of per-
forming, administering, or supporting qualified
countermeasure research and development activities,
the Secretary may, as the Secretary determines nec-
essary to respond to pressing qualified counter-
measure research and development needs under this
section, obtain by contract (in accordance with sec-
tion 3109 of title 5, United States Code, but without
regard to the limitations in such section on the pe-
riod 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 an-
nual rate of compensation for the President.
‘‘(2) FEDERAL TORT CLAIMS ACT COVERAGE.—
‘‘(A) IN GENERAL.—A person carrying out
a contract under paragraph (1), and an officer,
employee, or governing board member of such
person, shall be deemed to be an employee of
the Department of Health and Human Services
for purposes of claims under sections 1346(b)
and 2672 of title 28, United States Code, for
money damages for personal injury, including
death, resulting from performance of functions
under such contract.
‘‘(B) EXCLUSIVITY
OF
REMEDY.—The
remedy provided by subparagraph (A) shall be
exclusive of any other civil action or proceeding
by reason of the same subject matter against
the person, officer, employee, or governing
board member.
‘‘(3) INTERNAL
CONTROLS
TO
BE
INSTI-
TUTED.—
‘‘(A) IN
GENERAL.—The Secretary shall
institute appropriate internal controls for con-
tracts under this subsection, including proce-
dures for the Secretary to make a determina-
tion of whether a person, or an officer, em-
ployee, 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 STA-
TUS
TO
BE
FINAL.—A determination by the
Secretary under subparagraph (A) that a per-
son, 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
CON-
TRACTS LIMITED.—The number of experts and con-
sultants 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 Sec-
retary determines necessary to respond to pressing
qualified countermeasure research and development
needs under this section, without regard to such pro-
visions of title 5, United States Code, governing ap-
pointments in the competitive service, and without
regard to the provisions of chapter 51 and sub-
chapter III of chapter 53 of such title relating to
classification and General Schedule pay rates, ap-
point professional and technical employees, not to
exceed 30 such employees at any time, to positions
in the National Institutes of Health to perform, ad-
minister, or support qualified countermeasure re-
search and development activities in carrying out
this section.
‘‘(2) INTERNAL
CONTROLS
TO
BE
INSTI-
TUTED.—The Secretary shall institute appropriate
internal controls for appointments under this sub-
section.
‘‘(f) ACTIONS COMMITTED
TO AGENCY DISCRE-
TION.—Actions by the Secretary under the authority of
this section are committed to agency discretion.’’.
(b) TECHNICAL AMENDMENT.—Section 481A of the
Public Health Service Act (42 U.S.C. 287a-2) is
amended—
(1) in subsection (a)(1)—
(A) by inserting ‘‘or the Director of the
National Institute of Allergy and Infectious
Diseases’’ after ‘‘Director of the Center’’; and
(B) by inserting ‘‘, or in the case of the In-
stitute, to any qualified public or private enti-
ty,’’ after ‘‘private entities’’;
(2) in subsection (c)—
(A) in paragraph (1), by inserting ‘‘or the
Director of the National Institute of Allergy
and Infectious Diseases’’ after ‘‘Director of the
Center’’; and
(B) in paragraph (2), in the matter pre-
ceding subparagraph (A), by striking ‘‘sub-
section (i)’’ and inserting ‘‘subsection (i)(1)’’;
(3) in subsection (d), by inserting ‘‘or the Di-
rector of the National Institute of Allergy and Infec-
tious Diseases’’ after ‘‘Director of the Center’’;
(4) in subsection (e)—
(A) in paragraph (1)—
(i) in the matter preceding subpara-
graph (A), by inserting ‘‘or the Director of
the National Institute of Allergy and Infec-
tious Diseases’’ after ‘‘Director of the Cen-
ter’’;
(ii) in subparagraph (A), by inserting
‘‘(or, in the case of the Institute, 75 per-
cent)’’ after ‘‘50 percent’’; and
(iii) in subparagraph (B), by inserting
‘‘(or, in the case of the Institute, 75 per-
cent)’’ 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 ‘‘Di-
rector’’;
(5) in subsection (f)—
(A) in paragraph (1), by inserting ‘‘in the
case of an award by the Director of the Cen-
ter,’’ 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 ‘‘Di-
rector’’; 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 car-
rying out this section with respect to the National
Institute of Allergy and Infectious Diseases, there
are authorized to be appropriated such sums as may
be necessary for each of the fiscal years 2003 and
2004.’’.
(c) ADDITIONAL AUTHORITY.—Section 319F of the
Public Health Service Act (42 U.S.C. 247d–6) is
amended—
(1) by redesignating subsections (i) and (j) as
subsections (j) and (k), respectively; and
(2) by inserting after subsection (h) the fol-
lowing subsection:
‘‘(i) PRIORITY COUNTERMEASURES FOR STRATEGIC
NATIONAL STOCKPILE.—
‘‘(1) IN GENERAL.—The Secretary, taking into
consideration any recommendations of the working
group under subsection (a), may initiate and sustain
a program that results in the delivery of priority
countermeasures for placement in the stockpile
under section 319F–2.
‘‘(2) AUTHORIZATION
OF
APPROPRIATIONS.—
For the purpose of carrying out paragraph (1), there
are authorized to be appropriated such sums as may
be necessary for each of the fiscal years 2004
through 2013.’’.
(d) ADDITIONAL AUTHORIZATIONS OF APPROPRIA-
TIONS.—Section 2106 of the Public Health Service Act
(42 U.S.C. 300aa–6) is amended—
(1) in subsection (a), by striking ‘‘authorized to
be appropriated’’ and all that follows and inserting
the following: ‘‘authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2004 through 2013.’’; and
(2) in subsection (b), by striking ‘‘authorized to
be appropriated’’ and all that follows and inserting
the following: ‘‘authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2004 through 2013.’’.
(e) TECHNICAL AMENDMENTS.—Section 319F of the
Public Health Service Act (42 U.S.C. 247d–6) is
amended—
(1) in subsection (a), by inserting ‘‘the Sec-
retary of Homeland Security,’’ after ‘‘Management
Agency,’’; and
(2) in subsection (h)(4)(B), by striking ‘‘to di-
agnose conditions’’ and inserting ‘‘to treat, identify,
or prevent conditions’’.
(f) RULE OF CONSTRUCTION.—Nothing in this sec-
tion has any legal effect on sections 302(2), 302(4),
304(a), or 304(b) of the Homeland Security Act of 2002.
SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT.
(a) ADDITIONAL AUTHORITY REGARDING STRATEGIC
NATIONAL STOCKPILE.—
(1) TRANSFER OF PROGRAM.—Section 121 of
the Public Health Security and Bioterrorism Pre-
paredness 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 para-
graph (1), is amended to read as follows:
‘‘SEC. 319F–2. STRATEGIC NATIONAL STOCKPILE.
‘‘(a) STRATEGIC NATIONAL STOCKPILE.—
‘‘(1) IN GENERAL.—The Secretary of Homeland
Security (referred to in this section as the ‘Home-
land Security Secretary’), in coordination with the
Secretary and the Secretary of Veterans Affairs,
shall maintain a stockpile or stockpiles of drugs, vac-
cines 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 vul-
nerable populations, in the event of a bioterrorist at-
tack or other public health emergency.
‘‘(2) PROCEDURES.—The Secretary, in man-
aging 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 in-
ventory management and accounting, and for
the physical security of the stockpile;
‘‘(C) in consultation with Federal, State,
and local officials, take into consideration the
timing and location of special events;
‘‘(D) review and revise, as appropriate, the
contents of the stockpile on a regular basis to
ensure that emerging threats, advanced tech-
nologies, and new countermeasures are ade-
quately considered;
‘‘(E) devise plans for the effective and
timely supply-chain management of the stock-
pile, in consultation with appropriate Federal,
State and local agencies, and the public and
private health care infrastructure; and
‘‘(F) ensure the adequate physical security
of the stockpile.
‘‘(b) SMALLPOX VACCINE DEVELOPMENT.—
‘‘(1) IN GENERAL.—The Secretary shall award
contracts, enter into cooperative agreements, or
carry out such other activities as may reasonably be
required in order to ensure that the stockpile under
subsection (a) includes an amount of vaccine against
smallpox as determined by such Secretary to be suf-
ficient 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 sub-
section (a).
‘‘(c) ADDITIONAL
AUTHORITY
REGARDING
PRO-
CUREMENT
OF
CERTAIN
BIOMEDICAL
COUNTER-
MEASURES; 
AVAILABILITY
OF
SPECIAL
RESERVE
FUND.—
‘‘(1) IN GENERAL.—
‘‘(A) USE OF FUND.—A security counter-
measure may, in accordance with this sub-
section, be procured with amounts in the special
reserve fund under paragraph (10).
‘‘(B) SECURITY
COUNTERMEASURE.—For
purposes of this subsection, the term ‘security
countermeasure’ means a priority counter-
measure (as defined in section 319F(h) and as
determined by the Secretary in accordance with
such section and consistent with sections
302(2) and 304(a) of the Homeland Security
Act of 2002) that—
‘‘(i)(I) is against a chemical, biologi-
cal, radiological, or nuclear agent identified
as a material threat under paragraph
(2)(A)(ii);
‘‘(II) is determined under paragraph
(2)(B)(ii) to be a necessary counter-
measure; and
‘‘(III)(aa) is approved or cleared
under chapter V of the Federal Food,
Drug, and Cosmetic Act, or licensed under
section 351 of this Act, for use as a coun-
termeasure to a chemical, biological, radio-
logical, or nuclear agent identified as a
material threat under paragraph (2)(A)(ii);
or
‘‘(bb) is a priority countermeasure for
which the Secretary determines that suffi-
cient and satisfactory clinical experience or
research data (including data, if available,
from pre-clinical and clinical trials) sup-
port a reasonable conclusion that the coun-
termeasure will qualify for approval or li-
censing after the date of a determination
under paragraph (5); or
‘‘(ii) is authorized under section 564
of the Federal Food, Drug, and Cosmetic
Act for emergency use.
‘‘(2) 
DETERMINATION
OF
MATERIAL
THREATS.—
‘‘(A) MATERIAL THREAT.—The Homeland
Security Secretary, in consultation with the
heads of other agencies as appropriate, shall on
an ongoing basis—
‘‘(i) assess current and emerging
threats of chemical, biological, radiological,
and nuclear agents; and
‘‘(ii) determine which of such agents
present a material threat against the
United States population.
‘‘(B) PUBLIC HEALTH IMPACT; NECESSARY
COUNTERMEASURES.—The Secretary shall on
an ongoing basis—
‘‘(i) assess the potential public health
consequences of use against the United
States population of agents identified
under subparagraph (A)(ii); and
‘‘(ii) determine, on the basis of such
assessment, the agents for which priority
countermeasures are necessary to protect
the public health from a material threat.
‘‘(C) NOTICE
TO
CONGRESS.—The Sec-
retary and the Homeland Security Secretary
shall promptly notify the designated congres-
sional committees (as defined in paragraph (10)
that a determination has been made pursuant
to subparagraph (A) or (B). Such notice shall
be in unclassified or, if necessary, classified
form.
‘‘(D) ASSURING
ACCESS
TO
THREAT
IN-
FORMATION.—In making the assessment and
determination required under subparagraph
(A), the Homeland Security Secretary shall use
all information to which such Secretary is enti-
tled under section 202 of the Homeland Secu-
rity Act of 2002, including but not limited to
information, regardless of its level of classifica-
tion, relating to current and emerging threats
of chemical, biological, radiological, and nuclear
agents.
‘‘(3) ASSESSMENT OF AVAILABILITY AND AP-
PROPRIATENESS OF COUNTERMEASURES.—The Sec-
retary, in consultation with the Homeland Security
Secretary, shall assess on an ongoing basis the avail-
ability and appropriateness of specific counter-
measures to address specific threats identified under
paragraph (2).
‘‘(4) CALL FOR DEVELOPMENT OF COUNTER-
MEASURES; COMMITMENT
FOR
RECOMMENDATION
FOR PROCUREMENT.—
‘‘(A) PROPOSAL TO THE PRESIDENT.—If,
pursuant to an assessment under paragraph
(3), the Homeland Security Secretary and the
Secretary make a determination that a counter-
measure would be appropriate but is either cur-
rently unavailable for procurement as a security
countermeasure or is approved, licensed, or
cleared only for alternative uses, such Secre-
taries 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 counter-
measure that meets the conditions for pro-
curement under paragraph (5), the Secre-
taries will, based in part on information
obtained pursuant to such call, make a rec-
ommendation under paragraph (6) that the
special reserve fund under paragraph (10)
be made available for the procurement of
such countermeasure.
‘‘(B) 
COUNTERMEASURE
SPECIFICA-
TIONS.—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 regard-
less 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 re-
search, development, and manufacture of
the countermeasure or to provide specifica-
tions for the countermeasure.
‘‘(C) PRESIDENTIAL
APPROVAL.—If the
President approves a proposal under subpara-
graph (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 counter-
measure under subparagraph (B); and
‘‘(iii) the commitment described in
subparagraph (A)(ii).
‘‘(5) SECRETARY’S DETERMINATION OF COUN-
TERMEASURES
APPROPRIATE
FOR
FUNDING
FROM
SPECIAL RESERVE FUND.—
‘‘(A) IN GENERAL.—The Secretary, in ac-
cordance 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 sub-
section’).
‘‘(B) REQUIREMENTS.—In making a deter-
mination under subparagraph (A) with respect
to a security countermeasure, the Secretary
shall determine and consider the following:
‘‘(i) The quantities of the product
that will be needed to meet the needs of
the stockpile.
‘‘(ii) The feasibility of production and
delivery within five years of sufficient
quantities of the product.
‘‘(iii) Whether there is a lack of a sig-
nificant commercial market for the product
at the time of procurement, other than as
a security countermeasure.
determination by the Secretary is committed to
agency discretion.
‘‘(E) 
RULE
OF
CONSTRUCTION.—Rec-
ommendations and approvals under this para-
graph apply solely to determinations that the
special reserve fund under paragraph (10) will
be made available for a procurement of a secu-
rity countermeasure, and not to the substance
of contracts for such procurement or other mat-
ters relating to awards of such contracts.
‘‘(7) PROCUREMENT.—
‘‘(A) IN
GENERAL.—For purposes of a
procurement under this subsection that is ap-
proved by the President under paragraph (6),
the Homeland Security Secretary and the Sec-
retary shall have responsibilities in accordance
with subparagraphs (B) and (C).
‘‘(B) INTERAGENCY AGREEMENTS.—
‘‘(i) 
FOR
PROCUREMENT.—The
Homeland Security Secretary shall enter
into an agreement with the Secretary for
procurement of a security countermeasure
in accordance with the provisions of this
paragraph. The special reserve fund under
paragraph (10) shall be available for the
Secretary’s costs of such procurement,
other than as provided in clause (ii).
‘‘(ii) FOR ADMINISTRATIVE COSTS.—
The agreement entered into between the
Homeland Security Secretary and the Sec-
retary for managing the stockpile under
subsection (a) shall provide for reimburse-
ment of the Secretary’s administrative
costs relating to procurements under this
subsection.
‘‘(C) PROCUREMENT.—
‘‘(i) IN
GENERAL.—The Secretary
shall be responsible for—
‘‘(I) arranging for procurement
of a security countermeasure, includ-
ing negotiating terms (including quan-
tity, production schedule, and price)
of, and entering into, contracts and
cooperative agreements, and for car-
rying out such other activities as may
reasonably be required, in accordance
with the provisions of this subpara-
graph; and
‘‘(II) promulgating such regula-
tions as the Secretary determines nec-
essary to implement the provisions of
this subsection.
‘‘(ii) CONTRACT TERMS.—A contract
for procurements under this subsection
shall (or, as specified below, may) include
the following terms:
‘‘(I) PAYMENT CONDITIONED ON
SUBSTANTIAL
DELIVERY.—The con-
tract shall provide that no payment
may be made until delivery has been
made of a substantial portion (as de-
termined by the Secretary) of the
total number of units contracted for,
except 
that, 
notwithstanding 
any
other provision of law, the contract
may provide that, if the Secretary de-
termines (in the Secretary’s discre-
tion) that an advance payment is nec-
essary 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 ad-
vance payment is required to be re-
paid if there is a failure to perform
under the contract, except in special
circumstances as determined by the
Secretary on a contract by contract
basis. Nothing in this subclause may
be construed as affecting rights of
vendors under provisions of law or
regulation (including the Federal Ac-
quisition Regulation) relating to ter-
mination of contracts for the conven-
ience of the Government.
‘‘(II) CONTRACT
DURATION.—
The contract shall be for a period not
to exceed five years, except that, in
first awarding the contract, the Sec-
retary may provide for a longer dura-
tion, not exceeding eight years, if the
Secretary determines that complexities
or other difficulties in performance
under the contract justify such a pe-
riod. The contract shall be renewable
for additional periods, none of which
shall exceed five years.
‘‘(III) STORAGE
BY
VENDOR.—
The contract may provide that the
vendor will provide storage for stocks
of a product delivered to the owner-
ship 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 ship-
ping, handling, storage, and related
costs for such product.
‘‘(IV) NON-STOCKPILE
TRANS-
FERS
OF
SECURITY
COUNTER-
MEASURES.—The contract shall pro-
vide 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 Sec-
retary determines that there is a
pressing need for a procurement of a
specific countermeasure, the amount
of the procurement under this sub-
section 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 Administrative Services Act of
1949 (41 U.S.C. 252a(a)), of—
‘‘(aa) section 303(g)(1)(A)
of the Federal Property and Ad-
ministrative 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 
sub-
clause (I) and the provision of law
and regulations referred to in such
clause, each of the following provi-
sions shall apply to procurements de-
scribed in this clause to the same ex-
tent 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-Kick-
back Act of 1986 (41 U.S.C.
57(a) and (b)).
‘‘(cc) Section 304C of the
Federal Property and Adminis-
trative Services Act of 1949 (41
U.S.C. 254d) (relating to the ex-
amination of contractor records).
‘‘(iv) 
PROCEDURES
OTHER
THAN
FULL AND OPEN COMPETITION.—
‘‘(I) IN GENERAL.—In using the
authority 
provided 
in 
section
303(c)(1) of title III of the Federal
Property and Administrative Services
Act of 1949 (41 U.S.C. 253(c)(1)) to
use procedures other than competitive
procedures in the case of a procure-
ment 
under 
this 
subsection, 
the
phrase ‘available from only one re-
sponsible 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 AU-
THORITIES.—The 
authority 
under
subclause (I) is in addition to any
other authority to use procedures
other than competitive procedures.
‘‘(III) 
APPLICABLE
GOVERN-
MENT-WIDE REGULATIONS.—The Sec-
retary shall implement this clause in
accordance with applicable govern-
ment-wide regulations, including re-
quirements 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 consid-
ered.
‘‘(v) PREMIUM
PROVISION
IN
MUL-
TIPLE 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, wheth-
er 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 in-
crement identified under item
(aa), in accordance with the
terms and conditions of the con-
tract.
‘‘(II) DETERMINATION
OF
GOV-
ERNMENT’S
REQUIREMENT
NOT
RE-
VIEWABLE.—If the Secretary includes
in each of a set of contracts a provi-
sion as described in subclause (I),
such Secretary’s determination of the
total quantity of security counter-
measure required, and any amend-
ment of such determination, is com-
mitted to agency discretion.
‘‘(vi) EXTENSION OF CLOSING DATE
FOR RECEIPT OF PROPOSALS NOT REVIEW-
ABLE.—A decision by the Secretary to ex-
tend the closing date for receipt of pro-
posals for a procurement under this sub-
section is committed to agency discretion.
‘‘(vii) LIMITING
COMPETITION
TO
SOURCES RESPONDING TO REQUEST FOR
INFORMATION.—In conducting a procure-
ment under this subsection, the Secretary
may exclude a source that has not re-
sponded 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 activi-
ties 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 un-
dertaking under this paragraph shall not au-
thorize another agency to exercise the authori-
ties 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 para-
graph (10) shall not be used to pay—
‘‘(A) costs for the purchase of vaccines
under procurement contracts entered into be-
fore the date of the enactment of the Project
BioShield Act of 2003; or
‘‘(B) administrative costs.
‘‘(10) DEFINITIONS.—
‘‘(A) SPECIAL RESERVE FUND.—For pur-
poses of this subsection, the term ‘special re-
serve fund’ has the meaning given such term in
section 510 of the Homeland Security Act of
2002.
‘‘(B) DESIGNATED CONGRESSIONAL COM-
MITTEES.—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 Committee on Energy and Commerce,
the Committee on Appropriations, the
Committee on Government Reform, and
the Select Committee on Homeland Secu-
rity (or any successor to the Select Com-
mittee).
‘‘(ii) In the Senate: the Committee on
Health, Education, Labor, and Pensions,
the Committee on Appropriations, and the
Committee on Government Affairs.
‘‘(d) DISCLOSURES.—No Federal agency shall dis-
close under section 552 of title 5, United States Code, any
information identifying the location at which materials in
the stockpile under subsection (a) are stored.
‘‘(e) DEFINITION.—For purposes of subsection (a),
the term ‘stockpile’ includes—
‘‘(1) a physical accumulation (at one or more
locations) of the supplies described in subsection (a);
or
‘‘(2) a contractual agreement between the Sec-
retary 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 fis-
cal year 2002, and such sums as may be necessary
for each of fiscal years 2003 through 2006. Such
authorization is in addition to amounts in the special
reserve fund under subsection (c)(10).
‘‘(2) SMALLPOX VACCINE DEVELOPMENT.—For
the purpose of carrying out subsection (b), there are
authorized to be appropriated $509,000,000 for fis-
cal year 2002, and such sums as may be necessary
for each of fiscal years 2003 through 2006.’’.
(b) AMENDMENT TO HOMELAND SECURITY ACT OF
2002.—Title V of the Homeland Security Act of 2002
(116 Stat. 2212; 6 U.S.C. 311 et seq.) is amended by add-
ing at the end the following:
‘‘SEC. 
510. 
PROCUREMENT 
OF 
SECURITY 
COUNTER-
MEASURES 
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 sen-
tence, not to exceed $3,418,000,000 may be obligated dur-
ing 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 re-
serve fund’ means the appropriations account established
as a result of any appropriations made under subsection
(a).
‘‘(c) AVAILABILITY.—
‘‘(1) INTEGRITY OF SPECIAL RESERVE FUND;
LIMITATION OF OBLIGATIONAL AUTHORITY TO FUND
PURPOSES; INTENT
OF
CONGRESS
AGAINST
RE-
PROGRAMMING.—Subject to paragraph (2), all
amounts appropriated under subsection (a) are
available for obligation through the end of fiscal year
2013 and only for the specific purposes set forth in
the security countermeasures program. It is the in-
tent of the Congress that no portion of such amount
that remains unobligated for such purposes shall be
applied, through reprogramming or otherwise, to any
other purpose.
‘‘(2) INITIAL
AVAILABILITY
FOR
PARTICULAR
PROCUREMENTS.—Amounts appropriated under sub-
section (a) become available for a procurement
under the security countermeasures program only
upon the approval by the President of such avail-
ability for the procurement in accordance with para-
graph (6)(B) of such program.
‘‘(d) RELATED AUTHORIZATIONS
OF APPROPRIA-
TIONS.—
‘‘(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 author-
ized to be appropriated $5,000,000 for fiscal year
2003, and 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, bio-
logical, radiological, and nuclear threat assessment
(including but not limited to analysis of chemical, bi-
ological, radiological, and nuclear agents, the means
by which such agents could be weaponized or used
in a terrorist attack, and the capabilities, plans, and
intentions of terrorists and other non-state actors
who may have or acquire such agents). All such ana-
lysts shall meet the applicable standards and quali-
fications 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
INFRASTRUC-
TURE.—For the purpose of carrying out the acquisi-
tion and deployment of secure facilities (including
information technology and physical infrastructure,
whether mobile and temporary, or permanent) suffi-
cient to permit the Secretary to receive, not later
than December 31, 2003, all classified information
and products to which the Under Secretary for In-
formation Analysis and Infrastructure Protection is
entitled under subtitle A of title II, there are author-
ized to be appropriated such sums as may be nec-
essary for each of the fiscal years 2003 through
2006.’’.
SEC. 4. AUTHORIZATION FOR MEDICAL PRODUCTS FOR
USE IN EMERGENCIES.
Subchapter E of chapter V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is
amended by adding at the end the following section:
‘‘SEC. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR
USE IN EMERGENCIES.
‘‘(a) IN GENERAL.—
‘‘(1) EMERGENCY USES.—Notwithstanding sec-
tions 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 au-
thorize the introduction into interstate commerce,
during the effective period of a declaration under
subsection (b), of a drug, device, or biological prod-
uct intended for use in an actual or potential emer-
gency (referred to in this section as an ‘emergency
use’).
‘‘(2) APPROVAL STATUS OF PRODUCT.—An au-
thorization 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 emer-
gency use authorized under paragraph (1) for a
product is in addition to any other use that is au-
thorized for the product under a provision of law re-
ferred to in such paragraph.
‘‘(4) DEFINITIONS.—For purposes of this sec-
tion:
‘‘(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, de-
vice, or biological product.
‘‘(D) The term ‘unapproved product’ has
the meaning indicated for such term in para-
graph (2)(A).
‘‘(E) The term ‘unapproved use of an ap-
proved product’ has the meaning indicated for
such term in paragraph (2)(B).
‘‘(b) DECLARATION OF EMERGENCY.—
‘‘(1) IN GENERAL.—The Secretary may declare
an emergency justifying the authorization under this
subsection for a product on the basis of—
‘‘(A) a determination by the Secretary of
Homeland Security that there is a national
emergency, or a significant potential for a na-
tional emergency, involving a heightened risk of
attack with a specified biological, chemical, ra-
diological, or nuclear agent or agents;
‘‘(B) a determination by the Secretary of
Defense that there is a military emergency, or
a significant potential for a military emergency,
involving a heightened risk to United States
military forces of attack with a biological,
chemical, radiological, or nuclear agent or
agents; or
‘‘(C) a determination by the Secretary of a
public health emergency under section 319 of
the Public Health Service Act, affecting na-
tional security and involving a specified biologi-
cal, chemical, radiological, or nuclear agent or
agents, or a specified disease or condition that
may be attributable to such agent or agents.
‘‘(2) TERMINATION OF DECLARATION.—
‘‘(A) IN GENERAL.—A declaration under
this subsection shall terminate upon the earlier
of—
‘‘(i) a determination by the Secretary,
in consultation as appropriate with the
Secretary of Homeland Security or the
Secretary 
of 
Defense, 
that 
the 
cir-
cumstances described in paragraph (1)
have ceased to exist; or
‘‘(ii) the expiration of the one-year pe-
riod beginning on the date on which the
declaration is made.
‘‘(B) RENEWAL.—Notwithstanding sub-
paragraph (A), the Secretary may renew a dec-
laration under this subsection, and this para-
graph shall apply to any such renewal.
‘‘(3) ADVANCE NOTICE OF TERMINATION.—In
terminating a declaration under this section, the
Secretary shall provide advance notice that the dec-
laration will be terminated. The period of advance
notice shall be a period reasonably determined to
provide—
‘‘(A) in the case of an unapproved product,
a sufficient period for disposition of shipments
of the product, including the return of such
shipments to the manufacturer (in the case of
a manufacturer that chooses to have the ship-
ments returned); and
‘‘(B) in the case of unapproved uses of ap-
proved products, a sufficient period for the dis-
position of any labeling that was provided with
respect to the emergency use involved.
‘‘(4) 
PUBLICATION.—The 
Secretary 
shall
promptly publish in the Federal Register each dec-
laration, determination, and renewal under this sub-
section.
‘‘(c) CRITERIA FOR ISSUANCE OF AUTHORIZATION.—
The Secretary may issue an authorization under this sec-
tion with respect to the emergency use of a product only
if, after consultation with the Director of the National In-
stitutes of Health and the Director of the Centers for Dis-
ease Control and Prevention, to the extent feasible and
appropriate given the circumstances of the emergency in-
volved, 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 evi-
dence available to the Secretary, including data from
adequate and well-controlled clinical trials, if avail-
able, it is reasonable to believe that—
‘‘(A) the product may be effective in de-
tecting, diagnosing, treating, or preventing—
‘‘(i) such disease or condition; or
‘‘(ii) a serious or life-threatening dis-
ease or condition caused by a product au-
thorized under this section or approved
under this Act or the Public Health Serv-
ice Act, for detecting, diagnosing, treating,
or preventing such a disease or condition
caused by such an agent; and
‘‘(B) the known and potential benefits of
the product, when used to detect, diagnose, pre-
vent, or treat such disease or condition, out-
weigh the known and potential risks of the
product;
‘‘(3) that there is no adequate, approved, and
available alternative to the product for detecting, di-
agnosing, preventing, or treating such disease or
condition; and
‘‘(4) that such other criteria as the Secretary
may by regulation prescribe are satisfied.
‘‘(d) SCOPE OF AUTHORIZATION.—
‘‘(1) IN GENERAL.—An authorization of a prod-
uct under this section shall state—
‘‘(A) each disease or condition that the
product may be used to detect, diagnose, pre-
vent, or treat within the scope of the authoriza-
tion;
‘‘(B) the Secretary’s conclusions, made
under subsection (c)(2)(B), that the known and
potential benefits of the product, when used to
detect, diagnose, prevent, or treat such disease
or condition, outweigh the known and potential
risks of the product; and
‘‘(C) the Secretary’s conclusions, made
under subsection (c), concerning the safety and
potential effectiveness of the product in detect-
ing, diagnosing, preventing, or treating such
diseases or conditions, including an assessment
of the available scientific evidence.
‘‘(2) CONFIDENTIAL
INFORMATION.—Nothing
in this section alters or amends section 1905 of title
18, United States Code, or section 552(b)(4) of title
5 of such Code.
‘‘(e) CONDITIONS OF AUTHORIZATION.—
‘‘(1) UNAPPROVED PRODUCT.—
‘‘(A) REQUIRED
CONDITIONS.—With re-
spect to the emergency use of an unapproved
product, the Secretary, to the extent feasible
given the circumstances of the emergency, shall,
for persons who choose to carry out one or
more activities for which the authorization is
issued, establish such conditions on an author-
ization under this section as the Secretary finds
necessary or appropriate to protect the public
health, including the following:
‘‘(i) Appropriate conditions designed
to ensure that, to the extent feasible given
the circumstances of the emergency, health
care professionals administering the prod-
uct are informed—
‘‘(I) that the Secretary has au-
thorized the emergency use of the
product;
‘‘(II) of the significant known
and potential benefits and risks of the
emergency use of the product, and of
the extent to which such benefits and
risks are unknown; and
‘‘(III) of the alternatives to the
product that are available, and of
their benefits and risks.
‘‘(ii) Appropriate conditions designed
to ensure that, to the extent feasible given
the circumstances of the emergency, indi-
viduals to whom the product is adminis-
tered are informed—
‘‘(I) that the Secretary has au-
thorized 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 refus-
ing administration of the product, and
of the alternatives to the product that
are available and of their benefits and
risks.
‘‘(iii) Appropriate conditions for the
monitoring and reporting of adverse events
associated with the emergency use of the
product.
‘‘(iv) For manufacturers of the prod-
uct, appropriate conditions concerning rec-
ordkeeping 
and 
reporting, 
including
records access by the Secretary, with re-
spect to the emergency use of the product.
‘‘(B) AUTHORITY FOR ADDITIONAL CONDI-
TIONS.—With respect to the emergency use of
an unapproved product, the Secretary, to the
extent feasible given the circumstances of the
emergency, may, for persons who choose to
carry out one or more activities for which the
authorization is issued, establish such condi-
tions on an authorization under this section as
the Secretary finds necessary or appropriate to
protect the public health, including the fol-
lowing:
‘‘(i) Appropriate conditions on which
entities may distribute the product with re-
spect to the emergency use of the product
(including limitation to distribution by gov-
ernment 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 prod-
uct may be administered with respect to
such use.
‘‘(iii) For persons other than manu-
facturers of the product, appropriate con-
ditions concerning recordkeeping and re-
porting, including records access by the
Secretary, with respect to the emergency
use of the product.
‘‘(iv) With respect to the emergency
use of the product, waive or limit, to the
extent appropriate given the circumstances
of the emergency, conditions regarding
current good manufacturing practice other-
wise applicable to the manufacture, proc-
essing, packing, or holding of products
subject to regulation under this Act, in-
cluding such requirements established in
section 501.
‘‘(2) UNAPPROVED USE.—With respect to the
emergency use of a product that is an unapproved
use of an approved product:
‘‘(A) The Secretary may, for manufactur-
ers of the product who choose to carry out one
or more activities for which the authorization is
issued, establish any of the conditions described
in clauses (i) through (iv) of paragraph (1)(A).
‘‘(B)(i) If the authorization under this sec-
tion regarding the emergency use authorizes a
change in the labeling of the product, but the
manufacturer of the product chooses not to
make such change, such authorization may not
authorize distributors of the product or any
other person to alter or obscure the labeling
provided by the manufacturer.
‘‘(ii) In the circumstances described in
clause (i), an authorization under this section
regarding the emergency use may, for persons
who do not manufacture the product and who
choose to act under this clause, authorize such
persons to provide information on the product
in addition to the labeling provided by the man-
ufacturer, subject to compliance with clause (i).
Such additional information shall not be consid-
ered labeling for purposes of section 502.
‘‘(f) DURATION OF AUTHORIZATION.—
‘‘(1) IN GENERAL.—Except as provided in para-
graph (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 EFFEC-
TIVE PERIOD.—Notwithstanding the termination of
the declaration under subsection (b) or a revocation
under subsection (g), an authorization shall continue
to be effective for continued use with respect to pa-
tients to whom it was administered during the pe-
riod described by paragraph (1), to the extent found
necessary by such patients’ attending physicians.
‘‘(g) REVOCATION OF AUTHORIZATION.—
‘‘(1) REVIEW.—The Secretary shall periodically
review the circumstances and the appropriateness of
an authorization under this section.
‘‘(2) REVOCATION.—The Secretary may revoke
an authorization under this section if, in the Sec-
retary’s unreviewable discretion, the criteria under
subsection (c) for issuance of such authorization are
no longer met.
‘‘(h) PUBLICATION.—The Secretary shall promptly
publish in the Federal Register a notice of each authoriza-
tion, and each termination or revocation of an authoriza-
tion, and an explanation of the reasons therefor, under
this section.
‘‘(i) ACTIONS COMMITTED
TO AGENCY DISCRE-
TION.—Actions under the authority of this section by the
Secretary, by the Secretary of Defense, or by the Sec-
retary of Homeland Security are committed to agency dis-
cretion.
‘‘(j) RULES OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to impair or otherwise affect—
‘‘(1) the authority of the President as Com-
mander in Chief of the Armed Forces of the United
States under article II, section 2 of the United
States Constitution;
‘‘(2) the authority of the Secretary of Defense
with respect to the Department of Defense, includ-
ing the armed forces, under other provisions of Fed-
eral law; or
‘‘(3) the authority of the Secretary under sec-
tion 319F–2 to manage the stockpile under such
section.
‘‘(k) 
APPLICATION
TO
MEMBERS
OF
ARMED
FORCES.—
‘‘(1) WAIVER OF REQUIREMENT RELATING TO
OPTION TO REFUSE.—In the case of administration
of a countermeasure to members of the armed
forces, 
a 
requirement, 
under 
subsection
(e)(1)(A)(ii)(III), designed to ensure that individuals
are informed of an option to accept or refuse admin-
istration of a product, may be waived by the Presi-
dent if the President determines, in writing, that
complying with such requirement is not feasible, is
contrary to the best interests of the members af-
fected, or is not in the interests of national security.
‘‘(2) PROVISION OF INFORMATION TO MEMBER
OF THE ARMED FORCES.—If the Secretary makes a
determination that it is not feasible for the informa-
tion required by subsection (e)(1)(A)(ii) to be pro-
vided to a member of the armed forces prior to the
administration of the product, such information shall
be provided to such member of the armed forces (or
next-of-kin in the case of the death of a member) to
whom the product was administered as soon as pos-
sible, but not later than 30 days, after such adminis-
tration. Information concerning the administration
of the product shall be recorded in the medical
record of the member.
‘‘(3) EFFECT ON STATUTE PERTAINING TO IN-
VESTIGATIONAL NEW DRUGS.—In the case of an au-
thorization based on a determination by the Sec-
retary of Defense under subsection (b)(1)(B), sec-
tion 1107 of title 10, United States Code, shall not
apply to use of a product that is the subject of such
authorization, within the scope of such authorization
and while such authorization is effective.
‘‘(l) RELATION TO OTHER PROVISIONS.—If a prod-
uct is the subject of an authorization under this section,
the use of such product within the scope of the authoriza-
tion —
‘‘(1) shall not be subject to any requirements
pursuant to section 505(i) or 520(g); and
‘‘(2) shall not be subject to any requirements
otherwise applicable to clinical investigations pursu-
ant to other provisions of this Act.
‘‘(m) DISCRETION REGARDING USE OF AUTHORIZA-
TION.—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 Sec-
retary that the person will not be carrying out such activ-
ity, except that a manufacturer of a sole-source unap-
proved product authorized for emergency use shall notify
the Secretary within a reasonable period of time after the
issuance by the Secretary of such authorization if such
manufacturer does not intend to carry out an activity or
activities under the authorization. This section does not
have any legal effect on a person who does not carry out
any activity for which an authorization under this section
is issued, or who carries out such an activity pursuant to
other provisions of this Act or section 351 of the Public
Health Service Act.
‘‘(n) ENFORCEMENT.—A person who carries out an
activity pursuant to an authorization under this section,
but who fails to comply with applicable conditions under
subsection (e), is with respect to that act of noncompliance
subject to the provisions of law specified in subsection (a)
and to the enforcement of such provisions under section
301.’’.
SEC. 5. REPORTS REGARDING AUTHORITIES UNDER THIS
ACT.
(a) SECRETARY
OF HEALTH
AND HUMAN SERV-
ICES.—
(1) ANNUAL REPORTS ON PARTICULAR EXER-
CISES OF AUTHORITY.—
(A) RELEVANT
AUTHORITIES.—The Sec-
retary of Health and Human Services (referred
to in this subsection as the ‘‘Secretary’’) shall
submit reports in accordance with subpara-
graph (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) (re-
lating to simplified acquisition proce-
dures).
(II) Subsection (c)(7)(C)(iv) (re-
lating to procedures other than full
and open competition).
(III) Subsection (c)(7)(C)(v) (re-
lating to premium provision in mul-
tiple-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 Sec-
retary 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 counter-
measure with respect to which the author-
ity was used;
(ii) the reasons underlying the deci-
sion to use such authorities, including, as
applicable, the options that were consid-
ered and rejected with respect to the use of
such authorities;
(iii) the identification of each person
or entity that received, or was considered
and rejected for, grants, cooperative agree-
ments, or contracts pursuant to the use of
such authorities; and
(iv) whether, with respect to each pro-
curement that is approved by the President
under section 319F–2(c)(6) of the Public
Health Service Act (as added by section 3
of this Act), a contract was entered into
within one year after such approval by the
President.
(2) ANNUAL SUMMARIES REGARDING CERTAIN
ACTIVITY.—The Secretary shall annually submit to
the designated congressional committees a report
that summarizes the activity undertaken pursuant to
the following authorities under section 319F–1 of
the Public Health Service Act (as added by section
2 of this Act):
(A) Subsection (b)(3) (relating to in-
creased 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 pe-
riod for which the report is submitted, the number
of persons who were paid amounts greater than
$100,000 and the number of persons who were paid
amounts between $50,000 and $100,000.
(b) NATIONAL ACADEMY OF SCIENCES REVIEW.—
(1) IN GENERAL.—Not later than four years
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services shall request
the National Academy of Sciences to enter into an
agreement for a review of the biomedical counter-
measure research and development authorities estab-
lished in this Act to determine whether and to what
extent activities undertaken pursuant to such au-
thorities have enhanced the development of bio-
medical countermeasures affecting national security,
and to recommend any legislative or administrative
changes necessary to improve the ability of the Sec-
retary to carry out these activities in the future. The
Secretary shall ensure that the results of the study
are submitted to the designated congressional com-
mittees not later than five years after such date of
enactment.
(2) CERTAIN
CONTENTS.—The report under
paragraph (1) shall include—
(A) a summary of the most recent analysis
by the Department of Homeland Security and
the intelligence community of the domestic
threat from chemical, biological, radiological,
and nuclear agents;
(B) the Academy’s assessment of the cur-
rent availability of countermeasures to address
such threats;
(C) the Academy’s assessment of the ex-
tent to which programs and activities under this
Act will reduce any gap between the threat and
the availability of countermeasures to an ac-
ceptable level of risk; and
(D)(i) the Academy’s assessment of threats
to national security that are posed by tech-
nology that will enable, during the 10-year pe-
riod 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 address-
ing such threats, including recommendations for
Federal policies regarding research priorities,
the development of countermeasures, and in-
vestments in technology.
(c) GENERAL ACCOUNTING OFFICE REVIEW.—Four
years after the date of the enactment of this Act, the
Comptroller General of the United States shall initiate a
study—
(1)(A) to review the Secretary of Health and
Human Services’ utilization of the authorities grant-
ed under this Act with respect to simplified acquisi-
tion procedures, procedures other than full and open
competition, increased micropurchase thresholds,
personal services contracts, streamlined personnel
authority, and the purchase of security counter-
measures under the special reserve fund; and
(B) to recommend any legislative or administra-
tive changes necessary to improve the utilization or
effectiveness of such authorities in the future;
(2)(A) to review the internal controls instituted
by such Secretary with respect to such authorities,
where required by this Act; and
(B) to recommend any legislative or administra-
tive changes necessary to improve the effectiveness
of such controls; and
(3)(A) to review such Secretary’s utilization of
the authority granted under this Act to authorize an
emergency use of a biomedical countermeasure, in-
cluding the means by which the Secretary deter-
mines whether and under what conditions any such
authorizations should be granted and the benefits
and adverse impacts, if any, resulting from the use
of such authority; and
(B) to recommend any legislative or administra-
tive changes necessary to improve the utilization or
effectiveness of such authority and to enhance pro-
tection of the public health.
The results of the study shall be submitted to the des-
ignated congressional committees not later than five years
after the date of the enactment of this Act.
(d) REPORT REGARDING BARRIERS TO PROCURE-
MENT OF SECURITY COUNTERMEASURES.—
(1) BIOCONTAINMENT
FACILITIES.—Not later
than 120 days after the date of the enactment of
this Act, the Secretary of Homeland Security and
the Secretary of Health and Human Services shall
jointly report to the designated congressional com-
mittees whether there is a lack of adequate large-
scale biocontainment facilities necessary for the test-
ing of security countermeasures in accordance with
Food and Drug Administration requirements.
(2) ADDITIONAL
BARRIERS.—Not later than
one year after the date of enactment of this Act,
such Secretaries shall jointly report to the des-
ignated congressional committees any other potential
barriers to the procurement of security counter-
measures that have not been addressed by this Act.
(e) STATUS
OF PROGRAM
FOR CHEMICAL TER-
RORISM PREPAREDNESS.—Not later than 270 days after
the date of the enactment of this Act, the Secretary of
Homeland Security shall submit to the designated con-
gressional committees a report describing the status of the
program carried out by the Secretary to enhance the pre-
paredness of the United States to respond to terrorist at-
tacks involving chemical agents.
(f) DESIGNATED CONGRESSIONAL COMMITTEES.—
For purposes of this section, the term ‘‘designated con-
gressional committees’’ means the following committees of
the Congress:
(1) In the House of Representatives: the Com-
mittee on Energy and Commerce, the Committee on
Appropriations, the Committee on Government Re-
form, and the Select Committee on Homeland Secu-
rity (or any successor to the Select Committee).
(2) In the Senate: the Committee on Health,
Education, Labor, and Pensions, the Committee on
Appropriations, and the Committee on Government
Affairs.
SEC. 6. OUTREACH.
The Secretary of Health and Human Services shall
develop outreach measures to ensure to the extent prac-
ticable that diverse institutions, including Historically
Black Colleges and Universities and those serving large
proportions of Hispanics, Native Americans, Asian-Pacific
Americans, or other underrepresented populations, are
meaningfully aware of available research and development
grants, contracts, cooperative agreements, and procure-
ments conducted under sections 2 and 3 of this Act.
SEC. 7. RECOMMENDATION FOR EXPORT CONTROLS ON
CERTAIN BIOMEDICAL COUNTERMEASURES.
Upon the award of any grant, contract, or cooperative
agreement under section 2 or 3 of this Act for the re-
search, development, or procurement of a qualified coun-
termeasure 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 coop-
erative agreement is subject to existing export-related con-
trols and, if not, may make a recommendation to the ap-
propriate Federal agency or agencies that such counter-
measure should be included on the list of controlled items
subject to such controls.
SEC. 8. ENSURING COORDINATION, COOPERATION AND
THE ELIMINATION OF UNNECESSARY DUPLI-
CATION IN PROGRAMS DESIGNED TO PRO-
TECT 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 dupli-
cate programs to identify potential domestic threats from
biological, chemical, radiological or nuclear agents, detect
domestic incidents involving such agents, analyze such in-
cidents, and develop necessary countermeasures. The
aforementioned Secretaries shall further ensure that infor-
mation and technology possessed by the Departments rel-
evant to these activities are shared with the other Depart-
ments.
(b) DESIGNATION OF AGENCY COORDINATION OFFI-
CER.—The Secretary of Health and Human Services, the
Secretary of Homeland Security, and the Secretary of De-
fense shall each designate an officer or employee of their
respective Departments who shall coordinate, through reg-
ular meetings and communications, with the other afore-
mentioned Departments such programs and activities car-
ried out by their Departments.
Passed the House of Representatives July 16, 2003.
Attest:
Clerk.