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‘‘(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.—
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‘‘(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-
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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
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‘‘(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
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(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
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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);
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‘‘(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.—
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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
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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-
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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
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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
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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-
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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):
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‘‘(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
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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
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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-
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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
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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’
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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
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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
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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
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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
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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.’’.
HR 2122 PCS 
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
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‘‘(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).