111
(II) Subsection (b)(2) (relating to 
use of noncompetitive procedures). 
(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 use of noncompetitive proce-
dures). 
(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).
112
(III) Subsection (e) (relating to 
conditions on authorization). 
(B) CONTENTS
OF
REPORTS.—The Sec-
retary shall annually submit to the Congress a 
report that summarizes—
(i) the particular actions that were 
taken under the authorities specified in sub-
paragraph (A), including, as applicable, the 
identification of the threat agent, emer-
gency, or the biomedical countermeasure 
with respect to which the authority was 
used; 
(ii) the reasons underlying the decision 
to use such authorities, including, as appli-
cable, the options that were considered and 
rejected with respect to the use of such au-
thorities; and 
(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. 
(2) ANNUAL
SUMMARIES
REGARDING
CERTAIN 
ACTIVITY.—The Secretary shall annually submit to 
the Congress a report that summarizes the activity
113
undertaken pursuant to the following authorities 
under section 319F–1 of the Public Health Service 
Act (as added by section 2 of this Act): 
(A) Subsection (b)(3) (relating to increased 
micropurchase threshold). 
(B) Subsection (d) (relating to authority for 
personal services contracts). 
(C) Subsection (e) (relating to streamlined 
personnel authority). 
With respect to subparagraph (B), the report shall in-
clude a provision specifying, for the one-year period 
for which the report is submitted, the number of per-
sons 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.—Not 
later than three years after the date of the enactment of 
this Act, the Secretary of Health and Human Services shall 
request the National Academy of Sciences to enter into an 
agreement for a review of the biomedical countermeasure 
research and development authorities established in this Act 
to determine whether and to what extent activities under-
taken pursuant to such authorities have enhanced the devel-
opment of biomedical countermeasures affecting national se-
curity, and to recommend any legislative or administrative
114
changes necessary to improve the ability of the Secretary 
to carry out these activities in the future. The Secretary 
shall ensure that the results of the study are submitted to 
the Congress not later than five years after such date of 
enactment.
(c) GENERAL ACCOUNTING OFFICE REVIEW.—Four 
years after the date of the enactment of this Act, the Comp-
troller 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, use of noncompetitive procedures, in-
creased micropurchase thresholds, personal services 
contracts, streamlined personnel authority, and the 
purchase of security countermeasures under the spe-
cial 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
115
(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 determines 
whether and under what conditions any such author-
izations should be granted and the benefits and ad-
verse 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 protec-
tion of the public health. 
The results of the study shall be submitted to the Congress 
not later than five years after the date of the enactment 
of this Act.
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Project Bio-
Shield 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:
116
‘‘SEC. 319F–1. AUTHORITY FOR USE OF CERTAIN PROCE-
DURES REGARDING BIOMEDICAL COUNTER-
MEASURE RESEARCH AND DEVELOPMENT 
ACTIVITIES. 
‘‘(a) IN GENERAL.—
‘‘(1) AUTHORITY.—In conducting and 
supporting research and development ac-
tivities regarding biomedical counter-
measures under section 319F(h), the Sec-
retary may conduct and support such ac-
tivities in accordance with this section if 
the activities concern qualified counter-
measures. 
‘‘(2) QUALIFIED COUNTERMEASURE.—For 
purposes of this section, the term ‘quali-
fied countermeasure’ means a priority 
countermeasure (as defined in section 
319F(h)) that affects national security. 
‘‘(3) INTERAGENCY COOPERATION.—
‘‘(A) IN GENERAL.—In carrying out 
activities under this section, the Sec-
retary is authorized, subject to sub-
paragraph (B), to enter into inter-
agency agreements and other collabo-
rative undertakings with other agen-
cies of the United States Government.
117
‘‘(B) LIMITATION.—An agreement 
or undertaking under this paragraph 
shall not authorize another agency to 
exercise the authorities provided by 
this section. 
‘‘(4) AVAILABILITY OF FACILITIES TO THE 
SECRETARY.—In any grant or cooperative 
agreement entered into under the author-
ity provided in this section with respect 
to a biocontainment laboratory or other 
related or ancillary specialized research 
facility that the Secretary determines 
necessary for the purpose of performing, 
administering, and supporting qualified 
countermeasure research and develop-
ment, the Secretary may provide that the 
facility that is the object of such grant or 
cooperative agreement shall be available 
as needed to the Secretary to respond to 
public health emergencies affecting na-
tional security. 
‘‘(b) EXPEDITED
PROCUREMENT
AUTHOR-
ITY.—
118
‘‘(1) INCREASED SIMPLIFIED ACQUISITION 
THRESHOLD
FOR
BIOMEDICAL
COUNTER-
MEASURE PROCUREMENTS.—
‘‘(A) IN
GENERAL.—For any pro-
curement by the Secretary of prop-
erty or services for use (as deter-
mined by the Secretary) in per-
forming, administering, or supporting 
qualified countermeasure research or 
development activities under this sec-
tion that the Secretary determines 
necessary to respond to pressing re-
search 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 Prop-
erty and Administrative Services Act 
of 1949 (41 U.S.C. 252a(a)), shall be 
deemed to be $25,000,000 in the ad-
ministration, with respect to such 
procurement, of—
‘‘(i) section 303(g)(1)(A) of the 
Federal Property and Administra-
119
tive Services Act of 1949 (41 
U.S.C. 253(g)(1)(A)) and its imple-
menting regulations; and
‘‘(ii) section 302A(b) of such 
Act (41 U.S.C. 252a(b)) and its im-
plementing regulations. 
‘‘(B) APPLICATION OF CERTAIN PRO-
VISIONS.—Notwithstanding 
subpara-
graph (A) and the provision of law 
and regulations referred to in such 
subparagraph, each of the following 
provisions shall apply to procure-
ments described in this paragraph to 
the same extent that such provisions 
would apply to such procurements in 
the absence of subparagraph (A): 
‘‘(i) Chapter 37 of title 40, 
United States Code (relating to 
contract work hours and safety 
standards). 
‘‘(ii) Subsections (a) and (b) of 
Section 7 of the Anti-Kickback Act 
of 1986 (41 U.S.C. 57(a) and (b)). 
‘‘(iii) Section 304C of the Fed-
eral Property and Administrative
120
Services Act of 1949 (41 U.S.C. 
254d) (relating to the examination 
of contractor records). 
‘‘(C) INTERNAL CONTROLS TO BE IN-
STITUTED.—The Secretary shall insti-
tute appropriate internal controls for 
procurements that are under this 
paragraph, 
including 
requirements 
with regard to documenting the jus-
tification for use of the authority in 
this paragraph. 
‘‘(2) USE
OF
NONCOMPETITIVE
PROCE-
DURES.—In addition to any other author-
ity to use procedures other than competi-
tive procedures, the Secretary may use 
such other procedures when—
‘‘(A) the procurement is as de-
scribed by paragraph (1); and 
‘‘(B) 
the 
property 
or 
services 
needed by the Secretary are available 
from only one responsible source or 
only from a limited number of re-
sponsible sources, and no other type 
of property or services will satisfy the 
Secretary’s needs.
121
‘‘(3) 
INCREASED
MICROPURCHASE 
THRESHOLD.—
‘‘(A) IN GENERAL.—For a procure-
ment described by paragraph (1), the 
amount specified in subsections (c), 
(d), and (f) of section 32 of the Office 
of Federal Procurement Policy Act 
(41 U.S.C. 428) shall be deemed to be 
$15,000 in the administration of that 
section with respect to such procure-
ment. 
‘‘(B) INTERNAL CONTROLS TO BE IN-
STITUTED.—The Secretary shall insti-
tute appropriate internal controls for 
purchases that are under this para-
graph and that are greater than 
$2,500. 
‘‘(C) EXCEPTION
TO
PREFERENCE 
FOR
PURCHASE
CARD
MECHANISM.—No 
provision of law establishing a pref-
erence for using a Government pur-
chase card method for purchases 
shall apply to purchases that are 
under this paragraph and that are 
greater than $2,500.
122
‘‘(c) AUTHORITY
TO
EXPEDITE
PEER
RE-
VIEW.—
‘‘(1) IN GENERAL.—The Secretary may, 
as the Secretary determines necessary to 
respond to pressing qualified counter-
measure research and development needs 
under this section, employ such expe-
dited peer review procedures (including 
consultation with appropriate scientific 
experts) as the Secretary, in consultation 
with the Director of NIH, deems appro-
priate to obtain assessment of scientific 
and technical merit and likely contribu-
tion to the field of qualified counter-
measure research, in place of the peer re-
view and advisory council review proce-
dures that would be required under sec-
tions 
301(a)(3), 
405(b)(1)(B), 
405(b)(2), 
406(a)(3)(A), 492, and 494, as applicable to 
a grant, contract, or cooperative agree-
ment—
‘‘(A) that is for performing, ad-
ministering, or supporting qualified 
countermeasure research and devel-
opment activities; and
123
‘‘(B) the amount of which is not 
greater than $1,500,000. 
‘‘(2) 
SUBSEQUENT
PHASES
OF
RE-
SEARCH.—The Secretary’s determination 
of whether to employ expedited peer re-
view with respect to subsequent phases 
of a research grant or cooperative agree-
ment under this section shall be deter-
mined without regard to the peer review 
procedures used for any prior peer re-
view of that same grant or cooperative 
agreement. 
‘‘(d) AUTHORITY
FOR PERSONAL SERVICES 
CONTRACTS.—
‘‘(1) IN GENERAL.—For the purpose of 
performing, 
administering, 
and 
sup-
porting 
qualified 
countermeasure 
re-
search and development activities, the 
Secretary may, as the Secretary deter-
mines necessary to respond to pressing 
qualified countermeasure research and 
development needs under this section, 
obtain by contract (in accordance with 
section 3109 of title 5, United States Code, 
but without regard to the limitations in
124
such section on the period of service and 
on pay) the personal services of experts
or consultants who have scientific or 
other professional qualifications, except 
that in no case shall the compensation 
provided to any such expert or consult-
ant exceed the daily equivalent of the an-
nual rate of compensation for the Presi-
dent. 
‘‘(2) FEDERAL
TORT
CLAIMS
ACT
COV-
ERAGE.—
‘‘(A) IN
GENERAL.—A person car-
rying out a contract under paragraph 
(1), and an officer, employee, or gov-
erning 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 dam-
ages for personal injury, including 
death, resulting from performance of 
functions under such contract. 
‘‘(B) EXCLUSIVITY OF REMEDY.—The 
remedy provided by subparagraph
125
(A) shall be exclusive of any other 
civil action or proceeding by reason 
of the same subject matter against 
the person, officer, employee, or gov-
erning board member. 
‘‘(3) INTERNAL CONTROLS TO BE INSTI-
TUTED.—
‘‘(A) IN
GENERAL.—The Secretary 
shall institute appropriate internal 
controls for contracts under this sub-
section, including procedures for the 
Secretary to make a determination of 
whether a person, or an officer, em-
ployee, or governing board member 
of a person, is deemed to be an em-
ployee of the Department of Health 
and Human Services pursuant to 
paragraph (2). 
‘‘(B) DETERMINATION OF EMPLOYEE 
STATUS TO BE FINAL.—A determination 
by the Secretary under subparagraph 
(A) that a person, or an officer, em-
ployee, or governing board member 
of a person, is or is not deemed to be 
an employee of the Department of
126
Health and Human Services shall be 
final and binding on the Secretary 
and the Attorney General and other 
parties to any civil action or pro-
ceeding. 
‘‘(4) NUMBER
OF
PERSONAL
SERVICES 
CONTRACTS
LIMITED.—The number of ex-
perts and consultants whose personal 
services are obtained under paragraph 
(1) shall not exceed 30 at any time. 
‘‘(e) STREAMLINED PERSONNEL AUTHORITY.—
‘‘(1) IN GENERAL.—In addition to any 
other personnel authorities, the Sec-
retary may, as the Secretary determines 
necessary to respond to pressing quali-
fied countermeasure research and devel-
opment needs under this section, without 
regard to such provisions of title 5, 
United States Code, governing appoint-
ments in the competitive service, and 
without regard to the provisions of chap-
ter 51 and subchapter III of chapter 53 of 
such title relating to classification and 
General Schedule pay rates, appoint pro-
fessional and technical employees, not to
127
exceed 30 such employees at any time, to 
positions in the National Institutes of 
Health to perform, administer, or support 
qualified countermeasure research and 
development activities in carrying out 
this section. 
‘‘(2) INTERNAL CONTROLS TO BE INSTI-
TUTED.—The Secretary shall institute ap-
propriate internal controls for appoint-
ments under this subsection. 
‘‘(f) ACTIONS COMMITTED
TO AGENCY DIS-
CRETION.—Actions by the Secretary under the 
authority of this section are committed to 
agency discretion.’’. 
(b) TECHNICAL AMENDMENT.—Section 481A 
of the Public Health Service Act (42 U.S.C. 
287a–2) is amended—
(1) in subsection (a)(1), by inserting 
‘‘or the Director of the National Institute 
of Allergy and Infectious Diseases’’ after 
‘‘Director of the Center’’; 
(2) in subsection (c)—
(A) in paragraph (1), by inserting 
‘‘or the Director of the National Insti-
tute of Allergy and Infectious Dis-
128
eases’’ after ‘‘Director of the Center’’; 
and 
(B) in paragraph (2), in the matter 
preceding subparagraph (A), by strik-
ing ‘‘subsection (i)’’ and inserting 
‘‘subsection (i)(1)’’; 
(3) in subsection (d), by inserting ‘‘or 
the Director of the National Institute of 
Allergy and Infectious Diseases’’ after 
‘‘Director of the Center’’; 
(4) in subsection (e)—
(A) in paragraph (1)—
(i) in the matter preceding 
subparagraph (A), by inserting 
‘‘or the Director of the National 
Institute of Allergy and Infectious 
Diseases’’ after ‘‘Director of the 
Center’’; 
(ii) in subparagraph (A), by 
inserting ‘‘(or, in the case of the 
Institute, 75 percent)’’ after ‘‘50 
percent’’; and 
(iii) in subparagraph (B), by 
inserting ‘‘(or, in the case of the
129
Institute, 75 percent)’’ after ‘‘40 
percent’’;
(B) in paragraph (2), by inserting 
‘‘or the Director of the National Insti-
tute of Allergy and Infectious Dis-
eases’’ 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 In-
fectious Diseases’’ after ‘‘Director’’; 
(5) in subsection (f)—
(A) in paragraph (1), by inserting 
‘‘in the case of an award by the Direc-
tor of the Center,’’ before ‘‘the appli-
cant’’; and 
(B) in paragraph (2), by inserting 
‘‘of the Center or the Director of the 
National Institute of Allergy and In-
fectious Diseases’’ after ‘‘Director’’; 
and 
(6) in subsection (i)—
(A) 
by 
striking 
‘‘APPROPRIA-
TIONS.—For the purpose of carrying
130
out this section,’’ and inserting the 
following: ‘‘APPROPRIATIONS.—
‘‘(1) CENTER.—For the purpose of car-
rying out this section with respect to the 
Center,’’; and 
(B) by adding at the end the fol-
lowing: 
‘‘(2) NATIONAL
INSTITUTE
OF
ALLERGY 
AND
INFECTIOUS
DISEASES.—For the pur-
pose of carrying out this section with re-
spect to the National Institute of Allergy 
and Infectious Diseases, there are author-
ized to be appropriated such sums as may 
be necessary for fiscal year 2003.’’. 
SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT. 
(a) IN GENERAL.—Part B of title III of the 
Public Health Service Act, as amended by sec-
tion 2 of this Act, is amended by inserting 
after section 319F–1 the following section: 
‘‘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 ‘Homeland Security Sec-
retary’), in coordination with the Sec-
131
retary and the Secretary of Veterans Af-
fairs, shall maintain a stockpile or stock-
piles of drugs, vaccines and other biologi-
cal products, medical devices, and other 
supplies in such numbers, types, and 
amounts as are determined by the Sec-
retary to be appropriate and practicable, 
taking 
into 
account 
other 
available 
sources, to provide for the emergency 
health security of the United States, in-
cluding the emergency health security of 
children and other vulnerable popu-
lations, in the event of a bioterrorist at-
tack or other public health emergency. 
‘‘(2) PROCEDURES.—The Secretary, in 
managing the stockpile under paragraph 
(1), shall—
‘‘(A) consult with the working 
group under section 319F(a); 
‘‘(B) ensure that adequate proce-
dures are followed with respect to 
such stockpile for inventory manage-
ment and accounting, and for the 
physical security of the stockpile;
132
‘‘(C) in consultation with Federal, 
State, and local officials, take into 
consideration the timing and location 
of special events; 
‘‘(D) review and revise, as appro-
priate, the contents of the stockpile 
on a regular basis to ensure that 
emerging 
threats, 
advanced 
tech-
nologies, and new countermeasures 
are adequately considered; 
‘‘(E) devise plans for the effective 
and timely supply-chain management 
of the stockpile, in consultation with 
appropriate Federal, State and local 
agencies, and the public and private 
health care infrastructure; 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 ac-
tivities as may reasonably be required in 
order to ensure that the stockpile under 
subsection (a) includes an amount of vac-
133
cine against smallpox as determined by 
such Secretary to be sufficient to meet 
the health security needs of the United 
States. 
‘‘(2) RULE OF CONSTRUCTION.—Nothing 
in this section shall be construed to limit 
the private distribution, purchase, or sale 
of vaccines from sources other than the 
stockpile described in subsection (a). 
‘‘(c) ADDITIONAL
AUTHORITY
REGARDING 
PROCUREMENT OF CERTAIN BIOMEDICAL COUN-
TERMEASURES; AVAILABILITY
OF
SPECIAL
RE-
SERVE FUND.—
‘‘(1) IN GENERAL.—
‘‘(A) USE
OF
FUND.—A security 
countermeasure may, in accordance 
with this subsection, be procured 
with amounts in the special reserve 
fund under paragraph (10). 
‘‘(B) SECURITY COUNTERMEASURE.—
For purposes of this subsection, the 
term 
‘security 
countermeasure’ 
means a priority countermeasure (as 
defined in section 319F(h))—
134
‘‘(i) against a chemical, bio-
logical, radiological, or nuclear
agent identified as a material 
threat under paragraph (2)(A)(ii); 
‘‘(ii) that is determined under 
paragraph (2)(B)(ii) to be a nec-
essary countermeasure; 
‘‘(iii) that is designed, devel-
oped, modified, or procured for 
the 
specific 
purpose 
of 
pre-
venting, 
detecting, 
identifying, 
deterring, or mitigating actual or 
potential acts of chemical, biologi-
cal, radiological, or nuclear catas-
trophe; 
‘‘(iv)(I) that 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 counter-
measure to a chemical, biological, 
radiological, 
or 
nuclear 
agent 
identified as a material threat 
under paragraph (2)(A)(ii); or
135
‘‘(II) for which the Secretary 
determines that sufficient and 
satisfactory clinical experience or 
research data (including data, if 
available, from pre-clinical and 
clinical trials) support a reason-
able conclusion that the counter-
measure will qualify for approval 
or licensing after the date of a de-
termination under paragraph (5); 
and 
‘‘(v) that relates to an actual 
or potential act of terrorism or 
catastrophic event or to actual or 
potential warfare. 
‘‘(2) 
DETERMINATION
OF
MATERIAL 
THREATS.—
‘‘(A) 
MATERIAL
THREAT.—The 
Homeland Security Secretary, in con-
sultation with the heads of other 
agencies as appropriate, shall on an 
ongoing basis—
‘‘(i) assess current and emerg-
ing threats of chemical, biologi-
136
cal, 
radiological, 
and 
nuclear 
agents; and 
‘‘(ii) determine which of such 
agents present a material threat 
against the United States popu-
lation. 
‘‘(B) PUBLIC
HEALTH
IMPACT; NEC-
ESSARY
COUNTERMEASURES.—The Sec-
retary shall on an ongoing basis—
‘‘(i) assess the potential public 
health 
consequences 
of 
use 
against the United States popu-
lation 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 pub-
lic health from a material threat. 
‘‘(C) NOTICE
TO
CONGRESS.—The 
Secretary and the Homeland Security 
Secretary shall promptly notify the 
designated congressional committees 
(as defined in paragraph (10)) of any 
determination made pursuant to sub-
137
paragraph (A) or (B). Such notice 
shall be in unclassified and, if nec-
essary, classified form. 
‘‘(D) ASSURING
ACCESS
TO
THREAT 
INFORMATION.—In making the assess-
ment 
and 
determination 
required 
under subparagraph (A), the Home-
land Security Secretary shall use all 
information to which such Secretary 
is entitled under section 202 of the 
Homeland Security Act of 2002, in-
cluding but not limited to informa-
tion, regardless of its level of classi-
fication, 
relating 
to 
current 
and 
emerging threats of chemical, biologi-
cal, radiological, and nuclear agents. 
‘‘(3) ASSESSMENT OF AVAILABILITY AND 
APPROPRIATENESS OF COUNTERMEASURES.—
The Secretary, in consultation with the 
Homeland Security Secretary, shall as-
sess on an ongoing basis the availability 
and appropriateness of specific counter-
measures to address specific threats iden-
tified under paragraph (2).
138
‘‘(4) CALL FOR DEVELOPMENT OF COUN-
TERMEASURES; 
COMMITMENT
FOR
REC-
OMMENDATION FOR PROCUREMENT.—
‘‘(A) 
PROPOSAL
TO
THE
PRESI-
DENT.—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 currently unavailable for pro-
curement or available under unsuit-
able conditions, such Secretaries may 
jointly submit to the President a pro-
posal to—
‘‘(i) issue a call for the devel-
opment of such countermeasure; 
and 
‘‘(ii) make a commitment that, 
upon the first development of 
such countermeasure that meets 
the conditions for procurement 
under paragraph (5), the Secre-
taries will, based in part on infor-
mation obtained pursuant to such 
call, 
make 
a 
recommendation
139
under paragraph (6) that the spe-
cial reserve fund under para-
graph (10) be made available for
the procurement of such counter-
measure. 
‘‘(B) COUNTERMEASURE
SPECIFICA-
TIONS.—The Homeland Security Sec-
retary and the Secretary shall, to the 
extent practicable, include in the pro-
posal under subparagraph (A)—
‘‘(i) estimated quantity of pur-
chase (in the form of number of 
doses 
or 
number 
of 
effective 
courses of treatments regardless 
of dosage form); 
‘‘(ii) necessary measures of 
minimum safety and effective-
ness; 
‘‘(iii) estimated price for each 
dose or effective course of treat-
ment regardless of dosage form; 
and 
‘‘(iv) other information that 
may be necessary to encourage 
and facilitate research, develop-
140
ment, and manufacture of the 
countermeasure 
or 
to 
provide 
specifications for the counter-
measure. 
‘‘(C) PRESIDENTIAL
APPROVAL.—If 
the President approves a proposal 
under subparagraph (A), the Home-
land Security Secretary and the Sec-
retary shall make known to persons 
who may respond to a call for the 
countermeasure involved—
‘‘(i) the call for the counter-
measure; 
‘‘(ii) 
specifications 
for 
the 
countermeasure under subpara-
graph (B); and 
‘‘(iii) a commitment described 
in subparagraph (A)(ii). 
‘‘(5) SECRETARY’S
DETERMINATION
OF 
COUNTERMEASURES APPROPRIATE FOR FUND-
ING FROM SPECIAL RESERVE FUND.—
‘‘(A) IN
GENERAL.—The Secretary, 
in accordance with the provisions of 
this paragraph, shall identify specific 
security countermeasures that the
141
Secretary determines, in consultation 
with the Homeland Security Sec-
retary, to be appropriate for inclu-
sion in the stockpile under subsection 
(a) pursuant to procurements made 
with amounts in the special reserve 
fund under paragraph (10) (referred 
to in this subsection individually as a 
‘procurement under this subsection’). 
‘‘(B) REQUIREMENTS.—In making a 
determination under subparagraph 
(A) with respect to a security counter-
measure, the Secretary shall deter-
mine 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 produc-
tion and delivery within five 
years of sufficient quantities of 
the product. 
‘‘(iii) Whether there is a lack 
of a significant commercial mar-
ket for the product at the time of
142
procurement, other than as a se-
curity countermeasure. 
‘‘(6) RECOMMENDATION FOR PRESIDENT’S 
APPROVAL.—
‘‘(A) RECOMMENDATION
FOR
PRO-
CUREMENT.—In the case of a security 
countermeasure that the Secretary 
has, in accordance with paragraphs 
(2), (3), and (5), determined to be ap-
propriate for procurement under this 
subsection, the Homeland Security 
Secretary and the Secretary shall 
jointly submit to the President, in co-
ordination with the Director of the 
Office of Management and Budget, a 
recommendation that the special re-
serve fund under paragraph (10) be 
made available for the procurement 
of such countermeasure. 
‘‘(B) PRESIDENTIAL APPROVAL.—The 
special reserve fund under paragraph 
(10) is available for a procurement of 
a security countermeasure only if the 
President 
has 
approved 
a 
rec-
143
ommendation 
under 
subparagraph 
(A) regarding the countermeasure. 
‘‘(C) NOTICE
TO
CONGRESS.—The 
Secretary and the Homeland Security 
Secretary shall notify the designated 
congressional committees of each de-
cision of the President to approve a 
recommendation under subparagraph 
(A). Such notice shall include an ex-
planation of the decision to make 
available the special reserve fund 
under paragraph (10) for procure-
ment of such a countermeasure, in-
cluding, where available, the identi-
fication of the potential supplier or 
suppliers of such countermeasure, 
and whether other potential sup-
pliers of the same or similar counter-
measures were considered and re-
jected for procurement under this 
section and the reasons therefor. 
‘‘(D) SUBSEQUENT
SPECIFIC
COUN-
TERMEASURES.—Procurement 
under 
this subsection of a security counter-
measure for a particular purpose
144
does not preclude the subsequent 
procurement under this subsection of
any other security countermeasure 
for such purpose if the Secretary has 
determined under paragraph (5)(A) 
that such countermeasure is appro-
priate for inclusion in the stockpile 
and if, as determined by the Sec-
retary, such countermeasure provides 
improved safety or effectiveness, or 
for other reasons enhances prepared-
ness to respond to threats of use of a 
biological, chemical, radiological, or 
nuclear agent. Such a determination 
by the Secretary is committed to 
agency discretion. 
‘‘(E) RULE OF CONSTRUCTION.—Rec-
ommendations and approvals under 
this paragraph apply solely to deter-
minations that the special reserve 
fund under paragraph (10) will be 
made available for a procurement of 
a security countermeasure, and not to 
the substance of contracts for such
145
procurement or other matters relat-
ing to awards of such contracts. 
‘‘(7) PROCUREMENT.—
‘‘(A) IN GENERAL.—For purposes of 
a procurement under this subsection 
that is approved by the President 
under paragraph (6), the Homeland 
Security Secretary and the Secretary 
shall have responsibilities in accord-
ance with subparagraphs (B) and (C). 
‘‘(B) INTERAGENCY AGREEMENTS.—
‘‘(i) FOR
PROCUREMENT.—The 
Homeland 
Security 
Secretary 
shall enter into an agreement 
with the Secretary for procure-
ment 
of 
a 
security 
counter-
measure in accordance with the 
provisions of this paragraph. The 
special reserve fund under para-
graph (10) shall be available for 
the Secretary’s costs of such pro-
curement, other than as provided 
in clause (ii). 
‘‘(ii) 
FOR
ADMINISTRATIVE 
COSTS.—The 
agreement 
entered
146
into between the Homeland Secu-
rity Secretary and the Secretary 
for managing the stockpile under 
subsection (a) shall provide for 
reimbursement of the Secretary’s 
administrative costs relating to 
procurements 
under 
this 
sub-
section. 
‘‘(C) PROCUREMENT.—
‘‘(i) 
IN
GENERAL.—The 
Sec-
retary shall be responsible for—
‘‘(I) arranging for procure-
ment of a security counter-
measure, 
including 
negoti-
ating terms (including quan-
tity, production schedule, and 
price) of, and entering into, 
contracts 
and 
cooperative 
agreements, and for carrying 
out such other activities as 
may reasonably be required, 
in accordance with the provi-
sions of this subparagraph; 
and
147
‘‘(II) promulgating regula-
tions to implement clauses (v), 
(vi), and (vii), and any other 
provisions of this subsection. 
‘‘(ii) CONTRACT TERMS.—A con-
tract for procurements under this 
subsection shall (or, as specified 
below, may) include the following 
terms: 
‘‘(I) PAYMENT CONDITIONED 
ON
SUBSTANTIAL
DELIVERY.—
The contract shall provide 
that no payment may be made 
until delivery has been made 
of a substantial portion (as 
determined 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 Sec-
retary determines (in the Sec-
retary’s discretion) that an 
advance payment is necessary 
to ensure success of a project,
148
the Secretary may pay an 
amount, not to exceed 10 per-
cent of the contract amount, 
in advance of delivery. The
contract shall provide that 
such advance payment is re-
quired to be repaid if there is 
a failure to perform under the 
contract, except in special cir-
cumstances as determined by 
the Secretary on a contract by 
contract basis. 
‘‘(II) 
CONTRACT
DURA-
TION.—The contract shall be 
for a period not to exceed five 
years, except that, in first 
awarding the contract, the 
Secretary may provide for a 
longer duration, not exceed-
ing eight years, if the Sec-
retary determines that com-
plexities or other difficulties 
in 
performance 
under 
the 
contract justify such a period. 
The contract shall be renew-
149
able for additional periods, 
none of which shall exceed 
five years. 
‘‘(III) 
STORAGE
BY
VEN-
DOR.—The contract may pro-
vide that the vendor will pro-
vide storage for stocks of a 
product delivered to the own-
ership of the Federal Govern-
ment 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 avail-
able for costs of shipping, 
handling, storage, and related 
costs for such product. 
‘‘(IV) NON-STOCKPILE SALES 
OF
SECURITY
COUNTER-
MEASURES.—The contract may 
provide that the vendor will 
not at any time (including 
after performance under the
150
contract is otherwise com-
pleted) sell or otherwise pro-
vide such countermeasure to 
any domestic or foreign per-
son, or transfer to any such 
person any quantity of such 
security countermeasure, or 
any intellectual property re-
lating thereto that would en-
able the development or pro-
duction 
of 
the 
counter-
measure, without certification 
by the Secretary, in consulta-
tion with the Homeland Secu-
rity Secretary, the Secretary 
of Defense, and the Secretary 
of State, that such sale or 
transfer, or category of sales 
or transfers, would not ad-
versely affect the national se-
curity; and that, for each vio-
lation of this provision of the 
contract, the United States is 
entitled to recover from the 
person as liquidated damages
151
an amount equal to three 
times the sum of the pay-
ments made to the vendor 
under the contract. 
‘‘(iii) 
AVAILABILITY
OF
SIM-
PLIFIED
ACQUISITION
PROCE-
DURES.—
‘‘(I) 
IN
GENERAL.—The 
amount of any procurement 
under this subsection shall be 
deemed 
to 
be 
below 
the 
threshold amount specified in 
section 4(11) of the Office of 
Federal Procurement Policy 
Act (41 U.S.C. 403(11)), for 
purposes 
of 
application 
to 
such procurement, pursuant 
to section 302A(a) of the Fed-
eral Property and Administra-
tive Services Act of 1949 (41 
U.S.C. 252a(a)), of—
‘‘(aa) 
section 
303(g)(1)(A) of the Federal 
Property and Administra-
tive Services Act of 1949
152
(41 U.S.C. 253(g)(1)(A)) and 
its implementing regula-
tions; and 
‘‘(bb) section 302A(b) 
of such Act (41 U.S.C. 
252a(b)) 
and 
its 
imple-
menting regulations. 
‘‘(II) APPLICATION
OF
CER-
TAIN
PROVISIONS.—Notwith-
standing subclause (I) and the 
provision of law and regula-
tions 
referred 
to 
in 
such 
clause, each of the following 
provisions shall apply to pro-
curements described in this 
clause to the same extent that 
such provisions would apply 
to such procurements in the 
absence of subclause (I): 
‘‘(aa) Chapter 37 of 
title 
40, 
United 
States 
Code (relating to contract 
work hours and safety 
standards).
153
‘‘(bb) Subsections (a) 
and (b) of Section 7 of the
Anti-Kickback Act of 1986 
(41 U.S.C. 57(a) and (b)). 
‘‘(cc) Section 304C of 
the Federal Property and 
Administrative 
Services 
Act of 1949 (41 U.S.C. 
254d) (relating to the ex-
amination of contractor 
records). 
‘‘(iv) USE
OF
NONCOMPETITIVE 
PROCEDURES.—In addition to any 
other authority to use procedures 
other 
than 
competitive 
proce-
dures, the Secretary may use such 
other procedures for a procure-
ment under this subsection if the 
product is available from only one 
responsible source or only from a 
limited number of responsible 
sources, and no other type of 
product 
will 
satisfy 
the 
Sec-
retary’s needs.
154
‘‘(v) 
PREMIUM
PROVISION
IN 
MULTIPLE AWARD CONTRACTS.—
‘‘(I) IN GENERAL.—If, under 
this subsection, the Secretary 
enters 
into 
contracts 
with 
more than one vendor to pro-
cure 
a 
security 
counter-
measure, such Secretary may, 
notwithstanding 
any 
other 
provision of law, include in 
each of such contracts a pro-
vision that—
‘‘(aa) identifies an in-
crement of the total quan-
tity of security counter-
measure required, wheth-
er by percentage or by 
numbers of units; and 
‘‘(bb) promises to pays 
one or more specified pre-
miums based on the pri-
ority of such vendors’ pro-
duction and delivery of 
the increment identified 
under item (aa), in accord-
155
ance with the terms and 
conditions of the contract. 
‘‘(II) 
DETERMINATION
OF 
GOVERNMENT’S
REQUIREMENT 
NOT
REVIEWABLE.—If the Sec-
retary includes in each of a 
set of contracts a provision as 
described 
in 
subclause 
(I), 
such Secretary’s determina-
tion of the total quantity of 
security countermeasure re-
quired, and any amendment 
of such determination, is com-
mitted to agency discretion. 
‘‘(vi) EXTENSION
OF
CLOSING 
DATE
FOR
RECEIPT
OF
PROPOSALS 
NOT
REVIEWABLE.—A decision by 
the Secretary to extend the clos-
ing date for receipt of proposals 
for a procurement under this sub-
section is committed to agency 
discretion. 
‘‘(vii) LIMITING COMPETITION TO 
SOURCES
RESPONDING
TO
REQUEST 
FOR
INFORMATION.—In conducting
156
a procurement under this sub-
section, the Secretary may ex-
clude a source that has not re-
sponded to a request for informa-
tion under section 303A(a)(1)(B) 
of the Federal Property and Ad-
ministrative Services Act of 1949 
(41 U.S.C. 253a(a)(1)(B)) if such re-
quest has given notice that the 
Secretary may so exclude such a 
source. 
‘‘(8) INTERAGENCY COOPERATION.—
‘‘(A) IN GENERAL.—In carrying out 
activities 
under 
this 
section, 
the 
Homeland Security Secretary and the 
Secretary are authorized, subject to 
subparagraph (B), to enter into inter-
agency agreements and other collabo-
rative undertakings with other agen-
cies of the United States Government. 
‘‘(B) LIMITATION.—An agreement 
or undertaking under this paragraph 
shall not authorize another agency to 
exercise the authorities provided by
157
this section to the Homeland Security 
Secretary or to the Secretary. 
‘‘(9) RESTRICTIONS ON USE OF FUNDS.—
Amounts in the special reserve fund 
under paragraph (10) shall not be used to 
pay—
‘‘(A) costs for the purchase of vac-
cines under procurement contracts 
entered into before the date of the en-
actment of the Project BioShield Act 
of 2003; or 
‘‘(B) administrative costs. 
‘‘(10) DEFINITIONS.—
‘‘(A) SPECIAL
RESERVE
FUND.—For 
purposes of this subsection, the term 
‘special reserve fund’ has the mean-
ing given such term in section 510 of 
the Homeland Security Act of 2002. 
‘‘(B) DESIGNATED
CONGRESSIONAL 
COMMITTEES.—For purposes of this 
section, the term ‘designated congres-
sional committees’ means the fol-
lowing committees of the Congress: 
‘‘(i) In the House of Represent-
atives: the Committee on Energy
158
and Commerce, the Committee on 
Appropriations, the Committee on
Government Reform, and the Se-
lect Committee on Homeland Se-
curity (or any successor to the Se-
lect Committee). 
‘‘(ii) In the Senate: the Com-
mittee 
on 
Health, 
Education, 
Labor, and Pensions, the Com-
mittee on Appropriations, and the 
Committee on Government Af-
fairs. 
‘‘(d) DISCLOSURES.—No Federal agency 
shall disclose under section 552 of title 5, 
United States Code, any information identi-
fying the location at which materials in the 
stockpile under subsection (a) are stored. 
‘‘(e) DEFINITION.—For purposes of sub-
section (a), the term ‘stockpile’ includes—
‘‘(1) a physical accumulation (at one 
or more locations) of the supplies de-
scribed in subsection (a); or 
‘‘(2) a contractual agreement between 
the Homeland Security Secretary and a 
vendor or vendors under which such ven-
159
dor or vendors agree to provide to such 
Secretary supplies described in sub-
section (a). 
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—
‘‘(1) STRATEGIC NATIONAL STOCKPILE.—
For the purpose of carrying out sub-
section (a), there are authorized to be ap-
propriated $640,000,000 for fiscal year 
2002, and such sums as may be necessary 
for each of fiscal years 2003 through 2006. 
Such authorization is in addition to 
amounts in the special reserve fund 
under subsection (c)(10). 
‘‘(2) 
SMALLPOX
VACCINE
DEVELOP-
MENT.—For the purpose of carrying out 
subsection (b), there are authorized to be 
appropriated $509,000,000 for fiscal year 
2002, and such sums as may be necessary 
for each of fiscal years 2003 through 
2006.’’. 
(b) AMENDMENT
TO HOMELAND SECURITY 
ACT OF 2002.—Title V of the Homeland Secu-
rity Act of 2002 (116 Stat. 2212; 6 U.S.C. 311 et 
seq.) is amended by adding at the end the fol-
lowing:
160
‘‘SEC. 
510. 
PROCUREMENT 
OF 
SECURITY 
COUNTER-
MEASURES 
FOR 
STRATEGIC 
NATIONAL 
STOCKPILE. 
‘‘(a) AUTHORIZATION OF APPROPRIATIONS.—
For the procurement of security counter-
measures under section 319F–2(c) of the Pub-
lic Health Service Act (referred to in this sec-
tion as the ‘security countermeasures pro-
gram’), there is authorized to be appropriated 
up to $5,593,000,000 for the fiscal years 2004 
through 2013. Of the amounts appropriated 
under the preceding sentence, not to exceed 
$3,418,000,000 may be obligated during the fis-
cal years 2004 through 2008, of which not to 
exceed $890,000,000 may be obligated during 
fiscal year 2004. 
‘‘(b) SPECIAL
RESERVE
FUND.—For pur-
poses of the security countermeasures pro-
gram, the term ‘special reserve fund’ means 
the appropriations account established as a 
result of any appropriations made under sub-
section (a). 
‘‘(c) AVAILABILITY.—
‘‘(1) INTEGRITY
OF
SPECIAL
RESERVE 
FUND; 
LIMITATION
OF
OBLIGATIONAL
AU-
THORITY
TO
FUND
PURPOSES; INTENT
OF
161
CONGRESS AGAINST REPROGRAMMING.—Sub-
ject to paragraph (2), all amounts appro-
priated under subsection (a) are available 
for obligation through the end of fiscal 
year 2013 and only for the specific pur-
poses set forth in the security counter-
measures program. It is the intent of the 
Congress that no portion of such amount 
that remains unobligated for such pur-
poses 
shall 
be 
applied, 
through 
re-
programming or otherwise, to any other 
purpose. 
‘‘(2) INITIAL
AVAILABILITY
FOR
PAR-
TICULAR PROCUREMENTS.—Amounts appro-
priated under subsection (a) become 
available for a procurement under the se-
curity countermeasures program only 
upon the approval by the President of 
such availability for the procurement in 
accordance with paragraph (6)(B) of such 
program. 
‘‘(d) RELATED AUTHORIZATIONS OF APPRO-
PRIATIONS.—
‘‘(1) 
THREAT
ASSESSMENT
CAPABILI-
TIES.—For the purpose of carrying out the
162
responsibilities of the Secretary for ter-
ror threat assessment under the security 
countermeasures program, there are au-
thorized to be appropriated $5,000,000 for 
fiscal year 2004, and such sums as may be 
necessary for each of the fiscal years 2005 
and 2006, for the hiring of professional 
personnel within the Directorate for In-
formation Analysis and Infrastructure 
Protection, who shall be analysts respon-
sible 
for 
chemical, 
biological, 
radio-
logical, and nuclear threat assessment 
(including but not limited to analysis of 
chemical, biological, radiological, and nu-
clear agents, the means by which such 
agents could be weaponized or used in a 
terrorist attack, and the capabilities, 
plans, and intentions of terrorists and 
other non-state actors who may have or 
acquire such agents). All such analysts 
shall meet the applicable standards and 
qualifications for the performance of in-
telligence activities promulgated by the 
Director of Central Intelligence pursuant
163
to section 104 of the National Security 
Act of 1947. 
‘‘(2) 
INTELLIGENCE
SHARING
INFRA-
STRUCTURE.—For the purpose of carrying 
out the acquisition and deployment of se-
cure 
facilities 
(including 
information 
technology and physical infrastructure, 
whether mobile and temporary, or per-
manent) sufficient to permit the Sec-
retary to receive, not later than Decem-
ber 31, 2003, all classified information 
and products to which the Under Sec-
retary for Information Analysis and In-
frastructure Protection is entitled under 
subtitle A of title II, there are authorized 
to be appropriated such sums as may be 
necessary for each of the fiscal years 2003 
through 2006. 
‘‘(e) EMERGENCY DEVELOPMENT OF SECURITY 
COUNTERMEASURES.—If the Secretary of Home-
land Security and the Secretary of Health and 
Human Services jointly determine that pro-
curement of a security countermeasure that 
has been approved for procurement using the 
special reserve fund under subsection (a)—
164
‘‘(1) is not proceeding at a sufficiently 
rapid pace under 319F–2 of the Public 
Health Service Act to protect the national 
security; or 
‘‘(2) could be produced significantly 
less expensively by the government di-
rectly than through procurements under 
such section; 
then amounts in the special reserve fund may 
be used by the Secretary of Health and 
Human Services to produce security counter-
measures for placement in the stockpile 
under subsection (a) of section 319F–2 of such 
Act if the joint determination is submitted to 
the President and the President approves 
such use of the special reserve fund. Amounts 
made available for such use in accordance 
with the preceding sentence are available for 
obligation as of the date on which the presi-
dential approval is made, subject to applica-
ble law regarding the apportionment of ap-
propriations. This subsection applies notwith-
standing other provisions of this section, and 
notwithstanding section 319F–2 of the Public 
Health Service Act. This subsection may not
165
be construed as affecting the amounts speci-
fied in subsection (a) as authorizations of ap-
propriations or the obligation limits con-
tained therein.’’. 
(c) CONFORMING AMENDMENT.—Section 121 
of the Public Health Security and Bioter-
rorism Preparedness and Response Act of 
2002 (116 Stat. 611; 42 U.S.C. 300hh–12) is re-
pealed. With respect to the program estab-
lished under former section 121 of such Act, 
the repeal of such section under the pre-
ceding sentence applies as a modification of 
the program in accordance with the amend-
ment made by subsection (a) of this section, 
and not as the termination of the program 
and the establishment of a different program. 
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.—