I 
108TH CONGRESS 
1ST SESSION H. R. 2122
To enhance research, development, procurement, and use of biomedical coun-
termeasures to respond to public health threats affecting national secu-
rity, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 15, 2003
Mr. TAUZIN (for himself, Mr. DINGELL, Mr. COX, Mr. TOM DAVIS of Virginia, 
Mr. MARKEY, Mr. BILIRAKIS, Mr. DAVIS of Florida, Mr. UPTON, Mr. 
STEARNS, Mr. GREENWOOD, Mr. SHADEGG, Mr. ISSA, Mr. LINCOLN 
DIAZ-BALART of Florida, and Ms. ESHOO) introduced the following bill; 
which was referred to the Committee on Energy and Commerce, and in 
addition to the Committees on Government Reform and Select Homeland 
Security, for a period to be subsequently determined by the Speaker, in 
each case for consideration of such provisions as fall within the jurisdic-
tion of the committee concerned 
A BILL 
To enhance research, development, procurement, and use 
of biomedical countermeasures to respond to public 
health threats affecting national security, and for other 
purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
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 BIOMEDICAL 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)) that affects national secu-
rity. 
‘‘(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 or cooperative agreement 
entered into under the authority provided in this 
section with respect to a biocontainment laboratory 
or other related or ancillary specialized research fa-
cility that the Secretary determines necessary for the 
purpose of performing, administering, and sup-
porting qualified countermeasure research and devel-
opment, the Secretary may provide that the facility 
that is the object of such grant or cooperative agree-
ment shall be available as needed to the Secretary 
to respond to public health emergencies affecting na-
tional security. 
‘‘(b) EXPEDITED PROCUREMENT AUTHORITY.—
‘‘(1) 
INCREASED
SIMPLIFIED
ACQUISITION 
THRESHOLD
FOR
BIOMEDICAL
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) USE OF NONCOMPETITIVE PROCEDURES.—
In addition to any other authority to use procedures 
other than competitive procedures, the Secretary 
may use such other procedures when—
‘‘(A) the procurement is as described by 
paragraph (1); and 
‘‘(B) the property or services needed by 
the Secretary are available from only one re-
sponsible source or only from a limited number 
of responsible sources, and no other type of 
property or services will satisfy the Secretary’s 
needs. 
‘‘(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. 
‘‘(C) EXCEPTION
TO
PREFERENCE
FOR 
PURCHASE CARD MECHANISM.—No provision of 
law establishing a preference for using a Gov-
ernment purchase card method for purchases 
shall apply to purchases that are under this 
paragraph and that are greater than $2,500. 
‘‘(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 or cooperative agreement 
under this section shall be determined without re-
gard to the peer review procedures used for any 
prior peer review of that same grant or cooperative 
agreement. 
‘‘(d) AUTHORITY
FOR PERSONAL SERVICES CON-
TRACTS.—
‘‘(1) IN GENERAL.—For the purpose of per-
forming, administering, and 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,