IB 
Union Calendar No. 98
108TH CONGRESS 
1ST SESSION H. R. 2122
[Report No. 108–147, Parts I, II, and III] 
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 
JUNE 10, 2003
Reported from the Committee on Energy and Commerce 
JUNE 10, 2003
Referral to the Committee on Government Reform and the Select Committee 
on Homeland Security extended for a period ending not later than June 
13, 2003
JUNE 10, 2003
Referred to the Committee on Armed Services for a period ending not later 
than June 11, 2003 pursuant to clause 1(c), rule X 
JUNE 11, 2003
The Committee on Armed Services discharged 
JUNE 12, 2003
Reported from the Committee on Government Reform with an amendment
[Strike out all after the enacting clause and insert the part printed in italic] 
JUNE 13, 2003
Referral to the Select Committee on Homeland Security extended for a period 
ending not later than June 27, 2003
JUNE 27, 2003
Referral to the Select Committee on Homeland Security extended for a period 
ending not later than July 8, 2003
JULY 8, 2003
Additional sponsors: Mr. BURR and Mr. HALL
JULY 8, 2003
Reported from the Select Committee on Homeland Security with an amend-
ment, committed to the Committee of the Whole House on the State of 
the Union and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in boldface roman] 
[For text of introduced bill, see copy of bill as introduced on May 15, 2003] 
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—