IB 
Union Calendar No. 416 
109TH CONGRESS 
2D SESSION 
H. R. 5533 
[Report No. 109–686] 
To prepare and strengthen the biodefenses of the United States against 
deliberate, accidental, and natural outbreaks of illness, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 6, 2006 
Mr. ROGERS of Michigan (for himself, Ms. ESHOO, Mr. HOEKSTRA, and Mr. 
MCHUGH) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce 
SEPTEMBER 26, 2006 
Additional sponsors: Mr. BURGESS, Mr. JEFFERSON, Mr. CLYBURN, Mrs. 
CAPPS, Mr. GORDON, Mr. SHIMKUS, Mr. FERGUSON, and Mr. WYNN 
SEPTEMBER 26, 2006 
Reported with an amendment, 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 italic] 
[For text of introduced bill, see copy of bill as introduced on June 6, 2006] 
A BILL 
To prepare and strengthen the biodefenses of the United 
States against deliberate, accidental, and natural out-
breaks of illness, and for other purposes. 
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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 ‘‘Biodefense and Pan-
demic Vaccine and Drug Development Act of 2006’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents of this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
Sec. 3. Biomedical Advanced Research and Development Authority; National Bio-
defense Science Board. 
Sec. 4. Clarification of countermeasures covered by Project BioShield. 
Sec. 5. Technical assistance. 
Sec. 6. Procurement. 
SEC. 3. BIOMEDICAL ADVANCED RESEARCH AND DEVELOP-
MENT AUTHORITY; NATIONAL BIODEFENSE 
SCIENCE BOARD. 
Title III of the Public Health Service Act (42 U.S.C. 
241 et seq.) is amended by inserting after section 319K the 
following: 
‘‘SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DE-
VELOPMENT AUTHORITY. 
‘‘(a) BIOMEDICAL ADVANCED RESEARCH AND DEVEL-
OPMENT AUTHORITY.— 
‘‘(1) 
ESTABLISHMENT.—There 
is 
established 
within the Department of Health and Human Serv-
ices the Biomedical Advanced Research and Develop-
ment Authority. 
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‘‘(2) IN GENERAL.—The Secretary shall coordi-
nate and oversee the acceleration of countermeasure 
and product advanced research and development by— 
‘‘(A) facilitating collaboration among the 
Department of Health and Human Services, 
other Federal agencies, relevant industries, aca-
demia, and other persons, with respect to such 
advanced research and development; 
‘‘(B) promoting countermeasure and prod-
uct advanced research and development; 
‘‘(C) facilitating contacts between interested 
persons and the offices or employees authorized 
by the Secretary to advise such persons regard-
ing requirements under the Federal Food, Drug, 
and Cosmetic Act and under section 351 of this 
Act; and 
‘‘(D) promoting innovation to reduce the 
time and cost of countermeasure and product ad-
vanced research and development. 
‘‘(3) DIRECTOR.—The BARDA shall be headed 
by a Director (referred to in this section as the ‘Direc-
tor’) who shall be appointed by the Secretary and to 
whom the Secretary shall delegate such functions and 
authorities as necessary to implement this section. 
‘‘(4) DUTIES.— 
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‘‘(A) COLLABORATION.—To carry out the 
purpose described in paragraph (2)(A), the Sec-
retary shall— 
‘‘(i) facilitate and increase the expedi-
tious and direct communication between the 
Department of Health and Human Services 
and relevant persons with respect to coun-
termeasure and product advanced research 
and development, including by— 
‘‘(I) facilitating such communica-
tion regarding the processes for pro-
curing such advanced research and de-
velopment with respect to qualified 
countermeasures and qualified pan-
demic or epidemic products of interest; 
and 
‘‘(II) soliciting information about 
and data from research on potential 
qualified countermeasures and quali-
fied pandemic or epidemic products 
and related technologies; 
‘‘(ii) at least annually— 
‘‘(I) convene meetings with rep-
resentatives from relevant industries, 
academia, 
other 
Federal 
agencies, 
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international agencies as appropriate, 
and other interested persons; 
‘‘(II) sponsor opportunities to 
demonstrate the operation and effec-
tiveness of relevant biodefense counter-
measure technologies; and 
‘‘(III) 
convene 
such 
working 
groups on countermeasure and product 
advanced research and development as 
the Secretary may determine are nec-
essary to carry out this section; and 
‘‘(iii) carry out the activities described 
in section 6 of the Biodefense and Pandemic 
Vaccine and Drug Development Act of 2006. 
‘‘(B) SUPPORT ADVANCED RESEARCH AND 
DEVELOPMENT.—To carry out the purpose de-
scribed in paragraph (2)(B), the Secretary 
shall— 
‘‘(i) conduct ongoing searches for, and 
support calls for, potential qualified coun-
termeasures and qualified pandemic or epi-
demic products; 
‘‘(ii) direct and coordinate the counter-
measure and product advanced research and 
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development activities of the Department of 
Health and Human Services; 
‘‘(iii) establish strategic initiatives to 
accelerate countermeasure and product ad-
vanced research and development and inno-
vation in such areas as the Secretary may 
identify as priority unmet need areas; and 
‘‘(iv) award contracts, grants, coopera-
tive agreements, and enter into other trans-
actions, for countermeasure and product ad-
vanced research and development. 
‘‘(C) FACILITATING ADVICE.—To carry out 
the purpose described in paragraph (2)(C) the 
Secretary shall— 
‘‘(i) connect interested persons with the 
offices or employees authorized by the Sec-
retary to advise such persons regarding the 
regulatory requirements under the Federal 
Food, Drug, and Cosmetic Act and under 
section 351 of this Act related to the ap-
proval, clearance, or licensure of qualified 
countermeasures or qualified pandemic or 
epidemic products; and 
‘‘(ii) ensure that, with respect to per-
sons performing countermeasure and prod-
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uct advanced research and development 
funded under this section, such offices or 
employees provide such advice in a manner 
that is ongoing and that is otherwise des-
ignated to facilitate expeditious development 
of qualified countermeasures and qualified 
pandemic or epidemic products that may 
achieve such approval, clearance, or licen-
sure. 
‘‘(D) SUPPORTING INNOVATION.—To carry 
out the purpose described in paragraph (2)(D), 
the Secretary may award contracts, grants, and 
cooperative agreements, or enter into other trans-
actions, such as prize payments, to promote— 
‘‘(i) innovation in technologies that 
may assist countermeasure and product ad-
vanced research and development; 
‘‘(ii) research on and development of 
research tools and other devices and tech-
nologies; and 
‘‘(iii) research to promote strategic ini-
tiatives, such as rapid diagnostics, broad 
spectrum antimicrobials, and vaccine man-
ufacturing technologies. 
‘‘(5) TRANSACTION AUTHORITIES.— 
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‘‘(A) OTHER TRANSACTIONS.—In carrying 
out the functions under subparagraph (B) or (D) 
of paragraph (4), the Secretary shall have au-
thority to enter into other transactions for coun-
termeasure and product advanced research and 
development. 
‘‘(B) EXPEDITED AUTHORITIES.— 
‘‘(i) IN GENERAL.—In awarding con-
tracts, grants, and cooperative agreements, 
and in entering into other transactions 
under subparagraph (B) or (D) of para-
graph (4), the Secretary shall have the expe-
dited procurement authorities, the authority 
to expedite peer review, and the authority 
for personal services contracts, supplied by 
subsections (b), (c), and (d) of section 
319F–1. 
‘‘(ii) APPLICATION
OF
PROVISIONS.— 
Provisions in such section 319F–1 that 
apply to such authorities and that require 
institution of internal controls, limit re-
view, provide for Federal Tort Claims Act 
coverage of personal services contractors, 
and commit decisions to the discretion of 
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the Secretary shall apply to the authorities 
as exercised pursuant to this paragraph. 
‘‘(iii) AUTHORITY TO LIMIT COMPETI-
TION.—For purposes of applying section 
319F–1(b)(1)(D) to this paragraph, the 
phrase 
‘BioShield 
Program 
under 
the 
Project BioShield Act of 2004’ shall be 
deemed to mean the countermeasure and 
product advanced research and development 
program under this section. 
‘‘(iv) AVAILABILITY
OF
DATA.—The 
Secretary may require that, as a condition 
of being awarded a contract, grant, coopera-
tive agreement, or other transaction under 
subparagraph (B) or (D) of paragraph (4), 
a person make available to the Secretary on 
an ongoing basis, and submit upon request 
to the Secretary, relevant data related to or 
resulting from countermeasure and product 
advanced research and development carried 
out pursuant to this section. 
‘‘(C) ADVANCE PAYMENTS; ADVERTISING.— 
The authority of the Secretary to enter into con-
tracts under this section shall not be limited by 
section 3324(a) of title 31, United States Code, 
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or by section 3709 of the Revised Statutes of the 
United States (41 U.S.C. 5). 
‘‘(D) MILESTONE-BASED
PAYMENTS
AL-
LOWED.—In awarding contracts, grants, and co-
operative agreements, and in entering into other 
transactions, under this section, the Secretary 
may use milestone-based awards and payments. 
‘‘(E) FOREIGN NATIONALS ELIGIBLE.—The 
Secretary may under this section award con-
tracts, grants, and cooperative agreements to, 
and may enter into other transactions with, 
highly qualified foreign national persons outside 
the United States, alone or in collaboration with 
American participants, when such transactions 
may inure to the benefit of the American people 
and are consistent with National security. 
‘‘(F) ESTABLISHMENT
OF
ADVANCED
RE-
SEARCH CENTERS.—The Secretary may establish 
one or more federally-funded research and devel-
opment centers, or university-affiliated research 
centers in accordance with section 303(c)(3) of 
the Federal Property and Administrative Serv-
ices Act of 1949 (41 U.S.C. 253(c)(3)), provided 
that such centers are consistent and complemen-
tary with the duties described in paragraph (4), 
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and are consistent and complementary with, and 
deemed necessary after considering the avail-
ability of, existing federally-supported basic re-
search programs. 
‘‘(6) VULNERABLE POPULATIONS.—In carrying 
out the functions under this section, the Secretary 
may give priority to the advanced research and devel-
opment of qualified countermeasures and qualified 
pandemic or epidemic products that are likely to be 
safe and effective with respect to the emergency health 
security needs of children and other vulnerable popu-
lations. 
‘‘(7) PERSONNEL AUTHORITIES.— 
‘‘(A) SPECIALLY QUALIFIED SCIENTIFIC AND 
PROFESSIONAL PERSONNEL.—In addition to any 
other personnel authorities, the Secretary may— 
‘‘(i) without regard to those provisions 
of title 5, United States Code, governing ap-
pointments in the competitive service, ap-
point highly qualified individuals to sci-
entific or professional positions in BARDA, 
such as program managers, to carry out 
this section; and 
‘‘(ii) compensate them in the same 
manner in which individuals appointed 
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