109TH CONGRESS 
2D SESSION 
H. R. 5533
AN ACT 
To prepare and strengthen the biodefenses of the 
United States against deliberate, accidental, and 
natural outbreaks of illness, and for other pur-
poses.
109TH CONGRESS 
2D SESSION 
H. R. 5533
AN ACT 
To prepare and strengthen the biodefenses of the United 
States against deliberate, accidental, and natural out-
breaks of illness, 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 ‘‘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 
Biodefense 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 DE-
VELOPMENT AUTHORITY.—
‘‘(1) ESTABLISHMENT.—There is established 
within the Department of Health and Human Serv-
ices the Biomedical Advanced Research and Develop-
ment Authority. 
‘‘(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 inter-
ested persons and the offices or employees au-
thorized by the Secretary to advise such persons 
regarding requirements under the Federal 
Food, Drug, and Cosmetic Act and under sec-
tion 351 of this Act; and 
‘‘(D) promoting innovation to reduce the 
time and cost of countermeasure and product 
advanced research and development. 
‘‘(3) DIRECTOR.—The BARDA shall be headed 
by a Director (referred to in this section as the ‘Di-
rector’) who shall be appointed by the Secretary and 
to whom the Secretary shall delegate such functions 
and authorities as necessary to implement this sec-
tion. 
‘‘(4) DUTIES.—
‘‘(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 countermeasure and product advanced 
research and development, including by—
‘‘(I) facilitating such communica-
tion regarding the processes for pro-
curing such advanced research and 
development with respect to qualified 
countermeasures and qualified pan-
demic or epidemic products of inter-
est; 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,
international agencies as appropriate, 
and other interested persons; 
‘‘(II) sponsor opportunities to 
demonstrate the operation and effec-
tiveness of relevant biodefense coun-
termeasure technologies; and 
‘‘(III) 
convene 
such 
working 
groups on countermeasure and prod-
uct advanced research and develop-
ment as the Secretary may determine 
are necessary to carry out this sec-
tion; and 
‘‘(iii) carry out the activities described 
in section 6 of the Biodefense and Pan-
demic 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 coun-
termeasure and product advanced research 
and development activities of the Depart-
ment of Health and Human Services; 
‘‘(iii) establish strategic initiatives to 
accelerate countermeasure and product ad-
vanced research and development and in-
novation in such areas as the Secretary 
may identify as priority unmet need areas; 
and 
‘‘(iv) award contracts, grants, cooper-
ative agreements, and enter into other 
transactions, for countermeasure and prod-
uct advanced 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 
Secretary 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 approval, clearance, or licensure of
qualified countermeasures or qualified pan-
demic or epidemic products; and 
‘‘(ii) ensure that, with respect to per-
sons performing countermeasure and prod-
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 develop-
ment of qualified countermeasures and 
qualified pandemic or epidemic products 
that may achieve such approval, clearance, 
or licensure. 
‘‘(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 
transactions, such as prize payments, to pro-
mote—
‘‘(i) innovation in technologies that 
may assist countermeasure and product 
advanced research and development; 
‘‘(ii) research on and development of 
research tools and other devices and tech-
nologies; and
‘‘(iii) research to promote strategic 
initiatives, such as rapid diagnostics, broad 
spectrum antimicrobials, and vaccine man-
ufacturing technologies. 
‘‘(5) TRANSACTION AUTHORITIES.—
‘‘(A) OTHER TRANSACTIONS.—In carrying 
out the functions under subparagraph (B) or 
(D) of paragraph (4), the Secretary shall have 
authority to enter into other transactions for 
countermeasure 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 ex-
pedited procurement authorities, the au-
thority to expedite peer review, and the au-
thority for personal services contracts, sup-
plied 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 
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 develop-
ment program under this section. 
‘‘(iv) AVAILABILITY
OF
DATA.—The 
Secretary may require that, as a condition 
of being awarded a contract, grant, cooper-
ative agreement, or other transaction 
under subparagraph (B) or (D) of para-
graph (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 counter-
measure and product advanced research
and development carried out pursuant to 
this section. 
‘‘(C) 
ADVANCE
PAYMENTS; 
ADVER-
TISING.—The authority of the Secretary to 
enter into contracts under this section shall not 
be limited by section 3324(a) of title 31, United 
States Code, 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 
cooperative agreements, and in entering into 
other transactions, under this section, the Sec-
retary may use milestone-based awards and 
payments. 
‘‘(E) FOREIGN
NATIONALS
ELIGIBLE.—
The Secretary may under this section award 
contracts, 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 estab-
lish one or more federally-funded research and 
development centers, or university-affiliated re-
search centers in accordance with section 
303(c)(3) of the Federal Property and Adminis-
trative Services Act of 1949 (41 U.S.C. 
253(c)(3)), provided that such centers are con-
sistent and complementary with the duties de-
scribed in paragraph (4), and are consistent 
and complementary with, and deemed necessary 
after considering the availability of, existing 
federally-supported basic research programs. 
‘‘(6) VULNERABLE POPULATIONS.—In carrying 
out the functions under this section, the Secretary 
may give priority to the advanced research and de-
velopment 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 vulner-
able populations. 
‘‘(7) PERSONNEL AUTHORITIES.—
‘‘(A) SPECIALLY
QUALIFIED
SCIENTIFIC 
AND PROFESSIONAL PERSONNEL.—In addition 
to any other personnel authorities, the Sec-
retary may—
‘‘(i) without regard to those provisions 
of title 5, United States Code, governing 
appointments in the competitive service, 
appoint 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 
under section 9903 of such title are com-
pensated, without regard to the provisions 
of chapter 51 and subchapter III of chap-
ter 53 of such title relating to classification 
and General Schedule pay rates. 
‘‘(B) SPECIAL CONSULTANTS.—In carrying 
out this section, the Secretary may—
‘‘(i) appoint special consultants pursu-
ant to section 207(f); and 
‘‘(ii) accept voluntary and uncompen-
sated services. 
‘‘(c) INAPPLICABILITY OF CERTAIN PROVISIONS.—
‘‘(1) DISCLOSURE.—
‘‘(A) IN
GENERAL.—The Secretary shall 
withhold from disclosure under section 552 of 
title 5, United States Code, specific technical
data or scientific information that is created or 
obtained during the countermeasure and prod-
uct advanced research and development funded 
by the Secretary that reveal vulnerabilities of 
existing medical or public health defenses 
against biological, chemical, nuclear, or radio-
logical threats. Such information shall be 
deemed to be information described in section 
552(b)(3) of title 5, United States Code. 
‘‘(B) OVERSIGHT.—Information subject to 
nondisclosure under subparagraph (A) shall be 
reviewed by the Secretary every 5 years to de-
termine the relevance or necessity of continued 
nondisclosure. 
‘‘(2) FEDERAL
ADVISORY
COMMITTEE
ACT.—
Section 14 of the Federal Advisory Committee Act 
(5 U.S.C. App.) shall not apply to a working group 
of BARDA or to the National Biodefense Science 
Board under section 319M. 
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out advanced research and develop-
ment under this section, there are authorized to be appro-
priated $160,000,000 for each of the fiscal years 2007 
and 2008. Such authorizations are in addition to other 
authorizations of appropriations that are available for