I 
109TH CONGRESS 
2D SESSION 
H. R. 5533 
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 
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. 
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. 
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Sec.
4. Clarification of countermeasures covered by Project BioShield. 
Sec.
5. Technical assistance. 
Sec.
6. Procurement.
Sec.
7. Rule of construction. 
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) DEFINITIONS.—In this section: 
‘‘(1) BARDA.—The term ‘BARDA’ means the 
Biomedical Advanced Research and Development 
Authority. 
‘‘(2) FUND.—The term ‘Fund’ means the Bio-
defense Medical Countermeasure Development Fund 
established under subsection (d). 
‘‘(3) OTHER TRANSACTIONS.—The term ‘other 
transactions’ means transactions, other than pro-
curement contracts, grants, and cooperative agree-
ments, such as the Secretary of Defense may enter 
into under section 2371 of title 10, United States 
Code. 
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‘‘(4) QUALIFIED COUNTERMEASURE.—The term 
‘qualified countermeasure’ has the meaning given 
such term in section 319F–1. 
‘‘(5) QUALIFIED PANDEMIC OR EPIDEMIC PROD-
UCT.—The term ‘qualified pandemic or epidemic 
product’ has the meaning given the term in section 
319F–3. 
‘‘(6) ADVANCED
RESEARCH
AND
DEVELOP-
MENT.— 
‘‘(A) IN GENERAL.—The term ‘advanced 
research and development’ means, with respect 
to a product that is or may become a qualified 
countermeasure or a qualified pandemic or epi-
demic product, activities that predominantly— 
‘‘(i) are conducted after basic research 
and preclinical development of the product; 
and 
‘‘(ii) are related to manufacturing the 
product on a commercial scale and in a 
form that satisfies the regulatory require-
ments under the Federal Food, Drug, and 
Cosmetic Act or under section 351 of this 
Act. 
‘‘(B) ACTIVITIES
INCLUDED.—The term 
under subparagraph (A) includes— 
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‘‘(i) testing of the product to deter-
mine whether the product may be ap-
proved, cleared, or licensed under the Fed-
eral Food, Drug, and Cosmetic Act or 
under section 351 of this Act for a use 
that is or may be the basis for such prod-
uct becoming a qualified countermeasure 
or qualified pandemic or epidemic product, 
or to help obtain such approval, clearance, 
or license; 
‘‘(ii) design and development of tests 
or models, including animal models, for 
such testing; 
‘‘(iii) activities to facilitate manufac-
ture of the product on a commercial scale 
with consistently high quality, as well as to 
improve and make available new tech-
nologies to increase manufacturing surge 
capacity; 
‘‘(iv) activities to improve the shelf-life 
of the product or technologies for admin-
istering the product; and 
‘‘(v) such other activities as are part 
of the advanced stages of testing, refine-
ment, improvement, or preparation of the 
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product for such use and as are specified 
by the Secretary. 
‘‘(7) RESEARCH
TOOL.—The term ‘research 
tool’ means a device, technology, biological material 
(including a cell line or an antibody), reagent, ani-
mal model, computer system, computer software, or 
analytical technique that is developed to assist in the 
discovery, development, or manufacture of qualified 
countermeasures or qualified pandemic or epidemic 
products. 
‘‘(8) PROGRAM MANAGER.—The term ‘program 
manager’ means an individual appointed to carry out 
functions under this section and authorized to pro-
vide project oversight and management of strategic 
initiatives. 
‘‘(9) PERSON.—The term ‘person’ includes an 
individual, partnership, corporation, association, en-
tity, or public or private corporation, and a Federal, 
State, or local government agency or department. 
‘‘(b) STRATEGIC PLAN FOR COUNTERMEASURE RE-
SEARCH, DEVELOPMENT, AND PROCUREMENT.— 
‘‘(1) IN GENERAL.—Not later than 6 months 
after the date of enactment of the Biodefense and 
Pandemic Vaccine and Drug Development Act of 
2006, the Secretary shall develop, make public, and 
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present to the appropriate Congressional committees 
a strategic plan to integrate biodefense and emerg-
ing infectious disease requirements with the ad-
vanced research and development, strategic initia-
tives for innovation, and the procurement of quali-
fied countermeasures and qualified pandemic or epi-
demic products. The Secretary shall periodically re-
view and, as appropriate, revise the plan. 
‘‘(2) CONTENT.—The strategic plan under 
paragraph (1) shall— 
‘‘(A) guide research and development, con-
ducted or supported by the Department of 
Health and Human Services, of qualified coun-
termeasures and qualified pandemic or epidemic 
products against possible biological, chemical, 
radiological, and nuclear agents and to emerg-
ing infectious diseases; 
‘‘(B) guide innovation in technologies that 
may assist advanced research and development 
of qualified countermeasures and qualified pan-
demic or epidemic products (such research and 
development referred to in this section as ‘coun-
termeasure and product advanced research and 
development’); 
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‘‘(C) guide procurement of such qualified 
countermeasures and qualified pandemic or epi-
demic products by such Department; 
‘‘(D) include immediate, short-term, and 
long-term goals; 
‘‘(E) include immediate, short-term, and 
long-term procurement priorities; and 
‘‘(F) identify processes used to designate a 
range of funds available for various types of 
countermeasure procurements. 
‘‘(c) 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.—Based upon the strategic 
plan described in subsection (b), the Secretary shall 
coordinate and oversee the acceleration of counter-
measure and product advanced research and devel-
opment by— 
‘‘(A) facilitating collaboration among the 
Department of Health and Human Services, 
other Federal agencies, relevant industries, aca-
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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 
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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-
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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 7 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; 
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‘‘(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 
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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.— 
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‘‘(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 
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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 develop-
ment program under this section. 
‘‘(iv) AVAILABILITY
OF
DATA.—The 
Secretary shall 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, all data re-
lated to or resulting from countermeasure 
and product advanced research and devel-
opment carried out pursuant to this sec-
tion. 
‘‘(C) 
ADVANCE
PAYMENTS; 
ADVER-
TISING.—The authority of the Secretary to 
enter into contracts under this section shall not 
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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 peo-
ple. 
‘‘(F) ESTABLISHMENT OF RESEARCH CEN-
TERS.—The Secretary may establish one or 
more federally-funded research and development 
centers, or university-affiliated research centers 
in accordance with section 303(c)(3) of the 
Federal Property and Administrative Services 
Act of 1949 (41 U.S.C. 253(c)(3)), provided 
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that such centers are consistent and com-
plementary with the duties described in para-
graph (4), and are consistent and complemen-
tary with, and deemed necessary after consid-
ering the availability of, existing federally-sup-
ported 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 children, pregnant 
women, and other vulnerable 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 
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‘‘(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. 
‘‘(d) FUND.— 
‘‘(1) ESTABLISHMENT.—There is established 
the Biodefense Medical Countermeasure Develop-
ment Fund, which shall be available to carry out this 
section in addition to such amounts as are otherwise 
available for this purpose. 
‘‘(2) FUNDING.—To carry out the purposes of 
this section, there are authorized to be appropriated 
to the Fund— 
‘‘(A) $1,070,000,000 for fiscal years 2006 
through 2008, the amounts to remain available 
until expended; and 
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