‘‘(B) such sums as may be necessary for 
subsequent fiscal years, the amounts to remain 
available until expended. 
‘‘(e) 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 
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of BARDA or to the National Biodefense Science 
Board under section 319M. 
‘‘SEC. 319M. NATIONAL BIODEFENSE SCIENCE BOARD AND 
WORKING GROUPS. 
‘‘(a) IN GENERAL.— 
‘‘(1) ESTABLISHMENT
AND
FUNCTION.—The 
Secretary shall establish the National Biodefense 
Science Board (referred to in this section as the 
‘Board’) to provide expert advice and guidance to 
the Secretary on scientific, technical and other mat-
ters of special interest to the Department of Health 
and Human Services regarding current and future 
chemical, biological, nuclear, and radiological agents, 
whether naturally occurring, accidental, or delib-
erate. 
‘‘(2) MEMBERSHIP.—The membership of the 
Board shall be comprised of individuals who rep-
resent the Nation’s preeminent scientific, public 
health, and medical experts, as follows— 
‘‘(A) such Federal officials as the Sec-
retary may determine are necessary to support 
the functions of the Board; 
‘‘(B) four individuals representing the 
pharmaceutical, biotechnology, and device in-
dustries; 
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‘‘(C) four individuals representing aca-
demia; and 
‘‘(D) five other members as determined ap-
propriate by the Secretary. 
‘‘(3) TERM OF APPOINTMENT.—A member of 
the Board described in subparagraph (B), (C), or 
(D) of paragraph (2) shall serve for a term of 3 
years, except that the Secretary may adjust the 
terms of the initial Board appointees in order to 
provide for a staggered term of appointment for all 
members. 
‘‘(4) CONSECUTIVE APPOINTMENTS; MAXIMUM 
TERMS.—A member may be appointed to serve not 
more than 3 terms on the Board and may serve not 
more than 2 consecutive terms. 
‘‘(5) DUTIES.—The Board shall— 
‘‘(A) advise the Secretary on current and 
future trends, challenges, and opportunities pre-
sented by advances in biological and life 
sciences, biotechnology, and genetic engineering 
with respect to threats posed by naturally oc-
curring infectious diseases and chemical, bio-
logical, radiological, and nuclear agents; 
‘‘(B) at the request of the Secretary, re-
view and consider any information and findings 
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received from the working groups established 
under subsection (b); and 
‘‘(C) at the request of the Secretary, pro-
vide recommendations and findings for ex-
panded, intensified, and coordinated biodefense 
research and development activities. 
‘‘(6) MEETINGS.— 
‘‘(A) INITIAL
MEETING.—Not later than 
one year after the date of enactment of the Bio-
defense and Pandemic Vaccine and Drug Devel-
opment Act of 2006, the Secretary shall hold 
the first meeting of the Board. 
‘‘(B) 
SUBSEQUENT
MEETINGS.—The 
Board shall meet at the call of the Secretary, 
but in no case less than twice annually. 
‘‘(7) VACANCIES.—Any vacancy in the Board 
shall not affect its powers, but shall be filled in the 
same manner as the original appointment. 
‘‘(8) CHAIRPERSON.—The Secretary shall ap-
point a chairperson from among the members of the 
Board. 
‘‘(9) POWERS.— 
‘‘(A) HEARINGS.—The Board may hold 
such hearings, sit and act at such times and 
places, take such testimony, and receive such 
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evidence as the Board considers advisable to 
carry out this subsection. 
‘‘(B) POSTAL SERVICES.—The Board may 
use the United States mails in the same man-
ner and under the same conditions as other de-
partments and agencies of the Federal Govern-
ment. 
‘‘(10) PERSONNEL.— 
‘‘(A) EMPLOYEES OF THE FEDERAL GOV-
ERNMENT.—A member of the Board that is an 
employee of the Federal Government may not 
receive additional pay, allowances, or benefits 
by reason of the member’s service on the 
Board. 
‘‘(B) OTHER MEMBERS.—A member of the 
Board that is not an employee of the Federal 
Government may be compensated at a rate not 
to exceed the daily equivalent of the annual rate 
of basic pay prescribed for level IV of the Exec-
utive Schedule under section 5315 of title 5, 
United States Code, for each day (including 
travel time) during which the member is en-
gaged in the actual performance of duties as a 
member of the Board. 
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‘‘(C) TRAVEL
EXPENSES.—Each member 
of the Board shall receive travel expenses, in-
cluding per diem in lieu of subsistence, in ac-
cordance with applicable provisions under sub-
chapter I of chapter 57 of title 5, United States 
Code. 
‘‘(D) DETAIL OF GOVERNMENT EMPLOY-
EES.—Any Federal Government employee may 
be detailed to the Board with the approval for 
the contributing agency without reimbursement, 
and such detail shall be without interruption or 
loss of civil service status or privilege. 
‘‘(b) OTHER WORKING GROUPS.—The Secretary may 
establish a working group of experts, or may use an exist-
ing working group or advisory committee, to— 
‘‘(1) identify innovative research with the po-
tential to be developed as a qualified countermeasure 
or a qualified pandemic or epidemic product; 
‘‘(2) identify accepted animal models for par-
ticular diseases and conditions associated with any 
biological, chemical, radiological, or nuclear agent, 
any toxin, or any potential pandemic infectious dis-
ease, and identify strategies to accelerate animal 
model and research tool development and validation; 
and 
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‘‘(3) obtain advice regarding supporting and fa-
cilitating advanced research and development related 
to 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, and other issues 
regarding activities under this section that affect 
such populations. 
‘‘(c) DEFINITIONS.—Any term that is defined in sec-
tion 319L and that is used in this section shall have the 
same meaning in this section as such term is given in sec-
tion 319L. 
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated $1,000,000 to carry out 
this section for fiscal year 2007 and each fiscal year there-
after.’’. 
SEC. 4. CLARIFICATION OF COUNTERMEASURES COVERED 
BY PROJECT BIOSHIELD. 
(a) QUALIFIED COUNTERMEASURE.—Section 319F– 
1(a) of the Public Health Service Act (42 U.S.C. 247d– 
6a(a)) is amended by striking paragraph (2) and inserting 
the following: 
‘‘(2) DEFINITIONS.—In this section: 
‘‘(A) QUALIFIED COUNTERMEASURE.—The 
term ‘qualified countermeasure’ means a drug 
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(as that term is defined by section 201(g)(1) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321(g)(1))), biological product (as that 
term is defined by section 351(i) of this Act (42 
U.S.C. 262(i))), or device (as that term is de-
fined by section 201(h) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321(h))), 
that the Secretary determines to be a priority 
(consistent with sections 302(2) and 304(a) of 
the Homeland Security Act of 2002) to— 
‘‘(i) diagnose, mitigate, prevent, or 
treat harm from any biological agent (in-
cluding organisms that cause an infectious 
disease) or toxin, chemical, radiological, or 
nuclear agent that may cause a public 
health emergency affecting national secu-
rity; or 
‘‘(ii) diagnose, mitigate, prevent, or 
treat harm from a condition that may re-
sult in adverse health consequences or 
death and may be caused by administering 
a drug, biological product, or device that is 
used as described in this subparagraph. 
‘‘(B) INFECTIOUS DISEASE.—The term ‘in-
fectious disease’ means a disease potentially 
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caused by a pathogenic organism (including a 
bacteria, virus, fungus, or parasite) that is ac-
quired by a person and that reproduces in that 
person.’’. 
(b) SECURITY COUNTERMEASURE.—Section 319F– 
2(c)(1)(B)(i)(I) is amended by striking ‘‘to treat’’ the first 
place such term appears and all that follows through 
‘‘from a condition’’ and inserting the following: ‘‘to diag-
nose, mitigate, prevent, or treat harm from any biological 
agent (including organisms that cause an infectious dis-
ease) or toxin, chemical, radiological, or nuclear agent 
identified as a material threat under paragraph (2)(A)(ii), 
or to diagnose, mitigate, prevent, or treat harm from a 
condition’’. 
SEC. 5. TECHNICAL ASSISTANCE. 
Subchapter E of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is 
amended by adding at the end the following: 
‘‘SEC. 565. TECHNICAL ASSISTANCE. 
‘‘The Secretary, in consultation with the Commis-
sioner of Food and Drugs, shall establish within the Food 
and Drug Administration a team of experts on manufac-
turing and regulatory activities (including compliance with 
current Good Manufacturing Practice) to provide both off- 
site and on-site technical assistance to the manufacturers 
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of qualified countermeasures (as defined in section 319F– 
1 of the Public Health Service Act), security counter-
measures (as defined in section 319F–2 of such Act), or 
vaccines, at the request of such a manufacturer and at 
the discretion of the Secretary, if the Secretary determines 
that a shortage or potential shortage may occur in the 
United States in the supply of such vaccines or counter-
measures and that the provision of such assistance would 
be beneficial in helping alleviate or avert such shortage.’’. 
SEC. 6. PROCUREMENT. 
(a) SECURITY COUNTERMEASURES.—Section 319F– 
2 of the Public Health Service Act (42 U.S.C. 247d–6b) 
is amended— 
(1) in the section heading, by inserting ‘‘AND 
SECURITY
COUNTERMEASURE
PROCURE-
MENTS’’ before the period; and 
(2) in subsection (c)— 
(A) in the subsection heading, by striking 
‘‘BIOMEDICAL’’; 
(B) in paragraph (5)(B)(i), by striking ‘‘to 
meet the needs of the stockpile’’ and inserting 
‘‘to meet the stockpile needs’’; 
(C) in paragraph (7)(B)— 
(i) by striking the subparagraph head-
ing and all that follows through ‘‘Home-
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