186 
‘‘(1) the entity accepts such funding for such 
project from 2 or more such organizations; and 
‘‘(2) the entity provides assurances in its agree-
ment with the Food and Drug Administration that 
the results of the Critical Path Public-Private Part-
nership project will not be influenced by any source 
of funding. 
‘‘(d) ANNUAL REPORT.—Not later than 18 months 
after the date of the enactment of this section, and annu-
ally thereafter, the Secretary, in collaboration with the 
parties to each Critical Path Public-Private Partnership, 
shall submit a report to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives— 
‘‘(1) reviewing the operations and activities of 
the Partnerships in the previous year; and 
‘‘(2) addressing such other issues relating to 
this section as the Secretary determines to be appro-
priate. 
‘‘(e) DEFINITION.—In this section, the term ‘medical 
product’ includes a drug, a biological product, a device, 
and any combination of such products. 
‘‘(f) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there are authorized to be appro-
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priated $5,000,000 for fiscal year 2008 and such sums 
as may be necessary for each of fiscal years 2009 through 
2012.’’. 
TITLE VII—CONFLICTS OF 
INTEREST 
SEC. 701. CONFLICTS OF INTEREST. 
(a) IN GENERAL.—Subchapter A of chapter VII of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 
et seq.) is amended by inserting at the end the following: 
‘‘SEC. 712. CONFLICTS OF INTEREST. 
‘‘(a) DEFINITIONS.—For purposes of this section: 
‘‘(1) ADVISORY COMMITTEE.—The term ‘advi-
sory committee’ means an advisory committee under 
the Federal Advisory Committee Act that provides 
advice or recommendations to the Secretary regard-
ing activities of the Food and Drug Administration. 
‘‘(2) FINANCIAL INTEREST.—The term ‘finan-
cial interest’ means a financial interest under section 
208(a) of title 18, United States Code. 
‘‘(b) APPOINTMENTS TO ADVISORY COMMITTEES.— 
‘‘(1) RECRUITMENT.— 
‘‘(A) IN GENERAL.—Given the importance 
of advisory committees to the review process at 
the Food and Drug Administration, the Sec-
retary, through the Office of Women’s Health, 
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the Office of Orphan Product Development, the 
Office of Pediatric Therapeutics, and other of-
fices within the Food and Drug Administration 
with relevant expertise, shall develop and imple-
ment strategies on effective outreach to poten-
tial members of advisory committees at univer-
sities, colleges, other academic research centers, 
professional and medical societies, and patient 
and consumer groups. The Secretary shall seek 
input from professional medical and scientific 
societies to determine the most effective infor-
mational and recruitment activities. The Sec-
retary shall also take into account the advisory 
committees with the greatest number of vacan-
cies. 
‘‘(B) RECRUITMENT ACTIVITIES.—The re-
cruitment activities under subparagraph (A) 
may include— 
‘‘(i) advertising the process for becom-
ing an advisory committee member at med-
ical and scientific society conferences; 
‘‘(ii) making widely available, includ-
ing by using existing electronic commu-
nications channels, the contact information 
for the Food and Drug Administration 
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point of contact regarding advisory com-
mittee nominations; and 
‘‘(iii) developing a method through 
which an entity receiving funding from the 
National Institutes of Health, the Agency 
for Healthcare Research and Quality, the 
Centers for Disease Control and Preven-
tion, or the Veterans Health Administra-
tion can identify a person who the Food 
and Drug Administration can contact re-
garding the nomination of individuals to 
serve on advisory committees. 
‘‘(2) EVALUATION AND CRITERIA.—When con-
sidering a term appointment to an advisory com-
mittee, the Secretary shall review the expertise of 
the individual and the financial disclosure report 
filed by the individual pursuant to the Ethics in 
Government Act of 1978 for each individual under 
consideration for the appointment, so as to reduce 
the likelihood that an appointed individual will later 
require a written determination as referred to in sec-
tion 208(b)(1) of title 18, United States Code, a 
written certification as referred to in section 
208(b)(3) of title 18, United States Code, or a waiv-
er as referred to in subsection (c)(3) of this section 
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for service on the committee at a meeting of the 
committee. 
‘‘(3) PARTICIPATION OF GUEST EXPERT WITH 
FINANCIAL INTEREST.—Notwithstanding any other 
provision of this section, an individual with a finan-
cial interest with respect to any matter considered 
by an advisory committee may be allowed to partici-
pate in a meeting of an advisory committee as a 
guest expert if the Secretary determines that the in-
dividual has particular expertise required for the 
meeting. An individual participating as a guest ex-
pert may provide information and expert opinion, 
but shall not participate in the discussion or voting 
by the members of the advisory committee. 
‘‘(c) GRANTING AND DISCLOSURE OF WAIVERS.— 
‘‘(1) IN GENERAL.—Prior to a meeting of an 
advisory committee regarding a ‘particular matter’ 
(as that term is used in section 208 of title 18, 
United States Code), each member of the committee 
who is a full-time Government employee or special 
Government employee shall disclose to the Secretary 
financial interests in accordance with subsection (b) 
of such section 208. 
‘‘(2) FINANCIAL INTEREST OF ADVISORY COM-
MITTEE MEMBER OR FAMILY MEMBER.—No member 
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