184 
enabling the acceleration of medical product development, 
and enhancing medical product safety. 
‘‘(b) ELIGIBLE ENTITY.—In this section, the term 
‘eligible entity’ means an entity that meets each of the 
following: 
‘‘(1) The entity is— 
‘‘(A) an institution of higher education (as 
such term is defined in section 101 of the High-
er Education Act of 1965); or 
‘‘(B) an organization described in section 
501(c)(3) of the Internal Revenue Code of 1986 
and exempt from tax under section 501(a) of 
such Code. 
‘‘(2) The entity has experienced personnel and 
clinical and other technical expertise in the bio-
medical sciences. 
‘‘(3) The entity demonstrates to the Secretary’s 
satisfaction that the entity is capable of— 
‘‘(A) developing and critically evaluating 
tools, methods, and processes— 
‘‘(i) to increase efficiency, predict-
ability, and productivity of medical product 
development; and 
VerDate Aug 31 2005 
05:37 Jul 12, 2007
Jkt 059200
PO 00000
Frm 00184
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.RH
H2900
bajohnson on PROD1PC77 with BILLS
185 
‘‘(ii) to more accurately identify the 
benefits and risks of new and existing med-
ical products; 
‘‘(B) establishing partnerships, consortia, 
and collaborations with health care practitioners 
and other providers of health care goods or 
services; pharmacists; pharmacy benefit man-
agers and purchasers; health maintenance orga-
nizations and other managed health care orga-
nizations; health care insurers; government 
agencies; patients and consumers; manufactur-
ers of prescription drugs, biological products, 
diagnostic technologies, and devices; and aca-
demic scientists; and 
‘‘(C) securing funding for the projects of a 
Critical Path Public-Private Partnership from 
Federal and nonfederal governmental sources, 
foundations, and private individuals. 
‘‘(c) FUNDING.—The Secretary may not enter into 
a collaborative agreement under subsection (a) unless the 
eligible entity involved provides an assurance that the enti-
ty will not accept funding for a Critical Path Public-Pri-
vate Partnership project from any organization that man-
ufactures or distributes products regulated by the Food 
and Drug Administration unless— 
VerDate Aug 31 2005 
05:37 Jul 12, 2007
Jkt 059200
PO 00000
Frm 00185
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.RH
H2900
bajohnson on PROD1PC77 with BILLS
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-
VerDate Aug 31 2005 
05:37 Jul 12, 2007
Jkt 059200
PO 00000
Frm 00186
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.RH
H2900
bajohnson on PROD1PC77 with BILLS
187 
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, 
VerDate Aug 31 2005 
05:37 Jul 12, 2007
Jkt 059200
PO 00000
Frm 00187
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.RH
H2900
bajohnson on PROD1PC77 with BILLS