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‘‘(1) DETAIL FROM FEDERAL AGENCIES.—Fed-
eral Government employees may be detailed from 
Federal agencies with or without reimbursement to 
those agencies to the Foundation at any time, and 
such detail shall be without interruption or loss of 
civil service status or privilege. Each such employee 
shall abide by the statutory, regulatory, ethical, and 
procedural standards applicable to the employees of 
the agency from which such employee is detailed and 
those of the Foundation. 
‘‘(2) VOLUNTARY
SERVICE; ACCEPTANCE
OF 
FEDERAL EMPLOYEES.— 
‘‘(A) FOUNDATION.—The Executive Direc-
tor of the Foundation may accept the services 
of employees detailed from Federal agencies 
with or without reimbursement to those agen-
cies. 
‘‘(B) FOOD AND DRUG ADMINISTRATION.— 
The Commissioner may accept the uncompen-
sated services of Foundation fellows or trainees. 
Such services shall be considered to be under-
taking an activity under contract with the Sec-
retary as described in section 708. 
‘‘(l) ANNUAL REPORTS.— 
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‘‘(1) REPORTS TO FOUNDATION.—Any recipient 
of a grant, contract, fellowship, memorandum of un-
derstanding, or cooperative agreement from the 
Foundation under this section shall submit to the 
Foundation a report on an annual basis for the du-
ration of such grant, contract, fellowship, memo-
randum of understanding, or cooperative agreement, 
that describes the activities carried out under such 
grant, contract, fellowship, memorandum of under-
standing, or cooperative agreement. 
‘‘(2) REPORT TO CONGRESS AND THE FDA.— 
Beginning with fiscal year 2009, the Executive Di-
rector shall submit to Congress and the Commis-
sioner an annual report that— 
‘‘(A) describes the activities of the Foun-
dation and the progress of the Foundation in 
furthering the goals and priorities established 
under subsection (c)(2), including the practical 
impact of the Foundation on regulated product 
development; 
‘‘(B) provides a specific accounting of the 
source and use of all funds used by the Foun-
dation to carry out such activities; and 
‘‘(C) provides information on how the re-
sults of Foundation activities could be incor-
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porated into the regulatory and product review 
activities of the Food and Drug Administration. 
‘‘(m) SEPARATION OF FUNDS.—The Executive Di-
rector shall ensure that the funds received from the Treas-
ury are held in separate accounts from funds received 
from entities under subsection (i). 
‘‘(n) FUNDING.—From amounts appropriated to the 
Food and Drug Administration for each fiscal year, the 
Commissioner shall transfer not less than $500,000 and 
not more than $1,250,000, to the Foundation to carry out 
subsections (a), (b), and (d) through (m).’’. 
(b) OTHER FOUNDATION PROVISIONS.—Chapter VII 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
371 et seq.) (as amended by subsection (a)) is amended 
by adding at the end the following: 
‘‘SEC. 771. LOCATION OF FOUNDATION. 
‘‘The Foundation shall, if practicable, be located not 
more than 20 miles from the District of Columbia. 
‘‘SEC. 772. ACTIVITIES OF THE FOOD AND DRUG ADMINIS-
TRATION. 
‘‘(a) IN GENERAL.—The Commissioner shall receive 
and assess the report submitted to the Commissioner by 
the Executive Director of the Foundation under section 
770(l)(2). 
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‘‘(b) REPORT TO CONGRESS.—Beginning with fiscal 
year 2009, the Commissioner shall submit to Congress an 
annual report summarizing the incorporation of the infor-
mation provided by the Foundation in the report described 
under section 770(l)(2) and by other recipients of grants, 
contracts, memoranda of understanding, or cooperative 
agreements into regulatory and product review activities 
of the Food and Drug Administration. 
‘‘(c) EXTRAMURAL GRANTS.—The provisions of this 
subchapter and section 566 shall have no effect on any 
grant, contract, memorandum of understanding, or coop-
erative agreement between the Food and Drug Adminis-
tration and any other entity entered into before, on, or 
after the date of the enactment of this subchapter.’’. 
(c) CONFORMING AMENDMENT.—Section 742(b) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379l(b)) is amended by adding at the end the following: 
‘‘Any such fellowships and training programs under this 
section or under section 770(d)(2)(A)(ix) may include pro-
vision by such scientists and physicians of services on a 
voluntary and uncompensated basis, as the Secretary de-
termines appropriate. Such scientists and physicians shall 
be subject to all legal and ethical requirements otherwise 
applicable to officers or employees of the Department of 
Health and Human Services.’’. 
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SEC. 602. OFFICE OF THE CHIEF SCIENTIST. 
Chapter IX of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 391 et seq.) is amended by adding at the 
end the following: 
‘‘SEC. 910. OFFICE OF THE CHIEF SCIENTIST. 
‘‘(a) ESTABLISHMENT; APPOINTMENT.—The Sec-
retary shall establish within the Office of the Commis-
sioner an office to be known as the Office of the Chief 
Scientist. The Secretary shall appoint a Chief Scientist to 
lead such Office. 
‘‘(b) DUTIES OF THE OFFICE.—The Office of the 
Chief Scientist shall— 
‘‘(1) oversee, coordinate, and ensure quality and 
regulatory focus of the intramural research pro-
grams of the Food and Drug Administration; 
‘‘(2) track and, to the extent necessary, coordi-
nate intramural research awards made by each cen-
ter of the Administration or science-based office 
within the Office of the Commissioner, and ensure 
that there is no duplication of research efforts sup-
ported by the Reagan-Udall Foundation for the 
Food and Drug Administration; 
‘‘(3) develop and advocate for a budget to sup-
port intramural research; 
‘‘(4) develop a peer review process by which in-
tramural research can be evaluated; 
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‘‘(5) identify and solicit intramural research 
proposals from across the Food and Drug Adminis-
tration through an advisory board composed of em-
ployees of the Administration that shall include— 
‘‘(A) representatives of each of the centers 
and the science-based offices within the Office 
of the Commissioner; and 
‘‘(B) experts on trial design, epidemiology, 
demographics, pharmacovigilance, basic science, 
and public health; and 
‘‘(6) develop postmarket safety performance 
measures that are as measurable and rigorous as the 
ones already developed for premarket review.’’. 
SEC. 603. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS. 
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. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNER-
SHIPS. 
‘‘(a) 
ESTABLISHMENT.—The 
Secretary, 
acting 
through the Commissioner of Food and Drugs, may enter 
into collaborative agreements, to be known as Critical 
Path Public-Private Partnerships, with one or more eligi-
ble entities to implement the Critical Path Initiative of the 
Food and Drug Administration by developing innovative, 
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collaborative projects in research, education, and outreach 
for the purpose of fostering medical product innovation, 
enabling the acceleration of medical product development, 
manufacturing, and translational therapeutics, and en-
hancing 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 a consortium of 
such institutions; 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, which may include graduate train-
ing programs in areas relevant to priorities of the 
Critical Path Initiative. 
‘‘(3) The entity demonstrates to the Secretary’s 
satisfaction that the entity is capable of— 
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‘‘(A) developing and critically evaluating 
tools, methods, and processes— 
‘‘(i) to increase efficiency, predict-
ability, and productivity of medical product 
development; and 
‘‘(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 
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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 the entity provides assur-
ances in its agreement with the Food and Drug Adminis-
tration that the results of the Critical Path Public-Private 
Partnership 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 as defined 
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in section 351 of the Public Health Service Act, a device, 
and any combination of such products. 
‘‘(f) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there are authorized to be appro-
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.— 
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‘‘(A) IN GENERAL.—The Secretary shall— 
‘‘(i) develop and implement strategies 
on effective outreach to potential members 
of advisory committees at universities, col-
leges, other academic research centers, 
professional and medical societies, and pa-
tient and consumer groups; 
‘‘(ii) seek input from professional 
medical and scientific societies to deter-
mine the most effective informational and 
recruitment activities; and 
‘‘(iii) take into account the advisory 
committees with the greatest number of 
vacancies. 
‘‘(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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