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ration of the term of the member until a suc-
cessor is appointed. 
‘‘(4) COMPENSATION.—Members of the Board 
may not receive compensation for service on the 
Board. Such members may be reimbursed for travel, 
subsistence, and other necessary expenses incurred 
in carrying out the duties of the Board, as set forth 
in the bylaws issued by the Board. 
‘‘(e) INCORPORATION.—The ex officio members of the 
Board shall serve as incorporators and shall take whatever 
actions necessary to incorporate the Foundation. 
‘‘(f) NONPROFIT STATUS.—The Foundation shall be 
considered to be a corporation under section 501(c) of the 
Internal Revenue Code of 1986, and shall be subject to 
the provisions of such section. 
‘‘(g) EXECUTIVE DIRECTOR.— 
‘‘(1) IN GENERAL.—The Board shall appoint an 
Executive Director who shall serve at the pleasure of 
the Board. The Executive Director shall be respon-
sible for the day-to-day operations of the Foundation 
and shall have such specific duties and responsibil-
ities as the Board shall prescribe. 
‘‘(2) COMPENSATION.—The compensation of 
the Executive Director shall be fixed by the Board 
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but shall not be greater than the compensation of 
the Commissioner. 
‘‘(h) ADMINISTRATIVE POWERS.—In carrying out 
this subchapter, the Board, acting through the Executive 
Director, may— 
‘‘(1) adopt, alter, and use a corporate seal, 
which shall be judicially noticed; 
‘‘(2) hire, promote, compensate, and discharge 
1 or more officers, employees, and agents, as may be 
necessary, and define their duties; 
‘‘(3) prescribe the manner in which— 
‘‘(A) real or personal property of the 
Foundation is acquired, held, and transferred; 
‘‘(B) general operations of the Foundation 
are to be conducted; and 
‘‘(C) the privileges granted to the Board 
by law are exercised and enjoyed; 
‘‘(4) with the consent of the applicable executive 
department or independent agency, use the informa-
tion, services, and facilities of such department or 
agencies in carrying out this section; 
‘‘(5) enter into contracts with public and pri-
vate organizations for the writing, editing, printing, 
and publishing of books and other material; 
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‘‘(6) hold, administer, invest, and spend any 
gift, devise, or bequest of real or personal property 
made to the Foundation under subsection (i); 
‘‘(7) enter into such other contracts, leases, co-
operative agreements, and other transactions as the 
Board considers appropriate to conduct the activities 
of the Foundation; 
‘‘(8) modify or consent to the modification of 
any contract or agreement to which it is a party or 
in which it has an interest under this subchapter; 
‘‘(9) take such action as may be necessary to 
obtain patents and licenses for devices and proce-
dures developed by the Foundation and its employ-
ees; 
‘‘(10) sue and be sued in its corporate name, 
and complain and defend in courts of competent ju-
risdiction; 
‘‘(11) appoint other groups of advisors as may 
be determined necessary to carry out the functions 
of the Foundation; and 
‘‘(12) exercise other powers as set forth in this 
section, and such other incidental powers as are nec-
essary to carry out its powers, duties, and functions 
in accordance with this subchapter. 
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‘‘(i) 
ACCEPTANCE
OF
FUNDS
FROM
OTHER 
SOURCES.—The Executive Director may solicit and accept 
on behalf of the Foundation, any funds, gifts, grants, de-
vises, or bequests of real or personal property made to the 
Foundation, including from private entities, for the pur-
poses of carrying out the duties of the Foundation. 
‘‘(j) SERVICE OF FEDERAL EMPLOYEES.—Federal 
Government employees may serve on committees advisory 
to the Foundation and otherwise cooperate with and assist 
the Foundation in carrying out its functions, so long as 
such employees do not direct or control Foundation activi-
ties. 
‘‘(k) DETAIL OF GOVERNMENT EMPLOYEES; FEL-
LOWSHIPS.— 
‘‘(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. 
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‘‘(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.— 
‘‘(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. 
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‘‘(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-
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 
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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). 
‘‘(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 shall have no effect on any grant, contract, 
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memorandum of understanding, or cooperative agreement 
between the Food and Drug Administration and any other 
entity entered into before, on, or after the date of enact-
ment 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.’’. 
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. 
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‘‘(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; and 
‘‘(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 
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‘‘(B) experts on trial design, epidemiology, 
demographics, pharmacovigilance, basic science, 
and public health.’’. 
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, shall 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, 
collaborative projects in research, education, and outreach 
for the purpose of fostering medical product innovation, 
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— 
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‘‘(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 
‘‘(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-
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