H. R. 3580—74 
‘‘(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 procedures developed by the 
Foundation and its employees; 
‘‘(10) sue and be sued in its corporate name, and complain 
and defend in courts of competent jurisdiction; 
‘‘(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 necessary to carry 
out its powers, duties, and functions in accordance with this 
subchapter. 
‘‘(i) ACCEPTANCE OF FUNDS FROM OTHER SOURCES.—The Execu-
tive Director may solicit and accept on behalf of the Foundation, 
any funds, gifts, grants, devises, or bequests of real or personal 
property made to the Foundation, including from private entities, 
for the purposes 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 activities. 
‘‘(k) DETAIL OF GOVERNMENT EMPLOYEES; FELLOWSHIPS.— 
‘‘(1) DETAIL
FROM
FEDERAL
AGENCIES.—Federal Govern-
ment 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 Director of the 
Foundation may accept the services of employees detailed 
from Federal agencies with or without reimbursement to 
those agencies. 
‘‘(B) FOOD AND DRUG ADMINISTRATION.—The Commis-
sioner may accept the uncompensated services of Founda-
tion fellows or trainees. Such services shall be considered 
to be undertaking 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 
understanding, 
or 
cooperative agreement from the Foundation under this section 
shall submit to the Foundation a report on an annual basis 
for the duration 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 understanding, or cooperative 
agreement. 
‘‘(2) REPORT TO CONGRESS AND THE FDA.—Beginning with 
fiscal year 2009, the Executive Director shall submit to Con-
gress and the Commissioner an annual report that—
H. R. 3580—75 
‘‘(A) describes the activities of the Foundation 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 Foundation to carry out such 
activities; and 
‘‘(C) provides information on how the results of Founda-
tion activities could be incorporated into the regulatory 
and product review activities of the Food and Drug 
Administration. 
‘‘(m) SEPARATION
OF FUNDS.—The Executive Director shall 
ensure that the funds received from the Treasury are held in 
separate accounts from funds received from entities under sub-
section (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 Fed-
eral 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 ADMINISTRATION. 
‘‘(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 information provided by the 
Foundation in the report described under section 770(l)(2) and 
by other recipients of grants, contracts, memoranda of under-
standing, 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, memo-
randum of understanding, or cooperative agreement between the 
Food and Drug Administration 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 provision by such scientists and physicians of services on 
a voluntary and uncompensated basis, as the Secretary determines 
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.’’.
H. R. 3580—76 
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 Secretary shall estab-
lish within the Office of the Commissioner 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 programs of the Food and 
Drug Administration; 
‘‘(2) track and, to the extent necessary, coordinate intra-
mural research awards made by each center of the Administra-
tion or science-based office within the Office of the Commis-
sioner, and ensure that there is no duplication of research 
efforts supported by the Reagan-Udall Foundation for the Food 
and Drug Administration; 
‘‘(3) develop and advocate for a budget to support intra-
mural research; 
‘‘(4) develop a peer review process by which intramural 
research can be evaluated; 
‘‘(5) identify and solicit intramural research proposals from 
across the Food and Drug Administration through an advisory 
board composed of employees 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, demo-
graphics, 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 PARTNERSHIPS. 
‘‘(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 Partner-
ships, with one or more eligible entities to implement the Critical 
Path Initiative of the Food and Drug Administration by developing 
innovative, collaborative projects in research, education, and out-
reach for the purpose of fostering medical product innovation, 
enabling the acceleration of medical product development, manufac-
turing, and translational therapeutics, 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—
H. R. 3580—77 
‘‘(A) an institution of higher education (as such term 
is defined in section 101 of the Higher 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 biomedical sciences, which may 
include graduate training programs in areas relevant to prior-
ities of the Critical Path Initiative. 
‘‘(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, predictability, and 
productivity of medical product development; and 
‘‘(ii) to more accurately identify the benefits and 
risks of new and existing medical products; 
‘‘(B) establishing partnerships, consortia, and collabora-
tions with health care practitioners and other providers 
of health care goods or services; pharmacists; pharmacy 
benefit managers and purchasers; health maintenance 
organizations and other managed health care organiza-
tions; health care insurers; government agencies; patients 
and consumers; manufacturers of prescription drugs, 
biological products, diagnostic technologies, and devices; 
and academic scientists; and 
‘‘(C) securing funding for the projects of a Critical 
Path Public-Private Partnership from Federal and non-
federal 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 entity will not accept funding for 
a Critical Path Public-Private Partnership project from any 
organization that manufactures or distributes products regulated 
by the Food and Drug Administration unless the entity provides 
assurances in its agreement with the Food and Drug Administration 
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 annually thereafter, 
the Secretary, in collaboration with the parties to each Critical 
Path Public-Private Partnership, shall submit a report to the Com-
mittee on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives— 
‘‘(1) reviewing the operations and activities of the Partner-
ships in the previous year; and 
‘‘(2) addressing such other issues relating to this section 
as the Secretary determines to be appropriate. 
‘‘(e) DEFINITION.—In this section, the term ‘medical product’ 
includes a drug, a biological product as defined 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 sec-
tion, there are authorized to be appropriated $5,000,000 for fiscal