164 
‘‘Subchapter I—Reagan-Udall Foundation for 
the Food and Drug Administration 
‘‘SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE FOUN-
DATION. 
‘‘(a) IN GENERAL.—A nonprofit corporation to be 
known as the Reagan-Udall Foundation for the Food and 
Drug Administration (referred to in this subchapter as the 
‘Foundation’) shall be established in accordance with this 
section. The Foundation shall be headed by an Executive 
Director, appointed by the members of the Board of Direc-
tors under subsection (e). The Foundation shall not be 
an agency or instrumentality of the United States Govern-
ment. 
‘‘(b) PURPOSE OF FOUNDATION.—The purpose of 
the Foundation is to advance the mission of the Food and 
Drug Administration to modernize medical, veterinary, 
food, food ingredient, and cosmetic product development, 
accelerate innovation, and enhance product safety. 
‘‘(c) DUTIES OF THE FOUNDATION.—The Founda-
tion shall— 
‘‘(1) taking into consideration the Critical Path 
reports and priorities published by the Food and 
Drug Administration, identify unmet needs in the 
development, manufacture, and evaluation of the 
safety and effectiveness, including postapproval, of 
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devices, including diagnostics, biologics, and drugs, 
and the safety of food, food ingredients, and cos-
metics, and including the incorporation of more sen-
sitive and predictive tools and devices to measure 
safety; 
‘‘(2) establish goals and priorities in order to 
meet the unmet needs identified in paragraph (1); 
‘‘(3) in consultation with the Secretary, identify 
existing and proposed Federal intramural and extra-
mural research and development programs relating 
to the goals and priorities established under para-
graph (2), coordinate Foundation activities with 
such programs, and minimize Foundation duplica-
tion of existing efforts; 
‘‘(4) award grants to, or enter into contracts, 
memoranda of understanding, or cooperative agree-
ments with, scientists and entities, which may in-
clude the Food and Drug Administration, university 
consortia, public-private partnerships, institutions of 
higher education, entities described in section 
501(c)(3) of the Internal Revenue Code (and exempt 
from tax under section 501(a) of such Code), and 
industry, to efficiently and effectively advance the 
goals and priorities established under paragraph (2); 
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‘‘(5) recruit meeting participants and hold or 
sponsor (in whole or in part) meetings as appro-
priate to further the goals and priorities established 
under paragraph (2); 
‘‘(6) release and publish information and data 
and, to the extent practicable, license, distribute, 
and release material, reagents, and techniques to 
maximize, promote, and coordinate the availability of 
such material, reagents, and techniques for use by 
the Food and Drug Administration, nonprofit orga-
nizations, and academic and industrial researchers 
to further the goals and priorities established under 
paragraph (2); 
‘‘(7) ensure that— 
‘‘(A) action is taken as necessary to obtain 
patents for inventions developed by the Founda-
tion or with funds from the Foundation; 
‘‘(B) action is taken as necessary to enable 
the licensing of inventions developed by the 
Foundation or with funds from the Foundation; 
and 
‘‘(C) executed licenses, memoranda of un-
derstanding, material transfer agreements, con-
tracts, and other such instruments, promote, to 
the maximum extent practicable, the broadest 
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conversion to commercial and noncommercial 
applications of licensed and patented inventions 
of the Foundation to further the goals and pri-
orities established under paragraph (2); 
‘‘(8) provide objective clinical and scientific in-
formation to the Food and Drug Administration 
and, upon request, to other Federal agencies to as-
sist in agency determinations of how to ensure that 
regulatory policy accommodates scientific advances 
and meets the agency’s public health mission; 
‘‘(9) conduct annual assessments of the unmet 
needs identified in paragraph (1); and 
‘‘(10) carry out such other activities consistent 
with the purposes of the Foundation as the Board 
determines appropriate. 
‘‘(d) BOARD OF DIRECTORS.— 
‘‘(1) ESTABLISHMENT.— 
‘‘(A) IN GENERAL.—The Foundation shall 
have a Board of Directors (referred to in this 
subchapter as the ‘Board’), which shall be com-
posed of ex officio and appointed members in 
accordance with this subsection. All appointed 
members of the Board shall be voting members. 
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168 
‘‘(B) EX OFFICIO MEMBERS.—The ex offi-
cio members of the Board shall be the following 
individuals or their designees: 
‘‘(i) The Commissioner. 
‘‘(ii) The Director of the National In-
stitutes of Health. 
‘‘(iii) The Director of the Centers for 
Disease Control and Prevention. 
‘‘(iv) The Director of the Agency for 
Healthcare Research and Quality. 
‘‘(C) APPOINTED MEMBERS.— 
‘‘(i) IN
GENERAL.—The ex officio 
members of the Board under subparagraph 
(B) shall, by majority vote, appoint to the 
Board 12 individuals, from a list of can-
didates to be provided by the National 
Academy of Sciences. Of such appointed 
members— 
‘‘(I) 4 shall be representatives of 
the general pharmaceutical, device, 
food, cosmetic, and biotechnology in-
dustries; 
‘‘(II) 3 shall be representatives of 
academic research organizations; 
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169 
‘‘(III) 2 shall be representatives 
of Government agencies, including the 
Food and Drug Administration and 
the National Institutes of Health; 
‘‘(IV) 2 shall be representatives 
of patient or consumer advocacy orga-
nizations; and 
‘‘(V) 1 shall be a representative 
of health care providers. 
‘‘(ii) REQUIREMENT.—The ex officio 
members shall ensure the Board member-
ship includes individuals with expertise in 
areas including the sciences of developing, 
manufacturing, and evaluating the safety 
and effectiveness of devices, including 
diagnostics, biologics, and drugs, and the 
safety of food, food ingredients, and cos-
metics. 
‘‘(D) INITIAL MEETING.— 
‘‘(i) IN GENERAL.—Not later than 30 
days after the date of the enactment of 
this Act, the Secretary shall convene a 
meeting of the ex officio members of the 
Board to— 
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‘‘(I) incorporate the Foundation; 
and 
‘‘(II) appoint the members of the 
Board in accordance with subpara-
graph (C). 
‘‘(ii) SERVICE OF EX OFFICIO MEM-
BERS.—Upon the appointment of the 
members of the Board under clause (i)(II), 
the terms of service of the ex officio mem-
bers of the Board as members of the 
Board shall terminate. 
‘‘(iii) CHAIR.—The ex officio members 
of the Board under subparagraph (B) shall 
designate an appointed member of the 
Board to serve as the Chair of the Board. 
‘‘(2) DUTIES OF BOARD.—The Board shall— 
‘‘(A) establish bylaws for the Foundation 
that— 
‘‘(i) are published in the Federal Reg-
ister and available for public comment; 
‘‘(ii) establish policies for the selection 
of the officers, employees, agents, and con-
tractors of the Foundation; 
‘‘(iii) establish policies, including eth-
ical standards, for the acceptance, solicita-
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171 
tion, and disposition of donations and 
grants to the Foundation and for the dis-
position of the assets of the Foundation, 
including appropriate limits on the ability 
of donors to designate, by stipulation or re-
striction, the use or recipient of donated 
funds; 
‘‘(iv) establish policies that would sub-
ject all employees, fellows, and trainees of 
the Foundation to the conflict of interest 
standards under section 208 of title 18, 
United States Code; 
‘‘(v) establish licensing, distribution, 
and publication policies that support the 
widest and least restrictive use by the pub-
lic of information and inventions developed 
by the Foundation or with Foundation 
funds to carry out the duties described in 
paragraphs (6) and (7) of subsection (c), 
and may include charging cost-based fees 
for published material produced by the 
Foundation; 
‘‘(vi) specify principles for the review 
of proposals and awarding of grants and 
contracts that include peer review and that 
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are consistent with those of the Founda-
tion for the National Institutes of Health, 
to the extent determined practicable and 
appropriate by the Board; 
‘‘(vii) specify a cap on administrative 
expenses for recipients of a grant, con-
tract, or cooperative agreement from the 
Foundation; 
‘‘(viii) establish policies for the execu-
tion of memoranda of understanding and 
cooperative agreements between the Foun-
dation and other entities, including the 
Food and Drug Administration; 
‘‘(ix) establish policies for funding 
training fellowships, whether at the Foun-
dation, academic or scientific institutions, 
or the Food and Drug Administration, for 
scientists, doctors, and other professionals 
who are not employees of regulated indus-
try, to foster greater understanding of and 
expertise 
in 
new 
scientific 
tools, 
diagnostics, manufacturing techniques, and 
potential barriers to translating basic re-
search into clinical and regulatory practice; 
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‘‘(x) specify a process for annual 
Board review of the operations of the 
Foundation; and 
‘‘(xi) establish specific duties of the 
Executive Director; 
‘‘(B) prioritize and provide overall direc-
tion to the activities of the Foundation; 
‘‘(C) evaluate the performance of the Exec-
utive Director; and 
‘‘(D) carry out any other necessary activi-
ties regarding the functioning of the Founda-
tion. 
‘‘(3) TERMS AND VACANCIES.— 
‘‘(A) TERM.—The term of office of each 
member of the Board appointed under para-
graph (1)(C) shall be 4 years, except that the 
terms of offices for the initial appointed mem-
bers of the Board shall expire on a staggered 
basis as determined by the ex officio members. 
‘‘(B) VACANCY.—Any vacancy in the mem-
bership of the Board— 
‘‘(i) shall not affect the power of the 
remaining members to execute the duties 
of the Board; and 
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‘‘(ii) shall be filled by appointment by 
the appointed members described in para-
graph (1)(C) by majority vote. 
‘‘(C) PARTIAL TERM.—If a member of the 
Board does not serve the full term applicable 
under subparagraph (A), the individual ap-
pointed under subparagraph (B) to fill the re-
sulting vacancy shall be appointed for the re-
mainder of the term of the predecessor of the 
individual. 
‘‘(D) SERVING PAST TERM.—A member of 
the Board may continue to serve after the expi-
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 
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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 
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; 
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