183 
‘‘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
184 
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);
185 
‘‘(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
186 
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.
187 
‘‘(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 14 individuals, of which 9 shall be 
from a list of candidates to be provided by 
the National Academy of Sciences and 5 
shall be from lists of candidates provided 
by patient and consumer advocacy groups, 
professional scientific and medical soci-
eties, and industry trade organizations. Of 
such appointed members— 
‘‘(I) 4 shall be representatives of 
the general pharmaceutical, device,
188 
food, cosmetic, and biotechnology in-
dustries; 
‘‘(II) 3 shall be representatives of 
academic research organizations; 
‘‘(III) 2 shall be representatives 
of patient or consumer advocacy orga-
nizations; 
‘‘(IV) 1 shall be a representative 
of health care providers; and 
‘‘(V) 4 shall be at-large members 
with expertise or experience relevant 
to the purpose of the Foundation. 
‘‘(ii) REQUIREMENTS.— 
‘‘(I) EXPERTISE.—The ex officio 
members shall ensure the Board mem-
bership includes individuals with ex-
pertise in areas including the sciences 
of developing, manufacturing, and 
evaluating the safety and effectiveness 
of devices, including diagnostics, bio-
logics, and drugs, and the safety of 
food, food ingredients, and cosmetics. 
‘‘(II) FEDERAL
EMPLOYEES.— 
No employee of the Federal Govern-
ment shall be appointed as a member
189 
of the Board under this subparagraph 
or under paragraph (3)(B). 
‘‘(D) INITIAL MEETING.— 
‘‘(i) IN GENERAL.—Not later than 30 
days after the date of the enactment of 
this subchapter, the Secretary shall con-
vene a meeting of the ex officio members 
of the Board to— 
‘‘(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)— 
‘‘(I) the terms of service of the 
Director of the Centers for Disease 
Control and Prevention and of the Di-
rector of the Agency for Healthcare 
Research and Quality as ex officio 
members of the Board shall termi-
nate; and
190 
‘‘(II) the Commissioner and the 
Director of the National Institutes of 
Health shall continue to serve as ex 
officio members of the Board, but 
shall be nonvoting members. 
‘‘(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-
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-
191 
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 
are consistent with those of the Founda-
tion for the National Institutes of Health, 
to the extent determined practicable and 
appropriate by the Board;
192 
‘‘(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; 
‘‘(x) specify a process for annual 
Board review of the operations of the 
Foundation; and 
‘‘(xi) establish specific duties of the 
Executive Director;
193 
‘‘(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 
‘‘(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-
194 
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.—In carrying out sub-
section (b), the Board shall establish such policies and by-
laws under subsection (d), and the Executive Director 
shall carry out such activities under subsection (g), as may 
be necessary to ensure that the Foundation maintains sta-
tus as an organization that— 
‘‘(1) is described in subsection (c)(3) of section 
501 of the Internal Revenue Code of 1986; and
196 
‘‘(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; 
‘‘(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;
197 
‘‘(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. 
‘‘(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.—
198 
‘‘(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.—
199 
‘‘(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-
200 
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).
201 
‘‘(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.’’.
202 
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;
203 
‘‘(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,
204 
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—
205 
‘‘(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
206 
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
207 
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.—
208 
‘‘(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
209 
point of contact regarding advisory com-
mittee nominations; and 
‘‘(iii) developing a method through 
which an entity receiving funding from the 
National Institutes of Health, the Agency 
for Healthcare Research and Quality, the 
Centers for Disease Control and Preven-
tion, or the Veterans Health Administra-
tion can identify a person who the Food 
and Drug Administration can contact re-
garding the nomination of individuals to 
serve on advisory committees. 
‘‘(2) EVALUATION AND CRITERIA.—When con-
sidering a term appointment to an advisory com-
mittee, the Secretary shall review the expertise of 
the individual and the financial disclosure report 
filed by the individual pursuant to the Ethics in 
Government Act of 1978 for each individual under 
consideration for the appointment, so as to reduce 
the likelihood that an appointed individual will later 
require a written determination as referred to in sec-
tion 208(b)(1) of title 18, United States Code, a 
written certification as referred to in section 
208(b)(3) of title 18, United States Code, or a waiv-
er as referred to in subsection (c)(2) of this section
210 
for service on the committee at a meeting of the 
committee. 
‘‘(c) DISCLOSURES; PROHIBITIONS ON PARTICIPA-
TION; WAIVERS.— 
‘‘(1) DISCLOSURE OF FINANCIAL INTEREST.— 
Prior to a meeting of an advisory committee regard-
ing a ‘particular matter’ (as that term is used in 
section 208 of title 18, United States Code), each 
member of the committee who is a full-time Govern-
ment employee or special Government employee shall 
disclose to the Secretary financial interests in ac-
cordance with subsection (b) of such section 208. 
‘‘(2) PROHIBITIONS AND WAIVERS ON PARTICI-
PATION.— 
‘‘(A) IN
GENERAL.—Except as provided 
under subparagraph (B), a member of an advi-
sory committee may not participate with respect 
to a particular matter considered in an advisory 
committee meeting if such member (or an im-
mediate family member of such member) has a 
financial interest that could be affected by the 
advice given to the Secretary with respect to 
such matter, excluding interests exempted in 
regulations issued by the Director of the Office 
of Government Ethics as too remote or incon-
211 
sequential to affect the integrity of the services 
of the Government officers or employees to 
which such regulations apply. 
‘‘(B) WAIVER.—If the Secretary deter-
mines it necessary to afford the advisory com-
mittee essential expertise, the Secretary may 
grant a waiver of the prohibition in subpara-
graph (A) to permit a member described in 
such subparagraph to— 
‘‘(i) participate as a non-voting mem-
ber with respect to a particular matter 
considered in a committee meeting; or 
‘‘(ii) participate as a voting member 
with respect to a particular matter consid-
ered in a committee meeting. 
‘‘(C) LIMITATION ON WAIVERS AND OTHER 
EXCEPTIONS.— 
‘‘(i) DEFINITION.—For purposes of 
this subparagraph, the term ‘exception’ 
means each of the following with respect to 
members of advisory committees: 
‘‘(I) A waiver under section 
505(n)(4) (as in effect on the day be-
fore the date of the enactment of the
212 
Food 
and 
Drug 
Administration 
Amendments Act of 2007). 
‘‘(II) A written determination 
under section 208(b) of title 18, 
United States Code. 
‘‘(III) A written certification 
under section 208(b)(3) of such title. 
‘‘(ii) 
DETERMINATION
OF
TOTAL 
NUMBER OF MEMBERS SLOTS AND MEM-
BER
EXCEPTIONS
DURING
FISCAL
YEAR 
2007.—The Secretary shall determine— 
‘‘(I)(aa) for each meeting held by 
any advisory committee during fiscal 
year 2007, the number of members 
who participated in the meeting; and 
‘‘(bb) the sum of the respective 
numbers determined under item (aa) 
(referred to in this subparagraph as 
the ‘‘total number of 2007 meeting 
slots’’); and 
‘‘(II)(aa) for each meeting held 
by any advisory committee during fis-
cal year 2007, the number of mem-
bers who received an exception for the 
meeting; and
213 
‘‘(bb) the sum of the respective 
numbers determined under item (aa) 
(referred to in this subparagraph as 
the ‘‘total number of 2007 meeting 
exceptions’’). 
‘‘(iii) DETERMINATION OF PERCENT-
AGE REGARDING EXCEPTIONS DURING FIS-
CAL YEAR 2007.—The Secretary shall de-
termine the percentage constituted by— 
‘‘(I) the total number of 2007 
meeting exceptions; divided by 
‘‘(II) the total number of 2007 
meeting slots. 
‘‘(iv) LIMITATION FOR FISCAL YEARS 
2008 THROUGH 2012.—The number of ex-
ceptions at the Food and Drug Adminis-
tration for members of advisory commit-
tees for a fiscal year may not exceed the 
following: 
‘‘(I) For fiscal year 2008, 95 per-
cent of the percentage determined 
under clause (iii) (referred to in this 
clause as the ‘‘base percentage’’). 
‘‘(II) For fiscal year 2009, 90 
percent of the base percentage.