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;
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—
170 
‘‘(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-
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
172 
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;
173 
‘‘(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
174 
‘‘(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
175 
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;
176 
‘‘(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;
177 
‘‘(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.—
178 
‘‘(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.—
179 
‘‘(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-
180 
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).
181 
‘‘(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, 
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.’’.
182 
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; and
183 
‘‘(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.’’. 
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,
184 
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— 
‘‘(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
185 
‘‘(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 
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—
186 
‘‘(1) the entity accepts such funding for such 
project from 2 or more such organizations; and 
‘‘(2) the entity provides assurances in its agree-
ment with the Food and Drug Administration that 
the results of the Critical Path Public-Private Part-
nership 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, a device, 
and any combination of such products. 
‘‘(f) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there are authorized to be appro-
187 
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.— 
‘‘(A) IN GENERAL.—Given the importance 
of advisory committees to the review process at 
the Food and Drug Administration, the Sec-
retary, through the Office of Women’s Health,
188 
the Office of Orphan Product Development, the 
Office of Pediatric Therapeutics, and other of-
fices within the Food and Drug Administration 
with relevant expertise, shall develop and imple-
ment strategies on effective outreach to poten-
tial members of advisory committees at univer-
sities, colleges, other academic research centers, 
professional and medical societies, and patient 
and consumer groups. The Secretary shall seek 
input from professional medical and scientific 
societies to determine the most effective infor-
mational and recruitment activities. The Sec-
retary shall also take into account the advisory 
committees with the greatest number of vacan-
cies. 
‘‘(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
189 
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)(3) of this section
190 
for service on the committee at a meeting of the 
committee. 
‘‘(3) PARTICIPATION OF GUEST EXPERT WITH 
FINANCIAL INTEREST.—Notwithstanding any other 
provision of this section, an individual with a finan-
cial interest with respect to any matter considered 
by an advisory committee may be allowed to partici-
pate in a meeting of an advisory committee as a 
guest expert if the Secretary determines that the in-
dividual has particular expertise required for the 
meeting. An individual participating as a guest ex-
pert may provide information and expert opinion, 
but shall not participate in the discussion or voting 
by the members of the advisory committee. 
‘‘(c) GRANTING AND DISCLOSURE OF WAIVERS.— 
‘‘(1) IN GENERAL.—Prior to a meeting of an 
advisory committee regarding 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 Government employee or special 
Government employee shall disclose to the Secretary 
financial interests in accordance with subsection (b) 
of such section 208. 
‘‘(2) FINANCIAL INTEREST OF ADVISORY COM-
MITTEE MEMBER OR FAMILY MEMBER.—No member
191 
of an advisory committee may vote with respect to 
any matter considered by the advisory committee if 
such member (or an immediate family member of 
such member) has a financial interest that could be 
affected by the advice given to the Secretary with re-
spect to such matter, excluding interests exempted 
in regulations issued by the Director of the Office of 
Government Ethics as too remote or inconsequential 
to affect the integrity of the services of the Govern-
ment officers or employees to which such regulations 
apply. 
‘‘(3) WAIVER.—The Secretary may grant a 
waiver of the prohibition in paragraph (2) if such 
waiver is necessary to afford the advisory committee 
essential expertise. 
‘‘(4) LIMITATIONS.— 
‘‘(A) ONE WAIVER PER COMMITTEE MEET-
ING.—Notwithstanding any other provision of 
this section, with respect to each advisory com-
mittee, the Secretary shall not grant more than 
1 waiver under paragraph (3) per committee 
meeting. 
‘‘(B) SCIENTIFIC
WORK.—The Secretary 
may not grant a waiver under paragraph (3)
192 
for a member of an advisory committee when 
the member’s own scientific work is involved. 
‘‘(5) 
DISCLOSURE
OF
WAIVER.—Notwith-
standing section 107(a)(2) of the Ethics in Govern-
ment Act (5 U.S.C. App.), the following shall apply: 
‘‘(A) 15 OR MORE DAYS IN ADVANCE.—As 
soon as practicable, but in no case later than 
15 days prior to a meeting of an advisory com-
mittee to which a written determination as re-
ferred to in section 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 waiver as referred to in para-
graph (3) applies, the Secretary shall disclose 
(other than information exempted from disclo-
sure under section 552 of title 5, United States 
Code, and section 552a of title 5, United States 
Code (popularly known as the Freedom of In-
formation Act and the Privacy Act of 1974, re-
spectively)) on the Internet website of the Food 
and Drug Administration— 
‘‘(i) the type, nature, and magnitude 
of the financial interests of the advisory 
committee member to which such deter-
193 
mination, certification, or waiver applies; 
and 
‘‘(ii) the reasons of the Secretary for 
such determination, certification, or waiv-
er. 
‘‘(B) LESS THAN 30 DAYS IN ADVANCE.— 
In the case of a financial interest that becomes 
known to the Secretary less than 30 days prior 
to a meeting of an advisory committee to which 
a written determination as referred to in section 
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 
waiver as referred to in paragraph (3) applies, 
the Secretary shall disclose (other than infor-
mation exempted from disclosure under section 
552 of title 5, United States Code, and section 
552a of title 5, United States Code) on the 
Internet website of the Food and Drug Admin-
istration, the information described in clauses 
(i) and (ii) of subparagraph (A) as soon as 
practicable after the Secretary makes such de-
termination, certification, or waiver, but in no 
case later than the date of such meeting.
194 
‘‘(d) PUBLIC RECORD.—The Secretary shall ensure 
that the public record and transcript of each meeting of 
an advisory committee includes the disclosure required 
under subsection (c)(5) (other than information exempted 
from disclosure under section 552 of title 5, United States 
Code, and section 552a of title 5, United States Code). 
‘‘(e) ANNUAL REPORT.—Not later than February 1 
of each year, the Secretary shall submit to the Committee 
on Appropriations and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate, and the Com-
mittee on Appropriations and the Committee on Energy 
and Commerce of the House of Representatives a report 
that describes— 
‘‘(1) with respect to the fiscal year that ended 
on September 30 of the previous year, the number 
of vacancies on each advisory committee, the number 
of nominees received for each committee, and the 
number of such nominees willing to serve; 
‘‘(2) with respect to such year, the aggregate 
number of disclosures required under subsection 
(c)(5) for each meeting of each advisory committee 
and the percentage of individuals to whom such dis-
closures did not apply who served on such committee 
for each such meeting;
195 
‘‘(3) with respect to such year, the number of 
times the disclosures required under subsection 
(c)(5) occurred under subparagraph (B) of such sub-
section; and 
‘‘(4) how the Secretary plans to reduce the 
number of vacancies reported under paragraph (1) 
during the fiscal year following such year, and mech-
anisms to encourage the nomination of individuals 
for service on an advisory committee, including those 
who are classified by the Food and Drug Adminis-
tration as academicians or practitioners. 
‘‘(f) PERIODIC REVIEW
OF GUIDANCE.—Not less 
than once every 5 years, the Secretary shall review guid-
ance of the Food and Drug Administration regarding con-
flict of interest waiver determinations with respect to advi-
sory committees and update such guidance as necessary.’’. 
(b) CONFORMING AMENDMENT.—Section 505(n) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(n)) is amended— 
(1) by striking paragraph (4); and 
(2) by redesignating paragraphs (5), (6), (7), 
and (8) as paragraphs (4), (5), (6), and (7), respec-
tively. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect on October 1, 2007.
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TITLE VIII—CLINICAL TRIAL 
DATABASES 
SEC. 801. CLINICAL TRIAL REGISTRY DATABASE AND CLIN-
ICAL TRIAL RESULTS DATABASE. 
(a) IN GENERAL.—Title IV of the Public Health 
Service Act (42 U.S.C. 281 et seq.) is amended— 
(1) in section 402, by striking subsection (i); 
and 
(2) by inserting after section 492B the fol-
lowing new section: 
‘‘SEC. 492C. CLINICAL TRIAL REGISTRY DATABASE; CLIN-
ICAL TRIAL RESULTS DATABASE. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) APPLICABLE CLINICAL TRIAL.—The term 
‘applicable clinical trial’— 
‘‘(A) means a clinical trial that is con-
ducted to test the safety or effectiveness (in-
cluding comparative effectiveness) of a drug or 
device (irrespective of whether the clinical trial 
is federally or privately funded, and whether the 
clinical trial involves an approved or unap-
proved drug or device); 
‘‘(B) includes such a clinical trial that is 
conducted outside of the United States if—
197 
‘‘(i) there is an application or pre-
market notification pending before the 
Food and Drug Administration for ap-
proval or clearance of the drug or device 
involved under section 505, 510(k), or 515 
of the Federal Food, Drug, and Cosmetic 
Act or section 351 of this Act; or 
‘‘(ii) the drug or device involved is so 
approved or cleared; and 
‘‘(C) notwithstanding subparagraphs (A) 
and (B), excludes— 
‘‘(i) a clinical trial to determine the 
safety of a use of a drug that is designed 
solely to detect major toxicities in the drug 
or to investigate pharmacokinetics, unless 
the clinical trial is designed to investigate 
pharmacokinetics in a special population or 
populations; and 
‘‘(ii) a small clinical trial to determine 
the feasibility of a device, or a clinical trial 
to test prototype devices where the primary 
focus is feasibility. 
‘‘(2) CLINICAL TRIAL INFORMATION.—The term 
‘clinical trial information’ means those data elements 
that are necessary to complete an entry in the clin-
198 
ical trial registry database under subsection (b) or 
the clinical trial results database under subsection 
(c), as applicable. 
‘‘(3) COMPLETION DATE.—The term ‘comple-
tion date’ means the date of the final collection of 
data from subjects in the clinical trial for the pri-
mary and secondary outcomes to be examined in the 
trial. 
‘‘(4) DEVICE.—The term ‘device’ has the mean-
ing given to that term in section 201(h) of the Fed-
eral Food, Drug, and Cosmetic Act. 
‘‘(5) DRUG.—The term ‘drug’ means a drug as 
defined in section 201(g) of the Federal Food, Drug, 
and Cosmetic Act or a biological product as defined 
in section 351 of this Act. 
‘‘(6) RESPONSIBLE PARTY.—The term ‘respon-
sible party’, with respect to an applicable clinical 
trial, means— 
‘‘(A) the primary sponsor (as defined in 
the International Clinical Trials Registry Plat-
form trial registration data set of the World 
Health Organization) of the clinical trial; or 
‘‘(B) the principal investigator of such clin-
ical trial if so designated by such sponsor, so 
long as the principal investigator is responsible
199 
for conducting the trial, has access to and con-
trol over the data, has the right to publish the 
results of the trial, and has the responsibility to 
meet all of the requirements under this section 
that are applicable to responsible parties. 
‘‘(b) CLINICAL TRIALS REGISTRY DATABASE.— 
‘‘(1) ESTABLISHMENT.—To enhance patient en-
rollment and provide a mechanism to track subse-
quent progress of clinical trials, the Secretary, act-
ing through the Director of NIH, shall establish and 
administer a clinical trial registry database in ac-
cordance with this section (referred to in this section 
as the ‘registry database’). The Director of NIH 
shall ensure that the registry database is made pub-
licly available through the Internet. 
‘‘(2) CONTENT.—The Secretary shall promul-
gate regulations for the submission to the registry 
database of clinical trial information that— 
‘‘(A) conforms to the International Clinical 
Trials Registry Platform trial registration data 
set of the World Health Organization; 
‘‘(B) includes the city, State, and zip code 
for each clinical trial location or a toll free 
number through which such location informa-
tion may be accessed;
200 
‘‘(C) includes a statement of the estimated 
completion date for the clinical trial; 
‘‘(D) includes the identity and contact in-
formation of the responsible party; 
‘‘(E) if the drug is not approved under sec-
tion 505 of the Federal Food, Drug, and Cos-
metic Act or licensed under section 351 of this 
Act, or the device is not cleared under section 
510(k) or approved under section 515 of the 
Federal Food, Drug, and Cosmetic Act, speci-
fies whether or not there is expanded access to 
the drug or device under section 561 of the 
Federal Food, Drug, and Cosmetic Act for 
those who do not qualify for enrollment in the 
clinical trial and how to obtain information 
about such access; 
‘‘(F) includes, with respect to any indi-
vidual who is not an employee of the responsible 
party for the clinical trial or of the manufac-
turer of the drug or device involved, information 
on whether the responsible party or manufac-
turer has entered into any agreement with such 
individual that restricts in any manner the abil-
ity of the individual—