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‘‘(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 
of an advisory committee may vote with respect to 
any matter considered by the advisory committee if 
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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) 
for a member of an advisory committee when 
the member’s own scientific work is involved. 
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‘‘(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-
mination, certification, or waiver applies; 
and 
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‘‘(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. 
‘‘(d) PUBLIC RECORD.—The Secretary shall ensure 
that the public record and transcript of each meeting of 
an advisory committee includes the disclosure required 
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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; 
‘‘(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 
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‘‘(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— 
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‘‘(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-
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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 
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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; 
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‘‘(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— 
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‘‘(i) to discuss the results of the trial 
at a scientific meeting or any other public 
or private forum; or 
‘‘(ii) to publish the results of the trial, 
or a description or discussion of the results 
of the trial, in a scientific or academic 
journal; and 
‘‘(G) requires the inclusion of such other 
data elements to the registry database as ap-
propriate. 
‘‘(3) FORMAT AND STRUCTURE.— 
‘‘(A) SEARCHABLE CATEGORIES.—The Di-
rector of NIH shall ensure that the public may 
search the entries in the registry database by 1 
or more of the following criteria: 
‘‘(i) The indication being studied in 
the clinical trial, using Medical Subject 
Headers (MeSH) descriptors. 
‘‘(ii) The safety issue being studied in 
the clinical trial. 
‘‘(iii) The enrollment status of the 
clinical trial. 
‘‘(iv) The sponsor of the clinical trial. 
‘‘(B) FORMAT.—The Director of the NIH 
shall ensure that the registry database is easily 
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