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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196 
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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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-
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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 
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