235 
(B) REQUIRED
SUBMISSIONS.—Notwith-
standing the preceding paragraphs of this sub-
section, in any case in which the Secretary de-
termines that submission of clinical trial infor-
mation for an applicable clinical trial (as de-
fined in such section 492C) described in clause 
(i) or (ii) of subparagraph (A) is in the interest 
of the public health— 
(i) the Secretary may require that 
such information be submitted to the Sec-
retary in accordance with such section 
492C; and 
(ii) failure to comply with such a re-
quirement shall be treated as a violation of 
the corresponding requirement of such sec-
tion 492C. 
(7) 
STATUS
OF
CLINICALTRIALS.GOV 
WEBSITE.— 
(A) IN GENERAL.—After receiving public 
comment and not later than 90 days after the 
date of the enactment of this Act, the Secretary 
shall publish in the Federal Register a notice 
determining the more efficient approach to es-
tablishing the registry database described in 
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236 
subsection (b) of such section 492C and wheth-
er such approach is— 
(i) that such registry database should 
expand and build upon the data bank de-
scribed in section 402(i) of the Public 
Health Service Act (as in effect on the day 
before the date of the enactment of this 
Act); or 
(ii) that such registry database should 
supplant the data bank described in such 
section 402(i) (as in effect on the day be-
fore the date of the enactment of this Act). 
(B) CLINICALTRIALS.GOV SUPPLANTED.— 
If the Secretary determines to apply the ap-
proach described under subparagraph (A)(ii), 
the Secretary shall maintain an archive of the 
data bank described in such section 402(i) (as 
in effect on the day before the date of the en-
actment of this Act) on the Internet website of 
the National Library of Medicine. 
SEC. 802. STUDY BY GOVERNMENT ACCOUNTABILITY OF-
FICE. 
(a) IN GENERAL.—The Comptroller General of the 
United States shall conduct a study to determine whether 
information on the trials registry and database is consid-
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237 
ered promotional and to evaluate the implementation of 
this database. 
(b) REPORT.—Not later than one year after the date 
of the enactment of this Act, the Comptroller General shall 
complete the study under subsection (a) and submit to the 
Congress a report on the results of such study. 
TITLE IX—ENHANCED AUTHORI-
TIES 
REGARDING 
POSTMARKET 
SAFETY 
OF 
DRUGS 
SEC. 901. POSTMARKET STUDIES AND CLINICAL TRIALS RE-
GARDING HUMAN DRUGS; RISK EVALUATION 
AND MITIGATION STRATEGIES. 
(a) IN GENERAL.—Section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) is amended by 
adding at the end the following subsections: 
‘‘(o) POSTMARKET STUDIES AND CLINICAL TRIALS; 
LABELING.— 
‘‘(1) IN GENERAL.—A responsible person may 
not introduce or deliver for introduction into inter-
state commerce the new drug involved if the person 
is in violation of a requirement established under 
paragraph (3) or (4) with respect to the drug. 
‘‘(2) DEFINITIONS.—For purposes of this sub-
section: 
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238 
‘‘(A) RESPONSIBLE
PERSON.—The term 
‘responsible person’ means a person who— 
‘‘(i) has submitted to the Secretary a 
covered application that is pending; or 
‘‘(ii) is the holder of an approved cov-
ered application. 
‘‘(B) COVERED
APPLICATION.—The term 
‘covered application’ means— 
‘‘(i) an application under subsection 
(b) for a drug that is subject to section 
503(b); and 
‘‘(ii) an application under section 351 
of the Public Health Service Act. 
‘‘(C) NEW SAFETY INFORMATION; SERIOUS 
RISK.—The terms ‘new safety information’, ‘se-
rious risk’, and ‘signal of a serious risk’ have 
the meanings given such terms in section 505– 
1(b). 
‘‘(3) STUDIES AND CLINICAL TRIALS.— 
‘‘(A) IN GENERAL.—For any or all of the 
purposes specified in subparagraph (B), the 
Secretary may, subject to subparagraph (C), re-
quire a responsible person for a drug to conduct 
a postapproval study or studies of the drug, or 
a postapproval clinical trial or trials of the 
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