220 
‘‘(i) IN GENERAL.—If, based on a re-
view of the entries in the registry database 
under subsection (b), the Director of NIH 
determines that a responsible party has 
failed to submit required clinical trial in-
formation to the results database under 
subsection (c), the Director of NIH shall 
inform the responsible party involved of 
such failure and permit the responsible 
party to correct the failure within 30 days. 
‘‘(ii) FAILURE TO CORRECT.—If the 
responsible party does not correct a failure 
to submit required clinical trial informa-
tion within the 30-day period described 
under clause (i), the Director of NIH shall 
report such noncompliance to the scientific 
peer review committees of the Federal re-
search agencies and to the Office of 
Human Research Protections. 
‘‘(iii) PUBLIC NOTICE OF FAILURE TO 
CORRECT.—The Director of NIH shall in-
clude in the clinical trial registry database 
entry and the clinical trial results database 
entry for each applicable clinical trial a no-
tice of any uncorrected failure to submit
221 
required clinical trial information and shall 
provide that the public may easily search 
for such entries. 
‘‘(3) ACTION ON APPLICATIONS.— 
‘‘(A) VERIFICATION
PRIOR
TO
FILING.— 
The Secretary, acting through the Commis-
sioner of Food and Drugs, shall verify that the 
clinical trial information required under sub-
sections (b) and (c) for an applicable clinical 
trial is submitted pursuant to such subsections, 
as applicable— 
‘‘(i) when considering a drug or device 
for an exemption under section 505(i) or 
section 520(g) of the Federal Food, Drug, 
and Cosmetic Act; and 
‘‘(ii) prior to filing an application or 
premarket notification under section 505, 
510(k), or 515 of the Federal Food, Drug, 
and Cosmetic Act or section 351 of this 
Act, that includes information from such 
clinical trial. 
‘‘(B) NOTIFICATION.—If the Secretary de-
termines under subparagraph (A) that clinical 
trial information has not been submitted as re-
quired by subsection (b) or (c), the Secretary
222 
shall notify the applicant and the responsible 
party of such noncompliance and require sub-
mission of such information within 30 days. 
‘‘(C) REFUSAL TO FILE.—If the respon-
sible party does not remedy such noncompliance 
within 30 days of receipt of notification under 
subparagraph (B), the Secretary shall refuse to 
file, approve, or clear such application or pre-
market notification. 
‘‘(4) CONTENT REVIEW.— 
‘‘(A) IN
GENERAL.—To ensure that the 
summary documents described in subsection 
(c)(3) are non-promotional, and are not false or 
misleading in any particular under subsection 
(c)(5), the Secretary shall compare such docu-
ments to the results data of the clinical trial for 
a representative sample of applicable clinical 
trials by— 
‘‘(i) acting through the Commissioner 
of Food and Drugs to examine the results 
data for such clinical trials submitted to 
Secretary when such data are submitted— 
‘‘(I) for review as part of an ap-
plication under section 505 or 515 of 
the Federal Food, Drug, and Cos-
223 
metic Act or under section 351 of this 
Act or a premarket notification under 
section 510(k) of the Federal Food, 
Drug, and Cosmetic Act; or 
‘‘(II) in an annual status report 
on the drug or device under such ap-
plication; 
‘‘(ii) acting with the Federal agency 
that funds such clinical trial in whole or in 
part by a grant to examine the results data 
for such clinical trials; and 
‘‘(iii) acting through inspections under 
section 704 of the Federal Food, Drug, 
and Cosmetic Act to examine results data 
for such clinical trials not described in 
clause (i) or (ii). 
‘‘(B) NOTICE OF NONCOMPLIANCE.—If the 
Secretary determines that the clinical trial in-
formation submitted in such a summary docu-
ment is false or misleading in any particular, 
the Secretary shall notify the responsible party 
and give such party an opportunity to remedy 
such noncompliance by submitting the required 
revised clinical trial information within 30 days 
of such notification.
224 
‘‘(f) PENALTIES FOR NONCOMPLIANCE.— 
‘‘(1) IN GENERAL.—The following acts and the 
causing thereof are unlawful: 
‘‘(A) The failure to submit clinical trial in-
formation as required by this section. 
‘‘(B) The submission of clinical trial infor-
mation under this section that is false or mis-
leading in any particular in violation of sub-
section (b)(5) or (c)(5). 
‘‘(2) CERTAIN PENALTIES.—Section 303(a) of 
the Federal Food, Drug, and Cosmetic Act applies 
with respect to a violation of paragraph (1) to the 
same extent and in the same manner as such section 
303(a) applies with respect to a violation of section 
301 of such Act. 
‘‘(3) CONSIDERATIONS.—In determining wheth-
er to apply a penalty under paragraph (2) or under 
paragraph (4) for a violation described in paragraph 
(1), the Secretary, acting through the Commissioner 
of Food and Drugs, shall consider— 
‘‘(A) 
whether 
the 
responsible 
party 
promptly corrects the noncompliance when pro-
vided notice;