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-
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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. 
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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; 
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225 
‘‘(B) whether the responsible party has en-
gaged in a pattern or practice of noncompli-
ance; and 
‘‘(C) the extent to which the noncompli-
ance involved may have significantly misled 
health care providers or patients concerning the 
safety or effectiveness of the drug involved. 
‘‘(4) CIVIL PENALTIES.— 
‘‘(A) IN GENERAL.—A person is subject to 
a civil penalty in accordance with this para-
graph if the person commits a violation de-
scribed in paragraph (1) and fails to correct the 
violation by the end of the 30-day period de-
scribed in subparagraph (B). 
‘‘(B) NOTIFICATION.—If a person is in vio-
lation of paragraph (1), the Secretary shall no-
tify the person of such noncompliance and give 
the person a 30-day period to correct such vio-
lation before imposing a civil penalty under this 
paragraph. 
‘‘(C) AMOUNT OF PENALTY.—The amount 
of a civil penalty under this subsection shall be 
not more than a total of $15,000 for all viola-
tions adjudicated in a single proceeding in the 
case of an individual, and not more than 
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