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121 STAT. 920

Penalties.

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VerDate Aug 31 2005

19:49 Oct 12, 2007

PUBLIC LAW 110–85—SEPT. 27, 2007

have any bearing on the accuracy of the information
in the entry.’.
‘‘(vi) COMPLIANCE SEARCHES.—The Director of NIH
shall provide that the public may easily search the
registry and results data bank for entries that include
notices required under this subparagraph.
‘‘(6) LIMITATION ON DISCLOSURE OF CLINICAL TRIAL
INFORMATION.—
‘‘(A) IN GENERAL.—Nothing in this subsection (or under
section 552 of title 5, United States Code) shall require
the Secretary to publicly disclose, by any means other
than the registry and results data bank, information
described in subparagraph (B).
‘‘(B) INFORMATION DESCRIBED.—Information described
in this subparagraph is—
‘‘(i) information submitted to the Director of NIH
under this subsection, or information of the same general nature as (or integrally associated with) the
information so submitted; and
‘‘(ii) information not otherwise publicly available,
including because it is protected from disclosure under
section 552 of title 5, United States Code.
‘‘(7) AUTHORIZATION OF APPROPRIATIONS.—There are
authorized to be appropriated to carry out this subsection
$10,000,000 for each fiscal year.’’.
(b) CONFORMING AMENDMENTS.—
(1) PROHIBITED ACTS.—Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding
at the end the following:
‘‘(jj)(1) The failure to submit the certification required by section
402(j)(5)(B) of the Public Health Service Act, or knowingly submitting a false certification under such section.
‘‘(2) The failure to submit clinical trial information required
under subsection (j) of section 402 of the Public Health Service
Act.
‘‘(3) The submission of clinical trial information under subsection (j) of section 402 of the Public Health Service Act that
is false or misleading in any particular under paragraph (5)(D)
of such subsection (j).’’.
(2) CIVIL MONEY PENALTIES.—Subsection (f) of section 303
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333),
as redesignated by section 226, is amended—
(A) by redesignating paragraphs (3), (4), and (5) as
paragraphs (5), (6), and (7), respectively;
(B) by inserting after paragraph (2) the following:
‘‘(3)(A) Any person who violates section 301(jj) shall be subject
to a civil monetary penalty of not more than $10,000 for all violations adjudicated in a single proceeding.
‘‘(B) If a violation of section 301(jj) is not corrected within
the 30-day period following notification under section 402(j)(5)(C)(ii),
the person shall, in addition to any penalty under subparagraph
(A), be subject to a civil monetary penalty of not more than $10,000
for each day of the violation after such period until the violation
is corrected.’’;
(C) in paragraph (2)(C), by striking ‘‘paragraph (3)(A)’’
and inserting ‘‘paragraph (5)(A)’’;

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