121 STAT. 880
Publication.
Deadline. Records.
Publication.
Deadline.
dkrause on GSDDPC44 with PUBLAW
Public information. Web site.
VerDate Aug 31 2005
08:41 Jul 13, 2009
PUBLIC LAW 110–85—SEPT. 27, 2007
‘‘(4) EFFECT OF SUBSECTION.—Nothing in this subsection alters or amends section 301(j) of this Act or section 552 of title 5 or section 1905 of title 18, United States Code. ‘‘(e) NOTICE OF DETERMINATIONS ON STUDIES REQUIREMENT.— ‘‘(1) IN GENERAL.—The Secretary shall publish a notice of any determination, made on or after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, that the requirements of subsection (d) have been met and that submissions and approvals under subsection (b)(2) or (j) of section 505 for a drug will be subject to the provisions of this section. Such notice shall be published not later than 30 days after the date of the Secretary’s determination regarding market exclusivity and shall include a copy of the written request made under subsection (b) or (c). ‘‘(2) IDENTIFICATION OF CERTAIN DRUGS.—The Secretary shall publish a notice identifying any drug for which, on or after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, a pediatric formulation was developed, studied, and found to be safe and effective in the pediatric population (or specified subpopulation) if the pediatric formulation for such drug is not introduced onto the market within one year after the date that the Secretary publishes the notice described in paragraph (1). Such notice identifying such drug shall be published not later than 30 days after the date of the expiration of such one year period. ‘‘(f) INTERNAL REVIEW OF WRITTEN REQUESTS AND PEDIATRIC STUDIES.— ‘‘(1) INTERNAL REVIEW.—The Secretary shall utilize the internal review committee established under section 505C to review all written requests issued on or after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, in accordance with paragraph (2). ‘‘(2) REVIEW OF WRITTEN REQUESTS.—The committee referred to in paragraph (1) shall review all written requests issued pursuant to this section prior to being issued. ‘‘(3) REVIEW OF PEDIATRIC STUDIES.—The committee referred to in paragraph (1) may review studies conducted pursuant to this section to make a recommendation to the Secretary whether to accept or reject such reports under subsection (d)(3). ‘‘(4) ACTIVITY BY COMMITTEE.—The committee referred to in paragraph (1) may operate using appropriate members of such committee and need not convene all members of the committee. ‘‘(5) DOCUMENTATION OF COMMITTEE ACTION.—For each drug, the committee referred to in paragraph (1) shall document, for each activity described in paragraph (2) or (3), which members of the committee participated in such activity. ‘‘(6) TRACKING PEDIATRIC STUDIES AND LABELING CHANGES.—The Secretary, in consultation with the committee referred to in paragraph (1), shall track and make available to the public, in an easily accessible manner, including through posting on the Web site of the Food and Drug Administration— ‘‘(A) the number of studies conducted under this section and under section 409I of the Public Health Service Act; ‘‘(B) the specific drugs and drug uses, including labeled and off-labeled indications, studied under such sections;
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