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U.S. Department of Health and Human Services

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Federal Register Notice (71FR26102, issued 5/3/2006)

[Federal Register: May 3, 2006 (Volume 71, Number 85)]
[Notices]
[Page 26102]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my06-85]


[[Page 26102]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Summaries of Medical and Clinical Pharmacology Reviews of
Pediatric Studies; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of summaries of medical and clinical pharmacology reviews
of pediatric studies submitted in supplements for AGRYLIN (anagrelide),
ARGATROBAN (argatroban), CLOLAR (clofarabine), and MERIDIA
(sibutramine). These summaries are being made available consistent with
the Best Pharmaceuticals for Children Act (BPCA). For all pediatric
supplements submitted under the BPCA, the BPCA requires FDA to make
available to the public a summary of the medical and clinical
pharmacology reviews of the pediatric studies conducted for the
supplement.

ADDRESSES: Submit written requests for single copies of the summaries
to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Please specify by product name which summary
or summaries you are requesting. Send one self-addressed adhesive label
to assist that office in processing your requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
summaries.

FOR FURTHER INFORMATION CONTACT: Grace Carmouze, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6489, Silver Spring, MD 20993-0002, 301-
796-2200, e-mail: grace.carmouze@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of summaries of medical and
clinical pharmacology reviews of pediatric studies conducted for
AGRYLIN (anagrelide), ARGATROBAN (argatroban), CLOLAR (clofarabine),
and MERIDIA (sibutramine). The summaries are being made available
consistent with section 9 of the BPCA (Public Law 107-109). Enacted on
January 4, 2002, the BPCA reauthorizes, with certain important changes,
the pediatric exclusivity program described in section 505A of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355a).
Section 505A of the act permits certain applications to obtain 6 months
of marketing exclusivity if, in accordance with the requirements of the
statute, the sponsor submits requested information relating to the use
of the drug in the pediatric population.One of the provisions the BPCA
added to the pediatric exclusivity program pertains to the
dissemination of pediatric information. Specifically, for all pediatric
supplements submitted under the BPCA, the BPCA requires FDA to make
available to the public a summary of the medical and clinical
pharmacology reviews of pediatric studies conducted for the supplement
(21 U.S.C. 355a(m)(1)). The summaries are to be made available not
later than 180 days after the report on the pediatric study is
submitted to FDA (21 U.S.C. 355a(m)(1)). Consistent with this provision
of the BPCA, FDA has posted on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/pediatric/index.htm
summaries of medical and clinical pharmacology

reviews of pediatric studies submitted in supplements for AGRYLIN
(anagrelide), ARGATROBAN (argatroban), CLOLAR (clofarabine), and
MERIDIA (sibutramine). Copies are also available by mail (see
ADDRESSES).

II. Electronic Access

Persons with access to the Internet may obtain the document at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/pediatric/index.htm.


Dated: April 26, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-6706 Filed 5-2-06; 8:45 am]

BILLING CODE 4160-01-S