[Federal Register Volume 71, Number 85 (Wednesday, May 3, 2006)]
[Notices]
[Page 26102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-6706]



[[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: [email protected].

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://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://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