Document ID: FDA-2008-N-0324-0001
Agency: fda
Document Type: Notice
Title: Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability
Posted Date: 2008-06-11T04:00Z

[Federal Register: June 11, 2008 (Volume 73, Number 113)]
[Notices]               
[Page 33096-33097]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jn08-64]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0324]

 
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 ABILIFY 
(aripiprazole), ANDROGEL (testosterone), and DIOVAN (valsartan). These 
summaries are being made available consistent with the Best 
Pharmaceuticals for Children Act, enacted in 2002, (the 2002 BPCA). For 
all pediatric supplements submitted under the 2002 BPCA, the 2002 BPCA 
required FDA to make available to the public, including by publication 
in the Federal Register, 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, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, Silver Spring, MD 20993-0002. 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. 6460, Silver Spring, MD 20993-0002, 301-
796-0700, e-mail: grace.carmouze@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of summaries of medical and 
clinical

[[Page 33097]]

pharmacology reviews of pediatric studies conducted for ABILIFY 
(aripiprazole), ANDROGEL (testosterone), and DIOVAN (valsartan). The 
summaries are being made available consistent with section 9 of the 
2002 BPCA (Public Law 107-109). Enacted on January 4, 2002, the 2002 
BPCA reauthorized, 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 2002 BPCA added to the pediatric 
exclusivity program pertains to the dissemination of pediatric 
information. Specifically, for all pediatric supplements submitted 
under the 2002 BPCA, the 2002 BPCA required FDA to make available to 
the public, including by publication in the Federal Register, a summary 
of the medical and clinical pharmacology reviews of pediatric studies 
conducted for the supplement within 180 days of study submission to FDA 
(21 U.S.C. 355a(j)(1)).
    The pediatric exclusivity program described in section 505A of the 
act again was reauthorized on September 27, 2007, in title V of the 
Food and Drug Administration Amendments Act (FDAAA) (Public Law 110-
85). FDAAA revised the public dissemination provision previously found 
in 21 U.S.C. 355a(j)(1). As revised, not later than 210 days after the 
date of submission of a report on a pediatric study conducted under the 
pediatric exclusivity program, FDA must make available to the public 
the medical, statistical, and clinical pharmacology reviews of the 
pediatric studies (21 U.S.C. 355a(k)(1)). Under FDAAA, publication in 
the Federal Register is no longer required. FDA currently posts these 
reviews on the Internet at http://www.fda.gov/cder/pediatric/BpcaPrea_
full_review.htm.
    The three sets of summaries being announced in this issue of the 
Federal Register are the last summaries of reviews of supplements 
subject to the 2002 BPCA dissemination provision. Because publication 
in the Federal Register is no longer required, this will be the last 
notice announcing the availability of summaries of medical and clinical 
pharmacology reviews of pediatric studies conducted under the pediatric 
exclusivity program. 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 
ABILIFY (aripiprazole), ANDROGEL (testosterone), and DIOVAN 
(valsartan). 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: June 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-13099 Filed 6-10-08; 8:45 am]

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