[Federal Register: June 14, 2004 (Volume 69, Number 113)]
[Notices]               
[Page 33043]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jn04-94]                         

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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 Cipro 
(ciprofloxacin), Corlopam (fenoldopam), Glucovance (glyburide and 
metformin), Arava (leflunomide), Viracept (nelfinavir), Concerta 
(methylphenidate), Zemplar (paricalcitol), Zomig (zolmitriptan), and 
Ortho Tri-Cyclen (norgestimate and ethinyl estradiol). The 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 (HFD-960), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-7337, 
carmouzeg@cder.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of summaries of medical and 
clinical pharmacology reviews of pediatric studies conducted for Cipro 
(ciprofloxacin), Corlopam (fenoldopam), Glucovance (glyburide and 
metformin), Arava (leflunomide), Viracept (nelfinavir), Concerta 
(methylphenidate), Zemplar (paricalcitol), Zomig (zolmitriptan), and 
Ortho Tri-Cyclen (norgestimate and ethinyl estradiol). 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 (21 U.S.C. 
355a). Section 505A 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 (http://www.fda.gov/cder/pediatric/index.htm
) summaries of medical and 

clinical pharmacology reviews of pediatric studies submitted in 
supplements for Cipro (ciprofloxacin), Corlopam (fenoldopam), 
Glucovance (glyburide and metformin), Arava (leflunomide), Viracept 
(nelfinavir), Concerta (methylphenidate), Zemplar (paricalcitol), Zomig 
(zolmitriptan), and Ortho Tri-Cyclen (norgestimate and ethinyl 
estradiol). 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, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-13217 Filed 6-10-04; 8:45 am]
BILLING CODE 4160-01-S