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U.S. Department of Health and Human Services

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Federal Register Notice (69FR33043, issued 6/14/2004)

[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