[Federal Register Volume 68, Number 130 (Tuesday, July 8, 2003)]
[Notices]
[Page 40678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17134]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0285]


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 the medical and clinical pharmacology 
reviews of pediatric studies submitted in supplements for Hycamtin 
(topotecan), Pulmicort (budesonide), Temodar (temozolomide), Effexor 
(venlafaxine), Ditropan (oxybutynin), Flonase (fluticasone), Allegra 
(fexofenadine), Duragesic (fentanyl), and Monopril (fosinopril). 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: The summaries are available for public examination between 9 
a.m. and 4 p.m., Monday through Friday, in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. 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: Terrie L. Crescenzi, Center for Drug 
Evaluation and Research (HFD-950), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-7337, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of summaries of the medical and 
clinical pharmacology reviews of pediatric studies conducted for 
Hycamtin (topotecan), Pulmicort (budesonide), Temodar (temozolomide), 
Effexor (venlafaxine), Ditropan (oxybutynin), Flonase (fluticasone), 
Allegra (fexofenadine), Duragesic (fentanyl), and Monopril 
(fosinopril). 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 (http://www.fda.gov/cder/pediatric/index.htm) summaries of the medical and 
clinical pharmacology reviews of the pediatric studies submitted in 
supplements for Hycamtin (topotecan), Pulmicort (budesonide), Temodar 
(temozolomide), Effexor (venlafaxine), Ditropan (oxybutynin), Flonase 
(fluticasone), Allegra (fexofenadine), Duragesic (fentanyl), and 
Monopril (fosinopril). Copies are also available for public examination 
in the Division of Dockets Management or may be requested by mail (see 
ADDRESSES).

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 
http://www.fda.gov/cder/pediatric/index.htm.

    Dated: June 27, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-17134 Filed 7-7-03; 8:45 am]
BILLING CODE 4160-01-S