[Federal Register Volume 69, Number 33 (Thursday, February 19, 2004)]
[Notices]
[Pages 7761-7762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3644]


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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 Ciloxan 
(ciprofloxacin ophthalmic), Brevibloc (esmolol), Flovent (fluticasone), 
Fludara (fludarabine), Fosamax (alendronate), Lotensin (benazepril), 
Malarone (atovaquone and proguanil), Xenical (orlistat), and Ocuflox 
(ofloxacin ophthalmic). The summaries are being made available 
consistent with section 9 of 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: Grace N. Carmouze, Center for Drug 
Evaluation and Research (HFD-960), 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 medical and 
clinical pharmacology reviews of pediatric studies conducted for 
Ciloxan (ciprofloxacin ophthalmic), Brevibloc (esmolol), Flovent 
(fluticasone), Fludara (fludarabine), Fosamax (alendronate), Lotensin 
(benazepril), Malarone (atovaquone and proguanil), Xenical (orlistat), 
and Ocuflox (ofloxacin ophthalmic). 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

[[Page 7762]]

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 
Ciloxan (ciprofloxacin ophthalmic), Brevibloc (esmolol), Flovent 
(fluticasone), Fludara (fludarabine), Fosamax (alendronate), Lotensin 
(benazepril), Malarone (atovaquone and proguanil), Xenical (orlistat), 
and Ocuflox (ofloxacin ophthalmic). 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: February 12, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-3644 Filed 2-18-04; 8:45 am]
BILLING CODE 4160-01-S