[Federal Register: July 8, 2003 (Volume 68, Number 130)]
[Notices]
[Page 40678]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jy03-78]
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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,
CrescenziT@cder.fda.gov.
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