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U.S. Department of Health and Human Services

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Federal Register Notice (70FR43440, issued 7/27/2005)

[Federal Register: July 27, 2005 (Volume 70, Number 143)]
[Notices]
[Page 43440]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jy05-98]

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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 ADDERALL XR (mixed
salts of a single-entity amphetamine product), AVANDIA (rosiglitazone),
AVAPRO (irbesartan), RAPAMUNE (sirolimus), and ZOFRAN (ondansetron).
These 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: 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, e-mail:
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
ADDERALL XR (mixed salts of a single-entity amphetamine product),
AVANDIA (rosiglitazone), AVAPRO (irbesartan), RAPAMUNE (sirolimus), and
ZOFRAN (ondansetron). 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 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 at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/pediatric/index.htm, summaries of medical and

clinical pharmacology reviews of pediatric studies submitted in
supplements for ADDERALL XR (mixed salts of a single-entity amphetamine
product), AVANDIA (rosiglitazone), AVAPRO (irbesartan), RAPAMUNE
(sirolimus), and ZOFRAN (ondansetron). Copies are also available by
mail (see ADDRESSES).

II. Electronic Access

Persons with access to the Internet may obtain the document at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/pediatric/index.htm.


Dated: July 20, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-14747 Filed 7-26-05; 8:45 am]

BILLING CODE 4160-01-S