Document ID: FDA-2012-N-0793-0001
Agency: fda
Document Type: Notice
Title: Requests for Product Nominations: Specific Drug/Biologic Product(s) That Could be Brought Before Pediatric Subcommittee of Oncologic Drugs Advisory Committee
Posted Date: 2012-08-08T04:00Z

[Federal Register Volume 77, Number 153 (Wednesday, August 8, 2012)]
[Notices]
[Page 47397]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19330]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0793]

Request for Nominations of Specific Drug/Biologic Product(s) That 
Could Be Brought Before the Food and Drug Administration's Pediatric 
Subcommittee of the Oncologic Drugs Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for product nominations.

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SUMMARY: The Food and Drug Administration's (FDA) Office of Hematology 
and Oncology Products invites the public to suggest one or more 
specific drug or biologic products that could be brought before the 
December 4, 2012, Pediatric Subcommittee of the Oncologic Drugs 
Advisory Committee (ODAC). The number of drugs studied for use in 
pediatric patients is growing, and we see a reduction in off-label use. 
However, we would like to improve current and future pediatric product 
development by focusing on products whose development would benefit the 
most from the attention of an advisory committee. The company 
developing a product that is brought before the committee will be given 
the unique opportunity to present proposed pediatric studies in the 
United States, share their plans for global pediatric development, and 
hear discussions by the Pediatric Subcommittee on possible directions 
for their current or future pediatric oncology product development.

DATES: Nominations must be received by September 4, 2012, to receive 
consideration for inclusion. Nominations received after this date will 
receive consideration for future meetings of the Pediatric Subcommittee 
of the ODAC.

ADDRESSES: Email nominations to Christine.Lincoln@fda.hhs.gov, and 
please include the subject line ``Suggested Product for 2012 Pediatric 
Oncology Subcommittee of ODAC.''

FOR FURTHER INFORMATION CONTACT: Christine Lincoln, RN, MS, MBA, Center 
for Drug Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 22, Rm. 2206, Silver Spring, MD 20993, 301-
796-4117, Christine.Lincoln@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The Food and Drug Administration (FDA) 
Advisory Committees are an important, transparent interface that allows 
the Agency to include the public in its decision-making processes. 
Significant public health and safety issues are brought before these 
committees for deliberation, and the meetings bring together both 
experts with state-of-the-art knowledge and members of the public with 
relevant personal experiences. This broad participation gives FDA a 
unique perspective as it seeks to assure the safety, efficacy, and 
security of FDA-regulated products.
    Additional information about the prior November 2, 2011, Pediatric 
Oncology Subcommittee of the Oncologic Drugs Advisory Committee may be 
found on FDA's Web site at: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm274396.htm.

    Dated: August 2, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19330 Filed 8-7-12; 8:45 am]
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