[Federal Register Volume 66, Number 203 (Friday, October 19, 2001)]
[Notices]
[Page 53225]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-26314]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Pediatric Oncology Subcommittee of the Oncologic 
Drugs Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on November 28, 2001, from 
8 a.m. to 5 p.m.
    Location: Holiday Inn, Ballrooms A and B, Two Montgomery Village 
Ave., Gaithersburg, MD.
    Contact: Kimberly Littleton Topper or Karen M. Templeton-Somers, 
Center for Drug Evaluation and Research (HFD-21), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7001, 
or by e-mail at [email protected], or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12542. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: The subcommittee will discuss the implementation of the 
pediatric rule with regard to study designs, ethical and developmental 
considerations, and extrapolation of findings from adult to pediatric 
cancer patients.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the subcommittee. 
Written submissions may be made to the contact person by November 16, 
2001. Oral presentations from the public will be scheduled between 
approximately 8:15 a.m. and 8:45 a.m., and 1 p.m. and 1:30 p.m. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
November 16, 2001, and submit a brief statement of the general nature 
of the evidence or arguments they wish to present, the names and 
addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 12, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-26314 Filed 10-18-01; 8:45 am]
BILLING CODE 4160-01-S