[Federal Register: October 19, 2001 (Volume 66, Number 203)]
[Notices]
[Page 53225]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19oc01-84]
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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 TopperK@cder.fda.gov, 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