[Federal Register: August 24, 2000 (Volume 65, Number 165)]
[Notices]               
[Page 51624]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24au00-91]                         

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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 September 12, 2000, 1 
p.m. to 5:30 p.m.
    Location: Hyatt Regency, One Bethesda Metro Center, Bethesda, MD.
    Contact Person: 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, e-mail: 
SomersK@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 parameters used in oncology 
for extrapolation from the adult to the pediatric setting.
    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 September 6, 
2000. Oral presentations from the public will be scheduled between 
approximately 1:15 p.m. and 2:15 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before September 6, 
2000, 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. After the scientific 
presentations, a 30-minute open public session may be conducted for 
interested persons who have submitted their request to speak by 
September 6, 2000, to address issues specific to the topic before the 
subcommittee.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: August 15, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-21561 Filed 8-23-00; 8:45 am]
BILLING CODE 4160-01-F