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Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

Agenda:
The subcommittee will discuss the following topics: (1) Safety monitoring in clinical studies enrolling children with cancer, and (2) the use of nonclinical data to supplement clinical data for evaluation of cancer therapies.

Background material and meeting information will become available no later than the day before the meeting (Simply select the appropriate committee link).

Procedure:
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by March 10, 2004. Oral presentations from the public will be scheduled between approximately 10:30 a.m. and 11 a.m. and between approximately 2:30 p.m. and 3 p.m.. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before March 10, 2004, 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. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Beverly O’Neill at 301–827–7001 at least 7 days in advance of the meeting.

Contact Person:
Johanna M. Clifford, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301–827–7001, FAX: 301–827–6776, e-mail: cliffordj@cder.fda.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code3014512542. Please call the Information Line for up-to-date information on this meeting.

[ Full FR Notice ]