[Federal Register: September 30, 2002 (Volume 67, Number 189)]
[Notices]
[Page 61344]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30se02-65]
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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 October 17, 2002, from 8
a.m. to 4 p.m.
Location: Center for Drug Evaluation and Research Advisory
Committee conference room 1066, 5630 Fishers Lane, Rockville, MD.
Contact Person: Thomas H. Perez, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-6758, or e-mail: PerezT@cder.fda.gov or
the 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 timing of the initiation
of pediatric oncology clinical studies in a drug development program.
The input from this meeting will be used in developing FDA policy to
the application of the pediatric rule and the issuance of written
requests under the Best Pharmaceuticals for Children Act.
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 October 10,
2002. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before October 10, 2002, 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 notify Thomas Perez at least
7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: September, 20, 2002.
Linda Arey Skladany,
Senior Associate Commissioner for External Relations.
[FR Doc. 02-24677 Filed 9-27-02; 8:45 am]
BILLING CODE 4160-01-S