[Federal Register: October 1, 2003 (Volume 68, Number 190)]
[Notices]
[Page 56637]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01oc03-72]
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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 9, 2003, from 8
a.m. to 4:30 p.m.
Location: Holiday Inn, Kennedy Ballroom, 8777 Georgia Ave., Silver
Spring, MD.
Contact Person: Thomas H. Perez, 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, by phone at 301-827-6758, or by e-mail at 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: (1) Consider off-patent oncology
drugs for which pediatric studies are needed and discuss the
availability of information concerning the safe and effective use of
the drugs in the pediatric population, whether additional information
is needed, and whether new pediatric studies concerning the drugs may
produce health benefits in the pediatric population, as mandated by the
Best Pharmaceuticals for Children Act (BPCA), and (2) discuss age-
appropriate formulation changes to facilitate dosing of products used
in the pediatric oncology 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 October 2,
2003. Oral presentations from the public will be scheduled between
approximately 10 a.m. and 10:30 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
October 2, 2003, 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.
FDA regrets that it was unable to publish this notice 15 days prior
to the October 9, 2003, Pediatric Oncology Subcommittee of the
Oncologic Drugs Advisory Committee meeting. Because the agency believes
there is some urgency to bring these issues to public discussion and
qualified members of the committee were available at this time, the
Commissioner of Food and Drugs concluded that it was in the public
interest to hold this meeting even if there was not sufficient time for
the customary 15-day public notice.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: September 26, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-24920 Filed 9-26-03; 4:13 pm]
BILLING CODE 4160-01-S