[Federal Register: October 1, 2003 (Volume 68, Number 190)]
[Page 56637]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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]