[Federal Register: June 30, 2003 (Volume 68, Number 125)]
[Page 38714]
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 July 15, 2003, from 8 
a.m. to 4:30 p.m.
    Location: Center for Drug Evaluation and Research (CDER) Conference 
Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
    Contact Person: Thomas H. Perez, CDER (HFD-21), Food and Drug 
Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers 
Lane, rm. 1093), Rockville, MD 20857, 301-827-6758, 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. Background materials for this meeting, when available, will be 
posted on FDA's Web site 1-business day before the meeting at 
    Agenda: The subcommittee will discuss the following topics: (1) 
Pharmacogenetic testing for thiopurine methyltransferase deficiency in 
patients for whom treatment with 6-mercaptopurine is being considered; 
and (2) overcoming challenges in pediatric oncology product 
development: regulatory oversight of multinational clinical studies.
    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 July 7, 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 July 
7, 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 
    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: June 23, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-16359 Filed 6-27-03; 8:45 am]