[Federal Register: August 27, 2002 (Volume 67, Number 166)]
[Page 55024-55025]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

[[Page 55025]]

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: 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 September 24, 2002, from 
8:30 a.m. to 1:30 p.m.
    Location: Holiday Inn, Kennedy Ballroom, 8777 Georgia Ave., Silver 
Spring, MD.
    Contact Person: Karen M. Templeton-Somers, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7001, e-mail: 
SomersK@cder.fda.gov, or 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 
    Agenda: On September 24, 2002, the committee will discuss new drug 
application (NDA) 21-399, IRESSAr (gefitinib), AstraZeneca 
Pharmaceuticals LP, indicated for the treatment of patients with 
locally advanced or metastatic non-small cell lung cancer who have 
previously received platinum-based chemotherapy.
    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 September 16, 
2002. Oral presentations from the public will be scheduled between 
approximately 8:45 a.m. and 9:45 a.m. on September 24, 2002. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
September 16, 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 
    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 Karen Templeton-
Somers 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: August 20, 2002.
Linda Arey Skladany,
Senior Associate Commissioner for External Relations.
[FR Doc. 02-21737 Filed 8-26-02; 8:45 am]