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Notice

Oncologic Drugs Advisory Committee; Notice of Meeting

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

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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 meeting.

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 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 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).

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Dated: August 20, 2002.

Linda Arey Skladany,

Senior Associate Commissioner for External Relations.

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[FR Doc. 02-21737 Filed 8-26-02; 8:45 am]

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