[Federal Register: June 24, 2004 (Volume 69, Number 121)]
[Notices]               
[Page 35380]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jn04-84]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
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: 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 27, 2004, from 8:30 
a.m. to 5 p.m.
    Location: Center for Drug Evaluation and Research Advisory 
Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
    Contact Person: Johanna M. Clifford, Food and Drug Administration, 
Center for Drug Evaluation and Research (HFD-21), 5600 Fishers Lane 
(for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 
20857, 301-827-7001, FAX: 301-827-6776, e-mail: cliffordj@cder.fda.gov, 
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 3014512542. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: The committee will discuss new drug application (NDA) 21-
677, ALIMTA (pemetrexed) Eli Lilly, Inc., proposed indication for 
single-agent treatment of patients with locally advanced or metastatic 
nonsmall cell lung cancer after prior 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 July 20, 2004. 
Oral presentations from the public will be scheduled between 
approximately 11 a.m. and 12 noon. Time allotted for each presentation 
may be limited. Those desiring to make formal oral presentations should 
notify the contact person before July 20, 2004, 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 Trevelin Prysock at 
301-827-7001, 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 18, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-14304 Filed 6-23-04; 8:45 am]

BILLING CODE 4160-01-S