[Federal Register: November 18, 2003 (Volume 68, Number 222)]
[Page 65076-65077]
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.

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 December 16, 2003, from 
8 a.m. to 5 p.m.

[[Page 65077]]

    Location: Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Ave., 
Bethesda, MD.
    Contact Person: Johanna M. Clifford, 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, 301-827-7001, FAX: 301-827-6776 or 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 12542. Please call the Information 
Line for up-to-date information on this meeting.
    Agenda: The committee will discuss: (1) General issues on clinical 
trial design and endpoints; and (2) non-small cell lung cancer 
endpoints as a follow-up to issues discussed at an April 15, 2003, FDA 
    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 December 
9, 2003. Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. and 11 a.m., and between approximately 2:30 
p.m. and 3 p.m. Time allotted for each presentation may be limited. 
Those desiring to make formal oral presentations should notify the 
contact person before December 9, 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 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: November 10, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-28687 Filed 11-17-03; 8:45 am]