[Federal Register: November 18, 2003 (Volume 68, Number 222)]
[Notices]
[Page 65076-65077]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18no03-75]
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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 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
workshop.
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
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: November 10, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-28687 Filed 11-17-03; 8:45 am]
BILLING CODE 4160-01-S