[Federal Register: April 11, 2005 (Volume 70, Number 68)]
[Notices]
[Page 18406-18407]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ap05-97]
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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 May 5, 2005, from 8:30
a.m. to 4:30 p.m.
Location: FDA, Center for Drug Evaluation and Research Conference
Room, rm. 1066, 5630 Fishers Lane, Rockville, 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, 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-
824, proposed trade name ZARNESTRA (tipifarnib) Film Coated Tablets,
Tibotec Therapeutics, a Division of Ortho Biotech, L.P., proposed
indication for the treatment of elderly patients with newly diagnosed
poor-risk acute myeloid leukemia.
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 April 28,
2005. Oral presentations from the public will be scheduled between
approximately 11:30 a.m. to 12:30 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before April 28, 2005,
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 Liza Saavedra 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).
[[Page 18407]]
Dated: April 1, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-7130 Filed 4-8-05; 8:45 am]
BILLING CODE 4160-01-S