[Federal Register Volume 63, Number 241 (Wednesday, December 16, 1998)]
[Notices]
[Pages 69299-69300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33290]
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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 regulatory issues.
[[Page 69300]]
Date and Time: The meeting will be held on January 12, 1999, 8:30
a.m. to 5:30 p.m., and January 13, 1999, 8 a.m. to 5 p.m.
Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery
Village Ave., Gaithersburg, 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, 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 January 12, 1999, the committee will discuss: (1) New
drug application (NDA) 21-029, Temodal (temozolomide)
Capsules, Schering Corp., indicated for the treatment of adult patients
with malignant glioma (glioblastoma multiforme and anaplastic
astrocytoma) at first relapse, and (2) NDA 50-766 Prograf
(tacrolimus) capsules, 1 milligram (mg) and 5 mg, and Prograf
(tacrolimus) injection 5 mg (for IV infusion only), Fujisawa
Healthcare, Inc., indicated for the prophylaxis of graft-versus-host
disease in patients receiving allogenic bone marrow transplants. On
January 13, 1999, the committee will discuss: (1) NDA 20-954
BusulfexTM (busulfan) Injection, Orphan Medical, Inc.,
indicated for use in combination with other chemotherapeutic agents
and/or radiotherapy as a conditioning regimen prior to hematopoietic
progenitor cell transplantation. Diseases in which patient benefit from
this mode of therapy has been demonstrated include acute lymphocytic
leukemia, acute nonlymphocytic leukemia, acute myeloid leukemia,
chronic myeloid leukemia, non-Hodgkins lymphoma, Hodgkins disease,
multiple myeloma, myelodysplastic syndrome, breast cancer, ovarian
cancer, and genetic diseases, and (2) NDA 20-765 OraTestTM
(tolonium chloride), Zila, Inc., an oral rinse that is indicated for
use as a diagnostic adjunct in patients with oral lesions suspected or
known to be malignant, to help in detection of all sites of cancer,
definition of borders or cancerous lesions, and selection of sites to
be biopsied.
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 January 4,
1999. Oral presentations from the public will be scheduled between
approximately 8:45 a.m. and 9 a.m., and 1:45 p.m. and 2 p.m. on January
12, 1999; and between approximately 8:15 a.m. and 8:30 a.m., and 1:15
p.m. and 1:30 p.m. on January 13, 1999. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before January 4, 1999,
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. After the scientific presentations, a 30-
minute open public session will be conducted for interested persons,
who have submitted their request to speak by January 4, 1999, to
address issues specific to the submission or topic before the
committee.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: December 8, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-33290 Filed 12-15-98; 8:45 am]
BILLING CODE 4160-01-F
