[Federal Register Volume 63, Number 209 (Thursday, October 29, 1998)]
[Notices]
[Page 58054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28905]
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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). At least one
portion of the meeting will be closed 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 November 16, 1998, 8:30
a.m. to 5:30 p.m., and on November 17, 1998, 8 a.m. to 5 p.m.
Location: Holiday Inn, Kennedy Grand Ballroom, 8777 Georgia Ave.,
Silver Spring, 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 November 16, 1998, the committee will discuss: (1) New
drug application (NDA) 20-886 Panretin (alitretinoin) Gel 0.1
percent, Ligand Pharmaceuticals Inc., indicated for the first-line
topical treatment of cutaneous lesions in patients with acquired immune
deficiency syndrome (AIDS)-related Kaposi's sarcoma; and (2) NDA 21-041
DepoCytTM (cytarabine liposome injection), DepoTech Corp.
indicated for the intrathecal treatment of lymphomatous meningitis. On
November 17, 1998, the committee will discuss the labeling of NDA 17-
970/S-040 Nolvadex (tamoxifen citrate), Zeneca
Pharmaceuticals, and whether the indication should be ``for reducing
the short term incidence of breast cancer'' in women at high risk of
developing the disease or ``as a preventative agent for the reduction
of breast cancer in women at high risk for developing the disease. The
term prevention indicates a reduction in the incidence (risk) of
invasive breast cancer over the period of the NSABP P-1 trial, and does
not necessarily imply that the initiation of breast cancer has been
prevented or that the tumors have been permanently eliminated * * *.''
Procedure: On November 16, 1998, from 8:30 a.m. to 5:30 p.m., and
on November 17, 1998, from 8 a.m. to 1:30 p.m., the meeting is open to
the public. 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 November 9, 1998. Oral
presentations from the public will be scheduled between approximately
8:45 a.m. and 9 a.m., and between approximately 1:45 p.m. and 2 p.m. on
November 16, 1998, and between approximately 8:15 a.m. and 8:45 a.m. on
November 17, 1998. Time allotted for each presentation may be limited.
Those desiring to make formal oral presentations should notify the
contact person before November 9, 1998, 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 November 9, 1998, to address issues specific to the submission
or topic before the committee.
Closed Committee Deliberations: On November 17, 1998, from 1:30
p.m. to 5 p.m., the meeting will be closed to permit discussion where
disclosure would constitute a clearly unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). The committee will discuss personal
conflict of interest issues.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: October 22, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-28905 Filed 10-28-98; 8:45 am]
BILLING CODE 4160-01-F
