[Federal Register Volume 63, Number 220 (Monday, November 16, 1998)]
[Notices]
[Page 63740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30453]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Oncologic Drugs Advisory Committee; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of meeting of the Oncologic Drugs Advisory
Committee. This meeting was announced in the Federal Register of
October 29, 1998. The meeting will be open to the public. The amendment
is being made to cancel the entire session on November 17, 1998. There
are no other changes.
FOR FURTHER INFORMATION CONTACT: 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.
SUPPLEMENTARY INFORMATION: In the Federal Register of October 29, 1998
(63 FR 58054), FDA announced that a meeting of the Oncologic Drugs
Advisory Committee would be held on November 16 and 17, 1998. On page
58054, beginning in the second column, the Date and Time, Agenda, and
Procedure portions of this meeting are amended and the Closed Committee
Deliberations portion is removed to read as follows:
Date and Time: The meeting will be held on November 16, 1998, 8:30
a.m. to 5:30 p.m.
Agenda: On November 16, 1998, the committee will discuss: (1) New
drug application (NDA) 20-886 Panretin (alitretinoin) Gel
0.1%, 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.
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 November 9,
1998. 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
November 16, 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, an 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.
Dated: November 5, 1998
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-30453 Filed 11-13-98; 8:45 am]
BILLING CODE 4160-01-F
