Meetings: Oncologic Drugs Advisory Committee,

[Federal Register: November 16, 1998 (Volume 63, Number 220)]

[Notices]

[Page 63740]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr16no98-93]

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.

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‹Register› (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 DepoCyt‹SUP›TM‹/SUP› (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. 98-30453Filed11-13-98; 8:45 am]

BILLING CODE 4160-01-F