[Federal Register Volume 63, Number 93 (Thursday, May 14, 1998)]
[Notices]
[Page 26808]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12756]


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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.
    Date and Time: The meeting will be held on June 1, 1998, 8:30 a.m. 
to 5:30 p.m., and June 2, 1998, 8 a.m. to 5:30 p.m.
    Location: Gaithersburg Hilton, Grand Ballroom, 620 Perry Pkwy., 
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, 301-443-4090, 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 June 1, 1998, the committee will discuss: (1) New drug 
application (NDA) 20-892 AD 32 (valrubicin 40 milligrams/milliliter), 
Anthra Pharmaceuticals, Inc., indicated for the treatment of refractory 
carcinoma in situ of the urinary bladder; and (2) NDA supplement 20-
449/S-005 Taxotere<Register> (docetaxel) for injection concentrate, 
Rhone-Polenc Rorer Pharmaceuticals, Inc., indicated for the treatment 
of patients with locally advanced or metastatic breast cancer who have 
failed previous chemotherapy. On June 2, 1998, the committee will 
discuss: (1) Biologics license application (BLA) 97-1325 
ONTAK<SUP>TM</SUP> (denileukin diftitox) injection (DAB<INF>389</INF> 
IL-2), Seragen, Inc., indicated for the treatment of cutaneous T-cell 
lymphoma (CTCL); and (2) NDA supplement 20-671/S-004 Hycamtin<Register> 
(topotecan HCl) for injection, SmithKline Beecham Pharmaceuticals, 
indicated for the second-line treatment of patients with small cell 
lung cancer.
    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 May 22, 1998. 
Oral presentations from the public will be scheduled between 
approximately 8:45 a.m. and 9:15 a.m., on June 1, 1998, and between 
approximately 8:15 a.m. and 8:45 a.m., on June 2, 1998. Time allotted 
for each presentation may be limited. Those desiring to make formal 
oral presentations should notify the contact person before May 15, 
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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: May 7, 1998.
 Michael A. Friedman,
 Deputy Commissioner for Operations.
[FR Doc. 98-12756 Filed 5-13-98; 8:45 am]
BILLING CODE 4160-01-F