[Federal Register Volume 62, Number 234 (Friday, December 5, 1997)]
[Notices]
[Page 64387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31808]


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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 December 18, 1997, 8:30 
a.m. to 5:05 p.m., and December 19, 1997, 8 a.m. to 4:35 p.m.
    Location: Holiday Inn, Versailles Ballrooms I, II, and III, 8120 
Wisconsin Ave., Bethesda, MD.
    Contact Person: Jannette O'Neill-Gonzalez, or Robinette Taylor, 
Center for Drug Evaluation and Research (HFD-21), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5455, 
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 December 18, 1997, the committee will discuss: (1) New 
drug application (NDA) supplement 16-295/S-029, Droxia<Register> 
(hydroxyurea capsules, USP), for the treatment of sickle cell anemia in 
adult patients to prevent painful crises and to reduce the need for 
blood transfusions; and (2) NDA 20-798, Depocyt<Register> (cytarabine 
lipid-particle injection), for the intrathecal treatment of neoplastic 
meningitis of patients with solid tumors, lymphoma, or leukemia. On 
December 19, 1997, the committee will discuss: (1) Biologics licensing 
application (BLA) supplement 97-0501, Proleukin/Aldesleukin 
(recombinant human interlukin-2), for the treatment of adult patients 
with metastatic melanoma; and (2) NDA 20-806, Neomark<Register> 
(broxuridine for injection), for use as a cell proliferation marker to 
determine the labeling index in breast 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 December 10, 
1997. Oral presentations from the public will be scheduled between 
approximately 8:35 a.m. and 9:05 a.m. on December 18, 1997, and between 
approximately 8:05 a.m. and 8:35 a.m. on December 19, 1997. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
December 10, 1997, 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.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the December 18, 1997, Oncologic Drugs Advisory Committee meeting. 
Because the agency believes there is some urgency to bring these issues 
to public discussion and qualified members of the Oncologic Drugs 
Advisory Committee were available at this time, the Commissioner 
concluded that it was in the public interest to hold this meeting even 
if there was not sufficient time for the customary 15-day public 
notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: November 26, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-31808 Filed 12-4-97; 8:45 am]
BILLING CODE 4160-01-F