[Federal Register Volume 65, Number 26 (Tuesday, February 8, 2000)]
[Notices]
[Page 6214]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-2770]


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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's regulatory issues.
    Date and Time: The meeting will be held on March 16, 2000, from 
8:30 a.m. to 5:30 p.m., and March 17, 2000, from 8 a.m. to 1 p.m.
    Location: Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave., 
Bethesda, 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 March 16, 2000, the committee will discuss: (1) New drug 
application (NDA) 21-063, Eloxatin<Register> (oxaliplatin), Sanofi 
Pharmaceuticals, Inc., indicated for the first-line treatment of 
patients with advanced colorectal cancer in combination with 5-U based 
chemotherapy; and (2) NDA 20-571/SE1-009, Camptosar<Register> Injection 
(irinotecan hydrochloride injection), Pharmacia and Upjohn Co., 
indicated as a component of first-line therapy for patients with 
metastatic carcinoma of the colon or rectum. On March 17, 2000, the 
committee will discuss NDA 21-174, gemtuzumab zogamicin, Wyeth-Ayerst 
Laboratories, indicated for the treatment of patients with CD33 
positive acute myeloid leukemia in relapse.
    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 March 8, 2000. 
Oral presentations from the public will be scheduled between 
approximately 8:45 a.m. and 9:15 a.m., and 1:30 p.m. and 1:45 p.m. on 
March 16, 2000, and between approximately 8:15 a.m. and 8:45 a.m. on 
March 17, 2000. Time allotted for each presentation may be limited. 
Those desiring to make formal oral presentations should notify the 
contact person before March 8, 2000, 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 may be 
conducted for interested persons who have submitted their request to 
speak by March 8, 2000, to address issues specific to the submission or 
topic before the committee.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: January 28, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-2770 Filed 2-7-00; 8:45 am]
BILLING CODE 4160-01-F