[Federal Register Volume 64, Number 223 (Friday, November 19, 1999)]
[Notices]
[Page 63324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30213]


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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). At least one 
portion of the meeting will be closed 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 December 13, 1999, 9 
a.m. to 5:30 p.m. and December 14, 1999, 8 a.m. to 5 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 December 13, 1999, the committee will discuss: (1) New 
drug application (NDA) 21-055, Targretin (bexarotene) 
Capsules, 75 milligrams, Ligand Pharmaceuticals, Inc., indicated for 
the treatment of patients with all clinical stages (IA-IVB) of 
cutaneous T-cell lymphoma (CTCL) in the following categories: Patients 
with early stage CTCL who have not tolerated other therapies, patients 
with refractory or persistent early stage CTCL, and patients with 
refractory advanced stage CTCL; and (2) NDA 20-449/S-011, 
Taxotere (docetaxel) for Injection Concentrate, Rhone-Poulenc 
Rorer Pharmaceuticals, Inc., indicated for the treatment of patients 
with locally advanced or metastatic Non-small Cell Lung Cancer after 
failure of prior chemotherapy. On December 14, 1999, the committee will 
discuss: (1) The design and analysis of active control clinical trials; 
and (2) NDA 21-156, CelebrexTM (celecoxib), G. D. Searle & 
Co., indicated for the regression and prevention of adenomatous polyps, 
which may lead to the development of colorectal cancer in patients with 
familial adenomatous polyposis.
    Procedure: On December 13, 1999, from 9 a.m. to 5:30 p.m., and on 
December 14, 1999, from 8 a.m. to 3 p.m., the meeting is open to the 
public. 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 3, 1999. Oral 
presentations from the public will be scheduled between approximately 
9:15 a.m. and 9:30 a.m., and between approximately 1:30 p.m. and 1:45 
p.m. on December 13, 1999, and between approximately 10:15 a.m. and 11 
a.m. on December 14, 1999. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person before December 3, 1999, 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 will be conducted for interested persons who have 
submitted their request to speak by December 3, 1999, to address issues 
specific to the submission or topic before the committee.
    Closed Committee Deliberations: On December 14, 1999, from 3 p.m. 
to 5 p.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). 
The investigational new drug application (IND) and Phase I and Phase II 
drug products in process will be presented, and recent action on 
selected NDA's will be discussed. This portion of the meeting will be 
closed to permit discussion of this information.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: November 2, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-30213 Filed 11-18-99; 8:45 am]
BILLING CODE 4160-01-F