[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
