[Federal Register Volume 63, Number 225 (Monday, November 23, 1998)]
[Notices]
[Pages 64722-64723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31270]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Arthritis 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: Arthritis 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 1, 1998, 8 a.m.
to 5 p.m., and December 2, 1998, 8 a.m. to 4 p.m.
Location: Town Center Hotel, The Maryland Ballroom, 8727 Colesville
Rd., Silver Spring, MD.
Contact Person: Kathleen R. Reedy or LaNise S. Giles, 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 12532. Please call the Information Line for
up-to-date information on this meeting.
Agenda: The committee will discuss new drug application (NDA) 20-
998 CelebrexTM (celecoxib, Searle) for the treatment of
acute or chronic signs and symptoms of osteoarthritis and rheumatoid
arthritis and the management of pain.
Procedure: On December 1, 1998, from 8 a.m. to 5 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
November 25, 1998. Oral presentations from the public will be scheduled
between approximately 11 a.m. and 12 m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before November 25,
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.
[[Page 64723]]
Closed Committee Deliberations: On December 2, 1998, from 8 a.m. to
4 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
committee will be briefed on issues that may come before the committee
in the near future.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
FDA regrets that it was unable to publish this notice 15 days prior
to the Arthritis Advisory Committee meeting. Because the agency
believes there is some urgency to bring these issues to public
discussion and qualified members of the Arthritis 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.
Dated: November 17, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-31270 Filed 11-20-98; 8:45 am]
BILLING CODE 4160-01-F
