[Federal Register: December 27, 2000 (Volume 65, Number 249)]
[Notices]               
[Page 81875-81876]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27de00-96]                         

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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). The meeting will 
be open 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 February 7, 8, and 9, 
2001, 8 a.m. to 5 p.m.
    Location: Holiday Inn, The Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact: Kathleen R. Reedy or LaNise S. Giles, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), 
Rockville, MD 20857, 301-827-7001, FAX 301-827-6776, or e-mail 
reedyk@cder.fda.gov, 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: On February 7, 2001, the committee will discuss new drug 
application (NDA) 20-998/S009, Celebrex (celecoxib, G. D. 
Searle & Co.) approved for the treatment of signs and symptoms of 
osteoarthritis and rheumatoid arthritis in adults. The discussion is 
for modification of the label based on the results of the CLASS Trial, 
a study of the incidence of significant upper gastrointestinal effects. 
On February 8, 2001, the committee will discuss NDA 21-042/S007, 
VioxxTM (rofecoxib, Merck Research Laboratories) approved 
for the treatment of signs and symptoms of osteoarthritis and the 
management of acute pain. The discussion is for changes in the product 
label related to results of the VIGOR Trial concerning clinical 
gastrointestinal events. On February 9, 2001, the committee will 
discuss NDA 20-905/S006, AravaTM (leflunomide, Aventis) 
approved for the treatment of active rheumatoid arthritis. The 
discussion is for an indication to prevent disability as evidenced by 
improved physical function.

[[Page 81876]]

    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 January 30, 
2001. Oral presentations from the public will be scheduled between 
approximately 11 and 11:30 a. m. Time allotted for each presentation 
may be limited. Those desiring to make formal oral presentations should 
notify the contact person before January 30, 2001, 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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: December 18, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-32891 Filed 12-26-00; 8:45 am]
BILLING CODE 4160-01-F