[Federal Register Volume 64, Number 58 (Friday, March 26, 1999)]
[Notices]
[Page 14735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7362]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Arthritis Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

     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 April 20 and 21, 1999, 8 
a.m. to 5 p.m.
    Location: Holiday Inn, Walker and Whetstone Rooms, Two Montgomery 
Village Ave, Gaithersburg, 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, (for express delivery, 5630 Fishers Lane, rm. 1093), 
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 the safety and efficacy of new 
drug application (NDA) 21-042 VioxxTM (rofecoxib, Merck) for 
the treatment of acute or chronic signs and symptoms of osteoarthritis 
and the management of pain.
    Procedure: On April 20, 1999, 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 April 14, 
1999. Oral presentations from the public will be scheduled between 
approximately 11 a.m. and 12 noon. Time allotted for each presentation 
may be limited. Those desiring to make formal oral presentations should 
notify the contact person before April 14, 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.
    Closed Committee Deliberations: On April 21, 1999, from 8 a.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)).
     Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C., app.2).

    Dated: March 16, 1999.
 Michael A. Friedman,
 Deputy Commissioner for Operations.
[FR Doc. 99-7362 Filed 3-25-99; 8:45 am]
BILLING CODE 4160-01-F