[Federal Register Volume 63, Number 41 (Tuesday, March 3, 1998)]
[Notices]
[Pages 10399-10400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-5343]


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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 regulatory issues.
    Date and Time: The meeting will be held on March 24 and 25, 1998, 8 
a.m. to 5 p.m.
    Location: Holiday Inn Gaithersburg, 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, Rockville, MD 20857, 301-443-5455, 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 March 24, 1998, the committee will discuss safety 
issues, gastrointestinal tolerability, renal, bone and reproductive 
toxicity related to nonsteroidal anti-inflammatory drugs, for example, 
COX-2 and other agents. On March 25, 1998, the committee will discuss 
the pain claim structure for chronic and acute pain and onset of pain 
relief including appropriate study

[[Page 10400]]

design for prescription and nonprescription oral analgesics.
    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 March 18, 
1998. Oral presentations from the public will be scheduled between 
approximately 8 a.m. and 8:30 a.m. on March 24 and 25, 1998. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before March 
18, 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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 25, 1998.
Michael A. Friedman,
Deputy Commissioner of Operations.
[FR Doc. 98-5343 Filed 3-2-98; 8:45 am]
BILLING CODE 4160-01-F