[Federal Register Volume 63, Number 122 (Thursday, June 25, 1998)]
[Notices]
[Page 34655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16837]


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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 August 7, 1998, 8 a.m. 
to 5 p.m.
    Location: Bethesda Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, 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: The committee will discuss the safety and efficacy of new 
drug application 20-905 Arava (leflunomide, Hoechst Marion Roussel, 
Inc., Germany) for the treatment of rheumatoid arthritis.
    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 July 30, 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 July 30, 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: June 15, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-16837 Filed 6-24-98; 8:45 am]
BILLING CODE 4160-01-F