[Federal Register Volume 63, Number 163 (Monday, August 24, 1998)]
[Notices]
[Pages 45073-45074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22572]


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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 September 16, 1998, 8 
a.m. to 5 p.m.
    Location: Gaithersburg Holiday Inn, Walker and Whetstone Rooms, Two 
Montgomery Village Ave., Gaithersburg, MD.
    Contact Person: Gail M. Dapolito or Bill Freas, Center for 
Biologics Evaluation and Research (HFM-21),

[[Page 45074]]

Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-827-1289, 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 
biologics license application 98-0286, EnbrelTM (etanercept, 
Immunex) 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 September 10, 
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 September 10, 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: August 11, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-22572 Filed 8-21-98; 8:45 am]
BILLING CODE 4160-01-F