[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
