[Federal Register Volume 65, Number 56 (Wednesday, March 22, 2000)]
[Notices]
[Page 15344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7006]


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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). At least one 
portion of the meeting will be closed.
    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 11, 2000, 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 e-mail: [email protected], 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 biologics license application 
99-0884, EnbrelTM (etanercept, Immunex), for an indication 
in patients with early rheumatoid arthritis.
    Procedure: The meeting is open to the public from 8 a.m. to 2:30 
p.m. 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 3, 2000. Oral 
presentations from the public will be scheduled between approximately 
10:30 a.m. and 11:30 a.m. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person before April 3, 2000, 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: The meeting will be closed from 
2:30 p.m. to 5 p.m. 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 15, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-7006 Filed 3-21-00; 8:45 am]
BILLING CODE 4160-01-F