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[Federal Register: March 23, 2001 (Volume 66, Number 57)]
[Notices]               
[Page 16251-16252]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23mr01-90]                         

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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 to the public.

    Name of Committee: Arthritis Advisory Committee.
    General Function of the Committee: To provide advice and

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recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on April 19 and 20, 
2001, 8 a.m. to 5 p.m.
    Location: CDER Advisory Committee conference room 1066, 5630 
Fishers Lane, Rockville, MD. Parking and seating is limited.
    Contact: 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, FAX: 301-827-6776 or e-mail: 
<A HREF="mailto:reedyk@cder.fda.gov">reedyk@cder.fda.gov</A>, 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 April 19, 2001, the committee will discuss new drug 
application (NDA) 21-239, Aslera<Register> (prasterone, Genelabs 
Technologies, Inc.) for improvement in disease activity and/or its 
symptoms in women with mild to moderate systemic lupus erythematosus 
(SLE) and reduction of corticosteroid requirements in women with 
mild to moderate SLE.
    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 April 13, 
2001. Oral presentations from the public will be scheduled between 
approximately 11 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 13, 
2001, 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: On April 20, 2001, from 8 a.m. 
to 5 p.m., the meeting will be closed 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 16, 20001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-7183 Filed 3-22-01; 8:45 am]
BILLING CODE 4160-01-S

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