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[Federal Register: July 27, 2001 (Volume 66, Number 145)]
[Notices]               
[Page 39179-39180]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jy01-86]                         

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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 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on August 16 and 17, 2001, 
from 8 a.m. to 5 p.m.
    Location: Holiday Inn, Whetstone and Walker Rooms, Two Montgomery 
Village Ave., Gaithersburg, MD.
    Contact: Kathleen Reedy or LaNise 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 <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 August 16, 2001, the committee will discuss the efficacy 
and safety of submission tracking number (STN) 103950 Kineret\TM\ 
(anakinra), Amgen, Inc., for reduction in signs and symptoms of active 
rheumatoid arthritis. On August 17, 2001, the committee will discuss 
safety updates for Enbrel\TM\ (etanercept), Immunex, and Remicade\TM\ 
(infliximab), Centocor, for the treatment of rheumatoid arthritis.
    Procedure: On August 16, 2001, from 8 a.m. to 5 p.m. and on August 
17, 2001, from 10 a.m. to 5 p.m., the meeting is open to the public. 
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 August 10, 2001. Oral 
presentations from the public will be scheduled between approximately 
11 a.m. and 11:30 a.m. both days. Time allotted for each presentation 
may be limited. Those desiring to make formal oral presentations should 
notify the contact person before August 10, 2001,

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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 August 17, 2001, from 8 a.m. to 
9:30 a.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: July 20, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-18753 Filed 7-26-01; 8:45 am]
BILLING CODE 4160-01-S

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