[Federal Register Volume 68, Number 106 (Tuesday, June 3, 2003)]
[Notices]
[Page 33162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13757]


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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 June 23 and 24, 2003, 
from 8 a.m. to 5 p.m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, MD.
    Contact Person: Johanna Clifford, 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, 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: On June 23, 2003, the committee will discuss fibromyalgia, 
clinical trial design, including important disease endpoints in the 
study, and development of therapies and treatments. On June 24, 2003, 
the committee will discuss the safety and efficacy of submission 
tracking number 103795/5123, ENBREL (etanercept), Immunex, for reducing 
signs and symptoms of active ankylosing spondylitis.
    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 June 13, 2003. 
Oral presentations from the public will be scheduled between 
approximately 11:30 a.m. and 12 noon on both days. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before June 13, 2003, 
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.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact LaNise Giles at 301-
827-7001, at least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: May 24, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-13757 Filed 6-2-03; 8:45 am]
BILLING CODE 4160-01-S