[Federal Register Volume 68, Number 37 (Tuesday, February 25, 2003)]
[Notices]
[Pages 8771-8772]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-4350]


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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 March 4, 2003, from 9 
a.m. to 4 p.m. and on March 5, 2003, from 8 a.m. to 5 p.m.
    Location: Holiday Inn, Kennedy Ballroom, 8777 Georgia Ave., Silver 
Spring, MD.
    Contact Person: 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, 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 March 4, 2003, the committee will hear a safety update 
on tnf alpha inhibitors; Humira (adalimumab), Abbott Laboratories; 
REMICADE (infliximad), Centocor; and ENBREL (etanercept), Immunex. On 
March 5, 2003, the committee will discuss the approved product new drug 
application (NDA) 20-905, ARAVA, (leflunomide), Aventis 
Pharmaceuticals, Inc., clinical data regarding efficacy for improvement 
in physical function in rheumatoid arthritis, as well as a safety 
update. The background material for this meeting will be posted on the 
Internet when available or 1-working

[[Page 8772]]

day before the meeting at: www.fda.gov/ohrms/dockets/ac/acmenu.htm.
    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 February 25, 
2003. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on March 4, 2003, and between 
approximately 8:30 a.m. and 9 a.m. and 11:30 a.m. and 12 noon on March 
5, 2003. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before February 25, 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.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the March 4, 2003, Arthritis Advisory Committee meeting. Because the 
agency believes there is some urgency to bring these issues to public 
discussion and qualified members of the Arthritis Advisory Committee 
were available at this time, the Commissioner of Food and Drugs 
concluded that it was in the public interest to hold this meeting even 
if there was not sufficient time for the customary 15-day public 
notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 13, 2003.
Linda Arey Skladany,
Associate Commissioner for External Affairs.
[FR Doc. 03-4350 Filed 2-24-03; 8:45 am]
BILLING CODE 4160-01-S