[Federal Register: April 30, 2004 (Volume 69, Number 84)]
[Page 23794-23795]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Arthritis Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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 2 and 3, 2004, from 
8 a.m. to 5 p.m.
    Location: Food and Drug Administration, Center for Drug Evaluation 
and Research Advisory Committee Conference Room, 5630 Fishers Lane, rm. 
1066, Rockville, MD.
    Contact Person: Kimberly Littleton Topper, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane, (for express delivery, 5630 Fishers Lane, rm. 1091), 
Rockville, MD 20857, 301-827-7001, Fax: 301-827-6801, or e-mail: 
topperk@cder.fda.gov, or FDA Advisory Committee Information Line, 1-

800-741-8138 (301-443-0572 in the Washington, DC area), code 
3014512532. Please call the Information Line for up-to-date information 
on this meeting.
    Agenda: On June 2, 2004, the committee will discuss trial design 
and endpoints for drugs for chronic gout, including new drug 
application (NDA) 21-740, oxypurinol (proposed tradename, OXIPRIM), 
Cardiome. On June 3, 2004, the committee will discuss trial design and 
endpoints for drugs for acute gout, including NDA 21-389, etoricoxib 
(proposed tradename, ARCOXIA), Merck.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending

[[Page 23795]]

before the committee. Written submissions may be made to the contact 
person by May 19, 2004. Oral presentations from the public will be 
scheduled between approximately 1 p.m. and 2 p.m. on both days. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before May 
19, 2004, 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 
    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 Kimberly Littleton 
Topper 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: April 22, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-9801 Filed 4-29-04; 8:45 am]