[Federal Register: July 27, 2005 (Volume 70, Number 143)]
[Notices]               
[Page 43438]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jy05-94]                         


[[Page 43438]]

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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 September 6, 2005, from 
8:30 a.m. to 4:30 p.m.
    Location: Food and Drug Administration, Center for Drug Evaluation 
and Research Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, 
MD.
    Contact Person: Johanna M. 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: cliffordj@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: The committee will discuss biologics license application 
(BLA) 125118/0, proposed trade name ORENCIA (abatacept), Bristol Myers 
Squibb, proposed indication for the treatment of moderately to severely 
active rheumatoid arthritis. When available, background materials for 
this meeting will be posted 1 business day before the meeting on FDA's 
Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on 

the year 2005 and scroll down to Arthritis Advisory Committee.)
    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 August 26, 
2005. Oral presentations from the public will be scheduled between 
approximately 11:30 a.m. and 12:30 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before August 26, 2005, 
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 Johanna Clifford 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: July 20, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-14751 Filed 7-26-05; 8:45 am]

BILLING CODE 4160-01-S