[Federal Register: January 19, 2005 (Volume 70, Number 12)]
[Page 3044-3045]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0559]

Joint Meeting of the Arthritis Advisory Committee and the Drug 
Safety and Risk Management Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


[[Page 3045]]

    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 Committees: Arthritis Advisory Committee and the Drug 
Safety and Risk Management Advisory Committee.
    General Function of the Committees: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on February 16, 2005, from 
8 a.m. to 6 p.m., and on February 17 and 18, 2005, from 8 a.m. to 5 
    Addresses: Electronic comments should be submitted to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 Select ``2004N-0559--Overall Benefit to 

Risk Considerations for COX-2 Selective Nonsteroidal Anti-inflammatory 
Drugs and Related Agents'' and follow the prompts to submit your 
statement. Written comments should be submitted to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Comments received by 
February 4, 2005, will be provided to the committee before the meeting.
    Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 
620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Kimberly Littleton Topper or Dornette Spell-LeSane, 
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: 301-827-6801, 
e-mail: topperk@cder.fda.gov or spelllesaned@cder.fda.gov, or FDA 

Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), codes 3014512532 or 3014512535. Please call 
the Information Line for up-to-date information on this meeting.
    Agenda: The committees will discuss the overall benefit to risk 
considerations (including cardiovascular and gastrointestinal safety 
concerns) for COX-2 selective nonsteroidal anti-inflammatory drugs and 
related agents. The background material will become available no later 
than the day before the meeting and will be posted 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 under the headings 

``Arthritis Advisory Committee'' or ``Drug Safety and Risk Management 
Advisory Committee'' (click on the year 2005 and scroll down to the 
above named committee meetings).
    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 Division of Dockets Management 
(see Addresses). Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 3 p.m. on February 17, 2005. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
February 4, 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 
    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 Tony Slater 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: January 11, 2005.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 05-958 Filed 1-18-05; 8:45 am]