[Federal Register: January 19, 2005 (Volume 70, Number 12)]
[Notices]
[Page 3044-3045]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19ja05-68]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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[[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
p.m.
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
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 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]
BILLING CODE 4160-01-S