[Federal Register: October 20, 2006 (Volume 71, Number 203)]
[Notices]
[Page 61979-61980]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20oc06-53]
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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 November 29, 2006, from
8 a.m. to 5 p.m.
Location: Hilton Washington DC North/Gaithersburg, The Ballrooms,
620 Perry Pkwy., Gaithersburg, 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: Johanna.Clifford@fda.hhs.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. 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 heading ``Arthritis Advisory
Committee.'' (Click on the year 2006 and scroll down to the above named
committee meeting).
Agenda: The committee will discuss the safety and efficacy of the
nonsteriodal anti-inflammatory drug (COX-2 inhibitor) new drug
application (NDA) 20-998/S021, CELEBREX (celecoxib), Pfizer, Inc., for
the proposed indication of the relief of the signs and symptoms of
juvenile rheumatoid arthritis in patients 2 years and older.
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 on or before
November 15, 2006. 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 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
on or before November 15, 2006.
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
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: October 13, 2006.
Randall W. Lutter,
Associate Commissioner for Policy.
[FR Doc. 06-8787 Filed 10-19-06; 8:45 am]
BILLING CODE 4160-01-S