[Federal Register: March 3, 2006 (Volume 71, Number 42)]
[Notices]
[Page 10977-10978]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03mr06-57]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Peripheral and Central Nervous System Drugs 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: Peripheral and Central Nervous System Drugs
Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
[[Page 10978]]
Date and Time: The meeting will be held on May 17, 2006, from 8
a.m. to 5 p.m.
Location: Hilton Washington DC North/Gaithersburg, The Ballrooms,
620 Perry Pkwy., Gaithersburg, MD, 301-977-8900.
Contact Person: Darrell Lyons, 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, e-mail: Darrell.Lyons@fda.hhs.gov or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572) in the
Washington, DC area), code 3014512543. Please call the information line
for up-to-date information on this meeting.
Agenda: The committee will discuss supplemental new drug
application (NDA) 20823, SE1-016, EXELON (rivastigmine tartrate)
Capsules (1.5 milligrams (mg), 3.0 mg, 4.5 mg, and 6.0 mg), Novartis
Pharmaceuticals Corp., for the proposed indication of the treatment of
mild to moderate dementia associated with Parkinson's disease. 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 ``Peripheral and Central
Nervous System Drugs Advisory Committee.'' (Click on the year 2006 and
scroll down to the previously named 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 May 3, 2006.
Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before May 3, 2006, 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 Darrell Lyons 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: February 24, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-3021 Filed 3-2-06; 8:45 am]
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