[Federal Register Volume 71, Number 42 (Friday, March 3, 2006)]
[Notices]
[Pages 10977-10978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-3021]


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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: [email protected] 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://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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