[Federal Register Volume 68, Number 71 (Monday, April 14, 2003)]
[Notices]
[Pages 17958-17959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9032]


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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.
    Date and Time: The meeting will be held on May 16, 2003, from 8 
a.m. to 5 p.m.
    Location: Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Ave., 
Bethesda, MD, 301-652-2000.
    Contact Person: Karen M. Templeton-Somers, 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, or e-mail: [email protected], or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
in the Washington, DC area) code 12543. Please call the Information 
Line for up to date information on this meeting.
    Agenda: The committee will discuss supplemental new drug 
application (sNDA) 20-690, supplement SE1-020, ARICEPTR (donepezil 
hydrochloride tablets), Eisai Medical Research Inc., indicated for the 
treatment of vascular dementia. The background material will become 
available no later than the day before the meeting and will be posted 
under the Peripheral and Central Nervous System Drugs Advisory 
Committee docket site at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2003 and scroll down to the Peripheral 
and Central Nervous System Drugs Advisory 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 contact person by May 9, 2003. 
Oral presentations from the public will be scheduled between 
approximately 1:30 p.m. and 2:30 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before May 9, 2003, 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 Karen Templeton-
Somers at least 7 days in advance of the meeting.

[[Page 17959]]

    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: April 7, 2003.
Linda Arey Skladany,
Associate Commissioner for External Relations.
[FR Doc. 03-9032 Filed 4-11-03; 8:45 am]
BILLING CODE 4160-01-S