[Federal Register: April 14, 2003 (Volume 68, Number 71)]
[Notices]
[Page 17958-17959]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ap03-63]
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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: SomersK@cder.fda.gov, 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