[Federal Register: August 4, 2003 (Volume 68, Number 149)]
[Page 45827]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Peripheral and Central Nervous System Drugs Advisory Committee; 
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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 September 24 and 25, 
2003, from 8 a.m. to 5 p.m.
    Location: Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Ave., 
Bethesda MD, 301-652-2000.
    Contact Person: Anuja Patel, 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, or e-mail: patelA@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: On September 24, 2003, the committee will discuss new drug 
application (NDA) 21-487, memantine hydrochloride, Forest Laboratories, 
Inc., indicated for the treatment of moderate to severe dementia of the 
Alzheimer's type. On September 25, 2003, the committee will discuss NDA 
20-717, Provigil (modafinil) Tablets, Cephalon, Inc., indicated for use 
to improve wakefulness in patients with excessive sleepiness associated 
with disorders of sleep and wakefulness.
    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 September 15, 
2003. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on both days. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before September 15, 
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 
    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 Angie Whitacre at 
301-827-7001 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: July 25, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-19657 Filed 8-1-03; 8:45 am]