[Federal Register Volume 62, Number 201 (Friday, October 17, 1997)]
[Notices]
[Page 54118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27529]


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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 regulatory issues.
    Date and Time: The meeting will be held on November 18 and 19, 
1997, 8:30 a.m. to 5 p.m.
    Location: Quality Hotel, Maryland Ballroom, 8727 Colesville Rd., 
Silver Spring, MD.
    Contact Person: Ermona McGoodwin or Danyiel D'Antonio, Center for 
Drug Evaluation and Research (HFD-21), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-443-5455, 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 November 18, 1997, the Committee will discuss the 
evidence of safety and effectiveness in new drug application (NDA) 20-
861, Prosynap (lubeluzole injection, Janssen Research Foundation) for 
the treatment of acute ischemic stroke in adults. On November 19, 1997, 
the Committee will discuss the evidence of safety and effectiveness in 
NDA 20-764, Lamictal CD Chewable Dispersible Tablets (lamotrigine, 
Glaxo Wellcome) for the treatment of the generalized seizures of 
Lennox-Gastaut syndrome in pediatric and adult patients.
    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 November 12, 
1997. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on November 18, 1997, and between 9 
a.m. and 10 a.m. on November 19, 1997. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before November 12, 
1997, 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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app.2).

    Dated: October 9, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-27529 Filed 10-16-97; 8:45 am]
BILLING CODE 4160-01-F