[Federal Register Volume 63, Number 53 (Thursday, March 19, 1998)]
[Notices]
[Pages 13412-13413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7053]


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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.


[[Page 13413]]


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 regulatory issues.
    Date and Time: The meeting will be held on April 9, 1998, 8:30 a.m. 
to 5 p.m.
    Location: Holiday Inn, Versailles Ballrooms I, II, and III, 8120 
Wisconsin Ave., Bethesda, 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: The Committee will discuss further considerations on the 
efficacy of new drug application 20-654 Myotrophin (human 
mecasermin (recombinant deoxyribonucleic acid origin)) Injection, 
(Cephalon-Chiron Partners) for the treatment of amyotrophic lateral 
sclerosis.
    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 April 3, 1998. 
Oral presentations from the public will be scheduled between 
approximately 8:30 a.m. and 9:30 a.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before April 3, 1998, 
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: March 11, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-7053 Filed 3-18-98; 8:45 am]
BILLING CODE 4160-01-F