[Federal Register Volume 62, Number 78 (Wednesday, April 23, 1997)]
[Notices]
[Pages 19763-19764]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10541]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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 the Committee: Peripheral and Central Nervous System Drugs 
Advisory Committee.
    General Function of the Committee: The committee reviews and 
evaluates data on the safety and effectiveness of marketed and 
investigational human drugs for use in neurological disease.
    Date and Time: The meeting will be held on May 8, 1997, 8:30 a.m. 
to 5 p.m. An open public hearing portion is scheduled from 1 p.m. to 2 
p.m.
    Location: Holiday Inn--Bethesda, Versailles Ballrooms I, II, and 
III, 8120 Wisconsin Ave., Bethesda, MD.
    Contact Person: Ermona B. McGoodwin or Danyiel D'Antonio,

[[Page 19764]]

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 the safety and effectiveness of 
new drug application (NDA) 20-654 Myotrophin (human 
mecasermin (recombinant deoxyribonucleic acid (DNA) origin) Injection, 
Cephalon-Chiron Partners) for the treatment of amyotrophic lateral 
sclerosis (ALS).
    Procedure: The meeting is open to the public. Interested persons 
may present data, information, or views, orally or in writing, on 
issues pending before the committee. Written submissions should be made 
to the contact person by May 2, 1997. Those desiring to make formal 
presentations should notify the contact person before May 2, 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.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the May 8, 1997, Peripheral and Central Nervous System Drugs 
Advisory Committee meeting. Because the agency believes there is some 
urgency to bring this issue to public discussion and qualified members 
of the Peripheral and Central Nervous System Drugs Advisory Committee 
were available at this time, the Commissioner concluded that it was in 
the public interest to hold this meeting even if there was not 
sufficient time for the customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: April 18, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-10541 Filed 4-22-97; 8:45 am]
BILLING CODE 4160-01-F