[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]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 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
