[Federal Register Volume 63, Number 246 (Wednesday, December 23, 1998)]
[Notices]
[Page 71145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33916]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 January 29, 1999, 8:30
a.m. to 5 p.m.
Location: Holiday Inn, Kennedy Grand Ballroom, 8777 Georgia Ave.,
Silver Spring, MD.
Contact Person: Ermona B. McGoodwin or Mae Brooks, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-7001, 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 new drug application (NDA) 21-
000, cladribine (MylinaxTM, R. W. Johnson Pharmaceutical
Research Institute) for the treatment of relapsing-remitting and
secondary progressive multiple 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 January 22,
1999. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before January 22, 1999, 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: December 16, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-33916 Filed 121-22-98; 8:45 am]
BILLING CODE 4160-01-F
