[Federal Register: January 22, 2002 (Volume 67, Number 14)]
[Notices]
[Page 2891-2892]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22ja02-84]
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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 FDA's regulatory issues.
Date and Time: The meeting will be held on February 15, 2002, from
8 a.m. to 5 p.m.
Location: Holiday Inn, The Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact: Sandra Titus, Center for Drug Evaluation and Research
(HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express
delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 301-827-
7001, or e-mail Tituss@cder.fda.gov, 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 consider the safety and efficacy of
biologics license application (BLA) 103780/0 REBIF (Interferon beta-1A,
Serono), proposed for the treatment of relapsing-remitting multiple
sclerosis. The background material will become available the day before
the meeting and it will be posted under the Peripheral and Central
Nervous System Drugs Advisory Committee Docket site at: http://
www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2002 and
scroll down to the Peripheral and Central Nervous System Drugs
meetings.)
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 February 1,
2002. Oral presentations from the public will be scheduled from
approximately 11 a.m. to 12 noon. Time allotted for each presentation
may be limited. Those
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desiring to make formal oral presentations should notify the contact
person before February 1, 2002, 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: January 10, 2002.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 02-1409 Filed 1-18-02; 8:45 am]
BILLING CODE 4160-01-S