Food and Drug Administration, HHS.
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 Start Printed Page 2892desiring 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).Start Signature
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