[Federal Register Volume 66, Number 93 (Monday, May 14, 2001)]
[Notices]
[Page 24391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12085]


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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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SUMMARY: 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 June 6, 2001, 8 a.m. 
to 5 p.m..
    Location: Holiday Inn, 8120 Wisconsin Ave., Bethesda, MD.
    Contact: Sandra Titus, Food and Drug Administration, Center for 
Drug Evaluation and Research, (HFD-21), 5600 Fishers Lane, Rockville 
MD 20857, 301-827-7001, e-mail: Tituss@ cder.fda.gov. FAX 301-827-
6801, or FDA Advisory Committee Information Line at 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: On June 6, 2001, the committee will consider the safety 
and efficacy of new drug application (NDA) 21-196, Xyrem<Register> 
(sodium oxybate, Orphan Medical, Inc.) proposed to reduce the 
incidence of cataplexy and to improve the symptom of daytime 
sleepiness for persons with narcolepsy. A main focus of the 
deliberations will be on risk management issues.
    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 May 29, 
2001. 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 May 29, 2001, 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.
    Background material from the sponsor and FDA will be posted 24 
hours before the meeting at 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 2001 and scroll down 
to the Peripheral and Central Nervous Systems Drugs meetings.) This 
is the same Web site where you can find the minutes, transcript, and 
slides from the meeting. This material is generally posted about 3 
weeks after the meeting.

    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: May 8, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-12085 Filed 5-10-01; 10:28 am]
BILLING CODE 4160-01-S