[Federal Register: October 8, 2003 (Volume 68, Number 195)]
[Page 58115-58116]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Anesthetic and Life Support Drugs Advisory Committee; Notice of 

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). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Anesthetic and Life Support Drugs Advisory 
    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 November 18, 2003, from 
8 a.m. to 5 p.m. and on November 19, 2003, from 8 a.m. to 12 noon.
    Location: Holiday Inn, The Ballrooms, 2 Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Johanna M. Clifford, 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, FAX: 301-827-6776, or e-mail: cliffordj@cder.fda.gov, or FDA Advisory Committee Information Line: 1-
800-741-8138 (301-443-0572 in the Washington, DC area), code 12529. 
Please call the Information Line for up-to-date information on this 
    Agenda: On November 18, 2003, the committee will discuss the 
assessment and management of risk related to QTc prolongation by 
Droperidol (Inapsine) Akorn, Inc., indicated for nausea and vomiting in 
surgical and diagnostic

[[Page 58116]]

procedures, premedication, and neuroleptanalgesia.
    Procedure: On November 18, 2003, 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 
may be made to the contact person by November 10, 2003. Oral 
presentations from the public will be scheduled between approximately 1 
p.m. to 2 p.m. Time allotted for each presentation may be limited. 
Those desiring to make formal oral presentations should notify the 
contact person before November 10, 2003, 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 
    Closed Committee Deliberations: On November 19, 2003, from 8 a.m. 
to 12 noon, the meeting will be closed to permit discussion and review 
of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)).
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact John Lauttman at 
301-827-7001 at least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: September 29, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-25445 Filed 10-7-03; 8:45 am]