[Federal Register: October 8, 2003 (Volume 68, Number 195)]
[Notices]
[Page 58115-58116]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08oc03-59]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Anesthetic and Life Support 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). At least one
portion of the meeting will be closed to the public.
Name of Committee: Anesthetic and Life Support 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 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
meeting.
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
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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
presentation.
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
outlets.
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]
BILLING CODE 4160-01-S