[Federal Register: December 16, 1998 (Volume 63, Number 241)]
[Notices]               
[Page 69299]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16de98-75]

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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). The meeting will 
be open 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 January 12, 1999, 9 a.m. 
to 5 p.m.
    Location: FDA Bldg. 5630, conference room, 5630 Fishers Lane, 
Rockville, MD.
    Contact Person: Karen M. Templeton-Somers, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane, 301-827-7001, 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: The committee will hear presentations and discuss the 
cardiovascular safety data submitted regarding new drug application 
(NDA) 20-997, Chirocaine<SUP>TM</SUP> (levobupivacaine injection), 
Darwin Discovery Ltd., a local anesthetic agent indicated for surgical 
anesthesia and pain management.
    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 January 5, 
1999. Oral presentations from the public will be scheduled between 
approximately 9:15 a.m. and 9:45 a.m and between 1:15 p.m. and 1:45 
p.m. Time allotted for each presentation may be limited. Those desiring 
to make formal oral presentations should notify the contact person 
before January 5, 1999, 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: December 8, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-33291 Filed 12-15-98; 8:45 am]
BILLING CODE 4160-01-F