[Federal Register Volume 63, Number 241 (Wednesday, December 16, 1998)]
[Notices]
[Page 69299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33291]
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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, ChirocaineTM (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
