[Federal Register Volume 63, Number 17 (Tuesday, January 27, 1998)]
[Notices]
[Pages 3905-3906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2024]


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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 regulatory issues.
    Date and Time: The meeting will be held on February 5, 1998, 8 a.m. 
to 5:30 p.m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, MD.
    Contact Person: Karen M. Templeton-Somers, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug

[[Page 3906]]

Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-4090, 
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 
occurrence of spinal/epidural hematomas with the concurrent use of 
approved low molecular weight heparins or heparinoids and spinal/
epidural anesthesia or spinal puncture. The committee will also 
consider labeling for low molecular weight heparins and heparinoids 
concerning these adverse events. The approved drug products under 
discussion and their sponsors are: (1) Lovenox<Register> (enoxeparin 
sodium) Injection, Rhone-Poulenc Rorer Pharmaceuticals, Inc.; (2) 
Fragmin<Register> (dalteparin sodium) Injection, Pharmacia & Upjohn; 
(3) Orgaran<Register> (danaparioid sodium) Injection, Organon, Inc.; 
and (4) Normiflo<SUP>TM</SUP> (ardeparin sodium) Injection, Wyeth 
Laboratories, Inc.
    Procedure: On February 5, 1998, from 8 a.m. to 3:45 p.m., 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 
January 29, 1998. 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 January 29, 1998, 
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 February 5, 1998, from 3:45 p.m. 
to 5:30 p.m., the meeting will be closed to permit discussion and 
review of trade secret and/or confidential information (5 U.S.C. 
552b(c)(4)). The investigational new drug and Phase I and II drug 
products in process will be presented and recent action on selected new 
drug applications will be discussed.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the February 5, 1998, Anesthetic and Life Support Drugs Advisory 
Committee meeting. Because the agency believes there is some urgency to 
bring these issues to public discussion and qualified members of the 
Anesthetic and Life Support Drugs Advisory Committee were available at 
this time, the Commissioner concluded that it was in the public 
interest to hold this meeting even if there was not sufficient time for 
the customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: January 22, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-2024 Filed 1-23-98; 11:47 am]
BILLING CODE 4160-01-F