[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 (enoxeparin
sodium) Injection, Rhone-Poulenc Rorer Pharmaceuticals, Inc.; (2)
Fragmin (dalteparin sodium) Injection, Pharmacia & Upjohn;
(3) Orgaran (danaparioid sodium) Injection, Organon, Inc.;
and (4) NormifloTM (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