[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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