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Notice

Anesthetic and Life Support Drugs Advisory Committee; Notice of Meeting

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

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 June 14 and 15, 2001, 8 a.m. to 5 p.m.

Location: Holiday Inn, The Ballroom, Two Montgomery Village Ave., Gaithersburg, MD.

Contact: Kimberly Topper, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville MD 20857, 301-827-7001, e-mail: topperk@cder.fda.gov, FAX 301-827-6801, 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: On both days the committee will discuss the medical use of opiate analgesics in various patient populations, including pediatric patients and patients with chronic pain of nonmalignant etiology, as well as the risk to benefit ratio of extending opiate treatment into these populations. It will also address concerns regarding the abuse potential, diversion and increasing incidence of addiction to opiate analgesics, especially to the modified release opiate analgesics.

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 June 7, 2001. Oral presentation from the public will be scheduled between approximately 1 p.m. and 2 p.m each day. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before June 7, 2001, 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.

Background material from FDA will be posted 24 hours before the meeting at the Anesthetic and Life Support Drugs Advisory Committee docket site at http://www.fda.gov/​ohrms/​dockets/​ac/​acmenu.htm. (Click on the year 2001 and scroll down to Anesthetic and Life Support Drugs meetings.) This is the same Web site where you can find the minutes, transcript, and slides from the meeting. This material is generally posted about 3 weeks after the meeting.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

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Dated: April 27, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

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[FR Doc. 01-11157 Filed 4-30-01; 4:16 pm]

BILLING CODE 4160-01-S