Food and Drug Administration

Name of Committee: Anesthetic and Life Support Drugs Advisory Committee.

Date and Time: The meeting will be held on January 30 & 31, 2002, 8 a.m. to 5 p.m.

Location: Holiday Inn, 2 Montgomery Village Ave, Gaithersburg, MD 20877 in The Grand Ballroom

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.

Public Participation: The entire meeting is open and the public is invited to attend without pre-registration. In addition, a portion of the meeting, the open-public hearing, is set aside so that the public may present relevant views to the committee. This portion of the meeting will be held at approximately 8:20 on both days.

ALL SLOTS TO SPEAK AT THE OPEN PUBLIC HEARING ARE FULL AND WE HAVE CLOSED THE WAITING LIST.

IF YOU WISH TO SEND A STATEMENT FOR THE RECORD

All the letters already received will be posted under docket number 01N-0256. If you wish to send in a statement to be posted please go to: http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm select "Submit electronic comments" and follow the prompts.

Letters/statements may be mailed to:

Kimberly Topper

Food and Drug Administration, CDER,

Advisors and Consultants Staff, HFD-21

5600 Fishers Lane,

Rockville Maryland 20857

All comments submitted are public information - please consider what information you want released.

Due to the overwhelming interest in this meeting and time constraints - no statements will be read into the transcript by FDA staff. All statements received before the December 14th deadline will be available to the committee in advance.

If you have already submitted a comment it has been sent to the committee and there is no need to resubmit it.

FINDING INFORMATION ABOUT THE MEETING ON THE WEB

Because this meeting is not aimed at a single specific drug but to discuss the class of opiate analgesic drugs the background information has already been posted. All the information that is available for this meeting will be posted on the FDA web site at: http://www.fda.gov/ohrms/dockets/ac/acmenu.htm (Click on the year 2002 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. The final agenda will be posted 2 weeks prior to the meeting (the one posted is very close to what will become final).

We maintain our FDA Advisory Committee Information Line at 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.

Some of you received incorrect information about contacting me to arrange for TV, web or tape coverage. There are 3 private companies that provide this service and you must contact them directly at:

Video on Location

Jim or Alex

(301) 984-5823

Video Vision

Simone

(301) 438-8724

FDC Reports (Pink Sheet)

Tom

(301) 664-7211

Hotel reservations must be made on your own. There are 3 major hotel chains in the Gaithersburg Maryland area.