Dear Open Public Hearing (OPH) Speakers:
We have had many requests by individuals and organizations to participate in the January 30 & 31 advisory committee meeting. Please note your place and date on the attached OPH Speakers List. We have established the following guidelines for you to follow as you plan your statement.
- Your comments must be limited to three minutes or less. This will be timed with a "Stop Light" to maintain time equality among all the speakers. The "Stop Light" will show green for the first two minutes and turn yellow for the third minute. At the three-minute point the light will turn red. If you are still speaking at the end of your three minutes the Chair will interrupt you and thank you for your presentation.
- We will have reserved seating. When you come to the meeting you need to sign in at the front desk. Please ask the people at the front desk where those seats are. There will be one chair for you. The OPH is in the morning - you are more than welcome to move to another seat after the OPH ends. We will have a "speaker ready chair" near the podium. Please move to the chair if you are the next speaker.
- Please start your talk with a full disclosure on potential conflict of interest issues which are related to the issues of this meeting:
- If your presentation and/or related expenses have been or will be covered by a manufacturer of opiate analgesics.
- If you have ever been an investigator for any company that produces an opiate analgesic.
- If you have ever consulted on the development or analysis of opiate analgesics.
- If you were an investigator or consultant on opiate analgesics.
- If your organization (beyond your own answers to the above) receives pharmaceutical monies (please describe very briefly)
- If there is any other way that you may be conflicted.
- Submit in writing (e-mail to Topperk@cder.fda.gov) your complete statement that you wish to present by January 5, 2002. All statements will be posted on our web site: http://www.fda.gov/ohrms/dockets/ac/acmenu.htm Click on the year 2002 and go to the CDER meeting for Anesthetic and Life Support Drugs. We plan to have them posted before the meeting.
- You no longer need to bring copies for the head table. We will print up the material you submit to us for the committee's review. Only those submitted in advance will be given to the committee.
- If you have any questions, please call Kimberly Topper at 301-827-7001.