Dear Open Hearing Requesters:

Deadline for submitting intent is Sept 4- final statement also due on the same day.

We have established the following guidelines:

  1. Plan your comments for five minutes. If there is more time for the open public hearing, we will re-allocate it. This statement should be a summary statement since you have the opportunity to submit a detailed statement by August 26. THE FDA’s Presentations will take 1.5 hours and we will allocate 1.5 hours to be proportioned among sponsors’ presenting in the open public hearing. We would welcome a composite industry presentation.
  2. You need to make a full disclosure on potential conflict of interest issues which are related to the issues of this meeting:
  1. If you represent a sponsor that has a product in the class of drugs being discussed (APAP, ASA, NSAIDS). State the names of all the products involved.
  2. If you own stock in any of the sponsors that sell and distribute APAP, ASA or NSAIDS.
  3. If your presentation and related expenses have been or will be covered by a sponsor.
  4. If there is any other way that you may be conflicted.

3. Please review the material that is posted at that web site. This is a meeting to examine risk issues related to the products and whether the risks warrant labeling or other changes. Make it clear in your statement how you are addressing the risk issues that are under consideration.

  1. Submit in writing (e-mail to Tituss@cder.fda.gov) your complete statement that you wish to present by September 4, including your conflict of interest disclosure.
  2. Label your submission with the header either (Open APAP or Open NSAIDs or Open ASA) Submit separate submissions for each topic.
  3. All statements will be posted on our web site:

    4. http://www.fda.gov/ohrms/dockets/ac/acmenu.htm

    Click on the year 2002 and go to the CDER meeting for Nonprescription Drugs. We plan to have them posted before the meeting.

  4. We plan to post the agenda for speakers on our web site no later than 9:30am, the day before the meeting begins. If time permits, I will send an e-mail to you with an agenda attached. It is possible that not everyone that requests the opportunity to speak will be given the opportunity. This is a decision that will be made in conjunction with the Chair of the meeting.
  5. When you come to the meeting you need to sign in at the front desk. We hold a limited number of seats for open public hearing speakers. Please ask the people at the front desk where those seats are.
  6. You do not need to bring copies for the head table. We will print your statement for the committee’s review.
  7. If you have any questions, please call Sandra Titus, Ph.D. at 301-827-7001

Written Submission – Deadline is August 26,2002

  1. Please submit your submission in both hard copy and electronically. We prefer a word document. Do not submit a PDF file. (Electronic can be a disk or an e-mail to me – tituss@cder.fda.gov)
  2. Use a cover page that indicates the following:

    3. Background Package submitted by (name of your organization)

    Meeting topic: NDAC meeting on risks of APAP or NSAIDs or ASA (We think separate submissions would be desirable but you can use your own judgment.)

    (We do not place on the Internet complete articles, so you must provide a bibliography if you are citing articles. You can include for the committee’s review the actual articles. Your submission will be posted on the Internet no later than 9:30am, the day before the meeting.)

    Fed Ex Address is:

    Sandra Titus

    Advisors and Consultants Staff

    FDA/CDER

    5630 Fishers Lane

    Rockville, MD 20857

    301-827-7001

  3. Please submit 50 copies of your background material