DRAFT AGENDA
Microbiology Devices Panel Meeting
     Thursday, March 7, 2002

 Panel Chair: Michael L. Wilson, M.D.
Executive Secretary/ Chief, Bacteriology Branch: Freddie M. Poole
Division Director: Steven I. Gutman, M.D., M.B.A.

 10:30   Call to Order

            Opening Remarks…………………..…………Executive Secretary

            Introduction of Panel………………………….Panel Chair

  Classification: For unclassified preamendment devices to identify Bacillus anthracis, and Yersinia pestis.

10:45  FDA Presentation:

                        Roxanne Shively, MS…………………………………
                       
Sr. Review Scientist, Bacteriology Branch, DCLD

 11:15   Open Public Hearing

Public Attendees who have contacted the Executive Secretary prior to the meeting, will address the panel and present information relevant to unclassified preamendment devices to identify Bacillus anthracis and Yersinia pestis.  Speakers are to state whether or not they have any financial involvement with manufacturers of these devices.

 11:30   Open Committee Discussion

(This portion of the meeting is open to public observers. However, public observers may not participate except at the specific request of the Chairperson.)

 11:45   Lunch Break

 12:45   Open Committee Discussion

 (This portion of the meeting is open to public observers. However, public observers may not participate except at the specific request of the Chairperson.)

 2:15     Open Public Hearing

(This portion of the meeting is open for comments from the public to comment on related issues.)

2:45     Final Recommendations and Vote

            (The Panel will provide final recommendations to the FDA and vote on classification of the preamendment devices and complete classification questionaire.)

3:30     Adjourn