of the


Nineteenth  Meeting

Hilton Washington, D.C. North

620  Perry Parkway

 Gaithersburg, Maryland

June 17, 2005


Panel Chairperson                                                                                                                          Executive Secretary

Stephen J. Haines, M.D.                                                                                                       Janet L. Scudiero, M.S.


8:30         am  Call to Order

Conflict of Interest and Deputization to Voting Member Status Statements

                                Panel Introductions

Critical Path Initiative, Sousan S. Altaie, Ph.D.

Postmarket Study Design, Susan N. Gardner, Ph.D.  

                Division Update, Theodore R. Stevens, M.S.  


Olympic Medical Corporation, Olympic Cool-Cap®, PMA P040025


 9:15        am                1st Open Public Hearing*


 9:45        am                Sponsor Presentation

Edward B. Weiler, Ph.D., Vice President, Research & Development. Seattle,WA

                                                John S. Wyatt, M.D., University College Hospital, London, England

                                                Ping-Yu Liu, Ph.D., Drug & Device Development Co., Inc., Redmond, WA


10:45       am                 Break


11:00       am                FDA Presentation                                                         

                                                Kristen A. Bowsher, Ph.D.

                                                Susan K. McCune, M.D.

Jianxiong Chu, Ph.D.


12:00       m                Lunch


 1:00        pm                Deliberations

                                                Reese M. Clark, MD


 3:30        pm                Break


 3:45        pm                FDA and Sponsor Summations, up to 15 minutes each                                                                 


 4:15        pm                Panel Vote  


 5:00        pm                Adjournment                      


* Open Public Hearings – Interested persons may present data, information, or views, orally or in writing, on the issue pending before the panel.  Scheduled speakers who have requested time to address the panel will speak at this time.  After they have spoken, the Chair may ask them to remain if the panel wishes to question them. Then the Chair will recognize unscheduled speakers as time allows.  Only the panel may question speakers during the open public hearing.