Transmissible Spongiform Encephalopathies Advisory

							Draft revised 6/2/09


                                    DRAFT AGENDA
                Transmissible Spongiform Encephalopathies Advisory Committee 

                                  21st Meeting, June 12, 2009


                                          Holiday Inn 

                                 2 Montgomery Village Avenue 

                                    Gaithersburg, MD 20879 


Friday, June 12, 2009

8:00 a.m.	 Opening Remarks, TSEAC Chairman, Dr. Nick Hogan,
              University of Texas Southwestern Medical School

             Statement of Conflicts of Interest, Announcements

8:15 a.m.	 Topic I. FDA’s Risk Assessment for Potential Exposure to vCJD in U.S.-licensed
           Plasma-Derived Factor VIII

               A.	 Introduction and Overview of BSE and vCJD Issues Worldwide,
                   David Asher, M.D., DETTD, OBRR, CBER, FDA (15’)

               B.	 vCJD in the UK and the Transfusion Medicines Epidemiology Review,
                   Professor Robert G. Will, UK CJD Surveillance Unit and Western General
                   Hospital, Edinburgh (25’)

               C.	 FDA Geographic Donor Deferral Policies to Reduce the Risk of Transmitting
                   vCJD by Blood, Blood Components, and Plasma Derivatives: Rational,
                   Polices and Effects on Risk and Supply, Alan Williams, Ph.D., OBRR, CBER,
                   FDA (15’)

               D.	 Introduction to TSE Clearance in the Manufacture of Plasma-Derived FVIII,
                   Dorothy Scott, M.D., DH, OBRR, CBER, FDA (10’)

               E.	 TSE Clearance Studies for FVIII Products, Dr. Albrecht Groener , CSL
                   Behring GmbH (15’)

               F.	 FDA Assessment of Possible Risks for Plasma-Derived Products in the UK and
                   U.S., Steven Anderson, OBE, CBER, FDA (35’)

10:15 a.m.    Break

10:30 a.m.    Open Public Hearing

11:15 a.m.	 Open Committee Discussion

               G.	 Questions for the Committee

               H.	 Committee Discussion
Draft revised 6/2/09


TSEAC AGENDA, Friday, June 12, 2009 (page 2)

12:30 p.m.   Lunch

1:30 p.m.    Topic II: Informational Presentations

             A.	 BSE Surveillance and USDA-Regulated Food Controls in the U.S.,
                 Janet A. Hughes, DVM, PhD, APHIS, USDA (20’)

             B.	 BSE Surveillance and Food/Feed Controls in Europe, Koen van Dyck, DVM,
                 European Commission (20’)

             C.	 BSE Surveillance, Animal Feeds and Food Controls in Canada, Dr. Noel Murray,
                 Canadian Food Safety Inspection Agency (20’)

             D.	 FDA Enhanced Animal “Feed Ban”: Current Status, Burt Pritchett, DVM, CVM,
                 FDA (20’)

             E.	 FDA-Regulated Food Controls in the U.S., Amber McCoig, DVM, CFSAN,
                 FDA (20’)

             F. 	FDA Proposed BSE “Medical Products” Rule: Current Status,
                 Theresa Finn, Ph. D., OVRR, FDA (20’)

3:30 p.m.     Break

3:45 p.m.    Topic II: Informational Presentations (Continued)

             G. 	Recent Progress in Developing a Relevant Animal Model for vCJD Agent in
                Blood, Emmanuel Comoy, DVM, Ph.D, Commisariat a l’Energie Atomique,
                France (30’)

             H. 	Recent Progress in Developing Antemortem Tests for TSEs: Prospects for Blood-
                 based and Urine-based Tests, Luisa Gregori, Ph.D., DETTD, OBRR, CBER FDA
                (20’)

             I. 	Correlations Between Abnormal Forms of Prion Proteins and TSE Infectivity:
                 Implications for Test Development, Pedro Piccardo, M.D., DETTD, OBRR,
                 CBER, FDA (20’)

5:00 p.m.    Open Public Hearing

5:30 p.m.    Conclusion

5:45 p.m.    Adjourn Meeting