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February 27, 2013: Vaccines and Related Biological Products Advisory Committee Draft Agenda

DRAFT AGENDA
Food and Drug Administration
Center for Biologics Evaluation and Research
Vaccines and Related Biological Products Advisory Committee
132nd Meeting, February 27, 2013
NIH Fishers Lane Conference Center
Terrace Level, Rooms 508-510, 5635 Fishers Lane
Rockville, MD

Open Session
8:30 a.m.Call to Order and Opening Remarks
Conflict of Interest Statement
Robert Daum, M.D., Chair
Donald Jehn, M.S., FDA
Topic 1:
Strain Selection for the Influenza Virus Vaccine for the 2013-2014 Influenza Season
8:45IntroductionJerry Weir, Ph.D.
Director
Division of Viral Products
OVRR/CBER/FDA
8:55U.S. Surveillance: Influenza Activity Update:
2012-13 Season
Lyn Finelli, DrPH, MS
Lead, Influenza Surveillance and
Outbreak Response Team
Influenza Division, NCIRD
CDC
9:15World Surveillance/Virus CharacterizationNancy Cox, Ph.D.
Director, Influenza Division
Director, WHO Collaborating Center
For Surveillance, Epidemiology &
Control of Influenza,
National Center for Immunization &
Respiratory Diseases, CDC
10:00Break 
10:15DoD Vaccine Effectiveness ReportCDR Michael J. Cooper
USPHS MEDCOM
Armed Forces Health Surveillance
Center
10:35Vaccine ResponsesZhiping Ye, M.D., Ph.D.
Senior Investigator
Division of Viral Products
OVRR/CBER/FDA
10:55Availability of Vaccine Viruses & Reagents Manju Joshi, Ph.D.
Lead Biologist
Division of Biological Standards and Quality Control
OCBQ/CBER/FDA
11:15Comments from ManufacturersKathleen Coelingh, Ph.D.
Senior Director,
Medical and Scientific Affairs
MedImmune
11:35Lunch 
12:35 pmOpen Public Hearing 
1:35Committee Discussion and Recommendations 
2:45Adjournment