Expand the current electronic lot release submission pilot for H1N1 Influenza Virus Vaccine to seasonal Influenza Virus Vaccine, using the agency’s electronic gateway.Each year, FDA manages the lot release of seasonal flu vaccines. Because of the H1N1 outbreak in 2009, the FDA needed to optimize lot release efficiency to get the much needed vaccine out to the public in a timelier manner. To this end, OCBQ piloted an electronic lot release submission program for the H1N1 lot releases. Due to the pilot’s success, OCBQ decided to implement the new system for the 2010-2011 seasonal flu vaccine lot releases. As a result of tracking this significant project, almost all lot release protocols have been submitted electronically, resulting in decreased release time and more rapidly available vaccines to the public. OCBQ hopes to expand the program to all lot release products so biologic products can reach the public more efficiently and effectively.A. Identify OCBQ working group12/1/2009Completed11/24/2009B. Discuss expansion concept with the Industry12/17/2009Completed12/17/2009C. Hold meetings between FDA Office of Information Technology and the program office staffs5/21/2010Completed5/21/2010D. Hold meeting between OCBQ and pilot users (H1N1 influenza manufacturers)5/21/2010Completed5/21/2010E. Draft requirements for systems changes3/1/2010Completed3/19/2010F. Make all necessary systems changes5/28/2010Completed5/21/2010G. Conduct internal testing6/11/2010Completed5/28/2010H. Send notification to manufacturers7/15/2010Completed6/18/2010I. Conduct external testing by the applicants prior to implementation7/31/2010Completed7/31/2010J. Implement electronic submission of lot release for seasonal flu vaccines8/31/2010Completed8/31/2010K. Perform assessment10/30/2010Completed10/29/2010Molecular EpidemiologyMolecular epidemiology is a branch of medical science that focuses on the contribution of potential genetic and environmental risk factors, identified at the molecular level, to the etiology, distribution and prevention of disease within families and across populations.http://www.fda.gov/AboutFDA/Transparency/track/ucm206350.htmFDA-TRACK CBER Cross Program Support Offices Dashboard