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U.S. Department of Health and Human Services

About FDA

H1N1 Electronic Lot Release Submission Pilot

Description: Expand the current electronic lot release submission pilot for H1N1 Influenza Virus Vaccine to seasonal Influenza Virus Vaccine, using the agency’s electronic gateway.

Accomplishment: 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.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Identify OCBQ working group

12/1/2009

Completed 11/24/2009

B. Discuss expansion concept with the Industry

12/17/2009

Completed 12/17/2009

C. Hold meetings between FDA Office of Information Technology and the program office staffs

5/21/2010

Completed 5/21/2010

D. Hold meeting between OCBQ and pilot users (H1N1 influenza manufacturers)

5/21/2010

Completed 5/21/2010

E. Draft requirements for systems changes

3/1/2010

Completed 3/19/2010

F. Make all necessary systems changes

5/28/2010

Completed 5/21/2010

G. Conduct internal testing

6/11/2010

Completed 5/28/2010

H. Send notification to manufacturers

7/15/2010

Completed 6/18/2010

I. Conduct external testing by the applicants prior to implementation

7/31/2010

Completed 7/31/2010

J. Implement electronic submission of lot release for seasonal flu vaccines

8/31/2010

Completed 8/31/2010

K. Perform assessment

10/30/2010

Completed 10/29/2010

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.