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U.S. Department of Health and Human Services

About FDA

Expansion of Electronic Submissions Gateway Lot Release Pilot

Description: Further expand the electronic lot release program. A randomized sampling of biological product manufacturers subject to lot release will be invited to participate in the electronic submission of their lot release protocols, and will be instructed in preparation of the electronic protocols.

Accomplishment: In the effort to optimize lot release efficiency to get the much needed 2009 H1N1 influenza virus vaccine out to the public in a timelier manner, OCBQ piloted an electronic lot release submission program. Due to the pilot’s success, OCBQ decided to implement the new system for all 2010-2011 seasonal flu vaccine lot releases. During the current project, OCBQ developed and implemented the initial phase of an expansion plan to offer electronic submission for all products subject to lot release so biologic products can reach the public more efficiently and effectively.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Randomization of firms for first phase of electronic lot release expansion

1/14/2011

Completed 1/10/2011

B. Process map and instructions for electronic lot release expansion

2/28/2011

Completed 2/28/2011

C. Implement first phase of electronic lot release expansion

4/15/2011

Completed 4/13/2011

D. Evaluation of results of first phase of electronic lot release expansion

8/31/2011

Completed 8/26/2011

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.