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U.S. Department of Health and Human Services

About FDA

Enhanced Regulatory Workflow through Project Management System

Description: Implement enhanced Project Management System to monitor and improve regulatory workflow and milestone completion for licensing actions in the Office of Vaccines Research and Review

Accomplishment: TBD

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Evaluate system requirements

1/13/2010

Completed 1/13/2010

B. Identify system resource requirements

1/31/2010

Completed 1/31/2010

C. Define pilot program

3/21/2010

Completed 3/21/2010

D. Develop project management templates

4/14/2010

Completed 4/14/2010

E. Install software on Regulatory Project Manager (RPM) computers

4/14/2010

(12/31/2010)

Completed 10/27/2010

F. Train staff for managing the review of active submissions

4/14/2010

Completed 4/14/2010

G. Complete first Monthly Action Update using new system

4/14/2010

Completed 4/14/2010

H. Conduct review of system after first monthly update with staff

4/30/2010

Completed 4/30/2010

I. Conduct assessment after 3 months of deployment

7/15/2010

Completed 7/15/2010

J. Conduct assessment after 6 months of deployment

10/15/2010

Completed 10/15/2010

K. Conduct assessment after 12 months of deployment

4/30/2011

Completed 3/25/2011

L. Refine project system before full deployment

4/30/2011

Completed 4/30/2011

M. Go/No Go decision for full deployment

5/7/2011

Completed 5/7/2011

N. Implement system Office-wide

5/14/2011

Completed 5/14/2011

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.