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U.S. Department of Health and Human Services

About FDA

Implement Extramural Component of MCM Regulatory Science Program

Description: Build extramural component of the regulatory science program to engage entities outside of FDA (e.g., other U.S. government agencies, academia, non-governmental organizations, and industry) in medical countermeasure regulatory science

Accomplishment: FDA launched the extramural component of the MCM Regulatory Science Program in FY 2011. The MCM Regulatory Science Program focuses on high-priority projects that are of value for public health and national security. FDA initially developed and issued a request for information (RFI) in FY 2011 to lay the foundation for the extramural component of the MCMi regulatory science program. FDA then issued a broad agency announcement (BAA) in FY 2012 to solicit proposals for the extramural component of the MCM Regulatory Science Program. Five white papers were submitted and reviewed under the BAA in FY 2012; a single full proposal was reviewed and recommended for funding. The contract for this award has been signed.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Issue request for information (RFI) to obtain additional stakeholder input into medical countermeasure regulatory science program to help FDA assess and prioritize medical countermeasure regulatory science needs and gaps and further the understanding of existing regulatory science capabilities

8/15/2011

Completed 8/19/2011

2. Review submissions to RFI

11/30/2011

Completed 12/15/2011

3. Identify medical countermeasure regulatory science needs through a comprehensive Portfolio Review

1/30/2012

Completed 1/25/2012

4. Identify best vehicle(s) for executing extramural program to meet identified regulatory science needs

1/30/2012

Completed 1/30/2012

5. Launch MCM extramural regulatory science funding program

4/30/2012

Completed 5/23/2012

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.