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U.S. Department of Health and Human Services

About FDA

Implement Intramural Component of MCM Regulatory Science Program

Description: Build robust intramural regulatory science program designed to address identified MCM gaps; enhance FDA’s capacity to review, monitor, and assess MCMs; and prepare and respond to public health emergencies.

Accomplishment: FDA launched the intramural 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. To ensure that the MCM Regulatory Science Program is appropriately targeted and coordinated with priorities of the Public Health Emergency Medical Countermeasures Enterprise (Enterprise), FDA established a Steering Committee for Advancing MCMi Regulatory Science. This Steering Committee is comprised of Enterprise partners – including NIH, CDC, BARDA, and DoD – and is charged with evaluating and approving MCM regulatory science research proposals primarily based upon alignment with Enterprise priorities and secondarily based upon scientific/technical merit and feasibility. More than 90 intramural regulatory science projects across CBER, CDER and CDRH have been funded under the MCM Regulatory Science Program through FY 2012.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Identify specific intramural research programs for funding during FY 2011

7/30/2011

Completed 6/30/2011

2. Conduct an intramural portfolio review to re-assess gaps and unmet needs

9/30/2011

Completed 9/18/2011

3. Identify specific intramural projects for potential FY 2012 funding, budget permitting

12/30/2011

(6/30/2012)

Completed 6/22/2012

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.