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 FDA launched the extramural component of the <a href=http://www.fda.gov/EmergencyPreparedness/MedicalCountermeasures/ucm263071.htm target=”_blank”>MCM Regulatory Science Program</a> 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 <a href=http://grants.nih.gov/grants/guide/notice-files/NOT-FD-11-001.html target=”_blank”>request for information</a> (RFI) in FY 2011 to lay the foundation for the extramural component of the MCMi regulatory science program. FDA then issued a <a href=https://www.fbo.gov/index?s=opportunity&mode=form&id=37bb839589337c6344f0e8d02721e3b1&tab=core&_cview=0 target=”_blank”>broad agency announcement</a> (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. 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 http://www.fda.gov/AboutFDA/Transparency/track/ucm237964.htm FDA-TRACK Medical Countermeasures Initiative (MCMi) Dashboard http://www.fda.gov/EmergencyPreparedness/MedicalCountermeasures/default.htm Medical Countermeasures Initiative (MCMi) ਍††਍਍਍਍਍਍਍