The goal of this project is to develop and implement the use of comprehensive test panels for the evaluation of multi-use screening, detection, and characterization assays. The project, which will be carried out in collaboration with other government agencies, will support and expedite consequence management efforts in response to intentionally released or natural events associated with high priority biological threat agents. ON TRACK DELAYED 1. Clear a draft guidance document for Highly Multiplexed Microbiology/MCM Devices 6/30/2012 Completed 9/25/2012 2. Define, construct, and qualify validated nucleic acid panels to facilitate development of commercial and non-commercial MCM devices for the detection of biothreat agents 9/30/2012 <i>(9/30/2013)</i> On Track 3. Continue to implement and refine a process to help developers of influenza detection devices further evaluate reactivity of their devices for CLIA waiver purposes 9/30/2012 <i>(9/30/2013)</i> On Track 4. Hold at least one inter-agency meeting in support of our collaborative effort to develop and maintain a high quality reference database that can be utilized to validate results of nucleic acid /sequencing based diagnostic assays 9/30/2012 Completed 9/14/2012 The dates in italics under the milestone due dates are modified milestone due dates which had to be updated due to real-time delays. The milestone status reflects the revised dates. 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) ਍††਍਍਍਍਍਍਍