U.S. Food & Drug Administration (FDA) FDA-TRACK Update

FDA-TRACK is an agency-wide performance management system that monitors over 100 FDA program offices through key performance measures and projects.  These measures are reported monthly and updated quarterly on the website.
What's New with FDA-TRACK
February 2013 Performance Data Updates
New performance data are available for the dashboards below.
Cross Agency

• January 7, 2013: FDA-TRACK Medical Countermeasures Initiative (MCMi) Quarterly Briefing Summary 
• FDA-TRACK Medical Countermeasures Initiative (MCMi) Dashboard: The Office of Counterterrorism and Emerging Threats (OCET) added a new key project, Academic Development of a Training Program for Good Laboratory Practices in Maximum Biocontainment, to identify and share best practices ensuring data quality and integrity in animal studies in Biosafety Level (BSL) 4.

Center for Devices and Radiological Health (CDRH)  

• November 28, 2012: FDA-TRACK CDRH Quarterly Briefing Summary
• FDA-TRACK CDRH Management Dashboard: The office completed the Reduce Undelivered Orders Backlog key project.
• FDA-TRACK CDRH Office of Communication, Education, and Radiation Programs (OCER) Dashboard 
• FDA-TRACK CDRH Office of Compliance (OC) Dashboard 
• FDA-TRACK CDRH Office of Science and Engineering Laboratories (OSEL) Dashboard
• FDA-TRACK CDRH Office of Surveillance and Biometrics (OSB) Dashboard
• FDA-TRACK CDRH Premarket Dashboard 

Center for Veterinary Medicine (CVM)  

• January 28, 2013: FDA-TRACK CVM Quarterly Briefing Summary
• FDA-TRACK CVM Administrative Dashboard: As part of the “Pioneer and Generic Animal Drug User Fees Renegotiations” Project, OM held a public meeting to gather feedback on proposed recommendations to the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA) programs on December 18, 2012.  The reauthorization package, including revised recommendations, is currently in clearance for transmittal to Congress.
•  FDA-TRACK CVM Office of Research (OR) Dashboard: OR completed its “National Antimicrobial Resistance Monitoring System (NARMS)” Project to enhance data management systems for timely reporting of NARMS data.
• FDA-TRACK CVM Office of Surveillance and Compliance (OSC) Dashboard
• FDA-TRACK CVM Premarket Dashboard

  

National Center for Toxicological Research (NCTR) 

• January 7, 2013: FDA-TRACK NCTR Quarterly Briefing Summary
• FDA-TRACK NCTR Dashboard: DGMT completed their assessment of the research findings for the project “Develop and Validate Genetic Biomarkers”, and have begun to draft a manuscript. Additionally, all federal employees at NCTR completed required safety training within FY 2012, meeting RCRM’s target of 100%.

Office of the Commissioner (OC)

•  January 7, 2013: FDA-TRACK Office of the Chief Scientist Quarterly Briefing Summary
• FDA-TRACK OC Office of the Chief Scientist (OCS) Dashboard: Beginning in FY 2013 Quarter 3, Office of Minority Health (OMH) performance measures and key projects will be tracked on the OCS dashboard. 

March 2013 Upcoming Performance Data Updates

The below listed programs are expected to publish performance data updates in March 2013. Updates are posted to each dashboard approximately 30 business days after each quarterly briefing with FDA senior leadership.

• Center for Biologics Evaluation & Research (CBER)
• Center for Food Safety and Applied Nutrition (CFSAN)
• Health Care Reform
• Office of International Programs (OIP)
• Office of Regulatory Affairs (ORA)

General Program Updates

• Quarterly Briefing Summaries – Visit this page for public summaries of accomplishments discussed at each FDA-TRACK briefing. We post summaries approximately 30 business days after each quarterly briefing, along with updated performance measures and results. This page includes a new summary for CDRH, CVM, MCMi, NCTR, and OCS.
• Completed Key Projects – Visit this page to read about completed key projects to date. New additions include CDRH and NCTR.