FDA-TRACK presentation to FDA Alliance 04-15-2010 by rux99038


         Program Performance at FDA

                    April 15, 2010

Dr. Joshua Sharfstein, FDA Principal Deputy Commissioner
       Dr. Bernadette Dunham, CVM Center Director
  Malcolm Bertoni, Assistant Commissioner for Planning
             Tim Kiang, Planning Staff Director

                           FDA-TRACK Overview
    FDA-TRACK is FDA’s new performance management system designed to be tracked
    at the program (operational) office level. FDA-TRACK will enable FDA to:

•   Tell a more compelling story, better representing the breadth of FDA’s core responsibilities,
    and demonstrate the value of FDA’s contributions and accomplishments to public health;

•   Enable better decision-making with more timely performance information and to support
    continuous data-driven decisions;

•   Provide a better mechanism for linking core program activities with leadership priorities;

•   Decrease the variation in agency performance measurement so collecting and reporting
    performance data is less cumbersome and manually intensive.

                   Tracked at the Operational Level
  Over 100 FDA Program Offices have completed performance measures for monthly
  analysis and quarterly reviews.

                                                           Commissioner of
                                                            Food & Drugs
Office of the
Commissioner                Staff Support & Program                                   External Affairs &               34 offices
                                Coordination-19                                       Administration-15

                    Human                             Medical         Tobacco           Food &
   Product          Drugs
                                                      Devices          (New)           Cosmetics
                                                                                                           Drugs &
   Centers                                                                                                  Feed
                   Program           Program          Program         Program            Program           Program
                                                                                                                       57 offices
                   Offices-21        Offices-7        Offices-8       Offices - 5        Offices-11        Offices-5

                                                 Regulatory           Toxicological
                                                  Affairs              Research
Field Operations
                                    Regional          Regional       Research             Admin
  & Research                        Offices-6          Labs-3        Divisions-7         Offices-3
                                                                                                                       19 offices

      What is FDA-TRACK Reporting?
                             1. Common Measures
                             • Focused on Agency’s non-program priorities
                             • Example: Decrease % of employee turnover.
 Key Center Director         2. Key Center Director Measures
Measures (Center Wide)       • Focused on specific Center’s priorities
                             • Example: Increase % of technical publications.
                             3. Program Measures
                             • Focused on Program Offices’ program/public
                             health priorities.
                             • Example: Increase % of food and color additives
        Program Measures +   petition reviews completed within 360 of filing in the
           Key Projects      month.
           (Office Wide)     4. Key Projects
                             • Demonstrates Program Offices’ key projects and
                             • Example: Develop a risk based approach for
                             evaluating safety, effectiveness and quality of new
                             animal drugs.
        Common Measures
           (FDA Wide)

                               Typical FDA-TRACK Cycle

                        Data Collection        Trends             Quarterly            Quarterly            Briefing
                         and Analysis         Analysis            Reporting            Briefing            Follow Up

       Timing:    Monthly/Quarterly   Monthly/Quarterly         Quarterly            Quarterly             Ongoing

Responsibility:   Program Offices     Office of Planning    Office of Planning   Office of Planning    Office of Planning
                                        and Program                                                      and Program
                                            Offices                                                          Offices
      Process:      Monitor and        Collate data and       Prepare and        Conduct briefings      Define follow up
                    collect each      analyze for trends     define quarterly       with Principal     action plan based
                  measure’s data      and goals. Define      dashboard and             Deputy             on quarterly
                  and submit each             key               trends for         Commissioner          briefings and
                   month/quarter      accomplishments       quarterly briefing     and Center and       prepare for next
                                      and contribution to                        Office Directors to        quarter
                                         outcomes.                                discuss quarter’s

      Medium:          Excel                Excel                 Excel            Face to Face         Memorandum

    How is FDA-TRACK Different from GPRA?*
               FDA-TRACK                                                  GPRA

• More robust set of measures covering greater   • Limited set of measures
  portion of mission
• Measures are tallied monthly and analyzed      • Measures are reported annually
  and reported quarterly

• Measures are reported at the (operational)     • Measures are reported at Center and Agency
  program office level                             level

• Measures are discussed quarterly at meetings   • Measures are reported “passively”
  with senior managers

                                                           *Government Performance and Results Act of 1993   6
                                                 FDA-TRACK To Date
    FDA-TRACK became fully operational on April 7th, 2010 with over 100 Program Offices
    implemented. To date, FDA has completed the following:
•   Tested the FDA-TRACK concept by first implementing 16 Program Offices via a Pilot Program:
     –   Developed and completed the sets of measures and key projects
     –   Presented and briefed the Principal Deputy Commissioner in two rounds of quarterly briefings
     –   Obtained feedback from formal evaluations process
                                                                                                          “The process of
•   Began the monthly data reporting, collection and reporting processes                              tracking our operations
                                                                                                      has allowed us to focus
•   Implemented the quarterly briefing and follow up action processes                                      on how to gain
                                                                                                      favorable public health
•   Finalizing the FDA-TRACK briefing room on the White Oak campus

         We developed the FDA-TRACK                                                “The FDA-TRACK process is
        measures in parallel to a strategic                                           enabling us to consider
      planning initiative, and this effort was                                      measures that capture the
        invaluable as trends and analysis            ““FDA-TRACK is leading       scientific goals of our research
       give insight into improving our own           us to think about training               division.”
                 planning efforts.”                     our staff and moving
                                                     forward, how to optimize
                                                      training to complement
                                                    and leverage job function.”                                                 7
                Demonstration FDA-TRACK Website

•   Main Page

•   Office Descriptions

•   Dashboard


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