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U.S. Department of Health and Human Services

About FDA

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About FDA-TRACK

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Introduction

FDA-TRACK is FDA's agency-wide program performance management system that monitors over 100 FDA program offices through key performance measures and projects. These measures and projects are developed by the program offices across the FDA and reported on a monthly basis. Each quarter, monthly performance data is analyzed, and senior managers present this data to FDA senior leadership.

This website enables all interested external and internal visitors to view FDA’s performance data at the program office level and gain a better understanding of the breadth of FDA’s core responsibilities, as well as see progress on important projects and programs.

Want to learn more?  Watch the Introduction to FDA-TRACK video. 


Objectives

The objectives of FDA-TRACK can be explained through its name:

  • Transparency – provide interested parties an unprecedented look into how FDA performs its work.
  • Results – highlights performance measures and results with relevance to the agency’s public health mission.
  • Accountability – requires senior managers to develop, track, and report performance measures that will improve the agency’s accountability to the public; holds the program offices accountable for their priorities, plans and results.
  • Credibility – encourages sharing of information about FDA performance which is essential for the agency’s credibility; provides the opportunity to submit suggestions which will be considered as part of the continuous improvement efforts.
  • Knowledge-sharing - enables the identification of common issues and interdependencies among program offices to improve FDA’s operational effectiveness through better collaboration and sharing of ideas.


Implementation

FDA-TRACK was implemented through a phased rollout approach, starting with a pilot program consisting of 16 program offices. As it was rolled out across the agency, each program office worked with the Office of Planning to develop meaningful and substantive measures as well as significant key office projects. The program offices developed measures and report performance and related data in four categories:

  1. Common Measures: Common measures are agency-wide measures of interest that are applicable to each of the program offices. An example includes decreasing the percentage of employee turnover.
  2. Key Center Director Measures: Key Center Director measures focus on Centers' priorities and strategic goals. An example includes increasing the submission of manuscripts accepted for publication in scientific journals, which helps the National Center for Toxicological Research improve research information that is available to interested stakeholders.
  3. Program Measures: Program measures are program office-specific measures that are applicable to the office and reflect work important to the public and FDA’s mission. An example includes increasing the percentage of 510(k) (or Class II medical devices) decisions made on time during the month.
  4. Key Projects: Key projects are program office-specific projects that are applicable to the office and important to the mission and objectives of the office. Performance for key projects is measured through achievement of the established milestones within its project plan. An example includes the development of a new risk-based approach for evaluating safety, effectiveness, and quality of new animal drugs. 


 

Key Participants

  • Program Offices - Over 100 FDA program offices track and analyze their monthly data, participate in quarterly briefings with FDA senior leadership, and implement process improvements or action items identified during each quarterly briefing.
  • Office of Planning - The Office of Planning (within the Office of the Commissioner) organizes and coordinates the FDA-TRACK process across the Centers/organizations and program offices.  The Office of Planning also examines performance data and conducts trend analysis for purposes of quarterly briefing discussions.
  • FDA Senior Leadership - The Commissioner/Deputy Commissioners, Associate Commissioners, Assistant Commissioner for Planning, Center Directors, Office Directors, and other key managers participate in the quarterly briefings and make key decisions based on trends or issues discussed during the quarterly briefings.