FDA-TRACK: Agency-wide Program Performance

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Topics on this Page:

• Introduction
• Objectives
• Background: FDA-TRACK Implementation
• Latest Status

Introduction

FDA-TRACK is a new agency-wide program performance management system that monitors over 100 FDA program offices through key performance measures. These measures 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.

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We are interested in your thoughts, feedback, and inquiries as we move to fully implement FDA-TRACK. Some offices are not yet online. Other offices will be posting additional measures. FDA also anticipates that as the agency gains experience with the measures, some may be changed to better capture important data or goals. As FDA moves forward, the agency is interested in public feedback on the website and the measures. Please contact us with any comments or suggestions at FDATRACK@fda.hhs.gov.
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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.

Background: FDA-TRACK 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 that are applicable to each of the program offices and may focus on the agency’s most recent priorities. An example includes increasing the total number of employees who have completed the Incident Command System (ICS) training in the month, which helps the agency respond to emergencies.
2. Key Center Director Measures: Key Center Director measures are Center-specific measures that are applicable to each Center and are central to the Center’s priorities and strategic goals. An example includes monitoring the percentage of employees who receive training each month, which enables the Center for Devices and Radiological Health to ensure it is providing high value training opportunities to its employees.
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. 

Latest Status

As of August 2010

August 2010 Performance Data Updates

• Center for Devices and Radiological Health (CDRH) – The CDRH Premarket Dashboard now includes 510(K) data at the center and office levels. Also visit the Office of Compliance and Office of Communication, Education and Radiation Programs dashboards for new program measures.
• Office of the Commissioner (OC), Office of the Chief Scientist (OCS) – The OCS Dashboard now includes program measure explanations in the Measure Dictionary.
• Office of the Commissioner (OC), Office of International Programs (OIP)
• National Center for Toxicological Research

For the latest FDA-TRACK dashboards by program areas, please refer to the Cross-Agency FDA-TRACK Program Areas, Center FDA-TRACK Program Areas, or Dashboards links on the left side of this page.