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Details of New FDA-TRACK Management System for More Than 100 Programs

The Food and Drug Administration has launched a new organizational performance management system called "FDA-TRACK" in order to monitor program developments, provide accountability and transparency, and support the Open Government Initiative.

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More Than 100 FDA Program Offices to be Monitored

FDA-TRACK will monitor more than 100 FDA program offices through data from key performance measures established each year. Each program office will collect, analyze, and report its performance measures and results via FDA-TRACK dashboards, which will be updated quarterly.

FDA-TRACK Dashboards Cover International, Food, Cosmetic, Labeling Programs

Dashboard information for FDA program offices include those involved with international, food, cosmetic, labeling, enforcement, and other areas of responsibility. Information on the dashboards as well as sign-up information for electronic updates, is available here.

(FDA-TRACK monitors performance indicators in four categories:

Common Measures -- Agency-wide measures applicable to each program office that focus on the agency’s most recent priorities. Example: Increase the total number of employees who are trained in the Incident Command System, which helps the agency respond to emergencies.

Key Center Director Measures -- Center-specific measures that are applicable to each Center and are central to the Center’s priorities and strategic goals. Example: Increase the FDA’s technical guidance by increasing the number of technical publications drafted, which enables the Center to better prepare industry and consumers.

Program Measures -- Program office-specific measures that are applicable to the office and reflect work important to the public and to the FDA’s mission. Example: Monitor the percentage of 510(k) decisions meeting the 90-day Medical Device User Fee Act goal during a specific time period.

Key Projects -- 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 stated milestones within the project’s plan. Example: The development of a new risk-based approach for evaluating safety, effectiveness, and quality of new animal drugs.

See ITT's Online Archives or 09/02/10 news, 10090142, for earlier BP summary announcing FDA-TRACK's launch.)