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FDA Approval Author: U.S. Food and Drug Administration Last Updated: Aug 31, 2010 - 1:05:19 PM



FDA Launches New Organizational Performance Management System

By U.S. Food and Drug Administration
Aug 31, 2010 - 1:02:23 PM



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FDA-TRACK monitors accountability, transparency; supports Open Government Initiative

(HealthNewsDigest.com) - The U.S. Food and Drug Administration today launched an innovative performance management system designed to advance the President's commitment to transparency, public participation, and collaboration in the work of government.

The system, called FDA-TRACK, will monitor more than 100 FDA program offices through data from key performance measures established each year. That data will be gathered monthly, analyzed and presented each quarter to FDA senior leadership. Importantly, the public will be able to track this data and the agency's progress through the FDA-TRACK website.

"FDA-TRACK will bring the operations of this historically opaque Agency into the daylight and help us be even more responsive as we work to protect the public health," said FDA Commissioner Margaret Hamburg, M.D.

FDA-TRACK is designed to be informative, encourage accountability among the people who work at the FDA, and make that work more transparent. It gives managers and employees a new way to measure their effectiveness in meeting goals to protect the public health and provides a way for the public to monitor agency activities.

Adapted from several successful state and local performance management models, FDA-TRACK hopes to set the standard for open government at the federal level. The system monitors performance indicators in four categories:

Common Measures - Agency-wide measures applicable to each of more than 100 program offices and may 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.

For more information:

FDA-TRACK: Agency-wide Program Performance
http://www.fda.gov/AboutFDA/Transparency/track/default.htm

Department of Health and Human Services - New High-Value Data Sets and Tools
http://www.hhs.gov/open/plan/opengovernmentplan/transparency/dataset.html#track

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