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GAO-12-650R 1 (2012-04-18)

handle is hein.gao/gaobacfyr0001 and id is 1 raw text is: blAccountaybilit Integrity - Reliability United States Government Accountability Office Washington, DC 20548 April 18, 2012 The Honorable Richard Burr Ranking Member Subcommittee on Children and Families Committee on Health Education Labor and Pensions United States Senate The Honorable Tom Coburn Ranking Member Permanent Subcommittee on Investigations Committee on Homeland Security and Governmental Affairs United States Senate Subject: Food and Drug Administration: Employee Performance Standards for the Timely Review of Medical Product Applications This report formally transmits the attached briefing in response to your request that we provide information on the standards that the Food and Drug Administration (FDA) considers when assessing the performance of its employees. (See the enclosure.) You asked whether the agency's timeliness goals for processing medical product applications are reflected in the performance standards for FDA employees who have a role in reviewing these applications. These timeliness goals are one aspect that FDA may consider in assessing employee performance. The extent to which these goals are reflected as explicit expectations in employee performance standards varies by an employee's duties, level of responsibility, and organizational component. We provided the briefing to your staff on April 17, 2012. As agreed with your offices, unless you publicly announce the contents of this report earlier, we plan no further distribution until 30 days from the report date. At that time, we will send copies to the Commissioner of FDA and appropriate congressional committees. The report also will be available at no charge on the GAO website at http-//www gao.gov. GAO-12-650R FDA Employee Performance Standards

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