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U.S. Department of Health and Human Services

For Industry

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OC Plan Summary

Table of Contents: PDUFA III Five-Year Plan

Previous Section : ORA Plan Summary Tables

The Office of the Commissioner provides support to the process for the review of human drug applications in a variety of ways. It collects and manages the fee revenue, hires additional staff, coordinates the acquisition and management of the additional space, provides IT support, and reports to Congress on the financial aspects of the program each year. It is also responsible for the annual PDUFA performance report to Congress and for assisting with other management responsibilities including the PDUFA III goal for improved Performance Management and the various contracts associated with this goal.

OC personnel necessary to support the drug review process are paid for under the overhead calculation described below. The management of contract funds necessary for the Performance Management goals is then discussed.

Next Section : OC Plan Summary Tables