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U.S. Department of Health and Human Services

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Report on FY 2008 OCP Requirements

FY 2008 OCP Performance Report

OCP is required to provide an annual performance assessment for combination product applications. This section provides performance information for FY 2008 and updates the FY 2007 performance information in the subsection for “Timely and Effective Premarket Review” for reporting the timeliness in days of the reviews of combination products. Consistent with the mandated functions of OCP, data highlighted in this section include:

  • Timeliness in days of the assignment of combination products
  • Number and types of combination products under review
  • Timeliness in days of the reviews of combination products
  • Number of premarket reviews of combination products that involved a consulting Center
  • Timeliness in days of dispute resolutions regarding combination products

Unless otherwise noted, all performance information in this section is as of September 30, 2008.

Next page: Prompt Assignment of Combination Products