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U.S. Department of Health and Human Services

For Industry

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Summary Of Assessment

Table of Contents

Appendix A

Our research and understanding of the review activities and the associated calculations for each activity factor related to the adjustments for changes in review activities for the PDUFA IV Workload Adjuster were key in establishing the framework for making our assessment.

The alternative model used process costs for each application type as an additional weighing scheme for the time reporting percentages. This resulted in a 3.00% final adjustment, which is not significantly different from the 2.98% adjustment in the PDUFA IV Workload Adjuster.

In addition, the results of the Monte Carlo analysis for the baseline and alternative model generated a mean value of 3.11% for the final adjustment in workload. This outcome also provided a means to measure the reasonableness of the adjustments for changes in review activities.

Within the boundaries of the assumptions outlined in the Evaluation And Study Assumptions section, and based on our analysis and the data that was available to us, our assessment of the current PDUFA IV Workload Adjuster finds that it reasonably captures changes in workload for reviewing human drug applications under PDUFA IV.

Appendix A