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Appendix A: Diagram of PDUFA IV Workload Adjuster

Table of Contents

Appendix B

The next three diagrams represent our understanding of the PDUFA IV Workload Adjuster.

 PDUFA IV Workload Adjuster: Diagram 1

Diagram 1: 508-Compliant Narrative

 

 PDUFA IV Workload Adjuster: Diagram 2

Diagram 2: 508-Compliant Narrative

 

 PDUFA IV Workload Adjuster: Diagram 3

Diagram 3: 508-Compliant Narrative

 

Diagram 1 Summary submission count data for NDAs/BLAs, INDs, Manufacturing Supplements, and Efficacy Supplements from CDER and CBER are submitted to FDA personnel. These summary data are used to calculate the Base and Current 5-year Averages (Columns 1 and 2a, respectively).

Return to Diagram 1

Diagram 2 Summary data for Review Activity Components for NDAs/BLAs and INDs from CDER and CBER are submitted to FDA personnel. These summary data are used to calculate the Base and Current 5-year Averages (Columns 1 and 2a, respectively) for each Review Activity Component on a per application basis. The percent change for each Review Activity Component relative to the base year is then calculated.

Summary time reporting data for NDAs/BLAs and INDs from CDER and CBER are submitted to FDA personnel. This summary data is used to calculate the percent of CDER and CBER time spent on each Review Activity Component. In addition, this summary data is used to calculate the percent of CDER and CBER time spent on each application type. These results are multiplied together to calculate the Weighted Percent Changes for each Review Activity Component for both CDER and CBER. The Weighted Percent Changes for CDER and CBER are then summed to generate Time Weighting Factors for each Review Activity Component. The average Time Weighting Factor for each Review Activity Component is then calculated for the most recent 5-year period.

The percent change for each Review Activity Component is then multiplied by the appropriate Time Weighting Factor to generate an Adjustment Factor for each Review Activity. The Adjustment Factors for each application type are then totaled to generate the final Adjustments for Changes in Review Activities, shown in Column 2b.

Return to Diagram 2

Diagram 3 - The Current 5-year Averages (Column 2a) and the Adjustments for Changes in Review Activities (Column 2b) are used to calculate the Adjusted Current 5-year Averages (Column 2c). The Base 5-Year Averages (Column 1) and the Adjusted Current 5-Year Averages (Column 2c) are used to calculate the Percent Change for each Application Type (Column 3).

Work Units are calculated based on submission counts and estimates of the standard cost to review each submission type. Work Units are then aggregated to reflect application types included in the Workload Adjuster. The 5-year average number of Work Units is then calculated for each application type. The percent of total LOE for each application type is then calculated to generate the Weighing Factors (Column 4).

The Percent Change (Column 3) and Weighting Factor (Column 4) for each application type are multiplied together to calculate the Weighted Percent Change for each application type (Column 5). The Weighted Percent Changes are then totaled to calculate the final Workload Adjuster value.

Return to Diagram 3

Appendix B