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Appendix D: Methodology For The Alternative Workload Adjuster With Weighted Time Reporting Glossary

Table of Contents

Glossary

  1. First, calculate the total process costs for NDA/BLA and IND applications by adding together the standard process costs for the different types of NDAs/BLAs and active INDs for each fiscal year. The calculations were performed as follows:
    1. [A] = Total NDA/BLA Process Costs =

      (NDA NME with Clinical Data) +

      (NDA xNME with Clinical Data) +

      (NDA xNME without Clinical Data) +

      (BLAs reviewed by CDER) +

      (BLAs reviewed by CBER)

    2. [B] = Total IND Process Costs =

      (Drug INDs) +

      (Biologic INDs reviewed by CDER) +

      (Biologic INDs reviewed by CBER)

  2. Second, multiply the total NDA/BLA and IND process costs by the corresponding time weighting factor (already provided) to generate the weighted process costs for each review activity. The calculations for each review activity component were performed as follows, for each fiscal year for which data is available:
    1. [C] = Labeling Supplements Weighted Process Costs =
      [A] * (Time Weighting Factor for Labeling Supplements)
    2. [D] = Annual Reports Weighted Process Costs =
      [A] * (Time Weighting Factor for Annual Reports)
    3. [E] = NDA/BLA Meetings Scheduled =
      [A] * (Time Weighting Factor for NDA/BLA Meetings Scheduled)
    4. [F] = SPAs Weighted Process Costs =
      [B] * (Time Weighing Factor for SPAs)
    5. [G] = IND Meetings Scheduled =
      [B] * (Time Weighting Factor for IND Meetings Scheduled)
  3. Third, calculate the current 5-year average of the weighed process costs. The calculations were performed as follows:
    1. Labeling Supplements Weighted Time Reporting Percentage =
      (Current 5-Year Average of [C]) / (Current 5-Year Average of [A])
    2. Annual Reports Weighted Time Reporting Percentage =
      ([(Current 5-Year Average of [D]) / (Current 5-Year Average of [A])
    3. NDA/BLA Meetings Scheduled Weighted Time Reporting Percentage =
      (Current 5-Year Average of [E]) / (Current 5-Year Average of [A])
    4. SPAs Weighted Time Reporting Percentage =
      (Current 5-Year Average of [F]) / (Current 5-Year Average of [B])
    5. IND Meetings Scheduled Weighted Time Reporting Percentage =
      (Current 5-Year Average of [G]) / (Current 5-Year Average of [B])

    Once the process cost weighted time reporting percentages are calculated for each review activity component, the remaining calculations are performed according to the current methodology. (i.e., the adjustments for changes in review activities are still a sum of the individual activity factors as described above).

Glossary