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Evaluation And Study Assumptions

Table of Contents

Data Collection And Validation

Deloitte’s evaluation and study is based on the following assumptions.

  1. The information and data obtained from the FDA Project Officer and other FDA key team members are accurate and complete.[1]
  2. Operational data collected from CDER and CBER’s time reporting systems are adequate for capturing the human drug application review activities (e.g., number of SPAs, NDA/BLA meetings scheduled, annual reports, etc.).
  3. The eight-week samples used for CDER and CBER time reporting surveys are considered to be representative of the level of effort for application review-related activities for the entire year.
  4. Time reported using activity codes in the time reporting survey adequately reflect the actual application review activities associated with the level of effort expended by CDER and CBER.
  5. The percentage distributions of CDER and CBER time reported for each office in the standard cost model are valid and accurate.
  6. The methodology for developing relative weights based on standard costs is appropriate.
  7. Since pay and benefit costs represent the majority of the CDER and CBER expenses, the obligation amounts used in the standard cost model are a close representation of the actual total CDER and CBER expenses.
  8. According to FDA, the non-labor obligations are proportional to labor obligations. Therefore, FDA’s use of total obligations in the standard cost model to represent the process costs of the PDUFA-related activities is appropriate.
  9. The PDUFA IV Workload Adjuster and the adjustment for changes in review activities are unique. Currently, there is no authoritative guidance, existing metric, historical data, or other similar methodology available for measuring its effectiveness.

Data Collection And Validation

[1] Deloitte performed within scope validation work (see Section 4.2.2).