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  5. Exhibit 3-1 long description
  1. Prescription Drug User Fee Amendments

Exhibit 3-1 long description

Outlines the evaluation approach used by Booz Allen Hamilton (BAH) to analyze the impact of the CMA Pilots. Initially BAH generated hypotheses, and then developed metrics and analysis topics. Then simultaneously they performed FDA and sponsor interviews and did qualitative data analysis. They then did an evaluation of the benefits and effort, looked at the overall impact and finally summarized their conclusions and made recommendations.

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