Table of Contents

• Background 
• Objectives and Scope of the Study 
• Project Methodology 
• Work Performed: Understanding of the FDA Methodology 
• Evaluation And Study Assumptions 
• Data Collection And Validation 
• Approach And Results 
• Observations 
• Summary Of Assessment 
• Appendix A: Diagram of PDUFA IV Workload Adjuster 
• Appendix B: Supporting Information for Monte Carlo Analysis 
• Appendix C: Documents Provided By Client 
• Appendix D: Methodology For The Alternative Workload Adjuster With Weighted Time Reporting Glossary 
• Glossary