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U.S. Department of Health and Human Services

For Industry

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Appendix C: Documents Provided By Client

Table of Contents

Appendix D

The following represent the list of documents provided by FDA:

  • Documents from PDUFA History Lesson Meeting
  • Documents from CDER and CBER Time Reporting Briefings
  • Federal Register notice as of 08-01-08
  • Documents on original development of standard cost methodology from Arthur Andersen and KPMG reports
  • The standard cost model workbook
  • The PDUFA IV Workload Adjuster workbook
  • The PDUFA III Simulation workbook
  • List of Activity Codes from CDER Time Reporting System and CBER Resource Reporting System for PDUFA-related activities
  • Article entitled "Test Tube to Patient”
  • List of other review activities that were maintained and/or considered during the transition from PDUFA III to PDUFA IV
  • FY 2007 Financial Report
  • FY 2007 Performance Report
  • CDER and CBER data from FY 1997 through FY 2005
  • Data and clarification on the different types of meetings that occur during the PDUFA drug application review process
  • Time reporting percentages for FY 2006 and FY 2007
  • CDER submission counts and complexity factor data from FY 2002 through FY 2008
  • CBER submission counts and complexity factor data from FY 2002 through FY 2008

Appendix D