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