Commitment Accession Description of Change Description of Comment and Tracking Number Training Feedback Resolution Number Issue Date Required and Accession Number Change Notice Completion (Pre-Decisional, Date ML101400488 This revision updates the hyperlink to the OE Web page. N/A ML103490479 N/A 06/08/11 It adds use of SAPHIRE version 8 and updates the CN 11-010 participants and members of the SERP. The IMC has been better aligned with IMC0609 SDP to remove – redundancy. Clarification was for the deadline that licensees have to submit additional information. The term was changed to review’. ‘caucus’ ‘post-conference Clarification was added for findings in which the review determines the significance of a finding should be changed as a result of new data provided by the licensee, then the finding will be reviewed at a final SERP. The material covered at the final SERP should focus on those areas affected by the Regulatory Conference and that changed the original SERP outcome. A review of related documents will be completed to ensure conforming changes to other related areas in IMC0609, including those governing the scope and content of the final SERP package, are reflected as well (ROPFF 0609.01-1481). ML14153A568 Several significant changes to the guidance were made N/A ML15072A302 04/29/15 based on recommendations from the SDP Business ML14099A265 CN 15-008 Process Improvement (BPI) Report (ML14318A512) and ML14099A277 the ROP Independent Assessment Report ML14099A285 (ML14035A571). Incorporated recommendations from ROPFF 0609.01-1759, 1908, 1910.
Commitment Tracking Number Accession Number Issue Date Change Notice Description of Change Description of Training Required and Completion Date Comment and Feedback Resolution Accession Number (Pre-Decisional, N/A ML101400488 06/08/11 CN 11-010 This revision updates the hyperlink to the OE Web page. It adds use of SAPHIRE version 8 and updates the participants and members of the SERP. The IMC has been better aligned with IMC0609 – SDP to remove redundancy. Clarification was for the deadline that licensees have to submit additional information. The term ‘caucus’ was changed to ‘post-conference review’. Clarification was added for findings in which the review determines the significance of a finding should be changed as a result of new data provided by the licensee, then the finding will be reviewed at a final SERP. The material covered at the final SERP should focus on those areas affected by the Regulatory Conference and that changed the original SERP outcome. A review of related documents will be completed to ensure conforming changes to other related areas in IMC0609, including those governing the scope and content of the final SERP package, are reflected as well (ROPFF 0609.01-1481). N/A ML103490479 ML14153A568 04/29/15 CN 15-008 Several significant changes to the guidance were made based on recommendations from the SDP Business Process Improvement (BPI) Report (ML14318A512) and the ROP Independent Assessment Report (ML14035A571). Incorporated recommendations from ROPFF 0609.01-1759, 1908, 1910. N/A ML15072A302 ML14099A265 ML14099A277 ML14099A285
imc0609-att-1.docx