MacroGenics, Inc. - Comment

Please clarify the difference between “1.3.1.3 Change in Sponsor” and “1.3.1.5 Change in ownership of an application” since the sponsor is typically the owner of an application. Please clarify on section “1.4.4 Cross-reference to previously submitted information” as the previous title seemed clearer and more concise. For section “1.11.4 Multiple module information amendment,” please provide clarification. Does FDA expect one document that involves all modules, or would FDA still prefer to have it be broken up into granular components and submit them under 1.11.1 through 1.11.3? For section “1.20 GIP for initial IND,” does FDA expect sponsors to only submit a document to this upon initial IND, and subsequent GIPs to be submitted under the DSUR or AR (1.13.9). From a lifecycle management perspective, this will only be applicable once and the document will always remain "new," but it might be updated in 1.13.9 or DSUR Regional Appendix. Does FDA expect a single combined GIP for all studies conducted under all INDs for a single therapeutic in the DSUR? Why is section 1.20 needed?