0910-AI37 202104 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Investigational New Drug Application Annual Reporting

This proposed rule, if finalized would amend FDA’s requirements concerning annual reports submitted by sponsors to investigational new drug applications (INDs) by replacing FDA’s current annual reporting requirement with a new requirement for an FDA development safety update report (FDA DSUR). The proposed FDA DSUR is intended to be consistent with the format and content for IND annual reporting supported by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and is more comprehensive, informative than the IND annual report currently required by FDA.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined No 21 CFR 312.3 21 CFR 312.33 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 353 21 U.S.C. 355(i) 21 U.S.C. 371(a) 42 U.S.C. 262 No NPRM 10/00/2021 No Businesses None No No No No Dat Doan Supervisory Regulatory Health Project Manager 0910 Food and Drug Administration FDA 240 402-8926 dat.doan@fda.hhs.gov Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, WO 51, Room 3334, Silver Spring MD 20993