0910-AI37 201904 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 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 a development safety update report (DSUR). The proposed DSUR is intended to be generally consistent with the format and content for IND annual reporting supported by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and is more comprehensive, informative, and less burdensome than the IND annual report currently required by FDA.

]]> Other Significant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined No Deregulatory 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(a) No NPRM 03/00/2020 No Businesses None No No No No Ebla Ali Ibrahim Project Manager 0910 Food and Drug Administration FDA 301 796-3691 ebla.ali-ibrahim@fda.hhs.gov Center for Drug Evaluation and Research, Building 51, Room 6302, 10903 New Hampshire Avenue, Silver Spring MD 20993