0910-AH07 201610 The Regulatory Plan and the 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 revise the requirements concerning annual reports submitted to investigational new drug applications (INDs) by replacing the current annual reporting requirement with a requirement that is generally consistent with the format, content, and timing of submission of the development safety update report devised by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No 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(a) No NPRM 04/00/2017 Yes Businesses None No Yes 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