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HHS/FDA RIN: 0910-AI37 Publication ID: Fall 2021 
Title: 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.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 312.3    21 CFR 312.33   
Legal Authority: 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   
Legal Deadline:  None
Action Date FR Cite
NPRM  02/00/2022 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Dat Doan
Supervisory Regulatory Health Project Manager
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, WO 51, Room 3334,
Silver Spring, MD 20993
Phone:240 402-8926