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HHS/FDA RIN: 0910-AI37 Publication ID: Spring 2019 
Title: ● 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.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
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(a)   
Legal Deadline:  None
Action Date FR Cite
NPRM  03/00/2020 
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:
Ebla Ali Ibrahim
Project Manager
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, Building 51, Room 6302, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-3691