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HHS/FDA RIN: 0910-AH07 Publication ID: Fall 2016 
Title: 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).

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: No  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(a)   
Legal Deadline:  None
Action Date FR Cite
NPRM  04/00/2017 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
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