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HHS/FDA RIN: 0910-AH07 Publication ID: Spring 2014 
Title: ●Investigational New Drug Application Annual Reporting  
Abstract: 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 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: First time 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 USC 355(i)    21 USC 371(a)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/00/2015 
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:
Peter A. Taschenberger
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 51, Room 6312,
Silver Spring, MD 20993
Phone:301 796-0018
Fax:301 847-3529
Email: peter.taschenberger@fda.hhs.gov