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HHS/FDA RIN: 0910-AH32 Publication ID: Fall 2016 
Title: Responsibilities for the Initiation and Conduct of Clinical Investigations 
Abstract:

The proposed rule would update the investigational new drug application (IND) regulations to define and clarify the roles and responsibilities of the various persons engaged in the initiation, conduct, and oversight of clinical investigations subject to IND requirements. The proposed changes would better protect the rights, safety, and welfare of subjects and help ensure the integrity of clinical trial data.

 
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    21 CFR 16   
Legal Authority: 21 U.S.C. 355(i)    21 U.S.C. 3719(a)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  05/00/2017 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Molly Flannery
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 51, Room 6246, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-3543
Email: molly.flannery@fda.hhs.gov