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HHS/FDA RIN: 0910-AI09 Publication ID: Spring 2018 
Title: ●Responsibilities for the Initiation and Conduct of Clinical Investigations 

The proposed rule updates FDA’s 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.  The proposed rule should help reduce study misconduct and ensure the integrity of clinical trial data (benefits) while requiring additional documenting, reporting, and recordkeeping for clinical investigators (costs).

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Fully or Partially Exempt 
CFR Citation: 21 CFR 16    21 CFR 321   
Legal Authority: 21 U.S.C. 355(i)    21 U.S.C. 371(a)   
Legal Deadline:  None
Action Date FR Cite
NPRM  04/00/2019 
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:
Lori Bickel
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6316,
Silver Spring, MD 20993
Phone:301 796-0210