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HHS/FDA RIN: 0910-AI09 Publication ID: Fall 2019 
Title: Responsibilities for the Initiation and Conduct of Clinical Investigations 

The proposed rule will update FDA’s investigational new drug application (IND) regulations to better 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 are intended to better protect the rights, safety, and welfare of subjects participating in clinical investigations and help ensure the integrity of clinical trial data. The proposed rule is expected to help reduce study misconduct, enhance protection of subjects and ensure the reliability and integrity of clinical trial data (benefits) while requiring additional documenting and reporting for clinical investigators (cost). 

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously 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 312   
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    21 U.S.C. 360bbb    21 U.S.C. 371    42 U.S.C. 262   
Legal Deadline:  None
Action Date FR Cite
NPRM  09/00/2020 
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:
Suzanne Pattee
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 51, Room 3328, Center for Drug Evaluation and Research,
Silver Spring, MD 20993
Phone:301 796-1706