View Rule

View EO 12866 Meetings

Printer-Friendly Version Download RIN Data in XML

HHS/FDA

RIN: 0910-AI09

Publication ID: Spring 2019

Title: Responsibilities for the Initiation and Conduct of Clinical Investigations
Abstract: 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 should 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 should 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 321
Legal Authority: 21 U.S.C. 355(i) 21 U.S.C. 371(a)

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	04/00/2020

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 Email: suzanne.pattee@fda.hhs.gov