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