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HHS/FDA | RIN: 0910-AI09 | Publication ID: Spring 2018 |
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 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). |
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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 |
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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: 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 Email: lori.bickel@fda.hhs.gov |