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HHS/FDA | RIN: 0910-AI07 | Publication ID: Fall 2022 |
Title: Protection of Human Subjects and Institutional Review Boards | |
Abstract:
This proposed rule would harmonize, to the extent practicable and consistent with other statutory provisions, certain provisions of FDA’s regulations on human subject protection and institutional review boards with the revised "Federal Policy for the Protection of Human Subjects” (the revised Common Rule (45 CFR part 46, subpart A)). The rule also proposes minor amendments to related regulatory provisions. |
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Agency: Department of Health and Human Services(HHS) | Priority: Economically Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Yes | Unfunded Mandates: No |
CFR Citation: 21 CFR 50 21 CFR 56 21 CFR 812 | |
Legal Authority: 21 U.S.C. 343 21 U.S.C. 346 21 U.S.C. 348 21 U.S.C. 350a and 350b 21 U.S.C. 353 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 360c to 360e 21 U.S.C. 360j 21 U.S.C. 360hh to 360pp 21 U.S.C. 360rr to 360ss 21 U.S.C. 371 21 U.S.C. 379e 42 U.S.C. 262 |
Legal Deadline:
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Overall Description of Deadline: Section 3023 of the 21st Century Cures Act |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Sheila Brown Health Policy Analyst Department of Health and Human Services Food and Drug Administration Office of Clinical Policy, 10903 New Hampshire Avenue, WO 32, Room 5103, Silver Spring, MD 20993 Phone:301 796-6563 Email: sheila.brown@fda.hhs.gov |