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HHS/OASH RIN: 0937-AA08 Publication ID: Fall 2020 
Title: HHS Policy for the Protection of Human Research Subjects: Update to Subpart E (IRB Registration) 
Abstract:

This rule would amend subpart E of 45 CFR part 46 (Institutional Review Board (IRB) Registration) to align subpart E with recent amendments to the basic HHS Policy for the Protection of Human Subjects (subpart A of 45 CFR part 46, also known as the Common Rule) and to give effect to one of the policy goals of the subpart A revision (i.e., eliminating unnecessary administrative burden on IRBs and institutions regulated under 45 CFR part 46). The general compliance date of amendments to subpart A of 45 CFR part 46 was January 21, 2019.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Not subject to, not significant 
CFR Citation: 45 CFR 46   
Legal Authority: 5 U.S.C. 301    42 U.S.C. 289(a)    42 U.S.C. 300v-1(b)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  11/00/2020 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Related RINs: Related to 0937-AA02, Related to 0937-AA05 
Agency Contact:
Jerry Menikoff
Director, Office for Human Research Protections
Department of Health and Human Services
Office of Assistant Secretary for Health
1101 Wootton Parkway, Suite 200,
Rockville, MD 20852
Phone:240 453-6900
Email: jerry.menikoff@hhs.gov