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HHS/OASH RIN: 0937-AA10 Publication ID: Fall 2022 
Title: Federal Policy for the Protection of Human Subjects: Updates to Reduce Administrative Burdens 

This update to the regulatory text of 45 CFR part 46 will address a number of identified issues through the notice and comment rulemaking process that have caused significant confusion and compliance concerns within the regulated community.  OASH will collaborate with the 16 Common Rule Departments and Agencies during this process. Changes are intended to promote one of the main policy goals of the subpart A revision (i.e., eliminating unnecessary administrative burden on institutional review boards and institutions regulated under 45 CFR part 46). Examples of changes include ensuring that the assurance-related requirements that were intended to be eliminated by the revisions to the Common Rule are actually eliminated so that regulatory burden surrounding this provision is reduced, and clarifying that storing biospecimens or information (regardless of identifiability) collected directly from a person specifically for research purposes would satisfy the definition of human subject. This is necessary in order to maintain OHRP’s long-standing interpretation of the definition of a "human subject.”

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 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 5 U.S.C. 301    42 U.S.C. 289(a)    42 U.S.C. 300v-1(b)   
Legal Deadline:  None
Action Date FR Cite
NPRM  06/00/2023 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Federal 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
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