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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. All changes are bipartisan in nature and 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.”