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This update to the regulatory text of 45 CFR part 46 will address specific issues through the notice and comment rulemaking process that have caused confusion or compliance questions within the regulated community.  OASH will collaborate with the 18 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 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.”