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The Food and Drug Administration (FDA or the Agency) is issuing an advance notice of proposed rulemaking (ANPRM) to obtain information related to recalls of products subject to the jurisdiction of the FDA and to invite comments that may inform FDA’s intention to revise the Agency’s guidance on policy, procedures, and industry responsibilities for recalls (including product corrections) (FDA’s recall regulation).  Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation.