Periodic Review of Existing Regulations; Retrospective Review Under E.O. 13563

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In accordance with Executive Order 13563, "Improving Regulation and Regulatory Review," the Food and Drug Administration (FDA) is conducting a review of its existing regulations to determine, in part, whether they can be made more effective in light of current public health needs and to take advantage of and support advances in innovation. The goal of this review of existing regulations, as with our other reviews, is to help ensure that FDA's regulatory program is more effective and less burdensome in achieving its regulatory objectives. FDA is requesting comment and supporting data on which, if any, of its existing rules are outmoded, ineffective, insufficient, or excessively burdensome and thus may be good candidates to be modified, streamlined, expanded, or repealed. As part of this review, FDA also invites comment to help us review our framework for periodically analyzing existing rules.