Conforming Regulations Regarding Removal of Section 507 of the Federal Food, Drug, and Cosmetic Act

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The Food and Drug Administration (FDA) is amending its regulations to remove references to the repealed statutory provision of the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified antibiotic drugs. FDA is also removing references to the repealed antibiotic monograph regulations and to those regulations dealing with antibiotic applications. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws the direct final rule.