Conforming Regulations Regarding Removal of Section 507 of the Federal Food, Drug, and Cosmetic Act; Companion Document to Direct Final Rule

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The Food and Drug Administration (FDA) is proposing to amend its regulations to remove references to the repealed statutory provision of the Federal Food, Drug, and Cosmetic Act (the act), under which the agency certified antibiotic drugs. The agency is also proposing to remove references to the repealed antibiotic monograph regulations and to those regulations dealing with antibiotic applications.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). This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.