New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food

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The Food and Drug Administration (FDA or we) is proposing to amend our 2012 document entitled "New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food." The document proposed to revise the animal drug regulations regarding tolerances for residues of approved and conditionally approved new animal drugs in food by standardizing, simplifying, and clarifying the determination standards and codification style. We also proposed to add definitions for key terms. We are taking this action to more clearly explain our current thinking about certain provisions of the 2012 document based on comments from stakeholders, and to more accurately reflect the rationale FDA relied on in the past to approve certain new animal drugs without a tolerance. We are reopening the comment period only with respect to the specific issues identified in this supplemental proposed rule.