In the October 28, 2016, Federal Register, FDA proposed to amend its 2012 document titled "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. FDA also proposed to add definitions for key terms. In this document, FDA is proposing to revise or remove some of the previously proposed definitions (e.g., removing the definition for "regulatory method"), taking into account comments the Agency received, and to more accurately reflect the rationale FDA relied on in the past to approve certain new animal drugs without a tolerance. FDA is reopening the comment period only with respect to the specific issues identified in this supplemental proposed rule. Comments are due December 27, 2016.
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