The U.S. Food and Drug Administration issued a proposal today to amend its 2012 proposed rule for New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food.

The 2012 proposed rule included revisions to the animal drug regulations regarding tolerances for residues of approved and conditionally-approved new animal drugs in food. In addition to proposing to standardize, simplify, and clarify the standards of determination and codification style for tolerances, FDA proposed a new definition section. In direct response to comments received, the document issued today revises or removes some of the previously proposed definitions.

The FDA is also proposing to add definitions for key terms, in order to more clearly explain the current thinking about certain provisions of the proposed rule based on comments from stakeholders. The FDA is reopening the comment period only with respect to the specific issues identified in this supplemental proposed rule.

The FDA is accepting public comments beginning on October 28, 2016. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2012-N-1067 in the search box.

To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2012-N-1067 on each page of your written comments.

Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm526671.htm