Labeling of Drugs for Use in Milk-Producing Animals

The Food and Drug Administration (FDA) is amending the new animal drug regulations to remove the existing 96-hour withdrawal time limitation, eliminate the requirement to calculate and label on the basis of the number of 12-hour milking periods that have elapsed since treatment, and permit a milk-discard or withdrawal time to be calculated by elapsed hours since treatment. The agency is taking these actions to allow greater flexibility in the labeling of new animal drugs for use in milk-producing animals. The increased flexibility will make it easier and more economical for sponsors to comply with the regulations. These actions are part of FDA's continuing effort to achieve the objectives set forth in the President's ``National Performance Review'' initiative, which is intended to provide a comprehensive review of all rules to identify those that are obsolete and burdensome and to delete or revise them.