0910-AB71 200104 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Implementation of the Import Tolerance Provisions of the Animal Drug Availability Act of 1996 Section 4 of the Animal Drug Availability Act of 1996 (ADAA) (Pub. L. 104-250) permits the Secretary of HHS to establish tolerances for animal drugs used or intended for use in animals grown in an exporting nation from which an edible portion is imported into the United States. The standards used to establish tolerances are to be similar to the food safety criteria used by the Secretary to establish tolerances for drugs administered to animals grown in the United States. The data used for establishing the tolerances may be from the manufacturer and include data upon which a foreign approval is based or data available to an international organization such as the Codex Alimentarius Commission. This rule would implement the provisions in ADAA. Substantive, Nonsignificant Previously Published in The Unified Agenda Prerule Stage No Undetermined 21 CFR 556 21 USC 360b No ANPRM 07/00/2001 NPRM 02/00/2002 Undetermined Undetermined NA Not Collected Frances Pell 0910 Food and Drug Administration FDA 240 276-9211 240 276-9241 frances.pell@fda.hhs.gov E140/HFV-235, Center for Veterinary Medicine, Room 101 (MPN-4, HFV-235), 7500 Standish Place, Rockville MD 20855 Not Procurement Related No