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HHS/FDA RIN: 0910-AB71 Publication ID: Fall 2001 
Title: Implementation of the Import Tolerance Provisions of the Animal Drug Availability Act of 1996 
Abstract: 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. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 556   
Legal Authority: 21 USC 360b   
Legal Deadline:  None
Timetable:
Action Date FR Cite
ANPRM  08/10/2001  66 FR 42167   
NPRM  12/00/2002    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: No 
Agency Contact:
Frances Pell
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
E140/HFV-235, Center for Veterinary Medicine, Room 101 (MPN-4, HFV-235), 7500 Standish Place,
Rockville, MD 20855
Phone:240 276-9211
Fax:240 276-9241
Email: frances.pell@fda.hhs.gov