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HHS/FDA RIN: 0910-AF78 Publication ID: Spring 2011 
Title: Import Tolerances for Residues of Unapproved New Animal Drugs in Food 
Abstract: The Food and Drug Administration (FDA) plans to publish a proposed rule related to the implementation of the import tolerances provision of the Animal Drug Availability Act of 1996 (ADAA). The ADAA authorizes FDA to establish tolerances for unapproved new animal drugs where edible portions of animals imported into the United States may contain residues of such drugs (import tolerances). It is unlawful to import animal-derived food that bears or contains residues of a new animal drug that is not approved in the United States, unless FDA has established an import tolerance for that new animal drug and the residue of the new animal drug in the animal-derived food does not exceed that tolerance. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 USC 342    21 USC 360b(a)(6)    21 USC 371   
Legal Deadline:  None
Action Date FR Cite
NPRM  09/00/2011    
NPRM Comment Period End  12/00/2011    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes 
Agency Contact:
Thomas Moskal
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine, Room 101, (MPN-4, HFV-232), 7519 Standish Place,
Rockville, MD 20855
Phone:240 276-9242
Fax:240 276-9241