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HHS/FDA RIN: 0910-AF78 Publication ID: Fall 2017 
Title: Import Tolerances for Residues of Unapproved New Animal Drugs in Food 

This rule would institute procedures by which a person may request FDA establish or amend tolerances for unapproved new animal drugs where edible portions of animals imported into the United States may contain residues of such drugs (import tolerances), or to revoke an existing import tolerance. Such import tolerances provide a basis for legally marketing food of animal origin that is imported into the United States and contains residues of unapproved new animal drugs.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Fully or Partially Exempt 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 U.S.C. 342    21 U.S.C. 360b(a)(6)    21 U.S.C. 371   
Legal Deadline:  None
Action Date FR Cite
NPRM  01/25/2012  77 FR 3653   
NPRM Comment Period End  04/24/2012    
Final Rule  08/00/2018 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
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: No 
Agency Contact:
Charli Long
Supervisory Chemist
Department of Health and Human Services
Food and Drug Administration
7519 Standish Place, MPN-2, HFV-150,
Rockville, MD 20855
Phone:240 402-0850