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HHS/FDA RIN: 0910-AH66 Publication ID: Spring 2018 
Title: Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Veterinary Devices 

The FDA is issuing a direct final rule and a companion proposed rule to require that certain data elements be submitted to Customs and Border Protection and FDA for veterinary devices to ensure that FDA has adequate information to determine admissibility. This rule ensures that the regulations on import submissions for veterinary devices are the same as for all other FDA regulated products.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
EO 13771 Designation: Fully or Partially Exempt 
CFR Citation: 21 CFR 1.17    21 CFR 1.72    21 CFR 1.75   
Legal Authority: 21 U.S.C. 371    21 U.S.C. 381   
Legal Deadline:  None
Action Date FR Cite
Direct Final Rule  10/00/2018 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Randall Gnatt
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine, 7519 Standish Place, MPN-4, Room 168, HFV-200,
Rockville, MD 20855
Phone:240 402-7231