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HHS/FDA RIN: 0910-AH66 Publication ID: Fall 2019 
Title: Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Veterinary Devices 

FDA is proposing to require that certain data elements be submitted in ACE (Automated Commercial Environment) to Customs and Border Protection and FDA for veterinary devices to ensure that FDA has adequate information to determine admissibility. If finalized, this rule will ensure that information submitted for imported veterinary devices is the same as for other imported FDA regulated products.

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: 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
NPRM  11/00/2019 
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
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