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HHS/FDA RIN: 0910-AH66 Publication ID: Fall 2020 
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: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Other 
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  08/03/2020  85 FR 46566   
Comment Period End  10/19/2020 
Final Rule  08/00/2021 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
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:
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