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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 | |
Abstract:
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. |
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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 |
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Timetable:
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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 Email: randall.gnatt@fda.hhs.gov |