Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Veterinary Devices (Final Rule) Regulatory Impact Analysis

For veterinary devices being imported or offered for import into the United States, and where entry is electronically filed in the Automated Commercial Environment or any other electronic data interchange system authorized by U.S. Customs and Border Protection, this final rule requires the submission of certain data elements material to FDA's process of making decisions on admissibility. This final rule therefore simply extends to veterinary devices the submission of the data elements that are currently required for other FDA-regulated products by § 1.72 (21 CFR 1.72).

Cost savings will result from increased efficiency in, and streamlining of, FDA's imports admissibility process. These cost savings to the industry and FDA cannot be quantified because FDA currently lacks data to do so. Potential benefits to consumers, that we are similarly unable to quantify, will result from a reduction in the number of non-compliant veterinary device imports reaching U.S. consumers and from compliant imported veterinary devices reaching U.S. consumers faster.

The FDA has estimated the annualized costs of complying with this regulation to be between $0.056 million and $0.140 million per year (in 2020 dollars annualized over 20 years using 7 percent discount rate). These costs were already previously inadvertently included and the benefits discussed in the regulatory impact analysis (RIA) for the “Submission of Food and Drug Administration Import Data in the Automated Commercial Environment” final rule published in November 2016 (81 FR 85854).  Because we do not want to double count these costs to the industry, we have concluded that this final rule will have no additional costs beyond the costs that were included in that RIA.

Federal Register: 87 FR 62977 – October 18, 2022 

Docket: FDA-2018-N-4268