The Food and Drug Administration (FDA) is issuing a final rule to establish requirements for the electronic filing of entries of certain FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange system authorized by the U.S. Customs and Border Protection Agency (CBP), in order for the import entry filing to be processed by CBP and to help FDA in determining admissibility. This final rule concerns only the data elements for which the submission will be made mandatory in ACE. These elements would be collected for FDA by CBP via ACE to facilitate FDA’s process of making admissibility decision on certain FDA-regulated commodities imported or offered for import into the United States. Requiring submission of these data elements in ACE will help FDA to prevent some products that are not in compliance with the Food, Drugs and Cosmetics Act or the Public Health Service (PHS) Act, or that are otherwise subject to refusal of admission, from entering the U.S. and to improve efficiency of the FDA import entry process. In addition, this rule also establishes technical revisions to certain sections of 21 Code of Federal Regulations (CFR) Chapter I related to (1) updating the definition of owner or consignee; (2) updating the procedure for providing notice of sampling; (3) clarifying that FDA can provide electronic notices of hearing on refusal of admission or destruction related to FDA-regulated products imported or offered for import; and (4) specifying that importers of record of human cells, tissues or cellular or tissue-based products (HCT/Ps) that are regulated solely under section 361 of the PHS and 21 CFR part 1271, unless exempted, would be required to submit the applicable data elements included in this final rule in ACE.
Regulatory Impact Analysis
Federal Register: 81 FR 85854, November 29, 2016