On July 1, 2016, the Food and Drug Administration (FDA) published in the Federal Register a proposed rule to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by U.S. Customs and Border Protection (CBP), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. ACE is a commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, foster U.S. economic security through lawful international trade and policy, and to replace the Automated Commercial System (ACS). FDA is a Partner Government Agency (PGA) in the initiative to establish ITDS, the “single window” for the submission of import and export data to the United States Government. The proposed rule would also update certain sections of FDA regulations related to imports. The rule, as proposed, does not affect the ability of filers to continue to submit their import entries and entry summaries by paper for FDA-regulated products that are being imported or offered for import. Once finalized, this action will facilitate effective and efficient admissibility review by the FDA and protect public health by allowing FDA to focus its limited resources on those FDA regulated products being imported or offered for import that may be associated with a greater public health risk.
Electronic or written comments on the proposed rule must be submitted by August 30, 2016.