US Automated Commercial Environment (ACE) - CBP Trade Data Requirements PGA: Executive Order 13659; 21 CFR 1.71 to 1.76 Supply partner government agency data in the ACE single window, including FDA entry data

What does PGA require?

Executive Order 13659 (2014) required participating agencies to use ACE, as the International Trade Data System single window, as the primary means of receiving the standard data and documents needed to release imports and clear exports by 31 December 2016. For FDA-regulated articles, the ACE filer must submit, when filing entry in ACE, the FDA country of production, complete FDA product code and intended use code, and the importer of record's telephone and email, plus product-specific data such as, for human drugs, the foreign establishment's registration number and the National Drug Code listing number and any application number (21 CFR 1.72, 1.74), with parallel requirements for biologics, devices, radiation-emitting products, cosmetics, tobacco and food contact substances.