For Industry

Automated Commercial Environment/International Trade Data System (ACE/ITDS)

In collaboration with the U.S. Customs and Border Protection (CBP) and 46 partner government agencies, the Food and Drug Administration has been working to modernize business processes through the implementation of the Automated Commercial Environment/International Trade Data System (ACE/ITDS).

ACE/ITDS is a single access point whereby industry can electronically submit all data required by various government agencies involved in international trade. ACE will replace the Automated Commercial System and be fully functional by December 2016.
In preparation for the roll out of the ACE/ITDS Single Window Program, the FDA and CBP, together with the trade community, are performing a pilot to test and evaluate electronic filings through ACE/ITDS. This pilot assists users in transitioning to ACE filings prior to the mandatory date outlined above. FDA encourages potential pilot participants to contact their CBP client representative to test in CBP’s certification environment prior to participating in the ACE pilot for FDA-regulated commodities.
CBP issued a Federal Register Notice on Modification of the National Customs Automation Program Test Concerning the Submission of Certain Data Required by FDA using the PGA Message Set, to begin the FDA pilot, in August 2015. The initial commodities selected for the FDA pilot were: drugs, medical devices, and biologics; at the ports of Philadelphia, Baltimore, and Otay Mesa. As of December 2015, all commodities and ports are included in the pilot.
Through ACE/ITDS, importers and brokers will now have the option to uniquely identify firm information by providing the Dun & Bradstreet (D&B) Data Universal Number System (DUNS) Number, in addition to the firm name and address. To support this new feature, FDA has worked with D&B to develop the FDA ITDS/DUNS Portal. This website provides trade, at no cost, the ability to look up; verify; update; and if necessary, request new DUNS Numbers for use on FDA ACE/ITDS transactions, via a simple web interface.
A quick user guide and an in-depth step-by-step instruction guide have been developed to assist trade in using the portal.
For information about upcoming ACE webinars, please visit CBP's ACE webpage
For current FDA entry filings in ACE, please refer to FDA's Supplemental Guide for the Automated Commercial Environmental Trade Data System (ACE/ITDS) Version 2.4.1. The requirements in this version should be followed through February 8, 2017.
To review the specifications and requirements for filing in ACE as per the final rule, disclaimer iconSubmission of Food and Drug Administration Import Data in the Automated Commercial Environment, please refer to FDA’s Supplemental Guide for the Automated Commercial Environment/International Trade Data System (ACE/ITDS) Version 2.5. Please refer to CSMS #16-001033 for deployment information regarding version 2.5 of the supplemental guide, which will be fully implemented on February 9, 2017.
For questions about data requirements, the supplemental guide, testing, and the pilot, email or call toll free: 877-345-1101 or local/international: 571-620-7320.


Page Last Updated: 01/03/2017
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