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 replaced the Automated Commercial System in 2016.
In preparation for the roll out of the ACE/ITDS Single Window Program, the FDA and CBP, together with the trade community, performed a pilot to test and evaluate electronic filings through ACE/ITDS. This pilot assisted users in transitioning to ACE filings prior to the mandatory date. 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.
Through ACE/ITDS, importers and brokers 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.
For information about upcoming ACE webinars, please visit CBP's ACE webpage.
This project is mandated by the Security and Accountability for Every Port Act of 2006 and the Executive Order on Streamlining the Export/Import Process for America’s Businesses, issued February 2014.
To review the specifications and requirements for filing in ACE as per the final rule, Submission 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 2.5.3. Please refer to CSMS #46108784 for information regarding version 2.5.3 of the supplemental guide, which was posted on Feb 2, 2021.
Visit CBP's webpage to review the ACE Cargo Release Status Notification Implementation Guide.
For questions about data requirements and the supplemental guide, the FDA ACE support center can be reached from 8 a.m. to 8 p.m. EST, Monday-Friday (excluding federal holidays) at ACE_Support@fda.hhs.gov or 877-345-1101 (domestic toll-free) or 571-620-7320 (local/international).
Section 508 Compliance Disclaimer: Please use transcript provided for use along with video if needed. A closed captioned video will be replacing the current one.
- FDA ACE External Outreach Presentation
- FDA ACE External Outreach Presentation-Animal Drugs
- FDA ACE External Outreach Presentation-Biologics
- FDA ACE External Outreach Presentation-Cosmetics
- FDA ACE External Outreach Presentation-Drugs
- FDA ACE External Outreach Presentation-Human
- FDA ACE External Outreach Presentation- Medical Devices
- FDA ACE External Outreach Presentation- Radiation Emitting Products
- FDA ACE External Outreach Presentation-Tobacco
- Industry Quick Reference Guide to the FDA ACE Supplemental Guide v2.5.3
- Tips for Importing FDA-Regulated Products in ACE
- "NEW" - FDA Stakeholder Conference Call, Updates to FDA ACE Final Rule Implementation, June 29, 2017
- Transcript: FDA Stakeholder Conference Call, Updates to FDA ACE Final Rule - 6/29/17
- ACE/ITDS FAQ
- DUNS Portal Quick User Guide
- How to Look Up/Request a DUNS Number
- FDA ACE Quantity Data Instructions
- ACE Affirmations of Compliance Codes
- ACE AofC Code Quick Reference
- FDA Error Guide