The U.S. Food and Drug Administration (FDA) is one of 47 government agencies participating in the Automated Commercial Environment (ACE) in collaboration with U.S. Customs and Border Protection (CBP). FDA supports the continued development of ACE for all stakeholders. Along with our Participating Government Agency colleagues, FDA strongly urges the trade community to continue development of the systems necessary to transmit entry data via the ACE portal now and in the future.
There are many benefits for importers and their entry filers who make the transition to ACE. One of these benefits includes an overall decrease in entry processing times for ACE submitted entries compared with entries submitted via other means. Specifically, the average processing time for manual review of ACE submitted entries is 25% faster than the average processing time was for manual review of ACS submitted entries.
The FDA has and will continue to focus resources on ACE projects and ACE-related commerce to facilitate the transition to ACE, which include providing direct assistance for entry filers.
FDA is focusing resources to provide assistance to importers and their entry filer as they continue to use ACE by conducting 'production calls'.
FDA’s commitment to facilitating the transition to ACE includes conducting production calls with entry filers, importers, and other stakeholders who are starting to use ACE.
A production call is a meeting between the FDA, the entry filer and the entry filer’s software vendor (preferably) to walk through an entry that is being submitted via ACE. These production calls allow FDA and the entry filer to talk about the entry submission in real time.
FDA encourages entry filers to include their software vendors in the production calls as it assists in troubleshooting errors within a filer’s software, as well as enhancing the filer’s understanding of their software.
Although production calls are not mandatory, the FDA has found that these calls benefit the trade community and assist trade in making a smooth transition to ACE.
Upon request, FDA will assist in a filer’s first ACE submission or submissions per commodity to help ensure their understanding of all trade operations for which they participate.
Importers and their entry filers can arrange a production call by contacting ACE_Support@fda.hhs.gov and asking to set up a production call. The FDA strives to accommodate requested days for production calls to help facilitate the ACE transition.
Problem areas and issues can be immediately addressed, which makes the entry filer more efficient and productive during their transition to ACE. FDA and CBP collaborate on entries that require troubleshooting assistance from both agencies, which reduces the time it takes to identify and correct any issues uncovered.
Additional ACE Assistance
FDA is providing resources to assist importers of FDA-regulated products and their entry filers as they use ACE.
The FDA ACE Support Center is staffed from 8 a.m. to 8 p.m. EST, Monday-Friday (excluding federal holidays).
Questions about the ACE submission process can be submitted to:
- Domestic Toll Free: 877-345-1101
- Local/International: 571-620-7320
- General import operations and policy questions can be submitted to FDAImportsInquiry@fda.hhs.gov