As part of FDA’s commitment to facilitating the transition to ACE, FDA is providing priority processing for ACE entries of FDA-regulated products. The data shows average processing time for manual review and release of ACE submitted entries is 25% faster than for ACS submitted entries, and release times for document reviews is 33% faster than for ACS submitted entries (a time savings of 1 ½ days). We expect review times to improve as entry filers make the transition to ACE; FDA will be updating the data and charts on a weekly basis.
Additionally, FDA’s commitment to facilitating the transition to ACE includes conducting ‘production calls,’ which provide assistance to importers and their entry filers as they start to use ACE. These production calls allow FDA and the entry filer to discuss the entry submission in real time, and immediately address questions or issues; they also allow FDA and CBP to collaborate on entries requiring attention from both agencies. Software vendors are encouraged to be included to assist in troubleshooting and to help enhance the entry filer’s understanding of their software.
FDA is also assisting importers of FDA-regulated products and their entry filers as they use ACE, making FDA personnel available to answer questions regarding the Supplemental Guide, required data elements, and general ACE submission questions.
Importers and their entry filers can arrange a production call, or ask questions about the ACE submission process by contacting ACE_Support@fda.hhs.gov.
U.S. Customs and Border Protection (CBP) has implemented a staggered approach to the mandatory filing of electronic entries and corresponding entry summaries in ACE, and the decommissioning of electronic entry/entry summary filing capabilities in ACS. Use of ACE is mandated for FDA filings for select entry types as of June 15, 2016. Visit CBP.gov/ACE for more information about ACE mandatory transition dates.
Source Document CSMS #16-00487