“ACE” Is Here. Are You Ready? How FDA Intends to Help

By Dara K. Levy –

The Automated Commercial Environment (ACE), which went into effect for FDA-regulated products on June 15, 2016 (after several delays), is an electronic system operated by Customs and intended to automate import processing and expedite reviews for electronic import filings.  It replaces the Automated Commercial System (ACS) and is intended to implement the “single window” electronic submission requirement outlined in the International Trade Data System (ITDS) for import and export data provided to the U.S. Government.  The ITDS is “a partnership of government agencies committed to the modernization and facilitation of international trade.”  In February 2014, President Obama issued Executive Order 13659, Streamlining the Export/Import Process for America’s Businesses, which required this “single window” to go into effect by December 31, 2016 for all partner government agencies involved with the ITDS, which includes FDA.

The purpose of ACE, generally, is to improve the information flow to the U.S. Government about imports and exports and, ultimately, ease the burden on importers/exporters by reducing redundant submissions required by the different agencies that may review the entries.  As importers of FDA-regulated products already know, Customs may often release goods only for those goods to be held for substantial periods of time by FDA while it reviews entry information submitted.  FDA has acknowledged that the ACS system had allowed for incomplete and inaccurate data to be transmitted to FDA, which then required FDA to manually review entry information.  FDA estimates that it took approximately 28 hours for FDA to ultimately release an entry when it conducted a manual review under the legacy ACS system.  Not surprisingly, when complete and accurate information was submitted in ACS, and an automated review was sufficient, the release time was significantly quicker, taking approximately 24 minutes. 

FDA has estimated that with the implementation of ACE, and inclusion of the required (and optional) data elements, manual reviews of information are completed over 30% faster than previously with ACS.  The expectation is that review times will only improve.  Ultimately, the goal is to prioritize FDA resources for products that represent a greater public health risk, while automating the release of lower risk products.

On July 1, 2016, FDA published a proposed rule to establish certain data requirements for FDA-regulated import entries electronically filed in ACE.  Because ACE has already been implemented, much of the proposed rule is practically in effect.  FDA has confirmed that all but four ACE-required elements were previously captured in the legacy ACS system.  The four new elements include the following:  1) name, telephone number, and email address for one of the persons related to the importation of the product, which may include the manufacturer, shipper, importer of record, or Deliver to Party; 2) a telephone number and email address for the importer of record; 3) name and address of the ACE filer; and 4) brand name for tobacco products.

Where things may be different with ACE is in the level of detail that is now being requested as “optional” submission information.  FDA is strongly encouraging ACE filers to include certain “optional” information that will better enable FDA to make automatic admissibility determinations.  FDA is seeking comments on the advantages, disadvantages, and feasibility of requiring the submission of data elements currently identified as “optional,” such as the approval or clearance status of the product and intended use.  Comments are due August 30, 2016.

FDA has implemented a number of outreach programs to assist industry with the transition to ACE.  In addition to webinars, FDA has implemented the FDA ACE Support Center, staffed 24/7 and available to answer questions regarding the FDA Supplemental Guide, required data elements, and general ACE submissions.  FDA is also prioritizing assistance to industry through “Production Calls.”  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.”  While not mandatory, FDA encourages these calls and, upon request, will assist with a filer’s first ACE submission.  More information about ACE and FDA’s Facilitation of the ACE Transition can be found here and here.