CBP Makes ACE the Sole Authorized Electronic Filing System for Most Imports of FDA-Regulated Merchandise | Practical Law

CBP Makes ACE the Sole Authorized Electronic Filing System for Most Imports of FDA-Regulated Merchandise | Practical Law

US Customs and Border Protection (CBP) and the Food and Drug Administration (FDA) have released a general notice encouraging importers of FDA-regulated merchandise to use the Automated Commercial Environment (ACE) for their electronic filings, which will soon replace the Automated Commercial System (ACS).

CBP Makes ACE the Sole Authorized Electronic Filing System for Most Imports of FDA-Regulated Merchandise

by Practical Law Commercial Transactions
Published on 05 Apr 2016 • USA (National/Federal)
US Customs and Border Protection (CBP) and the Food and Drug Administration (FDA) have released a general notice encouraging importers of FDA-regulated merchandise to use the Automated Commercial Environment (ACE) for their electronic filings, which will soon replace the Automated Commercial System (ACS).
On March 31, 2016, CBP and the FDA released a general notice (81 Fed. Reg. 18634) announcing that their ongoing test of ACE has been a success. The pilot program, which began August 27, 2015 (80 Fed. Reg. 52051), tested ACE’s ability to satisfy FDA data requirements under the Partner Government Agency (PGA) Message Set.
According to CBP, the use of ACE with the PGA Message Set:
  • Improves communications between multiple agencies and filers.
  • Enables the trade community to submit trade-related data only once to CBP.
  • Eliminates processing of paper documents.
  • Shortens entry processing times.
Because ACE has successfully met the FDA’s PGA Message Set requirements for both formal and informal consumption entries, the pilot program is scheduled to end on May 2, 2016.
Though ACS will remain in place at this time, the agencies are encouraging importers of FDA-regulated merchandise to begin using ACE now for their electronic filings.
For more general information on importing goods into the US, see Practice Note, US and International Regulation of Tariffs: US Tariff System.

Update

On May 16, 2016, CBP announced that on June 15, 2016, ACE will become the sole electronic data interchange system authorized for processing electronic entries and entry summary filings accompanied by FDA data for certain entry types (81 Fed. Reg. 30320-02).
The covered entry types include, among others:
  • Type 01 (Consumption).
  • Type 03 (Antidumping/Countervailing Duty).
  • Type 06 (Foreign Trade Zone).
  • Type 11 (Informal).
Importers of FDA-regulated merchandise will no longer be authorized to use ACS for electronic filings for these entry types on the effective date. CBP will provide further notice when electronic filing of other entry types is transitioned from ACS to ACE.
For more information on import requirements for FDA-regulated merchandise, see Practice Note, FDA Prior Notice Requirement for Imported Food.