ACE Entries of FDA-Regulated Goods May Temporarily Omit Four Data Elements

Excerpt from Sandler, Travis & Rosenberg Trade |  March 23, 2016

U.S. Customs and Border Protection reports that the Food and Drug Administration will temporarily allow the submission of Automated Commercial Environment entries without the transmission of four data elements currently listed as mandatory in the FDA Supplemental Guidance document:

  • intended use code
  • brand name
  • device listing number and
  • active ingredient producer (entity role code GD).

CBP states that if filers are unable to obtain this information at the time of transmission, a value of “UNK” (unknown) will be allowed to assist in the transition from ACS to ACE.

Specifically, beginning April 4, UNK will be a valid syntax for the intended use code, PG07 brand name and description of affirmation of compliance LST, and entity role code GD will be temporarily not required for the active ingredient producer.

CBP notes that the FDA requires the information associated with these four data elements to make admissibility decisions and that failure to transmit the complete information, including UNK, will result in CBP rejecting the entry. The FDA therefore highly encourages filers to transmit complete data sets, including intended use, brand name, device listing number and active ingredient producer, when required by the specific commodity. Filers that transmit complete information will receive priority review of entries and an expedited review process.

The FDA will be hosting a webinar March 23 to review the technicality of these temporary changes. Click here to register.

For more information on FDA and ACE, click here.