FDA published its final electronic import-data rule on November 29, 2016, with effectiveness set for December 29. That was not the launch date of the Automated Commercial Environment, or ACE. The agency reported that ACE had become the sole electronic system authorized by Customs and Border Protection for FDA-regulated entries on July 23. [2016-28582]

An earlier document helps explain what this sequence did not mean. The July 1 proposal said it would preserve the ability to file import entries and entry summaries on paper. That statement belongs to the proposal. It prevents reading the earlier electronic-data plan as a universal paper ban, but does not by itself establish every final-rule exception. [2016-15684]

The final text focused on the information accompanying electronic entries. Section 1.81 clarified that FDA could reject filings missing complete and accurate required data. FDA also required intended-use codes while allowing UNK in that particular field at entry. It declined to accept that placeholder for the other required data elements. Unknown intended use was consequently not a substitute for a complete record. [2016-28582]

FDA further explained that UNK could lead to manual review and did not relieve a filer of supplying other applicable data. These distinctions separate the transmission system, the filing requirements and the admissibility decision. Both documents belong to one rulemaking chain. They establish the agency's design and timetable, not measured clearance speeds or a guarantee that a submitted shipment would be admitted. [2016-28582][2016-15684]

Source documents

  1. Submission of Food and Drug Administration Import Data in the Automated Commercial Environmenthttps://www.govinfo.gov/content/pkg/FR-2016-11-29/html/2016-28582.htm
  2. Submission of Food and Drug Administration Import Data in the Automated Commercial Environmenthttps://www.govinfo.gov/content/pkg/FR-2016-07-01/html/2016-15684.htm