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FDA Proposes Regulations on Entry Filing in ACE, Seeks Comments

June 30, 2016 |FDA

The Food and Drug Administration is proposing to codify its procedures for electronic filing of entries of FDA-regulated products in ACE. The agency’s proposed rule (here) would add new sections to the FDA regulations specifying the data elements that must or may be filed in ACE at the time of entry, and make “technical revisions” to existing FDA regulations, including an alignment of the FDA definition of owner or consignee with CBP’s definition. Comments on the proposed rule are due Aug. 30. In addition to general comments, FDA is also seeking specific input on a variety of ACE requirements FDA is proposing to codify in its regulations, including the following:

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  • The advantages, disadvantages and feasibility of providing active pharmaceutical ingredient (API) data elements for human and animal drugs, which are currently optional, if they were to become mandatory data elements for entry filing in ACE.
  • The advantages, disadvantages and feasibility of requiring the submission of data elements related to the approval or clearance status of FDA-regulated medical products, such as application numbers.
  • The advantages, disadvantages and feasibility of the Agency requiring the submission of the following data elements in ACE at the time of entry: (1) An intended use code for the FDA-regulated article being imported or offered for import and (2) a disclaimer indicating that that the article is not currently regulated by FDA or that FDA does not currently have any requirements for submission of data for importation of that article per Agency guidance.
  • The advantages, disadvantages and feasibility of allowing the ACE filer to submit the total value of the entry or the total value apportioned to the article(s) in each import line.
  • The advantages, disadvantages, and feasibility of requiring an ACE filer to submit the FDA quantity of the article(s) in each import line in ACE at the time of entry.
  • The advantages, disadvantages and feasibility of requiring an ACE filer to submit the name, telephone, and email address of any one of the persons related to the importation of the article(s) in the entry, in ACE at the time of entry.
  • The advantages, disadvantages and feasibility of requiring an ACE filer to submit the investigational new drug (IND) number for these combination products in ACE at the time of entry.
  • The advantages, disadvantages and feasibility of requiring an ACE filer to submit the Drug Listing Number for those articles that are Center for Biologics Evaluation and Research-regulated drugs.
  • The advantages, disadvantages and feasibility of requiring that the name and address of the ACE filer for import entries that include a tobacco product be submitted in ACE at the time of entry.

(Federal Register 07/01/16)