The Food and Drug Administration is proposing to require that certain data elements material to admissibility determinations on FDA-regulated products be submitted in the Automated Commercial Environment (or any other electronic data interchange system authorized by U.S. Customs and Border Protection) at the time of entry. The FDA states that this rule would facilitate automated “may proceed” determinations for low-risk FDA-regulated products and thus allow the agency to focus its limited resources on those products that may be associated with a greater public health risk. Failure to submit any of the proposed data elements would result in the entry being rejected. Comments on this proposed rule are due no later than Sept. 6.
The proposed rule would require that the following data elements be submitted in ACE at the time of entry for food (as applicable), drugs, biological products, human cells, tissues and cellular and tissue-based products, medical devices, radiation-emitting electronic products, cosmetics and tobacco products. The specific information to be submitted may vary depending on the article being imported or offered for import.
- the country where the article was last manufactured, processed or grown (including harvested or collected and readied for shipment to the U.S.)
- complete FDA product code
- total value of the entry as required by CBP or total value of the article(s) in each import line
- quantity of the article in each import line, including the quantity of each layer/level of packaging, the unit of measure that is the description of each type of package, and the volume and/or weight of each of the smallest of the packaging units
- name, telephone number and email address of any one of the persons related to the importation, which may include the manufacturer, shipper, importer of record or “deliver to” party
- email and phone number of the importer of record
- product-specific data elements
This rule would also make technical revisions to certain sections of the FDA’s regulations to make updates and provide clarifications. These include updating the definition of “owner” or “consignee” to make it consistent with title 19 of the U.S. Code, allowing the FDA to provide notice of sampling directly to an owner or consignee, and clarifying that written notice can be provided electronically to owners or consignees of FDA actions to detail, refuse and/or subject certain products to administrative destruction.