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FDA Seeks Comments on Importer’s Entry Notice

Wednesday, November 27, 2013
Sandler, Travis & Rosenberg Trade Report

The FDA is seeking input from interested parties by Jan. 27 on the importer’s entry notice. Section 801 of the FD&C Act charges the FDA with the responsibility of assuring that foreign-origin, FDA-regulated foods, drugs, cosmetics, medical devices, radiological health and tobacco products offered for import into the U.S. meet the same requirements of the FD&C Act as do domestic products. The discharge of this responsibility involves close coordination and cooperation between FDA headquarters and field inspectional personnel and CBP. This information collection gathers data for FDA-regulated products being imported into the U.S. and is being used by the agency to review and prevent imported products from entering the country if they do not meet the same FD&C Act requirements as domestic products.

Most of the information the FDA requires to carry out its regulatory responsibility under section 801 is already provided electronically by filers to CBP. Because CBP relays this data to the FDA using an electronic interface, the majority of data submitted by the entry filer need be completed only once.

At each U.S. port of entry where foreign-origin, FDA-regulated products are offered for import, the FDA is notified through the Automated Commercial System by the importer (or his/her agency) of the arrival of each entry. Following such notification, the FDA reviews relevant data to ensure the imported product meets the required standards, decides on the admissibility of the imported product, and informs the importer and CBP of its decision. A single entry frequently contains multiple lines of different products. The FDA may authorize products listed on specific lines to enter the U.S. unimpeded, while other products listed in the same entry may be held pending further FDA review/action.

The FDA’s electronic screening criteria program has been applied nationwide since the inception of the interface with ACS, eliminating the issue of “port shopping.” Every electronically submitted entry line of foreign-origin, FDA-regulated product undergoes automated screening and the screening criteria can be set to be as specific or as broad as applicable. The FDA notes that this capability is of tremendous value in protecting the public if there is a need to immediately halt specific product from entering the U.S. 

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