FDA Proposes to Add Tobacco Products' Submission Tracking Number to ACE Entry
The FDA is proposing to amend its regulations to require entry filers for e-cigarettes and other electronic nicotine delivery systems (ENDS) to submit in ACE a submission tracking number data element at time of entry. The agency is accepting public comments on the proposed rule through Oct. 15, it said in a notice.
Sign up for a free preview to unlock the rest of this article
Timely, relevant coverage of court proceedings and agency rulings involving tariffs, classification, valuation, origin and antidumping and countervailing duties. Each day, Trade Law Daily subscribers receive a daily headline email, in-depth PDF edition and access to all relevant documents via our trade law source document library and website.
The FDA says the proposed rule would facilitate the agency's automated review process by assisting FDA in making decisions about the admissibility of ENDS products. Though the STN data element is currently optional for tobacco products, "we have found that ACE filers are not submitting the STN for an ENDS product in ACE at the time of entry," the FDA said.
The STN would give the FDA better visibility into the marketing authorization status of ENDS by allowing the agency to verify it electronically using the FDA's internal databases, the agency said. It would also increase instances of "May Proceeds" issued by the FDA for imports of ENDS products and decrease the need for manual reviews, "which may involve document requests and communication with ACE filers or importers," it said.
The agency says it is seeking comment on the following topics: "(1) whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology."
Should the rule be finalized, its effective date would be 30 days after the final rule is published in the Federal Register.