The Food and Drug Administration and U.S. Customs and Border Protection have announced that effective Oct. 1 they will implement across the nation a streamlined notification process that will allow for the timely issuance of demands for redelivery of goods refused by the FDA.
Under the new process the FDA will issue the notice of refusal and CBP will subsequently issue Form 4647, Demand for Redelivery. All locations will use the new process for all FDA refusals, including locations where the FDA and CBP were previously issuing a joint notice of refusal and demand for redelivery.
CBP will use the new ACE forms application for the issuance of Form 4647, which will then be sent via the ACE portal (or mailed to the importer if it has not opted to receive forms electronically through the portal). A copy of the form will also be emailed to the FDA and the broker if the importer has not designated the broker to receive it via the ACE portal.
The role of CBP’s Centers of Excellence and Expertise will be limited to the issuance and final close out of Form 4647. As a result, the importer of record and/or broker will need to coordinate redelivery to export or destroy refused FDA-regulated goods with their local FDA office as well as the cargo office at the CBP port where the cargo will be redelivered.
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