CBP, FDA to Implement New Redelivery Notification Process on Oct. 1
CBP and FDA will implement a “streamlined information process” between the agencies beginning on Oct. 1, said Dan Solis, FDA assistant commissioner-import operations, in a letter dated Sept. 19. The new process will be “largely seamless for the trade” but will “allow for the timely issuance of the demand for redelivery of goods refused by FDA," Solis said.
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The new approach “provides CBP, FDA, and the trade with an efficient means of receiving notification of FDA refusals across the nation as well as CBP’s subsequent issuance of the CBP Form 4647 Demand for Redelivery,” and establishes “clear lines of communication and predictable results,” the letter said.
The process brings CBP’s Centers of Excellence and Expertise into the process, though their role is “limited to the issuance and final close out of the CBP Form 4647” demand for redelivery on an account basis and the importer or broker “will need to coordinate the redelivery to export or destroy the 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.”
As part of the process, CBP will use the new ACE forms application to issue Form 4647, which will then be sent via the ACE portal, or mailed to importers that have not opted to receive forms electronically. Copies also will be sent to FDA and the broker, the letter said. “The issuance of the CBP form 4647 Demand for Redelivery via the ACE forms module will provide consistency and will allow trade users to view, respond and manage electronic versions of the forms,” Solis said.
The Oct. 1 implementation of the new process follows a pilot that FDA and CBP began in early 2021 that was limited to the service ports of Laredo, San Francisco and Baltimore, and since expanded to Detroit and New York, as well as some ports in the Atlanta service area, the letter said.
“It should be noted that all locations will use the new process for all FDA refusals effective October 1, 2022; this includes locations where the FDA and CBP were previously issuing a joint notice of refusal and demand for redelivery,” Solis said.