NCBFAA Questions FDA Entry Filing Time Commitment Estimate
.FDA's estimate of the work required to file an entry "does not begin to account for the work required to file an FDA import entry," the National Customs Brokers & Forwarders Association of America said in comments on an FDA notice that sought input on the burden of its import entry process.
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"Missing from the equation" from FDA's estimate of 2.68 minutes per unique entry line "is the time and effort to get to the point of data entry: gathering and validating the data elements on the product, the importer and entities in the supply chain; educating the importer on what supply chain information is required; training staff on how to submit compliant entries for FDA-regulated products; and developing/maintaining databases to support this work," NCBFAA said in the letter.
NCBFAA did their own study and found that it takes 5:19.8 minutes to file an FDA line on an entry, nearly double the time the FDA estimated, according to the letter. NCBFAA added that their estimate "only considers the transactional aspect" and does not include other aspects of the process, including "the effort leading up to or following submission of an FDA entry line, including tracking the Automated Broker Interface (ABI) results," they wrote in the letter. "We urge the agency to recalculate this cost estimate, using a more accurate basis for measuring the cost and providing greater transparency on its methodology and assumptions."
NCBFAA also expressed their disappointment with the Import Trade Data Auxiliary System (ITACS) and stressed the importance of a true Single Window, the promise of which has "not been matched by reality," the trade group said in the letter. "The 'Single' Window has instead become a multi-paned window with many duplicate and repetitive entry requirements," including ITACS. Data must be reuploaded from CBP’s Document Image System (DIS) into ITACS, and ITACS does not always receive arrival information from CBP, and only allows search by entry number, according to the letter.
"We encourage FDA to step up efforts to align its own systems and processes with ACE and CBP, as well as other PGAs," NCBFAA said. "The development of ACE 2.0 provides the opportunity to achieve a true Single Window and we hope FDA will be an enthusiastic participant to that end."
NCBFAA also made some additional suggestions on how to simplify the current process. The suggestions included eliminating duplicate or redundant data elements, allowing data submissions to be amended, "clear and consistent definitions" for terms and parties, and allowing for change in the port of arrival, NCBFAA said. NCBFAA also said FDA should "consistently allow inspections to occur at destination" and create an advisory board to "provide greater certainty and accuracy for complex products where the product code cannot be readily determined."