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U.S. Department of Health and Human Services

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Reasoning: Draft Proposal 4

In order to foster a more uniform and efficient process, FDA should review existing procedures used to conduct evaluations of importers, or third parties working on behalf of importers, who file information electronically about products offered for import into the United States.  This review of the overall process should include what to examine during the evaluation, the error rate classification, the process of discussing the findings with the firm, and the final classification.  It should also include the process for handling evaluations of those filers who file entries without being physically located at the port where the product enters the United States.

Reasoning:

Importers, or third parties working on behalf of importers, file information about the product offered for import at one of the ports of entry into the United States.  The accuracy of this information is important to FDA’s work to effectively protect the public from potentially harmful products.  Under FDA’s current procedures, evaluations of filers who submit information electronically to FDA are conducted based on where the broker is physically located.

According to the importer community, however, an increasing number of filers are using the CBP Remote Location Filing Program, which permits importers to file information about products being presented for import at locations where the filer is not physically present.  Given this trend, the Task Force concluded that FDA should review the existing procedures for filer evaluations to see if there should be any improvements made to the evaluation system. 

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