FDA Reviewing Import Filer Evaluation Process, Changes Forthcoming
Sources at the Food and Drug Administration state that a working group from the New York district office is currently reviewing the import filer evaluation process and will be making changes in the next few months. This follows a statement by the FDA that they recognize that the filer evaluation process currently does not distinguish between serious mistakes or omissions and typographical errors, and is working to improve this process. The FDA is also exploring procedures that would speed up this re-evaluation, which would provide an incentive for filers to improve their outcomes quickly.
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(Importers, or third parties working on behalf of importers, file information about products offered for import into the United States. The FDA conducts evaluations of those filers who submit information electronically to help ensure that they are submitting accurate data.)
Current Filer Evaluation Process Includes Random Investigations w/ 10% Threshold
According to sources at the FDA, the import filer evaluation process begins with random evaluations of importer records. If these evaluations find an error rate in excess of 10%, then the importer may still file online, but the FDA requests a corrective action plan for improving the quality of the data being submitted. Should the FDA find repeated failures to successfully execute a corrective action, the filer is returned to Dual Mode (electronic and paper submissions).
In general, the FDA attempts to re-evaluate filers with excessive error rates within nine months, as volume and resource constraints permit. The FDA is exploring procedures that would speed up this re-evaluation, which would provide an incentive for filers to improve their outcomes quickly.
Filer Evaluation Outcomes Posted Online
The FDA is posting filer evaluation outcomes on-line, prospectively, starting from the beginning of fiscal year 2012, to help increase the accuracy of the information submitted to the FDA and the accountability among the actors in the supply chain. This list will be updated monthly, and it will post the most recent outcome for each filer. The list discloses one of five different outcomes for each filer:
- Paperless -- Satisfactory evaluation result; FDA has determined that electronic filing is appropriate.
- Corrective Action Plan -- Based on the filer’s error rate, FDA has determined that continued electronic filing is appropriate, but FDA has requested a corrective action plan.
- Dual-Mode Filer -- The filer has been returned to Dual-Mode (electronic and paper submissions) after FDA found repeated failures to successfully execute a Corrective Action Plan for improving the quality of the data being submitted.
- New Filer -- FDA has insufficient information to determine whether electronic filing, alone, is sufficient; FDA requires both electronic and paper submissions.
- Inactive -- The most recent evaluation determined that the firm is either out of business or inactive in FDA commodities.
The FDA notes that, because this list is prospective, and updated monthly, interested parties should not make any inferences with regard to the status of filers that do not have filer evaluation outcomes posted on this site.
The FDA’s full list of filer evaluation outcomes, updated on March 26, is available here.
(See ITT’s Online Archives 12032003 for summary of the FDA’s announcement that import filer evaluation outcomes are posted online.)