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U.S. Department of Health and Human Services

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Import Process


Background

Summary of Public Comments

Considerations

Transparency Report Arrow View All Import Process Actions and Draft Proposals


Actions and Draft Proposals

Actions:

Action 15:

FDA will publish on the FDA Web site contact information for each Import Program Manager and update that list on a regular basis.

Action 16:

FDA will allow interested members of the public to receive email notifications when an Import Alert is posted on the FDA Web site, or an existing Import Alert is updated.

Action 17:

As part of FDA’s efforts to implement the forthcoming Strategic Import Plan, FDA will develop and execute a project to promote more uniform processes and procedures across districts, when appropriate, and inform industry of district and port-specific practices and procedures.  This project will be tracked on FDA-TRACK.

Action 18:

If a general question about the import process or existing policy is submitted to the Division of Import Operations and Policy (DIOP) in the Office of Regulatory Affairs (ORA) or to a FDA field office, DIOP or the field office should provide a response, if practicable, within 5 business days or acknowledge receipt of the inquiry and provide an estimated time frame for response.  DIOP will compile a list of answers to questions frequently asked by industry and post this information on the FDA Web site.

Action 19:

FDA will work with Customs and Border Protection to explore developing a process by which brokers and filers can correct inadvertent data errors submitted about imported products and FDA should post that process online.

Draft Proposals:

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.

Draft Proposal 5:

FDA should initiate a planning process to develop a web-based system that would help importers more easily determine the proper requirements for importation, the correct data codes, and any special requirements.  FDA will engage industry in the planning process.