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U.S. Department of Health and Human Services

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Reasoning: 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.

Reasoning:

Both FDA and the importer community have an interest in transparency with respect to regulatory requirements.  The Task Force recognizes the need to clearly convey requirements and expectations to the importer community to promote understanding of, and compliance with, the rules and regulations set up to protect the food and medical product supply.  Compliance with regulatory requirements in turn helps protect the public health because fewer violative products enter the U.S.

FDA should explore ways in which existing information about the import process can be made more accessible.  Making existing information accessible through the website may allow limited agency resources to be used in other ways and may allow helpful information to be found more quickly and reliably by importers, leading to greater efficiencies for both FDA and industry. 

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