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U.S. Department of Health and Human Services

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Reasoning: 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.

Reasoning:

Setting an expectation for responses to general questions about the import process or existing FDA policy regarding imports helps bring clarity and more certainty to the process.  The Task Force concluded that the importer community should expect a response to general questions about the import process or existing policy within 5 business days, or receive acknowledgment from FDA if a response cannot be provided within that timeframe.  In the agency’s experience, some questions may require additional expertise, and in those cases, the inquiry may be forwarded to the appropriate office or employee for additional information.  In setting an expectation for response to all general questions, the Task Force felt it was important to incorporate the reality that the vast majority of ORA employees are located in the field.

Further, in an effort to make more basic regulatory information about the import process broadly available, DIOP will post answers to questions that are frequently asked by industry on the FDA Web site.

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