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U.S. Department of Health and Human Services

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Reasoning: 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.

Reasoning:

As described above, ORA staff are dispersed throughout the United States, with most of the ORA staff working in regional and district offices.  This nationwide structure is needed since FDA-regulated products are found throughout the country.  Different issues may arise in different areas of the country, so uniform procedures on all matters may not be appropriate.  At the same time, the comment argued that there are cases in which identical products are handled differently in different districts.  Processes and procedures should be uniform to the maximum extent possible to facilitate efficiency and predictability.

The Task Force concluded that there may be circumstances where the efficiencies to be gained from uniform processes are feasible and supportive of public health.  FDA’s implementation of the forthcoming Strategic Import Plan will address this issue. 

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