The Food Marketing Institute (FMI) is pleased to respond to the Food and Drug Administration’s (FDA’s) request for comments on the Agency’s implementation of Section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). As discussed more fully below, the regulations should provide for a flexible system that permits registration either electronically or by first class mail, and allows facilities to decide whether to file a single registration from corporate headquarters to cover all commonly held facilities or individual registrations from separate facilities. Registration should be required only once, with amendments as necessary to reflect significant changes in the information contained in the registration. No fees should be assessed. FDA’s implementing regulations should reflect the scope of the facility definition provided in the statute as clarified by the legislative history.

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