Draft Guidance for Industry: Submitting Food Canning Establishment Registration Form and Food Process Filing Forms to the Food and Drug Administration in Electronic or Paper Format; Availability

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The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled "Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format." The draft guidance is intended to alert stakeholders to changes we are planning for the administrative procedures currently used by commercial processors that manufacture, process, or pack acidified foods (AF) and/ or thermally processed low-acid foods packaged in hermetically sealed containers (historically referred to as "low-acid canned foods" or "LACF"). These changes include new food process filing forms and a new "smart form" system for electronic submission of these forms. The draft guidance, when finalized, will supersede the July 2012 guidance entitled "Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541a and FDA 2541c (Food Process Filing Forms) to FDA in Electronic or Paper Format" when the new food process filing forms and the new "smart form" electronic system become operational.