United States: FDA Issues Draft Guidance "Qualified Facility Attestation Using Form FDA 3942a (For Human Food) Or Form FDA 3942b (For Animal Food)"

In the May 16, 2016, Federal Register, FDA announced the availability of a draft guidance for industry titled "Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)." This draft guidance explains how to determine whether a business is a "qualified facility" that is subject to modified requirements under the Preventive Controls for Human/Animal Food Rules. This draft guidance also explains FDA's current thinking on how a business would submit Form FDA 3942a or Form FDA 3942b attesting to its status as a qualified facility under the Preventive Controls for Human Food Rule or the Preventive Controls for Animal Food Rule, respectively. Comments are due July 15, 2016.

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