Guidance for Industry: Registration of Food Facilities: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide


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You may submit either electronic or written comments regarding this guidance at any time.

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Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852

All comments should be identified with the docket number FDA-2018-D-1468.

Contains Nonbinding Recommendations

May 2018

This is a revision of the guidance “What You Need To Know About Registration of Food Facilities” that was issued in December 2012. We are issuing revised guidance because in the Federal Register of July 14, 2016 (81 FR 45911), we published a final rule pertaining to registration of food facilities entitled “Amendments to Registration of Food Facilities” (the final rule). The final rule amends the regulations at 21 CFR Part 1, Subpart H (21 CFR 1.225 through 1.245). The final rule became effective on September 12, 2016. This guidance reflects changes made by the final rule. We also have made editorial changes for clarity.

We have prepared this Small Entity Compliance Guide (SECG) in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28). This guidance document is intended to help small entities comply with the food facility registration regulations set forth in 21 CFR, Part 1, Subpart H (21 CFR 1.225 through 1.245). These regulations are binding and have the full force and effect of law.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

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Page Last Updated: 09/15/2018
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