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SMALL ENTITY COMPLIANCE GUIDE

CVM GFI #241 Small Entity Compliance Guide – What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507) November 2016

Download the Final Small Entity Compliance Guide Read the Federal Register Notice
Final
Docket Number:
FDA-2011-N-0922
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

The Food Safety Modernization Act of 2011 (FSMA) directs the Food and Drug Administration (FDA) as the food regulatory agency of the U.S. Department of Health and Human Services to better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety. On September 17, 2015, FDA published the final rule Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PCAF or the rule) (80 FR 56173). 

The regulation creates new current good manufacturing practice (CGMP) requirements for animal food facilities. In addition, it creates new requirements for certain animal food facilities to establish and implement risk-based preventive controls. The regulations are found at Title 21 of the Code of Federal Regulations part 507 (21 CFR part 507).

FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. Law 104-121). The intent of this guide is to inform domestic and foreign animal food facilities about the PCAF regulations and enable them to better understand the requirements of the rule. It contains important information that may affect your facility.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2011-N-0922.

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