Rules and Regulations. Notification of availability

Agency: Food and Drug Administration, HHS
Action: Notification of availability
Citation: FR Doc. 2018-10148 · Docket No. FDA-2018-D-1378 · 21 CFR 1, 11, 16, 106, 110, 111, 112, 114, 117, 120, 123, 129, 179, 211, 507

Summary

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled “The FDA Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need to Know About the Food and Drug Administration Regulation—Small Entity Compliance Guide.” The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled “The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification for Certain Provisions of Four Implementing Rules.”

Dates

The announcement of the guidance is published in the Federal Register on May 14, 2018.

Supplementary Information

I. Background In the Federal Register of August 24, 2016 (81 FR 57784), we issued a final rule entitled “The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification for Certain Provisions of Four Implementing Rules” (the final rule) that extended compliance dates to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules. The final rule became effective August 24, 2016. We examined the economic implications of the final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined that the final rule will not have a significant economic impact on a substantial number of small entities. In compliance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121, as amended by Pub. L. 110-28), we are making available the SECG to reduce the burden of determining how to comply by further explaining and clarifying the actions that a small entity must take to comply with the rule. We are issuing this SECG consistent with our good guidance practices regulation (21 CFR 10.115(c)(2)). This SECG represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 117 have been approved under OMB control number 0910-0751. The collections of information in 21 CFR part 507 have been approved under OMB control number 0910-0789. The collections of information in 21 CFR part 1, subpart L have been approved under OMB control number 0910-0752. The collections of information in 21 CFR part 112 have been approved under OMB control number 0910-0816. III. Electronic Access Persons with access to the internet may obtain the SECG at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance. Dated: May 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-10148 Filed 5-11-18; 8:45 am]