Proposed Rules. Notification of availability

Agency: Food and Drug Administration, Health and Human Services (HHS)
Action: Notification of availability
Citation: FR Doc. 2022-09232 · Docket No. FDA-2022-D-0370 · 21 CFR 1

Summary

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled “The Accredited Third-Party Certification Program: Questions and Answers.” The draft guidance, when finalized, will answer frequently asked questions relating to the requirements of the Accredited Third-Party Certification Program, and is intended to assist accreditation bodies', third-party certification bodies', and eligible entities' understanding of the regulation and program requirements.

Dates

Submit either electronic or written comments on the draft guidance by July 28, 2022 to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance.

Supplementary Information

I. Background We are announcing the availability of a draft guidance for industry entitled “The Accredited Third-Party Certification Program: Questions and Answers.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic.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 alternate approach if it satisfies the requirements of the applicable statutes and regulations. The FDA Food Safety Modernization Act (Pub. L. 111-353) added section 808 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384d), which directs FDA to establish a program for accreditation of third-party certification bodies to conduct food safety audits and to certify that eligible foreign food entities (including registered foreign food facilities) and food produced by such entities meet applicable FDA requirements for purposes of sections 801(q) (21 U.S.C. 381(q)) and 806 (21 U.S.C. 384b) of the FD&C Act. On November 27, 2015, FDA issued the final rule, “Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications” (also referred to as the TPP regulation) (80 FR 74569; 21 CFR part 1, subpart M). This draft guidance, when finalized, will answer frequently asked questions relating to the requirements of the Accredited Third-Party Certification Program established in 21 CFR part 1, subpart M (21 CFR 1.600 through 1.695, 21 CFR 1.700 through 1.725), and is intended to assist the accreditation bodies', third-party certification bodies', and eligible entities' understanding of the TPP regulation and program requirements. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information under the TPP regulation in 21 CFR part 1, subpart M have been approved under OMB control number 0910-0750. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance. Dated: April 25, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022-09232 Filed 4-28-22; 8:45 am]