0910-AI44 202110 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Requirements For Additional Traceability Records For Certain Foods

This rule will establish additional recordkeeping requirements for facilities that manufacture, process, pack, or hold foods that are designated as high-risk foods.

]]> Economically Significant Previously Published in The Unified Agenda Long-Term Actions Yes Private Sector 21 CFR 1, subpart S sec. 204 of the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) (21 U.S.C. 2223(d)) sec. 701(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(a)) sec. 361 of the Public Health Service Act (42 U.S.C. 264) Judicial Final 11/07/2022 The consent decree entered on June 11, 2019, requires FDA to submit a final rule to the Office of the Federal Register by November 7, 2022. Statutory NPRM 01/04/2013 Sec. 204(d)(1) of FSMA (21 U.S.C. 2223(d)(1)) states, “… not later than 2 years after the date of enactment of this Act. No NPRM 09/23/2020 85 FR 59984 NPRM Comment Period End 01/21/2021 NPRM Comment Period Extended 12/18/2020 85 FR 82393 NPRM Comment Period End 02/22/2021 Final Rule 11/00/2022 Yes Businesses Undetermined No Yes Yes Katherine Vierk Supervisory Management 0910 Food and Drug Administration FDA 240 402-2122 katherine.vierk@fda.hhs.gov 5001 Campus Drive, CPK1, Room 2B014, HFS-005, College Park MD 20740