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HHS/FDA RIN: 0910-AI44 Publication ID: Fall 2020 
Title: 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.

Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: Private Sector 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 1, subpart S     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 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)   
Legal Deadline:
Action Source Description Date
NPRM  Statutory  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.  01/04/2013 
NPRM  Judicial  the consent decree entered on June 11, 2019, requires FDA to submit a notice of proposed rulemaking to the Office of the Federal Register by September 8, 2020.  09/08/2020 
Action Date FR Cite
NPRM  09/23/2020  85 FR 59984   
NPRM Comment Period End  01/21/2021 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: No 
Agency Contact:
Katherine Vierk
Director, Division of Public Health Informatics and Analytics
Department of Health and Human Services
Food and Drug Administration
5001 Campus Drive, CPK1, Room 2B014, HFS-005,
College Park, MD 20740
Phone:240 402-2122