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HHS/FDA RIN: 0910-AI44 Publication ID: Fall 2019 
Title: ●Enhanced Traceability Record Requirements For Certain Foods 

This proposed rulemaking, if finalized, would 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: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: Undetermined 
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(d) 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))   
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 two years after.  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  09/00/2020 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: No 
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