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HHS/FDA RIN: 0910-AG36 Publication ID: Fall 2013 
Title: Hazard Analysis and Risk-Based Preventive Controls 
Abstract: This proposed rule would require a food facility to have and implement preventive controls to significantly minimize or prevent the occurrence of hazards that could affect food manufactured, processed, packed, or held by the facility. This action is intended to prevent or, at a minimum, quickly identify foodborne pathogens before they get into the food supply. 
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 
CFR Citation: 21 CFR 110   
Legal Authority: 21 USC 342    21 USC 371    42 USC 264    PL 111-353 (signed on Jan. 4, 2011)   
Legal Deadline:
Action Source Description Date
Final  Statutory  Final rule must be published no later than 18 months after the date of enactment of the FDA Food Safety Modernization Act.  07/04/2012 
Timetable:
Action Date FR Cite
NPRM  01/16/2013  78 FR 3646   
NPRM Comment Period End  05/16/2013 
NPRM Comment Period Extended  04/26/2013  78 FR 24691   
NPRM Comment Period Extended End  09/16/2013 
NPRM Comment Period Extended  08/09/2013  78 FR 48636   
NPRM Comment Period Extended End  11/15/2013 
NPRM Comment Period Extended  11/20/2013  78 FR 69604   
NPRM Comment Period Extended End  11/22/2013 
Additional Information: Includes Retrospective Review under E.O. 13563.
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
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: Yes 
Agency Contact:
Jenny Scott
Senior Advisor
Department of Health and Human Services
Food and Drug Administration
5001 Campus Drive, Room 3B014,
College Park, MD 20740
Phone:240 402-1488
Email: jenny.scott@fda.hhs.gov