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HHS/FDA

RIN: 0910-AG36

Publication ID: Spring 2015

Title: Current Good Manufacturing and Hazard Analysis, and Risk-Based Preventive Controls for Human Food
Abstract: This 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: Final Rule Stage
Major: Yes	Unfunded Mandates: Private Sector
CFR Citation: 21 CFR 117
Legal Authority: 21 U.S.C. 342 21 U.S.C. 371 42 U.S.C. 264 Pub. L. 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
Supplemental NPRM	09/29/2014	79 FR 58523
Supplemental NPRM Comment Period End	12/15/2014
Final Rule	08/00/2015

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: Yes
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