Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls For Human Food

 
Docket ID: FDA-2011-N-0920
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Summary:

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.

RIN: 0910-AG36
Impacts and Effects: International
CFR Citation: 21 CFR 117
Priority: Economically Significant
UA and Regulatory Plan Information open glossary dialog  
Publication Period: Fall 2015
Agenda Stage of Rulemaking: Completed Action
Major Rule: Yes
Legal Authorities: 21 U.S.C. 342, 21 U.S.C. 371, 42 U.S.C. 264, Pub. L. 111-353 (signed on Jan. 4, 2011)
Government Levels Affected: No
Federalism Implications: No
Unfunded Mandates: Private Sector
Requires Regulatory Flexibility Analysis: Business
Small Entities Affected: No
International Impacts: Yes
Included in Regulatory Plan: No
Legal Deadline
ActionSourceDescriptionDate
JudicialOther08/30/2015
Timetable
ActionDateFR Citation
NPRM01/16/201378 FR 3646
NPRM Comment Period Extended04/26/201378 FR 24691
NPRM Comment Period End05/16/2013
NPRM Comment Period Extended08/09/201378 FR 48636
NPRM Comment Period Extended End09/16/2013
NPRM Comment Period Extended End11/15/2013
NPRM Comment Period Extended11/20/201378 FR 69604
NPRM Comment Period Extended End11/22/2013
Supplemental NPRM09/29/201479 FR 58523
Supplemental NPRM Comment Period End12/15/2014
Final Rule09/17/201580 FR 55907
Final Action Effective11/16/2015
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: FDA-2011-N-0921
Short Title: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls For Human Food
Keyword(s): CGMP, 0910-AG36, 0910-0751, 2015-953, Current Good Manufacturing Practice, Hazard, Analysis, and Risk-Based Preventive Controls, for Human Food, Clarification of, Compliance Date for Certain Food Establishments., Jenny Scott, CFSAN, NCIMS, 2015-952, Final rule, 2015-1036, Current Good Manufacturing Practice, Hazard, Analysis, and Risk-Based Preventive Controls, for Human Food, Technical Amendment, 2015-1275, Current Good Manufacturing Practice, Hazard, Analysis, and Risk-Based Preventive Controls, for Human Food, Correction, 2015-1079, 2016-622
Type: Rulemaking
Docket Status: OPEN
Center: CFSAN
Docket Item Code: N
 

Primary Documents

View All  (50)
Comment Period Closed
Dec 15, 2014 11:59 PM ET
Proposed Rule
Posted: 09/29/2014
ID: FDA-2011-N-0920-1553
Comment Period Closed
Nov 22, 2013 11:59 PM ET
Other
Posted: 12/23/2013
ID: FDA-2011-N-0920-0411
Comment Period Closed
Nov 22, 2013 11:59 PM ET
Proposed Rule
Posted: 11/20/2013
ID: FDA-2011-N-0920-0288
Comment Period Closed
Nov 22, 2013 11:59 PM ET
Proposed Rule
Posted: 08/09/2013
ID: FDA-2011-N-0920-0188
Comment Period Closed
Nov 15, 2013 11:59 PM ET
Proposed Rule
Posted: 02/19/2013
ID: FDA-2011-N-0920-0013

Supporting Documents

View All  (132)
Comments Not Accepted
Supporting & Related Material
Posted: 09/17/2015
ID: FDA-2011-N-0920-2031
Comments Not Accepted
Supporting & Related Material
Posted: 09/17/2015
ID: FDA-2011-N-0920-2002
Comments Not Accepted
Supporting & Related Material
Posted: 09/17/2015
ID: FDA-2011-N-0920-2032

Comments

View All  (1,902)

71,386
Comments Received*
Regulatory Timeline
Pre Rule
Current Stage
Proposed Rule
Current Stage
Final Rule
Current Stage
Completed
Current Stage
Agency Contact
Jenny Scott
Senior Advisor
FDA/HHS
Office of Food Safety, 5100 Paint Branch Parkway
College Park, MD 20740
*This count refers to the total comment/submissions received on this docket, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.