0910-AG36 201310 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Hazard Analysis and Risk-Based Preventive Controls Economically Significant Previously Published in The Unified Agenda Proposed Rule Stage Yes Private Sector 21 CFR 110 21 USC 342 21 USC 371 42 USC 264 PL 111-353 (signed on Jan. 4, 2011) Statutory Final 07/04/2012 Final rule must be published no later than 18 months after the date of enactment of the FDA Food Safety Modernization Act. No 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 Includes Retrospective Review under E.O. 13563. Yes Businesses None No Yes Yes Jenny Scott 0910 Food and Drug Administration FDA 240 402-1488 jenny.scott@fda.hhs.gov 5001 Campus Drive, Room 3B014, College Park MD 20740