Next Steps in Change Process March 12, :00 – 11:45 am Steven Mandernach Bureau Chief Food and Consumer Safety Iowa Department of Inspections and Appeals Timothy Weigner Staff Director U.S. FDA Office of Regulatory Affairs Office of Partnerships Standards Implementation Staff

Building the Framework for MFRPS Change Process Many thanks for all the State Participation on the MFPA Workgroups Stds 1, 7, 8 and 9 Workgroup: CA, CT, GA, IL, IN, KS, MD, MN, MS, TX, VA, WA, WY and FDA Stds 2, 3, 4 and 6 Workgroup: AK, GA, IA, KY, MI, MN, MO, MS, NY, OR, PA, TX, WA and FDA Stds 5 and 10 Workgroup: CA, CT, FL, GA, MA, MD, MS, VA, VT, WA, WI and FDA

Next Steps: MFRPA Recommendations Submitted to PFP MFRPS Alliance reports final approved recommendations to the PFP Governance Council for consideration. PFP Governing Council Committee (State, Local, and FDA Senior Management) deliberates MFRPS Alliance recommendations. PFP Governing Council forwards recommendations to the FDA Office of Partnerships for consideration. Returned for Clarification, Elaboration, or Additional Information FDA Office of Partnerships

Next Steps: MFRPS Change Process w/i FDA FDA Office of Partnerships makes final determination on proposed recommendations (accepted and rejected) Accepted recommendations are coordinated for review by FDA Offices/Center:  FDA Field Food Committee (FFC)  CFSAN  ORA Office of Policy and Risk Management (OPRM) Disapproved recommendations returned to the Alliance Board

Review of Proposed MFPRS Prior to Internal FDA Review Format layout and numbering system Summary and Outcome Statements Check terminology and definitions Cross reference individual standards with corresponding appendices and other standards

MFRPS Format (Numbering)

Next Steps: MFRPS Change Process w/i FDA (cont.) FDA Office of Partnerships coordinate with FDA Office of Policy and Risk Management (ORPM) for submission of next MFRPS version to OMB for review and approval  Paperwork Reduction Act  Burden of Work Statement  Federal Register postings  Process may take up to a year FDA OP publishes OMB approved document (2016 MFPRS)

Clearance Process ORA Office of Foods MFRPS sent To OMB PRA OCC RPMS Review cmts 60-day FR notice OMB review OMB approval 30-day FR notice OCC (Office of Chief Counsel) PRA (Paperwork Reduction Act Staff) RPMS (Regulatory Policy Management Staff) OMB (Office of Management and Budget) OMB Review Process

FDA Timeline Apr, 2015 – PFP GC Receives MFRPA Recommendations (2 weeks for PFP GC review) Apr, 2015 – PFP Forwards MFRPA recommendations May – Aug, 2015, OP Format/layout/cross check process Sep, 2015 – Submit to FDA Field Food Committee for Review Oct, 2015 – Incorporate final changes Dec, 2015 – Prep for OMB Submission Mar, 2016 – OMB 60-day submission Jun, 2016 – OMB 30-day submission Sep, 2016 – OMB approval and public release of MFRPS Phase in period –

Target Date for 2016 MFPRS September 30 th 2016

Questions