next steps in change process march 12, 2015 11:00 – 11:45 am steven mandernach bureau chief food...
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Next Steps in Change ProcessMarch 12, 2015
11:00 – 11:45 am
Steven MandernachBureau Chief
Food and Consumer SafetyIowa Department of Inspections
and Appeals
Timothy WeignerStaff 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
ORAOffice
of Foods
MFRPS sentTo OMB
PRAOCC RPMS
Review cmts
60-dayFR notice
OMBreviewOMB approval
30-dayFR 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 30th
2016
Questions
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