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