1. Where Are We Now With Implementation March 11, 2015 8:00 – 8:45 am Ellen Buchanan Director U.S. FDA Office of Regulatory Affairs, Office of Operations, Audit Staff Timothy Weigner Staff Director U.S. FDA Office of Regulatory Affairs, Office of Partnerships, Standards Implementation Staff

2. Agenda Where Are We Now With Implementation? Who’s Involved? Determining and Measuring Implementation and Conformance Standards Implementation Staff Data Evaluation Audit Staff Data Evaluation, Scheduling, and Compliance Q & A

3. FDA Coordination and Support to MFRPS State MFRPS Implementation ORA/OP/SISORA/OP/CGSORA/OO/ORSORA/OO/Audit StaffORA/ORM/DHRDORA/OO/OFFO/DOFDA/CFSAN

4. Office of Partnerships Standards Implementation Staff and Office of Operations Audit Staff Working Together Weekly MFRPS Team Meetings Comparing Data Findings and Continuous Improvement (QMS) Standardize via joint visits (state MFPRS visits and assessments) Across Matrix communication

5. Determining State MFRPS Implementation and Conformance Using multiple tools: Office of Partnership/Standards Implementation Staff annual visit and review (more frequent if on special condition status) Mid-year and year-end deliverables and report reviews Office of Operations/Audit Staff scheduled assessments and audits: −18-months, 36-months, 60-month comprehensive, Bi- annually after 60-month Information from FDA District Offices and Office of Regulatory Science

6. OP/SIS Evaluation of State MFPRS Implementation

8. OP/SIS MFPRS Data Analysis by State

9. State Implementation Progress of MFRPS Standard 1 – Regulatory Foundation (n = 40)

10. State Implementation Progress of MFRPS Standard 2 – Training Program (n = 40)

11. State Implementation Progress of MFRPS Standard 3 – Inspection Program (n = 40)

12. State Implementation Progress of MFRPS Standard 4 – Audit Program (n = 40)

13. State Implementation Progress of MFRPS Standard 5 – Food-Related Illness & Outbreak Response (n = 40)

14. State Implementation Progress of MFRPS Standard 6 – Compliance & Enforcement Program (n = 40)

15. State Implementation Progress of MFRPS Standard 7 – Industry & Community Relations (n = 40)

16. State Implementation Progress of MFRPS Standard 8 – Program Resources (n = 40)

17. State Implementation Progress of MFRPS Standard 9 – Program Assessment (n = 40)

18. State Implementation Progress of MFRPS Standard 10 – Laboratory Support (n = 40)

19. 2014 – 18 Month PAVA Implementation

20. 2014 – 36 Month PAVA Implementation

21. 2014 – 60 Month Audit Implementation

22. 2014 – 60 Month Audit Conformance

23. Pilot State Aggregate

24. Questions