1. Future Funding Model Update Guy Delius, FDA Travis Goodman, FDA February 2, 2016

2. FDA-State Future Funding Model 2

3. Leadership Vision Advance an Integrated Food Safety System (IFSS) Combine/bundle like or similar Programs/Cooperative Agreements/Grants when possible Reduce workload and administrative burden to State agencies and FDA Increase flexibility in funding opportunities to State programs (one size no longer fits all) Develop Cooperative Agreements that span several years to reduce yearly application processing 3

4. Sustainability Future Funding Model Workgroup Charge To develop a recommendation for a future funding model for Manufactured Food Regulatory Program Standards (MFRPS), Rapid Response Teams (RRT), Food Protection Task Force Programs (FPTF) and other related grant programs to streamline the numerous cooperative agreements/grants, improve outcomes and move closer to an integrated Food Safety System (IFFS). 4

5. Current System Pipelines (Deliverables and $) from FDA to States and vice versa – Separate pipeline for each Grant or Cooperative Agreement (CA) to and from FDA – Separate applications for each Grant or CA to and from FDA – Separate deliverables/timelines/due dates for each Grant or CA – Dedicated State Staff to apply for and monitor each Grant or CA – Dedicated FDA Staff to review/monitor each separate Grant or CA 5

6. Need to Find a Better Way How can we assemble “like or similar” grants or cooperative agreements together to save time/effort/cost for both FDA and States? How can FDA be understanding and flexible to State needs regarding funding opportunities? How do we recognize and highlight differences in State agencies, i.e. size, number of firms, citizen population, land mass, food risk, etc., and fairly/equitably share funding with all? Continue support of proven programs: MFRPS, RRT, FPTF 6

7. MFRPS/RRT Phases of Growth Development (Implementation) Phase: Most effort, policies identified and written, procedures established, majority of employees trained, etc. – MFRPS- 5 years and significant conformance – RRT- 3 years – FPTF- 1 year (can be picked in either phase) Maintenance Phase: Maintain growth realized (e.g. resources, infrastructure, trained staff) in the Development Phase and continuously evaluate/improve: – Future Funding may be different depending which Phase a program is operating within 7

8. Benefits of Proposal Will consolidate funding for programs with inter- related activities/goals Same personnel working on many CAs – If different, it forces them to work together/improves efficiencies for State and FDA Will align due dates and reporting – Two larger progress reports to review rather than 5 separate reports Still QMS focused (training, continuous improvement Moves into a variable rate funding model and requires state cost matching during longer term maintenance stage 8

9. Preparing for the Transition Cooperative Agreements that will be merged (MFRPS, RRT, FPTF) will be aligned so the Future Funding Model can begin in 2018 – MFRPS- 1 year extension – RRT- 2 or 3 year extension – FPTF- variable 9

10. Progress Since Last MFRPA Research conducted: – Other Federal models- EPA, FSIS, CDC, CMS – Gathered and tested alternate data sets Workgroup progress – Narrowing down criteria based data points – Expanded Workgroup – Reviewed by statistician – Tested the model Outreach conducted – FDA State Strategy Workgroup – PFP – MFRPA 10

11. Future Funding Schematic Review 11

12. OR Base Funding OPTIONAL Pick List/Menu Options MFRPS (Maintenance) Variable funding: Level 1: $150,000 Level 2: $225,000 Level 3: $300,000 Determination of applicant’s funding level will be based on the following criteria: FSMA Non High Risk Firm Count FSMA High Risk Firm Count Indicator of Program Operating Costs (determined using Cost per GMP Inspection; food contract) Food Protection Task Force (meetings/workshops) Flat rate: $10,000/year/grantee; Limit 1 per state. Available during Development and Maintenance Rapid Response Team (RRT) (Maintenance) Will be open competition for funding with each FOA iteration. Development rate: up to $300,000/year/grantee. Limit 3 years, then must transition to maintenance funding. Maintenance phase: Variable funding: Level 1: $150,000 Level 2: $225,000 Level 3: $300,000 Determination of applicant’s funding level will be based on the following criteria: State Population FSMA High Risk/Non High Risk Firm Count Count of multi-state outbreaks state is involved in (average over past 10 years) Must Choose: May Choose: MFRPS Implementation (Development) Development rate : up to $300,000/year/grantee All funding (base and menu options) is subject to availability of funds and acceptable grantee performance. Funding strategy: Award base funding tracks (MFRPS) first (if recommended for funding by objective review panel), and then allocate whatever remains of the total program funding to optional pick list/menu options in a prioritized manner based on objective review panel ranking of proposals. Future Funding Model 12 Once in MFRPS Maintenance, the entire cooperative agreement (inclusive of all pick options) is subject to a 25% cost matching requirement (in-kind contributions allowed).

13. MFRPS Maintenance Determining Funding Levels MFRPS (Maintenance) Variable funding: Level 1: $150,000 (3-4 points) Level 2: $225,000 (5-7 points) Level 3: $300,000 (8-9 points) Determination of applicant’s funding level will be based on the following criteria: FSMA Non High Risk Firm Count FSMA High Risk Firm Count Indicator of Program Operating Costs (determined using Cost per GMP Inspection; food contract) CriteriaRange*Value FSMA Non High Risk Firm Count (Ranges will be established using the most current FSMA inventory data from FDA as of the submission of the final draft FOA (Dec2016)) ≤25 th percentile1 point 25 th -75 th percentile2 points ≥ 75 th percentile3 points FSMA High Risk Firm Count (Ranges will be established using the most current FSMA inventory data from FDA as of the submission of the final draft FOA (Dec2016)) ≤25 th percentile1 point 25 th -75 th percentile2 points ≥ 75 th percentile3 points Indicator of Program Operating Costs (determined using Cost per GMP Inspection for the food contract; Ranges will be established using the most current food inspection contract data from FDA as of the submission of the final draft FOA (Dec2016) ≤25 th percentile1 point 25 th -75 th percentile2 points ≥ 75 th percentile3 points *All ranges listed are tentative, for discussion purposes only and subject to management approval

14. MFRPS Maintenance Determining Funding Levels MFRPS (Maintenance) Variable funding: Level 1: $150,000 (3-4 points) Level 2: $225,000 (5-7 points) Level 3: $300,000 (8-9 points) Determination of applicant’s funding level will be based on the following criteria: FSMA Non High Risk Firm Count FSMA High Risk Firm Count Indicator of Program Operating Costs (determined using Cost per GMP Inspection; food contract) CriteriaRange*Value FSMA Non High Risk Firm Count (Ranges established using FY16 FSMA inventory data from FDA) ≤ 370 firms1 point 371 – 1292 firms2 points ≥ 1293 firms3 points FSMA High Risk Firm Count (Ranges established using FY16 FSMA inventory data from FDA) 0 – 167 firms1 point 168 – 541 firms2 points ≥ 542 firms3 points Indicator of Program Operating Costs (determined using Cost per GMP Inspection for the food contract; Ranges established using 2014-2015 food inspection contract data from FDA) ≤ $598.091 point $598.10 – $1007.242 points ≥ $1007.253 points *All ranges listed are tentative, for discussion purposes only and subject to management approval

15. RRT Maintenance Determining Funding Levels Rapid Response Team (RRT) (Maintenance) Will be open competition for funding with each FOA iteration. Maintenance phase: Variable funding: Level 1: $150,000 (3-4 points) Level 2: $225,000 (5-7 points) Level 3: $300,000 (8-9 points) Determination of applicant’s funding level will be based on the following criteria: State Population FSMA High Risk/Non High Risk Firm Count Count of multi-state outbreaks state is involved in (average over past 10 years) CriteriaRange*Value State population (Ranges will be established using data from the most recent US Census as of the submission of the final draft FOA (Dec2016)) ≤25 th percentile1 point 25 th -75 th percentile 2 points ≥ 75 th percentile 3 points FSMA High Risk/Non High Risk Firm Count (Ranges will be established using the most current FSMA inventory data from FDA as of the submission of the final draft FOA (Dec2016)) ≤25 th percentile1 point 25 th -75 th percentile 2 points ≥ 75 th percentile3 points Count of multi-state outbreaks state is involved in (average over past 10 years) (Ranges will be established using the most current CDC NORS/FOOD tool data as of the submission of the final draft FOA (Dec2016)). ≤25 th percentile 1 point 25 th -75 th percentile 2 points ≥ 75 th percentile3 points *All ranges listed are tentative, for discussion purposes only and subject to change pending management approval

16. RRT Maintenance Determining Funding Levels Rapid Response Team (RRT) (Maintenance) Will be open competition for funding with each FOA iteration. Maintenance phase: Variable funding: Level 1: $150,000 (3-4 points) Level 2: $225,000 (5-7 points) Level 3: $300,000 (8-9 points) Determination of applicant’s funding level will be based on the following criteria: State Population FSMA High Risk/Non High Risk Firm Count Count of multi-state outbreaks state is involved in (average over past 10 years) CriteriaRange*Value State population (Ranges established using data from the 2010 census) ≤ 1,839,6681 point 1,839,669 – 6,636,085 2 points ≥ 6,636,0863 points FSMA High Risk/Non High Risk Firm Count (Ranges established using FY16 FSMA inventory data from FDA) ≤ 506 firms1 point 507 – 1,469 firms 2 points ≥ 1,470 firms3 points Count of multi-state outbreaks state is involved in (average over past 10 years) (Ranges established using CDC NORS/FOOD data from 2009- 2013) ≤ 2.21 point 2.3 – 5.62 points ≥ 5.73 points *All ranges listed are tentative, for discussion purposes only and subject to change pending management approval

17. We Need Your Input! We want this to be a practical model for sustaining these key cooperative agreements in the future We need your input to improve this model and appreciate all the feedback we have received – Used all the input from last year’s MFRPA to conduct research on criteria based data points and test the model 17

18. Contacts Guy Delius, Guy.Delius@fda.hhs.govGuy.Delius@fda.hhs.gov – 240-479-8593 Travis Goodman, Travis.Goodman@fda.hhs.govTravis.Goodman@fda.hhs.gov – 240-479-8614 Lauren Yeung, Lauren.Yeung@fda.hhs.govLauren.Yeung@fda.hhs.gov – 301-796-6623 18

19. Questions and Answers Session 19