Dr. Katherine Bond, Director , Office of Strategy, Partnerships and Analytics, FDA

2. Dr. Katherine Bond, Director, Office of Strategy, Partnerships and Analytics, FDA “Over the next decadeFDA will continue to transform from a predominately domestically focused agency operating in a globalized economy to an Agency fully prepared prepared for a regulatory environment in which FDA-regulated products know no borders.” FDA global engagement report April 2012

3. Four pillars • Partner with foreign counterparts to create global coalitions of regulators to insure and improve global product safety • Build global data information systems and networks and proactively share data with peers • Expand intelligence gathering with an increase focus on risk analytics and thoroughly modernized IT capabilities • Effectively allocate agency resources based on risk leveraging the combined efforts of government industry and public and private third parties 

4. Four pillars • Partner with foreign counterparts to create global coalitions of regulators to insure and improve global product safety • Build global data information systems and networks and proactively share data with peers • Expand intelligence gathering with an increase focus on risk analytics and thoroughly modernized IT capabilities • Effectively allocate agency resources based on risk leveraging the combined efforts of government industry and public and private third parties 

5. 6 Organizations 15 Relationships 30 Application Programming Interface (API) Handshakes Achieving this goal by using current standard IT Accepted API security protocols can quickly become mathematically impossible

6. 12 Organizations 66 Relationships 132 Application Programming Interface (API) Handshakes

7. We Need New Connectivity Tools For A Global Solution • Even 12 Organizational databases connected in prior example becomes almost unmanageable for IT support • There is no discoverability in model to avoid redundancy of data entry and duplication of systems • There is no ability to perform gap analysis and provide efficient coordination of all stakeholders • There is no coordinated access by all participating databases leaving exposure to security breaches that can’t be seen by all participants

8. The Puzzle Analogy Joe Corby 2013 Food Safety Summit “ We are building the Food Safety System one piece of the puzzle at a time”. Mike Taylor 2012 Partnership for Food Protection “ The challenge of the integrated Food Safety System is gluing the pieces of the puzzle together”.

9. Stakeholders not all on the same page Ownership of the puzzle pieces, politics, funding allocation and turf issues are significant challenges to all aspects of an integrated Food Safety System….

10. Currently are focused on individual pieces of information sharing without looking at the big “fully integrated” picture FSMA and IFSS focus on developing a systems based, integrated, collaborative approach.

11. While it easy for public and private organizations to be focused on their respective piece of the puzzle…… • It is critical to know what it will look like when we get there. • What is the glue that Mike Taylor references? • What secures it and holds it together? • How do all the pieces interact?

12. Developing an Information Sharing FrameworkFor All Stakeholders Academics Institutes & Associations International Organizations Industry Government Secure Interoperability, with scalable and measured global performance are keys to success

13. Developing an Information Sharing Framework For All Stakeholders • How do we ensure Industry engagement? • What is the big global picture we are striving for? • What is the glue to the integrated puzzle? • What is the WIIFM for all stakeholders? • What are the definitions for understanding and equivalency? • How do we achieve interoperability with appropriate security? • How do we measure success?

14. Stakeholders must get CCCET (pronounced “set”) Getting CCCET is applying specific strategies and solutions that enable standardized, secure and measurableCommunication, Coordination, Collaboration, Educationand Training

15. Being • Don’t just say, “we communicated, coordinated or collaborated.” • Being CCCET means you have utilized strategies to ensure the right people were targeted and engaged and that appropriate feedback mechanisms are in place. • Don’t just say, “we educated and trained.” • Being CCCET means not only were the right people engaged but, you have a strategy to rapidly retrieve who has this skillset for emergency response.

16. Being • Searchable, secure Information sharing vs spam (discoverable) • Aligned and targeted roles, functions, capability based information sharing vs titles, program names (applicable) • Taxonomy indexed/mapped terms vs market basket terminology (equivalent) • Sharable, maintained, community based and current knowledgebase vs key individual and no succession planning. (participative wiki like vs personal files) • Integrated, consolidated interpretive metrics mapped to outcomes vs stand alone metrics and data capture

17. What is a CCCET Framework? A CCCET Framework employs standards and tools that engage CCCET strategies and solutions. This framework helps connect disparate systems to facilitate effective, interoperable information sharing between you and partner organizations Enter data once, use many ways Get the right information to the right person at the right time.

18. Developing CCCET based Information Sharing Framework to Comply with FSMA Entity/People/Activity Relationships & Connections Leverage Community of SME’s to Build Relationships Of Disparate Systems (Crowd Sourcing) • Data Discovery Value propositions Entity/People/Activity Unique Identifiers & Aliases Organizations, Agencies Individuals Roles, Functions Products, Supply Chains Credentials, Certifications, Education, Training, Audits, Accreditation • Security at individual level Entity/People Associated Activity Performance Measures Discover and aggregate existing/new metrics from all sources to tell the story • Outcomes based Performance Reporting FSMA, NIPP PPD-8, HSPD-9

19. Tools of the CCCET Framework Entity/People/Activity Unique Identifiers & Aliases Entity/People Associated Activity Performance Measures Registry of Entities & Data Presentation of Performance Relationship of Entities & Data Entity/People/Activity Relationships & Connections

20. Uses Wiki like pages to hold, organize and align data to be shared • Wiki approach allows community to provide resources to data index and meta-tag alignment of who, what, where, how, what, why within a common framework. • Wikis employ CCCET strategies to organize data • CCCET –wiki pages are templated to specific informational needs activity/process, role/function, agency/organization, industry/commodity, tool/program/app, workgroup, project, committee and law,/regulation/requirement

25. Who Has Food Safety Credentials? 6 Organizations FDA 15 Relationships 12 API Programmed Handshakes NEHA FSCR

26. Who Has Food Safety Training and Certificates associated with these Credential Holders? 6 Organizations 15 Relationships API programing FDA IFPTI NEHA FSCR

27. What are the roles, agencies and contact information associated with these individuals? 6 Organizations 15 Relationships API programing FDA IFPTI NCFPD CoreSHIELD NEHA FSCR

28. Who Else Has NEHA worked with on Food Safety Credentials In Credential Registry 15 Organizations 69 Relationships API Programmed Handshakes 3 Trusted Enterprise Relationships NEHA FSCR- Org 2 NEHA FSCR- Org 1 FDA IFPTI NEHA FSCR- Org 3 NCFPD CoreSHIELD NEHA FSCR NEHA FSCR- Org 6 NEHA FSCR- Org 4 NEHA FSCR- Org 5

29. Who Else Besides NEHA have Food Safety Credentials? 15 Organizations 69 Relationships API Programmed Handshakes 3 Trusted Enterprise Relationships NEHA FSCR- Org 2 NEHA FSCR- Org 1 FDA IFPTI NEHA FSCR- Org 3 NCFPD CoreSHIELD NEHA FSCR NEHA FSCR- Org 6 NEHA FSCR- Org 4 NEHA FSCR- Org 5

30. Who Else Has Food Safety Credentials Declared but not validated? 15 Organizations 69 Relationships API Programmed Handshakes 3 Trusted Enterprise Relationships NEHA FSCR- Org 2 NEHA FSCR- Org 1 FDA IFPTI NEHA FSCR- Org 3 NCFPD CoreSHIELD NEHA FSCR NEHA FSCR- Org 6 NEHA FSCR- Org 4 NEHA FSCR- Org 5

31. But…….. Are we actually accomplishing anything?????

32. SCORECARD - Sector Critical Objectives Realized Effectiveness is a CCCET Framework product that helps to align/collate disparate CRE and Connect the Dots relationally based outputs into meaningful metrics.  HSPD9 reporting PPD-8 reporting FSMA reporting National Outcomes NIPP dashboard IFPTI Training Database SCOREcard CCCET Panel Environment Picture worth a thousand words

33. A SCOREcard is a compilation of activities aligned under Goals/Objectives. • Other Scorecards can use same activities for different Outcome reporting • Activities are discoverable within the CCCET Framework search engine for association to other related measurements. • Activities can be compiled, aggregated and summarized from local to state to federal or within organizations

35. Uses Activity/Process CCCET Wiki pages to hold, organize and align activity data to be shared • Scorecard forces all Activities to define “What’s Good and What’s Bad” on simple 1-5 color coded scale • Enables ability to stack and aggregate and associate activity based metrics/measurements mapped to these CCCET wikis • Enables additional attributes (goals, tasks, subjective measurements) to also be gathered and tracked for seeing measured progress

36. Other SCOREcard Inputs to Tell the Story FSMA Sec.108 Implementation CIFOR Implementation ISO 17025 Implementation Food Code Adoption Recall Effectiveness 3rd Party Auditor Engagement (FSMA Sec. 307 Implementation)

37. In Summary Through this improved:Communication, Coordination, Collaboration, Education & Training This Food and Agriculture Sector Information Sharing Environment (ISE) facilitates development and implementation of best practices while enhancing gap analysis, emergency response capability, and sector metrics. The Food and Agriculture Sector will be CCCET