Industry Day Consolidated Meeting Minutes.pdf

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Meeting Minutes: FDA Contact Center Optimization Project Industry Day Date: March 5, 2026 Time: 9:30 AM - 12:00 PM Location: FDA Headquarters – Great Room

FDA Leadership and Panel Members:

• Dr. Butler - Chief Operating Officer

• Shailesh Shah - Program Manager, Contact Center Optimization Project

• Melissa Shea - Deputy COO (Facilitator for Q&A)

• Sean Hanlon - Office of Digital Transformation (Security)

• Tonya Wilbon - CDRH Representative

• Josh Lehman - ODT Representative

• Mary Kremzner - CDER Representative

• Deborah Price - Foods & Cosmetic Information Center Representative

• Danni Gaines - ODT Representative

• Lilibeth Deato - Office of Acquisition and Grants Services (OAGS)

• Laura Alvey - Center for Veterinary Medicine (CVM)

• Melanie Keller - Incoming Chief Operating Officer (effective April 5)

I. Welcome and Opening Remarks

• Introduction o Meeting commenced at 9:30 AM o Purpose: Industry Day for Contact Center Optimization Project o Agenda overview provided

• Opening Remarks (Dr. Butler) o Key Announcements:

Dr. Butler announced retirement, effective with transition on April 5, Melanie Keller will assume Chief Operating Officer role Melissa Shea will become Deputy COO o Mission Statement:

FDA operates 100+ intake pathways processing 200,000+ inquiries annually Current systems are fragmented, limiting visibility and response time o Vision:

Single intelligent front door to the agency with enterprise visibility o Transformation Goals:

Unified contact center capability across 6 external-facing centers (Phase 1)

Enterprise CRM platform for signal detection and predictive insights Tiered, intelligent engagement structure

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Self-service capabilities for stakeholders Consolidated intake with intelligent routing o Business Value:

Earlier detection of emerging safety signals Economies of scale through consolidation Reduced technical debt Dynamic resource allocation Consistent stakeholder experience

II. Ground Rules

• Vendors must identify name and company before asking questions

• One follow-up question allowed if time permits

• Q&A exchanges limited to 2-3 minutes

• FDA will not discuss proprietary information, preferred vendors, source selection criteria, or budget-sensitive information

• Only written responses to formal questions are binding

• FDA reserves right to decline answering premature or inappropriate questions

• All Q&A will be shared with attendees post-event

• Session recorded and transcribed for documentation

• Q&A content may be incorporated into FAQ document

• Industry Day information is for guidance only and does not constitute solicitation or commitment III. Project Overview and Goals

• Vision and Architecture o Current State:

Multiple intake pathways across FDA Fragmented systems built for local needs Limited enterprise-level pattern identification o Future State:

Single front door with unified operating model Tiered structure (Tier 0-3) Enterprise CRM platform AI-powered chatbot capabilities Integration with existing systems (Genesis telephony, Salesforce, Appian, ServiceNow)

• Three Core Goals o Goal 1: Implement Tiered Contact Center Structure Tier 0 - Self-Service:

• Update operational governance and best practices for FDA digital content

• Conduct inventory of public FDA websites and consolidate redundant pages

• Improve FDA digital content search functionality

• Consolidate multiple intake forms and email addresses into unified intake tool (UIT) Tier 1 - Initial Contact:

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• Establish enterprise Tier 1 call center for current and anticipated volumes

• Work with centers to define and script Tier 1 calls and escalation procedures

• Require FDA-wide use of automated call distribution system

• Route calls through single point of entry

Tier 2 & 3 - Escalation and Expertise:

• Maintain Tier 2 and Tier 3 calls in appropriate business units

• Ensure specialists and experts maintain knowledge of specific products/policies

• Tier 3 to remain with government subject matter experts o Goal 2: Form Business Advisory Group Establish small advisory group with representation from FDA centers, offices, and programs Provide authoritative governance for long-term improvements Advise on key project components including:

Workflow and system requirements Vendor selection (RFI to RFQ) Change management, communication, and training Agency protocols and metrics Maintain focus on public experience Integrate Tier 0 changes into overall website plan o Goal 3: Establish CRM Governance Assess current state of FDA-wide CRM processes and workflow systems Provide operational governance and best practices Consolidate contracts, licenses, and new development Enterprise CRM Solution - key requirements:

• Comprehensive case and ticket management

• Customer relationship and contact management

• Tier structure and escalation management

• Regulatory compliance and security

• Reporting, analytics, and performance management

• Integration and interoperability with single sign-on

• User experience and interface

• Scalability and future enhancement

IV. Question and Answer Session

Key Questions and Responses:

• Q: Tier 0 content updates and publishing platform integration o A: Vendors will work with existing team supporting content and publishing platform to make suggested implementation updates.

• Q: Lessons learned from prior modernization efforts

Page | 4 o A: Change management is critically important. Strong stakeholder communication and thorough discovery/assessment are essential.

• Q: Self-service scope and innovation boundaries o A: Think as broad and wide as possible. FDA does not want to limit innovation potential.

• Q: Center involvement in developing unified solution o A: All centers have representatives on the Integrated Product Team (IPT).

Centers will evaluate responses and have voice in decision-making.

• Q: Assessment vs. solution development concerns o A: Assessment will determine if existing investments should be included or if new capabilities provide better value.

• Q: Tier 2 and Tier 3 staffing o A: Clarification provided: Tier 1 will be contractor-staffed. Tier 2 open to proposed solutions. Tier 3 will be government-staffed subject matter experts.

• Q: Solicitation timeline o A: Target release within next 60-90 days (fiscal year 2026). Leadership pushing for release this fiscal year.

• Q: Small business and subcontracting requirements o A: Still in development. FDA welcomes suggestions. Small business requirements will be included.

• Q: Change management evaluation o A: Yes, change management will be a significant evaluation factor in proposals.

• Q: Initial Operating Capability (IOC) expectations o A: Phase 1 (base year) should include operating capability, not just setup.

Transition of multiple contact centers to be addressed in proposals.

• Q: AI integration and Elsa o A: External solutions have flexibility. Integration with data platform and AI platform (Elsa) expected. Diagram showing Elsa incorporation will be provided.

• Q: Technology consolidation across departments o A: Long-term goal is one platform for all tiers using same CRM tool.

Assessment will determine best approach.

• Q: Tier 0 architecture and intake system

• A: Tier 0 focuses on clear self-service through website. Information about intake system design will be provided in RFP.

• Q: Customer experience goals and success metrics o A: Success means clear public reporting pathways, quick signal analysis, no delays, and ability to track all interactions across centers.

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• Q: End user support at Tier 1 o A: Focus is on external FDA intakes and complaints, not internal end-user support.

• Q: Signal detection scope o A: All signal detection in scope. Analytics component critical for identifying patterns across all intake channels.

• Q: Adverse event reporting integration o A: FAERS currently separate effort but could receive feeds from this system at Tier 3 level.

• Q: Year 1 expectations o A: Understanding entire environment, clear website with unified intake, CRM operational with analytics, system in place with rollout plan beginning.

V. Clarifications and Additional Information

• Technology and Integration:

o FDA not married to single platform; seeking best-of-breed solutions o Existing systems include Genesis (telephony), Salesforce, Appian, ServiceNow o AI integration required with human-in-the-loop for decision-making o Unified analytics platform expected across all channels o Theme of consolidation across FDA operations

• Contracting Approach:

o Statement of Objectives (SOO) to Performance Work Statement (PWS) approach o Vendors will write PWS based on SOO o Full and open competition o Small business participation encouraged o No preferred vendors or solutions

• Center-Specific Considerations:

o CDRH: Access to combination product information across centers; accurate and expeditious information delivery o CDER: Case history visibility across centers; minimize delays o Foods & Cosmetics: Emergency escalation protocols; reporting capabilities;

survey feedback integration o CVM: Small center needing translation of emails into structured data o Security: Compliance with NIST 800-53, FedRAMP standards

• Performance Expectations:

o No dropped calls during transition o No delays in current service levels

Page | 6 o Service Level Agreements (SLAs) will be developed o Key Performance Indicators (KPIs) open to vendor suggestions o Both system-related and user outcome metrics

• Assessment Role:

o Vendors will serve dual role as consultant and solution provider o Will assess existing solutions and create evaluation criteria o Government will make final decisions based on vendor recommendations o No baggage regarding existing systems or vendors

VI. Closing Remarks: Dr. Butler and Melissa Shea

• Emphasized level playing field for all vendors

• No sunk cost constraints

• Industry experience valued (vendors have done this at scale)

• Encouraged unconstrained thinking followed by practical implementation

• Focus on what's achievable in Year 1

• Questions will remain open via SAM.gov

• FDA moving quickly to finalize documents and release solicitation

• Additional industry days planned for future solicitations

• Feedback on forum format welcomed

VII. Next Steps

• Submit questions via SAM.gov

• Prepare for RFP release (60-90 days)

• Consider teaming arrangements

• Review requirements for PWS development

• FDA Actions:

o Finalize solicitation documents o Post Q&A summary to SAM.gov o Release RFP in fiscal year 2026 o Provide additional technical documentation (Elsa integration diagram, intake system architecture)

• Timeline:

o Solicitation release: 60-90 days (target) o Melanie Keller assumes COO role: April 5, 2026 o Dr. Butler transition to consultant role: Following April 5

VIII. Post-meeting

• Government personnel exited room to protect acquisition integrity

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• Vendors provided networking opportunity until 1:00 PM

• Room remained available for vendor collaboration