Industry Day Mar 2026.pptx

Contact Center Optimization Project Industry Day March 5, 2026

Industry Day Agenda Office of Operations March 2026 8:00 A.M. to 9:15 A.M. – Check-in/Registration, nametags, logistics (coffee/tea, restrooms, etc.)

9:30 A.M. to 10: A.M. – Welcome remarks and Introductions FDA Panel Introductions Welcome remarks from Dr. Butler 10:00 A.M. to 10:30 A.M. – Project Overview, Objectives and Goals 10:45 A.M. to 12:00 P.M. – General Q&A Ground rules (see next slide) 12:00 P.M. to 1:00 P.M. – Vendor networking

Disclaimer: “This Industry Day is for planning and information-gathering purposes only and does not constitute a solicitation or commitment by the Government.”

Ground rules during Q&A Office of Operations March 2026 Vendors must identify their name and company name before asking a single question. One follow-up question will be allowed if time permits.

Each question-and-answer exchange is limited to 2-3 minutes combined. If necessary, the FDA facilitator has the option to cut-off the question.

Government will not answer any questions on proprietary information, promise awards, indicate a preferred vendor, discuss source selection criteria in details or reveal budget-sensitive/acquisition-sensitive information.

Responses provided during Industry Day do not constitute official answer. Only written responses to formal questions submitted through proper channels are binding.

FDA representatives will determine which questions can be answered immediately versus those requiring written follow-up, and the government reserves the right to decline answering questions that are premature, inappropriate, or outside the scope.

All questions and answers will be shared with all attendees through post-event summaries or in real-time, and the session will be recorded and transcribed for documentation purposes.

Q&A content may be incorporated into a Frequently Asked Questions (FAQ) document to provide ongoing guidance to all potential vendors.

All Industry Day information, including Q&A content, is provided for general guidance only and does not amend or modify the official solicitation document, with unanswered questions held for written response after the event.

Disclaimer: “This Industry Day is for planning and information-gathering purposes only and does not constitute a solicitation or commitment by the Government.”

Vision and Scope Office of Operations Vision: Reimagine and modernize FDA’s contact center operations, delivering a unified, consistent, and resilient contact experience across the agency.

In-Scope:

Immediate – Establish a structured tiered contact center and enterprise CRM to support the integrated customer journey for inquiries and complaints raised to FDA Long-Term – Leverage the structure tiered contact center and enterprise CRM implemented for inquiries and complaints by applying all FDA contact centers.

Critical integration points Tier 0 to Unified Intake Tool (UIT) UIT to CRM Out of scope

UIT

UIT integration with downstream systems Other applications used for industry submissions, data storage, publishing, regulatory review and assessment management, or inspections and compliance management March 2026

Customer Relationship Mgmt (CRM)-like system manage engagement workflows Tier 2/3: COP’s Evaluation, determination, closure Simplified FDA Customer Journey of an Inquiry or Complaint

Tier 0

Unified Intake Tool (UIT) Completion of inquiries & complaints, incl. food and medical product safety reporting, allegations

ACD

Non-I or C Tier 1: Contact Center Facilitate routing, resolve simple calls and inquiries

Adverse Event Mgmt system(s) Safety reports and product problems

Other systems Complaint: (SMG 2180.2) Any voluntary submission to FDA alleging potential violation(s) of federal law, or an illicit or unsafe product or activity.

Inquiry: Requests for information or questions, submitted to FDA, that do not allege potential violation(s) of federal law, or an illicit or unsafe product or activity.

I or C

Automated Call Distribution Self-service id. of resources on fda.gov Yes Inquiries and Complaints Other processes

200,000 p.a.

To do: Centralize 20+ webforms

To do: Expand to all FDA

To do: Digitize and route mail

IN SCOPE

OUT of SCOPE Regulated industry electronic submissions Complaints Inquiries Complaints

ICOnS Inquiries and Complaints Optimization Solution

Goals

Goal 1: Implement a tiered (0-3) contact center structure with an enterprise CRM solution.

Goal 2: Form the business advisors working group to be the long-term business process owner.

Goal 3: Establish CRM Governance.

Goal 1: Tiered Contact Center Structure Office of Operations Establish a tiered (0-3) contact center structure by implementing the following:

March 2026 Tier 0 (self-service) Update operational governance, best practices, and standards for FDA's digital content.

Conduct an inventory of public fda.gov sites, consolidate redundant COP pages, and update content to better support self-service.

Improve FDA digital content search functionality.

Consolidate multiple inquiry intake forms and email addresses to the Unified Intake Tool for entry to the CRM.

Tier 1-3 (routing increased complexity/expertise) Establish an enterprise Tier 1 call center to accommodate current and anticipated volume for all FDA COPs.

Work with COPs to define and script Tier 1 calls and escalation to Tier 2.

Require FDA-wide use of the Automated Call Distribution system by removing or rerouting numerous contact center phone numbers to the Tier 1 queue.

Maintain Tier 2 and 3 calls in the appropriate business units/COPs.

Assures specialists and experts maintain knowledge and understanding of the specific products/policies in question.

Enterprise CRM solution Comprehensive case and ticket management Customer relationship and contact management Tiered support structure and escalation management Regulatory compliance and security Reporting, analytics, and performance management Integration and interoperability, single sign-on User experience and interface Scalability and future enhancement

Goal 2: Business Process Owners Office of Operations Form the business advisors group to be the long-term business process owner.

Small advisory group with representation from FDA Center/Office/Programs responsible for submitted public inquiries, voluntary complaints, and mandatory safety reports.

Complements ~150 subject matter experts involved with CHIME and ICONS projects.

Authority to serve this function.

Advise on key components or phases of project work, e.g., high-level process/system requirements.

Participate and provide approval on requirements, vendor selection (from RFI to RFQ), change management, e.g., communication, training.

Develop Agency protocols and metrics and hold Tier 2&3 managers (and vicariously their agents) accountable if they’re not following them.

Keep the public’s experience in mind and push back at center-requested changes that overly complicate consumer experience.

Maintain the CRM functionality (and O&M and DM&E) and work with their COPs to change/adapt it over time.

Integrate Tier 0 changes into the overall website plan.

Goal 3: CRM Governance

Establish CRM governance to address the following:

Assess current state FDA-wide CRM/process workflow systems (e.g., Appian, Genesys, Salesforce, ServiceNow).

Provide operational governance, best practice, and standards to optimize system use.

Consolidate contracts, licenses, and new development.

Q&A

Thank you!

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