Contact Center Optimization SOO_DRAFT.pdf

Food and Drug Administration (FDA) Contact Center Optimization Program

Statement of Objective

DRAFT

Statement of Objectives (SOO) Contact Center Optimization Program Food and Drug Administration (FDA)

Office of Operations

Table of Contents

1. Background

2. Scope

2.1Establish a structured tiered contact center for inquiries and complaints with an enterprise Customer Relationship Management (CRM) solution

2.2 Expand inquiries and complaints tiered contact center and enterprise CRM solution to all contact centers within FDA

3. Performance Objectives and Outcomes

3.1 Modernization of Contact Center Operations

3.2 Technology Standards

3.4 Capacity

3.5 Accessibility and User Experience

3.6 Security and Compliance

3.7 Development Approach and Methodology

3.8 Operations and Maintenance (O&M)

3.12 Transition Out

3.13 Performance Console

4. Constraints and Assumptions

5. Place of Performance

6. Desired Period of Performance

7. Proposed Contract Type

8. Key Personnel

9. Government Furnished Equipment (GFE)/Government Furnished Information (GFI) ...10

10. 508 Standard Requirements

11. Baseline Security Requirements

12. Other Pertinent Information or Special Considerations

13. Appendix

13.1 Inquiries and Complaints Environment

13.2 ERIC Environment

1. Background The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

The FDA recognizes the critical role that inquiries, complaints, and mandatory reports play in protecting public health, building public trust, and informing regulatory action. Currently, FDA operates a fragmented contact center environment with over 100 intake mechanisms and 20+ web-based structures processing approximately 200,000 inquiries and complaints annually. This distributed approach has resulted in inconsistent customer experience across Centers, Offices, and Programs (COPs), siloed data systems, inflated operational costs, varied staffing models and workflow processes, limited integration between systems, and delays and risks to public health due to inefficient information flow.

FDA's distributed contact center approach has led to various entry and routing points, a varied mix of FTE and contracted support, various workflow processes (in systems and manual), and multiple data and management systems. This has ultimately led to inconsistent and poor customer experience, siloed data systems, inflated costs/low efficiency, delays and risks to public health.

To address these challenges, FDA seeks to modernize its enterprise-wide customer engagement infrastructure by implementing a comprehensive, tiered contact center solution integrated with an enterprise Customer Relationship Management (CRM) system. This initiative will transform how FDA receives, manages, and responds to inquiries and complaints from the public, industry stakeholders, healthcare professionals, and other external parties.

2. Scope

The FDA seeks contractor support services to define, design, develop, implement, configure, integrate, train, operate, and maintain a unified Contact Center Optimization (CCO) solution that establishes an enterprise-wide contact center capability across all FDA centers, offices, and programs. The CCO solution will serve as a single point of entry for all agency inquiries, complaints, and service requests, providing a consistent and seamless customer experience.

2.1Establish a structured tiered contact center for inquiries and complaints with an enterprise Customer Relationship Management (CRM) solution.

• Tier 0: Self-Service and Automated Support – Provide customers with immediate access to automated resources, including AI-powered chatbots, interactive voice response (IVR) systems, knowledge base articles, FAQs, and guided troubleshooting tools. This will enable users to resolve common inquiries independently without agent intervention, reducing overall contact volume and improving response times.

• Consolidate Tier 1 – Consolidate Tier 1 across six centers (i.e. CDRH, CDER, CVM, CTP, FCIC, CBER) to handle initial contacts for general inquiries and/or complaints, perform intake and triage functions.

• Tier 2 and Tier 3 routing – Leverage AI-assisted classification and intelligent routing to direct inquiries to the appropriate FDA resource or escalation path based on complexity, urgency, and subject matter expertise.

• Enterprise CRM - Implement an enterprise CRM platform that captures, manages, and maintains a comprehensive, 360-degree view of customer interactions across all communication channels, including but not limited to voice, email, web, chat, and other digital channels. Incorporate AI-enabled and analytics-driven capabilities, including but not limited to Natural Language Processing (NLP) for inquiry classification and case tagging, and Machine Learning (ML) techniques to support intelligent routing, prioritization, and workload distribution. It should be a comprehensive solution that includes case management, customer relationship management, tiered support structure, regulatory compliance, reporting and analytics, integration capabilities, user experience design, and scalability planning.

• Integration – A seamless integrations between Tier 0 self-service, Unified Intake Tool, enterprise CRM, and downstream applications and data warehouses

2.2 Expand inquiries and complaints tiered contact center and enterprise CRM solution to all contact centers within FDA.

• Employee Resource & Information Center (ERIC) - ERIC is the agency’s unified one-stop Help Desk operations center providing support to all FDA users requesting administrative, Information Technology, Facilities, Human Resources, and other employee services.

• Other FDA Contact Centers – An inventory will need to be conducted to determine other contact centers that exists within FDA. A component of the research will need to determine purpose of the contact center, service it provides, volume of contact over email and/or phone, number of agents triaging, types of agents (FTE and/or contractors), operational hours, etc.

3. Performance Objectives and Outcomes

3.1 Modernization of Contact Center Operations

Design, develop, and implement a unified, enterprise functional architecture aligned with government and industry standards, including data migration from legacy systems, configuration of innovative capabilities, and comprehensive user training prior to deployment. The platform will implement a digital tier to human tier approach by establishing as a single point of entry through a unified contact center with a three-tier service model (general intake and triage, specialized program support, and subject matter expert escalation). It will be built on a secure cloud-based or hybrid PaaS/SaaS architecture with full system integrations, seamless Genesys Cloud interoperability, and scalability. Leveraging modern, scalable technologies and AI to improve service efficiency, adaptability, and sustainability, the platform will require seamless transition to Operations and Maintenance support upon successful deployment to ensure system stability, performance, and continuous improvement.

3.2 Technology Standards

Adhere to government and industry standards including Agile development, SDLC, and FDA's EPLC methodology, while delivering a modern, responsive web-based interface with omnichannel capabilities for seamless customer interactions. Built on a cloud-native, microservices-based architecture, the platform will ensure scalability, resiliency, and modular deployment, leveraging an enterprise API Gateway for secure system integrations, enterprise certificate management, and FDA IAM integration to support SSO and role-based access control. The solution will provide essential interoperability through connectivity with the Unified Intake Tool (UIT) for self-service escalation, real-time enterprise CRM data exchange, and downstream integration with FDA systems and data warehouses for enterprise-wide information flow, while incorporating secure cloud-based document management with access controls, retention policies, and auditability alongside enterprise-grade databases that support high-volume transaction processing and maintain data integrity, availability, and performance.

3.4 Capacity

Support high-volume operations with thousands of concurrent users while maintaining optimized response times that enables on-demand scaling of storage, processing, and user capacity. In addition, it should have monitoring and alerting capabilities that notify administrators when system components reach capacity for proactive resource management. The solution shall include backup and disaster recovery capabilities to ensure business continuity, auditing of critical business data elements in accordance with FDA security standards, centralized secure logging, and data archiving with audit trails to support regulatory compliance and operational transparency.

3.5 Accessibility and User Experience

Be accessible to domestic and international users with 24/7 availability, 99.95% system uptime, validation across standard web browsers, and an English-language user interface with multilingual capabilities to serve FDA's diverse stakeholder community. The platform will provide a single, intuitive point of entry through a 508-compliant, standards-based graphical user interface employing modern, responsive design with contextual guidance, workflow support for common actions, clear user feedback, online user guides, context-sensitive help, and training materials to support effective system use. Core functionality will include robust search capabilities, comprehensive input validation aligned to business rules, and complete record management features to enable efficient navigation, accurate data entry, and maintenance of data quality and integrity.

3.6 Security and Compliance

Comply with all U.S. Government requirements for Federal Websites and Digital Services, FDA security standards, and FISMA requirements, utilizing FDA SSO and identity management infrastructure to provide secure login mechanisms with appropriate session management and security controls. The platform will implement role-based access controls to accommodate various user roles and permissions, ensure the security and privacy of information, validate data readiness for appropriate release, and prevent unauthorized data disclosure, while all uploaded files will be scanned and validated with appropriate user messages to ensure file integrity and security compliance throughout all operations.

3.7 Development Approach and Methodology

The CCO solution will comply with all U.S. Government requirements for Federal Websites and Digital Services, FDA security standards, and FISMA requirements, utilizing FDA SSO and identity management infrastructure to provide secure login mechanisms with appropriate session management and security controls. The platform will implement role-based access controls to accommodate various user roles and permissions, ensure the security and privacy of information, validate data readiness for appropriate release, and prevent unauthorized data disclosure, while all uploaded files will be scanned and validated with appropriate user messages to ensure file integrity and security compliance throughout all operations.

3.8 Operations and Maintenance (O&M)

Following the transition from development activities, ongoing Operations and Maintenance (O&M) support will be required for the cloud-based application components, including monitoring and performance management, bug fixes and system maintenance, and scaling and capacity planning to accommodate growth and changing operational demands. Operational support services will encompass helpdesk support for user inquiries, user education and training, and troubleshooting and issue resolution to maintain system availability and performance, ensuring the Contact Center Optimization solution continues to meet FDA's operational requirements and delivers consistent, reliable service to all stakeholders throughout the system's lifecycle.

3.12 Transition Out

Establish a transition out plan following the period of performance expiration or when contract is terminated for the convenience of the Government, ensuring smooth transition of all contracted activities and services.

3.13 Performance Console

Provide comprehensive real-time analytics and dashboards that deliver actionable insights into contact center operations, customer engagement metrics, and system performance to support data-driven decision-making and continuous improvement. The dashboards will feature customizable visualizations and reporting capabilities that enable leadership and operational staff to monitor enterprise and tier-specific metrics including First Call Resolution (FCR), Mean Time to Resolve (MTTR), service level agreements, customer interaction trends, operational bottlenecks, and agent productivity across all channels and FDA centers. Built with role-based access controls and intuitive navigation, the dashboards will support strategic oversight and tactical management through drill-down capabilities, automated alerts for critical thresholds, exportable reports, and a continuous improvement framework to facilitate performance management, resource allocation, and stakeholder communication throughout the enterprise.

4. Constraints and Assumptions The following constraints and assumptions are incorporated into this project:

• All work completed by the contractor is owned and retained by the Government

• Nondisclosure and information security provisions are in force

• All development must comply with FDA security and architectural standards

• System must integrate with existing FDA infrastructure without disruption

• Solution must be scalable to support future expansion across FDA enterprise

• All deliverables must adhere to HHS 508-compliance requirements and FDA professional standards

5. Place of Performance The service-oriented goal is to have services performed at FDA facilities (White Oak Campus) and contractor facilities, with attendance at meetings in the Washington DC area as required.

Travel will be reimbursed per government travel regulations.

6. Desired Period of Performance The desired period of performance is five years, beginning August 3, 2026 through August 2, 2031, with a base period of twelve months and four additional option periods of twelve months each.

7. Proposed Contract Type The proposed contract type is a Firm-Fixed-Price contract.

8. Key Personnel The key personnel specified in this contract are considered essential to work performance:

Project Manager

• Extensive PM experience managing large business process and enterprise solution projects

• PMP certification recommended

• Agile software development certification required

Senior Business Analyst

• Demonstrated skills in enterprise architecture analysis and recommendations

• CBAP certification recommended

• Experience with Business Intelligence/Knowledge Management concepts

Senior Solution Architect

• Expert in architecting end-to-end application development projects

• Experience with enterprise architecture strategies

• Knowledge of cloud-based and hybrid solutions

Senior Test Manager

• Strong leadership in managing testing performance and deliverables

• Deep knowledge of various testing approaches

• Experience with test automation frameworks

Senior Contact Center Specialist

• Subject matter expert in contact center operations and optimization

• Experience with CRM systems and contact center technologies

• Knowledge of customer experience design and quality management

9. Government Furnished Equipment (GFE)/Government Furnished Information (GFI)

Item Description

PIV Badge PIV badge will be issued by security office, upon successful Level-5 security clearance

Laptop Computer

An FDA laptop, with standard FDA "image" will be provided. Laptop can only be accessed using PIV Badge

Network Access

Access to FDA network and relevant data systems

Software Licenses

Necessary software licenses and development tools

10. 508 Standard Requirements All electronic and information technology (EIT) must meet the applicable accessibility standards at 36 CFR 1194. The Contractor shall comply with Section 508 requirements to ensure that deliverables are fully Section 508-accessible.

11. Baseline Security Requirements Comply with all FDA security standards, FISMA requirements, and federal information security policies. All contractor personnel must obtain appropriate security clearances and complete mandatory FDA training before beginning work.

12. Other Pertinent Information or Special Considerations Observance of Legal Holidays & Other Government Closings

FDA personnel observe federal holidays as designated. Contractor personnel will not be able to perform on-site work during these holidays except for designated around-the-clock or emergency operations.

Organizational Conflict of Interest (OCI)

Ensure compliance with organizational conflict of interest requirements and shall not compete for or provide services that would create conflicts with this contract.

13. Appendix

13.1 Inquiries and Complaints Environment

Approximate annual contact (email, phone) for inquiries and complaints is 127,500 with the following breakdown by center:

***Tier 0 is not measured in these counts.

Tasks and CRM systems by center:

Tasks CDER CDRH HFP / Cosmetic CTP CVM CBER

Respond to general inquiries on the phone, email, snail mail, Intake complaints (adverse events, product quality, etc)

Intake Allegations - Whistleblower

Respond to regulatory questions

FDA.gov content development / management

External outreach (webinar, conference management, etc)

Professional Education

Customer Relationship Management

Salesforce, Appian Salesforce Salesforce

Potential Tobacco Product Violations Reporting (PTVR), Appian Outlook

BIT-COMP,

Excel

13.2 ERIC Environment

*Information forthcoming