Contact Center Optimization RFI with attachment.pdf

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov Page 1 of 12

Request for Information:

FDA Contact Center Optimization Initiative

October 6, 2025

Silver Spring, MD 20993 www.fda.gov Page 2 of 12

RFI Response Guidelines

This is a Request for Information (RFI) to determine available sources and their capability to provide the products or services described within this RFI. This request for information does not constitute a solicitation and is not an indication that the government will contract for any of the items and services discussed in this notice. Submission of a response to this RFI is entirely voluntary. The voluntary submissions of answers to this RFI shall not obligate FDA to pay or entitle the submitter of information to claim any direct or indirect costs, charges, or other compensation whatsoever.

Any information considered proprietary should be noted via appropriate markings. The government will use such information only to inform and support any potential solicitation and contract or for such other purposes as described within this RFI.

A complete response to the RFI should include answers to all the questions below. Additionally, responses should demonstrate capability not merely affirm the respondent's capability (i.e., the response must go beyond the statement that, "XYZ company can provide O&M support").

Additionally, interested parties responding to this RFI should adhere to the following instructions to facilitate FDA’s structured review:

Response Format: Please begin with a brief “Executive Summary” of your overall approach (no more than one to two pages). Thereafter, organize your response to correspond to the numbered topic areas listed in the “Information Requested” section above. You do not have to repeat the questions, but please label each section of your response with the corresponding topic name/number (e.g., 1. Company and Experience, 2. Functionality, 3. Data Migration, 4.Call Center, etc). This structure will help ensure all key objectives are addressed. Supporting diagrams or tables are welcome where they enhance clarity; they will count toward the page limit, except for an optional appendix as noted below.

Capability Statement and Company Information: Please provide a capability statement and the following information about your company (no more than one page):

o Company Name o Your Company’s Primary Business Product or Service Line o Commercial and Government Entity (CAGE) Code o Address Including Telephone Number and Email Address o Points of Contact o Size of Business Pursuant to North American Industry Classification System (NAICS)

Codes o If applicable, state whether your company is Small Business; Woman Owned Small

Business; Small Disadvantaged Business; 8(a) Certified; HUBZone Certified; Veteran Owned Small Business; or Service-Disabled Veteran Small Business; or a Large Business o Capability Statement

Page Limit: The response should be concise and focused, not exceeding 10 pages in total length (i.e., Letter Size: 8.5 by 11 inches, Font Size: 11 point and Font Type: Arial or Times New Roman). This limit does not include a cover page if you choose to include one or an optional

Silver Spring, MD 20993 www.fda.gov Page 3 of 12 appendix of up to 5 additional pages for supplemental material such as architectural diagrams, references, or case studies. FDA values quality of insight over quantity so please ensure all content is directly relevant to the RFI topics. The responses should provide specific and actionable information about your proposed solution.

Inquiries: Provide your questions about the RFI and associated materials via email to Min Jie Zeng at Minjie.Zeng@fda.hhs.gov and Lilibeth Deato at Lilibeth.Deato@fda.hhs.gov no later than 5:00 p.m. Eastern time (ET) on October 13, 2025, with the subject line “FDA Contact Center Optimization RFI Questions – [Your Company Name]”. In the email, include a primary contact name, title, organization, and contact information (phone number and email address) for any follow-up.

Submission: Provide your responses to this RFI via email to Min Jie Zeng at Minjie.Zeng@fda.hhs.gov and Lilibeth Deato at Lilibeth.Deato@fda.hhs.gov no later than 5 p.m.

ET on October 27, 2025, with the subject line “FDA Contact Center Optimization RFI Response

– [Your Company Name]”. In the email, include a primary contact name, title, organization, and contact information (phone number and email address) for any follow-up. Please make sure that the submission package and any associated attachments are compressed into one .zip file.

FDA’s electronic mail (email) file size limitation is 75 MB. However, FDA recommends sending smaller files to avoid sending and receiving issues. Optional: If your response includes any proprietary information, please mark each page containing proprietary content with “Proprietary” or a similar header/footer. Do not include any classified information in your response. FDA will treat all RFI responses as sensitive and use them solely for the purposes of this market research and planning.

Industry Day/Follow-Up: Based on the responses received, FDA may schedule in November 2025 for one-on-one meetings or technical exchanges with certain respondents to clarify understanding or gather additional insights. FDA may also use the information provided to help shape a future acquisition strategy or solicitation. Respondents are advised that the government may utilize non-government contractor support who are bound by nondisclosure agreements to review RFI responses for administrative purposes.

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FDA Contact Center Optimization Initiative

FDA seeks to rationalize and harmonize related processes, tools, and contact centers to provide deliver a unified, consistent, and resilient experience across the agency.

Introduction

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.

FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

The FDA recognizes the critical role that inquiries, complaints, and mandatory reports play in protecting public health, building public trust, and informing regulatory action. As a result, the Agency is committed to continually improving how it engages with the public, handles information, and coordinates across its Centers, Offices, and Programs.

The American people play an important public health role by reporting to FDA any adverse reactions, complaints, or other problems with products the agency regulates. A complaint is any voluntary submission to FDA alleging potential violation(s) of federal law, or an illicit or unsafe product or activity.

Mandatory reporting to FDA from regulated industry, includes various types of information from manufacturers, importers, and drug sponsors.

FDA uses more than 100 intake mechanisms and more than 20 different web-based structures to receive and process 200,000 inquiries and complaints every year. FDA seeks to rationalize and harmonize related processes, tools, and contact centers to provide deliver a unified, consistent, and resilient experience across the agency.

We seek to achieve this vision with the following three aims:

Decrease the risk to public health by detecting problems sooner.

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Improve the public’s trust in the Agency by improving the consumer experience.

Improve operational efficiency.

Consistent with Executive Order 14243, we intend to eliminate information silos to remove unnecessary barriers to data access. Consistent with Executive Order 14338, we intend to improve our service to the American people by streamlining and simplifying how the public reports problems to the FDA and learns about what we do. We will adhere to the 21st Century Integrated Digital Experience Act (IDEA), Public Law 115-336, focused on modernizing websites, digitizing services and forms, improving customer experience, and standardizing and transitioning to centralized shared services.

Purpose

The purpose of this Request for Information (RFI) is to gain a better understanding of, and potentially leverage, current and emerging industry capabilities to modernize FDA’s technology and service for information flow into and through the FDA. More specifically, FDA aims to gather insights from industry on solutions to achieve a modern, integrated, and secure approach to unified inquiry intake and information flow. To this end, FDA is seeking innovative approaches to contact centers and help desks.

It is important to note that lessons learned from past efforts and internal audits include the need for comprehensive planning, realistic cost/schedule estimates, robust testing, and strong oversight to inform FDA’s approaches.

FDA is issuing this RFI solely for information and planning purposes, and it does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. This RFI does not commit the government to contract for any supply or service whatsoever. Further, FDA is not at this time seeking proposals and will not accept unsolicited proposals. Responders are advised the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI. All costs associated with responding to this RFI will be solely at the interested party’s expense. Not responding to this RFI does not preclude participation in any future RFP, if any is issued.

Background – Current state and associated challenges

FDA’s mission-critical operations rely on a complex set of solutions over time, often developed in silos for specific programs or functions. Over time, this has led to a fragmented process and technology environment which are not fully integrated.

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. Some key challenges are:

FDA website is not consistently updated with latest policy, regulations, education, and general information leading to increased phone and email inquiries.

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Use of the Automated Call Distribution system is inconsistent, with most centers receiving phone calls directly. FDA receives approximately 127,500 calls every year routed to one of six centers that triage their own calls with limited resources who have multiple roles and responsibilities.

More mature triaging process and technology in some organizations compared to others; Plus, multiple platforms used as CRMs or to support specific or subsets of customer engagement workflow (e.g. Appian, Genesys, Salesforce, Service Now)

Though there is Agency-wide definition of inquiries and complaints, there are differences in how they are interpreted and triaged. Some of these differences are merited by the vast array of different inbounds received, Currently no organization is using a fully tiered call center approach.

Scope Immediate scope – Inquiries and Complaints

FDA seeks solutions for a structured tiered contact center and enterprise CRM system to support the integrated customer journey for inquiries and complaints raised to FDA.

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

o Conduct an inventory of public fda.gov sites, consolidate redundant COP (Center, Offices, and Programs) pages, and update content to better support self-service.

o Improve FDA digital content search functionality.

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

Tier 1-3 o Triage contacts at all steps, stages, or timepoints o Establish an enterprise Tier 1 call center to accommodate current and anticipated volume for all FDA COPs.

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

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

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

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

Enterprise CRM solution o Comprehensive case and ticket management o Customer relationship and contact management o Tiered support structure and escalation management

Silver Spring, MD 20993 www.fda.gov Page 7 of 12 o Regulatory compliance and security o Reporting, analytics, and performance management o Integration and interoperability, single sign-on o User experience and interface o Scalability and future enhancement o Training, support, and change management

Refer to attachment in Attachment section for high level business requirements on above scope.

Compatibility - Critical Integration Points o Seamless Tier 0 to Unified Intake Tool (UIT) Integration: The self-service platform must provide smooth escalation pathways when customers cannot resolve their needs independently, directing them seamlessly to the appropriate UIT submission process.

o UIT to CRM Integration: General inquiries requesting information or guidance must be routed to the enterprise Customer Relationship Management systems for assignment to appropriate FDA subject matter experts o CRM integration to downstream applications and data warehouses

A successful implementation will enable FDA to efficiently manage the high volume of stakeholder submissions while ensuring appropriate routing based on submission type, content urgency, and regulatory implications.

Long-term scope – Tiered contact center and enterprise CRMs across FDA

In addition to establishing a structured tiered contact center and enterprise CRM solution for inquiries and complaints, there is also a need to establish the same for the wider FDA. It is imperative the solutions being implemented for inquiries and complaints can be expanded and scalable to support other existing contact centers, help desk, or new contact centers yet to be formally established.

For example, the FDA Office of Information Management Technology (OIMT) provides centralized information technology management, services and support to the approximately 23,000 FDA employees and contractors worldwide. Internal FDA users (including FDA contractors) are typically accessing the applications to process or report on submitted information.

User support can be requested 24 hours a day, 7 days a week, 365 days a year through the 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. IT Help Desk support falls within ERIC which includes Tier 1/IT Call Center, Tier 2 Desk Side Support, and Systems Admin Support. Application Help Desk as well as travel management and financial

Silver Spring, MD 20993 www.fda.gov Page 8 of 12 management support can also be obtained through ERIC. Technical support requests have a variety of intake methods such as phone, fax, email, chat/IM or self-service ticketing though a common support platform (currently ServiceNow).

Technical support is provided to FDA employees across six regions in the United States: Mid- Atlantic, Northeast, Southeast, Southwest, Central, and Pacific. Because of the geographical dispersion of the FDA user base, user support is typically provided almost entirely by phone and personal computer (PC)-to-PC remote control while some more complex issues may require physical Desk Side services support.

Out of scope

Unified Intake Tool (UIT): When self-service options cannot address public stakeholder needs, users navigate to the online UIT form to submit formal inquiries or complaints. The UIT accepts submissions through both web-based forms and email channels, providing a centralized entry point that will consolidate the existing 20+ webforms across FDA. Note: UIT requirements have been completed, and the tool is currently in development.

Seamless UIT Integration with Downstream Systems:

UIT to adverse event system integration: Complaints alleging potential violations of federal law or unsafe products/activities can be submitted anonymously, must be captured in the enterprise Customer Relationship Management system, and automatically routed to the Adverse Event Management System for appropriate safety evaluation and regulatory response.

Not included are systems for industry submissions, data storage or analytics, publishing, regulatory review and assessment management, or inspections and compliance management. Concurrent modernization in these areas is underway.

Note: While out of scope, the solution should be designed to offer future possibility to integrate.

Guiding Questions for FDA’s Future State Needs

FDA invites interested vendors, technology integrators, and other experts to provide information, ideas, and recommendations on how to modernize, consolidate or create FDA’s contact centers to include an enterprise CRM to address the current challenges and meet the scope described in this RFI.

Respondents should feel free to propose innovative solutions, architectures, and approaches. FDA is particularly interested in understanding from respondents how a solution-based approach would handle the inherent complexity of FDA’s siloed contact centers with varied technical solutions and whether such an approach envisions a complete rebuild (i.e., greenfield approach), an incremental modernization of existing components, or a hybrid approach. Your architectural approach must be expandable, to include areas we have not considered.

Please base your responses on the information noted in this RFI and your knowledge of best practices and successful case studies in modernizing large-scale government or commercial contact centers

Silver Spring, MD 20993 www.fda.gov Page 9 of 12 while ensuring business continuity FDA personnel (internal users) and non-FDA personnel (external users). FDA is also interested in gaining insights even if Respondents are not experts in addressing all of scope stated in this RFI but have a novel idea or strategy on how we could integrate or fix a certain component of the problems.

Specifically, FDA is seeking input on the following areas:

1. Experience

a. Do you have any experience implementing similar solutions for federal agencies? If so, which agency/agencies? How long ago was the implementation?

b. If you have not implemented a similar solution at federal agencies, but in the private sector, then describe which industry (or industries)? How long ago was the implementation? Is this still an existing client(s)? What is that client’s current contact center volume and complexity (call types, channels, peak periods, etc.)?

c. How many of your existing full-time staff has experience in implementing a structured tiered contact center and enterprise CRM solutions? Will all of them be assigned on a full-time basis to support this? If not, how many will be assigned and what would be their roles and responsibilities? How many years of experience does each resource have?

d. Do you use any subcontractors or third-party partners to provide your solution? If so, please describe them.

i. Note: While FDA is not committed to an execution approach or procurement strategy at this stage, we are interested in governance models that ensure unity of vision. We favor lead system integrator models with or without system responsibility. This requires the integrator to be responsible for the overall technical integration and successful delivery of a complex system of systems, requiring a holistic, strategic approach to ensure interoperability, performance, and adherence to overall requirements.

2. Functionality

a. How does your solution handle omnichannel communication (phone, email, chat, social media)?

b. What workflow automation, case routing, and escalation management features are available? Describe, with visual diagrams, how you can automate and customize workflows for different tiers including automatic escalation rules and internal notifications.

c. Describe how your system can route customer inquiries or complaints to different tiers of agents

d. How does the interface provide a seamless agent experience, including the ability to hand-off to a higher tiered agent with full context?

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e. Describe reporting, analytics, and performance monitoring capabilities for overall and each tier

f. What knowledge management and self-service options does your platform provide?

g. Does your solution leverage AI? If so, how is it used and what are the core benefits? By how much will it reduce call volumes or emails?

h. In addition to the requirements outlined for Tier 0, what other improvements and/or features do you propose for Tier 0? Why and what are the benefits?

i. Do you recommend a CRM solution built from ground up? Or a consolidated CRM solution based on one or more of the platforms in use by FDA? For either recommendation, describe why, what are the benefits, and disadvantages.

j. Where will the solution/product be hosted?

i. What is the total cost of ownership considerations including maintenance and support?

k. How is the solution/product licensed?

i. Provide detailed pricing models (per-user, per-interaction, enterprise licensing)

3. Data Migration

a. Whether CRM solution is built from ground up or consolidated, what is your data migration approach?

b. What is your process for data cleansing and de-duplication? What tools do you use?

c. What is your approach to bringing on stakeholder groups/teams who do not currently utilize a contact center (they have a manual process and/or utilize basic tools such as MS Excel and email)?

d. How will your tool handle bad or invalid data without causing migration process to fail?

e. What is your validation approach to ensure all data has been accurately migrated?

f. How will you decommission or transition away from legacy systems and migrate data with minimal disruption?

4. Call Center

a. Can you describe the team structure, including their roles, skills and languages supported? What are the qualifications of the team members?

b. How many agents will be required for Tier 1? Provide breakdown on number of full-time agents vs part-time agents. Also, provide breakdown of agents by shifts.

c. Where do you propose the call center to be setup? At FDA site? Or off-site (must be in the continental US)?

d. Will the call center agents be co-located?

e. What percentage of your new hires from employee referrals?

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f. What is your average tenure of salaried staff? Hourly staff?

g. What is your average agent attrition rate?

h. How do you manage ongoing training and development for your agents?

5. Technical Architecture and Integration

a. How does your proposed solution integrate with existing FDA systems and databases?

b. What is your integration approach?

c. What APIs, middleware, or integration platforms does your solution support?

d. Describe your solution's scalability, redundancy, and disaster recovery capabilities

e. What are the technical requirements for deployment (cloud, on-premise, hybrid)?

f. What technology stacks are included in your architecture?

6. Security

a. Cloud Environment Compliance:

i. Responses must confirm solution(s) comply with FedRAMP Assessment and

Authorization (A&A) requirements with a valid FedRAMP approved authority to operate (ATO)

ii. Responses must include Documentation of FedRAMP authorization for cloud-based services including Software-as-a-Service (SaaS), Infrastructure-as-a- Service (IaaS), and Platform-as-a-Service (PaaS).

b. Zero Trust Architecture (ZTA):

i. Provide details on how your solution supports ZT principles, including:

1. Continuous verification of user and device identities.

2. Least privilege access enforcement.

3. Micro-segmentation and secure access to resources.

c. Compliance with Federal Standards:

i. Responses must confirm compliance with applicable federal cybersecurity standards, including:

1. Federal Information Security Modernization Act (FISMA)

2. National Institute of Standards and Technology (NIST) Special

Publication 800-53 and 800-210.

d. Describe your approach to vulnerability management and security monitoring

7. Implementation

a. What is your implementation approach? – single release or phased releases? For either implementation approach, provide a roadmap with a SDLC breakdown of key activities, deliverables and milestones.

i. For single release, what is the projected timeline and estimated cost?

ii. For phased approached:

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1. How many phases? What is the proposed scope/feature set for each phase? What is the projected timeline for each phase? What is the estimated cost for each phase?

b. What change management support do you provide during the transition to new solution?

8. Support and Maintenance

a. Is there Hypercare post deployment? If so, what services are provided and for how long?

b. Post Hypercare, what ongoing technical support and maintenance services do you provide?

c. Describe your service level agreements and response time commitments

d. How do you handle system updates, patches, and feature enhancements?

e. What backup and business continuity services are included?

9. Training

a. Describe your training and onboarding process for new users, including materials and resources provided

b. How does the solution support agent productivity and performance management?

c. What customization options are available for different user roles and departments?

10. Governance

a. Describe guidance and best practices that should be established in governing contact centers and enterprise CRM solutions. Key areas are:

i. Accountability and enforcement of processes

ii. Management of change requests – defects, maintenance and enhancements

iii. Data stewardship

iv. Escalation management

v. Ongoing strategic vision and planning

Attachment

Attachment 1 - Contact Center Optimization High Level Business Requirement

FDA

CONTACT CENTER OPTIMIZATION TIERED

STRUCTURE WITH ENTERPRISE CRM:

HIGH-LEVEL BUSINESS REQUIREMENTS

Attachment 1

Background The FDA receives approximately 200,000 voluntary inquiries and complaints annually from external sources, including but not limited to regulated industry, healthcare professionals, and consumers regarding illicit or unsafe products or activities, potential federal law violations, and requests for regulatory information or food and medical product safety reporting, etc.

For the scope of this RFI, FDA is looking for consolidation of workflows for voluntary intake/communications vice regulated industry intake/communications:

• Voluntary intake/communications: direct engagement with the public and external stakeholders, including but not limited to consumers, health care professionals, media, Congress, other government agencies, academia, and special interest groups

• Regulated industry intake/communications: direct engagement with FDA regulated industry, including but not limited to mandatory AE reporting workstreams, Emergency Response delays, Drug Shortage notifications, Counterfeits, Reg communication delays, Field Alert reports received through Center specific intake/workstreams. etc.

Current Process Overview The FDA customer journey for inquiries and complaints begins through multiple intake channels including webforms, email, postal mail, and telephone calls. Currently, the agency operates over 20 separate webforms across different program areas, creating a fragmented stakeholder experience that requires consolidation and streamlining.

System Architecture and Integration Requirements

• Tier 0 - Self-Service Component: Customers access self-service resources on fda.gov to independently resolve inquiries through searchable knowledge bases, FAQs, video tutorials, and automated resource identification tools. This tier serves as the initial point of contact to reduce volume requiring human intervention.

• Unified Intake Tool (UIT): When self-service options cannot address stakeholder needs, users navigate to the UIT form to submit formal inquiries or complaints. The UIT accepts submissions through both web-based forms and email channels, providing a centralized entry point that will consolidate the existing 20+ webforms across FDA. Note: UIT requirements have been completed and the system is currently in development.

Critical Integration Points

• Seamless Tier 0 to UIT Integration: The self-service platform must provide smooth escalation pathways when customers cannot resolve their needs independently, directing them seamlessly to the appropriate UIT submission process.

• Seamless UIT Integration with Downstream Systems:

o UIT to AEMS Integration: Complaints alleging potential violations of federal law or unsafe products/activities must be automatically routed to the Adverse Event Management System for appropriate safety evaluation and regulatory response o UIT to CRM Integration: General inquiries requesting information or guidance must be routed to Customer Relationship Management systems for assignment to appropriate FDA subject matter experts

Scope of Current RFI This RFI seeks solutions for Tier 0 self-service capabilities and CRM system requirements to complete the integrated customer journey. The UIT component, while referenced for integration purposes, has completed its requirements phase and is currently under development.

The successful implementation of these integrated systems will enable FDA to efficiently manage the high volume of stakeholder submissions while ensuring appropriate routing based on submission type, content urgency, and regulatory implications.

Enterprise Contact Center Tier 0 Self-Service Creating a comprehensive ecosystem of self-service resources empowers regulated industry, healthcare professionals, and consumers to resolve inquiries quickly and independently. By building a robust knowledge base, utilizing AI assistants, incorporating video tutorials, and continuously optimizing self-service channels, FDA can reduce the burden on contact center staff while delivering faster, more satisfying experiences for those seeking FDA information and guidance.

With these tools in place, the FDA inquiries and complaints process can scale effectively to handle the approximately 200,000 annual submissions, saving both time and resources while ensuring that stakeholders feel supported and can access the regulatory information they need.

Key Self-Service Components for FDA:

• Comprehensive FAQ and Knowledge Base with Regular Updates: Clear, searchable content with step-by-step guides for common questions

• Video Content and Tutorials: Visual guidance for complex regulatory processes, submission procedures, and compliance requirements as well as system tutorials

• Clear/easy URL address for the Universal Intake Tool: Clear, searchable URL address to the Unified

Intake Tool (UIT).

This approach supports the FDA's mission to protect public health while efficiently managing the high volume of inquiries and complaints through the Unified Intake Tool and broader customer journey process.

Enterprise Contact Center Tier 1

1. Organizational Structure and Staffing

• Consolidation of Tier 1 into one organization: All Tier 1 support functions must be unified under a single organizational structure to ensure consistency and streamlined operations.

• Staffing model assessment: Vendor must provide assessment and recommendations on the optimal balance between FDA Full-Time Employees (FTE) versus contract support, including specific percentages for each resource type.

• Geographic distribution analysis: Vendor assessment required on the optimal locations for Tier 1 resources to ensure effective coverage and operational efficiency.

• Time zone coverage evaluation: Vendor must assess and recommend time zone coverage for receiving responses from Tier 1 resources to ensure appropriate customer service availability.

2. Customer Communication Standards

• Standardized FDA training, scripts, and communications: Implementation of standardized FDA training, scripts, and communication templates for responses to both inquiries and complaints to ensure consistent messaging and quality.

• Preparedness and Response protocols: Establishment of uniform preparedness and response procedures that align with FDA's regulatory mission and public health objectives.

3. Case Management and Tracking

• Inquiry and complaint tracking system: Comprehensive tracking capabilities for all inquiries and complaints processed through Tier 1.

• Unique identifier assignment: Each inquiry and complaint must receive a unique identifier for tracking and reference purposes.

• Customer notification and tracking capability: Future potential requirement to inform customers of their unique identification number for self-tracking.

• Query and viewing capabilities: Ability to search, query, and view details of each inquiry and complaint within the system.

• Multi-faceted case management: Ability to break down multi-faceted inquiries or complaints for multiple workstreams

4. Data Integration and System Connectivity

• CRM and AEMS synchronization: Seamless data integration and synchronization between the

Customer Relationship Management system and the Adverse Event Management System (AEMS).

• Record management: Comprehensive tracking and management of records within the CRM, including detailed logging of notes and interactions, ensuring FOIA requirements are met.

• UIT integration assessment: Vendor must assess how to incorporate the Unified Intake Tool (UIT) into Tier 1 processes, including data synchronization and harmonization requirements.

5. Performance Monitoring and Reporting

• Metrics and reporting capabilities: Robust reporting functionality to track Tier 1 performance metrics and operational efficiency.

• Activity logging: Comprehensive logging of all Tier 1 activities for performance analysis and quality assurance.

Enterprise Contact Center Tier 2 FDA Centers’ Technical Specialists

1. Organizational Structure and Staffing

• Structured specialist organization: Transform the current "pool of resources" into organized teams with clear specialization areas aligned with FDA program centers (CDER, CBER, CDRH, CFSAN, etc.).

• Cross-training matrix: Develop capabilities for specialists to handle multiple but related subject areas to provide flexibility during peak demand periods or staff unavailability.

• Escalation capacity management: Maintain appropriate staffing levels to handle escalated cases without creating bottlenecks in the customer journey process.

• Geographic and time zone coverage: Ensure specialist availability across time zones to support urgent technical inquiries and maintain service level agreements.

2. Advanced Case Management

• Complex case handling workflows: Specialized processes for managing intricate regulatory inquiries that require detailed analysis, research, or multi-departmental coordination.

• Case collaboration tools: Enhanced functionality for working on cases that span multiple FDA centers or require input from various subject matter experts.

• Research and investigation capabilities: Tools for conducting in-depth regulatory research, accessing technical databases, and compiling comprehensive responses to complex inquiries.

• Case documentation standards: Enhanced documentation requirements including technical analysis, regulatory citations, detailed rationale for recommendations provided, and clearance history.

3. Subject Matter Expertise Management

• Specialization tracking: System capabilities to track and leverage individual specialist expertise across specific regulatory areas, product types, or industry sectors.

• Knowledge contribution tools: Mechanisms for specialists to contribute to the knowledge base, update FAQs, and share insights from complex cases to benefit Tier 1 operations.

• Continuing education management: Advanced training tracking for maintaining current expertise in rapidly evolving regulatory landscapes and emerging technologies.

• Expert consultation networks: Integration with external expert networks and inter-agency coordination capabilities for highly specialized inquiries.

4. Advanced Analytics and Decision Support

• Predictive case complexity assessment: Tools to identify cases that may require Tier 3 escalation based on content analysis, stakeholder profile, and historical patterns.

• Regulatory precedent database: Access to historical decisions, guidance interpretations, and case law to ensure consistent and well-informed responses.

• Impact assessment tools: Capabilities to evaluate the broader implications of responses and recommendations before final delivery to stakeholders.

• Cross-reference verification: Automated tools to verify consistency of advice with existing FDA guidance, regulations, and previous agency positions.

Tier 3 Requirements: Expert Level (SME MAPPs for Centers)

1. Expert Resource Management

• Center-specific expertise mapping: Clear identification and organization of subject matter experts aligned with each FDA center's mission and regulatory authority.

• Expert availability and scheduling: Advanced scheduling and consultation management systems to optimize access to limited expert resources.

• Succession planning: Knowledge transfer protocols and mentorship programs to ensure continuity of expert-level support as staff retire or transition.

• Cross-center collaboration: Enhanced coordination mechanisms for cases requiring expertise from multiple FDA centers or involving overlapping jurisdictions.

2. Strategic Case Handling

• High-impact case management: Specialized workflows for handling Congressional inquiries, media requests, industry precedent-setting questions, and inter-agency coordination matters.

• Policy interpretation and development: Tools supporting experts in providing authoritative interpretations of regulations and contributing to policy development processes.

• Crisis and emergency response: Rapid response capabilities for public health emergencies, product recalls, or other urgent situations requiring expert intervention.

• Stakeholder relationship management: Enhanced CRM capabilities for managing relationships with key industry leaders, professional organizations, and government officials.

3. Advanced Knowledge Management

• Expert knowledge capture: Sophisticated tools for documenting expert decisions, rationale, and precedents to build institutional knowledge and ensure consistency.

• Regulatory guidance development: Integration with FDA's guidance development processes, allowing experts to contribute insights from stakeholder interactions to policy formation.

• Training and mentorship tools: Platforms for experts to provide advanced training to Tier 1 and Tier

2 staff, sharing specialized knowledge and regulatory insights.

• External consultation management: Systems for coordinating with external advisory committees, academic experts, and international regulatory counterparts.

4. Compliance and Quality Assurance

• Expert review and approval workflows: Multi-level review processes for responses that could establish regulatory precedents or have significant policy implications.

• Regulatory consistency validation: Advanced tools to ensure all expert responses align with current agency positions and don't create conflicting interpretations.

• Documentation and audit trails: Enhanced record-keeping requirements for expert-level decisions to support regulatory transparency and accountability.

• Legal and policy coordination: Integration with FDA's legal and policy offices to ensure responses comply with statutory requirements and agency priorities.

Cross-Tier Integration Requirements

1. Seamless Escalation and De-escalation

• Intelligent routing algorithms: AI-powered systems to determine optimal escalation paths based on case complexity, stakeholder importance, and subject matter requirements.

• Handoff documentation standards: Comprehensive transfer protocols ensuring complete case context preservation during tier transitions.

• Collaborative case management: Tools enabling multiple tiers to work simultaneously on complex cases while maintaining clear ownership and accountability.

• Performance impact tracking: Metrics to monitor how escalation and de-escalation patterns affect overall system efficiency and customer satisfaction.

2. Knowledge Sharing and Continuous Improvement

• Cross-tier learning platforms: Systems enabling knowledge flow from expert tiers back to frontline staff through case studies, lessons learned, and best practices sharing.

• Feedback loops: Mechanisms for Tier 3 experts to provide guidance on improving Tier 1 and Tier 2 capabilities and reducing unnecessary escalations.

• System optimization analytics: Data analysis tools to identify patterns in escalation triggers and develop strategies for resolving more cases at lower tiers.

• Innovation and process improvement: Collaborative platforms for all tiers to contribute ideas for system enhancements and operational improvements.

3. Performance Management Across Tiers

• Tier-specific metrics: Customized KPIs for each tier reflecting their unique roles and responsibilities within the overall customer service ecosystem.

• Cross-tier collaboration metrics: Measurements of how effectively the tiers work together to achieve overall customer satisfaction and regulatory compliance goals.

• Resource optimization: Analytics to ensure appropriate case distribution across tiers and identify opportunities for efficiency improvements.

• Strategic planning support: Data and insights to inform long-term staffing, training, and technology investment decisions across all support tiers.

High-Level Business Requirements for Enterprise CRM

1. Multi-Channel Communication Management

• Unified Communication Hub: The system must support integrated handling of all communication channels including emails, mails, phone calls, web, social media, and web portals within a unified workflow framework

• Automated Channel Routing: Implement intelligent routing capabilities that automatically direct communications to appropriate teams based on source, content type, stakeholder classification

(consumer vs. industry), and predefined business rules

• Channel-Specific Features: Support channel-specific requirements such as telephone system integration with FDA's Automated Call Distribution (ACD), email template management with rich text capabilities, and physical mail digitization workflows (future)

2. Comprehensive Case and Ticket Management

• End-to-End Lifecycle Management: Manage complete inquiry lifecycles from initial receipt through final resolution, including automated case identification generation with customer details, subject matter, and contact information

• Workflow Automation and Routing: Implement sophisticated workflow capabilities with automated assignment, escalation procedures, approval workflows, and alert notifications for designated personnel

• Status Tracking and History: Provide comprehensive tracking of case statuses (open, closed, pending), complete historical information including dates, creators, editors, and full interaction history linked to customer profiles

• Integration Capabilities: Interface seamlessly with existing FDA systems such as Microsoft Outlook active directory, Salesforce platforms, and specialized FDA applications

3. Knowledge Management and Repository

• Centralized Knowledge Base: Establish a unified repository containing questions, answers, regulatory guidance, food safety information, dietary supplements data, cosmetics information, and other relevant resources accessible across all departments

• Content Management System: Provide comprehensive content management capabilities including creation, editing, deletion, storage, viewing, and dissemination with proper version control, approval workflows, and content categorization

• Advanced Search and Retrieval: Enable sophisticated search functionality across all fields, content types, and knowledge areas with support for keyword tagging, category-based searches, and intelligent content recommendations

4. Customer Relationship and Contact Management

• 360-Degree Customer View: Maintain comprehensive customer profiles with complete contact history, previous inquiries, and interaction tracking across all communication channels with the option for anonymity, if selected

• Stakeholder Classification: Support clear differentiation and specialized handling for various stakeholder types including consumers, industry representatives, government officials, Congress members, media/trade press inquiries, and foreign regulators

• Contact Data Management: Provide robust contact information management including phone numbers, email addresses, physical addresses, and integration with existing FDA contact databases

5. Tiered Support Structure and Escalation Management

• Multi-Level Support Framework: Implement a structured tiered support system with clearly defined levels including Level 1 (General Information Specialists), Level 2 (Technical Specialists), and Level 3

(Expert)

• Case Routing, Escalation, and Notification: Implement the ability to route and escalate inquiries to appropriate support tiers and send email notifications

• Performance Metrics by Tier: Track and report tier-specific performance metrics including case resolution times, escalation rates, knowledge utilization, and workload distribution to optimize support efficiency

• Specialized Escalation Paths: Support specialized escalation procedures for high-priority scenarios including Congressional inquiries, media requests, adverse event reports, regulatory violations, inter-agency coordination requirements, whistleblower complaints, GAO audit requests, writing campaigns, security threats, and emergency IND requests

• De-escalation and Case Return Capabilities: Provide mechanisms for returning cases to lower tiers when appropriate, with complete audit trails and handoff documentation to ensure continuity of service

6. Regulatory Compliance and Security

• Security and Access Control: Implement role-based access controls with varying privilege levels, PII encryption capabilities, PIV security integration where required, and compliance with FDA security guidelines

• Regulatory Compliance Features: Support multiple Standard Operating Procedures (SOPs), handle specialized requirements such as eIND workflow management, inadvertent disclosure protocols, and inter-agency coordination procedures

• Audit and Documentation: Maintain comprehensive audit trails for all interactions, document storage and retrieval capabilities, and compliance reporting functions

• Disaster Recover and Continuity of Operations (COOP): Ensure system outages and recovery align with best practices, ensuring continuity of operations that follow scripted procedures for various scenarios such as system outages, government shutdowns, etc.

• Staff identity masking: Replace real names with system-generated codes or identifiers that cannot be traced back to individual staff members

7. Reporting, Analytics, and Performance Management

• Comprehensive Reporting Suite: Generate productivity reports, performance metrics, staff analytics, question types/volumes analysis, entity contact statistics, and trend analysis with flexible date range options

• Advanced Analytics: Provide data analysis tools for trend identification, process improvement support, and predictive analytics to enhance operational efficiency

• Customizable Dashboards: Offer intuitive dashboard functionality for different user roles including agents, supervisors, and senior management with real-time performance monitoring

• Management Oversight Tools: Enable senior management to analyze trends, monitor operations across all channels, and support strategic decision-making through comprehensive metrics

8. Integration and Interoperability

• External System Integration: Connect with existing FDA systems such as ACD, Computer Integrated Call

(CIC) system, SharePoint sites, and other agency databases

• Cross-Platform Compatibility: Support integration with Salesforce platforms, Microsoft Office suite, and other enterprise applications used across FDA divisions

• API and Data Exchange: Provide robust API capabilities for data exchange with external systems and support for future integrations

9. User Experience and Interface

• Unified User Interface: Deliver a consistent, intuitive interface for handling multiple communication types with quick access to relevant procedures, templates, and tools

• Self-Service Capabilities: Support future implementation of public web portals allowing external users to access knowledge repositories and submit inquiries

10. Training, Support, and Change Management

• Comprehensive Training Program: Develop and maintain user guides, training materials, PowerPoint presentations, and ongoing technical support resources

• User Adoption Support: Provide change management support, user…