RFI for Task Management Tool (FDA-RFI-2026-131587).pdf

Request for Information (RFI):

Commercial Off-the-Shelf (COTS) Task Management Tool (TMT)

October 24, 2025

1. PURPOSE and SUBMISSION GUIDELINES

The purpose of this request for information is to obtain technical and/or business information and input from the marketplace for project planning purposes regarding the availability of existing or potential solutions, pursuant to FAR Part 10 Market Research, to identify potential parties from the marketplace capable of providing Task Management Tools.

This is a REQUEST FOR INFORMATION ONLY. It 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 Government is not responsible for any cost incurred by stakeholders in furnishing information. All costs (time/material/services) associated with responding to this RFI will be solely at the interested stakeholder's expense. Not responding to this RFI does not preclude participation in any future RFI, Vendor Day, or RFQ, if any are issued. Any information submitted by stakeholders to this RFI is strictly voluntary. All submissions will become Government property and will not be returned. The Government reserves the right to request clarifying remarks from RFI submissions. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Federal Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). The RFI does not commit the Government to award a contract now or in the future for any supply or services whatsoever. Furthermore, the FDA will not accept unsolicited proposals.

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.

The FDA will use the results of the market research to determine if sources capable of satisfying the agency's requirements exist based on its response to the information requested in this notice.

The FDA does not intend to make a selection decision or award a contract on the basis of responses.

Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this RFI with any interested parties. However, FDA reserves the right to contact vendors if additional information is required.

For purposes of the RFI, the response shall not exceed 8 pages of text; graphics, tables, diagrams, and spreadsheets do not count toward the page limit. The document(s) shall be prepared using Times New Roman 12-point font style for printing on 8.5 X 11-inch paper. Each page shall identify the submitting respondent and page number. Page Margins shall be no less than 0.5” on all sides.

A complete response to the RFI should include answers to all the information requested. Please note that a respondent’s failure to provide a complete response to the information requested will be interpreted to mean that it does not understand what information is being requested and does not demonstrate the capability to meet the requirement. 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”).

Please provide the following information about your company on the cover page (no more than one page and not counted toward the 8-page limit):

o Company Name o Your Company’s Primary Business Product or Service Line o Commercial and Government Entity (CAGE) Code o Unique Entity Identifier (UEI) number 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 GWAC contract number: if your company has any NASA SEWP, GSA, NITTAC, or other GWAC contract through that the Government can buy the proposed solution, please provide the contract number and the expiration date and any option.

RFI Question Due Date/Time: 5PM EST, 10/31/2025 Email questions to Min Jie Zeng at minjie.zeng@fda.hhs.gov and Lilibeth Deato at lilibeth.deato@fda.hhs.gov.

RFI Response Due Date/Time: 5PM EST, 11/15/2025 Email responses to: Min Jie Zeng at minjie.zeng@fda.hhs.gov and Lilibeth Deato at lilibeth.deato@fda.hhs.gov.

Please include the RFI number FDA-RFI-2026-131587 - Commercial Off-the-Shelf (COTS) Task Management Tool (TMT) in the subject line of your email. In the email, include a primary contact name, title, organization, and contact information (phone number and email address) for any follow-up. No phone calls will be accepted for this notice.

2. INTRODUCTION

The U.S. Food and Drug Administration (FDA) is seeking information from qualified vendors regarding Task Management Tool solutions that can support an enterprise-wide need for effective task management. Effective task management is critical for FDA’s operational success, ensuring that teams can track assignments, automate workflows, and maintain visibility into project progress.

FDA seeks a solution that provides a robust set of capabilities across the organization through the analysis of FDA’s predominant needs and primary use cases listed in the following sections.

3. OBJECTIVES

1. Vendor Identification: Identify vendors offering comprehensive enterprise Task

Management Tools and solutions, including licensing, and support, and documentation.

2. Gather information on how the tools can support effective task management, and with minimum effort and cost.

3. Scalability and Security: Evaluate tools for scalability, security, and seamless integration.

4. Total Cost of Ownership (TCO): Analyze cost-effectiveness, advantages, and drawbacks of various solutions.

4. BACKGROUND

The approximately 20,000 federal and contractor staff at FDA are responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

Our national and global operations are also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, affordable, and by helping the public get the accurate, science-based information they need to use medicines and foods that maintain and improve their health. Additionally, the FDA has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. Globalization and the explosion of digital information pertaining to regulated industries has challenged the FDA to manage and utilize its information to meet its regulatory and scientific mission more effectively.

The FDA aims to implement an efficient task management tool to more effectively manage the thousands of requests for information and responses to inquiries from the public, industry, and Congress.

5. SCOPE OF INFORMATION REQUESTED

Vendors are encouraged to provide details on the following capabilities within their COTS task management solutions.

Functional Requirements

5.1 Advanced Task Creation & Management

• Ability to create tasks with predefined templates or ad-hoc entries.

• Allow efficient creation of tasks with customizable workflows.

• Support point-and-click assignment of tasks to individuals or teams.

• Enable breakdown of tasks into subtasks.

• Task priority settings (high, medium, low).

• Role-based access control for assignments.

• Customizable statuses (e.g., Not Started, In Progress, Completed, Blocked).

• Recurring task scheduling.

• Provide clear accountability and tracking mechanisms.

5.2 Configurable Workflows & Automation

• Support the creation and configurability of automated workflows.

• Support for complex approval workflows and inter-office collaboration.

• Provides pre-built templates for common processes and configurable templates for repetitive processes.

• Ability to configure workflows to suit different FDA Offices’ needs.

• Enable automated task routing and approvals.

• Conditional triggers for task progress (e.g., auto-assign next task based on completion of previous tasks).

• Automated notifications for task updates, deadlines and reminders.

• Integration with approval workflows for critical tasks.

• Task dependencies and hierarchies (parent-child relationships).

• Five-Phase Workflow Model: Support for structured workflow phases (i.e., Create, Assign

Team, Assign Tasks, Complete Tasks, Close Record).

• Parallel and Sequential Task Processing: Flexibility to configure tasks that run simultaneously or in sequence based on business needs.

• Dynamic Team Assignment: Ability to assign entire teams to records/projects with subsequent individual task distribution.

• Low-Code/No-Code Configuration: Ability to modify drop-down menus, task types, and workflows without developer involvement.

• Office-Specific Configuration: Configurable workflows and fields that can be tailored to different FDA offices while maintaining enterprise consistency.

5.3 Collaboration & Communication

• Commenting and discussion threads within tasks.

• File attachments and document linking.

• Real-time updates and shared task views.

• Integration with messaging apps (Microsoft Teams).

• Ability to interface with FDA Consolidated Contact Center for triage and assignment.

• Live Document Editing: Real-time collaborative document editing capabilities within the task management environment.

• Contextual Commenting: In-line commenting and discussion capabilities tied to specific tasks and documents.

• Cross-Office Collaboration: Support for collaboration across different FDA Office/Centers.

5.4 Reporting & Analytics

• Custom dashboards for tracking task progress and workload distribution.

• Custom dashboards for different user roles.

• Exportable reports in multiple formats (PDF, Excel, CSV).

• Performance tracking (completion rates, overdue tasks).

• Real-time reporting on task progress and performance.

• Drill-down capabilities for detailed task analysis.

• Support creation of audit trails for compliance tracking.

• AI-based insights for optimizing task management efficiency.

5.5 Granular User Management & Integration

• API support for third-party software integration.

• Compatibility with Jira, Salesforce, and ServiceNow.

• Single Sign-On (SSO) integration with Active Directory/LDAP.

• Permission based access at the task, reporting, and admin level.

• Mobile app availability for task management on the go.

5.6 Audit Trails & Digital Certificates

• System generated digital certificates for task approvals and document validation. Digital certificates are needed for content that leaves the system and shows a valid signature by FDA.

• Digital certificates should be at the server level, not document level.

• Compliance with federal and industry standards (e.g., NARA, ESIGN Act, UETA, and FDA

Title 21 CFR Part 11).

• Multi-factor authentication (MFA) for digital certificate authorization.

• Audit trails and timestamping to track approval history.

• Role-based digital certificate permissions to ensure controlled access to critical approvals.

5.7 Advanced Search & Discovery Capabilities

• Federated Search: Ability to search across multiple enterprise systems simultaneously (SharePoint, Teams, ServiceNow, Outlook) from within the task management interface.

• Assist Search: AI-powered automatic analysis of current task data to surface relevant historical tasks without user prompting.

• Global Task Search: Enterprise-wide search capabilities for leadership oversight and instant access to task information across all organizational units.

• Data Lake Connectivity: Integration with enterprise data lakes for enhanced reporting and analytics capabilities.

• Cross-System Data Correlation: Ability to pull and correlate data from multiple FDA systems within task context.

• Enhanced Visualization: Advanced data visualization capabilities beyond standard reporting.

5.8 AI-Powered Content Generation & Assistance

• Model-Agnostic Architecture: Flexibility to integrate with various AI platforms and existing organizational AI capabilities.

o Conversational Chatbot: System that indexes organizational documents and provides contextual responses with linked citations.

o Document Synthesis: AI-powered capability to generate executive summaries and first drafts from multiple aggregated documents.

o Contextual Proofreading: AI assistance for document formatting according to organizational standards.

5.9 Template & Process Standardization

• End-User Template Creation: Ability for users to create, save, and schedule repeatable processes without IT involvement.

• Quick Tasking Templates: Single-click assignment capabilities for bulk operations and organizational-wide tasks. It is anticipated that 60% of processes will be templated and 40% Ad Hoc.

• Standardized Text Responses: Pre-configured response templates for common task communications.

5.10 Advanced Task Views & Visualization

• Multiple View Options: Support for grid, Gantt, Kanban/card, calendar, and tree-level views.

• Dynamic Tree Level View (DTLV): Clean, formatted reporting with drill-down capabilities.

• Color-Coded Status Indicators: Visual indicators for task status (red=overdue, yellow=approaching, green=on track).

• Real-Time Task Modification: Ability to modify task structures dynamically rather than rigid workflow constraints.

5.11 Task Intake & Form Management

• Embedded Forms: Task intake system with forms embedded directly on dashboards.

• Cascading Tasks: Ability to create workflows where tasks can be dependent on the completion of other tasks, and have outcomes linked and automatically adjusted.

• No-Code Form Creation: Ability to create and modify intake forms without developer involvement.

• Dynamic Permissions: Users can see only relevant tasks based on their role and organizational position.

• Email Intake Integration: Ability to create tasks and projects directly from email submissions without manual data entry.

• Automated Record Creation: System automatically processes incoming requests and creates structured records from unstructured email content.

• Dual Intake Methods: Support for both automated email intake and manual task creation within the same workflow.

5.12 External Collaboration & Communication

• External User Access: Controlled permissions for external users or alternative tracking methods for external collaboration.

• Email Integration: Capability to generate emails to external parties with task tracking capabilities.

Non-Functional Requirements

5.13 Data Security

• Adherence to FDA’s security standards and protocols.

• Compliance with FedRAMP, FISMA, NIST, and other federal security standards.

• Multi-factor authentication (MFA).

• Role-based permissions and audit trails.

• End-to-end encryption for task data.

• Secure cloud-hosting options that adhere to FedRAMP standards.

5.14 Usability & Accessibility

• Intuitive UI/UX for ease of use, minimizing training requirements.

• User-friendly navigation for seamless adoption across various roles.

• Compliance with ADA/WCAG accessibility standards for inclusivity.

• Mobile-friendly design and offline task management capabilities.

• Should not require users to exist the system to complete tasks.

5.15 Performance & Reliability

• Provides a consistent response for processing, reporting, and submitting of capabilities regardless of load.

• Enterprise platforms integrations are maintained to align with cloud providers upgrade paths.

• Cloud-based deployment options, with 99.99% reliability.

• Load balancing and redundancy for fault tolerance.

• System meets or exceeds industry standard for system up time.

5.16 Internal Configuration & Maintenance Capability

• Agency/Department Optimization: Solutions designed to support FDA/HHS workflows, compliance requirements, and operational needs.

• Reduced External Dependency: Capability to maintain and enhance the system using internal FDA resources.

5.17 Platform Integration, Scaling & Compatibility

• ATO Requirements: Solutions built on existing authorized platforms to eliminate separate authorization needs (i.e., ServiceNow, MS365, Appian, Salesforce, AWS).

• Data Sovereignty: All data remains within customer's tenant/environment.

• API and Integration Architecture: Robust APIs supporting external system integration and document management providing seamless data exchange between task management system and enterprise systems.

• Scalable Architecture: Ability to support potential expansion to the broader Department of Health and Human Services (HHS), scaling from center-level to agency-wide (FDA) to department-wide (HHS) implementation. Ability to support 20,000 to 100,000 concurrent users efficiently. Maintain responsiveness and performance under increasing loads and have auto-scaling capabilities for enterprise environments.

• Compatibility for Native FDA System Connectivity: Built-in integration capabilities with existing FDA infrastructure (i.e., Documentum, SharePoint, etc.).

• Legacy System Support: Ability to work with and enhance existing FDA technology investments rather than replacing them.

5.18 Training & Adoption Support

• Computer-Based Training (CBT): Comprehensive training resources including interactive classes and train-the-trainer options.

• Quick Adoption Timeline: Solutions that enable basic functionality within 30 seconds to minutes of provisioning.

• Scalable Training Approach: Support for training large user bases (16,000-20,000+ users) with manageable class sizes.

• Free Educational Resources: Access to vendor-provided educational platforms and courses.

5.19 Specialized Compliance & Records Features

• RADS Integration: Records Archive Delivery System capabilities for exporting to official records systems.

• NARA-Compliant Archival: Built-in compliance with National Archives and Records

Administration requirements for federal record keeping.

• Automated Records Lifecycle: Seamless transition from active task management to official records archival.

• Support for in-place records management and emerging compliance trends.

• CAC/PIV Card Integration: Government-issued card compatibility for digital certificates.

• Privacy Controls: Configurable private task settings and firewall capabilities for sensitive investigations.

• Issue Security Features: Role-based permissions down to individual issue/task level.

• Commissioner Priority Alignment: Ability to track and manage tasks related to FDA

Commissioner's strategic priorities (e.g., Gold Standard initiatives).

• Congressional Response Capability: Specific workflows for handling congressional inquiries and data requests.

• Public Health Focus: Task management capabilities designed around public health priorities and community impact assessment.

5.20 Document Management Enhancements

• Three-Tier Document Libraries: Structured document organization (instructions, supporting documents, final documents).

• Version Control: Document versioning and attachment management capabilities.

• Document Builder: Automated document creation with digital certificate integration.

• Documentum Integration: Native integration with FDA's existing Documentum records management system.

• SharePoint Integration: Seamless connection while maintaining documents in original repositories.

• Document Linking: Ability to link to external documents rather than requiring uploads.

5.21 Cost & Licensing Flexibility

• Flexible User Licensing: Cost-efficient models where only creators/maintainers need full licenses.

• Per-App Licensing Options: Minimum licensing requirements for Power Apps or similar platforms.

• Government Contract Options: Availability of government-wide contracts with favorable pricing.

• Professional Services Inclusion: Access to vendor professional services for implementation and training.

5.22 Implementation & Deployment

• Rapid Deployment: Support for implementation timelines of weeks to months rather than years.

• Pilot Capabilities: Ability to implement pilot programs within weeks.

• Environment Setup: Quick environment provisioning and configuration.

• Data Migration Support: CSV import and API capabilities for migrating historical data from existing systems.

Other Considerations

5.23 Total Cost of Ownership

• FDA Enterprise TCO: Including internal development resources, maintenance, and long-term sustainability.

• HHS Enterprise TCO: Including internal development resources, maintenance, and long-term sustainability.

5.24 Planning for Scaling

• Phased Implementation Strategy: Ability to start at center level and scale to agency and department levels.

• Cross-Center Harmonization: Standardization capabilities across different FDA centers while maintaining operational flexibility.

• Enterprise Architecture Alignment: Integration with broader FDA and HHS technology modernization initiatives.

5.25 Quantified Performance Improvement Metrics

• Performance improvements based on demonstrated results, and how this is calculated:

o Process Efficiency: <Example: Target 87% decrease in approval processing time.

Calculated by delta in historical average in approval time compared to current approval time.> o Due Date Management: <Example: Achieve 20-30% reduction in missed due dates.

Calculated by…> o Development Cycle: <Example: Reduce product development cycle time by 10+ days.

Calculated by…> o Process Standardization: <Example: Support for standardizing and automating 80+ organizational processes. Calculated by…>

6. USE CASES

The FDA envisions the following scenarios where task management solutions can enhance operational efficiency. Vendors should indicate how their solutions can be customized to address these specific use cases, ensuring adaptability to FDA operation workflows:

6.1 Executive Functions

• Executive Secretariat (ExecSec) - Document clearance processes, executive briefings, congressional correspondence, senior leadership meeting coordination, and cross-agency communication tracking.

• Office of Policy, Legislation, and International Affairs (OPLIA) - Policy development workflows, legislative tracking and response coordination, international agreement negotiations, regulatory impact analysis coordination, and stakeholder engagement management.

• Office of External Affairs (OEA) - Press release coordination and approval, media inquiry tracking, public communication campaigns, crisis communication workflows, and stakeholder outreach coordination.

• Office of the Chief of Staff - Strategic initiative tracking, priority project management, cross-office coordination, and agency-wide communication distribution.

• Office of Operations - Resource allocation tracking, facility management coordination, emergency response protocols, and operational continuity planning. Strategic plan implementation tracking, performance measurement coordination, staff manual guide development workflows, travel workflows, and organizational assessment management.

Quality management system coordination, process improvement initiatives, performance metric tracking, and audit coordination. Budget planning workflows, procurement workflows, financial reporting coordination, and audit response management.

6.2 Regulatory and Scientific Centers

• Center for Drug Evaluation and Research (CDER) - New Drug Application (NDA) review workflows, Abbreviated New Drug Application (ANDA) processing, drug safety surveillance coordination, post-market study tracking, and regulatory meeting scheduling.

• Center for Biologics Evaluation and Research (CBER) - Biologics License Application (BLA) reviews, vaccine approval processes, blood product oversight, clinical trial coordination, and adverse event tracking.

• Center for Devices and Radiological Health (CDRH) - Premarket Approval (PMA) workflows, 510(k) clearance processes, device recall coordination, quality system regulation compliance tracking, and radiological health assessments.

• Human Foods Program (HFP) - Food safety inspection coordination, nutrition labeling reviews, dietary supplement oversight, foodborne illness outbreak response, and HARPC (Hazard Analysis and Risk-Based Preventive Controls) compliance tracking.

• Center for Tobacco Products (CTP) - Tobacco product application reviews, compliance and enforcement coordination, youth tobacco prevention programs, and modified risk tobacco product assessments.

• Center for Veterinary Medicine (CVM) - New Animal Drug Application (NADA) review workflows, Abbreviated New Animal Drug Application (ANADA) processing, veterinary feed directive coordination, antimicrobial resistance monitoring, animal food safety oversight, medicated feed mill inspection coordination, and veterinary adverse drug event tracking.

6.3 Compliance and Enforcement

• Office of Inspections and Investigations (OII) - Field inspection coordination, import alert management, enforcement action tracking, laboratory sample coordination, and compliance monitoring workflows.

• Office of Criminal Investigations (OCI) - Case management workflows, inter-agency coordination, evidence tracking, and investigative milestone management.

• Office of Compliance and Biologics Quality - Manufacturing inspection coordination, quality system assessments, corrective action tracking, and compliance verification processes.

6.4 Legal and Administrative Support

• Office of the Chief Counsel - Legal review workflows, litigation management, regulatory interpretation coordination, Freedom of Information Act (FOIA) response tracking, and contract review processes.

• Office of Equal Employment Opportunity and Workplace Relations - Employee complaint tracking, workplace investigation coordination, diversity and inclusion initiative management, and training program coordination.

6.5 Information Technology and Data Management

• Office of Digital Transformation - IT project management, system integration coordination, cybersecurity incident response, and digital modernization initiative tracking.

• Office of Data, Analytics, and Surveillance - Data sharing agreements, surveillance program coordination, analytics project management, and real-world evidence initiative tracking.

6.6 Human Resources and Training

• Office of Talent Solutions - Employee lifecycle process tracking including onboarding, recruitment, hiring and offboarding workflows. Performance management coordination, training program delivery, and workforce planning initiatives.

• Office of Training and Development - Curriculum development coordination, training delivery tracking, competency assessment management, and continuing education program oversight.

6.7 International and Interagency Coordination

• International Programs - Mutual recognition agreement coordination, international inspection planning, global regulatory harmonization initiatives, and foreign facility oversight.

• Interagency Coordination - Cross-agency working group management, federal advisory committee coordination, public-private partnership tracking, and emergency response collaboration.

6.8 Public Health and Emergency Response

• Office of Emergency Operations - Emergency response activation, medical countermeasure coordination, supply chain disruption management, and crisis communication workflows.

6.9 Budget and Financial Management

• Resource allocation and fiscal compliance tracking. Financial management and audit reporting.

Travel authorizations, reimbursements, and financial transactions.

6.10 Equal Employment Opportunity

• Complaints, reasonable accommodation request and compliances tracking systems.

6.11 Operational Performance and Strategy

• Strategic plan implementation, performance measurement coordination, and organizational assessment management tracking. Key performance indicator reporting, risk management monitoring, and service level agreement tracking.

7. OTHER PERTINENT INFORMATION

FDA wishes to determine applicability of Buy American statute, Trade Agreement Act, or exception to Buy American statute and is seeking to determine whether there are domestic end products available for this acquisition. Reference (see FAR part 25 including subparts 25.1, Buy American Act—Supplies;

subpart 25.2—Buy American Act—Construction Materials; and FAR subpart 25.4, Trade Agreements.)

7.1 Performance Requirements

• Critical performance requirements must be measured as part of FDA’s market research.

Section 5.25 above lists four metrics. FDA is interested in:

o How do you measure each metric.

o What commercial solutions can address the requirement? Is a commercial solution available to meet the Government’s needs?

o What are the requirements/performance trade-offs to better align with the commercial market?

o How does industry sell the solution, and are the requirements written in those terms?

7.2 Market Intelligence/Industry Analysis

FDA is seeking market intelligence though this RFI and is interested in information such as:

• What is the availability of the solution?

• What is the Government’s market share/leverage in the marketplace (e.g., is the Government the only buyer, making a minority of buys in the market, or making the majority of buys)?

• What is the pricing structure?

8. INFORMATION REQUESTED

Interested vendors should provide information on the following:

• Executive Summary: Overview of the company and product offerings

• Capabilities Overview: Details of the task management features

• Security & Compliance: Federal standards adherence

• Integration & Scalability: Compatibility with federal IT systems and growth potential

• Use Case Alignment: How the solution addresses FDA-specific needs

• Cost Estimate: Preliminary pricing details for licensing, implementation, and support at both the FDA Enterprise level of 20,000 users, and at the HHS Enterprise level of 80,000 users.

• Past Performance: Relevant government or enterprise deployments

• Other Pertinent Information: Information that will help if there is a future solicitation, in determining applicability of Buy American statute, Trade Agreement Act, or exception to Buy American statute and is seeking to determine whether there are domestic end products available for this acquisition. Information on critical performance requirements. Information needed for mandatory market intelligence/industry analysis that must be prepared.

8. INFORMATION REQUESTED