TMT RFI HHS Versionv2.pdf

FDA-RFI-2026-032726 Version 2

Request for Information (RFI):

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

Revised March 12, 2026

1. PURPOSE and SUBMISSION GUIDELINES The purpose of this Request for Information (RFI) is to obtain technical and business information from the marketplace regarding the availability of Commercial Off-the-Shelf (COTS) solutions capable of supporting the U.S. Food and Drug Administration (FDA) Executive Secretariat's correspondence and task management requirements. This RFI is issued pursuant to FAR Part 10 Market Research to identify potential vendors capable of providing comprehensive solutions for executive correspondence workflows, document clearance processes, inter-agency coordination, task tracking, and workflow automation.

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 Response Due Date/Time: 5PM EST 03/27/2026 Email responses to: Lilibeth Deato at lilibeth.deato@fda.hhs.gov.

Please include the RFI number FDA-RFI-2026-032726 - 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 solutions that can support an enterprise-wide need for effective executive-level correspondence and task management operations.

FDA seeks a solution that provides a robust set of capabilities to support executive secretariat operations through the analysis of FDA's predominant needs and primary use cases listed in the following sections.

3. OBJECTIVES

• Vendor Identification: Identify vendors offering comprehensive enterprise Task Management Tools and solutions including licensing, support, and documentation.

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

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

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

4. BACKGROUND

The approximately 16,000 federal 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 Office of the Executive Secretariat (ExecSec) serves as the central coordination point for all correspondence, coordination, and information flow to and from the Office of the Commissioner, managing critical communications with the White House, Congress, the Department of Health and Human Services (HHS) operating divisions and agencies, and other federal partners.

FDA’s ExecSec engages and coordinates internally across FDA’s Centers, Offices, and Programs (COPs), and externally with other Executive Secretariat offices, the Office of Chief Counsel, and external stakeholders. Effective correspondence and task management is critical for ExecSec's operational success, ensuring that the office can track time-sensitive assignments, automate complex clearance workflows, maintain visibility into correspondence progress across multiple reviewing offices, meet response deadlines, and preserve institutional knowledge through comprehensive audit trails.

5. SCOPE OF INFORMATION REQUESTED

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

5.1 Correspondence and Task Management Capabilities

FDA is exploring the marketplace to understand the range of capabilities available in modern COTS task management solutions that could support executive correspondence and task management operations. We are interested in learning how vendors approach the challenges of managing high-volume, time-sensitive correspondence workflows that require multi-office coordination, statutory deadline compliance, and comprehensive audit trails. Vendors should describe their solution's core capabilities for correspondence intake and management, including how correspondence enters the system from various channels, how it is categorized and routed to appropriate personnel, how deadlines are calculated and tracked, and how the system provides visibility into correspondence status throughout its lifecycle. We are particularly interested in understanding the flexibility and configurability of these capabilities, whether they can be adapted to different organizational structures and workflow requirements, and what level of technical expertise is required to configure and maintain these functions.

5.2 Document Clearance and Approval Workflow Capabilities

We seek information on how vendor solutions support complex document clearance and approval workflows that may involve both sequential and parallel routing across multiple organizational units. Describe how your solution manages clearance processes where documents must be reviewed by numerous offices in specific sequences or simultaneously, how comments and edits are captured and managed throughout the clearance process, how version control is maintained, and how final approvals are documented and authenticated. We are interested in understanding the workflow configuration capabilities of your solution, including whether workflows can be created or modified by business users without coding, how conditional logic and routing rules are implemented, and how the system handles exceptions and escalations. Additionally, describe how your solution supports collaboration among distributed teams during the clearance process, including capabilities for commenting, document editing, and real-time communication.

5.3 Integration, Security and Compliance

FDA is interested in understanding how vendor solutions address the unique requirements of federal executive correspondence management, including integration with federal systems and compliance with federal security and records management standards. Describe your solution's approach to integrating with common federal enterprise systems such as Microsoft SharePoint, Teams, Outlook, and agency-specific records management systems. Explain how your solution supports federal identity and access management requirements including Single Sign-On, multi-factor authentication, and CAC/PIV card integration. We seek information on your solution's compliance with federal security frameworks including FedRAMP authorization status, FISMA compliance, and alignment with NIST cybersecurity standards. Describe how your solution addresses federal records management requirements including NARA compliance, audit trail capabilities, digital signature functionality meeting regulatory standards such as FDA Title 21 CFR Part 11, and support for records lifecycle management from active use through archival and disposition.

5.4 Scalability, Performance, and Implementation Approach

Finally, FDA seeks to understand the scalability, performance, and total cost of ownership characteristics of vendor solutions. Describe your solution's architecture and its ability to scale from beginning with an initial FDA deployment that could support up to 16,000 personnel and HHS Deployment up to 50,000 personnel. Explain your solution's performance characteristics under load, including response times, concurrent user capacity, and availability guarantees. We are interested in understanding your licensing models and how costs scale with user count, including whether you offer flexible licensing options such as different license types for creators versus viewers. Describe your typical implementation approach and timeline for deployments of this scale, including data migration capabilities, training and change management support, and ongoing operational support requirements. Additionally, provide information on any advanced capabilities your solution offers such as AI-powered search, analytics, or automation features that could enhance task management efficiency and effectiveness.

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 Congressional Inquiry Workflow

FDA receives a congressional inquiry requiring a 30-day response with multi-office coordination. The Congressional Office submits an inquiry to FDA ExecSec Intake, where the system performs automated triage and assignment to the appropriate action officer. The action officer drafts a response with supporting documentation, leveraging templates and accessing historical responses for consistency. The system initiates parallel clearance routing to relevant FDA COPs, allowing multiple offices to review simultaneously. Following parallel clearance, the response proceeds through sequential clearance via Legal Review, Office of Policy, Legislation, and International Affairs (OPLIA), and ExecSec for final review. Throughout the clearance process, the system manages comment resolution and version control.

The Commissioner provides approval with digital signature, creating a legally binding approval record.

The response is submitted to the Congressional Office and HHS if applicable, with the system maintaining a complete audit trail and automatically archiving the correspondence.

The system must automatically calculate the 30-day deadline and provide escalation alerts at 15 days and when approaching the deadline. Real-time visibility for all authorized stakeholders must allow leadership to monitor progress without requesting status updates. Integration with congressional tracking systems should maintain comprehensive records. A searchable history of previous responses to similar inquiries should enable consistency in agency positions.

6.2 White House Tasking Workflow

FDA receives an urgent White House tasking requiring 24-48 hour response. The White House submits a tasking to HHS Office of the Secretary, which routes it through HHS SPS to FDA ExecSec. The system performs urgent assignment with immediate notification to the action officer via email, Teams, and mobile push notification. The action officer develops a rapid response with expedited clearance, potentially bypassing standard clearance steps when appropriate. The system supports a streamlined approval process involving only essential reviewers. The Commissioner provides approval, and the response is submitted through FDA ExecSec to HHS SPS to White House.

The system must meet the 2-hour acknowledgment requirement by automatically sending acknowledgment to HHS SPS upon receipt. Integration with HHS Secretary's Policy System (SPS) should enable automated tasking receipt and response submission. The platform must support expedited workflow that bypasses standard clearance steps when appropriate. Mobile access for urgent approvals should enable executives to review and approve from any location. Real-time status updates to HHS and White House should ensure visibility into FDA's progress.

6.3 Multi-Office Document Clearance Workflow

A Commissioner-level policy document requires clearance from multiple FDA offices and legal review.

ExecSec assigns the document to a lead action office, which drafts the policy document using templates.

The system initiates parallel clearance to multiple FDA Centers and Offices simultaneously. The platform performs automated comment aggregation and resolution tracking, collecting feedback from all reviewers. Following parallel clearance, the document proceeds through sequential clearance via Office of Chief Counsel, OPLIA, and ExecSec for final review. The system supports final review and approval with digital signature and distribution.

The system must support both parallel and sequential clearance routing, executing complex workflows that combine simultaneous and sequential review steps. Version control with tracked changes should ensure all reviewers see edits made by previous reviewers. Comment threading and resolution workflow should allow reviewers to discuss comments. Office-specific clearance deadlines should ensure each reviewing office completes their review within allocated time. Delegation capabilities during staff absences should allow clearance authority to be temporarily transferred.

6.4 HHS Secretary Data Call Workflow

The HHS Secretary requests data from FDA requiring coordination across multiple centers. HHS Office of the Secretary submits a data call through HHS SPS to FDA ExecSec. The system assigns the data call to a coordinating office, which is responsible for gathering information from multiple FDA centers. The coordinating office initiates multi-office data collection coordination, sending data requests to relevant centers and tracking their responses. The system supports draft consolidated response development, providing tools to aggregate data from multiple sources. The response proceeds through clearance and quality review. The Commissioner provides approval, and the response is submitted through FDA ExecSec to HHS SPS to HHS Office of the Secretary.

The system must integrate with HHS SPS for automated tasking receipt, eliminating manual entry.

Coordination across multiple FDA offices for data gathering should provide a structured approach.

Template support for common data call formats should reduce formatting time. Tracking of recurring data calls should identify when similar requests have been made previously. A historical data call repository should allow staff to review previous submissions.

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:

• How do you measure each metric.

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

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

• 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:

8.1 Executive Summary

• Overview of your company including relevant experience with federal executive secretariat or similar high-level correspondence management implementations

• Description of your proposed COTS solution and how it aligns with FDA's mission to manage executive-level correspondence, taskings, and information flows

• Key differentiators and unique value propositions, particularly related to executive correspondence management, statutory deadline compliance, and multi-office clearance workflows

• Summary of past performance with similar federal implementations

8.2 Capabilities Overview

• Describe correspondence intake capabilities from multiple channels, workflow management for sequential and parallel clearance routing, and whether business users can configure workflows without coding

• Explain deadline tracking and escalation features for statutory deadlines, collaboration capabilities including commenting and version control, reporting and analytics features, and any AI-powered automation capabilities

8.3 Security & Compliance

• Provide current FedRAMP authorization level and expiration date, compliance with FISMA and NIST standards, and security features including multi-factor authentication, role-based access control, encryption, and audit logging

• Describe digital signature compliance with FDA Title 21 CFR Part 11, ESIGN Act, and UETA, plus records management capabilities including NARA compliance, FDA Documentum integration, and RADS support

8.4 Integration & Scalability

• Describe integration capabilities with Microsoft SharePoint, Teams, Outlook, Single Sign-On with Active Directory/LDAP, CAC/PIV card integration, and experience with HHS Secretary's Policy System or similar federal systems

• Describe the integration capabilities with architecture environment like FDA and/OR HHS environment.

• Explain your solution's scalability from an initial FDA deployment of licenses (distributed across viewer, creator, and administrator tiers) ranging to a potential HHS enterprise deployment, cloud deployment architecture, data sovereignty, performance under load, auto-scaling features, and your largest current deployment size.

• Describe product roadmap and planned enhancements over next 2-3 years, and explain measurable performance improvements your solution delivers with calculation methodologies and actual results from similar implementations

8.5 Use Case Alignment

• Describe how your solution addresses described needs.

• Provide specific examples from existing federal deployments demonstrating similar executive secretariat or high-level correspondence management scenarios with measurable outcomes achieved

8.6 Cost Estimate

• To facilitate a clear comparison of pricing models, please provide a preliminary cost estimate based on the following illustrative scenario. This scenario is for estimation purposes only and does not represent a final procurement quantity.

Illustrative Scenario: License Distribution based on the organizations described o Approximately 75% Viewer Licenses – For read-only access, status tracking, and general monitoring activities o Approximately 15% Creator Licenses – For drafting, editing, and active workflow participation o Approximately 10% Administrator Licenses – For system configuration, user management, and administrative function

• Based on this scenario, please provide a detailed breakdown of costs for licensing, implementation, data migration, training, annual maintenance, and professional services to calculate a total cost of ownership for Years 1-5.

• Provide a preliminary pricing model for a potential HHS Enterprise expansion with incremental costs, licensing models, government contract vehicles available (GWAC, GSA Schedule), and volume discount structures

• Describe your volume discount structures and how pricing for each license tier (Viewer, Creator, Administrator) would adjust at this larger scale. Detail the incremental costs for this expansion.

8.7 Past Performance

Provide detailed information for at least three relevant federal or large enterprise deployments, such as Executive secretariat operations, Congressional correspondence management, White House or executive branch coordination, Multi-office clearance workflows, Federal records management and NARA compliance, FedRAMP authorized deployments. Include:

• Customer: Name and contact information

• Deployment Scale: Number of users and organizational scope

• Scope: Types of correspondence or task managed

• Timeline: Implementation timeline from contract award to go-live

• Implementations: Workflows and integration implemented

• Challenges: Challenges encountered and how they were addressed

• Outcomes: Measurable outcomes (clearance cycle time reduction, deadline compliance improvement, user adoption rates)

8.8 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.