SOURCES SOUGHT NOTICE.pdf

SOURCES SOUGHT NOTICE ONLY

FDA-SS-2026-040726

1 | P a g e

Title: ThinkTrends Software Implementation and Support

Agency: U.S. Food and Drug Administration (FDA)

Notice Type: Sources Sought / Market Research

Posting Date: April 7, 2026

Response Due Date: April 17, 2026

NAICS Code: 541511 – Custom Computer Programming Services (or appropriate) Size Standard: $30M

1. Purpose

The FDA is conducting market research to identify capable vendors to support the implementation and integration of ThinkTrends software and related human interventions across FDA operations. This enhanced effort will leverage Artificial Intelligence (AI), automation, and emerging technologies to improve operational efficiency, data management, and regulatory processes.

This Sources Sought notice is for information and planning purposes only and is not a solicitation. Responses will be used to determine the availability of qualified vendors and to inform future acquisition strategy, including potential sole-source justification or competitive procurement.

2. Background

The BPA will support FDA’s efforts in:

• Advanced Data Management: Data migration, integration, cleansing, cataloging, annotation, and implementation of data lakes or data mesh architectures.

• Emerging Technology Integration: RPA, AI-based OCR (>90% accuracy), blockchain, edge computing, generative AI, NLP, and LLMs for document summarization.

• Intelligent Question-Answering: AI-assisted drafting of regulatory responses, highlighting issues, and providing contextual/historical data.

• Advanced Visualization & Analytics: Interactive dashboards, predictive analytics, and virtual/augmented reality for data visualization.

• Automation & Process Enhancements: Workflow automation, AI-driven quality control, and regulatory tracking.

• FDA System Enhancements: Next-generation OCR, FAERS support with AI signal detection, and intelligent digitization of document rooms.

2 | P a g e

• Data-Driven Tools: AI decision support, predictive models, and digital twins to optimize regulatory processes.

• User Experience Improvements: Intuitive AI-assisted interfaces, personalized dashboards, and voice-activated assistants.

• Comprehensive Support: ThinkTrends license acquisition, agile project management, and continuous staff training.

3. Capability Requirements

Interested vendors should demonstrate experience in:

1. Implementing AI-based software solutions in large-scale enterprise environments.

2. Data migration, integration, and management using modern architectures (data lakes, data mesh).

3. AI/ML model development, deployment, and explainability.

4. OCR, NLP, RPA, and emerging technology solutions in highly regulated environments.

5. Designing user interfaces and dashboards for diverse user roles.

6. Agile project management and technology adoption support in federal or regulated organizations.

4. Response Instructions

Please submit responses in PDF format via email to Lilibeth Deato at lilibeth.deato@fda.hhs.gov by COB, April 17, 2026. Responses should be no longer than 6 pages and include:

1. Company name, business size, and point of contact.

2. Description of relevant experience, including past performance.

3. Capabilities related to AI, automation, and emerging technologies listed above.

4. Any certifications, licenses, or unique capabilities relevant to the requirement.

5. Ability to support a BPA with multiple optional tasks or pilot projects.

6. If on GSA, identification of the firm's GSA Schedule contract(s) by Schedule number and

SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement.

mailto:lilibeth.deato@fda.hhs.gov

3 | P a g e

5. Additional Information

• This is market research only; no award will result from this notice.

• Responses will assist the Government in determining:

o Availability of qualified sources o Potential for small business set-asides o Whether a sole-source BPA is justified

• All questions regarding this notice should be submitted in writing to Lilibeth Deato at lilibeth.deato@fda.hhs.gov by COB, April 17, 2026.

6.Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published. However, responses to this notice will not be considered adequate responses to a solicitation.

7.Confidentiality

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

(End of SS) mailto:lilibeth.deato@fda.hhs.gov