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This Subcontract opportunity from Department Of Health And Human Services was posted on September 22, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

AI/ML Model Developer (Regulatory Analytics)

Closed
Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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693JJ3 Acquisition And Grants Mgt

POSTED

about 17 hours ago

DEADLINE

in about 1 month

AI Contract Overview

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This small business set-aside subcontract, titled AI/ML Model Developer (Regulatory Analytics), supports the FDA Office of Acquisitions and Grant Services within the Department of Health and Human Services. The project focuses on the development and deployment of advanced AI and machine learning models, specifically utilizing large language models, natural language processing, and generative AI. Key deliverables include AI-powered signal detection for FAERS, predictive models for regulatory outcomes, and the creation of digital twins to simulate regulatory processes. The contract requires the delivery of trained machine learning models, signal detection algorithms, and process simulation software. Performance will take place in Silver Spring, Maryland, under NAICS code 541715. The solicitation was posted on September 22, 2026, with a response deadline of September 28, 2026.

General Info

Small business subcontract for FDA AI/ML model development and regulatory analytics in Maryland.

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Place of Performance

Silver Spring, MD, 20903, USA

Set-Aside

SBA

Documents

This scope was carved out of 75F40126R00097.

The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

Think Trends Software Implementation and Support

AI Contract Breakdown

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Timeline

PhaseClosed
Posted

subcontract

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs
ContactsNo contacts available
OfficeN/A
Office AddressN/A
ContactsNo contact information available

Full Description

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Develops and deploys AI and Machine Learning models for prime contractors on FDA Office of Acquisitions and Grant Services projects. Implements AI-powered signal detection for FAERS, develops predictive models for regulatory outcomes, and creates Digital Twins to simulate regulatory processes. Utilizes LLMs, NLP, and Generative AI. Delivers trained ML models, signal detection algorithms, and process simulation software.

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Same awarding agency

NAICS: 541990
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DEADLINE

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NAICS: 541611
Federal
FDA/CDRH Scientific Technical Capacity for Regulatory Review
Solicitation # 75F40127Q00006
The FDA Center for Devices and Radiological Health (CDRH) has issued a Sources Sought Notice under solicitation 75F40127Q00006 to conduct market research for a Blanket Purchase Agreement. The objective is to secure advanced professional and scientific consultants to provide technical capacity for regulatory reviews across the total product lifecycle of medical devices. Required expertise spans a vast array of disciplines, including biomedical engineering, computer science, cybersecurity, data science, and various clinical specialties such as anesthesiology, toxicology, and virology. These consultants will support critical activities including research, digital health consultations, auditing, and the evaluation of the safety and effectiveness of devices approved, cleared, or authorized by the FDA. The anticipated period of performance includes a twelve-month base year starting January 30, 2027, followed by four twelve-month option years and a final six-month extension option ending July 29, 2032. Services will be performed both remotely via the FDA network and on-site at the White Oak Headquarters in Silver Spring, Maryland. The government is considering NAICS code 541611 for this effort and is seeking information from large and small businesses, including various socio-economic categories. Interested vendors must submit their responses, including a completed Vendor Feedback Form and capability statement, to the designated contract specialists by 2:00 PM EST on November 17, 2026.
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Earlier notices in this NAICS code

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