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Regulatory Decision Frameworks and Predictive Modeling

Active

Federal

Contract Overview

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

AI Contract Overview

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The contract involves the development of AI and machine learning-driven predictive models and decision support tools aimed at enhancing regulatory decision-making processes. Leveraging both high-quality scientific data and real-world data, the objective is to improve the accuracy and efficiency of regulatory evaluations. This initiative is critical for advancing the FDA's ability to assess and manage health-related risks more effectively. This subcontract falls under the NAICS code 541990 and is managed by the FDA Office of Acquisitions and Grants Services within the Department of Health and Human Services. The work will be performed in Silver Spring, Maryland, and focuses on creating frameworks that support regulatory decisions through sophisticated data analysis and predictive modeling techniques. The contract was posted in January 2026 and seeks specialized expertise to integrate innovative technologies into regulatory workflows.

General Info

Develop AI-driven predictive models to improve FDA regulatory decision accuracy and efficiency.

Agency

Department Of Health And Human Services → FDA Office Of Acquisitions And Grants Services

NAICS

541990 - All Other Professional, Scientific, and Technical Services

Place of Performance

Silver Spring, MD, 20993, USA

Set-Aside

NONE

Documents

This scope was carved out of FDABAA-25-00123_Award.

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

View the prime solicitation

FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science

AI Contract Breakdown

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No documents to break down

The breakdown needs solicitation documents. None were found from this contract's source.

Timeline

PostedJan 13

subcontract

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Office Of Acquisitions And Grants Services

ContactsNo contacts available

OfficeN/A

Organization / AgencyDepartment Of Health And Human Services → FDA Office Of Acquisitions And Grants Services

Office AddressN/A

ContactsNo contact information available

Full Description

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Build AI/ML-driven predictive models and decision support tools to enhance regulatory decision-making using high-quality scientific and real-world data.

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