Real-World Application for Innovation and Development (RAPID)

Closed Pre-Solicitation Posted

Solicitation number
FDA-SSN-75F40125Q00192
Agency
Responses due
Set-aside
Total Small Business

Opportunity facts

Place of performance
North Bethesda, Maryland, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The U.S. Food and Drug Administration (FDA) is seeking small businesses to support the Real-World Application for Innovation and Development (RAPID) platform, a cloud-based and on-premises environment designed to enhance regulatory review processes through advanced technological solutions. The procurement focuses on developing and improving applications, databases, and analytical tools that leverage artificial intelligence, machine learning, and data science capabilities. Interested vendors must submit a 10-page capability statement by May 27, 2025, at 12:00 PM ET to Noah.Padilla@fda.hhs.gov, demonstrating expertise in cloud environments, AI technologies, and innovative analytical solutions. The contract requires contractors to support the FDA's Office of Computational Science in modernizing regulatory review processes, with a specific emphasis on developing prototypes, proof-of-concepts, and cutting-edge technologies across multiple cloud platforms including AWS and Azure. Evaluation criteria will likely focus on vendors' experience in AI development, cloud computing, data integration, and ability to support transdisciplinary scientific needs.

The contract is designated as a Total Small Business set-aside, specifically targeting businesses on GSA MAS Schedules 54151S and 54151HEAL in the Computer Systems Design Services (NAICS 541512) category. While specific award values are not explicitly stated, the scope suggests a comprehensive, multi-phase engagement involving research, innovation, prototype development, and ongoing platform maintenance. The RAPID platform aims to create a technological sandbox that enables FDA scientists to spend less time managing complex data and more time applying expert analysis. The contract will likely involve continuous development and enhancement of the platform, with a focus on supporting individual regulatory research, evaluating new analytic tools, and exploring artificial intelligence use cases. The procurement represents a significant opportunity for small businesses to contribute to the FDA's technological modernization efforts in regulatory science and data analysis.

Notice text

The U.S. Food and Drug Administration (FDA) is issuing this source sought notice as a means of conducting market research, pursuant to FAR Part 10 Market Research, to identify viable industry parties capable of supporting FDA’s Real-World Application for Innovation and Development (RAPID), enhancement of the current AWS platform, development of new applications prototypes and Proof of Concepts.


The mission of CDER’s Office of Computational Science (OCS) is to modernize the Center’s regulatory review process and enable reviewers to spend less time dealing with complex data and more time applying their expertise to information through the use of integrated tools, services, and training. OCS’ efforts to accomplish this mission involve developing technology and analytics to support regulatory review work. RAPID was developed as a means to implement a cloud-based and on-premises environment to develop and continuously improve the applications and databases needed to meet the innovation and analytical needs of FDA users.

The RAPID platform is capable of supporting a variety of cloud and other operations including, supporting individual regulatory research, ingest, evaluate, and validate new analytic tools and methodologies, support new methods of multi data base curation, characterization and integration for transdisciplinary analysis of complex and big data, and a range of artificial intelligence tools and use cases for FDA needs.

RAPID is a sandbox that promotes the development of innovative analytic tools, supports data science research, and the evaluation of cutting-edge technologies. The RAPID System in its current form uses Artificial Intelligence (AI) and cloud-based compute facilities to develop innovative analytical solutions that support regulatory decision making and scientific analysis. Refer to the National Academies of Sciences “Convergence”, https://www.nae.edu/113283.aspx, report to get an understanding of what ”transdisciplinary FDA scientific need” must include.

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Opportunity Agency Set-aside Responses due
Contractor-Hosted Fully Integrated Records Facility (FIRF) IDIQ Silver Spring, Maryland 20993, United States · NAICS 541611 FDA Office of Acquisition and Grant Services Service-Disabled Veteran-Owned Small Business

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