Real-World Application for Innovation and Development
Closed Pre-Solicitation Posted
- Solicitation number
- FDA-SSN-75F40125Q00029
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 541512 Computer Systems Design Services
- Place of performance
- Silver Spring, Maryland 20903, United States
- Points of contact
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 environment designed to enhance regulatory review processes through advanced data analytics and artificial intelligence technologies. The procurement aims to improve the FDA's Office of Computational Science capabilities by developing innovative analytical solutions, supporting data science research, and evaluating cutting-edge technologies across multiple cloud service providers including AWS, Azure, and Google GCP. Potential vendors must demonstrate expertise in AI development, cloud computing architecture, DevSecOps, and AI Risk Management, with a focus on creating customized Large Language Models and multi-modal AI solutions. Interested parties are required to submit a 10-page capability statement addressing technical experience and specific qualifications by February 11, 2025, at 12:00 PM ET to Noah.Padilla@fda.hhs.gov. The procurement will specifically target vendors on GSA MAS Schedules 54151S and 54151HEAL who can support the platform's complex data integration, analytical tool development, and regulatory decision-making needs.
The opportunity is designated as a Total Small Business set-aside under the Computer Systems Design Services NAICS category, with a contract structure anticipated to be a Blanket Purchase Agreement. The contract will have a one-year base period with four potential option years, running from September 28, 2025, to September 28, 2030. While specific award values were not explicitly detailed, the scope suggests a significant investment in technological innovation and platform enhancement. Work will predominantly be performed off-site, with occasional meetings at the FDA's White Oak campus in Silver Spring, Maryland. Contractors must meet stringent security requirements, including personnel background investigations and compliance with HSPD-12 residency standards. The platform will require supporting various data analytics tools like R-Studio Connect, Jupyter Analytics, Qlik Sense, and Tableau, with an emphasis on developing and implementing advanced AI and machine learning solutions that can scale to meet FDA's complex regulatory and scientific analysis needs.
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.
Files
| File | Type | Posted |
|---|---|---|
| FDA-SSN-75F40125Q00029_RAPID VI_SOW Draft.pdf | ||
| FDA-SSN-75F40125Q00029_RAPID VI_Instructions.pdf |
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