Real-World Application for Innovation and Development
ID: FDA-SSN-75F40125Q00029Type: Sources Sought
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFFOOD AND DRUG ADMINISTRATIONFDA OFFICE OF ACQ GRANT SVCSBeltsville, MD, 20705, USA

NAICS

Computer Systems Design Services (541512)

PSC

IT AND TELECOM - HIGH PERFORMANCE COMPUTING (HPC) SUPPORT SERVICES (LABOR) (DB01)

Set Aside

Total Small Business Set-Aside (FAR 19.5) (SBA)

Original Source

https://sam.gov/opp/92aaebdd080e4f7595b932e0a6004816/view
Timeline
    Description

    The U.S. Food and Drug Administration (FDA) is seeking qualified small businesses to support its Real-World Application for Innovation and Development (RAPID) program, which aims to enhance regulatory processes through advanced data analytics and artificial intelligence. The primary objectives include the development and deployment of innovative prototypes, system maintenance, and the integration of advanced analytics into the regulatory framework to improve drug safety evaluations and regulatory reviews. This initiative is crucial for enabling FDA reviewers to efficiently access real-time data and analytics, particularly during public health events. Interested vendors must submit a capability statement by February 11, 2025, detailing their qualifications in relevant areas such as AI and cloud technologies, and can contact Noah Padilla at Noah.Padilla@fda.hhs.gov for further information.

    Point(s) of Contact
    Noah Padilla
    Noah.Padilla@fda.hhs.gov
    Files
    Title
    Posted
    FDA-SSN-75F40125Q00029_RAPID VI_Instructions.pdf
    The U.S. Food and Drug Administration (FDA) has issued a Sources Sought Notice to gather market research on potential services for its Real-World Application for Innovation and Development (RAPID) platform. This initiative, under the Center for Drug Evaluation and Research, aims to enhance the existing AWS platform and develop innovative applications and prototypes to modernize the regulatory review process. The FDA seeks to identify small businesses eligible under GSA MAS Schedules 54151S (IT Professional Services) and 54151HEAL (Health IT Services) that can support various objectives, including system maintenance, upgrades, and innovative AI and cloud technologies. The RAPID platform is integral to enabling FDA reviewers to access real-time data and analytics to inform regulatory decisions efficiently, especially during public health events. Interested vendors are requested to submit a capability statement detailing their qualifications and previous experiences in relevant areas such as AI, data integration, and cloud deployment, by February 11, 2025. This notice does not commit the government to any award and emphasizes voluntary participation from interested parties.
    FDA-SSN-75F40125Q00029_RAPID VI_SOW Draft.pdf
    The U.S. Food and Drug Administration (FDA) is soliciting proposals for the Real-World Application for Innovation and Development (RAPID) program, aimed at advancing innovative regulatory processes through enhanced data analytics and artificial intelligence. The RAPID platform is designed to support FDA operations by improving the efficiency and effectiveness of drug safety evaluations and regulatory reviews via cloud-based technologies and data analysis tools. The primary objectives include developing and deploying prototypes that fulfill mission-critical needs, maintaining existing systems, and integrating advanced analytics into the regulatory framework. Important tasks for contractors encompass project management, research, and continued innovation while adhering to strict compliance with security protocols, organizational conflict of interest considerations, and accessibility standards under Section 508. The contract structure features a base period of one year with four option years, focusing on project governance, database administration, and collaborative development. Contractors must adhere to comprehensive reporting requirements and are responsible for the transition of services as necessary. Overall, this initiative reflects the FDA's commitment to leverage cutting-edge technology to enhance public health oversight and regulatory capacity.
    Lifecycle
    Title
    Type
    Real-World Application for Innovation and Development
    Currently viewing
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