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
    Sources Sought
    Similar Opportunities
    Facility Management System (FMS) Systems Administration and Data Management
    Buyer not available
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking qualified contractors to provide systems administration and data management services for its Facility Management System (FMS). The procurement involves a firm-fixed-price contract for the administration and management of the FMS, particularly the ARCHIBUS platform, which is crucial for efficient facility tracking and space management in compliance with federal guidelines. This total small business set-aside solicitation is set to commence on March 24, 2025, and will run for one year, with four optional renewal periods extending through 2030. Interested vendors should direct inquiries to Kimberly Pennix at kimberly.pennix@fda.hhs.gov, and must adhere to various federal regulations, including security clearance standards and confidentiality agreements.
    Notice of Intent to Sole Source - FDA_2272025
    Buyer not available
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), intends to issue a Sole Source Firm Fixed Price contract for the procurement of two Emulate Zoe CM1 Organ-On-A-Chip culture modules and one Orb Hub Module-1. This procurement aims to evaluate microphysiological systems (MPS) as alternatives to traditional in-vitro models in pharmacokinetic and toxicology studies, which are crucial for advancing FDA's scientific operations and regulatory practices. The selected modules will support the FDA's Division of Applied Regulatory Science (DARS) and must be delivered and installed within 12 months post-award at the FDA’s White Oak Campus in Silver Spring, Maryland. Interested suppliers who believe they can meet the requirements outlined in the Statement of Work are invited to submit capability statements by March 7, 2025, to Hilda Aryeh at hilda.aryeh@fda.hhs.gov.
    PRIMO Software Licensing
    Buyer not available
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking qualified small businesses to provide PRIMO Software Licensing and Maintenance Support Services. The procurement involves supplying 21 PRIMO software licenses for a base year, with two additional option years, to ensure the continuous operation of the FDA's CFSAN CAEMS system. This software is crucial for pharmacovigilance and regulatory compliance, enhancing the FDA's capabilities in monitoring food safety. Interested parties must submit their quotes by August 26, 2024, and are encouraged to contact Roosevelt Walker at roosevelt.walker@fda.hhs.gov for further details. The contract will be awarded as a firm-fixed-price purchase order, emphasizing compliance with federal acquisition regulations and accessibility standards.
    Health Technology Capability Statement Collection
    Buyer not available
    The Department of Defense, through the Defense Health Agency (DHA), is seeking insights from contractors regarding their capabilities in the Defense Health Information Technology sector as part of a Health Technology Capability Statement Collection initiative. This Request for Information (RFI) aims to enhance procurement decisions for fiscal year 2025 by evaluating vendors' abilities to adapt to emerging technologies, particularly in artificial intelligence (AI). The information gathered will contribute to a market research repository that supports the government's commitment to innovation in healthcare technology and procurement processes. Interested contractors must submit their capability statements electronically in PDF format by December 31, 2024, with responses accepted on a rolling quarterly basis thereafter. For further inquiries, contact Sharria T. Wells at sharria.t.wells.civ@health.mil.
    Office-Wide Innovative Solutions Opening for Health Science Futures (HSF)
    Buyer not available
    The Department of Health and Human Services, through the National Institutes of Health's Advanced Research Projects Agency for Health (ARPA-H), is soliciting proposals for the Innovative Solutions Opening (ISO) aimed at advancing healthcare technologies. This initiative seeks innovative, disease-agnostic research projects that can significantly improve health outcomes, focusing on areas such as maternal and fetal health, genetic therapies, and novel diagnostic tools. The solicitation emphasizes the development of transformative solutions rather than incremental research, with submissions required to follow a two-step process: an initial solution summary followed by a full proposal based on feedback received. Interested parties must submit their solution summaries by March 3, 2029, via the designated ARPA-H portal, and are encouraged to review the detailed submission guidelines outlined in the provided documentation.
    Office-Wide Innovative Solutions Opening for Proactive Health Office (PHO)
    Buyer not available
    The Department of Health and Human Services, through the National Institutes of Health's Advanced Research Projects Agency for Health (ARPA-H), is soliciting innovative research proposals aimed at enhancing health outcomes via the Proactive Health Office (PHO). The initiative focuses on developing solutions that prioritize disease prevention, early intervention, and scalable wellness-promoting behaviors, moving away from traditional reactive healthcare models. This opportunity is significant for entities capable of delivering transformative health solutions, with proposals evaluated based on scientific merit and relevance, and funding potentially awarded through Other Transactions or Cooperative Agreements. Interested parties must submit a mandatory solution summary by March 3, 2029, and can direct inquiries to the designated contact via the provided submission platforms.
    ARPA-H ImagiNg Data EXchange (INDEX)
    Buyer not available
    The Department of Health and Human Services, through the National Institutes of Health's Advanced Research Projects Agency for Health (ARPA-H), is soliciting proposals for the Imaging Data Exchange (INDEX) program aimed at enhancing access to medical imaging data. The primary objective is to develop a sustainable platform that connects medical imaging data providers with researchers and developers, leveraging artificial intelligence and machine learning to address the shortage of qualified radiologists and improve healthcare outcomes. This initiative is critical for advancing algorithm development and clinical studies by creating a comprehensive repository of diverse imaging datasets, including cancer digital pathology and surgical videos. Interested parties must submit their Solution Summary by January 28, 2025, with the full proposal due by March 27, 2025. For further inquiries, contact the INDEX Team at INDEX@arpa-h.gov.
    Request For Information for Information Collection Request, Review & Approval System Maintenance and Support (ICRAS)
    Buyer not available
    The Department of Education is issuing a Request for Information (RFI) to identify qualified small business vendors for the maintenance and support of the Information Collection Request, Review & Approval System (ICRAS). The procurement aims to gather insights for a planned re-compete of a single award contract, which will involve managing ICRAS within a cloud environment, ensuring compliance with federal regulations, and delivering essential project management and operational support services. This initiative is crucial for enhancing the Department's efficiency in managing educational data collections and adhering to federal laws such as the Paperwork Reduction Act. Interested vendors must submit their capability statements and business details by March 11, 2025, to the designated contacts, Michael Rivera and Katie Opper, at their respective email addresses, as the information gathered will inform a future solicitation planned for release in Spring 2025.
    Office-Wide Innovative Solutions Opening for Resilient Systems Office (RSO)
    Buyer not available
    The Department of Health and Human Services, through the National Institutes of Health's Advanced Research Projects Agency for Health (ARPA-H), is soliciting innovative solutions aimed at enhancing the resilience of healthcare systems via its Resilient Systems Office (RSO). This opportunity invites submissions from eligible entities, including universities, nonprofits, and small businesses, to address systemic challenges in healthcare and public health by leveraging cutting-edge technologies that improve care quality and availability. The solicitation emphasizes the importance of sociotechnical system innovations and adaptive solutions that enhance the reliability and interoperability of health ecosystems. Interested parties must submit solution summaries for feedback before full proposal submissions, with the solicitation open until March 3, 2029. For further inquiries, submissions should be directed to the designated online platforms, and the primary contact email is provided in the solicitation details.
    Office-Wide Innovative Solutions Opening for Scalable Solutions Office (SSO)
    Buyer not available
    The Department of Health and Human Services, through the National Institutes of Health's Advanced Research Projects Agency for Health (ARPA-H), is soliciting innovative solutions aimed at enhancing healthcare accessibility, affordability, and scalability. This opportunity invites universities, non-profits, small businesses, and similar entities to submit solution summaries and proposals that address health disparities, improve the distribution of healthcare technologies, and advance biomanufacturing innovations. The solicitation emphasizes the development of scalable technologies and collaborative distribution networks, with a focus on interdisciplinary approaches to revolutionize biomedicine and public health outcomes. Interested parties must submit their solution summaries by March 3, 2029, and can find further details and submission guidelines at https://solutions.arpa-h.gov. For inquiries, questions should be directed to the same website.