What: On December 19, 2025, the Food and Drug Administration (FDA) and Office of Digital Transformation (ODT) (collectively, FDA/ODT) published a Request for Information (RFI) for a proposed “Foundational Innovation and RAPID Engagement (FIRE)” contract vehicle that would allow FDA to work more directly with innovative companies, especially startups backed by venture capital (VC). Under this model, the FDA would establish contracts with qualified VC firms, and companies in those firms’ portfolios could then compete for and perform FDA task orders as subcontractors.
Why: The FDA is seeking information from VC firms regarding their interest in and requirements for a novel contract vehicle that would enable portfolio companies to compete directly for FDA contracts and task orders. The FDA will use the responses to the RFI to determine if VC firms can satisfy the agency’s requirements based on its response to the questions contained in this notice. The FDA does not intend to make a selection decision or award a contract based on responses.
Small entities and their representatives can help the FDA understand whether this approach expands or narrows opportunities for startups and small firms and what safeguards or flexibilities are needed to avoid unintended barriers. The RFI specifically seeks feedback that is highly relevant to small business stakeholders and their advocates, including:
- Barriers for VC-backed startups in federal contracting: The FDA asks about the main obstacles that innovative, smaller companies face when trying to serve as prime or subcontractors (for example, complex requirements, cashflow risks, or compliance burdens) and how a FIRE-type-vehicle could reduce those obstacles.
- Qualification and compliance expectations: The FDA seeks comment on what qualification criteria, financial standards, and organizational structures are reasonable for VC firms and their portfolios, including how to ensure small companies can meet security, regulatory, and reporting obligations without disproportionate burden.
- Maintaining competition and access: The FDA is interested in how to structure the vehicle so that it supports fair competition and avoids shutting out innovative small businesses that are not in the portfolios of selected VC firms.
Action: The FDA’s Request for Information is published on SAM.gov. Comments must be emailed to Phillip.frame@fda.hhs.gov on or before January 18, 2026.
REQUEST FOR INFORMATION:
Foundational Innovation and RAPID Engagement (FIRE)
AGENCY CONTACT:
ADVOCACY CONTACT:
Will Purcell
EMAIL:
TOPIC(S):
TAG(S):
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