The U.S. Food and Drug Administration (FDA) has posted its Fiscal Year 2026 (FY26) Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science on the federal contracting portal SAM.gov.
The FDA describes this BAA as a contract-based mechanism used to support extramural regulatory science and innovation, enabling external partners to contribute scientific and technical solutions that align with FDA’s mission and priority needs.
Key deadline and what “Stage I” includes
For FY26 funding consideration, applicants are expected to submit a Stage I package by February 24, 2026.
FDA materials describe Stage I as requiring a freestanding Concept Paper and a freestanding Full Proposal prepared according to the BAA’s submission guidance.
FDA also notes that submissions received after February 24, 2026 may still be accepted during an open period, but they may not be considered for FY26 awards due to timing and funding availability, and could instead be considered for FY27.
What this funding opportunity is designed to support
On FDA’s “Regulatory Science Extramural Research and Development Projects” page, the agency explains that extramural work funded through the Advancing Regulatory Science BAA is intended to address priority needs within its Regulatory Science Framework, which includes modernizing product development and evaluation, strengthening post-market surveillance and labeling, and invigorating public health preparedness and response.
The same page indicates that FDA has solicited proposals through this BAA mechanism since 2012 and positions the BAA as a way to draw on expertise and infrastructure from industry, academia, and other government entities to solve complex regulatory science challenges.
Oncology Center of Excellence: Scientific Interest Areas highlighted for proposals
The FDA Oncology Center of Excellence (OCE) publishes its Scientific Interest Areas to help applicants understand the types of oncology regulatory science topics that may be responsive. These areas include, among others, cell and gene therapies (including personalized neoantigen-based approaches), immuno-oncology, patient-focused drug development, oncology safety, clinical trial designs and endpoints/statistical methodologies, pediatric oncology, precision oncology, rare cancers, and oncology real-world data/real-world evidence.
Across these sections, OCE frames its interests around improving clinical evaluation approaches, understanding and managing toxicities, developing fit-for-purpose endpoints and trial designs, advancing biomarker science, and strengthening the quality and use of real-world data in oncology decision-making.
FAQs: eligibility, award type, duration, and communications
FDA’s OCE FAQ page clarifies several practical points for oncology researchers and institutions. It states that the BAA is open to “all responsible sources,” including private sector, academic, and nonprofit institutions, and that international institutions may apply as long as they can complete SAM.gov registration in time for an award.
The same FAQ page notes that the BAA results in a research and development (R&D) contract (not a grant), with reporting requirements managed through the FDA contracting office, and that projects may be supported for up to five years.
For communication norms, the FAQ describes an option to seek clarification about the scientific interest areas prior to submission and indicates that after a submission is made, communications about the proposal must go through the FDA Contracting Office.
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Written by Nare Hovhannisyan, MD