Overview of the Opportunity
The Biomedical Advanced Research and Development Authority (BARDA), through the Rapid Response Partnership Vehicle (RRPV), has released a new Request for Information (RFI) titled “Biosafety Level 4 Preclinical and Nonclinical Support for Medical Countermeasure Development (BSL4)”. Issued July 9, 2026, the RFI is a market research exercise to map out who can deliver preclinical and nonclinical work in Biosafety Level 4 (BSL4) settings, and who can provide critical support services around those studies.
The focus is on partners that can support medical countermeasures for high‑consequence pathogens, including filoviruses such as Ebola, Bundibugyo, Sudan, and Marburg viruses, using relevant animal models under FDA’s Animal Rule and associated compliance program.
Two Types of Organizations
BARDA is using this RFI to identify two broad groups of organizations:
- BSL4 study performers: Institutions that can execute animal model studies at BSL4, including mouse, guinea pig, ferret, and nonhuman primate (macaque) models of filovirus infection. These studies range from model characterization and early proof‑of‑concept to adequate and well‑controlled efficacy studies that support licensure or approval under the Animal Rule.
- BSL4 study support providers: Organizations that may not run the BSL4 facilities themselves but can partner with BSL4 labs to provide project management, quality assurance/quality control, statistical analysis, pathology, assay development/validation, SENDIG‑AR dataset generation, technical/report writing, and preparation of regulatory documents and FDA submissions, including eCTD‑compliant packages.
BARDA emphasizes interest in capabilities that can deliver GLP‑aligned studies or, at minimum, work under a quality management system sufficient to meet FDA’s Animal Rule Compliance Program 7348.007. Respondents are asked to detail BSL4 capacity (animal numbers, study throughput, key personnel), GLP/Animal Rule experience, and specific operational or regulatory challenges they see in running countermeasure studies at BSL4.
Key Dates and How to Respond
- RFI issued: July 9, 2026
- Responses due: July 24, 2026, by 1 p.m. ET
Responses must be submitted via the RFI Submission Form and uploaded in PDF or Word format. The form can be found on the RRPV Opportunities page.
Respondents do not need to be RRPV members to answer this RFI, but they must join the RRPV consortium to respond to any future Request for Project Proposals (RPP) that may follow. The RFI is for information and planning purposes only and does not guarantee that BARDA or RRPV will issue an RPP or make awards.
Why This Matters for Innovators
BSL4 work is the chokepoint for a lot of serious filovirus countermeasure programs. There are only a handful of labs that can run these studies, and BARDA is clearly trying to map who can actually deliver end-to-end Animal Rule-aligned packages rather than just individual experiments.
For product developers, CROs, and platform companies, this RFI is a low‑friction way to get on the radar with BARDA and RRPV and signal that you can operate or support BSL4 labs if a future program is issued
EverGlade is a national advisory firm helping innovators navigate the federal funding ecosystem. We support companies across the funding lifecycle, from early-stage strategy through proposal development, negotiations, and post-award execution, ensuring you win the award and deliver the program.
For additional information on where your capabilities could plug in or support on a submission, schedule a conversation with our team.
