Opportunity Information: Apply for PA 18 525
The Radiological/Nuclear Medical Countermeasure Product Development Program (SBIR) funding opportunity (PA 18-525) is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grant program designed to push promising radiological and nuclear medical countermeasures closer to regulatory submission. The core goal is to support targeted product development work that results in a complete, high-quality package suitable for submission to the U.S. Food and Drug Administration (FDA) as either an Investigational New Drug (IND) application (for drug and biologic candidates) or an Investigational Device Exemption (IDE) application (for device candidates). In practical terms, this opportunity is meant for small companies that are past the earliest discovery stage and need funding to perform the specific studies, documentation, and development steps that de-risk a countermeasure and make it ready to enter the FDA-regulated clinical development pathway. As stated in the title and solicitation, clinical trials are not allowed under this FOA, so supported activities must remain in the preclinical and product development space rather than enrolling human subjects in clinical efficacy or safety trials.
This FOA sits within NIH and is tied to the health funding activity category (CFDA 93.855). It uses the SBIR grant mechanisms R43/R44, which generally correspond to a phased approach (Phase I and Phase II) for small business R&D. While the notice emphasizes encouraging both new and renewal applications, the common theme is that proposed work should be clearly aligned with tangible product development milestones that lead directly to IND or IDE readiness. The emphasis on radiological/nuclear medical countermeasures indicates that NIH is looking for candidate drugs, biologics, devices, or related technologies intended to prevent, diagnose, mitigate, treat, or otherwise respond to injuries and health threats associated with radiological or nuclear incidents.
Eligibility is restricted to small businesses, consistent with SBIR rules, and there are clear limitations on foreign participation. Non-domestic (non-U.S.) entities, meaning foreign institutions, are not eligible to apply as applicants. In addition, non-domestic components of U.S. organizations are not eligible to apply. However, the FOA notes that certain foreign components may be allowed as defined in the NIH Grants Policy Statement, which typically refers to discrete elements of a project performed outside the U.S. when they are well-justified and meet NIH policy requirements. Applicants are expected to consult the full funding announcement for the precise eligibility and foreign component rules, since NIH often requires explicit justification and may apply additional restrictions depending on the program.
Key administrative details from the source data include the opportunity category (discretionary), the funding instrument (grant), and the sponsoring agency (National Institutes of Health). The opportunity was created on 2017-12-19, and the original closing date listed is 2021-01-05. The listing does not provide an award ceiling or expected number of awards in the provided fields, which usually means applicants would need to review the full FOA text or NIH budget guidance for typical SBIR award ranges, project period expectations, and the number of awards anticipated in a given fiscal year.
Overall, the program is best understood as a translational SBIR pathway for small businesses working on radiation/nuclear preparedness and response technologies, with funding targeted at the concrete development work needed to reach an IND or IDE submission package, while explicitly excluding clinical trials from the scope of supported activities.Apply for PA 18 525
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Radiological/Nuclear Medical Countermeasure Product Development Program (SBIR) (R43/R44 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
- This funding opportunity was created on 2017-12-19.
- Applicants must submit their applications by 2021-01-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
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