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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FAQs: Radiological/Nuclear Medical Countermeasure Product Development Program (SBIR) (PA 18-525)
What is this funding opportunity?
This is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grant opportunity called the Radiological/Nuclear Medical Countermeasure Product Development Program (PA 18-525). It is designed to fund targeted product development work that moves promising radiological and nuclear medical countermeasures closer to a regulatory submission to the U.S. Food and Drug Administration (FDA).
What is the main goal of the program?
The core goal is to support development activities that result in a complete, high-quality regulatory package suitable for FDA submission as either an Investigational New Drug (IND) application (for drug and biologic candidates) or an Investigational Device Exemption (IDE) application (for device candidates).
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH).
What type of funding is this?
This is a discretionary grant funding opportunity under the NIH SBIR program.
Which SBIR mechanisms does this opportunity use?
The opportunity uses NIH SBIR grant mechanisms R43/R44, which generally align with a phased approach (Phase I and Phase II) for small business research and development.
What kinds of projects are a good fit?
Projects that are past the earliest discovery stage and need funding for specific preclinical and product development steps that reduce risk and directly support IND or IDE readiness are a good fit. The emphasis is on tangible product development milestones that lead directly to a regulatory submission package.
What kinds of countermeasures are in scope?
Radiological and nuclear medical countermeasures, including 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.
Are clinical trials allowed under this funding opportunity?
No. Clinical trials are explicitly not allowed under this FOA. Supported activities must remain in the preclinical and product development space and cannot include enrolling human subjects in clinical efficacy or safety trials.
What is meant by "closer to regulatory submission" in practical terms?
In practical terms, this program is meant to fund the studies, documentation, and development work needed to produce a submission-ready IND or IDE package. The focus is on development steps that de-risk the product and position it to enter the FDA-regulated clinical development pathway.
Who is eligible to apply?
Eligibility is restricted to small businesses, consistent with SBIR rules.
Can foreign organizations apply?
No. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as applicants.
Can a U.S. organization with non-U.S. components apply?
Non-domestic components of U.S. organizations are not eligible to apply. The announcement also notes that certain foreign components may be allowed as defined in the NIH Grants Policy Statement, typically for discrete elements of a project performed outside the U.S. when well-justified and consistent with NIH policy requirements.
Are foreign components ever allowed?
The opportunity indicates that certain foreign components may be allowed under NIH policy if they are clearly justified and meet NIH Grants Policy Statement requirements. Applicants are expected to consult the full funding announcement for the precise rules and any additional restrictions.
What is the CFDA number and funding activity category listed?
The listing ties this opportunity to the health funding activity category (CFDA 93.855).
What is the opportunity category and funding instrument?
The opportunity category is listed as discretionary, and the funding instrument is a grant.
When was the opportunity created?
The opportunity was created on 2017-12-19.
What is the closing date shown in the provided information?
The original closing date listed is 2021-01-05.
Does the provided listing include an award ceiling or expected number of awards?
No. The provided fields do not include an award ceiling or the expected number of awards. Applicants would typically need to review the full FOA text or NIH SBIR budget guidance for typical award ranges, project period expectations, and how many awards may be anticipated.
Is the program open to new applications and renewals?
The notice emphasizes encouraging both new and renewal applications, with the common theme that proposed work should align with clear product development milestones leading to IND or IDE readiness.
What is the overall purpose of this SBIR program in plain terms?
It functions as a translational SBIR pathway for small businesses developing radiation and nuclear preparedness or response technologies, funding concrete development work needed to reach an IND or IDE submission package while excluding clinical trials from the scope.
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Previous opportunity: NIH Exploratory/Developmental Research Grant Program ( Parent R21 Clinical Trial Not Allowed)
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