Medical Devices for Pediatric Population Affected by Substance Use and Addiction (R41 - Clinical Trials Optional) | RFA DA 26 017

Frequently Asked Questions (FAQs)

1) What is the name and identifier of this funding opportunity?

This opportunity is titled Medical Devices for Pediatric Population Affected by Substance Use and Addiction (R41 - Clinical Trials Optional). The funding opportunity number is RFA-DA-26-017.

2) What agency is offering this grant?

The opportunity is offered by the National Institutes of Health (NIH) under its Small Business Innovation Research (SBIR) program.

3) What is the purpose of this SBIR solicitation?

The purpose is to support early-stage research and development of medical devices intended specifically for children, adolescents, and young adults affected by substance use and addiction. The emphasis is on translating a device concept toward commercialization and real-world clinical use in pediatric contexts.

4) What does "pediatric" mean for this program?

In this program, "pediatric" follows the FDA Center for Devices and Radiological Health (CDRH) definition: ages 0 through 21. Proposed devices should be clearly indicated for that age range and designed with pediatric needs, safety considerations, and clinical contexts in mind.

5) What types of projects are a good fit?

Projects are a good fit when the core innovation is a medical device (or a device-led system) designed to address pediatric substance use or addiction-related needs. Strong proposals typically define the specific pediatric problem, explain why a device solution is needed, and outline a development path that fits pediatric clinical realities and device regulatory requirements.

6) What types of projects are not the primary focus of this NOFO?

The overall focus is on device-based solutions. The NOFO is not described as primarily supporting a purely behavioral program, a basic science project, or a general public health intervention unless the innovation is fundamentally a medical device or device-led system.

7) What does the SBIR R41 mechanism mean in practice?

The NOFO uses the SBIR R41 mechanism, which is typically associated with Phase I work such as feasibility, proof-of-concept, and early prototype development or refinement. Applicants are expected to propose a credible early development plan that can move a device toward commercialization.

8) Are clinical trials required?

No. The NOFO is labeled "Clinical Trials Optional", meaning a clinical trial may be included if it is appropriate and justified for the stage of development, but a clinical trial is not required.

9) What range of activities can be proposed?

Projects can range from non-clinical engineering and usability work through early clinical evaluation, as long as the proposed activities align with the maturity of the technology and the risks are managed appropriately for a pediatric population.

10) Who is eligible to apply?

Eligibility is limited to U.S. small business concerns (SBCs), consistent with SBIR rules.

11) Are foreign organizations eligible to apply?

No. Foreign organizations are not eligible to apply.

12) Are non-U.S. components of a U.S. organization eligible?

No. Non-U.S. components of U.S. organizations are not eligible for this opportunity.

13) Are any international activities allowed at all?

Possibly. The NOFO indicates that "foreign components" may be permitted in some cases as defined by the NIH Grants Policy Statement. This generally means a discrete element of the project can be conducted outside the U.S. when it is strongly justified and appropriately documented, while the applicant organization remains an eligible U.S. small business and the overall structure complies with NIH policy.

14) What is the maximum award amount?

The posting indicates an award ceiling of $400,000. Applicants should size the scope of proposed aims and activities to fit within this ceiling.

15) What is the closing date for the opportunity?

The original closing date listed is February 26, 2025.

16) What is the CFDA number and activity area listed?

The opportunity is listed as a discretionary grant in the education and health activity area with CFDA 93.279.

17) What should applicants consider when planning the project scope and budget?

Because the award ceiling is $400,000 and the mechanism is aimed at Phase I-type work, applicants should plan a focused set of activities (for example, engineering development, verification activities, usability testing, and any optional clinical components) that can realistically be completed within the budget and appropriate to early-stage development.

18) What does NIH appear to expect in a competitive application?

Based on the description provided, competitive applications typically:

• Clearly define the pediatric substance use or addiction-related problem being addressed
• Explain why a device solution is needed and why existing tools are insufficient
• Make the pediatric indication explicit (ages 0 through 21)
• Address age-appropriate design constraints, including human factors, usability, safety, and privacy where relevant
• Include a plausible plan for validation, risk management, and eventual adoption in settings serving youth affected by substance use and addiction
• Describe a credible pathway toward commercialization and real-world clinical use, consistent with SBIR expectations

19) How important is it to address pediatric-specific safety and usability?

It appears central to this NOFO. The device should be designed with pediatric needs, safety considerations, and clinical contexts in mind, and strong proposals are described as addressing human factors, usability, safety, and privacy where relevant for the target age range.

20) What planning steps are suggested ahead of the deadline?

The opportunity description suggests planning backward from the February 26, 2025 closing date to allow time for items such as required registrations, subcontractor arrangements, letters of support, regulatory strategy development, and assembling a commercialization narrative consistent with SBIR expectations.