Opportunity Information: Apply for RFA DA 19 015
The National Institutes of Health (NIH) funding opportunity RFA-DA-19-015 supports small businesses that want to build and test digital loyalty or reward-based technologies aimed at improving adherence to FDA-approved medications used to treat substance use disorders. The core idea is to develop a technology platform, often delivered through a mobile medical app/device setup or similar digital tools, that can reinforce consistent medication-taking behavior through structured incentives. These incentives are not meant to be one-off gift cards handed out manually; the program emphasizes rewards and behavioral contingencies that can be delivered in a self-sustaining way, meaning the system should be designed to operate reliably over time without requiring constant hands-on administration.
The grant uses the SBIR phased structure under the R41/R42 mechanism, with clinical trials described as optional depending on what is necessary to achieve the project goals. Phase I (R41) is focused on demonstrating feasibility and/or validating the device or platform. In practical terms, this usually means proving that the technology can accurately track relevant behaviors, function in real-world settings, and integrate the core reward/loyalty logic in a way that is usable and acceptable for the intended users. Phase II (R42) then scales up to test efficacy in a larger sample, moving beyond feasibility into a more rigorous demonstration that the platform actually improves outcomes. Across both phases, the main outcome the program cares about is medication adherence to FDA-approved pharmacotherapies for substance use disorders, so projects should be designed with adherence as the primary endpoint, not as an indirect or secondary measure.
A key program expectation is that the technology includes a provider-facing component. This front-end interface should allow treatment providers (or clinic staff) to monitor participant progress and manage reward delivery in a structured way. The platform can incorporate advanced or novel features, and the announcement explicitly welcomes tools such as automated tracking systems, real-time measurements of patient progress, verification of medication intake, and momentary assessment approaches. The intent is to support technologies that go beyond basic reminders by pairing measurement with meaningful reinforcement, ideally in a manner that can adapt to patient behavior and maintain engagement over time.
Another important aspect is the regulatory trajectory. The funding announcement states that data generated through these studies should be usable to support a future FDA 510(k) submission, with the goal of seeking clearance as an FDA-cleared device. That implies applicants should be thinking early about design controls, validation, documentation, and the kind of performance evidence that would map onto a device clearance pathway. In other words, the research is not only about publishing results; it is also meant to move a product toward commercialization and regulatory acceptance.
Eligibility is restricted to small businesses, consistent with SBIR expectations. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, foreign components may be allowed under NIH policy definitions, meaning a U.S.-based applicant might still be able to include certain foreign collaborations if they meet NIH requirements and are justified appropriately. The opportunity is categorized as discretionary grant funding within education and health activities (CFDA 93.279), administered by NIH, with an original closing date listed as December 14, 2018, and a creation date of September 18, 2018.Apply for RFA DA 19 015
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Loyalty and Reward-Based Technologies to Increase Adherence to Substance Use Disorder Pharmacotherapies (R41/R42 - Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
- This funding opportunity was created on 2018-09-18.
- Applicants must submit their applications by 2018-12-14. (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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Frequently Asked Questions (FAQs)
What is the NIH funding opportunity RFA-DA-19-015 about?
RFA-DA-19-015 supports small businesses developing and testing digital loyalty or reward-based technologies designed to improve adherence to FDA-approved medications used to treat substance use disorders. The goal is a technology platform (often delivered through a mobile medical app/device setup or similar digital tools) that reinforces consistent medication-taking behavior using structured incentives.
Who is this grant intended for?
The opportunity is restricted to small businesses, consistent with the NIH SBIR program requirements.
What problem is the program trying to solve?
The program targets medication nonadherence among people prescribed FDA-approved pharmacotherapies for substance use disorders. Projects are expected to focus on improving consistent medication-taking as the primary outcome.
What types of technologies are supported?
The announcement supports digital platforms that implement loyalty/reward-based approaches and can measure and reinforce adherence-related behaviors. Examples mentioned include automated tracking systems, real-time measurements of patient progress, verification of medication intake, and momentary assessment approaches.
Are simple reminder apps a fit for this opportunity?
The intent is to support tools that go beyond basic reminders by pairing measurement with meaningful reinforcement. The platform should include structured incentives tied to behavioral contingencies, ideally in a way that can adapt to patient behavior and maintain engagement over time.
What does "loyalty or reward-based" mean in this context?
It refers to structured incentive mechanisms that reinforce medication-taking behavior. The program emphasizes rewards and behavioral contingencies that can be delivered digitally and reliably, rather than one-off, manually administered incentives.
Does the program expect the rewards system to be self-sustaining?
Yes. The opportunity emphasizes incentive delivery that is "self-sustaining," meaning the system should be designed to operate reliably over time without requiring constant hands-on administration.
What is the SBIR mechanism used for this funding opportunity?
The funding uses the NIH SBIR phased structure under the R41/R42 mechanism.
What is the focus of Phase I (R41)?
Phase I is focused on demonstrating feasibility and/or validating the device or platform. Practically, this includes showing the technology can accurately track relevant behaviors, function in real-world settings, and integrate reward/loyalty logic in a usable and acceptable way for the intended users.
What is the focus of Phase II (R42)?
Phase II scales up to test efficacy in a larger sample. It moves beyond feasibility to a more rigorous demonstration that the platform improves outcomes, with medication adherence expected to be the primary endpoint.
Are clinical trials required?
Clinical trials are described as optional, depending on what is necessary to achieve the project goals.
What outcome does NIH care about most for this program?
The main outcome emphasized is medication adherence to FDA-approved pharmacotherapies for substance use disorders. Projects are expected to be designed with adherence as the primary endpoint, not as an indirect or secondary measure.
Is a provider-facing component required?
Yes. A key expectation is that the technology includes a provider-facing component so treatment providers or clinic staff can monitor participant progress and manage reward delivery in a structured way.
What should the provider-facing interface enable?
Based on the description, it should allow providers or clinic staff to monitor participant progress and manage reward delivery in a structured manner.
Can the platform include advanced features like real-time monitoring or verification of medication intake?
Yes. The announcement explicitly welcomes features such as automated tracking, real-time measurement of patient progress, verification of medication intake, and momentary assessment approaches.
How does the opportunity relate to FDA clearance?
The funding announcement states that data generated through these studies should be usable to support a future FDA 510(k) submission, with the goal of seeking clearance as an FDA-cleared device. This implies applicants should consider design controls, validation, documentation, and performance evidence aligned with a device clearance pathway.
Is the intent only to publish research findings?
No. While research results matter, the opportunity is also intended to move a product toward commercialization and regulatory acceptance, including generating data usable for a future FDA 510(k) submission.
Are foreign (non-U.S.) institutions eligible to apply?
No. Foreign institutions (non-U.S. entities) are not eligible to apply.
Can a U.S. applicant include non-U.S. components of their organization?
No. Non-U.S. components of U.S. organizations are also stated as not eligible.
Are any foreign collaborations allowed at all?
Foreign components may be allowed under NIH policy definitions. That means a U.S.-based applicant might be able to include certain foreign collaborations if they meet NIH requirements and are appropriately justified.
Which agency administers this opportunity?
The opportunity is administered by the National Institutes of Health (NIH).
What is the CFDA number associated with this opportunity?
The opportunity is listed under CFDA 93.279.
How is the funding categorized?
It is categorized as discretionary grant funding within education and health activities.
What were the key dates listed for the opportunity?
The creation date is listed as September 18, 2018, and the original closing date is listed as December 14, 2018.
What kinds of delivery formats are envisioned for the technology?
The description points to platforms often delivered through a mobile medical app/device setup or similar digital tools, with integrated tracking and incentive logic and a provider-facing component.
Does the incentive delivery need to be automated or digitally managed?
The emphasis is on reward delivery that can be administered in a structured and self-sustaining way, rather than manual, one-off distribution. The announcement also welcomes automated tracking and real-time measurement approaches, aligning with digitally managed incentives.
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