Service-Ready Tools for Identification, Prevention, and Treatment of Individuals at Risk for Suicide (R43/R44 Clinical Trial Optional) | RFA MH 21 112

Opportunity Information: Apply for RFA MH 21 112

The National Institute of Mental Health (NIMH), part of the National Institutes of Health (NIH), released an SBIR grant opportunity called "Service-Ready Tools for Identification, Prevention, and Treatment of Individuals at Risk for Suicide (R43/R44 Clinical Trial Optional)" under Funding Opportunity Number RFA-MH-21-112. It is a discretionary grant in the health area (CFDA 93.242) intended specifically for small businesses. The overall aim is to move beyond early prototypes and support the development and testing of practice-ready, commercially viable suicide prevention tools that can be implemented in real-world service settings, not just researched in controlled environments.

A central theme of the opportunity is building tools that are "service-ready," meaning they are mature enough to be deployed in routine care and can be integrated into everyday clinical workflows. NIMH is looking for technologies and other practical products that help with identification of suicide risk, prevention efforts, and treatment for people who are at risk. The announcement also highlights adjacent but critical needs in suicide prevention services, such as tools that strengthen provider training, enable quality monitoring, and support quality improvement activities. The intent is to improve access to, and the availability of, evidence-based suicide prevention services by making it easier for systems of care to deliver them consistently and at scale.

The FOA emphasizes work along the effectiveness-implementation continuum. On one side, applicants are encouraged to develop and test the effectiveness of optimized tools that are ready for service delivery, including demonstrating that the tool actually works for its intended purpose in relevant settings. On the other side, the FOA explicitly supports research that tests strategies for getting these tools adopted and used correctly over time. This includes improving adoption (whether organizations and clinicians decide to use the tool), implementation fidelity (whether it is delivered as intended), and sustainment (whether it continues to be used after initial rollout). Rather than treating implementation as an afterthought, the program expects projects to be guided by an implementation science framework, meaning applicants should deliberately plan for real-world uptake, measure implementation outcomes, and account for barriers and facilitators within the settings where the tool will be deployed.

Because the end goal is broad, reliable use in practice, NIMH encourages approaches that make products scalable and resistant to "implementation drift," the common problem where an intervention slowly changes over time as it spreads across sites, staff turnover occurs, or workloads increase. The announcement points applicants toward technology and design features that support consistency, usability, and robustness, such as automation where appropriate, clear workflows, and built-in supports that help maintain quality. It also encourages a deployment-focused development approach that includes the perspectives of key stakeholders such as service users (patients and families), providers, and administrators. In practical terms, this means the tool should be designed with end users in mind and tested in settings that reflect where it will actually be used, with attention to workflow fit, training burden, staffing constraints, and other system-level realities like workforce capacity that can make or break successful integration.

The mechanism is R43/R44, which refers to the SBIR Phase I and Phase II structure commonly used to support small business innovation: Phase I typically supports early feasibility and proof-of-concept work, while Phase II supports more advanced development and testing. The announcement notes "Clinical Trial Optional," indicating that applicants may propose clinical trials if appropriate, but they are not strictly required for every project. The FOA was created on 2020-11-13, and the original closing date listed is 2022-06-15.

Eligibility is restricted to small businesses, and the FOA clearly states that non-U.S. (non-domestic) entities are not eligible to apply. It also states that non-U.S. components of U.S. organizations are not eligible to apply, though "foreign components" may be allowed under NIH policy definitions and conditions, so applicants with any cross-border elements would need to review the NIH Grants Policy Statement and the specific FOA language closely. Overall, this opportunity is aimed at companies that can deliver practical, market-viable suicide prevention solutions and can demonstrate not only that the tool works, but also that it can be adopted, implemented with fidelity, and sustained in real service systems.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Service-Ready Tools for Identification, Prevention, and Treatment of Individuals at Risk for Suicide (R43/R44 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242.
• This funding opportunity was created on 2020-11-13.
• Applicants must submit their applications by 2022-06-15. (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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