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.Apply for RFA MH 21 112
- 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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Frequently Asked Questions (FAQs)
What is the name of this SBIR funding opportunity?
The opportunity is titled "Service-Ready Tools for Identification, Prevention, and Treatment of Individuals at Risk for Suicide (R43/R44 Clinical Trial Optional)."
Who is sponsoring and administering this grant opportunity?
The sponsor is the National Institute of Mental Health (NIMH), which is part of the National Institutes of Health (NIH).
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-MH-21-112.
What type of funding mechanism is being used?
This is an SBIR award using the R43/R44 mechanism, which corresponds to the Small Business Innovation Research (SBIR) Phase I (R43) and Phase II (R44) structure.
Is this a discretionary grant and what area does it fall under?
Yes. It is described as a discretionary grant in the health area.
What is the CFDA number for this opportunity?
The CFDA number provided is 93.242.
Who is eligible to apply?
Eligibility is restricted to small businesses. The opportunity is intended specifically for small business applicants pursuing SBIR funding.
Are non-U.S. (foreign) entities eligible to apply?
No. The FOA explicitly states that non-U.S. (non-domestic) entities are not eligible to apply.
Can a U.S. small business apply if it has non-U.S. components?
The FOA states that non-U.S. components of U.S. organizations are not eligible to apply. It also notes that "foreign components" may be allowed under NIH policy definitions and conditions, so applicants with cross-border elements would need to review the NIH Grants Policy Statement and the FOA language closely.
What is the main goal of this funding opportunity?
The goal 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 (routine care), not only studied in controlled research environments.
What does NIMH mean by "service-ready" tools?
"Service-ready" implies the tool is mature enough for deployment in routine care and can be integrated into everyday clinical workflows. It emphasizes readiness for real-world implementation, workflow fit, usability, and consistent delivery in service settings.
What kinds of tools or products is NIMH seeking?
NIMH is looking for technologies and other practical products that support identification of suicide risk, prevention efforts, and treatment for individuals at risk for suicide. The FOA also highlights needs adjacent to direct care, such as tools to strengthen provider training, enable quality monitoring, and support quality improvement activities.
Is the focus limited to clinical interventions, or can tools support systems and providers too?
The opportunity is not limited to direct clinical interventions. It explicitly includes tools that support provider training, quality monitoring, and quality improvement, as these can improve access to and availability of evidence-based suicide prevention services at scale.
What is meant by improving access and availability of evidence-based services "at scale"?
The FOA aims to make it easier for systems of care to deliver evidence-based suicide prevention services consistently and broadly, by developing tools that are implementable in real-world settings and can be adopted and sustained across routine service environments.
What is the "effectiveness-implementation continuum" mentioned in the FOA?
The FOA emphasizes projects that address both (1) effectiveness of optimized, service-ready tools in relevant settings and (2) implementation research that tests strategies to improve adoption, implementation fidelity, and sustainment of those tools over time.
Does the FOA require implementation science, or is it optional?
The FOA expects projects to be guided by an implementation science framework. This includes planning for real-world uptake, measuring implementation outcomes, and accounting for barriers and facilitators within the service settings where the tool will be deployed.
What implementation outcomes does the FOA emphasize?
The FOA specifically highlights 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).
What is "implementation drift" and why does it matter for this opportunity?
"Implementation drift" refers to the tendency for an intervention to gradually change over time as it spreads across sites, staff turnover occurs, or workloads increase. NIMH encourages approaches that make products scalable and resistant to drift, supporting consistent and robust delivery in routine practice.
What kinds of design features does the FOA encourage to support consistent real-world use?
The FOA points to features that support consistency, usability, and robustness in real-world settings, such as appropriate automation, clear workflows, and built-in supports that help maintain quality over time.
How important is stakeholder input in tool development for this FOA?
Stakeholder input is strongly encouraged. The FOA promotes a deployment-focused development approach that includes perspectives of key stakeholders such as service users (patients and families), providers, and administrators.
What types of real-world constraints should applicants consider in their designs and tests?
The FOA highlights practical realities that can determine successful integration, including workflow fit, training burden, staffing constraints, and system-level issues such as workforce capacity.
What is the difference between SBIR Phase I (R43) and Phase II (R44) in this context?
Phase I (R43) typically supports early feasibility and proof-of-concept work. Phase II (R44) typically supports more advanced development and testing, aligned with producing a more mature, deployable, and commercially viable product.
Are clinical trials required under this FOA?
No. The FOA is labeled "Clinical Trial Optional," meaning applicants may propose clinical trials if appropriate, but clinical trials are not required for every project.
When was this FOA created and what is the listed closing date?
The FOA was created on 2020-11-13, and the original closing date listed is 2022-06-15.
What is the overall emphasis on commercialization?
The FOA emphasizes development of practice-ready, commercially viable tools. In other words, the expected outputs are not just research prototypes but products positioned for real-world deployment and market use in service settings.
What settings are emphasized for testing and deployment?
The FOA emphasizes real-world service settings and routine care environments, with tools designed to integrate into everyday clinical workflows rather than being limited to controlled research settings.
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| Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed) Apply for PAR 21 053 Funding Number: PAR 21 053 Agency: National Institutes of Health Category: Health Funding Amount: $250,000 |
| Service-Ready Tools for Identification, Prevention, and Treatment of Individuals at Risk for Suicide (R34 Clinical Trial Optional) Apply for RFA MH 21 111 Funding Number: RFA MH 21 111 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Service-Ready Tools for Identification, Prevention, and Treatment of Individuals at Risk for Suicide (R01 Clinical Trial Optional) Apply for RFA MH 21 110 Funding Number: RFA MH 21 110 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
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| NIDCR Small Grant Program for New Investigators (R03 Clinical Trial Not Allowed) Apply for PAR 21 084 Funding Number: PAR 21 084 Agency: National Institutes of Health Category: Health Funding Amount: $100,000 |
| Limited Competition: Small Grant Program for ORIP Special Emphasis Research Career Award (SERCA) K01 Recipients (R03 Clinical Trials Not Allowed) Apply for PAR 21 090 Funding Number: PAR 21 090 Agency: National Institutes of Health Category: Health Funding Amount: $75,000 |
| NEI Institutional Mentored Physician Scientist Award (K12 Clinical Trial Optional) Apply for PAR 21 073 Funding Number: PAR 21 073 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
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