Opportunity Information: Apply for PA 18 579
The Complex Technologies and Therapeutics Development for Mental Health Research and Practice (R41/R42) opportunity (Funding Opportunity Number PA-18-579) is a National Institutes of Health grant solicitation run through the National Institute of Mental Health (NIMH) under the Small Business Innovation Research (SBIR) program. Its central purpose is to help small businesses build and advance technologies that directly support NIMH's mission across the mental health pipeline, from foundational neuroscience work connected to mental disorders, through translational and clinical research, to practical tools for clinical diagnosis and treatment, and on to real-world dissemination of evidence-based mental health care.
What makes this specific SBIR opportunity distinctive is its emphasis on "complex technologies" and therapeutics development efforts that are too large, too technically demanding, or too time-intensive for the standard SBIR funding levels and project timelines. In other words, it is aimed at R and D projects that require more resources and longer development arcs than a typical small business SBIR project, such as sophisticated platforms, integrated hardware-software systems, advanced therapeutic approaches, or other high-complexity solutions intended to improve mental health research or care delivery. The intent is to encourage more ambitious development work that can still be pursued within an SBIR framework, helping companies de-risk and mature technologies that could ultimately have strong scientific, clinical, and public health impact.
The funding mechanism is the NIH SBIR phased award structure using R41/R42, which generally corresponds to a Phase I effort (feasibility, proof of concept, early prototype, or initial validation) followed by a Phase II effort (expanded development, refinement, and more rigorous testing). The funding instrument type is a grant, and the activity category is health, with CFDA number 93.242. Eligibility is limited to small businesses. Foreign institutions (non-U.S. entities) are explicitly not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply. However, foreign components may be allowed when they meet the NIH definition and policy requirements described in the NIH Grants Policy Statement, meaning some limited, justified international involvement might be permissible under NIH rules even though the applicant organization itself must be an eligible U.S. small business.
Administrative details included with the listing note an original closing date of 2021-04-05 and a creation date of 2018-01-12. The public summary does not specify an award ceiling or expected number of awards in the provided source data, which typically means applicants would need to consult the full FOA text and related NIH SBIR policy guidance for budget limits, duration expectations, and any topic-specific caps or justifications required for the higher funding levels associated with complex technology projects.Apply for PA 18 579
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Complex Technologies and Therapeutics Development for Mental Health Research and Practice (R41/R42)" 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 2018-01-12.
- Applicants must submit their applications by 2021-04-05. (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: Complex Technologies and Therapeutics Development for Mental Health Research and Practice (R41/R42) - PA-18-579
What is this funding opportunity?
This is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grant opportunity titled "Complex Technologies and Therapeutics Development for Mental Health Research and Practice (R41/R42)." The Funding Opportunity Number (FOA) is PA-18-579, and it is administered through the National Institute of Mental Health (NIMH).
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH), and the specific NIH institute running the solicitation is the National Institute of Mental Health (NIMH).
What is the main purpose of the program?
The central purpose is to help eligible small businesses build and advance technologies that directly support NIMH's mission across the mental health pipeline. This includes work ranging from foundational neuroscience related to mental disorders, to translational and clinical research, to practical tools for clinical diagnosis and treatment, and ultimately to real-world dissemination of evidence-based mental health care.
What makes this SBIR opportunity different from a standard SBIR solicitation?
This opportunity emphasizes "complex technologies" and therapeutic development efforts that are too large, too technically demanding, or too time-intensive for standard SBIR funding levels and typical SBIR project timelines. It is designed for more ambitious research and development arcs that still fit within an SBIR framework.
What types of projects are envisioned under "complex technologies"?
The description points to projects such as sophisticated platforms, integrated hardware-software systems, advanced therapeutic approaches, and other high-complexity solutions intended to improve mental health research or care delivery. The common theme is higher complexity and a need for additional resources and longer development than a typical SBIR project.
What does the R41/R42 mechanism mean?
R41/R42 refers to the NIH SBIR phased award structure. It generally corresponds to a Phase I effort followed by a Phase II effort, supporting a progression from early feasibility work to expanded development and testing.
What is typically supported in Phase I (R41)?
Phase I generally supports feasibility and early-stage work such as proof of concept, early prototyping, or initial validation.
What is typically supported in Phase II (R42)?
Phase II generally supports expanded development, refinement, and more rigorous testing of the technology or therapeutic approach.
What is the funding instrument and activity category?
The funding instrument type is a grant. The activity category is health.
What is the CFDA number for this opportunity?
The CFDA number listed for this opportunity is 93.242.
Who is eligible to apply?
Eligibility is limited to small businesses under the SBIR program requirements.
Are foreign institutions eligible to apply?
No. Foreign institutions (non-U.S. entities) are explicitly not eligible to apply.
Are non-U.S. components of U.S. organizations eligible to apply?
No. Non-U.S. components of U.S. organizations are also explicitly not eligible to apply.
Can a U.S. small business include any international involvement in the project?
Potentially, yes, in limited circumstances. The listing notes that foreign components may be allowed when they meet the NIH definition and policy requirements described in the NIH Grants Policy Statement. This means the applicant must still be an eligible U.S. small business, and any foreign component would need to be justified and compliant with NIH policy.
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PA-18-579.
What is the listed closing date?
The administrative details note an original closing date of 2021-04-05.
What is the creation date of the opportunity listing?
The creation date provided is 2018-01-12.
Is there an award ceiling listed in the provided summary?
No. The public summary provided does not specify an award ceiling.
Does the provided summary say how many awards will be made?
No. The provided source data does not include an expected number of awards.
Where should applicants look for budget limits, duration expectations, or any caps related to higher-cost projects?
The summary indicates applicants would need to consult the full FOA text and related NIH SBIR policy guidance for budget limits, duration expectations, and any topic-specific caps or justifications that may be required for the higher funding levels associated with complex technology projects.
What kinds of outcomes is the program trying to achieve?
The program intent is to encourage ambitious development work that can be pursued within an SBIR framework, helping companies de-risk and mature technologies that could ultimately have strong scientific, clinical, and public health impact in mental health research and care delivery.
Is this opportunity focused only on research, or also on practical clinical tools?
It spans the pipeline described in the summary: foundational neuroscience connected to mental disorders, translational and clinical research, practical tools for clinical diagnosis and treatment, and dissemination of evidence-based mental health care in real-world settings.
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