Opportunity Information: Apply for PA 18 566
The funding opportunity titled "Complex Technologies and Therapeutics Development for Mental Health Research and Practice (R43/R44 Clinical Trial Optional)" (PA-18-566) is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grant program run through the National Institute of Mental Health (NIMH). It is designed to support U.S. small businesses that are building or advancing technologies and therapeutics that align with NIMH's mission, including work that strengthens basic neuroscience relevant to mental disorders, improves translation from lab research into practical tools, supports clinical research on mental disorders, enhances diagnosis or treatment, and helps spread evidence-based mental health care into real-world practice settings. In plain terms, the program is meant to help small companies take high-impact mental health innovations from the development stage toward something that can be tested, validated, and ultimately used by researchers, clinicians, or health systems.
A key feature of this announcement is that it targets "complex" projects that need more time and money than what standard SBIR limits typically allow. That usually means technologies that are harder to engineer, validate, integrate into workflows, or scale for real use, such as advanced digital health platforms, sophisticated clinical decision-support tools, novel therapeutic approaches, multi-component devices, or other integrated systems that require substantial research and development before they are ready for commercialization or widespread deployment. The emphasis is not just on incremental product tweaks, but on meaningful development efforts that could materially improve mental health research capabilities or patient care.
The mechanism includes both Phase I (R43) and Phase II (R44) SBIR pathways, and it is labeled "Clinical Trial Optional." That indicates applicants may propose projects that include a clinical trial if it makes sense for the technology or therapeutic being developed, but a clinical trial is not automatically required. This flexibility matters because some projects may focus on preclinical development, feasibility testing, usability, or validation studies that are not structured as clinical trials, while others may need clinical evaluation to demonstrate safety, effectiveness, or clinical utility.
Eligibility is limited to small businesses, and the opportunity explicitly excludes non-U.S. (foreign) institutions from applying. It also states that non-domestic components of U.S. organizations are not eligible to apply. However, it notes that "foreign components" as defined by NIH policy may be allowed, which typically means certain project elements can be conducted outside the U.S. only with NIH approval and with strong justification, while the applicant organization itself must remain a compliant U.S. small business. The program is categorized as a discretionary grant in the health funding activity area (CFDA 93.242) administered by NIH.
Administrative details provided in the source include a creation date of January 12, 2018, with an original closing date listed as April 5, 2021. An award ceiling and expected number of awards are not specified in the excerpt, which often means applicants need to consult the full announcement and NIH SBIR budget guidance for allowable costs and any special budget limits associated with this particular complex-technology FOA. Overall, the opportunity is positioned as a development-focused SBIR pathway for small businesses pursuing higher-effort, higher-complexity mental health technologies or therapeutics that can advance research, improve clinical diagnosis and treatment, or strengthen the delivery and dissemination of proven mental health care.Apply for PA 18 566
- 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 (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 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 (R43/R44 Clinical Trial Optional) (PA-18-566)
What is this funding opportunity?
This is an NIH Small Business Innovation Research (SBIR) funding opportunity run through the National Institute of Mental Health (NIMH) titled "Complex Technologies and Therapeutics Development for Mental Health Research and Practice (R43/R44 Clinical Trial Optional)" (PA-18-566).
Which NIH institute is administering this program?
The program is administered by the National Institutes of Health (NIH) through the National Institute of Mental Health (NIMH).
Who is the intended applicant?
The opportunity is intended for U.S. small businesses. Eligibility is limited to small business applicants, consistent with the SBIR program.
Are non-U.S. (foreign) institutions eligible to apply?
No. The opportunity explicitly excludes non-U.S. (foreign) institutions from applying.
Can a U.S. organization apply if part of the work will be done outside the United States?
Non-domestic components of U.S. organizations are not eligible to apply. However, the opportunity notes that "foreign components" (as defined by NIH policy) may be allowed with NIH approval and strong justification, while the applicant itself must be a compliant U.S. small business.
What kinds of projects is NIMH trying to support with this SBIR?
The program supports small businesses building or advancing technologies and therapeutics that align with NIMH's mission. This includes work that strengthens basic neuroscience relevant to mental disorders, improves translation of lab research into practical tools, supports clinical research on mental disorders, enhances diagnosis or treatment, and helps spread evidence-based mental health care into real-world practice settings.
What does "complex technologies" mean in the context of this announcement?
It targets projects considered "complex" because they may require more time and funding than standard SBIR limits typically allow. These are often technologies that are harder to engineer, validate, integrate into workflows, or scale for real-world use.
What are some examples of the kinds of complex projects this FOA is meant to cover?
Examples described include advanced digital health platforms, sophisticated clinical decision-support tools, novel therapeutic approaches, multi-component devices, and other integrated systems that require substantial R&D before they are ready for commercialization or widespread deployment.
Is this program meant for small incremental improvements to existing products?
The emphasis is on meaningful development efforts that could materially improve mental health research capabilities or patient care, rather than incremental product tweaks.
What SBIR phases and activity codes are included?
This funding opportunity includes both Phase I (R43) and Phase II (R44) SBIR pathways.
What does "Clinical Trial Optional" mean?
"Clinical Trial Optional" means an applicant may propose a project that includes a clinical trial if it makes sense for the technology or therapeutic being developed, but a clinical trial is not automatically required.
If clinical trials are optional, what other study types could fit this program?
The description indicates that some projects may focus on preclinical development, feasibility testing, usability, or validation studies that are not structured as clinical trials, while others may need clinical evaluation to demonstrate safety, effectiveness, or clinical utility.
What is the overall goal of the program in plain language?
The goal is to help small companies move high-impact mental health innovations from development toward technologies or therapeutics that can be tested, validated, and ultimately used by researchers, clinicians, or health systems.
What types of impact is NIMH looking for?
Projects should be positioned to advance mental health research, improve clinical diagnosis and treatment, and/or strengthen the delivery and dissemination of evidence-based mental health care in real-world practice settings.
What is the CFDA number and funding category mentioned?
The opportunity is listed in the health funding activity area under CFDA 93.242 and is categorized as a discretionary grant administered by NIH.
When was this funding opportunity created, and what closing date is listed?
The source information includes a creation date of January 12, 2018, and an original closing date listed as April 5, 2021.
Does the excerpt specify an award ceiling or the expected number of awards?
No. The excerpt states that an award ceiling and the expected number of awards are not specified.
How should applicants interpret budget limits if an award ceiling is not specified in the excerpt?
The excerpt suggests that applicants may need to consult the full announcement and NIH SBIR budget guidance for allowable costs and for any special budget limits that may apply to this complex-technology FOA.
Is this opportunity more focused on early research or on development toward practical use?
It is positioned as development-focused, supporting higher-effort, higher-complexity projects that move technologies or therapeutics toward testing, validation, and eventual use in research or clinical/practice settings.
Browse more opportunities from the same category: Health
Next opportunity: NIMH Biobehavioral Research Awards for Innovative New Scientists (NIMH BRAINS) (R01 Clinical Trial Optional)
Previous opportunity: BRAIN Initiative: Research Resource Grants for Technology Integration and Dissemination (U24)
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| Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use disorder and Alcohol-related disorders (U44 - Clinical Trial Optional) Apply for PAR 18 578 Funding Number: PAR 18 578 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
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| Clincal Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed) Apply for PAR 18 597 Funding Number: PAR 18 597 Agency: National Institutes of Health Category: Health Funding Amount: $225,000 |
| Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R01 Clinical Trial Optional) Apply for PAR 18 596 Funding Number: PAR 18 596 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Coordination Center for Programs to Increase Diversity Among Individuals Engaged in Health-Related Research (PRIDE) (U24 Clinical Trial Not Allowed) Apply for RFA HL 19 001 Funding Number: RFA HL 19 001 Agency: National Institutes of Health Category: Health Funding Amount: $320,000 |
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