Opportunity Information: Apply for PA 18 567
The opportunity titled "Competing Renewal Awards of SBIR Phase IIB Grants for Brain and Behavior Tools (R44 Clinical Trial Optional)" is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) funding announcement designed to help small businesses push promising mental health-related technologies beyond the earlier SBIR phases. The focus is on continuing and advancing development work that was already started under a previously funded SBIR Phase II award, with the specific intent of moving complex tools closer to real-world readiness and broader adoption in research or clinical settings. In practical terms, this is a Phase IIB competing renewal mechanism under the R44 grant activity, meaning it is not meant for brand-new ideas from scratch, but rather for teams that already have a Phase II SBIR project and can justify the need for an additional, later-stage development period.
The scope centers on "brain and behavior tools" relevant to mental disorders, with examples explicitly including complex instrumentation, clinical research tools, and behavioral interventions. This framing allows a wide range of product types, such as hardware or software instrumentation used to measure or influence brain function, tools that support clinical research workflows (for example, assessment platforms, digital phenotyping systems, data acquisition/analysis solutions, or specialized devices used in psychiatric research), and structured behavioral intervention products that can be deployed and evaluated systematically. The key theme is maturation and refinement: improving performance, reliability, usability, validation, scalability, manufacturability, and readiness for broader testing or implementation, rather than early feasibility exploration.
A notable feature of the announcement is that it is "Clinical Trial Optional." That wording generally signals that applicants may propose clinical trial activities if they are appropriate and justified for the stage of development, but a clinical trial is not required for every project. This gives applicants flexibility to tailor their development plan to what is most sensible for the tool or intervention being advanced, whether that is engineering refinement and verification, human factors work, larger-scale validation studies, or a clinical evaluation pathway when warranted.
Eligibility is limited to small businesses, consistent with the SBIR program rules. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply. However, the announcement notes that "foreign components" as defined in the NIH Grants Policy Statement may be allowed, which typically refers to discrete, well-justified elements of a project being carried out outside the United States under specific NIH rules and with appropriate approvals. The practical takeaway is that the applicant organization must be a qualifying U.S. small business, and any international involvement would need to fit NIH's narrow definition of an allowable foreign component rather than constituting a non-U.S. applicant or major non-U.S. organizational component.
From the administrative details provided, this is a discretionary grant opportunity administered by NIH in the health funding area, with CFDA number 93.242. The funding opportunity number is PA-18-567, and it was created on 2018-01-09. The listed original closing date is 2021-04-05, indicating the opportunity was time-bound around that cycle. The award ceiling shown is $1,000,000, suggesting an upper limit on the total award amount per project under the parameters captured in the source data. The announcement is aimed at enabling further development work at a level that can be expensive and technically demanding, which aligns with the emphasis on complex instrumentation and later-stage tool maturation.
Overall, this FOA is best understood as a bridge funding mechanism for SBIR Phase II projects in the mental health technology space that have produced encouraging results and now need an additional, competitively reviewed Phase IIB period to reach key development milestones. The NIH intent is to accelerate the availability of robust brain and behavior tools and interventions that can improve mental health research and, potentially, clinical care, while keeping the applicant pool focused on U.S. small businesses that have already demonstrated progress through a prior Phase II SBIR award.Apply for PA 18 567
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Competing Renewal Awards of SBIR Phase IIB Grants for Brain and Behavior Tools (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 2018-01-09.
- 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.)
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- Eligible applicants include: Small businesses.
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Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The opportunity is titled "Competing Renewal Awards of SBIR Phase IIB Grants for Brain and Behavior Tools (R44 Clinical Trial Optional)."
Which agency is offering this grant?
This is a National Institutes of Health (NIH) funding announcement under the Small Business Innovation Research (SBIR) program.
What is the funding opportunity number (FOA number)?
The funding opportunity number is PA-18-567.
What type of award mechanism is this?
This is an SBIR Phase IIB competing renewal mechanism under the R44 grant activity. It is intended for later-stage development work that continues a previously funded SBIR Phase II project.
Is this opportunity meant for brand-new projects or ideas?
No. The announcement is positioned as a Phase IIB competing renewal and is described as not being intended for brand-new ideas from scratch. It is meant for teams that already have a Phase II SBIR project and can justify the need for an additional, later-stage development period.
What is the main purpose of this Phase IIB competing renewal?
The purpose is to help small businesses push promising mental health-related technologies beyond earlier SBIR phases by continuing and advancing development started under a prior SBIR Phase II award, moving complex tools closer to real-world readiness and broader adoption in research or clinical settings.
What is the scientific or technology focus area?
The scope centers on "brain and behavior tools" relevant to mental disorders, with examples that explicitly include complex instrumentation, clinical research tools, and behavioral interventions.
What kinds of projects might fit under "brain and behavior tools" in this announcement?
Based on the examples provided, relevant projects may include complex instrumentation; tools that support clinical research workflows (such as assessment platforms, digital phenotyping systems, data acquisition/analysis solutions, or specialized devices used in psychiatric research); and structured behavioral intervention products that can be deployed and evaluated systematically.
What stage of development is NIH looking to support through this FOA?
The emphasis is on maturation and refinement of tools rather than early feasibility work. This includes improving performance, reliability, usability, validation, scalability, manufacturability, and overall readiness for broader testing or implementation.
Does this FOA require a clinical trial?
No. The FOA is described as "Clinical Trial Optional," meaning applicants may propose clinical trial activities if appropriate and justified, but a clinical trial is not required for every project.
What does "Clinical Trial Optional" imply for project planning?
It implies flexibility to propose the development plan that best matches the tool's stage and needs, such as engineering refinement and verification, human factors work, larger-scale validation studies, or a clinical evaluation pathway when warranted.
Who is eligible to apply?
Eligibility is limited to small businesses, consistent with SBIR program rules.
Are foreign institutions eligible to apply?
No. Foreign institutions (non-U.S. entities) are 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 not eligible to apply.
Are any international activities allowed as part of the project?
The announcement notes that "foreign components" (as defined in the NIH Grants Policy Statement) may be allowed. This typically refers to discrete, well-justified elements of the project carried out outside the United States under specific NIH rules and with appropriate approvals.
What is the practical takeaway regarding international involvement?
The applicant must be a qualifying U.S. small business. Any international involvement would need to fit NIH's narrow definition of an allowable foreign component and cannot be a non-U.S. applicant organization or a major non-U.S. organizational component.
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.242.
What is the award ceiling shown for this opportunity?
The award ceiling shown is $1,000,000, indicating an upper limit on the total award amount per project under the parameters captured in the source data.
When was this funding opportunity created?
The opportunity was created on 2018-01-09.
What is the listed original closing date?
The listed original closing date is 2021-04-05, indicating the opportunity was time-bound around that cycle.
What funding category and grant type are indicated?
The information provided describes it as a discretionary grant opportunity administered by NIH in the health funding area.
Why does this FOA emphasize complex instrumentation and later-stage tool maturation?
The announcement is framed around advancing complex tools toward real-world readiness, and the administrative details include an award ceiling that aligns with development work that can be expensive and technically demanding, such as improving reliability, validation, scalability, and manufacturability.
What is the overall intent of this FOA in the mental health technology space?
It is described as a bridge funding mechanism for SBIR Phase II projects that have produced encouraging results and now need an additional, competitively reviewed Phase IIB period to reach key development milestones, accelerating the availability of robust brain and behavior tools and interventions for mental health research and potentially clinical care.
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| NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U44 - Clinical Trials Optional) Apply for PAR 18 563 Funding Number: PAR 18 563 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
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| Lab to Marketplace: Tools for Brain and Behavioral Research (R43/R44 - Clinical Trial Optional Apply for PAR 18 565 Funding Number: PAR 18 565 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
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| Emotional Function in Normal Aging and/or MCI and AD/ADRD (R21 - Clinical Trial Not Allowed) Apply for PAR 18 582 Funding Number: PAR 18 582 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| 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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| Complex Technologies and Therapeutics Development for Mental Health Research and Practice (R41/R42) Apply for PA 18 579 Funding Number: PA 18 579 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Discovery of the Genetic Basis of Childhood Cancers and of Structural Birth Defects: Gabriella Miller Kids First Pediatric Research Program (X01, Clinical Trials Not Allowed) Apply for PAR 18 583 Funding Number: PAR 18 583 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Medications Development for the Treatment of Alcohol Use Disorder - CT optional (U01) Apply for RFA AA 18 009 Funding Number: RFA AA 18 009 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Pragmatic Trials for Dementia Care in Long-term Services and Support (LTSS) Settings (R61/R33 - Clinical Trial Required) Apply for PAR 18 585 Funding Number: PAR 18 585 Agency: National Institutes of Health Category: Health Funding Amount: $500,000 |
| Somatic Cell Genome Editing Dissemination and Coordinating Center (U24 Clinical Trial Not Allowed) Apply for RFA RM 18 018 Funding Number: RFA RM 18 018 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Alzheimer's Disease Research Centers (P30 - Clinical Trials Not Allowed) Apply for RFA AG 19 001 Funding Number: RFA AG 19 001 Agency: National Institutes of Health Category: Health Funding Amount: $2,000,000 |
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