Development and/or Validation of Devices or Electronic Systems to Monitor or Enhance Mind and Body Interventions (R41/R42 Clinical Trial Optional) | PAS 18 121

Frequently Asked Questions (FAQs)

What is the name of this NIH funding opportunity?

The funding opportunity is titled "Development and/or Validation of Devices or Electronic Systems to Monitor or Enhance Mind and Body Interventions (R41/R42 Clinical Trial Optional)."

What is the opportunity number and CFDA listing?

The opportunity number is PAS 18-121, and the CFDA number listed is 93.213.

Which agency is offering this grant?

The agency offering the opportunity is the National Institutes of Health (NIH).

What type of funding mechanism is this?

This opportunity uses the STTR (Small Business Technology Transfer) mechanism and is offered as a grant.

What is the activity category for this program?

The activity category is health.

Who is eligible to apply under this STTR opportunity?

Eligible applicants are small business concerns that will carry out the project in formal collaboration with a research institution, consistent with STTR requirements.

Are foreign (non-U.S.) organizations eligible to apply?

No. Non-U.S. (non-domestic) entities (foreign institutions) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply.

Are any foreign activities allowed at all?

Potentially. The opportunity notes that "foreign components" (as defined in the NIH Grants Policy Statement) may be allowed in some cases. This generally refers to discrete parts of the project conducted outside the U.S. with appropriate justification and compliance, rather than a foreign organization serving as the applicant.

What is the main purpose of this funding opportunity?

The purpose is to support small businesses, working with a research institution, to create, adapt, repurpose, and/or validate device-based or electronic technologies that either (1) monitor key biological or behavioral processes involved in mind and body interventions or (2) help enhance how those interventions are practiced and how effective they are.

What does NIH mean by "mind and body interventions" in this FOA?

The FOA uses the term broadly. It includes mind/brain focused approaches (such as meditation or hypnosis), body-based approaches (such as acupuncture, massage, or spinal manipulation/mobilization), and combined approaches often described as meditative movement (such as yoga, tai chi, and qigong).

What kinds of technologies are being sought?

NIH is looking for device-based or electronic systems that can measure what is happening in the body or brain during mind and body interventions (for example, physiologic signals or behavioral markers), and/or technologies that can guide, optimize, personalize, strengthen, or otherwise improve the delivery and effectiveness of the intervention.

Does the technology have to be brand new to be eligible?

No. The FOA allows multiple development paths, including entirely new technologies, adaptation of innovative technologies that already exist, and repurposing of existing devices or electronic systems for use in mind and body interventions.

What does "repurpose" mean in the context of this FOA?

Repurposing refers to taking an existing device or electronic system (including underlying sensors, hardware, or software) and applying it to mind and body intervention research or practice, particularly where the technology has not yet been validated for that specific context.

Is validation specifically encouraged?

Yes. The title and description explicitly include development and/or validation, and the FOA highlights validating devices or electronic technologies in the context of mind and body interventions.

What outcomes or mechanisms should the technology connect to?

Supported technologies are expected to connect directly to the mechanisms or functional outcomes of mind and body interventions. Examples mentioned include stress physiology, autonomic balance, pain processing, sleep patterns, attention regulation, movement quality, adherence, and symptom outcomes.

Can projects focus on individual components instead of a fully integrated system?

Yes. The FOA explicitly encourages testing individual components or combinations of components that could later become part of an integrated solution, especially solutions aimed at long-term use.

Is NIH interested in wearable or long-term monitoring solutions?

Yes. The FOA specifically mentions interest in concepts such as an integrated, long-term, automated, wearable monitoring and/or stimulation device or electronic system, suggesting an emphasis on tools suitable for repeated or continuous use, including outside laboratory settings.

Does the project need to work outside a laboratory setting?

The FOA signals interest in real-world tools that can operate outside a laboratory setting and support continuous or repeated use, particularly via integrated, long-term, automated, wearable monitoring and/or stimulation systems.

What do R41 and R42 mean in this opportunity?

The announcement is structured around the R41/R42 phases, which generally align with early-stage feasibility work (Phase I, R41) followed by continued development and validation (Phase II, R42).

Are clinical trials required?

No. The FOA is labeled "Clinical Trial Optional," meaning applicants may propose a clinical trial if it fits the aims, but a clinical trial is not required for every project.

When might a clinical trial be included under "Clinical Trial Optional"?

A clinical trial may be proposed when it fits the project aims. The FOA notes that this flexibility can be helpful because device and system development may involve engineering development and bench or pilot testing before a full clinical evaluation.

What is the opportunity category?

The opportunity category is listed as discretionary.

When was this opportunity created?

The opportunity was created on November 28, 2017.

What is the closing date shown in the provided information?

The original closing date listed in the provided source data is July 5, 2020.

Is award size (ceiling) provided in the information given?

No. The source data provided does not include an award ceiling.

Does the information provided state how many awards NIH expects to make?

No. The source data provided does not include the expected number of awards.

Where would an applicant typically look for budget limits and allowable costs?

The provided information indicates that applicants would generally need to consult the full FOA and NIH budget guidance for STTR R41/R42 applications to understand typical budget limits, allowable costs, and expected project periods.

What is the overall goal of NIH in supporting these technologies?

The overall goal is to move practical, research-grounded technologies forward so mind and body interventions can be measured more objectively, delivered more consistently, personalized more effectively, and evaluated more rigorously in both research and real-world care settings.