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

Opportunity Information: Apply for PAS 18 121

The National Institutes of Health (NIH) is offering an STTR (Small Business Technology Transfer) funding opportunity titled "Development and/or Validation of Devices or Electronic Systems to Monitor or Enhance Mind and Body Interventions (R41/R42 Clinical Trial Optional)" under opportunity number PAS 18-121 (CFDA 93.213). The purpose of this announcement is to support small business concerns working in partnership with a research institution to create, adapt, repurpose, and/or validate device-based or electronic technologies that can either track key biological or behavioral processes involved in mind and body interventions, or actively help improve how those interventions are practiced and how effective they are. In practical terms, NIH is looking for technology that can measure what is happening in the body or brain during these interventions (for example, physiologic signals or behavioral markers), or technology that can help guide, optimize, personalize, or strengthen the intervention itself.

The FOA is centered on non-pharmacological "mind and body interventions." NIH uses this term broadly, covering 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. The technologies supported by this program are expected to connect directly to the mechanisms or functional outcomes of these interventions, meaning applicants should be thinking about what the intervention is supposed to change (for example, stress physiology, autonomic balance, pain processing, sleep patterns, attention regulation, movement quality, adherence, or symptom outcomes) and how a device or electronic system can monitor those changes or enhance them.

NIH is open to a wide range of technology development paths within this FOA. Projects can propose entirely new technologies, or they can adapt an innovative technology that already exists to make it applicable to mind and body research or practice. Applicants may also repurpose existing devices or electronic systems for this new use case, which can be especially relevant when the underlying sensors, hardware, or software already exist but have not been validated in the context of these interventions. Another explicitly encouraged direction is testing individual components or combinations of components that could eventually become part of an integrated solution, particularly solutions aimed at long-term use. The FOA specifically mentions the concept of an integrated, long-term, automated, wearable monitoring and/or stimulation device or electronic system, which signals interest in real-world tools that can operate outside a laboratory setting and support continuous or repeated use.

Because this is an STTR mechanism, the eligible applicants are small businesses, and the work is expected to involve formal collaboration with a research partner consistent with STTR requirements. The funding instrument is a grant, and the activity category is health. The announcement is structured around the R41/R42 phases, which generally align with early-stage feasibility (Phase I) followed by continued development and validation (Phase II). The FOA is labeled "Clinical Trial Optional," meaning applicants may propose a clinical trial if it fits their aims, but a clinical trial is not required for every project. This is helpful for device and system development efforts that may need engineering development and bench or pilot testing before moving into a full clinical evaluation.

Eligibility rules are also clearly stated with respect to foreign participation. Non-U.S. (non-domestic) entities, meaning foreign institutions, are not eligible to apply. In addition, non-U.S. components of U.S. organizations are not eligible to apply. That said, "foreign components" as defined under the NIH Grants Policy Statement may be allowed in some cases, which typically refers to discrete parts of the project carried out outside the U.S. under specific justification and compliance requirements, rather than a foreign organization serving as the applicant.

The opportunity was created on November 28, 2017, and the original closing date listed in the provided source data is July 5, 2020. The agency is NIH, and the opportunity category is listed as discretionary. The source data does not provide an award ceiling or expected number of awards, so applicants would generally need to look to the full FOA and NIH budget guidance for STTR R41/R42 applications to understand typical budget limits, allowable costs, and project period expectations. Overall, the program is aimed at moving practical, research-grounded technologies forward so that 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.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development and/or Validation of Devices or Electronic Systems to Monitor or Enhance Mind and Body Interventions (R41/R42 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213.
• This funding opportunity was created on 2017-11-28.
• Applicants must submit their applications by 2020-07-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAS 18 121

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