Opportunity Information: Apply for RFA NS 23 007

The HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Not Allowed) funding opportunity (RFA-NS-23-007) is a National Institutes of Health (NIH) Small Business Technology Transfer (STTR) grant solicitation designed to accelerate practical, science-driven solutions that can reduce reliance on opioids and help address the broader opioid public health crisis. The central aim is to push forward new and improved approaches to pain management by supporting small businesses that are working in partnership with a research institution, with an emphasis on turning promising discoveries into tangible therapies, tools, and technologies that can improve how pain is treated and assessed.

This FOA is specifically oriented toward enhanced pain management innovations. That includes development of non-addictive pain medications, novel devices or device-based interventions intended to treat pain, and technologies that enable more objective measurement of pain. The emphasis on objective pain measurement reflects a major gap in the field: pain is often assessed using subjective self-report scales, which can be limited in certain populations and can complicate treatment decisions and evaluation of new interventions. By encouraging objective measurement approaches, NIH is signaling interest in tools that could improve diagnosis, monitoring, treatment selection, and outcome measurement across clinical and research settings, even though this particular FOA does not allow clinical trials.

In addition to therapies and measurement technologies, NIH highlights interest in new screening tools and models that are tailored specifically to pain and to the development pipeline for pain therapeutics. In practice, this can encompass improved assays, platforms, preclinical models, translational models, or other enabling technologies that make it easier to identify, validate, or optimize potential pain treatments. The intent is to strengthen the end-to-end pipeline for pain innovation, from early discovery and validation through the kinds of development work that position a product for later-stage testing and eventual commercialization.

The funding mechanism is the STTR program using the R41/R42 activity codes, which generally correspond to a phased approach to research and development. Phase I (R41) is typically aimed at feasibility and proof-of-concept work, while Phase II (R42) supports further development and refinement toward a commercially viable product. As an STTR program, it is designed for eligible U.S. small businesses collaborating with a nonprofit research institution (for example, a university or research hospital). The eligible applicant type listed is small businesses, reinforcing that this opportunity is meant to help small companies translate research into usable products and technologies rather than support purely academic research projects.

A key boundary condition is that clinical trials are not allowed under this FOA, as stated directly in the title. That means applicants should propose development activities that remain preclinical or otherwise fall short of NIH's definition of a clinical trial. Projects can still be highly translational and product-oriented, but they must be structured so that human-subject interventional studies that meet the NIH clinical trial definition are not part of the proposed work under this announcement. Applicants typically need to plan development milestones accordingly, focusing on lab validation, prototyping, optimization, performance testing, verification, and other readiness activities that build a strong foundation for subsequent clinical evaluation through a different mechanism or later funding pathway.

Eligibility and foreign involvement rules are also clearly defined. Non-U.S. entities (foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, may be allowed in some cases, meaning a U.S.-based applicant might be able to include limited foreign participation if it meets NIH policy requirements and is justified scientifically. In practical terms, the main applicant and core project leadership are expected to be U.S.-based and aligned with STTR eligibility requirements.

Administrative details from the source information include the sponsoring agency (NIH), the funding instrument type (grant), and the opportunity category (discretionary). The original closing date is listed as 2025-04-04. The opportunity is associated with multiple CFDA numbers (now commonly referred to through broader assistance listing structures), reflecting that multiple NIH Institutes or Centers may participate or that the scope aligns with several NIH program areas relevant to pain, neuroscience, substance use, and related health domains. The posting/creation date in the source data is 2022-09-15. The award ceiling and expected number of awards are not provided in the excerpt, which usually means applicants should consult the full FOA text for budget caps, project period limits, and any institute-specific guidance.

Overall, this FOA is best understood as a commercialization-oriented NIH HEAL Initiative solicitation for U.S. small businesses that can bring forward non-addictive pain treatment options, pain-related devices, objective pain assessment technologies, and enabling screening/modeling platforms that improve the development of pain therapies. It is explicitly structured for STTR-phase product development work that advances readiness without running a clinical trial under this announcement.

  • The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Not Allowed)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213, 93.233, 93.242, 93.273, 93.350, 93.351, 93.393, 93.395, 93.396, 93.837, 93.838, 93.839, 93.840, 93.846, 93.853, 93.859, 93.865, 93.866.
  • This funding opportunity was created on 2022-09-15.
  • Applicants must submit their applications by 2025-04-04. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Small businesses.
Apply for RFA NS 23 007

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