Opportunity Information: Apply for RFA NS 23 006

The HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 Clinical Trial Not Allowed) is an NIH Small Business Innovation Research (SBIR) funding opportunity designed to accelerate practical, science-based solutions that can help reduce the public health burden tied to opioids. The central aim is to move promising pain management innovations forward, with an emphasis on approaches that improve how pain is treated and measured while supporting the broader national response to the opioid crisis. As an SBIR announcement, it is structured to help small businesses translate research into tangible products, tools, and enabling technologies that can ultimately strengthen pain care and reduce reliance on addictive treatments.

The scope is focused on enhanced pain management and includes several key categories of interest. One major priority is the development of new, non-addictive pain medications, meaning therapeutics that can relieve pain without the addiction and overdose risks associated with many opioid drugs. Another priority is the development of devices and technologies that can improve pain treatment, which can include therapeutic devices, digital or hardware-enabled interventions, and other technology-driven solutions intended to improve outcomes for people experiencing pain. The announcement also highlights a strong interest in objective pain measurement, reflecting the ongoing challenge that pain is often assessed through subjective self-report; technologies that can quantify or more reliably characterize pain could improve diagnosis, treatment selection, monitoring, and clinical decision-making. In addition to direct treatments and measurement tools, NIH signals interest in new screening tools and models that are specifically designed for pain research and pain-therapy development, such as assays, platforms, preclinical models, or other systems that make it easier to identify and optimize pain therapeutics and evaluate mechanisms relevant to pain.

This opportunity is offered as a discretionary grant under the NIH umbrella and is tied to the HEAL (Helping to End Addiction Long-term) Initiative. The funding mechanism is the SBIR phased approach using the R43/R44 activity codes, which generally support early-stage feasibility and prototype development in Phase I (R43) and more advanced research and development in Phase II (R44). A key restriction in the title is "Clinical Trial Not Allowed," which means applicants are expected to propose development and validation work that stops short of conducting an NIH-defined clinical trial within this specific award. In practice, that typically steers proposals toward preclinical development, engineering development, benchtop testing, algorithm development, or other translational activities that prepare a technology for later clinical evaluation without actually running a clinical trial as part of the project supported by this FOA.

Eligibility is limited to small businesses, consistent with SBIR rules. Foreign (non-U.S.) institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, the announcement notes that foreign components, as defined in the NIH Grants Policy Statement, may be allowed in some circumstances, which commonly means discrete parts of the work may be performed abroad if they meet NIH requirements and are well-justified, even though the applicant organization itself must be a U.S. small business. Applicants considering any foreign component would need to pay close attention to NIH policy definitions and justification expectations.

Administrative details from the source information include the funding opportunity number RFA-NS-23-006 and an original closing date of 2025-04-04. The sponsoring agency is the National Institutes of Health, and the opportunity is categorized under Health, Income Security and Social Services, reflecting its public health and healthcare impact focus. Multiple CFDA (now often referenced through Assistance Listing) numbers are associated with the announcement, indicating that multiple NIH institutes or funding lines may be involved in supporting awards under this FOA. The listing does not provide an award ceiling or the expected number of awards in the provided text, which usually means applicants need to consult the full FOA and NIH guidance to understand typical SBIR budget limits, phase caps, and program-specific expectations.

Overall, the opportunity is aimed at U.S. small businesses developing non-addictive pain treatments, pain management technologies, and objective pain measurement methods, as well as the tools and models that make pain-therapy development faster and more reliable. The program intent is translational and solution-oriented: it is about advancing innovations that can materially improve pain care and contribute to reducing opioid-related harms, while staying within a non-clinical-trial project design for this specific funding mechanism.

  • The National Institutes of Health in the 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 (R43/R44 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, 93.837, 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 23 006

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