HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed) | RFA NS 20 011

Opportunity Information: Apply for RFA NS 20 011

The funding opportunity titled "HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-NS-20-011) is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grant solicitation designed to accelerate practical, science-based solutions to the opioid public health crisis. It sits under the broader NIH HEAL (Helping to End Addiction Long-term) Initiative, with an emphasis on advancing better ways to treat pain so that reliance on addictive opioid medications can be reduced. The mechanism used is the SBIR R43/R44 pathway, which generally supports a staged development process where early feasibility work (Phase I, typically R43) can transition into more advanced development and commercialization-focused work (Phase II, typically R44). A key boundary for this specific announcement is that clinical trials are not allowed, meaning applicants need to focus on preclinical development, validation, and other non-clinical trial activities that still move a product or enabling technology closer to readiness for later-stage testing.

Programmatically, the FOA is centered on improving pain treatment through the development of therapies and technologies that can either replace opioids or make pain care more effective and precise. NIH is explicitly interested in new, non-addictive medications as well as devices that can improve pain management. Alongside treatment options, the announcement highlights objective pain measurement as a priority area, reflecting the long-standing challenge that pain is often assessed subjectively and can be difficult to quantify consistently across patients and settings. By supporting objective measurement approaches, the FOA encourages tools that could help clinicians evaluate pain more accurately, tailor therapies to individual patients, monitor response to treatment over time, and potentially reduce inappropriate prescribing or ineffective care.

Beyond direct therapeutics and devices, the opportunity also calls out the need for improved screening tools and models specifically designed for pain. This can include novel assays, platforms, translational models, and other development tools that make it easier to discover and optimize pain therapies, test mechanisms of action, or better predict real-world therapeutic performance. The underlying idea is that progress in pain medicine is slowed not only by the difficulty of developing new analgesics, but also by gaps in the research and development toolkit used to identify promising candidates and evaluate them rigorously before they ever reach human testing. By funding these enabling technologies and models, the FOA aims to strengthen the pipeline for future pain therapies and accelerate overall innovation in the space.

Eligibility is limited to small businesses, consistent with the SBIR program’s purpose of stimulating technological innovation and commercialization within the U.S. small business community. The notice is explicit that non-U.S. (foreign) institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. That said, the FOA notes that foreign components, as defined under the NIH Grants Policy Statement, may be allowed in some circumstances, which typically means discrete parts of the project may be conducted outside the U.S. when well-justified and permitted under NIH policy. Applicants would need to follow the eligibility and foreign component guidance in the full funding announcement to ensure compliance, because these distinctions can affect budgeting, scope of work, and administrative review.

Administratively, the opportunity is categorized as a discretionary grant with an activity area spanning education, health, income security, and social services, reflecting the cross-cutting public health and societal impact of improved pain management and reduced opioid dependence. The listed CFDA numbers (including 93.213, 93.233, 93.273, 93.286, 93.350, 93.393, 93.394, 93.395, 93.399, 93.837, 93.838, 93.839, 93.840, 93.846, 93.853, 93.865, 93.866, 93.867) indicate that multiple NIH institutes or programs may participate or provide support under this announcement, which is common for broad initiatives like HEAL that span many disease areas and scientific disciplines. The original posting date is listed as 2019-10-04, and the original closing date is 2022-09-08, indicating a defined submission window for that cycle of funding.

In practical terms, this FOA is best read as a product-development-oriented opportunity for qualified U.S. small businesses that are building non-addictive pain therapeutics, pain-related devices, objective pain assessment tools, or specialized screening and modeling platforms that directly improve the development and delivery of pain care. Because clinical trials are not allowed, the strongest applications are typically those with a clear development plan that can demonstrate feasibility, performance, and readiness milestones using non-trial methods such as benchtop testing, engineering verification, preclinical studies, analytical validation, usability work that does not qualify as a clinical trial, and other translational activities that de-risk the technology and position it for future clinical evaluation outside the scope of this award.

• 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 (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, 93.273, 93.286, 93.350, 93.393, 93.394, 93.395, 93.399, 93.837, 93.838, 93.839, 93.840, 93.846, 93.853, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2019-10-04.
• Applicants must submit their applications by 2022-09-08. (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 20 011

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: