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.Apply for RFA NS 23 006
- 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.
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FAQs: HEAL Initiative - Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 Clinical Trial Not Allowed)
What is this funding opportunity?
This is an NIH Small Business Innovation Research (SBIR) funding opportunity under the HEAL (Helping to End Addiction Long-term) Initiative. It supports small businesses working on practical, science-based innovations to improve pain management and help reduce opioid-related public health harms.
What is the official funding opportunity number?
The funding opportunity number provided is RFA-NS-23-006.
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH).
What is the purpose of the HEAL Initiative in this context?
The purpose is to accelerate pain management solutions that can reduce reliance on addictive treatments and support the broader national response to the opioid crisis.
What funding mechanism does this use?
This opportunity uses the SBIR phased mechanism with activity codes R43/R44. In general terms, R43 aligns with Phase I feasibility and early proof-of-concept work, and R44 aligns with Phase II more advanced research and development to move toward a product or enabling technology.
What types of projects are within scope?
The scope focuses on enhanced pain management, including: (1) development of new non-addictive pain medications, (2) development of devices and technologies that improve pain treatment (including digital or hardware-enabled interventions), (3) objective pain measurement technologies, and (4) screening tools and models that support pain research and pain-therapy development (such as assays, platforms, or preclinical models).
Does this opportunity support development of non-addictive pain therapeutics?
Yes. A major priority described is the development of new, non-addictive pain medications intended to relieve pain without the addiction and overdose risks associated with many opioid drugs.
Are pain management devices and technology-based interventions eligible topics?
Yes. The announcement highlights interest in devices and technologies that can improve pain treatment, including therapeutic devices and other technology-driven solutions.
What does "objective pain measurement" mean in this opportunity?
It refers to technologies that can quantify or more reliably characterize pain beyond subjective self-report. The goal is to improve diagnosis, treatment selection, monitoring, and clinical decision-making by making pain assessment more measurable and consistent.
Are screening tools, assays, or models for pain research supported?
Yes. The opportunity indicates interest in new screening tools and models designed for pain research and pain-therapy development, such as assays, platforms, preclinical models, or other systems that help identify and optimize pain therapeutics and evaluate pain-relevant mechanisms.
Is this opportunity focused on research or on product development?
Based on the description, the intent is translational and solution-oriented: helping small businesses translate research into tangible products, tools, and enabling technologies that can materially improve pain care and reduce reliance on addictive treatments.
Are clinical trials allowed under this announcement?
No. The title specifies "Clinical Trial Not Allowed," meaning applicants are expected to propose development and validation activities that do not include an NIH-defined clinical trial within this award.
What kinds of activities are consistent with "Clinical Trial Not Allowed"?
The description indicates this typically steers projects toward preclinical development, engineering development, benchtop testing, algorithm development, and other translational work that prepares a technology for later clinical evaluation without actually running a clinical trial as part of the funded project.
Who is eligible to apply?
Eligibility is limited to small businesses, consistent with SBIR rules.
Can a non-U.S. (foreign) institution apply?
No. Foreign (non-U.S.) institutions are not eligible to apply.
Can a U.S. small business include non-U.S. components?
Non-U.S. components of U.S. organizations are not eligible. However, the information provided notes that "foreign components" (as defined in the NIH Grants Policy Statement) may be allowed in some circumstances if well-justified and compliant with NIH requirements.
What is the practical meaning of "foreign components may be allowed"?
Based on the description, it commonly means discrete parts of the work could potentially be performed abroad if they meet NIH policy definitions and are strongly justified, even though the applicant organization must be a U.S. small business.
Is this a discretionary grant?
Yes. The opportunity is described as a discretionary grant under the NIH umbrella.
What category is this opportunity listed under?
It is categorized under Health, Income Security and Social Services, reflecting a public health and healthcare impact focus.
What is the closing date for this opportunity?
The source information lists an original closing date of 2025-04-04.
How many awards will be made and what is the maximum award amount?
The provided text does not list an expected number of awards or an award ceiling. Applicants would typically need to consult the full FOA and NIH SBIR guidance for budget limits, phase caps, and any program-specific expectations.
Are multiple NIH funding lines involved?
The information notes that multiple CFDA (now often referred to through Assistance Listing) numbers are associated with the announcement, which suggests multiple NIH institutes or funding lines may be involved in supporting awards under this FOA.
What is the main public health problem this opportunity is trying to address?
The central public health goal is to reduce the burden tied to opioids by advancing better pain management approaches, including non-addictive treatments and improved ways to treat and measure pain.
What kinds of outcomes is NIH looking for from SBIR projects here?
From the description provided, NIH is looking for innovations that can be translated into tangible products, tools, and enabling technologies that strengthen pain care and reduce reliance on addictive treatments, while staying within a non-clinical-trial project design for this specific announcement.
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