Opportunity Information: Apply for RFA NS 20 009

The National Institutes of Health (NIH) released this funding opportunity under the HEAL (Helping to End Addiction Long-term) Initiative to push forward practical, science-based solutions that can improve pain care and, in turn, help reduce reliance on opioids. The program uses the Small Business Technology Transfer (STTR) mechanism, meaning it is built specifically to support partnerships between a small business and a U.S. research institution, with the goal of moving promising early innovations toward real-world products. The opportunity is titled "HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Not Allowed)" and is identified as RFA-NS-20-009.

At its core, this FOA is aimed at accelerating the development of better pain management options. NIH is looking for projects that can lead to new therapies, technologies, or enabling tools that make pain treatment more effective, safer, and less dependent on addictive drugs. A major emphasis is on creating non-addictive medications and devices for pain, as well as technologies that can measure pain more objectively. Because pain is often assessed through self-report and subjective clinical judgment, tools that provide more objective, quantifiable, or biologically grounded pain measurement are explicitly within scope. Alongside treatment-focused innovations, NIH also signals strong interest in the earlier parts of the development pipeline, such as novel screening tools and improved experimental models that are specifically designed for pain research and for evaluating potential pain therapies. In practical terms, this could include new assay systems, better translational models, or platform technologies that help identify and optimize candidate therapeutics or devices aimed at pain.

The award mechanism is STTR, using the R41/R42 phases. In the typical STTR structure, Phase I (R41) supports feasibility work, proof-of-concept development, and early validation, while Phase II (R42) supports more advanced R and D aimed at strengthening the evidence base, improving the prototype or lead candidate, and preparing for later commercialization and broader deployment. The fact that this announcement states "Clinical Trial Not Allowed" is important for project planning: applicants need to propose work that does not meet NIH's definition of a clinical trial. This generally steers projects toward preclinical development, benchtop validation, engineering iteration, analytical validation, and other non-clinical human-subject research activities that do not involve prospectively assigning human participants to interventions to study health-related outcomes.

Eligibility is limited to small businesses, consistent with the STTR program. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply as applicant organizations. However, the announcement notes that "foreign components," as defined in the NIH Grants Policy Statement, may be allowed in some cases, which typically means certain discrete parts of the project could be conducted outside the U.S. if well-justified and permissible under NIH policy. The exact boundaries of what is acceptable depend on the NIH policy definitions and the specific structure of the proposed work, so applicants would need to confirm details in the full funding announcement and align their budgets, subawards, and statements of work accordingly.

Administratively, the opportunity is offered by NIH as a discretionary grant program within broad public health-related activity areas (education, health, income security, and social services). It is associated with multiple CFDA listings (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), reflecting the cross-cutting NIH institutes and centers that may participate or the multiple program areas that intersect with pain research and technology development. The announcement was created on 2019-10-04, and the original closing date listed is 2022-09-08. The provided source data does not specify an award ceiling or the expected number of awards, which typically means applicants must refer to the full FOA text or NIH related notices for the most precise funding and competitiveness details.

In summary, this HEAL Initiative STTR opportunity is designed for U.S. small businesses collaborating with research institutions to develop non-addictive pain treatments, pain management devices, objective pain measurement methods, and pain-focused screening tools or models, all while staying within a non-clinical-trial scope. The overarching intent is to shorten the time between promising pain science and usable products that can improve patient care and help address the opioid crisis through better, safer pain management options.

  • 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, 93.273, 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 20 009

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Frequently Asked Questions (FAQs)

What is the title and identifier of this funding opportunity?

The opportunity is titled "HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Not Allowed)" and is identified as RFA-NS-20-009.

Which agency is offering this grant opportunity?

The funding opportunity is offered by the National Institutes of Health (NIH).

What larger initiative is this funding opportunity part of?

This opportunity is part of the HEAL (Helping to End Addiction Long-term) Initiative, which aims to advance practical, science-based solutions to improve pain care and reduce reliance on opioids.

What is the overall goal of this program?

The goal is to accelerate the development of improved pain management options, including new therapies, technologies, and enabling tools that can make pain treatment more effective, safer, and less dependent on addictive drugs.

What funding mechanism does this program use?

This program uses the Small Business Technology Transfer (STTR) mechanism, specifically the R41/R42 phased structure.

What does STTR mean for applicants and project structure?

STTR is designed to support partnerships between a small business and a U.S. research institution. The intent is to help move promising early innovations toward real-world products through a structured collaboration.

What are the two phases (R41 and R42) intended to support?

Phase I (R41) supports feasibility work, proof-of-concept development, and early validation. Phase II (R42) supports more advanced research and development to strengthen the evidence base, improve a prototype or lead candidate, and prepare for later commercialization and broader deployment.

What types of projects are within scope?

Projects are expected to support better pain management through development of therapies, technologies, devices, or enabling tools. The scope includes non-addictive medications and devices for pain, and technologies intended to measure pain more objectively.

Does this opportunity prioritize non-addictive pain treatments?

Yes. A major emphasis is on creating non-addictive medications and devices for pain management as part of improving care and reducing opioid reliance.

Are pain measurement technologies eligible under this FOA?

Yes. Technologies that measure pain more objectively are explicitly within scope, including tools that provide more objective, quantifiable, or biologically grounded pain measurement.

Why is there interest in objective pain measurement?

The opportunity highlights that pain is often assessed through self-report and subjective clinical judgment, so tools that improve objectivity and quantification are considered important and relevant.

Are screening tools and experimental models for pain research allowed?

Yes. NIH signals strong interest in earlier development pipeline needs such as novel screening tools and improved experimental models designed specifically for pain research and for evaluating potential pain therapies.

What are examples of early-pipeline or enabling technologies mentioned as relevant?

The provided description includes examples such as new assay systems, improved translational models, and platform technologies that help identify and optimize candidate therapeutics or devices aimed at pain.

Are clinical trials allowed under this announcement?

No. The funding opportunity is explicitly labeled "Clinical Trial Not Allowed," which is an important constraint on the proposed work.

What does "Clinical Trial Not Allowed" mean in practical planning terms?

Applicants should propose work that does not meet NIH's definition of a clinical trial. The description indicates this generally steers projects toward preclinical development, benchtop validation, engineering iteration, analytical validation, and other non-clinical human-subject research activities that do not involve prospectively assigning human participants to interventions to study health-related outcomes.

Who is eligible to apply?

Eligibility is limited to small businesses, consistent with the STTR program requirements.

Do applicants need to partner with a research institution?

Yes. Because this is an STTR opportunity, it is built specifically to support partnerships between a small business and a U.S. research institution.

Are foreign (non-U.S.) institutions eligible to apply as applicant organizations?

No. Foreign institutions (non-U.S. entities) are not eligible to apply as applicant organizations.

Can non-U.S. components of U.S. organizations apply?

No. Non-U.S. components of U.S. organizations are also not eligible to apply as applicant organizations.

Are any foreign activities allowed at all?

The description notes that "foreign components," as defined in the NIH Grants Policy Statement, may be allowed in some cases. This typically means discrete parts of the project could be conducted outside the U.S. if well-justified and permissible under NIH policy.

How should applicants handle questions about foreign components?

The boundaries depend on NIH policy definitions and how the work is structured. The description indicates applicants should confirm details in the full funding announcement and align budgets, subawards, and statements of work accordingly.

What is the funding opportunity trying to achieve in the real world?

The intent is to shorten the time between promising pain science and usable products that improve patient care, while helping address the opioid crisis through better and safer pain management options.

What type of grant program is this described as administratively?

It is described as a discretionary grant program within broad public health-related activity areas, including education, health, income security, and social services.

Which CFDA listings are associated with this opportunity?

The opportunity is associated with multiple CFDA listings: 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.

Why are there multiple CFDA numbers attached to this FOA?

The description indicates the multiple CFDA listings reflect cross-cutting NIH institutes and centers that may participate and/or multiple program areas that intersect with pain research and technology development.

When was this announcement created?

The announcement was created on 2019-10-04.

What is the original closing date listed for this opportunity?

The original closing date listed is 2022-09-08.

Is the award ceiling stated in the provided information?

No. The provided source data does not specify an award ceiling.

Is the expected number of awards stated in the provided information?

No. The provided source data does not specify the expected number of awards.

Where should applicants look for exact funding amounts and competitiveness details?

The description indicates applicants typically need to refer to the full FOA text and any NIH related notices for the most precise funding details, including potential award sizes and expected number of awards.

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