Opportunity Information: Apply for RFA DA 19 019
The HEAL Initiative: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Epidemic (R43/R44 - Clinical Trial Optional) grant opportunity (Funding Opportunity Number RFA-DA-19-019) is a National Institutes of Health program led by the National Institute on Drug Abuse (NIDA) that uses the SBIR mechanism to fund small businesses developing practical, research-driven technologies aimed at addressing the opioid crisis. The central goal is to accelerate innovations that can prevent opioid misuse, improve treatment and recovery outcomes, reduce overdose deaths, and lessen the broader harms opioids have caused to individuals, families, and communities. The program sits within the broader NIH HEAL (Helping to End Addiction Long-term) Initiative, which focuses on speeding up scientific solutions to addiction and pain.
This opportunity is structured around the SBIR R43/R44 pathway, meaning it supports both early-stage feasibility work and more advanced development toward commercialization. In practice, applicants can propose Phase I-type activities (proof of concept, prototype feasibility, early validation) and Phase II-type activities (further R and D, refinement, scaling, and preparation for real-world implementation). The "clinical trial optional" designation indicates that projects may include clinical trial work if it is appropriate for the technology and stage of development, but applicants are not required to run a clinical trial to be eligible. The program is positioned for companies building tangible products or technology-enabled services that translate research into deployable tools, consistent with NIDA's research and development mission and the FOA's stated topical areas.
Eligibility is limited to United States small business concerns that meet SBIR requirements and have the technical capacity to carry out the proposed research and development. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, "foreign components" as defined by the NIH Grants Policy Statement may be permitted, which typically means a portion of the work can occur outside the U.S. under specific circumstances and with appropriate justification and approvals, while the applicant organization itself must remain a U.S. small business.
From an administrative standpoint, this is a discretionary grant program under the NIH, categorized under education and health, with CFDA numbers 93.279 and 93.350. The opportunity was created on 2018-12-10 and had an original closing date of 2021-09-08. While the provided source data does not list an award ceiling or the expected number of awards, the intent is clearly to fund multiple small business projects that can contribute meaningful, scalable solutions to the opioid epidemic through technology development and related translational research.Apply for RFA DA 19 019
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "HEAL Initiative: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Epidemic (R43/R44 - Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279, 93.350.
- This funding opportunity was created on 2018-12-10.
- Applicants must submit their applications by 2021-09-08. (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 SBIR (R43/R44) - Technologies to Stop the Opioid Epidemic (RFA-DA-19-019)
What is this funding opportunity?
This is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) funding opportunity under the HEAL (Helping to End Addiction Long-term) Initiative. It is led by the National Institute on Drug Abuse (NIDA) and focuses on supporting small businesses developing practical, research-driven technologies to help address the opioid epidemic.
What is the official name and funding opportunity number?
The opportunity is titled: "The HEAL Initiative: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Epidemic (R43/R44 - Clinical Trial Optional)". The Funding Opportunity Number is RFA-DA-19-019.
Which agency and institute run this program?
The program is part of the NIH and is led by NIDA (National Institute on Drug Abuse).
What problem area is this grant trying to address?
The central goal is to accelerate innovations that can prevent opioid misuse, improve treatment and recovery outcomes, reduce overdose deaths, and reduce broader opioid-related harms affecting individuals, families, and communities.
How does this relate to the NIH HEAL Initiative?
This opportunity sits within the broader NIH HEAL Initiative, which is designed to speed up scientific solutions related to addiction and pain, including technology development that can be translated into real-world impact.
What funding mechanism is used?
This opportunity uses the SBIR mechanism and specifically follows the R43/R44 pathway.
What does the R43/R44 pathway mean for applicants?
R43/R44 indicates support for both early-stage feasibility and more advanced development toward commercialization. Applicants can propose Phase I-type efforts (proof of concept, prototype feasibility, early validation) and Phase II-type efforts (further research and development, refinement, scaling, and preparation for real-world implementation).
What kinds of projects are a good fit?
The opportunity is positioned for companies building tangible products or technology-enabled services that translate research into deployable tools. Proposed work should align with NIDA's research and development mission and the topical areas described in the funding opportunity.
Are clinical trials required?
No. The funding opportunity is labeled "Clinical Trial Optional," meaning projects may include clinical trial work if appropriate, but running a clinical trial is not required to be eligible.
Can a project include a clinical trial if it makes sense?
Yes. Clinical trial work may be included when it is appropriate for the technology and its development stage.
Who is eligible to apply?
Eligibility is limited to U.S. small business concerns that meet SBIR requirements and have the technical capacity to carry out the proposed research and development.
Are non-U.S. (foreign) organizations eligible to apply?
No. Foreign institutions (non-U.S. entities) are not eligible to apply.
Can a U.S. company include work performed outside the United States?
Non-U.S. components of U.S. organizations are not eligible. However, "foreign components" (as defined by the NIH Grants Policy Statement) may be permitted in certain cases, typically meaning a portion of the work can occur outside the U.S. with appropriate justification and any required approvals, while the applicant organization remains a U.S. small business.
What type of grant is this from an administrative standpoint?
This is described as a discretionary grant program under NIH and is categorized under education and health.
What are the CFDA numbers associated with this opportunity?
The CFDA numbers listed are 93.279 and 93.350.
When was this opportunity created and what was the closing date?
The opportunity was created on 2018-12-10. The original closing date listed is 2021-09-08.
Does the provided information include an award ceiling or number of awards?
No. The provided source data does not list an award ceiling or the expected number of awards.
What is the overall intent of the funding opportunity?
Based on the description, the intent is to fund multiple small business projects that can contribute meaningful, scalable solutions to the opioid epidemic through technology development and translational research.
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| Funding Opportunity |
|---|
| HEAL Initiative: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Epidemic (R41/R42 - Clinical Trial Optional) Apply for RFA DA 19 020 Funding Number: RFA DA 19 020 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Clinical Research Centers (UG1 Clinical Trial Optional) Apply for RFA DA 19 025 Funding Number: RFA DA 19 025 Agency: National Institutes of Health Category: Education, Health Funding Amount: $1,500,000 |
| HEAL Initiative Limited Competition: Behavioral Research to Improve MAT: Ancillary Studies to Enhance Behavioral or Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R01, Clinical Trials Optional) Apply for RFA AT 19 007 Funding Number: RFA AT 19 007 Agency: National Institutes of Health Category: Education, Health Funding Amount: $400,000 |
| HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (U01 Clinical Trial Optional) Apply for RFA HL 19 029 Funding Number: RFA HL 19 029 Agency: National Institutes of Health Category: Education, Health Funding Amount: $750,000 |
| HEAL Initiative: Effectiveness Trials to Optimize, Implement, Scale, and Sustain the Collaborative Care Model for Individuals with Opioid Use Disorders and Mental Health Conditions (U01 Clinical Trial Required) Apply for RFA MH 19 525 Funding Number: RFA MH 19 525 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (R01 - Clinical Trial Not Allowed) Apply for RFA HL 19 028 Funding Number: RFA HL 19 028 Agency: National Institutes of Health Category: Education, Health Funding Amount: $350,000 |
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| NIH Pathway to Independence Award (Parent K99/R00 - Independent Clinical Trial Not Allowed) Apply for PA 19 130 Funding Number: PA 19 130 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Laboratories for Early Clinical Evaluation of Pharmacotherapies for Substance Use Disorders (UG1 Clinical Trial Required) Apply for RFA DA 19 018 Funding Number: RFA DA 19 018 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| Academic Research Enhancement Award for Undergraduate-Focused Institutions (R15 - Clinical Trial Required) Apply for PAR 19 133 Funding Number: PAR 19 133 Agency: National Institutes of Health Category: Education, Health Funding Amount: $300,000 |
| End-of-Life and Palliative Needs of Adolescents and Young Adults (AYA) with Serious Illnesses (R01 Clinical Trial Optional) Apply for PAR 19 136 Funding Number: PAR 19 136 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Analytical Tools and Approaches for (Multidimensional) Scholarly Research Assessment and Decision Support in the Biomedical Enterprise (R41/R42 - Clinical Trial Not Allowed) Apply for RFA DA 19 030 Funding Number: RFA DA 19 030 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Analytical Tools and Approaches for (Multidimensional) Scholarly Research Assessment and Decision Support in the Biomedical Enterprise (R43/R44 - Clinical Trial Not Allowed) Apply for RFA DA 19 031 Funding Number: RFA DA 19 031 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Revisions for Incorporation of Novel NCI-Supported Technology to Accelerate Cancer Research (U2C Clinical Trial Optional) Apply for RFA CA 19 028 Funding Number: RFA CA 19 028 Agency: National Institutes of Health Category: Education, Health Funding Amount: $150,000 |
| Drug Discovery For Nervous System Disorders (R01 Clinical Trials Not Allowed) Apply for PAR 19 147 Funding Number: PAR 19 147 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Drug Discovery For Nervous System Disorders (R21 Clinical Trial Not Allowed) Apply for PAR 19 146 Funding Number: PAR 19 146 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Bioengineering Research Grants (BRG) (R01 Clinical Trial Required) Apply for PAR 19 159 Funding Number: PAR 19 159 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
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