Opportunity Information: Apply for RFA DA 23 020
This grant opportunity, RFA-DA-23-020, is an NIH small business funding announcement designed to speed up the creation and regulatory approval of new treatments for substance use disorders (SUD). It uses the SBIR mechanism (R43/R44) and is listed as "Clinical Trial Optional," meaning applicants can propose projects that do or do not involve clinical trials, as long as the work fits the overall goal of developing broadly useful development tools rather than focusing only on a single product.
The central aim is to support research and development of novel Drug Development Tools (DDTs) and Medical Device Development Tools (MDDTs) that can ultimately be submitted to the FDA for formal qualification. These tools are meant to be used across the field to make SUD therapy development faster, more reliable, and more efficient. In practice, that means creating or refining things like biomarkers, clinical outcome assessments, patient-reported outcome measures, digital endpoints, validation methods, modeling approaches, or device-related testing and evaluation tools that developers can use in studies and regulatory submissions. The announcement specifically points toward the FDA qualification pathways managed by either CDER (Center for Drug Evaluation and Research) for DDTs or CDRH (Center for Devices and Radiological Health) for MDDTs. A key emphasis is that once a tool is qualified, it becomes publicly available for broader use and can address unmet needs in SUD biomedical product development, rather than remaining a proprietary, one-off solution.
From a programmatic standpoint, the intended impact is to reduce common bottlenecks in SUD therapy development, such as the lack of accepted endpoints, insufficiently validated measures of clinically meaningful change, limited predictive markers of response or relapse risk, and difficulties standardizing data collection in real-world or decentralized settings. By investing in tools that regulators recognize and that multiple sponsors can adopt, the FOA is trying to improve study design, strengthen evidentiary standards, and ultimately shorten timelines between discovery and patient access.
Eligibility is limited to small businesses, consistent with the R43/R44 SBIR structure. 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. However, "foreign components" may be allowed under NIH policy, meaning certain international activities or collaborations might be permissible if they meet the NIH Grants Policy Statement definition and are appropriately justified and approved. The opportunity is categorized under education and health, associated with CFDA number 93.279, and is administered by the National Institutes of Health.
Key administrative details included in the source information are that the FOA was created on 2022-06-10, with an original closing date of 2022-11-14. The listing indicates an award ceiling and expected awards fields, but those values are not provided in the supplied text. Overall, the opportunity is best understood as a targeted SBIR funding pathway for small companies that can build enabling, regulator-ready development tools intended to be qualified through FDA programs and then used broadly to accelerate the development of new SUD therapies.Apply for RFA DA 23 020
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Novel Drug (DDT) and Medical Device Development Tools (MDDT) to Help Expedite Creation and Regulatory Approvals of New Therapies for Substance Use Disorders (SUD) (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.
- This funding opportunity was created on 2022-06-10.
- Applicants must submit their applications by 2022-11-14. (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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Frequently Asked Questions (FAQs) - RFA-DA-23-020 (NIH SBIR)
What is RFA-DA-23-020?
RFA-DA-23-020 is an NIH small business funding opportunity that uses the SBIR mechanism (R43/R44). Its purpose is to speed the creation and regulatory acceptance of new approaches that help develop treatments for substance use disorders (SUD).
What is the main goal of this funding opportunity?
The main goal is to support research and development of broadly useful Drug Development Tools (DDTs) and Medical Device Development Tools (MDDTs) that can ultimately be submitted to the FDA for formal qualification, so they can be used across the field to make SUD therapy development faster and more reliable.
What kinds of projects does this announcement support?
This announcement supports projects focused on developing or refining development tools (not just a single proprietary product). Examples include biomarkers, clinical outcome assessments, patient-reported outcome measures, digital endpoints, validation methods, modeling approaches, and device-related testing or evaluation tools, as long as they address unmet needs in SUD biomedical product development.
Does the project have to include a clinical trial?
No. The FOA is listed as "Clinical Trial Optional," which means applicants may propose projects that include clinical trials or do not include clinical trials. Either approach can be appropriate if it fits the overall aim of creating broadly useful, regulator-ready development tools.
What is meant by creating a "development tool" instead of a single product?
The emphasis is on tools that can be used by multiple sponsors and across multiple programs, rather than a one-off solution designed only to advance one company’s single therapeutic or device. The intent is to reduce field-wide bottlenecks by improving how SUD therapies are evaluated and supported in regulatory submissions.
What are DDTs and MDDTs in this context?
DDTs are Drug Development Tools intended to support drug development and regulatory review. MDDTs are Medical Device Development Tools intended to support medical device development and evaluation. The FOA supports development of either type when the tool helps accelerate and strengthen SUD therapy development.
Which FDA programs are referenced for tool qualification?
The opportunity points to FDA qualification pathways managed by CDER (Center for Drug Evaluation and Research) for DDTs and CDRH (Center for Devices and Radiological Health) for MDDTs.
What does FDA "qualification" imply for tools funded under this FOA?
The FOA’s goal is to advance tools toward FDA qualification. A key emphasis is that once a tool is qualified, it becomes publicly available for broader use, supporting the wider SUD field instead of remaining a proprietary or limited-use approach.
What bottlenecks in SUD treatment development is this FOA trying to address?
The FOA is intended to reduce common development bottlenecks, including lack of accepted endpoints, insufficient validation of measures that reflect clinically meaningful change, limited predictive markers of response or relapse risk, and challenges in standardizing data collection in real-world or decentralized settings.
What is the expected impact of developing these tools?
By investing in tools that regulators recognize and that multiple sponsors can adopt, the FOA aims to improve study design, strengthen evidentiary standards, and shorten timelines between discovery and patient access for SUD therapies.
Who is eligible to apply?
Eligibility is limited to small businesses, consistent with the SBIR R43/R44 structure.
Are foreign (non-U.S.) institutions eligible to apply?
No. Foreign institutions (non-U.S. entities) are not eligible to apply under this opportunity.
Can a U.S. small business include non-U.S. components in the application?
No. Non-U.S. components of U.S. organizations are also not eligible to apply.
Are any international activities allowed at all?
Possibly. While foreign institutions and non-U.S. components are not eligible to apply, the FOA notes that "foreign components" may be allowed under NIH policy if they meet the NIH Grants Policy Statement definition and are appropriately justified and approved.
What funding mechanism is used?
The funding mechanism is SBIR using the R43/R44 grant structure.
What agency administers this opportunity?
The opportunity is administered by the National Institutes of Health (NIH).
What CFDA number is associated with this opportunity?
The opportunity is associated with CFDA number 93.279.
What topic area does this opportunity fall under?
It is categorized under education and health.
When was the FOA created and what was the original closing date?
The FOA was created on 2022-06-10, and the original closing date listed is 2022-11-14.
Is the award ceiling provided in the information given?
No. The listing indicates an award ceiling field, but the actual value is not provided in the supplied text.
Is the number of expected awards provided in the information given?
No. The listing indicates an expected awards field, but the actual value is not provided in the supplied text.
How should applicants think about "regulator-ready" tools for this FOA?
Based on the description, applicants should focus on tools that can be validated and positioned for formal FDA qualification pathways (CDER for DDTs and CDRH for MDDTs), with the expectation that qualified tools become publicly available and broadly usable by the field.
Is the FOA focused only on drugs, only on devices, or both?
Both. The FOA supports Drug Development Tools (DDTs) and Medical Device Development Tools (MDDTs), as long as the tools address SUD therapy development needs and can move toward FDA qualification.
Does the FOA allow work in real-world or decentralized settings?
The FOA highlights difficulties standardizing data collection in real-world or decentralized settings as a development bottleneck, which signals that tools aimed at improving standardization in those contexts are within scope.
Why does the FOA emphasize public availability after qualification?
The emphasis reflects the FOA’s intent to create field-wide enabling infrastructure. Publicly available qualified tools can be reused by multiple sponsors, helping raise consistency and efficiency across SUD therapy development programs.
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