Opportunity Information: Apply for RFA DA 23 019
This grant 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) (R41/R42 Clinical Trial Optional)," is a National Institutes of Health (NIH) small business-focused funding announcement (Funding Opportunity Number RFA-DA-23-019; CFDA 93.279). It uses the SBIR mechanism (R41/R42), with clinical trials allowed but not required, and it is designed to move the field beyond individual product concepts by strengthening the shared "tools" that drug and device developers rely on to prove safety, effectiveness, and performance for substance use disorder treatments.
The core goal is to accelerate development of Drug Development Tools (DDTs) and Medical Device Development Tools (MDDTs) that are mature enough to be submitted to the FDA for formal qualification. In practice, this means NIH is looking to fund research that produces tools with enough evidence, standardization, and regulatory relevance that they can enter FDA qualification pathways within either CDER (Center for Drug Evaluation and Research) for drug-related tools or CDRH (Center for Devices and Radiological Health) for device-related tools. A key theme is that qualified tools are not just helpful to one company; once qualified, they can be broadly used by sponsors to support multiple development programs, which can cut down on duplicated effort and reduce uncertainty during regulatory review.
The opportunity emphasizes unmet needs in biomedical product development for SUD, where progress is often slowed by gaps in measurement, endpoints, biomarkers, performance assessments, or other evidentiary tools needed to design efficient studies and satisfy regulators. By investing in the development and validation of these tools, the FOA aims to shorten timelines and lower barriers that can keep promising medications or devices from reaching patients. The intended downstream impact is practical: better tools should enable clearer decision-making during development, more reliable interpretation of clinical data, and smoother regulatory interactions, ultimately helping innovative SUD therapies reach the market faster.
Eligibility is limited to small businesses, consistent with the SBIR R41/R42 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 as applicants. However, the announcement notes that foreign components, as defined by the NIH Grants Policy Statement, may be allowed in some cases, meaning specific project elements could potentially be carried out abroad if they meet NIH policy requirements and are appropriately justified, even though the applicant organization itself must be U.S.-based and eligible.
Administratively, this is a discretionary grant program under the NIH, categorized under education and health in the source listing. The opportunity was created on 2022-06-10, with an original closing date of 2022-11-14. While the listing does not provide an award ceiling or expected number of awards in the provided text, the main takeaway is that the funding is positioned to push tool concepts toward FDA qualification-readiness rather than simply supporting early exploratory ideas. In other words, the work is expected to be translational and targeted, with a clear regulatory endpoint: producing a DDT or MDDT package that can credibly move into FDA's qualification programs and then be used broadly to strengthen and speed SUD therapy development.Apply for RFA DA 23 019
- 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) (R41/R42 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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