Digital Technologies to Address the Social Determinants of Health in Context of Substance Use Disorders (SUD) (R43/R44 Clinical Trial Optional) | RFA DA 21 032

Frequently Asked Questions (FAQs)

What is the name and identifier of this funding opportunity?

This NIH Small Business Innovation Research (SBIR) funding opportunity is RFA-DA-21-032, titled "Digital Technologies to Address the Social Determinants of Health in Context of Substance Use Disorders (SUD) (R43/R44 Clinical Trial Optional)."

Which agency is sponsoring this opportunity?

The sponsoring agency is the National Institutes of Health (NIH).

What type of grant program is this?

This is an SBIR discretionary grant program in the health arena (CFDA 93.279) designed specifically for small businesses developing commercially viable digital health products.

Who is eligible to apply?

Eligibility is limited to small businesses, consistent with SBIR requirements. The applicant organization must be a U.S. small business.

Are non-U.S. organizations allowed to apply?

No. Non-U.S. entities (foreign institutions) are not eligible to apply.

Can a U.S. organization apply if part of the work will take place outside the United States?

Non-U.S. components of U.S. organizations are not eligible to apply. However, "foreign components" (as defined in the NIH Grants Policy Statement) may be allowed under specific NIH rules and typically require compliance with NIH policies and prior approval. The applicant must still be a U.S. small business.

What is the overall goal of the opportunity?

The central aim is to support research and development of digital technologies that improve outcomes for people affected by substance use disorders (including opioid use) by targeting social and environmental conditions that increase risk or make recovery harder.

What does it mean that the opportunity focuses on "social determinants of health" (SDOH)?

It means projects should address upstream, real-world conditions that influence substance use risk and recovery outcomes, not just clinical treatment processes. The FOA emphasizes digital interventions that help people navigate or improve the social and structural factors that can undermine recovery even when clinical care is available.

What kinds of SDOH factors are specifically mentioned?

The announcement highlights factors such as housing instability, unemployment and income insecurity, lack of transportation, food insecurity, limited access to supportive services, social isolation, exposure to violence, involvement with the justice system, and other community or structural barriers.

Is this opportunity limited to opioid-related projects?

No. The focus is substance use disorders broadly, and opioid use is included as an example area within that scope.

What kinds of digital technologies or products could be supported?

The FOA points to a range of digital product types, including mobile apps, web platforms, telehealth enhancements, care coordination tools, decision-support systems, remote monitoring approaches, digital navigation and referral tools, and other software-driven solutions.

Does the technology have to be "commercializable"?

Yes. The funded work is expected to produce commercializable digital health-based products, meaning applicants should be developing something that could realistically be brought to market and adopted in real-world settings.

What does "commercializable" imply in practical terms?

It implies there should be a plausible path to real-world adoption and scale, with a product designed for use in practical environments and with users who would realistically adopt it. The emphasis is on measurable improvements tied to SDOH and substance use outcomes, not technology for its own sake.

Where are these digital products expected to be used?

The FOA anticipates adoption in real-world settings such as community organizations, treatment programs, primary care practices, recovery support services, public health agencies, or justice-related settings.

Is the funding meant for clinical treatment tools only?

No. While clinical care can be part of the context, the emphasis is on digital tools that address SDOH-related risks and barriers that affect recovery and outcomes, including navigation of services and support systems.

What does R43/R44 mean?

R43/R44 refers to the SBIR phased structure. Phase I is the R43 component and typically supports early feasibility, prototype development, and proof-of-concept work. Phase II is the R44 component and generally supports more advanced development, refinement, and evaluation steps to move the product toward commercialization.

What is typically supported in Phase I (R43)?

Phase I (R43) typically supports early-stage work such as feasibility research, prototype development, and proof-of-concept efforts.

What is typically supported in Phase II (R44)?

Phase II (R44) typically supports later-stage work such as more advanced product development, refinement, and evaluation activities that help position the product for commercialization.

Does an applicant have to propose a clinical trial?

No. The FOA is labeled "Clinical Trial Optional," meaning clinical trial elements may be included if appropriate, but a clinical trial is not required.

If clinical trials are optional, what kinds of studies might be appropriate?

Based on the FOA description, proposals could range from formative research and user-centered design through pilot testing and broader effectiveness evaluations, depending on the maturity of the product and the research questions.

How does the FOA define success or impact?

The emphasis is on digital solutions that measurably improve SDOH-related risks and support people who use drugs or are in recovery. Strong projects typically connect the digital intervention directly to measurable improvements in social determinants that matter for substance use outcomes.

What makes an application "strong" based on the description provided?

The description suggests strong projects typically demonstrate: (1) a clear understanding of the target population and setting; (2) a plausible pathway to adoption and scale; and (3) a development and evaluation plan that ties the solution to measurable improvements in relevant SDOH factors and substance use outcomes.

What is the CFDA number for this opportunity?

The CFDA number is 93.279.

When was this opportunity created and what was the original closing date?

The opportunity was created on December 22, 2020, and the original closing date was February 26, 2021.

Does the provided information include the award ceiling or number of expected awards?

No. The provided source text does not list an award ceiling or the number of expected awards.

Where should applicants look for budget limits, project periods, and review considerations?

Applicants would normally look to the full Funding Opportunity Announcement (FOA) and NIH SBIR policy guidance for details such as budget limits, project periods, and review considerations.

Is this funding focused on developing new technology or deploying existing tools?

The description emphasizes research and development (R&D) leading to commercializable products, which suggests a focus on creating and advancing digital technologies (from early feasibility and prototyping through refinement and evaluation), rather than only deploying existing tools without R&D.

Does the FOA allow different product formats, or does it require a specific platform (like mobile only)?

It allows multiple formats. The examples include mobile apps, web platforms, telehealth enhancements, and other software-driven solutions, indicating flexibility in platform and delivery approach as long as the product addresses SDOH in the context of SUD.