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Seeking Products to Address Social Needs impacting Substance Use Disorders (SUD) (R43/R44 Clinical Trial Optional)

Description:

Purpose The purpose of this notice of funding opportunity (NOFO) is to support applications from small business concerns (SBC) to develop technologies for commercialization to address health-related social needs that impact substance use disorders (SUD), excluding alcohol use disorder. Background In 2021, the Substance Abuse and Mental Health Services Administration (SAMHSA) noted that 61 million people ages 12 and older used illicit drugs in the past year. Nationwide, the Association of American Medical Colleges has reported 21 million people with a SUD, and just 11% of them received treatment. With so many individuals struggling with SUD, and very few receiving treatment, the SUD crisis will worsen. It will take a more comprehensive approach to address the crisis; including addressing the individual's health-related social needs (HRSN) that are influenced by their living conditions. The health of people struggling with SUD is inextricably bound to their social environment. Social determinants of health (SDH) can directly shape health risk behaviors. Moreover, public health experts have long recognized the impact of SDH on health outcomes. While SDH are seen as the surrounding conditions of people’s existence, HRSN are the individual’s unique social conditions from five core categories established by the Centers for Medicare and Medicaid Services (CMS) Accountable Health Communities Model (housing instability, food insecurity, nonmedical transportation, utility needs, and personal safety) resulting from fundamental SDH. SDH manifest in the living conditions and resources that indirectly exacerbate the consequences of drug use. For example, inadequate housing can increase the likelihood of infectious disease transmission, stable social relationships can offer protective financial and emotional resources, and more cohesive neighborhoods are more likely to provide appropriate support and care. HRSN are displayed as people struggling with SUD being able to pay their utility bills while living in inadequate housing, being able to purchase food without sacrificing money for rent, and being able to navigate their community without concern for their personal safety. While SDH, such as poverty, homelessness, and incarceration, among others, impact behaviors that lead to SUD, being able to identify and address the unique HRSN of people struggling with SUD, by using technology, can serve as a catalyst to filling the service gaps that government and the medical community cannot do alone. The public and private sectors, utilizing the infinite capabilities of technology, can collaborate to create new paths and form new business models to address the many direct health-related social needs of people already struggling with SUD. Research Objectives A variety of products addressing the individual-level factors of HRSN should be considered to confront SUD. Additionally, technology, such as telemedicine and mobile health applications, provide an opportunity to address HRSN with the ability to provide tested, accessible, and ongoing solutions for individuals who are the most at-risk for these risk factors that impact SUD. According to SAMHSA, technology has several advantages in addressing Substance SUD including decreased waiting periods, decreased stigma impact, and increased privacy. The advantages of technology are also exhibited in its capability to make treatment services more accessible and convenient which can aid to improve SUD outcomes and reduce disparities. Regarding this NOFO, a product is any source of value for the end-users and customers. A product can be a physical/tangible device as well as digital services, software as a service, or non-physical/non-tangible products (including but not limited to digital applications, digital platforms, or service models). These and other comparable examples could be considered eligible products. Products can be the result of original scientific research, recycled existing technology for SUD, extension of an observation into SUD area, development of a new business model or distribution/delivery channel that reveals currently unseen value, or the delivery of a product or service to disregarded consumers. The National Institute on Drug Abuse (NIDA) supports the development of evidence-based SUD care and treatment technology from multiple funding opportunities published elsewhere. The eligible small businesses can submit applications focusing on products that reduce costs, time, and/or increase access in addressing HRSN including, but not limited to, housing instability, non-medical transportation, food insecurity, utility needs, and personal safety. The products should provide the best feasible and accessible opportunities for the intended end-users to measurably improve their HRSN and SUD. Products of interest that address, but are not limited to, the following HRSN include: Access to housing services. Soft skills development and/or job training (e.g., in entrepreneurship, literacy and financial literacy, IT skills) for employment. Stigma and nurture compassion. Family healthy behaviors, social skills, community opportunities, and productive social involvement. Social stability (community, tradition, faith, family), self-regulation and resilience. Well-being (mental, physical, spiritual), communal belonging, and positive productivity. Social support networks for recovery, engagement with care, and/or access to needed services. Successful community reintegration for formerly incarcerated people. Social needs service engagement and coordination among justice-involved organizations. Employer education to hire, retain, and facilitate treatment for employees seeking help for SUD. Applications Not Responsive to this NOFO The following will be deemed not responsive and will be returned without review Applications solely focused on the research and development of solutions to provide medical care and/or treatment. Applications focusing solely on health-related social needs in the context of Alcohol Use Disorders. The SBIR/STTR program is a phased program. The main objective in SBIR/STTR Phase I is to establish the technical merit and feasibility of the proposed research and development efforts, whereas in SBIR/STTR Phase II it is to continue the R&D efforts to advance the technology toward ultimate commercialization. An overall objective of the SBIR and STTR programs is to increase private sector commercialization of innovations derived from federally supported research and development. At the conclusion of an SBIR/STTR Phase II, the small business is expected to fully commercialize their product or technology using non-SBIR/STTR funds (either federal or non-federal). Three types of applications are accepted in response to this NOFO: Phase I. The objective of Phase I is to establish the technical merit, feasibility, and commercial potential of the proposed R/R&D efforts and to determine the quality of performance of the small business awardee organization prior to proceeding to Phase II. Fast-Track (Phase I/ Phase II) applications should include a clear rationale of feasibility of the proposed approach and/ or technology application in SUD area; demonstrate a high probability of commercialization; propose clear, appropriate, meaningful, and measurable goals (milestones) to be achieved prior to initiating Phase II; and indicate potential Phase III support/interest (non-SBIR/STTR) from future commercialization partners. An NIH SBIR Fast-Track incorporates a submission and review process in which both Phase I and Phase II applications are submitted and reviewed together as one application to reduce or eliminate the funding gap between phases. Phase II. The objective of Phase II (as a part of Fast Track applications) is to continue the R&D efforts initiated in Phase I to advance technologies to potential commercialization. Projects proposed for Phase II are based on the results achieved in Phase I (or equivalent) and aim to demonstrate scientific and technical merit and commercial potential. NIDA seeks to determine that both technical feasibility and commercial feasibility are established in Phase I before making the decision about proceeding to Phase II. Special Considerations NIDA applicants are strongly encouraged to review the guidelines and adhere to the requirements applicable to their research listed in the Special Considerations for NIDA Funding Opportunities and Awards. Upon award, these considerations will be included in the Notice of Grant Award.
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