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The purpose of this Funding Opportunity Announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Innovation Research (SBIR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The projects must focus on products related to the mission and goals of the NIDDK and may evaluate drugs, biologics, or devices, as well as surgical, behavioral or rehabilitation therapies. The purpose of this Funding Opportunity Announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Innovation Research (SBIR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The projects must focus on products related to the mission and goals of the NIDDK and may evaluate drugs, biologics, or devices, as well as surgical, behavioral or rehabilitation therapies.

The overarching goal of the Small Business Innovation Research (SBIR) program is to support small businesses to develop technologies that can advance the mission of the National Institute of Mental Health (NIMH), through research priorities identified by the Division of AIDS Research. This funding opportunity announcement encourages SBIR grant applications to support the development of new technologies for HIV prevention or treatment or the application of existing technologies to behavioral and social science HIV research in these domains.

The overarching goal of the Small Business Technology Transfer (STTR) program is to support small businesses to develop technologies that can advance the mission of the National Institute of Mental Health, through the identified research priorities of Division of AIDS Research. This funding opportunity announcement encourages STTR grant applications to support the development of new technologies for HIV prevention or treatment or the application of existing technologies to behavioral and social science HIV research in these domains.

This Funding Opportunity Announcement (FOA) issued by the National Institutes of Health (NIH) invites eligible United States small business concerns (SBCs) to submit Small Business Technology Transfer (STTR) grant applications. United States SBCs that have the research capabilities and technological expertise to contribute to the R&D mission(s) of the NIH awarding components identified in this FOA are encouraged to submit STTR grant applications in response to identified topics. The NIDCD supports research on the normal mechanisms of, as well as on diseases and disorders of hearing, balance, smell, taste, voice, speech and language. The Institute also supports research related to disease prevention and health promotion. The NIDCD addresses special biomedical and behavioral problems associated with people who have communication impairments or disorders. The NIDCD also supports efforts to create and refine devices, as well as develop cellular-based applications that may replace or substitute for lost and impaired sensory and communication functions.

This Funding Opportunity Announcement (FOA) supports Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that will develop and/or validate devices or electronic systems that can: 1) monitor biologically- or behaviorally-based processes applicable to mind and body interventions or 2) be used to assist in optimizing the practice or increasing the efficacy of mind and body interventions.  The applications should: 1) lead to the development of new technologies, 2) adapt existing innovative technologies, devices and/or electronic systems, 3) repurpose existing devices and electronic systems, or 4) conduct testing of single or combined components of an integrated, long term, automated, wearable monitoring, stimulation device or electronic system in order to monitor or enhance the mechanistic processes or functional outcomes of mind and body interventions. For the purposes of this FOA, mind and body interventions are defined as non-pharmacological approaches that include mind/brain focused interventions (e.g., meditation, hypnosis), body-based approaches (e.g., acupuncture, massage, spinal manipulation/mobilization), or combined mind and body meditative movement approaches (e.g., yoga, tai-chi, qigong).  

This funding opportunity announcement (FOA) encourages applications from small business concerns (SBCs) for Small Business Technology Transfer (STTR) projects to develop novel tools and devices to improve handling of laboratory animals, to ease the management of animal facilities, and to enhance experiments which use animal models. The intent is to facilitate the development and implementation of tools and devices to directly benefit the welfare of research animals, and to advance equipment to improve infrastructure and environmental conditions of animal facilities that support biomedical and bio-behavioral research.

The involvement of small businesses in translational aging research could substantially hasten the pace at which scientific advances are transformed into commercial products to improve or maintain the health and functional independence of older adults. Therefore, this funding opportunity announcement (FOA) is intended to encourage a greater involvement by small businesses through the SBIR mechanism in transforming scientific advances in aging research into novel devices, products, health care practices and programs that will benefit the lives of older adults. For the purposes of this FOA, T1 translational research on aging is defined as the application of basic and clinical biomedical or basic behavioral and social research findings towards the development of new strategies for prevention and treatment of age-related pathologies. T1 translational research approaches could include the development of new research tools or improving existing technologies to diagnose, prevent or treat age-related conditions, functional decline and disability.

This Funding Opportunity Announcement (FOA) encourages Small Business Technology Transfer (STTR) applications from small business concerns (SBCs) that propose the development of therapeutic agents for disorders that fall under the mission of NIAAA.  An identified candidate, having sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required prior to application. The FOA supports Investigational New Drug (IND)-enabling studies for the therapeutic candidate. At the end of the funding period, a successful project should have, at a minimum, an IND application submitted to the U.S. Food and Drug Administration (FDA). The program supports early-phase clinical trials, although these are not required.