Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs

Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA). Provides funding for small businesses to develop solutions for alcohol use disorder.

Small Business Funding Considerations and Contacts | Grants & Funding U.S. Department of Health and Human Services National Institutes of Health Small Business Funding Considerations and Contacts This page provides ICO-specific interest areas, due dates, and contacts related to small business. The information found in the Small Business overview applies across all NIH institutes, centers, and offices (ICOs).

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Visit our Institutes, Centers, and Offices page and browse our ICO profiles to discover each ICO's mission, interest areas, and funding National Center for Advancing Translational Sciences (NCATS) NCATS supports research including, but not limited to, clinical technology, instruments, devices, and related methodologies that may have broad application to clinical research and better patient care.

Our interests are in four main categories- (1) Preclinical Drug Discovery and Development; (2) Biomedical, Clinical and Health Research Informatics; (3) Clinical, Dissemination and Implementation Research and (4) Rare Diseases and Unmet Needs.

Approved Topics for Awards Over Statutory Budget Guidelines: Innovative platforms for identification and prioritization of targets for therapeutic intervention with clear Technologies to determine alternative uses for existing therapeutic interventions. Tools and technologies to allow assaying of activities of compounds on currently “non- druggable” targets.

Phenotypic assay development, including stem cell technology platforms for human “disease in a dish” applications and the evaluation of toxicity. Co-crystallization high-throughput screening techniques. Small molecule and biologics analytical characterization.

Tools and technologies that increase the predictivity or efficiency of medicinal chemistry, biologic, or other intervention optimization. Accelerate bioengineering approaches to the development and clinical application of biomedical materials, devices, therapeutics, and/or diagnostics.

Tools and technologies that increase the efficiency of human subjects research, including development of technologies that facilitate rapid diagnosis and/or clinical trial recruitment and subject tracking, IRB evaluation, and/or regulatory processes.

Novel platforms, technologies and tools for: (1) enabling clinical and translational research, particularly those with mechanisms for addition of patient reported data and (2) integration of patient data collected from multiple devices and wide-ranging clinical studies.

Searchable access to information about researchers and their expertise, including but not limited to their publications, published data sets, methods, patents, clinical trials, partnerships, collaborators, and clinical specialty/expertise (if applicable). Tools for meaningful sharing of research data with low barrier for provision and user-friendly access. Microphysiological Systems (MPS)/Tissue Chips.

Tools for building, maintaining, and utilizing knowledge networks, including but not limited to the use of large language models and other artificial intelligence software to mine the biomedical knowledge base, supporting NCATS goals such as drug repurposing for disease treatment.

Algorithms and validation frameworks for the application of artificial intelligence towards all stages of the Phase IIB & Commercialization Readiness Pilot (CRP): NCATS accepts Phase IIB SBIR projects NCATS accepts Commercialization Readiness Pilot (CRP) projects NCATS does not accept clinical trials through the SBIR programs NCATS does not accept clinical trials through the STTR programs NCATS does not accept clinical trials through the Phase IIB SBIR program NCATS does not accept clinical trials through the Commercialization Readiness Pilot (CRP) National Center for Complementary and Integrative Health (NCCIH) The NCCIH will support applications on the development of technologies and therapies relevant to complementary and integrative approaches.

Complementary health approaches include a broad range of practices and interventions that can be classified by their primary therapeutic input, including nutritional and natural products (e.g., special diets, dietary supplements, botanicals, probiotics, and microbial-based therapies), psychological (e.g., meditation, hypnosis, music-based interventions, relaxation therapies), physical (e.g., acupuncture, massage, chiropractic manipulation, other force-based manipulations, or devices related to these approaches), or a combination of psychological and physical (e.g., yoga, tai chi, or some forms of art therapies, such as music-based interventions) input.

Additionally, NCCIH will support applications that explore the impact of complementary and integrative health approaches on health promotion, resilience, and whole person health.

Overall, NCCIH will support applications that include complementary and integrative health approaches, including multicomponent interventions that combine two or more complementary and integrative health approaches, or one or more complementary approaches integrated with one or more conventional care interventions.

Approved Topics for Awards Over Statutory Budget Guidelines: Novel technologies/methods to study the mechanistic effects of complementary and integrative health (CIH) Research to enhance the safety, scalability, reproducibility, and translatability of CIH interventions Innovative methods and technologies to evaluate evidence-based CIH approaches Studies to optimize the impact of natural product(s) on target engagement(s) Development of diagnostic and prognostic technologies to support CIH interventions Technologies to integrate CIH approaches into healthcare delivery Phase IIB & Commercialization Readiness Pilot (CRP): NCCIH does not accept Phase IIB SBIR projects NCCIH does not accept Commercialization Readiness Pilot (CRP) projects NCCIH accepts clinical trials through the SBIR programs NCCIH accepts clinical trials through the STTR programs NCCIH does not accept clinical trials through the Phase IIB SBIR program NCCIH does not accept clinical trials through the Commercialization Readiness Pilot (CRP) Name: NCCIH DER Funding Questions National Cancer Institute (NCI) NCI supports the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs across the United States to develop innovative technologies to reduce or eliminate the burden of cancer.

Technical areas of interest include, but are not limited to, novel therapeutics, medical devices for cancer treatment (including radiation therapy), in vitro and in vivo diagnostics, cancer imaging technologies, cancer research tools, cancer prevention, and digital health technologies.

Priority is given to projects that have a clear commercial product focus, address significant unmet medical needs, and have a well thought out pathway to commercialization. Priority is given to technologies exploiting novel targets, novel mechanisms of action, and precision medicine-based approaches. Supporting companies and teams new to SBIR and STTR funding is also of interest.

For the Commercialization Readiness Pilot (CRP) Program, the NCI will prioritize applications from companies that can accomplish significant commercial milestones through a CRP award, for example completing a clinical trial, and that demonstrate strong commercial readiness.

Evidence of commercial readiness may include, but is not limited to, raised funds from third party investors, formed strategic partnerships with established commercial players, completed some meetings with FDA, and awarded intellectual property patents. For the Strategic Breakthrough program, the NCI is focused on supporting late-stage clinical trials of drugs and devices for rare and pediatric cancers.

Projects should demonstrate a clear regulatory path, strong scientific rationale, matching funds, and potential to improve survival in areas of unmet need where standard of care has not advanced. This initiative is designed to incentivize private-sector investment in rare and pediatric cancer by partnering with the NCI. Applications for non-pediatric or non-rare adult cancer indications will not be considered.

Approved Topics for Awards Over Statutory Budget Guidelines: A. Therapeutics (e.g., Small Molecules, Biologics, Radiomodulators, Gene/Cell-based Therapies and Drug Development-Related Tools, and Algorithm Development) B. In Vitro and In Vivo Diagnostics (e.g., Companion Diagnostics, Prognostic Technologies, Treatment Monitoring and Diagnostic-Related Tools, and Algorithm Development) C.

Imaging Technologies (e.g., Agents, Devices, Software Tools, Algorithm Development, and Image-Guided Interventions) D. Devices for Cancer Therapy (e.g., Interventional Devices, Drug Delivery Devices, Software Tools, Algorithm Development, Surgical, Radiation, and Ablative Therapies) E. Agents for Cancer Prevention (e.g., Vaccines, but not “Technologies for Cancer Prevention”) F.

Development of Low-Cost Technologies for Low-Resource Settings G.

Development of Digital Health Tools Phase IIB & Commercialization Readiness Pilot (CRP): NCI accepts Phase IIB SBIR projects NCI accepts Commercialization Readiness Pilot (CRP) projects NCI accepts clinical trials through the SBIR programs NCI accepts clinical trials through the STTR programs NCI accepts clinical trials through the Phase IIB SBIR program NCI accepts clinical trials through the Commercialization Readiness Pilot (CRP) Commercialization Readiness Pilot (CRP) Program: NCI generally supports CRP projects that include clinical trials, clinical validation studies, or other later-stage commercialization-focused research and development activities up to the SBA guideline maximum of $4,191,495.

NCI generally supports up to $500,000 of technical assistance activities in CRP projects.

Project Period Considerations: Generally, NCI supports Phase I projects of 1 or 2 years Generally, NCI supports Phase II projects of 2 or 3 years Generally, NCI supports CRP projects of 2 or 3 years Generally, NCI supports Phase IIB Strategic Breakthrough projects of 4 years NCI SBIR Development Center National Eye Institute (NEI) NEI supports research including, but not limited to, the following: Commercializable research and clinical innovations in ophthalmology and vision sciences Commercializable therapeutics including drugs, biologics, devices, or combination therapeutics that prevent or reduce blindness or improve ocular health Market-ready technologies and diagnostic tools for predicting, identifying, or monitoring eye diseases and vision-related conditions Commercializable devices and services that assist people with blindness or visual impairments to improve quality of life Commercial-grade devices and support services that help individuals with blindness or vision impairments to improve and enhance their daily living experience Market-ready technologies that correct, enhance, or augment human vision Approved Topics for Awards Over Statutory Budget Guidelines: New or improved ophthalmic or surgical instruments for diagnosis and treatment of eye disorders Drug delivery systems; gene therapy, cell-based therapy or regenerative medicine New therapeutic approaches for inflammatory and degenerative diseases and for inhibition of abnormal angiogenesis in the retina and choroid New therapeutic approaches, artificial corneas, and drug delivery methods for the treatment of corneal injury, infection, dry eye, ocular pain, and other ocular surface disorders New approaches in the management of cataracts New therapeutic agents for treatment of glaucoma New or improved devices, systems, or programs that meet the rehabilitative and everyday living needs of blind or visually impaired persons Phase IIB & Commercialization Readiness Pilot (CRP): NEI accepts Phase IIB SBIR projects NEI accepts Commercialization Readiness Pilot (CRP) projects NEI accepts clinical trials through the SBIR programs NEI accepts clinical trials through the STTR programs NEI accepts clinical trials through the Phase IIB SBIR program NEI accepts clinical trials through the Commercialization Readiness Pilot (CRP) National Human Genome Research Institute (NHGRI) Significant innovations in genomic methods or technology development.

This includes, but is not limited to, advancements in nucleic acid sequencing, synthetic nucleic acid synthesis, functional genomics, single cell genomic analysis, transcriptomics, multi-omics, instrumentation, or molecular kits.

Tools and techniques that use genomics to improve patient health, such as approaches to incorporate genomic results into electronic medical records, clinical decision support tools, or genomic directed health care. Strategies to enhance ethical, legal, and social aspects of genomics research or translation of genomics into health care.

Bioinformatics software or platforms for genomic, genetic, or sequence data processing or analysis, functional genomics, associations between genomic data and diseases or phenotypes, interpretation of variants, or genomic data integration into clinical decision making. Databases and data management platforms for genomics research and application including platforms for sequence, functional, or phenotypic data or annotation of variants.

Development and application of methods for machine learning, pattern detection, or knowledge networks for genomics science or translation into health care. Informatics methods and platforms that adopt data standards, enhance data sharing with privacy, and improve data exchange in genomics science or translation of genomics into health care.

Use of cloud and other computing models to improve scale, reproducibility, interoperability, cost-effectiveness, and utility of genomic and clinical data in genomics or translation into health care. Development of curriculum and educational opportunities that increase the genomics knowledge of participants at the undergraduate, postbaccalaureate, graduate, postdoctoral, or professional levels.

Approved Topics for Awards Over Statutory Budget Guidelines: Significant innovations in genomic methods or technology development. This includes, but is not limited to, advancements in nucleic acid sequencing, synthetic nucleic acid synthesis, functional genomics, single cell genomic analysis, instrumentation, or molecular kits.

Tools and techniques that use genomics to improve patients’ health, such as approaches to incorporate genomic results into electronic medical records, clinical decision support tools, or genomic directed health care.

Strategies to enhance ethical, legal, and social aspects of genomics research or translation of genomics into Bioinformatics software or platforms for genomic, genetic, or sequence data processing or analysis, functional genomics, associations between genomic data and diseases or phenotypes, interpretation of variants, or genomic data integration into clinical decision making.

Databases and data management platforms for genomics research and application including platforms for sequence, functional, or phenotypic data or annotation of variants. Development and application of methods for machine learning, pattern detection, or knowledge networks for genomics science or translation into health care.

Informatics methods and platforms that adopt data standards, enhance data sharing with privacy, and improve data exchange in genomics science or translation of genomics into health care. Use of cloud and other computing models to improve scale, reproducibility, interoperability, cost-effectiveness, and utility of genomic and clinical data in genomics or translation into health care.

Development of curriculum and educational opportunities that increase the genomics knowledge of participants at the undergraduate, postbaccalaureate, graduate, postdoctoral, or professional levels.

Phase IIB & Commercialization Readiness Pilot (CRP): NHGRI does not accept Phase IIB SBIR projects NHGRI accepts Commercialization Readiness Pilot (CRP) projects NHGRI accepts clinical trials through the SBIR programs NHGRI accepts clinical trials through the STTR programs NHGRI does not accept clinical trials through the Phase IIB SBIR program NHGRI does not accept clinical trials through the Commercialization Readiness Pilot (CRP) National Heart, Lung, and Blood Institute (NHLBI) The National Heart, Lung, and Blood Institute (NHLBI) is interested in supporting the development of novel therapeutics, devices, diagnostics, digital health technologies, research tools, and other innovative solutions for advancing the prevention, diagnosis, and treatment of heart, lung, blood, and sleep (HLBS) diseases and disorders.

Topics of particular interest include, but are not limited to, the following topics: Technologies addressing HLBS complications relevant to maternal health and women’s health Artificial Intelligence/Machine Learning technologies to improve diagnosis, treatment, and prevention of disease Precision medicine treatment approaches to treatment New approach methodologies, tools, and point-of-care technologies to improve disease detection and therapeutic development Approved Topics for Awards Over Statutory Budget Guidelines: Small and large animal testing of biomedical technologies for HLBS diseases and disorders.

Human clinical studies for HLBS diseases and disorders. Development of therapeutics for HLBS diseases and disorders. Development of devices (including software and digital health tools) for HLBS diseases and disorders.

Diagnostics development for HLBS diseases and disorders. Investigation of biomarkers and biosignatures for HLBS diseases and disorders. Tools and technologies to enhance biomedical and clinical research for HLBS diseases and disorders.

Tools, technologies, and novel strategies to improve the dissemination and implementation of evidence-based interventions for HLBS diseases and disorders.

Phase IIB & Commercialization Readiness Pilot (CRP): NHLBI accepts Phase IIB SBIR projects NHLBI accepts Commercialization Readiness Pilot (CRP) projects NHLBI accepts clinical trials through the SBIR programs NHLBI accepts clinical trials through the STTR programs NHLBI accepts clinical trials through the Phase IIB SBIR program NHLBI does not accept clinical trials through the Commercialization Readiness Pilot (CRP) Project Period Considerations: NHLBI generally supports the following project periods: Phase II/IIB up to three years Phase IIB up to four years Human subjects and clinical trial applicants are encouraged to propose a two-year project period for Phase I and a three-year project period for Phase II/IIB, and a four-year project period for Phase IIB.

Human subjects and clinical trial applicants are encouraged to reach out to NHLBI program staff before submitting their application. National Institute on Aging (NIA) The NIA is interested in proposals to develop and validate technologies that enhance the health and wellbeing of older adults.

Areas of high interest include technologies intended to address unmet needs and have clear competitive advantages, development of commercialized solutions that are cost-effective and widely available, projects that include strong scientific rigor in the approach, projects that address gaps in NIA-funded research, and small businesses that are new to SBIR/STTR funding.

Scientific areas of interest include but are not limited to : Alzheimer's Disease (AD), AD-Related Dementias (ADRD), and Age-Related Cognitive Decline: Development of innovative tools, technologies, and interventions to prevent, diagnose, treat, monitor, or slow progression of AD/ADRD, cognitive decline, age-related sleep disorders, and delirium, including: Biomarkers, research tools, diagnostics, imaging technologies, and AI/ML methods for early detection and monitoring.

Treatments, including cell and gene therapies, exosome-based therapeutics, behavioral and digital interventions as well as other novel approaches.

Aging Biology and Age-Related Diseases: Development of technologies, therapeutics, biomarkers, and tools to measure, prevent, treat, or slow progression of age-related biobehavioral decline and conditions, including: Therapeutics targeting aging biology mechanisms and personalized medicine approaches. Research tools and data science technologies to understand aging and predict health outcomes.

Aging in Place of Choice and Care Delivery: Development of technologies and interventions that promote healthy aging, support aging in place of choice, improve care delivery, or reduce caregiving burden, including: Assistive devices, robotics, sensors, digital health products, and technologies to enhance care.

Approved Topics for Awards Over Statutory Budget Guidelines: Development of innovative tools, technologies, biomarkers, data science methods, and personalized and therapeutic approaches including but not limited to imaging, diagnostics, AI/ML, exosome-based therapeutics, and cell and gene therapies to measure, prevent, treat, or slow the progression of age-related diseases and conditions, including Alzheimer's disease and AD-related dementias.

Development and evaluation of technologies, devices, tools, and innovative measures including minimally intrusive sensors, assistive devices, robotics, digital health products, and interventions targeting social, behavioral, economic, environmental, and regional factors to promote healthy aging, support aging in place, improve care coordination and management, enhance quality of life, or reduce caregiving burden.

Development and validation of research tools, technologies, and approaches that identify or predict age-related biobehavioral decline, dysfunction, diseases, and conditions, including Alzheimer's disease and AD-related Phase IIB & Commercialization Readiness Pilot (CRP): NIA accepts Phase IIB SBIR projects NIA accepts Commercialization Readiness Pilot (CRP) projects NIA accepts clinical trials through the SBIR programs NIA accepts clinical trials through the STTR programs NIA accepts clinical trials through the Phase IIB SBIR program NIA accepts clinical trials through the Commercialization Readiness Pilot (CRP) NIA encourages SBIR and STTR projects addressing Alzheimer's Disease and Related Dementias (AD/ADRD) and may provide funding up to $700,000 in Phase I and $3 Million in Phase II.

For all other SBIR and STTR projects within the NIA mission space, NIA will support projects up to $500,000 in Phase I and $2. 5 Million in Phase II. All limits are in total costs per project.

Project Period Considerations: The NIA will support Phase I project periods up to 2 years and Phase II project periods up to 3 years. NIA Scientific/Research Contact: NIA Small Business Programs: [email protected] Financial/Grants Management Contact: NIA Grants Management: [email protected] Please include the NOFO number, formatted with hyphens, in the email subject line to ensure the message is routed to the appropriate contact.

National Institute on Alcohol Abuse and Alcoholism (NIAAA) NIAAA-specific SBIR and STTR interests are tailored toward commercializing technologies that address the unique physiological, social, and clinical challenges of alcohol misuse.

The NIAAA specifically encourages small business applications in the following high-priority areas: Biosensors and Wearables: Developing non-invasive, wearable devices for real-time alcohol monitoring (e.g., transdermal sensors) that provide more accurate data than self-reporting for research and clinical use.

Digital Health and Telehealth: Creating mobile applications, AI-driven platforms, and software for the remote delivery of evidence-based treatments, such as Cognitive Behavioral Therapy (CBT) or recovery support services. Pharmacotherapy Development: Advancing the discovery and testing of new medications to treat Alcohol Use Disorder (AUD), specifically focusing on those with commercial potential and lower side-effect profiles.

Diagnostic Tools and Biomarkers: Innovating point-of-care diagnostic tests and biological markers for early detection of alcohol-induced organ damage (liver, brain, heart) and Fetal Alcohol Spectrum Disorders (FASD). Advanced Data Analytics: Utilizing machine learning and big data tools to analyze large health datasets to predict relapse, identify high-risk drinking patterns, or personalize treatment plans.

Regulatory Support: Utilizing the Commercialization Readiness Pilot (CRP) to fund late-stage R&D, such as IND-enabling studies, manufacturing scale-up, or clinical trial verification required for FDA clearance.

Behavioral Interventions : Developing tools designed to improve treatment adherence, reduce stigma, or provide prevention and therapies to treat alcohol use disorder Approved Topics for Awards Over Statutory Budget Guidelines: Development and testing of drug candidates for treating AUD and health-related effects of alcohol misuse or for diagnosing and evaluating conditions related to alcohol misuse.

Development, optimization, validation, and/or testing of novel technologies, devices, methods or applications for neuroscience research (e.g., the effects of alcohol on central nervous system structure and activities). Development, optimization, validation, and/or testing of novel technologies, devices, methods or applications to support screening, brief intervention, referral to treatment, and recovery.

Development, optimization, validation, and/or testing of novel technologies, devices, methods or application to prevent harmful drinking during pregnancy. Development, optimization, validation, and/or testing of novel technologies, devices, methods or application to identify prenatal alcohol exposure, and enhance outcomes of individuals with Fetal Alcohol Spectrum Disorder.

Development, optimization, validation, and/or testing of novel technologies, devices, methods or application for preventing or treating alcohol-induced tissue injury or for the treatment of AUD. Development, optimization, validation, and/or testing of novel technologies, devices, methods or application for measuring alcohol consumption.

Development, optimization, validation, and/or testing of novel technologies, devices, methods or application for the prevention of death or serious injury due to extreme alcohol exposure/poisoning.

Development and validation of tools, models, and/or technologies for alcohol-related laboratory studies, such as animal strains, cell lines, stem cells, in vitro techniques, neuroimaging, ligands, in vivo detection of neuromodulators, or computational tools.

Development and validation of tools, models, and/or technologies for conducting and supporting research in alcohol field (e.g., mobile application and assessment development, electronic data management system, ecological momentary assessment). Development of biomolecular signatures of alcohol exposure and alcohol-induced tissue injury. Digital health therapeutics and/or devices to treat or diagnose AUD or alcohol misuse.

Genotyping of DNA samples from subjects with addiction and substance use disorders.

Phase IIB & Commercialization Readiness Pilot (CRP): NIAAA accepts Phase IIB SBIR projects NIAAA accepts Commercialization Readiness Pilot (CRP) projects NIAAA accepts clinical trials through the SBIR programs NIAAA accepts clinical trials through the STTR programs NIAAA accepts clinical trials through the Phase IIB SBIR program NIAAA accepts clinical trials through the Commercialization Readiness Pilot (CRP) National Institute of Allergy and Infectious Diseases (NIAID) The NIAID Small Business portfolio supports product development and commercialization in the areas of: The immune system, microbe biology, and host-microbe interactions, Diagnostic and prevention strategies Treatment and cure strategies Approved Topics for Awards Over Statutory Budget Guidelines: Asthma & allergy: Asthma, rhinitis, rhinosinusitis, IgE-mediated food allergy, eosinophilic gastrointestinal disorders, Food Protein-Induced Enterocolitis Syndrome, atopic dermatitis, urticaria & drug allergy.

Diagnostic, prognostic, predictive, monitoring & response biomarkers, particularly in relation to immunologic interventions & approaches for detecting infants at risk for allergic diseases. Basic immunology: Immune system development/function in humans & animal models, including computational/emerging technologies. Novel adjuvants.

Preventative/therapeutic antibodies against pathogens; Biomarkers of immune protection/pathogenesis; Sample-sparing assays or organoids to study human immunity across the lifespan; Immunologic reagents for non-mammalian (e.g. Xenopus) & under-represented mammalian (e.g. ferret, bat) models. Autoimmunity, inborn errors of immunity (not HIV) & mucosal immunity: Mechanisms, diagnosis & treatment in animals/humans.

Treatments, standardized diagnostic criteria, outcome measures, high throughput assays of immune cell activity. Prognostic, predictive, monitoring & response biomarkers. Transplantation: Clinical research & translationally relevant animal/non-animal model research in organ, pancreatic islet allogenic, xenogeneic transplantation & vascularized composite allotransplantation.

Immunomodulatory strategies promoting tolerance, graft survival, facilitating immunosuppression minimization; Non-invasive immune biomarkers/assays for subclinical graft rejection or predicting tolerance; Genetic approaches, analytical tools predicting transplant outcomes & improving donor/recipient matching.

Mitigation/treatment of radiation injuries: Preclinical research for radiation medical countermeasures (MCMs) & biodosimetry devices to generate data for FDA submission packages, focusing on diagnosing, mitigating or treating radiation injuries post-incident.

Includes safety/efficacy studies, formulation optimization & Chemical countermeasures: Preclinical MCM research to mitigate the acute and long-term health effects after exposure to Department of Homeland Security-designated Chemicals of Concern, including predictive disease models, response biomarkers and treatments. Biomarkers: Infectious disease-related biomarkers.

May utilize emerging data science technologies, computational Diagnostics: Sensitive, specific & cost-effective clinical diagnostics including user-friendly point-of-care tools for detecting infections, such as HIV or toxin exposure. Assays for drug detection in human samples to monitor adherence. At-home self-testing tools for the detection/monitoring of infectious diseases.

Immunoprophylaxis: Developing/evaluating vaccine or immunoprophylaxis strategies/tools for infectious diseases. Vector-borne pathogens: Arthropod monitoring, management/control to prevent transmission of vector-borne Chemical prophylaxis: Long-acting (min. 30 days) sustained or extended-release pre-exposure prophylaxis, post-exposure prophylaxis & multipurpose prevention technologies for systemic protection from infection.

Therapeutics: Next-gen therapeutics (e.g. immunotherapeutics/biologics) to prevent infection/transmission or for infectious diseases treatment, including HIV. May utilize novel computational approaches to support . Cure of persistent infections: Strategies to cure HIV & hepatitis B virus infections or achieve sustained remission w/o daily drug therapy.

Detecting/quantifying persistent reservoirs of replication-competent latent virus in blood/tissues, including bioimaging techniques. Formulation: Improved formulation/dosage technologies (e.g. less toxic, longer lasting) to prevent or treat infectious diseases, including HIV. Implementation science: Behavioral/social sciences, epidemiology, implementation science & information dissemination related to infectious diseases.

Phase IIB & Commercialization Readiness Pilot (CRP): NIAID accepts Phase IIB SBIR projects NIAID accepts Commercialization Readiness Pilot (CRP) projects NIAID accepts clinical trials through the SBIR programs NIAID does not accept clinical trials through the STTR programs NIAID accepts clinical trials through the Phase IIB SBIR program NIAID does not accept clinical trials through the Commercialization Readiness Pilot (CRP) NIAID Small Business Team National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) The NIAMS small business program supports research and development of products and services for prevention, diagnosis and treatment of rheumatic, musculoskeletal and skin diseases.

The research topics include, but are not limited to, the following: Rheumatic Diseases.

The NIAMS supports research on rheumatic and related diseases including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Lyme arthritis, viral arthritis, gout, calcium pyrophosphate deposition disease (CPDD), spondyloarthropathies, and systemic autoimmune diseases such as systemic lupus erythematosus (SLE), systemic scleroderma (SSc), and autoimmune myositis. Musculoskeletal Diseases.

The musculoskeletal system is composed of the skeleton, the muscles, and connective tissues such as cartilage, tendon, and ligament. The NIAMS supports research aimed at improving the diagnosis, treatment, and prevention of diseases and injuries of the musculoskeletal system and its component tissues.

The topics in this area include research on musculoskeletal diseases such as osteoporosis, osteoarthritis, muscular dystrophy, and osteogenesis imperfecta; tissue engineered products; orthopedic devices and implants; and sports medicine and fitness. Skin Diseases.

The NIAMS supports research on chronic inflammatory skin diseases such as psoriasis, rosacea, acne vulgaris, atopic dermatitis; autoimmune skin diseases such as pemphigus, vitiligo, and alopecia areata; skin repair and regeneration in treatment of chronic wounds and reducing scar formation; and skin cancer prevention such as products preventing skin cancer in early-stage development.

Approved Topics for Awards Over Statutory Budget Guidelines: Research and development of new therapies using small molecules or biologics for arthritis, musculoskeletal and Research and development of novel biomedical devices or tissue engineered products for arthritis, musculoskeletal and skin diseases.

Research and development of new biomarkers or novel imaging technologies for arthritis, musculoskeletal and skin Research and development of innovative AI technologies to manage arthritis, musculoskeletal and skin diseases.

Phase IIB & Commercialization Readiness Pilot (CRP): NIAMS does not accept Phase IIB SBIR projects NIAMS accepts Commercialization Readiness Pilot (CRP) projects NIAMS does not accept clinical trials through the SBIR programs NIAMS does not accept clinical trials through the STTR programs NIAMS does not accept clinical trials through the Phase IIB SBIR program NIAMS does not accept clinical trials through the Commercialization Readiness Pilot (CRP) NIAMS does not accept clinical trials through any SBIR/STTR programs.

Grants Management Contact: National Institute of Biomedical Imaging and Bioengineering (NIBIB) The NIBIB Small Business Program aims to translate cutting edge technologies into commercial products to address critical healthcare challenges. Through grants and contracts, the program supports the development of innovative biomedical technologies that improve human health.

Areas of interest span biomedical imaging, medical devices, health informatics, diagnostic and therapeutic technologies, and related innovations at the intersection of biology and engineering. Projects should demonstrate strong commercial potential while addressing significant unmet clinical needs in biomedical imaging and bioengineering.

Specific program guidance includes: Technologies may be demonstrated using a specific indication or model system, but the core innovation must be broadly applicable without significant reengineering. Applications fall outside NIBIB's mission if the primary focus is developing technologies to elucidate basic biological functions or disease mechanisms, or applying and testing previously developed tools or technologies.

NIBIB may modify or decline funding applications for budgetary, administrative, or programmatic reasons. This includes reducing budgets, shortening award periods, or choosing not to fund applications.

Awardees are strongly encouraged to contact NIBIB's Small Business Team about the Concept to Clinic: Commercializing Innovation (C3i) Program , a mentored, entrepreneurial training course that provides innovators with essential business tools to assess the commercial viability and potential business opportunity for their product.

Approved Topics for Awards Over Statutory Budget Guidelines: Development of innovative biomedical imaging technologies to transform our understanding of biological and disease processes for improving diagnostics, image-guided therapies, and human health.

This may include innovations in areas such as bio-electromagnetic technologies, bioanalytical sensors, image-guided interventions, magnetic resonance imaging, molecular probes and imaging agents, nuclear medicine, optical imaging and spectroscopy, photoacoustic/optoacoustic technologies, diagnostic or interventional ultrasound, or X-ray and computed tomography (CT).

Development of broadly applicable biomedical technologies, without preference for any disease or application, that directly interface with, monitor, and regulate biological processes and functions of human physiology. This may include innovations in areas such as bionics, medical devices, medical simulators, or robotics. C.

Biological and Materials Engineering Development of broadly applicable biomedical technologies, without preference for any disease or application, that directly interface with, monitor, and regulate biological processes and functions of human physiology.

This may include innovations in areas such as biomolecular technologies, cellular and multicellular technologies, living materials, manufacturing and biomanufacturing tools, molecular materials, nanomaterials, physiomimetic materials, or screening and high-throughput tools. Development of science and technology for processing and evaluating complex biomedical information for solutions to real-world healthcare problems.

Research should build toward practical, patient-centered applications such as medical image improvement through advanced methodologies, next-generation intelligent image and data analysis tools, or mobile health.

Projects may include innovations in areas such as artificial intelligence, machine learning, and deep learning, digital/mobile/telehealth, biomedical informatics, image processing, visual perception and display, or bioanalytical sensors. E. Point of Care Technologies Development of healthcare