The National Institutes of Health Small Business Innovation Research Program
Executive Summary:
The NIH, CDC, and FDA are jointly awarding up to $2.1 million per company through the SBIR Program to support U.S. small businesses developing innovative health, biomedical, and life science technologies. Companies can apply for Phase I (proof-of-concept), Phase II (R&D and commercialization), or Fast-Track awards. Applications are due on January 5th, April 5th, and September 5th each year, with funding typically beginning 9 months after submission. Companies should begin preparing applications at least 12 weeks before a due date to complete registrations and submission.
How much funding would I receive?
Awards provide up to $314,363 for Phase I projects (up to 6 months) and $2,095,748 for Phase II projects (up to 2 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.
What could I use the funding for?
Funds may support research and development toward a commercially viable product or service aligned with the missions of NIH, CDC, or FDA (see below). Eligible costs include personnel, materials, prototypes, testing, IP protection, and other R&D expenses. Phase II and IIB funds may also be used for scale-up, validation, regulatory preparation, and commercialization efforts. Click below to see the various areas of interest:
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Alzheimer’s Disease (AD), AD-Related Dementias (ADRD), and Age-Related Change in Brain Function. Research and development of novel interventions to ameliorate AD/ADRD; improve AD/ADRD care; or further the understanding of the etiology of AD/ADRD, neurodegeneration, brain connectivity, neuroplasticity, or brain-– behavior relationships. This includes drug and non-drug interventions for age-related cognitive decline, delirium, sleep disorders, or other central nervous system dysfunctions, including dysfunctions of the motor, emotional, sensory, and neuroimmune systems. This also includes novel biomarkers of neural stem cell functions and new technologies or imaging devices that improve or study brain connectivity; metabolism; sleep; or cognitive, motor, emotional, or sensory activity.
Aging in Place of Choice. Research and development of social, behavioral, and environmental interventions that promote independence and aging in place by addressing the unique needs of older adults, their healthcare providers, and caregivers. This includes prosthetics, assistive devices and robotics, digital technologies and software, and technology to mitigate age-related physical and behavioral health challenges or toimprove healthcare delivery, care coordination, and disease management.
Age-Related Diseases and Conditions. Research and development of new diagnostic tools and methods, biomarkers, therapeutics, imaging devices, and technologies to monitor, diagnose, predict, prevent, treat, and further the understanding of the molecular mechanisms of aging or age-related diseases and conditions.
Research Tools. Development and validation of innovative tools, resources, or methodologies that promote the efficient, cost-effective, and high-quality collection, analysis, or interpretation of aging-related quantitative or qualitative data. This includes bioinformatics tools; screening platforms; surveying, sampling, and behavioral/behavioral economics methods; and clinical instruments to enhance the study of aging, cellular resiliencies, and aging-related diseases.
Special Areas of Interest. Areas of particular interest related to aging biology, aging-related diseases and conditions, behavioral health, and AD/ADRD include, but are not limited to the following:
A. Companion diagnostics and other forms of personalized medicine.
B. Bioinformatics, public health informatics, or data science technologies/methods (e.g., machine learning, artificial intelligence) to better understand aging biology and/or predict health outcomes.
C. Novel cell and gene therapies, as well as other novel therapeutic approaches to AD/ADRD.
D. Biomarkers and diagnostic tools for the early detection of disease.
E. Prevention and therapeutics that directly target mechanisms related to aging biology.
F. Assistive technology, devices, and mobile applications for older adults and caregivers.
G. Tools, technologies, and analytic methods to address health disparities among older adults and/or biological determinants of health disparities.
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New tools, techniques, paradigms, and technology are needed to enable researchers to further understand the underlying biological and behavioral mechanisms through which conditions associated with AUD develop:
Induced pluripotent stem cells (iPS), including disease specific cell lines and gene-edited models (e.g., alcohol-related organ damage and disease with human iPS cell-derived organoids) and from adult-derived human iPSCs cells representing genetic variations in alcohol metabolism (e.g., alcohol dehydrogenase (ADH), aldehyde dehydrogenase (ALDH), cytochrome P450 isozyme CYP2E1, and glutathione S-transferase (GST)) or models of normal development and alterations by prenatal alcohol exposure, and embryonic stem cell models of development and effects of alcohol exposure.
Novel technologies to measure and interpret non-coding RNA (ncRNA) gene expression, following alcohol exposure, in the brain at the cellular level or in non-animal research models.
Using single-cell transcriptomics and multiomics technologies and sequencing to reveal the molecular fingerprint of cell states and their predicted signaling circuits in tissues across development and AUD.
Tools to detect dynamic and concurrent changes of neurotransmitters and neuromodulators in the brain of behaving animals.
Tools to detect the effects of alcohol on the central nervous system (CNS) structure and activity.
Novel animal models, including transgenic animals.
Hepatocyte cell line capable of maintaining viability and metabolic functions in culture systems for an indefinite period.
Experimental systems that mimic organ function.
New methods of ethanol administration to animals that produce precise dose control or that closely mimic types of alcohol exposure occurring in humans.
New ligands that will enhance the potential usefulness of PET and SPECT neuroimaging technologies for the study of the etiology of AUD and related brain pathology.
Humanized animal models to study AUD in different organ systems.
Methods to detect epigenetic changes as disease drivers due to metabolic reprogramming by alcohol.
Tools to determine the prevalence of alcohol associated organ diseases: alcoholic cardiomyopathy, sarcopenia, pancreatitis, pulmonary, immune and bone diseases.
Optoelectronics probes and devices used to manipulate nerve cell activity in awake animals to better study nerve cell function in the body’s periphery.
Generate organoids from iPSCs that specifically model sleep-regulating brain regions affected by alcohol, providing a platform for studying alcohol's neurobiological impacts on sleep at the organ level.
Prevention, Treatment, & Recovery. Prevention strategies/programs and educational services, behavioral treatment programs, medications, and digital health technologies are crucial in ameliorating the negative health effects and consequences associated with AUD and alcohol misuse and recovery.
Medications Development
Preclinical and/or clinical development of therapeutics for AUD and alcohol-related complications (e.g., craving, sleep problems, withdrawal symptoms, and negative affect).
Early therapeutic discovery activities (e.g., target ID, lead compound target validation).
Investigational New Drug (IND)-enabling studies.
Extended formulations or reformulations of existing medications that improve efficacy or compliance.
Therapeutics for individuals with co-occurring health conditions, such as post-traumatic stress disorder (PTSD), HIV, alcoholic hepatitis, liver fibrosis, cirrhosis, pancreatitis, cardiomyopathy, or other alcohol-induced tissue damage.
Development of precision medicine tools (e.g., biomarker panel) to predict treatment outcomes among AUD patients.
Programs or Therapies to Prevent or Treat AUD and/or the Consequences of Alcohol Misuse, Hazardous Drinking, and AUD Across the Lifespan
Novel behavioral health or educational programs aimed at preventing or treating AUD or associated consequences of AUD, alcohol misuse, or hazardous drinking across the life span.
Prevention or treatment programs tailored specifically to the needs of the following groups: children of individuals with AUD, women, racial and ethnic underrepresented populations, sexual and gender minority populations, individuals with Fetal Alcohol Spectrum Disorders (FASD) across the lifespan, persons with disabilities, adolescents/young adults, the elderly, individuals in rural settings, individuals with psychiatric comorbidities (e.g., PTSD, major depressive disorder, etc.).
Computerized versions of empirically supported prevention or treatment programs, including but not limited to in languages other than English.
Prevention curricula, videos, multi-media programs, and training materials for use with adolescents and other population groups and in the NIAAA priority areas.
Therapeutic, skill-building, and educational program products that enhance behavioral, neurocognitive, social, adaptive, and motor function to improve the overall well-being of individuals with FASD and their families.
Therapies to mitigate alcohol-associated adverse impact on the development of liver and/or lung diseases.
Strategies and methods to increase awareness and salience among high-risk groups of the tragic consequences of driving after drinking.
Therapies or programs specifically focused on sustaining mid- and long-term recovery from AUD.
Digital Health Tools (mHealth, health IT, wearable devices, telehealth, telemedicine, and personalized medicine)
Wearable Alcohol Biosensor - minimally invasive, near real-time detection, remote monitoring, infrared or other non-sweat based technology preferred.
Validation of promising technologies, biosensors, and research tools.
Development of precision medicine tools to predict an individual’s risk for developing AUD and/or quantify progression to an AUD diagnosis.
Tools to improve the prevention or treatment of AUD and alcohol-related problems.
Applications that facilitate long-term recovery support and improve continued engagement in recovery support services.
Tools to improve the identification and diagnosis of FASD and prenatal alcohol exposure.
Applications or tools to improve medication safety (e.g., multiple medications, interactions with alcohol).
Mobile device applications or other health technologies to improve the effectiveness, accessibility, and use of behavioral interventions for AUD and co-occurring disorders, including HIV.
Solutions or applications to improve minority health and health disparities with capabilities of reaching persons in rural, remote, and under-resourced/under-served communities.
Virtual reality (VR) technology to create immersive environments that simulate real-world scenarios involving alcohol consumption and its effects on behavior and sleep, for understanding environmental and social factors in AUD.
Non-invasive, wearable devices capable of monitoring physiological and biochemical markers of alcohol intake and its impact on sleep patterns in real-time, utilizing technologies like bioimpedance.App-based digital platforms that offer personalized cognitive-behavioral therapy forinsomnia (CBT-I) and other sleep improvement techniques for individuals with AUD, integrating wearable sleep data.
Diagnostics. Improving the current battery or developing new approaches to measurement, diagnosis, and assessment of the severity of AUD, alcohol misuse and health consequences, FASD, and alcohol- related organ damage.
Imaging Examination Technologies for Early and Precise Diagnosis of Alcohol-Related Organ Damage
Biomarkers for AUD and alcohol-related health effects
Detection (e.g., biochemical, unbiased assay) of alcohol intake for extended period (e.g., 2 weeks, 2 months) after drinking episode.
Signatures of alcohol-induced organ damage and familial risk.
Reduction of time to results for current assays (e.g., phosphatidylethanol (Peth), ethyl glucuronide (EtG)).
Increase accuracy of alcohol intake detection by developing a novel combination of biomarkers (e.g., PEth, EtG)).
Improve assay methodologies for established biomarkers of alcohol consumption considering cost, timeliness, and accessibility in a range of clinical settings.
Point of care devices, for use in rural or remote primary care and hospital settings.
Validation of promising biomarkers that can be used to improve clinical research and practice (for example, diagnosis, prognosis, and treatment response) for alcohol related health conditions, including AUD, FASD, and alcohol associated organ injury.
Tools or kits to measure aristolochic acid (AA)-adducts and advanced glycation end products (AGEs) in serum, cerebral spinal fluid, and brain and other organs impacted by AUD in animal models and pre-clinical settings including their relationship to the biomarkers of neuro- inflammation.
Tools to detect alcohol-induced damage in those patients with HIV infection or co-infection.
Measurement and integration of ‘omics data for AUD and alcohol-related organ damage.
Data Science. Software and tools can be used for discovery of new biomarkers and targets, precision medicine, and other applications to increase the efficiency and efficacy of treating AUD and alcohol-related health effects.
Algorithms for integrative analysis incorporating multiple current NIAAA supported (current and legacy), government, and public datasets, including machine learning, deep learning, artificial intelligence, data mining and other model based and model-free approaches.
Software applications for data interfaces for aggregation, imputation, harmonization, or visualization of data from multiple sources, including current and future NIH data systems.
Algorithms and/or software tools for improving data collection, i.e., smart phone apps, extraction of specific alcohol research parameters from existing large databases and established public health studies, biological sensors or wearable devices.
Computational and/or systems biology models of alcohol exposure, tolerance, and resilience.
Computational, statistical or bioinformatics tools to organize and manage high throughput data obtained by genomic, functional genomic, or other ‘omic strategies.
Computational tools to combine multiple data modalities (e.g., omics, imaging).
Application of machine learning and artificial intelligence, including large language models, in alcohol research, including ethics and privacy concerns.
Translation of ‘omics’ data into clinically relevant predictions and outcomes for AUD and alcohol- related organ damage.
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Division of AIDS (DAIDS) supports a global research portfolio to advance biological knowledge of HIV/AIDS, its related co-infections, and co-morbidities. With the ultimate goal of creating an “AIDS-Free Generation,” the division develops and supports the infrastructure and biomedical research needed to: 1) Reduce HIV incidence through the development of effective biomedical prevention strategies, including vaccines that are safe and desirable, 2) Develop novel approaches for the treatment and cure of HIV infection, 3) Develop interventions to treat and/or prevent co-infections and co-morbidities of greatest significance, and 4) Engage scientific and community stakeholders to equitably implement effective interventions.
Basic Sciences Program supports basic and applied research on the causes, diagnosis, treatment, and prevention of HIV and AIDS.
Epidemiology Branch. Population-based research, modeling, and comparative effectiveness studies (not including clinical trials) that assess the natural history, biologic, and clinical course of HIV/AIDS, and related outcomes, and could advance treatment and prevention of HIV. Specific interests include phylodynamics and other factors related to HIV transmission and associated biological and behavioral factors, basic research on immunology, virology, and antiretroviral therapy, issues surrounding care for HIV and other co-morbidities, interactions and impact on clinical outcomes. Development of novel electronic tools, including devices and computer programs to enhance behaviors, such as treatment adherence or uptake of treatment guidelines, is also of interest.
Pathogenesis & Basic Research Branch. Innovative technologies for at-home self-testing to directly detect HIV during the earliest stages of acute infection (before antibody response) or to detect viral rebound following long-term suppression of viremia. Identification and validation of new targets for discovery or design of strategies to prevent HIV transmission, inhibit replication, control viremia in the absence of antiretroviral drugs, or eradicate reservoirs of HIV that persist despite long-term antiretroviral therapy. Innovative approaches for predicting post-treatment immunologic control of viral rebound or for monitoring changes in the size of the rebound- competent HIV reservoir. Determination of atomic structures relevant to HIV prevention, treatment, or cure.
Targeted Interventions Branch. Discovery and development of small molecule inhibitors with novel or underexplored mechanisms of action using standard and high-throughput technologies; cell-based and gene therapies; RNA-based therapeutics; next-generation biologics; novel targeting and delivery vehicles for agents active against HIV; therapeutic vaccines and monoclonal antibodies; protein chemistry-based anti-HIV approaches; assays to quantitate latent virus; animal models to facilitate evaluation of agents to treat or cure HIV infection.
Vaccine Research Program supports the discovery, development and clinical evaluation of an HIV/AIDS vaccine.
Vaccine Clinical Research Branch. Research areas: (1) phase I, II, and III domestic and international clinical trials of candidate AIDS and TB vaccines and anti-HIV antibodies; (2) evaluation and characterization of immune responses, virologic markers, and improved diagnostic approaches in HIV-infected and uninfected immunized volunteers, and (3) technologies and methods to improve clinical efficacy or reduce the burden of vaccine or monoclonal antibody administration.
Preclinical Research and Development Branch. Preclinical research to assess and overcome specific biomedical obstacles in HIV vaccine discovery, especially by application of innovative technologies, and/or by the development and supply of novel reagents/resources useful for advancing original vaccine platforms including monoclonal antibody discovery and development for prevention of HIV infection.
Vaccine Translational Research Branch. VTRB enables research by advancing innovative vaccine concepts and scalable unit operations into the development of cGMP manufactured products. VTRB’s efforts to accelerate the development of preventive HIV-1 vaccines involves identifying, supporting and advancing: (a) cell line development to increase Env expression, production, quality, and yield; (b) evaluation of phase-appropriate upstream and downstream manufacturing processes;(c) scalable and prototype process development and purification platforms; (d) cGMP manufacturing of broad portfolio of vaccine products ranging from complex HIV Env protein immunogens, nanoparticle-based vaccines, viral vectors, virus-like particles (VLP), nucleic acid-based vaccines (DNA and mRNA), monoclonal antibodies for testing in early phase human clinical trials; (e) manufacturing new and/or alternative adjuvant analogs with similar agonist functions as those currently available for optimal immune response; (f) novel and emerging nanoparticle antigen and adjuvant delivery modalities and dosage forms, coformulation technologies and platforms for immunization; (g) antigen-adjuvant formulation development, analytics development to support product characterization, in-process operations, release, and stability testing; and (h) preclinical safety, immunogenicity, and toxicology testing.
Therapeutics Research Program develops and oversees research and development of therapies for HIV disease, including complications, co-infections and co-morbidities, in adults.
Drug Development and Preclinical Research Branch. Basic, preclinical, and translational research for development of new therapies for HIV and HIV-associated co-infections, including Mycobacterium tuberculosis and viral hepatitis; development of safer, more efficacious antiviral, antimicrobial, and immune-based therapies, and combinations thereof, including long-acting/extended-release approaches; target identification and validation for HIV-related co-infections and assay development for screening potential therapeutics; preclinical research to elucidate the biology of HIV-related co-infections, including pathogenesis, immune protection and control, and persistence and latency; maintenance of a database of potential anti-infectives for HIV and HIV-related coinfections.
Laboratory and Clinical Sciences Branch. Research focused on biomarker discovery/validation and assay development for diagnostics, including development and evaluation of practical and affordable tests to measure viral load, drug toxicities, and drug resistance for clinical use; development and testing of new or improved methodologies for diagnosing, monitoring, and following patients under treatment, including tests to detect early infection in seropositive HIV-infected adult and pediatric individuals in poor resource settings; clinical development of laboratory assays; clinical immunology, virology, and pharmacology related to the design and conduct of clinical trials; management of quality assurance contracts for oversight of the quality of clinical laboratory testing in support of clinical trials.
HIV Research Branch. Clinical research in adults to evaluate chemotherapeutic and immune-based interventions to treat acute and chronic HIV infection and approaches to achieve sustained remission or cure; strategies to augment HIV-specific immune responses and general host immunity to control or clear HIV infection.
Complications & Co-Infections Research Branch. Clinical research in adults to evaluate new or improved therapies and related strategies for the treatment and/or prevention of HIV-related co-infections (exclusive of Mycobacterium tuberculosis) and non-infectious co-morbidities, including Immune Reconstitution Inflammatory Syndrome (IRIS), in people living with HIV.
Tuberculosis Clinical Research Branch. Clinical research in adults to evaluate therapeutics, therapeutic vaccines and strategies to prevent disease recurrence for tuberculosis in people living with HIV, including those with additional medical conditions that may affect disease outcomes; clinical trials with a primary objective to elucidate the pathophysiology and immunopathogenesis of HIV/TB co-infection including the study of co-infection interactions and changes in the course, pathology, treatment responses, and outcome of either infection.
Prevention Science Program develops and oversees research and development of 1) non-vaccine biomedical HIV prevention strategies in adolescents and adults, and 2) therapies for cure, management, treatment and prevention of HIV and HIV-associated complications in pregnant women, infants, children, and adolescents, including pediatric-friendly formulations. Supports domestic and international phase I, II, and III clinical trials to evaluate these prevention or therapeutic strategies in relevant populations.
Preclinical Microbicides and Prevention Research Branch. Development of non-vaccine biomedical HIV prevention products including topical microbicides, pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), and multipurpose prevention technologies (MPT). Emphasis on drug delivery systems (DDS) designed to achieve systemic protection for ≥ 3 months. Development of shorter-duration products (i.e., minimum of 7 days to <3 months), which address a compelling specific public health need. Key populations are adolescents, cisgender women, men who have sex with men (MSM), and transgender people.
Clinical Prevention Research Branch. Development of safe and effective non-vaccine biomedical and integrated HIV prevention interventions to reduce the number of new HIV infections in adults and adolescents. Support the development of HIV incidence assays, biomarkers of adherence, mathematical modeling, and other tools needed to accomplish these objectives. Clinical development of topical microbicides to prevent HIV infection with the goal to advance safe, effective, and acceptable microbicide products toward licensure.
Maternal, Adolescent and Pediatric Medicine Branch. Therapies for cure, management, treatment and prevention of HIV and HIV-associated complications including TB, in pregnant women, infants, children, and adolescents, including development of pediatric-friendly formulations. Strategies to reduce transmission of HIV and HIV co-infections from mother to child.
Division of Allergy, Immunology, and Transplantation (DAIT). The Division of Allergy, Immunology, and Transplantation (DAIT) supports studies of the immune system in health and the cause, pathogenesis, diagnosis, prevention, and treatment of disease caused by immune dysfunction.
Allergy, Asthma and Airway Biology Branch. Conditions of interest: asthma, food allergy, eosinophilic esophagitis and gastroenteritis in relation to food allergy, atopic dermatitis, urticaria, rhinitis, rhinosinusitis, drug allergy, sepsis. The Branch supports basic and clinical studies investigating mechanisms of disease and new approaches to diagnose, treat or prevent these conditions. Special interest for SBIR/STTR includes a) the development of biomarkers as diagnostic markers, markers of disease severity and predictive markers for treatment effectiveness, particularly of immunologic interventions such as allergen immunotherapy for food and respiratory allergy; b) the development of new forms of allergen immunotherapy aiming at increased tolerogenic immune responses and decreased allergenicity.
Basic Immunology Branch. The Branch supports basic and clinical research in the following areas: adjuvant discovery and development; origin, maturation, and interactions of immune cells; immune cell receptors, and ligands; cytokine biology; molecular basis of immune activation, antigen recognition, and immune tolerance; immune response regulation; hematopoiesis and stem cell biology; computational immunology; immunologic mechanisms associated with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome; assessment and analysis of vaccine effectiveness in neonates, pregnant women, and adults, and basic immunology of vaccines and immunotherapeutics as medical countermeasures for biodefense. Special interests for SBIR/STTRs include: adjuvant discovery , development, production of biosimilars, and/or head-to-head comparisons; bioinformatics tools for immune epitope predictions/visualization, and/or for the analysis of multi-parameter or systems immunology data; development and validation of immunologic reagents for analysis of immunity in non-mammalian (e.g., Xenopus laevis, zebrafish, C. elegans) and under-represented mammalian (e.g., pig, ferret, cow, sheep, bat) models, and development of novel/improved sample sparing methods to analyze human immune responses from limited amounts of human sample (tissue, cells, serum, etc.).
Autoimmunity and Mucosal Immunology Branch. Preclinical and clinical research to develop and improve the diagnosis and treatment of autoimmune diseases and primary immune deficiencies/inborn errors of immunity (not HIV); basic research of autoimmune disease mechanisms and biomarkers; immunotherapy of disease processes; disorders mediated by lymphocyte products; and discovery and/or development of reagents and other tools for analysis of mucosal immunity.
Transplantation Branch. Preclinical and clinical research in organ, vascularized composite tissue and cellular transplantation: acute and chronic graft rejection, allogeneic and xenogeneic transplantation, development of immunomodulatory agents to prevent and treat graft rejection and to promote acute and long term graft acceptance and immunologic tolerance, genomics of the alloimmune response, graft versus host disease for hematopoietic stem cell transplantation, minor histocompatibility antigens, complications of immunosuppression in transplantation, and major histocompatibility complex (MHC) region genomics, technologies for MHC typing, and clinical applications of high-resolution HLA typing.
Radiation and Nuclear Countermeasures Program (RNCP). The RNCP will consider preclinical research to support product development activities leading to interactions with the Food and Drug Administration (FDA). Approaches could include those used to diagnose, mitigate, and/or treat acute or delayed effects of radiation exposure resulting from a radiological or nuclear incident. It is anticipated that in most cases, approval will occur in accordance with the FDA Animal Rule (21 CFR 314.600 Subpart I for drug products and 21 CFR 601.90 Subpart H for biologic products).
Proposed activities could include:
Animal model studies or ex vivo approaches (e.g., human tissue chips) to confirm/optimize product efficacy;
Mechanism of action studies needed for FDA consideration;
Good Laboratory Practice (GLP)/non-GLP pharmacology/toxicology/pharmacokinetics/pharmacodynamics;
GLP pilot animal efficacy studies;
Good Manufacturing Practice product scale-up and stability studies;
Biomarker and biodosimetry assay/device development to determine radiation dose and/or the biological impact of radiation exposure (in vivo and ex vivo models acceptable).
Priority areas of product development include:
Approaches targeting organ systems/microbiota, for which no treatments are available (e.g., gastrointestinal, lung, kidney, cardiac, vascular, and skin);
Approaches to mitigate and/or treat radiation injury given 24 hours or later post-irradiation;
Minimally invasive, predictive radiation markers, diagnostics and devices for biodosimetry;
Radionuclide decorporation agents.
The Division of Microbiology and Infectious Diseases (DMID) supports research to better understand, treat, and ultimately prevent infectious diseases caused by virtually all infectious agents, except HIV. DMID supports a broad spectrum of research from basic molecular structure, microbial physiology, and pathogenesis, to the development of new and improved vaccines, therapeutics, and vector control measures. DMID also supports medical diagnostics research, which is defined as research to improve the quality of patient assessment and care that would result in the implementation of appropriate therapeutic or preventive measures. In addition, DMID supports studies to better understand mechanisms of pathogen transmission that may include environmental factors. DMID does not support research directed at decontamination or the development of environmentally oriented detectors, whose primary purpose is the identification of specific agents in the environment. Note that some of the organisms and toxins listed below are considered NIAID priority pathogens or toxins for biodefense and emerging infectious disease research.
Bacteriology and Mycology Branch. The branch oversees research and product development related to:
Bacterial infections with emphasis on hospital-associated pathogens, including Acinetobacter, Klebsiella, Serratia, Legionella, Pseudomonas, Aeromonas, Enterobacter, Proteus, non-enteric E.coli, staphylococci, enterococci, actinomycetes among others;
Bacterial zoonoses, including plague, anthrax, tularemia, glanders, melioidosis, Lyme disease, borrelial relapsing fevers, rickettsial diseases, anaplasmosis, ehrlichiosis, bartonellosis, scrubtyphus, Q fever, and leptospirosis;
Fungal infections including those caused by Candida, Aspergillus, Cryptococcus, Coccidiodes, Histoplasma, Blastomyces, Pneumocystis, Microsporidia, and other pathogenic fungi.
Research is encouraged in the following general areas: (1) vaccines, adjuvants, therapeutics and diagnostics (including target identification and characterization, device or apparatus development, novel delivery, and preclinical evaluation); (2) strategies to combat antibacterial and antifungal drug resistance; (3) applied proteomics and genomics; (4) host-pathogen interactions, including pathogenesis and host response; (5) genetics, molecular, and cell biology; and (6) microbial structure and function.
Research on all of the above is welcome, but the following areas are of particular interest to the branch:
Vaccines, therapeutics, and medical diagnostics for hospital infections
Adjunctive therapies and non-traditional approaches to combat and treat antimicrobial resistance
Diagnostics for invasive fungal diseases
Novel approaches for the diagnosis of Lyme disease
Vaccines against Coccidioidomycosis
Enteric and Sexually Transmitted Infections Branch.
Enteric Infections Section research portfolios focus on enteric bacterial pathogens, their toxins, and their infectious diseases; related sequela; and the gastrointestinal microbiota and microbiome. Special emphasis areas include but are not limited to those below:
Development of vaccines to prevent bacterial enteric diseases, to protect against neurotoxins and enterotoxins, and to combat enteric diseases in vulnerable populations.
Development of therapeutics that focus on novel targets, that target toxin activities, and that treat recurrent diseases.
Development of live biotherapeutic products to restore colonization resistance to enteric pathogens, to combat recurrent or chronic enteric disease, and to restore host immunity against enteric pathogens.
Development of adjunctive therapies and non-traditional approaches to treat resistant bacteria and to combat further development of antibacterial resistance.
Development of rapid diagnostics to identify multiple pathogens and their antimicrobial resistance profiles that are appropriate for use in low-resource, outbreaks, and clinical settings, as well as diagnostic approaches that differentiate asymptomatic colonization from infection.
Sexually Transmitted Infections. Areas of emphasis include the development of medical diagnostics including better and more rapid multiplex point of care tests, ability to rapidly determine antibiotic sensitivity, and novel technologies enabling testing in low resource settings while maintaining high sensitivity/specificity; development of new classes of antimicrobials and non-antimicrobial treatment approaches, particularly those focused on reducing the development of antibiotic resistance; novel delivery systems for multipurpose prevention technologies, vaccines and therapeutics for Sexually Transmitted Infections (STIs) and other reproductive tract syndromes such as bacterial vaginosis and pelvic inflammatory disease; understanding vaginal ecology and immunology and approaches to developing synthetic microbiota for use as biotherapeutics or as adjunct therapy to antibiotic treatment; development of epidemiologic and behavioral strategies to reduce transmission of STIs; developing and evaluating interventions and products to better serve adolescents, medically underserved populations, and minority groups who are disproportionately affected by STIs; development of multipurpose prevention technologies to prevent STIs, HIV, and unintended pregnancies; better understanding of the role of STIs in infertility, premature birth, and adverse outcomes of pregnancy and how to improve outcomes; and better understanding of the role of STIs in HIV transmission and the role of HIV in altering the natural history of STIs.
Respiratory Diseases Branch. Research areas include:
(1) viral respiratory diseases caused by influenza viruses, human coronaviruses including SARS, MERS, and novel emerging coronaviruses, rhinoviruses, respiratory syncytial virus and other related pneumoviruses and paramyxoviruses;
(2) mycobacterial diseases, including tuberculosis (TB) caused by bacteria of the Mycobacterium tuberculosis complex, leprosy, Buruli ulcer and non- tuberculous mycobacterial (NTM) diseases, particularly pulmonary infections in persons not afflicted with HIV/AIDS;
(3) other bacterial respiratory diseases including bacterial pneumonia primarily caused by Streptococcus pneumoniae, Pseudomonas aeruginosa, and Haemophilus influenzae, pertussis, Group A and B streptococcal diseases, meningitis, upper respiratory infections, acute exacerbations of chronic obstructive pulmonary disease, and cystic fibrosis; and (4) mixed viral/bacterial respiratory infections.
Special emphasis areas include:
Development of new or improved antimicrobials (especially for antimicrobial-resistant pathogens) and antivirals, including immunotherapeutics, immunomodulators, and host-directed therapies to augment anti-infectives;
New or improved vaccines (with and without adjuvants);
Improved delivery systems and formulations for drugs/vaccines;
Microbial and host biomarkers and biosignatures suitable for diagnostic tests;
Development of novel or improved diagnostic tools for detection of infection and drug resistance, including rapid point of care diagnostics and quantitation of pathogen in response to therapy;
Diagnostics to distinguish viral from bacterial infections.
There is particular need for preventive and treatment countermeasures for influenza, including universal vaccine platforms and broad-spectrum antivirals; for novel treatment of respiratory syncytial virus (RSV) and related pneumovirus and paramyxovirus infections; for next generation vaccines, therapeutics, and diagnostics for the prevention and treatment of COVID-19, including pan-coronavirus approaches; for diagnostics including diagnostics for pediatric populations, novel therapeutics, and vaccines (including adjuvants) against Mycobacterium tuberculosis (TB); for relevant diagnostics, preventive and curative interventions against non-HIV associated pulmonary Non-tuberculous mycobacteria (NTM); and for the prevention, diagnosis, and treatment of Bordetella pertussis, Group A streptococcus, and Streptococcus pneumoniae infections and other antibacterial resistant infections
Parasitology and International Programs Branch. Research areas:
(1) protozoan infections, including amebiasis, cryptosporidiosis, cyclosporiasis, giardiasis, leishmaniasis, malaria, trypanosomiasis, toxoplasmosis; helminth infections, including cysticercosis, echinococcosis, lymphatic filariasis, schistosomiasis, onchocerciasis, others (e.g., roundworms, tapeworms, and flukes); invertebrate vectors/ectoparasites responsible for human disease (.e.g., mosquitoes, black flies, sandflies, tsetse flies, ticks, triatomine bugs, fleas, lice, mites), and selected intermediate hosts of parasites (e.g., snails);
(2) parasite biology (genetics, genomics, physiology, molecular biology, and biochemistry);
(3) protective immunity, immunopathogenesis, and evasion of host defense;
(4) clinical, epidemiological, and natural history studies of parasitic diseases;
(5) research and development of vaccines, drugs, immunotherapeutics and immunoprophylaxis, and medical diagnostics; and
(6) vector biology and management/control and mechanisms of pathogen transmissions.
Research on the above is welcome, but research on the following is of particular interest to the branch:
New drug discovery or re-purposing of existing drugs to prevent infection and/or transmission, or to treat parasitic diseases
Highly sensitive and specific diagnostics tools for parasitic diseases
Vaccines and vaccine technologies, monoclonal antibodies, and other immune-mediated interventions applicable to prevention or elimination of parasitic diseases
Technologies or approaches that address arthropod vector monitoring, management, and control, to prevent transmission of vector-borne pathogens to humans
Virology Branch. The Virology Branch focuses on:
Acute viral infections caused by arthropod-borne (e.g., mosquito, tick-borne) and rodent-borne viruses, including: dengue, zika, west nile, Japanese encephalitis, chikungunya, yellow fever, hanta, crimean-congo hemorrhagic fever (CCHF), hazara, severe fever with thrombocytopenia syndrome (SFTS), heartland, bourbon, tick-borne encephalitis (TBE), powassan , lacrosse, cache valley, rift valley fever, punta toro, andes, sin nombre, hantaan; viruses causing hemorrhagic fevers:
ebola, lassa, junin, venezuelan equine encephalitis (VEE), etc.; and other viruses, including nipah, hendra, measles, polio, coxsackie, entero, pox, rabies, rubella, astro, calici, and rota; pathogen X
Persistent viral infections caused by viruses including adeno, borna, corona, herpes, human T-lymphotrophic, human papilloma, parvo, and human polyoma (JC, BK, and emerging);
Acute infections with hepatitis viruses A, B, C, D and E (HAV, HBV, HCV, HDV, and HEV); chronic infections with hepatitis viruses, B, C, D and E;
Transmissible Spongiform Encephalopathies (TSE)
Areas of emphasis for SBIR/STTR applications include:
Development of vaccines and vaccine platforms;
Development of techniques to improve vaccine stability;
Approaches to identify antiviral targets and agents;
Chemical design and synthesis of novel antiviral agents;
Development of therapeutic, prophylactic, and postexposure prophylactic interventions;
Development and validation of point of care assays for disease diagnosis and to measure response to therapy;
Development of new preclinical animal model systems that predict clinical efficacy of vaccines, therapeutics and diagnostics.
The Office of Genomics and Advanced Technologies focuses on broad-based research that emphasizes the development and improvement of high-throughput and large-large scale genomics and other advanced technologies for the understanding of infectious diseases and the development of multiplex platforms for medical diagnostics. The technological scope encompasses genomics, genomic epidemiology, phylogenomics, functional genomics, proteomics, metabolomics, glycomics, structural biology, systems biology, computational biology, bioinformatics, and diagnostics, usually across multiple pathogens or pathogen groups. The goal of our program is:
(1) to support large-scale experiments using omics, structural and computational biology approaches,
(2) to deepen the comprehension of pathogen-host interactions and
(3) to accelerate the discovery of innovative diagnostics, vaccines, and therapeutics for infectious diseases. Our program supports the advancement of technologies and platforms that are pathogen-independent or address multiple pathogens and may include sample preparation, instrumentation, and instrument validation.
Special emphasis areas include:
Development and advancement of genomic, phylogenomic, proteomic, metabolomic, glycomic, structural biology and related technologies for infectious diseases, including single-cell omics technologies and platforms;
Development of bioinformatic and computational biology, including artificial intelligence/machine learning methods and tools to advance infectious disease research; and
Development of modeling and bioinformatic tools to integrate omics data that supports the development of vaccines, therapeutics and diagnostics.
The Office of Biodefense Research and Surety (OBRS) supports and oversees a trans-NIH research portfolio to advance discovery and early development of medical countermeasures (MCMs) against chemical threats. To learn more about OBRS and its leadership role in chemical countermeasures research at the NIH, see NIH CCRP: A Collaborative Opportunity to Develop Effective and Accessible Chemical Medical Countermeasures for the American People, published in the Wiley journal Drug Development Research.
Biodefense Research Countermeasures Branch (BRCB). The Chemical Countermeasures Research Program (CCRP) supports preclinical basic and applied research towards understanding acute and long-term chronic toxicity resulting from exposure to Department of Homeland Security-designated Chemicals of Concern (CoC) and early development of MCMs to prevent mortality and serious morbidities. The ideal MCM should have rapid post-exposure efficacy, is easily administered in a mass casualty situation (likely by first responders in personal protective equipment) and is widely accessible in the community.
The specific injuries caused by toxic chemical exposure often manifest similarly to conditions observed in conventional clinical practice, such as acute lung injury, acute respiratory distress syndrome, coagulopathy, tissue fibrosis, keratopathy, neovascularization, seizure, and neurodegeneration. As such, "treat the symptom” projects aiming to repurpose already FDA-approved products or those in late-stage development for a conventional clinical indication are highly encouraged.
Areas of Emphasis include but not limited to:
Pulmonary Agents: Development of MCMs to prevent and treat acute and/or chronic lung injury (including edema, capillary leak, and fibrosis) resulting from exposure to agents such as sulfur mustard, chlorine, acrolein, and phosgene.
Ultra-Potent Synthetic (UPS) Opioids: Development of MCMs to treat life-threatening respiratory depression caused by acute intoxication. Treatments should be fast-acting and effective against a variety of synthetic UPS opioids such as fentanyl, carfentanil, and related analogs, and have a mechanism of action different from existing opioid receptor antagonists.
Vesicants: Development of MCMs that mitigates dermal, ocular, and/or systemic (including myelosuppression) toxicities after exposure to chemicals such as sulfur mustard, nitrogen mustard, Lewisite, phosgene oxime. Candidate MCM(s) with the potential to prevent or ameliorate chronic effects such as keratopathy is encouraged.
Blood/Cellular Respiration Agents: Development of MCMs to treat metabolic dysfunction and/or coagulopathy resulting from exposure to agents such cyanide, hydrogen sulfide, and brodifacoum. Candidate cyanide and hydrogen sulfide MCM(s) should also be effective against smoke inhalation-related exposure.
Nerve Agents and Organophosphorus (OP) Pesticides: Development of MCMs to treat acute muscarinicand nicotinic toxicities, including benzodiazepine refractory seizures, after exposure to agents such as sarin, soman, and VX.
OBRS does not support research directed at diagnostic device development, decontamination, or the development of environmentally oriented detectors, whose primary purpose is the identification of specific chemicals in the environment.
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Particular areas of programmatic interest relative to small business initiatives include, but are not limited to:
Innovative research on women’s health in the areas of musculoskeletal, rheumatic and skin diseases
Innovative research on health disparity in the areas of musculoskeletal, rheumatic and skin diseases
Innovative diagnostic technology for improving outcomes for maternal health in NIAMS mission areas
Innovative research on rare musculoskeletal, rheumatic and skin diseases
Multiplex assay development for arthritis and musculoskeletal and skin diseases
Lab to marketplace: translation of scientific discoveries in NIAMS mission areas f rom labs into products on the market
Test and/or validation of novel, state-of-the-art candidate biomarker platforms for predicting the onset and progression of inflammatory diseases of interest to the NIAMS and for determining the pharmacodynamics, safety and/or efficacy of therapeutic agents targeting those diseases.
The general purpose of the SBIR/STTR program is to stimulate technological innovation and increase private sector commercialization of Innovations. Due to budget constraints, NIAMS will consider the following research topics a lower program priority:
Research on a product or a technology to show equivalence to existing products
A product or a technology has been well funded for more than 10 years, but has not shown any progress towards clinical testing
A research topic on which multiple similar technologies have been funded and have shown scientific success
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Bio-Electromagnetic Technologies. Development of technologies that use static or dynamic electromagnetic fields for sensing, imaging, or therapeutic effects. The emphasis is on increasing the sensitivity, spatial/temporal resolution, efficacy, or safety of bioelectromagnetic devices through the development of novel hardware, method of operation, or pre-/post-processing techniques for single modalities or the combination of multiple modalities. This program may support the development of magnetic particle imaging, electrical impedance tomography, electroencephalography, magnetoencephalography, electromagnetic-field-induced hyperthermia/ablation, and microwave/terahertz imaging, for example.
Bioanalytical Sensors. Development of sensor technologies for the detection and quantitation of clinically relevant analytes in complex matrices for use in biomedical applications. Emphasis is on engineering the components and functionality of bioanalytical sensors. Detection could be based on optical, chemical, electrochemical, and/or physical (such as mechanical, gravimetric, thermal) perturbation of a sample, for example. Examples of technologies of interest include, but are not limited to, nano-textured substrates for analyte detection, DNA sensors for liquid biopsy, and small molecule detectors for diagnosing infectious diseases.
Image-Guided Interventions. Development of novel image-directed technologies for guidance, navigation, tissue differentiation, and disease identification for reaching specified targets during therapeutic procedures, which may range along the continuum from non-invasive to minimally invasive to open surgical interventions. These technologies may range from molecular to macroscopic scale levels. Overall emphasis is on the engineering of novel image-guided interventions to improve outcomes of interventional procedures. In addition, emphasis includes technologies that expand needed procedural access for individuals otherwise excluded by disease characteristics, co-morbidities, and other parameters. Areas of priority include development of real-time or near real-time novel image-guided technologies, with robust procedural direction or a robust receiver operating characteristic curve. In addition, cost-efficient technologies, appropriate for low resource settings, and/ or applicable to multiple types of interventions are strongly encouraged.
Magnetic Resonance Imaging. Development of in vivo MR imaging and MR spectroscopy, for both animal and human research and potential clinical applications. The emphasis is on the development of MRI hardware and methodologies, including image acquisition and reconstruction techniques, that would improve the speed, spatial resolution, information content, efficiency, robustness, quality, patient experience, and safety. The emphasis should be on technological development rather than detailed applications to specific diseases or organs.
Molecular Probes and Imaging Agents. Development and biomedical application of molecular probes and imaging agents across all imaging modalities for the visualization, characterization and quantification of normal biological and pathophysiological processes and anatomy in living organisms at the molecular, cellular and organ levels. The emphasis is on engineering of targeting and responsive molecular probes of high sensitivity and specificity for PET and SPECT (radiotracers), MR (T1, T2, CEST, hyperpolarized agents), EPR, CT, optical (fluorescent and bioluminescent probes), ultrasound (microbubbles) and photoacoustic imaging. The imaging agents may be based on nano- and micro-particles, liposomes, dendrimers, proteins, small organic and inorganic molecules etc., and detectable by one or more imaging modalities. Imaging agent development through methodologies such as chemical synthesis, biological mutagenesis, microfabrication, etc., may be pursued with an intent of leading to in vivo biomedical application.
Nuclear Medicine. Research and development of technologies and techniques that create images out of the gamma- ray (SPECT) or positron (PET) emissions from radioactive agents that are injected, inhaled, or ingested into the body. The emphasis is on simulation and development of new detectors, collimators, and readout methods that enhance the signal quality of detecting isotope emissions; designs of novel camera geometries; and correction methods that compensate for the radiation physics properties to improve the clinical reliability of the image. Of interest are improvements and corrections for interaction events in PET detectors and enhancement to time of flight (TOF) image generation methods (reconstructions algorithms); as well as new collimator and camera designs for SPECT.
Optical Imaging and Spectroscopy. Development and application of optical imaging, microscopy, and spectroscopy techniques for improving disease prevention, diagnosis, and treatment in the medical office, at the bedside, or in the operating room. Examples of research areas include fluorescence imaging, bioluminescence imaging, OCT, SHG, IR imaging, diffuse optical tomography, optical microscopy and spectroscopy, confocal microscopy, and multiphoton microscopy. The emphasis is on development of cost effective, portable, safe, and non-invasive or minimally invasive devices, systems, and technologies for early detection, diagnosis, and treatment for a range of diseases and health conditions.
Ultrasound: Diagnostic and Interventional. Development and improvement of technologies for diagnostic or therapeutic uses of ultrasound. The diagnostic ultrasound program includes, but is not limited to the design, development and construction of transducers, transducer arrays, and transducer materials, innovative image acquisition and display methods, innovative signal processing methods and devices, and optoacoustic and thermoacoustic technology. It also includes the development of image-enhancement devices and methods, such as contrast agents, image and data presentation and mapping methods, such as functional imaging and image fusion. The therapeutic ultrasound program includes, but is not limited to the design, development, and construction of transducers, transducer arrays, interventional technologies, adjunct enhancement of non-ultrasound therapy applications, high-intensity focused ultrasound (HIFU), or hyperthermia applications. It also includes non-invasive or minimally invasive interventional surgical or therapy tools, ultrasound contrast agents for therapy, targeted drug delivery, neuromodulation, and biopsy.
X-ray, Electron, and Ion Beam. Research and development of technologies and techniques that create images of internal structures, contrast agents, or molecular probes using x-rays transmitted through the body (CT, mammography) or x-ray stimulation of secondary emissions (x-ray fluorescence tomography). Emphasis is on simulation, design and development of new detector systems; new readout methods that enhance the signal quality for x-ray image generation; designs of novel imaging geometries; algorithms that compensate for the physical properties of the detection system to improve the clinical reliability of the image (reconstruction algorithms); and approaches to radiation dose reduction, especially in CT. Of interest are diagnostic image enhancements via photon counting, dual energy, and new applications of cone-beam tomography.
Biomolecular Technologies. Development and demonstration of broadly applicable biomolecular technologies to enable new paradigms of human health. The emphasis is on the development of biomolecular technologies and associated computational models for biomedical intervention. NIBIB interests include but are not limited to: molecular switches for synthetic genetic circuits; nucleases and genome editors for DNA manipulation and regulation; engineered viruses and extracellular vesicles for therapeutic agent delivery; transmembrane CARs for extracellular sensing; photoactive molecular complexes for optogenetics.
Bionics. Development and demonstration of broadly applicable bionic systems to enable new paradigms of human health. The emphasis is on the development of bionic systems hardware, software, and methodologies to improve patient health. NIBIB interests include but are not limited to: artificial organs to replace function; electrodes and 3D printed tactile sensors for prosthetics; implantable bioelectronic sensors and actuators for real-time, closed-loop control of tissues and organs.
Cellular and Multicellular Technologies. Development and demonstration of broadly applicable cellular and multicellular technologies to enable new paradigms of human health. The emphasis is on the development of cellular and multicellular technologies and associated computational models for biomedical intervention. NIBIB interests include but are not limited to: synthetic genetic circuits for cellular control and decision-making; engineered bacteria for microbiome regulation; engineered T-cells for immune regulation and cancer therapy; organoids and scaffold-free tissue assemblies for replacing organ function.
Living Materials. Development and demonstration of broadly applicable living materials to enable new paradigms of human health. The emphasis is on the development of living materials and associated computational models for biomedical intervention. NIBIB interests include but are not limited to: bacteria-laden hydrogels to deliver therapeutics; co-designed stem cells and scaffolds to grow implantable tissues.
Manufacturing and Biomanufacturing Tools. Development and demonstration of broadly applicable manufacturing and biomanufacturing tools to enable the translation of new paradigms of human health. The emphasis is on the development of manufacturing and biomanufacturing tools and associated computational models to enable biomedical interventions. NIBIB interests include but are not limited to: bioinks and bioprinters for 3D tissue construction; continuous production methods for scalable manufacturing of drug delivery vehicles; inline sensors for non-destructive evaluation of manufactured therapeutic cells; bioreactors for organoid manufacturing.
Medical Devices. Development and demonstration of broadly applicable biomedical devices to enable new paradigms of human health. The emphasis is on the development of medical device hardware, software, and models to improve patient health. NIBIB interests include but are not limited to: implantable bioelectronic stimulators and sensors for monitoring and modulating human physiology; wearable sensors for monitoring health vitals; micro devices and injection systems for therapeutic delivery; anti-bacterial and anti-coagulating coatings for implantable devices; biohybrid devices for replacing organ function.
Medical Simulators. Development and demonstration of broadly applicable medical simulators to enable new paradigms of human health. The emphasis is on the development of medical simulator hardware, software, and methodologies, primarily to improve patient outcomes, especially through the reduction of medical errors. NIBIB interests include but are not limited to: virtual coaches incorporating artificial intelligence for performance training in medical procedures and workflows; simulation interfaces to facilitate dissemination and use of virtual environments; realistic representations of anatomy, tissue, instrument, tactile feedback, and collision dynamics; simulator designs that focus on complicated or rare procedures, including rare adverse events; simulators that replicate realistic workflows, including planning, warm-up exercises, and rehearsal leading up to the actual procedure; portable, easy-to-use simulators for skilled practitioners in rural and low-resource settings.
Molecular Materials. Development and demonstration of broadly applicable molecular materials to enable new paradigms of human health. The emphasis is on the development of molecular materials and associated computational models for biomedical intervention. NIBIB interests include but are not limited to: lipid nanoparticle coatings for evading the immune system; supramolecular polymers for targeted protein degradation; drug conjugates for targeted drug delivery.
Nanomaterials. Development and demonstration of broadly applicable nanomaterials to enable new paradigms of human health. The emphasis is on the development of nanomaterials and associated computational models for biomedical intervention. NIBIB interests include but are not limited to: magnetic and acoustic nanoparticles for ablating cells and tissues; plasmonic nanorods for tissue suturing; functionalized nanocarriers for drug delivery and immunotherapy.
Physiomimetic Materials. Development and demonstration of broadly applicable physiomimetic materials to enable new paradigms of human health. The emphasis is on the development of physiomimetic materials and associated computational models for biomedical intervention. Projects might focus on: elucidating important engineering design rules or key foundational principles underlying future engineering, including the use of computational methods; prototyping or redesigning platform technologies; characterizing (in vitro, ex vivo, or in vivo) broadly applicable technologies and prototypes. NIBIB interests include but are not limited to: electrically conductive and mechano-sensitive scaffolds for repairing tissue; photoactive adhesives for surgical sealants; biomimetic matrices for T cell activation; artificial cells for therapeutic agent delivery.
Robotics. Development and demonstration of broadly applicable robotic systems to enable new paradigms of human health. The emphasis is on the development of robotic systems hardware, software, and methodologies to improve patient health. NIBIB interests include but are not limited to: robots for minimally invasive surgeries; microgrippers and drills for surgical robots; robotic nurses for isolated patient care; soft robotic exoskeletons to replace lost capabilities; soft elastomeric actuators for assistive robotics.
Screening and High-Throughput Tools. The emphasis is on the development of screening and high-throughput tools and associated computational models to enable biomedical interventions. Projects might focus on: elucidating important engineering design rules or key foundational principles underlying future engineering, including the use of computational methods; prototyping or redesigning platform technologies and approaches; characterizing (in vitro, ex vivo, or in vivo) broadly applicable technologies, prototypes, and lead candidate products. NIBIB interests include but are not limited to: evolution methods for identifying therapeutic protein targets; organs-on-chips for drug screening; microfluidic systems for high-throughput screening of extracellular vesicles.
Artificial Intelligence, Machine Learning, and Deep Learning. Design and development of artificial intelligence, machine learning, and deep learning to enhance analysis of complex medical images and data. The emphasis is on development of transformative machine intelligence-based systems, emerging tools, and modern technologies for diagnosing and recommending treatments for a range of diseases and health conditions. Unsupervised and semi-supervised techniques and methodologies are of particular interest.
Biomedical Informatics. Development of structures and algorithms to improve the collection, annotation, aggregation, anonymization, classification, retrieval, integration, analysis, and dissemination of quantitative and qualitative biomedical data. The emphasis is on using biomedical information to achieve better health outcomes and smarter health care. Examples of technical development areas in this program include but are not limited to informatics tools and resources such as: databases, standards for enhanced interoperability, collaborative analysis environments, data modeling and representation, and techniques for the integration of heterogeneous data, rational data-driven design of experiments, visualization of data, and digital representation of rich qualitative data. This program is intended to support NIBIB’s other program areas in biomedical imaging and bioengineering research.
Digital Health-Mobile Health and Telehealth. Development of enabling technologies that emphasize the integration of wireless technologies with human and biological interfaces. This program includes the development of software and hardware for telehealth and mobile health studies. This program includes the development of software and hardware for telehealth and mobile health studies and the input and delivery of healthcare information digitally for the analysis or monitoring of health or disease status. The emphasis is on developing mobile health technologies driven by clinical needs and integrating these technologies in healthcare delivery, wellness, and daily living.
Point of Care Technologies-Diagnostics. Development of rapid in-vitro diagnostic technologies and monitoring platforms that provide real time medical evaluation and analysis of the disease status or condition at the time and place of patient care. The program includes the delivery of healthcare that is safe, effective, timely, patient-centered, efficient, and available in centralized and decentralized locations. The emphasis is on developing technologies driven by clinical needs. Examples of technology development areas in this program include but are not limited to disposable lateral flow assays, nucleic acid testing platforms, glucose monitoring devices, etc.
Image Processing, Visual Perception, and Display. Design and development of algorithms for post-acquisition image processing and analysis, the development of theoretical models and analysis tools to evaluate and improve the perception of medical images, and the development of visualization tools for improved detection. The emphasis is on using image data to achieve better health outcomes and smarter health care. Examples of technology development areas in this program include but are not limited to models, algorithms, software, methodologies, and other tools that will: facilitate medical imaging research; support clinical detection, diagnosis and therapy; and improve patient healthcare.
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Major Portfolio Areas:
Therapeutics (e.g., Small Molecules, Biologics, Radiomodulators, and Cell-based Therapies)
In Vitro and In Vivo Diagnostics (e.g., Companion Diagnostics and Prognostic Technologies)
Imaging Technologies (e.g., Agents, Devices, and Image-Guided Interventions)
Devices for Cancer Therapy (e.g., Interventional Devices, Surgical, and Radiation and Ablative Therapies, Hospital Devices)
Agents and Technologies for Cancer Prevention
Technologies for Cancer Control (e.g., Behavioral Health Interventions, Tools for Genetic, Epidemiologic, Behavioral, Social, and/or Surveillance Cancer Research)
Tools for Cancer Biology Research
Digital Health Tools and Software Platforms for Cancer-Related Technologies
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The major NICHD research priority areas for each Branch are listed below. Investigator initiated applications that have commercial potential that fall outside these topic areas but fall within the research mission of the NICHD are also considered through this Omnibus solicitation.
A. Child Development and Behavior Branch. The CDBB encourages innovative developmentally-sensitive, theoretically-grounded, and evidence based small business initiatives that develop technology and products addressing the psychological, social and emotional, psychobiological, language, numerical, literacy, cognitive and intellectual development and health of persons from infancy through the transition to adulthood, recognizing the important role others have in contributing to the healthy development of an individual. Products that target at-risk populations and/or exploit new technologies that can expand the effective reach or inclusion of underserved populations in order to encourage healthy development and/or our understanding of the inf luences of context and/or behavior on development are especially encouraged. CDBB is also interested in research on innovative approaches to both imaging and other non-invasive measurement approaches to capture real time brain activation activity in typical and atypical infants and young children (birth to age three). Foci of specific interest include, but are not limited to:
Enhancing Bilingual and Biliteracy Development: Adaptive learning technology to enhance bilingual and/or biliteracy development in English-language learning children and youth.
Bi- or Multi-Lingual Measures of Neurodevelopment: Develop easy to administer objective neurodevelopmental measures f rom evidence-based neurocognitive research specific to typically developing infants through pre-K children f rom diverse language homes that are shown to correlate with development of brain connectivity and activation. Remote administration measures are a high priority.
Pediatric Primary Care Behavioral and Health Promotion Interventions: Facilitate research on the impact of behavioral and health promotion interventions in pediatric primary care and related clinical settings with a focus on child and adolescent health outcomes.
Psychosocial Adjustment for Individuals in High-Risk Environments: Develop measures to identify and tools to stimulate developmental factors and mechanisms which promote short- and long-term psychosocial adjustment for children and adolescents exposed to high-risk family and neighborhood environments.
School Readiness Skills in Economically and Socially Disadvantaged Children: Develop mobile device apps and/or hand-held devices that assess and/or promote the development of executive functioning (EF) and school readiness skills and abilities in infancy and early childhood and in diverse populations of children as well as measures of home, childcare and preschool environments and practices that are related to child learning and development.
Reading, Writing, and Mathematics Struggling Learners: Develop assistive technology to enhance learner outcomes for individuals that struggle to acquire literacy and/or numeracy skills, grounded in current scientific understanding of these challenges.
Assessment and Enhancement of Reasoning Development: Develop validated and specific assessment tools that are sensitive to contributing factors (e.g., biobehavioral, environmental, cultural, academic, and cognitive factors) to facilitate research on and the promotion of neurocognitive development of reasoning (e.g., quantitative, deductive, inductive, causal) in typically developing populations.
Fostering inclusion of typically-developing or at-risk infants, toddlers and children in neuroimaging activities: Develop products or new strategies to facilitate neuroimaging of typically-developing or at-risk infants, toddlers and children.
B. Contraception Research Branch. The CRB supports research on developing new and improved methods of fertility regulation as well as research on the benefits and risks of contraceptive drugs, devices and surgical procedures. Areas of interest include, but are not limited to:
Development of new and improved methods of fertility regulation, for men and women, that are safe, effective, inexpensive, reversible and acceptable with priority given to nonhormonal and on-demand methods.
Synthesis and testing of novel chemical compounds that are potential contraceptives
Multipurpose prevention technologies designed to prevent sexually transmitted infections, such as HIV, as well as pregnancy
C. Developmental Biology and Congenital Anomalies Branch. The DBCAB supports biomedical research on the cellular, molecular, and genetic aspects of typical and atypical embryonic development including early embryogenesis, organogenesis, as well as topics in stem cell and regenerative biology. The overall goal is to promote research on developmental biology to understand the causes of structural birth defects. Areas of interest include but are not limited to:
Development of new model systems (animal or other) to study developmental mechanisms and causes of structural birth defects
Innovative technologies for in vivo imaging of developmental processes (cell and tissue dynamics) and gene expression
Development of antibodies, novel ligands, and other probes to facilitate our understanding of typical and atypical embryonic development in model organisms
Technologies for quantitative measurement of physical properties of cells/tissues in vivo during development
Innovative technologies for studying metabolomics in developing vertebrate embryos
Technologies to facilitate and advance systems biology approaches to the study of embryonic development and structural birth defects
Technologies to facilitate and advance high throughput chemical screening (including small molecules) for advancing structural birth defects research
Software development to facilitate the collection and analyses of data generated using medium-high throughput screening platforms in model systems (model organisms, cellbased models)
Software development to facilitate the collection, mining and analyses of genomic and phenotypic data f rom children affected with structural birth defects, and cross-analysis with model organism data
Development of user-friendly software for biomedical researchers with limited knowledge of computational biology to analyze large-scale human and other datasets associated with structural birth defects
Technologies/methodologies to generate, and software to mine, data related to wound healing and regenerative responses across animal species
Novel reagents for activation and mobilization of endogenous/adult stem cells to promote in vivo tissue regeneration
Methodologies to drive limb regeneration in higher vertebrates (including in mammals) that might otherwise lack the capacity for regeneration.
Technologies for iPSC-based regenerative medicine in the context of structural birth defect
Screening technologies for small molecules in human Embryonic Stem (ES) Cells or Induced Pluripotent Stem Cells (iPSCs) and disease specific iPSCs for targeted modification of regulatory networks affected in structural birth defects
D. Fertility and Infertility Branch. The FIB supports research on the reproductive processes of men and women and of animals with similar reproductive systems related to developing safer and more effective means of regulating, preserving or achieving fertility. Areas of interest include but are not limited to:
Development of reagents and tools, such as high-resolution technologies to facilitate study of reproductive and developmental processes, including gamete and early embryo development, and reproductive track development
Development of techniques and identification of novel biomarkers to produce, identify, and use healthy gametes as well as advancement on preservation of human gametes
Development of organoid cultures and physiomimetic systems ideal for study of gametogenesis and normal or diseased reproductive tissues/organs
Development of improved methods of growing and differentiating stem cell lines in vitro, including feeder cell-free approaches to facilitate reproductive research
Development of improved technologies for the reprogramming of cells, including embryonic stem cells or adult cells, into eggs and sperm
Development of improved technologies for preimplantation genetic diagnosis
Development of omics technologies to diagnose impairments in sperm function, fertilization, ovulation, implantation, decidualization and other aspects of reproductive processes
Use of genomics and proteomics to develop novel diagnostics and treatments for reproductive diseases and disorders
Use of semen, vaginal or cervical fluid, or menstrual effluent to diagnose fertility status or other health conditions
Development of novel assays, kits, and devices to monitor and treat infertility
Development of Artificial Intelligence techniques/methods for selection of best sperm cells, oocytes, and embryos to generate better predictive models for in vitro fertilization
Development of innovative technologies for point-of-care testing for fertility/infertility and reproductive diseases and disorders
Development of patient-specific treatment regimen for infertility diseases using Artificial Intelligence methods/technologie
Development of tools, technologies or apps for diagnosis and treatment of infertility in resource limited settings to increase community and individual resources to address infertility
Development of tissue engineering technologies for uterine tissue regeneration and reproductive track reconstruction for treatment of infertility
Identification and/or validation of putative male or female infertility targets
Development of novel drugs or devices to treat male or female infertility.
Development of high-throughput screening methodologies for small molecule drugs addressing infertility
E. Gynecologic Health and Disease Branch. The GHDB supports biomedical research related to gynecologic health throughout the reproductive lifespan, beginning at puberty and extending through perimenopause. Areas of interest include, but are not limited to:
Development of new diagnostic approaches and treatments for female pelvic floor disorders, including drugs, and devices used for treatment of pelvic organ prolapse, urinary incontinence, fecal incontinence, and other female pelvic floor disorders
Development of new diagnostic methods and novel surgical and non-surgical treatments for uterine fibroids, endometriosis, adenomyosis, and benign ovarian cysts. Non-invasive diagnostics and/or diagnostics that make use of menstrual effluent are of particular interest.
Production of marketable novel or improved methods, devices, and technologies for the diagnosis, monitoring and therapy of gynecologic pain disorders including chronic pelvic pain, vulvodynia/vestibulodynia, and dysmenorrhea
Generation of new approaches for the diagnosis, monitoring and treatment of abnormal menstrual cyclicity
Surgical and non-surgical treatments for girls and women with reproductive tract abnormalities, including congenital structural abnormalities and complications f rom female genital cutting
Devices and/or technologies designed to address surgical challenges in gynecologic surgeries, including hysterectomy
Technologies designed to apply -omics platforms (genomics, proteomics, metabolomics etc.) to questions of gynecologic health and disease
F. Intellectual and Developmental Disabilities Branch. The IDDB sponsors research aimed at preventing, diagnosing, and ameliorating intellectual and developmental disabilities (IDD). Emphasis is on studies related to IDD, including common and rare neurodevelopmental and neuromuscular disorders, such as autism spectrum disorders, Down, Fragile X, and Rett syndromes, mitochondrial conditions, inborn errors of metabolism, and others. Areas of interest include, but are not limited to:
Innovative tools, including molecular, imaging, statistical or behavioral tools, to characterize the etiology and pathophysiology of abnormal nervous system development.
Methods and devices to delineate genetic, genomic, and epigenetic causes of IDD and develop gene-based treatments.
Methods or devices designed to screen for, diagnose, treat, and manage IDD and other conditions, particularly those identified or identifiable by newborn screening.
Assessment tools for use in the clinic or community settings to enable the accurate measurement of change in response to interventions.
Development of early interventions leading toward the prevention, diagnosis, treatment, and management of IDD.
Methods or devices to develop or adapt smart technologies (such as wearable devices, mobile health applications (apps), and electronic medical records (EMR)-based tools) to assist in remote health monitoring, to service as point -of-care diagnostic tools, and/or to enhance screening, diagnosis, prevention, treatment, or management for individuals with IDD to improve their quality of life.
Development of assessment measures or treatments for co-morbid symptoms in those with IDD including disordered sleep, self-injurious behaviors, obesity, gastrointestinal dysfunction, seizures/epilepsy, attention def icit/hyperactivity disorder, anxiety, depression, psychosis, immune dysregulation, self-injurious behaviors, and ADHD and other mental health disorders.
Innovative and new digital technologies and mHealth solutions for improving transition of adolescents to adult healthcare providers by improving health literacy, enabling self -management, and encouraging adherence to existing treatments among adolescents.
Methods and devices to facilitate inclusion of people with all levels of IDD in research and clinical care – both research/care targeted toward IDD populations and research/care for more general populations where people with IDD are typically categorically excluded.
G. Maternal and Pediatric Infection Disease Branch. MPIDB supports domestic and international research on human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) and other infectious diseases (such as CMV, Syphilis, tuberculosis, hepatitis and malaria) in people of child bearing age, pregnant people, mothers, fetuses, infants, children and adolescents. Specific areas of interest include but are not limited to epidemiology, clinical manifestations, immune-pathology, pathogenesis, transmission, treatment and prevention (including immune-therapeutics like monoclonal antibodies, vaccines and other biomedical modalities) of HIV infection, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, and other pertinent infectious diseases in children, adolescents and pregnant people, with a focus on prevention of vertical transmission of HIV and other congenital infections, and HIV-related and other infectious-disease related complications in these populations. Additional areas of interest include:
New technologies relevant to resource-limited countries for:
Screening, diagnosis, and management of infectious diseases in pregnant women, infants, and children, including but not limited to HIV such as SARS -CoV-2, congenital CMV, congenital Syphilis, tuberculosis, and Zika virus)
Rapid assays to monitor disease activity and response to therapy as well as immune response to vaccinations against relevant infections in infants and children (e.g., malaria, tuberculosis), which can be used at the individual level and/or as part of public health campaigns (e.g., eradication of outbreaks and prevention of spread)
Diagnosis and treatment of HIV-related co-morbidities (e.g., diagnosis of tuberculosis, STIs)
Diagnosis and treatment of SARS-CoV-2 infection-related outcomes in mothers and infants
Simple and less technologically demanding point of care assays to monitor CD4 cell percentage/count, HIV viral load, or other surrogate markers of HIV disease progression in children
Simple and easy to use/at home use diagnostics and point of care assays to monitor clinical symptomatology and prognosis of SARS-CoV-2 infection and recovery in children
Interventions designed to promote or optimize medication adherence
Child-friendly formulations (preferably not liquid preparations) of drugs used to treat or prevent HIV infection, complications of HIV infection, and/or other high-priority infections such as tuberculosis, hepatitis, Syphilis, CMV, and malaria relevant to children, particularly in resource- limited countries; Fixed-dose drug formulations and innovative methodologies for development of solid heat stable formulations capable of being administered to young children (e.g., sustained release beads, etc.) and/or improve pill or volume burden
Innovative long-lasting drug formulations for antiretroviral and other anti-infective drugs that would allow less frequent drug administration (e.g., once daily, weekly, or monthly)
Simple, standardized, validated tools to evaluate neurodevelopmental outcomes in children
Innovative data collection and database development approaches to leverage and link electronic medical records and/or other health information systems to better understand treatment and prevention of infectious diseases among infants, children, adolescents, and people of child-bearing age.
Biomedical modalities including vaccines and methods to assess efficacy of vaccines, to prevent acquisition of HIV and other infectious diseases in children, adolescents, and women.
Topical microbicide agents, wearable, implantable, or insertable devices releasing medications alone or as part of multipurpose prevention technologies (MPTs), to prevent sexual acquisition of HIV and other sexually transmitted infections in adolescents, adult women, and pregnant or postpartum people.
New, non-invasive technologies to evaluate complications of antiretroviral drugs (e.g., mitochondrial toxicity, bone toxicity) in HIV-infected infants, children, adolescents, pregnant people, and their fetuses.
New or improvements to existing technologies for measuring the HIV latent reservoir, or other long-term effects of infectious diseases, including high-throughput, visualization algorithms, and improvement in assay reliability and sensitivity in children.
H. Obstetric and Pediatric Pharmacology and Therapeutics Branch. The OPPTB supports research and research training on the development and use of safe and effective therapeutic drugs and therapeutic -related medical devices for children and pregnant and lactating people, including during the postpartum period. The branch promotes basic, translational, and clinical research to improve the safety and efficacy of therapeutics, primarily pharmaceutical drugs and medical devices. It is responsible for developing and supporting a comprehensive national effort to increase the knowledge base for understanding how to appropriately treat disease during pregnancy, lactation, infancy, childhood, and adolescence using evidence-based therapeutic approaches. This includes support for the development and validation devices to inform treatment decisions and enhance precision drug delivery. The goal of these efforts is to assure that medications are appropriately tested for dosing, safety, and effectiveness for individuals within their target populations. Of note: NICHD considers applications for pediatric conditions that have significant efforts at other NIH institutes (e.g., sickle cell disease, pediatric oncology, juvenile diabetes) to be of lower programmatic priority. Applications to advance the study of obstetric and pediatric therapeutics include but are not limited to:
Understanding Differences and Heterogeneity in Pediatric Disease Treatment. Research to quantitatively understand differences in drug action and related pathophysiology between childhood and adult disease and conditions unique to pediatrics. This includes developing tools (e.g., biomarkers, outcome measures, and physiologically based pharmacokinetic/pharmacodynamic models) to support pediatric drug discovery and development and to facilitate the application of precision medicine approaches in children.
Pharmacology and Pathophysiology of Pregnancy. Developmental pharmacology research and approaches that explore the intersections of physiological changes in pregnant people and during fetal development with drug action (e.g., pharmacokinetic, pharmacodynamics, and pharmacogenomics) and with molecular pathways that may serve as novel therapeutic targets for disease-modifying therapies specific to these populations. Critical areas include pain management in pregnant and lactating people and treatment of gestational diabetes, preeclampsia, and prevention of preterm delivery.
Novel Alternatives to Traditional Pediatric and Obstetric Clinical Trials. Development of innovative approaches and algorithms to determine drug dosing, safety, and effectiveness in children and in women during pregnancy and lactation. This includes artificial intelligence-driven modeling and simulation methods, novel approaches to utilizing existing data and archived biosamples/biospecimens, and pragmatic trials.
Population- and Individual-Specific Diagnostic and Therapeutic Devices that can advance precision medicine through individualized diagnosis, drug delivery, and non-drug therapy appropriate for use in neonates, children, and obstetric and lactating people. This may include 3D bioprinting, AI-enhanced pharmacometrics modeling, AI-driven diagnostic and decision-making tools, novel drug delivery devices, and formulations.
New Uses for Drugs, Biologics, and Other Therapeutics. This includes the development and use of preclinical experimental models (e.g., animal models and human biomimetics), use of organotypic microphysiologic cell culture systems and strategies for assessing pharmacologic and toxicologic effects of therapeutics, use of genetically diverse model organisms to assess precision prescribing approaches for interindividual manifestation of disease or response to therapeutic agents, and computation models or the accumulation of real-world evidence in support of new therapeutic uses.
I. Pediatric Growth and Nutrition Branch. The PGNB supports research designed to support short and long-term health so that children can achieve their full potential through an expanded understanding of those factors that influence metabolism, growth (body composition and linear growth) and neurodevelopment. An additional focus is on those biological (e.g., genetic, nutritional, endocrinological) factors that contribute the early life origins of non-communicable disease (e.g., obesity, diabetes, cardiovascul ar disease, osteoporosis). The PGNB encourages research that focuses on detecting the biological antecedents of these conditions during pregnancy, infancy, and childhood. Areas of interest include, but are not limited to: New research tools, improved measurement methods, and technologies that enhance our understanding of:
Growth:
Physical growth, body composition, bone health, nutrition, and obesity
Determinants of normal bone mineral accretion and peak bone mass. Interactions of muscle and bone during infancy and childhood
Neuroendocrinology of puberty, linear growth, body composition
Mechanisms of hormone action during linear growth, pubertal maturation, and other aspects of physical development
Biological antecedents of childhood obesity and its short and long-term consequences:
Genetic and molecular mechanisms of obesity, psychosocial risks of obesity, and therapeutic interventions for obesity in children and adolescents
Impact of early life exposures including infant feeding practices on short and long- term health and development
Biology of nutrition as it pertains to health and development (physical and neurological function) during pregnancy, infancy and childhood including discovery, development and deployment of biomarkers for early detection of :
Mal-(over-/under) nutrition; including biomarkers of exposure, status, function and effect (i.e., impact on early life development including neurodevelopment)
Enhanced understanding of the role of human milk in child health and development.
Maternal nutrition (pre-pregnancy, pregnancy, and lactation)
Novel approaches to enhanced infant feeding practices in term and pre-term infants
Developmental origins of health and disease including:
Ascertain biomarkers early in life that predict the onset of chronic diseases such as diabetes, osteoporosis, and the metabolic syndrome later in life. The PGNB emphasizes the life course model to develop primary preventive approaches to chronic diseases.
Develop platforms for implementation of biomarkers of disease status, nutritional status, and biological function f rom infancy through adolescence
J. Pediatric Trauma and Critical Illness Branch. The PTCIB supports research and research training in pediatric trauma, injury prevention, and critical illness across the continuum of care. These efforts include research focused on the prevention, treatment, and management of physical and psychological trauma and the surgical, medical, psychosocial, and systems interventions needed to improve outcomes for critically ill and injured children and adolescents. Additionally, the PTCIB supports basic, clinical, and translational research that explores short - and long- term consequences of traumatic experiences such as exposure to disasters, all forms of violence against children, exposure to critical illness environment, and experiences of bereavement, grief, and loss. Applications of interest include, but are not limited to the research and development of:
Technologies, devices, and equipment used by pediatric critical care, emergency care, and trauma care personnel.
Novel technologies in caring for injured children prior to and during transport to treatment settings.
Tools and technologies for screening and diagnosis of injuries related to forms of child maltreatment.
Devices and innovative therapeutic technologies for management of medical conditions and related problems stemming f rom critical illness and serious or life-threatening injuries.
Preventive intervention tools, materials, and technologies designed to improve clinical practice, parenting, and social system support for injured or traumatized children.
Tools, materials, and technologies designed to reduce pediatric trauma exposure and the number and severity of pediatric injuries and deaths.
Tools and technologies to improve the environment of pediatric intensive care including resources to promote patient safety and to enhance clinical education and training of critical care personnel
Tools and technologies that support the diagnoses and treatment of critical illness in children, including nosocomial infections and iatrogenic injury.
K. Population Dynamics Branch. PDB supports research and research training in demography, reproductive health, and population health. In demography, the Branch supports research on the scientific study of human populations, including fertility, mortality and morbidity, migration, population distribution, nuptiality, family demography, population growth and decline, and the causes and consequences of demographic change. In reproductive health, the Branch supports behavioral and social science research on sexually transmitted diseases, HIV/AIDS, family planning, and infertility. In population health, the Branch supports data collection and research on human health, productivity, behavior, and development at the population level, using such methods as inferential statistics, natural experiments, policy experiments, statistical modeling, and gene/environment interaction studies. Applications are encouraged, but are not limited to these areas:
Technological innovations or inventions to improve collection of biomarker and anthropometric data in large population-representative surveys
Hardware or software to improve the collection of accurate cause of death information or health diagnosis such as information related to infant and maternal morbidity and mortality, in large population-representative surveys or in administrative data sets
Methods for integrating data science, including artificial intelligence and machine learning, into demographic research
Methods for improving the collection, documentation, archiving, linking, and dissemination of population representative data sets, especially data sets that are complex, multilevel or multimodal
Methods for protecting and assuring confidentiality for human subjects when collecting, archiving, linking, or disseminating population-representative data sets, especially data sets that are longitudinal or that include both spatial and individual -level data
Methods for reducing the costs of collecting, linking, and disseminating large-population representative data sets
Development and dissemination of effective tools for prevention research and intervention programs related to STIs/HIV; pregnancy; contraceptive use; adolescent, young adult, and maternal mortality; child health; at -risk youth; and other health-related topics relevant to PDB science
Innovative approaches and techniques for research design, measurement, and data collection and analysis in the social and behavioral sciences, with particular attention to methodology and measurement issues related to protecting research subjects, archiving and disseminating complex datasets, and studying diverse populations and/or sensitive or confidential behaviors
L. Pregnancy and Perinatology Branch. The PPB supports research in the following areas: the physiology of pregnancy and labor; high- risk pregnancies, including those with hypertensive disorders, diabetes or seizure disorders; fetal pathophysiology; premature labor and birth; diagnostic, monitoring, and therapeutic devices and instruments for newborn infants in the nursery and in Neonatal ICU setting; improving the existing products or developing new products that would improve the routine and extended care of the newborn infants; products and agents related to breastfeeding; hospital supplies specifically related to use in the care of newborn infants; nanotechnology and its application for the care of newborn infants; instruments and devices for assessing and monitoring the nursery environment (noise, lighting, and odor); disorders of the newborn; sudden infant death syndrome; and biological and behavioral antecedents of low birth weight. The following topic areas are of high priority:
Non-invasive (or minimally invasive) methods to assess preeclampsia; gestational diabetes; fetal well-being; spontaneous preterm birth; and stillbirth
Methods to characterize the bioactive components of human milk
Non-invasive methods to longitudinally identify predictors and indicators of placental dysfunction including malperfusion, abnormal placental development, and impaired placental function (nutrient transfer, metabolic function, exchange of respiratory gases, and hormone production).
Devices, instruments, and tools to minimize bacterial colonization, reduce proclivity forthrombus formation, and reduce healthcare associated infection risks
Lab-on-a-chip; specifically, non- or minimally-invasive approaches for assessing metabolic profiles (e.g., glucose and lactate/pyruvate), ketone bodies, bilirubin (unconjugated, free, indirect, and total), and other major analytes (Na+ Ca+ Cl+ K+ etc.)
Rapid methods for diagnosis of bacterial infections and the assessment of antibiotic sensitivity
Improved syringes, needles, and injection set ups to help administer small doses of medications over prolonged periods (e.g., insulin for treating hyperglycemia)
Methods to assess pain in the newborn, analgesia, and the evaluation of neonatal opioid withdrawal syndrome
Non-invasive measures to assess brain energy utilization in the newborn, especially glucose, oxygen, lactate, ketones, and other energy substrates
Improved devices and instruments for assisted ventilators for use in the neonatal ICU
M. National Center for Medical Rehabilitation Research. This Center supports innovative research on the restoration, replacement, enhancement or adaptation of function for people with chronic physical disabilities. This includes rehabilitative approaches across etiologies and the lifespan, as well as the environmental and policy factors that promote full participation. We encourage studies that integrate biomedical, engineering and/or psychosocial approaches to develop practical and creative solutions to the daily functioning of people with disabilities and their families. The mission of the NCMRR is to increase the effectiveness of medical rehabilitation practices through research. Information about specific program areas within NCMRR can be found here. Examples may include but are not limited to:
Adaptation and Plasticity: Develop non-invasive and surrogate measures of plasticity that would be appropriate for use in a clinical setting to target rehabilitation therapies and monitor treatment effectiveness (e.g., biomarkers, imaging)
Novel Technology: Orthotics, prosthetics, and robotics devices and interfaces; Assistive technologies; Invasive and non-invasive biological sensors, prosthetic systems or implants to improve function; New control methods and improved sensory feedback; Strategies for controlling and adapting to the environment; Advanced wheelchair designs and enhancements and other mobility devices; Biomaterials and tissue interfaces, nanotechnology, bionics
Rehabilitation Interventions: Development and use of robotics; Gaming applications; Virtual and Augmented Reality; Simulations; M-health and other approaches to promote participation, understand and support healthy behaviors, reduce health disparities, and enhance clinical compliance, especially in children with physical disabilities.
Chronic Symptom Management: Methods to increase screening for chronic conditions or preventable secondary conditions in individuals with physical disability; Prevention and treatment strategies for mitigating symptoms associated with multiple chronic conditions in individuals with physical impairments, including persistent pain, symptoms of obesity, diabetes, cardiovascular deconditioning, fatigue, symptoms of overuse injuries, pressure ulcers, sleep disturbances, and depressive symptoms; Improving muscle capacity in chronic physical disability to include therapeutic or adaptive exercise and muscle stimulation; muscle-disuse syndromes and contractures; Rehabilitation interventions for improvement of physical disability and comorbid cognitive, sensory, or somatic consequences of impairment, disease or injury; Autonomic function in the context of injury or specific conditions.
Rehabilitation in the Community: Strategies to build or modify community and/or environmental resources that provide effective rehabilitation and health promotion services within the individual’s own community. Development of engineering, crowdsourcing, and social science approaches to promote, monitor, and sustain outcomes in real world settings.
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The major NIDA SBIR/STTR portfolio areas of interest are listed below as a general guide. Applications proposing innovative technologies in substance use and addiction with strong commercial potential that fall outside these portfolio areas are also encouraged through this Omnibus solicitation.
Biomarker Development for SUDs. Currently, there are no biomarkers to assess or predict treatment efficacy or categorize SUDs into clinical subtypes. Thus, it is impossible to design treatments for effective and long-term recovery by classifying SUD patients into categories that have reproducible and predictive validity. Long-term use of opioids and other substances alters the integrity of homeostasis, changing the endogenous opioid, endogenous cannabinoid, and almost all receptor systems studied so far in the brain and peripheral immune cells. Biomarkers and signatures in patients diagnosed with an SUD can be very different from those observed in patients without SUDs. These biomarkers or potential predictive markers could serve as objective prognostic indicators to develop SUD. In addition, they could act as response predictors to SUD therapeutics in adults, or as diagnostic biomarkers for infants with neonatal abstinence syndrome (NAS). Furthermore, artificial intelligence (AI)-related technologies are being investigated in healthcare to analyze patients’ big data, such as electronic health records of historical and current patient treatments, to create more effective and better patient outcomes and to identify new diagnostic tools and novel analyses. Accordingly, AI-related tools are of interest to accelerate traditional and innovative areas of SUD biomarker development. The proposed biomarker research should emphasize the importance of biomarker signatures that can intersect SUD and related conditions that are considered important to the mission of NIDA. Proposed projects may include biomarkers that assess the probability of SUD or allow an assessment of the treatment trajectory in patients under treatment for SUD. Specific projects may encompass, but not restricted to:
Biomarkers with high specificity and sensitivity for opioids, stimulants, cannabis and other emerging substances;
Biomarkers that can detect substance use in early stage;
Development of biomarkers that provide objective measures of substance use.
Biomarkers that can predict an individual’s response to different treatment modalities.
Biomarkers suitable for longitudinal monitoring of substance use.
Biomarkers capable of detecting concurrent use of multiple substances
Projects solely focused on biomarkers for pain and alcoholism are of limited interest.
Personalized Medicine for SUDs. Advancements in technology and our deepening understanding of underlying neurobiology have provided us with the chance to target specific neurobiological processes and tailor interventions approaches to individual patients based on their unique genetic, neurobiological, and environmental characteristics. This personalized approach recognizes the significant variability among individuals in how they respond to medications, therapies, and other interventions. Genetic variations can influence a person’s susceptibility to developing SUD, and treatment response. Genetic testing would identify specific gene variants associated with SUD risk, metabolism of drugs and treatment response. Further, neurobiological differences in brain structure and function can impact how an individual’s experiences and respond to different substances. Identifying aberrant brain connectivity patterns and assessing neurotransmitter levels can guide the treatments to modulate the pathways. Finally, social, cultural, and environmental factors play a significant role in the development and course of SUDs. Areas of interest include but are not limited to: a) Identifying and leveraging existing social support networks and recognizing environmental triggers that contribute to substance use and modifications to mitigate the impact and b) utilizing big-data analytics and predictive modeling to identify patterns and predictors of treatment response and refine personalized treatment approaches. Overall, personalized medicine holds promise for improving the effectiveness and outcomes of SUD treatment by addressing the biological and social factors that contribute to substance use disorders.
SUD Drug Discovery and Development. Pharmacotherapy offers an important means of treating SUDs. Currently, there are five pharmacotherapies approved by the Food and Drug Administration (FDA) for the treatment of Opioid Use Disorder (OUD) and mitigation of opioid withdrawal symptoms: methadone, buprenorphine, extended-release naltrexone, naloxone, and lofexidine. In addition, varenicline is an approved drug for the treatment of nicotine cessation. However, given the diverse nature of SUDs, many patients have limited responses to available medications and, consequently, there is an urgent need for novel treatments. It remains of program interest to identify and develop improved pharmacotherapeutics with clear advantages over our current approved pharmacotherapeutics for OUD treatment and for nicotine cessation treatment. Additionally, there are no FDA-approved medications for cocaine, methamphetamine, or cannabis use disorders. Broadly, novel pharmacotherapeutics are encouraged for the range of unmet medical needs in SUD, for polysubstance use, and for emerging novel treatment modalities and mechanisms of action for SUD treatments. Developing and evaluating new, more efficacious medications remains a high priority. Candidate medications may include either novel or re-purposed compounds. Specific areas of interest include medications that target one or more domains of the addiction cycle, including reward, stress and negative affect, incentive salience, executive function, habituation, and impulsivity/compulsivity. Proposed projects may include emerging technologies and platforms for SUD medication development with a focus on products with the potential to minimize drug seeking, compulsive behavior, overdose prevention, and reversal. Specific projects may include, but are not limited to:
Early therapeutic discovery activities ranging from target identification and validation through lead development;
SUD phenotypic assay development (e.g., organoids, organ-on-a-chip technologies, and higher content invertebrate models, ex vivo bioassays) with validation studies in animal models (e.g., rodent models).
Preclinical and/or clinical drug development;
Medications that would address specific symptoms of withdrawal, such as cravings, depression, cognitive impairments, pain, and sleep problems;
Medications (neurochemicals) involved in social bonding that also modulates key processes associated with addiction, including reward and stress responses, and may enhance the efficacy of psychosocial addiction treatments;
Big-data analytics and machine-learning algorithms analysis yielding insight into behavioral and biological markers of relapse risk;
Artificial Intelligence (AI)-related tools in SUD drug discovery and development to increase innovation and support a cost- and time-effective SUD drug development of pharmacotherapies.
Combination of pharmacotherapeutics to improve SUD treatment adherence and decrease risk of relapse. Molecules may include new and investigational compounds and repurposed approved medications
Projects proposing to study compounds already extensively investigated or currently being studied in patients with SUD, and projects solely focused on pain or on alcoholism not associated with SUD are of limited interest.
FDA-regulated Medical Therapeutic and Diagnostic Devices for Substance Use and Addiction. Medical Devices, including Software as Medical Device (SaMD), offer promising means to monitor, diagnose, and treat patients who use substances for medical purposes, in addition to patients with SUDs. Currently, there are only a few devices that are cleared by the FDA for the treatment of SUD. As such, the investigation and development of new safe and effective medical devices intended to prevent, monitor, diagnose, and treat substance use and addiction is a high priority. Applications in this area are expected to address the needs of those who actively use substances, chronically use substances, or have a diagnosed SUD, and their caregivers, to ensure access to high-quality, safe, and effective medical devices. It is expected that proposed approaches will include activities that will lead to regulatory submissions for pre-market clearance / approval, including interactions with the FDA via the following pathways: pre-submission (Q-submission), Investigational Device Exemption, 510(k), DeNovo, or Premarket Approval (PMA) application. Additional pre-clinical activities may include, but are not limited to, a) bench testing or computational modeling studies; b) good laboratory practice animal studies; c) good manufacturing practice studies; d) toxicology and biocompatibility studies; e) software verification and validation; f) usability/user experience testing. Specific areas of interest include, but are not limited to:
Imaging devices intended to investigate brain function and enhance monitoring, diagnosis, and/or treatment of SUD;
Devices that directly diagnose and/or reduce craving and withdrawal symptoms;
Devices that identify and/or treat NAS;
SaMD focused on behavioral health interventions to alleviate the burden of SUD;
Therapeutic devices (e.g., neuromodulation) intended to improve SUD treatment outcomes and relapse prevention;
Physiological monitoring devices, including remote detection (e.g., wearables, sensors, health monitoring/emergency notification systems), specifically intended for use in patients affected by substance use and addiction.
Harm Reduction Technologies. Harm reduction is an evidence-based public health approach that that directly engages people who use drugs (PWUD) to prevent overdose, disease transmission, and other harms associated with drug use. NIDA included harm reduction in its FY 2022-2026 Strategic Plan in Priority Scientific Area #2: Develop and Test Novel Prevention, Treatment, Harm Reduction, and Recovery Support Strategies. Harm reduction was also identified as a federal drug policy priority in the 2022 National Drug Control Strategy from the White House Office of National Drug Control Policy (ONDCP) and is also one of the strategic priorities of the U.S. Department of Health and Human Services (HHS) Overdose Prevention Strategy. Decades of evidence has shown that strategies for harm reduction substantially reduce HIV and hepatitis C infection among people who inject drugs, reduce overdose risk, enhance health and safety, and increase the likelihood of PWUD to initiate substance use disorder (SUD) treatment (SAMHSA Harm Reduction Framework 2023). The ideology behind harm reduction is based on helping PWUD increase their quality of life even if they are not yet ready to enter treatment. The ONDCP’s Guiding Principles on Harm Reduction are: 1) supporting individuals and overcoming obstacles in accessing all types of care, from overdose prevention strategies to medications and mental health services, 2) providing ongoing support to individuals once harm reduction or treatment services are initiated, 3) creating connections for PWUD with caring staff or volunteers as part of receiving health and social services, and 4) treating PWUD with respect and dignity to help them achieve better outcomes. Harm reduction strategies can address safer practices, safer settings, access to healthcare, transitions to care, sustainable infrastructure, and a sustainable workforce. Applications addressing harm reduction principles include, but are not limited to, technologies for:
Education about the value of harm reduction and reduction of stigma surrounding drug use;
Prevention, treatment, recovery, and general health promotion for PWUD;
Addressing overdose education, detection, and naloxone use;
Promoting safer use (e.g., drug-checking, reducing infection risk);
Prevention, testing, and treatment for sexually transmitted infections;
Ensuring access to and assistance with nutrition, clothing, shelter, housing;
Enabling peer support and the inclusion of people with lived experience in all aspects of care;
Increasing access to low-barrier treatment services, including access to healthcare and oral health services;
Ensuring access to medication and treatment on-demand, including mobile buprenorphine and methadone;
Expanding telehealth and addressing low technology literacy;
Ensuring coordination of care for individuals leaving carceral settings.
Technological Approaches to Decrease Stigma Associated with Substance Use and Addiction. Stigma is understood as a socially constructed phenomenon that occurs when members of a group experience status loss or discrimination based on some shared characteristic that is deemed undesirable by others. Its effects can occur through attitudes and beliefs internalized by impacted individuals (self- stigma), through overt discrimination by others (experienced or enacted stigma), and through the fear of such discrimination (felt stigma). The stigma around substance use and addiction represents a significant public health problem, despite the growing understanding that substance use and addiction are complex brain disorders with behavioral and physiological components. As for other disorders, medical care is often necessary to facilitate recovery and prevent adverse outcomes, including overdose. Patients can recover from substance use and addiction and lead healthy lives; however, stigma limits successful access to care. Stigma often may be related to multiple conditions, such as SUD, mental illness, or infectious disease; behaviors such as specific drug use practices (e.g., opioid injection); or identity statuses related to gender, sexual orientation, sexual identity, race/ethnicity, or socioeconomic factors, such as personal income. It is expected that leveraging state-of-the-art technologies and the latest science will allow to develop and commercialize the products and services aimed at reducing the stigma around substance use and addiction. Applications in this topic may propose projects demonstrating how latest technology and evidence-based science could meaningfully reduce the stigma associated with substance use and addiction. Applications may address individual (internalized, anticipated, or enacted), interpersonal, organizational, and/or structural levels of stigma. Applications and focus can be on any entry point along the continuum of care. Areas of specific research interest and substance use and addiction service contexts include, but are not limited to:
Providing anti-stigma training for medical professionals;
Targeting stigma reduction of non-medical providers (social workers, criminal justice, family members, and educators);
Enhancing both employee well-being and effectiveness of a drug-free and stigma-free workplace program;
Anti-stigma training specific to adolescent substance use and prevention;
Digital certification program for nonprofessional care givers who provide support services for patients with SUD;
Virtual employee assistance programs with focus on SUD and mental health.
Additionally, examples of technological approaches include, but are not limited to:
Natural language processing, computer vision, and other machine learning tools to detect and analyze provider behaviors and medical records reflecting stigma around substance use and addiction alone and intersectional stigma;
Digital compassion (anti-stigma) coaching for medical professionals delivering treatment to SUD patients exploring immersive technologies such as extended reality;
Ecological momentary sampling and other digital phenotyping patient-centered tools to detect points of vulnerability and counteract internal stigma supporting the whole-person model of recovery;
Neural activity-based tools and services to help develop and disseminate the most effective anti-stigma campaign.
Prevention Technology to Address Substance Use and Addiction in Various Underserved Populations. Differences in race, socioeconomic status, sex, and geography have created inequities in care for substance use and addiction. Alternatives in healthcare that emerged during the pandemic, such as virtual doctor visits, along with new tools to facilitate telehealth, may help address some of the barriers to SUD care for currently underserved populations. There are three categories for which prevention technology can address substance use and addiction in various underserved populations despite the aforementioned differences. Primary prevention provides tools to intervene before health effects occur. Secondary prevention provides screening tools to identify diseases in the earliest stages before the onset of signs and symptoms. Tertiary prevention provides tools to manage disease post-diagnosis to slow or stop disease progression. Applications may address micro- (individual, internalized, anticipated, or enacted), or macro- (interpersonal, organizational, and/or structural) levels of health inequities related to various underserved populations. The focus of applications can be on any entry point along the continuum of substance use and addiction care. Examples include:
Primary prevention through measures such as altering risky behaviors (cannabis and/or tobacco use), and banning substances known to be associated with a disease or health condition.
Secondary prevention through measures such as SBIRT (Screening, Brief Intervention, Referral to Treatment).
Tertiary prevention through measures such as rehabilitation, and medication assisted therapy.
Areas of specific research interest with respect to substance use and addiction service contexts include, but are not limited to:
Providing prevention education and behavior change training for medical professionals; targeting knowledge awareness and behavior change for non-medical providers (social workers, criminal justice, family members, and educators);
Digital or non-digital behavior change interventions enhancing both employee well-being and effectiveness of a drug-free workplace program;
Digital or non-digital prevention education training specific to adolescent substance use and prevention;
Additionally, examples of technological approaches include, but are not limited to:
Machine learning tools (e.g., natural language processing) for provider/medical record substance use and addiction bias;
Digital mindfulness coaching for medical professionals delivering substance use and addiction services with virtual reality;
Ecological momentary sampling and other digital phenotyping patient-centered tools to detect points of vulnerability and address them with a whole-person model of recovery.
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The NIDCD accepts a broad range of small business applications that are significant, innovative, and relevant to its mission. Some examples of research topics within the NIDCD mission areas include topics shown below; further example can be found on the NIDCD Strategic Plan website (https://www.nidcd.nih.gov/about/strategic-plans).
Priority is given to meritorious applications that are likely to develop innovative technologies, provide clear evidence of effectiveness, and bring novel products to the commercial marketplace.
Hearing and Balance Program
Development of treatment modalities to prevent or lessen the effects of hearing disorders; development of new hearing aids, over the counter hearing aids, cochlear implants, and other assistive devices; development of improved screening technologies to assess hearing loss, in adults as well as in neonates and infants. Development of technologies that provide self-fitting, self-adjusting, or other features that increase performance, accessibility, or affordability of hearing aids; development of new outcome measures for assessing the efficacy of treatments for hearing disorders. Development of technologies for the diagnosis and treatment of tinnitus. Development of technologies for the diagnosis and treatment of otitis media including non-invasive diagnostics to identify middle ear pathogens, novel antibacterial strategies, and prophylactic anti-microbial strategies. Development of technologies for the study, diagnosis and treatment of noise-induced and age-related hearing loss.
Development of technologies for the study, diagnosis and treatment of balance disorders, particularly for the elderly; development of clinical tests and instruments to assess balance/vestibular function; development of instruments and tests measuring head stability and vestibular function during natural stimulation of the vestibular system; development of perceptual reporting techniques and psychological indices for clinical assessment of the balance-disordered patient; development of tests and new outcome measures for assessing the efficacy of physical rehabilitative regimens for balance disorders; and development of assistive devices for balance disorders, including neural prostheses for the vestibular system.
Development of new research tools to aid in the study of the auditory and/or balance systems that can provide an improved understanding of fluctuating patterns of neural circuit structure and function over time and across large assemblies of neurons; new animal models of impaired function; improved diagnostic tools for inner ear function, including DNA-based assays and biochemical markers of disease; innovative tests and instruments to screen for and diagnose inner ear function. Development of technologies to enable gene transfer to the inner ear, including viral vectors and cell type specific markers and probes to examine cell lineage in inner ear regeneration. Development of innovative in vivo imaging capabilities to significantly advance visualization, diagnosis, and treatment of disorders in the clinic.
Voice, Speech, and Language Programs
NIDCD is interested in the development of technologies for the study of communication disorders: nature, causes, diagnosis, treatment, and prevention. These communication disorders include but are not limited to: aphasia, apraxia, developmental language disorders, dysarthria, dysphonia, and stuttering. In addition, research is needed for communication challenges that may accompany individuals with autism, deafness, hearing loss, or the inability to rely on spoken language as a primary means of communication. NIDCD is particularly interested in projects that employ a user-centered design or similar approach that engages the target end user throughout the development and research process. In addition, these technologies should be accessible to culturally and linguistically diverse populations.
The emphasis of responsive projects may include the development of technologies such as: augmentative and alternative communication (AAC) devices; assistive device enhancements that better simulate natural speech (e.g. age, gender, emotion); brain computer interface (BCI) communication prosthesis; mobile health applications; gender affirming voice care; flexible and adaptable treatment delivery systems or intervention protocols that can be easily tailored to the needs of an individual; improved artificial larynges and tracheoesophageal shunts; artificial intelligence computer models that simulate normal and disordered communication; virtual/augmented reality approaches to treatment; and technologies that assist in the access to or delivery of healthcare during a public health crisis.
Taste and Smell Program
Development of easily administered diagnostic tools for testing human chemosensory function throughout the lifespan; development of intervention strategies and targeted drugs for the treatment of taste and smell disorders; preventive measures to limit the harmful effects of infections, airborne toxins, radiation, chemotherapy and other drugs on chemosensory function; novel therapies to stimulate regeneration of mature sensory neurons in damaged and/or aged tissue; development of biomarkers for neurodegenerative disease; development of tools to facilitate chemosensory research including improved neuroimaging techniques and visualization at structural and cellular levels.
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Translational Developmental Biology and Mammalian Genetics and Genomics
Priorities are to 1) understand the development of craniofacial complex and 2) elucidate the mechanisms underlying dental, oral, and craniofacial (DOC) conditions and disorders. The ultimate goal is to enable early prevention, diagnoses, and treatments of DOC conditions and disorders on individual basis. Interests in this area include but are not limited to:
Develop advanced assays and reagents that allow robust and scalable throughput to genetically engineer and functionally characterize organisms in craniofacial development and genetics studies.
Develop novel or improved methods and devices that are minimally or non-invasive, cost effective, and sensitive, for early detection of DOC conditions and disorders using imaging, multi-omic, and other state-of-the art technologies and approaches. Methods and devices suitable for Point of Care, at home, and telemedicine uses are encouraged.
Develop methods that are applicable to early treatments (as early as in utero or perinatal, or at a later developmental stage) for human DOC conditions and disorders.
Translational Dental, Oral, and Craniofacial Data Science
Priorities are to 1) maximize the utility of Big Data to accelerate DOC research and 2) better enable evidence-based and data science-driven clinical practices. Interests in this area include but are not limited to:
Develop advanced analytics to retrieve diverse, multi-dimensional data from data repositories, knowledgebases, literature, electronic health/dental/medical/records, and other sources, and infer relations between data elements to inform basic and clinical DOC research. Machine Learning/Deep Learning/Artificial Intelligence (ML/DL/AI) and natural language processing tools are considered highly relevant.
Develop phenotyping, data curation, and data analysis web interfaces for clinicians to support clinical decision making.
Develop devices, including those for Point of Care, at home, and telemedicine uses, for the diagnoses of DOC conditions and disorders. Examples include, but are not limited to, imaging and AI based facile devices.
Infectious Diseases and Immunity
Research relating to the etiology, pathogenesis, prevention, diagnosis and treatment of infectious diseases of the oral cavity is supported by the NIDCR. This includes research on practical ways to effectively use the host immune system to prevent or treat oral infectious diseases and microbial-induced inflammation. Infectious diseases of the oral cavity include caries, periodontitis, candidiasis, peri- implantitis, pulpitis, and various viral, bacterial, and fungal infections of the oral mucosa and research on the diagnosis and prevention of oral manifestations and malignancies of HIV infection and AIDS. Specific examples of technology development needs include but are not limited to:
Develop ways to overcome or eliminate the risk of oral infections in persons who smoke or chew tobacco, drink alcohol, or are immunosuppressed, have diabetes, are malnourished, or are psychologically stressed.
Explore novel methods or agents to eradicate oral biofilms (dental plaque) on teeth, oral soft tissues, and dental implants without adversely affecting the normal oral flora.
Isolate, synthesize or prepare new antibiotics and antimicrobial agents that can overcome bacterial and fungal resistance to current compounds. Formulate combinatorial drug regimens to attack microbes growing in oral biofilms (dental plaque).
Develop controlled release systems for local delivery of synthetic peptides, recombinant proteins, or other chemical or immunotherapeutic agents to prevent, control, and/or treat oral infectious diseases, or the oral manifestations of HIV infection.
Develop biological response modifiers or other immunological approaches to reduce or eliminate microbial-induced chronic inflammation or the tissue destruction associated with chronic inflammation in the oral cavity.
Develop ways to interfere with microbial colonization and growth through the use of antimicrobial agents and chemotherapy.
Identify and exploit the structural features of oral biofilms for increased therapeutics delivery.
Develop computer programs and apply systems biology approaches to model biologically active peptide regions of oral components that have anti-fungal, anti-bacterial and anti-viral activities.
Develop substitutes of naturally occurring chemicals (phytochemicals) known to have a role in controlling opportunistic infections induced by HIV.
Develop synthetic peptides and recombinant proteins of oral components with anti-fungal, anti- bacterial and anti-viral activities including those against HIV and oral opportunistic pathogens.
Develop oral topical formulations with combined microbicide, analgesic, and anti-inflammatory activities to enhance oral mucosal defenses and prevent and/or control oral infections and lesions in HIV-infected and/or immunosuppressed subjects.
Discover, test, standardize, and validate novel biomarkers present in oral biospecimens for screening and clinical diagnosis of HIV, and oral opportunistic pathogens infections and AIDS malignancies. Apply similar strategies as listed below for oral, oropharyngeal and salivary gland cancers to AIDS malignancies.
Develop the next generation of rapid tests and point of care devices to detect, quantify, screen, and diagnose HIV and oral opportunistic pathogens. Develop novel assays to quantify oral mucosal reservoirs for oral viruses, oral immune responses to viral prophylactic and therapeutic vaccines, and viral changes due to anti-viral treatments.
Develop safe and effective targeted diagnostic and therapeutic technologies in response to endemic and pandemic infections.
Oral, Oropharyngeal and Salivary Gland Cancers
Emphasis is on molecular mechanisms of oral epithelial cell deregulation that lead to oral cancers. Research related to early detection, diagnosis, and prevention, and treatment of oral cancers is of particular interest. Examples include but are not limited to the following areas:
Develop imaging techniques for the early detection, diagnosis and prognosis of pre-malignant lesions.
Develop effective pharmacological, immunological and radiological modalities for treatment of pre- malignant and malignant lesions in preclinical models.
Develop novel technologies for the genetic and molecular-targeted therapy (e.g. siRNAs, peptide- based therapies) in preclinical models.
Develop genetic animal models of oral cancer premalignancy and oral cancer progression that mimic human oral cancers, including HPV-associated oropharyngeal cancers.
Develop animal models to facilitate the testing of therapeutic and chemopreventive agents for oral cancers.
Temporomandibular Disorders and Orofacial Pain
Emphasis is on research for chronic disabling painful diseases of the oral-craniofacial-dental areas including chronic pain, neuropathies, and diseases of the temporomandibular joint. NIDCR encourages applications that include but are not limited to:
Develop improved methods and technologies for measuring nociceptive, chemosensory, tactile, kinesthetic, or proprioceptive function involving craniofacial structures. Such measures may be useful in screening for deficits, improving diagnosis, or for evaluating responses to orofacial treatments or interventions.
Develop improved biomarkers for neuropathic pain conditions affecting oral-craniofacial tissues or structures.
Develop assays facilitating reliable evaluations of relationships between biological and other risk factors as they relate to onset, and exacerbation of pain and for examining transition from acute pain to chronic pain conditions.
Identify and develop novel pharmacologic or biological agents, and non-pharmacologic methods/approaches, including but not limited to small molecules, peptides, recombinant proteins, nucleic acids, electrical stimulation, and others which could be grouped broadly to electromagnetic induction to modulate mood/nerves, to prevent, control, and/or treat orofacial pain.
Develop animal models to facilitate testing of therapeutic agents for orofacial pain.
Saliva, Salivary Diagnostics, and Salivary Gland Diseases
Emphasis is on salivary gland physiology and pathophysiology and in the repair and restoration of the damaged gland. Examples include but are not limited to:
Develop viral, non-viral and gene therapy-based approaches to address compromised salivary gland function. Develop cell and tissue-based strategies and technologies for restoration of damaged or destroyed salivary gland function.
Develop novel compounds or materials that protect and preserve salivary glands from head and neck cancer irradiation therapy.
Develop non-invasive methods for the determination of efficacy and safety of artificial saliva, sialogogues, and their delivery vehicles used in addressing the diminution or lack of saliva (xerostomia) due to Sjögren’s Syndrome or head and neck cancer irradiation therapy.
Develop biomarker-based technologies for the identification of Sjögren’s Syndrome using blood or saliva as body fluids.
Identify biomarkers derived from oral fluids that are predictive of the onset, progression and recurrence of oral diseases and conditions, such as periodontal diseases, caries, and oral, oropharyngeal and salivary gland cancers.
Develop immunological strategies and immunotherapy-based approaches for addressing xerostomia from Sjögren’s Syndrome.
Improve existing or develop new tools for early detection of salivary gland cancers.
Biotechnology, Biomaterials, and Applications for Regeneration and Restoration of Oral, Dental and Craniofacial Tissues
Emphasis is placed on the development of a broad range of technologies targeted at regeneration and restoration of diseased and injured hard and soft tissues of the oral and craniofacial complex and on translating these applications to the clinic. Tissues of interest include craniofacial and alveolar bone, the periodontal ligament, TMJ bone and cartilage, oral mucosa, facial skeletal muscle, vasculature and nerves. Also of interest are multi-tissue composites and organs, such as vascularized and innervated bone and muscle, salivary gland, tooth, periodontium, bone-periodontal ligament-cementum interface and osteochondral complexes. Specific topics could include but are not limited to:
Develop technologies for design, fabrication, and manufacturing of biomimetic and biocompatible biomaterials and a range of structurally complex scaffolds, including nanomaterials and self-assembling nano-scaffolds, for tissue engineering and regenerative medicine applications. Projects need to include assessments demonstrating the ability of biomaterials and scaffolds to support generation and regeneration of mineralized tissues that replicate the mechanical, physical and biological properties of dentin, enamel, cementum, or bone.
Develop cell-based technologies, including stem cell-based technologies. These include, designing strategies for isolation, purification, differentiation, scaled up production, manufacturing, standardization and quality control of stem and progenitor cells and their differentiated progenies, derivation of efficient and predictable methodologies for cellular reprogramming, and advancing technologies for reconstruction of stem cell niches for augmenting tissue regeneration.
Develop bioreactor systems to facilitate design, fabrication, and manufacturing of soft and hard tissues of dental, oral and craniofacial complex. These bioreactors may be able to mimic biophysical forces, such as mechanical and electrical forces that normally guide tissue morphogenesis in vivo. Among other desirable features of the bioreactors are maintenance of tissue construct oxygenation and real-time tissue assessment to encompass metabolites, gene expression, or proteomics evaluation, in addition to morphology and spatial imaging by labeling capabilities.
Develop improved dental composite materials and bonding agents, including biomimetic and self-healing materials and adhesive sealants. These include but are not limited to materials to replace Bis-GMA resin-based systems that are suitable for restoring crowns of posterior teeth and exposed roots of the teeth. Any novel dental composite restorative components or systems must include assessments in a physiologically relevant test system that mimics microbial and physicochemical conditions found in the oral cavity.
Develop methods, materials, and devices for orthodontic, prosthetic, periodontic, endodontic and craniofacial applications including those that can be used for craniofacial bone distraction, reconstruction, hard and soft craniofacial tissue healing and regeneration, and scarless craniofacial tissue repair.
Develop miniaturized artificial tissue and organ mimics/tissue chips and organoids that can be adapted to high-throughput formats for a broad range of applications, such as analysis of biomaterial and tissue function, drug efficacy and toxicology assays, biocompatibility assays, genetic screening and elucidating mechanisms of dental, oral and craniofacial development and disease.
Develop mathematical, computational, and bioinformatics approaches for modeling oral and craniofacial tissues and organ function and physiology to address needs of systems biology, synthetic biology, and single cell analysis. Develop new approaches for utilizing novel biomolecules, including growth factors, cytokines, small molecules, siRNAs, and others for counteracting diseases and injuries of oral and craniofacial tissues and promoting their healing and regeneration.
Develop new approaches to study molecular or cellular interactions between hard and soft tissues such as between the nervous system and mineralized tissues. Approaches can include development of new technologies or application of existing technologies that are newly applied to the dental and craniofacial field.
Develop advanced viral and non-viral based biomolecule delivery approaches, including nanotechnology-based technologies that can precisely deliver and release therapeutic proteins, nucleic acids, small molecules, or combinations thereof with predictable temporal kinetics to target specific tissue sites.
Develop imagining diagnostics to accelerate clinical implementation of reliable, reproducible, highly specific and sensitive diagnostic instruments for various applications, including but not limited to dental caries, cracked teeth, pulp vitality, bone quality, and periodontal disease.
Develop imaging diagnostics to accelerate clinical implementation of reliable, reproducible, highly specific and sensitive diagnostic instruments for various applications, including but not limited to dental caries, cracked teeth, pulp vitality, bone quality, and periodontal disease.
Develop safe and effective biosensors for noninvasive, dynamic real-time monitoring of physiological processes in the human body using the oral cavity as the sensing site. These biosensors will be able to assess health and disease states and receive feedback from body fluids and clinical compounds that are found in or pass through the oral cavity and in certain cases, will be able to communicate these outputs wirelessly and remotely.
Develop safe and effective biosensors, monitoring devices and systems, data driven and computer science tools for automated detection, diagnosis and treatment of dental, oral and craniofacial disease.
Develop effective multimodal breakthrough technologies for real-time detection of proven disease biomarkers, viruses and/or pathogens with high sensitivity and specificity that integrate detection technologies, such as optical spectroscopy, electrical impedance, radio frequency, acoustic, and immunosensing, with multiplexing capability.
Preclinical Research
Preclinical research and development activities for dental and craniofacial technologies including the translation of innovations devices, drugs, biologic and combination products (reconstructive materials, regenerative products, pharmaceuticals, therapeutics, vaccines, digital health technologies) that require review and approval by the FDA as a regulated product before commercial distribution.
Biomedical Clinical Research
Emphasis is on development of methods, drugs and materials to diagnose or treat oral and craniofacial diseases and conditions. Areas of interest include but are not limited to projects that:
Develop improved methods to detect and predict progression of dental caries, periodontal disease, reversible and irreversible pulpitis.
Develop improved methods or materials to prevent dental, oral, and craniofacial diseases or conditions.
Develop new or improved methods or materials to enhance oral and craniofacial surgery. This would include both intraoral and extra-oral surgery.
Develop improved methods or materials to mechanically and/or biologically repair or treat tooth structure damaged by dental caries or periodontal disease.
Develop, customize, and validate data-driven technologies coupled with automated high throughput tools that accelerate development and regulatory evaluation of novel biomaterials.
Develop improved appliances to aid suckling and improve speech production by newborn infants with cleft palate and cleft lip.
Develop safe and efficacious methods to diagnose caries, pulp vitality and / or periodontal diseases utilizing non-ionizing radiation.
Develop technologies for local delivery of drugs to treat oral and craniofacial diseases or disorders.
Develop novel non-opioid pharmacological medications for management of acute dental pain.
Develop safe and efficacious methods or medications to manage complications of head and neck cancer treatment.
Develop tools for implementation of precision medicine in the oral cavity.
Develop methods and tools to detect soft tissue pathologies in the oral cavity.
Develop oral devices and materials for monitoring local and systemic conditions.
Behavioral Clinical Research
Provides support for the development of evidence-based products related to behavioral and social aspects of oral health, oral health prevention or treatment interventions, and other patient-oriented aspects of oral health. This includes support for clinical trials and patient-oriented research to establish safety and initial efficacy of products. NIDCR is especially interested in applications that significantly improve oral health by 1) being broadly applicable to many populations, 2) contributing to meaningful oral health improvements for a specific population, 3) expediting translation of research findings into oral health improvements, and/or 4) equipping oral health care providers, educators or researchers with tools to improve public oral health. Examples of studies of interest include, but are not limited to, the following:
Develop and test the effectiveness of innovative teaching or educational tools or curricula to inform oral health professionals and dental students regarding the role of genetics and genomics, including the oral microbiome, in oral diseases, conditions and oral health care; and/or oral cancer prevention and early detection.
Develop and test digital health, connected technologies, and approaches to improve time- sampled monitoring of behavioral adherence with preventive, condition management, or therapeutic regimens specifically relevant to oral diseases/conditions. Such devices or methods could be utilized in a variety of settings, including naturalistic settings, within clinical trials, within oral health care delivery systems, etc.
Develop and test novel compliance and survey measures or tools to identify the underlying causes of insufficient preventive dentistry for specific underserved populations.
Develop and test for safety, efficacy, and/or effectiveness of measures or materials for diagnosing, preventing, or treating oral, dental, and craniofacial conditions and disorders.
Develop or adapt for use in new populations or settings: Novel measures or methods for identifying individual, family, group, or other processes that explain oral health behavior; oral health interventions utilizing technology to improve efficiency of delivery (e.g., management of chronic pain related to temporomandibular joint disorders, etc.); interventions addressing health behaviors highly associated with oral health (e.g., tobacco, alcohol, and other drug use; management of diabetes, HIV infection, or other chronic illnesses; etc.).
Develop and test innovative methods for facilitating collaborations, referrals, and/or ongoing follow- ups between oral health professionals and other health care professionals across primary and specialty practices.
Develop technologies or modules beyond existing web-based platforms to improve preventive oral health hygiene for children and adolescents (e.g., social marketing via app- and web- based interaction, virtual reality “worlds”, “massively multiplayer online games”, etc.).
Develop and test web-based training or other innovative approaches for oral health care professionals to accelerate accurate translation of new knowledge regarding oral diseases and their effective prevention or treatment into clinical or public health practice.
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Diabetes, Endocrinology and Metabolic Diseases
The Division of Diabetes, Endocrinology and Metabolic Diseases supports SBIR/STTR projects in the areas of type 1 and type 2 diabetes, endocrine disorders, and neuroendocrinology. High priority topic areas are listed below:
Sensors, Hormone Replacement, Delivery Devices, and Other Technologies for Diabetes Treatment:
Novel accurate, reliable, and user-friendly continuous monitoring sensor technologies relevant to diabetes treatment and monitoring. Preferably, these sensors should have long functional life, and for glucose sensing be accurate at all glycemic ranges, particularly at concentrations below 54 mg/dl.
Use of Artificial Intelligence, Machine Learning (AI/ML) tools to enable fully automated closed loop pancreatic hormone delivery systems in response to multi-analyte physiological input.
Novel insulin and glucagon formulations showing improved kinetics and stability.
Telemedicine/remote monitoring approaches that can be incorporated as components/and or adjuvants of closed loop systems for better diabetes self-management.
Technologies that may promote and facilitate adherence/compliance by users of diabetes monitoring and control devices.
More reliable and efficient biocompatible infusion sets for automated hormone delivery and improved kinetics.
New implantable and easy to replace technologies that may mimic the beneficial effect of gastric bypass/bariatric surgery for the treatment of diabetes without the need of a major invasive surgical procedure.
Diabetic Wound Healing and Diabetic Neuropathy:
Drugs, biologic therapies, and novel delivery systems that accelerate healing of diabetic foot ulcers and prevent recurrences.
Off-loading devices that improve patient acceptability and adherence.
Diagnostic and predictive biomarkers, including improved outcome measures, for diabetic foot ulcers that can be used to diagnose biofilms, predict healing, select treatment strategies, or determine risk of primary or secondary occurrence of foot ulcers. The biomarkers may use biosamples, images or sensors.
Educational approaches and new technologies that increase adherence to preventative measures for diabetic foot ulcers in high-risk patients or increase adherence to off-loading and other recommended treatment regimens for diabetic foot ulcers.
Disease-modifying therapies for the prevention and treatment of diabetic neuropathy.
Sensors, algorithms, and patient interfaces that can provide feedback to diabetic individuals with insensate feet to prevent diabetic foot ulcers.
Biomarkers to monitor disease progression and response to therapy for diabetic neuropathy, including peripheral sensory, autonomic, and painful diabetic neuropathy.
Immune Modulation and Cell Replacement Therapies:
Development of immunomodulation/tolerance strategies, including cell-based, to prevent, revert or slow progression of type 1 diabetes.
Development and optimization of engineered islet cell replacement sources with improved transplant graft attributes, including but not exclusive to: graft function durability under transplantation and metabolic stress; graft survival with lowered or no systemic immunosuppression and non-invasive quantitative monitoring of graft mass.
Novel biomimetic and immuno-engineering strategies for the development of immune evasive cells/islets and biomaterials/devices for successful long-term engraftment with no need of systemic immunosuppression.
Development of reproducible methods that improve yield/viability/function of islets/insulin producing cells and allow their ex-vivo expansion for transplantation.
Prediction, Screening, Diagnostics, and Monitoring:
Development of methodologies, products, or biomarkers useful for predicting, preventing or delaying progression of pre-diabetes or diabetes, including tests for identifying patients at risk, and methods of monitoring disease progression.
Validated tests for autoantibody detection, auto-reactive T-cells and other immune/metabolic parameters for type 1 diabetes early diagnosis and monitoring. Improvements could include higher throughput - point of care technologies (reliable, accurate, cost-effective, highly sensitive, and standardized with rapid turnaround time).
Multiplexed assays for peptides and proteins that are used as biomarkers in diabetes and metabolic diseases (e.g., insulin, pro-insulin, glucagon, c-peptide, HbA1c..etc).
Development of non-invasive technologies such as imaging for the in vivo measurement/evaluation of pancreatic islet’s cell mass, function and inflammation.
Artificial Intelligence, Machine Learning, and Deep Learning driven methods and technologies that may optimize prediction, diagnosis, monitoring and treatment of diabetes, endocrine and metabolic disorders.
Pre-Clinical Research and Disease Modeling:
Development and optimization of microphysiological/organ on chip platforms in the application of pre-clinical testing and/or modeling of physiological and pathophysiological aspects of diabetes, endocrine and metabolic disorders.
Development of methods utilizing replenishable cell sources, that generate functional islet like cells/tissues that can be successfully tested in microphysiological systems and/or in vivo models of the disease.
Development and testing of in silico/simulation models with predictive capability to complement and/or replace in vitro and in vivo pre-clinical testing.
Tools for Measuring Peripheral Neurotransmitters and Neuromodulation:
Devices that modulate or control the hepatic or pancreatic branches of the vagus nerve with the aim of relieving diabetes or other metabolic disorders. Projects concerned with the liver should be focused on the regulation of glucose or lipid metabolism. Technologies would include closed
- or open-loop neural stimulators of sensory or motor nerves originating from or terminating in the endocrine pancreas or liver.
Tools that provide high spatio-temporal resolution of neurotransmitter release in the endocrine pancreas or liver.
Tools that measure autonomic activity in the liver, endocrine pancreas, or adipose tissue in animal models or humans.
Digestive Diseases and Nutrition
The Division of Digestive Diseases and Nutrition supports research in diseases and disorders of the digestive tract; esophagus, stomach, intestine, colon, anorectum, pancreas, liver, gallbladder, and biliary tract; as well as research in nutrition and obesity. Innovative investigator-initiated projects that are not mentioned below are also encouraged. Examples of areas that may be of interest to small businesses include, but are not limited to:
Gastrointestinal
Development of new diagnostic techniques and tests, including non-invasive tests and imaging for detecting Barrett’s esophagus, GERD, and other intestinal disorders.
Development of agents and techniques to measure, diagnose, stimulate regeneration of enteric neurons, and treat motility disorders.
Development of novel therapies to modulate/enhance GI lymphatic function for the treatment of GI pathologies.
Development of gut-derived biomarkers of neurodegenerative brain disease.
Development of approaches to simultaneously interrogate or modulate the central nervous system (CNS) and the gastrointestinal system.
Development and validation of neurotechnologies that improve the association of symptoms, pathophysiology, and function for gastrointestinal disorders.
Development of novel proteomic or metabolomic technologies designed to study digestive diseases and their complications.
Development of assays and screening methods for detection of biomarkers for diagnosis, grading and staging digestive diseases.
Development of Live Biotherapeutic Products (LBPs), such as probiotic organisms for the prevention or treatment of gastrointestinal conditions, or to enhance the nutritional properties of dietary components. These LBPs would not include vaccines, oncolytic bacteria, or gene therapy agents.
Liver
Development of novel antifibrotic therapies for chronic progressive liver diseases.
Development of quantitative tests of hepatic “reserve” for assessment of therapeutic intervention, transplantation, or surgical risk in patients with liver disease.
Development of point-of-care, serologic, and rapid tests for rapid diagnosis, treatment requirements and genotyping of hepatitis.
Development of rapid, reliable, and inexpensive tests for genetic screening and risk markers important in liver disease.
Development of sensitive and reliable non-invasive techniques to detect and monitor liver fibrosis and other chronic liver diseases and the associated complications.
Creation of bio-artificial organs for temporary hepatic support in patients with acute liver failure.
Pancreas
Development of and validation of therapeutic interventions for treatment of pancreatitis and its complications.
Development of more accurate, non-invasive approaches to the diagnosis of chronic pancreatitis by functional, radiologic, endoscopic, or pathologic/cytologic means.
Nutrition/Obesity
Development of novel methods and tools to accurately evaluate nutritional status, physical activity, and energy expenditure.
Development of non- or minimally invasive technologies that allow access and/or delivery to discrete regions of the digestive tract.
Development of novel breath, urine, or blood tests to accurately measure dietary intake.
Development of non-invasive neurotechnologies to stimulate and/or modulate hormone/peptide release from the gastrointestinal system for the treatment of metabolic disorders such as obesity.
Kidney, Urologic and Hematologic Diseases
The Division of Kidney, Urologic, and Hematologic Diseases provides research funding and support for basic, translational, and clinical research studies of the kidney, urinary tract, and disorders of the blood and blood-forming organs. Projects may include development of tools to improve understanding of the physiology, pathophysiology, and diseases of the kidney, urinary tract, and blood and blood forming systems, or to develop rational diagnostics, treatments, and prevention strategies for these diseases. Projects may be to develop tools/technologies to support clinical care, population health and/or pragmatic research to improve health outcomes in populations with kidney diseases and/or urologic conditions. Projects to develop tools or technologies to address health disparities or promote health equity are encouraged. NIDDK encourages research that takes a holistic perspective of human health by considering biological, behavioral, and social contributors to the scientific exploration, prevention, and management of these diseases/conditions. Development of -omics, bioinformatics, and multi-scale technologies for the study of these systems, especially where these systems interact, is also encouraged. Research opportunities that may be of interest to small businesses include, but are not limited to:
Kidney Diseases. Areas of research include chronic kidney disease, end-stage renal disease, diabetic kidney disease, polycystic kidney disease, hypertensive kidney injury, acute kidney injury, kidney donation (delayed graft function and chronic rejection), congenital kidney disorders, glomerular and tubulointerstitial diseases, IgA nephropathy, hemolytic uremic syndrome, fluid and electrolyte disorders, kidney repair and regeneration, and normal and abnormal kidney development and physiology.
Dialysis, Devices and Medical Technologies
Development of innovative forms of renal dialysis which improve efficiency, have lower associated morbidity (e.g., tissue engineered artificial kidneys, implantable or wearable dialyzers), reduce side effects and constraints of dialysis treatment, and/or improve access, experience, and quality of life.
Development of functional nephrons for transplantation.
Development of pharmacological agents, devices, techniques, or diagnostics that enhance maturation and longevity of a vascular access.
Development of dialysis membrane technologies with enhanced biocompatibility and anti- fouling properties.
Development of a means to provide continuous anticoagulation to permit renal replacement therapy.
Development of reliable, non-invasive, wearable or online monitoring systems for real- time assessment and adjustment of treatment parameters such as blood volume, access flow, and urea clearance.
Development of hemodialysis or peritoneal dialysis catheters using improved biomaterials, which reduce catheter-related infections, the foreign body response, biofouling, and biofilm formation.
Development of novel methods to generate dialysate for hemodialysis or peritoneal dialysis.
Development of devices or techniques to enhance the long-term success of kidney transplantation (e.g., techniques for repairing kidneys or for kidney storage and preservation).
Development of technologies to improve kidney biopsies (i.e., to improve safety or tissue acquisition).
Health Information Technologies
Development of health information technologies or mobile technologies that enhance delivery of care, population health management, health equity, and/or research for patients with kidney diseases.
Development of applications or application programming interfaces that use health data standards (e.g., Fast Healthcare Interoperability Resources [FHIR], clinical terminologies) to improve accessibility, accuracy, and/or completeness of real-world health, behavioral, and societal/contextual data for research and care of individuals with kidney diseases.
Development of technologies to engage patients with kidney diseases in their care or to support interaction with caregivers.
Development of innovative technologies or platforms to facilitate kidney research training and education, which could include software or simulation tools.
Development of clinical assays that enable biopsychosocial precision medicine approaches to treating kidney diseases.
Development of technologies that use artificial intelligence/machine learning (AI/ML) or other advanced statistical approaches to integrate disparate data types to inform diagnosis of kidney diseases. AI/ML approaches should leverage data from diverse populations and apply equity considerations to ensure resulting models do not further embed structural racism or discrimination.
Development of platforms for pre-analytical preparation, imaging, and automated analysis of kidney tissue.
Development of non- or minimally invasive methods for evaluating kidney functions, including in individuals with congenital genitourinary conditions.
Reliable, non-invasive, non-radioactive methods of measuring glomerular filtration rate (GFR) or tubular functions.
Translation of biomarkers of acute kidney injury or chronic kidney disease with clinical utility into commercial assays.
Translation of biomarkers for early detection of kidney diseases or prediction of kidney disease progression, recovery, or drug response.
Development of improved renal imaging techniques, differential renal function assessment, diagnostic assessment of non-malignant kidney diseases, or measurement of perinatal nephron endowment.
Development of technology to improve collection of real-time data (e.g., biomarkers, diet, physical activity, patient reported outcomes, vital signs, patient experience of kidney or urologic disease or its treatment, social or environmental factors which affect the development or progression of kidney disease), patient outcomes, and adherence for clinical studies.
Development of imaging or molecular analysis technologies to enhance information extraction from renal biopsies and development of antibodies or other probes for unique cell types of the kidney.
Therapeutics Discovery and Development
Lead optimization and preclinical development of pharmacological agents that might be used to intervene in acute or chronic renal disorders and in disorders of renal hemodynamics, blood pressure, electrolyte metabolism, and extracellular volume regulation.
Development of drugs or biologics designed to specifically target kidney cell types.
Development of drugs or biologics to stimulate productive kidney repair or regeneration.
Development of technologies to enhance the validation of kidney disease targets or to screen compounds for efficacy or toxicity (e.g., kidney organoids or tissue chips, more relevant animal models of acute kidney injury).
Development of data and cell banks (e.g., of diabetic kidney disease families and polycystic kidney disease families) for use by the research community.
Development of preventative measures for acute kidney injury (e.g., during coronary artery bypass grafting, sepsis, or treatment with nephrotoxic agents).
Urologic Diseases. Areas of research include benign prostatic hyperplasia, lower urinary tract symptoms (LUTS) including urinary incontinence, urinary tract infections, urinary stone disease, erectile dysfunction, urologic chronic pelvic pain syndromes (including interstitial cystitis and chronic prostatitis), congenital urologic disorders, repair and regeneration of lower urinary tract organs, normal and abnormal lower urinary tract development, and physiology of the urinary system and male genital organs (excluding applications targeting male fertility).
Diagnostics and Imaging
Translation of blood or urine biomarkers in the lower urinary tract or other urologic disorders into commercial assays with clinical utility.
Development of non-invasive or minimally invasive methods to diagnose bladder inflammation or changes in the urothelium that are not of a cancerous origin.
Development of new technologies for rapid clinical diagnosis and characterization of urinary tract infection (UTI).
Development of new technologies or methods with reduced radiation dose for evaluating vesico-ureteral reflux in children and infants.
Development of diagnostic modes to clinically and non-invasively or minimal- invasively measure bladder outlet obstruction before and after surgical or pharmaceutical intervention.
Development of objective diagnostic devices or methods for the assessment of urinary storage and voiding disorders, including stress, urge, and mixed incontinence, in both adults and children.
Development of wireless and non-invasive or minimally invasive measurement technologies for real-time assessment of lower urinary tract function, which can include neuro- pharmacological/neuro-physiological urodynamics.
Development of radiation-free and accurate imaging technologies for urinary stone disease.
Development of technologies that use artificial intelligence/machine learning (AI/ML) to integrate disparate data types to inform diagnosis of urologic diseases. AI/ML approaches should leverage data from diverse populations and apply equity considerations to ensure resulting models do not further embed structural racism or discrimination.
Development of platforms for pre-analytical preparation, imaging, and automated analysis of genitourinary tissues.
Drug and Device (Therapeutic) Interventions
Lead optimization and preclinical development of pharmacological agents for treatment or prevention of urinary stone disease, urological chronic pelvic pain syndromes, urinary tract infections, or other urologic diseases or conditions within NIDDK’s mission.
Development of novel neuromodulation devices, which restore function or mitigate pain conditions of the lower urinary tract.
Development of urinary catheters which reduce the incidence of infection in the urinary tract and decrease urethral and bladder inflammation.
Development of technologies for treatment of bladder outlet obstruction.
Development of bioengineered materials or structures, including cell-laden structures, for the repair or regeneration of genitourinary organs.
Health Information Technologies
Development of health information technologies or mobile technologies that enhance delivery of care, population health management, health equity, and/or research for patients with urologic diseases or conditions.
Development of applications or application programming interfaces that use health data standards (e.g., Fast Healthcare Interoperability Resources [FHIR], clinical terminologies) to improve accessibility, accuracy, and/or completeness of real-world health, behavioral, or social data for research and care of individuals with urologic diseases or conditions.
Development of technologies to engage patients with urologic diseases or conditions in their care or to support interaction with caregivers.
Development of innovative technologies or platforms to facilitate urology research training and education, which could include software or simulation tools.
Research Tools
Development of tools for elucidating the role of urinary or gut microbiome in urinary stone disease or other urologic diseases or conditions within NIDDK’s mission.
Development of novel models of benign prostatic hyperplasia.
Development of technology to improve collection of real-time data (e.g., biomarkers, diet, physical activity, vital signs, psychological parameters, and social or environmental factors), patient- reported outcomes, and adherence for clinical studies (e.g., studies of gene-environment interactions in the manifestation of urologic diseases).
Hematologic Diseases. The NIDDK hematology research program focuses on understanding basic cellular and molecular mechanisms that underlie the production and function of blood cells in health and disease. The program emphasizes translational applications of new insights and knowledge gained from basic research in these areas toward the development of novel or improved approaches for the diagnosis, stratification, and treatment of hematologic diseases. This includes the development of disease biomarkers, gene targeted therapies, or hematopoietic stem cell transplantation for acquired and heritable blood diseases (e.g., hemoglobinopathies, such as sickle cell disease or thalassemia; hemochromatosis, iron overload, porphyrias, amyloidosis, iron deficiency anemia, and cytopenias resulting from bone marrow failure disorders, congenital dyserythropoietic anemias, Schwachman-Diamond syndrome, myelodysplastic syndrome, neutropenias, myelofibrosis, essential thrombocythemia, or polycythemia vera), and the measurement and chelation of tissue iron in iron overload disorders. The NIDDK hematology research program provides resources for basic and preclinical development efforts leading up to IND or IDE submissions but does not fund clinical trials. The program has a particular focus on myeloid lineage and hematopoietic stem cells, including the effects of aging on hematopoiesis.
Drug Discovery and Development
Establishment of robust in vitro or animal models of benign hematologic diseases for drug discovery or development.
Development of therapeutics that target elements of hematopoietic stem cell niches (e.g., stromal cells, osteoblasts, endothelium, macrophages, pericytes, nerve cells).
Development of novel bone marrow conditioning regimens that promote hematopoietic stem cell homing, engraftment, and hematopoiesis.
Development of therapeutics that modulate blood cell production from hematopoietic stem cells and progenitors based upon understanding of physical and chemical regulatory pathways.
Development of therapeutics that modulate metabolism, storage, and transport of iron or heme.
Cell Therapies
Development of equipment, chemically defined reagents, and methods for high volume ex vivo expansion, isolation, and/or differentiation of highly purified human hematopoietic stem and progenitor cells.
Development of equipment, chemically defined reagents, and methods for selective removal or destruction of diseased human hematopoietic stem and progenitor cells (e.g., in myelodysplastic syndrome, MDS). Treatment of malignant clones and blood cancers are not within the scope of the NIDDK Hematology mission.
Development of therapeutics that induce fetal hemoglobin synthesis by chemical means, genome editing, or other means.
Development of therapeutics that target blood cell membrane structure.
Diagnostics and Imaging, Medical Technologies, and Research Tools
Development and validation of sensitive, specific, reproducible, quantitative, and clinically applicable assays for measuring levels or expression of iron regulatory molecules or for measuring misfolded or aggregate amyloid proteins such as amyloid A transthyretin or immunoglobulin light chain in blood.
Development of technologies to track, purify, monitor or assay single-cells in vivo or in vitro.
Development of non-invasive systems for monitoring circulating blood cells, blood chemistry or blood cell production.
Development of imaging technology for the non-invasive measurement of bone marrow cellularity, fibrosis, and function.
Development of imaging technology for the non-invasive measurement of tissue iron loading and distribution.
Development of technologies to understand the roles of mitochondria in non- malignant hematologic diseases.
Development of technologies that use artificial intelligence/machine learning (AI/ML) to integrate disparate data types (e.g., histomorphology, karyotyping, next generation sequencing, immunophenotyping, and flow cytometry) to inform diagnosis of non- malignant hematologic diseases. AI/ML approaches should leverage data from diverse populations and apply equity considerations to ensure resulting models do not further embed structural racism or discrimination.
Development of platforms for pre-analytical preparation, imaging, and automated analysis of the bone marrow.
Development of innovative technologies or platforms to facilitate hematology research training and education, which could include software or simulation tools.
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Exposure Assessment Tools
The NIEHS Exposure Biology and the Exposome Program supports technologies to better understand how a person’s environment contributes to their health. Sensor technologies, computational approaches, improved biomarkers, and biomonitoring capabilities, are needed to measure, analyze, and predict a wide range of internal and external exposures and health outcomes across diverse geographic populations. These tools should be designed fit-for-purpose in collaboration with the stakeholders (e.g., community engagement programs, citizen scientists, disaster response personnel, epidemiologists, or clinical researchers).
Examples include:
Sensors and Other Exposure Assessment Tools
Technologies and methodologies to assess personal exposure to specific or combined air pollutants in population studies, including wearable monitors and sensor networks.
Devices for collecting exposure measurements across multiple stressors and scales, with an emphasis on high sensitivity and specificity and low-cost devices, when feasible. High-priority analytes include contaminants of emerging concern (e.g., perfluorinated compounds, and toxins produced in harmful algal blooms) as well as ultrafine particulates, microplastics, pesticide exposures, and industrial chemicals.
Novel sampling technologies to enable subsequent targeted and untargeted laboratory analysis
Sensor technologies that can be integrated into existing smart devices for sensing personal environment as well as provide chemical speciation data.
Tools and approaches for identifying and characterizing contaminants in drinking water that may pose a risk to human health, with a particular emphasis on new contaminants or compounds that are of emerging concern.
Note that identification of environmental pathogens in drinking water is not within the NIEHS mission.
Computational and Informatics-based Tools and Methods for Exposure Assessment
Informatics tools and platforms to organize, store, retrieve, extract, and integrate data on exposures and health effects.
Application of machine learning methods and natural language processing for extracting and integrating diverse data types and for generating causal networks from experimental data and public knowledgebases
Computational and statistical approaches to integrate exposure data from different sources, including publicly available databases and information from monitoring approaches (e.g., sensors, remote sensing, and biomonitoring), to provide quantitative exposure estimates, identification, and characterization of adverse effects on human health.
Adapting or developing new methods and tools for automating environmental health-related literature and systematic reviews, including article selection and prioritization, data extraction, study quality evaluation, and summarization of for environmental health impacts
Nano Environmental Health and Safety. The NIEHS Nano Environmental Health and Safety (Nano EHS) program is interested in the detection of engineered nanomaterials (ENMs) in the environment, in consumer products, and in biological samples, and is interested in technologies or methods that can predict toxicity potential of ENMs.
High priority engineered nanomaterials of interest are those with a potential for human exposure. Examples include:
Sensors, tools or technologies that can detect metal and carbon-based engineered nanomaterials or micro/nanoplastics in air, water, and consumer products, and provide a contextual assessment of the toxicological potential.
Mid- to high-throughput and high-content assays using in vitro or tissue chip technologies to screen and rank toxicity of emerging engineered nanomaterials for cytotoxicity, genotoxicity, and metabolic or other human relevant toxicity.
Methods and tools to assess leaching of engineered nanomaterials from nanotechnology-based water filtration systems.
Technologies to assess the life cycle of nanomaterials from nano-enabled products in the market
Development of tools and technology platforms for the isolation, quantification, physical and chemical characterization of various forms of micro/nanoplastics from diverse media including biological samples, aqueous sources, air and food samples and assessment of their toxicity potential and human health effects
Toxicity Screening, Testing, and Modeling. NIEHS supports research to identify the hazards, as well as the mechanistic understanding, of the effects of environmental stressors on biological systems that can lead to adverse human health outcomes. To increase the ability to characterize or predict the toxicity and hazard of environmental stressors, the National Toxicology Program (NTP) Home - National Toxicology Program (nih.gov) at NIEHS is interested in technologies to support the goals and initiatives of the Tox21 Program Tox21 (nih.gov).
Technologies that support Tox21 and other NTP goals may include the development and/or application of in vitro physiologically relevant cell-based systems that effectively model responses in humans or animals and may be used to reduce or replace in vivo animal use. High priority areas are the development of metabolically competent in vitro screening models and assay systems for various tissue types (e.g., cardiac, neurological, liver, GI tract, kidney, mammary gland, lung, and immune function) for assessing the effects of the environmental stressors.
Toxicity Screening Approaches
Improved or new approach methodologies (NAMs) including human organotypic culture models (OCM), and microphysiological systems (MPS) that more accurately predict in vivo function for characterizing toxicity and/or related disease processes. Priority areas are improved capability for generating more mature cells from embryonic stem (ES) or induced pluripotent (iPS) cells for organotypic models, integrating multiple MPS together under physiologically relevant conditions, and the ability to conduct in vitro pathology studies using OCM, MPS or 3D culture models.
Organotypic models using cells from rat or mouse models or other experimental animal models, with a focus on comparisons between in vivo and in vitro toxicity endpoints.
Approaches to characterize and integrate key molecular and cellular changes related to effects of toxicant exposures in carcinogenicity, developmental neurotoxicity, cardiotoxicity or immune functions.
In vitro model systems that incorporate barrier functionality and transport functions into tissue models (e.g., kidney, placenta, or blood-brain barrier)
Enhanced lower organism models (e.g., zebrafish or C. elegans) for toxicity screening.
Stem cell models and assays for evaluating the effects of toxicants on cell differentiation with multiple functional endpoints.
Screening systems that incorporate genetic diversity into toxicology testing (e.g., panels of tissue- specific human iPS cells or rodent stem cells)
In vitro systems that focus on responses to mixtures of xenobiotics, chronic exposure studies, or provide insights into the molecular characteristics of multiple chemical-biological interactions and toxicodynamics.
Short-term tests, assays, or systems designed specifically to reduce or replace existing regulatory animal studies for acute toxicity (oral or inhalation), reproductive or developmental toxicity, carcinogenicity, or ocular toxicity.
Cage-based technologies to monitor physiological and behavioral changes in experimental animals in chemical toxicology studies.
Computational Approaches for Predictive Toxicology
New computational systems and tools for integrating toxicity data, including in vivo and in vitro data, to analyze and visualize data across different screening systems and predict chemical hazard/risk.
Computational tools to integrate and visualize transcriptomic and metabolomic data in affected signaling and biochemical pathways.
Improved computational tools for in vitro to in vivo extrapolation of xenobiotic exposures and modeling metabolic transformation of xenobiotics.
Advanced computational approaches (e.g., artificial intelligence/machine learning) to integrate and develop multi-omics classifiers for exposures and pathology image analysis tools for environmentally induced diseases.
Other Technologies Focused on Enhancing Toxicology Testing
Alternative or improved methods for fixing and preserving tissues that maintain cellular structure for histopathology while minimizing degradation of nucleic acids (RNA, miRNA, DNA, methylated DNA), proteins or metabolites, so that archival tissue blocks can be better used for molecular analysis.
Liquid biopsy methods for isolation and novel assays of circulating nucleic acids that reflect environmental chemical exposures or toxicity. These could include exosome-packaged or cell-free nucleic acids altered by environmental exposures.
Alternative or improved methods for extracting high quality RNA, miRNA, DNA, methylated DNA, proteins, or metabolites from existing archived tissues.
Tools and technologies for isolation and characterization of exosome and/or extracellular microvesicles from biological fluids
Biomarkers of Exposure and Response
To better understand the risks to human health from environmental agents, NIEHS supports the development and validation of biomarkers of exposure, including improved measures of internal dose, DNA adduct identification, and untargeted analysis for metabolite identification, and biomarkers of response, including assays that can distinguish reversible from irreversible changes in target organs or surrogate tissues. Examples include:
Biomonitoring Technology
Personal or point-of-care monitoring technologies for rapid detection of multiple exposures in biospecimens using non- or minimally invasive approaches.
Improved methods to detect DNA or protein adducts resulting from exogenous exposures
Exposure assessment methods in novel matrices or small volumes
Biological Response Markers
Markers of oxidative stress, inflammation, DNA damage response, immune function, mitochondrial dysfunction, or altered epigenetic regulation.
High priority human biomarkers include, but are not limited to inflammation biomarkers, plasma- or serum-based markers that reflect altered RNA, protein expression, or metabolite profiles, markers developed in exhaled breath, buccal cells, or other easily accessible, non-invasive biological samples, miRNA or other exosome biomarkers, and epigenetic markers in surrogate tissue reflecting modifications in target tissues
Intervention Technologies. NIEHS supports efforts to prevent or reduce exposures to environmental chemical stressors that affect human health. Technologies to reduce exposure may include:
Technologies for detecting and/or removing contaminants from drinking water, primarily for home use.
Approaches for use in the home, workplace, and school settings for reducing volatile compounds and other inhaled toxicants. Examples may include improved air filtration systems as well as technologies to monitor the efficacy of filtration systems.
Technologies and applications that can provide real-time alerts about relevant environmental exposure levels for sensitive populations (such as asthmatic populations)
Education and Participatory Science
As part of its Partnerships for Environmental Public Health (PEPH) Program, NIEHS is interested in developing tools that build capacity, improve environmental health literacy, and support participatory science endeavors. These approaches or resources should be fit for purpose to meet the needs of the following audiences: community members, health care and public health professionals, educators, and students of all ages. Approaches may include:
Mobile applications that provide environmental health information about exposures of concern in food, air, drinking water, or consumer products. These may include
Interactive apps that provide the context and risks of exposures such as single or multiple, interacting exposures, level of exposure, frequency and proximity to source and health risks
Apps that can be adapted for various age groups, races, ethnicities and/or languages
Devices for collecting and reporting information on exposures in environmental samples for educational purposes in schools or communities.
Systems that can utilize public and voluntary population data from sensors, activity trackers, GIS enabled devices, social communications, and surveillance cameras; for example, to assist disaster response and communication.
Educational resources and tools related to environmental health in school settings or community education programs.
Training materials for wider dissemination of risk information (e.g., resources for high school students or community leaders to build capacity of other community residents)
Exposure and Response to Vaping and Electronic Nicotine Delivery Systems (ENDS)
NIEHS is interested in technologies to assess exposure to aerosols from e-cigarettes and other vaping devices, including analyses of the chemical constituents in these aerosols. In addition, approaches to test the toxicity and biological responses to ENDS aerosol constituents are of interest.
Disaster Response
NIEHS is interested in sensors and informatics tools that can be rapidly deployed after disasters, including extreme weather events or climate change-related events. These tools can be used by researchers to follow emergency response workers and individuals in the community to help understand dermal, water and/or airborne exposure levels, locations, and times.
Environmental sensors that can be rapidly deployed during or after a disaster to track exposures.
Informatic tools to rapidly build environmental health disaster research protocols similar to the NIEHS RAPIDD Protocol Disaster Research Response (DR2) Program (nih.gov) from existing information, tools, and platforms (e.g., PhenX, PROMIS, and Disaster Research Response DR2 Repository) to support rapid research response efforts
Data management tools for disaster response that enable rapid collation and integration of data from stationary sources and personal exposure monitors and survey information collected from individuals.
Mobile devices and applications for collecting information on environmental exposures from study participants involved in disaster research responses.
Hazardous Substances Remediation and Site Characterization SBIR Program
The NIEHS Superfund Research Program (SRP) "Hazardous Substances Remediation and Detection Program" supports Small Business Innovation Research Grants (SBIR R43, R44) to foster the commercialization of novel, cost-competitive technologies, products, and devices for remediation and detection of hazardous substances in the environment. The SRP is specifically interested in proposals applying new engineering, materials science, and biotechnology approaches. In addition, applicants are encouraged to develop sustainable strategies such as offering low carbon footprint, reduced energy consumption, utilization of renewable energy sources, resilient to weather extremes, and with reuse / regeneration capabilities.
Remediation
Novel technologies for in situ remediation of contaminated sediments, soils, and groundwater with testing/modeling to optimize product for long-term stability
Innovative bioremediation technologies including development and culturing/propagation of novel plants, bacterial strains, or fungal species for implementing bioremediation
Technologies to remediate chemical mixtures in environmental media
New strategies for delivery of reagents/amendments for groundwater remediation and/or recovery/extraction of contaminants in groundwater
New amendments to stabilize contaminants and/or to use in caps for soil and sediment remediation
New technologies and strategies to cleanup large complex sites with multiple sources
Resilient novel remediation approaches capable of withstanding climate change-related impacts such as: fire, flooding groundwater level fluctuation, land use changes, and other catastrophic events
Sustainable, energy efficient approaches with a net lifecycle benefit such as net zero emission technologies; technologies that reduce waste generation; processes that recycle/reuse/regenerate active components; long-term remediation approaches equipped with solar or wind energy
Detection Technologies
Machine learning, computational, geographical information system-based, or modeling products for predicting fate and transport of contaminants, rates of remediation, bioavailability, or for identifying contamination sources
Real-time, field deployable, on-site analysis: soil, surface water, groundwater, subsurface, sediments, air (such as volatile releases from sites), including
rapid, portable monitoring and screening of contaminants
multi-analyte sampling
remote monitoring/data capture/data processing capabilities such as time-integrated and/or repeated measures
Accurate and reliable new passive sampler devices
Products that allow for rapid sample clean-up/preparation for analysis of environmental samples and/or technologies for rapid extraction or processing of soil for incremental sampling methodologies (ISM)
Non-targeted or multi-analyte field sampling devices or kits, including sample collection products that can sequester a suite of analytes for later analysis
Novel techniques, sensors, and field analytical methods and real-time mapping/data visualization for development of subsurface conceptual site models
Innovative tracer technologies for tracking contaminant migration/pathways
Examples of remediation and detection technology needs:
Vapor Intrusion: Improved technologies for predicting/anticipating time-periods for occurrence of reasonable maximum indoor exposure(s) in impacted buildings, during which sampling is recommended.
PFAS: Soil, sediment, and groundwater remediation technologies for mixtures and degradation byproducts of per- and polyfluoroalkyl substances (PFAS); including technologies for complete PFAS destruction; sustainable solutions with low energy input and/or minimal secondary waste generation;
and/or PFAS removal technologies for heterogenous water chemistries; rapid sensors to aid in site monitoring and/or prioritizing site sampling protocols.
Novel, sustainable, nontoxic chemistries or processes to aid regeneration, reuse, and/or reactivation of spent treatment residues (e.g., from granular activated carbon).
Development of adsorption and concentration materials to reduce the volume of material to be treated and/or to further concentrate the waste stream generated from standard treatment technologies (e.g., granular activated carbon, reverse osmosis) as part of a “treatment train”.
Development of polishing treatments tailored for specific PFAS (e.g., shorter chain, emerging PFAS replacements).
Development of novel catalysts or other additives to lower needed temperature for complete thermal destruction.
Development of novel air pollution control technologies as a polishing step to reduce emissions from PFAS management or treatment facilities (e.g., thermal destruction, air sparging, Supercritical water oxidation (SCWO), hazardous waste landfill facilities, etc.).
Development of novel materials or processes for solid waste and/or biosolids treatment and/or stabilization.
Mining: Active or passive remediation technologies for mining influenced water; technologies to mitigate effects from acid drainage; portable neutralization treatment systems; strategies to target remediation of sources such as mining waste piles; and separation technologies that remove elements or compounds of concern from water and/or reclaim potentially valuable critical elements dissolved in contaminated fluids
Complex Site/Geology:
Site characterization techniques and strategies for complex geology (fractured bedrock, karst, and heterogeneous layered deposits) including understanding the fate of contaminants within rock matrices and properties that affect back diffusion
Improved technologies for treating low permeability and heterogeneous lithology, including amendment delivery methods
Devices to detect and measure non-aqueous phase liquids (NAPLs) in the subsurface
In-well real-time and/or continuous monitoring tools to assess the efficacy of remediation; presence/absence of key factors required for remediation (e.g., biological, geological, chemical); and/or to identify rebound events
Robotic sampling for highly contaminated / remote sites
Disaster Response: Technologies for measuring/treating environmental contamination as part of a disaster response effort
Worker Training Program
The major objective of the NIEHS Worker Training Program (WTP) is to prevent work related harm by training workers in how best to protect themselves and their communities from exposure to hazardous materials. The NIEHS WTP is interested in the development of e-Learning Technology- Enhanced Training Products from a variety of delivery methods to assist both students and instructors in the training and education process. These Technology-Enhanced Training Products are for the health and safety training of hazardous materials (HAZMAT) workers; waste treatment personnel; skilled support personnel associated with an emergency/disaster; emergency responders in biological hazard response, infectious disease response and medical waste cleanup; emergency responders in disasters; and worker resiliency training. Technology-Enhanced Training Products as defined by the WTP includes, but are not limited to, online training, mobile device training, augmented reality (AR), virtual reality (VR), and serious gaming. These advanced technologies complement all aspects of training that can enhance, supplement, improve, and provide health and safety training for hazardous materials workers. WTP accepts solicitations via requests for applications (RFA). Please contact Kathy Ahlmark (ahlmark@niehs.nih.gov) for information on the next solicitation date, which differs from the standard receipt dates of this NIH omnibus.
Information on the WTP program can be found at About the Worker Training Program (WTP) - Training for Workers in Hazardous Environments (nih.gov)
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General Research and Development Topics: NEI is interested in providing support for the development of new technologies, strategies, research tools, reagents and methods that can be applied to basic and translational research which will benefit vision health. This encompasses research and development of innovative enabling technologies in areas of genomics, proteomics and nanotechnology. More specific topics include drug and high throughput assays; drug delivery systems; gene therapy, cell-based therapy and regenerative medicine; development of in vitro and in vivo disease models; surgical devices and materials; telemedicine, mobile health, and health education; and design/fabrication of new or improved ophthalmic instruments for diagnosis and treatment of eye disorders.
Retinal Diseases: New therapeutic approaches for inflammatory and degenerative diseases and for inhibition of abnormal angiogenesis in the retina and choroid; Better methods of diagnosing and treating diabetic retinopathy and other vascular diseases; Non-invasive techniques for early diagnosis of macular degeneration and other retinal degenerative diseases; Instruments and procedures for improved surgical management of retinal detachments; Retinal prostheses to help restore visual function; Gene therapy/optogenetic methods for light sensitivity restoration in the retina; Better methods for cell or tissue transplantation; New animal models/systems that better mimic human retinal disease.
Corneal Diseases: New diagnostic tools, therapeutic agents and drug delivery methods for the treatment of corneal injury, infection, dry eye, ocular pain, and other ocular surface disorders; New biomaterials for corneal prostheses and corneal transplants; Instruments and procedures for correcting the refractive power of the cornea and/or measuring the cornea's optical properties or other physiological properties.
Lens and Cataract: New approaches in the post-operative management of cataract surgery; New surgical instruments for cataract extraction and new biomaterials for replacement of the natural lens; Design/fabrication of aspheric, toric, multifocal and accommodating intraocular lenses.
Glaucoma and Optic Neuropathies: New therapeutic agents, instruments, and procedures for the diagnosis and treatment of glaucoma; Non-invasive methods to measure changes in the optic nerve head and retinal fiber layer.
Strabismus, Amblyopia, and Refractive Error: New approaches to detect and treat strabismus, amblyopia, and myopia; New tools and techniques for vision screening; New or improved methods and materials for correcting the refractive power of the eye and/or measuring the eye's optical properties or other physiological properties; New materials and manufacturing processes for eyeglasses and contact lenses; prosthetic devices (both cortical and subcortical) for vision restoration.
Visual Impairment and Blindness: Instruments and methods to better specify, measure, and categorize residual visual function; New or improved devices, systems, or programs that meet the rehabilitative, adaptive, and everyday living needs of visually impaired/blind people.
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Biophysics, Biomedical Technology, and Computational Biosciences.
Bioinformatics and Computational Biology Branch
Health Informatics. Development of computational and informatics tools and methods for data privacy, harmonization, integration and analysis using electronic health records and other biomedical data aimed at elucidating biological function, ontology development, or developing models of biological and biochemical processes. Areas of interest include population pharmacokinetics, pharmacovigilance, drug discovery and drug repurposing.
Bioinformatics. Development of algorithms and computational tools for collecting, managing, analyzing, visualizing, and interpreting complex biomedical data; or using data science methods and tools to extract and discover new knowledge about biological systems. The scope of studies includes the development of computational algorithms to analyze data from nucleic acid sequencing, proteomics, metabolomics, and multi-omics, and development of methods for large scale data management including data curation, standardization, and ontology.
Biostatistics. Development of advanced statistical techniques and methodologies for study design, data analysis and interpretation. The scope of studies ranges from those focused-on sequencing, -omics, bioimaging, high-through-put technologies in molecular and cellular biology data, pharmacology, and populational studies.
Software and Tools. Algorithm design and software development for bioinformatics research. The scope of studies includes software and tools development to facilitate biological data analysis, interpretation, and visualization to address research questions in basic biology. Areas of interest include software to analyze cellular processes and interactions and software engineering for ontology and data structure.
Multi-scale Modeling. Development of new computational algorithms and mathematical methods for integrative understanding of biological systems that may span temporal and spatial domains. The system scale ranges from subcellular to cellular to tissue, organ, organoids/3D cultures, and organismic systems. Topics include cellular regulatory processes such as gene expression and metabolism, cellular architecture and intracellular dynamics, cell communication and motility, cell division and differentiation, tissue formation, organogenesis, and tissue and organ functions.
Infectious Disease Modeling. Development of computational modeling for understanding population dynamics related to the interaction of organisms with their physical environment and between species. In this context, infectious disease models are used to understand the spread of parasites, viruses, and infectious diseases.
Biomedical Technology
Technologies for Structural Biology. Development of new or improved instruments, methods, and related software to elucidate 3D structures of macromolecules and macromolecular complexes. Relevant technologies cover areas of sample handling; X-ray diffraction and other X-ray techniques; magnetic resonance techniques such as NMR, EPR, and ESR; microscopic techniques that resolve at the molecular level such as single particle cryo-electron microscopy, micro electron diffraction (micro-ED) and tomography (cryo-ET); computational tools for data collection, processing, interpretation, curation, and mining.
Bioanalytical Technologies. Development of new or improved techniques, instruments, tools, or methods for quantitative analyses of biomolecules such as proteins, carbohydrates, lipids, nucleic acids, metabolites, and complexes. Technologies and methods development areas include mass spectrometry; magnetic resonance technologies; surface plasmon resonance; optical and vibrational spectroscopy; sample handling and separations; labeling methods; microfluidics, flow-based systems; high-throughput techniques; biosensors and electrochemical tools; and associated computational tools for data mining, analysis, interpretations, -omics, and simulation of molecular dynamics.
Technologies for Microscopy and Imaging. Development of new or improved laboratory/experimental techniques, instruments, or supporting software that measure the location and dynamics of molecules in situ, and organelles, cells, or tissues on the nanometer and micrometer length scales. These include instrument design; development of integrative multiscale or multimodal approaches for measuring cell structure and function; new illumination/excitation sources and detectors of heat, sound, light, electrons, and X-rays; imaging modes of spectroscopy; development of particles, physiochemical or mechanical probes; computational approaches to image formation including super-resolution microscopy and tomography; image analysis and processing algorithms of image sets for data interpretation, curation, mining, and visualization; development of sample preparations and modifications for imaging; probes, molecular reporters and fluorescent indicators for structural or functional imaging or microscopy/nanoscopy.
Technologies for Investigating and Manipulating Cells. Development of new or improved tools and methods that directly manipulate or investigate the properties of cells and their environment. These include the development of methods for the design and delivery of molecules and nanoparticles into cells or transport between cellular compartments, such as electroporation, co-transporters, or partitioning; tools for cell engineering or direct measurement of cell function; development of biological, chemical, or physical assays for measuring the function of macromolecular complexes within the cellular milieu, the behavior of organelles, or for characterizing cell phenotype.
Biophysics
Molecular Modeling, Theory, and Design. Includes theoretical, computational, and physics-based studies of the fundamental behaviors of atoms to molecules and their interactions, including predominantly theoretical and computational studies in the following areas: quantum mechanical and molecular dynamics simulations; thermodynamics and statistical mechanics; basic principles of molecular recognition; development and validation of force fields and scoring functions; and algorithms for prediction of molecular properties; macromolecule-ligand binding predictions by docking and other in silico screening methods applicable to drug design; predictions of protein and other macromolecular structures; and studies in macromolecular design, protein folding, RNA folding, macromolecular dynamics, molecular interactions, membrane and membrane protein simulations, phase separation, aggregation, and complex formation.
Biophysics of Proteins – Folding, Interactions, Structure/Dynamics, Mechanisms. Biophysical studies of all aspects of protein structure and function in which the goal is to elucidate general principles, including establishing the physical and thermodynamic basis for native structure; protein-protein interactions; protein-ligand recognition; folding mechanisms and kinetics; and protein de novo design and engineering. Experimental studies of intrinsically disordered proteins; folding upon binding, protein aggregation, and phase separations. Included are studies of structural dynamics in protein function and allosteric control. Experimental methods may include confirmatory in vivo studies and/or established computational methods.
Biophysics of Nucleic Acids and Nucleoprotein Complexes. Research involving the application of physical principles to the study of nucleic acids and protein-nucleic acid complexes. Areas of research include physical and chemical studies on the structure of nucleic acids and protein-nucleic acid complexes; analysis of protein–nucleic-acid interactions and assembly mechanisms; ligand-nucleic acid interactions; development of physical, chemical, and theoretical/computational techniques for the analysis of nucleic acids and their complexes.
Biophysics of Membranes and Membrane Proteins. General principles of membrane structure and function, including the behavior of lipids, bilayers, and other lipid phases; membrane protein structure and function, including folding, assembly, dynamics, and general mechanisms of action, conformational changes, and energy coupling; membrane protein-lipid interactions, effects of lipid compositions and phase separated domains; physical studies of fusion, fission, and deformation processes; as studied through the application of primarily biophysical methods and approaches.
Biophysical Studies of Supramolecular Complexes. Research on the mechanisms of assembly, structure, and function of cellular ultra-structures larger than a few million Daltons and dependent on high levels of molecular organization. These include large cellular machines such as the ribosome, spliceosome, cytoskeletal structures, interactions between intracellular and extracellular matrix components, signaling networks that depend on large-scale interactions when studied primarily by multiple methods and/or by methods that are not routine, such as single particle cryo-electron microscopy, cryo-electron tomography, scanning probe microscopy, and other force transduction methods.
Biophysical Studies of the Viral Life Cycle. Research involving the application of physical principles to the study of viral attachment, fusion/penetration, uncoating, assembly, and budding/release. Areas of research include analysis of virus-host interactions; phage and viral packaging; the structure and mechanism of assemblies from viral and host components; and determining factors and energetics that regulate protein-nucleic acid interactions necessary for virion entry, packaging, maturation, and release.
Pharmacology, Physiology, and Biological Chemistry
Physiology and Clinical Sciences
Anesthesia and Perioperative Pain. Basic, translational, and clinical research in anesthesiology, as well as studies of pain in the perioperative period. This may include studies focusing on: molecular pharmacology and mechanisms of action of local and general anesthetics; pharmacokinetics and pharmacodynamics of anesthetics; pharmacological effects of anesthetics on tissue, organ, and organ systems; mechanisms of adverse action and toxicity of anesthetics; underpinnings of anesthesia-induced unconsciousness and emergence from anesthesia; malignant hyperthermia as it relates to anesthesia; or mechanisms involved in acute pain or the transition to chronic pain following surgery, and resolution of postoperative pain.
Drug Metabolism, Transport, and Kinetics. Research on generalizable principles of pharmacokinetics (PK), pharmacodynamics (PD), and pharmacogenomics (PG), as well as drug-drug, drug-nutrient, drug-microbiome interactions and consequent adverse effects. Areas of interest include drug metabolizing enzymes, drug transporters (excluding nutrient and neurotransmitter transporters), the role of the gut microbiota in drug metabolism, studies to examine the impact of genetic variability on drug response, large-scale evaluation of information on drug pathways from studies using biobanks and electronic health records, and studies on developing and employing optimal technologies and tools (e.g., biomarkers, research organisms, and 3D tissue models) for PK/PD/PG studies. Studies may include approaches to understand population pharmacogenetics, pharmacogenomics, physiologically based pharmacokinetic (PBPK) studies, and drug toxicity. NOTE: When the research is focused on a specific organ or organ system, disease or condition, it will likely fall within the mission of the appropriate categorical institute.
Injury and Critical Illness. Research on total body responses to injury (traumatic, thermal, or surgical) and shock from post-injury period to acute phase through long-term effects, until recovery or mortality. Studies on host response to injury and shock may include research on mechanisms of pathophysiological systemic responses (e.g., altered immune response, hypermetabolism, endotheliopathy/coagulopathy) or research on complications seen in critical care medicine (e.g., systemic inflammatory response syndrome, multiple organ dysfunction syndrome mechanisms and others). NOTE: Studies focused on specific organs or conditions, such as traumatic brain injury, pathogenic infections, skin grafts, etc., are outside NIGMS mission and should be directed to the institutes covering those mission areas.
Multi-organ Physiology. Research on systemic biological responses to challenges spanning multiple organ systems, including the physiological consequences of circadian rhythms and stress, as related to human health. This may include research on the physiology of integration of total body responses or interdisciplinary studies aimed at elucidating the complex interactions between circadian rhythms, metabolism, immune function, and physiological processes across multiple organ systems. NOTE: Studies of pathophysiology of sleep and circadian rhythm disorders are outside the NIGMS mission, as are studies focusing on physiology of specific organs or organ systems within the missions of other institutes.
Drug Delivery Systems. Research on delivery systems and novel strategies designed to improve permeability, absorption, stability, bioavailability, biodistribution and pharmacokinetics of small molecules and biologics. These can include antibodies, aptamers, extracellular vesicles, nanoparticle systems (e.g., lipid nanoparticles, solid lipid nanoparticles, liposomes, dendrimers, micelles, nanospheres, silica particles), nucleic acids, proteins and peptides, viruses, chemical cages, novel materials, polymeric particles and implants, and platforms/devices with an emphasis on drug targeting, release and pharmacokinetics. May also include studies on understanding and manipulating the transport of therapeutic agents across biological barriers, routes of administration to improve drug delivery, engineering approaches to enhance drug and gene delivery, and development of next-generation drug delivery systems to improve the efficacy and specificity of treatments by leveraging advanced materials and nanotechnology. NOTE: Studies aimed at efficacy for specific diseases (including but not limited to pre-clinical models), or those focused on obtaining regulatory approval, will not be accepted and should be discussed with the institutes focused on those missions.
Sepsis and Septic Shock. Basic and clinical studies focused on sepsis and septic shock, with an emphasis on the host response. This includes studies on unraveling the complex pathophysiology and heterogeneity of sepsis, identifying novel biomarkers for early diagnosis and patient stratification, and developing strategies for translating this knowledge into improved diagnostics and therapies for sepsis patients. Preclinical studies relying on murine models of sepsis are unlikely to be supported by NIGMS; for more details on NIGMS priorities for sepsis research, please see NOT-GM-19-054.
Systemic Immune/Inflammatory Responses. Research aimed at improving understanding the mechanisms governing innate immune responses and host-pathogen dynamics. This includes studies elucidating the complex networks and pathways that underpin innate immunity and acute inflammation, with implications for developing novel therapeutic strategies against infectious diseases, inflammation, and immune dysregulation. Examples of studies in this portfolio include cellular and molecular mediators of inflammation and immunity underlying complex body-wide pathophysiological responses, examination of the host defense mechanisms in model organisms (such as plants, C. elegans, and fruit flies), in vitro studies of host defense using cutting-edge technologies, host defense mechanisms in the context of multi-organ interactions or evolution, and novel non-organ-specific host defense pathways. NOTE: Studies focusing on the pathogenicity of microorganisms, antibiotic resistance, adaptive immunity or its mechanisms in allergic or autoimmune diseases, or of immune cells related to immune-related conditions will, in most cases, be more appropriate for NIAID.
Wound Healing. Basic mechanistic, translational, and clinical studies addressing physiology, biochemistry, and immunology of wound healing after injury (traumatic, burn, and surgical). This includes: research directed toward an improved understanding of the fundamental processes underlying normal, excessive or impaired wound healing, tissue repair and regeneration; studies aimed at understanding phases and signaling pathways that regulate the wound healing process; and how dysregulation of these processes impacts injury-related wound healing. Research focusing on healing of wounds associated with specific conditions (e.g., diabetic chronic wounds, keloids, fibrosis, mouth ulcers) should be directed to the appropriate categorical institute.
Biochemistry and Molecular Pharmacology
Bioenergetics and Mitochondria. Energy transducing enzymes of the mitochondrial inner and outer membranes, chloroplasts, and microorganisms; electron transport, photosynthesis, including biogenesis of cofactors and substrate transport.
Calcium Signaling and Compartmentalization. Temporal and spatial signaling within cells, including calcium fluxes, diffusion, and pumps; regulation of signaling molecules by compartmentalization within organelles, and cellular sinks and releasing proteins.
Cell Surface Receptors, Ligands, and Interactions. G protein-coupled receptors and cell surface receptors for drugs, endogenous ligands, and other stimuli; purpose is to understand basic biology and/or for validation as potential therapeutic targets.
Enzyme Mechanisms, Regulation, and Inhibition. Individual enzyme mechanisms, regulation, modification, and inhibition to understand the catalytic specificity of synthesis, modification, or degradation of metabolites and macromolecules.
Intracellular Mediators of Signal Transduction. Molecular pathways for signal transduction and regulation within cells, including second messengers such as kinases, phosphatases, adapter proteins, lipid messengers, phospholipases and others (excluding calcium). Includes intracellular nuclear and cytosolic receptors.
Membrane Channels. Pore-forming proteins specialized for ions (Na, K, Cl), ligand and voltage-gated, found at cell surface and organelle membranes. Includes ion channel blockers such as venoms and toxins.
Membrane Components and Cell-to-Cell Communications. Scaffolding and functional components of cellular membranes and vesicles: structural lipids (e.g., cholesterol), integral proteins, and their modifications. Gap junctions and communications between cells.
Metalloprotein Mechanisms. Functions and mechanisms of metalloenzymes, including natural and synthetic macromolecules that form transition metal-utilizing proteins and transporters.
Pathways of Intermediary Metabolism and Catalysis. Metabolic pathways and information flow; includes studies of transient intermediates and stable multi-enzyme complexes, and how catalytic processes and fluxes are affected by the intracellular milieu.
Redox Reactions and Oxidative Stress. Pathways responsible for generation or decomposition of reactive species (O, N, S), and the modification of cellular constituents by oxidative stressors; chemistry and maintenance of cellular redox balance.
Trace Metal Transport and Homeostasis. Regulation of trace metal ions (e.g., Fe, Co, Ni, Cu, Zn, As, Se, Mo, W), their transport, intracellular concentrations and speciation, and metal ion chaperones and ionopheres. Includes restriction of metal ion availability as a therapeutic intervention.
Chemistry and Chemical Biology
Bioinorganic Chemistry. Research focused on understanding and manipulating the roles of metal ions in biological processes by investigating their complex interactions with biological systems. Approaches that leverage a multidisciplinary approach, combining cutting-edge techniques in synthetic chemistry, spectroscopy, and molecular biology to create and study novel metal complexes and their interactions with enzymes and other biological molecules essential to life.
Chemical Biology. Technology development for basic biomedical research, including engineering tools and materials for applications at the molecular level. Using chemical methods to produce tools to study or manipulate biology. Development of chemical tools, such as probes, polymers, and nanostructured assemblies for potential use in biological systems and medical applications.
Chemical Catalysis. Development of catalytic reactions, including transition metal catalysis, organocatalysis, photochemical and electrochemical reactions.
Chemical Synthetic Methods. Development of reagents and new synthetic methods. Includes theoretical studies of reaction mechanisms and computational approaches.
Design and Synthesis of Chemical Probes. Design, synthesis, and testing of novel small molecule probes that target specific biological entities and pathways intended for the study of biological function. Includes development and approaches with docking libraries and screens. Research aimed at an organ or organ system, or the pathophysiology or treatment of an identified disease, will in most cases be more appropriate for another institute.
Glycochemistry. Design and synthesis of carbohydrate structures and their production through chemical synthesis or chemoenzymatic synthesis. This includes the development of sophisticated glycochemical techniques (design and assembly of sugars and their analogs) that expand current methodologies for the synthesis, analysis, and utilization of complex carbohydrates, driving forward both fundamental science and translational research opportunities.
Glycosciences. Carbohydrate-containing macromolecules with an emphasis on carbohydrates and their binding partner(s). Includes sugar transporters and carrier lipids, glycan processing enzymes, protein: glycan mediated interactions, and peptidoglycans.
Natural Products Discovery and Analysis. Identification and study of substances produced by living organisms that may form the foundation for therapeutic development. Analysis of organisms and their environments through the study of genetic information and biosynthetic pathways. Includes molecules produced and altered in microbial communities. Studies focused on human microbiome metabolites and their associated disease pathogenesis may be more appropriate for other NIH Institutes or Centers.
Peptide Chemistry and Engineering. Advancements in peptide research from the synthesis of novel scaffolds for enhanced stability and function to the use of peptides as chemical biology tools for studying enzyme functions and cellular processes. This also includes innovative methods in peptide synthesis, improved strategies for overcoming cellular barriers, and new therapeutic strategies.
Synthetic Biology. Engineering technologies to produce useful biological materials. Uses biological methods to produce tools to study or manipulate biology. Mixture of physical and genetic engineering to create new biological entities and systems, or redesign of naturally occurring systems.
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Cardiovascular Sciences. The Division of Cardiovascular Sciences (DCVS) supports basic, clinical, population, and health services research on the causes, prevention, and treatment of cardiovascular diseases. The research programs of the Division encompass investigator-initiated research, Institute-initiated research in targeted areas of research need and scientific opportunity, specialized centers of research focused on selected research topics, and clinical trials. Research supported by the Division is concerned with the etiology, pathogenesis, prevention, diagnosis, and treatment of coronary artery disease and atherothrombosis; pediatric and structural heart disease; heart failure and arrhythmias; and hypertension and vascular diseases. DCVS also supports investigations into the development and use of medical devices, imaging devices, software programs, AI/ML technologies, molecular technologies and other tools to improve cardiovascular health. A broad array of epidemiological studies is supported by the DCVS to describe disease and risk factor patterns in populations and to identify risk factors for disease. Also supported are clinical trials of interventions to prevent and treat disease; studies of genetic, behavioral, sociocultural, and environmental influences on disease risk and outcomes; and studies of the application of prevention and treatment strategies to determine how to improve clinical care and public health. If you would like to learn more about the scientific areas covered by the DCVS and connect with a program officer, please visit the division website: Division of Cardiovascular Sciences | NHLBI, NIH.
Lung Diseases. The Division of Lung Diseases (DLD) supports research on the causes, diagnosis, management, prevention, and treatment of lung diseases and sleep disorders. Research is funded through investigator- initiated and Institute-initiated grant and contract programs in areas including asthma, bronchopulmonary dysplasia, chronic obstructive pulmonary disease, cystic fibrosis, respiratory neurobiology, critical care and acute lung injury, developmental biology, pediatric and neonatal pulmonary diseases and care, immunologic and fibrotic pulmonary disease, rare lung disorders, pulmonary vascular disease, and pulmonary complications of AIDS and tuberculosis. Also supported are mechanistic and non-mechanistic clinical trials to predict, prevent and treat pulmonary disease; digital health including mobile / tele-health, wearable devices, respiratory surgical devices, aerosol drug or gas delivery, supplemental oxygen, bioinformatics, mechanical ventilation, imaging devices, personalized medicine and AI/ML to help inform clinical decision making in pulmonary medicine. If you would like to learn more about the scientific areas covered by the DLD and connect with a program officer, please visit the division website: Division of Lung Diseases | NHLBI, NIH.
Sleep and Circadian Biology. The National Center for Sleep Disorders Research (NCSDR) supports research on the causes, prevention, and treatment of sleep disorders and the promotion of sleep health. Research is funded through investigator- initiated and Institute-initiated, grant, and contract programs in sleep and circadian biology research projects. The NCSDR is interested in funding projects related to the regulation of sleep and sleep disorders including circadian disorders, insomnia and obstructive sleep apnea. The NCSDR is also interested in research focused on the development of tools, devices and data science approaches for the early prediction, detection, and treatment of sleep deficiency and sleep and circadian disorders. If you would like to learn more about the scientific areas covered by the NCSDR and connect with a program officer, please visit the website: National Center on Sleep Disorders Research | NHLBI, NIH.
Blood Diseases and Resources. The Division of Blood Diseases and Resources (DBDR) supports research on the causes, prevention, and treatment of nonmalignant blood diseases, including anemias, sickle cell disease, hemophilia and thalassemia; premalignant processes such as myelodysplasia and myeloproliferative disorders; and other abnormalities of hemostasis and thrombosis; and immune dysfunction. Research supported by the Division encompasses a broad spectrum of topics ranging from basic biology and mechanism of action, to medical management of blood diseases. The Division has a major responsibility for research to improve the adequacy and safety of the nation's blood supply. It also plays a leading role in transfusion medicine and blood banking, including research to evaluate blood donation screening, manufacturing, processing technologies and storage. The Division also has a major responsibility supporting research in hematopoiesis and stem cell biology and disease. It also supports hematopoietic stem cell transplantation research and the application of stem cell biology findings to the development of new cell-based therapies to repair and regenerate human tissues and organs. If you would like to learn more about the scientific areas covered by the DBDR and connect with a program officer, please visit the division website: Division of Blood Diseases and Resources | NHLBI, NIH.
Center for Translation Research and Implementation Science. The Center for Translation Research and Implementation Science (CTRIS) plans, fosters, and supports an integrated and coordinated program of research to understand the multi-level processes and factors that are associated with successful integration of evidence-based interventions within specific clinical and public health settings such as worksites, communities, and schools; identifies and makes readily available to implementation and dissemination practitioners emergent knowledge about the late phases of translation research, especially the "T4" phase, for rapid and sustained adoption of effective interventions in real world settings; leads the NHLBI effort in the rigorous, systematic evidentiary reviews and subsequent NHLBI participation in the collaborative model for clinical practice guidelines development; supports training and career development of personnel in "T4" translation research and health inequities relating to heart, lung, and blood diseases; provides a focal point for advice and guidance on matters pertaining to minority health, health inequities and minority participation in research; represents the NHLBI to other governments, other Federal Departments and agencies, international organizations, and the private sector on global health issues; and provides data analytics and portfolio analysis to evaluate and inform future directions of implementation research programs. If you would like to learn more about the scientific areas covered by the CTRIS and connect with a program officer, please visit the division website: Center for Translation Research and Implementation Science | NHLBI, NIH.
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Technology and Methods Development. Technology development in DNA sequencing, genotyping, and single-cell analysis are examples of activities that have changed the nature of what scientific research questions are practical to address, have enabled new approaches, and have facilitated the development of new community resource data sets. Many areas of critical importance to the realization of the genomics-based vision for biomedical research require continued technological and methodological developments before pilots and then large-scale approaches can be attempted. Accordingly, the NHGRI will continue to support the development of new, fundamental technologies in all areas of genomics. Important areas in which technology development applications would be responsive include (but are not limited to) experimental technologies and computational methods to analyze gene expression and other molecular phenotypes; discovery and characterization of genetic variation; identification of the genetic contributions to health, disease, and drug response; statistical analytic methods for understanding human genomic variation and its relationship to health and disease; and chemical genomics. There is also continued need to support technology development for the comprehensive discovery of functional elements in the human and model organism genomes and new nucleic acid sequencing technology. Many of these assays would benefit from the ability to work with very small amounts of starting material down to the level of single cells and subcellular compartments, along with minimally invasive human specimens that are easy to collect, handle, and store. As these technologies mature, emphasis should be on high throughput, cost-effective methods that consistently produce very high- quality data.
The Institute also places high priority on contributing selectively to the development of new and needed technology in related areas, such as proteomics and systems biology research, when NHGRI funding can be used to further a truly unique development that will have a significant impact on the field.
Further information on opportunities related to technology and methods development is available on the NHGRI Genome Technology Program website.
Bioinformatics, Computational Genomics, and Data Science. The ongoing development of new sequencing technologies has dramatically increased the amount of data produced for genomics in basic science and translation to medicine. NHGRI encourages new computational approaches for the analysis, visualization, and integration of genomic information in basic and clinical research and in applications to improve its utility in healthcare. These approaches may include the development of methods for processing, annotating, interpreting, analyzing, and sharing of sequencing data with associated phenotypes and other large-scale genomic data sets such as haplotype maps, genetic variants, transcriptome measurements, functional elements, and, in some cases, protein interactions. New tools for population-based analysis using the pangenome reference are of interest. NHGRI also encourages the development of better computational solutions for storage, access, compression, secure sharing, privacy, and transfer of large genomic datasets by biomedical researchers.
NHGRI will support projects to improve informatics tools to make them more easily adopted by any biomedical research laboratory that wishes to use genomic technologies to address biomedical questions. This may include making them more efficient, reliable, robust, well- documented, and well- supported, or deploying them in containers or at scale in a cloud-based platform.
Where possible, existing or emerging community data standards, models, and methods for data representation and exchange should be used in the development of these new methods and tools as well as other approaches to enhance reproducibility. Standards-based approaches such as GA4GH are also encouraged to integrate and share genomics and phenotype data for data mining with other sources including for clinical application. Projects that will make genomic digital objects Findable, Accessible, Interoperable, Reusable (FAIR) in the broader community are highly recommended.
Further information on programs related to NHGRI supported research in these areas is available on the Computational Genomics and Data Science Program website.
Population Genomics and Genomic Medicine. Advances in the understanding of genomic variation across human populations and the functional consequences of variants independently, in combination, and in different environmental contexts have significantly impacted how genomic information can be used in both public health and clinical practice settings, alternatively known as genomic medicine. An existing challenge is how to capture, interpret, and return genomic information at high volumes and in a cost-effective manner. Innovative technologies and methods are needed to allow information on genomic variation to be used broadly in clinical settings while meeting regulatory requirements, to inform public health efforts, and to accurately convey genomic risk profiles to a lay audience.
Biotechnology and informatics have enhanced our ability to survey the entire genome within and among populations. This progress has allowed for improved inferences about evolution of the genome and better characterization of populations, key elements of populations genomics. An existing challenge is how to assemble and analyze multiple genomes using computational methods to identify patterns of genomic divergence. Technology is needed to enable nuanced incorporation of population-based discovery with detailed investigation of disease-based cohorts and prospective variant evaluation. Population genomic information can be used to understand disease process, improve risk prediction, and apply the results in patient care.
The research scope of Population Genomics and Genomic Medicine at NHGRI includes: characterizing the spectrum and distribution of genetic variation in humans and other biomedically relevant organisms; developing statistical and computational methods for comparing genomes and genome function within and across species as well as for relating genetic variation to health- and disease-related traits; developing resources and statistical methods for observational studies and clinical trials incorporating advanced genomic technologies; conducting proof-of-principle studies that apply genomic technologies to epidemiologic and clinical research; developing research methods and infrastructure needed for future epidemiologic and clinical studies of genetic and environmental contribution to disease; investigations of whether and how clinical genome variation impacts disease prevention diagnosis, and treatment; studies of approaches to improve the identification and interpretation of genomic variation for dissemination in clinical settings; assessing phenotypic manifestations of genetic variation through electronic medical records (EMRs); integrating genomic results and clinical decision support into EMRs; studies that address current barriers to the implementation of clinical genome sequencing; and assessing the impact of genetic information on clinical utility, health outcomes, and delivery of care.
For additional information about Genomic Medicine at NHGRI, please visit the Division of Genomic Medicine website.
Ethical, Legal and Social Implications. NHGRI, through the ELSI Research Program, supports research studies that examine and address the ethical, legal, and social implications of genomics. These studies may focus on issues associated with genomic research, genomic healthcare, the interplay between the field of genomics and organizations, institutions, or other organized stakeholders, and broader values and societal effects that shape and are shaped by genomics.
More detailed information on specific ELSI research priorities within each of these broad areas is available on the ELSI Research priorities website.
Genomic training and education. NHGRI supports educational activities and curriculum development that increase genomics knowledge of students, trainees, and genomics professionals. The goal of these activities is to provide an avenue for entry and pursuit of genomics careers. The widespread impact of genomics creates a need to train diverse groups of people to develop innovative and impactful genomic research approaches and resources. Training opportunities may be proposed at the undergraduate, postbaccalaureate, graduate, postdoctoral, or professional level.
For more information on genomic training and education at NHGRI, please visit the Training Program website.
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Division of Neuroscience and Basic Behavioral Science (DNBBS)
The Division of Neuroscience and Basic Behavioral Science provides support for research programs in the areas of basic neuroscience, genetics, basic behavioral science, research training, resource development, technology development, drug discovery, and research dissemination. The Division has the responsibility, in cooperation with other components of the Institute and the research community, for ensuring that relevant basic science knowledge is generated and then harvested to create improved diagnosis, treatment, and prevention of mental and behavioral disorders.
In this Division, the SBIR and STTR programs support research and the development of tools related to basic brain and behavioral science, genetics, and drug discovery and development relevant to the mission of the NIMH. Such tools include software (such as informatics tools and resources and tools for analyzing data); hardware (such as the development of instrumentation or devices); wetware (such as the use of iRNAs or other bioactive agents as research tools or molecular imaging agents or genetic approaches to label neural circuits or modify circuit functions); and drug discovery related technologies such as high throughput screening (HTS) or computational pharmacology approaches. Assay development projects should follow the best practices laid out in the Assay Guidance Manual: https://www.ncbi.nlm.nih.gov/books/NBK53196/.
Areas of Emphasis:
Novel imaging probes to study brain structure and function at all levels, from the molecular level to the whole organ, using any imaging modality (PET, fMRI, optical, etc.) in animal or human studies.
Drug discovery/drug development of novel compounds which act on molecular pathways (receptors, enzymes, second messengers, etc.) that are not typically targeted with currently available psychiatric drugs, and that have a strong biological justification as a novel mechanism for treatment of psychiatric disorders.
First in human drug trials.
Novel screening assays for high throughput acquisition and analysis of data about behavior and the brain, from the level of genes to behavior.
Novel technologies that would enable researchers to study how populations of neural cells work together within and between brain regions, in order to understand how changes in neural activity contributes to mental disorders, using animals or when applied to humans.
Develop informatics tools to facilitate the analysis and sharing of data between laboratories about behavior and the brain. This could include common data element efforts but is not limited to that area.
Technologies consistent with the goals of the BRAIN Initiative: http://www.braininitiative.nih.gov/, including human/ clinical-based technologies.
Division of Translational Research (DTR)
The DTR directs, plans, and supports programs of research and research training that translate knowledge from basic science to discover the etiology, pathophysiology, and trajectory of mental disorders and develops effective interventions for children and adults. DTR supports integrative, multidisciplinary research on the following areas: the phenotypic characterization and risk factors for psychiatric disorders; neurobehavioral mechanisms of psychopathology; trajectories of risk and resilience based on the interactive influences of genetics, brain development, environment, and experience; and design and testing of innovative psychosocial, psychopharmacologic, and somatic treatment interventions.
In this Division, the SBIR and STTR Programs support research aimed at facilitating the validation and commercialization of new methods of assessing psychopathology and measuring treatment response to therapeutic agents. In addition, the SBIR and STTR Programs support the clinical development of interventions, including novel pharmacologic agents or brain stimulation devices as well as technology development used to deliver novel psychosocial approaches to the treatment of mental illness in adults, pediatrics and geriatrics. For more information on NIMH supported clinical trials and requirements, see: https://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml
Areas of Emphasis:
Develop valid measures of the various constructs in the Research Domain Criteria (RDoC) matrix (see https://www.nimh.nih.gov/research/research-funded-by-nimh/rdoc/index.shtml), e.g., behavioral tasks, psychometrically sophisticated self-report measures, and measures of physiological and neural activity, into a commercial product.
Conduct early stage, proof of concept clinical trials to advance the development of novel therapeutics. The clinical trials are expected to include biological/behavioral data to assess target engagement and to help determine potential success or failure of the compound before moving on to larger clinical trials (see NOT-MH-11-015 http://grants.nih.gov/grants/guide/notice-files/NOT-MH-11-015.html).
Develop, test and perform initial validation of reliable and stable biomarkers that can identify at-risk individuals prior to disease onset, improve diagnosis and classification, predict treatment response, or to measure disease progression. Biomarkers are also needed in clinical trials to identify dose ranges, to identify a specific subpopulation of subjects to enroll in a treatment trial, or to measure efficacy or toxicity/side effects. Biomarkers in psychiatry will initially be appropriate as clinical research tools, and only after significant technical and clinical validation, could move toward diagnostic utility or other context of uses.
Development of novel diagnostic tools and innovative measures of treatment response and disease progression, preclinical or clinical efficacy testing, or toxicity measures for drug development.
Development of hardware and software tools to enable refined physiological and behavioral assessment of normal and atypical neurodevelopment focused on pediatrics, adult and geriatric age ranges.
Web-based tools and biosensors to enhance prevention, early identification and treatment of pediatric mental disorders by various educational and health professionals.
Development of hardware and software tools to support operations of multi-site clinical trials.
Development of novel methods to enhance efficiency of early phase clinical trials.
Novel technologies and data analytic tools to enable quantification of behavioral data that is relevant to research or clinical trials in mental disorders and/or autism.
Development of imaging technologies that can reveal specific pathologies in major mental disorders.
Division of AIDS Research (DAR)
The NIMH DAR supports scientific research to understand and alleviate the consequences of HIV disease on the central nervous system, and research to strengthen the provision and outcomes of HIV/AIDS prevention and treatment. Examples of high-priority research areas for SBIR/STTR applications are described below.
Develop and test novel, non-invasive diagnostic approaches (instrumentation, imaging, biomarkers, central nervous system [CNS] cell-based in vitro models) to comprehend HIV-1 associated CNS dysfunction and innovative technologies to study the mechanisms involved in HIV-1 associated neuropathogenesis and persistence of HIV-1 in the CNS.
Design and test novel therapeutic interventions aimed at amelioration of HIV-1 associated CNS dysfunction, and/or eradication of HIV-1 from CNS reservoirs, and/or strategies to prevent viral resurgence in the CNS upon cessation of anti-retroviral therapy.
Tools to assess neurotoxicity profiles of antiretroviral medications and pharmacological strategies to reduce adverse effects of anti-retroviral drugs (neuropsychiatric side effects and drug-drug interactions).
Develop new tools/ techniques to aid in deciphering the complex neuro-immune interactions at a molecular and cellular level in the context of HIV.
Develop or adapt neurological/neuropsychological/neurobehavioral assessments to evaluate HIV-1 associated abnormalities in adults or children in resource limited environments that are adaptable to different cultures and languages.
Build and optimize informatics tools to aid in analyzing and characterizing the phenotype of CNS disease modalities associated with HIV by using machine learning, big data and systems biology- based approaches.
Develop technologies and tools to increase regular HIV testing and support uptake, adherence, and persistence to biomedical HIV prevention regimens among persons behaviorally vulnerable to HIV or to biomedical HIV treatment regiments among people newly diagnosed with HIV.
Develop innovative tools and approaches that use existing patient-level data, such as electronic medical records and prescription refill or claim data, to improve engagement in HIV care or HIV treatment adherence to strengthen sustained viral suppression, including development and testing of predictive algorithms to identify those at risk for future non-adherence.
Develop approaches that seamlessly integrate tools for mental health screening and treatment into HIV healthcare or increase the capacity of HIV clinics to address mental health concerns.
Develop decision support tools that help individuals, couples, and clinicians make informed choices about the increasing number of proven and available HIV prevention and treatment regimens, including long-acting regimens and multipurpose prevention technologies (MPTs).
Develop innovative wireless technologies, remote sensing devices, biomarkers, assays, or other novel methods to improve scientific measurement of HIV exposure due to sexual behavior, or scientific measurement of social determinants that influence HIV treatment and prevention. Assessment approaches could occur retrospectively (not a clinical trial – using existing data, such as electronic medical records).
Develop and improve digital communication technologies to raise HIV awareness and promote accurate and timely health information to users, groups, and geographic regions most impacted by HIV.
Develop and test tools, curricula, and strategies that seek to reduce documented HIV-related disparities and health inequities (e.g., age, sex, gender identity, sexual orientation, race, ethnicity, socioeconomic circumstance, etc.) in HIV incidence and HIV prevention, treatment, and cure outcomes.
Develop innovative long-acting systemic and non-systemic multipurpose prevention technologies that prevent HIV infection and pregnancy (hormonal and non-hormonal methods) in adolescents and young women.
Division of Services and Intervention Research (DSIR)
The Division of Services and Intervention Research (DSIR) SBIR/STTR supports two critical areas of research for people with or at risk for mental illness:
Intervention research to evaluate the efficacy and effectiveness of pharmacologic, psychosocial, somatic, rehabilitative, sequential and combination interventions on mental and behavior disorders- including acute and longer-term therapeutic effects on functioning across domains for children, adolescents, and adults.
Mental health services research to improve the access, continuity, equity, value, quality and outcomes of mental health care, as well as to improve the dissemination of information about and the implementation of effective interventions, to strengthen the public health impact of NIMH research.
The intervention research program aligns with NIMH Strategic Objectives 3.2 and 3.3 and addresses the efficacy/effectiveness of treatment and preventive interventions in usual practice and community settings with the purpose of informing clinicians, patients, families, and health policy makers on evidence-based practices. In funding decisions, special emphasis is placed on the potential clinical and/or public health impact of the research activities and on the implications of the research findings for improving community practice and health outcomes. Types of interventions include the full range of behavioral, psychotherapeutic, pharmacologic, and non-pharmacologic somatic or complementary/alternative interventions, as well as rehabilitation or other adjunctive services, e.g., integrated approaches to chronic mental illness. Examples of areas of interest are:
Analyses of naturalistic databases to evaluate the effectiveness of preventive and treatment interventions.
Randomized clinical trials evaluating the effectiveness of preventive and treatment interventions that have been augmented or refined with the intent to enhance their clinical potency or efficiency.
Identifying moderators and mediators of intervention effects as a step to design and test personalized interventions.
Moderator/mediator identification could occur retrospectively (not a clinical trial – using EHR).
Moderator/mediator identification could occur prospectively (within the context of a clinical trial).
Evaluating the effectiveness of predictive algorithms to improve identification and intervention of individuals at elevated risk of mental illness and suicide.
Evaluating the combined or sequential use of interventions.
Evaluation of combined/sequential interventions could occur retrospectively (not a clinical trial – using EHR).
Evaluation of combined/sequential interventions could occur prospectively (within the context of a clinical trial).
Determining the optimal duration, frequency and intensity of an intervention to optimize improvements in symptoms and functioning, establishing the utility of preventive intervention or continuation or maintenance treatment (that is, for prevention of relapse or recurrence).
Evaluation of the optimal length of an intervention could occur retrospectively (not a clinical trial – using EHR).
Evaluation of the optimal length of an intervention could occur prospectively (within the context of a clinical trial).
Evaluating the long-term impact of preventive and therapeutic interventions on symptoms, functioning, and quality of life.
Evaluation of the optimal length of an intervention could occur retrospectively (not a clinical trial) – using EHR or survey data).
Evaluation of the optimal length of an intervention could occur prospectively (within the context of a clinical trial).
Services research covers all mental health services across the lifespan for all mental health disorders, includes clinical trial and non-clinical trial designs, and aligns with NIMH Strategic Objective 4 , which includes but is not limited to:
Service settings at the patient, provider, health system, and cross system levels to include primary care, specialty mental health, emergency departments, integrated care, general medical, and other delivery settings (such as employment, educational, veteran, military, criminal justice, child welfare, juvenile justice and other community settings).
Enhanced capacity for conducting services research by developing and utilizing innovative and established methodologies, including health economics, to inform decisions about the organization, delivery and financing of care.
The clinical epidemiology of mental disorders to include development and use of data sets from health surveillance activities, decision support tools, administrative claims, mobile apps and similar technologies, electronic health record (EHR), disease registries, and other databases where epidemiological data (to include big data) reside.
Interventions and other research to improve access, continuity, engagement, quality, uptake, equity, efficiency, and cost of care.
Research that reduces disparities and advances equity in mental health interventions, services, and outcomes for racial and ethnic minority groups, individuals limited by language or cultural barriers, sexual and gender minorities, individuals living in rural areas, socioeconomically disadvantaged persons and other underserved groups.
The dissemination of information about and implementation of evidence-based interventions, programs, support tools, or other practices or technologies into service settings.
For both interventions and services research, DSIR supports the development and testing of digital health tools. These tools include technology-assisted approaches to assessment (e.g., technology-assisted screening and diagnosis) and intervention (e.g., m-health and other technology platforms to support the delivery of preventive, therapeutic, and services interventions). DSIR encourages efforts to employ technology-assisted approaches to expand the reach, efficiency, continuity, quality, and/or boost the therapeutic benefit of research-informed strategies, rather than mere translation of research-supported strategies onto new or emerging technology platforms. Collaboration with NIMH-supported researchers for the development of software for new analytic techniques and/or decision-making algorithms is encouraged. Also supported is research and the development or adaptation of tools and technologies to be used to enhance the training and development of new generations of researchers and practitioners and to keep established researchers and practitioners up-to-date on the findings, implementation, and methods of interventions and services research.
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Applicants are encouraged to engage in research and development that results in a product, process or service that will improve minority health and eliminate health disparities and that by design targets or involves any of the topics listed in the NIMHD waiver list or otherwise will contribute to the NIMHD mission.
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The NINDS accepts a broad range of small business applications that are significant, innovative, and relevant to its mission. Examples of research topics within the mission of NINDS are shown below. This list is not all inclusive and some research areas fall into multiple categories.
Therapeutics and Diagnostics Development for Neurological Disorders, including biomarker and diagnostic assays, therapeutics (drugs, biologics, and/or devices) for treatment of neurological disorders, and technologies/methodologies to deliver therapeutics to the nervous system.
Clinical and Rehabilitation Tools, including intraoperative technologies for neurosurgeons, rehabilitation devices and programs for neurological disorders, and brain monitoring systems
Technology and Tools, including technologies to image the nervous system, neural interfaces technologies, and tools for neuroscience research and drug development.
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NINR has developed a research framework that takes advantage of what makes the Institute unique by focusing on a holistic, contextualized approach to optimizing health for all people, rather than on specific diseases, life stages, or research topics. The framework builds on the strengths of nursing research, spans the intersection of health care and public health, and encompasses the clinical and community settings where nurses engage in prevention, treatment, and care—including hospitals and clinics, schools and workplaces, homes and long-term care facilities, justice settings, and throughout the community. The framework encourages research that informs practice and policy and improves health and quality of life for all people, their families and communities, and the society in which they live. NINR’s research framework includes guiding principles and research lenses that promote innovative and rigorous multilevel study designs that look upstream, midstream, and downstream to discover solutions to the nation’s most pressing and persistent health challenges. NINR’s guiding principles describe the qualities that investigators should emphasize in all NINR-supported research. In considering awards for funding, the extent to which studies reflect these principles will factor into our decisions.
NINR will prioritize research that:
Tackles today’s pressing health challenges and stimulates discoveries to prepare for, prevent, or address tomorrow’s challenges.
Discovers solutions across clinical, community, and policy settings to optimize health for individuals, families, communities, and populations.
Advances equity by removing structural barriers from research, cultivating diversity in perspectives and ideas, and fostering inclusion and accessibility in designing, conducting, and participating in research; and
Is innovative, develops or applies the most rigorous methods, and has the potential for the greatest impact on health.
NINR identified five complementary and synergistic research lenses that best leverage the strengths of nursing research and promote multilevel approaches, cross-disciplinary and -sectoral collaboration, and community engagement in research. It is important to note that the lenses are not research topics, but rather perspectives through which to consider the full spectrum of nursing research topics that encompass health and illness within the context of people’s lived experiences. These lenses allow nursing research to examine new topics while also allowing scientists to take a different look at long- standing areas of interest. The research lenses are:
Health Equity: Reduce and ultimately eliminate the systemic and structural inequities that place some at an unfair, unjust, and avoidable disadvantage in attaining their full health potential.
Social Determinants of Heath: Identify effective approaches to improve health and quality of life by addressing the conditions in which people are born, live, learn, work, play, and age
Population and Community Health: Address critical health challenges at a macro level that persistently affect groups of people with shared characteristics
Prevention and Health Promotion: Prevent disease and promote health through the continuum of prevention – from primordial to tertiary
Systems and Models of Care: Address clinical, organizational, and policy challenges through new systems and models of care
NINR does not generally support the development of technologies in the following topic areas:
Technologies designed for staffing purposes.
Technologies designed to provide nurse educational and professional training (e.g., VR simulations).
Technologies that assess or limit exposure to occupational health stressors.
Technologies for sanitization or decontamination in a clinical setting.
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Preclinical Drug Discovery and Development
Innovative platforms for identification and prioritization of targets for therapeutic intervention with clear clinical impact; such as those that are: implicated for disease, have genetic variations that have been identified in functional regions of receptor targets, and/or have high potential for biased signaling that would promote the beneficial effects of receptor signaling and reduce the unwanted effects
Tools and technologies to enable high throughput screening of compound activity on currently “non- druggable” targets
Assays for high-throughput screening of rare-diseases-related targets
Co-crystallization high-throughput screening techniques
Fluorescence probes to replace antibodies for determination of cellular protein translocation
Phenotypic assay development, including stem cell technology platforms for human “disease-in-a- dish” applications and the evaluation of toxicity
Interventions that target molecular pathways or mechanisms common to multiple diseases
Platforms for non-antibody biologics, cell-based therapies and gene therapy discovery
Small molecule and biologics analytical characterization
Accelerated bioengineering approaches to the development and clinical application of biomedical materials, devices, therapeutics and/or diagnostics
Development of novel technologies for enzyme replacement therapies (e.g., new cell culture/expression system) to solve major bottlenecks in rare diseases research
Innovative methods to determine alternative uses for existing therapeutic interventions for high priority areas, such as rare diseases and pain.
Tools and technologies that increase the predictivity or efficiency of medicinal chemistry, biologic or other intervention optimization
Technologies to deliver nucleic acid therapeutics to tissues other than the liver
Methodologies and technologies to increase efficiencies of manufacturing therapeutics
Development of novel high-throughput technologies that focus on making translational research more efficient
GMP production of exosome/extracellular vesicles
Generation of producer lines for large scale production of exosomes/extracellular vesicles
Extracellular RNA-based biomarkers and therapeutics of human diseases
Approaches to targeting the human microbiome for therapeutic or diagnostic purposes
Scale up, manufacturing and characterization of IPS cells
3D printing technologies
Technologies to substantially improve the efficiency and reduce the cost of clinical grade gene therapy vector manufacturing
Development of in vitro human tissue models (organs, 3D printing)
Technologies to allow therapeutic proteins other than lysosomal enzymes to be secreted and taken up by other cells via cross-correction
Novel strategies to prevent deleterious immune responses to gene therapy, to improve efficiency genome editing and/or enzyme replacement therapy
Establishing more robust phenotypic screens that may help prioritize candidate compounds for further testing
Innovative technology for non-small molecule delivery
High-throughput epigenetics screening/characterization tools and technologies
Microphysiological systems (MPS)/Tissue Chips, including MPS/Tissue Chips that incorporate known functional variants, e.g., ACMG 59 or CPIC A alleles, for study comparison using the same derived genetic background across a set of tissue chips with the functional variant
Volatile organic compounds (odors, scents) as biomarkers for disease
Bacteriophage-based therapeutics for disease and as modulators of the microbiome and microbiome natural products
High throughput Surface Plasmon Resonance devices for detecting protein small molecule interactions
New class of quantum-enabled sensing technologies for advancing translational sciences (e.g., point of care ultrasensitive high-throughput technologies for diagnostics, and miniaturized benchtop technologies for chemical/bioanalyte characterization).
Development of diagnostics or useful drug targets for rare diseases by using Pangenome data.
Biomedical, Clinical, & Health Research Informatics
Searchable access to information about research resources, facilities, methods, cells, genetic tests, molecules, biologic reagents, animals, assays, and/or technologies with evidence about their use in research studies
Cloud-based tools and methods for meaningful sharing, re-use and integration of research data
Novel platforms, technologies and tools for: (1) enabling clinical and translational research, particularly those with mechanisms for inclusion of patient-reported data and (2) integration of patient data collected from multiple devices and multiple/diverse clinical studies
Development of personalized phenotypic profiling (as well as personalized intervention) based on patient-centered integration of data from multiple data sources, including social media
Development of predictive models for translational science
Digital applications and tools (including telemedicine platforms) that facilitate/enhance translational research and medicine in rural populations
Generic Disease Registry template platforms that can be reused for multiple diseases.
Mobile device validation tools to ensure data from different brands or versions have compatible results.
Tools to assess with algorithms developed with artificial intelligence, machine learning.
Tools that allow for persistent identifier and attribution for data contributors that give credit to the data producers while ensuring that shared data has not been altered
Patient Mobile Tool Platforms that facilitate tool developers to build “apps” that integrate into their medical records.
Tools and environments that enable an easy interrogation of publicly available data
Innovative approaches like nanoneedles and nano particles to help improve early disease detection and targeted therapeutic delivery
Tools and technologies that leverage AI and real-world data for enhanced product evaluation and surveillance that could be used to provide a resource for rapid response to public health needs
Clinical, Dissemination and Implementation Research
Tools and technologies that:
increase the efficiency of human subjects research, that facilitate the rapid diagnosis and/or clinical trial recruitment and subject tracking, institutional review board evaluation and/or regulatory processes
evaluate and improve the process of informed consent
address medication adherence in clinical settings
address and improve community engagement
address the rapid diagnosis and/or clinical management of rare diseases
help characterize human disease states and assist in assessing the impact of interventions
support unique approaches to advance diversity, equity and inclusion.
mine published data and generate usable knowledge and analytics to advance research
Increased efficiency of clinical research conduct, including but not limited to regulatory decision support, patient eligibility analysis and recruitment and retention tracking
Educational tools for clinical and translational science
Computational or web-based health research methods, including:
Platforms for generally applicable and scalable multi-disease registries and natural history studies
Clinical trial designs and analyses (e.g., for pragmatic clinical trials)
Approaches, tools, platforms and environments that:
Integrate data in novel ways for development of new biomarkers that can be tested in translational research paradigms for which there are barriers or bottleneck
Engage prospective research participants who are from under-represented communities and impacted by disparities and the digital divide
Strategies to enhance the quality of and accelerate the conduct of dissemination and implementation research
Sustainable solutions for effective tools and environments in translational research
Development and validation of patient reported outcomes, clinician-reported outcomes and biomarkers for rare diseases that are not already supported by a disease-specific NIH Institute or Center
Patient empowerment tools/apps that allow users to compare their treatment and outcomes to normative populations existing treatment guidelines
Telemedicine or digital health applications that focus on research in rural populations
Tools and technologies that enhance the quality, safety, efficiency, effectiveness of new innovations in community settings
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Natural Products (including botanicals, herbs, probiotics, prebiotics, dietary supplements, special medicinal diets, and microbiome- /microbial-based therapeutics):
Development and validation of technologies for standardization and characterization of biologically active ingredients in natural products.
Development and validation of technologies for taxonomic identification of botanical raw materials or detection of adulterants.
Development and validation of technologies for the identification and characterization of bioactive metabolites derived from oral consumption of natural products.
Development and validation of methods for the sustainable production of low-yield natural products of commercial interest.
Development of novel analytical tools and technologies to study the microbiome, including its composition, genetics, and bioactivity, that can help clarify associations between the human microbiome and brain function and health.
Development of gut microbiome monitoring assays for validating safety and functional analysis of genomic and microbiota interactions.
Development of complementary and integrative therapeutic approaches to modify and balance the gut microbiota in healthy populations and individuals with disrupted microbiota and related diseases.
Clinical testing of natural products for the management of hard-to-treat symptoms such as pain, sleep disorders, or mild-to-moderate anxiety and depression to allow development of an evidence base that would accelerate U.S. Food and Drug Administration (FDA) approval of a drug indication for the natural product.
Mind and Body Approaches (including meditation, mindfulness, hypnosis, yoga, tai chi, acupuncture, manual therapies, and music/art therapies):
Development, testing, and validation of appropriate objective and/or quantitative measures and instruments to assess or monitor mind and body approaches in different contexts (e.g., classrooms, families, child welfare, juvenile justice systems).
Development, testing, and validation of measures and tools to assess training or fidelity of implementation of mind and body approaches in different settings (e.g., health care, community, families, schools, child welfare, juvenile justice systems).
Development and testing of technologies for the implementation of mind and body approaches in group or individual settings and/or self-care strategies. Examples may include but are not limited to the use of mobile health technologies such as smartphone apps, sensors, online delivery, or phone- based delivery.
Development and validation of methods for standardization and characterization of the active components of mind and body approaches.
Development and validation of methods for standardization of multimodal interventions to study whole person health.
Development and validation of imaging tools or instruments for studying manual therapies, including but not limited to massage, acupuncture, or spinal manipulation.
Development and testing of innovative technologies for multisensory delivery of mind and body approaches.
Development, testing, and validation of innovative technologies to enhance sensory-based (temperature, light, olfaction, etc.) therapies.
Development, testing, and validation of innovative technologies to facilitate delivery of music/art- based interventions and to identify novel outcome measures and biomarkers for these interventions.
General Tool/Technology Development:
Development and validation of biomarkers that correlate with efficacy of complementary and integrative health approaches.
Development and validation of standardized, reliable, and cost-effective tools that correlate with brain imaging in response to mind and body interventions.
Development and validation of tools, technologies, and instruments, including gaming and virtual reality technologies, for the accurate assessment of adherence and/or fidelity to the use of mind and body practices and interventions.
Development and validation of tools to improve patient-reported outcome measures of importance in clinical studies of complementary and integrative health approaches.
Development, pilot testing, and validation of wireless technologies for real-time data collection and monitoring of brain activity or other physiological signals for mind and body approaches.
Development or adaptation of biochemical or epigenetic monitoring devices for complementary and integrative health approaches.
Development and validation of tools to improve biological and physiological outcome measures for use in clinical studies of complementary or integrative health approaches.
Development or adaptation of technologies for objective assessment of pain with relevance to complementary and integrative health approaches.
Development of sleep monitoring technologies or biomarker panels to assess sleep deprivation, sleep deficiency, circadian rhythm dysregulation, and connection of sleep disturbances with health risks.
Development and testing of in vivo labeling technology of tissues or cells responsible for generating signals in response to different internal senses (e.g., mechanical force, temperature, osmolarity, oxygen levels).
Development and testing of technology or methods for quantifying biomechanical forces applied to internal tissues or cells.
Development and testing of mobile health technology or nonmobile technology and methods to monitor or quantify physical and/or emotional well-being, breathing, or sleep.
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NLM’s SBIR/STTR grant programs are focused on areas of particular interest from small business. The following narrative indicates the scope of projects suitable for the SBIR/STTR program that fit within the mission of NLM. They are not listed in priority order.
Development of new, innovative tools and methods for annotating, curating, and managing biomedical data resources
Advanced information retrieval and knowledge discovery from very large and/or heterogeneous data sets to support biomedical research
Development of novel approaches enabling analysis and discovery at scale across biomedical domains, research institutions, or health care sectors, including those leveraging high-performance cloud computing and federated learning
Novel platforms, technologies, tools, and techniques enabling multimodal data analysis to support health research or health care applications
Multi-level, reusable, data analytic models, simulations, information visualization, and presentation approaches to enhance decisions, learning or understanding of biological and clinical processes
Computational approaches integrating structured and unstructured data, natural language processing, automated metadata assignment to support biomedical research
Data science methods, approaches, or tools that enhance the quality, confidentiality, security, and/or utility of biomedical data, including personal health information
Artificial Intelligence techniques for characterizing and minimizing the impact of errors, incompleteness, missingness, within health-related data sets
Novel data-driven methods to facilitate real-time decision-making in clinical practice and public health
Analytical tools, technologies, and other data-driven strategies to track disease outbreaks, epidemics, and pandemics
Tools and technologies for understanding and predicting climate and environmental effects on human health
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Division of Comparative Medicine
Development of in vitro animal cell culture techniques, microphysiological systems (organs- on-a-chips, organoids) or computational (in silico) methods to reduce the number of animals used in studies and to replace certain tests conducted in animal models with novel alternative methods (NAMS).
Development of improved reagents and cost-effective methods and technologies to accurately screen and diagnose selected diseases of laboratory animal, and to perform overall assessments of animal quality and health status. An urgent need currently exists for the development of improved methods for detection of active tuberculosis in nonhuman primates (NHPs).
Development of improved reagents, techniques, and devices/tools for genomic and transcriptomic analysis and data mining from tissue or single cells of laboratory animals and animal models of human diseases.
Development of new technologies for rapid or high throughput animal characterization and deep phenotyping (at tissue, organ, cellular or molecular levels) .
Development of nonintrusive, wearable technologies to identify or assess biomarkers in well validated animal models.
Development of prophylactics or new therapeutic agents to prevent and/or control infectious diseases of laboratory animals. One high priority need is to develop methods to control and prevent monkey B virus (Macacine alphaherpesvirus-1) infections.
Identification, development, and characterization of spontaneous (naturally occurring) and engineered vertebrate animal models for studies of various human diseases (excluding most random mutagenesis projects performed on rodents).
Development and refinement of high-throughput technologies, cryoprotectants and devices for the cryopreservation, vitrification, long-term maintenance, and revival of cells, tissues and organs, as well as laboratory animal embryos and gametes, especially for Drosophila, aquatic models of biomedical value, swine, and NHPs.
Development of technologies, tools, and devices for the effective monitoring of frozen, cryopreserved cells and biological materials/tissues as well as laboratory animal embryos and gametes (including monitoring conditions during their distribution).
Development of technologies for improved embryo transfer within a single animal species or of intraspecific embryo transfer to allow preservation of rare or unique animal species that may have unique value in biomedical research as animal models for human disease.
Development of improved reagents, artificial intelligence/machine learning technologies, tools, devices, and high-throughput technologies to perform, analyze, capture, and process data gathered in “omics” studies (genomics, transcriptomics, epigenomics, proteomics, lipidomics, glycomics, metabolomics, and phenomics, among others) in normal, diseased, and intervention conditions in animal/biological models to support or validate pre-clinical analyses.
Development of biological tools and reagents for reconstruction, remodeling, repair, and regeneration of tissues damaged by injury or disease. Development of the technologies and procedures to test efficacy and safety of these experiments in animal models. Approaches to detect and track survival of implanted cells and tissues in vivo.
Development of reagents (including antibodies), assays, and technologies that will facilitate research using aquatic biomedical models, such as zebrafish or Xenopus, for understanding basic aspects of development, physiology, or genetics.
Development of reagents (including antibodies), assays, and technologies that will facilitate research using NHPs for understanding basic aspects of development, physiology, or genetics. High priority needs include reagents for NHP species other than the rhesus macaque.
Development of rapid and sensitive technology for the accurate detection and diagnosis of polymicrobial infections in biomedical laboratory animal models, including those agents involved in vertical transmission of diseases into embryos and larvae.
Technologies for improved sex determination of embryonic, neonatal, and juvenile stages of animals, with one high priority need being nonmammalian species.
Development of rapid and sensitive technology for the detection and study of emerging human pathogens in animal models.
Development of non-invasive, micro-sensor technologies (e.g., embedded sensors, devices, microchips) for NHPs and other live animal models to collect data related to neuroimaging, behavioral and cognitive assessments, metabolism, microbiomes, and other biomedical research areas. Of special interest are wearable, swallowable sensitive and selective probes/sensors for detecting physiological fluctuations in living animals, with the capability of monitoring at deep tissues level.
Development of technologies for cell-based therapies that could be used as implantable biocomputers in animal models of human disease, to perform complex logic computations that integrated signals from multiple metabolites/pathways. These include remote-controlled switches and natural, nontoxic, highly soluble, and potentially beneficial to health trigger molecules.
Development of technologies and tools (biosensors, imaging approaches, and reagents such as antibodies (especially nanobodies)), to facilitate validation and use of multiple model organisms in research studies to enhance the rigor, and reproducibility of animal research and their clinical and translational research potential.
Division of Construction and Instruments
The Division of Construction and Instruments supports the development and implementation of technologies that enhance and improve the welfare and research facilities of animal models in biomedical and behavioral research. In particular, the areas being supported include novel tools and equipment that improves and facilitates the care and monitoring of animals. One area of interest is the integration of technological features for detecting, measuring, monitoring, recording, analyzing, and reporting physiological, biobehavioral, and environmental conditions to allow for documenting these physiological parameters and extrinsic factors and enhancing scientific rigor and reproducibility in animal studies. Another area of interest encompasses the improvement of laboratory equipment to maintain the environmental conditions and upkeep of the infrastructure within animal facilities. Of special importance is the employment of green technologies. Examples of topics of special interest include (but are not limited to) the development of better, more reliable, and more efficient:
Equipment such as vacuum cleaners, air filters, hoods, snorkels, and autoclaves for animal research facilities, for barrier facilities, and other facilities with special needs and requirements.
Equipment/devices to distribute water and food and to monitor and record their intake by research animals.
Equipment to increase the quality of life and prevent injuries of research animals, staff, and investigators.
Technology to monitor and protect the well-being of animals, including IT-supported tools.
Equipment and its use for maintenance of disease-free colonies and healthy animals.
Equipment to disinfect devices, furnishings, and other apparatus in animal facilities such as aquaria, cages, tunnels, and racks.
Cost-effective husbandry and colony management techniques, equipment, and/or new approaches to improve laboratory animal welfare and assure efficient and appropriate research use.
Specialized equipment and caging for laboratory animals to permit optimal environmental control, and operational efficiency, including improvements in caging, identification/tagging of animals and remote monitoring in animal facilities.
Specialized equipment to permit integrated environmental factor measuring, monitoring, reporting, recording and documentation (such as for air quality, temperature, humidity, lighting, sound, and vibration level).
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ORWH will consider co-funding for applications that have a central focus on the health of women, as demonstrated through specific aims that EITHER explicitly address a particular condition in women OR focus on one of the high priority topics below. In either approach, intersectional and/or multidimensional approaches that consider the health of women in context (e.g., projects accounting for social and structural variables—including race, ethnicity, socioeconomic status, and State and Federal policies— that affect women’s health) are strongly encouraged. While projects are not required to exclusively focus on women for ORWH co-funding, studies that include more than one sex or gender should be designed and powered to make generalizable conclusions about women and enable sex or gender difference comparison. ORWH intends to prioritize interdisciplinary research that:
Addresses the influence of sex-linked biology, gender-related factors, or their intersections on health.
Addresses how physical, mental, and psychological health outcomes interact with structural factors to either mitigate or exacerbate health disparities and aims to create behavioral interventions to address these issues.
Advances the translation of research advancements and evidence in women’s health into practical benefits for patients and providers.
Informs and develops multi-sector partnerships to advance innovation in women's health research.
Increases public awareness of the need for greater investment in and attention to women’s health research, as well as women’s health outcomes across the lifespan.
Advances research to reduce health disparities and inequities affecting women’s health, including those related to race, ethnicity, age, socioeconomic status, disability, and exposure to environmental factors and contaminants that can directly affect health.
Increases uptake of evidence-based interventions that advance women’s health.
Addresses topics identified in the Women’s Health Innovation Opportunity Map.
Reduces violence, stigma, and trauma related to HIV.
Develops woman-centered self-tests for HIV viral load monitoring, including in breast milk.
Develops topical microbicide agents, wearable, implantable, or insertable devices releasing medications alone or as part of multipurpose prevention technologies (MPTs), to prevent sexual acquisition of HIV, other sexually transmitted infections and/or unplanned pregnancy across the lifespan including in pregnant or postpartum people.
Promotes the use of advanced statistical modeling, data visualization, artificial intelligence (AI), and machine learning (ML) methods for research on the health of women.
Develops methods, tools, or technologies to increase data sharing and improve data management practices to align with the Findability, Accessibility, Interoperability, and Reusability (FAIR) data principles and enhances the utility of new and existing data on the health of women.
Methods for integrating data science, including artificial intelligence and machine learning, into research on the health of women.
Develops cutting-edge computational tools and technologies to facilitate screening for prevention, diagnosis, and treatment of diseases that affect women.
Improves estimates of the impact of chronic conditions in women, including projects to diagnose and reduce misclassification of female-specific and gynecologic conditions, conditions that predominantly impact women or affect women differently, and projects to characterize differences in chronic condition presentation by gender, race and ethnicity and the various structural and social determinants that these women experience or are affected by.
Explores the role of hormonal fluctuations on the development of chronic conditions in women, including the influence of age of menarche; the role of menstrual cycle ir/regularity, length, and phase; the length of the reproductive window; the link between adverse pregnancy outcomes and development of chronic conditions later in life; and the effect of exogenous hormones on the development of chronic conditions
Develops new and better approaches for addressing the symptoms that affect women during perimenopause, menopause, and postmenopause
Improves early and accurate detection and diagnosis of chronic conditions in women, including the diagnosis of multiple chronic conditions
Elucidates gender differences in access and use of health care services, including methods for assessing discrimination (e.g., sexism, racism, ageism, and homophobia) encountered by women when accessing health care services for chronic conditions.
Are there any additional benefits I would receive?
Beyond the formal funding award, awardees gain several strategic advantages:
Government Validation and Credibility:
Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.Enhanced Visibility and Market Recognition:
Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.Access to the Federal Innovation Ecosystem:
Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.Stronger Commercial and Exit Potential:
By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.
What is the timeline to apply and when would I receive funding?
Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.
Where does this funding come from?
Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.
Who is eligible to apply?
Applicants must be U.S. small business concerns (SBCs) that:
Are organized for profit with a U.S. place of business.
Have ≤ 500 employees including affiliates.
Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.
What companies and projects are likely to win?
Projects that demonstrate:
A clear unmet medical or public-health need,
Strong scientific rationale and feasibility,
High commercialization potential, supported by a realistic market and regulatory strategy, and
Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).
Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.
Are there any restrictions I should know about?
Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.
Foreign entities are not eligible.
Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.
How long will it take me to prepare an application?
For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.
How can BW&CO help?
Our team specializes in complex federal R&D proposals and can:
Triple your likelihood of success through proven strategy and insider-aligned proposal development
Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations
Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.
How much would BW&CO Charge?
Our full service support is available for
Phase I: $9,000 Flat Fee + a 5% Success Fee.
Phase II: $13,000 Flat Fee + a 5% Success Fee.
Fast-Track: $13,000 Flat Fee + a 5% Success Fee.
Fractional support is $300 per hour.
For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.
Additional Resources
Webinar - NIH Grant Admin for Academic Spin-Outs & First-Time Applicants