NIH, CDC and FDA Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Optional) - PA-27-100

Executive Summary:

The NIH, CDC, and FDA Parent SBIR program provides non-dilutive funding to U.S. small businesses developing innovative health, life sciences, biomedical, public health, and FDA-relevant technologies. This program supports projects from early-stage feasibility through later-stage R&D and commercialization activities through Phase I, Phase II, Direct to Phase II (NIH only), and Fast-Track (NIH only) awards.

This is one of the broadest health-focused SBIR opportunities available and is designed for companies whose technologies align with the mission of a participating NIH Institute, CDC Center, or FDA Center. Clinical trials are optional, although not all participating components accept clinical trial applications.

The first application deadline is September 05, 2026 by 5:00 PM local time of applicant organization. Additional deadlines occur on a recurring schedule through the expiration of the NOFO. No late applications will be accepted.

How much funding would I receive?

Funding depends on the participating Institute, Center, or Office (ICO), project phase, and project scope. Award amounts generally may not exceed SBA guidelines unless specifically allowed by the participating component.

Examples of NIH component budgets include:

Phase I

• Up to $700,000: NCI, NIA, NIAID, NIGMS, NIMH, NINDS, NCCIH

• Up to $400,000: NHLBI, NHGRI, NIAAA, NICHD, NIDCD, NIDDK, NIDA, NINR, and others

• SBA guideline budgets for certain Institutes and Offices

Phase II

• Up to $3,000,000: NHLBI, NIA, NIAID, NIDCD, NIDA, NIGMS, NIMH, NINDS

• Up to $2,500,000: NCI, NIAAA, NICHD, NIDDK, NINR, ORWH

• SBA guideline budgets for certain Institutes and Offices

Applicants should propose a budget that is reasonable and appropriate for completion of the project.

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:

• National Center for Advancing Translational Sciences (NCATS)

  NCATS supports research including, but not limited to, clinical technology, instruments, devices, and related methodologies that may have broad application to clinical research and better patient care. Our interests are in four main categories

  (1) Preclinical Drug Discovery and Development

  (2) Biomedical, Clinical and Health Research Informatics

  (3) Clinical, Dissemination and Implementation Research

  (4) Rare Diseases and Unmet Needs.

  Indications Of Interest:

  • Intestinal fibrosis

  • Cardiovascular disease / cardiac regeneration

  • Cancer (including cancer immunotherapy and solid tumors)

  • Facioscapulohumeral muscular dystrophy (FSHD)

  • Primary ciliary dyskinesia

  • Pulmonary fibrosis

  • Cystic fibrosis

  • Asthma

  • Chronic obstructive pulmonary disease (COPD)

  • Non-cystic fibrosis bronchiectasis

  • Lung cancer

  • Huntington's disease (including prodromal Huntington's disease)

  • Heart failure

  • Hypertension

  • Cardiomyopathies

• National Center for Complementary and Integrative Health (NCCIH)

  The NCCIH will support applications on the development of technologies and therapies relevant to complementary and integrative approaches.

  Complementary health approaches include a broad range of practices and interventions that can be classified by their primary therapeutic input, including:

  • nutritional and natural products (e.g., special diets, dietary supplements, botanicals, probiotics, and microbial-based therapies),

  • psychological (e.g., meditation, hypnosis, music-based interventions, relaxation therapies),

  • physical (e.g., acupuncture, massage, chiropractic manipulation, other force-based manipulations, or devices related to these approaches), or

  • a combination of psychological and physical (e.g., yoga, tai chi, or some forms of art therapies, such as music-based interventions) input.

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

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

  Indications Of Interest:

  • Anxiety disorders

  • Major depressive disorder / depression

  • Stress-related psychiatric disorders

  • Chronic inflammatory disorders

  • Chemotherapy-induced nausea and vomiting (CINV)

  • Youth mental health / social isolation

• National Cancer Institute (NCI)

  NCI supports the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs by engaging domestic small business concerns in federal cancer research and development that has the potential for commercialization. 

  Indications Of Interest:

  • Skin cancer (melanoma and non-melanoma)

  • Lung cancer (including non-small cell lung cancer)

  • Liver cancer / hepatocellular carcinoma

  • Pancreatic cancer (pancreatic ductal adenocarcinoma, including mutant KRAS/RAS)

  • Prostate cancer (including metastatic castration-resistant prostate cancer)

  • Colorectal cancer (including microsatellite stable colorectal cancer)

  • Head and neck squamous cell carcinoma (HNSCC)

  • Oral / oropharyngeal squamous cell carcinoma

  • Breast cancer

  • Ovarian cancer

  • Cervical / gynecological cancer (dysplasia screening)

  • Glioblastoma / glioma / brain cancer

  • Melanoma (metastatic / Stage IV)

  • Cholangiocarcinoma

  • Multiple myeloma

  • Acute lymphoblastic leukemia (pediatric)

  • Acute myeloid leukemia (AML)

  • Lymphoma (including non-Hodgkin's lymphoma / relapsed-refractory B-cell malignancies)

  • Hereditary cancer syndromes (e.g., Lynch syndrome) / cancer previvors

  • Cancer-related fatigue and sleep disturbances (cancer survivorship)

  • Solid tumors / pan-cancer (general)

  • Diabetic foot ulcers and knee osteoarthritis (secondary indications)

  • Liver transplant ischemia-reperfusion injury / end-stage liver disease (secondary indication)

• National Eye Institute (NEI)

  NEI supports research including, but not limited to, the following:

  • Commercializable research and clinical innovations in ophthalmology and vision sciences

  • Commercializable therapeutics including drugs, biologics, devices, or combination therapeutics that prevent or reduce blindness or improve ocular health

  •  Market-ready technologies and diagnostic tools for predicting, identifying, or monitoring eye diseases and vision-related conditions

  • Commercializable devices and services that assist people with blindness or visual impairments to improve quality of life Commercial-grade devices and support services that help individuals with blindness or vision impairments to improve and enhance their daily living experience

  • Market-ready technologies that correct, enhance, or augment human vision

  Indications Of Interest:

  • Age-related macular degeneration (neovascular/wet AMD and dry AMD)

  • Dry eye disease (including Meibomian gland dysfunction)

  • Glaucoma (including post-trabeculectomy scarring and intraocular pressure management)

  • Diabetic retinopathy (including diabetic macular edema)

  • Retinitis pigmentosa / inherited retinal degeneration

  • Leber congenital amaurosis type 1 (LCA1)

  • Retinopathy of prematurity (ROP)

  • Corneal endothelial disease / Fuchs' endothelial corneal dystrophy

  • Corneal injuries and wounds (e.g., alkali burns)

  • Persistent corneal epithelial defects (PCED) / neurotrophic keratitis

  • Myopia (pediatric myopia and myopia progression)

  • Optic neuropathies / neuro-ophthalmic disease (including optic neuritis)

  • Visual impairment following traumatic brain injury (mTBI/concussion)

  • Refractive error / higher-order aberrations (contact lens correction)

  • Uveitis and ocular infections (secondary)

  • Blindness and low vision (assistive technology / accessibility focus)

• National Human Genome Research Institute (NHGRI)

  Interest Areas:

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

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

  • Strategies to enhance ethical, legal, and social aspects of genomics research or translation of genomics into health care. 

  • Bioinformatics software or platforms for genomic, genetic, or sequence data processing or analysis, functional genomics, associations between genomic data and diseases or phenotypes, interpretation of variants, or genomic data integration into clinical decision making. 

  • Databases and data management platforms for genomics research and application including platforms for sequence, functional, or phenotypic data or annotation of variants. 

  • Development and application of methods for machine learning, pattern detection, or knowledge networks for genomics science or translation into health care. 

  • Informatics methods and platforms that adopt data standards, enhance data sharing with privacy, and improve data exchange in genomics science or translation of genomics into health care. 

  • Use of cloud and other computing models to improve scale, reproducibility, interoperability, cost-effectiveness, and utility of genomic and clinical data in genomics or translation into health care. 

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

• National Heart, Lung, and Blood Institute (NHLBI)

  Interest Areas:

  The National Heart Lung and Blood Institute (NHLBI) is interested in supporting the development of novel therapeutics, devices, diagnostics, digital health technologies, research tools, and other innovative solutions for advancing the prevention, diagnosis, and treatment of heart, lung, blood, and sleep (HLBS) diseases and disorders. 

  Topics of particular interest for the NHLBI SBIR/STTR program include, but are not limited to, the following topics: 

  • Technologies addressing HLBS complications relevant to maternal health and women’s health  

  • Artificial Intelligence/Machine Learning technologies to improve the diagnosis, treatment, and prevention of HLBS diseases and disorders 

  • Precision medicine approaches to treating HLBS diseases and disorders 

  • New approach methodologies, tools, and point-of-care technologies to improve detection and therapeutic development for HLBS diseases and disorders

  Indications Of Interest:

  Lung / respiratory

  • Idiopathic pulmonary fibrosis (IPF) / interstitial lung disease

  • Chronic obstructive pulmonary disease (COPD)

  • Asthma

  • Cystic fibrosis and primary ciliary dyskinesia

  • Pulmonary hypertension

  • Sarcoidosis

  • Acute respiratory distress syndrome (ARDS) / acute lung injury

  • Radiation-induced lung injury (pneumonitis/fibrosis)

  • Respiratory failure (ECMO/mechanical ventilation context)

  • Empyema / parapneumonic effusion

  • Pulmonary embolism

  • End-stage lung disease (lung transplant)

  • Other fibroses noted: scleroderma skin fibrosis, kidney fibrosis (CKD), intestinal fibrosis (Crohn's)

  Heart / cardiovascular

  • Cardiovascular disease (general risk assessment)

  • Coronary artery disease / coronary heart disease

  • Myocardial infarction / ischemic heart disease (including reperfusion injury)

  • Heart failure (including HFrEF and chronic heart failure)

  • Coronary microvascular and vasomotor dysfunction (CMVD)

  • Ventricular tachycardia / arrhythmias

  • Cardiac arrest / ventricular fibrillation (including refractory)

  • Mitral regurgitation / mitral valve disease

  • Heart valve disease (transcatheter and surgical valves)

  • Hypertrophic and dilated cardiomyopathies (HCM/DCM)

  • Hypertension

  • Congenital heart disease (including hypoplastic left heart syndrome / single-ventricle / Fontan physiology, pulmonary valve defects)

  • Infantile hemangioma

  • Abdominal and thoracic aortic aneurysm

  • Aortic dissection

  • Atrial fibrillation / stroke prevention

  • Peripheral artery disease / critical limb ischemia (CLTI)

  • Conduction system disorders / pacing (bradycardia, LV dysfunction)

  Blood / hematologic

  • Sickle cell disease / sickle cell anemia

  • Anemia

  • Hemophilia A

  • Thrombosis / clotting disorders (including catheter-related thrombosis)

  • Heparin-induced thrombocytopenia (HIT)

  • Bleeding / hemostasis (antiplatelet reversal)

  • Hematologic malignancies / blood disorders (hematopoietic stem cell transplant)

  • Neutropenia

  • Graft-versus-host disease (GVHD) / alloimmunization

  Sleep

  • Obstructive sleep apnea (infants, children, adults)

  • Central sleep apnea

  Other / cross-cutting

  • Organ transplantation (heart, lung, liver, kidney; xenotransplantation)

  • Perioperative / postoperative complications

  • Sepsis

  • PFAS exposure / cardiometabolic risk

• National Institute on Aging (NIA)

  The NIA is interested in proposals to develop and validate technologies that enhance the health and wellbeing of older adults. Areas of high interest include technologies intended to address unmet needs and have clear competitive advantages, development of commercialized solutions that are cost-effective and widely available, and small businesses that are new to SBIR/STTR funding.

  Scientific areas of interest include but are not limited to:

  Alzheimer's Disease (AD), AD-Related Dementias (ADRD), and Age-Related Cognitive Decline:

  Development of innovative tools, technologies, and interventions to prevent, diagnose, treat, monitor, or slow progression of AD/ADRD, cognitive decline, age-related sleep disorders, and delirium, including:

  • Biomarkers, research tools, diagnostics, imaging technologies, and AI/ML methods for early detection and monitoring.

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

  Aging Biology and Age-Related Diseases:

  Development of technologies, therapeutics, biomarkers, and tools to measure, prevent, treat, or slow progression of age-related biobehavioral decline and conditions, including:

  • Therapeutics targeting aging biology mechanisms and personalized medicine approaches.

  • Research tools and data science technologies to understand aging and predict health outcomes.

  Aging in Place of Choice and Care Delivery:

  Development of technologies and interventions that promote healthy aging, support aging in place of choice, improve care delivery, or reduce caregiving burden, including: 

  • Assistive devices, robotics, sensors, digital health products, and technologies to enhance care.

  Indications Of Interest:

  Cognitive / neurodegenerative (the dominant focus)

  • Alzheimer's disease (diagnosis, biomarkers, therapeutics — by far the largest area)

  • Alzheimer's disease and related dementias (ADRD) / dementia generally

  • Mild cognitive impairment (MCI)

  • Lewy body disease / Lewy body pathology

  • Frontotemporal dementia (FTD)

  • Amyotrophic lateral sclerosis (ALS)

  • Limbic-predominant age-related TDP-43 encephalopathy (LATE)

  • Agitation/aggression and behavioral and psychological symptoms of dementia (BPSD)

  • Postoperative delirium / perioperative neurocognitive disorders (elderly)

  • Delirium (hospitalized elderly)

  • Vascular dysfunction in AD / amyloid-related imaging abnormalities (ARIA)

  Other aging-related conditions

  • Sarcopenia / age-related muscle loss (including GLP-1–associated)

  • Obesity (older adults)

  • Menopause / menopausal symptoms

  • Falls and fall-related injuries

  • Pressure ulcers / pressure injuries (including in darkly pigmented skin)

  • Urinary/fecal incontinence (in dementia)

  • Hearing loss (with co-occurring memory concerns)

  • Osteoporosis / vertebral compression fractures

  • Knee osteoarthritis (total knee arthroplasty)

  • Chronic low back pain / chronic pain

  • Obstructive sleep apnea

  • Insomnia

  • Social isolation / loneliness

  • Dysphagia / upper-extremity mobility impairment (self-feeding)

  • Sepsis and ARDS (geriatric)

  • Systemic sclerosis-associated interstitial lung disease (SSc-ILD)

  • Anticholinergic drug-induced cognitive impairment / polypharmacy adverse events

  • Post-acute sequelae of COVID-19 (Long COVID) neurocognitive deficits

  • General biological aging (epigenetic/senescence biomarkers, healthspan)

  • Conditions monitored via digital biomarkers: UTIs, C. difficile infection, GI bleeding, dehydration, constipation, colorectal cancer

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  Interest Areas:

  NIAAA-specific SBIR and STTR interests are tailored toward commercializing technologies that address the unique physiological, social, and clinical challenges of alcohol misuse.

  The NIAAA specifically encourages small business applications in the following high-priority areas:

  • Biosensors and Wearables: Developing non-invasive, wearable devices for real-time alcohol monitoring (e.g., transdermal sensors) that provide more accurate data than self-reporting for research and clinical use.

  • Digital Health and Telehealth: Creating mobile applications, AI-driven platforms, and software for the remote delivery of evidence-based treatments, such as Cognitive Behavioral Therapy (CBT) or recovery support services.

  • Pharmacotherapy Development: Advancing the discovery and testing of new medications to treat Alcohol Use Disorder (AUD), specifically focusing on those with commercial potential and lower side-effect profiles.

  • Diagnostic Tools and Biomarkers: Innovating point-of-care diagnostic tests and biological markers for early detection of alcohol-induced organ damage (liver, brain, heart) and Fetal Alcohol Spectrum Disorders (FASD).

  • Advanced Data Analytics: Utilizing machine learning and big data tools to analyze large health datasets to predict relapse, identify high-risk drinking patterns, or personalize treatment plans.

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

  • Behavioral Interventions: Developing tools designed to improve treatment adherence, reduce stigma, or provide prevention and therapies to treat alcohol use disorder

• National Institute of Allergy and Infectious Diseases (NIAID)

  Interest Areas:

  The NIAID Small Business portfolio supports product development and commercialization in the areas of: 

  • The immune system, microbe biology, and host-microbe interactions, 

  • Diagnostic and prevention strategies 

  • Treatment and cure strategies 

  Indications Of Interest:

  Bacterial infections / antimicrobial resistance

  • Tuberculosis (drug-susceptible, drug-resistant, and latent TB)

  • Nontuberculous mycobacterial pulmonary disease (M. abscessus, M. avium complex)

  • Pseudomonas aeruginosa infections (including in bronchiectasis)

  • Bronchiectasis (with chronic respiratory infection)

  • Sexually transmitted infections (including multidrug-resistant N. gonorrhoeae)

  • Recurrent bacterial vaginosis

  • Burn wound and skin/soft-tissue infections (multidrug-resistant)

  • Healthcare-associated infections / surface biofilms (incl. C. difficile, Candida auris)

  • Acinetobacter baumannii (carbapenem-resistant) infections

  • Klebsiella pneumoniae infections

  • Spontaneous bacterial peritonitis

  • Bloodstream infections

  • Surgical site / post-surgical infections (GI surgery)

  • Clostridioides difficile infection (including with IBD)

  • Cholera

  • Pertussis (whooping cough)

  • Q fever, leptospirosis

  • Secondary bacterial pneumonia (NTHi after influenza)

  Fungal infections

  • Invasive / drug-resistant fungal infections (Candida, C. auris, Aspergillus, Cryptococcus)

  • Invasive aspergillosis

  • Mucormycosis

  • Cutaneous fungal infections / ringworm (dermatophytes)

  • Onychomycosis

  • Pneumocystis (and other DHFR-target fungi)

  • Alcohol-associated hepatitis (fungal/Candida target)

  Viral infections

  • HIV (treatment, prevention, cure/reservoir)

  • SARS-CoV-2 / COVID-19

  • Influenza (seasonal and pandemic)

  • Respiratory syncytial virus (RSV)

  • Human metapneumovirus

  • Chronic hepatitis B (including HIV/HBV co-infection)

  • Hepatitis A

  • Cytomegalovirus (drug-resistant, in transplant)

  • Neonatal herpes simplex virus

  • High-risk human papillomavirus (cervical cancer prevention)

  • Marburg and Ebola virus disease

  • Dengue

  • Powassan virus

  • Prion diseases / transmissible spongiform encephalopathies (CJD)

  Parasitic / vector-borne

  • Malaria

  • Babesiosis

  • Cryptosporidiosis

  • (Mosquito control for dengue, yellow fever, Zika)

  Autoimmune / immune-mediated and allergic diseases

  • Systemic lupus erythematosus / lupus nephritis

  • Sjögren's syndrome

  • Immune thrombocytopenia (ITP)

  • Immune-mediated thrombotic thrombocytopenic purpura (iTTP)

  • Type 1 diabetes

  • Celiac disease

  • Alopecia areata / autoimmune skin diseases

  • Multiple sclerosis

  • Severe allergic asthma

  • Food allergy / peanut allergy

  • Chronic urticaria

  Immunodeficiency / cellular-therapy targets

  • Primary immunodeficiencies / inborn errors of immunity (incl. ADA-SCID, CARD11 gain-of-function)

  • Common variable immune deficiency (CVID)

  • Enzymopathies (e.g., Mucopolysaccharidosis type I / Hurler syndrome)

  • Transplant rejection and graft-versus-host disease (kidney transplant, HSCT)

  Other / cross-cutting

  • Acute radiation syndrome (gastrointestinal ARS)

  • Cyanide poisoning (antidote)

  • Acute respiratory distress syndrome (ARDS)

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  Interest Areas:

  The NIAMS small business program supports research and development of products and services for prevention, diagnosis and treatment of rheumatic, musculoskeletal and skin diseases. The research topics include, but are not limited to, the following: 

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

  2. Musculoskeletal Diseases.  The musculoskeletal system is composed of the skeleton, the muscles, and connective tissues such as cartilage, tendon, and ligament. The NIAMS supports research aimed at improving the diagnosis, treatment, and prevention of diseases and injuries of the musculoskeletal system and its component tissues. The topics in this area include research on musculoskeletal diseases such as osteoporosis, osteoarthritis, muscular dystrophy, and osteogenesis imperfecta; tissue engineered products; orthopedic devices and implants; and sports medicine and fitness. 

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

  Indications Of Interest:

  Muscle / muscular dystrophies

  • Duchenne muscular dystrophy / dystrophinopathies (including Becker)

  • Myotonic dystrophy type 1 (DM1)

  • Limb-girdle muscular dystrophy 2B (LGMD2B) / dysferlinopathies

  • Skeletal muscle loss/trauma (regenerative reconstruction)

  Joints / bone / orthopedic

  • Rheumatoid arthritis

  • Osteoarthritis (including knee OA)

  • Meniscal injuries / post-meniscectomy syndrome / post-traumatic osteoarthritis

  • Arthrofibrosis

  • Distal femoral / traumatic fractures (nonunion)

  • Revision total knee arthroplasty (implant longevity)

  • Diabetic Charcot foot / Charcot osteoarthropathy and osteomyelitis

  • Lumbar interbody fusion / degenerative spine

  • Limb loss / amputation (skeletal prosthesis attachment)

  • Chronic / neuropathic joint pain (RA-associated)

  Skin

  • Psoriasis

  • Acne vulgaris

  • Allergic contact dermatitis

  • Wound healing / surgical flap reconstruction

• National Institute of Biomedical Imaging and Bioengineering (NIBIB)

  Interest Areas:

  The NIBIB Small Business Program aims to translate cutting edge technologies into commercial products to address critical healthcare challenges. Through grants and contracts, the program supports the development of innovative biomedical technologies that improve human health. Areas of interest span biomedical imaging, medical devices, health informatics, diagnostic and therapeutic technologies, and related innovations at the intersection of biology and engineering. Projects should demonstrate strong commercial potential while addressing significant unmet clinical needs in biomedical imaging and bioengineering.

  Specific program guidance includes:

  • Technologies may be demonstrated using a specific indication or model system, but the core innovation must be broadly applicable without significant reengineering. 

  • Applications fall outside NIBIB's mission if the primary focus is

    • developing technologies to elucidate basic biological functions or disease mechanisms, or

    • applying and testing previously developed tools or technologies.

  • Per NOT-EB-21-005, NIBIB only supports early-stage clinical trials, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform technology development. NIBIB will notsupport applications with efficacy, effectiveness, or a post-market concern as an outcome.

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

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

  Indications Of Interest:

  Traumatic internal hemorrhage / occult abdominal bleeding

  • CNS diseases requiring blood-brain-barrier crossing: Alzheimer's disease, Parkinson's disease, glioblastoma, brain metastases

  • Adverse pregnancy outcomes (fetal growth restriction, preeclampsia)

  • Otitis media (pediatric acute otitis media and otitis media with effusion)

  • Critical-illness / surgical organ-function monitoring (and catheter-associated bloodstream infections)

  • Spinal surgery complications (dura / nerve root injury)

  • Bone marrow / hematologic sampling adequacy (diagnostic)

  Note: Several awards (surgical suturing trainer, X-ray detectors, small-animal imager, antibody purification) are general-purpose tools or manufacturing platforms with no specific disease indication.

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  Interest Areas:

  NICHD supports research that includes, but not limited to the following:

  • Reproductive health, including fertility, conception, contraception, and pregnancy

  • Health of women before, during, and after pregnancy, and fetal development and infant survival

  • Typical and atypical development and growth in children and adolescents, including experiences of trauma and critical illness 

  • Gynecologic health and disease; safe and effective therapeutics and devices for children and pregnant and lactating women; dynamics of human populations across the lifespan

  • Optimizing function in people with intellectual, developmental, and physical disabilities

  Indications Of Interest:

  Gynecologic / reproductive / contraception

  • Infertility (IVF, male infertility, tubal patency evaluation)

  • Endometriosis

  • Uterine fibroids (hysterectomy / myomectomy)

  • Vulvodynia / vestibulodynia and chronic pelvic pain

  • Pelvic floor disorders (vaginal stenosis, dyspareunia, vaginismus, vaginal atrophy)

  • Contraception (non-hormonal female, male, and multipurpose prevention against HIV/STIs)

  • Perimenopause / menopause

  • Vaginal cuff dehiscence (surgical complication)

  Maternal / pregnancy

  • Severe maternal morbidity and mortality

  • Maternal / postpartum hemorrhage

  • Preterm / impending labor prediction

  • Adverse pregnancy outcomes (fetal growth restriction, preeclampsia)

  • Labor induction/augmentation and postpartum uterine atony (oxytocin)

  Neonatal / pediatric

  • Preterm infant nutrition (NICU, total parenteral nutrition, human-milk fortification)

  • Necrotizing enterocolitis (NEC)

  • Pediatric injury prevention (side-impact head injury in child safety seats)

  Rare metabolic / genetic / neurodevelopmental disorders

  • Long-chain fatty acid oxidation disorders (LCFAODs)

  • Urea cycle disorders / hyperammonemia

  • Homocystinuria

  • Rare monogenic neurodevelopmental disorders

  Disability / rehabilitation

  • Limb loss / amputation (pediatric and adult prosthetics)

  • Spinal cord injury / tetraplegia

  • Traumatic brain injury / concussion and chronic brain injury

  • Stroke (upper-extremity rehabilitation)

  • Pediatric neuromuscular conditions (mobility / standing wheelchair)

  • Intellectual and developmental disabilities (IDD)

  Child development / behavioral / family

  • Child behavior problems / self-regulation and behavioral sleep problems

  • Effects of high-conflict divorce on children

  Other diagnostic targets

  • Muscle injury (rhabdomyolysis, muscular dystrophy), cardiac injury, and inflammatory myopathies (dermatomyositis, polymyositis) via CPK testing

• National Institute on Drug Abuse (NIDA)

  Interest Areas:

  Consistent with NIH and Presidential priorities, the NIDA Small Business Program supports research and development of innovative medical and non-medical products and services for substance use disorders (SUDs) and adverse health consequences related to non-disordered drug use. Proposed solutions should improve access, affordability, and coordinated care across prevention, diagnosis, treatment, and recovery. NIDA prioritizes scalable solutions deployable within integrated delivery networks across healthcare, criminal justice, workforce, education, housing, and social service systems. Specific areas include, but are not limited to:

  • Novel, mechanism-based treatments addressing the evolving overdose crisis (e.g., synthetic opioids, stimulants, polysubstance use)

  • Best-in-class opioid use disorder treatments that improve retention and outcomes for individuals not adequately served by existing medications

  • Innovative smoking cessation therapies that enhance adherence and long-term effectiveness

  • First-in-class pharmacotherapeutics and medical devices for stimulant and cannabis use disorders

  • Diagnostic tools for detection and quantification of drug exposure

  • Medical devices, including digital diagnostics and therapeutics, and clinical decision support systems supporting SUDs and comorbid mental health conditions, with particular attention to pediatric populations.

  • Digital health technologies addressing health-related social needs

  • Human-biology-based new approach methodologies and other commercial research tools

  • Forensic testing technologies identifying emerging drugs

  • FDA Drug Development Tools and Medical Device Development Tools

  NIDA strongly encourages applications that include early FDA engagement, consideration of regulatory pathways, payer engagement strategies, real-world evidence generation, and plans for sustainable adoption within integrated delivery networks and value-based care models.

  Indications Of Interest:

  • Opioid use disorder (OUD) — the dominant focus (medications, digital therapeutics, monitoring, diagnostics)

  • Substance use disorder (general / polysubstance)

  • Opioid overdose and opioid-induced respiratory depression

  • Opioid withdrawal syndrome

  • Cocaine use disorder

  • Methamphetamine / amphetamine / stimulant use disorder

  • Nicotine dependence / smoking cessation

  • Nicotine vaping dependence (vaping cessation)

  • Cannabis use (youth)

  • Anabolic androgenic steroid / performance-enhancing drug use

  • Xylazine intoxication (including fentanyl-xylazine)

  • Neonatal abstinence syndrome

  • Substance use disorder in co-occurring conditions (e.g., autism spectrum disorder, psychiatric comorbidity)

  Note: Many awards are fentanyl/xylazine detection tools, overdose-detection wearables, and digital therapeutics that all sit under the OUD/SUD umbrella above.

• National Institute on Deafness and other Communication Disorders (NIDCD)

  Interest Areas:

  NIDCD supports research including, but not limited to, the following:  

  • Novel technologies for studying, diagnosing, and treating hearing loss, tinnitus, or balance disorders.  

  • Novel diagnostic tools for testing human chemosensory function throughout the lifespan. 

  • Novel technologies for studying, diagnosing, and treating voice, speech, and language disorders such as laryngeal dystonia (spasmodic dysphonia), phonotrauma, stuttering, dysarthria, developmental language disorders, and aphasia.   

  • Innovative in vivo imaging capabilities that significantly advance visualization, diagnosis, and treatment of communication disorders in the clinic.  

  • Novel systems of augmentative and alternative communication (AAC) for individuals with motor speech impairment, including a brain-computer interface (BCI) prosthesis for communication. 

  • Novel assessments and interventions for late talking children or minimally verbal/ non-speaking individuals. 

  • Novel applications of machine learning / artificial intelligence algorithms in hearing aids, cochlear implants, AAC devices, or for the analysis of voice, speech, and language. 

  Indications Of Interest:

  • Hearing loss (sensorineural and severe-to-profound; cochlear implants and hearing aids)

  • Congenital / genetic hearing loss (e.g., TOMT- and otoferlin-linked)

  • Noise-induced hearing loss (occupational and recreational)

  • Age-related hearing loss / presbycusis

  • Tinnitus (including pulsatile tinnitus)

  • Otitis media with effusion (the leading cause of childhood hearing loss)

  • Newborn / pediatric hearing screening and diagnosis (auditory brainstem response)

  • Olfactory dysfunction / smell disorders

• National Institute of Dental and Craniofacial Research (NIDCR)

  Interest Areas:

  NIDCR supports small business–led development of technologies and products that translate dental, oral, and craniofacial (DOC) research into clinically actionable solutions across the lifespan. Emphasis is on feasibility, validation, regulatory readiness, and commercialization. Projects should align with NIDCR’s goal to rapidly translate oral health innovations toward clinical impact. Early engagement with program staff is encouraged to ensure alignment with mission and priorities. Scientific areas of interest include: 

  • Targeted DOC diagnostics and therapeutic platforms for tooth-related diseases and periodontal/peri-implant conditions

  • Orofacial pain assessment and management technologies, including clinical decision support

  • Oral microbiome-based diagnostics and therapeutic platforms for polymicrobial diseases

  • AI/ML-enabled predictive health and clinical decision support tools for DOC care

  • Advanced dental materials, restorative technologies, and digital manufacturing systems

  • Regenerative medicine technologies for craniofacial and dental tissue reconstruction

  • Immunomodulatory and precision therapeutic delivery systems for oral and craniofacial conditions

  • Digital behavioral and monitoring tools targeting DOC outcomes

  • Real-world evidence and patient outcome data platforms to support clinical adoption, evidence generation, and downstream coverage considerations

  • Implementation and dissemination technologies for priority-population oral health interventions

  • Integrated oral–systemic health assessment and intervention platforms

  • Regulatory and commercialization readiness tooling to support evidence generation, usability, and market adoption

  Indications Of Interest:

  • Dental caries / tooth decay (remineralization, caries arrest, diagnosis)

  • Periodontitis / periodontal disease (alveolar bone loss)

  • Xerostomia / dry mouth (radiation-induced, Sjögren's syndrome, medication-induced, age-related)

  • Radiation-induced oral and salivary gland fibrosis (head and neck cancer)

  • Oral cancer and oral lichenoid / premalignant lesions

  • Oropharyngeal squamous cell carcinoma (HPV-related)

  • Acute and subacute oral/dental pain (opioid-free analgesia)

  • Pulp and dentin damage from decay or trauma (regeneration / endodontics)

  • Tooth loss / dental implants (osseointegration and bone-quality assessment)

  • Oral and craniomaxillofacial bone defects (guided bone regeneration)

  • Craniomaxillofacial reconstruction (congenital, acquired, post-traumatic, and oncologic defects; nasal reconstruction)

  • Infant cranial malformations (e.g., plagiocephaly / craniosynostosis)

  • Obstructive sleep apnea (oral-cavity-based screening)

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  Interest Areas:

  NIDDK is interested in projects that include robust timelines for commercialization, requisite fundraising, and all required regulatory milestones.

  For those projects intended to support completion of research needed for an Investigational New Drug (IND) application, Investigational Device Exemption (IDE), or other regulatory clearance or approval, NIDDK is interested in projects that demonstrate how formal consultation with the U.S. Food and Drug Administration (FDA) has informed the research strategy.

  NIDDK is interested in Phase IIB and Commercialization Readiness Pilot projects that propose to continue the process of developing products that ultimately require clinical evaluation and approval by a Federal regulatory agency, and that position the projects for independence from NIH support after the project period. 

  Indications Of Interest:

  • Type 1 diabetes (monitoring, prevention/delay, bioartificial pancreas, therapeutic antibodies)

  • Type 2 diabetes / general diabetes management (continuous glucose and metabolic monitoring)

  • Obesity and associated metabolic disorders (insulin resistance, dyslipidemia, fatty liver disease)

  • Childhood nephrotic syndrome

  • Glycogen storage disease type 1b (with associated neutropenia and inflammatory bowel disease)

  • Lipodystrophy

  • Variceal bleeding / upper GI hemorrhage (in cirrhosis / portal hypertension)

• National Institute of Environmental Health Sciences (NIEHS)

  Interest Areas:

  NIEHS SBIR/STTR grants help small businesses transform cutting-edge research into developing innovative and commercially viable products such as tools, technologies, assays, or services to translate and communicate environmental health research into improvements in human health. NIEHS SBIR/STTR program uses a combination of research & development, technology transfer, and communication strategies to aid the mission of NIEHS. 
  The institute’s scientific areas of emphasis include, but are not limited to, the following: 
  •    Tools/technologies such as sensors, computational methods, and exposomics approaches  for detecting and assessing human exposures to environmental hazards 
  •    Innovative and/or alternative high-throughput or high-content assays/model systems,  computational toxicology approaches, and other related new approach methodologies (NAMs) for toxicity testing and understanding effects on human health and disease
  •    Tools/methods/applications for evaluating environmental health and safety of engineered nanomaterials and micro/nanoplastics
  •    Biomonitoring technologies   such as point-of-care approaches for personal exposure assessment and exposure mediated biological response biomarkers.
  •    Intervention technologies and precision environmental health approaches to prevent or reduce human exposures or adverse health effects related to environmental stressors
  •    Educational materials to promote or support understanding of environmental health science
  The NIEHS Superfund Research Program (accepting SBIR applications only) focused on detection and remediation technologies for hazardous substances with relevance to Superfund and/or other contaminated sites

  The NIEHS Worker Training Program (accepting SBIR applications only) also participates

  Indications Of Interest:

  • Obesity / metabolic disorders (endocrine-disrupting chemical exposure)

  • Organophosphate/carbamate pesticide toxicity (cholinergic neurotoxicity)

  • PFAS-related health effects (thyroid dysfunction, cancer, developmental toxicity)

  • Particulate matter / air pollution effects on cardiovascular and respiratory health

  • Heavy-metal exposure (arsenic, lead) from mining dust

  • Harmful algal bloom (eutrophication)-related health risks

  • Chemical genotoxicity / cancer risk (susceptibility in sensitive populations)

• National Institute of General Medical Sciences (NIGMS)

  Interest Areas:

  NIGMS supports the development of technologies to address complex and interdisciplinary research questions in i) basic research, ii) clinical areas that impact multiple organs systems and iii) biomedical workforce development/training through educational activities, that may require additional resources.

  Indications Of Interest:

  • Burn injuries and wounds (severity assessment; relevant to infection and hypertrophic scarring)

  Note: The other two awards are general-purpose technologies — long-acting peptide drug delivery (microencapsulation) and lipid-nanoparticle manufacturing for nucleic-acid delivery — with no specific disease indication.

• National Institute of Mental Health (NIMH)

  Interest Areas:

  To advance its mission, NIMH supports small businesses to develop technologies, including, but not limited to, the following: 

  • Neurotechnology development to enhance research on brain structure and function 

  • Central nervous system (CNS) drug discovery/development for treating mental disorders – novel drug screening assays, novel compounds and drug targets; Research & Development (R&D) ranging from compound synthesis up to early stage clinical trials 

  • Novel brain modulation methods/devices as potential therapeutics 

  • Biological markers for CNS dysregulation/function and mental illness - objective, measurable biological indicators of physiological or disease processes to further assess replicability, reproducibility, stability, etc. at the subject level 

  • Digital health technologies – as interventions or service delivery tools, to augment clinical care, and/or to enhance clinical research, and clinical trial design/implementation at the subject/patient level 

  • Technologies addressing basic, behavioral, and implementation science related to people living with HIV – including all areas listed above 

  Indications Of Interest:

  • Depression

  • Anxiety

  • Suicidal behavior / suicide risk and non-suicidal self-injury (including among juvenile-justice-involved youth)

  • Early childhood / child mental health problems (externalizing and internalizing symptoms)

• National Institute of Neurological Disorders and Stroke (NINDS)

  Interest Areas:

  NINDS utilizes the SBIR and STTR programs to enable the commercial development of tools and technologies that serve the NINDS mission space. Priority is given to proposals with the greatest potential to advance the NINDS mission. 

  NINDS is especially interested in the following, in no preferential order:

  1. Novel and innovative technologies that address significant unmet needs 

  2. Technologies in development for their first indication or initial market opportunity

  3. Technologies with a compelling need for federal support, such as those at a stage of development requiring de-risking to attract private investment, New Approach Methodologies (NAMs), and those addressing underserved markets including rare and pediatric disease indications

  4. Under-resourced technologies, indications, markets, and geographical regions within the NINDS SBIR/STTR portfolio and mission space

  5. New applicants pursuing their first SBIR/STTR-funded technology

  6. Applicants with a demonstrated track record of advancing technologies through commercialization milestones

  7. For continuation applications, applicants who have achieved intended outcomes under prior funding

  8. Applications demonstrating robust rigor in their approach and preliminary data

  Indications Of Interest:

  Neurodegenerative

  • Parkinson's disease (including deep brain stimulation programming)

  • Huntington's disease

  • Frontotemporal dementia / frontotemporal lobar degeneration

  • CLN1 Batten disease

  Cerebrovascular

  • Acute ischemic stroke (thrombolysis, cell therapy, and neurorehabilitation)

  Injury / trauma

  • Traumatic brain injury (recovery monitoring and therapeutics)

  • Spinal cord injury

  • Peripheral nerve injuries

  Seizure / pain / headache

  • Epilepsy (including treatment-resistant epilepsy)

  • Migraine (episodic and chronic)

  • Painful diabetic neuropathy / neuropathic pain

  Lysosomal storage / genetic

  • Mucopolysaccharidosis I (Hurler syndrome), IIIB, and IIIC

  Tumors / structural

  • Brain tumors (intraoperative surgical guidance)

  • Schwannoma / NF2-related schwannomatosis

  • Hydrocephalus (ventricular shunt monitoring)

  Note: A few awards are enabling neurosurgical/imaging tools (portable intraoperative MRI, real-time resting-state fMRI) applied broadly across brain disease rather than to a single indication.

• National Institute of Nursing Research (NINR)

  Interest Areas:

  Areas of interest include innovative small business proposals as they relate to NINR research priority areas of intervening on the conditions of daily life that influence health, using multilevel or multi-sectoral approaches to prevent chronic conditions and improve the outcomes of those with chronic conditions, promoting healthy school environments, meaningful engagement of communities at all stages of the research process, and integrating technological advancements, particularly in artificial intelligence (AI), to streamline and improve healthcare outcomes.

  Indications Of Interest:

  • Adolescent and young adult cancer (and febrile neutropenia as the key treatment complication)

  • Work-related musculoskeletal back injuries (occupational injury prevention among direct care workers)

• National Library of Medicine (NLM)

  Interest Areas:

  The NLM Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) program supports the development of biomedical informatics tools and methods which are best disseminated through commercialization.

  The program aims to encourage small businesses to develop innovative technologies, tools, methods, and software platforms that advance:

  • Trustworthy, reproducible, and rigorous biomedical AI

  • Biomedical data infrastructure at scale

  • Sustainable biomedical reference resources and platform science

  • Market innovative human-centered use and impact informed biomedical informatics tools and methods

  Applications which utilize, integrate, or build upon data, resources, and tools fostered by NLM and NIH supported communities are encouraged. 

  Indications Of Interest:

  • Obstructive lung disease (COPD and asthma) — detection and monitoring

• Office of Research Infrastructure Programs (ORIP)

  Interest Areas:

  ORIP supports research projects to develop technology including, but not limited to, the following: 

  • Create, characterize, or improve models of human disease; and develop new approach methodologies (NAMs) to complement or reduce the use of animal models in research. 

  • Preservation, revival and monitoring of cells, tissue, organs or gametes from model systems. 

  • Validate research models to enhance the rigor and reproducibility of pre-clinical studies. 

  • Devices and technologies required for development and maintenance of conventional and NAM biological model systems, including those for advancing the care, welfare, housing, and management of these models; or sensor and monitoring technologies for the surveillance of models or environmental factors that lead to improved rigor and reproducibility for studies using these models.

Are there any additional benefits I would receive?

In addition to funding, companies receive:

• Validation through a competitive federal peer-review process

• Support through the NIH, CDC, and FDA SBIR ecosystem

• Opportunity to advance toward commercialization

• Ability to retain SBIR/STTR data rights for up to 20 years after the award date, consistent with SBIR/STTR policy

The NIH Fast-Track mechanism allows eligible applicants to submit Phase I and Phase II together, potentially reducing the funding gap between phases.

NIH also allows Direct to Phase II applications for companies that have already demonstrated feasibility but did not previously receive a Phase I SBIR or STTR award for that project.

What is the timeline to apply and when would I receive funding?

Open Date (Earliest Submission Date): August 05, 2026.

Application Deadlines (all due by 5:00 PM local time of applicant organization):

• September 05, 2026

• January 05, 2027

• April 05, 2027

For the September 05, 2026 submission cycle:

• Scientific Merit Review: November 2026

• Advisory Council Review: January 2027

• Earliest Start Date: April 2027

For the January 05, 2027 submission cycle:

• Scientific Merit Review: March 2027

• Advisory Council Review: May 2027

• Earliest Start Date: July 2027

For the April 05, 2027 submission cycle:

• Scientific Merit Review: July 2027

• Advisory Council Review: August 2027

• Earliest Start Date: December 2027

The first application deadline is September 05, 2026 by 5:00 PM local time of applicant organization. No late applications will be accepted.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services through participating organizations including:

• National Institutes of Health (NIH)

• Centers for Disease Control and Prevention (CDC)

• U.S. Food and Drug Administration (FDA)

The SBIR program is a congressionally mandated program that supports commercialization of innovative technologies developed by U.S. small businesses. NIH, CDC, and FDA set aside a portion of their extramural research budgets to fund SBIR awards.

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?

The NOFO states that reviewers evaluate applications based on:

• Significance

• Investigator(s)

• Innovation

• Approach

• Environment

Strong applications are likely to:

• Address an important unmet health, scientific, or public health need

• Demonstrate strong scientific and technical merit

• Present a compelling commercialization opportunity

• Show a clear path toward product development and market adoption

• Align closely with the mission and priorities of the target NIH Institute, CDC Center, or FDA Center

• Be led by a qualified team with the expertise needed to execute the proposed work

For Phase II and Fast-Track applications, commercialization potential and market opportunity are specifically evaluated.

Are there any restrictions I should know about?

Key restrictions include:

• Only U.S. small businesses are eligible.

• Foreign organizations are not eligible.

• Applications involving foreign subawards or subcontracts will not be considered for funding.

• Clinical trials are not accepted by certain participating Institutes and Centers, including NIAMS, NIDCR, NCATS, ORIP, and all participating FDA Centers under this NOFO.

• Cost sharing is not required.

• Companies must satisfy applicable SBA performance benchmark requirements.

• Duplicate or highly overlapping applications are not permitted.

• Phase I projects generally require at least 67% of research effort to be performed by the small business.

• Phase II projects generally require at least 50% of research effort to be performed by the small business.

Additional national security, foreign relationship, and foreign ownership restrictions apply and may result in denial of award.

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?

BW&CO can support applicants by:

• Evaluating program fit and Institute alignment

• Identifying the most appropriate NIH, CDC, or FDA component

• Developing the technical narrative

• Building commercialization strategy and positioning

• Preparing budgets and supporting documentation

• Managing submission through the federal application process

• Coordinating reviewer-focused proposal development and compliance review

Additional Resources

Review the solicitation here.