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.

Development of Candidate Medical Countermeasures (MCMs) and Technologies Against Chemical or Radiation/Nuclear (CRN) Threats

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

This NIH opportunity (RFA-AI-27-014) supports the development of medical countermeasures (MCMs) and enabling technologies to address chemical and radiation/nuclear (CRN) threats in civilian settings. The program is administered by NIAID through the Radiation and Nuclear Countermeasures Program (RNCP) and Chemical Countermeasures Research Program (CCRP). It is designed to fund early and preclinical work that can diagnose, mitigate, or treat injuries following exposure.

This is a forecasted opportunity with an Estimated Application Due Date: October 9, 2026. Founders working in radiological, nuclear, or chemical threat preparedness should begin positioning now, as this is a complex NIH cooperative agreement with long lead times.

How much funding would I receive?

Funding amounts are not specified in the solicitation, but we anticipate funding to range from $500k - $2m.

What could I use the funding for?

Funding supports research and development of medical countermeasures and enabling technologies addressing CRN threats, including:

Radiation and Nuclear Countermeasures Program (RNCP):

• Radiation-focused models

• Biomarkers of radiation damage

• Devices to assess and predict injury

• Products to improve survival and reduce morbidity across organ systems

Chemical Countermeasures Research Program (CCRP):

• Preclinical development of products

• Technologies to mitigate or treat injury after exposure to Chemicals of Concern

• Solutions designed for post-exposure, civilian mass casualty settings

All work must align with developing capabilities to diagnose, mitigate, or treat acute and delayed effects of radiation or chemical exposure during or after public health emergencies.

Are there any additional benefits I would receive?

• Not specified in the solicitation.

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

• Estimated Post Date: July 10, 2026

• Estimated Application Due Date: October 9, 2026

• Estimated Award Date: July 1, 2027

• Estimated Project Start Date: July 1, 2027

Additional timeline details are not specified in the solicitation.

Where does this funding come from?

This funding is provided by the National Institute of Allergy and Infectious Diseases (NIAID) on behalf of the NIH.

It is authorized under:

• Sections 301 and 405 of the Public Health Service Act (42 USC 241 and 284)

• Federal Regulations: 42 CFR Part 52 and 2 CFR Part 200

The program is supported by a congressional mandate (Public Law 109-149, Dec. 30, 2005) to advance research addressing chemical and radiological threats.

Who is eligible to apply?

For-profit:

• Small businesses

• For-profit organizations other than small businesses

What companies and projects are likely to win?

Projects that align closely with the stated program goals, including:

• Development of medical countermeasures for radiation or chemical exposure

• Technologies addressing post-exposure treatment in civilian mass casualty scenarios

• Preclinical-stage innovations with clear pathways to mitigating injury or improving survival

• Tools for diagnostics, biomarkers, or injury assessment

Further selection criteria are not specified in the solicitation.

Are there any restrictions I should know about?

• Funding instrument is a cooperative agreement

• No cost sharing or matching requirement

Additional restrictions are not specified in the solicitation.

How long will it take me to prepare an application?

Given this is an NIH cooperative agreement focused on preclinical and translational research, preparation timelines are typically substantial, but exact expectations are not specified in the solicitation.

How can BW&CO help?

BW&CO can support:

• Translating your technology into NIH-aligned positioning

• Mapping your solution to RNCP or CCRP priorities

• Structuring a competitive preclinical development narrative

• Managing the full application process ahead of the October 9, 2026 deadline

Additional Resources

Review solicitation here.

BARDA: Small Molecule Approaches for Rapid and Robust Treatment (SMART) Antiviral Prize

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The Small Molecule Approaches for Rapid and Robust Treatment (SMART) Antiviral Prize is a $100 million, multi-stage prize competition designed to accelerate the development of broad-spectrum small-molecule antivirals targeting viruses in the Flaviviridae and/or Togaviridae families.

The program is designed to move promising antiviral candidates from early concept through preclinical development and toward Investigational New Drug (IND) readiness through staged evaluations and prize funding.

The first entry point is the Concept Stage, where applicants submit a concept paper describing a plan to discover or advance a broad-spectrum antiviral candidate.

Applications for the Concept Stage are open now through May 11, 2026.

Companies developing novel small-molecule antivirals with activity across multiple viruses within these families should evaluate this opportunity quickly if they intend to apply before the May 11, 2026 deadline.

How much funding would I receive?

The SMART Antiviral Prize includes up to $100 million in total prize funding across multiple stages.

Concept Stage funding includes:

• Up to eight prizes of $2.5 million each

• $20 million total prize pool for this stage

Future stages may provide additional funding, including:

• Stage 1 (Hit-to-Lead): up to six prizes of $6 million each

• Funding for later stages is not specified in the provided materials.

What could I use the funding for?

Prize funding is intended to support development of broad-spectrum small-molecule antiviral candidates progressing toward clinical readiness.

Activities supported through the staged competition may include:

• Discovery or advancement of broad-spectrum antivirals targeting Flaviviridae and/or Togaviridae

• Hit validation and identification of promising chemical series

• Lead optimization

• IND-enabling preclinical work

• Development of a data package suitable for Investigational New Drug (IND) submission and human clinical trials

Concept Stage submissions specifically require a concept paper describing the scientific approach and development plan, supported by existing evidence.

Are there any additional benefits I would receive?

In addition to prize funding, participants may receive:

• Visibility and expert feedback from subject-matter experts evaluating submissions

• Access to optional technical meetings with BARDA subject-matter experts for eligible entrants

• Opportunities to collaborate with partners through the prize ecosystem and networking resources

The competition is intended to foster public-private collaboration and accelerate promising antiviral candidates toward early clinical development.

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

Key timeline details include:

• Concept Stage application deadline: May 11, 2026

After submission:

• Applications are evaluated by a panel of subject-matter experts

• Selected entrants receive Concept Stage awards and invitations to advance to later stages

Future stages will require additional technical submissions as candidates advance through hit validation, lead optimization, and IND-enabling work.

Specific timelines for award decisions or funding distribution are not specified in the provided materials.

Where does this funding come from?

The SMART Antiviral Prize is funded by:

• Biomedical Advanced Research and Development Authority (BARDA)

• Within the Administration for Strategic Preparedness and Response (ASPR)

• Part of the U.S. Department of Health and Human Services (HHS)

The prize is administered through the BARDA Accelerator Network’s VITAL Hub.

Who is eligible to apply?

Eligible entrants include:

• Antiviral developers

• Academic groups

• Strategic partnerships and collaborative teams

Applicants must:

• Submit a concept describing a plan to discover or advance broad-spectrum small-molecule antivirals

• Control the relevant intellectual property and have freedom to operate for the proposed concept

Additional eligibility requirements are not specified in the provided materials.

What companies and projects are likely to win?

Winning teams will likely propose antiviral candidates that demonstrate:

• A credible antiviral target and scientific rationale

• A clear development and regulatory strategy

• Strong team capabilities and partnerships

The program is focused on candidates that could become broad-spectrum antivirals active against multiple viruses within the Flaviviridae or Togaviridae families.

Projects that present a clear path toward IND readiness and early clinical development are aligned with the program’s stated objectives.

Are there any restrictions I should know about?

The following restrictions apply to eligible antiviral candidates:

Eligible candidates

• Small-molecule drugs with molecular weight ≤900 Daltons

• Candidates in discovery through IND-enabling preclinical stages

• Broad-spectrum antivirals with activity against multiple pathogens within the Flaviviridae or Togaviridae families

Not eligible

• Biologics or nucleic-acid-based drugs, including peptide-based products or antibody-drug conjugates

• Clinical-stage compounds that have already been investigated in humans

• “One-bug, one-drug” antivirals targeting a single virus without credible broad-spectrum potential

How long will it take me to prepare an application?

The Concept Stage requires a concept paper describing the proposed antiviral discovery or development approach.

The materials indicate that no new data is required, and submissions should rely on existing evidence and a development plan.

Specific preparation timelines or page limits are not specified in the provided materials.

How can BW&CO help?

BW&CO can support teams applying to the SMART Antiviral Prize by:

• Evaluating whether your antiviral candidate aligns with program scope

• Structuring a competitive concept paper and development strategy

• Translating your science into a clear, review-ready proposal aligned with the program’s evaluation criteria

• Helping prepare teams for expert panel review and later technical submissions

How much would BW&CO Charge?

We have both fractional engagements ($250 an hour) and full engagements ($15,000 + 5%) available.

Additional Resources

Review the solicitation here.

Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 - Clinical Trial Not Allowed)

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

This NIH funding opportunity (PAR-25-338) opens a repeated standard R01 grant mechanism to support academic-industrial partnerships that translate scientific discoveries and engineering developments into new technologies, methods, tools, assays, devices, or systems relevant to disease diagnosis, risk assessment, detection, prevention, treatment, or monitoring — with the expectation of translation to use and end users. This NOFO does not allow clinical trials and does not support basic research that lacks a translational component. Multiple standard NIH due dates run through January 8, 2028 (expiration), with recurring application windows (e.g., Feb 5, 2026; Jun 5, 2026; Oct 5, 2026, etc.) — all due by 5:00 PM local time on each date.

How much funding would I receive?

Award budget limit: up to $499,000 per year in direct costs.

1. Maximum project period: 5 years.

2. Number of awards: contingent on NIH appropriations and meritorious applications (not specified).

What could I use the funding for?

Funds may be used to enhance, adapt, optimize, validate, and otherwise translate technologies, methods, assays, devices, or systems that:

• Address problems in biology, pathology, risk-assessment, detection, diagnosis, treatment, or monitoring disease.

• Advance capabilities that are suitable for end users in pre-clinical or clinical research or clinical care.

• Examples include diagnostic/imaging systems, informatics tools, analytical methods, harmonized data methods, shared research resources, and technologies optimized for low-resource settings.

Are there any additional benefits I would receive?

The NOFO does not include special supplements, set-aside support, or technical assistance beyond standard NIH funding. (Not specified in the NOFO.)

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

• Open/earliest submission: January 5, 2025.

• Standard NIH due dates: recurring submission windows including Feb 5, Jun 5, Oct 5 of each calendar year, through January 8, 2028 (expiration). All are due by 5:00 PM local time.

• Applicants should allow time to correct any errors before each deadline.

• Estimated award start dates follow NIH standard review cycles (months after each review).

Where does this funding come from?

• Funding agency: National Institutes of Health (NIH), U.S. Department of Health and Human Services.

• Participating NIH components:

  • National Cancer Institute (NCI)

  • National Eye Institute (NEI)

  • National Institute of Dental and Craniofacial Research (NIDCR)

  • Office of Research on Women’s Health (co-funding support)

Who is eligible to apply?

Eligible applicant organizations include:

• Higher education institutions (public/private).

• Nonprofits (with or without 501(c)(3)).

• For-profit organizations (including small businesses).

• Local/state governments; federally recognized tribal governments.

• Federal agencies; non-U.S. entities (foreign) and foreign components of U.S. organizations.

Eligible individuals: Anyone with the skills/resources to carry out the proposed research as PD/PI.

What companies and projects are likely to win?

Likely competitive projects will:

• Form true academic-industrial partnerships with complementary expertise.

• Target translation of a technology/method toward a defined end-user application.

• Demonstrate a coherent plan to enhance, optimize, validate, or translate the proposed technology.

• Show clear metrics, milestones, and feasibility for implementation or adoption.

• Address problems relevant to participating NIH institutes.

Are there any restrictions I should know about?

• Clinical Trials: Not allowed under this NOFO.

• Commercial production: NOT supported; the grant supports translation up to pre-commercial readiness, not manufacturing.

• Basic research: Projects lacking translation emphasis are non-responsive.

• Applications must conform to NIH research and submission policies (e.g., DMS, registrations).

How long will it take me to prepare an application?

Time depends on readiness of data, partnerships, and NIH registrations (e.g., SAM, eRA Commons). Typical R01 applications require weeks to months of preparation, including:

• Strategic alliance planning

• Preliminary data assembly

• Detailed research strategy

• Budget and justification

• Registrations (SAM/eRA Commons) prior to submission (can take ~6+ weeks).

How can BW&CO help?

BW&CO can:

• Clarify partner roles and narrative strategy for academic-industrial teams.

• Translate technical aims into NIH-aligned specific aims and research strategy.

• Advise on regulatory, translational, and commercialization framing.

• Support budget planning consistent with NIH guidelines.

How much would BW&CO Charge?

We have both fractional engagements ($250 an hour) and full engagements ($13,000 + 5%) available.

Additional Resources

Review the solicitation here.

PAR-26-040: Advancing Bioinformatics, Translational Bioinformatics and Computational Biology Research (R01 Clinical Trial Optional)

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

PAR-26-040 invites research teams to lead transformational advances in bioinformatics, translational bioinformatics, and computational biology. This opportunity from the National Library of Medicine (NLM) supports projects that create cutting-edge methods, tools, and computational approaches for extracting actionable knowledge from complex biological and biomedical data. Applications open April 6, 2026 and follow NIH standard due dates (first due June 5, 2026). This initiative supports scalable, generalizable innovations that accelerate biomedical discovery and improve health outcomes.

How much funding would I receive?

• Direct cost limit: Up to $250,000 per year (applicants must justify budget based on project needs).

• Anticipated total program funding: Approximately $2,500,000.

• Estimated number of awards: 10.

What could I use the funding for?

Fund research projects that:

• Develop new computational methods and tools for bioinformatics and biomedical data science.

• Leverage AI, machine learning, and large-scale computation to interpret diverse biological datasets.

• Produce durable, generalizable artifacts (software, workflows, resources) that benefit the wider research community.

• Enable translational insights with potential impact on health outcomes.

Excluded: incremental tweaks to existing tools, projects outside core bioinformatics/computational biology focus, social/ethical studies unrelated to computational method advancement.

Are there any additional benefits I would receive?

• Projects are expected to produce open science outputs (e.g., FAIR tools, publicly available code, datasets).

• Participation in NIH peer review and community of biomedical informatics researchers.

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

• Standard NIH due dates: June 5, October 5, February 5 recurring through 2029 (all due by 5:00 PM local time of the applicant).

• NOFO expiration date: March 6, 2029.

• Earliest possible project start: July 2026.

Where does this funding come from?

This opportunity is funded by the U.S. Department of Health and Human Services (HHS) through the National Institutes of Health (NIH), specifically the National Library of Medicine (NLM).

Who is eligible to apply?

Eligible applicants include:

• Higher education institutions (public and private).

• Nonprofits (with or without 501(c)(3) status).

• For-profit organizations, including small businesses.

• Local and state governments.

• Tribal governments and organizations.

• Foreign organizations (subject to NIH policies).

Important NIH policy: NIH will not issue awards for applications that include foreign subawards or subcontracts unless submitted to a NOFO specifically for international collaborations.

What companies and projects are likely to win?

Competitive applications will:

• Demonstrate high innovation and impact in computational biology/bioinformatics.

• Deliver tools and methods that are publicly accessible and broadly usable.

• Show rigorous validation and clear plans for dissemination.

• Integrate interdisciplinary approaches and emphasize scalability.

Are there any restrictions I should know about?

• Foreign subawards/subcontracts are not allowed (projects with those elements will be noncompliant).

• Cost sharing/matching is not required.

• The project must align with NLM’s focus areas; non-responsive or tangential projects will not be reviewed.

How long will it take me to prepare an application?

Preparation time varies by complexity, but obtaining organizational registrations (SAM, eRA Commons) alone can take several weeks. Technical application drafting with rigorous computational research plans, data management strategy, and dissemination plans typically requires multiple months of coordinated effort.

How can BW&CO help?

BW&CO can:

• Translate scientific aims into NIH-aligned application narratives.

• Help articulate innovation, significance, and approach clearly.

• Build budget justification and milestone plans that meet NIH expectations.

• Develop data management, dissemination, and impact strategies that strengthen score.

How much would BW&CO Charge?

We have both fractional engagements ($250 an hour) and full engagements for submitting application ($13,000) available.

Additional Resources

Review the solicitation here.

PAR-26-042: Research Grants in Clinical Informatics (R01 Clinical Trial Optional)

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

This funding opportunity from the National Library of Medicine (NLM) at NIH supports investigator-initiated research grants in clinical informatics that develop innovative, generalizable methods and tools to transform complex health data into actionable knowledge and improve decision-making and health outcomes. Applications must be submitted by 5:00 PM local time on one of the standard NIH due dates (next dates include June 5, 2026; October 5, 2026; February 5, 2027, etc.) and the NOFO remains active until its expiration on March 6, 2029.

How much funding would I receive?

• Direct cost limit: Up to $250,000 per year (applicants must justify budget based on project needs).

• Anticipated total program funding: Approximately $2,500,000.

• Estimated number of awards: 10.

What could I use the funding for?

Fund research focused on the design, implementation, and evaluation of clinical informatics tools and methods that:

• Enable data-driven discovery and evidence-based decision-making.

• Transform raw, heterogeneous health data (e.g., EHRs, clinical notes, imaging, patient-generated data) into usable knowledge.

• Produce scalable, reproducible, domain-independent approaches broadly applicable across clinical settings.

• Improve clinical workflows, predictive analytics, decision support, interoperability, and precision health.

Are there any additional benefits I would receive?

• Potential to accelerate scientific insights and inform future research beyond the project period.

• Alignment with NLM’s mission to advance data-driven biomedical research and healthcare.

• Software, datasets, methods, and resources are expected to be disseminated widely to maximize impact.

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

• Standard NIH due dates: June 5, October 5, February 5 recurring through 2029 (all due by 5:00 PM local time of the applicant).

• NOFO expiration date: March 6, 2029.

• Earliest possible project start: July 2026.

Where does this funding come from?

This opportunity is funded by the U.S. Department of Health and Human Services (HHS) through the National Institutes of Health (NIH), specifically the National Library of Medicine (NLM).

Who is eligible to apply?

Eligible applicants include:

• Higher education institutions (public and private).

• Nonprofits (with or without 501(c)(3) status).

• For-profit organizations, including small businesses.

• Local and state governments.

• Tribal governments and organizations.

• Foreign organizations (subject to NIH policies).

Important NIH policy: NIH will not issue awards for applications that include foreign subawards or subcontracts unless submitted to a NOFO specifically for international collaborations.

What companies and projects are likely to win?

Competitive applications will:

• Address transformative clinical informatics challenges and align tightly with NLM goals.

• Demonstrate innovation, scalability, and generalizability beyond narrow disease-specific problems.

• Provide clear plans for evaluation, dissemination, and sustainability of tools and methods.

• Present metrics for impact and comparison to existing approaches.

Are there any restrictions I should know about?

• Projects must be clearly focused on clinical informatics and not be incremental improvements of existing tools.

• Projects primarily focused on social determinants of health or ethical/legal/social issues are considered non-responsive.

• Applications with foreign subawards/subcontracts are noncompliant and will not be reviewed.

How long will it take me to prepare an application?

Preparation time depends on your readiness, but NIH typically recommends starting months before the nearest due date to:

• Complete registrations (Grants.gov, eRA Commons, SAM/NCAGE, UEI).

• Develop a rigorous research plan with evaluation and dissemination strategies.

• Coordinate any institutional approvals.

Begin ASAP to ensure you meet the due date’s 5:00 PM local time deadline.

How can BW&CO help?

BW&CO can:

• Translate scientific aims into NIH-aligned application narratives.

• Help articulate innovation, significance, and approach clearly.

• Build budget justification and milestone plans that meet NIH expectations.

• Develop data management, dissemination, and impact strategies that strengthen score.

How much would BW&CO Charge?

We have both fractional engagements ($250 an hour) and full engagements for submitting application ($13,000) available.

Additional Resources

Review the solicitation here.

ARPA-H - Critical Illness Immunological Reprogramming and Control Point Learning Engine (CIRCLE)

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The Advanced Research Projects Agency for Health (ARPA-H), Resilient Systems Office (RSO), has released an Innovative Solutions Opening (ISO) for the Critical Illness Immunological Reprogramming and Control Point Learning Engine (CIRCLE) (Solicitation Number: ARPA-H-SOL-26-139, Amendment 1).

CIRCLE seeks to reduce ICU stay length and improve outcomes by developing integrated systems that:

• Measure tissue-specific immuno-inflammatory biomarkers in near real time

• Build mechanistic, patient-specific computational “digital twin” models

• Modulate immune dysfunction using personalized therapeutic interventions

The program aims for a 25% reduction in average ICU stay length and progression toward FDA-compliant systems and clinical adoption.

Solution Summaries are due March 30th.

How much funding would I receive?

The solicitation states that multiple awards are anticipated.

• Awards will be made as Other Transaction (OT) agreements.

• The number of awards will depend on the quality of proposals and the availability of funds.

• Individual award amounts are not specified in the solicitation.

• Cost share requirements are not specified in the solicitation.

ARPA-H reserves the right to:

• Fund proposals in phases

• Segregate portions into pre-priced options

• Make partial awards

• Make no awards at all

What could I use the funding for?

Funding supports the integrated development of a Measure–Model–Modulate system for critical illness, including:

TA1 – Measurement

• Biomarker discovery and validation

• Tissue-specific immune monitoring technologies

• Data generation suitable for mechanistic modeling

TA2 – Modeling

• Mechanistic computational digital twin models

• In silico clinical trials

• FDA-compliant digital twin platforms

TA3 – Modulation

• Repurposing FDA-approved immunomodulatory therapies

• Development of novel immune-modulating approaches (if justified)

• Pre-clinical and clinical validation

Associate Performers (AP1, AP2, AP3)

• Data infrastructure and standards (AP1)

• Regulatory-compliant digital twin validation environment (AP2)

• ICU-realistic validation infrastructure and clinical trial support (AP3)

Projects must focus on immuno-inflammatory mechanisms common across critical illness and integrate into ICU workflows.

Are there any additional benefits I would receive?

CIRCLE performers will receive:

• Access to ARPA-H resources supporting regulatory approval

• Access to clinical trial consortia to accelerate FDA approvals

• Integration into a shared CIRCLE database that will ultimately become a public resource

• Structured cross-team collaboration across TAs and APs

• Government Purpose Rights (GPR) for certain deliverables

• Potential flexible IP treatment for commercially sensitive technologies (with approval)

Open-source development is highly encouraged using permissive licenses (e.g., CC-BY, BSD, MIT, Apache 2.0).

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

Key deadlines (Eastern Time):

• Proposers’ Day: Wednesday, March 11, 2026

• Solution summary submission: Monday, March 30, 2026, 1:00 PM

• Questions & Answers (Q&A) submission: Friday, May 22, 2026, 1:00 PM

• Proposal submission: Thursday, May 28, 2026, 1:00 PM

Deadlines will be strictly enforced.

Period of Performance

The program includes milestones extending up to 5 years from award date, including:

• 3 months: Coordination plans and metric establishment

• 6 months: Research plan finalization and approvals

• 1–3 years: Model development, calibration, validation

• 4–5 years: Integrated system validation and first-in-human adaptive platform trial

Funding timing after selection is not specified in the solicitation.

Where does this funding come from?

Funding comes from:

• Advanced Research Projects Agency for Health (ARPA-H)

• Resilient Systems Office (RSO)

Solicitation Number: ARPA-H-SOL-26-139 (Amendment 1)

Awards will be issued as Other Transaction (OT) agreements.

Who is eligible to apply?

Eligible proposers include:

• Universities

• Non-profit organizations

• Small businesses

• Other than small businesses

FFRDCs and U.S. Government entities:

• May not respond as prime or sub-performers

• May engage with ARPA-H separately under specific conditions

Non-U.S. entities:

• May participate if compliant with applicable laws and regulations

• Awards will not be made to entities organized under the laws of a covered foreign country, foreign entities of concern (per CHIPS and Science Act), or individuals involved in a Malign Foreign Talent Recruitment Program.

All proposers must disclose Organizational Conflicts of Interest (OCI).

What companies and projects are likely to win?

Selectable proposals will:

• Directly address CIRCLE’s goals and objectives

• Integrate measurement, modeling, and modulation components

• Present realistic commercialization plans (for TA proposals)

• Demonstrate regulatory strategy and transition planning

• Provide strong interdisciplinary integration

• Include complete and realistic budgets

Proposals are evaluated individually (not comparatively) based solely on published evaluation criteria.

Budgets that are unrealistically high will be viewed unfavorably.

Are there any restrictions I should know about?

Key restrictions include:

• Funding cannot be used for human subjects research until all approvals are granted.

• Animal research requires IACUC approval prior to incurring costs.

• Performers must comply with federal human subjects and animal welfare regulations.

• Certain software and system components must be delivered with Government Purpose Rights.

• ARPA-H may impose publication restrictions if research involves sensitive information.

• All APIs must use open standards (e.g., REST, JSON, JSON-LD) unless otherwise approved.

• Existing data standards (e.g., HL7, FHIR, DICOM, LOINC, SNOMED CT) must be used where applicable.

Non-conforming proposals may be rejected without further review.

How long will it take me to prepare an application?

The solicitation warns that parts of the submission process may take from one business day to one month to complete.

Given the complexity of:

• Multi-TA integration

• Regulatory planning

• Data standards compliance

• Commercialization strategy

• Cross-team coordination

Companies should expect a significant preparation effort. The exact preparation time will depend on team readiness and prior integration planning.

How can BW&CO help?

BW&CO can support you by:

• Structuring your technical narrative around the Measure–Model–Modulate framework

• Stress-testing alignment with evaluation criteria

• Translating complex science into a fundable ARPA-H narrative

• Designing commercialization and transition strategies

• Supporting budget justification and value positioning

• Coordinating multi-institutional team structures

• Preparing for OT negotiation

CIRCLE is a systems-level, high-integration program. Positioning and coherence across TAs and AP interfaces will be critical.

How much would BW&CO Charge?

We have both fractional engagements ($250 an hour) and full engagements for submitting the Solution Summary ($7,500) available.

Additional Resources

Review the solicitation here.

BRAIN Initiative: Theories, Models and Methods for Analysis of Complex Data from the Brain

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The NIH BRAIN Initiative: Theories, Models and Methods for Analysis of Complex Data from the Brain (RFA-DA-27-004) is a competitive R01 research grant supporting the development of innovative theories, computational models, and analytical tools to advance understanding of brain function from complex neuroscience data. This funding is part of the NIH BRAIN Initiative, aiming to transform neuroscience through quantitative, predictive frameworks. Applications are due as soon as October 6th, 2026.

How much funding would I receive?

Application budgets are not limited, but NIH expects direct costs of approximately $150,000 – $350,000 per year.

Awards are for up to 3 years of support.

NIH anticipates funding multiple awards each cycle, depending on score and available appropriations.

What could I use the funding for?

Theories of brain function

Development of predictive, mathematically-grounded theories explaining how behavior arises from neural structure, circuit dynamics, computation, cognition, and environmental variables. Examples include:

• Theories of embodied computation that anchor the neural representation of sensory, cognitive, and motor variables to an individual/animal’s ongoing interactions with the environment through dynamic, moment-to-moment, circular, and iterative processes.

• Theories that bridge multiple scales of spatial organization (e.g., molecular, synaptic, cellular, circuit, systems) and/or temporal dynamics (e.g., milliseconds to lifetimes) to generate testable predictions of brain-behavior links or cognitive function.

• Theories linking circuit dynamics and function to specific properties of cell types or anatomical connections, identifying general rules, scaling principles, and contributions of specific circuit motifs to computation.

• Theories elucidating fundamental computational principles employed by biological neural networks, potentially drawing inspiration from or contrasting with artificial networks, but firmly grounded in biological constraints (e.g., neuronal/synaptic dynamics, connectivity patterns, metabolic limits, specific cell-type properties, learning rules).

Computational models of neural and behavioral dynamics

Development and validation of quantitative models that are mechanistically grounded, interpretable, predictive, and rigorously tested against neural and behavioral data. Examples include:

• Mechanistic, interpretable, and/or predictive models of neural dynamics, circuit function, or brain-behavior links that integrate biological details with computational principles.

• Models that integrate knowledge across multiple levels (e.g., linking behavior to neural population activity and cellular/circuit properties).

• Models of cognitive processing (e.g., sensory coding, decision-making, motor control, learning, memory) that are mechanistically grounded in identified circuit elements and dynamics, make quantitative predictions, and are rigorously tested against neural and behavioral data, potentially under ecologically relevant or challenging conditions (e.g., limited information, dynamic environments).

• Development and analysis of neural-inspired computational architectures or artificial intelligence/machine learning systems explicitly designed to gain novel insights into brain function.

Methods for complex data analysis

Development of novel computational, statistical, and analytical techniques designed to extract key insights from complex, large-scale neuroscience datasets. Examples include:

• Development of innovative and scalable computational/statistical methods for dimensionality reduction, identifying latent structure, disentangling contributing factors (e.g., sensory, motor, cognitive, state variables), extracting key dynamical features, or characterizing information flow within large, complex neural and behavioral datasets.

• Novel approaches for principled data fusion and assimilation to quantitatively integrate heterogeneous datasets (e.g., linking behavior with multi-regional activity, anatomical connectivity, and cell-type information) to infer new theories of brain function, or to constrain and validate multi-scale computational models.

• Novel statistical/signal processing methods (e.g., component analysis, graphical models, compressed sensing) to track structure in neural data and link to biophysical signals for mechanistic insights across scales.

Are there any additional benefits I would receive?

• Collaboration with NIH program staff and participation in the broader BRAIN Initiative network.

• Tools developed are expected to be shared with the neuroscience community, enhancing visibility and impact.

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

Application Due Dates (all by 5:00 PM local time):

• Cycle 2: October 6, 2026

• Cycle 3: October 6, 2027

Expiration of this NOFO: November 9, 2027

Following review, awards generally begin in March–July of the year after submission.

Where does this funding come from?

This funding is provided by the National Institutes of Health (NIH) through multiple participating Institutes and Centers under the NIH BRAIN Initiative, including NIDA, NEI, NIA, NIAAA, NIBIB, NICHD, NIDCD, NIMH, NINDS, and NCCIH.

Who is eligible to apply?

Eligible applicant organizations include:

• Higher Education Institutions

• Nonprofit organizations

• For-profit organizations (including small businesses)

• Local/state governments and tribal governments

• Foreign organizations (with restrictions on foreign subawards)

• Other research or non-profit entities

Eligible individuals are those qualified to lead the proposed research.

What companies and projects are likely to win?

Strong applicants typically:

• Propose novel and rigorous theoretical or computational frameworks.

• Demonstrate deep expertise in neuroscience, modeling, or computational analysis.

• Have clear plans to validate and share tools with the research community.

• Show relevance to BRAIN Initiative goals and the integration of complex datasets.

Are there any restrictions I should know about?

• Clinical trials are not allowed—only research on theory/model/method development.

• Proposed work must go beyond simple data collection and focus on quantitative theories or analytical tools.

• Foreign subawards are not permitted; collaborations must be unfunded or through other compliant mechanisms.

How long will it take me to prepare an application?

Plan 4-5 months minimum for:

• Concept development

• Budget preparation

• Letters of support and team coordination

• Registering with Grants.gov and eRA Commons (if not already completed)

NIH registration processes can take 6+ weeks, so start early.

How can BW&CO help?

BW&CO can assist with:

• Translating your science aims into NIH-ready specific aims.

• Coordinating NIH format and submission requirements.

• Aligning proposal with BRAIN Initiative priorities.

How much would BW&CO Charge?

We have both fractional engagements ($250 an hour) and full engagements ($13,000 + 5%) available.

Additional Resources

Review the solicitation here.

NIDDK: Advancing Research on the Application of Digital Health Technology to the Management of Type 2 Diabetes

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

NIH/NIDDK is seeking investigator teams to lead clinical trials testing digital health technologies in Type 2 Diabetes management. This R01 requires a clinical trial and aims to build evidence on how digital tools (e.g., continuous glucose monitors, mobile apps, telehealth, wearables) can improve glycemic and related outcomes in people with Type 2 Diabetes. Applications are due October 6, 2026 by 5:00 PM local time — plan ahead to prepare a full clinical trial proposal that adheres to NIH requirements.

How much funding would I receive?

Funds anticipated: Direct costs ~

• $1.5M in FY2026,

• $3.0M in FY2027-2030,

• $1.5M in FY2031.

Award budget: Not capped — must reflect actual needs of the proposed clinical trial project.

Project period: Up to 5 years.

What could I use the funding for?

General principles:

• Multimodality DHT interventions that for example, combine CGM concurrently with other digital interventions in a virtual remote continuous care intervention, though not required, are of particular interest to this NOFO.

• All investigators are expected to include meaningful engagement approaches with the relevant research population in designing and implementing the proposed trial. This may involve engagement with patients, family members or caregivers, community members, community-based organization, clinicians and other care providers, health care systems, or other relevant partners throughout the research process. Meaningful engagement must entail more than focus groups, surveys, or other activities where partners are only involved as participants or respondents. Engagement must be designed to ensure that the research is practical and aligns with partners' preferences and values. Meaningful collaboration will lead to optimal trial recruitment and conduct as well as potential for future dissemination and sustainability. 

• Multiple digital interventions have applicability to management of both T1 and T2 diabetes and these DHT interventions are of interest to this NOFO.

• Partnering with industry providers of virtual diabetes clinic offerings is allowed but not required.

• Clinical trials funded in response to this NOFO are expected to provide efficacy data that will enable future large multicenter clinical effectiveness studies on the application of DHT to PWD.

Examples of DHT interventions to be tested include, but are not limited to:

• Continuous glucose monitoring:

  • Studies on the efficacy of CGM in T2D, including in PWD not taking insulin

  • Studies on the utility of CGM in persons with prediabetes, for example, interventions that prevent the progression of prediabetes to diabetes

  • Studies examining the role of CGM in monitoring and adapting dietary interventions

  • Studies on the dose and duration of CGM usage necessary to effect change in health activation and healthy behaviors

  • Studies to assess and promote the accessibility, adoption and sustainability of CGM interventions

  • Studies assessing and improving the integration of CGM into clinic workflow, particularly in primary care settings

• Activity monitoring:

  • Studies examining the role of digital monitoring of activity on improvement of glycemia and other metabolic parameters in PWD

• Digital nutritional monitoring

  • The use of mobile applications to facilitate measures of macronutrient content of meals in PWD, and the impact of these interventions on diabetes-specific outcomes.

• Telemedicine, directed text messaging, patient portals, and peer-support

  • Studies assessing the incorporation of virtual communication into a multimodality virtual diabetes clinic model

  • Studies examining the influence of digital methods of multi-touchpoint peer support on glycemic and non-glycemic diabetes-specific outcomes

• Gaming and gamification

  • Studies examining the effect of digital gamification on the uptake and sustained adoption of diabetes education to improve knowledge and promote self-care behaviors (dietary, activity, and medication adherence) in a manner that improves diabetes-specific outcomes

• DHT adoption and sustainment

  • Studies examining factors predicting and improving patient engagement, adoption, and sustained use and utility of DHT interventions in PWD, and phenotyping according to acceptance of different modalities of DHT (CGM, wearables, telehealth, etc.) 

  • Studies examining the role of interventions to improve access of DHT for all PWD; to evaluate, measure, and improve digital literacy; and examine the influence of health beliefs and trust in the HCS on the successful utilization of all forms of DHT, including telemedicine 

  • Studies examining the influence of DHT interventions on patient engagement, self-empowerment, diabetes distress, and quality of life using validated measures.

  • Studies including a specific aim to determine the cost-effectiveness of specific DHT interventions in PWD 

  • Studies examining the effect of incentivizing PWD, providers and the health care system to incorporate DHT into diabetes management 

  • Studies examining the role of digital health navigators, including AI-based systems, in improving the acceptability and sustainability digital health interventions in PWD 

Are there any additional benefits I would receive?

• Potential to position your digital health intervention for future large multicenter effectiveness studies if early clinical evidence is strong.

• Grant support includes access to NIH peer review and scientific oversight.

Note: There’s no letter of intent required.

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

Posted Date: September 17, 2025

Application Due: October 6, 2026 by 5:00 PM local time

Where does this funding come from?

NIH — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the U.S. Department of Health and Human Services.

CFDA: 93.847 — Diabetes, Digestive, and Kidney Diseases Extramural Research.

Who is eligible to apply?

Eligible domestic applicants include:

• Higher education institutions (public/private)

• Nonprofits (with or without 501(c)(3) status)

• For-profit organizations (including small businesses)

• Local and state governments

• Tribal governments/organizations

• Public housing authorities

• Independent school districts

• U.S. Federal agencies are eligible

Foreign organizations are NOT eligible.

What companies and projects are likely to win?

Strong proposals will have:

• A clearly defined clinical trial plan with measurable outcomes.

• Meaningful patient, provider, and community engagement integrated into design and implementation.

• Digital interventions that are ready for testing, not just conceptual.

• Evidence of feasibility and mechanism for adoption in real-world settings.

Are there any restrictions I should know about?

Not responsive:

• Projects developing new digital devices or algorithms.

• Studies focused on automated insulin delivery, artificial pancreas, or hybrid closed-loop tech.

• Research using DHT data only for subtyping/classification.

• Mechanistic trials that are not testing an intervention’s effectiveness.

How long will it take me to prepare an application?

Typical NIH R01 applications take several months to:

• Develop a rigorous clinical trial design,

• Form research team + collaborations,

• Draft research strategy + human subjects sections,

• Complete registrations (SAM, eRA Commons).

Most institutions begin 6-12 months before due date.

How can BW&CO help?

BW&CO can assist with:

• Translating this technical RFA into a clinical trial proposal roadmap.

• Crafting aims, hypotheses, and outcomes tables tailored to NIH review criteria.

• Aligning digital intervention strengths with NIH priorities.

• Supporting human subjects/clinical trial documentation and compliance.

How much would BW&CO Charge?

We have both fractional engagements ($250 an hour) and full engagements ($13,000 + 5%) available.

Additional Resources

Review the solicitation here.

Development of Radiological/Nuclear Medical Countermeasures (MCMs) And Biodosimetry Devices

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institute of Allergy and Infectious Diseases (NIAID) is actively seeking proposals to develop radiological/nuclear medical countermeasures (MCMs) or biodosimetry biomarkers and devices to support response to a radiological or nuclear public health emergency. This is a cost-reimbursement contract opportunity, not a grant, and is intended to advance technologies that reduce mortality, guide triage, and improve treatment decisions after radiation exposure. Proposals are due May 4th, 2026.

How much funding would I receive?

• Total contract value: Not specified (listed as “TBD” in the solicitation)

• Contract type: Cost-reimbursement with fixed fee

• Base period funding: TBD

• Option periods: Up to two option periods, funding TBD

Because dollar amounts are not pre-set, funding levels will depend on scope, cost realism, and negotiation with NIAID.

What could I use the funding for?

Funding must support one of the two objectives below.

A. Radiological/Nuclear Medical Countermeasures (MCMs)

Funding may be used to develop safe and effective MCMs that:

• Mitigate and/or treat normal tissue injuries caused by ionizing radiation

• Reduce radiation-associated mortality or major morbidities

• Are efficacious 24 hours or later post-exposure (MCMs intended for immediate post-exposure use are generally excluded, unless otherwise noted in the objectives)

B. Biodosimetry Biomarkers and Devices

Funding may be used to advance biodosimetry biomarkers and/or devices that:

• Inform triage and treatment strategies

• Are suitable for use during a radiation public health emergency

Allowable Cost Categories (with Contracting Officer approval where required) include:

• Personnel and research labor

• Subcontracts and consultants

• Travel (including foreign travel)

• Patient care costs

• Equipment and materials

• Printing and reporting

• Research-related conferences and meetings

Are there any additional benefits I would receive?

In addition to funding, awardees receive:

• A direct contractual relationship with NIH/NIAID

• Eligibility for option period extensions at the government’s discretion

• The ability to generate patents, subject to federal invention regulations

• Increased credibility for future BARDA, NIH, and DoD opportunities

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

• Solicitation issued: February 10, 2026

• Questions due: March 3, 2026 (recommended)

• Proposal deadline: May 4, 2026 at 3:00 PM ET

• Contract period of performance: TBD

• Funding start: After award and contract execution (date not specified)on maturity or need

Where does this funding come from?

This funding is provided by the National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health (NIH), U.S. Department of Health and Human Services.

Who is eligible to apply?

Eligible applicants include:

• For-profit companies

• Small businesses

• Nonprofits and research institutions

• Universities

• Domestic and foreign entities

Applicants must be registered in SAM prior to award.

What companies and projects are likely to win?

NIAID is looking for teams that:

• Have strong scientific and technical rationale

• Address clearly defined unmet needs in radiation response

• Can demonstrate feasible development and execution plans

• Align tightly with the Research and Technical Objectives in the solicitation

Projects are evaluated primarily on technical merit, relevance to agency priorities, and availability of funds.

Are there any restrictions I should know about?

Key restrictions include:

• You may only submit one focus per proposal (MCM or biodosimetry)

• Certain costs require prior Contracting Officer approval

• Strict compliance with human subjects, animal welfare, data sharing, and publication policies

• Funds may not be used for prohibited activities (e.g., abortion, human embryo research, needle exchange, promotion of controlled substances legalization)

How long will it take me to prepare an application?

Most companies should plan for 8–12+ weeks to prepare:

• A full technical proposal and Statement of Work

• A detailed cost proposal and supporting documentation

• Required representations, certifications, and attachments

How can BW&CO help?

BW&CO can:

• Translate the BAA into a clear win strategy

• Define scope, milestones, and budget that survive NIH negotiation

• Draft or review the technical and business proposals

• Ensure compliance with NIH contract requirements

• Position your company for option periods and follow-on funding

How much would BW&CO Charge?

Fractional support is $300 per hour.

For startups, we offer a discounted rate of $250 per hour to make top-tier consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

Additional Resources

Review the solicitation here.

NIH STTR RFA-DA-25-047: Seeking Products to Address Social Needs Impacting Substance Use Disorders (SUD)

Executive Summary:

The National Institute on Drug Abuse (NIDA) is awarding up to $2.0 million per project for U.S. small businesses to develop technologies addressing social needs that impact substance use disorders (SUD), excluding alcohol use disorder. Applications are due March 13, 2026. Companies should start preparing at least 16 weeks prior to ensure registration and submission compliance. Partnership with a research organization is required.

How much funding would I receive?

$314,363 for Phase I projects (up to 6 months).

What could I use the funding for?

A variety of products addressing the individual-level factors of health-related social needs (HRSN) should be considered to confront SUD. Additionally, technology, such as telemedicine and mobile health applications, provide an opportunity to address HRSN with the ability to provide tested, accessible, and ongoing solutions for individuals who are the most at-risk for these risk factors that impact SUD. According to the Substance Abuse and Mental Health Services Administratio (SAMHSA), technology has several advantages in addressing SUD including decreased waiting periods, decreased stigma impact and increased privacy. The advantages of technology are also exhibited in its capability to make treatment services more accessible and convenient, which can aid to improve SUD outcomes and reduce disparities.

Regarding this NOFO, a product is any source of value for the end-users and customers. A product can be a physical/tangible device as well as digital services, software as a service, or non-physical/non-tangible products (including but not limited to digital applications, digital platforms, or service models). These and other comparable examples could be considered eligible products. Products can be the result of original scientific research, recycled existing technology for SUD, extension of an observation into SUD area, development of a new business model or distribution/delivery channel that reveals currently unseen value, or the delivery of a product or service to disregarded consumers.

The National Institute on Drug Abuse (NIDA) supports the development of evidence-based SUD care and treatment technology from multiple funding opportunities published elsewhere. The eligible small businesses can submit applications focusing on products that reduce costs, time, and/or increase access in addressing HRSN including, but not limited to, housing instability, non-medical transportation, food insecurity, utility needs, and personal safety. The products should provide the best feasible and accessible opportunities for the intended end-users to measurably improve their HRSN and SUD. Products of interest that address, but are not limited to, the following HRSN include:

• Access to housing services.

• Soft skills development and/or job training (e.g., in entrepreneurship, literacy, financial literacy, IT skills) for employment.

• Stigma and nurture compassion.

• Family healthy behaviors, social skills, community opportunities, and productive social involvement.

• Social stability (community, tradition, faith, family), self-regulation, and resilience.

• Well-being (mental, physical, spiritual), communal belonging, and positive productivity.

• Social support networks for recovery, engagement with care, and/or access to needed services.

• Successful community reintegration for formerly incarcerated people.

• Social needs service engagement and coordination among justice-involved organizations.

• Employer education to hire, retain, and facilitate treatment for employees seeking help for SUD.

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 STTR 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?

• Next Application Deadlines: March 13, 2026

• Scientific Review: July following submission

• Council Review: October

• Earliest Start Date: December of the same year

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.

• Must partner with a nonprofit research institution.

What companies and projects are likely to win?

Projects that demonstrate:

• Measurable improvement in one or more social determinants of health affecting SUD outcomes.

• Use technology (digital, AI-enabled, or connected health tools) to reduce costs, stigma, or access barriers.

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Align with NIDA’s goals to integrate behavioral health and social needs solutions into recovery ecosystems

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 partner with a research institution who performs a minimum of 30% and maximum of 60% of the work.

• 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

View the RFA Here