NICHD Small Business Programs: Considerations, Contacts, and Priorities

Contact: Courtney Gallen, Ph.D. 

Learn more about CDBB portfolio/priorities and CDBB research programs. Topic areas of interest include:

• Bilingual and biliteracy development
• Measures of neurodevelopment, including those specific to typically and atypically developing children ages birth through pre-kindergarten, and children from bilingual or multilingual homes
• Pediatric primary care behavioral and health promotion interventions, with a focus on child and adolescent health outcomes
• Psychosocial adjustment for individuals in high-risk environments, including measures of developmental factors and mechanisms that promote short- and long-term psychosocial adjustment
• School readiness skills and practices in economically and socially disadvantaged children, with a focus on executive functioning, as well as measures of home, child care, and preschool environments
• Learner outcomes for those struggling with reading, writing, and mathematics
• Assessment and enhancement of reasoning development skills (e.g., quantitative, deductive, inductive, causal), including those sensitive to contributing factors (e.g., biobehavioral, environmental, cultural, academic, and cognitive factors)
• Inclusion of typically developing or at-risk infants, toddlers, and children in neuroimaging activities

Contact: Steven C. Kaufman, M.D., M.S.

Learn more about CRB portfolio/priorities and CRB research programs. Topic areas of interest include:

• Fertility regulation for men and women that are safe, effective, inexpensive, reversible, and acceptable, with priority given to nonhormonal and on-demand methods
• Novel chemical compounds as potential contraceptives
• Multipurpose technologies that prevent sexually transmitted infections, such as HIV, as well as pregnancy

Contact: Mahua Mukhopadhyay, Ph.D. 

Learn more about DBCAB portfolio/priorities and DBCAB research programs. As a reminder, DBCAB does not support clinical trials through the SBIR/STTR program. Topic areas of interest include:

• New model systems (animal or other) to study developmental mechanisms and causes of structural congenital anomalies
• In vivo imaging of developmental processes (cell and tissue dynamics) and gene expression
• Antibodies, novel ligands, and other probes to facilitate understanding of typical and atypical embryonic development in model organisms
• Quantitative measurement of physical properties of cells/tissues in vivo during development
• Studies of metabolomics in developing vertebrate embryos
• Systems biology studies of embryonic development and structural congenital anomalies
• High-throughput chemical screening (including small molecules) for structural congenital anomaly research
• Collection and analyses of data generated using medium- to high-throughput screening platforms in model systems (model organisms, cell-based models)
• Collection, mining, and analyses of genomic and phenotypic data from children affected with structural congenital anomalies, and cross-analysis with model organism data
• Computational biology, including user-friendly options for novices, to analyze large-scale human and other datasets associated with structural congenital anomalies
• Generation and analyses of data related to wound healing and regenerative responses across animal species
• Activation and mobilization of endogenous/adult stem cells to promote in vivo tissue regeneration
• Limb regeneration in higher vertebrates, including mammals, that might otherwise lack the capacity for regeneration
• Screening for small molecules in human Embryonic Stem Cells or Induced Pluripotent Stem Cells (iPSCs) and disease specific iPSCs for targeted modification of regulatory networks affected in structural birth defects
• Regenerative medicine, including iPSC-based options, in the context of structural birth defects

Contact: Clara Cheng, Ph.D. 

Learn more about FIB portfolio/priorities and FIB research programs. Topic areas of interest include:

• Reproductive and developmental processes, including gamete and early embryo development, and reproductive tract development
• Production, identification, and use of healthy gametes as well as advancing preservation of human gametes
• Systems, including organoids and physiomimetic, for studying gametogenesis and typical or diseased reproductive tissues/organs
• Growth and differentiation of stem cell lines in vitro, including feeder cell-free approaches to facilitate reproductive research
• Cell reprogramming, including embryonic stem cells or adult cells, into eggs and sperm
• Preimplantation genetic diagnosis
• Diagnosis, using genomics, epigenomics, or proteomics, of impairments in sperm function, fertilization, ovulation, implantation, decidualization, and other aspects of reproductive processes
• Novel diagnostics and treatments, using genomics and proteomics, for reproductive diseases and disorders
• Diagnosis, using semen, vaginal or cervical fluid, or menstrual effluent, of fertility status or other health conditions
• Monitoring and treatment of male or female infertility
• Selection of best sperm cells, oocytes, and embryos through artificial intelligence (AI) techniques/methods to generate better predictive models for in vitro fertilization
• Point-of-care testing for fertility/infertility and reproductive diseases and disorders
• Patient-specific treatment regimen for infertility diseases using AI methods and techniques
• Diagnosis and treatment of infertility in resource-limited settings to increase community and individual resources to address infertility
• Uterine tissue regeneration and reproductive tract reconstruction, including tissue-engineering, for treating infertility
• Identification and/or validation of putative male or female infertility targets
• Development, including use of high-throughput screening, of small-molecule drugs addressing infertility

Contact: Helena Ahn, Ph.D. 

Learn more about GHDB portfolio/priorities and GHDB research programs. Topic areas of interest include:

• Treatments for female pelvic floor disorders (PFDs), including pelvic organ prolapse, urinary incontinence, fecal incontinence, and other female PFDs
• Uterine fibroids, endometriosis, adenomyosis, and benign ovarian cysts, including use of menstrual effluent as a diagnostic tool
• Diagnosis, monitoring, and therapy of gynecologic pain disorders, including chronic pelvic pain, vulvodynia/vestibulodynia, and dysmenorrhea
• Diagnosis, monitoring, and treatment of atypical menstrual cyclicity
• Surgical and non-surgical treatments for girls and women with reproductive tract anomalies, including congenital structural anomalies and complications from female genital cutting
• Challenges in gynecologic surgeries, including hysterectomy
• Application of -omics platforms (genomics, proteomics, metabolomics, etc.) to questions of gynecologic health and disease

Contact: Sujata Bardhan, Ph.D. 

Learn more about IDDB portfolio/priorities and IDDB research programs. Topic areas of interest include:

• Molecular, imaging, statistical, or behavioral characterization of the etiology and pathophysiology of atypical nervous system development
• Delineation of genetic, genomic, and epigenetic causes of IDDs and development of gene-based treatments
• IDDs and other conditions identified or identifiable by newborn screening
• Assessments in clinic or community settings to accurately measure change in response to interventions
• Prevention, diagnosis, treatment, and management of IDDs
• Smart technologies, such as wearable devices, mobile health applications, and electronic medical records-based tools, to assist in remote health monitoring, serve as point-of-care diagnostic tools, and/or enhance screening, diagnosis, prevention, treatment, or management for individuals with IDDs to improve their quality of life
• Co-occurring symptoms in those with IDDs, including disordered sleep, obesity, gastrointestinal dysfunction, seizures or epilepsy, attention deficit/hyperactivity disorder, anxiety, depression, psychosis, immune dysregulation, self-injurious behaviors, and other mental health disorders
• Solutions for improving transition of adolescents to adult health care providers by improving health literacy, enabling self-management, and encouraging adherence to existing treatments among adolescents
• Inclusion of people with all IDD levels in research and clinical care focused both on IDD populations and more general populations where people with IDDs are typically excluded

Contact: Sai Majji, Ph.D. 

Learn more about MPIDB portfolio/priorities and MPIDB research programs. Topic areas of interest include:

• Screening, diagnosis, and management of infectious diseases in pregnant people, infants, and children, including but not limited to HIV, SARS-CoV-2, congenital cytomegalovirus (CMV), congenital syphilis, tuberculosis (TB), and Zika virus
• Rapid assays to monitor disease activity and response to therapy as well as immune response to vaccinations against relevant infections in infants and children (e.g., malaria, TB) for use at the individual level and/or as part of public health campaigns (e.g., eradication of outbreaks and prevention of spread)
• Diagnosis and treatment of HIV-related co-occurrences (e.g., diagnosis of TB)
• Diagnosis and treatment of SARS-CoV-2 infection-related outcomes in mothers and infants
• Simple and less technologically demanding point-of-care assays to monitor CD4 cell percentage/count, HIV viral load, or other surrogate markers of HIV disease progression in children
• Simple and easy-to-use/at-home-use diagnostics and point-of-care assays to monitor clinical symptomatology and prognosis of SARS-CoV-2 infection and recovery in children
• Medication adherence promotion or optimization
• Child-friendly formulations (preferably not liquid preparations) of drugs used to prevent HIV or treat complications of HIV and/or other high-priority infections, such as TB, hepatitis, syphilis, CMV, and malaria relevant to children
• Fixed-dose drug formulations and innovative methodologies to develop solid heat-stable formulations capable of being administered to young children (e.g., sustained release beads, etc.) and/or improve pill or volume burden
• Innovative long-lasting drug formulations for antiretroviral and other anti-infective drugs that would allow less frequent drug administration (e.g., once daily, weekly, or monthly)
• Evaluation of neurodevelopmental outcomes in children in resource-limited settings
• Leverage and linkage of electronic medical records and/or other health information systems to better understand treatment and prevention of infectious diseases among infants, children, adolescents, and people of child-bearing age
• Prevention of acquisition of HIV and other infectious diseases in children, adolescents, and women
• Medication release, alone or as part of multipurpose prevention technologies, to prevent sexual acquisition of HIV and other sexually transmitted infections in adolescents, adult women, and pregnant or postpartum people
• Evaluation of antiretroviral drug complications (e.g., mitochondrial toxicity, bone toxicity) in infants, children, adolescents, and pregnant people and their fetuses with HIV
• Measurement of the HIV latent reservoir, or other long-term effects of infectious diseases, including high-throughput, visualization algorithms, and improvement in assay reliability and sensitivity in children

Contact: Antonello Pileggi, M.D., Ph.D., M.S.C.T.I. 

Learn more about OPPTB portfolio/priorities and OPPTB research programs.

Topic areas of interest include the following. Please note that NICHD gives lower programmatic priority to applications that focus on pediatric conditions with greater research presence at other NIH institutes (e.g., sickle cell disease, pediatric oncology, or juvenile diabetes).

• Quantitative understanding of differences in drug action and related pathophysiology between childhood and adult disease and conditions unique to pediatrics, including developing tools (e.g., biomarkers, outcome measures, and physiologically based pharmacokinetic/pharmacodynamic models) to support pediatric drug discovery and development and to facilitate the application of precision medicine approaches in children
• Exploration of the intersections of physiological changes during pregnancy and fetal development with drug action (e.g., pharmacokinetic, pharmacodynamics, and pharmacogenomics) and with molecular pathways that may serve as novel therapeutic targets for disease-modifying therapies specific to these populations; critical areas include pain management in pregnant and lactating people and treatment of gestational diabetes, preeclampsia, and prevention of preterm delivery
• Drug dosing, safety, and effectiveness in children and in pregnant and lactating people, including artificial intelligence (AI)-driven modeling and simulation methods, novel approaches to utilizing existing data and archived biosamples/biospecimens, and pragmatic trials
• Advancement of precision medicine through individualized diagnosis, drug delivery, and non-drug therapy appropriate for use in neonates, children, and pregnant and lactating people; this may include 3D bioprinting, AI-enhanced pharmacometrics modeling, AI-driven diagnostic and decision-making tools, novel drug delivery devices, and formulations
• Development of new uses for drugs, biologics, and other therapeutics, including the development and use of preclinical experimental models (e.g., animal models and human biomimetics), use of organotypic microphysiologic cell culture systems and strategies for assessing pharmacologic and toxicologic effects of therapeutics, use of genetically diverse model organisms to assess precision prescribing approaches for interindividual manifestation of disease or response to therapeutic agents, and computation models or the accumulation of real-world evidence in support of new therapeutic uses

Contact: Karen Winer, M.D. 

Learn more about PGNB portfolio/priorities and PGNB research programs. Topic areas of interest include:

• Understanding of physical growth, body composition, bone health, nutrition, and obesity
• Determinants of typical bone mineral accretion and peak bone mass
• Interactions of muscle and bone during infancy and childhood
• Neuroendocrinology of puberty, linear growth, and body composition
• Mechanisms of hormone action during linear growth, pubertal maturation, and other aspects of physical development
• Biological antecedents of childhood obesity and its short- and long-term consequences
• Genetic and molecular mechanisms of obesity, psychosocial risks of obesity, and therapeutic interventions for obesity in children and adolescents
• Effect of early life exposures including infant feeding practices on short- and long-term health and development
• Biology of nutrition as it pertains to health and development (physical and neurological function) during pregnancy, infancy, and childhood and discovery, development, and deployment of biomarkers for early detection of mal-(over-/under-) nutrition including biomarkers of exposure, status, function, and effect (i.e., effect on early life development including neurodevelopment)
• Enhanced understanding of the role of human milk in child health and development
• Maternal nutrition (pre-pregnancy, pregnancy, and lactation)
• Novel approaches to enhanced infant feeding practices in term and pre-term infants
• Developmental origins of health and disease including ascertainment of biomarkers early in life that predict the onset of chronic diseases such as diabetes, osteoporosis, and the metabolic syndrome later in life
• Development of platforms for implementation of biomarkers of disease status, nutritional status, and biological function from infancy through adolescence

Contact: Tessie October, M.D., M.P.H. 

Learn more about PTCIB portfolio/priorities and PTCIB research programs. Topic areas of interest include:

• Pediatric critical care, emergency care, and trauma care
• Care of injured children prior to and during transport to treatment settings
• Screening and diagnosis of injuries related to forms of child maltreatment
• Management of medical conditions and related problems stemming from critical illness and serious or life-threatening injuries
• Improvement of clinical practice, parenting, and social system support for injured or traumatized children
• Reduction of pediatric trauma exposure and the number and severity of pediatric injuries and deaths
• Improvement of the pediatric intensive care environment including resources to promote patient safety and enhance clinical education and training of critical care personnel
• Diagnoses and treatment of critical illness in children, including nosocomial infections and iatrogenic injury

Contact: Ronna Popkin, Ph.D. 

Learn more about PDB portfolio/priorities and PDB research programs. Topic areas of interest include:

• Biomarker and anthropometric data in large population-representative surveys
• Accurate cause-of-death information or health diagnosis, such as information related to infant and maternal morbidity and mortality, in large population-representative surveys or in administrative datasets
• Integration of data science, including artificial intelligence and machine learning, into demographic research
• Improved collection, documentation, archiving, linking, and dissemination of population representative datasets, especially datasets that are complex, multilevel, or multimodal
• Protection and confidentiality for human subjects when collecting, archiving, linking, or disseminating population-representative datasets, especially datasets that are longitudinal or that include both spatial and individual-level data
• Cost reduction for collecting, linking, and disseminating large population-representative datasets
• Prevention research and intervention programs related to sexually transmitted infections including HIV; pregnancy; contraceptive use; adolescent, young adult, and maternal mortality; child health; at-risk youth; and other health-related topics relevant to PDB science
• Methodology and measurement issues in the social and behavioral sciences related to protecting research subjects, archiving and disseminating complex datasets, and studying diverse populations and/or sensitive or confidential behaviors

Contact: Diane Gumina, Ph.D. 

Learn more about PPB portfolio/priorities and PPB research programs. Topic areas of interest include:

• Assessment of preeclampsia, gestational diabetes, fetal well-being, spontaneous preterm birth, and stillbirth
• Identification of the bioactive components of human milk
• Longitudinal assessment of the structure and functions of the human placenta, such as placental metabolism, placental perfusion, and analyte transfer from the mother to the fetus
• Reduction of bacterial colonization, proclivity for thrombus formation, and health care-associated infection risks
• “Lab-on-a-chip” assessment of metabolic profiles (e.g., glucose and lactate/pyruvate), ketone bodies, bilirubin (unconjugated, free, indirect, and total), and other major analytes (Na+ Ca+ Cl+ K+ etc.)
• Diagnosis of bacterial infections and assessment of antibiotic sensitivity
• Improved syringes, needles, and injection setups to help administer small doses of medications over prolonged periods (e.g., insulin for treating hyperglycemia)
• Pain assessment in the newborn, analgesia, and the evaluation of neonatal opioid withdrawal syndrome
• Assessment of brain energy utilization in the newborn, especially glucose, oxygen, lactate, ketones, and other energy substrates
• Assisted ventilators for use in NICU

Contact: Toyin Ajisafe, Ph.D.

Learn more about NCMRR portfolio/priorities and NCMRR research program areas. Topic areas of interest include:

• Adaptation and plasticity for use in a clinical setting to target rehabilitation therapies and monitor treatment effectiveness (biomarkers, imaging)
• Orthotics, prosthetics, and robotics devices and interfaces; assistive technologies; invasive and non-invasive biological sensors, prosthetic systems, or implants to improve function; new control methods and improved sensory feedback; strategies for controlling and adapting to the environment; advanced wheelchair designs and enhancements and other mobility devices; biomaterials and tissue interfaces, nanotechnology, bionics
• Development and use of robotics, gaming applications, virtual and augmented reality, simulations, mHealth, and other approaches to promote participation, understand and support healthy behaviors, reduce health disparities, and enhance clinical compliance, especially in children with physical disabilities
• Chronic symptom management, including an increase in screening for chronic conditions or preventable secondary conditions in individuals with physical disability; mitigation of symptoms associated with multiple chronic conditions in individuals with physical impairments, including persistent pain, symptoms of obesity, diabetes, cardiovascular deconditioning, fatigue, symptoms of overuse injuries, pressure ulcers, sleep disturbances, and depressive symptoms; improvement of muscle capacity in chronic physical disability to include therapeutic or adaptive exercise and muscle stimulation; muscle-disuse syndromes and contractures; improvement of physical disability and co-occurring cognitive, sensory, or somatic consequences of impairment, disease, or injury; autonomic function in the context of injury or specific conditions
• Strategies to build or modify community and/or environmental resources that provide effective rehabilitation and health promotion services within the individual's own community; development of engineering, crowdsourcing, and social science approaches to promote, monitor, and sustain outcomes in real-world settings

Investigators proposing budgets that exceed the guidelines are encouraged to contact program staff 6 weeks prior to submitting the application.