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The NICHD conducts and supports research and research training on biological and behavioral aspects of human development. Primary program areas include: reproduction and population studies, pregnancy, perinatal biology, maternal and infant well-being, developmental and reproductive immunology, congenital defects, developmental biology, teratology, nutrition and growth, human learning and behavior, learning disabilities, cognitive and social development, mental retardation and developmental disabilities, pediatric, adolescent, and maternal AIDS and HIV, obstetric and pediatric pharmacology, and medical rehabilitation. For additional information about areas of interest to the NICHD, please visit our home page at Phase IIB Competing Renewal Awards NICHD will accept Phase IIB SBIR Competing Renewal grant applications to continue the process of developing products that require approval of a Federal regulatory agency (e.g., FDA, FCC). Such products include, but are not limited to: medical implants, drugs, vaccines, and new treatment or diagnostic tools that require FDA approval. This renewal grant should allow small businesses to get to a stage where interest and investment by third parties is more likely. Applicants who received NICHD SBIR Phase I or Phase II support and who are currently Phase II awardees are eligible. Budgets for Phase IIB renewals should not exceed 3 million dollars total costs for three years. Depending on the research proposed the amounts may vary each year for the time requested. You are strongly encouraged to contact Dr. Louis Quatrano (contact information provided below) before beginning the process of putting a Phase IIB Competing Renewal application together. Prospective applicants are strongly encouraged to submit to the program contact a letter of intent that includes the following information: • Descriptive title of the proposed research • Name, address, and telephone number of the Principal Investigator • Names of other key personnel • Participating institutions • Funding Opportunity Announcement Number (e.g., PA-10-XXX) Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH staff to estimate the potential review workload and plan the review. It is expected that only a portion of NICHD SBIR/STTR Phase II awards will be eligible for a Phase IIB Competing Renewal grant. Examples of research that would be considered responsive to this announcement are listed below for illustrative purposes and are not exclusive of other appropriate activities. Preclinical studies, including pharmacology and toxicology, and other clinical studies beyond those conducted under the initial Phase II (R42, R44) grants such as: • innovative assistive devices and techniques to minimize residual disability and to impact on critical illness, physical behavior and cognitive development in childhood; • novel assays, kits, and devices to monitor fertility; • new and improved methods of fertility regulation, for men and for women, that are safe, effective, inexpensive, reversible, and acceptable; • new tools to monitor the state of various organ systems during therapy in pregnancy or infancy; and, • Evaluation of neuroimaging tools specific to brain development in pediatric populations or individuals with injuries. Direct your questions about scientific/research issues to: Louis A. Quatrano, Ph.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development 301-402-4221, Fax: 301-402-0832 Email: Population Research Research on topics in reproductive sciences, contraceptive development, and demographic and behavioral sciences. Examples of research topics that may be of interest to small businesses include, but are not limited to: A. Reproductive Sciences. Research on the reproductive processes of men and women and of animals with similar reproductive systems related to developing safer and more effective means of regulating, preserving or achieving fertility. Particular areas of programmatic interest relative to small business initiatives include, but are not limited to: • Development of reagents to facilitate study of reproductive and developmental processes. • Development of improved methods of growing and differentiating stem cell lines in vitro, including feeder cell-free approaches. • Development of novel assays, kits, and devices to monitor fertility and treat infertility and gynecological disorders. • Use of genomics and proteomics to develop novel diagnostics and treatments for reproductive diseases and disorders. • Development of high resolution technologies to provide invasive or noninvasive assessments of reproductive and developmental competence. • Development of experimental animal models that would be useful for studying the physiology and pathophysiology of reproductive processes. • Development of improved and novel technologies for the preservation of human gametes. • Development of improved technologies for preimplantation genetic diagnosis. • Development of improved technologies for the reprogramming of cells, including embryonic stem cells or adult cells, into eggs and sperm. Dr. Richard J. Tasca 301-435-6973, Fax: 301-496-0962 Email: B. Contraception and Reproductive Health Research. Emphasis is on developing new and improved methods of fertility regulation; developing new and improved treatments for disorders of the reproductive system including female pelvic floor disorders; and research on the benefits and risks of contraceptives and other drugs, devices, and surgical procedures as they affect reproductive health. Areas of interest include, but are not limited to: • Developing new and improved methods of fertility regulation, for men and for women that are safe, effective, inexpensive, reversible, and acceptable. This includes, but is not limited to, synthesis and testing of novel chemical compounds. • Developing new and improved treatments for disorders of the male and female reproductive system, including those used for hormone therapy and drugs, graft materials, and devices used for non-surgical and surgical treatment of pelvic organ prolapse, urinary incontinence, and other female pelvic floor disorders. • Discovering and disseminating new knowledge about the medical benefits and risks of contraceptives and other drugs, devices, and surgical procedures affecting reproductive health. We will primarily support applied research projects such as epidemiologic studies or Phase III trials designed to detect clinically significant adverse effects, particularly those too rare to be determined through the FDA's premarketing approval process. Laboratory models will be used when human studies are not feasible or to explore mechanisms of action or supplement epidemiologic and clinical observations. • Studies relating contraception or reproductive health to STDs such as HIV, including but not limited to development of new contraceptive products with microbicidal activity against STDs such as HIV; studies to define the relationships among contraceptive methods and HIV acquisition, transmission, or disease progression; and studies to clarify mechanism of interaction between contraceptives and other disease processes or conditions. Dr. Steven Kaufman 301-435-6989, Fax: 301-480-1972 Email: C. Demographic and Behavioral Sciences. Research on the size, growth, and composition of populations and the impact of changes in population on the health and well-being of individuals, families, and the population itself. The program emphasizes not only factors affecting fertility, mortality, population movement and compositional change, but also demographic, social, and behavioral research on teenage childbearing, AIDS, single-parent families, fatherhood, racial and ethnic differentials in infant mortality and child health, migration, and the well-being of children. Applications are encouraged, but are not limited to these areas: • Technological innovations/inventions to help collect biomarker data, especially technologies that can be used in large surveys. • Creation of hardware/software to aide in the collection of accurate cause of death/health diagnosis for the purposes of statistical analysis in population based datasets. • Innovative use/implementation in integrating geographical information systems, spatial network analysis, and/or simulation methods for demographic research. • Innovative approaches to analyzing and disseminating large-scale data sets. • Development of effective tools for prevention research and intervention programs related to STD/HIV, pregnancy, divorce, child health, at risk youth, and other health-related topics. • Innovative approaches to teaching population studies and other behavioral and social sciences at the undergraduate and graduate level. • Innovative approaches for research design, data collection techniques, measurement, and data analysis techniques in the social and behavioral sciences, with particular attention to methodology and measurement issues in studying diverse populations, sensitive behaviors, confidential behaviors; in issues related to the protection of research subjects; and in issues related to the archiving and disseminating complex datasets. Dr. Michael L. Spittel 301-435-6983, Fax: 301-496-0962 Email: Research for Mothers and Children Research in three major program areas includes: learning disabilities; cognitive and social development; nutrition and growth; obstetric and pediatric pharmacology, and pediatric, adolescent, and maternal AIDS. Topics that may be of interest to small businesses include, but are not limited to, those identified below. A. Child Development and Behavior. Research programs on psychological, social and emotional, psychobiological, and educational development from conception to maturity, specifically: • Social and Affective Development, Child Maltreatment and Violence, including normative social, affective, and personality development and the impact of the physical and social environments on health and psychological development; investigations of socio-cultural, familial, individual, and biological influences on development; and child developmental processes in high-risk settings (e.g., in violent or abusive environments, or families experiencing stressors such as poverty, unemployment or parental depression). • Developmental Cognitive Psychology, Behavioral Neuroscience, and Psychobiology, including linkages among developing brain, behavior, and genes; developmental pathways leading to normal and atypical brain development and behaviors and their underlying developmental mechanisms at the molecular, genetic, cellular and network levels; biological and behavioral indices of individual differences predictive of development at different points of development; neuroanatomical, neurofunctional, electrophysiological and neurochemical correlates of sensorimotor and cognitive abilities; tools to measure these; the effect of hormonal influences on behavioral development, including the development of gender-specific behaviors, the role of endocrines in social, emotional, and cognitive development, and the interaction of hormones and stress-related behaviors during development. • Risk Prevention and Health Promotion: behavioral and developmental aspects of health risk behaviors and health promotion from infancy to young adulthood, including individual, interpersonal, and social factors; environmental and contextual factors; and interactions of genes and environment as they relate to health and health behaviors. Issues of risk behaviors, health literacy, adherence, pain, obesity, influence of electronic media, and influences of religiosity and spirituality are of interest. • Reading, Writing, and Related Learning Disabilities: relative contributions of environmental, experiential, instructional, cognitive, linguistic, genetic, and neurobiological factors to the developmental reading process and to reading disabilities and writing, including the longitudinal course of development and the interactions among these factors at different stages of reading development, in both mono- and bilingual individuals; use of technology to facilitate development of reading and/or writing skills, these technologies could include but are not limited to assistive technologies, interactive technologies for use by children, adolescent or adult struggling learners as well as technologies for instructors, parents and/or caregivers for use within or outside of the classroom context, as appropriate. • Language and Bilingualism: language development and disorders and second language acquisition, including studies within a developmental context, that identify and explicate the cognitive, linguistic, social, cultural, socioenvironmental, geographic, environmental, instructional, and neurobiological factors affecting the development of language abilities. • Early Learning and School Readiness: experiences children need from birth to age eight to prepare them to learn, read, and succeed in school; early interactions with adults and peers; early childhood education teaching methods and curricula; comprehensive early childhood interventions that support learning and development; use of technology in promoting school readiness skills in disadvantaged children from birth to age six, including interactive technologies for use by parents, child care providers, and teachers and technologies for direct use by children. • Math and Science Cognition, Learning and Learning Disabilities: mathematical thinking and problem solving; scientific reasoning, learning, and discovery; studies that explore the genetic and neurobiological substrates of normal and atypical development in mathematics and science learning and cognition, as well as cognitive, linguistic, sociocultural, and instructional factors; individual differences that may moderate achievement; the delineation of skill sets needed to attain proficiency; development of effective instructional methods for typical development and interventions for learning disabilities. Dr. Peggy McCardle 301-435-6863, Fax: 301-480-7773 Email: B. Endocrinology, Nutrition, and Growth. Research on the nutritional needs of pregnant women and their fetuses; aspects of nutrients related to reproduction, growth, and development; breast feeding and lactation; the immunology of breast milk; development of the gastrointestinal system; childhood obesity and the nutritional antecedents of adult disease; developmental endocrinology; mechanisms of hormone action during growth and development, and the impact of hormonally active agents in the environment on growth and development. Applications to advance the study of obstetric and pediatric pharmacology include: Research and tools to better characterize the impact of physiological and developmental changes on pharmacokinetics and pharmacodynamics; advancements in modeling which improve therapy during pregnancy, among premature infants, children and adolescents; research on tools to monitor the state of various organ systems during therapy in pregnancy or infancy; such as, cerebral monitors, placental function, etc.; models to characterize molecular, dosing or other modification to improve therapy. Dr. Gilman D. Grave 301-496-5593, Fax: 301-480-9791 Email: C. Pediatric, Adolescent, and Maternal AIDS. Domestic and international research on human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) in women of child-bearing age, pregnant women, mothers, fetuses, infants, children and adolescents. Specific areas of interest include but are not limited to epidemiology, clinical manifestations, pathogenesis, transmission, treatment and prevention of HIV infection, including prevention of mother to child transmission, and HIV-related complications in these populations. Additional areas of interest include: • New technologies relevant to resource-limited countries for: o diagnosis of HIV infection in infants; o diagnosis and treatment of HIV-related complications of HIV (e.g., diagnosis of tuberculosis in children); o simple and less technical assays to monitor CD4 cell percentage/count, HIV viral load, or other surrogate markers of disease progression in children. • Drug formulations for antiretroviral drugs and/or drugs used to treat complications of HIV infection relevant to children (preferably not liquid preparations), particularly in resource-limited countries and including fixed dose drug formulations and innovative methodologies for development of solid formulations capable of being administered to young children (e.g., sustained release beads, etc). • Simple, standardized tools to evaluate neurodevelopmental outcome in children in resource-limited settings. • Topical microbicide agents to prevent sexual acquisition of HIV in women or in adolescents. • New, non-invasive technologies to evaluate complications of antiretroviral drugs in HIV-infected infants, children, adolescents (e.g., mitochondrial toxicity) and pregnant women, their fetuses and children. Dr. Kevin Ryan 301-435-6871, Fax: 301-496-8678 Email: Developmental Biology & Perinatal Medicine Research Research in three major program areas includes: pregnancy and Perinatology; developmental biology, genetics and teratology; and mental retardation and developmental disabilities. Topics that may be of interest to small businesses include, but are not limited to, those identified below. A. Pregnancy and Perinatology. The topic areas of research include the physiology of pregnancy and labor; high-risk pregnancies, including those with hypertensive disorders, diabetes or seizure disorders; fetal pathophysiology; premature labor and birth; diagnostic, monitoring, and therapeutic devices and instruments for newborn infants in the nursery and in Neonatal ICU setting; improving the existing products or developing new products that would improve the routine and extended care of the newborn infants; products and agents related to breastfeeding; hospital supplies specifically related to use in the care of newborn infants; nanotechnology and its application for the care of newborn infants; instruments and devices assessing and monitoring the nursery environment (noise, lighting, and odor); disorders of the newborn; sudden infant death syndrome; and biological and behavioral antecedents of low birth weight. The following topic areas are of high priority: • Non-invasive methods for assessing cardiovascular and pulmonary functions, including cardiac output, systemic blood pressure, airway resistance, pulmonary compliance, vital capacity and various lung volumes. • Metabolic profile assessment using non-invasive or minimally invasive approaches. Particular area of expertise include measurement of glucose and lactate/pyruvate; assessing ketone body measurements; free indirect bilirubin (uncongjugated, free indirect); major chemicals (Na+ Ca+ Cl+ K+ etc.) in the blood. • Improved point of care methods to measure plasma glucose concentrations quickly and accurately. • Devices, instruments, and tools to minimize bacterial colonization, reduce proclivity for thrombous formation; reduce health-care associated infection risks. • Rapid methods for diagnosis of bacterial infections and inflammation. • Non-invasive measures to assess brain energy utilization, especially glucose, oxygen, lactate, ketones, and other energy substrates. • Innovative ideas to reduce stress for the staff, parents and infants in the NICU. Dr. Tonse Raju 301-496-5575, Fax: 301-496-3790 Email: B. Developmental Biology, Genetics, and Teratology. Biomedical research on the cellular, molecular, and genetic aspects of normal and aberrant embryonic and fetal development including early embryogenesis, limb formation, organ and limb regeneration, development of the nervous system, developmental immunology, and causative factors in teratogenesis. Areas of interest included but are not limited to: • development and application of new animal model systems • innovative and high throughput genomic and proteomic techniques • systems biology approaches to advance the study of embryonic development and structural birth defects • in vivo techniques for optical imaging and quantitative measurement of physical properties of cells/tissues • innovative technologies for imaging of developmental processes and gene expression Dr. Lorette Javois 301-496-5541, Fax: 301-480-0303 Email: C. Intellectual and Developmental Disabilities. Biomedical, behavioral and biobehavioral research in neuroscience, genetics, biochemistry, molecular biology, and psychobiology aimed at identifying factors that cause abnormal brain maturation and function; identification of direct and indirect environmental factors (e.g., social, economic and cultural) that influence the occurrence of intellectual and developmental disabilities (IDD); and research leading to the prevention, amelioration, assessment and treatment of IDD, including approaches that involve expanded newborn screening and prenatal diagnosis. Dr. Tiina K. Urv 301-402-7015, Fax: 301-496-3791 Email: Medical Rehabilitation Research This Center supports innovative research on the restoration, replacement, enhancement or adaptation of function for people with chronic physical disabilities. This includes rehabilitative approaches across etiologies and the lifespan, as well as the environmental and policy factors that promote full participation. We encourage studies that integrate biomedical, engineering and/or psychosocial approaches to develop practical and creative solutions to the daily functioning of people with disabilities and their families. The mission of the NCMRR is to increase the effectiveness of medical rehabilitation practices through research. Information about specific program areas within NCMRR can be found at: Examples may include but are not limited to: • Enabling technologies for restoration of function. • Promoting behavioral adaptation to functional losses. • Assessing the efficacy and outcomes of medical rehabilitation therapies and practices. • Developing improved assistive technology. • Promoting rehabilitative outcomes in pediatric critical care. • Understanding whole body system responses to physical impairments and functional changes. • Developing more precise methods to measure impairments, disabilities, and societal limitations. • Training health professionals in the field of medical rehabilitation. • Development of Home Centered Rehabilitation care systems. • Promoting profession structured/directed self care and wellness. • Development of tools to assist and facilitate families in their involvement in rehabilitation. Investigators proposing budgets exceeding the guidelines are encouraged to contact program staff six weeks prior to submitting the application. For additional information on research topics, contact: Nancy Shinowara, Ph.D. 301-495-6838, Fax: (302) 402-0832 Email: or Louis A. Quatrano, Ph.D. 301-402-4221, Fax: 301-402-0832 Email: Other Research Topic(s) Within the Mission of the Institute For additional information on research topics, contact: Louis A. Quatrano, Ph.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development 301-402-4221, Fax: 301-402-0832 Email: For administrative and business management questions, contact: Mr. Ted Williams Grants Management Specialist Eunice Kennedy Shriver National Institute of Child Health and Human Development 301-435-6996, Fax: 301-451-5510 Email:
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