NIH has received new funds for Fiscal Years 2009 and 2010 as part of the American Recovery & Reinvestment Act of 2009 (Recovery Act), Pub. L. No. 111-5. The NIH has designated at least $200 million in FYs 2009 – 2010 for a new initiative called the NIH Challenge Grants in Health and Science Research.

This new program will support research on topic areas that address specific scientific and health research challenges in biomedical and behavioral research that would benefit from significant 2-year jumpstart funds.

The NIH has identified a range of Challenge Areas that focus on specific knowledge gaps, scientific opportunities, new technologies, data generation, or research methods that would benefit from an influx of funds to quickly advance the area in significant ways. Each NIH Institute, Center, and Office has selected specific Challenge Topics within the broad Challenge Areas related to its mission. The research in these Challenge Areas should have a high impact in biomedical or behavioral science and/or public health.

NIH anticipates funding 200 or more grants, each of up to $1 million in total costs, pending the number and quality of applications and availability of funds. In addition, Recovery Act funds allocated to NIH specifically for comparative effectiveness research (CER) may be available to support additional grants. Projects receiving these funds will need to meet this definition of CER: “a rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients. Such a study may compare similar treatments, such as competing drugs, or it may analyze very different approaches, such as surgery and drug therapy.” Such research may include the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data as they apply to CER.

The application due date is April 27, 2009.

Broad Challenge Areas and Specific Challenge Topics

Note: Those marked with an asterisk (*) are the highest priority topics; however, applicants may apply to any of the topics.

For NICHD, the Challenge Topics are:

(01) Behavior, Behavioral Change, and Prevention
(02) Bioethics
(03) Biomarker Discovery and Validation
(04) Clinical Research
(05) Comparative Effectiveness Research
(06) Enabling Technologies
(07) Enhancing Clinical Trials
(08) Genomics
(09) Health Disparities
(10) Information Technology for Processing Health Care Data for Research
(11) Regenerative Medicine
(12) Science, Technology, Engineering and Mathematics (STEM) Education
(13) Smart Biomaterials – Theranostics
(14) Stem Cells
(15) Translational Science
Contacts

(01) Behavior, Behavioral Change, and Prevention

01-HD-101: Behavioral Interventions. Behavioral interventions are especially needed: to increase women’s and couples’ correct and consistent use of family planning methods; and to improve parental adherence with medical and health recommendations, such as well-baby/well-child visits and vaccination schedules. New technology has created opportunities for the development and/or testing of interventions such as automated reminders, electronic records checks, and other innovative methods to improve adherence. Development and/or testing of interventions that work on multiple scales (e.g., the individual, family, community, school, religious congregation, organized social group, etc.), or examine the roles of social networks are particularly encouraged.

Contact: Rebecca L. Clark, Ph.D., Acting Chief, Demographic and Behavioral Sciences Branch, NICHD, (301) 296-1175, rclark@mail.nih.gov.

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(02) Bioethics

02-OD(OSP)-101*: Unique Ethical Issues Posed by Emerging Technologies. Advances in biotechnology and biomedical science raise novel ethical, legal, and social issues. Research in this area is needed to understand the unique ethical concerns related to emerging technologies (e.g., biotechnology, tissue engineering, nanomedicine, and synthetic biology). These include issues such as dual use research, privacy, safety, intellectual property, commercialization and conflict of interest, among others. Research is also needed to assess how these novel issues are addressed under current oversight and regulatory structures and identify where there may be gaps and/or need for revised or new oversight approaches.

Contact: at OD(OSP): Abigail Rives, (301) 594-1976, rivesa@od.nih.gov; at NICHD: James Hanson, M.D., Director, Center for Developmental Biology and Perinatal Medicine, (301) 496-8535, hansonj@mail.nih.gov.

02-OD(OSP)-102*: Ethical Issues in Health Disparities and Access to Participation in Research. Research is needed to assess the under-representation in biomedical and clinical research of U.S. minority populations, underserved populations, and populations who may be vulnerable to coercion or undue influence, to identify barriers to participation in research and to develop approaches for overcoming them. Additionally, studies are needed to assess the impact and ethical considerations of conducting biomedical and clinical research internationally in resource-limited countries.

Contact: at OD(OSP): Abigail Rives, (301) 594-1976, rivesa@od.nih.gov; at NICHD: Regina James, M.D., Director, Division of Special Populations, NICHD, (301) 435-2692, rjames@mail.nih.gov.

02-OD(OSP)-104*: Ethical Issues in the Translation of Genetic Knowledge to Clinical Practice. Genetics and genomics have great promise for the development of personalized medicine, yet the ethical, legal and social implications of both the research and application of genetic and genomic knowledge and technology are far reaching. Studies are needed to better understand the factors that influence the translation of genetic information to improved human health and the associated ethical issues. Examples of studies include those to address ethical issues related to broad sharing and use of new genetic information and technologies for research to improve human health, human subjects protection in genetic and genomic research, the identifiability of genetic/genomic information and how our understanding of identifiability is evolving, return of research results and incidental findings to subjects, alternative models of informed consent for broad data sharing for research, and the impact of intellectual property (IP) issues on development of new technologies.

Contact: at OD(OSP): Abigail Rives, (301) 594-1976, rivesa@od.nih.gov; at NICHD: James Hanson, M.D., Director, Center for Developmental Biology and Perinatal Medicine, NICHD, (301) 496-8535, hansonj@mail.nih.gov.

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(03) Biomarker Discovery and Validation

03-HD-101: Biomarkers to Assess Maternal and Child Health. Research is needed to accelerate the development and validation of biomarkers that can be used to assess normal and abnormal child development and human reproductive function. Biomarkers could help identify individuals at risk for serious disorders or help physicians determine the severity of conditions where symptoms develop over longer periods of time. Examples where biomarker discovery would make a significant advance include:

Contact: Louis DePaolo, Ph.D., Chief, Reproductive Sciences Branch, NICHD, (301) 435-6970, ld38p@nih.gov;
Contact: Michael Spittel, Ph.D., Program Director, Demographic and Behavioral Sciences Branch, NICHD, (301) 435-6983, spittelm@mail.nih.gov;
Contact: Gilman Grave, M.D., Acting Director, Center for Research for Mothers and Children, NICHD, (301) 496-5593, gg37v@nih.gov;
Contact: Beth Ansel, Ph.D., Chief, Traumatic Brain Injury and Stroke Rehabilitation Program, National Center for Medical Rehabilitation Research, NICHD, (301) 496-5289, ba25e@nih.gov.

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(04) Clinical Research

04-HD-101*: Identify the Factors that Place Women at Risk for Preterm Birth. More than 12 percent of births happen prematurely, and the rate is rising—increasing the risk of adverse outcomes for babies and mothers. However, most of these births occur in women who do not have any of the few known risk factors for preterm birth. New approaches and technologies (such as fetal imaging, fetal EKG, blood or urine tests, or response to maternal position or exercise) are urgently needed to improve physicians’ ability to identify women at increased risk for preterm birth, so that preventive interventions can be developed.

Contact: Catherine Spong, M.D., Chief, Pregnancy and Perinatology Branch, NICHD, (301) 435-6894, spongc@mail.nih.gov.

04-HD-102*: Development of Pediatric Medical Devices. Currently, many cardiovascular, surgical, prosthetic, and diagnostic devices originally designed for adults are also being adapted for use in young children, without having demonstrated that they are safe, effective, and appropriately sized. Pediatric medical devices need to be developed that are properly designed for children, with safety and effectiveness demonstrated rather than presumed, and with accurate risk assessments.

Contact: Steven Hirschfeld, M.D., Associate Director for Clinical Research, NICHD, (301) 496-0044, hirschfs@mail.nih.gov.

04-HD-103: Vaginal Microbicides. Vaginal microbicides are currently under study as female-controlled interventions to prevent heterosexual HIV transmission, but the effect of the microbicides on normal vaginal physiology, including during pregnancy, has not been evaluated. Studies are needed to assess vaginal physiology and milieu (including cytokines) and the effect of candidate microbicide formulations, in normal women; in women with various co-infections; and in pregnant women.

Contact: Lynne Mofenson, M.D., Chief, Pediatric, Adolescent, and Maternal AIDS Branch, NICHD, (301) 435-6870, mofensol@mail.nih.gov.

04-HD-104: Glucose Levels and Brain Development. Young children with type 1 diabetes experience large daily fluctuations in levels of plasma glucose ranging from brain-threatening levels of hypoglycemia to organ-damaging levels of hyperglycemia. Studies are needed on 4- to 8-year-old diabetic children using the new technology of minimally invasive, continuously monitored glucose sensing in conjunction with periodic MRI studies of brain anatomy and function to ascertain how conditions of hyper- and hypoglycemia affect brain development prospectively. These studies should determine the neurodevelopmental changes that occur over the course of two years in diabetic children in comparison with (1) control children without diabetes, and (2) publicly available normative data in the NIH Pediatric MRI Study of Normal Brain Development.

Contact: Karen Winer, M.D., Program Director, Endocrinology, Nutrition, and Growth Branch, NICHD, (301) 435-6877, winerk@mail.nih.gov.

04-HD-105: Advanced Imaging to Assess Impact of HIV on Child Development. In the United States, perinatally infected children are surviving into young adulthood; however, complications of multiple organ systems are in need of study. For example, a critical need is to assess the cardiovascular impact of HIV and its treatment in perinatally infected adolescents using newer cardiac and vascular imaging techniques. Moreover, new neuroimaging technologies offer opportunities to assess the effect of HIV on the brain in children and to assess the effect of in utero exposure to antiretroviral drugs in uninfected children.

Contact: Lynne Mofenson, M.D., Chief, Pediatric, Adolescent and Maternal AIDS Branch, NICHD, (301) 435-6870, mofensol@mail.nih.gov.

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(05) Comparative Effectiveness Research

For this RFA, there is no NICHD-specific Challenge Topic in this Challenge Area.

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(06) Enabling Technologies

06-HD-101*: Improved Interfaces for Prostheses to Improve Rehabilitation Outcomes. Mechanical design and control algorithms for prosthetic limbs have seen remarkable advances recently. Still lacking, however, are robust interfaces for these limbs to both the brain and the skeleton. The foci of this challenge will be to improve functional rehabilitation outcomes by 1) developing or refining control interfaces that can utilize signals from cerebral cortex to drive the latest generation of arm prostheses; 2) developing or refining methods for anchoring prosthetic arms directly into residual bone without risk of infection; and 3) incorporating these technologies into standard rehabilitation practices to improve patient quality of life. These improvements in prosthetic limbs could potentially provide enhanced functionality for recipients while reducing the time and cost of rehabilitation efforts.

Contact: Michael Weinrich, M.D., Director, National Center for Medical Rehabilitation Research, NICHD, (301) 402-0832, weinricm@mail.nih.gov.

06-HD-102: Point of Care Diagnosis and Assessment. Development of rapid point-of-care diagnosis could result in dramatic improvements in targeted therapy, outcomes, and cost of care. Research is needed to jumpstart the development and application of these techniques, particularly for newborn screening and diagnosis of serious conditions in infants. Examples of NICHD’s interest in this area include:

Contact: James Coulombe, Ph.D., Program Director, Developmental Biology, Genetics and Teratology Branch, NICHD, (301) 451-1390, CoulombeJ@mail.nih.gov;
Contact: Tiina Urv, Ph.D., Program Director, Mental Retardation and Developmental Disabilities Branch, NICHD, (301) 402-7015, urvtiin@mail.nih.gov;
Contact: Lynne Mofenson, M.D., Chief, Pediatric, Adolescent, and Maternal AIDS Branch, NICHD, (301) 435-6870, mofensol@mail.nih.gov;
Contact: Tonse Raju, M.D., D.C.H., Medical Officer, Pregnancy and Perinatology Branch, NICHD, (301) 402-1872, rajut@mail.nih.gov.

06-HD-103: Novel Imaging Technologies to Determine Fetal Maturity. There is an increasing trend for an elective delivery in the United States, resulting in more infants being delivered early and a concomitant increase in infant morbidities associated with a premature birth. Proof-of-concept studies are needed for developing novel imaging technologies to determine fetal maturity in utero. This would help physicians more accurately assess fetal maturity before scheduling elective deliveries.

Contact: John V. Ilekis, Ph.D., Program Director, Pregnancy and Perinatology Branch, NICHD, (301) 435-6895, ilekisj@mail.nih.gov.

06-HD-104: Development of Catheters for Use in Newborns. Intravascular catheters used in newborn infants can cause thrombus formation, leading to stagnation of blood flow, activation of platelets, and formation of clots. Such clots can cause vascular obstruction, catheter malfunction, or life-threatening embolization. Research is needed to develop ultra-small (21 to 24 gauge) intravascular catheters coated with nitric oxide- secreting polymers that function similar to vascular endothelium, producing nitric oxide locally, preventing biofilm, repelling platelets, and preventing thrombus formation.

Contact: Tonse Raju, MD, D.C.H., Medical Officer, Pregnancy and Perinatology Branch, NICHD, (301) 402-1872, rajut@mail.nih.gov.

06-HD-105: Solid Oral Dosage Forms for Pediatric Medications. There is a pressing medical need to develop technologies to produce solid oral dosage forms that allow the correct dosage to be administered (e.g., micro-pellets in small drug amounts) and that are orally dissolvable. These solid dosage forms would also be environmentally stable, could be measured for individualized dosing and administration, and could be administered orally for treatment of chronic childhood diseases such as asthma, seizure disorders, immunomodulation, or antimicrobial therapy.

Contact: Anne Zajicek, M.D., Pharm.D., Acting Chief, Obstetric and Pediatric Pharmacology Branch, NICHD, (301) 435-6865, zajiceka@mail.nih.gov.

06-HD-106: Imaging Techniques for Research on Early Development. A current barrier to our understanding of normal (and abnormal) developmental processes is the lack of high resolution imaging techniques that limit our ability to visualize the dynamic molecular and cellular changes that occur at various developmental stages. Research is needed to develop, optimize, and/or validate advanced three-dimensional imaging techniques, including non-invasive approaches and high throughput analysis of images that will specifically allow researchers to visualize developmental processes in living embryos. Studies can be targeted to fundamental developmental events in animal models that can be easily translated into improved assessment of anatomic and genetic abnormalities associated with human structural birth defects.

Contact: Mahua Mukhopadhyay, Ph.D., Program Director, Developmental Biology, Genetics, and Teratology Branch, NICHD, (301) 435-6886, mukhopam@mail.nih.gov.

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(07) Enhancing Clinical Trials

For this RFA, there is no NICHD-specific Challenge Topic in this Challenge Area.

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(08) Genomics

08-HD-101: Genetic and Environmental Exposures and Autism Spectrum Disorders (ASD). It is generally agreed that both genetic and environmental factors contribute to the causes of ASD, and it is well known that infant siblings of individuals with ASD have significantly greater probability to develop ASD than the general population. Additional pilot studies are needed to determine the contributions of specific genetic variations (such as mutations or structural genetic variations, either inherited or de novo) and environmental exposures (such as prenatal or perinatal exposure to pollutants, pesticides, or viruses), or their interactions, to the development of ASD in high-risk populations.

Contact: Alice Kau, Ph.D., Program Director, Mental Retardation and Developmental Disabilities Branch, NICHD, (301) 496-1385, kaua@mail.nih.gov.

08-HD-102: Genome-wide Association Studies (GWAS) research may help scientists achieve greater understanding of pediatric and reproductive health conditions. Areas of special interest to the NICHD include:

• Learning Disabilities: Estimates for learning disabilities range from 5% to 20% of the school-age population, yet the relationship between observed learning disabilities and possible genetic predispositions is poorly understood. Exploratory research is needed to identify associations across the genome for individuals identified with one or more learning disabilities, with or without comorbid conditions, such as Attention Deficit Hyperactivity Disorder (ADHD), using pre-existing, well-characterized samples of genetic materials. Collection of genetic material from individuals, and family members, to compliment previous and ongoing data collection efforts is also encouraged.
• Bone Mineral Accretion During Childhood: Exploratory GWAS research could take advantage of the public use data now available from the NICHD Bone Mineral Density in Childhood Study, a population-based study that involves 2,000 children and adolescents. Focus is needed on the genetic variants associated with impaired acquisition of bone particularly during childhood and adolescence, to help identify genetic regulatory mechanisms that can ultimately help to prevent osteoporosis.
• Reproductive Diseases and Disorders: Studies are needed in reproductive diseases and disorders that have been shown to have a hereditary component (i.e., polycystic ovarian syndrome, endometriosis, and premature ovarian insufficiency). Identifying phenotypes for control and affected populations would yield valuable data, as would conducting single-nucleotide polymorphism (SNP) analyses of available DNA samples and/or studying regions of the human genome not captured by SNP-based GWAS analysis.

Contact: Brett Miller, Ph.D., Program Director, Child Development and Behavior Branch, NICHD, (301) 496-9849, brett.miller@nih.gov;
Contact: Susan Taymans, Ph.D., Program Director, Reproductive Sciences Branch, NICHD, (301) 496-6517, st56q@nih.gov;
Contact: Karen Winer, M.D., Medical Officer, Endocrinology, Nutrition and Growth Branch, NICHD, (301) 435-6877, winerk@mail.nih.gov.

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(09) Health Disparities

09-HD-101: Youth Violence. Having direct exposure to and being a victim of violence have profound long-term effects, both physiologically and psychologically, and are especially pervasive in underserved and low-income communities. Interventions are needed that build on and strengthen community resources to specifically target these issues and hasten progress in preventing negative impacts on child and adolescent development. Investigators should propose intensive two-year pilot studies of acute pharmacologic and behavioral interventions to prevent and ameliorate the psychological consequences of exposure to violence, including the development of collaborative community research protocols that could heighten the comparability of results across communities.

Contact: Valerie Malhomes, Ph.D., Program Director, Child Development and Behavior Branch, NICHD, (301) 496-1514, maholmev@mail.nih.gov.

09-HD-102: Telehealth in rural areas. Compared with urban areas, children living in rural areas have higher poverty rates, tend to be in poorer health, and have fewer doctors, hospitals, and other health resources available to them. Pilot telemedicine interventions offer a great opportunity to improve health access and care for children living in rural communities. Studies are needed to evaluate and document feasibility and reliability of pediatric applications of telehealth in rural communities.

Contact: Regina James, M.D., Director, Division of Special Populations, NICHD, (301) 435-2692, rjames@mail.nih.gov.

09-HD-103: Disparities in Adolescent Obesity. In the United States, it is estimated that 14 percent of adolescents age 12 to 19 years are at risk or are already overweight. African American, Hispanic, Native American/Alaskan Native and Pacific Islander teens are more likely to be at risk or overweight when compared to their White counterparts. Pilot intervention studies are needed to address this epidemic in African American, Hispanic, Native American, and Pacific Islander teens, capitalizing on the utilization of communication technologies (e.g., Web sites, cellular telephones, wireless personal digital assistants [PDAs]) as a tool to monitor and modify behaviors associated with food intake, physical activity, and adherence to recommended treatment.

Contact: Regina James, M.D., Director, Division of Special Populations, NICHD, (301) 435-2692, rjames@mail.nih.gov.

09-HD-104: HIV in Minority Female Youth. Currently, HIV incidence in the United States is concentrated among minority youth; however, identifying female youth of color with behaviorally acquired undiagnosed HIV infection poses a daunting challenge for adolescent healthcare providers. To combat the rising incidence of HIV among this population, research is urgently needed to develop novel clinical and epidemiologic strategies aimed at identifying such youth and their subsequent linkage to health care services, and/or to implement these approaches using feasibility and acceptability studies.

Contact: Bill Kapogiannis, M.D., Medical Officer, Pediatric, Adolescent and Maternal AIDS Branch, NICHD, (301) 402-0698, kapogiannisb@mail.nih.gov.

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(10) Information Technology for Processing Health Care Data for Research

10-HD-101: Monitoring Rehabilitation Outcomes. Computerized systems are needed to monitor rehabilitation outcomes across diverse health care environments (such as hospital, rehabilitation facility, nursing facilities, or home care) to help determine the most effective strategies for treating chronic illness, reducing disability and secondary conditions, improving health outcomes, and reducing health-care burden. Researchers are encouraged to build on existing research networks, databases, and innovative platform technologies to identify positive trends and successful strategies.

Contact: Louis Quatrano, Ph.D., Chief, Behavioral Sciences and Rehabilitation Technology Branch, National Center for Medical Rehabilitation Research, NICHD, (301) 402- 4221, Quatranl@mail.nih.gov.

10-HD-102: Data Archiving and Dissemination. Additional research is needed to develop technologies, methods, and practices for archiving and disseminating demographic and behavioral data sets that ensure stringent protection of individual privacy while enhancing usability. Developing methods of archiving and disseminating multi-level and/or multi-method datasets are particularly encouraged.

Contact: V. Jeffrey Evans, Ph.D., Program Director, Demographic and Behavioral Sciences Branch, NICHD, (301) 496-1176, evansvj@mail.nih.gov.

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(11) Regenerative Medicine

For this RFA, there is no NICHD-specific Challenge Topic in this Challenge Area.

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(12) Science, Technology, Engineering and Mathematics (STEM) Education

12-HD-101: Educational Interventions to Increase Science Literacy. Development and/or testing of educational interventions appropriate for different age groups designed to increase science literacy are urgently needed to: (1) increase a consumer’s ability to synthesize, evaluate, and act on information from various sources (e.g., television, newspapers, word-of-mouth) related to health topics such as diet and nutrition, effects of violent television and video games, the risks/benefits of immunizations, etc.; and (2) reduce harmful effects of making decisions based on information that has no scientific basis (e.g., fad diets, untested “miracle” cures, medical noncompliance). Development and/or testing of educational interventions that work on multiple levels (e.g., the individual, family, school, community) to promote science literacy are encouraged.

Contact: James Griffin, Ph.D., Program Director, Child Development and Behavior Branch, NICHD, (301) 435-2307, james.griffin@nih.gov.

12-HD-102: Optimal Environments and Techniques for Science Learning. Little is known about the optimal learning environments for elementary and middle school children learning science concepts, although we do know that they should be taught these concepts earlier than is current practice in schools to help prevent misconceptions from forming, which must then be “unlearned” as correct concepts are taught. Research is needed to test optimal methods for presenting science concepts at various ages to maximize science learning, such as using oral vs. written presentation of information, hands-on experiential learning vs. use of static or animated graphic representations, and direct instruction vs. discovery learning approaches.

Contact: Kathy Mann Koepke, Ph.D., Program Director, Child Development and Behavior Branch, NICHD, (301) 435-6855, kmk@nih.gov.

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(13) Smart Biomaterials - Theranostics

For this RFA, there is no NICHD-specific Challenge Topic in this Challenge Area.

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(14) Stem Cells

14-HD-101: Stem Cell Research for Down, Rett and Fragile X Syndromes and Other Neurodevelopmental Disorders. With the successful creation of neurons derived from induced pluripotent stem cells (iPSCs) from individuals with spinal muscular atrophy, researchers are poised to refine and adapt this technology to other neurodevelopmental disorders. Targeted efforts are needed to produce redifferentiated neurons from iPSCs derived from skin fibroblasts of individuals with conditions that share phenotypic characteristics but have different genetic origins, such as Down syndrome, Rett syndrome, and Fragile X syndrome, or that have well-defined genetic origins, such as Williams syndrome or other chromosomal aneusomies. Such research holds the potential to better understand neurodevelopmental disorders at the cellular and molecular level by developing and characterizing iPSCs from individuals with specific genetic conditions or partial duplications or deletions of defined chromosomal regions.

Contact: Mary Lou Oster-Granite, Ph.D. Program Director, Mental Retardation and Developmental Disabilities Branch, NICHD, (301) 435-6866, granitem@mail.nih.gov.

14-HD-102: Identifying Reprogramming Factors for Oocytes. Studies aimed at using gene expression arrays to identify oocyte cytoplasmic factors responsible for the reprogramming ability of oocytes offer significant scientific opportunities. Oocyte cytoplasmic factors may be helpful in designing new approaches to the reprogramming of somatic cells into induced pluripotent stem cells (iPSCs) and to help understand the pluripotential properties of embryonic stem cells (ESCs). Research is needed to identify key reprogramming factors and the comparative expression profiling between oocyte cytoplasm, iPSCs and ESCs.

Contact: Richard Tasca, Ph.D., Program Director, Reproductive Sciences Branch, NICHD, (301) 435-6973, rt34g@nih.gov.

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(15) Translational Science

15-HD-101*: Developing New Antimicrobials from Oligosaccharides. Oligosaccharides are the third most prevalent component of human breast milk and have been shown to have antimicrobial properties against organisms including Campylobacter jejuni and caliciviruses. Research is needed to determine how oligosaccharides prevent infections and to stimulate the development of synthetic oligosaccharides that can be used to treat such conditions as necrotizing enterocolitis, newborn sepsis, or other infections in children or adults that may have become resistant to existing antibiotics.

Contact: Gilman Grave, M.D., Acting Director, Center for Research for Mothers and Children, NICHD, (301) 496-5593, gg37v@nih.gov

15-HD-102*: Pelvic Pain. New animal models and epidemiologic studies are urgently needed to increase understanding of the mechanisms underlying the development of chronic pelvic pain conditions in women, including but not limited to uterine fibroids, vulvodynia, and endometriosis. Research is needed specifically to identify and measure the biological, clinical, and behavioral factors involved in determining the responses of patients to therapeutic interventions for chronic pelvic pain conditions.

Contact: Estella Parrott, M.D., M.P.H., Program Director, Reproductive Sciences Branch, NICHD, (301) 435.6971, parrotte@mail.nih.gov; or Lisa Begg, Ph.D., Director of Research Programs, Office of Research on Women’s Health, (301) 496-7853, beggl@mail.nih.gov.

15-HD-103: Understanding Drug-Induced Fetal Effects. There is a lack of a mechanistic approach to studying drug-induced fetal effects, including the impact of medications on fetal malformations. A large percentage of pregnancies are unintended, and, since women take a large number and range of medications, research is needed to understand the fetal effects of medications. Within a two-year timeframe, mechanistic animal models could be developed to enable new drugs to be developed that would avoid the potential of causing malformations.

Contact: Anne Zajicek, M.D., Pharm.D., Acting Chief, Obstetric and Pediatric Pharmacology Branch, NICHD, (301) 435-6865, zajiceka@mail.nih.gov.

15-HD-104: Multi-drug Combination Therapy for Traumatic Brain Injury (TBI) and Stroke Treatment. The potential to capture the earliest recovery window, via early neuroprotection, is a major priority for treatment of TBI and stroke. Key first steps (addressed via partnership with industry and academia) will be to develop preclinical data on multiple drug combination interventions as a precursor to clinical research in humans; to provide pilot data to assess the safety and benefit of combination pharmacotherapies; and to determine optimal dosing and schedules for drug combinations. These data will provide the basis to launch clinical trials in humans using these optimal combinations. Contact: Beth Ansel, Ph.D., Chief, Traumatic Brain Injury and Stroke Rehabilitation Program, National Center for Medical Rehabilitation Research, NICHD, (301) 496-5289, ba25e@nih.gov.

15-HD-105: Models to predict health effects of climate change. Quantitative estimates and predictive models of effects of climate change on disease burden and health outcomes are needed. Approaches may include statistical, spatial, or other modeling methods to quantify the current impacts of climate on a diversity of communicable or non-communicable diseases, or project impacts of different climate and socio-economic scenarios on health. For example, new and innovative approaches to develop projections of changes in disease burden in specific regions or populations will facilitate public health planning. Existing databases on population and environmental variables, such as air quality, and climatologic episodes should be used to test the utility of these models where possible.

Contact: Rebecca L. Clark, Ph.D., Acting Branch Chief, Demographic and Behavioral Sciences Branch, NICHD, (301) 296-1175, rclark@mail.nih.gov.

15-HD-106: Environmental and Child Health: Exposure to Cooking Emissions. Home cook stove emissions in low-resource settings, including the developing world, are a major risk for pneumonia (the leading cause of death in children younger than age five—more than malaria, measles, and HIV combined). These emissions produce black carbon, the second leading green house emission in the world, but unlike CO2, they have a short half-life in the atmosphere, so interventions to reduce cooking emissions would have prompt environmental benefits. Research is needed to assess the impact of inexpensive, more efficient cooking stoves on environmental pollution, carbon particulate exposure, low birth weight, and infections such as sepsis and pneumonia. Immediate research results in this area could underscore the need for expanded U.S. production of this environmentally-friendly export technology.

Contact: Linda L. Wright, M.D., Deputy Director, Center for Research on Mothers and Children, NICHD, (301) 402-0830, wrightl@mail.nih.gov.

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For general information on NICHD implementation of NIH Challenge Grants, contact:

Eugene Hayunga, Ph.D.
Director, Office of Extramural Policy
Office of the Director, NICHD
National Institutes of Health
Phone: (301) 435-6856
E-mail: ehayunga@mail.nih.gov

For Financial or Grants Management questions, contact:

Bryan S. Clark
Chief Grants Management Officer
Grants Management Branch, Office of the Director, NICHD
National Institutes of Health
Phone: (301) 435-6975
E-mail: clarkb1@mail.nih.gov