Notice Number: NOT-HD-17-027

Key Dates
Release Date: November 22, 2017

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

Purpose

The purpose of this Notice is to announce an expansion in the scientific topics of interest for applications submitted to the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in response to PA-17-299 "Small Grants for Secondary Analyses of Existing Data Sets and Stored Biospecimens (R03)”.

Part 2.Section1. Funding Opportunity Description has been updated as follows:

Currently reads:

This initiative will support secondary analyses of NICHD-supported data as well as data that can advance the scientific priorities of NICHD extramural branches, including but not limited to:

• Physiological factors affecting change (e.g., endocrine, musculoskeletal health, reproductive health, intellectual function, and behaviors) at different points in the life span, including factors contributing to health and healthy development across the life course;
• Determinants, including genetic determinants, of health, human development, disability, and disease in conditions of interest to the NICHD;
• How positive and negative risk factors for health, health behaviors, and healthy development differ by age;
• How positive and negative risk factors differ for health and developmental outcomes differ across stages of disease or condition progression, and/or in the presence or absence of co-existing conditions;
• Early exposures and conditions, including those experienced prenatally and or by prior generations, that influence health, development, or risk of disease and injury in later life, including later in childhood, adolescence, and young adulthood;
• Long-term effects of interventions aimed at addressing conditions related to health, development, disability, or injury, including both the long-term effects on the targeted condition itself and other health-related outcomes;
• Health effects, direct and/or indirect, resulting from exposure to a traumatic event or chronic and persistent exposure to trauma;
• How alternative treatment regimens or health care management strategies influence the effectiveness and safety of treatment;
• How the effects of interventions in clinical trials differ by age, race, gender, disability, or other factors;
• Exploratory analysis, including assays on stored biospecimens, to explore effects of interventions on additional outcomes;
• Analysis and meta-analysis of existing data sets to inform designs of future clinical trials (e.g., to determine prevalence of a disease or condition, or a combination of conditions in a population of interest; to estimate effects size of an intervention and duration of treatment in a population of interest, etc.);
• Analysis or meta-analysis of existing data sets to explore opportunities for and determine the need for comparative effectiveness clinical trials in a topic area;
• Methodology development: Single or multiple data sets may be used to develop and test new analytic approaches for any of the above topics;
• Natural history studies of rare or common disorders or conditions that may inform stratification of cohorts for biomarker discovery or development of treatments or interventions;
• Identifying biomarkers of disease or injury progression, functional impairment, treatment response, and functional recovery;
• Environmental factors that support or challenge health maintenance and/or recovery following injury or illness;
• Analyses defining outcomes related to disability or injury effective at different time points after onset;
• Pharmacokinetics analysis of existing data sets that will help improve pharmacotherapy for neonatal and pediatric populations;
• Genotyping utilizing existing samples to assist in pediatric personalized medicine;
• Genotype-phenotype correlations based on existing data and samples to assist setting up primary outcomes for pediatric clinical trials;
• Analysis of maternal blood or imaging data to establish differences between normal versus pathological placental development and/or function across pregnancy.

Modified to read as:

This initiative will support secondary analyses of NICHD-supported data as well as data that can advance the scientific priorities of NICHD extramural branches, including but not limited to:

• Physiological factors affecting change (e.g., endocrine, musculoskeletal health, reproductive health, intellectual function, and behaviors) at different points in the life span, including factors contributing to health and healthy development across the life course;
• Determinants, including genetic determinants, of health, human development, disability, and disease in conditions of interest to the NICHD;
• How positive and negative risk factors for health, health behaviors, and healthy development differ by age;
• How positive and negative risk factors differ for health and developmental outcomes differ across stages of disease or condition progression, and/or in the presence or absence of co-existing conditions;
• Early exposures and conditions, including those experienced prenatally and or by prior generations, that influence health, development, or risk of disease and injury in later life, including later in childhood, adolescence, and young adulthood;
• Long-term effects of interventions aimed at addressing conditions related to health, development, disability, or injury, including both the long-term effects on the targeted condition itself and other health-related outcomes;
• Health effects, direct and/or indirect, resulting from exposure to a traumatic event or chronic and persistent exposure to trauma;
• How alternative treatment regimens or health care management strategies influence the effectiveness and safety of treatment;
• How the effects of interventions in clinical trials differ by age, race, gender, disability, or other factors;
• Exploratory analysis, including assays on stored biospecimens, to explore effects of interventions on additional outcomes;
• Analysis and meta-analysis of existing data sets to inform designs of future clinical trials (e.g., to determine prevalence of a disease or condition, or a combination of conditions in a population of interest; to estimate effects size of an intervention and duration of treatment in a population of interest, etc.);
• Analysis or meta-analysis of existing data sets to explore opportunities for and determine the need for comparative effectiveness clinical trials in a topic area;
• Methodology development: Single or multiple data sets may be used to develop and test new analytic approaches for any of the above topics;
• Natural history studies of rare or common disorders or conditions that may inform stratification of cohorts for biomarker discovery or development of treatments or interventions;
• Identifying biomarkers of disease or injury progression, functional impairment, treatment response, and functional recovery;
• Environmental factors that support or challenge health maintenance and/or recovery following injury or illness;
• Analyses defining outcomes related to disability or injury effective at different time points after onset;
• Pharmacokinetics analysis of existing data sets that will help improve pharmacotherapy for neonatal and pediatric populations;
• Genotyping utilizing existing samples to assist in pediatric personalized medicine;
• Genotype-phenotype correlations based on existing data and samples to assist setting up primary outcomes for pediatric clinical trials;
• Analysis of maternal blood or imaging data to establish differences between normal versus pathological placental development and/or function across pregnancy;
• Analysis of NIH and NICHD-supported HIV/AIDS data and specimens to advance scientific knowledge related to HIV pathogenesis, transmission, prevention and cure for infants, children, adolescents, and women of reproductive age (pregnant and non-pregnant).

All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Regina Bures, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-9485
Email: [email protected]