Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	Office of Behavioral and Social Sciences Research (OBSSR) National Cancer Institute (NCI) National Eye Institute (NEI) National Institute on Aging (NIA) National Institute on Alcohol Abuse and Alcoholism (NIAAA) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Drug Abuse (NIDA) National Institute on Deafness and Other Communication Disorders (NIDCD) National Institute of Dental and Craniofacial Research (NIDCR) National Institute of Environmental Health Sciences (NIEHS) National Institute of Mental Health (NIMH) National Institute of Nursing Research (NINR) National Library of Medicine (NLM)
Funding Opportunity Title	Behavioral and Social Science Research on Understanding and Reducing Health Disparities (R21)
Activity Code	R21 Exploratory/Developmental Research Grant Award
Announcement Type	Reissue of PAR-10-137
Related Notices	NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015) June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
Funding Opportunity Announcement (FOA) Number	PA-13-288
Companion Funding Opportunity	PA-13-292, R01 Research Project Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.399; 93.866; 93.173; 93.273; 93.121; 93.399; 93.396; 93.395; 93.394; 93.393; 93.865; 93.242; 93.867; 93.879; 93.113; 93.279; 93.361
Funding Opportunity Purpose	The purpose of this FOA is to encourage behavioral and social science research on the causes and solutions to health and disabilities disparities in the U. S. population. Health disparities between, on the one hand, racial/ethnic populations, lower socioeconomic classes, and rural residents and, on the other hand, the overall U.S. population are major public health concerns. Emphasis is placed on research in and among three broad areas of action: 1) public policy, 2) health care, and 3) disease/disability prevention. Particular attention is given to reducing health gaps among groups. Applications that utilize an interdisciplinary approach, investigate multiple levels of analysis, incorporate a life-course perspective, and/or employ innovative methods such as systems science or community-based participatory research are particularly encouraged.

Posted Date	August 2, 2013
Open Date (Earliest Submission Date)	September 16, 2013
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Standard AIDS dates apply, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date	Standard dates apply
Expiration Date	September 8, 2016
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Background

The National Institutes of Health (NIH) issues this Funding Opportunity Announcement (FOA) to encourage research project grant applications (R21) employing behavioral and social science theories, concepts, and methods (1) to improve understanding of the causes of disparities in health and disability among the various populations of the United States and (2) to develop and test interventions for reducing and eventually eliminating health disparities. The goal is to move beyond documenting the existence of health and disability disparities to addressing causes and solutions.

Definition of Health Disparities

Public and private agencies provide various definitions of a health disparity for their own program-related purposes, but these definitions tend to have several aspects in common. In general, health disparities are defined as significant differences in health status and outcomes between one population and another (See Office of Minority Health, U.S. Department of Health and Human Services). The Minority Health and Health Disparities Research and Education Act of 2000, which authorizes several HHS programs, describes these disparities as differences in " the overall rate of disease [or disability] incidence, prevalence, morbidity, mortality or survival rates as compared to the health status of the general population." Although many different populations experience health disparities, this FOA is restricted to health disparities among populations defined by race/ethnicity, socioeconomic status, and/or rural-urban residence.

Fuller Understandings of Causes and Implications for Solutions

Scientific research supported by the NIH has been of great benefit to the health of the population in the United States. Research to improve diagnosis, treatment, and prevention has led to advances in health for most Americans and significant declines in disability, morbidity, and mortality from numerous diseases and conditions. As a result, the population can expect to live longer, be more productive and enjoy a higher quality of life. However, these gains have not affected all segments of the population equally. Examples of persistent health disparities include:

• Over the last decade, the infant mortality rate remains more than twice as high among African Americans as compared to European Americans, even when controlling for socioeconomic factors. American Indians and Alaskan Native infants also have a death rate almost double that of European Americans.
• A disproportionate burden of death and disability from cardiovascular disease and stroke is found in low-income populations and among African Americans.
• Incidence of reported lung, colon, rectal, and cervical cancer is substantially higher in the Appalachian region, where the incidence of lung and cervical cancer is one third higher than the national average.
• The disease burden associated with mental disorders falls disproportionately on certain ethnic/racial populations. Native Americans and Alaska Natives not only suffer disproportionately from depression, but also experience a higher rate of suicide and alcohol use disorders, and alcohol-related traffic deaths.
• There are differences in patterns of alcohol consumption or alcohol-related consequences/problems/morbidity across a variety of racial and ethnic groups. These alcohol-related problems may exist in the absence of overall higher rated of alcohol use disorders (AUDs). For example, although Hispanics have lower rates of AUDs than non-Hispanic Whites, the alcohol-related cirrhosis death rates are higher among Hispanic Whites compared to Blacks of Hispanic or non-Hispanic heritage and European Americans.
• The prevalence of osteoarthritis, hypertension, cervical cancer, and of all chronic diseases combined progressively decreases as socioeconomic status increases.
• Surveillance data indicates that 69% of new HIV infections are in individuals from racial and ethnic minority groups (i.e., African Americans, Hispanics, Native American/Alaska Natives, Asian/Pacific Islanders/Native Hawaiians) although these communities make up 30% of the U.S. population.
• Disparities in the identification and treatment of communication disorders (i.e., disorders of hearing, balance/vestibular, smell, taste, voice, speech, and language) in diverse populations result in a disproportionate burden of these disorders among groups of lower socioeconomic status and selected racial/ethnic backgrounds.
• Disparities exist in the prevalence of dental caries, oral and pharyngeal cancer and periodontal disease for racial/ethnic minorities and the poor. African American males and some Hispanic males are at increased risk for late-stage oral malignancies. The prevalence of dental caries is of concern in Native American/Alaska Natives, Hispanics, African Americans and the poor across the life span. Edentulism is highest amongst Appalachians. Trend analyses indicate that disparities have increased for disadvantaged populations.
• There are differential rates of drug use among racial and ethnic groups. Among African Americans, rates of drug use are lower in adolescence but increase in young adulthood and older. The health and legal consequences are also greater for racial and ethnic groups with African Americans and Hispanics receiving harsher conviction and sentencing rates than whites.
• Communities of color, tribal communities, and low-income communities often suffer from more frequent and greater levels of environmental exposures. Such disproportionate exposures may be contributors to health disparities. For example, Tribal communities face disproportionate environmental exposures from sources such as past mining and formerly used defense sites, which have led to adverse health outcomes. A major question is how multiple environmental exposures may interact either synergistically or cumulatively.
• Individuals from sexual minority groups, such as lesbian, gay, bisexual, transgender, and intersex (LGBTI), experience worse health outcomes than their heterosexual peers.
• Health disparities research has often found male-female differences within various racial/ethnic populations, lower socioeconomic classes, rural residents, etc. In order to harness the full research and translational potential of research conducted under this FOA, for projects involving both male and females, applicants are strongly encouraged to pose gender-based hypotheses and analyze the data for gender differences.

In sum, U.S. populations defined by lower socioeconomic status, certain racial/ethnic backgrounds, and rural residence continue to experience substantial disparities in the burden of disease and death when compared to the U.S. population as a whole or to European Americans.

Given the extensive scientific literature documenting health inequities, this announcement calls for research to address and to improve understanding of the causes of health disparities. In so doing, the announcement stresses the explicit employment of concepts and models from the behavioral and social sciences to guide applications in basic social and behavioral, and applied social and behavioral research by focusing on three action areas: public policy, health care, and disease/disability prevention. It emphasizes (1) basic social and behavioral research acting with or through biological pathways that give rise to disparities in health and (2) applied or translational research on the development, testing, adaptation, and delivery of interventions to reduce disparities. It encourages a multi-level analytic framework (i.e., ranging from individuals to societies) in investigating public health issues and their interactions (e.g., multiple morbidities rather than single illnesses) as well as attention to risk factors or causal processes common to various health conditions (e.g., smoking, diet, exercise, environmental risk, and access to health care).

Moreover, this announcement encourages research on the causes of and solutions to the health differences between a focus-population group and a reference-population group. By definition, health disparities refer to the health of a group in comparison to that of other groups. Although improving the absolute level of a group’s health is a laudable goal, it may not result in changing the group’s relative level of health. The reference population’s health might also improve, thereby maintaining or widening the gap. The study of a single population group, in order to elucidate the circumstances that may contribute to health disparities or to test an intervention targeting a particular group, may be included under this announcement; however, the relevance to disparities must be addressed explicitly.

While understanding the causes of poor health in a given population may be necessary to explaining differences in health between groups, it is not sufficient to be considered health disparities research for the purposes of these announcements. That is, the same cause may depress the health of both groups equally and may not be a source of one group’s having poorer health than the other. One intention of this FOA is to stimulate research on the fundamental causes of health differentials between groups.

Similarly, applied research under this FOA should be aimed at narrowing the differential between groups by targeting interventions at the causes or consequences of health disparities. Applicants should justify their proposed interventions by citing previous basic and applied research on the causes or consequences of the health disparity.

Areas of Action Affecting Health Disparities

This FOA focuses on three broad areas of action influencing health disparities: public policy, healthcare, and disease/disability prevention. For the purposes of this FOA, these action areas are defined as:

PUBLIC POLICY: Public policy may be defined as the means employed by governments and other institutions to influence the function and well-being of individuals, groups, communities, and society as a whole. Some public policies at the national, state, and local levels are designed explicitly to affect health and may have direct impacts on health disparities. Examples include medical insurance programs for the elderly, disabled, and poor; alterations in health programs to contain costs; occupational safety regulations; and regulation of environmental hazards.

In addition, policies with no explicit health focus may affect health disparities indirectly. For example, laws prohibiting discriminatory housing practices or providing housing subsidies may reduce health disparities by ameliorating exposures to environmental toxins among poor and ethnic/racial populations. The provision of child-care centers in workplaces may increase breastfeeding. Income maintenance programs may help to reduce stress and improve diets. Whereas such effects are plausible given known pathways linking socioeconomic disadvantage and racial/ethnic status to health, research evidence documenting their existence and strength is largely lacking.

Advancing knowledge about the potential for reducing health disparities through policy mechanisms requires a broad set of research studies, including both basic and intervention research. Further, interdisciplinary efforts are needed to bridge the many different kinds of economic, social, and behavioral processes involved in translating public policy into public health. Examples include research on:

• Innovative policy approaches to addressing pathways linking social and behavioral factors to health disparities, e.g., policies with the potential to build social capital, alleviate stressors associated with disadvantage, or address targeted advertising of alcohol and tobacco in disadvantaged populations.
• Cost-effectiveness of different policy strategies for addressing health disparities.
• Development of research designs and methodologies, including advanced statistical techniques for studying policy effects on health disparities, including experimental, comparative, and other observational methods, including design, cultural factors, and knowledge transfer.

HEALTH CARE: Health-care is defined as the timely delivery of care and/or medical/dental services by general or specialty providers to persons in need for the purpose of diagnosis, assessment, or treatment in order to improve or protect health status. Differences in the quantity and quality of health care targeted to and received by members of population groups are critical to understanding disparities in health.

Increased conceptual and empirical efforts are needed to identify and understand the processes leading to inequities in health care and to develop intervention strategies. Note that merely documenting or comparing utilization rates is not compliant with this FOA. Explanatory analyses of the origins of differential rates or evidence-based interventions to reduce health disparity rates are the focus of this FOA.

Disparities in the quantity and quality of health care may result from the interaction of several factors. Among these are, but not limited to:

• Differential mix of health care services available to and accessible by various population groups. For instance, physicians may tend to avoid areas with large racial/ethnic populations when establishing private practices or distances to health care services may be greater for those living in racial/ethnic communities. A related question is how the currently evolving health care and insurance systems, e.g., HMOs, mid-level providers, lay health workers, affect health disparities.
• Inadequate economic resources or poverty-related factors (e.g., time constraints, lack of transportation, unsafe environments) may result in foregoing or postponing medical services.
• Cultural, attitudinal, or communication-style differences between members of various populations and health-care providers may lead to miscommunication, misunderstanding, and deficiencies in health care for example, differences in disease expression, translation issues, or adoption of prevention/treatment regimens.
• Perceived prejudice and discrimination may impact negatively upon clinical care relationships. Differential utilization may result in delays in seeking care and/or poor adherence to provider recommendations.

DISEASE/DISABILITY PREVENTION: Prevention research encompasses investigations designed to yield results directly applicable to identifying and assessing risk, and to developing interventions for reducing risk and increasing health-promoting behaviors and reducing the occurrence of disease/disorder/injury or the progression of detectable but asymptomatic disease. Prevention research also includes studies to develop and evaluate disease/disability prevention, health promotion recommendations and public health programs:

• Identification of modifiable risk and protective factors for diseases/disorders/injuries that may differ across populations;
• Development and evaluation of individual- or group-level interventions to promote health of individuals or populations without recognized signs or symptoms of the target condition;
• Translation of proven effective prevention interventions in the general population into practice among populations that experience health disparities;
• Effectiveness studies that explicate behavioral and social factors related to the organization, management, financing, and adoption of prevention services and practices; and
• Methodological and statistical procedures for assessing population-based risk and resilience, and measuring the differential effects of preventive interventions among populations experiencing health disparities.

While interventions to improve health-enhancing behaviors in the areas of smoking and other environmental exposures, drinking, physical activity, and diet have been developed, there has not been extensive testing of the effectiveness of these interventions in diverse population groups. Similarly, theoretical models of health behavior change have not been applied extensively to diverse populations. In addition, gaps remain in the development and testing of community level interventions to reduce health disparities. Also needed is research on personal, cultural, and institutional barriers to intervention availability, delivery and effectiveness, as well as the mechanisms of intervention that work best to prevent disease in population groups experiencing health disparities.

CROSSING BOUNDARIES: The boundaries between these three broad topics are arbitrary and permeable. For example, policy is often directed explicitly at health care or prevention. Similarly, how health care is provided influences prevention (and vice versa). These categories are provided as heuristics for organizing topics. This FOA encourages research on topics falling within more than one of these categories or on the interplay among the categories.

To achieve the twin goals of a more comprehensive understanding of the causes of health disparities and to design and implement effective interventions to reduce and ultimately eliminate health disparities, this FOA encourages the application of several research perspectives and themes. The NIH believes these approaches may move current research efforts to the next level of accomplishment. Applicants are not required to incorporate all of the below themes into their research applications; however, applicants should explicitly address at least one.

Interdisciplinary collaborations. Addressing health disparities requires an understanding of the factors that determine health - biological, medical, behavioral, social, and environmental and of their complex interrelationships. In many instances, a single research discipline is best suited to tackle specific health problems. However, it is increasingly recognized that many problems may require a more comprehensive approach, possibly including sectors outside of health. New discoveries and innovative solutions are possible when researchers meet at the interfaces and frontiers of different disciplines to pool their diverse knowledge. Interdisciplinary collaborations refer to scientific endeavors in which investigators from a variety of disciplines work together closely from the outset to form a shared conceptual framework to address a problem. Interdisciplinary research is distinct from multidisciplinary research in that the latter refers to a process in which researchers in different disciplines work relatively independently, each from his/her own disciplinary perspective with limited direct interaction and little cross-fertilization among disciplines. This FOA encourages interdisciplinary studies that cross the traditional boundaries within and between biological, behavioral, and social sciences.

Levels of analyses. A variety of scientists have offered the concept of levels of analysis to capture the distinct but interdependent levels at which health, and the determinants of health, can be understood. One schema identifies five major levels of analysis in health research: social/environmental, behavioral/psychological, organ systems, cellular, and molecular. Most research focuses on a specific level, which roughly corresponds to the domain of specific scientific disciplines. A variety of conceptual models exist to address the linkages among levels of analysis, from the macro-societal levels to the biology of a disease, but they have not been uniformly accepted or systematically applied in empirical studies of health. One framework links social structure or social position (e.g., class, age, gender, race, ethnicity), environmental context or place (e.g., geographic location, housing conditions, access to services), lifestyles (e.g., smoking, physical activity), and physiology (e.g., blood pressure, cholesterol, obesity). Such models help to guide the development of multi-level research.

They also illustrate how such research can inform public knowledge about health policy, organizational- and community-level primary and secondary interventions. Models that integrate, for example, factors operating at the social and cultural levels with those operating at the psychological and biological levels are especially encouraged. Many multi-level studies are also multi-method studies that integrate quantitative and qualitative data and thus strengthen measurement validity while retaining the capacity for statistical inference.

A concern for health at the population rather than the individual level underscores the need to take social and cultural processes into account. An understanding of current and changing population rates of morbidity, survival, mortality, and use of health services requires that we consider the demographic, social, economic, and cultural features of the population. Needed is the investigation of the social, economic, and cultural systems as well as the individuals who participate in them.

Systems science methodologies. Systems science methodologies are specific methodological approaches that have been developed to understand connections between a systems structure and behavior over time. Systems science methodologies is an umbrella term referring to a variety of methodologies including (but not limited to), agent-based modeling, micro-simulation, system dynamics modeling, network analysis, discrete event analysis, Markov modeling, many operations research and engineering methods, plus a variety of other modeling and simulation approaches.

A system, in this context, refers to the particular configuration of all relevant entities, resources, and processes that together adequately characterize the problem space under study. Importantly, a system is defined by the boundaries that stakeholders use to determine which acts/observations are relevant for their inquiry as well as the interpretations/judgments that they use to guide decisions or actions. Systems science methodologies are valued for their ability to address the complexity inherent in behavioral and social phenomena; for example, they excel at identifying non-linear relationships, threshold phenomena, bi-directional relationships (aka, feedback loops), long delays between cause and effect, emergent properties of the system, and oscillating system behavior. Systems approaches offer insights into the nature of the whole system that often cannot be gained by studying the component parts in isolation.

Applicants are encouraged to learn more about systems methodologies and their role in behavioral and social science research at NIH by visiting the OBSSR Systems Science and Health webpage at http://obssr.od.nih.gov/scientific_areas/methodology/systems_science/index.aspx

Life-course perspective. Cumulative processes over the life course across multiple life domains at the individual and community levels are of central importance for understanding health disparities. For example, racial/ethnic status influences fetal and early life conditions that may be linked with later life expectancy and disease risks. Consequently, integrated investigation of psychosocial and physiological interrelationships over the life course and at critical developmental transitions are required in order to more fully understand the contemporaneous and cumulative impact of differential life experiences that underlie health disparities. Specifically, normative transitions (e.g., birth of a child, beginning school, emerging adulthood, retirement) often represent periods of increased vulnerability to health problems and unique opportunities for intervention. For example, the early adolescent period involves a combination of biological (e.g., puberty), social (e.g., increased role of peers), ecological (e.g., middle school), and cognitive (e.g., increasing capacity for abstract thinking) changes as well as increased risk for depression and substance use. Yet, our understanding of the role of such developmental processes in the emergence, maintenance and potential alleviation of health disparities is limited. Thus, focusing attention on transitions across the lifespan and associated risk and protective factors is needed for the ultimate development and testing of innovative interventions. Such an approach emphasizes the fact that early life disadvantage need not lead to later negative outcomes, provided there are compensating experiences in the intervening years. Attention should be given to the positive aspects of people’s lives (e.g., positive social or family relationships, education) that may buffer the effects of adversity.

Community-based participatory research/Community-engaged research. Community-engaged research is an approach that calls for conducting research in a collaborative manner that involves community and academic partners. The premise is an exchange of expertise between academics, as scientific experts, and communities, as local and cultural experts, to foster bi-directional learning that increases impact. Engaging communities for research entails dialogue, as well as the formation of dynamic relationships and partnerships between researchers and communities.

Community-based participatory research (CBPR) is defined as scientific inquiry conducted in communities and in partnership with researchers. Inclusion of key community members in research through CBPR promises to deepen our scientific base of knowledge in the areas of health promotion, disease/disability prevention, and health disparities. Community-engaged and community-partnered research processes offer the potential to generate better-informed hypotheses, develop more effective and sustainable interventions, and enhance the translation of the research results into practice.

Prejudice and discrimination. Disparities in health exist for many reasons, but prejudice and discrimination whether intentional/ conscious or unintentional/unconscious on the basis of race/ethnicity, gender, social class, sexual orientation, etc. appear to contribute significantly to differences in health care (also see http://grants.nih.gov/grants/guide/pa-files/PA-11-162.html). For example, a study of factors that contribute to differences in diagnosis and treatment demonstrated that racial bias is a significant influence on recommendations for cardiac catheterization for patients with chest pain.

Bias, discrimination and prejudice are hypothesized to contribute to disparities in health through increased exposure and susceptibility to: 1) Economic and social deprivation; 2) toxic substances and hazardous conditions; 3) socially inflicted mental and physical trauma, either directly experienced or witnessed; 4) targeted marketing of potentially harmful commodities such as tobacco, alcohol, illicit drugs; and 5) inadequate or degrading medical care.

Perceived (e.g., stereotype threat ) prejudice and discrimination also can be sources of acute and chronic stress, which have been linked to cardiovascular disease and alcohol abuse. Discrimination can restrict the educational, employment, economic, residential and partner choices, affecting health through pathways linked with human or social capital. Environmental influences from industry, toxic waste disposal sites, and other geographic aspects linked with poverty and racial/ethnic status can result in serious disadvantages to a population groups' health.

Evidence is insufficient to evaluate the magnitude of the relationship among prejudice, discrimination, and health. In addition, much of the empirical work investigating the effects of prejudice and discrimination on health has focused on African Americans. Few studies have addressed how these affect others such as Native Americans, Asian Americans and Latinos or other socially-defined populations. Prejudice and discrimination have helped shape the social position of each racial and ethnic group in the U.S. and, consequently, they may have unique associations with health for each group. Finally, an insufficient focus on societal forces has hindered our ability to understand and effectively address the influence of prejudice and discrimination on health disparities. The growing evidence that health, socioeconomic status, and macro-economics are inextricably linked emphasizes the importance of research to examine the influence of bias in the context of the other factors thought to affect racial/ethnic health.

Social context. The social environments in which processes affecting health and health disparities play out are often referred to as social context. These include familial, demographic, economic, political, legal, organizational, physical environmental, and cultural factors that affect the resources available to individuals. Applicants are encouraged to conceptualize and measure social contexts in order to specify which particular aspects of social context are factors in the production or maintenance of the health disparity under examination. They are also encouraged to conceptualize and measure the social processes that operate within and across social contexts and between social contexts and individuals.

Social context can be roughly divided into four inter-related domains: families and households; social networks; neighborhoods; and formal institutions. Economic, social, and cultural processes interweave all of these domains.

• Family structure, resources, and processes influence health across the life course. Families are centrally important for child health and development, influencing outcomes through parenting, adequate nutrition, and obtaining health care, among others. Throughout life, families tend to operate as economic units and provide social, emotional, and instrumental supports (or stresses) that influence health and health-related behaviors. Family financial status affects the ability to live in a safe and healthy environment, and to provide members with a variety of goods and services including medical care and nutrition that affect their health. The educational levels of adults in a family are related to health knowledge and behaviors, which subsequently impact other family members such as children. Family processes reflect cultural understandings and also imbue or reinforce them in family members. Racial or ethnic identity affects family interactions and rituals, and may provide resilience in the face of discrimination and stress.
• Social networks are defined as a web of social ties that connect people to others. Social networks provide social support that may include emotional support that buffers individuals from poor physical or mental health, information or instrumental help that can be used to maintain or improve health. Persons living in large, urban high-rises with little social organization and support or in rural areas may be at a disadvantage for developing supportive social networks. Social networks also channel the diffusion of ideas and practices. They therefore may play a vital role in community-based interventions that depend on the spread of new ideas for their success.
• Neighborhoods and communities provide important health-related resources. These include the level of income in the community, the quality of community organizations and formal institutions, and employment opportunities. Social processes that determine the degree of social interaction, crime levels, and political activity characterize communities. Structural characteristics of neighborhoods, such as demographic composition, population density, and housing stocks, have an impact on social processes and the neighborhood resources. Racial/ethnic and poor communities are disproportionately exposed to health-damaging physical environments characterized by overcrowding, noise, poor housing public services, and toxic chemicals (including air pollution). A close connection exists among the physical, built, and social environments, including the availability of full service grocery stores, well-lit sidewalks and parks. Communities that have higher incomes and more effective community and political organizations may be better positioned to create and maintain physically healthy environments.
• Formal institutions (e.g., school, childcare, and recreational facilities, law enforcement and justice programs, social services, religious institutions, and the media) affect the health of individuals and populations within a community. For example, poorly functioning institutions provide inadequate services and diminish the social capital of communities. Alternatively, well-functioning formal institutions create and implement effective community action toward population health, design and operate prevention programs, and provide health services.

Applications should be relevant to both the objectives of the FOA and to at least one of the participating Institutes and Centers' research interests. Researchers are strongly encouraged to review the general research interests of the participating ICs and the examples of topics of interest specific to health/disabilities disparities, which are posted at http://obssr.od.nih.gov/Content/Health_DisparitiesPAR_R21.htm.

National Cancer Institute (NCI)

Much of research generally in the area of social determinants of health (SDOH) focuses on delineating differences among racial/ethnic groups and understanding the barriers in prevention and care for specific underserved populations; and the subsequent development of behavioral interventions for these groups. In general, these interventions have only been partially successful by targeting individual behaviors and barriers but have not consistently sought to change the conditions in which people live, work, and play. Despite the growing evidence of the effects of SDOH on both short term and long term health outcomes, there is little emphasis on developing theory and evidence based multilevel, multifactorial, and population (e.g. community, policy) interventions, that target both structural and individual factors. For these interventions to be effective, it necessitates the development of new measures on inequity, social environment; the adaptation of existing measures of SDOH; and a comprehensive understanding of the pathways by which the social context affects health.

Areas for further exploration:

A. Measurement

• How can we develop models and tools for measuring and supporting harmonized use and reporting of the effects of social context (i.e., concept of place, built environment, and policy implications) on health among diverse populations?
• How can we develop models to compare the effects of social context on health patterns and trends within various settings including community and clinical settings? What are common measures across settings and how may these be leveraged to promote greater data harmonization and comparability of information across settings?
• How can real time data collection and the changing mobile and medical technology landscape be garnered to have greater impact on health promotion and disease prevention in low income and hard-to-reach populations, particularly among the elderly for whom the digital divide poses the greatest challenge?
• How can we use existing tools more efficiently to build large datasets to understand population health changes in designing programs for health promotion and disease prevention?

B. Social Context

• How does social context (built environment, rural vs. urban, etc.) contribute to disparities in cancer incidence and mortality?
• How does social context affect biological processes that make individuals more susceptible to carcinogenic effects of environmental toxicants?
• What is the influence of individual or area based factors of SDOH on health outcomes?
• What is the difference in risk of cancer among individuals with differential geographic proximity to environmental toxicants?
• Does chronic exposure to stressful social environments throughout the life course increase risk of cancer later in life?
• Are there specific periods throughout the life course where individuals may be more vulnerable to the effects of their social context that may increase risk of cancer later in life?

C. Multilevel interventions

Promoting Prevention

• What are the key factors (including psychological, social, environmental, and policy-level) influencing cancer prevention strategies? How do interventions, particularly multilevel and multifactorial approaches, addressing cancer-relevant behaviors effect health disparities and underserved populations? How can these multilevel interventions be scaled to be cost effective and sustainable in real-life contexts? What factors within the social context and the intervention development process influence potential for sustainability?
• How can we design and implement culturally appropriate interventions among indigent and medically underserved populations (including cancer survivors) to improve the health and quality of life of these populations? For example:
• What patient and health care team or organizational-level factors (systems) impede the delivery of post-treatment follow up care to indigent and medically underserved cancer survivors?
• How can we deliver post-treatment follow up care to minority and medically underserved cancer survivors that is based on knowledge about their disease and treatment, co-morbid health conditions, the need for support, and capacity to self-manage their health?
• How do we intervene in groups and organizations to remove systematic barriers to care and accommodate cultural and individual diversity?

Sustaining Interventions

To what extent are clinical and community-based intervention programs designed to address cancer disparities informed by evidence from science, practice, and policy?

• What program characteristics (e.g., costs, resources, sustainability measures, staff expertise, implementation setting, clinical and community integration, etc.) are required and adopted within low-resource settings to impact cancer outcomes?
• What adaptations of evidence-based interventions are needed to ensure cultural relevance (e.g., translation, health literacy, culturally competent implementers, significant user input, etc.) in low-resource settings?
• What are the multi-level and sequential (e.g. participation, outcome, maintenance; less focus on other critical issues) unintended consequences on health equity of programs and policies being implemented?
• Which social determinants influence program effectiveness and how are intervention components addressing such social determinants to increase reach/access to prevention and care in low-resource settings?

National Eye Institute (NEI)

The NEI supports basic, translational and clinical research with respect to blinding eye diseases, visual disorders, preservation of sight, mechanisms of normal visual function, and the special health problems and requirements of individuals with impaired vision. The NEI also supports the development of new technologies, strategies, and research tools that can be applied to basic and translational research which will benefit vision health.

Specific areas of research interest include studies of glaucoma, myopia, and diabetic retinopathy with special emphasis on Hispanic, Native American, and African-American populations. Other areas are investigations of health services, in order to determine the number of Americans with eye disease and visual impairment; to measure the associated medical and societal costs; and to identify factors associated with the most effective delivery and use of vision care services.

National Institute on Aging (NIA)

The National Institute on Aging especially encourages applications for:

• Research on factors in early and mid-life that lead to health disparities at older ages.
• Studies of the antecedents and consequences of socioeconomic and regional differences in adult health outcomes, disability and functioning, and how these interact with disparities among racial and ethnic groups.
• Cross-national comparative research on health disparities and life expectancy at older ages.
• Studies of the trajectories of acute and long-term care for the chronically ill and disabled and their role in producing disparities in outcomes and functioning.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIAAA is interested in several research priorities that could have significant impact on understanding and addressing health disparities in special populations:

• Research on use of Evidence Based Interventions (EBI) both treatment and prevention interventions - with health disparities and URM populations, including rigorous research on if, when and how such EBI may need to be adapted to enhance acceptance, dissemination and efficacy.
• Prevention of alcohol use among underage populations; understanding how cultural variables may be employed to delay onset of heavy alcohol use.
• Conduct studies of interventions to prevent prenatal exposure to alcohol among high-risk health disparity populations, taking into account cultural barriers to and facilitators of prevention interventions.
• Examine the role of alcohol consumption on intentional and unintentional injury and death (including homicide, suicide, and traffic crashes) among health disparity populations.
• Identify genetic and environmental factors which alter risk for alcohol-induced health problems and organ damage such as heart disease, cancer, liver disease and HIV/AIDS in health disparities populations.
• Determine effects of policies, laws and regulations that set blood alcohol content (BAC) limits, mandate driver's license revocation, adjudicate offenders to alcohol courts, or increase the price of alcoholic beverages.
• Enhance understanding of how culture may mediate and moderate mechanism underlying alcohol use and behavior change and application of this knowledge in the development of interventions to prevent and treat alcohol use disorders in health disparity populations.
• Increase understanding of factors affecting access to alcohol treatment for health disparity populations, including barriers to treatment, insurance coverage and other financial limitations, and availability of linguistically and culturally appropriate behavioral treatment.
• Identify genetic factors that influence risk for AUDs among health disparities populations, especially among African American and Hispanic/Latino Americans. In particular, the use of newer genetic technologies such as whole-exome sequencing to identify rare functional variants in these populations would have significant impact.
• Identify epigenetic factors that influence the trajectory of risk for alcoholism among health disparities populations especially among African American and Hispanic/Latino Americans.

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

The NICHD has an interest in basic and applied/intervention research on the causes of, and means of addressing, disparities in health, disability, and developmental outcomes from the pre-conception period into adulthood. Applicants responding to this FOA are encouraged to include a cover letter with their application that describes the scientific expertise needed to review the application and suggests review group(s) with the appropriate expertise to review the application.

Examples of topics of interest to NICHD that would be appropriate for this FOA include research on:

• Disparities in the health of pregnant women, pregnancy outcomes, and infant and maternal mortality and morbidity.
• Disparities in children’s health, including diabetes, obesity, injury, developmental disabilities, and the early antecedents of adult chronic disease.
• Disparities in health-related behaviors, including aggression, substance use, and self-injurious behaviors in childhood and adolescence and sexual behaviors and contraceptive use from early adolescence through the reproductive years.
• Disparities in disability, the rehabilitation of disabled persons, and the ability of individuals and families to overcome the burden of disability in their lives.
• Links between environmental processes at multiple levels (institutions, communities and neighborhoods, families, social networks) and behavioral, psychological, and biological factors in health disparities.
• Links between health disparities and socioeconomic, spatial and/or distal factors affecting health (e.g. poverty, discrimination, housing and zoning policies, literacy).
• Models of how population processes (fertility, family formation, population distribution and immigration) affect and are affected by health disparities.
• Reducing health disparities by understanding differences in access and availability of health care services; symptom presentation; and patient/provider perceptions of disease, and patient adherence to medical advice.

National Institute on Drug Abuse (NIDA)

HIV/AIDS and other medical consequences of drug use continue to increase among African Americans, approximately 13% of the U.S. population, who comprised 44% of the new HIV infections among adults and adolescents in 2010. The rate for Hispanics is also disproportionately high (19% of new diagnoses of HIV in 2009). Limited epidemiologic data on Asian Americans exist, but some local data and the reports of clinicians and service providers working in those communities suggest that drug use and addiction are a hidden and growing problem. Moreover, the problem varies by ethnicity/country of origin within the broader racial/ethnic classification of Asian American/Pacific Islander.

The National Institute on Drug Abuse (NIDA) is interested in research projects that address drug abuse and addiction and health disparities. Priority areas in health disparities research include:

• Disparities in HIV/AIDS in racial/ethnic populations, particularly among African Americans and Hispanics.
• Criminal justice-related health disparities among racial/ethnic populations.
• Health disparities in urban/rural communities and among the socioeconomically disadvantaged.
• Patterns of drug use, effects and potential adverse behavioral, social and health consequences or differential treatment outcomes within and across racial/ethnic populations. (See NIDA’s Strategic Plan on Health Disparities at: http://www.drugabuse.gov/StrategicPlan/HealthStratPlan.html).

Areas of research interest include but are not limited to:

• Research to elucidate the relationship between drug use, abuse, and dependence on the incidence and prevalence of HIV/AIDS and AIDS-related morbidity and mortality among racial/ethnic minority populations, especially among HIV risk groups (e.g., MSM, women, homeless, youth, older adults).
• Research on treatment and service delivery models to address HIV/AIDS among racial/ethnic minority populations.
• Studies that lead to development of effective, culturally sensitive prevention, intervention, and treatment services and programs for drug abuse and HIV/AIDS.
• Studies that identify risk factors and pathways between drug abuse and criminal justice involvement, and their relationship to HIV/AIDS among racial/ethnic minorities.
• Research to effectively integrate HIV/AIDS prevention and treatment services for racial/ethnic minorities in the criminal justice system, juvenile justice system, child welfare system and other systems/settings that serve high risk populations/families.
• Research on drug use and addiction and the related consequences in rural areas; paying attention to issues such as confidentiality, access to services, and a limited cadre of researchers and health care providers in rural areas.
• Research on adaptation and implementation of evidence based interventions not developed for or tested in ethnic/minority, low income or other health disparity populations.
• Research on how health disparity related risk factors and cultural factors may mediate and/or moderate intervention effects and application of these findings to inform development and adaptation of interventions to prevent and treat drug use problems in health disparity populations.
• Implementation research to examine implementation and scale up of evidence based drug use and HIV prevention and treatment interventions in settings that serve and are frequented by health disparity populations and to better understand the role of health disparities on uptake, scale up, and effectiveness when delivered in real-world settings.

National Institute on Deafness and Other Communication Disorders (NIDCD)

Disparities in the identification and treatment of communication disorders (i.e., disorders of hearing, balance/vestibular, smell, taste, voice, speech, and language) in diverse populations result in a disproportionate burden of these disorders among groups of lower socioeconomic status and selected racial/ethnic backgrounds. For example, outcomes (communicative, academic, and psychosocial) in children with mild to severe hearing loss are affected by health disparities. Applications addressing this concern should be multidisciplinary and have a primary focus on determining the impact of intervention, child, and family factors on communicative, educational and social development outcomes in children with mild to severe hearing loss. The intent is to consider more than auditory, speech and linguistic capabilities of children, but all factors influencing the child as a whole , such as family, cultural, demographic, and individual child characteristics.

Many other examples of differential impact on outcomes due to health disparities can be found across the lifespan in the seven different mission areas of NIDCD. Please contact the NIDCD program officer for more information.

National Institute of Dental and Craniofacial Research (NIDCR)

The National Institute of Dental and Craniofacial Research is committed to reducing the disproportionate burden of oral diseases experienced by vulnerable segments of society. The diseases that are the focus of NIDCR’s health disparities efforts are caries including Early Childhood Caries, oral and pharyngeal cancer, and periodontal disease. Interdisciplinary research teams and the full participation of the community are viewed by NIDCR as essential components of any health disparities research.

NIDCR has particularly interest in studies that will provide essential information in preparation for interventions, and research that evaluates or informs clinical practice, public health policy, health care provision, community and/or individual action. Studies with strong conceptual models or that are grounded in behavioral and social science theory are needed. Examples of health disparities research of interest to the NIDCR include but are not limited to:

• Studies, in specific subpopulations, that provide essential information in preparation for intervention research. These studies may include ethnographic, qualitative, mixed methods and other approaches and may require several stages.
• Targeted/tailored research that takes a holistic approach to understand and address multi-level determinants of oral health status across the life course.
• Health services research that explores alternative approaches to delivering oral health care and that integrates oral health into general health care and community settings.
• Studies that explore common risk factors or that take an upstream or systems approach.
• Studies that assess multifaceted strategies at several levels within society and multi-sectoral approaches that engage agencies and organizations outside of the health sector.
• Research that evaluates rapidly changing health care funding approaches, policies and systems.
• Dissemination and implementation research at multiple organizational levels.
• Effectiveness studies that tailor/target preventive approaches to communities/individuals/organizations.
• Research that explores uses of technology for translation, implementation, adoption, adherence and acceptance of oral disease prevention programs in defined, diverse populations, clinics, and communities.

Applications that are limited to the assessment of disease prevalence or explore a limited range of potential determinants are not appropriate for this FOA.

NIDCR supports health disparities intervention research designed to have a meaningful impact on caries, oral and pharyngeal cancer, periodontal disease, or oral health related quality of life and that influence action. Please note that the NIDCR does not accept applications that include clinical trials in response to trans-NIH-FOAs. Applicants proposing health disparities clinical trials should refer to the following NIDCR websites: http://www.nidcr.nih.gov/clinicaltrials/ and http://grants.nih.gov/grants/guide/pa-files/PAR-11-338.html.

Applicants are strongly encouraged to contact the health disparities program official.

National Institute of Environmental Health Sciences (NIEHS)

The mission of the National Institute of Environmental Health Sciences is to discover how the environment affects people in order to promote healthier lives. NIEHS recognizes that environmental exposures often disproportionately affect minority, rural and low income populations and may have an even greater effect on the most vulnerable individuals within these communities, such as children and the elderly. Such disproportionate affects are known as environmental health disparities.

NIEHS primary interests are to support research projects that focus on the underlying causes of EHD. Of particular interest are projects that engage communities in the design and conduct of research and the translation of findings in culturally appropriate formats, and that promote approaches for addressing EHDs that are broadly applicable. An additional interest is in projects that address EHD in underserved regions where the environment, and it’s potential relation to negative health outcomes, is relatively unknown and unexplored.

Research topics of interest include, but are not limited to:

• Studies that examine the role of the environmental exposures that leads to disproportionate burden of disease. This may include psychosocial factors and other indicators of community vulnerability and resilience that play a role in EHD in the context of disproportionate environmental exposures.
• Intervention research projects that incorporate modifiable factors such as dietary, behavioral and life style changes, or that study the role of healthy behaviors to reduce environmental health disparities.
• Studies that develop new strategies, or evaluate the effectiveness of existing preventive strategies, to reduce environmental health disparities.
• Studies that develop new or consider existing policy and communication approaches and their effectiveness at reducing environmental health disparities.

National Institute on Mental Health (NIMH)

The National Institute of Mental Health (NIMH) is interested in applications relevant to understanding and reducing health disparities in both non AIDS-related and AIDS-related mental health conditions within the U.S. population. Examples of specific areas of interest for NIMH are included below. NIMH recommends, for both non-AIDS- and AIDS-related studies , that applications proposing an adaptation to existing interventions should provide an empirical rationale for the need for and focus of the adaptation, consistent with NAMHC Workgroup Report recommendations on intervention adaptation (http://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/reports/fromdiscoverytocure.pdf) and consult with relevant Institute Program Staff.

Non-AIDS

• Effectiveness studies on the implementation or scale-up of evidenced based interventions for mental disorders with demonstrated likelihood of improved clinical, functional, and economic outcomes for members of diverse racial and ethnic groups.
• Develop and test interventions to reduce disparities in health outcomes (e.g. cardiovascular risk factors and disease, diabetes, respiratory disorders) among people with severe mental illness (e.g. schizophrenia, bipolar disorder) who are members of racial and ethnic minority groups.
• Use mobile or IT interventions to increase use of evidence-based mental health care for individuals in hard-to-reach remote communities.

AIDS

• Develop/test novel interventions with strong public health impact to prevent high-risk behaviors and HIV transmission for gay men, men who have sex with men (MSM) & other high-risk vulnerable individuals from diverse underrepresented populations.
• Develop/test novel multilevel preventive interventions and/or combination biomedical-behavioral approaches to advance HIV prevention with individuals in those from diverse underrepresented populations most impacted by HIV.
• Basic behavioral and social science studies to better understand factors and mechanisms that may underlie and explain health disparities in HIV prevention and treatment.
• Develop/test interventions based on mechanisms that explain HIV-related disparities (e.g., factors like stigma, social/sexual networks, access to and quality of health care, developmental considerations, characteristics of health biology).
• Examine treatment as prevention strategy by reaching out to high risk individuals from diverse underrepresented populations not recently tested (seek), engaging in HIV testing (test) and initiating HAART for those testing positive (treat).
• Dissemination and implementation science studies to better understand the influence of health disparities on the uptake and effectiveness of proven interventions when delivered in community and clinical settings.

National Institute of Nursing Research (NINR)

The National Institute of Nursing Research (NINR) is interested in applications leading to interventions that promote and improve the health of individuals, families, communities, and populations. Specific topics that would be appropriate to this FOA and of interest to the NINR include, but are not limited to:

• Assess behavioral and social risk factors and responses to treatment, including the identification of biomarkers (e.g., neurohumoral markers for differential responses to behavioral interventions); identify susceptibility genes for such risk factors, and design interventions to moderate risk.
• Identify and develop individual and family interventions designed to sustain health-promoting behaviors over time (e.g., prevention of obesity; prevention of HIV/AIDS transmission).
• Design intervention studies using community-based approaches to facilitate health promotion/risk reduction behaviors (e.g., families with special needs, such as parents or caregivers of persons with chronic illness or developmental disabilities).

Elucidate mechanisms underlying health disparities and design interventions to eliminate them, with particular attention to issues of geography (rural and remote settings), minority status, underserved populations, and persons whose chronic or temporary disabilities limit their access to care.

National Library of Medicine (NLM)

The National Library of Medicine’s (NLM) specific interests are in supporting research in biomedical informatics where it intersects with behavioral and social science research on understanding and reducing health disparities. NLM defines biomedical informatics as the intersection of computer and information sciences with an application domain such as health care, public health, basic biomedical research, or clinical translational research. We are particularly interested in the role informatics could play in helping those segments of the population experiencing health disparities find, understand, and use information to help alleviate health disparities. Examples of health disparities research of interest to NLM include but are not limited to:

• Research in informatics approaches to knowledge transfer in the context of policy formation and implementation.
• Research on health disparities involving the innovative development and use of systems science methodologies, including but not limited to agent-based modeling; system dynamics simulation; network analysis, including social network analytic methods; and discrete event simulation.
• Research themes that reach into the information sciences (such as information seeking/information needs studies, human-computer interaction and information design, and decision support systems), as they are applied to behavioral and social science research on understanding and reducing health disparities.
• Research on developing and testing informatics approaches for discovering causal relationships using large datasets from multiple sources (e.g. EMR, GPS, environmental, behavioral, socio-economic, and longitudinal) related to the identification, elimination, and prevention of health disparities.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Resubmission Revision The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	Application budgets are not to exceed two years. Direct costs are limited to $275,000 over a two-year period with no more than 200,000 in direct costs in any single year.
Award Project Period	The total project period may not exceed 2 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide..

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this FOA, please note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS)

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: [email protected]

Michael Spittel, Ph.D.
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-451-4286
Email: [email protected]

Rina Das, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6184
Email: [email protected]

Shobha Srinivasan, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6938
Email: [email protected]

Cheri Wiggs, Ph.D.
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]

John Haaga, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3131
Email: [email protected]

Judith A. Arroyo, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301- 402-0717
Email: [email protected]

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

Dionne Jones, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1984
Email: [email protected]

Howard Hoffman, M.A.
National Institute on Deafness and Communication Disorders (NIDCD)
Telephone: 301-402-1843
Email: [email protected]

Ruth Nowjack-Raymer, MPH, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5394
Email: [email protected]

Symma Finn, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: (919) 541-4258
Email: [email protected]

Charlene Le Fauve
National Institutes of Mental Health (NIMH)
Telephone: 301-435-4582
Email: [email protected]

David M. Stoff, Ph.D. (AIDS applications)
National Institute of Mental Health (NIMH)
Telephone: 301-443-6100
Email: [email protected]

Mary C. Roary, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-594-6908
Email: [email protected]

Alan VanBiervliet, Ph.D.
National Library of Medicine (NLM)
Telephone: 301- 594-4882
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

William Darby
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]

John Bladen
National Institute on Aging (NIA)
Telephone: 301-496-1472
Email: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

Bryan Clark, M.B.A.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

Edith Davis
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6710
Email: [email protected]

Chris Myers
National Institute on Deafness and Communication Disorders (NIDCD)
Telephone: 301-402-0909
Email: [email protected]

Dede Rutberg, M.B.A.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: [email protected]

Molly Puente, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1373
Email: [email protected]

Rebecca Claycamp, M.S., CRA
National Institute of Mental Health (NIMH)
Telephone: 301-443-2811
Email: [email protected]

Judy Sint
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
Email: [email protected]

Arnita Miles
National Library of Medicine (NLM)
Telephone: 301-496-4221
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. .