Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) http://www.nih.gov

Components of Participating Organizations
Office of Behavioral and Social Sciences Research (OBSSR) http://obssr.od.nih.gov
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) http://www.nichd.nih.gov/
National Cancer Institute (NCI) http://www.nci.nih.gov/
National Center for Complementary and Alternative Medicine (NCCAM) http://nccam.nih.gov/
National Eye Institute (NEI) http://www.nei.nih.gov/
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) http://www.niams.nih.gov
National Institute of Dental and Craniofacial Research (NIDCR) http://www.nidcr.nih.gov
National Institute of Environmental Health Sciences (NIEHS) http://www.niehs.nih.gov
National Institute of Mental Health (NIMH) http://www.nimh.nih.gov
National Institute of Nursing Research (NINR) http://www.ninr.nih.gov
National Institute on Aging (NIA) http://www.nia.nih.gov
National Institute on Alcohol Abuse and Alcoholism (NIAAA) http://www.niaaa.nih.gov/
National Institute on Deafness and Communication Disorders (NIDCD) http://www.nidcd.nih.gov/
National Institute on Drug Abuse (NIDA) http://www.nida.nih.gov
National Library of Medicine (NLM) http://www.nlm.nih.gov/
Office of Disease Prevention (ODP) http://prevention.nih.gov/

Title: Behavioral and Social Science Research on Understanding and Reducing Health Disparities (R21)

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of PAR-07-380.

Update: The following updates relating to this announcement have been issued:

• August 2, 2013 - This PA has been reissued as PA-13-288.
• February 1, 2011 - See Notice NOT-DK-11-005 The purpose of this notice is to clarify that the National Institute of Diabetes and Digestive and Kidney Diseases is not a participant in this PAR.
• January 7, 2011 - See Notice NOT-OD-11-032 Notice of Change in Agency Contact.
• August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
• September 29, 2010 (NOT-OD-11-007) - NIH to Require Use of Updated Electronic Application Forms in 2011. Adobe B1 forms are required for due dates on or after May 8, 2011.
• June 24, 2010 - See Notice NOT-TW-10-008 Notice to Highlight Current NIH Funding Opportunities that Promote Research on the Human Health Effects of Climate Change.

Program Announcement (PA) Number: PAR-10-137

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.393, 93.213,93.867, 93.846, 93.865, 93.121, 93.113, 93.242, 93.361, 93.866, 93.272, 93.173, 93.279, 93.879

Key Dates
Release/Posted Date: March 18, 2010
Opening Date: August 14, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): August 14, 2010, December 11, 2010, April 11, 2011, August 14, 2011, December 11, 2011, April 11, 2012, August 14, 2012, December 14, 2012
April 11, 2013
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): September 14, 2010, January 11, 2011, May 11, 2011, September 14, 2011, January 11, 2012, May 11, 2012, September 14, 2012, January 14, 2013, May 11, 2013
AIDS Application Due Date(s): Not applicable
Peer Review Date(s): February-March 2011, June-July 2011, October-November 2011, February-March 2012, June-July 2012, October-November 2012, February-March 2013, June-July 2013, October-November 2013
Council Review Date(s): May 2011, October 2011, January 2012, and May 2012, October 2012,
January 2013, and May 2013, October 2013, January 2014
Earliest Anticipated Start Date(s): July 2011. December 2011, March 2012, and July 2012, December 2012, March 2013, July 2013, December 2013, March 2014
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: May 12, 2013

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. 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. Proposals that utilize an interdisciplinary approach, investigate multiple levels of analysis, incorporate a life-course perspective, and/or employ innovative methods such as system science or community-based participatory research are particularly encouraged.
• Mechanism of Support. This FOA will use the NIH Exploratory/Developmental (R21) grant mechanism and runs in parallel with a FOA of identical scientific scope, PAR-10-136, that encourages applications under the R01.
• Funds Available and Anticipated Number of Awards. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received.
• Budget and Project Period. The total project period for an application submitted in response to this funding opportunity may not exceed two years. Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year.
• Application Research Strategy Length: The R21 Research Strategy section may not exceed 6 pages, including tables, graphs, figures, diagrams, and charts. See. See Table of Page Limits
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/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.
• Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application.
• Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.
• Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
• Renewals. Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted.
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates
• Application Materials. See Section IV.1 for application materials.
  All applications, including resubmissions submitted for due dates January 25, 2010 and beyond, must utilize the current forms and instructions.
• General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
  • SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
  • General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The National Institutes of Health (NIH) issues this Funding Opportunity Announcement (FOA) to encourage research project grant applications (R01) 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 more effective 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

Different public and private agencies have various definitions of a health disparity for their own program-related purposes, but these definitions tend to have several things in common. In general, health disparities are defined as significant differences between one population and another. (See Office of Minority Health, U.S. Department of Health and Human Services, http://www.omhrc.gov/templates/content.aspx?ID=3559. ) 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 socioeconomic status, race/ethnicity, and/or rural-urban residence.

Fuller Understandings of Causes and Implications for Solutions

Scientific research supported by the National Institutes of Health (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 improvements in health care for most Americans, and significant declines in disability, morbidity, and mortality from numerous diseases and conditions. As a result, the population can expect not only to live longer, but to be more productive and to enjoy a higher quality of life. However, these gains have not affected all segments of the population equally. A few examples of persistent health disparities are

• 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. African Americans have both a higher overall incidence and a higher death rate than any other racial or ethnic group.
• 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.
• Substantive differences exist in patterns of alcohol consumption or alcohol-related consequences/problems 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) in the ethnic/racial minority, rural or socioeconomic population. For example, alcohol-related cirrhosis-related death rates are higher among Hispanic Whites compared to non-Hispanic Black and European Americans even though Hispanics have lower rates of AUDs than non-Hispanic Whites. The frequency of alcohol-related traffic deaths is much higher among American Indians and Alaska Natives compared to other minority populations.
• The prevalence of osteoarthritis, hypertension, cervical cancer, and of all chronic diseases combined progressively decreases as socioeconomic status increases.
• The prevalence of diabetes is greater in African Americans, Hispanic Americans, American Indians, certain Pacific Islanders and Asian American populations, and in economically disadvantaged people than in the overall European American population.
• 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 less than 25% 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 subgroups of Hispanic male populations are at increased risk for late-stage oral malignancies. The prevalence of dental caries is of concern in disadvantage populations, including Native American/Alaska Natives, Hispanics, African Americans and the poor across the life span. Edentulism is highest amongst Appalachians. Recent trend analyses indicate that disparities have increased for disadvantaged populations.
  

In sum, US 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 US population as a whole or to European Americans.

The research opportunities identified in this announcement are the result of discussions between the extramural research community and the NIH Behavioral and Social Sciences Research Coordinating Committee as well as at the NIH Conference on Understanding and Reducing Disparities in Health: Behavioral and Social Sciences Research Contributions (October 23-24, 2006). This announcement highlights important areas for investigation that may not be included in the health-disparities strategic plans of individual NIH Institutes or Centers. (See Strategic Research Plan and Budget to Reduce and Ultimately Eliminate Health Disparities, FY 2002-2006, http://ncmhd.nih.gov/our_programs/strategic/volumes.asp.)

Given the extensive scientific literature documenting health disparities, this announcement calls for research to improve and elaborate explanations and understandings of the causes for health disparities. In so doing, the announcement stresses the explicit employment of concepts and models from the behavioral and social sciences to guide basic and applied research by focusing on three action areas: Public Policy, Health Care, and Disease/disability prevention. (See below.) It emphasizes (1) basic research on the behavioral and social acting with or through biological pathways that give rise to disparities in health and (2) applied or translational research on the development, testing, 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, 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 (e.g., African Americans vs. European Americans or the US population as a whole). By definition, health disparities refer to the health of a group in comparison to the health of other groups. Although improving the absolute level of a population 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 even 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. Also of interest is research on the causes of disparities within a single population group (e.g., among African Americans).

Note: Many applications to the 2007 FOA failed to address health disparities between groups but rather focused solely on the health status of a particular group. The FOA calls for research on previously documented health disparities, defined in terms of socioeconomic status, race/ethnicity, and/or rural (as opposed to urban) residence. The emphasis is on the health status of populations defined by these demographic variables in comparison to the larger US population or other defined populations. This does not necessarily imply that the research design must include participants from more than one population group.

The primary basic research question is the causes of differences in the health status of populations. While understanding the causes of poor health in a given population may be necessary to explaining differences in health between groups, it is probably 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 why there are 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 research on the causes or consequences of the health disparity.

Areas of Action Affecting Health Disparities

This Funding Opportunities Announcement 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 also affect health and health disparities indirectly. For example, laws prohibiting discriminatory housing practices or 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.

Public and private sector policies are an important and modifiable element of the complex social environmental system that contributes to health disparities. Although scientific knowledge is rarely the only factor driving the formation of policies, rigorous and objective scientific studies can help to inform policy making by providing data on which to base assumptions about the costs and benefits and likely effects of various policy options.

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, behavioral, and biological processes involved in translating public policy into public health. Examples include research on:

• The interacting and cumulative effects on health disparities of policies formulated at a variety of levels national, state, local, and nongovernmental.
• Innovative policy approaches to addressing pathways linking social and behavioral factors to health disparities, e.g., policies with the potential to build social capital in communities, alleviate stressors associated with disadvantage, or address targeted advertising of alcohol and tobacco in disadvantaged populations.
• The behavioral and social mechanisms and processes linking policy to health disparities, including the role of social, cultural, and economic factors in mediating impacts and producing variations in policy implementation that affect outcomes.
• Knowledge transfer in the context of policy formation and implementation. Incorporating scientific knowledge with other kinds of information in the community, economic, bureaucratic, and legal processes that leads to the development of policies to affect health disparities?
• Cost-effectiveness of different policy strategies for addressing health disparities.
• Development of research designs and methodologies for studying policy effects on health disparities, including experimental, comparative, and other observational methods.
  

HEALTH CARE: Health-care is defined as the timely delivery of care and/or medical 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.

For example, members of certain racial/ethnic groups are less likely than the general population to receive health-care services. For example, blacks are less likely than whites to receive common diagnostic procedures and treatments or to receive intensive interventions such as by-pass surgery. Furthermore, racial disparities exist in important qualitative aspects of medical care, e.g., receiving care from a private physician vs. hospital outpatient or emergency departments.

Increased conceptual and empirical efforts are needed to identify and understand the processes leading to differentials in health care and to develop intervention strategies. Note that merely documenting or comparing utilization rates is not in the purview of this FOA. Explanatory analyses of the origins of differential rates or evidence-based interventions to improve 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, but not limited to, are:

• Differential mix of health care services available to and accessible by various population groups. For example, physicians may tend to avoid areas with large racial/ethnic populations when establishing private practices; distances to health care services may be greater for those living in racial/ethnic communities; outreach and health promotion activities of agencies may be less effective. A related question is how the currently evolving health care system, e.g., HMOs, affects health disparities.
• Inadequate economic resources or poverty-related factors (e.g., time constraints, lack of access to transportation, unsafe environments) may result in foregoing or postponing medical services. For example, Hispanic adults are substantially more likely to be uninsured than white or black adults.
• 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.
• Individuals from a racial/ethnic, rural, or low-SES population may express their disease symptoms in ways different from members of the general population, which may lead to errors in diagnoses and treatment.
• Prejudice and discrimination may influence decisions about providing healthcare services.
• Anticipated prejudice and discrimination may impact negatively upon clinical care relationships and 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 preventing or ameliorating high-risk behaviors, the occurrence of disease/disorder/injury or progression of detectable but asymptomatic disease. Prevention research also includes research studies to develop and evaluate disease/disability prevention and health promotion recommendations and public health programs. Included, but not limited to, is research on:

• Identification of modifiable risk and protective factors for diseases/disorders/injuries that may differ across populations;
• Development of population-appropriate methods, drawing upon behavioral and social science findings, for screening and identification of markers for those at risk for onset or progression of asymptomatic diseases/disorders, or at risk for adverse high-risk behaviors/injuries;
• Using behavioral and social science theory and findings to develop and evaluate 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 risk and measuring the differential effects of preventive interventions among populations experiencing health disparities.
  

While several interventions to improve health-enhancing behaviors in the areas of smoking, drinking, physical activity, and diet have been developed, there continues to be a need to test the effectiveness of these interventions for vulnerable populations in diverse population groups. Although a variety of theoretical models (health belief model, theory of reasoned action, trans-theoretical model and stages of change, etc.) have been developed to describe the process of health behavior change, still unknown is the relevance of different theories for changing particular behaviors in various populations. In addition to research on individual level behavior change, gaps remain in the development and testing of community level interventions for a diversity of communities experiencing health disparities. Also needed is research on personal, cultural, and institutional barriers to intervention availability, delivery and effectiveness as a function of population-group membership, 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. Consequently, the NIH encourages research on topics falling within more than one of these categories or on the interplay among the categories.

Research Perspectives and Themes

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 these themes into their research proposals.

Interdisciplinary collaborations. Addressing health disparities requires a greater understanding of the full range of 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 particular problems cannot be adequately addressed within a single discipline, and instead require a more comprehensive approach. New discoveries and innovative solutions may become possible when researchers in different disciplines meet at the interfaces and frontiers of those disciplines to pool their diverse knowledge. Interdisciplinary collaborations refer to scientific endeavors in which 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 or her own disciplinary perspective with limited direct interaction and little cross-fertilization among disciplines. The NIH 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. However, while the disciplines concerned with health research may be separated conceptually, methodologically, and administratively, the processes about which they are concerned are inextricably linked. A levels-of-analysis approach offers a framework for understanding the interdependence among levels. 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). Others suggest a metaphor of Chinese boxes to guide a new eco-epidemiology which treats relationships within and between localized structures that are bounded socially, biologically, or topographically . Such frameworks 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 interventions, and primary and secondary intervention. Thus, 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.

An accumulated body of empirical findings has clearly demonstrated that social and cultural factors create conditions of life that can protect or damage health. These conditions influence health by affecting such things as exposure and vulnerability to disease, risk-taking behaviors, the effectiveness of health promotion efforts, and access to, availability of, and quality of health care. They play a critical role in shaping individuals responses to health problems and influence how poor health affects individuals lives and well-being. The social sciences contribute to the nation s health research agenda by addressing the dynamics of these social and cultural processes and the mechanisms through which they affect health.

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 thinking refers to bringing a perspective to problem-solving in which the problem space is conceptualized as a system of interrelated component parts. The system is viewed as a coherent whole. The relationships among the components are also recognized and seen as critical to the system, for they give rise to the emergent properties of the system. Emergent properties are those properties that can only be seen at the system level and are not attributes of the individual components themselves (e.g., a flock emerges when a group of birds flies together; it is a property of the system, not of any individual bird). Systems approaches offer insights into the nature of the whole system that often cannot be gained by studying the component parts in isolation. Moreover, a systems approach recognizes that embedded in the system are feedback loops, stocks and flows, that change over time (i.e., dynamic complexity of the system). Advantages of utilizing systems approaches as a complementary method for addressing complex problems include the fact that non-linear relationships, unintended effects of intervening in the system, and time-delayed effects are often missed with traditional reductionistic approaches, whereas systems approaches excel at detecting these.

Systems approaches are able to address a broad range of factors within a single framework from genetic to environmental, cellular to behavioral, and biological to social levels of analysis. Systems thinking is also logically related to knowledge and computing infrastructures necessary to link networks of researchers in their collaborative work. Successful application of these approaches in defense, business, and cellular biology have resulted in a growing interest in the use of systems approaches to population health research. The belief is that a systems approach shows promise for understanding and intervening on the complex, multi-dimensional relationships underlying health disparities.

A wide variety of methodologies are encompassed under systems science. Any variety is acceptable under this FOA. Here are some examples of the methodologies being sought under this FOA; note that this list is meant to be illustrative and not exhaustive:

• Agent based modeling
• System dynamics simulation
• Network analysis, including social network analytic methods
• Discrete event simulation
• Markov modeling
• Stochastic modeling
• Differential equation/compartmental modeling
  

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 the associations between membership in socially-defined population groups and health. For example, racial/ethnic group status influences early life conditions, including the fetal environment, 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 both mental and physical health problems, and as such offer unique opportunities for intervention. For example, the early adolescent period has been identified as one which involves a combination of biological (e.g., puberty), social (e.g., increased role of the peer group), ecological (e.g., middle school), and cognitive (e.g., increased capacity for abstract thinking) changes as well as increased risk for certain disorders such as depression. 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 a wide variety of transitions across the lifespan along with the risk and protective factors related to them is needed for the ultimate development and testing of innovative interventions that target high risk periods across the life course. Such an approach emphasizes the fact that early life disadvantage and adversity need not lead to later negative outcomes, provided there are compensating positive experiences in the intervening years. Similarly, attention should be given to the positive aspects of people’s lives (e.g., positive social relationships and social support, education) that may buffer or compensate for the effects of adversity.

Community-based participatory research (CBPR). CBPR is defined as scientific inquiry conducted in communities and in partnership with researchers. The process of scientific inquiry is such that community members, persons affected by the health condition, disability or issue under study, or other key stakeholders in the community's health have the opportunity to be full participants in each phase of the work (e.g., from conception, design, conduct, analysis, interpretation, conclusions to communication of results). CBPR is characterized by substantial community input in the development of the grant application (http://obssr.od.nih.gov/scientific_areas/methodology/community_based_participatory_research/index.aspx ).

Community-partnered approaches to research promise to deepen our scientific base of knowledge in the areas of health promotion, disease/disability prevention, and health disparities. Community-partnered research processes offer the potential to generate better-informed hypotheses, develop more effective 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 intentional and conscious as well as unintentional and 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-08-083.html.) For example, a study of racial factors that contribute to differentials in diagnosis and treatment demonstrated that racial bias is a significant influence on the likelihood that cardiac catheterization will be recommended 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.

The influence of actual as well as perceived (e.g., stereotype threat ) prejudice and discrimination is not limited to access to health care. They can be sources of acute and chronic stress, which have been linked to conditions such as cardiovascular disease and alcohol abuse. Discrimination can restrict the educational, employment, economic, residential and partner choices of individuals, affecting health through pathways linked with what psychosocial scientists refer to as 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 and health has focused on African Americans. Few studies have addressed systematically how prejudice and discrimination affect other racial/ethnic groups 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 the impact of 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 undertaking a program of research to examine the relative magnitude of 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 throughout their life course. 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 five inter-related domains: families and households; social networks; neighborhoods; formal institutions; and public policy. Economic, social, and cultural processes interweave all of these domains.

• Family structure, family resources, and family processes influence health across the life course. Families are centrally important for child health and development, influencing outcomes through parenting, adequate nutrition, obtaining health care, instilling healthy behaviors, and providing education and financial resources. Throughout life, families tend to operate as economic units and provide social, emotional, and instrumental supports (or create interpersonal stresses) that influence health and health-related behaviors. Socioeconomic status includes income, education, employment opportunities, and job characteristics. 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 (e.g., the ability to follow medical protocols) and behaviors (e.g, smoking and drug use), which subsequently impact other family members such as children. Family processes reflect cultural understandings and also imbue or reinforce them in family members. For example, family racial or ethnic identity is played out in family interactions and rituals, and may provide a source of resilience in the face of discrimination and stress. Family values regarding appropriate responses to disease symptoms are reinforced in parenting practices and affect the timing of health care seeking.
  
  
• Social networks are defined as a web of social ties that connect people to others. Social networks provide individuals and their families with social support that may come in the form of emotional support that buffers individuals from poor physical or mental health, or in the form of information or instrumental help that can be used to maintain or improve health. Persons living in large, urban high-rise housing developments with little social organization and community support or in sparsely populated rural areas may be at a disadvantage for developing supportive social networks. Social networks also channel the diffusion of ideas and practices; they are the nexus for the creation of cultural norms and beliefs. 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 resources that are important for the health of its members. These resources 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 age, racial and ethnic composition, population density, and housing stocks, have an impact on social processes and the resources available to neighborhood residents. Racial/ethnic and poor communities are disproportionately exposed to health-damaging physical environments characterized by overcrowding, noise, substandard housing, insufficient public services, and toxic chemicals (including air pollution). A close connection exists among the physical, built, and social environments within neighborhoods and communities. For example, communities that have higher incomes and more effective community and political organizations may be better positioned to create and maintain physically healthy environments.
  Finally, formal institutions (e.g. institutions, including schools and childcare facilities, 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. Formal institutions are central to this announcement: they create and implement policies, design and operate prevention programs, and provide health services.
  

Examples of Research Topics

Applications should be relevant to both the objectives of the FOA and to at least one of the participating Institutes research interests. Researchers are strongly encouraged to review the general research interests of the participating Institutes 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.

Additional Information about the R21

The evolution and vitality of the biomedical, behavioral, and social sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research.

The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications. Projects of limited cost or scope that use widely accepted approaches and methods within well established fields are better suited for the R03 small grant mechanism. Information on the R03 program can be found at http://grants.nih.gov/grants/funding/r03.htm.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This FOA will use the NIH Exploratory/Developmental Research Grant (R21) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts see SF424 (R&R) Application Guide). It also uses modular as well as non-modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. 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.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

• Public/State Controlled Institutions of Higher Education
• 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
• 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)
• Small Businesses
• For-Profit Organizations (Other than Small Businesses)
• State Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribally Designated Organizations
• County Governments
• City or Township Governments
• Special District Governments
• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• U.S. Territory or Possession
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Organizations)
• Other(s):
  • Eligible Agencies of the Federal Government
  • Faith-based or Community-based Organizations.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI 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.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) are permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Original new applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals. Exploratory/developmental grant support is for new projects only; renewal (formerly competing continuation ) applications will not be accepted.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

• Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered.

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email [email protected]

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  Email [email protected]

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

• The individual designated as the PD/PI on the application must also be registered in the NIH eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov.
• The PD/PI must hold a PD/PI account in the Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI.
• This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the Commons.
• Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6. regarding appropriate required budget component.)

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Foreign Organizations (Non-domestic [non-U.S.] Entities)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from Foreign organizations must:

• Request budgets in U.S. dollars;
• Prepare detailed budgets for all applications (that is, complete the Research & Related Budget component of the SF424 (R&R) application forms not the PHS398 Modular Budget component)(see NOT-OD-06-096);
• Not include any charge-back of customs and import fees;
• Comply with the format specifications, which are based upon a standard U.S. paper size of 8.5 x 11 within each PDF;
• If appropriate, request funds for up to 8% Facilities and Administrative (F&A) costs (excluding equipment) ( see NOT-OD-01-028, March 29, 2001);
• Comply with Federal/NIH policies on human subjects, animals, and biohazards; and
• Comply with Federal/NIH biosafety and biosecurity regulations (see Section VI.2., Administrative and National Policy Requirements )

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States (U.S.) or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered on the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled Multiple PD/PI Leadership Plan , must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates
Opening Date: August 14, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): August 14, 2010, December 11, 2010, April 11, 2011, August 14, 2011, December 11, 2011, April 11, 2012, August 14, 2012, December 14, 2012
April 11, 2013
Application Due Date(s): September 14, 2010, January 11, 2011, May 11, 2011, September 14, 2011, January 11, 2012, May 11, 2012, September 14, 2012,
January 14, 2013, May 11, 2013
AIDS Application Due Date(s): Not applicable
Peer Review Date(s): February-March 2011, June-July 2011, October-November 2011
February-March 2012, June-July 2012, October-November 2012, February-March 2013, June-July 2013, October-November 2013
Council Review Date(s): May 2011, October 2011, January 2012, and May 2012, October 2012,
January 2013, and May 2013, October 2013, January 2014
Earliest Anticipated Start Date(s): July 2011. December 2011, March 2012, and July 2012. December 2012, March 2013, July 2013, December 2013, March 2014

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research.
• Name, address, and telephone number of the PD(s)/PI(s).
• Names of other key personnel.
• Participating institutions.
• Number and title of this funding opportunity.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Michael Spittel, Ph.D.
Health Scientist Administrator
Office of Behavioral and Social Sciences Research
Office of the Director National Institutes of Health
31 Center Drive
Building 31/Room B1C19
Bethesda, MD 20892-2027
Phone: 301-451-4286
Fax: 301-402-1150
E-mail: [email protected]
http://obssr.od.nih.gov

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

3.C. Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :

• All registrations must be complete prior to the submission deadline
• The application must receive a Grants.gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date.
• Any system identified errors/warnings must be corrected and the submission process completed within the error correction window.

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

• Initial application submission must be on-time.
• The AOR/institutions is expected to enforce that application changes made within the error correction window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes.
• Proof of on-time submission (e.g., Grants.gov timestamp and tracking number) and description of all changes made within the window must be documented in the PHS 398 Cover Letter component of the application.

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

• If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
• Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12 of the SF 424 (R&R) application guide, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
• If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two weekdays.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs Important Tips -- Electronic Submission of Grant Applications.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS398 Research Plan Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following requirements for R21 applications:

• Introduction (required for a resubmission or revision application) is limited to 1 page.
• Specific Aims is limited to 1 page.
• Research Strategy, including tables, graphs, figures, diagrams, and charts, is limited to 6 pages. See Table of Page Limits.
• Preliminary data are not required but may be included if available.

Budget Component

U.S. applicants submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) must use the PHS398 Modular Budget component.

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.

R21 applications will use the modular as well as non-modular budget formats and "Just-in-Time" information concepts, with direct costs requested in $25,000 modules, up to the total direct costs limitation of $275,000 over an R21 two-year period. No more than $200,000 in direct costs will be allowed in any single year.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm). Also see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process or not reviewed.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(a) Data Sharing Plan: Not Applicable

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)

Foreign Applications (Non-domestic (non-U.S.) Entity)

Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established Public Health Service (PHS) referral guidelines.

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by CSR and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the initial merit review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned an impact/priority score;
• Receive a written critique; and
• Receive a second level of review by the appropriate national advisory council or board.

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.

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority 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 five scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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? Does the project improve understanding of disparities in health or contribute to reducing health disparities?

Investigator(s). Are the PD/PIs, 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?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, 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.

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.

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, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), 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.

Renewal Applications. Renewals are not permitted for this FOA.

Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), 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.

Additional Review Considerations

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

Applications from Foreign Organizations. As applicable for the FOA or submitted application, 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 Agents 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 (Not Applicable); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. 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.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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. See Section IV.5., Funding Restrictions.

2. Administrative and National Policy Requirements

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.

3. Reporting

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

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:

For general information:

Michael Spittel, Ph.D.
Health Scientist Administrator
Office of Behavioral and Social Sciences Research
Office of the Director National Institutes of Health
31 Center Drive
Building 31/Room B1C19
Bethesda, MD 20892-2027
Phone: 301-451-4286
Fax: 301-402-1150
E-mail: [email protected]
http://obssr.od.nih.gov

Participating Components:

National Cancer Institute (NCI/NIH) http://www.nci.nih.gov/

Shobha Srinivasan, Ph.D.
Health Disparities Research Coordinator
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd., Room 6126
Bethesda, MD 20892-7338
Tel.: 301.435.6614
Fax: 301.594.6787
E-mail: [email protected]

National Center for Complementary and Alternative Medicine (NCCAM/NIH) http://nccam.nih.gov/

Sheila A. Caldwell, Ph.D.
Program Director
Special Populations
Division of Extramural Research
National Center for Complementary andAlternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892
Ph: (301) 594-3396
Fax: (301) 480-3621
Email: [email protected]

National Eye Institute (NEI/NIH) http://www.nei.nih.gov/

Dr. Eleanor Schron
Division of Extramural Research
National Eye Institute
5635 Fishers Lane, MSC 9300
Bethesda, MD 20892-9300
Tel.: 301.451.2020
Fax: 301.402.0528
E-mail: [email protected]

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS/NIH) http://www.niams.nih.gov

Phil Tonkins, Dr PH
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Blvd., MSC 4872
Bethesda, MD 20892-4872
Tel.: 301.594.5032
E-mail: [email protected]

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD/NIH) http://www.nichd.nih.gov/

Regina M. Bures, PhD
Demographic and Behavioral Sciences Branch
Center for Population Research
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 8B07, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301- 496-9485
Email: [email protected]

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK/NIH) http://www.niddk.nih.gov/

Lawrence Agodoa, Ph.D
Director Office of Minority Health Research Coordination
National Institute of Diabetes and Digestive and Kidney Diseases
6706 Democracy Blvd., MSC 5454
Bethesda, MD 20892-5454
Tel.: 301.594.1932
Fax: 301.594.9358
E-mail: [email protected]

National Institute of Dental and Craniofacial Research (NIDCR/NIH)http://www.nidcr.nih.gov

Ruth Nowjack-Raymer, MPH, PhD
Director, Health Disparities Research Program
National Institute of Dental and Craniofacial Research
45 Center Drive, Building 45, Room 4AS-43F
Bethesda, MD 20892-6401
Tel.: (301) 594-5394
FAX: (301) 480-8322
E-mail: [email protected]

National Institute of Environmental Health Sciences (NIEHS/NIH) http://www.niehs.nih.gov

Kimberly Gray, Ph.D.
National Institute of Environmental Health Sciences
P.O. Box 12233 MD EC-21
111 T.W. Alexander Drive
Research Triangle Park , NC 27709
Tel.: 919.541.0293
Fax: 919.316.4606
E-mail: [email protected]

National Instiute of Mental Health (NIMH/NIH) http://www.nimh.nih.gov

Robert A. Mays Jr., Ph.D.
Office for Research on Disparities & Global Mental Health
National Institute of Mental Health
6001 Executive Boulevard, Room 6216, MSC 9659
Bethesda, MD 20892-9659
Telephone:301-443-2847
Email: [email protected]

National Institute of Nursing Research (NINR/NIH) http://www.ninr.nih.gov/

Paul A. Cotton, Ph.D., RD
Health Behavior and Minority Health
National Institute of Nursing Research
6701 Democracy Blvd., Suite 710
One Democracy Plaza
Bethesda, MD 20892-4870
Tel.: 301.402.6423
Fax: 301.451.5647
E-mail: [email protected]

National Institute on Aging (NIA/NIH) http://www.nia.nih.gov

John Haaga, Ph.D.
Division of Behavioral and Social Research
National Institute on Aging
Gateway Bldg., Rm. 533
7201 Wisconsin Ave., MSC 9205
Bethesda, MD 20892-9205
Tel.: 301.496-3131
E-mail: [email protected]

National Institute on Alcohol Abuse and Alcoholism (NIAAA/NIH) http://www.niaaa.nih.gov/

Judith A. Arroyo, Ph.D.
Division of Epidemiology and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2079
Bethesda, MD 20892-9034
Tel.: 301.402-0717
Fax: 301.443.8615
E-mail: [email protected]

National Institute on Deafness and Communication Disorders (NIDCD/NIH) http://www.nidcd.nih.gov/

Howard J. Hoffman, M.A.
Director, Epidemiology and Biostatistics Program
Translational Research Branch
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400A
6120 Executive Blvd., MSC 7180
Bethesda, MD 20892-7180
Tel.: 301.402.1843
Fax: 301.402.0390
E-mail: [email protected]

National Institute on Drug Abuse (NIDA/NIH) http://www.nida.nih.gov

Dionne J. Jones, Ph.D.
Services Research Branch
Division of Epidemiology
Services & Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5185, MSC 9589
Bethesda, MD 20892
Tel.: 301-402-1984
Fax: 301-443-6815
E-mail: [email protected]

National Library of Medicine (NLM/NIH) http://www.nlm.nih.gov/

Hua-Chuan Sim, M.D
Program Officer
Division of Extramural Programs
National Library of Medicine
6705 Rockledge Drive, Suite 301
Bethesda, MD 20892-7968
Tel.: 301.594.4882
Fax: 301.402.2952
E-mail: [email protected]

2. Peer Review Contacts:

Dr. Gabriel Fosu
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive MSC 7808
Bethesda, MD 20892-7808
Tel.: 301.435.3562
E-mail: [email protected]

3. Financial or Grants Management Contacts:

National Center for Complementary and Alternative Medicine (NCCAM/NIH) http://nccam.nih.gov/

George Tucker
Grants Management Officer
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Room 401, MSC 5475
Bethesda, MD 20892-5475
Tel.: 301.594.9102
E-mail: [email protected]

National Cancer Institute (NCI/NIH) http://www.nci.nih.gov/

Crystal Wolfrey
Deputy Director
Office of Grants Administration
National Cancer Institute
National Institutes of Health
6120 Executive Blvd., Suite 243
Bethesda, MD 20892
Tel:. 301.496.8634
Fax: 301.496.8601
E-mail: [email protected]

National Eye Institute (NEI/NIH) http://www.nei.nih.gov/

William W. Darby
Grants Management Officer
Division of Extramural Research
National Eye Institute
National Institutes of Health
Suite 1300
5635 Fishers Lane, MSC 9300
Bethesda, MD 20892-9300
Tel.: 301.451.2020
Fax: 301.496.9997
E-mail: [email protected]

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS/NIH) http://www.niams.nih.gov

Gail Hamilton
Senior Grants Management Specialist
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Boulevard, Suite 800
Bethesda, MD 20892
Tel.: 301. 594.3506
Fax: 301.480.5450
E-mail: [email protected]

National Institute on Aging (NIA/NIH) http://www.nia.nih.gov

John Bladen
Grants Management Specialist
The National Institute on Aging
Grants and Contracts Management Office
Gateway Bld., Ste. 2N212
7201 Wisconsin Avenue
Bethesda, MD 20902
Tel: 301.496.1472
Fax: 301.402.3672
E-mail: [email protected]

National Institute of Mental Health (NIMH/NIH) http://www.nimh.nih.gov

Rebecca Claycamp, MS, CRA
Chief, Grants Management Officer
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Tel.: 301.443.2811
Fax: 301.480.1956
E-mail: [email protected]

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD/NIH) http://www.nichd.nih.gov/

Cecilia E. Bruce
Supervisory Grants Management Specialist (Team Leader)
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Blvd - Room 8A17L
Rockville, MD 20852
Tel.: 301.496.1304
Fax: 301.480.4782
E-mail: [email protected]

National Institute of Nursing Research (NINR/NIH) http://www.ninr.nih.gov/

Randi Freundlich
Grants Management Specialist
National Institute of Nursing Research
6701 Democracy Blvd., Suite 710, MSC 4870
Bethesda, MD 20892-4870
Tel.: 301.594.5974
Fax: 301.402.4502
E-mail: [email protected]

National Institute on Alcohol Abuse and Alcoholism (NIAAA/NIH) http://www.niaaa.nih.gov/

Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023
Bethesda, MD 20892-9034
Tel.: 301.443.4704
Fax: 301.443.3891
E-mail: [email protected]

National Institute on Deafness and Communication Disorders (NIDCD/NIH) http://www.nidcd.nih.gov/

Chris Myers
Grants Management Branch
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400B
6120 Executive Blvd., MSC 7180
Bethesda, MD 20892-7180
Tel.: 301.402.0909
Fax: 301.402.1798
E-mail: [email protected]

National Institute on Drug Abuse (NIDA/NIH) http://www.nida.nih.gov

Edith Davis
Grants Management Branch
National Institute on Drug Abuse,
6101 Executive Boulevard, Room 270, MSC 8403
Rockville, MD 20852
Tel.: 301-443-6710
Fax: 301- 594-6849
E-mail: [email protected]

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK/NIH) http://www.niddk.nih.gov/

Robert Pike
Chief, Grants Management Officer
National Institute of Diabetes & Digestive & Kidney Diseases
National Institutes of Health
2 Democracy Plaza, MSC 5450
6707 Democracy Blvd., Room 731
Bethesda, MD 20892-5450
Tel: 301.594.8854
Fax: 301.594.9523
E-mail: [email protected]

National Institute of Dental and Craniofacial Research (NIDCR/NIH) http://www.nidcr.nih.gov

Mary Daley Greenwood
Chief Grants Management Officer
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd., Rm. 658, MSC 4878
Bethesda, MD 20892-4808
Tel.: (301) 594-4808
Fax: (301) 480-3562
E-mail: [email protected]

National Institute of Environmental Health Sciences (NIEHS/NIH) http://www.niehs.nih.gov

Donald Ellis
Grants Management Specialist
NIEHS Grants Management Branch
P.O. Box 12233, MD/EC-22
Research Triangle Park, NC 27709
Tel.: (919) 541-1874
E-mail: [email protected]

National Library of Medicine (NLM/NIH) http://www.nlm.nih.gov/

Arnita Miles
Grants Management Specialist
Division of Extramural Programs
National Library of Medicine
6705 Rockledge Drive, Suite 301
Bethesda, MD 20892-7968
Tel.: 301.496.4221
Fax: 301.402.0421
E-mail: [email protected]

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants ( NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.