Required Application Instructions

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

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

This FOA encourages R01 applications that apply system science approaches such as system dynamic modeling, agent-based modeling, social network analysis, discrete event analysis, and Markov modeling to better understand complex and dynamic behavioral and social sciences processes and problems relevant to health. Research projects applicable to this FOA are those that are either applied or basic in nature (including methodological development), have a human behavioral and/or social science focus, and employ systems science methodologies, a suite of methods suited to addressing the complexity inherent in behavioral and social phenomena. This FOA will utilize the R01 funding mechanism. A companion FOA entitled, Systems Science and Health in the Behavioral and Social Sciences (R21) will be issued in parallel and will utilize the R21 funding mechanism (See PAR-15-047).

This FOA is intended to increase the breadth and scope of topics that can be addressed with systems science methodologies. This FOA calls for research projects that are applied and/or basic in nature (including methodological and measurement development), have a human behavioral and/or social science focus, and employ methodologies suited to addressing the complexity inherent in behavioral and social phenomena, referred to as systems science methodologies. Additionally, this FOA seeks to promote interdisciplinary collaboration among health researchers and experts in computational approaches to further the development of modeling- and simulation-based systems science methodologies and their application to important public health challenges.

Systems science methodologies are specific methodological approaches that have been developed to understand connections between a system’s structure and its behavior over time. Systems science methodologies is an umbrella term that refers to a variety of such methodologies including, but not limited to, agent-based modeling, microsimulation, system dynamics modeling, network analysis, discrete event analysis, Markov modeling, control systems engineering and related engineering methods, and a variety of other dynamic and computational modeling and simulation approaches.

A system, in this context, refers to the particular configuration of all relevant entities, resources, and processes that together adequately characterize the problem space under study (i.e., a system is defined by the boundaries that stakeholders use to determine which acts/observations are relevant for their inquiry as well as the interpretations/judgments that they use to guide decisions or actions). Systems science methodologies are valued for their ability to address the complexity inherent in behavioral and social phenomena. For example, these approaches excel at identifying non-linear relationships, bi-directional feedback loops, time delayed effects, emergent properties of the system, and oscillating system behavior.

There has been rapidly growing interest in systems science methodologies among the behavioral and social science research community in the past few years. For example, in 2010 the Institute of Medicine (IOM) released a report, For the Public’s Health: The Role of Measurement in Action and Accountability (December 2010, available at: http://www.nap.edu/catalog.php?record_id=13005). The report gives specific recommendations on what the U.S. Department of Health and Human Services should do to improve population health data collection, analysis, and reporting. Relevant to systems science is recommendation #6 in this report: The pathways between the social, economic, and environmental causes of poor health are complex and interconnected. Models and other novel analytic tools can elucidate these pathways and relationships and be used to assess the benefits and harms of policy and intervention options. These tools are needed to support policy-making, including resource allocation. Therefore, the committee recommends that the Department of Health and Human Services (HHS) coordinate the development and evaluation and advance the use of predictive and system-based simulation models to understand the health consequences of underlying determinants of health. HHS should also use modeling to assess intended and unintended outcomes associated with policy, funding, investment, and resource options.

Moreover, another recent IOM report, Bridging the Evidence Gap in Obesity Prevention: A Framework to Inform Decision Making (April 2010, available at: http://books.nap.edu/openbook.php?record_id=12847), included the recommendation that to address the obesity problem successfully, a systems perspective will be needed. The report elaborated on this as an approach that encompasses the whole picture, highlighting the broader context and interactions among levels, to capture the complexity of obesity prevention and other multifactorial public health challenges.

The Department of Health and Human Services has been heeding this call. Several NIH Funding Opportunity Announcements now include language encouraging systems science approaches and the Office of Behavioral and Social Sciences includes Systems Thinking Approaches to Health as one of four primary themes in its strategic prospectus (available at: http://obssr.od.nih.gov/about_obssr/strategic_planning/strategicPlanning.aspx).

Moreover, in late 2010, the Department released a report entitled, "Ending The Tobacco Epidemic: A Tobacco Control Strategic Action Plan for the U.S. Department of Health and Human Services" (available at: http://www.hhs.gov/ash/initiatives/tobacco/tobaccostrategicplan2010.pdf). The specific strategic actions recommended in the report were based on policy relevant to modeling and simulation.

There are now several examples of how systems science methodologies have been utilized to inform health policy. A system dynamics model of polio transmission in the context of different vaccination strategies convinced the World Health Organization (WHO) to modify their approach to polio from one of control to one of eradication. The NIGMS initiative, Models of Infectious Disease Agents Study (MIDAS), used a variety of modeling strategies, including agent based modeling, to explore policy questions around flu vaccination and antiviral use (e.g., how should resources be used to limit spread of an infection?) and school closure in the event of a pandemic (see https://www.epimodels.org/midas/about.do). Finally, simulation models developed under NCI's Cancer Intervention and Surveillance Modeling Network (CISNET) were used to inform guidelines issued by the U.S. Preventive Services Task Force for breast cancer screening (http://www.uspreventiveservicestaskforce.org/uspstf/uspsbrca.htm) and colorectal cancer screening (http://www.uspreventiveservicestaskforce.org/uspstf/uspscolo.htm). Moreover, CISNET models were used to perform technology assessments to inform the Centers for Medicare and Medicaid Services (CMS) for reimbursement decisions regarding DNA stool testing (http://www.cms.gov/medicare-coverage-database/details/technology-assessments-details.aspx?TAId=52), the fecal immunochemical test (FIT, http://www.cms.gov/medicare-coverage-database/details/technology-assessments-details.aspx?TAId=20), and CT colonography(http://www.cms.gov/medicare-coverage-database/details/technology-assessments-details.aspx?TAId=58).

Therefore, the Institutes, Centers, and Offices of NIH that are listed as participating in this FOA issue this announcement in response to the above developments, to encourage basic and applied research projects that address behavioral and social aspects of health and utilize systems science methodologies.

Examples of research topics encouraged under this FOA include, but are not limited to, those listed below.

NCI is interested in research projects that address the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients. Further information on NCI’s interests can be found at http://www.cancer.gov/aboutnci/overview/mission. The Behavioral Research Program (BRP) is within the National Cancer Institute s Division of Cancer Control and Population Sciences. BRP initiates, supports, and evaluates a comprehensive program of research ranging from basic behavioral research to the development, testing, and dissemination of interventions in areas such as tobacco use, screening, dietary behavior, and sun protection. Projects that utilize systems science methodologies to increase the breadth, depth, and quality of behavioral research in cancer prevention and control would be appropriate to this FOA and of interest to the NCI.

Example projects that would be appropriate to this FOA and of interest to the NCI include, but are not limited to:

• Develop decision models to assist states and communities in their efforts to promote effective dissemination, implementation of multi-pronged and coordinated approaches to cancer control and health promotion.
• Elucidate the relationships between healthcare delivery processes (e.g., network measures of referral patterns) and health outcomes across the entire system of care --from structural factors to healthcare process to patient health outcomes.
• Study features of complex social/environmental cancer-related health behaviors (e.g., physical activity, diet/nutrition, sun exposure, and tobacco use) in order to identify underlying mechanisms and leverage points for intervention.
• Examine multi-level effects of health promotion and disease prevention interventions, for example, to investigate whether the effects of interventions aimed at the individual level have effects on the network in which individuals are embedded, or to assess how changes at higher levels (e.g., policy) affect individual behavior.
• Build on traditional cancer surveillance models to examine the interactivity among units of analysis (e.g., social, political, cultural, economic, and individual determinants of risk factor changes, screening behavior, and treatment choices), and include dynamic feedback loops to provide a more comprehensive understanding of the impact of trends across the cancer control spectrum.
• Capture the interaction of psychosocial and behavioral intervention mechanisms with genetic dispositions and stratification by condition. Such models could capture transmission of attitudes across networks, an understanding of the follow-through effects, and impacts on multiple related health behavior outcomes exhibited or avoided over time, and effects of social environments altered by interventions on all of the above as a dynamical system.
• Investigate possible benefits and/or unintended consequences of community, city, or state policies designed to affect behavior change among cancer-related health behaviors such as physical inactivity, unhealthy diet, sun exposure, and tobacco use.
• Model idiographic changes in behavior over time (e.g., increases and decreases in physical activity or smoking) using temporally dense sensor and ecological momentary assessment data to better understand the influences of these cancer risk behaviors.

NIA supports genetic, biological, clinical, behavioral, social, and economic research related to the aging process and the life course, diseases and conditions associated with aging, and other special problems and needs of older Americans. Further information on NIA’s interests can be found at: http://www.nia.nih.gov/research/dbsr. Specific topics that would be appropriate to this FOA and of interest to the NIA include, but are not limited to projects that utilize systems science methodologies for:

• Social Insurance Systems - including projects that measure costs and benefits of Social Security, Medicare, Medicaid, and other programs. Appropriate projects would also consider key factors such as the impact of population aging, health care cost growth, programmatic changes, and uncertainty on social insurance forecasts as well as decompose the impact of key factors on forecasts. Examination of regional and cross-national differences to elucidate these issues is also encouraged.
• Race, Ethnicity, and Socioeconomic Status (SES) - including projects which examine the complex causal relationships between those characteristics and health and morbidity across the life course. Improved understanding of the degree to which SES produces differences in health outcomes over the life course, and the mechanisms involved. Efforts to identify social or environmental factors affecting health outcomes and comparative cross-national analyses are encouraged.
• Macroeconomic Impact of Population Aging - including projects that explore (1) the relationship between population aging or other demographic changes and economic growth as well as savings, interest rates, labor supply, earnings, investment, and international capital flows, (2) the influence on nations age structures on migratory flows, and (3) the effect of institutions on the macroeconomic consequences of aging.
• Pathways and Modification research that illuminates the pathways by which social, psychological, economic, and behavioral factors affect health throughout the life course, including individual or group social or economic behaviors and their interactions with affective, rational, and social contagion factors. Also, research which examines how organizational structures or individual behaviors can be modified to improve health outcomes at different life stages.
• Reversing the Effects of Disadvantage - research that describes the mechanisms through which early life disadvantages affect wellbeing later in life and evaluates options for ameliorating those effects, including critical periods or optimal timing for reversibility.
• Psychosocial Stress, Health, and Aging - Research on psychosocial stress that examines how social, behavioral, psychological, and biological factors interact, either through processes of biological embedding or cumulative effects over developmental time, to impact later life health.
• Coordinating Care Delivery in Complex Health Systems - Analysis of alternative models for coordinating care delivery in complex health care systems, including accountable care organizations and medical homes, as well as estimation of clinical and economic benefits.

NIAAA conducts and supports research in a wide range of scientific areas including genetics, neuroscience, epidemiology, health risks and benefits of alcohol consumption, prevention, and treatment. Further information on NIAAA s interests can be found at http://www.niaaa.nih.gov/about-niaaa. Research topics appropriate to this FOA and of interest to NIAAA include, but are not limited to, projects that use systems science methodologies to:

• Advance understanding of the causes, consequences, treatment, and prevention of alcohol-related problems and alcohol use disorders, for example, through: modeling to characterize the linkages between personal or environmental risk factors, alcohol-related behaviors, and health outcomes; analyses of the role of alcohol in population-level health and economic outcomes; examination of determinants of drinking behaviors and outcomes on multiple time scales ranging from momentary decision-making to life-cycle and trans-generational influences; models of the causes and consequences of changes in drinking before, during, and after treatment; and studies of the determinants of treatment-seeking and utilization of health care services related to or caused by alcohol.
• Strengthen the research foundations for understanding how preventive interventions may reduce the adverse consequences associated with alcohol, for example through: studies of the causal mechanisms through which effective prevention measures affect individual behaviors and health outcomes; modeling of the interactions of individual, community, economic, and environmental factors that contribute to or inhibit effective preventive interventions; and research that characterizes the intended and unintended effects of public policies (such as alcohol taxes, availability restrictions, or ignition-interlock device requirements) on alcohol-related behaviors and outcomes as well as on economic and social outcomes that are not themselves directly related to alcohol.
• Extend knowledge of effective treatment and recovery from alcohol use disorders (AUDs), for example through: studies of the interactions of biological factors and contextual social factors as contributors to decisional processes involved in treatment and recovery; models of the differential action or interactions of different treatment modalities and interventions in the course of recovery, including pharmaceutical, behavioral, social, and personal factors; and models of alternative financial and organizational arrangements in the delivery of AUD treatment services to identify opportunities to enhance efficiency in service provision.

NIBIB is dedicated to improving health by leading the development and accelerating the application of biomedical technologies http://www.nibib.nih.gov/About. The Institute is committed to integrating the physical and engineering sciences with the life sciences to advance basic research and medical care. This is achieved through: research and development of new biomedical imaging and bioengineering techniques and devices to fundamentally improve the detection, treatment, and prevention of disease; enhancing existing imaging and bioengineering modalities; supporting related research in the physical and mathematical sciences; encouraging research and development in multidisciplinary areas; supporting studies to assess the effectiveness and outcomes of new biologics, materials, processes, devices, and procedures; developing technologies for early disease detection and assessment of health status; and developing advanced imaging and engineering techniques for conducting biomedical research at multiple analytic scales.

Specific topics that would be appropriate to this FOA and of interest to NIBIB include, but are not limited to, projects that utilize systems science methodologies to:

• Develop new systems science methodologies to address issues in behavioral and social sciences and health, such as methods to reduce medical errors, affect clinical decision support, and design predictive computational models for understanding and translating knowledge to the clinic.
• Develop new systems science methodologies to complement technology development in all program areas of the NIBIB with relevance to behavioral and/or social science, http://www.nibib.nih.gov/research/scientific-program-areas.

NICHD is interested in basic and applied research on models of behavioral and social processes associated with health, disability, and developmental outcomes from pre-conception to adulthood. See: http://www.nichd.nih.gov/about. Applications would be of interest to NICHD if they primarily focus on computational, econometric, mathematical, or engineering methods to improve the measurement and modeling of the following topics:

• Child, maternal, reproductive and population health models utilizing multi-level perspectives. Of particular interest are systems models of: 1) behavior and development in childhood and adolescence; 2) sexual behavior, and 3) contraceptive use from early adolescence through the reproductive years;
• Models of the complex relationships among demographic, social, and environmental factors and their effects on health and population processes, including fertility, family formation and dissolution, population distribution, and migration;
• Models that address complex social and behavioral factors affecting intellectual, behavioral and physical disability outcomes, rehabilitation outcomes, and long-term impacts of disability on individuals and families;
• Complex models of developmental issues over the life course for example, models that link variations in childhood health and development and environmental context and exposure during childhood with health trajectories or disability in later life;
• Models that address policy resistant health problems for example, modeling how community characteristics and processes interact with individual characteristics to contribute to risk of chronic diseases such as childhood obesity and sexually transmitted diseases.
• Models of the complex relationships among clinical, demographic, social, and environmental factors and their effects on adverse pregnancy outcomes and disparities in perinatal and infant outcomes.

NIDCR supports research that examines community characteristics, the organization of health care systems, and the social contexts that contribute to oral health. Many of the opportunities for improving oral health lie in achieving behavioral, lifestyle and social changes objectives that are shared with many other scientific areas. Drawing from the expertise of diverse fields presents an important opportunity to develop models and approaches that will produce meaningful improvements in oral health. This approach dovetails with the view of oral health as an essential component of general health as cited in the 2000 Surgeon General's report on oral health in America (http://www.nidcr.nih.gov/DataStatistics/SurgeonGeneral/). The NIDCR supports systems science projects that explain the determinants of and/or methodologies to improve dental, oral, and craniofacial health. Specific topics that would be appropriate to the NIDCR include, but are not limited to, projects that utilize systems science methodologies to:

• Model environmental and social variables in relation to incidence and prevalence of oral diseases and craniofacial conditions.
• Address and model barriers and facilitators for the population to access dental diagnosis, preventive and treatment services. Of particular interest is identifying causal mechanisms of oral health outcomes.
• Understand effective dissemination pathways of evidence-based dental knowledge and practices between oral health providers and the public.
• Examine and address common causal pathways and interrelationships between oral health behaviors and common risk factors for other conditions (e.g. poor diet and nutrition, tobacco use, physical inactivity, obesity, etc.) and how they affect effective interventions, programs or policies.

NIEHS supports research that spans the range from basic mechanistic research, research involving laboratory animal models and systems, to clinical and epidemiologic studies using human subjects (see http://www.niehs.nih.gov/research/supported/index.cfm). NIEHS is particularly interested in projects that address complex, multi-faceted problems related to how environmental pollutants impact human health. Projects should involve environmental scientists and test scientific questions and/or develop simulations models to examine how environmental exposures (physical, chemical, and biological) interact with social and behavioral conditions to influence the development and progression of human disease. The ultimate goal of this research should be to generate knowledge that can inform the development and prioritization of environmental policies, interventions, and programs that are designed to promote healthier lives. Specific topics that would be appropriate to this FOA and of interest to the NIEHS include, but are not limited to projects that utilize systems science methodologies to:

• Examine how environmental pollutants interact with both harmful and beneficial aspects of the social and physical environment that are differentially distributed by neighborhoods and how such interactions may result in a greater impact of environmental exposures on certain groups (e.g., by socio-economic status or ethnicity).
• Examine the cumulative health impacts of multiple environmental exposures (physical, chemical, biological, social, and psychosocial) at multiple levels (i.e., the home, workplace, neighborhoods, and community/population).
• Understand why the implementation of policies, programs, and/or interventions designed to reduce exposure to environmental contaminants that are known to cause or exacerbate adverse health outcomes sometimes fails (e.g., asthma and air pollution, adaptive responses to the health impacts of climate change)

NIMH supports research to transform the understanding and treatment of mental illnesses through basic, translational, clinical, and services research, paving the way for prevention, recovery, and cure. Specific topics that would be appropriate to this FOA and of interest to NIMH include, but are not limited to research that applies systems science methodologies to:

• Develop decision models to assist decision makers in selecting and promoting the implementation, dissemination, and sustained use of evidence-based interventions to (a) prevent the onset or escalation of mental illness or (b) improve functioning for individuals with a mental disorder.
• Analyze complex social networks and/or agent-based behaviors among diverse racial and ethnic groups regarding decisions to seek mental health care and engage in treatment.
• Better understand the relations among mental health care organizational factors, delivery processes, and mental health outcomes in different mental health service settings (e.g., specialty care, schools, primary care, emergency departments, criminal justice, etc.).
• Apply agent based modeling, social network analysis, or systems dynamics models to (1) expand access to mental health services, (2) enhance treatment coordination within complex systems, (3) increase the effectiveness of multicomponent service interventions, (4) understand the nature of mental health disparities and identify levers to reduce racial and ethnic disparities in access, quality, and outcomes of mental health care, and (5) study the pathways of diagnosing and treating first episode psychoses and to compare the efficiency of different approaches.

NIMH also has particular interest in research that uses systems science methods to study suicide prevention (see http://actionallianceforsuicideprevention.org/task-force/research-prioritization), including the following topics:

• Test approaches to using multi-level (e.g., biological, behavioral, social, cultural, environmental) data that may help detect risk and protective factors associated with different self-harm behaviors, including self-mutilation, suicidal ideation, suicide attempt, and suicide death.
• Model the onset of suicidal behaviors related to stressful events, health conditions and/or contagion linked to exposure to others suicidal behaviors, and identify key intervention points.
• Develop a model for achieving maximum reductions in U.S. suicide attempts and/or suicide deaths by applying various suicide prevention strategies with well-defined subpopulations of individuals at risk for suicide.

NINR is interested in research projects that promote and improve the health of individuals, families, communities, and populations. The Institute supports and conducts clinical and basic research and research training on health and illness across the lifespan to build the scientific foundation for clinical practice, prevent disease and disability, manage and eliminate symptoms caused by illness, and improve palliative and end-of-life care. Further information on NINR’s interests can be found at http://www.ninr.nih.gov/aboutninr/ninr-mission-and-strategic-plan.

Specific topics that would be appropriate to this FOA and of interest to the NINR include, but are not limited to projects that utilize systems science methodologies to:

• Assess behavioral and social risk factors and responses to treatment, including the identification of biomarkers (e.g., neurohumoral markers for differential responses to behavioral interventions); identify susceptibility genes for such risk factors, and design interventions to moderate risk.
• Develop or improve biobehavioral methods, measures, and intervention strategies to optimize symptom and self-management and improve palliative care and end of life.
• Identify and understand factors that influence decision-making that results in behavioral changes that promote health and prevent disease and disability.
• Identify and develop individual and family symptom or self-management interventions designed to sustain health-promoting behaviors over time.
• Design intervention studies using community-based approaches to facilitate health promotion/risk reduction behaviors (e.g., families with special needs, such as parents or caregivers of persons with chronic illness or developmental disabilities).
• Elucidate mechanisms underlying health disparities and design interventions to eliminate them, with particular attention to issues of geography (rural and remote settings), minority status, underserved populations, and persons whose chronic or temporary disabilities limit their access to care.

NIGMS is interested in supporting research that brings together mathematicians, computer scientists, engineers, and systems-level methodologists with a broad range of content area experts in the biological and social and behavioral sciences to develop and test new or innovative theories or computational, mathematical, engineering, or statistical models of collective behavior.

Specific areas of interest would include but are not limited to:

• Developing and testing innovative multi-scale, complex systems approaches to understanding basic biobehavioral phenomena and processes of relevance to health. How phenomena and processes at the individual and population level influence phenomena and processes at the biological level, and vice versa, are of particular interest.

• Improving the variety, quality, and applicability of computational, mathematical, engineering, and statistical approaches and tools for modeling individual and collective behavior.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

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

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

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

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

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

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

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

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

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

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

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

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

The letter of intent should be sent to:

Elizabeth M. Ginexi, Ph.D.
Health Scientist Administrator
Office of Behavioral and Social Sciences Research
National Institutes of Health
Telephone: 301-594-4574
Fax: 301-402-1150
Email: LGinexi@mail.nih.gov

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

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

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

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

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

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications submitted for the January 25, 2015, due date or after are expected to comply with the NIH Genomic Data Sharing Policy as detailed in NOT-OD-14-111, as applicable.
• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Software Sharing Plan: If software is developed within the project, a software dissemination plan, with appropriate timelines, is expected to be included in the application. This should be included in a separate heading in the Resource Sharing Plan(s). There is no prescribed single license for software produced through grants responding to this announcement. However, NIH does have goals for software dissemination, and reviewers will be instructed to evaluate the dissemination plan relative to these goals:

1. The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.

2. The terms of software availability should permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.

3. To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

4. The terms of software availability should include the ability of researchers to modify the source code and to share modifications with other colleagues. An applicant should take responsibility for creating the original and subsequent official versions of a piece of software.

5. To further enhance the potential impact of their software, applicants may consider proposing a plan to manage and disseminate the improvements or customizations of their tools and resources by others. This proposal may include a plan to incorporate the enhancements into the official core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution.

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

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Applicants are required to follow our Post Submission Application Materials policy.

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

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

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

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? Will the proposed research contribute significantly to the existing body of behavioral and social sciences research while addressing an important health topic?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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? ? Does the investigative team have sufficient expertise in the proposed systems science methodology? Does the investigative team have appropriate behavioral and/or social science expertise? Does the investigative team have appropriate content area expertise in the relevant health domain(s)?

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?

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 human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Does the project propose to utilize systems science methodologies? Are the methodologies proposed appropriate for the research question being addressed? Is there a strong rationale for use of the selected methodologies over non-systems science methods?

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

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

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

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

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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

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.

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

For Renewals, the committee will consider the progress made in the last funding period.

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

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

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.

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).

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

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

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

As part of the scientific peer review, all applications:

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

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

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

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

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

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

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

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-945-7573
Email: GrantsInfo@nih.gov

Stephen E. Marcus, PhD
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-7934
Email: marcusst@mail.nih.gov

Kara Hall, P.h.D.
National Cancer Institute (NCI)
Telephone: 240-276-6831
Email: hallka@mail.nih.gov

John W. R. Phillips, PhD
National Institute on Aging (NIA)
Telephone: 301-496-3138
Email: John.Phillips@nih.gov

Gregory Bloss
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-3865
Email: gbloss@mail.nih.gov

Grace C.Y. Peng, PhD
National Institute of Biomedical Imaging & Bioengineering (NIBIB)
Telephone: 301-451-4778
Email: penggr@mail.nih.gov

Regina M. Bures, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-9485
Email: regina.bures@nih.gov

David B. Clark, Dr PH
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4814
Email: David.Clark2@nih.gov

Bonnie Joubert, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone:919-541-7667
Email: joubertbr@niehs.nih.gov

Agnes Rupp, PhD
Senior Research Economist
National Institute of Mental Health (NIMH)
Telephone: 301-443-3725
Email: arupp@mail.nih.gov

Augie Diana, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: (301) 402-6423
Email: dianaa@mail.nih.gov

Elizabeth M. Ginexi, Ph.D.
Office of Behavioral and Social Sciences Research
Telephone: 301-594-4574
Email: LGinexi@mail.nih.gov

Gabriel Fosu, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-3562
Email: focug@csr.nih.gov

Lori Burge
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-3781
Email: burgle@nigms.nih.gov

Carol A. Perry
National Cancer Institute (NCI)
Telephone: 301-496-7205
Email: perryc@mail.nih.gov

John Bladen
The National Institute on Aging (NIA)
Telephone: 301-496-1472
Email: bladenj@nia.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

James Huff
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4786
Email: huffj@mail.nih.gov

Bryan Clark
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Diana Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: diana.rutberg@nih.gov

Bryann Benton
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-4259
Email: bentonb@niehs.nih.gov

Lori Burge
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-3781
Email: burgle@nigms.nih.gov

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail.nih.gov

Judy Sint
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
Email: sintj@mail.nih.gov

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

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