Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of Behavioral and Social Sciences Research (OBSSR)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Nursing Research (NINR)

Funding Opportunity Title

Systems Science and Health in the Behavioral and Social Sciences (R21)

Activity Code

R21 Exploratory/Developmental Research Grant Award

Announcement Type

New

Related Notices

  • June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

PAR-11-315

Companion FOA

PAR-11-314, R01 Research Project Grant,

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.837, 93.866, 93.273,93.286, 93.865, 93.121, 93.113, 93.859, 93.242, 93.361

FOA Purpose

This Funding Opportunity Announcement (FOA) issued by the Office of Behavioral and Social Sciences Research (OBSSR), and the National Heart, Lung, and Blood Institute (NHLBI), the National Institute on Aging (NIA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Biomedical Imaging and Bioengineering (NIBIB), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute of Dental and Craniofacial Research (NIDCR), the National Institute of Environmental Health Sciences (NIEHS), the National Institute of General Medical Sciences (NIGMS), the National Institute of Mental Health (NIMH), and the National Institute of Nursing Research (NINR) at the National Institutes of Health, encourages Research Project Grant (R21) applications from institutions/organizations that propose to develop basic and applied projects utilizing systems science methodologies relevant to human behavioral and social sciences and health. This FOA is intended to encourage a broader scope of topics to be addressed with systems science methodologies, beyond those encouraged by existing open FOAs. 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 feature systems science methodologies.

Key Dates
Posted Date

August 17, 2011

Open Date (Earliest Submission Date)

September 16, 2011

Letter of Intent Due Date

30 days prior to application receipt date.

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard dates apply

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

September 8, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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.


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Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

This FOA issued by the Office of Behavioral and Social Sciences Research (OBSSR), National Institutes of Health, and the National Heart, Lung, and Blood Institute (
NHLBI), the National Institute on Aging (NIA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Biomedical Imaging and Bioengineering (NIBIB), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD),  the National Institute of Dental and Craniofacial Research (NIDCR),the National Institute of Environmental Health Sciences (NIEHS), the National Institute of General Medical Sciences (NIGMS), the National Institute of Mental Health (NIMH), and the National Institute of Nursing Research (NINR) at the National Institutes of Health, encourages (R21) applications that propose to develop basic and applied projects utilizing systems science methodologies relevant to human behavioral and social sciences and health.  This FOA is intended to encourage a broader scope of topics to be addressed with systems science methodologies, beyond those encouraged by existing open FOAs. 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 feature systems science methodologies. This FOA will utilize the R21 funding mechanism. A companion FOA entitled, Systems Science and Health in the Behavioral and Social Sciences (R01) will be issued in parallel and will utilize the R01 funding mechanism (See PAR-11-314).    

The evolution and vitality of the biomedical 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.

Background

This FOA (PAR-11-315) “Systems Science and Health in the Behavioral and Social Sciences (R21)” is intended to increase the breadth and scope of topics that can be addressed with systems science methodologies beyond those encouraged by existing open FOAs. 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 feature systems science methodologies.

Systems science methodologies are specific methodological approaches that have been developed to understand connections between a systems structure and its behavior over time. “Systems science methodologies” is an umbrella term to refer 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, many operations research and engineering methods, and a variety of other modeling and simulation approaches.

A system, in this context, refers to the particular configuration of all relevant entities, resources, and processes that together adequately characterize the problem space under study (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) (Ulrich, 2002). Systems science methodologies are valued for their ability to address the complexity inherent in behavioral and social phenomena, for example they excel at identifying non-linear relationships, 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, the Institute of Medicine (IOM) recently 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 modeling and simulation. From the report: “These actions are high-impact interventions that include smoke-free air for everyone, tobacco price increases, and adequately funded mass-media educational campaign, and full access to comprehensive tobacco cessation services. The most current and authoritative model of the effect of comprehensive tobacco control measures concludes that, with all of these interventions implemented simultaneously, the Healthy People objective of reducing the adult smoking rate to 12% can be reached by 2020 [Levy et al., 2010].” 

The international health community is also embracing systems science approaches. The International Council for Science (ICSU) recently released a Scientific Plan on Health and Wellbeing in the Changing Urban Environment: a Systems Approach (http://www.icsu.org/icsu-asia/publications/science-planning-reports/science-plan-on-health-and-wellbeing-in-the-changing-urban-environment-1/). This initial report focuses on the Asia and Pacific region and is part of a more ambitious global initiative, the framework for which will be published in September (at www.icsu.org). According to the regional report, “System science makes it clear that the behavior of a complex system cannot be understood or reliably improved by studying the behavior of its parts in isolation. Much better results are obtained when the system is viewed as a dynamic interactive whole. The major drivers of health and wellbeing in urban contexts arise from the links between social, cultural, economic, technological and biophysical factors in the larger human-environment system. Therefore, problems at the intersection of health and urban design must be studied in as broad a system context as possible.”

There are now several examples of how systems science methodologies have been utilized to inform health policy. Notable examples include a system dynamics model developed by Thompson and Duintjer (2007) that convinced the World Health Organization (WHO) to modify their strategy on polio from one of control to one of eradication. Another example is work done by NIGMS' Models of Infectious Disease Agents Study (MIDAS), an initiative that has 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.

NHLBI provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives. Further information on the broad spectrum of research supported by the NHLBI can be found at www.nhlbi.gov.  Specific topics appropriate to this FOA and of interest to the NHLBI include, but are not limited to, projects that use system science analytical approaches to:

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/AboutNIA.  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:  

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

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:

NICHD supports research on topics related to the health of children, adults, families, and populations. Further information on NICHD’s interests can be found at http://www.nichd.nih.gov/about.  Specific topics that would be appropriate to this FOA and of interest to the NICHD include, but are not limited to, projects that utilize systems science methodologies to: 

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 within the social and behavioral sciences 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.surgeongeneral.gov/library/oralhealth/). The NIDCR supports systems science projects that explain the determinants of and/or methodologies to improve oral, dental and craniofacial health. Please note the NIDCR will not accept any clinical intervention studies submitted through this FOA. For more information on the NIDCR policy for submitting clinical trials please see NOT-DE-08-002 (http://grants.nih.gov/grants/guide/notice-files/NOT-DE-08-002.html).

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 the 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 reduce the burden of human illness and disability. 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:

NIGMS is interested in supporting research projects relevant to its core areas of cell biology, biophysics, genetics, developmental biology, pharmacology, physiology, and biological chemistry (http://www.nigms.nih.gov/Research/)  as well as its new program in social and behavioral modeling/computational social sciences. Two major objectives of this new modeling program are to encourage systems biologists to work with researchers at other levels/scales (including those at the brain, individual, community, societal, and environmental levels) and to apply computational thinking and mathematical/simulation modeling to understanding behavioral and social phenomena.

With regard to this FOA, NIGMS is interested in supporting research that brings together mathematicians, computer scientists, and systems-level methodologists with scientists from a broad range of disciplines and content area expertise – including behavioral and social sciences, biological sciences, and engineering and physical sciences – to develop and test new or innovative multiscale systems theories or computational, mathematical, or statistical models of human behavior.

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

NIMH supports research to transform the understanding and treatment of mental illnesses through basic and clinical 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 projects that utilize systems science methodologies to:  

NINR is interested in research projects that promote and improve the health of individuals, families, communities, and populations. NINR supports and conducts clinical and basic research and research training on health and illness across the lifespan. The research focus encompasses health promotion and disease prevention, quality of life, health disparities, and end-of-life. NINR seeks to extend nursing science by integrating the biological and behavioral sciences, employing new technologies to research questions, improving research methods, and developing the scientists of the future. Further information on NINR’s interests can be found at http://www.ninr.nih.gov/AboutNINR/NINRMissionandStrategicPlan.  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:

The evolution and vitality of the biomedical 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.

Additional Resources related to this FOA:

In 2007 OBSSR, in conjunction with CDC and various components of NIH, produced a four-part lecture series entitled: 2007 Symposia Series on Systems Science and Health. This symposia series is aimed at introducing systems science to behavioral and social scientists for applications in health and is available indefinitely as a public resource via videocast; contact Patty Mabry (email: mabryp@od.nih.gov) if you have any difficulties accessing these lectures.

            To download Video or Audio Podcast follow this link: http://www.videocast.nih.gov/Summary.asp?File=13712   

            To download Video or Audio Podcast follow this link: http://www.videocast.nih.gov/Summary.asp?File=13878    

            To download Video or Audio Podcast follow this link: http://www.videocast.nih.gov/Summary.asp?File=13931   

            To view videocast with Real Player follow this link: http://www.videocast.nih.gov/ram/ss083007.ram    

            To download Video or Audio Podcast follow this link: http://www.videocast.nih.gov/Summary.asp?File=14005    

About the NIH BSSR-Systems Science Listserv

Persons who are interested in applying to this FOA, may be interested in joining the NIH BSSR-Systems Science Listserv, which has content relevant to the topic of this FOA. The main purpose of listserv is to keep members informed of events/news related to the overlap between systems science methodologies, behavioral and social sciences research (BSSR), and health.  Lectures and articles of interest, training opportunities, and funding announcements are the sorts of items posted.

Only the listowner may add new subscribers. To subscribe, email Patty Mabry at mabryp@od.nih.gov with full contact info, including name, title, degree, institutional affiliation, department, discipline, email address, and phone number, and a brief description of your educational background and current professional interests (2-3 sentences). The BSSR-Systems Science Listserv is not a discussion board; only the listowner can post to the list.

References

Levy DT, Mabry PL, Graham AL, Orleans CT, Abrams DB. Reaching healthy people 2010 by 2013: a simsmoke simulation. American Journal of Preventive Medicine 2010;38(3 Supplement 1):S373–S381.

Thompson KM, Duintjer Tebbens RJ. Eradication versus control for poliomyelitis: an economic analysis. Lancet. 2007;369:1363–1371.

Ulrich W. Boundary critique. In: Daellenbach HG, Flood RL, editors. The Informed Student Guide to Management Science. London: Thomson; 2002. p. 41-42. http://www.geocities.com/csh_home/downloads/ulrich_2002a.pdf

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

 

New
Resubmission
Revision
The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Award Budget

The combined budget for direct costs for the two year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.

Award Project Period

The maximum period is 2 years. 

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

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

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.   

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (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.

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 SF 424 (R&R) Application Guide.   

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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

Letter of Intent

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 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

The letter of intent should be sent VIA EMAIL to:

Patricia L. Mabry, Ph.D.
Senior Advisor
Office of Behavioral and Social Sciences Research
Office of the Director, NIH
31 Center Drive
Room B1-C19, MSC 2027
Bethesda, MD 20892
Telephone: 301-402-1753
Email: LOISystemsScienceFOA@mail.nih.gov

Required and Optional Components

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

Page Limitations

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

PHS 398 Research Plan Component

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

Resource Sharing Plan

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

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) in the PHS398 Specific Research Plan Component. 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.

The adequacy of the software sharing plans will be considered by Program staff when making recommendations about funding applications. In making such considerations, prior to funding, program staff may negotiate modifications of software sharing plans with the Principal Investigator before recommending funding of an application. Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support and abide by the plan. The final version of any accepted software sharing plans will become a condition of the award of the grant. The effectiveness of software sharing may be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., Reporting.

Appendix

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

Foreign Organizations

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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.

4. Intergovernmental Review (E.O. 12372)

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 only as described in the NIH Grants Policy Statement.   

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

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

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

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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.

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 Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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.

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.

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 review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Will the proposed research contribute significantly to the existing body of behavioral and social sciences research while addressing an important health topic? 

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?  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)?

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?

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? 

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 evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Not Applicable

Revisions

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

Additional Review Considerations

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/priority score.

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information

1. Award Notices

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 business official.

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

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

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. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Patricia L. Mabry, PhD (Patty)
Senior Advisor
Office of Behavioral and Social Sciences Research (OBSSR)
Office of the Director, NIH
Telephone:  (301) 402-1753
Email: mabryp@od.nih.gov
Lawton Cooper, MD, MPH

Medical Officer
Clinical Applications and Prevention Branch
Prevention and Population Sciences Program
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: (301) 435-0419
Email: cooperls@mail.nih.gov

Aaron D. Laposky, PhD
Program Director, Sleep and Neurobiology
Division of Lung Diseases
National Heart, Lung and Blood Institute (NHLBI)
Telephone: (301) 435-0193
Email: laposkya@nhlbi.nih.gov

Antonello Punturieri, MD, PhD
Program Director, Chronic Obstructive Pulmonary Disease
Division of Lung Diseases
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: (301) 435-0230
Email: punturieria@nhlbi.nih.gov

Virginia Taggart, MPH
Program Director, Asthma
Division of Lung Diseases
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: (301) 435-0202
taggartv@nhlbi.nih.gov

Ellen M. Werner, PhD
Program Director
Division of Blood Diseases and Resources (NHLBI)
National Heart, Lung, and Blood Institute
Telephone: (301) 435-0050
Email:   wernere@nhlbi.nih.gov

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

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

Grace C.Y. Peng, PhD
Chair, Interagency Modeling and Analysis Group
Program Director
National Institute of Biomedical Imaging & Bioengineering (NIBIB)
Telephone:  (301)-451-4778
Email:  penggr@mail.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)
Telephone: (301) 496-9485 
Email: regina.bures@nih.gov

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

Caroline H. Dilworth, PhD
Program Administrator
Susceptibility and Population Health Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
Telephone: (919) 541-7727
Email: dilworthch@mail.nih.gov

Stephen E. Marcus, PhD
Epidemiologist and Program Director
Social and Behavioral Modeling Research Program
Center for Bioinformatics and Computational Biology
National Institute of General Medical Sciences (NIGMS)
Telephone: (301) 594-7934
Email: marcusst@mail.nih.gov

Beverly Pringle, PhD
Program Chief
Child & Adolescent Mental Health Services Research
Services Research and Clinical Epidemiology Branch
Division of Services and Intervention Research
National Institute of Mental Health (NIMH)
Telephone: (301) 443-3725
E-mail: bpringle@mail.nih.gov

Paul A. Cotton, PhD, RD
Program Director
Health Behavior & Minority Health
Division of Extramural Activities
National Institute of Nursing Research (NINR)
Telephone: (301) 402-6423
Email: Paul.Cotton@nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Hubert Walters
Grants Management Specialist
Office of Grants Management
Division of Extramural Research Activity
National Heart Lung and Blood Institute (NHLBI)
Telephone: (301) 435-0155
Email: waltersh@mail.nih.gov

John Bladen
Grants Management Specialist
Grants and Contracts Management Office
The National Institute on Aging (NIA)
Telephone: 301.496.1472
E-mail: bladenj@nia.nih.gov

Judy Fox
Grants Management Officer
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: 301-301451-4786
Email: huffj@mail.nih.gov 

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

Mary Greenwood
Chief Grants Management Officer
Division of Extramural Activities
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: (301) 594-4808
Email:  daleym@mail.nih.gov

Molly Puente, PhD
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
Telephone: (919) 541-1373
Email: puentem@mail.nih.gov

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

Joy R. Knipple
Division of Extramural Activities
National Institute of Mental Health (NIMH)
Telephone: (301) 443-8811
Email: jk173r@nih.gov   

Diana Ly
Grants Management Specialist
National Institute of Nursing Research (NINR)
Telephone: (301) 594-1764
Email: dianaly@mail.nih.gov 

Section VIII. Other Information

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.

Authority and Regulations

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.


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