Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov/content)
Fogarty International Center (FIC) (http://www.fic.nih.gov)
Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD) (http://www.nichd.nih.gov)
National Cancer Institute (NCI) (http://www.cancer.gov)
National Center for Complementary and Alternative Medicine (NCCAM) (http://nccam.nih.gov)
National Heart Lung and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/index.htm)
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)
National Institute on Aging (NIA) (http://www.nia.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov)
National Institute on Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov)
Office of Disease Prevention (ODP) (http://odp.od.nih.gov)
Office of Dietary Supplements (ODS) (http://ods.od.nih.gov)

Title: Using Systems Science Methodologies to Protect and Improve Population Health (R21)

Announcement Type
New

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

Program Announcement (PA) Number: PAR-08-224

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

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

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

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

Catalog of Federal Domestic Assistance Number(s)
93.989, 93.213, 93.399, 93.837, 93.866, 93.273, 93.865, 93.279, 93.121, 93.113, 93.242

Key Dates
Release/Posted Date: August 1, 2008
Opening Date: September 16, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): September 16, 2008
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: September 8, 2011

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives


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

Section III. Eligibility Information
1. Eligible Applicants

A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

This FOA solicits Exploratory/Developmental (R21) applications from institutions/organizations that propose to apply one or more specific system science methodologies to policy resistant public health problems and contribute knowledge that will enhance effective decision making around the development of and prioritization of policies, interventions, and programs to improve population health in the U.S. and abroad, especially where resources are limited and only a limited number of programs/policies/interventions can be implemented. Systems science methodologies, discussed in more detail below, are specific methodologies that have been developed to understand connections between a systems structure and its behavior over time; these methods are often capable of illuminating a range of policy resistant problems where interventions, programs, or policies typically have unexpected, unintended, or counter-intuitive consequences. 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 the boundaries that stakeholders use to determine which facts/observations are relevant for their inquiry as well as the interpretations/judgments that they use to guide decisions or actions) (Ulrich, 2002).

In responding to this FOA, applicants are encouraged to:

Complex Health Problems Systems Science Methodologies

Approximately 50% of premature deaths and 70% of chronic illnesses in U.S. are preventable by changing behavioral risk factors and the related social and physical systems necessary to achieve and sustain those changes (Mokdad et al., 2004). Indeed chronic diseases, which are reaching epidemic proportions worldwide with 80% of chronic disease deaths occurring in low- and middle-income countries, are largely preventable (Jamison, et al., 2006). Globally, up to 80% of premature deaths from heart disease, stroke and diabetes can be averted with known behavioral and pharmaceutical interventions (WHO, 2005). There is a growing recognition that most major threats to the publics health - including cardiovascular disease, pulmonary disease, cancer, diabetes, mental health problems, HIV, substance abuse, violence, emerging infectious diseases, obesity, sedentary lifestyle, poor diet, sleep disorders, and moreare complex in the sense that each one arises from an intricate mix of behavioral, economic and social factors interacting with biological factors, as well as each other, over the lifespan and across an array of settings (e.g., home, school, workplace, neighborhood, etc.). For example, tobacco use and successful cessation are influenced by host of interrelated factors, including: the tobacco product itself (e.g., percent free-base nicotine content, presence or absence of menthol/other flavoring, and other product constituents), the person (e.g., genetic predisposition), influences on the person (peer influence, media exposure - both tobacco promotion and health messages, cultural norms, prior tobacco exposure, availability and usage of pharmacotherapy, history of quit attempts, presence of workplace smoking bans), and the tobacco industry (product design, marketing, pricing; for a discussion of the myriad of factors in tobacco control, see NCI, 2007).

Most of the problems related to human health and disease are dynamically and relationally complex. Such problems have typically been approached using correlation-based analytic methods (e.g., regression), which are useful for identifying linear relationships but are limited because of their inability to set up and test a web of causal relationships. While such methods can be valuable in providing detailed information about various aspects of the problem, used alone they are insufficient for addressing complex problems that are dynamic (i.e., change over time) and complex in terms of the large number of relationships in the system.

Systems science methodologies provide a way to address complex problems, while taking into account the big picture and context of such problems. These methods enable investigators to examine the dynamic interrelationships of variables at multiple levels of analysis (e.g., from cells to society) simultaneously (often through causal feedback processes), while also studying the impact on the behavior of the system as a whole over time (Midgely, 2003). They are also useful for making implicit assumptions about complex phenomena explicit, which exposes gaps in knowledge about the problem. Moreover, simulation modeling can be used to generate alternative futures allowing decision makers (e.g., policy makers) to simulate the impact of various policy decisions and how they play out over time before actually putting them into practice (Sterman, 2006). For example, insights gained by the use of simulation models can help policy makers choose the most effective option among competing strategies when resources for combating the problem are limited. Systems science methodologies are also extremely useful for understanding why programs and interventions fail to have their intended effects (and in the worst cases magnify the problem; Sterman, 2000).

Systems science methodologies can also be used to refine and reform systems of care to enable planners to identify impediments to implementing proven innovations in everyday treatment and prevention practice. Dynamic models can facilitate the adoption of proven new therapeutic and business practices to ensure effective interface within existing complex systems of care. Decision tools and models can be developed to discover unanticipated effects of change on barriers to treatment and prevention services access, gaps in resource allocation, new training requirements, insufficient inter-organizational linkages, and numerous other factors affecting healthcare systems improvements.

Specific examples of systems science methodologies include, but are not limited to: systems dynamics modeling (Sterman, 2000), agent based modeling (Epstein, 2006), discrete event simulation (Banks et al., 2005), network analysis (Wasserman & Faust, 1994; Scott, 2000), dynamic microsimulation modeling (e.g., Mitton, Sutherland & Weeks, 2000), and Markov modeling (Sonnenberg & Beck, 1993). These techniques (among others) are particularly well-suited for understanding connections between a systems structure and its behavior over time; anticipating a range of plausible futures based on explicit scenarios for action or inaction in certain areas; identifying unintended or counter-intuitive consequences of interventions; evaluating both the short- and long-term effects of policy options; and guiding investments in new research or data collection to address critical information needs. Such tools have proven heuristic power, typically integrating data from multiple prior studies and surveillance systems, and can offer innovative solutions to seemingly intractable problems. For example, systems modeling can enhance decision making and policy decisions by showing how to strike a more effective balance between treatment and prevention approaches.

Many system modeling methodologies are not new and indeed are now used routinely in fields such as corporate management, economics, engineering, physics, energy, ecology, biology, and others precisely because these methods add value compared with alternative techniques or unaided decision-making. System-oriented methods have been slower to diffuse in health-related behavioral and social science. Not surprisingly, as the appreciation for the complexity of many problems in the public health sphere has grown, there have been calls recently to address public health problems with systems science (Gerberding, 2007; Homer & Hirsch, 2006; Mabry, et al. 2008; Madon, et al., 2007; Milstein, 2008). For instance, systems science methodologies have already begun to be employed for planning and preparing against acute threats to public health (Lasker, 2004) such as global spread of a pandemic flu (Germann, Kadau, Longini, & Macken, 2006).

About Policy Resistance

Why do some public health problems seem intractable and resistant to the effects of planned interventions? Numerous well-known initiatives have greatly improved population health. But there are many other situations where health and social policy ventures ultimately were unsuccessful or made matters worse.

Typically labeled unintended consequences, side-effects (i.e., a secondary and usually adverse effect), or short-term results, our encounters with unsuccessful or less than fully successful interventions are rarely studied systematically. Those experiences cut across diverse content areas and their patterns and precursors are not well defined. Moreover, this phenomenon is not unique to the field of population health. The experience is so common, it has been given the generic name "policy resistance," defined as follows:

Policy resistance is the tendency for a policy, program, or an intervention to be delayed, diluted, or defeated by the responses of people, organizations, or the natural environment to the intervention itself. (adapted from Meadows, 1982).

(Note that policy resistance refers to policy in the broad sense to include policies as well as the interventions and programs that flow from them).
Responses to significant health-related problems often fail to recognize and/or address complex conditions that prevail in neighborhoods across the nation, or in the health protection system at large. Thus it is increasingly important that we understand policy resistance where it affects the public's health.

Here are three real-world examples of policy resistance operating in the public health domain:

1) Low tar/nicotine cigarettes were designed by cigarette manufacturers, and promoted by public health officials as a way to reduce the health hazards associated with smoking. Consumers compensated by smoking more of these light cigarettes per day than the regular kind, took longer, more frequent drags, and held the smoke in their lungs longer. These changes in consumer behavior defeated the products design so that ultimately the health threat to smokers remained (adapted from Sterman, 2006; for expanded treatment of this issue see NCI, 2001).

2) Supported by scientific studies, and promoted by the federal government, the food industry, health practitioners and the popular media, low fat diets became very popular in the 1980s and 90s. However this significant shift in dietary intake did not have the desired effect on the national trends of overweight and obesity. Despite their increasing intake of low-fat food items, Americans grew heavier over the ensuing decades, not thinner, and now population rates of overweight and obesity are at or near historic highs. No one had predicted that the food industry would produce such an array of low-fat but relatively high calorie foods, nor that Americans would overindulge in them. Evidence is mixed about whether the introduction of lower-fat foods actually caused people to gain more weight (i.e., by increasing overall caloric intake). But one thing seems certain, the policy of introducing these novel foods was not effective enough to stem the rising tide overweight and obesity across the country (for full treatment of this subject, see La Berge, 2008).

3) Highly active antiretroviral therapy (HAART) works well to reduce mortality among those living with HIV/AIDS. But since the advent of HAART in 1996, high-risk sexual behaviors among men who have sex with men have markedly increased, further increasing this groups risk of contracting HIV/AIDS. Paradoxically, some part of this increase in risk-taking behavior may have been triggered by the availability of the new therapy itself by conveying an optimism that HIV is not as devastating a diagnosis as it once was (see Sullivan, Drake, & Sanchez, 2007 for an extensive list of references). While the causes of this observed behavior change are likely multiply-determined (Elford, 2006), the post-HAART increase in high-risk sexual behavior was somewhat unanticipated and has contributed to a rebound in HIV incidence and the proliferation of multiply-resistant strains of HIV. In some geographic populations this increase in risky behavior appears to be significant enough to offset the beneficial effects afforded by HAART (e.g., Bezemer et al, 2008). (This example was adapted from Sterman, 2006; see also Imrie, et al., 2007).

Applicants are strongly encouraged to read a fuller discussion of the concept of policy resistance by Sterman (2006).

Applications funded under this FOA are encouraged to extend the understanding of public health problems and contribute knowledge that will enhance effective decision making around the prioritization of policies, interventions, and programs, especially where resources are limited and only a limited number of programs/policies/interventions can be implemented.

The objectives of this research program are to provide funding for applicants to use system science methodologies to address one or more specific opportunities to protect and improve population health. Applicants are encouraged to plan projects that tackle policy resistant health problems (i.e., ones in which the effects of planned interventions tend to be delayed, diluted or defeated by responses of the system to the intervention itself) using a systems science methodology.

Methodological approaches sought under this FOA are those that seek to understand the bigger picture i.e., a group of related components that comprise a system in which the problem can be defined by an explicit and testable causal hypothesis. Multi-method approaches are welcome. Methodologies employed should be capable of addressing multiple relationships and changes in the systems over time. Such approaches include but are not limited to: microsimulation modeling, agent-based modeling, system dynamics simulation modeling, network analysis, Markov modeling, and stochastic modeling. In addition, proposed research should be problem-focused, that is, the project outcomes should be directly applicable to the translation implementation, dissemination and adoption in one or more real-world settings. (For more on this topic, see p. 17-18 of the OBSSR strategic prospectus available at: http://obssr.od.nih.gov/Content/Strategic_Planning/Strategic+Plan_2007/ObssrIndex.htm) The results of the proposed project should be of the type that could inform decisions related to programs, policies, or interventions that are designed to impact the identified problem. Applicants are encouraged to form investigative teams that include members with expertise in the relevant systems science methodology (or methodologies), along with researchers with expertise related to the content area and the various components of the system under study, and where applicable, public health practitioners or others in charge of making decisions related to the policies/program/interventions under study. Note that it is possible that two or more of the above named qualities may be found in a single team member.

Examples of Research Topics Being Sought

The following are examples of research topics sought under this FOA; note that appropriate topics include but are not limited to those listed below.

Additional Resources related to this FOA:

References

Banks, J., Carson, J., Nelson, B., & Nicol, D. (2005). Discrete-event system simulation. 4th edition. Englewood Cliffs, New Jersey: Prentice Hall.

Bezemer, D., de Wolf, F., Boerlijst, M.C., van Sighem, A., Hollingsworth, T.D., Prins, M., Geskus, R.B., Gras, L., Coutinho, R.A., & Fraser, C. (2008). A resurgent HIV-1 epidemic among men who have sex with men in the era of potent antiretroviral therapy. AIDS;22(9):1071-7.

Elford J. (2006). Changing patterns of sexual behaviour in the era of highly active antiretroviral therapy. Current Opinion in Infect Disease;19(1):26-32.

Epstein, J. M. (2006). Generative Social Science: Studies in Agent-Based Computational Modeling. Princeton, N.J.: Princeton University Press.

Gerberding, J. (2007). Health Protectionomics: A New Science of People, Policy and Politics., Public Health Grand Rounds, September 19, 2007. George Washington University School of Public Health and Health Services: Washington, D.C. Retrieved July 14, 2008 from http://www.kaisernetwork.org/health_cast/hcast_index.cfm?display=detail&hc=2349 click on video or transcripts.

Germann, T.C., Kadau, K., Longini, I.M., Jr, & Macken, C.A. (2006). Mitigation strategies for pandemic influenza in the United States. Proceedings of the National Academy of Sciences USA; 103(15):5935-40.

Homer, J.B. & Hirsch, G.B. (2006). System dynamics modeling for public health: background and opportunities. Am J Public Health; 96(3):452-8.

Imrie J., Elford, J., Kippax, S., & Hart, G.J. (2007). Biomedical HIV prevention--and social science. Lancet; 370(9581):10-1.

Jamison, D. T. et al. (eds) (2006). Priorities in Health. World Bank, Washington D.C. Available at http://www.dcp2.org.

La Berge AF. (2008). How the ideology of low fat conquered America. J Hist Med Allied Sci.;63(2):139-77.

Lasker RD. (2004). Redefining readiness: terrorism planning through the eyes of the public. New York, NY: The New York Academy of Medicine; September 14, 2004. http://www.cacsh.org/eptpp.html

Mabry, P. Olster, D., Morgan, G., & Abrams, D. (2008). Interdisciplinarity and Systems Science to Improve Population Health: A View from the NIH Office of Behavioral and Social Sciences Research. American Journal of Preventive Medicine; Vol 35, Supplement; pp.S211-S224. Available online at http://dx.doi.org/10.1016/j.amepre.2008.05.018.

Madon, T., Hofman, K.J., Kupfer, L., & Glass, R.I. (2007). Implementation Science. Science; 318: 1728-1729.

Meadows, D.H. (1982). Whole earth models and systems. CoEvolution Quarterly, Summer, 98-108.

Midgley, G. (Ed). (2003). Systems Thinking. Thousand Oaks, CA: Sage Publications.

Mitton, L., Sutherland, H., & Weeks, M. (2000). Microsimulation Modelling for Policy Analysis: Challenges and Innovations. University Press, Cambridge.

Milstein B. (2008). Hygeia's constellation: navigating health futures in a dynamic and democratic world. Atlanta, GA: Syndemics Prevention Network, Centers for Disease Control and Prevention. Available at http://www.cdc.gov/syndemics/monograph/index.htm

Mokdad, A.H., Marks, J.S., Stroup, D.F., & Gerberding, J.L. (2004). Actual causes of death in the United States, 2000. JAMA;291(10):1238-45. Review. Erratum in: JAMA. 2005 Jan 19;293(3):293-4, 298.

National Cancer Institute. (2001). Risks Associated with Smoking Cigarettes with Low Tar Machine-Measured Yields of Tar and Nicotine. Tobacco Control Monograph No. 13. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute.

National Cancer Institute. (2007). Greater Than the Sum: Systems Thinking in Tobacco Control. Tobacco Control Monograph No. 18. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute. NIH Pub. No. 06-6085.

Sullivan, P.S., Drake, A.J., & Sanchez, T.H. (2007). Prevalence of treatment optimism-related risk behavior and associated factors among men who have sex with men in 11 states, 2000-2001. AIDS Behav;11(1):123-9.

Scott J. (2000). Social network analysis: a handbook, 2nd edition. Thousands Oaks, CA: Sage Publications.

Sonnenberg, F.A. & Beck, J.R. (1993). Markov models in medical decision making: a practical guide. Medical Decision Making;13(4): 322-338.

Sterman, J.D. (2000). Business Dynamics. Systems Thinking and Modeling for a Complex World. Boston: McGraw-Hill.

Sterman, J.D. (2006). Learning from Evidence in a Complex World. American Journal of Public Health, 96(3): 505-514.

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

Wasserman S., & Faust, K. (1994). Social network analysis: methods and applications. Cambridge, England: Cambridge University Press.

World Health Organization. (2005). Preventing Chronic Diseases: A Vital Investment (WHO, Geneva).

Purpose of the R21 Mechanism

The evolution and vitality of the behavioral and social sciences requires 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, and methodologies that have the potential to substantially advance behavioral and social science research.

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

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

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

Section II. Award Information


1. Mechanism of Support

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

This FOA uses Just-in-Time information concepts see SF424 (R&R) Application Guide). It also uses the modular as well as non-modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 3.4, Modular Budget Component, of the Application Guide).

2. Funds Available

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

All foreign applicants must complete and submit budget requests using the Research & Related Budget component.

F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

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

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

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

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

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

Applicants may submit a resubmission, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information


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

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

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

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

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

2) Organizational/Institutional Registration in the eRA Commons

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

Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

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

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

For further assistance, contact GrantsInfo -- Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

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

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

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

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

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

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

Applications from Foreign organizations must:

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

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

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

Information for the Contact PD/PI should be entered in Item 13 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

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

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

Applications Involving a Single Institution

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

Applications Involving Multiple Institutions

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

When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 3.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: September 16, 2008 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): September 16, 2008
Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

Patricia L. Mabry (Patty)
Health Scientist Administrator/Behavioral Scientist
Office of Behavioral and Social Sciences Research
Office of the Director, NIH
31 Center Drive, Building 31, Room B1-C19; MSC 2027
Bethesda, MD 20892-2027
Phone: (301) 402-1753
email: mabryp@od.nih.gov

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

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

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.

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

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

All investigators are encouraged to attend the annual grantee meeting for this FOA and consult their respective funding agencies to provide travel support when necessary. Applicants to this FOA must allocate funds for at least two key investigators with complementary expertise to travel to the annual grantee meetings.

6. Other Submission Requirements

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

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

Organizational DUNS

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

PHS398 Research Plan Component Sections

While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

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

Appendix Materials

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

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

Resource Sharing Plan(s)

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

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., Reporting.

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

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

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

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

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

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

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

The following will be considered in making funding decisions:

The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research.

Because the Research Plan component is limited to 6 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious impact/priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

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

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

Significance: Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Will the results of the project be able to inform public health practitioners an d other relevant parties regarding decisions relevant to the policy resistant problem under study?

Investigator(s): Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, 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 include members with expertise in systems science methodology as well as those with health and medical expertise in the appropriate content area for the problem under study ?

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? Is the primary approach one that is centered in systems science methodology? Is the subject of the study a policy resistant problem? Does the approach incorporate behavioral and social factors that influence health?

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

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

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

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

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

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.


Additional Review Considerations

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

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

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

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.

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 (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).


2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or impact/priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

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

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

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

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., Funding Restrictions.

2. Administrative and National Policy Requirements

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

3. Reporting

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

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

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Patricia L. Mabry, Ph.D. (Patty)
Health Scientist Administrator/Behavioral Scientist
Office of Behavioral and Social Science Research
Office of the Director
National Institutes of Health
31 Center Drive, Building 31, Room B1-C19; MSC 2027
Bethesda, MD 20892-2027
Phone: (301) 402-1753
email: mabryp@od.nih.gov

Xingzhu Liu, Ph.D.
Program Officer
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31, Room B2-C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: 301-402-6681
Fax: 301-402-0779
Email: Xingzhu_Liu@nih.gov

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

Erica S. Breslau, Ph.D.
Applied Cancer Screening Research Branch
Behavioral Research Program Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard
Room 4098, MSC 7331
Bethesda, MD 20892-7331
Telephone: (301) 435-2839
Fax: (301) 480-6637
Email: breslaue@mail.nih.gov

Catherine M. Stoney, Ph.D.
National Center for Complementary & Alternative Medicine
National Institutes of Health
6707 Democracy Blvd, Suite 401, MSC 5475
Bethesda, Maryland 20892-5475 (for express mail, use 20817)
Tel.: 301 402 1272
Fax: 301 480 3621
E-mail: stoneyc@mail.nih.gov

Susan Czajkowski, Ph.D., M.S.
Division of Prevention and Population Sciences
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Suite 10118, MSC 7936
Bethesda, MD 20892-7936
Telephone: (301) 435-0406
Fax: (301) 480-1773
Email: czajkows@mail.nih.gov

Caroline H. Dilworth, PhD
Health Scientist Administrator
Susceptibility and Population Health Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
National Institutes of Health
P.O. Box 12233 (MD EC-21)
Research Triangle Park, NC 27709
Phone: 919-541-7727
Email: dilworthch@niehs.nih.gov

Agnes Rupp, Ph.D.
Senior Research Economist and Chief, Financing and Research Methods Program
Services Research and Clinical Epidemiology Branch
Division of Services and Interventions Research
National Institute of Mental Health
National Institutes of Health
6001 Executive Boulevard, Room 7139, MSC 9631
Bethesda, MD 20892-9631
Telephone: (301) 443-6234
FAX: (301) 443-4045
Email: arupp@mail.nih.gov

John W. R. Phillips, PhD
Chief, Population and Social Processes Branch
Division of Behavioral and Social Research
National Institute on Aging
National Institutes of Health
7201 Wisconsin Avenue, Gateway 533
Bethesda, MD 20892
Phone: (301) 496-3138
Fax: (301) 402-0051
Email: PhillipJ@mail.nih.gov

Gregory Bloss
Division of Epidemiology and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
5635 Fishers Lane, Suite 2075
Bethesda, MD 20852
Tel: 301-443-3865
Fax: 301-443-8614
Email: gbloss@mail.nih.gov

Melissa W. Riddle, Ph.D.
Chief, Behavioral and Social Sciences Research Branch
National Institute of Dental and Craniofacial Research
National Institutes of Health
6701 Democracy Blvd.
Room 646, Mail Stop 4878
Bethesda, MD 20892-4878
Tel: (301) 451-3888
Email: riddleme@mail.nih.gov

Thomas F. Hilton, Ph.D.
Program Official for Implementation,
Organizational, & Management Sciences
National Institute on Drug Abuse
Health Services Research Progam
National Institutes of Health
6001 Executive Blvd. Rm. 5197
Bethesda, MD 20892-9589
Telephone: (301) 435-0808
Fax: (301) 443-6815
Email: mailto:tom.hilton@nih.gov

Rebecca B. Costello, Ph.D., F.A.C.N.
Director of Grants and Extramural Activities
Office of Dietary Supplements
National Institutes of Health
6100 Executive Blvd., Room 3B01, MSC 7517
Bethesda, Maryland 20892-7517
Tel: (301) 435-2920
Fax: (301) 480-1845
Email:
CostellB@od.nih.gov

2. Peer Review Contacts:

Not applicable

3. Financial or Grants Management Contacts:

Mr. Bruce R. Butrum
Chief Grants Management Officer
OD, Fogarty International Center, NIH
Building 31, Room B2C29
31 Center Drive
Bethesda, MD 20892-2220
Phone # 301-496-1670
Fax # 301-594-1211
E-mail: butrumb@nih.gov

Ms. Cecilia Bruce
Grants Management Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17L, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1304
Fax: (301) 480-4782
Email: cb156n@nih.gov

Ms. Crystal Wolfrey
Chief, Cancer Control and Population Sciences Branch
Office of Grants Administration
National Cancer Institute
6120 Executive Blvd., Suite 243
Bethesda, MD 20892 (regular mail)
Rockville, MD 20852 (express mail)
FAX: 301-496-8601
Phone: 301-496-8634
Email : wolfreyc@mail.nih.gov

Mr. George Tucker
Grants Management Officer
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Room 401, MSC 5475
Bethesda, MD 20892-5475
Tel.: 301.594.9102
E-mail: tuckerg@nccam.nih.gov

Ms. Teresa Marquette
Prevention and Population Sciences Grants Management Branch
Office of Grants Management
National Heart Lung and Blood Institute
RK2/7128
6701 Rockledge Drive, MSC 7926
Bethesda, MD 20892-7926
Phone: 301-435-0166
Email: marquettet@nhlbi.nih.gov

Ms. Dorothy G. Duke, Branch Chief
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233 (MD EC-22)
Research Triangle Park, NC 27709
Phone: 919-541-2749
Email: duke3@niehs.nih.gov

Ms. Joy R. Knipple
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: 301-443-8811
Fax: 301-443-6885
E-mail: knipplej@mail.nih.gov

Ms. Robin Laney
Grants and Contracts Management Office (GCMO)
National Institute on Aging
Gateway Building, Suite 2N212
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
Telephone: (301) 496-1473
Fax: 301-402-3672
Email: laneyr@mail.nih.gov

Ms. Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane
Room 3023, Bethesda, MD 20892-9304
Phone: 301-443-4704
Fax: 301-443-3891
Email: jfox@mail.nih.gov

Ms. Mary Daley
Chief Grants Management Officer
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd.
Room 658, MSC 4878
Bethesda, MD 20892-4878
Phone: 301-594-4808
Fax: 301-480-3562
email: md74u@nih.gov

Ms. Edith Davis
Grants Management Branch
National Institute on Drug Abuse
6010 Executive Boulevard, Room 260
Bethesda, MD 20892-8403
Telephone: 301-443-6710
Fax: 301-594-6849
Email: Edavis1@nida.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

Sharing Research Data:
All applicants are expected to include a plan for sharing research data and for projects involving modeling, the plan should address model datasets used for parameter estimation, model building, and model validation as described in their application. The NIH data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible. (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the impact/priority score.

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

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

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

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

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

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

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

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

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

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

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

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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

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


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NIH Funding Opportunities and Notices


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