Department of Health and Human Services

Part 1. Overview Information

Key Dates

Required Application Instructions

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

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The incidence and prevalence of pre-diabetes and diabetes mellitus (DM) markedly increase with advancing age in later life such that, depending on diagnostic criteria used, 50-80% of persons 65 years old and older have either diagnosed or undiagnosed diabetes or pre-diabetes. Marked ethnic and racial disparities are observed in diabetes prevalence and outcomes, even in populations with similar access to care, and such trends appear to persist regardless of age. The underlying cause of these disparities is poorly understood. In addition, cardiovascular disease (CVD) complications from diabetes also increase with advancing age and are associated with higher morbidity and mortality, compared to younger diabetics. Currently, the majority of the $300 billion for diabetes-related healthcare costs in the United States is spent on older adults. As Baby Boomers age and this segment of the population rapidly expands, the prevalence and impact of diabetes and cardiovascular disease on morbidity, mortality, disability, quality of life, and costs will rapidly escalate.

The overarching goal of this funding initiative is to support a broad range of research strategies to improve our understanding of how specific age-related changes (including body composition, genomic, tissue and cellular function, and glucose and lipid metabolism) may predispose older adults to the development of DM and CVD complications, and impact their diagnosis and treatment strategies in older persons,. Ultimately, the research supported by this initiative will help prevent and/or reduce the burden of DM and CVD, improve meaningful outcomes to older patients (quality of life, and preservation of function, cognition and independence), and reduce the financial impact on the healthcare system.

With advancing age, a myriad of changes including molecular, cellular, metabolic, genetic, and body composition occur resulting in alterations in glucose and insulin metabolism. Although both an age-related decline in insulin secretion and decreased insulin sensitivity (increased insulin resistance) are thought to contribute to impaired glucose metabolism and diabetes, the specific mechanism(s) underlying these age-related changes have yet to be elucidated. Further investigation into the specific contribution of aging changes in body composition (including increased visceral adiposity and diminished skeletal muscle mass) to increased insulin resistance, including the potential and relative role(s) of adipokines, inflammation/inflammasomes, oxidative stress, mitochondrial dysfunction and intrinsic decline in muscle fiber insulin sensitivity, might lead to lifestyle or therapeutic targets to reduce the onset or subsequent burden and complications of pre-diabetes and diabetes, especially in older adults. Further, elucidating the mechanisms underlying why older adults appear more susceptible to prolonged exposure to hyperglycemia, which appears to alter protein structure and function, and may play an important role in diabetic complications through DNA damage and degradation, oxidative stress and muscle and arterial pathophysiology, may assist clinicians in formulating more specific recommendations regarding glucose testing, monitoring, risk assessment and therapeutic goals for older persons. Basic and clinical research that improves our understanding of why older adults appear more vulnerable to the onset and complications of DM may also shed light on the heterogeneity of pre-diabetes and diabetes in older persons, especially within specific racial and ethnic groups, so that more patient-centered strategies to prevent, reduce, and/or treat DM may be developed.

Similar aging changes as those just described that predispose older adults to diabetes also promote changes in the CV system, which, in older adults with diabetes, accelerate subclinical and clinical CV disease and are associated with worse outcomes compared to non-diabetic adults of any age. Visceral adiposity and insulin resistance promote dyslipidemia, which activate changes in endothelial cell and macrophages ultimately leading to atherogenesis. Further clarification of mechanisms underlying the observed link between insulin resistance and lipotoxicity may ultimately identify ways to prevent, reverse, or reduce the particular vulnerability of the cardiovascular system to DM in older adults, including endothelial dysfunction, thrombogenicity, left ventricular hypertrophy, arterial stiffness, and impaired left ventricular diastolic relaxation and their related clinical sequelae of atherosclerosis and ischemic heart disease, arterial restenosis, heart failure (especially with preserved systolic function), isolated systolic hypertension, atrial fibrillation, peripheral vascular disease and stroke. Lifestyle changes, including caloric restriction, aerobic exercise, strength training and weight loss may be more beneficial in older patients to reduce and even prevent DM and/or its CV complications, but further studies are needed in older patients, especially those over 80 years old, to clarify the role of these potential interventions. Future research should emphasize reexamining current clinical Guidelines and prevention/treatment recommendations for diabetes and cardiovascular care of older diabetics (and other pertinent Guidelines), as most are based on evidence from randomized clinical trials that mainly excluded older patients, especially those with multiple chronic conditions including diabetes. Moreover, the relationship of hypoglycemia as well as hyperglycemia to CVD events in older patients needs to be further explored.

Research initiatives described above, which highlight the heterogeneity of diabetes, embrace the clinical complexity of most older adults, and employ multidisciplinary, patient-centered approaches are highly encouraged. Thus, incorporation of important, common geriatric concepts including polypharmacy, multiple chronic conditions, aging of multiple organ systems, frailty, and possible functional and cognitive impairment may help to improve diabetic +/- CVD screening, diagnosis, and care strategies of older persons. The potential use of biomarkers and risk assessment/stratification tools, as well as screening and diagnostic tests, need further investigation in older persons, given that these common geriatric issues superimposed on age-related pathological changes in insulin secretion and resistance can impact on currently used assessment tools, such as the oral glucose tolerance test. Importantly, the impact of age-related decline in kidney function, which is further accelerated in older diabetics, on screening, diagnosis and treatment strategies in older patients needs further study. Similarly, how age-related changes accelerate other diabetic complications, such as wound healing, impaired immunity, eyesight impairment and peripheral neuropathy, may inform preventative or therapeutic targets to reduce these quality of life-compromising burdens. In developing patient-centered care recommendations and priorities for older persons at risk for, or with, diabetes, studies incorporating outcomes meaningful to older persons, such as overall and health-related quality of life, independence, and physical and cognitive function, are encouraged.

To summarize the current state of understanding of the impact of age on diabetes and cardiovascular disease, and to identify gaps in our knowledge of the mechanisms and opportunities for improved treatment and outcomes in older adults, the National Institute on Aging, the Association of Specialty Professors, and the John A. Hartford Foundation sponsored a multidisciplinary workshop in Arlington, Virginia, on April 4-5, 2013. Participants included leaders in the field of DM-CVD in older adults, including basic and clinical researchers and clinicians in endocrinology, geriatrics, cardiology, cardiothoracic and vascular surgery, neurology, nephrology, and internal medicine. Also participating were representatives from the American Diabetic Association, the National Institute on Aging, National Heart, Lung, and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, and the Centers for Disease Control and Prevention. A summary of this workshop is available at Halter J et al. Diabetes 63(8):2578-89, 2014 including a detailed list of research opportunities to advance knowledge and care of DM and CVD in older adults.

Specific Areas of Research Interest

This FOA invites applications proposing mechanistic and/or clinical research in both animal models and in humans, addressing the etiology and risk factors, racial-ethnic disparities, pathophysiology, diagnosis, prevention, treatment and/or cardiovascular consequences of pre-diabetes or diabetes in older adults. Types of studies may include observational, quasi-experimental, or interventional studies using primary data collection and/or secondary analyses. Leveraging on-going cohorts, intervention studies, networks, data and specimen repositories, and other existing resources and infrastructure are encouraged. Multidisciplinary approaches and research emphasizing meaningful, patient-centered outcomes including quality of life are also encouraged.

The Small Research Grant (R03) supports small research projects that can be carried out in a short period of time with limited resources, such as pilot and feasibility studies, secondary analysis of existing data, small, self-contained research projects, development of research methodology, and development of new research technology.

Examples of specific areas of research include, but are not limited to, the following:

Epidemiology of DM +/- CVD

• Identification of factors, such as genetic, biologic, environmental, lifestyle, behavioral, and healthcare access that contribute significantly to racial/ethnic disparities in the development, management, and outcomes of diabetes in older subjects.
• Clarification of the association between the duration and level of hyperglycemia / hypoglycemia and the development and severity of cardiovascular disease and other complications of diabetes in older adults, and determination of the potential impact of glycemic intervention (therapeutic and/or lifestyle) on diabetic complications in older patients or animal models.
• Determination of the extent to which risk factors for diabetes development (and its complications) in middle aged and younger adults differ with advancing age; identification and validation of more predictive risk factors (including possible biomarkers) for the development, response to intervention, and/or outcomes of diabetes in older persons.
• Determination of the potential impact of various factors in early adulthood, including diet, exercise, lifestyle, environmental exposures, body composition/anthropometrics, other morbidities, behavior/social factors, and access to care, on the development and possible heterogeneity of diabetes in later life.

Pathophysiology of DM +/- CVD in Older Adults

• Determination of the underlying mechanisms contributing to decreased pancreatic beta cell function and insulin secretion with advancing age and identification of specific targets for prevention or intervention.
• Elucidation of the relative role(s) of visceral adiposity, adipokines, chronic inflammation, oxidative stress, sarcopenia, mitochondrial dysfunction, altered protein synthesis/degradation, glycosylation/glycation, diminished muscle fiber insulin sensitivity and other alterations in age-related insulin resistance, and determination if any of these potential mechanisms offer targets for preventative or therapeutic strategies.
• Determination of the extent to which differing mechanisms underlying decreased insulin secretion and/or increased insulin resistance result in heterogeneous glycemic subgroups (dysglycemic/pre-diabetes/diabetes), and whether such knowledge can be used for risk stratification or predicting response to intervention.
• Identification of the independent and common mechanisms underlying the interaction between advancing age and diabetes on arterial stiffness and endothelial dysfunction, atherogenicity and thrombogenicity, and their modulation by insulin resistance, elevated glucose levels, and other common risk factors such as hyperlipidemia, abdominal obesity, or hypertension.
• Determination of aging- and/or diabetes-related mechanisms underlying metabolic changes, including dyslipidemia, and their associated CVD risk in older adults or animal models with diabetes.
• Elucidation of the mechanisms through which various age-related changes in other organ systems (kidney, brain), other co-morbidities and their associated treatments, and alterations in pharmacokinetic/pharmacodynamic responses contribute to the pathophysiology of diabetes and risk for CVD complications.
• Understanding of the impact of acute or prolonged exposure to hyperglycemia and/or hypoglycemia in older subjects on the development and outcomes of CVD, other diabetic complications, or cognitive function, and the resultant implications for therapy and monitoring.

Screening, Diagnosis, Intervention, Prevention of DM +/- CVD in Older Adults

• Determination of the most effective screening, diagnostic and monitoring strategies that appropriately risk stratify older, medically complex patients for diabetes-related complications including morbidity, mortality, disability, cognitive impairment, and diminished quality of life.
• Development and evaluation of patient-centered therapeutic strategies, including lifestyle, behavioral-social, nutraceutical, genetic-based, surgical, pharmaceutical, and/or complementary and alternative therapies to prevent or treat diabetes and its associated complications and to improve quality of life in medically complex older persons; strategies that give attention to racial/ethnic considerations are particularly encouraged.
• Evaluation of minimally invasive or catheter-based interventional strategies for cardiovascular complications in older diabetics, especially as an option for those with multiple morbidities and functional or cognitive impairment.
• Identification of the most significant risk factors (traditional vs. novel) in older DM patients for CVD and other diabetic complications to determine safe goals and priorities in care strategies; i.e., prioritizing interventions effective at reducing more than one type of diabetic complication with minimal risk to the patient; evaluation of differing risk factors across racial-ethnic groups is encouraged.
• Development of strategies that focus on patient self-management and are aligned with the patient’s goals of care, particularly with attention to racial-ethnic disease disparities.
• Creation and validation of transdisciplinary care strategies for older patients with DM +/- CVD in hospital, sub-acute, transitional, rehabilitation, outpatient, and home care settings.
• Development and evaluation of effective, feasible and safe lifestyle interventions (diet, exercise and/or stress management) for older persons at risk for diabetes or its complications in real-world settings.
• Elucidation of mechanisms of action for nutraceutical or pharmacological strategies such as antioxidants, nitric oxide boosters, anti-inflammatory agents, glucose/insulin-regulating or CVD risk-reducing agents, and modulators of energy-sensing pathways and mitochondrial function.
• Understanding of the impact of differences in cultural beliefs and/or acculturation across minority subgroups on lifestyle, medication adherence, and outcomes; for example, evaluation of the impact of quality improvement programs and culturally tailored interventions in older adults with diabetes.

Additional Guidance and Resources

Specific age ranges for older patients or aged animals are not specified for this FOA; rather, age ranges and groups should be selected to address the study hypotheses and effectively utilize the demographic composition of available patient groups, study cohorts, or data sets. Applications may address changes across a span of ages as appropriate for the study questions, and younger age groups may be included for comparison purposes. Applicants are encouraged to enroll subjects who represent accurately the broad range of age, gender, race, ethnicity, health, and functional level in the geriatric population. Applicants are discouraged from excluding subjects with cognitive impairment, frailty, or other age-related complicating conditions without reasonable scientific justification. Applicants studying human subjects are encouraged to use standard assessment instruments and techniques that have been developed and validated in older populations when possible, or may propose to test and validate such new instruments. Applicants proposing studies on treatment outcomes are encouraged to consider including measures of overall health status, functional status, and quality of life, as well as specific measures related to study hypotheses. A multidisciplinary research approach, including expertise in endocrinology, cardiology, neurology, nephrology, cardiothoracic surgery, physiatry and rehabilitation medicine, immunology, hematology, physiology, biology of aging, neurobiology of aging, ethics, psychiatry/psychology, pharmacology, and/or geriatrics is strongly encouraged.

Resources that may be useful for researchers developing proposals for this FOA include longitudinal datasets designed for the study of older populations, administrative datasets with medical information, and datasets from large observational or intervention studies in specific diseases or conditions. NIH-sponsored longitudinal aging cohorts that may be particularly relevant for questions regarding diabetes and CVD in older persons include:

• Health and Retirement Survey (HRS)
• Baltimore Longitudinal Study on Aging (BLSA)
• Lifestyle Intervention for Elders (LIFE) study
• Cardiovascular Health Study (CHS)
• Multi-Ethnic Study of Atherosclerosis (MESA)
• Action to Control Cardiovascular Risk in Diabetes (ACCORD) (clinical trial)

Datasets may be augmented through data linkage or by collection of additional information targeted toward specific study questions. Potential study populations that focus on aging beyond those mentioned above are listed in NIA's Population Studies Database . Large longitudinal and epidemiological studies that focus on factors related to cognitive and emotional health/impairment in adults are listed in the NIH Cognitive and Emotional Health Project database (http://trans.nih.gov/cehp/hbq/search.asp ).

Animal models may be used to address questions that cannot be easily addressed in humans. Applicants proposing basic research projects are encouraged to use aging and diabetic models most comparable to human physiology, where possible. NIA's Scientific Resources, including the Nonhuman Primate Tissue Bank and Rodent Resources, are described at http://www.nia.nih.gov/research/scientific-resources

Section II. Award Information

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

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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

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

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

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

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

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(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

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.

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

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

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

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

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

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

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

Modular or R&R Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

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

• All applications submitted for the January 25, 2015, due date or after are expected to comply with the NIH Genomic Data Sharing Policy as detailed in NOT-OD-14-111, as applicable.

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.

No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the Appendix.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

Foreign Institutions

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

3. Submission Dates and Times

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

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

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

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

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 SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Post Submission Materials

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

Section V. Application Review Information

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

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.

For this particular announcement, note the following:

The R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

Overall Impact

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

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?

Investigator(s)

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

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

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 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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

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

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 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) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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) in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

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

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’s business official.

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

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

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 Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-945-7573
Email: [email protected]

Scientific/Research Contact(s)

Susan Zieman, MD, PhD
National Institute on Aging (NIA)
Telephone: 301-496-6761
Email: [email protected]

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)

Ryan Blakeney
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: [email protected]

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.