Required Application Instructions

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

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

 

The purpose of the U.S.-India Bilateral Collaborative Research Partnerships (CRP) on Diabetes Research is to advance science and technology important to understanding, preventing, and treating diabetes and its complications through the collaborative efforts of U.S. and Indian investigators and their institutions.

Diabetes affects nearly 26 million people in the United States and over 62 million in India, placing these nations second and third in the world in terms of population burden of diabetes. While increasing rates of overweight and obesity and sedentary lifestyle are widely recognized to contribute to rising rates of type 2 diabetes in both countries, our understanding of underlying causes of diabetes, the effects of environment on risk, and the differences in the epidemiology and pathophysiology of diabetes and its complications among different populations remains incomplete. In the United States, significant health disparities exist in terms of the burden of diabetes and its complications. In India, widespread access to affordable health care is a challenge. In both nations, diabetes is striking increasingly in younger age groups, with potentially devastating implications for the health, well-being, and productivity of future generations. To reduce both the human toll and the societal burden of diabetes in both countries, affordable, practical, and effective approaches and technologies for preventing and managing diabetes and its complications are urgently needed.

Scientific cooperation between the United States and India has been successfully conducted for over forty years under a variety of bilateral agreements. Recognizing that cooperative research focused on diabetes would be of mutual benefit to the United States and India, in June 2012 the U.S. Secretary of Health and Human Services (HHS) and the Indian Minister of Health and Family Welfare signed a Joint Statement on Collaboration on Diabetes Research. The Joint Statement is intended to foster collaborative efforts between the United States and India that could lead to advances in science and technology important to understanding, preventing, and treating diabetes and its complications. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Indian Council of Medical Research (ICMR) are the primary organizations responsible for implementing the joint statement.

The Joint Statement called for the establishment of a Joint Steering Committee (JSC) to develop strategic plans for collaboration and to facilitate the expedited review and clearance of proposed bilateral projects. Under the auspices of the JSC, an Indo-U.S. workshop titled Innovative Approaches and Technologies for Diabetes Prevention and Management was held on February 4-6, 2013, in New Delhi, India. The primary goal for this meeting was to bring together leadership from NIDDK and ICMR with diabetes experts from across the United States and India to identify opportunities for collaboration in high priority diabetes research areas of joint interest. The discussion at the meeting was used by the JSC to inform the development of a joint funding opportunity, represented in the United States by this FOA.

A critical feature of this FOA is the establishment and support of CRPs among researchers and institutions in the United States and India. Applications may be derived from existing collaborations with an established history of interaction, or from new partnerships developed in response to this FOA. The CRP must be based on interactive relationships that maximize the expertise of the individual U.S. and Indian research teams and interactions between their parent institutions and granting agencies. It is expected that the unique opportunity available through the U.S.-India Collaborative Research Program will foster collaborative partnerships that may subsequently mature and expand beyond the scope of the work proposed in the R21 application. It is anticipated that some of these partnerships will also be relevant to translation into public health activities in the United States and/or India.

U.S. and Indian collaborating investigators should work together to develop and submit corresponding applications to NIH and ICMR. U.S. investigators will respond to this announcement from NIH, and Indian investigators will respond in parallel to a separate funding announcement from the ICMR. If an application is selected for funding, the NIH will only provide funds to support the U.S. component; the Indian component will be supported by the ICMR. By sending an application to NIH, the applicant agrees to provide a complete copy of their submitted NIH application and summary statement to their Indian counterpart and, upon request, the ICMR, to facilitate interactions between the NIH and the ICMR in making funding decisions. Both the U.S. and the Indian application must be determined to be meritorious and responsive to the funding announcements (in the parallel processes conducted by the NIH and ICMR) to be considered for funding under this program.

It is anticipated that funding from the Indian component will support research activities within India, salaries of Indian research personnel, and other expenses. NIH funding will similarly support salaries of U.S. personnel and research activities within the U.S. U.S. applicants should not request support for direct contact with research subjects in India including delivery of interventions, clinical tests, or any measurements or other activities with the potential to incur subject harm. All clinical research in India must be conducted in accordance with both U.S. and Government of India regulations for the protection of human subjects.

Because this FOA represents a broad-based international collaborative program to address diabetes pathogenesis, prevention, and/or management, U.S. applicants are strongly encouraged to focus their application and to discuss the scope of their proposed application and its responsiveness to the FOA with the relevant Scientific/Research contact listed in Section VII prior to submission.

The proposed studies must take into account the time limit and budget imposed by the R21 mechanism (See Section II. Award Information). Where possible, the proposed studies should interact with or build on ongoing diabetes research efforts in India and the United States.

Specific areas of interest for this FOA include studies that may address or be focused within one or more of the following broad research areas:

1. Prevention and Management of Diabetes or Its Complications

• Research in the United States and in India has shown that lifestyle change and the generic drug metformin are effective in reducing the development of type 2 diabetes in individuals with prediabetes who are at high risk for progression to type 2 diabetes. However, the very high rates of prediabetes and large populations at risk for type 2 diabetes in both countries create challenges in public health translation of interventions validated in landmark clinical trials. The development of safe, effective and acceptable prevention strategies must integrate efforts to understand how factors affecting susceptibility and progression to diabetes interact with the implementation of a prevention strategy. Efforts in this area may also address biological issues that could alter the potential effectiveness of interventional prevention strategies in at-risk individuals or populations. Also, while control of glycemia, blood pressure and lipids is well established to reduce diabetes complications, only a small proportion of people with diabetes have optimal control of these risk factors. Thus strategies to improve treatment outcomes could reduce the huge toll of diabetes complications, such as diabetic retinopathy and diabetic nephropathy, on individual and societal health in both countries. Strategies addressing behaviors and social contexts of at-risk populations with the potential for scale-up are critical to the development of effective and sustainable prevention strategies for both type 2 diabetes and diabetes complications. Examples of joint research that could facilitate diabetes prevention and management in both countries include, but are not limited to:
  
  
• Evaluation of strategies for early identification of individuals with or at high risk for type 2 diabetes and/or its complications;
  
  
• Innovative systems and multilevel prevention approaches involving schools and other community resources;
  
  
• Life course approach to the prevention of diabetes (e.g., interventions focused on maternal diabetes/nutrition during pregnancy or interventions focused on youth with intrauterine metabolic exposures increasing type 2 diabetes risk);
  
  
• Studies to develop and evaluate cost effective approaches to behavioral and lifestyle intervention;
  
  
• Studies to determine if and why responses to interventions to prevent or delay type 2 diabetes and/or its complications may differ in the United States and India;
  
  
• Studies to elucidate and compare the roles of the hypothalamic pituitary axis, stress, and depression in development of and response to prevention strategies for type 2 diabetes;
  
  
• Evaluation of alternative medicine approaches (e.g., yoga, meditation) for type 2 diabetes prevention;
  
  
• Studies of dietary strategies to reduce diabetes risk (e.g., brown/white rice, vegetarian diets);
  
  
• Development of strategies to promote adherence by health care providers to guidelines for management of diabetes and/or its complications;
  
  
• Comparative studies of approaches to promote patient education, adherence to therapy and effective self-management of diabetes and/or its complications; and
  
  
• Development of management approaches for specific phenotypes, such as low BMI type 2 diabetes.

1. 2. Pathogenesis and Pathophysiology of Diabetes and Its Complications
   In the context of a metabolically toxic environment, South Asians have enhanced susceptibility to type 2 diabetes. Moreover, type 2 diabetes risk increases at lower BMI levels in South Asians than is seen in other populations. Understanding the basis for this enhanced susceptibility has important implications for understanding the pathogenesis of the disease in all populations and for identifying new therapeutic targets that can benefit both South Asians and other racial and ethnic groups. An important aspect of research to improve our understanding of differences in disease pathogenesis will be validation of common approaches to compare phenotypes between Indians and other populations, through standardized, state of the art assays. Examples of joint research that could enhance our understanding of pathogenesis and pathophysiology of diabetes or its complications in both countries include, but are not limited to:
   
   

• Identification of genetic variants that explain Indians' enhanced susceptibility to type 2 diabetes, such as genetic variants associated with non-alcoholic fatty liver disease (NAFLD) or its metabolic surrogates;
  
  
• Cross validation of GWAS findings between India and the United States and/or validation of human genetic findings in mouse models;
  
  
• Examination of novel genetic variants found in other populations through in depth sequencing in Indians;
  
  
• Identification of phenotypic similarities and differences between Indians and other populations during the progression from normal glucose tolerance to diabetes (e.g. insulin secretion, insulin resistance, body fat content, fat distribution, ectopic lipid, energy expenditure, exercise response, autoimmunity) or to complications of diabetes (such as diabetic retinopathy and diabetic nephropathy);
  
  
• Validation of common approaches to compare phenotypes between Indians and other populations through standardized state of the art assays;
  
  
• Examination of differences in the progression of diabetic complications, NAFLD, dysglycemia and/or other metabolic processes between Indians and other populations;
  
  
• Examination of mechanisms underlying the interaction between diabetes and infectious diseases such as tuberculosis with regard to increasing the risk for developing and/or accelerating the progression of each condition;
  
• Identification of phenotypic differences within the Indian population (rural/urban, North/South, India/U.S. residence, male/female) along the spectrum from no diabetes to diabetes;
  
  
• Determination of how rates of complications differ between Indians and other populations;
  
  
• Understanding how maternal diet and metabolic status during pregnancy affect fat distribution in the offspring;
  
  
• Understanding how birth characteristics and weight gain in early life influence adipose mass and distribution over the lifespan;
  
  
• Examination of generational effects on glucose metabolism, including effects of acculturation in the United States; and
  
  
• Examination of biomarkers to predict and/or assess risk and response to intervention of diabetic complications.

3. Diabetes in Youth

Diabetes is one of the most common and costly chronic pediatric diseases. Assessing the burden of diabetes in youth and characterizing diabetes in youth by diabetes type are essential for health programs in both India and the United States. Both countries have ongoing studies to provide contemporary estimates of rates of diabetes in youth. Standardization and harmonization of these research efforts and joint analyses of data on rates and types of diabetes in youth would greatly enhance the value of the ongoing surveillance efforts in both countries. Earlier age of diabetes onset and longer disease duration increase risk for developing diabetes complications and presage complications occurring earlier in the lifespan. This premature diabetes morbidity has profound implications for quality and length of life, productivity, and health care costs. Thus, it is of paramount importance to develop improved strategies for prevention and management of diabetes in youth. Examples of joint research that could facilitate surveillance, prevention, and management of diabetes in youth in both countries include, but are not limited to:

• Harmonization of U.S. and Indian registries of childhood diabetes;
  
  
• Comparison of prevalence and incidence of youth onset diabetes in India and the United States;
  
  
• Comparison of phenotypic and demographic characteristics of youth onset diabetes in India and the United States;
  
  
• Comparison of the burden of complications (including mortality) of youth onset diabetes between the two countries as well as comparison with adult diabetes;
  
  
• Comparison of characteristics of South Asian children with type 2 diabetes in the United States and India using standardized measures;
  
  
• Comparison of therapeutic strategies used in the United States and India and studies to identify best practices; and
  
  
• Studies of intrauterine exposures associated with type 2 diabetes risk in childhood.

 

4. Innovative Technologies for Management and Prevention of Diabetes and/or Its Complications

Recent decades have seen major advances in the use of technology for diabetes detection, monitoring and management that have improved the lives of people with diabetes. The huge burden of diabetes and its complications in the United States and India and the rapid emergence of mobile health technology provide impetus to explore the use of these technologies to improve and expand diabetes prevention and control efforts. Mobile technologies can serve as platforms both for delivery of care and for research. A number of programs are developing and testing use of texting services and smart phone applications for improving self-management behaviors. Wireless transmission of blood glucose meter data can alert caregivers to out-of-range glucose values and failure to test. Mobile applications for tracking diet, medications, weight, physical activity, and glucose levels are being developed to provide coaching based on biometric information. Examples of joint research that could facilitate application of new technologies to diabetes prevention and management in both countries include, but are not limited to:

• Development or adaptation of mobile health tools to improve self-management, including the testing of such tools in low resource settings;
  
  
• Development of tools to improve the quality of outpatient care through IT support for health care workers, particularly in rural or low resource settings;
  
  
• Development of effective and affordable tools and/or strategies for screening and diagnosis of diabetes and/or its complications, particularly point of care devices;
  
  
• Development of new tools for detecting and monitoring diabetes complications such as diabetic retinopathy in low resource settings;
  
  
• Development of standardized and validated patient-reported outcome measures for Indian populations in the United States and India; and
  
  
• Collaboration between U.S. and Indian investigators to develop innovative, accurate and inexpensive devices for monitoring diet, activity, or glucose levels.

5. Gestational Diabetes

Gestational diabetes mellitus (GDM) confers risk for the mother to subsequently develop type 2 diabetes. In addition, diabetes during pregnancy is associated with subsequent risk of obesity, type 2 diabetes and other metabolic disorders in the offspring. Furthermore, the Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) study demonstrated that hyperglycemia at levels lower than established thresholds for GDM is associated with increased weight, fat mass and c-peptide levels in offspring at birth. Therefore, pregnancy represents an important opportunity to intervene to decrease diabetes burden in both the mother and her offspring. Examples of joint research between U.S. and Indian investigators that could enhance our understanding of the prevention, treatment or pathophysiology of GDM (including metabolic imprinting) include, but are not limited to:

• Collaboration across birth cohorts in India and the United States to determine and understand the effect of GDM on the subsequent development of diabetes or risk factors for diabetes in offspring, especially studies directed at understanding mechanisms driving metabolic imprinting;
  
  
• Studies to determine factors that predict risk of developing GDM among women in the United States and India;
  
  
• Studies to develop and evaluate cost-effective approaches to limiting weight gain during pregnancy in women at risk for developing GDM; and
  
  
• Studies to define and understand the risk for subsequent development of type 2 diabetes in U.S. compared with Indian women with GDM.

 

 

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

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

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

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

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

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

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

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

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

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

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

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

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

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

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

 

The letter of intent, preferably electronically, should be sent to:

Francisco Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 752
Bethesda, MD 20892-5452
Telephone: (301) 594-8897
Fax: (301) 480-3505
Email: [email protected]

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

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

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

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

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

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

Other Attachments: Applications are required to include a Collaborative Strategy as a separate attachment in the the application. This strategy should not exceed 3 pages. The Collaborative Strategy should include a description of how the proposed collaboration will be maintained throughout the duration of the award. The following areas should be addressed:

• Organizational structure
• Management plan detailing how existing resources will be utilized
• Planned interaction and responsibilities of key personnel
• Description of how research teams will communicate (e.g., video/teleconference, web meeting)
• Plans for making decisions and procedures for resolving conflicts
• Details of what materials (e.g. patient samples, data, reagents) will be used for the study and how these will be shared.

Provide the information as a single PDF file with the name Collaboration.pdf.

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

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

Budget Justification: The applicant should include an explanation of all costs associated with the U.S. component of the project.

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

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

Specific Aims: Indicate which partner of the collaboration (U.S., India, or jointly) will be responsible for accomplishment of each proposed specific aim.

 

Research Strategy: Applicants should propose a single Research Strategy for the combined efforts of the two organizations (U.S. and Indian collaborators). The Research Strategy should provide a complete description of the research demonstrating the integration of the U.S. and Indian researchers' efforts. Within the page limitation of the Research Strategy section, there needs to be a plan for how resources will be shared and detail on how the coordination will benefit diabetes research.

In preparing the R21 application, investigators should consider clarity and completeness of the application with regard to specific goals and the proposed interactions of the U.S. and Indian collaborators. A poorly developed collaboration strategy that is not sufficient for assessing the potential for a successful R21 research effort will reflect poorly on the scientific merit of the application.

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

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

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

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 by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIDDK Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

 

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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 R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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

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

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 New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the U.S. and Indian collaborators bring complementary or unique experience to the project that enhance the research application?

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? Is the collaboration plan well-defined with clearly identified responsibilities for the U.S. and Indian collaborators, and does it take advantage of the strengths of each collaborator? Does the U.S.-Indian collaboration enhance the existing research capacity at each site?

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?

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

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDDK 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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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

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

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

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

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

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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

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

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

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

eRA Commons Help Desk (Questions regarding 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: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: [email protected]
Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: [email protected]

For NIDDK applications dealing with pediatric populations:
Barbara Linder, M.D., Ph.D.
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-0021
Email: [email protected]

For NIDDK applications dealing with adult populations:
Andrew Bremer, M.D., Ph.D.
Division of Diabetes Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-2555
Email: [email protected]

For NEI applications dealing with diabetic retinopathy:
Grace Shen, Ph.D.
Retinal Diseases Program
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]

Francisco Calvo, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8897
Email: [email protected]

Diana O Donovan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8868
Email: [email protected]

William Darby
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]

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

 

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