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

Type 1 diabetes is a disease caused by the autoimmune destruction of the insulin-secreting beta cells of the pancreas. Type 1 diabetes requires daily insulin administration, but episodes of hyperglycemia and hypoglycemia are common, and as a result patients with type 1 diabetes may suffer devastating consequences including accelerated cardiovascular and peripheral vascular diseases, nephropathy, retinopathy, neuropathy, oral diseases and premature death. The incidence of type 1 diabetes appears to be increasing worldwide. Although the disease may occur at any age, the onset of type 1 diabetes peaks prior to twenty years of age. In some populations, about one percent of all newborns will develop type 1 diabetes during their lifetime.

Recent advances in fundamental science and in our understanding of the pathogenic processes underlying type 1 diabetes and its complications in animal models offer tremendous promise for the development of new therapies. Recently, a few immunoregulatory agents have shown promise for the delay of type 1 diabetes onset or progression in human studies. However, for such agents to reach their full therapeutic potential, a number of obstacles must be overcome. These include a better understanding of triggers of autoimmunity, immunoregulation and tolerance to self, mechanisms of immune-mediated destruction of pancreatic beta cells, and beta cell growth, function and regeneration. Better understanding in these areas is needed to develop therapies that will block beta cell autoimmune destruction, spare normal immune responses to pathogens, and allow beta cells to recover function in already affected patients. Research is needed for the development of improved models, in which to test new therapies and measures to predict or assess response to therapy in early trials of potential therapies. Also needed are improved methods to monitor disease progression, such as methods to assess beta cell mass and inflammation non-invasively.

The success of islet transplantation in freeing individuals with established and brittle type 1 diabetes from the need for insulin therapy has yielded great excitement. However, islet transplantation requires immunosuppression that is associated with significant side effects and long-term risks. Moreover, protocols generally require two donor pancreata per recipient; therefore, current levels of organ donation do not provide sufficient organs for all of the people who could potentially benefit from this therapy. Finally, the transplanted islets often are observed to decline in function with time, and many patients eventually need to resume some exogenous insulin therapy. The recent success in islet transplantation provides additional impetus for research to develop methods to attain an unlimited supply of islets or beta cells for transplantation; to improve the viability of transplanted islets; and to minimize the toxicity of immunomodulation required for transplant acceptance and maintenance.

The complications of type 1 diabetes account for most of the burden of this disease. Intensive insulin therapy and inhibitors of the angiotensin signaling pathway have led to a decrease in the incidence in some of the complications. Yet, even with these therapies, individuals still face significant morbidity and premature death from diabetes complications. Hyperglycemia induces a number of metabolic changes within the cell. A better understanding is needed of the link among these molecular and cellular abnormalities and the pathophysiology of diabetes seen at the tissue and organ system levels. Two emerging areas of interest are the role of reactive oxygen species and abnormal angiogenesis in the development of diabetes complications. These areas and other emerging pathways provide multiple potential targets for therapeutic intervention.

Hypoglycemia is a devastating complication of type 1 diabetes that often limits the ability to rigorously control blood glucose. Research is needed to foster translation of new understandings about the mechanisms of hypoglycemia unawareness and defective counter-regulation into new approaches to reduce the occurrence of hypoglycemia and pharmacologic approaches to restore counter-regulation. Improved devices for measuring and monitoring glycemia and/or development of closed loop systems linking glucose sensors and insulin delivery devices are needed. Research is needed to improve the ability of health care providers, patients and parents to manage diabetes, maximizing glycemic control while minimizing the hypoglycemia and stress associated with diabetes control. An opportunity exists to incorporate behavioral approaches into deployment of new devices through research that examines optimum patient and provider use of the information delivered by these new technologies.

Research supported by these awards would be expected to address significant barriers to prevention and reversal of type 1diabetes and its complications. Examples of opportunities that could be pursued to address current roadblocks to progress include, but are not limited to:

• Developing new immunomodulatory strategies to prevent or reverse disease;
• Identifying novel biomarkers of type 1 diabetes and its complications to monitor disease progression and response to therapy;
• Developing animal models useful to explore the pathogenesis and therapy of type 1 diabetes and its complications;
• Developing measurements of oxidative stress and other metabolic abnormalities induced by hyperglycemia that could eventually be used as a biomarker in humans;
• Elucidating the mechanisms that lead to abnormal angiogenesis in type 1 diabetes; for example, the excess vascularization seen in diabetic retinopathy and the reduced angiogenic response in diabetic wound healing; and developing therapies that can impede these processes;
• Identifying components of the beta cell and its environment required for maintenance and function and/or instrumental in its pathogenic destruction; or to restore beta cell function or mass through regeneration;
• Developing methods for the measurement of beta cell mass or function that may be used as endpoints in studies of preventing or ameliorating type 1 diabetes;
• Developing cell based therapies to enhance or restore glycemic control;
• Discovering new molecular pathways and expanding on current knowledge of molecular pathways involved in cellular damage from hyperglycemia, including pathways involved in specific cell types or more general pathways;
• Developing approaches to improve clinical management of type 1 diabetes (e.g., incorporating human factor and/or behavioral research with use of new technologies, such as continuous glucose monitors and research that test methods to tighten glucose control in adolescents and young adults).

The Type 1 Diabetes Pathfinder Award was first initiated in 2008 to support exceptional new investigators who propose highly innovative new research approaches that have the potential to produce a major impact on important problems in biomedical and behavioral research related to type 1 diabetes and its complications. The term award is used to mean a grant for conducting research, rather than a reward for past achievements. Biomedical and behavioral research is defined broadly in this announcement as encompassing scientific investigations in the biological, behavioral, clinical, social, physical, chemical, computational, engineering, and mathematical sciences. While R01 grants will continue to be the primary source of NIH support for new investigators, the Type 1 Diabetes Pathfinder Award is designed to support a small number of exceptionally creative new investigators whose research is focused on type 1 diabetes research. The research proposed need not be in a conventional biomedical or behavioral discipline but must be relevant to type 1 diabetes. The purpose of this award is to provide a foundation for the investigator to develop an innovative approach to research questions in type 1 diabetes that are major obstacles to curing, preventing and treating individuals with type 1 diabetes.

Investigators who have not previously studied diabetes are encouraged to apply. Examples would be investigators with experience in vascular biology, immunology or neuroscience who would like to apply their expertise to type 1 diabetes research. These investigators are strongly encouraged to obtain collaborators with a strong background in diabetes research. Diabetes Research Centers (http://www.diabetescenters.org/) may be a resource for establishing these collaborations.

The proposed research must be directly relevant to type 1 diabetes. Research on diabetes complications or the pancreatic beta cell does not have to focus exclusively on type 1 diabetes; it may include animal models of type 2 diabetes or humans with type 2 diabetes, if the results of the research would further our understanding of type 1 diabetes and the development of new therapies.

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 not 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 the purpose of this FOA, multiple PD(s)/PI(s) are not allowed.

Applicants must meet the definition of an Early Stage Investigator (ESI). An ESI is a new investigator (defined as a PD/PI who has not completed successfully for a significant NIH independent research award) who is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent). A complete list of NIH grants that do not disqualify a PD/PI as a new investigator can be found at: http://grants.nih.gov/grants/new_investigators/. Frequently Asked Questions about the NIH Early Stage Investigator (ESI) Policy can be found at http://grants.nih.gov/grants/new_investigators/.

An extension to the 10-year period may be granted under special circumstances (e.g., family care responsibilities, extended periods of clinical training, disability or illness, etc.). To request an extension, an applicant MUST complete the Form for Requesting an Extension in the Early Stage Investigator (ESI) Period (http://grants.nih.gov/grants/new_investigators/esi_extension_add.htm). A request for extension must be approved at the time the Type 1 Diabetes Pathfinder Award application is submitted. It may take up to several weeks for the approval process, so applicants should plan accordingly.

Applicants are responsible for reviewing and/or updating their degree information in their eRA Commons account in a timely fashion. Applicants should allow several weeks for an extension request to be processed. NOTE: If an applicant is not identified as an ESI in the eRA Commons, it may result in the application not being reviewed.

Applicants also must hold an independent research position at a domestic (U.S.) institution as of September 1 of the fiscal year of the competition. For the purpose of this FOA, independent research position means a position that automatically confers eligibility, by the applicant s institutional policy, for an investigator to apply for R01 grants, with an appropriate commitment of facilities to be used for the conduct of the proposed research. Investigators still in training or mentored status (postdoctoral fellows) are not eligible to apply unless they have a written commitment of an independent faculty position as of September 1 of the fiscal year of the competition that is certified by submission of the application from that institution.

Applicants may submit or have an R01 (or other equivalent) grant application pending concurrently with their Type 1 Diabetes Pathfinder Award application. However, if that pending R01 (or other equivalent) grant is awarded in the fiscal year of the competition (fiscal years end September 30) with a start date of September 30 or earlier in that fiscal year, then the applicant is no longer eligible to receive the Type 1 Diabetes Pathfinder Award. Please see section 3, below, for more information about limitations on overlapping applications.

Awardees are required to commit at least 3 person months of their research effort each year to activities supported by the Type 1 Diabetes Pathfinder Award.

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

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

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

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

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

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

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

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

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

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

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

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: 301-594-8897
Email: [email protected]

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

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

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

Agency Routing Identifier: Enter Science Area Designations. Designate two scientific areas (a primary and secondary) from the list below. For each area, enter the one-digit code and abbreviation (e.g., 1 BBS).

1 BBS - Behavioral and Social Science

2 CB - Chemical Biology

3 CTR - Clinical and Translational Research

4 IMM - Immunology

5 IE - Instrumentation and Engineering

6 MCB - Molecular and Cellular Biology

7 NS - Neuroscience

8 HIB - High-Throughput and Integrative Biology

9 QCB - Quantitative and Computational Biology

The areas of science listed above are very broad and frequently overlapping. Type 1 Diabetes Pathfinder Award reviewers are chosen for their breadth of knowledge and expertise and will be able to review a broad range of applications. Choose the two science areas that are most appropriate for your proposed project.

The selection of scientific areas by applicants is solely to aid in selection of the most appropriate group of peer reviewers and does not in itself affect an application’s funding potential. The application requirements and instructions are identical for all the science areas. All applications are reviewed in the same time period and by the same panel, and compete for a single source of funds.

IMPORTANT: For each of the two science area designations enter the one-digit code followed by one space and then the corresponding abbreviation. Enter the primary area first and secondary area second. Separate the two entries by a semicolon.

Correct Example: 1 BBS; 7 NS

Proposed Project: The start date should be September 30 of the fiscal year and the end date should be June 30 of the fiscal year five years hence (for example, Start: 09/30/2016 and End: 06/30/2021).

Total Federal Funds Requested: Enter $1,500,000.

Total Non-Federal Funds: Enter $0.

Total Federal & Non-Federal Funds: Enter $1,500,000.

Estimated Program Income: Enter $0.

Note: The Budget Request is entered only in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds" as described above. Funds may be requested for personnel (including collaborators), supplies, equipment, sub-contracts, and other allowable costs. Only the five-year total $1.5 million -- should be entered in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds". Applicable Facilities and Administrative (F&A) costs will be determined at the time of award and should not be included in the budget request. A detailed budget is not requested and will not be accepted.

Cover Letter: Provide names and affiliations of significant collaborators for the Type 1 Diabetes Pathfinder Award project. Biosketches of collaborators are not allowed. Provision of names here is only to help exclude conflicts during reviewer assignment. Information regarding any collaborators may be included in the Essay.

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:

Bibliography & References Cited: Do not use. Reference citations are not required, but may be included in the essay and are included in the page limit.

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

Profile - Project Director/Principal Investigator Field -  Current and Pending Support:  Attach a list of Current and Pending Support from all sources, including current year direct costs and percent effort devoted to each project.

Profile - Senior Key Person 1:  Do not use.  Submit information only for PD(s)/PI(s).  Information on collaborators or other key personnel is not required but may be included in the Essay.

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: Do not use.

Research Strategy: Upload Essay here. Submit an essay that addresses (1) the significance and potential impact of the project and (2) what makes the approaches exceptionally innovative and how the applicant will address risks and challenges. The description of the scientific plan should be written with a level of detail appropriate for reviewers who are broadly knowledgeable but who may not be directly involved in the proposed area of research. To focus the essay on the goals of the Type 1 Diabetes Pathfinder Award program and the review criteria for applications, presentation of the proposed research as a series of specific aims is discouraged. Preliminary data are allowed but not required. The essay should include the following sections within the page limit, in the following order, with the headings shown:

Statement of research effort commitment: A statement must be included that, if chosen to receive an award, the applicant will commit a minimum of 3 person months effort to the project supported by the Type I Diabetes Pathfinder Award.

Project Description: Describe the scientific problem that you propose to address, its importance, and how solving this problem would have a major impact on a broad area of biomedical/behavioral science. Why is the planned research uniquely suited to the Type 1 Diabetes Pathfinder Award program, rather than a traditional grant mechanism? How is this project distinct from other research that may be supported in your laboratory? The essay should provide a brief overview of the future direction of work after completion of the research in the initial grant

Innovation: State clearly and concisely what makes your project unusually innovative. If the approaches entail a high degree of risk, what will you do if these approaches are not successful?

Investigator Qualifications: Provide evidence to support your claim of innovativeness and creativity in your research. For example, which experiences demonstrate your inclination to challenge paradigms and take intellectual risks, develop unique collaborations, integrate diverse sources of information, or develop novel approaches when new challenges or opportunities arise?

Note: Bibliographic citations are not required but if included must fit within the page limit. Figures and illustrations may be included but must also fit within the page limit.

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:

• Generally, Resource Sharing Plans are expected, but for this FOA, the resource sharing plans will be requested as just-in-time information if an award is being considered.

Appendix: Appendix materials are not allowed.

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.

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. 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.

Since these awards will be issued with a 5-year budget and project period from the same fiscal year, the grantee will not have any authority for an automatic extension nor will one be permitted with NIH prior approval. Funds will not be available for expenditure beyond the 5th fiscal year after the period of availability. Thus, extensions of the budget/project period will not be allowed.

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 and responsiveness by NIDDK. Applications that are incomplete, non-compliant 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.

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.

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 Type 1 Diabetes Pathfinder Award (DP2) grant supports innovative research that has the potential to produce a major impact on a broad area of biomedical or behavioral research that is relevant to type 1 diabetes and its complications. A DP2 grant application does not have extensive background material, and the essay focuses on the goals of the Type 1 Diabetes Pathfinder Award program. Preliminary data are not required but may be included. Accordingly, reviewers will emphasize the following: 1) the importance of the scientific problem and the potential impact of the research, 2) the novelty and innovativeness of the approach, and 3) evidence of the applicant's potential for creative and innovative research as an early stage investigator.

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

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

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Are the PD/PI, 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 the project is collaborative, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the PD/PI devote 3 person months or more of his/her research effort on the Type 1 Diabetes Pathfinder Award project each year?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

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

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

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

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

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

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

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

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

Not Applicable

Not Applicable

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.

Not Applicable

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

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

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) 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 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 National Diabetes and Digestive and Kidney Diseases Advisory Council . The following will be considered in making funding decisions:

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

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

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

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

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the Progress reports for multi-year funded awards are due annually on or before the anniversary of the budget/project period start date of award. The reporting period for multi-year funded award progress report is the calendar year preceding the anniversary date of the award. Information on the content of the progress report and instructions on how to submit the report using the RPPR are posted at http://grants.nih.gov/grants/policy/myf.htm.

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

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

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

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 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)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

James F. Hyde, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7692
Email: [email protected]

Katarzyna Bourcier, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3482
Email: [email protected]

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

Christine Gill l
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-435-2816
Email: [email protected]

Michael Fato
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2968
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 Part 75. This FOA is supported under the authority of PL 114-10, "The Medicare Access and CHIP Reauthorization Act of 2015; Section 213. Extension of special diabetes program for type I diabetes and for Indians.