Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Office of The Director, National Institutes of Health (OD)

Funding Opportunity Title
New Investigator Gateway Awards for Collaborative T1D Research (R03 Clinical Trial Not Allowed)
Activity Code

R03 Small Grant Program

Announcement Type
Reissue of RFA-DK-21-030
Related Notices
  • April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084.
  • August 31, 2022- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 5, 2022- Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
Funding Opportunity Number (FON)
RFA-DK-26-009
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.847
Funding Opportunity Purpose

The New Investigator Gateway Award in T1D Research is designed to support a robust pipeline of innovative projects and talented new investigators in T1D research. In addition to providing support for preliminary research, the Gateway program provides an opportunity for new Program Directors/Principal Investigators (PD/PIs) to pursue their studies within the intellectual environment of a select number of large, ongoing collaborative research programs. Embedding awardees within an established scientific framework in each of these consortia will provide unique opportunities for New and Early Stage Investigators to increase their understanding of key questions in the field, to network, and to establish unique and potentially long-lasting collaborations that will propel their careers forward. Bringing New and Early Stage Investigators into existing collaborative research networks will also benefit the networks by providing new ideas and perspectives. 

This NOFO is associated with the Special Diabetes Program (https://www.niddk.nih.gov/about-niddk/research-areas/diabetes/type-1-diabetes-special-statutory-funding-program/about-special-diabetes-program) which funds research on the prevention, treatment, and cure of type 1 diabetes and its complications, including unique, innovative, and collaborative research consortia and clinical trials networks.  

Funding Opportunity Goal(s)

To promote extramural basic and clinical biomedical research that improves the understanding of the mechanisms underlying disease and leads to improved preventions, diagnosis, and treatment of diabetes, digestive, and kidney diseases. Programmatic areas within the National Institute of Diabetes and Digestive and Kidney Diseases include diabetes, digestive, endocrine, hematologic, liver, metabolic, nephrologic, nutrition, obesity, and urologic diseases.

Key Dates

Posted Date
January 22, 2025
Open Date (Earliest Submission Date)
May 26, 2025
Letter of Intent Due Date(s)

May 26, 2025 and February 6, 2026

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
June 26, 2025 June 26, 2025 Not Applicable November 2025 January 2026 April 2026
March 06, 2026 March 06, 2026 Not Applicable July 2026 October 2026 December 2026

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
March 07, 2026
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

Type 1 diabetes (T1D) is an autoimmune disease that destroys insulin-producing cells in the pancreas. The loss of proper glucose control that ensues leads to a variety of pathologic consequences, including complications affecting the heart, eye, nerves, kidney and urogenital systems. While the incidence of T1D is increasing worldwide, research continues into the underlying mechanisms contributing to disease onset and severity, and into the development of therapies to effectively prevent or intervene in the disease process.

The Gateway Award in T1D Research is designed to ensure a robust pipeline of innovative research and talented new investigators in T1D research. In addition to providing support for preliminary research, the Gateway program provides an opportunity for new investigators to pursue their studies within the intellectual environment of a select number of large, ongoing collaborative research programs. Embedding awardees within the established scientific framework afforded by each of these consortia will provide unique opportunities for New Investigators (NI) and Early Stage Investigators (ESI) to increase their understanding of key questions in the field, and for networks to benefit from new ideas and diverse perspectives.


Objectives and Scope

The Gateway Award in T1D research supports New Investigators and Early Stage Investigators who are interested in pursuing careers in T1D, including qualified researchers from diverse scientific backgrounds. The goal of the program is to provide support for high quality innovative and significant research by junior faculty engaged in basic, translational and clinical research that will firmly establish the awardees in a T1D-oriented career path and set the stage for competitive first R01 submissions.

A second key feature of the Gateway program is the opportunity it provides for awardees to enhance their careers through networking with investigators currently engaged in specific T1D-oriented research networks, trials and consortia. Given this feature, research to be supported should address significant barriers in T1D research that fit conceptually within the scope and goals of one of the consortia listed below. 

The Human Islet Research Network (HIRN): The Human Islet Research Network (HIRN; www.hirnetwork.org) supports collaborative research into the loss of functional beta cell mass in type 1 diabetes (T1D). HIRN’s overall mission is to better understand how human beta cells are lost in T1D, and to find innovative strategies to protect or replace functional beta cell mass in people with T1D. The HIRN program is configured as a modular network of research consortia, each defined by a specific set of research priorities.

The four current HIRN consortia include:

(1) The Consortium on Beta Cell Death and Survival (HIRN-CBDS) that is using human cells and tissues to discover highly specific biomarkers of beta cell injury in asymptomatic T1D and developing strategies to stop beta cell destruction early in the disease process;

(2) The Human Pancreas Analysis Consortium (HIRN-HPAC) that is investigating the physical and functional organization of the human islet tissue environment, the cell-cell relationships within the pancreatic tissue ecosystem, and the contributions of non-endocrine components (acinar, ductal, vascular, perivascular, neuronal, lymphatic, immune) to islet cell function and dysfunction.

(3) The Consortium on Modeling Autoimmune Diabetes (HIRN-CMAD) that supports the development of in vitro and in vivo models of type 1 diabetes (T1D) to enable studies of human T1D pathophysiology and to serve as platforms for preclinical assessments of new T1D interventions.

(4) The Pancreas Knowledgebase Program (HIRN-PanKbase) that is developing a centralized resource of the human pancreas for diabetes research that will provide access to deeply curated high-quality datasets, knowledge in computable forms, and advanced data science tools and workflows; and enable open and reproducible multidisciplinary collaboration toward accelerating biomarker and therapeutic target development.

Research opportunities that could be pursued in collaboration with HIRN consortia include, but are not limited to:

  • Using human islets and pancreatic tissues to identify components of the beta cell and its environment required for maintenance and function and/or instrumental in its pathogenic destruction;
  • Identifying therapeutic targets of early disease to prevent the development of a fully developed autoimmune response, or to protect and replenish residual beta cell mass in at-risk or recently-diagnosed individuals;
  • Using humanized in vivo models for exploration of the T1D pathogenesis and/or to test potential therapies;
  • Developing a biomimetic system that will allow for the exploration of immune?beta cell interactions;
  • Developing immune-cell engineering strategies to enhance or restore glycemic control.
  • Identifying novel biomarkers of T1D or developing synthetic reporter systems to monitor disease initiation, progression and response to therapy; and
  • Developing methods for the non-invasive measurement of beta cell mass or function that may be used as endpoints in studies of preventing or ameliorating T1D.
  • Studying how human genetics and environmental perturbations interact to contribute to T1D pathogenesis and the heterogeneity of clinical responses to interventions;
  • Designing and validating workflows that can be integrated into the PanKbase analytical library, enhancing its capabilities, reproducibility, and usability for researchers.
  • Developing use cases for PanKbase resources to map molecular and mechanistic processes underlying T1D etiology, pathology, and prognosis, and to identify composite biomarkers.
  • Creating advanced AI models and intelligent agents for information and knowledge extraction. Leveraging prior knowledge to augment and improve the training of AI models on multimodal T1D pancreas datasets.
     

Type 1 Diabetes TrialNet: Using knowledge gained through clinical research, TrialNet's mission is to prevent T1D and stop disease progression by preserving insulin production before and after diagnosis (see https://trialnet.org). TrialNet performs multicenter clinical trials of disease-modifying therapies, and longitudinal studies of the natural history of disease and mechanisms of T1D pathogenesis. TrialNet is an international collaborative effort involving clinical investigators, immunologists, islet cell biologists, industry and foundation partners, and families of people with diabetes working together to bring disease-modifying therapies into clinical practice.

Research opportunities that could be pursued in collaboration with TrialNet include, but are not limited to, topics outlined in https://www.trialnet.org/researchers such as:

  • Studies of well-characterized biomarkers that have the potential to inform the outcomes of clinical trials, such as surrogate endpoints;
  • Defining biomarkers that identify different patient subpopulations based upon mechanism of disease progression, facilitating clinical trial design including therapy selection;
  • Research into immune or metabolic pathways that provide insights into pathogenesis and/or therapeutic mechanisms of action;
  • Biomarker studies that will validate biomarkers against TrialNet clinical endpoints;
  • Development of novel assays to measure key features of disease progression or response to therapy; and,
  • Research related to the performance of more effective and efficient clinical trials for the prevention of T1D, such as strategies for participant engagement, recruiting, and retention.

The Environmental Determinants of Diabetes in the Young (TEDDY) Study: The long-term goal of the TEDDY study is to identify infectious agents, dietary factors, or other environmental agents, including psychosocial factors, that trigger T1DM in genetically susceptible individuals or that protect against the disease. Identification of such factors will lead to a better understanding of disease pathogenesis and may result in new strategies to prevent, delay or reverse T1DM. TEDDY currently consists of a consortium of six Clinical Centers (CC) and a Data Coordinating Center (DCC) that is carrying out studies to identify environmental causes of T1DM in genetically susceptible individuals.

The TEDDY study investigates: (1) genetic and genetic-environmental interactions, including gestational infection or other gestational events; and (2) childhood infections or other environmental factors after birth, in relation to the development of prediabetic autoimmunity and Type I Diabetes Mellitus (T1DM). The CCs recruit and enroll subjects, including obtaining informed consent from parents prior to or shortly after birth, obtain genetic and other samples from neonates and parents, and prospectively follow selected neonates throughout childhood or until development of islet autoimmunity or T1DM. With this approach, the TEDDY Consortium provides a coordinated, multi-disciplinary approach to this complex disease. It is anticipated that collection of information and samples in the standardized manner used by TEDDY may provide greater statistical power in research studies than might be possible in smaller independent investigations. The TEDDY has initiated a nested case-control study that includes samples from children who have developed autoantibodies or have been diagnosed with type 1 diabetes, and their age matched controls’ samples, that are analyzed in TEDDY laboratories. Analyses being conducted on the samples include assays of the gut microbiome, gene expression, proteomics, metabolomics, dietary biomarkers, SNPs, and whole genome sequencing. Data from these assays are available from the NIDDK Central Repository as well as the TEDDY study website. Please see https://teddy.epi.usf.edu/research/.

Research opportunities for data analysis that could be pursued in collaboration with the TEDDY study include, but are not limited to:

  • Identifying environmental agents
  • Identifying biomarkers of disease
  • Identifying infectious agents
  • Defining etiology and pathogenesis of disease

The Diabetic Foot Consortium (DFC)- The DFC is the first national network for the study of diabetic foot ulcers (DFUs) with the long-term goal of developing effective interventions that promote DFU healing and prevent recurrences.  The current focus of the DFC is developing and validating DFU biomarkers that can predict healing, infection, or recurrence and monitor treatment.  The consortium, which consists of a data coordinating center, multiple biomarker analysis units, and seven clinical sites, takes the approach that “No DFU Patient Goes Unstudied”.  It uses a platform approach with a Master Protocol to collect comprehensive data that include the medical history, social factors, and wound therapies and images and biosamples that include wound fluid and tissue, blood and urine.  The Master Protocol can be amended to add additional clinical testing and biosample collection.

People with type 1 diabetes (T1D) develop DFUs at a younger age and are at a much greater risk of amputation and hospitalization secondary to a DFU compared to people type 2 diabetes (T2D). The difference between outcomes for individuals with T1D versus T2D is  poorly understood and understudied.  Approximately 9% of DFC participants have T1D  and plans are proposed to enrich the T1D population in the DFC cohort in the future.  Research on DFUs through the Gateway Award is limited to studies on DFUs in T1D either alone or in comparison to T2D 

For more information on the DFC and its Ancillary Study policy, please see https://diabeticfootconsortium.org/researchers/

Research opportunities that could be pursued in collaboration with the DFC include, but are not limited to:

  • Studying the role of T1D specific co-morbidities, including autoimmunity, insulin deficiency and early age of onset, in DFU healing.
  • Identifying and developing biomarkers that predict healing or nonhealing for DFUs in T1D and identify DFUs that would respond to specific interventions.
  • Comparing the differences in DFU healing and infections between T1D and T2D using the data and biosamples currently being collected in the DFC Master Protocol
  • Enhancing recruitment at a current DFC clinical site of people with T1D and a DFU into the DFC Master Protocol through targeted outreach activities

Cardiovascular Repository - Type 1 Diabetes (CaRe-T1D) – The goal of this program is to advance and support discovery and mechanistic research that increases the understanding of cardiovascular disease in T1D.  CaRe-T1D was established in 2022 to first build a biorepository of human cardiovascular tissue (cardiac, aorta, carotid artery, and kidney tissue) from a balanced mix of organ donors with T1D, type 2 diabetes and without diabetes.  After infrastructure was formed and biorepository implemented, in 2024, a consortium was formed with six investigative teams proposing  hypothesis-driven projects using the CaRe-T1D biosamples and innovative, multimodal approaches.

Grant awardees from this Gateway program would join CaRe-T1D as additional investigative teams.  RFA-DK-23-021 gives more information about CaRe-T1D, the role of the investigative teams in the consortium and research opportunities using the CaRe-T1D samples. The size of the R03 Gateway awards may limit the scope of the projects.  Given the availability of different tissue types and current research projects, preference will be given to applications using tissues other than coronary arteries. Small amounts of tissue can be obtained from CaRe-T1D to obtain preliminary data on feasibility

For more information on CaRe-T1D, please see https://www.care-t1d.org/

Research topics for collaborative projects with CaRe-T1D can be found in RFA-DK-23-021.  

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Resubmission - Resubmission applications from RFA-DK-21-030 and from the current active NOFO RFA-DK-26-009 may be submitted in response to this NOFO.

The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

NIDDK intends to commit $4,000,000 in FY 2026 and $4,000,000 in FY 2027 to fund up to 20 awards.

Award Budget

Applications may request budgets of up to $100,000 in direct costs per year for up to two years.

Award Project Period

The maximum project period is 2 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local 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).

Federal Governments

  • 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
Foreign Organizations

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

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

  • System for Award Management (SAM) – 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.
    • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. 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 SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for 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 How to Apply-Application Guide.

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

Applicants must meet the definition of a New Investigator (NI) or Early Stage Investigator (ESI) at the time of application. A New Investigator is defined as PD/PI who has not competed successfully for a significant NIH independent research award. An Early Stage Investigator (ESI) is a New Investigator who is within 10 years of completing his/her terminal research degree or end of post-graduate clinical training. See the Office of Extramural Research for a complete list of NIH grants that do not disqualify a PD/PI as a new investigator and for frequently asked questions about the NIH Early Stage Investigator (ESI) Policy.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Letter of Intent

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

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

  • Descriptive title of proposed 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 to:

John Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7797
Email: NIDDKLetterofIntent@mail.nih.gov

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply- Application Guide must be followed.

Other Attachments:

Proposed Affiliation Letter: Name the PDF formatted letter "Proposed_Affiliation_Ltr.pdf". Applications must include a one page letter that includes a brief statement identifying the specific NIDDK consortium or network that is within scope of the proposed aims. In addition, the applicant must outline in the letter how the objectives and design of the application are related to, but distinct from, ongoing studies in the consortium or network of interest, and describe how developing a relationship with the chosen consortium or network would be expected to facilitate the applicant's research and career goals. Applications that lack the proposed Affiliation Letter are considered incomplete and will not be peer reviewed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply- Application Guide must be followed.

R&R or Modular Budget

All instructions in the How to Apply- Application Guide must be followed.

Applicants should also follow these additional instructions:

Applicants should budget for travel to one meeting of the proposed affiliated consortium or network per year. Except in unusual circumstances, only the PD/PI may be supported by R03 funds to travel to consortium meetings. There is no specific line item in which to list travel costs ($2000/year) in the modular budget format; instead, the proposed travel should be described in the budget justification section.

R&R Subaward Budget

All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply- Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

Protocol, tool and reagent sharing: The applicant should discuss plans for sharing and distribution of non-data resources that will be generated by the proposed project, including models, protocols, computational tools, biomaterials, and reagents. As one of the essential goals of the Gateway program is to support high impact advances, NIDDK intends that tools and reagents generated by the Gateway program will be made broadly available and distributed at minimal cost, and without undue intellectual property constraints, so that they can be as widely used as possible, thus enabling rapid downstream applications for the reagents by the larger scientific community. Applicants are expected to register resources supported by this NOFO with the NIDDK Information Network (dkNET) at https://dknet.org/ and use Research Resource Identifiers (RRID) assigned through dkNET in any publication supported by this NOFO. Applicants should also be familiar with the NIH statements regarding intellectual property of resources developed with Federal funds (NIH Research Tools Policy (https://grants.nih.gov/grants/intell-property_64FR72090.pdf) and other related NIH sharing policies at http://sharing.nih.gov

Other Plan(s): 

All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions:

  • All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. 

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply- Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply-Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply 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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply 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.

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Scored Review Criteria

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. 

 

Significance

  • Evaluate the importance of the proposed research in the context of current scientific challenges and opportunities, either for advancing knowledge within the field, or more broadly. Assess whether the application addresses an important gap in knowledge in the field, would solve a critical problem, or create a valuable conceptual or technical advance.
  • Evaluate the rationale for undertaking the study, the rigor of the scientific background for the work (e.g., prior literature and/or preliminary data) and whether the scientific background justifies the proposed study.

Innovation

  • Evaluate the extent to which innovation influences the importance of undertaking the proposed research. Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be of critical importance for the field.
  • Evaluate whether the proposed work applies novel concepts, methods or technologies or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project.
 

Approach

  • Evaluate the scientific quality of the proposed work. Evaluate the likelihood that compelling, reproducible findings will result (rigor) and assess whether the proposed studies can be done well and within the timeframes proposed (feasibility).

Rigor:

  • Evaluate the potential to produce unbiased, reproducible, robust data.
  • Evaluate the rigor of experimental design and whether appropriate controls are in place.
  • Evaluate whether the sample size is sufficient and well-justified.
  • Assess the quality of the plans for analysis, interpretation, and reporting of results.
  • Evaluate whether the investigators presented adequate plans to address relevant biological variables, such as sex or age, in the design, analysis, and reporting.
  • For applications involving human subjects or vertebrate animals, also evaluate:
    • the rigor of the intervention or study manipulation (if applicable to the study design).
    • whether outcome variables are justified.
    • whether the results will be generalizable or, in the case of a rare disease/special group, relevant to the particular subgroup.
    • whether the sample is appropriate and sufficiently diverse to address the proposed question(s).
  • For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.

Feasibility:

  • Evaluate whether the proposed approach is sound and achievable, including plans to address problems or new challenges that emerge in the work. For proposed studies in which feasibility may be less certain, evaluate whether the uncertainty is balanced by the potential for major advances.
  • For applications involving human subjects, including clinical trials, evaluate the adequacy and feasibility of the plan to recruit and retain an appropriately diverse population of participants. Additionally, evaluate the likelihood of successfully achieving the proposed enrollment based on age, racial, ethnic, and sex or gender categories.
  • For clinical trial applications, evaluate whether the study timeline and milestones are feasible.
 

 

Investigator(s)

Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.

Environment

Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.

Additional Review Criteria

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

 

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, 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 categories of research that are exempt under 45 CFR Part 46, 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 research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

 

When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.

 

As applicable, evaluate the full application as now presented.

 

As applicable, evaluate the progress made in the last funding period.

 

As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.

Additional Review Considerations

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

 

For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources.

 

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

2. Review and Selection Process

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

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.

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

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 NOFO. 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

  1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and 
  2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

A final RPPR, 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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Olivier Blondel, Ph.D. (for HIRN-related inquiries)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-7344
Email: blondelo@nih.gov

Lisa Spain, Ph.D. (for TrialNet-related inquiries)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-9871
Email: lisa.spain@nih.gov

Beena Akolkar, Ph.D. (for TEDDY-related inquiries)
National Institute of Diabetesand Digestive and Kidney Diseases (NIDDK)
Telephone: 240-593-1733
Email: beena.akolkar@nih.gov

Teresa Jones, MD (for CARE-T1D and DFC)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-435-2966
Email: jonest@nih.gov 

Vicki Shanmugam, MBBS, MRCP, FACR, CCD
Director, Office of Autoimmune Disease Research
Office of Research on Women's Health  

Peer Review Contact(s)

Xiaodu Guo, M.D., Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4719
Email: guox@niddk.nih.gov  
 
 

Financial/Grants Management Contact(s)

Natasha Loveless
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8853
Email: lovelessnd@niddk.nih.gov



 

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

This NOFO is supported under the authority of P.L. 118-158, American Relief Act, 2025; Division C, Section 3102. “Extension of special diabetes programs".

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®