RFA-DK-27-109-Full-Announcement.html

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)

National Heart, Lung, and Blood Institute (NHLBI)

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

Funding Opportunity Title

Single Source Competition: Continuation of the Cardiovascular Repository for Type 1 Diabetes (CaRe-T1D) - Resource Center (U24 Clinical Trial Not Allowed)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

Reissue of

RFA-DK-21-010

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

RFA-DK-27-109

Companion Funding Opportunity

RFA-DK-27-108

, U01 Research Project (Cooperative Agreements)

Number of Applications

Only one application per institution is allowed, as defined in Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.847, 93.310, 93.233, 93.837, 93.838, 93.839, 93.840

Funding Opportunity Purpose

This Notice of Funding Opportunity (NOFO) invites a single cooperative agreement application for the Resource Center for the Cardiovascular Repository for Type 1 Diabetes (CaRe-T1D). The purpose of CaRe-T1D is to support innovative, discovery and mechanistic research through the study of human cardiovascular (CV) tissue. This research seeks to better understand cardiovascular disease (CVD) in type 1 diabetes, highlight differences compared to type 2 diabetes, and ultimately guide the development of therapies to treat this major cause of morbidity and mortality for individuals with type 1 diabetes. To achieve these goals, the Resource Center will expand the CaRe-T1D biorepository of human CV tissue, further develop the data commons for data sharing and for artificial intelligence (AI) tools, coordinate the research activities of the investigative teams in the CaRe-T1D consortium, and make CaRe-T1D resources accessible to the broader research community.

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.

This is a Notice of Funding Opportunity (NOFO) for a Single Source that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding.

Funding Opportunity Goal(s)

The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to promote biomedical research that improves the understanding of the mechanisms underlying disease and leads to improved prevention, diagnosis and treatment of diabetes and its complications.

Key Dates

Posted Date

June 04, 2026

Open Date (Earliest Submission Date)

August 30, 2026

Not Applicable

September 30, 2026

Not Applicable

July 2027

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

October 01, 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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Notice of 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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

This is a Notice of Funding Opportunity (NOFO) for a Single Source that will invite an application from an eligible organization to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application will be peer-reviewed, and only a meritorious application will be considered for funding.

Purpose This Notice of Funding Opportunity (NOFO) invites a single cooperative agreement application for the Resource Center for the Cardiovascular Repository for Type 1 Diabetes (CaRe-T1D). The purpose of CaRe-T1D is to support innovative, discovery and mechanistic research through the study of human cardiovascular (CV) tissue. This research seeks to better understand cardiovascular disease (CVD) in type 1 diabetes, compare differences with type 2 diabetes, and ultimately guide the development of therapies to treat this major cause of morbidity and mortality for individuals with T1D. To achieve these goals, the Resource Center will expand the CaRe-T1D biorepository of human CV tissue, further develop the data commons for data sharing and for artificial intelligence (AI) tools, coordinate the research activities of the investigative teams in the CaRe-T1D consortium, and make CaRe-T1D resources accessible to the broader research community.

Background Premature atherosclerosis is the leading cause of death for people living with type 1 diabetes. Treatments directed at established CV risk factors such as hyperglycemia, hypertension and hyperlipidemia have improved outcomes, but type 1 diabetes still confers a 2- to 4-fold higher risk of CV events and mortality compared to the general population. A major knowledge gap is the limited understanding of the differences in the pathophysiology of CVD in people with type 1 diabetes compared to those with type 2 diabetes and without diabetes. These differences have major implications for treatment and prevention of CVD in type 1 diabetes.

A significant limitation to advancing research to more fully understand the development of CVD in type 1 diabetes has been the lack of availability of well-characterized human tissue and research networks for synergistic projects. Human tissue is optimal for studying disease pathogenesis in that it takes a human-first approach to identify genetic, molecular and cellular disease markers that can be further validated mechanistically in animal, cellular and computational models. CVD in individuals with type 1 diabetes develops over many years to decades and involves numerous biologic pathways. Addressing these challenges requires a broad range of perspectives, expertise and approaches working together to dissect the similarities and differences in atherosclerosis and cardiomyopathy between type 1 and type 2 diabetes.

NIDDK, in partnership with NHLBI, created the CaRe-T1D program in 2022 through RFA-DK-21-010 to address these knowledge and research gaps. CaRe-T1D established a biorepository from organ donors with type 1 diabetes, type 2 diabetes or no diabetes that includes heart, kidney and arterial tissue, as well as careful clinical characterization. All tissues undergo rigorous quality control procedures and analysis, including imaging for vascular calcification and microscopic evaluations. Beyond CaRe-T1D, there are no comparable national-scale biorepositories focused on the study of T1D CVD with standardized tissue processing and operating protocols. In 2024, six investigative teams were added to the consortium through RFA-DK-23-021 to perform hypothesis-driven research on CVD disease mechanisms with CaRe-T1D resources.

Research Goals and Objectives The objective of this funding opportunity is to continue and expand the current effective infrastructure of the CaRe-T1D Resource Center and advance research on CVD disease mechanisms through the following research activities, with the goal of driving groundbreaking discoveries that foster the development of novel, targeted therapies for CV and renal diseases for people with type 1 and type 2 diabetes.

This funding opportunity will support continuation of the basic infrastructure of CaRe-T1D, with the Resource Center serving three critical functions: Biorepository, Data Commons, and Coordinating Center. Investigative teams funded through RFA-DK-27-108 have the charge to perform pioneering, innovative and hypothesis-driven research as separate and collaborative projects on the pathogenesis of CVD in type 1 diabetes and its distinctions from type 2 diabetes.

Biorepository – The Resource Center will continue to obtain hearts (including coronary arteries, myocardium and epicardial fat), arteries (carotid and aorta), kidneys and blood from U.S. Organ Procurement Organizations through the generosity of organ donors and their families. In addition, the Resource Center, upon advice from its scientific advisory board or requests from investigators, will explore the ability to collect other tissue types relevant to an improved understanding of complications pathogenesis in type 1 diabetes. All tissue must meet the CaRe-T1D selection criteria for quality. Donors with type 2 diabetes and no diabetes will be matched to type 1 diabetes donors, with approximately equal numbers of cases across the three groups and a total of about 30 cases collected per year. An extensive medical history will be obtained for each donor together with a careful characterization of the type of diabetes that will include autoantibody evaluation, genetic testing, and pancreatic tissue analysis. A comprehensive case summary will be annotated to each case and available to investigators in the Data Commons.

The Resource Center will continue its extensive quality control testing and tissue characterization, including histopathologic examinations, electron microscopic evaluation, and RNA quality assessments. Whole hearts will undergo microCT imaging to detect and quantify vascular calcification. Tissue will be stored in a variety of modalities to support a wide range of modern techniques. Additional testing will be conducted through the biorepository when appropriate to benefit individual and collaborative projects within the consortium. All results will be incorporated into the case records and made accessible to investigators through the Data Commons. The Resource Center will also manage the distribution of biosamples to investigators who have been approved through the CaRe-T1D Ancillary Study process, with shipping costs covered by the recipient.

When feasible, the Resource Center will adapt its collection protocols in response to new scientific opportunities being explored by the consortium. This may include obtaining tissue from surgical specimens, targeting a population subgroup, or modifying tissue collection procedures to support emerging research needs.

Data Commons- CaRe-T1D will continue to expand its Data Commons, which currently includes all clinical data and the results of analysis performed by the Resource Center and investigative teams, and is accessible with different levels of clearance via the CaRe-T1D website. The Data Commons will also continue its collaboration with the NHLBI BioData Catalyst cloud-based ecosystem for secure, long-term data storage.

Funding through this NOFO will support three interconnected objectives for the Data Commons as follows:

1) Shared Data Resources – The results and descriptions of specific assays, donor-specific data, and available biospecimens will be made accessible to investigators for downloading and for tissue requests. The Data Commons will collaborate with investigators to integrate results from diverse approaches, including single cell and –omics analyses and tissue imaging;

2) Artificial Intelligence (AI) Recommender System – This system will allow investigators to submit study questions inputted in plain language and receive recommended biospecimens and datasets, accompanied by an explanation of the rationale for those selections;

3) AI-Assisted High-Level Analysis System – The well-curated CaRe-T1D Data Commons will be optimized for large-scale, multimodal data analysis using the most advanced and ever-improving AI tools.

For all aspects of the Data Commons, best practices will be followed to ensure data privacy, established policy guardrails for prohibited uses, detect and mitigate bias, and provide robust model validation and explainability.

Coordinating Center - The Resource Center will coordinate CaRe-T1D activities for the Biorepository, Data Commons and investigative teams to leverage the consortium infrastructure and build synergies across all the parts of CaRe-T1D with the goal of providing insights in CVD mechanisms to illuminate the path to new therapies. The coordinating center will:

NIH Gold Standard Science – The tenets of Gold Standard Science will be embedded CaRe-T1D Resource Center activities. CaRe-T1D is a collaborative, interdisciplinary group of investigators, each contributing unique expertise to this research endeavor. The Resource Center will facilitate meetings that encourage critical evaluation of findings, including those that may refute a hypothesis. A core purpose of the Data Commons is to transparently share results, enabling other investigators to reproduce study findings. Priority will be given to Ancillary Study requests that seek biosamples for reproducibility studies.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed

Renewal

Revision applications are allowed to request an expansion of the scope of the ongoing, awarded project.

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. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIDDK intends to commit $2 million in FY 2027 to fund one award.

Award Budget

Application budgets are limited to $1.5 million in direct costs each year.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 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

Only the following applicant is eligible to apply for this single source funding: University of Florida. Please refer to Section I. Notice of Funding Opportunity Information for more details.

Foreign Organizations/Foreign Collaborations

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 not 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 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. Foreign organizations must obtain a NATO Commercial and Government Entity (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.

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.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

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.

Only the current CaRe-T1D Resource Center funded under RFA-DK-21-010 is eligible to apply.

2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement 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:

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 (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

SF424(R&R) Other Project Information

SF424(R&R) Senior/Key Person Profile

R&R Budget

The budget should include travel to the CaRe-T1D annual meeting in Bethesda, MD.

R&R Subaward Budget

The budget should include funds for small subawards to domestic investigators for pilot and feasibility projects through a Special Opportunity funding program.

PHS 398 Cover Page Supplement

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.

Other Plan(s):

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

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed.

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

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.

Study title: Possible Collection of Surgical Tissue Specimens for CaRe-T1D Clinical trial: No Justification for the possible collection of surgical tissue specimens and participants' medical histories to supplement tissue collection from organ donors.

PHS Assignment Request Form

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 components of participating organizations, NIH. 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.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the proposed Resource Center address the needs of the CaRe-T1D consortium that it will coordinate? Is the scope of activities proposed for the Resource Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research consortium?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Resource Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing human tissue research? Do the investigators demonstrate significant experience with coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Resource Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Innovation

Does the application propose novel strategies for biospecimen and data sharing and analysis in the CaRe-T1D consortium the Resource Center will serve? Are the data and biospecimen sharing strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of management strategies proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the CaRe-T1D consortium the Resource Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the consortium is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium? Is an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables in their tissue selection criteria?

Environment

Will the institutional environment in which the Resource Center will operate contribute to the probability of success in facilitating the CaRe-T1D consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Resource Center proposed? Will the Resource Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Additional Review Criteria

None

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 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.

This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.

Inclusion of Human Subjects Policies

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

Not Applicable

Biohazards

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

Resubmissions

Not Applicable

Renewals

For Renewals (as applicable), the committee will consider the progress made in the last funding period.

Revisions

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

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources

For consortia involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by CSR, in accordance with NIH peer review policies and practices, 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.

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

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.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy."

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

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:

Cybersecurity plans and procedures must at minimum include the following:

Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data: Identify: Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.

Detect: Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.

Recover: Investigate incidents and plug any security gaps identified.

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings. Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety. If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on MAT/MOUD.

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in…