Part 1. Overview Information

Key Dates

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.

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.

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.

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 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. 

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is announcing its intent to issue a single source cooperative agreement award to Beckman Research Institute/City of Hope for the currently funded Integrated Islet Distribution Program (IIDP) to renew the program and maintain support for its continuing mission to provide the scientific community with important islet resources for diabetes research. The IIDP facilitates the distribution of human islets to biomedical researchers by establishing partnerships with qualified islet isolation facilities to prepare and distribute human islets. Human islets remain an essential resource for diabetes research to advance our understanding of human islet cell biology, and to promote the development of new therapies for the prevention and treatment of diabetes.

Objective

The Integrated Islet Distribution Program (IIDP) facilitates the distribution of human islets for biomedical research. By fostering the use of human islets in scientific exploration, IIDP resources promote advances in human islet biology and support the development of new therapies for the prevention and treatment of diabetes.

Background

The National Institutes of Health (NIH) supports an array of programs that are designed to accelerate diabetes research, including numerous investigator-initiated projects and multidisciplinary consortia. Dependable access to high quality human islets has become a necessity for many of these programs. In recognition of this need, NIH has provided support for the procurement, processing, and distribution of human islets to the research community for over twenty years. As part of these efforts, the NIDDK Integrated Islet Distribution Program (IIDP) has distributed more than 175 million human islet equivalents to over 310 investigators since 2009. Many key advances in human islet biology have been made as a result of the availability of IIDP resources, and documented differences between human and murine islets underscore the need for continuing to support access to human tissue to advance research in this challenging field.

The IIDP currently serves a national research base of over 180 researchers, and functions as an organizing intermediary between investigators and the islet isolation centers that procure and prepare islets for research purposes. To receive research islets through the IIDP, investigators must have ongoing, peer reviewed grant funding or approval from an IIDP-empaneled scientific review committee. Electronic application materials and other program information are made available through online web services. When a donor pancreas is recovered and the processed islets are directed for research use, an electronic system matches the characteristics of islets being offered with requirements specified by investigators and notifies the researcher of islet availability.

Unlike rodent islet processing, the preparation of human islets requires expertise that is available in relatively few laboratories. In addition, providing islets for research at regular predictable intervals is costly. Procurement of human pancreata for research purposes can exceed $7500 per organ, and islet processing can cost from $6,000 to as much as $48,000 per isolation. Rigorous characterization of the islet preparations being shipped to researchers adds further expense. IIDP-affiliated investigators currently pay $0.15 per islet equivalent plus shipping costs, and islet production facilities are reimbursed per islet equivalent shipped. In addition, as part of its ongoing mission to serve the diabetes research community, the IIDP has expanded procurement and distribution of human islets from donors with a history of Type 2 diabetes. Future activities may include facilitating the procurement of organs from prediabetic donors or providing islets from donors with other forms of diabetes mellitus. The IIDP program manages all of these transactions.

Scope of Activities

The IIDP will continue to oversee the distribution of human islets from islet isolation centers to researchers, ensuring that the process is timely and equitable. In addition, the IIDP will continue to be responsible for maintaining quality control across the multiple procurement and isolation centers, for providing rigorous and reproducible analyses of islet preparations, and for fostering and promoting information exchange among investigators engaged in human islet research.

Toward these goals, the IIDP will engage in three interrelated functions:

Administrative Functions 

Administrative activities of the IIDP will consist of initiating subcontracts with qualified islet isolation centers and providing the needed infrastructural support to maintain efficient and cost-effective oversight of resources and data that are distributed via the IIDP network of centers and investigators.

IIDP Administrative Functions include:

• Receiving online islet request applications, and processes these data to maintain a complete and continuously updated electronic roster of approved investigator users and their projected needs;
• Soliciting and qualifying potential islet production centers, assuring quality performance standards of prepared islets, providing training for standardized shipping/distribution protocols, subcontracting to appropriate laboratories to provide islets and adjusting these subcontracts as warranted;
• Implementing, maintaining and continuously improving the electronic notification system;
• Providing an electronic financial database documenting payment records;
• Maintaining accurate records of islet shipments from production sites to islet recipients including quantities and batch release test characteristics, analyzing trends in demand for islets and projecting future islet requirements, ensuring timely submission of quality control data to the IIDP website;
• Collecting information on user satisfaction and analyzing these data for quality improvements;
• Maintaining and enhancing the IIDP public and password-protected website to foster communication and information exchange between islet investigators, islet isolation centers, and the research community, implementing procedures to achieve NIH goals of Findability, Accessibility, Interoperability and Reproducibility for IIDP data and resources (FAIR principles);
• Tracking scientific progress directly attributable to IIDP resources as shown by publications and other tangible results;
• Overseeing a robust and competitive opportunity pool program. The IIDP Opportunity Pool will be deployed with the primary goal of enhancing the use of human islets in fundamental research. Among other uses, opportunity funds may subsidize the distribution of islets to early stage investigators and/or to researchers new to the field of human islet research. The IIDP-Opportunity Pool may also be used to enhance the availability of islets from diseased or rare patient populations, including patients with a history of diabetes. Small feasibility studies designed to address key questions related to islet procurement, production or delivery, as well as studies that focus on reuse of IIDP data (including data held in the IIDP Research Data Repository (RDR))  may also be supported by the IIDP opportunity pool. Importantly, defining the scientific scope of IIDP Opportunity Pool programs is not the sole responsibility of the IIDP Steering Committee.   Instead, IIDP's primary responsibility is to manage the initiative process on behalf of the IIDP investigator community  based on needs and opportunities identified by the research community. Under certain circumstances, the IIDP may be called upon to contribute to the development of initiative ideas by partnering with NIH staff on workshops in specific topic areas.The IIDP will oversee the electronic submission, review and progress reporting, as well as financial tracking of any opportunity pool awards.      While a defined pool of funds has been set aside in this NOFO to support the IIDP opportunity pool, additional funds may be made available at a later time to support and expand opportunity pool collaborative activities should uniquely compelling opportunities arise;
• Coordinating and providing statistical, technical, administrative, and logistical support for the activities of IIDP External Scientific Consultants and any other committees that may be empaneled to assist with the overall scientific direction, management, and direction of the IIDP. These responsibilities include preparation of rosters, scheduling of meetings and conference calls, preparation of materials, arranging travel and meeting logistics, and preparation of meeting summaries;
• Developing a PI succession plan to ensure sustainability of the program and its objectives; and
• Presenting as appropriate at scientific meetings.

Centralized Phenotyping and Genotyping of IIDP islets 

Phenotyping and genotyping assays to be pursued by the program are a key element of IIDP's efforts to ensure that rigorous and reproducible analyses of human islet preparations and associated data are provided to the investigator community. Data obtained via IIDP's phenotyping and genotyping pipelines will be essential for developing recommendations for standardizing procedures at islet production centers (where feasible) and for providing a systematic assessment of samples being distributed throughout the network. Through the continuing implementation of these standardized protocols and procedures, the IIDP ensures that key features of each islet batch shipped to investigators are independently analyzed and verified. Genotyping and phenotyping data should be acquired and uploaded directly to the IIDP website and be provided in readily accessible forms/formats that can be linked to information provided by the Organ Procurement Organizations (OPOs), including donor data obtained from medical charts.

IIDP Phenotyping and Genotyping Responsibilities include:

• Devising, standardizing and implementing a human islet phenotyping pipeline. This IIDP phenotyping pipeline will perform a defined set of assays that will assess the quantity, quality, and function of each islet shipment provided by IIDP-affiliated islet isolation centers. Tests should be designed to be cost-effective, and to maximize the information obtained from the smallest number of islet equivalents. Protocols to be used should be designed to subject islet preparations to multiple tests in parallel and/or in sequence to maximize information obtained from each islet preparation. Reproducibility, sensitivity and accuracy of any proposed tests should be provided. The battery of tests to be performed should include histopathological analyses as well as assays specifically designed to mirror tests performed at islet isolation centers. Additional assays that can be justified as particularly informative and cost-effective as advised by external consultants and/or by the research community may be incorporated into the IIDP Phenotyping and Genotyping pipelines;
• Deploying a standardized genotyping pipeline that uses state-of-the-art techniques and community standards to perform a comprehensive assessment of common and low frequency genetic variation in islet samples distributed through the IIDP network. The workflow and analysis should be performed using methods that will ensure any data obtained is interoperable with other similar genotyping programs, and allow for integration of donor genotypes with molecular, cellular and functional phenotypes being generated both by the IIDP project team and by the islet users;
• Regular monitoring to ensure the accuracy and efficiency of data generation in IIDP phenotyping and genotyping pipelines. The pipelines will be required to return data expeditiously to investigators for approximately 120 islet shipments annually, assayed at the rate of approximately 10 islet shipments/month; and
• Developing strategies to seamlessly report and upload data to the IIDP website. The intent is to provide IIDP customers and affiliated islet isolation centers with timely, useful and standardized quality assessments as measured following receipt of islet preparations from the islet isolation centers. In addition, IIDP will be responsible for extracting and uploading to the IIDP web services any appropriate data elements that need to be linked to the genotyping and phenotyping data records.

Enabling submission, access and reuse of IIDP data

The IIDP Research Data Repository (RDR) is an accessible database of donor and islet isolation information that is designed to support secondary data analyses by researchers. The RDR contains data on islet purity, composition, and function; de-identified donor data, including data provided by Organ Procurement Organizations (OPOs); and partitioned genetic risk scores (pGRS) for type 1 and type 2 diabetes that are based on genetic characteristics of each donor.

Data Submission and Delivery to the Research Community: Including Data Standards, Storage, and Dissemination

• Continuing to evolve and improve the IIDP RDR Data Portal to ensure user-friendly submission of and access to IIDP data, metadata, analysis and visualization tools. The web-interface should provide controlled-access to IIDP investigators and the broader scientific community, and should be easily accessible through the main IIDP Web Portal;
• Ensuring the database is flexible and extensible to manage and integrate multiple types of data that may be acquired by the program in the next project period, including but not limited to: genomics, proteomics, molecular and cellular imaging. Approaches for data acquisition, analysis and display should harmonize with methods being used in other ongoing human pancreas phenotyping programs across the NIH, including HIRN-HPAP and the NIH Cell Senescence Network;
• Working closely with the research community and NIH staff to harmonize and/or establish common data elements, data standards, metadata requirements, and use of consistent controlled vocabularies for all IIDP data to ensure that the data are findable, accessible, interoperable, and reusable (FAIR) and to ensure the data and results are maximally useful to the research community;
• Developing webinars, tutorials, detailed walkthroughs, and an array of innovative approaches that will facilitate the use of IIDP-generated data by the broader scientific community; managing or facilitating outreach activities, including but not limited to, organizing tutorials and presentations at scientific meetings and managing the IIDP social media presence;
• Working closely with NIH staff and relevant public data/resource repositories to ensure the long-term archiving and distribution of the most important datasets and resources developed by the IIDP beyond its funding period;
• Providing NIH staff with quantitative updates on data deposition, data quality, and data usage statistics upon request; and
• Developing and implementing methods to perform rigorous and timely evaluations of RDR function and utility on a regular basis and documenting actions taken to evolve and/or improve the system based on these evaluations.

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

Section II. Award Information

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

Only the following applicant is eligible to apply for this single source funding: Beckman Research Institute/City of Hope.  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. 

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.
• 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.

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.

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.

The PD/PI should be a senior established investigator with expertise in providing oversight and financial management of complex programs that provide resources to the diabetes research community. It is further expected that the PD/PI will have a depth of expertise and track record in human islet biology research with a strong record of providing high quality human islets. If the PD/PI is not an expert in human islet biology and islet quality control, a senior independent investigator with expertise in human islets must be included as a part of the leadership team for the IIDP.

Only the PI/PDs associated with the award issued under RFA-DK-20-509 to Beckman Research Institute/City of Hope is eligible to apply for this single source funding.  Please refer to Section I. Notice of Funding Opportunity Information for more details.

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:

• 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).

Only a single award will be issued to Beckman Research Institute/City of Hope under this single source funding opportunity.   Please refer to Section I. Notice of Funding Opportunity Information for more details.

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.

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.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

Annual budgets are limited to $825,000 direct costs per year to support IIDP Administrative Functions, with a minimum of 50% of overall personnel costs to be directed to support database programmers and web developers, as well as needed bioinformatics and statistical expertise. The remaining administrative budget should be constructed to support shipping, meeting expenses, supplies, and travel; up to $680,000 direct costs per year to support the IIDP phenotyping pipeline inclusive of F&A required by any subcontracted institutions; up to $275,000 direct costs per year to support IIDP genotyping assays inclusive of any F&A required by subcontracted institutions; $165,000 to support the procurement of islets to be assayed through the IIDP phenotyping and genotyping pipelines; and $330,000 direct costs to fund a restricted opportunity pool to support pilot awards and incentive programs. All opportunity pool award costs are inclusive of pilot award F&A and any consortium F&A.

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:

Research Strategy

The applicant should:

• Explain how the project as designed will address the needs of the research community and how the planned activities are designed to meet future research needs. Explain how successful completion of the aims will bring about unique advantages or capabilities to the field.
• Explain how the track records of the PD(s)/PI(s) provide evidence of their ability to provide services to the diabetes research community, and to provide effective financial oversight of core activities and facilities as well as expertise in human islet biology.
• Explain any novel strategies that will be used to coordinate activities, and identify any novel concepts, strategies, instrumentation or management strategies that will be employed.
• Provide an appropriate plan for work-flow and a well-established timeline for providing services in a timely and efficient manner.
• Verify that resources are available within the scientific environment to support all aspects of the center activity, including electronic information handling.
• Describe how the center will provide the administrative support required to support steering committee meetings, subcontracting to islet distribution sites, oversight of quality control activities, curation of website and intranet sites, and continued improvements in associated databases to enhance interoperability between the IIDP and other related programs.
• Provide plans for developing and maintaining IIDP Phenotyping and Genotyping services, and for how these services will be assessed periodically for utility and quality.
• Explain how the opportunity pool program will be managed, including plans for submission, review, and award.

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.

• 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.

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 should not exceed two (2) pages. 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

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.

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

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. 

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.

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

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

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

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.

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.

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.

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. 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:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.

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:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• 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.

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.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • 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.

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.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Recipient(s) will be primarily responsible for defining the objectives and approaches, planning, conduct, analysis, and publication of results, interpretations, and conclusions of studies conducted under the terms and conditions of the cooperative agreement award.
• The Program Director/Principal Investigator (PD/PI) will assume responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the research supported under this Notice of Funding Opportunity Announcement (NOFO) in accordance with the terms and conditions of award, as well as all pertinent laws, regulations and policies.
• Recipient(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.
• Recipients are responsible for their staff in maintaining confidentiality of the information as developed by the network/consortium, including, without limitation, study protocols, data analysis, conclusions, etc. per policies approved by the Steering Committee (SC) as well as any confidential information received by third party collaborators.
• Recipients must analyze, publish and/or publicly release and disseminate results, data and other products of the study in a timely manner, concordant with the approved plan for making quality-assured data and materials available to the scientific community and the NIH, consistent with NIH policies and achieving the goals of the NOFO.
• Data Management and Sharing Plan: In accordance with the NIH Policy for Data Management and Sharing (NIH NOT-OD-21-013), the NIDDK approved plan will become a term and condition of award, be routinely monitored during the award period, and compliance may factor into future funding decisions. By the end of the funding or proprietary period, a recipient or study group may not continue to use or share study generated resources until those resources are available to the public via a NIDDK approved repository per the NIDDK approved plan.
• Recipient(s) will be required to participate in a cooperative and interactive manner with members of the network/consortium including designated NIH staff (e.g., Program Official, Project Scientist, Project Coordinator).
• Recipient(s) agree to establish agreements amongst themselves that address the following issues: (1) procedures for data sharing among network/consortium members and data sharing with industry partners; (2) procedures for safeguarding confidential information, including without limitation, any data generated by the network/consortium as well as information and/or data received from external collaborators; (3) procedures for addressing ownership of intellectual property that result from aggregate multi-party data; (4) procedures for sharing bio-specimens under an overarching Material Transfer Agreement (MTA) amongst network/consortium members that operationalizes material transfer in an efficient and expeditious manner; (5) procedures for reviewing publications, determining authorship, and industry access to publications.
• Any third-party collaboration (including but not limited to interactions with organizations from industry, academia, and nonprofit institutions) should be governed by a research collaboration agreement (e.g., Clinical Trial Agreement, Research Collaborative Agreement, etc.) or any third-party contract mechanism(s) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH/NIDDK policies and procedures, applicable network/consortium policies, and with written approval from NIDDK Program staff. Any relevant proposed third-party agreements related to the network/consortium studies between grantee and third-party will be provided to the NIDDK Program staff and NIDDK Technology Advancement Office for review, comment, and approval to assure compliance with NIH/NIDDK policies and network/consortium policies. Further, at the request of the NIDDK Program staff, any other network/consortium-relevant third-party agreements must be shared with NIDDK. Failure to comply with this term may prompt action in accordance with NIH Grants Policy Statement, Section 8.5 titled:“Special Award Conditions and Remedies for Noncompliance (Special Award Conditions and Enforcement Actions)”, and Section 8.5.2, titled: “Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding Support”, noncompliance with the terms and conditions of award will be considered by the funding IC for future funding and support decisions and may result in termination of the award.”
• Any involvement of a third-party (including but not limited to industry, academia, and nonprofit institutions) in the study and network/consortium activities that includes access to any network/consortium generated resources (i.e., data and biosamples), or study results that are not publicly available, or using the name of the network/consortium or study or the name of the NIH or NIDDK, is permitted only after written permission by the NIDDK Program staff who will consult with others at NIH and NIDDK Technology Advancement Office.
• Recipients must agree to comply with the processes and goals as delineated within the NOFO.
• Recipient(s) agree to the governance of the study through a Steering Committee:
• The PD/PI, or contact PD/PI in the case of multi-PD/PI awards, will serve as a voting member of the Steering Committee and will attend all meetings of the Steering Committee.
• Each full member will have one vote.
• The Recipient will be responsible for accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the Steering Committee and subcommittees.
• Recipients must serve on Subcommittees as needed. Subcommittees will report progress at Steering Committee Meetings and/or lead discussions at the Annual Investigator’s Retreat.
• Recipients may be asked to scientifically review applications for special opportunity pool funds, as it is deemed appropriate.   

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The NIDDK [and other involved NIH ICs or federal agencies] will designate program staff, including a Program Official and a Grants Management Specialist to provide normal program stewardship and administrative oversight of the cooperative agreement. The Program Official and Grants Management Specialist will be named in the Notice of Grant Award (NOA).

An NIH IC Project Scientist will be substantially involved in this project above and beyond the normal stewardship of an NIH IC Program Official as follows:

1. Serve as the contact point for all facets of the scientific interaction with the recipient(s). As required for the coordination of activities and to expedite progress, NIDDK may designate additional NIDDK staff to provide advice to the recipient on specific scientific and/or analytic issues.
2. For multi-center studies, participate in the Steering Committee that oversees study conduct. The NIDDK Project Scientist will be a full participant and voting member of the Steering Committee and, if applicable, subcommittees.
3. Serve as a resource to study investigators with respect to other ongoing NIDDK activities that may be relevant to the study to facilitate compatibility with the NIDDK missions and avoid unnecessary duplication of effort.
4. Have substantial involvement assisting in the design and coordination of research activities for Recipients as elaborated below:
   1. Assisting by providing advice in the management and technical performance of the investigations, coordinating required regulatory clearances for investigational agents used in the study, which are held by NIDDK. The NIDDK may reserve the right to cross file or independently file an Investigational New Drug Application or an Investigational Device Exemption form with the FDA.
   2. The NIDDK Project Scientist or Project Coordinator may coordinate activities among recipients by assisting in the design, development, and coordination of a common research or clinical protocol and statistical evaluations of data; in the preparation of questionnaires and other data recording forms; and in the publication of results. 
   3. Reviewing procedures for assessing data quality and study performance monitoring.

The NIDDK Program Official identified in the Notice of Award will:

1. Interact with the Program Director(s)/Principal Investigator(s) on a regular basis to monitor study progress. Monitoring may include regular communications with the Program Director/Principal Investigator and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Steering Committee, data safety and monitoring board, and related meetings. The NIDDK retains, as an option, periodic review of progress by researchers not involved with the study.
2. Review and approve protocols prior to implementation to ensure they are within the scope of peer review, for safety considerations, as required by federal regulations.
3. The NIDDK Program Official will monitor protocol progress, and may request that a protocol study be closed to accrual for reasons including: (a) accrual rate insufficient to complete study in a timely fashion; (b) accrual goals met early; (c) poor protocol performance; (d) participant safety and regulatory concerns; (e) study results that are already conclusive; (f) low likelihood of showing a benefit of the intervention (futility); and (g) emergence of new information that diminishes the scientific importance of the study question. The NIDDK will not permit further expenditures of NIDDK funds for a study after requesting closure except as specifically approved by the NIDDK.
4. Make recommendations for continued funding based on: a) overall study progress, including sufficient patient and/or data accrual; b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality of research, which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements.
5. Appoint an independent Data and Safety Monitoring Board (DSMB) as appropriate for Phase III clinical trials or other high-risk studies, or an Observational Study Monitoring Board (OSMB) for observational/epidemiologic studies; these Boards will review study progress, safety data, and interim results, as appropriate, and provide guidance to the NIDDK. The NIDDK Program Official or their Project Coordinator will serve as the Executive Secretary and/or NIDDK program representative on the DSMB/OSMB.

• The NIDDK  may invite External Consultants [External Experts] with relevant scientific expertise for the sole purpose of consultative advice on scientific developments and opportunities that may enhance the achievement of the study goals.
• The NIDDK Project Scientist(s), Project Coordinator, and Program Official will review and approve applications of the Special Opportunity Funds to ensure that they are within the scope of network/consortium research as described in the NOFO and NIH guidelines.

Areas of Joint Responsibility include:

• Through the Recipient, Steering Committee and NIH staff, the study members will cooperatively develop and implement processes to submit information and data to the Coordinating Center (CC), determine criteria and processes for quality control of information and data to be posted for the research community, refine scientific objectives, and implement research advances to facilitate the goals of the study, consistent with NIH policies and achieving the goals of the program as described in the NOFO.

Executive Committee (EC)

• The EC will consist of: The Director of the Coordinating Center, the NIDDK Project Scientist(s) or Project Coordinator, and representative Principal Investigator(s) chosen among the Recipients; the EC is not a governing body and does not cast votes.
• The EC will review the progress of all NIH-funded special funding opportunity programs and make recommendations for improvement. Annual reports will be prepared for each special funding opportunity to coincide with one of the annual SC meetings.
• The EC will be responsible for organizing the yearly Scientific Retreat.
• The EC will have meetings that will be organized by the Director of the Coordinating Center. Any EC member may place items on the agenda. These should be communicated in advance of the meeting to the Project Scientist(s) or Project Coordinator who will distribute these to all members. The designated NIDDK Program Official(s) of UXX may be asked to participate in order to provide additional information and to summarize actions that are taken.

Steering Committee (SC)

A Steering Committee organized by the study investigator(s) will be the main governing body of the study.

The Steering Committee has primary responsibility to design research activities, establish priorities, develop common protocols and manuals, questionnaires and other data recording forms, establish and maintain quality control among recipients, review progress, monitor patient accrual, coordinate and standardize data management, and cooperate on the publication of results.  Major scientific decisions regarding the core data will be determined by the Steering Committee. The Steering Committee will document progress in written reports to the NIDDK Program Official and will provide periodic supplementary reports upon request.The Steering Committee will be composed of all Program Director(s)/Principal Investigator(s), (including those of data coordinating/statistical centers, if any) and co-investigator(s) as deemed necessary, and the NIDDK Project Scientist.  The final structure of the Steering Committee and voting procedures will be established at the first meeting.  The NIDDK Project Scientist will have voting membership on the Steering Committee, and as appropriate, its subcommittees.  The frequency of Steering Committee meetings will be dictated by a vote of the members of the Steering Committee.  The NIDDK Program Official may serve as a non-voting member on the Steering Committee. All NIH staff involved in the SC will have one combined vote in support of the project. 

A Chairperson of the Steering Committee will be selected and voted on by the Steering Committee members.  The Chairperson provides leadership to the Committee by conducting the Steering Committee meetings and by interacting closely with the recipients during protocol development and implementation.  The NIDDK Project Scientist may not serve as Chairperson.  The NIDDK program official will review the Committee’s selection for potential bias, conflicts of interest, or lack of required expertise. If the Program Official has concerns regarding selection of the Chairperson which are not satisfactorily resolved, the Program Official may withhold concurrence if approved by the Director, Division of Extramural Activities, NIDDK based on written justification.  In cases where Program Official concurrence is withheld, the Steering Committee will be required to make another selection.

External Consultants

An independent panel of External Consultants may be established by the Steering Committee.  The External Consultants may periodically review interim progress of the project(s) and provide reports to the Steering Committee. Members of the panel of External Consultants may be asked, on an ad hoc basis, to participate in the peer review of applications for new research initiatives that utilize special “opportunity pool” funds. The NIDDK Program Official will review the Committee’s selections for potential bias, conflicts of interest, or lack of required expertise. If the NIDDK Program Official has concerns regarding selection of one or more External Consultants which are not satisfactorily resolved, the NIDDK Program Official may withhold concurrence if approved by the Director of NIDDK Division of Extramural Activities based on written justification.  In cases where NIDDK Program Official concurrence is withheld, the Steering Committee will be required to make another selection.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual Recipient. This special dispute resolution procedure does not alter the Recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Data Management and Sharing

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 should not exceed two (2) pages. Where the DMS Plan Format Page requires a “Yes or No” response, no additional narrative is allowed. 

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.

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.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Email: NIDDK_DEM@nih.gov
 

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).  NOFOReviewContact@csr.nih.gov can also be contacted.

Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Email: NIDDKGMBManagementTeam@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.

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.