Part 1. Overview Information

Key Dates

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

For over 25 years, the George M. O’Brien Kidney Centers have played an essential role in advancing kidney research. To expand the breadth and impact of this important program, the NIDDK aims to improve coordination, enhance national outreach and sharing, and promote continuous innovation by establishing the “O’Brien Kidney Consortium.” This Consortium will combine innovative National Resource Centers (NRCs) tasked with developing and sharing specialized kidney resources, tools, technologies, services, and expertise and a National Coordinating Center (NCC) to lead, manage, and harmonize all aspects of the Consortium.

Research Objectives and Scope

The NRCs will provide kidney researchers with specialized resources, tools, technologies, services, and expertise beyond those typically available in an individual lab or institutional core.

In particular, the NRCs will:

• Select a theme, focused on a fundamental challenge in kidney research, and propose unique resources to address that challenge.
• Work collaboratively to share these specialized kidney resources, tools, technologies, services, and expertise, and to support and expand the national pool of investigators pursuing kidney research.
• Identify emerging trends and anticipate the changing needs of the national kidney research community.
• Promote the development and implementation of new research resources to meet these national needs and spur innovation.
• Educate the community about kidney research and run a summer student enrichment program.
• Include investigators from a broad range of scientific disciplines and expertise.
• Include investigators and fellows from diverse backgrounds. See the Notice of NIH's Interest in Diversity (NOT-OD-20-031).
• Attract investigators from fields not traditionally involved in kidney research.
   

To accomplish these objectives, the Consortium will consist of ~8 NRCs. Each NRC must have:

1. an Administrative Core to lead, manage, and harmonize all aspects of the NRC and facilitate close collaboration with the other NRCs and the NCC.
2. a maximum of two Biomedical Resource Core(s) to share specialized kidney resources, tools, technologies, services, and expertise to address a fundamental challenge in kidney research.
3. a Resource Development Core to continually develop new and improved research resources to be shared by the Biomedical Resource Core(s).
    

It is expected that every level of NRC leadership will consist of diverse scientific expertise. Inclusion of key personnel from backgrounds underrepresented in science is always encouraged.

Essential objectives include:

1. Administrative Core

• Lead, manage, and harmonize all aspects of the NRC and ensure that Center resources are shared nationally.
• Collaborate with the Consortium to:
  • Prioritize external requests for efficient distribution of resources.
  • Enhance national outreach and impact.
  • Educate the community about kidney research.
  • Monitor emerging advances in science and anticipate the needs of the national kidney research community.
• Attract early-stage investigators and people new to kidney research.
• Enhance the diversity of the NRC.
• Plan and execute a Summer Student Enrichment program to support students including but not limited to, high school students, undergraduates, graduates, clinical and non-clinical fellows, etc.

2. Biomedical Resource Core(s)

• Provide unique resources, tools, technologies, services, and/or expertise that address a fundamental challenge in kidney research and are beyond those typically available in an individual lab or institutional core. The cores may support basic, translational, clinical, and/or implementation science.
• Collaborate with the Consortium to broadly share specialized kidney resources to maximize national impact.
• Lower the barrier to entry for early-stage investigators and people new to kidney research.
• Ensure that all shared resources undergo strict quality control measures and validation.
• Collaborate with the Consortium to periodically evaluate the usefulness of resources offered to the community.

3. Resource Development Core

• Promote the continuous development of novel kidney resources, based on stakeholder engagement and in anticipation of future needs of kidney researchers.
• Establish and nurture a dynamic “incubator space” that promotes innovation.
• Ensure robust validation of all new and improved resources.
• Prioritize and implement new and/or improved resources within a Biomedical Research Core(s), which may include the de-prioritization of existing resources.
   

Expected outcomes from the project period will be:

• Nation-wide effort to advance kidney research.
• Successful sharing of unique resources, tools, technologies, services, and/or expertise that address fundamental challenges in kidney research.
• Broad sharing of resources that will effectively lower the barrier to entry for new investigators and those that are from fields not traditionally involved in kidney research.
• Successful identification of emerging areas of science and anticipate the needs of the national kidney research community.
• Cultivate a dynamic “incubator space” that develops and/or improves new kidney resources.
• Implementation of a rigorous Consortium-wide quality management plan that involves, active monitoring and reporting of QA/QC (Quality Assurance/Quality Control) for all consortium resources .
• Periodic evaluation of the usefulness of all shared resources and emphasize/deemphasize as necessary.
• Enhance the diversity of the kidney research workforce.
   

Project Organization

The George O’Brien Kidney Consortium will consist of ~8 NRCs and one NCC. Whereas the NRCs will establish highly synergistic theme-based cores focused on generating shared resources, the NCC will facilitate the sharing of these resources with the wider kidney research community. The coordinated efforts of the NRCs and the NCC will be governed by a Steering Committee (SC) composed of contact Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) from each of the NRCs, the PD(s)/PI(s) of the NCC, and the NIDDK Project Scientist(s) (see under Section VI, Cooperative Terms and Conditions). Oversight will be provided by the NIDDK advisory council, which will act as an advisory to the NIDDK. Additional oversight will be provided by an external Consortium Management Board (CMB) that will be advisory to the NDDK Advisory Council and provide input into the overall progress of the Consortium. The CMB members will be appointed by the NIDDK and not by the grantees. Applicants should not propose CMB members. Consortium leadership and relevant investigators are expected to actively participate in all Consortium meetings, which will be arranged and coordinated by the NCC. Consortium members are expected to meet at least once a year for a face-to-face Steering Committee (SC) meeting in the Bethesda, MD area. All PDs/PIs are required to attend the first meeting of the Consortium, which is expected to take place in October 2023.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) will host a pre-application webinar for those interested in learning more about Funding Opportunity Announcements (FOAs) RFA-DK-22-007, "George M. O'Brien Kidney National Resource Centers (U54 - Clinical Trial Not Allowed)" and RFA-DK-22-008, "George M. O'Brien Kidney National Coordination Center (U24 - Clinical Trial Not Allowed)"(details are forthcoming).

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 FOA.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

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

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

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

Applicant organizations

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

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); 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 full SAM and 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.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. See, Reminder, Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

While the PD(s)/PI(s) is not required to have expertise or background in kidney research, the PD(s)/PI(s) should have the necessary skills, knowledge, and resources to carry out the proposed research.

National Resource NRC Director(s)

The NRC Director(s) must be an investigator with demonstrable expertise in their field and who can provide effective administrative and scientific leadership. The NRC Director(s) is expected to work closely with the other NRCs, NCC, and NIDDK, including through participation in the SC, regular teleconference calls and at relevant meetings and workshops supporting the Consortium objectives. One or more Associate Directors may be named, and their roles should be specified and justified. The NRC Director(s) will be responsible for the following duties, that include, but are not limited to:

• Maintaining the NRC’s vision and ensuring that all NRC resources are shared with the national research community immediately upon validation to advance kidney research.
• Ensuring communication and cooperation among the NRCs, NCC, associated NIDDK Programs, and NIDDK Program Staff.
• Internal monitoring to ensure efficient and productive NRC operations, including performance of all personnel, budget, policy, collaboration, research conflicts or others, as needed.
• Representing the NRC at all Consortium meetings including the SC and external oversight groups (the CMB).
   

Applications for the NCC are solicited through a separate, companion FOA (RFA-DK-22-008). While eligible applicant institutions may apply for both an NRC (RFA-DK-22-007) and an NCC (RFA-DK-22-008), individual PD(s)/PI(s) can only apply for either an NRC or an NCC. A named PD(s)/PI(s) for an NRC or NCC application may serve as an unpaid consultant on another NRC or NCC application for which he/she is not the PD/PI. Potential applicants are encouraged to contact the Program Official named in Section VII to discuss their applications.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique DUNS number of NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. 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 Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

John F. Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7797
Email: [email protected]

Page Limitations

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Biomedical Resource Cores: required
• Resource Development Core: required

Overall Component

When preparing your application, use Component Type ‘Overall’.

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Other Attachments: Statement of Willingness:
This statement should be provided as a PDF attachment and should be entitled “Willingness”. It is expected that the PD(s)/PI(s), as well as the applicant institution, have a commitment to serve the Consortium objectives as outlined in this FOA. Thus, applicant(s) should provide a statement counter signed by the Department Chair indicating their willingness to:

• Cooperatively work with the Consortium and the NIDDK to share all NRC resources with the national research community and participate in all Consortium projects, working groups, activities, conference calls, meetings, or as needed during the award.

• Actively seek input from the Consortium and NIDDK regarding resource or expertise needs that may arise during the performance of the project.

• Cooperatively work with the NCC to develop and execute Material Transfer Agreements (MTAs) to permit sharing of resources, including but not limited to tools, technologies, services, protocols, biological specimens, molecules, cells, animals, genetic material, de-identified patient samples, de-identified patient data, and images.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

Each applicant institution will specify a contact PD/PI and all other PD/PIs responsible for the organization and operation of the NRC. The PD(s)/PI(s), as well as the applicant institution, should have a commitment to serve the Consortium objectives as outlined in this FOA, including the sharing of all NRC resources with the national research community. The PD(s)/PI(s) should coordinate, integrate, and provide guidance in promoting the continuous development of novel kidney resources, based on stakeholder engagement and in anticipation of future needs. This commitment will require significant effort from each PD(s)/PI(s).

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Research Strategy: Overall, the NRCs will establish theme-based cores to develop and share unique resources, tools, technologies, services, and expertise to support and expand the pool of investigators pursuing kidney research.

The Overall Research Plan should include:

• An overview of the entire NRC, its objectives, and how they are aligned with the objectives of the Consortium. Describe the significance of the NRC’s theme and the fundamental challenge it will address in kidney research.

• An organizational chart of the NRC showing the required Cores, as well as any additional organizational entities, identifying the proposed PD(s)/PI(s), Core leaders, and other key personnel.

• A description of the relevant expertise, experience, and accomplishments of the proposed key personnel in the successful planning, direction, coordination, and management of a complex multi-institution Consortium. It is expected that investigators with diverse scientific expertise will be included at every level of NRC leadership. Inclusion of key personnel from groupsunderrepresented in science as identified in the NIH policy NOT-OD-20-031 is always encouraged.

• Plans for internal QA/QC of all NRC activities.

• Information on the support and commitment of the parent institution for the NRC.

Letters of Support: Letters of support should be provided, where appropriate, to demonstrate collaboration, access to key resources, and institutional commitment. The applicants should not include letter of support from any internal or external core users. Letters of support for the overall NRC should be included with the Overall Component. For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional official, must be submitted with the application. Appropriate letters of support from the PD(s)/PI(s) should be included with the application detailing plans for appropriate integration and synergy of the NRC activities. In addition, applicants should address the potential for integration, harmonization, and enhancement of NRC activities through cooperation with other NIH- supported Core facilities at the applicant institution. Other NIH-supported cores at the institution(s) should be identified, and assurances provided that overlap or redundancy in core services will be avoided unless expressly required to fulfill the mission of the NRC.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

All applications, regardless of the amount of direct costs requested for any one year, should address a Resource Sharing Plan with the following modification:

The NIDDK intends the resource sharing plans for the George M. O’Brien Kidney Consortium (including the NRCs and NCC) to follow the policy and objectives stated in the original FOAs. Specifically, consistent with achieving the objectives of the Consortium, all resources, tools, technologies, services, expertise, protocols (including analytical methods), ontologies, biological samples and other research resources are to be shared immediately across the Consortium and made publicly available to the larger national research community as soon as QA/QC procedures have been completed, and in accordance with the policies developed by the SC. Any preliminary data included in this application must be made available to the Consortium upon award. Limited exceptions to the requirement for community dissemination may be identified by the SC. The NIDDK, will make all final decisions concerning resource sharing and data access policies, and all policies are subject to change by the NIH as deemed necessary to sustain program principles and priorities, or to ensure the highest standards for responsible research conduct within the project.

Awardees will comply with and implement the recommendations and decisions of the SC with respect to the sharing of resources developed by the Consortium investigators under the Consortium.

Awardees are expected to register resources supported by this FOA 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 FOA.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

PHS Assignment Request Form (Overall)

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

Administrative Core

When preparing your application, use Component Type ‘Admin Core.’

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information

• Type of Applicant (optional)

• Descriptive Title of Applicant’s Project

• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Administrative Core Director’ and provide a valid eRA Commons ID in the Credential field.

• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. The overall NRC Director will serve as the Administrative Core director.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Personnel: The minimum level of effort for the National Resource NRC Director (as an Administrative Core Director) is 1.2 person months (10%). Administrative Core Associate Directors may be named as well, but the total, combined Administrative Core Directorship efforts may not exceed 2.4 person months (20%). The Administrative Core may also include an administrative assistant(s), if justified.

Travel: Include the costs of domestic and foreign travel only if the travel is directly related to the activities of the NRC and may include travel of investigators to learn new laboratory techniques, develop new collaborations, or engage in scientific information exchange. The proposed budget should include travel for the NRC Directors and other key personnel, to attend SC meetings and an annual Consortium meeting in the Bethesda MD area. Include a statement of willingness to attend these meetings. Additionally, the proposed budget may include travel for the NRC Director/s and NRC-associated students to attend the annual KUH Summer Undergraduate Research Symposium.

The Administrative Core budget must include at least $25,000 direct costs every year specifically devoted to supporting a summer student enrichment program.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

The Administrative Core will lead, manage, and harmonize all aspects of the NRC and facilitate close collaboration with the other NRCs and NCC (i.e., the Consortium).

Research Strategy: The Administrative Core Research Plan should outline strategies to:

• Lead, manage, and harmonize all aspects of the NRC.

• Collaborate with the Consortium to:

  • Monitor emerging advances in science and anticipate the needs of the national kidney research community.

  • Enhance national outreach and impact.

  • Educate the community about kidney research.

• Attract early-stage investigators and people new to kidney research.

• Enhance the diversity of the NRC.

• Plan and execute a Summer Student Enrichment program to support students including but not limited to, high school students, undergraduates, graduates, clinical and non-clinical fellows, etc. This program is not intended to support postdocs.

Core Access and Cost Recovery: It is acceptable to propose a cost recovery system to help defray costs to the NRC. This system would charge a fee to all NRC users for resources and services provided by the NRC. If a cost recovery system is proposed, a detailed description and budget justification must be provided within the application. All cost recovery systems must be presented to and approved by the SC before implementation.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a resource Sharing Plan. Applicant may state that the Resource Sharing Plan outlined in the Overall Component applies to the Core.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Biomedical Resource Core(s)

When preparing your application, use Component Type ‘Res Core.’

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

SF424 (R&R) Cover (Biomedical Resource Core(s))

Complete only the following fields:

• Applicant Information

• Type of Applicant (optional)

• Descriptive Title of Applicant’s Project

• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Biomedical Resource Core(s))

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Biomedical Resource Core(s))

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Biomedical Resource Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Biomedical Resource Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.

• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Biomedical Resource Core)

Budget forms appropriate for the specific component will be included in the application package.

Personnel: This category should include salary support for key personnel, including all Core Directors, and other professional and technical personnel. The Core Directors must devote a minimum of 1.2-person month to the Core to ensure adequate oversight. The salary amount charged to the NRC must be commensurate with the time spent on Core activities and is subject to institutional and NIH salary policies. Salary support for other Core personnel including postdocs is allowable in accordance with the volume and type of work in the Core. Stipends (and tuition support) for research trainees such as graduate or undergraduate students are not available through the NRC.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Biomedical Resource Core)

The Biomedical Resource Core(s) will share specialized kidney resources, tools, technologies, services, and expertise to address a fundamental challenge in kidney research.

Research Strategy: The Biomedical Resource Core(s) Research Plan should outline strategies to:

• Provide unique resources, tools, technologies, services, and/or expertise that will support the NRC theme and address a fundamental challenge in kidney research, and are beyond those typically available in an individual lab or institutional core.

• Collaborate with the Consortium to broadly share specialized kidney resources to maximize national impact and advance kidney research.

• Share resources to lower the barrier to entry for early-stage investigators and people new to kidney research.

• Ensure that all shared resources undergo strict quality control measures and validation.

• In collaboration with the Consortium, periodically evaluate the usefulness of resources offered to the community and plans to emphasize/deemphasize as needed.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Resource Sharing Plan. Applicant may state that the Resource Sharing Plan outlined in the Overall Component applies to the Core.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Biomedical Resource Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Resource Development Core

When preparing your application, use Component Type ‘Dev Core.’

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

SF424 (R&R) Cover (Resource Development Core)

Complete only the following fields:

• Applicant Information

• Type of Applicant (optional)

• Descriptive Title of Applicant’s Project

• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Resource Development Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Resource Development Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Resource Development Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Resource Development Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.

• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Resource Development Core)

Budget forms appropriate for the specific component will be included in the application package.

Personnel: This category should include salary support for key personnel, including all Core Directors, and other professional and technical personnel. The Core Directors must devote a minimum of 1.2-person month to the Core to ensure adequate oversight. The salary amount charged to the NRC must be commensurate with the time spent on Core activities and is subject to institutional and NIH salary policies. Salary support for other Core personnel including postdocs is allowable in accordance with the volume and type of work in the Core. Stipends (and tuition support) for research trainees such as graduate or undergraduate students are not available through the NRC.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Resource Development Core)

The Resource Development Core will continually develop new and improved research resources to be shared by the Biomedical Resource Core(s).

Research Strategy: The Resource Development Core Research Plan should outline strategies to:

• Continuously develop novel kidney resources, based on stakeholder engagement and in anticipation of future needs of the national kidney research community.

• Establish and nurture a dynamic “incubator space” that fosters a robust community of investigators with diverse scientific backgrounds and promotes innovation.

• Ensure robust validation of all new and improved resources.

• Collaborate with the Consortium to prioritize and implement new and/or improved resources within a Biomedical Research Core(s), which may include the de-prioritization of existing resources.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Resource Sharing Plan. Applicant may state that the Resource Sharing Plan outlined in the Overall Component applies to the Core.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Resource Development Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

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

See Part 1. 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. Overview Information 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) using ASSIST or other electronic submission systems. 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 Policy on Late Application Submission.

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

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

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.

7. Other Submission Requirements and Information

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

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

The applicant organization must ensure that the unique entity identifier (UEI) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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.

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" (https://cde.nlm.nih.gov/home) 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.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

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

For this particular Funding Opportunity Announcement, note the following:

Reviewers will be asked to evaluate the following individual sections. The overall impact score is not the average for these components.

• Administrative Core:
  • Including the focus on promoting collaborations among members to enhance national outreach and impact.
  • Abilities of key personnel to lead, manage and harmonize all aspects of the NRC,
  • Plans to attract early-stage investigators and people new to kidney research,
  • Plans to actively monitor and report QA/QC for all resources.
  • Plans to execute summer student program and educate the community about kidney research.

• Biomedical Resource Core:
  • Including the theme-based resources, tools, technologies, services, and/or expertise that will address a fundamental challenge in kidney research and advance kidney research nationally
  • Commitment to collaborate with the consortium to broadly share specialized kidney resources to maximize national impact.
  • Capability to train other investigators, who wish to learn the unique procedures or technologies developed by the center, thus lowering the barrier to entry for early-stage investigators and people new to kidney research.

• Resource Development Core:
  • Including plans to promote the continuous development of novel kidney resources, based on stakeholder engagement and in anticipation of future national needs.
  • Expertise and experience of the key personnel to promote de novo creation of resources or the improvement of excising resources.
  • Proposed strategies to cultivate a dynamic “incubator space” to develop new and/or improve existing kidney resources that will be needed by the national kidney research community.
  • Plans to prioritize and implement new and/or improved nationally sharable resources within a Biomedical Research Core(s), which may include the de-prioritization of existing resources.
     
• Center Director(s) (PD(s)/PI(s)),including leadership and commitment to the stated goals of the NRC and the Consortium.

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

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

Significance

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

Specific to this FOA: What are the strengths of the NRC? How appropriate is the overall theme and design of the NRC in addressing a fundamental challenge in kidney research? How likely are the theme-based resources to advance kidney research nationally? How likely are the theme-based resources to effectively lower the barrier to entry for investigators that are new to kidney research or from non-kidney fields? What is the likelihood that the NRC will increase efficiency; promote new research directions and meaningful collaborations within and outside of the NRC?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA: How appropriate is the expertise, experience, and accomplishments of the key personnel in working within a complex multi-institution Consortium? Do the proposed Center Director(s) and Associate Director(s) have the appropriate administrative abilities and scientific expertise for effective management of the NRC? How appropriate are the plans for inclusion of diverse scientific expertise at every level of NRC leadership? How appropriate are the plans for inclusion of key personnel?

Innovation

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

Specific to this FOA: How innovative are the proposed strategies to provide new methods, techniques, and/or resources, identify emerging trends and anticipate the changing needs of the national kidney research community?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Specific to this FOA: How appropriate and relevant are the proposed Cores and their modes of operation (such as prioritization of requests for providing resources and services and development of novel resources)? How appropriate are the plans for Cores to provide resources not otherwise available to the investigators; represent appropriate cost savings/cost sharing advantage; and stimulate the development of new resources? How appropriate is the administrative organization proposed for the following:

• establishment and maintenance of internal communication and cooperation among the Center investigators;
• mechanism for selecting and replacing professional or technical personnel within the Cores;
• management capabilities, including fiscal administration, procurement, property and personnel management, planning, budgeting, and other appropriate capabilities;
• plans for internal quality control of shared resources;
• plans to measure the use and utility of Cores and successful implementation of a cost structure to support all NRC activities;

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

Environment

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

Specific to this FOA: How appropriate is the institutional commitment to the NRC, including lines of accountability regarding management of the NRC award and the institution's contribution to the management capabilities of the NRC? How appropriate is the institution’s environment to support synergy between the cores?

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

Protections for Human Subjects

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

For projects 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 the NIDDK, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. The following will be considered in making funding decisions:

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

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 VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

Institutional Review Board or Independent Ethics Committee Approval: Grantee 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.

Prior Approval of Pilot Projects

Recipient-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution's specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 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.

The following special terms of the 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 (DHHS) grant administration regulations at 45 CFR Part 75, 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 recipient is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's purpose is to support and stimulate the recipient's activities by involvement in and otherwise working jointly with the award 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 reside with the recipient for the project as a whole, although specific tasks and activities may be shared among the recipient and the NIH as defined below.

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

• Ensuring adherence to the overall objectives of the NRC.
• Cooperating with the other funded NRCs and NCC to share all Consortium resources with the national research community immediately upon validation.
• Convening regular meetings to evaluate the progress of the NRC.
• Providing information and data to the CMB as requested by the NIDDK.
• Serve as a voting member of the SC, and participate, along with critical staff, in SC meetings including face-to-face meetings as scheduled in the Bethesda MD area or at an alternate location approved by the NIDDK.
• Apprise the NIDDK Project Officer (PO) and Project Scientist (PS) of any potential impediments to the execution of the objectives of the project.
• Abiding by the governance of the Consortium and all program policies agreed upon by the SC and approved by the NIDDK.
• Supporting the Opportunity Pool recipients (funded by the NCC).
• Provide representation on all relevant committees and working groups established by the SC.
• Participating in any additional meetings and activities of the funded NRCs and NCC to promote cross-program sharing of best practices.
• Reporting annual and ad hoc progress reports to the NIDDK on all NRC activities.
• Participation in NRC program evaluation activities, including ad hoc site visits by the NIDDK and other external evaluators.
• 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, and with written approval from NIDDK Program staff. Any relevant proposed third-party agreements related to the network studies between the grantee and the 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 policies. Further, at the request of the NIDDK Program staff, any other network-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 activities that includes access to any network generated resources (i.e., data and biosamples), or study results that are not publicly available, or using the name of the network 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.
   

Resource Management and Sharing Plan:

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 an NIDDK-approved repository per the NIDDK-approved sharing plan. The NIDDK has established a Central Repository to support the receipt, storage, and distribution of data, biosamples, and other resources generated in clinical studies funded by the NIH/NIDDK. When the NIDDK Central Repository is to be utilized, prior to enrolling participants, the PI or his/her designee will coordinate with the NIDDK Program and Central Repository staff to prepare for the eventual archiving and distribution of the study generated resources that are to be maintained in the Central Repository. All resources transferred to the Central Repository will be under the custodianship of the NIDDK. The study’s leadership will have proprietary control of and exclusive access to the resources per the NIDDK-approved sharing plan. Subsequently, these resources will be available to the wider scientific community in accordance with the NIH policy on Data Sharing (http://grants.nih.gov/grants/policy/data_sharing and, https://grants.nih.gov/policy/sharing.htm, and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm) as well as the NIDDK policy for resource sharing, https://www.niddk.nih.gov/-/media/Files/Research-Funding/Process/PublicversionNIDDKdatasharingpolicy2013July2013.pdf.

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

The NIDDK will designate program staff, including a Project Scientist (PS), a Program Officer (PO), and a Grants Management Specialist to provide normal program stewardship and administrative oversight of the cooperative agreement. The PO and Grants Management Specialist will be named in the Notice of Grant Award. The NIDDK will also invite an independent panel of external experts with relevant scientific expertise to form the CMB (Consortium Management Board). The CMB will meet to review the progress of the Consortium periodically and provide input to the NDDK Advisory Council.

The role of the PS in the cooperative agreement is to support and encourage the recipient's activities by substantial involvement as partners and facilitators in the process without assuming responsibilities that remain with the PD(s)/PI(s). The PS will:

• Help guide the development of each NRC by providing advice and coordination.
• Facilitate interactions between the NRCs and the NCC.
• Facilitate partnership with the NIDDK and ensure that the directions taken by each NRC are consistent with the NIDDK missions and objectives.
• Assist in avoiding unnecessary duplication of effort across the Consortium and help coordinate collaborative research efforts that involve multiple sites.
• Identify appropriate expertise for the CMB.
• Attend and participate as a voting member in all SC meetings and serve as the liaison between the SC and CMB.
• Participate in organizing the annual meeting of program stakeholders, specialized workshops, and webinars of the Consortium.
• Review the scientific progress of the Consortium for compliance with operating policies developed by the SC, and may recommend to the NIDDK to withhold support, suspend, or terminate an award for lack of scientific progress or failure to adhere to policies established by the SC.
   

The PO is responsible for the normal scientific and programmatic stewardship of the award. The PO will:

• Interact with the PD(s)/PI(s) on a regular basis to monitor study progress. Monitoring may include: regular communications with the PD(s)/PI(s) 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 SC and related meetings. The NIDDK retains, as an option, a periodic review of progress by researchers not involved with the study.
• Form a CMB, comprised of the PS, PO, other NIH extramural staff with relevant scientific expertise or who manage research grant programs that relate scientifically to the objectives of the Consortium, and outside experts selected by the NIH.
• Serve as Executive Secretary to the CMB or delegate these responsibilities.
• Have the option to recommend, following evaluations of Consortium progress by the CMB (if applicable), the possible withholding, reduction, or reallocation, as appropriate, of support from any Consortium component that substantially fails to achieve its objectives according to the approved milestones or fails to comply with the Terms and Conditions of the award, at the appropriate times. The NIDDK will not permit further expenditures of NIDDK funds for a study after requesting closure except as specifically approved by the NIDDK.
• Have the option to recommend, following evaluations of Consortium progress by the CMB (if applicable), an increase in support to engage in further research efforts within the original research scope, as appropriate, for any Consortium component exceeding its objectives according to the approved milestones and substantially improving state-of-the-art capabilities, at the appropriate times.
• Participate in the SC meetings as an annex officio (non-voting) member.
• Retain the option to recommend, with the advice of the PS, re-allocation of NIH support among recipients, as scientific objectives evolve.
• Carry-out continuous review of all activities to ensure objectives are being met.
• Consult the NIDDK Technology Advancement Office to facilitate a review, comment, and approval of any Consortium management agreements or research collaboration agreements with third-party collaborators to assure compliance with NIH/NIDDK policies and network policies.
• Serve as the official NIH representative in all communication with the SC.
   

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

The PD(s)/PI(s) and NIH PS will be jointly responsible for participating in Consortium-wide activities and for establishing collaborations across the Consortium and with other related activities.

Steering Committee (SC):

The SC will be the primary governing body for all Consortium activities and . The voting membership of the SC will include: one PD/PI from each funded NRC and NCC and the NIH PS. The Chair(s) of the SC will be assigned by NIH Program Staff and may be chosen from outside the Consortium. A portion of the SC meetings may be open to the public. All aspects of the Consortium will be governed by the SC and overseen by the NIDDK and an NIDDK-appointed CMB.

If needed, other NIH staff members may also participate in SC meetings as nonvoting members. All SC decisions and recommendations that require voting will be based on a majority vote. The SC will meet bi-monthly by videoconference and in-person at the annual SC meeting. The frequency of SC meetings can be adjusted on a Consortium need basis.

The SC will:

• Identify scientific and administrative issues that can benefit by being addressed at the Consortium level and for addressing such issues.
• Review progress of the Consortium toward meeting the overall Consortium objectives.
• Ensure that all NRC members attest to the guidelines developed by the NCC and NIDDK.
• Discuss and prioritize the projects from the National Opportunity Pool program, which will be managed by the NCC.
• Ensure that the Consortium takes advantage of existing NIDDK and NIH resources and programs.
• Establish, as necessary, subcommittees or working groups to ensure the progress and productivity of the Consortium.
• Work with the CMB, which will evaluate the progress of the Consortium and advise the SC regarding the scientific directions of the program.
• Foster collaboration, synergy, and sharing among the Consortium sites and investigators.
• Oversee the planning of Consortium scientific activities, including dynamic adjustment as needs and opportunities arise.
• Guide the development and documentation of the Consortium standards and guidelines.
• Establish a rigorous administrative process with appropriate oversight to prioritize (including rigorous external peer review), select, disburse, and track Opportunity Pool awards.
• Evaluate progress in the Consortium sites and recommend adjustments in approaches if necessary, including implementation of new projects and changes to ongoing studies and termination of projects.
• Develop and approve the Consortium-wide intellectual property agreements consistent with the terms and conditions of the cooperative agreement awards, applicable regulations, and the policies and practices of the recipient institutions.
   

The NIDDK intends the resource sharing plans for the George M. O’Brien Kidney Consortium (including the NRCs and NCC) to follow the policy and objectives stated in the original FOAs. Specifically, consistent with achieving the objectives of the Consortium, all resources, tools, technologies, services, expertise, protocols (including analytical methods), ontologies, biological samples, and other research resources are to be shared immediately across the Consortium and made publicly available to the larger national research community as soon as QA/QC procedures have been completed, and in accordance with the policies developed by the SC. Any preliminary data included in this application must be made available to the Consortium upon award. Limited exceptions to the requirement for community dissemination may be identified by the SC. The SC, in consultation with the NIDDK, will make all final decisions concerning resource sharing, and all policies are subject to change by the NIDDK as deemed necessary to sustain program principles and priorities, or to ensure the highest standards for responsible research conduct within the project.

Recipients will comply with and implement the recommendations and decisions of the SC with respect to the sharing of resources developed by the Consortium investigators under the Consortium.

Recipients are expected to register resources supported by this FOA 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 FOA.

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 SC 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.

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.

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. NIH FOAs 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

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)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Deepak Nihalani, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-6417
Email: [email protected]

Ivonne Schulman, MD.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-435-3350
Email: [email protected]

Ann A. Jerkins, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-2242
Email: [email protected]

Tommy Gunter
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-3447
Email: [email protected]

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 45 CFR Part 75 and 2 CFR Part 200.