Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

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

Funding Opportunity Title
Reconfiguration of GenitoUrinary Development Molecular Anatomy Project (GUDMAP) /(Re)Building A Kidney (RBK) Data Hub (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices

  • December 09, 2020 - Notice of Clarification of Award Budget Instructions for the Opportunity Pool within RFA-DK-20-014. See Notice NOT-DK-21-010.

Funding Opportunity Announcement (FOA) Number
RFA-DK-20-014
Companion Funding Opportunity

RFA-DK-20-013 - GenitoUrinary Development Molecular Anatomy Project (GUDMAP) - Atlas Projects (U01 Clinical Trial Not Allowed), U01 Research Project – Cooperative Agreements

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.847

Funding Opportunity Purpose

This Funding Opportunity Announcement invites applications for a consolidated Data Hub for the GenitoUrinary Development Molecular Anatomy Project (GUDMAP) and the (Re)Building a Kidney (RBK) consortium.

The GUDMAP/RBK Data Hub will have both scientific and administrative responsibilities, including the operation of a searchable web-based data repository. The Data Hub will implement FAIR (Findable, Accessible, Interoperable, and Reusable) principles and have appropriate domain expertise, such as in bioinformatics, website and software development, biocuration and ontology development (including specific expertise in appropriate organ anatomy and physiology), and workshop planning and administration. The Data Hub will also oversee an Opportunity Pool Program that will allow the consortium to proactively adapt to a changing scientific landscape and identify gaps within the RBK and GUDMAP consortia.

Key Dates

Posted Date
November 23, 2020
Open Date (Earliest Submission Date)
January 18, 2021
Letter of Intent Due Date(s)

January 18, 2021

Application Due Date(s)

February 18, 2021

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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

AIDS Application Due Date(s)

Not Applicable

 

 

Scientific Merit Review

June/July, 2021

Advisory Council Review

October 2021

Earliest Start Date

December 2021

Expiration Date
February 19, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

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

Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The NIDDK GenitoUrinary Development Molecular Anatomy Project (GUDMAP) and (Re)Building a Kidney (RBK) consortia are currently supported by separate Data Hubs in which data and resources are openly shared with the research community.

The GUDMAP consortium has generated a murine molecular atlas of the urogenital tract in the developing embryo and a human molecular atlas of the developing kidney. The GUDMAP website allows access to a database of gene expression of the developing urogenital tract. To date the database contains >460 microarray CEL files and >13,027 whole-mount or section imaging samples (11,454 in-situ hybridizations images, 1,176 immunohistochemistry images, 380 histology slide images, and 17 nanoCT scans) representing 22,971 genes. Transcriptional profile datasets include 375 bulk RNA seq datasets collected from renal sub-compartments captured by laser and from the use of translating ribosome affinity purification (TRAP). 218 single cell/single nuclei RNA-Seq datasets with visualization images covering 19,515 genes are included in the database. All data are annotated in detail against a standard anatomical ontology developed by the GUDMAP consortium that is updated as data reveals new genetic sub-compartments. In addition, the database houses data sheets on 150 characterized transgenic lines and 80 antibodies and supports 81 protocols.

The RBK Consortium is a network of individual research projects focused on the expansion of tools, resources, and knowledge, that will guide studies to either (1) stimulate productive kidney repair/regeneration in vivo, or (2) generate functional kidney tissue ex vivo for transplantation. To date the RBK database contains > 213 whole-mount or section imaging (183 in-situ hybridizations and 30 immunohistochemistry images) representing 102 genes. Transcriptional profile datasets include 272 bulk RNA seq samples; and 31 single cell/single nuclei RNA-Seq samples (with visualization images covering 17,913 genes), 7 parental and 15 reporter iPS cell lines, 70 metabolomic samples, 201 antibody tests, and 26 protocols.

To maximize scientific exchange and accelerate research, all data and resources generated by GUDMAP Atlas and RBK Research Projects are made publicly available prior to publication.

GUDMAP/RBK Consolidated Data Hub

The current GUDMAP and RBK data repositories represent the efforts of over 36 laboratories, and as such, the GUDMAP/RBK Data Hub should be flexible and nimble to meet the needs of a diverse group of consortia researchers, and a broad basic science research community, including users with extensive bioinformatics experience seeking level 1 data for analysis and the user interested in access to output from Data Hub data analysis. In addition to its scientific duties, the Data Hub will also have administrative duties to ensure coordination amongst GUDMAP Atlas Projects and RBK Research Projects, and outreach to the basic science research community.

The Data Hub should support a coordinated, focused, adaptive, and interactive platform and through these efforts, the Data Hub should promote FAIR Principles (Findable, Accessible, Interoperable, and Reusable). The combined data repository will contain data and resources generated by the GUDMAP Atlas and RBK Research Projects and as such, access to the GUDMAP and RBK consortia specific content may be achieved through individual landing pages. The Data Hub should include appropriate domain expertise. This includes, but is not limited to, the anatomical and biological expertise for appropriate relevant organs, expertise in bioinformatics, website and software development, biocuration and ontology development, and expertise in workshop planning and administration.

During the funding period, technologies will change, and new data types are likely to be generated by GUDMAP Atlas and RBK Research Projects. The Data Hub should be committed to adapting strategies to incorporate new data types into the database.

The Data Hub’s scientific duties include but are not limited to:

  1. Integrate the existing GUDMAP and RBK data repositories.
  2. Develop and maintain a FAIR, web-based data repository, including resources that serve the collective interests of the GUDMAP and RBK consortia.
  3. Integrate newly generated data with existing data (described above) and conduct analyses to increase the searchability (e.g., data analysis to identify new cell types or cell compartments).
  4. Ingest data and associated metadata in a matter that supports the goals of the consortia, including making the data FAIR.
  5. Develop or expand ontologies, controlled vocabularies, spatio-temporal frameworks, and metadata standards, as needed to increase searchability within the Data Hub data repository and to facilitate searches across scientifically related repositories such as the Kidney Precision Medicine Project (KPMP) and Human Biomolecular Atlas Program (HuBMAP).
  6. Adapt to new and emerging data types, and work with stakeholders to deploy relevant tools to analyze or visualize these data.
  7. Submit datasets with additional sharing requirements to public databases (e.g., Gene Expression Omnibus, GEO, and/or database of Genotypes and Phenotypes, dbGaP) on a regular basis to be determined by the Steering Committee (SC), work with all stakeholders to fulfill reporting requirements, and implement practices that make data linkable and citable by other databases.
  8. Implement industry best practices for data security as well as a backup strategy.
  9. Prioritize open source software and ensure all data and documentation are easily transferable at the end of the project

The Data Hub’s administrative responsibilities include but are not limited to:

  1. Facilitate and promote interactions between members of GUDMAP and RBK and the broader research community.
  2. Organize and manage meetings to enhance consortia interactions and sharing of data and resources. These include GUDMAP and RBK SCs and Consortium Management Board meetings, monthly webinars, and, when necessary, meetings on the fly.
  3. Provide scientific, technical, administrative, operational and logistical support for working groups tasked by GUDMAP and RBK consortia.
  4. Coordinate common research activities and harmonize aspects of the work conducted by GUDMAP and RBK members to promote synergy and reproducibility and develop and implement documents to support interactions within the consortia, including but not limited to confidentiality and sharing agreements between all GUDMAP and RBK members and other collaborators.
  5. Coordinate efforts to educate the broader research community about the goals, objectives, activities and progress of the GUDMAP and RBK consortia, and coordinate efforts with other consortia generating related data and knowledge such as KPMP and HuBMAP.
  6. Advertise and develop a system for the distribution of induced pluripotent stem cell (iPSC) tagged lines through a contract with a third party.
  7. Develop, execute, and manage a Partnership Project Program thru the Opportunity Pool Program. Through the Partnership Project Program, the consortium will proactively adapt to the changing scientific landscape and to fill gaps within the RBK or GUDMAP by engaging external investigators. Support of a specific Partnership Project is limited to two years with an option to extend the study for an additional year pending review of progress. The Opportunity Pool should be flexible as the size and use of the "pool" may change over time. Specifically, the application should describe plans to:

a. Continually monitor the scientific, infrastructure and resource needs.

b. Coordinate requests for applications, manage acceptance and organize external peer-review.

c. Establish an administrative structure to select projects for funding, disburse and track awards.

d. Establish procedures, formats and timelines, for monitoring and reporting, progress and outcomes (e.g., publications, subsequent awards).

During the funding period, technologies will improve, and the rate of progress and focus of work supported by the cooperative agreement might change. As a member of the SC, the Program Directors/Principal Investigators of the Data Hub, in consultation with NIH program staff and the Consortium Management Board, will make any necessary adjustments to accommodate the changing research environment, in order to remain focused on overall goals to maintain excellent coordination with other relevant projects and to incorporate new technological advances. It is expected that the Data Hub will make necessary administrative adjustments to accommodate changes to the GUDMAP and RBK consortia.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?
Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The NIDDK intends to commit $1,400,000 to support one award under this FOA in FY 2021.

Award Budget

Direct costs are expected to be approximately $750,000 per year. Application budgets need to reflect the actual needs of the proposed project. Included within the $750,000 per year, applicants may request $400,000 in direct cost or more per year for the Opportunity Pool. All Opportunity Pool costs are inclusive of any consortium F&A.

Award Project Period

The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

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

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

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

Required Registrations

Applicant organizations

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

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) – 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.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For 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.

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

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this 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 instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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: NIDDKLetterofintent@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Statement of Willingness.

Please provide a statement indicating willingness to:

  • Work with NIDDK to participate in the initial and semi-annual meetings during the course of the grant award;
  • Cooperatively interact with NIDDK in support of the projects and activities;
  • Actively seek input from NIDDK regarding resource or expertise needs that may arise during the performance of the project; and
  • Participate in monthly conference calls.
SF424(R&R) Senior/Key Person Profile

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

The applicants should describe the key personnel (with the appropriate expertise and necessary effort) to create, maintain, and continually improve a searchable web-based data repository for the GUDMAP and RBK consortia.

R&R Budget

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

The GUDMAP/RBK Data Hub Director(s) must budget for at least a total of 2.4 person months effort. The investigative group will apply appropriate domain expertise and provide minimal effort in bioinformatics (9 months), website and software development (18 months total across the team), biocuration and ontology development (including specific expertise in appropriate organ anatomy and physiology; 9 months), and workshop planning and administration (2.4 months). The minimal domain expertise effort may be met by employment of teams of individuals.

The in-person meetings and the audio/video calls of the GUDMAP and RBK consortia are the responsibility of the Data Hub. There will be semi-annual meetings of the RBK consortium and an annual meeting of GUDMAP consortium. It is anticipated that all meetings will take place in Bethesda, MD. The Data Hub application should request a budget for the costs of the consortia meetings (except for the costs of travel and attendance of the project investigators) and should include costs for travel and attendance of the three to five External Experts. There will also be monthly conference calls of the Steering Committee (SC) of each consortium, weekly calls between the Data Hub and NIDDK and additional calls as needed.

The budget should request $50,000 to support the cost of distributing the iPSC tagged lines through a third party and at least $400,000 per year for an Opportunity Pool Program.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy:

A central role of the Data Hub is to interact with the other PDs/PIs and the scientific community, in order to synthesize and usefully present research results and information using FAIR principles. The Research Strategy should describe strategies to create, maintain, and continually improve a searchable web-based data and resource repository for GUDMAP and RBK that is of utility to both the lay-user and bioinformatician.

The application should provide a clear strategy demonstrating the ability to interface with the scientific areas of investigation that are included within these consortia. The Research Strategy should include plans to fulfill all scientific and administrative duties as outlined in Section I.

The datasets from the GUDMAP and RBK consortia have been integrated into a single functioning platform for storing, visualization and analysis of data using FAIR principles. The GUDMAP/RBK consortia have datasets that complement other NIH-sponsored consortia including Kidney Precision Medicine Project (KPMP) and the Human BioMolecular Atlas Program (HuBMAP). Applications should describe ways in which to coordinate sharing of information (data) and expertise with these consortia.

The Research Strategy should also describe strategies for leveraging existing infrastructures, resources, and platforms to reduce cost and for managing the data access and production including but not limited to:

  • How the configuration of the consolidated RBK and GUDMAP data repository and landing pages(s) will improve the user experience and refine strategies to globally navigate the different data types;
  • How educational materials will be generated to improve data repository accessibility for both the causal user and bioinformatics savvy user;
  • How the integrated data repository will be (re)modeled using FAIR principles;
  • How the global integrity of the ontology for all components of the genitourinary system will be maintained and expanded;
  • How the investigative team will apply appropriate domain expertise and effort in bioinformatics, website and software development, biocuration and ontology development (including specific expertise in appropriate organ anatomy and physiology) to achieve the goals of the consortia;
  • How incorporation of data generated by GUDMAP Atlas and RBK Research Projects will be integrated and continuously updated in the integrated data base and;
  • How meta-analyses of data will be employed to identify atlas relevant compartments and sub-compartments to improve usability and utility of the data repository.

The GUDMAP/RBK Data Hub will also administer a single Opportunity Pool Program. The Research Strategy should describe how the Opportunity Pool Program will be used to augment the goals of the GUDMAP and RBK consortia, (i.e., Partnership Projects) and to increase the utility of the consolidated database. The application should describe how these projects would be solicited and selected for support, but should not include detailed projects. The size of the Opportunity Pool Program budget is likely to vary from year to year. The Research Strategy should also describe plans to:

  • Continually monitor the scientific, infrastructure and resource needs.
  • Coordinate requests for applications, manage acceptance and organize external peer-review.
  • Establish an administrative structure to select projects for funding, disburse and track awards.
  • Establish procedures, formats and timelines, for monitoring and reporting, progress and outcomes (e.g., publications, subsequent awards).

The GUDMAP and RBK consortia have overlapping interest with several NIH sponsored consortia. Applications should describe ways in which to coordinate sharing of information (data) and expertise with other NIH-supported consortia (e.g., the KPMP, HUBMAP etc.). The Data Hub also has administrative responsibilities. The Research Strategy should describe ways for efficient organization of meetings and workshops as needed to enhance sharing of data and resources across the field; the coordination and administration of the activities and meetings (including conference calls) of the SC, subcommittees, working groups and external experts; the generation and maintenance of minutes for meetings of the SC and Subcommittees as approved by the chairs and membership of those committees; and maintaining records for action by committees, subcommittees and working groups as established by policies of the SC.

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.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan that includes plans to ensure datasets and documentation are in a mutually agreed upon "standard format" for maximum use (open access) and in accordance with FAIR Principles. This plan should also address methods for continuing to make data available to the NIH and the research community upon completion or termination of the project so that accumulated data remain accessible, for example through public repositories, if available.
  • Applicants are expected to include a plan addressing if, or how, they will exercise their intellectual property rights while making available to the broader scientific community patentable research resources, consistent with achieving the goals of this program. These plans must be fully supported by the applicant's institution.
Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the 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 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.

PHS Assignment Request Form

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). 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.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by 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" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

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

1. Criteria

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

For this announcement, note the following:

The proposed consolidated Data Hub will be responsible for (1) the continued integration of the GUDMAP and RBK data repository into a single database accessible from both the GUDMAP and RBK landing pages or a shared entry point, and improving the utility and usability of the web-based search capacity, (2) maintaining and upgrading the GUDMAP/RBK data repository, and (3) performing administrative functions, including overseeing the Opportunity Pool Program.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the 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: Does the project address critical access issues for the casual user and the bioinformatic savvy user? Does the project maximize opportunities for sharing of knowledge, resources and tools generated by GUDMAP Atlas and RBK Research Projects?

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: Does the application define key personnel with appropriate domain expertise in bioinformatics, website and software development, biocuration and ontology development (including specific expertise in appropriate organ anatomy and physiology)? Do the key personnel commit the necessary effort to accomplish the goals of the proposed repository? All SC information can be found: https://www.rebuildingakidney.org/downloads/RBK-Standards-of-Conduct-V3.pdf.

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: Are innovative approaches used to improve queries across multiple datatypes or improve the representation of relationships of structures/cells across data types, to make data accessible to all levels of user (i.e., casual user to savvy user), and to create relevant citable digital objects?

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: Is the approach feasible and likely to be successful in implementing FAIR principles? Will it allow for 1) a web-based faceted search interface and extensive cross-linkage of data (findability); 2) permanent, versioned identifiers for all data and metadata (accessibility and reusability); 3) open interfaces for finding, retrieving, creating, updating, and modifying data and metadata (accessibility); 4) one-click interfaces for exporting metadata in standard formats such as csv and json (interoperability), 5) standardized ontologies (interoperability and reusability), and for a rich data model (reusability)? Will the overall strategy improve the utility and usability of the GUDMAP/RBK data repository and the user experience, and allow for efficient navigation of multiple data types? Will the overall methodologies allow for efficient maintenance and upgrading the GUDMAP/RBK data repository and be adaptable to new data types? Are the plans for ensuring the global integrity of the ontology for all components of the genitourinary system adequate? Are the strategies to develop/integrate new analytical tools to utilize the database, including image analysis adequate? Are there adequate plans for accommodating non-GUDMAP/RBK data? Are the plans for the Opportunity Pool Program flexible and adequate to reach out to the larger community? Are the plans for coordinating efforts to introduce and educate the research community to the use of GUDMAP/RBK data repository likely to succeed?

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?

Additional Review Criteria

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

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the 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 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 (NDDKAC). 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 the NIH Grants Policy Statement.

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

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

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

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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

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

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. This includes ensuring programs are accessible to persons with limited English proficiency. 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 and http://www.hhs.gov/ocr/civilrights/understanding/section1557/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.

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 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 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 awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the 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 resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

  • All aspects of the scientific activities, including defining the objectives and approaches, planning, conduct, analysis, and publication of results, interpretations, and conclusions of studies conducted under the terms and conditions of the cooperative agreement award.
  • Collaborating with other investigators in the program for protocol development, sample, reagents and data sharing as appropriate, data quality control, and data organization
  • Accountability towards the applicant organization officials and to the NIDDK for the performance and proper conduct of the research supported by the project in accordance with the terms and conditions of the award
  • Serving as a voting member of the GUDMAP SC and the RBK SC and will attend the Planning Meeting and a SC meeting for both consortia and the monthly GUDMAP and RBK teleconference calls.
  • Accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the SCs and subcommittees and be responsible for close coordination and cooperation with the GUDMAP Atlas and RBK Research Projects and with NIH staff.
  • Adhering to PHS policy for the distribution of unique research resources produced with PHS funding as described under Special Requirements.
  • Establishing written milestones for the project, in negotiation with NIDDK Project Staff prior to funding.
  • Release all study design materials and procedure manuals into the public domain and/or make them available to other investigators, according to the approved plan for making data and materials available to the scientific community and the NIDDK, for the conduct of research at no charge other than the costs of reproduction and distribution, consistent with achieving the goals of this program initiative.
  • Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies
  • Any third-party (including industry, academia, and foundations) collaboration 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 grantee and third-party will be provided to the NIDDK Program staff and NIDDK Technology Advancement Office for review, comment, and approval to assure compliance with NIH/NIDDK policies and network 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 industry, academia, and foundations) in the study and network activities that includes access to any network study 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.

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

  • An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. However, the dominant role and prime responsibility for the project as a whole resides with the awardees, although specific tasks and activities in carrying out the studies will be shared by awardees and the NIDDK.
  • NIDDK will designate a Project Officer and a Grants Management Specialist to provide normal program stewardship and administrative oversight of the cooperative agreements for the GUDMAP and RBK consortia.
  • NIDDK will form a separate Consortium Management Board (CMB) for the GUDMAP and the RBK consortia. The CMB will be comprised of an NIDDK Project Scientist and other NIH extramural staff with relevant scientific expertise or who manage research grant programs that relate scientifically to the goals of the GUDMAP and RBK consortia, and outside advisors selected by the NIDDK.
  • The CMB will meet annually with the GUDMAP and RBK SC, to review and assess progress and to advise NIDDK of scientific developments and opportunities that may enhance the achievement of the GUDMAP and RBK goals.
  • A NIDDK Project Scientist will attend and participate as a voting member in all meetings of the SC, and provide liaison between the SC and the CMB.
  • A NIDDK Project Scientist will help the SC develop and draft operating policies.
  • The appropriate NIDDK Project Officer will review separately the Data Hub and the scientific progress of the GUDMAP Atlas Projects and will review Data Hub and the scientific progress of RBK Research Projects, 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.
  • 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. The assigned Program Officer may also serve as an NIH Project Scientist.

Areas of Joint Responsibility include:

  • The CMB will meet annually with the GUDMAP SC and semi-annually with the RBK SC to review and assess the progress of the consortia and to advise NIDDK of scientific developments and opportunities that
  • There will be two separate SCs, one for the GUDMAP consortium and one for the RBK consortium - The NIH Project Scientist, PIs from the project funded through this FOA and RFA-DK-20-013 (GUDMAP) and PIs from the project funded through this FOA and RFA-DK-19-007 (RBK) will be responsible for forming the GUDMAP and the RBK SC, respectively. An arbitration system, as detailed below, will be available to resolve disagreements among members of the SC. The respective SCs will be the main governing board of the GUDMAP and RBK consortia. It will develop collaborative protocols, identify technological impediments to success and strategies to overcome them, develop shared software tools for disseminating information about the projects, and identify opportunities for sharing techniques and tools that might be developed in future GUDMAP Atlas and RBK Research Projects
  • The GUDMAP SC will be composed of the PIs from the project funded through this FOA, RFA-DK-20-013, and a Project Scientist. The RBK SC will be composed of the PIs from the project funded through this FOA and RFA-DK-19-007, and a NIDDK Project Scientist. The SC PIs will each have one vote. The NIDDK Project Scientist will have one vote. Each SC will select a chairperson who will be someone other than an NIH staff member.
  • Each SC may, as it deems necessary, invite additional, non-voting scientific advisors to meetings at which research priorities and opportunities are discussed. The NIH reserves the right to augment the scientific or consumer expertise of the SC when necessary.
  • There will be two annual SC meetings for the RBK consortium and a single annual meeting for the GUDMAP consortium. The first meeting will be a Planning Meeting where the SC will be formed, and a chairperson selected from among the members. The SC may: (a) draft a charter to detail policies and procedures, a process for monitoring compliance with the policies and procedures, and a process for recommending that the NIH Project Administrators act on evidence of non-compliance of any Consortium component with SC policies; (b) agree upon the terms of the charter; and (c) devise separate plans for interactions between the GUDMAP/RBK Data Hub and GUDMAP Atlas and the RBK Research Projects, respectively.
  • At the second and subsequent meetings, the SC for GUDMAP will refine the GUDMAP scientific objectives and implementation as necessary, consistent with data produced by former and possible future GUDMAP atlas projects and from other laboratories, while the RBK SC meeting will share scientific advances and establish collaborative activities between projects.
  • The GUDMAP and RBK SCs will plan workshops, to inform the research community of the progress made toward development of the GUDMAP atlas or the efforts of the RBK, and to inform the research community of any technological advances related to the implementation of the consolidated GUDMAP/RBK data repository. The NIDDK Project Scientist(s), the CMB, and other NIH staff as appropriate will provide the SC with advice on participants for the workshops and symposia.
  • The SC may establish subcommittees as it deems appropriate awardee members of the SC will be required to accept and implement policies approved by the SC.
  • The CMB will meet annually with the GUDMAP SC and semi-annually with the RBK SC to review and assess the progress of the consortia and to advise NIDDK of scientific developments and opportunities that may enhance the achievement of the GUDMAP or RBK goals.

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 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 awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the 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.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, 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 75 – Award Term and Conditions 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.

Application Submission Contacts

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

Finding Help Online: 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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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

Scientific/Research Contact(s)

Eric W. Brunskill, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: (301) 215-1698
Email:  eric.brunskill@nih.gov

Peer Review Contact(s)

Ryan Morris, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-480-1296
Email: ryan.morris@nih.gov

Financial/Grants Management Contact(s)

Charlette Kenley
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8847
Email: ck128i@nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.


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