NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

It is critical that applicants follow the instructions in the Multi-Project Instructions for 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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This Funding Opportunity Announcement (FOA) requests applications for the Kidney Precision Medicine Project (KPMP) Central Hub (CH) to aggregate, analyze and visualize all data and samples, and provide scientific, infrastructure and administrative support for the entire KPMP. The CH will collaborate with the KPMP Recruitment Sites (RS) and Tissue Interrogation Sites (TIS) to obtain and evaluate kidney biopsies from study participants with acute kidney injury (AKI) or chronic kidney disease (CKD), create a kidney tissue atlas, define disease subgroups, and identify cells, pathways and targets for novel therapies. The CH should: 1) collect, curate, aggregate and ensure quality control of all data and samples, 2) coordinate storage and distribution of all data and samples, 3) facilitate data analyses and visualization, 4) create a kidney tissue atlas, 5) provide administrative support and establish necessary working groups, 6) solicit patient input and feedback, 7) develop and manage a website for internal and external communication, analysis and discovery, and 8) administer an Opportunity Pool of funds to form new partnerships.

Projects proposed in response to this FOA will need a multidisciplinary team including nephrologists, radiologists, pathologists, statisticians, ethicists, biologists, bioinformaticians, web-developers, administrators and patients.

AKI and CKD impose a significant global health burden. Yet, no effective therapies currently exist for AKI, and only a few are available for CKD. Community feedback indicates that despite significant effort from industry and academia development of pharmacologic therapies for AKI and CKD has been hampered by non-predictive animal models, the inability to identify and prioritize human targets, the limited availability of human kidney biopsy tissue, and a poor understanding of AKI and CKD heterogeneity [Kidney Research National Dialogue 2014; AKI Outcomes Meeting 2015; Kidney Precision Medicine Meeting 2016]. Historically, AKI and CKD have been described as single, uniform diseases; however, growing consensus suggests that different disease pathways lead to different subgroups of AKI and CKD (AKIs and CKDs). Access to human kidney biopsy tissue is a critical first step to define disease heterogeneity and determine the precise molecular pathways that will facilitate identification of specific drug targets and ultimately enable individualized care for people with AKI and CKD.

Recent advances in multi-scale interrogation of human tissue and single cells have set the stage for precision medicine to be applied to AKI and CKD. The objectives of the KPMP are to ethically obtain and evaluate human kidney biopsies from participants with AKI or CKD, create a kidney tissue atlas, define disease subgroups, and identify critical cells, pathways and targets for novel therapies. The KPMP will be made up of three distinct, but highly interactive activities:

1. Recruitment Sites: recruit people with AKI or CKD for longitudinal cohort studies that include a research kidney biopsy.

2. Tissue Interrogation Sites: use and develop innovative technologies to analyze human kidney tissue.

3. Central Hub: aggregate, analyze and visualize all data and samples, and provide scientific, infrastructure and administrative support for the entire KPMP (this FOA).

All data and samples from the RS and TIS will go to the CH. In addition to an Administrative Core (AC), the CH will have a Data and samples Coordinating Center (DCC) and a Data Visualization Center (DVC). The DCC will perform standard clinical data assessments (e.g., patient data reports, recruitment tables, observational study reports), whereas the DVC will perform digital pathological assessments and create a kidney tissue atlas (incorporating data and images generated by the RS and TIS) to help define disease subgroups and identify critical cells, pathways and targets for novel therapies. The DVC will also manage a KPMP website to facilitate the sharing of all de-identified data and samples with the broader research community.

While kidney tissue from transplant, nephrectomy, and autopsy will be used to optimize tissue interrogation methods, these do not provide the quality and diversity of tissue to meet all of the KPMP objectives. The KPMP requires research kidney biopsies (or clinical biopsies with research core(s); collectively called research kidney biopsies throughout this document) linked to longitudinal clinical phenotypic data and biosamples.

It is anticipated that the KPMP will be conducted in stages:

• Stage 1: Optimize and validate tissue processing and interrogation methods. Establish common clinical protocols and cohort studies enrolling a small number of AKI or CKD patients. Assess quality of phenotype data and biopsy protocols at each site. Begin work on kidney tissue atlas. Optimize next generation assays.
• Stage 2: Small scale proof of concept studies to determine if clinical and analytic pipelines are robust. Enrich the kidney tissue atlas. Implement next generation tissue interrogation assays. Expand longitudinal cohort studies in initial AKI or CKD populations.
• Stage 3: Expand to larger cohort studies (expected next project period).

To provide a community resource for advancing research in this area, all KPMP activities must meet rigorous sharing and quality control standards. Given the risk of complications from kidney biopsy, the KPMP will hold ethical and participant safety considerations paramount. The KPMP will work closely with participants to ensure that their viewpoints, priorities, and preferences inform all aspects. All of the KPMP activities will be overseen by an Observational Safety Monitoring Board (OSMB) constituted by the NIDDK that will focus on participant safety, study burden and scientific validity of the clinical data; and an External Evaluation Panel (EEP) constituted by the NIDDK that will focus on the overall scientific progress and direction of the KPMP.

The CH will be responsible for establishing and managing critical resources for the KPMP, and the broader scientific community, to achieve the following objectives:

1. Public resource. Establish a publicly available data hub with clinical, imaging, cellular and molecular data. Anonymized data will be available to the research community upon validation.

2. Kidney tissue atlas. Create a set of maps used to classify and locate different cell types and interstitial components. The atlas will help define disease subgroups and identify cells, pathways and targets for novel therapies.

3. State/transition markers. Identify a set of cellular and molecular markers that classify cells as healthy, injured, activated, or undergoing recovery via adaptive or maladaptive repair.

4. Disease subgroups. Use all available data, including the kidney tissue atlas, to define patient subgroups and allow for clinical stratification into distinct endophenotypes.

5. Molecular pathways. Use data to identify and understand healthy and disease pathways that are activated in a particular cell type in a particular subgroup of patients.

6. Biomarkers. Discover a set of subgroup and pathway biomarkers. Ideally plasma or urine protein/antibody pairs, but could be urinary exosomes, miRNA, epigenetic marks, etc.

It is expected that these resources will seed future partnerships, ancillary studies, investigator-initiated endeavors and industry collaborations.

The CH will consist of three Components:

1. Data and sample Coordinating Center (DCC) Facilitate clinical protocol development; provide sample size and statistical calculations; curate and analyze patient data; monitor recruitment, retention, and follow-up of participants; coordinate sample (including biopsy tissue) tracking, storage and distribution; manage efforts to ensure quality control; and facilitate whole genome sequencing.

2. Data Visualization Center (DVC) Provide digital pathological assessments; facilitate data aggregation and meta-analyses; create a kidney tissue atlas; develop a website for internal and external communication, analysis and discovery.

3. Administrative Core (AC) Provide administrative support and establish necessary working groups; solicit patient input and feedback to inform all aspects of the KPMP; administer an Opportunity Pool of funds to form new partnerships.

The KPMP investigators will collaboratively devise a set of studies that will be reviewed by the EEP and approved by the NIDDK. Thus, all studies proposed in the applications will be a starting point for discussions regarding the research to be undertaken. It is unlikely that any proposed research will be undertaken exactly as planned, or at an individual site.

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

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

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)

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)
• 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

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.

• 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) (formerly CCR) 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

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.

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

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

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).

A button to access the online ASSIST system 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.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the Multi-Project Instructions for the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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, preferably electronically, should be sent to:

Michele Barnard, Ph.D.
Deputy Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Rm. 7353
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: 301-594-8898
Fax: 301-480-3505
Email:[email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	6
DCC (use for Data and sample Coordinating Center)	12
DVC (use for Data Visualization Center)	12
Admin Core	6

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

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
• Data and sample Coordinating Center (DCC): required
• Data Visualization Center (DVC): required
• Administrative Core (AC): required

When preparing your application in ASSIST, use Component Type Overall .

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

Complete entire form.

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

Follow standard instructions.

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.

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

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.

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.

Specific Aims: Briefly describe the overall Specific Aims of the proposed CH.

Research Strategy: The Overall section of the application should describe proposed plans for the organization and staffing of the CH, how the components of the organization, including key personnel, will interact and ensure efficient cooperation, communication and coordination, and how the proposed organization of the individual Components will create an integrated entity capable of effectively providing scientific, infrastructure and administrative support for the entire KPMP and facilitating the KPMP objectives.

Include the following:

• An overall organizational chart showing the three required CH Components (DCC, DVC and AC), as well as any additional organizational entities, identifying the proposed PD(s)/PI(s), the Component Leaders, and staff serving in a senior role.
• An overall discussion of governance, internal and external communication, and coordination concepts important to the success of a large, multicomponent project.
• An overall discussion of considerations of protocol design, development and monitoring of the KPMP data and sample collection (including those supported by the Opportunity Pool). Address the applicability of current and new innovative strategies, methodologies and approaches to overcome common problems and difficulties.
• State a willingness to accept the overall governance, common protocols, publication policies, collaborative procedures, confidentiality policies and data sharing plans to be developed by the KPMP.

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 Data Sharing Plan, which includes plans to ensure dataset and documentation are in a mutually agreed upon "standard format" for maximum use (open access).

• All applications under KPMP will be required to submit a data sharing plan. Applicants and their institutions are expected to describe their plans for making all protocols, technologies, data, samples and other research resources broadly available to the research community. Applicants should include in their data sharing plan the assurance that data and samples will be made available as soon as quality control procedures have been completed at the local institution. Any sharing plans by the institution represent a commitment by the institution (and its subcontractors, if any) to support and abide by the plan
• This plan should also address methods for continuing to make the KPMP data available to the NIH and the research community upon completion or termination of the site so that accumulated data remain accessible, for example, through the NIDDK Central Repositories.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

When preparing your application in ASSIST, use Component Type DCC.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

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.

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.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of DCC 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 forms appropriate for the specific component will be included in the application package.

Applicants should budget for:

• Travel and other expenses for Senior/Key Personnel to attend two SC meetings per year in the Bethesda MD/Washington DC area
• IRB coordination
• Training of clinical site personnel in data and sample collection
• Site monitoring and quality control
• Support of biosample transfer to central biorepositories and long-term biosample storage
• Budget $15,000 per year for shipment of biopsies and biosamples to and from the CH
• Do not budget for whole genome sequencing on all study participants or for shipment of biosamples to the NIDDK Central Repositories

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.

Specific Aims: Briefly describe the overall Specific Aims of the proposed Component.

Research Strategy: This section of the application should propose plans to facilitate clinical protocol development; provide sample size and statistical calculations; curate and analyze patient data; monitor recruitment, retention, and follow-up of participants; coordinate sample (including biopsy tissue) tracking, storage and distribution; manage efforts to ensure quality control; and facilitate whole genome sequencing. Include an organizational chart listing the tasks that this Component will accomplish. Identify the types of staff associated with each task and describe their respective roles and responsibilities. Discuss prior experience in coordinating research networks and present examples of challenges that were encountered and solutions offered.

Specifically, propose plans to:

• Provide oversight to ensure adherence to the highest ethical, research and clinical standards, and any required regulatory standards.
• Coordinate the development of a standardized kidney biopsy protocol for implementation at the RS.
• Coordinate the development of study protocols and longitudinal studies of participants with AKI and CKD.
• Provide sample size calculations and statistical advice to facilitate longitudinal cohort studies.
• Facilitate whole genome sequencing on all study participants. Do not budget for whole genome sequencing.
• Develop uniform case report forms and manage IRB submissions on behalf of the KPMP investigators. Ensure that appropriate local IRB approvals and appropriate patient consent are obtained for data and sample acquisition, transfer and use.
• Establish and monitor quality assurance and control standards.
• Catalyze the incorporation and harmonization of data and samples from other existing longitudinal cohorts.
• Conduct standard clinical data assessments, including development of data reports, recruitment tables, observational study reports, quality evaluation, etc.
• Monitor adverse complications and prepare regular reports for the EEP and OSMB, whose membership will be determined by the NIDDK subsequent to award.
• Develop and coordinate staff training for all activities, including patient recruitment and retention, biopsy performance, biological sample collection, interrogation and handling, etc.
• Collect and curate all data and samples.
• Track and coordinate all data and biosamples (including kidney biopsy) storage, transfer and distribution, including archiving in the NIDDK Central repositories.
• Provide a timeline for submission of all data to public databases (GEO and/or dbGaP).
• Monitor Electronic Health Record (EHR) integration plans for the RS and encourage the return of study and diagnostic data back to participants and the (re)incorporation into EHR systems as feasible and appropriate.

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 Data Sharing Plan, which includes plans to ensure dataset and documentation are in a mutually agreed upon "standard format" for maximum use (open access).

• All applications under KPMP will be required to submit a data sharing plan. Applicants and their institutions are expected to describe their plans for making all protocols, technologies, data, samples and other research resources broadly available to the research community. Applicants should include in their data sharing plan the assurance that data and samples will be made available as soon as quality control procedures have been completed at the local institution. Any sharing plans by the institution represent a commitment by the institution (and its subcontractors, if any) to support and abide by the plan.
• This plan should also address methods for continuing to make the KPMP data available to the NIH and the research community upon completion or termination of the site so that accumulated data remain accessible, for example, through the NIDDK Central Repositories.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Data and sample Coordinating Center (DCC)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type 'DVC.'

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

SF424 (R&R) Cover (Data Visualization Center)

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 (Data Visualization Center)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Visualization Center )

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) (Data Visualization Center)

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 (Data Visualization Center)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of DVC 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 (Data Visualization Center)

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

Applicants should budget for:

• Travel and other expenses for Senior/Key Personnel to attend two SC meetings per year in the Bethesda MD/Washington DC area
• Website development

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 (Data Visualization Center)

Specific Aims: Briefly describe the overall Specific Aims of the proposed Component.

Research Strategy: This section of the application should propose plans to provide digital pathological assessments; facilitate data aggregation and meta-analyses; create a kidney tissue atlas; develop a website for internal and external communication, analysis and discovery.

Specifically, propose plans to:

• Establish a digital repository of existing and new clinical biopsy slides and material.
• Perform conventional and advanced (e.g., omic, 3-Dimensional imaging) pathologic reading of all available tissue, and compare to the clinical diagnosis and local site pathologic analysis.
• Implement novel histological methods based on digital imaging (e.g., histology, tissue CyTOF, tissue mass-spec) to improve diagnoses, prognosis, and treatment drug selection.
• Develop tools for image (including histological) data comparisons and search-ability.
• Aggregate and integrate data and metadata from a broad range of experimental and computational projects.
• Develop and/or adapt data analysis tools for searching, integration, cross-validation and visualization.
• Perform high-order mining of clinical, histological, tissue, cellular and molecular data to create a 2- or 3-Dimensional kidney tissue atlas or conceptual model that visualizes multi-level data and generates usable information.
• Provide high-quality spatio-temporal annotation and develop ontologies. Extend existing ontologies to resolve interstitial components, cell type and cell state.
• Adopt standardized structural and histologic ontologies to develop annotated kidney tissue atlas maps representing health, disease, sex, age, race and ethnicity.
• Identify cell types and interstitial components (including fibrosis) of the kidney. Identify molecular or cellular markers (e.g., anchor genes, proteins) and define the structural relationships of each cell type and interstitial component to its neighbors.
• Integrate molecular characterization of cell types with data from omic analyses (e.g., genomic, epigenomic, transcriptomic, proteomic, metabolomic).
• Manage quality control, cleaning and harmonization of data received from all KPMP sites and other outside sources.
• Develop and manage the KPMP website to serve as both an internal resource and public interface. Build focus area-specific domains to facilitate interactions. Develop and adapt innovative tools for navigating, analyzing, visualizing and downloading data to maximize broad usability. Incentivize public interrogation and discovery.
• Identify and implement data structures that facilitate users efforts to define disease subgroups, and identify cells, pathways and targets for novel therapies.
• Utilize and develop open-source and well-documented software, which supports the sustainability of the resources developed.
• Evaluate the reliability, validity and usability of the KPMP website for the broader research community.

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 Data Sharing Plan, which includes plans to ensure dataset and documentation are in a mutually agreed upon "standard format" for maximum use (open access).

• All applications under KPMP will be required to submit a data sharing plan. Applicants and their institutions are expected to describe their plans for making all protocols, technologies, data, samples and other research resources broadly available to the research community. Applicants should include in their data sharing plan the assurance that data and samples will be made available as soon as quality control procedures have been completed at the local institution. Any sharing plans by the institution represent a commitment by the institution (and its subcontractors, if any) to support and abide by the plan.
• This plan should also address methods for continuing to make the KPMP data available to the NIH and the research community upon completion or termination of the site so that accumulated data remain accessible, for example, through the NIDDK Central Repositories.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Data Visualization Center)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, 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 AC 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 (Administrative Core)

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

Applicants should budget for:

• Travel and other expenses for Senior/Key Personnel to attend two SC meetings per year in the Bethesda MD/Washington DC area
• Travel and other expenses for four patient members of the Patient Engagement Working Group to attend two SC meetings per year in the Bethesda MD/Washington DC area
• Travel and other expenses for six EEP and six OSMB members to attend two SC meetings per year in the Bethesda MD/Washington DC area
• Travel and other expenses for six members to attend two OSMB meetings per year in the Bethesda MD/Washington DC area
• Applicants should budget $1,000,000 or more total costs per year for the Opportunity Pool of the CH award.
• In addition, applicants should budget for costs associated with the administration of the Opportunity Pool. It is anticipated that, every year, the Opportunity Pool will support about 5 pilot/partnership studies per year (with each award being about $200,000 total costs).

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)

Specific Aims: Briefly describe the overall Specific Aims of the proposed Core.

Research Strategy: This section of the application should propose plans to coordinate the operations of the KPMP, establish necessary working groups (including a Patient Engagement Working Group), and administer an Opportunity Pool to form new partnerships. Include an organizational chart listing the tasks that this Component will accomplish. Identify the types of staff associated with each task and describe their respective roles and responsibilities. Discuss prior experience in coordinating research networks and present examples of challenges that were encountered and solutions offered. The structure of the proposed AC should identify lines of authority, personnel with specific responsibilities for internal function, quality assurance and control, and personnel with financial responsibilities for the management of the CH Award.

Specifically, propose plans to:

• Coordinate common research activities and harmonize aspects of the work conducted by the KPMP to promote synergy and reproducibility.
• Coordinate all functions of the Steering Committee (SC), EEP and OSMB and their interactions with the KPMP investigators.
• Organize and support at least 2 face-to-face meetings of the SC per year and provide travel for the EEP. The first SC should be held in August or September of 2017.
• Organize and support at least 2 face-to-face meetings of the OSMB per year.
• Provide scientific, technical, administrative, operational and logistical support for working groups tasked by the SC (e.g., Clinical Recruitment, Kidney Biopsy, Publication, External Collaboration, Patient Engagement).
• Lead a Patient Engagement Working Group to educate AKI and CKD patients, physicians and other stakeholders about the need and ethical basis for performing research kidney biopsies. The Patient Engagement Working Group should:
• Identify key patient-centered factors to be included in the development of common protocols for obtaining informed consent and performing research kidney biopsies.
• Develop novel approaches for actively engaging relevant local stakeholders (e.g., participants, physicians, IRB representatives, ethicists, providers) in the development of research kidney biopsy protocols that ensure safety, minimize risk and adhere to the principles delineated in federal guidelines for research. Do not propose to use national groups such as the Patient and Family Partnership of the Kidney Health Initiative (KHI; a joint venture between the American Society of Nephrology and FDA), as they will be added once the KPMP is formed.
• Disseminate engagement strategies, based on patient and provider input.
• Develop a plan for continued engagement with participants as the research progresses, including a patient-centered information system that will offer clinical diagnoses for enrolled participants and their providers.
• Develop a communication plan to disseminate proposed operating procedures and results to the larger kidney research and patient communities.
• Establish and manage agreements (e.g., confidentiality, data sharing, publications) between all KPMP investigators and other collaborators, including industry.
• Present a plan for rapidly building an effective trans-KPMP team employing expertise in group dynamics/performance and systems thinking to enhance stakeholders engagement in shared decision-making and shared accountability for setting and reaching goals.
• Coordinate efforts to educate the broader research community about the goals, objectives, activities and progress of the KPMP.
• Create and administer an Opportunity Pool to form new partnerships. The organization of the Opportunity Pool Program should be flexible as the size and use of the pool may change. Specifically, the application should describe plans to:
• Continually monitor the scientific, infrastructure and resource needs of the KPMP.
• Develop 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).

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 Data Sharing Plan, which includes plans to ensure dataset and documentation are in a mutually agreed upon "standard format" for maximum use (open access).

• All applications under KPMP will be required to submit a data sharing plan. Applicants and their institutions are expected to describe their plans for making all protocols, technologies, data, samples and other research resources broadly available to the research community. Applicants should include in their data sharing plan the assurance that data and samples will be made available as soon as quality control procedures have been completed at the local institution. Any sharing plans by the institution represent a commitment by the institution (and its subcontractors, if any) to support and abide by the plan. This plan should also address methods for continuing to make the KPMP data available to the NIH and the research community upon completion or termination of the site so that accumulated data remain accessible, for example, through the NIDDK Central Repositories.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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.

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.

This initiative is not subject to intergovernmental review.

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.

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: https://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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 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.

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 (SAM). 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.

In order to expedite review, applicants are requested to notify the NIDDK Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Central Hub 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 CH 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 CH that by its nature is not innovative may be essential to advance a field.

Does the CH address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the CH 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?

How will successful completion of the aims affect the collection, analysis and visualization of kidney biopsies for clinical assessment and research? Are the proposed studies sufficiently compelling to justify research kidney biopsies? Will the biopsies be used in a way that maximizes their value as a precious resource?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the CH? If Early Stage Investigators or New Investigators, or 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?

Have the applicants demonstrated a willingness to accept the overall governance, common protocols, publication policies, collaborative procedures, confidentiality policies and data sharing plans to be developed by the KPMP? Is the expertise of the proposed multidisciplinary team adequate? Have the applicants demonstrated the ability to oversee and work with large collaborative groups?

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?

Have the applicants proposed novel methods to improve the analysis and visualization of kidney biopsies for clinical assessment and research? Do the applicants provide innovative strategies for the incorporation and harmonization of data and samples from other existing longitudinal cohorts?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the CH? 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?

If the CH 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 children, justified in terms of the scientific goals and research strategy proposed?

Do the applicants propose adequate strategies to ensure adherence to the highest ethical, research and clinical standards? Do the applicants propose adequate strategies to develop and coordinate staff training for all activities, including patient recruitment and retention, biopsy performance, biological sample collection, tissue interrogation and handling, etc.?

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?

As applicable for the CH 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.

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

When the proposed CH 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 children 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.

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.

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.

Not Applicable

Not Applicable

Not Applicable

As applicable for the CH 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.

Not Applicable

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).

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 .

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.

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

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 DCC that by its nature is not innovative may be essential to advance a field.

Significance

Does the DCC address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the DCC 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?

How will successful completion of the aims affect the collection, analysis and visualization of kidney biopsies for clinical assessment and research? Are the proposed studies sufficiently compelling to justify research kidney biopsies? Will the biopsies be used in a way that maximizes their value as a precious resource?

Investigator(s)

Are the DCC lead(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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?

Do the DCC personnel have the necessary expertise and experience to provide sample size and statistical calculations?

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?

Have the applicants proposed novel methods to curate and analyze patient data?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the DCC? 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?

If the DCC 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 children, justified in terms of the scientific goals and research strategy proposed?

Have the applicants proposed adequate plans to support clinical protocol development and to monitor recruitment, retention and follow-up of participants? Do the applicants present adequate strategies to track, curate and distribute samples? Do the applicants present adequate strategies to ensure data and sample quality control?

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?

Does the institution have the necessary experience and infrastructure to coordinate sample (including biopsy tissue) storage and distribution?

As applicable for the DCC 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 six 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 six 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 Children

When the proposed DCC 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 children 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.

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.

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 DVC that by its nature is not innovative may be essential to advance a field.

Significance

Does the DVC address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the DVC 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?

How will successful completion of the aims affect the analysis and visualization of kidney biopsies for clinical assessment and research? Are the proposed scientific questions and proposed studies sufficiently compelling to justify research kidney biopsies? Will the biopsies be used in a way that maximizes their value as a precious resource?

Investigator(s)

Are the DVC lead(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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?

Do the applicants have the necessary expertise and experience to provide digital pathological assessments? Do the applicants have the necessary expertise and experience to facilitate data aggregation and meta-analyses? Do the applicants have the necessary expertise and experience to create a kidney tissue atlas? Do the applicants have the necessary expertise and experience to develop a website for internal and external communication, analysis and discovery?

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?

Have the applicants proposed novel methods to improve the analysis and visualization of kidney biopsies for clinical assessment and research? Have the applicants proposed novel analytical and mapping/modeling techniques? Have the applicants proposed innovative strategies to curate, aggregate and integrate data and metadata from a broad range of experimental and computational projects? Have the applicants proposed innovative strategies to develop and/or adapt data analysis tools for searching, integration, cross-validation and visualization? Have the applicants proposed innovative strategies to perform high-order mining of clinical, histological, tissue, cellular and molecular data to generate a 2- or 3-Dimensional kidney tissue atlas?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the DVC? 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?

If the DVC 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 children, justified in terms of the scientific goals and research strategy proposed?

Do the applicants propose adequate plans to provide digital pathological assessments? Are the computational strategies sound and developed to reduce bias? Do the applicants propose adequate strategies to create a kidney tissue atlas? Do the applicants propose adequate plans to develop a website for internal and external communication, analysis and discovery? Is there a proposed approach to assess the user-friendliness and potential for wide adoption/usage of the website and data displays/visualizations by the relevant research community?

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?

Does the institution have the necessary experience and infrastructure to establish a digital repository of existing and new clinical biopsy slides and material? Does the institution have the necessary experience and infrastructure to develop and maintain a website for internal and external communication, analysis and discovery?

As applicable for the DVC 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 six 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 six 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 Children

When the proposed DVC 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 children 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

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 .

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.

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, an AC that by its nature is not innovative may be essential to advance a field.

Significance

Does the AC address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the AC 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?

Are the proposed scientific questions and proposed studies sufficiently compelling to justify research kidney biopsies? Will the biopsies be used in a way that maximizes their value as a precious resource?

Investigator(s)

Are the AC lead(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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)? Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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?

Have the applicants proposed novel methods to coordinate the KPMP? Do the applicants propose innovative strategies for rapidly building an effective trans-KPMP team employing expertise in group dynamics/performance and systems thinking to enhance stakeholders engagement in shared decision-making and shared accountability for setting and reaching goals?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the AC? 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?

If the AC 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 children, justified in terms of the scientific goals and research strategy proposed?

Do the applicants propose adequate plans to coordinate common research activities and harmonize aspects of the work conducted by the KPMP to promote synergy and reproducibility? Do the applicants propose adequate plans to coordinate all functions of the SC, EEP and OSMB and their interactions with the KPMP investigators? Do the applicants propose adequate plans to provide administrative support and establish necessary working groups? Do the applicants propose adequate plans to solicit patient input and feedback (though the Patient Engagement Working Group) to inform all aspects of the KPMP? Do the applicants propose adequate plans to administer an Opportunity Pool of funds, including review of applications? Do the applicants propose innovative strategies for monitoring scientifically robust outcomes of Opportunity Pool awardees?

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?

As applicable for the AC 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 six 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 six 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 Children

When the proposed AC 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 children 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 .

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened the 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:

• 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.
• Will receive a written critique.

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.
• Evidence that the applicant and investigators are committed to policies as established by the SC including with regard to confidentiality, sharing of information and resources, and cooperative interaction.
• Evidence of previous productive, cooperative, collaborative interaction.
• Diverse recruitment and complementary approaches are being applied across the KPMP.

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.

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.

Awardee-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 awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.
• The awardee 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: 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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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.

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.

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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

After completion of the initial review, NIH program staff will be responsible for any additional administrative review of the plan for sharing data. The adequacy of any data sharing plan will be considered by program staff when making funding decisions. Any final accepted data sharing plan will become a term and condition of the award of the cooperative agreement. The effectiveness of the data sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report.

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 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 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 primary responsibility of the PD(s)/PI(s) will be:

• Determine experimental approaches, design protocols, ensure participant safety, set project milestones, conduct experiments, and analyze and interpret research data.
• Provide objectives for projects and protocols and costs to the NIH Project Officer (PO) and Project Scientist (PS), at the outset of the award, following re-negotiation of the milestones after the first meeting of the SC and at six-month intervals thereafter, in consultation with the KPMP, PO, PS, EEP and OSMB.
• Ensure that all projects involving human subjects have the appropriate clearances (e.g., IRB, Federalwide Assurance, human subject’s research training, and other required documentation) prior to implementation.
• Serve as a voting member of the SC, and participate, along with critical staff, in SC meetings including two face-to face meetings per year in the Bethesda MD/Washington DC area.
• Adhere to the KPMP guidelines and other policies that might be established, as agreed upon by the SC, and the PO to the extent consistent with the applicant’s submitted statements and applicable grant regulations.
• Apprise the PO and PS of any potential impediments to execution of the objectives of the project.
• Ensure that primary and secondary data, protocols, procedures and any other project-derived resources are made available to the KPMP (e.g., deposited in a centralized database, as specified by the PO and PS) according to a timeline agreed upon by the SC and PO and to the extent consistent with the applicant’s submitted statements and applicable grant regulations.
• Providing representation on all relevant subcommittees and working groups established by the SC. Issues to address in working groups may include participant safety, quality control, pathology, molecular interrogation, ancillary studies, publication, intellectual property, data access, etc.
• Agree not to disclose confidential information obtained from other members of the KPMP and agree to the KPMP intellectual property agreements, consistent with the terms and conditions of the cooperative agreement awards, applicable regulations, and the policies and practices of the awardee institutions.
• Be prepared for annual administrative site visits by NIH staff.
• Be solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed for the awardee to perform the project.
• Be required to report to the U.S. Government all inventions made in the performance of the project, as specified by 35 U.S.C. Sec. 200-212 (Bayh-Dole Act).
• Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any proprietary rights, including intellectual property rights, or any materials needed by the awardee to perform the project.
• 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.

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

NIH Project Scientists (PS)

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:

• Work closely with the PD(s)/PI(s) and other KPMP investigators to facilitate collaborations and to leverage the resources available to the sites and the KPMP. They will assist in the integration of the individual RS, TIS, and CH sites into a collaborative research project.
• Monitor the progress of the Recruitment Sites, Interrogation Sites, and CH, help coordinate research approaches, and contribute to the shaping of research projects or approaches as warranted. The PS will support and facilitate this process but will not direct it.
• Assist in avoiding unnecessary duplication of effort across the KPMP, and help coordinate collaborative research efforts that involve multiple sites.
• Keep the PDs/PIs informed about other ongoing studies supported by the NIH to avoid duplication of effort and encourage resource sharing and collaboration. The PS will coordinate access to other NIH resources, as well as assist the research efforts of the KPMP by facilitating access to fiscal and intellectual resources provided by industry, private foundations, NIH intramural scientists and other federal government agencies as appropriate.
• Serve as voting members of the SC and assist in developing the KPMP priorities and research agenda, operating guidelines and consistent policies for dealing with situations that require coordinated action.
• Retain the option to recommend to the PO the withholding or reduction of support from any cooperative agreement that substantially fails to achieve its objectives according to the milestones agreed to at the time of the award or fails to comply with the Terms and Conditions of the award.
• Serve as scientific liaison between the awardees and other NIH program staff.
• Review and comment on critical stages of the KPMP progress.
• Share opportunities and discuss strategies and potential avenues of collaborations (such as with industry, private foundations and/or NIH intramural scientists).

NIH Program Official (PO)

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

• Provide approval for transition of projects to the UH3 phase.
• Form an EEP and OSMB, 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 KPMP, and outside experts selected by the NIH.
• Have the option to recommend, following consultation with the EEP and OSMB (if applicable), the possible withholding, reduction, or reallocation, as appropriate, of support from any KPMP component that substantially fails to achieve its objectives according to the milestones agreed to at the time of the award or fails to comply with the Terms and Conditions of the award, at the appropriate times.
• Have the option to recommend, following consultation with the EEP and OSMB (if applicable), an increase in support to engage in further research efforts within the original research scope, as appropriate, for any KPMP 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 ex officio (non-voting) member.
• Retain the option to recommend, with the advice of the NIH PS, re-allocation of NIH support among awardees, as scientific objectives evolve.
• Carry-out continuous review of all activities to ensure objectives are being met.
• 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 SC will be the primary governing body for all KPMP scientific activities. The SC will coordinate all sites awarded under these FOAs. The voting membership of the SC will include: one PD/PI from each award made under this and the companion FOAs, the NIH PS, and a representative from the Patient Engagement Working Group of the CH. The Chair of the SC will be assigned by NIH Program Staff, and may be chosen from outside the KPMP. Face-to-face meetings of this committee will occur at least two times a year. A portion of the SC meeting may be open to the public.

SC Composition - Voting members of the SC may include:

• The Program Directors/Principal Investigators (PDs/PIs) of each KPMP award
• The NIH Project Scientists (together representing a minority of voting members - not to exceed 1/3 of SC membership). Other NIH Program staff may attend the meeting as non-voting members.

SC Functions

The SC will be the primary governing body for all of the KPMP scientific activities. The SC will coordinate all projects awarded under the KPMP FOAs.

The role of the SC includes:

• Foster collaboration, synergy and sharing among the KPMP sites and investigators.
• Provide the primary mechanism for interactions with the NIH.
• Oversee the planning of the KPMP scientific activities, including dynamic adjustment as needs and opportunities arise.
• Guide the development and documentation of the KPMP standards and guidelines.
• Prioritize the use of the KPMP resources including systems biology analyses and bioinformatics.
• Evaluate progress in the KPMP sites and recommend adjustments in approaches if necessary, including implementation of new projects and changes to ongoing studies and termination of projects and sites.
• Foster partnerships and collaborations that will facilitate the extension of the approach to new technologies and their application to related kidney disease.
• Develop and approve the KPMP-wide intellectual property agreements consistent with the terms and conditions of the cooperative agreement awards, applicable regulations, and the policies and practices of the awardee institutions.

Responsibilities of the SC include:

• The SC will convene at least two face-to-face meetings a year in the Bethesda MD/Washington DC area. The first meeting will be a two-day meeting in August or September of 2017. Additional regular meetings will be conducted by teleconference or videoconference. Prior to each meeting, teleconference or videoconference, the SC Chair will prepare an agenda for review and approval, and distribute to members of the SC. Following these meetings, a list of participants and summary of discussion, action items, and recommendations will be prepared and submitted to the PO by the SC. Part of these meetings may be open to the public. The SC Chair may convene additional teleconferences, videoconferences, or electronic reviews to avoid delays in addressing key issues that cannot be evaluated at the regularly scheduled meetings. Regularly scheduled SC meetings will be convened in order to:
• Review progress of the KPMP sites; review progress of standardization and validation studies, other performance assessments, and future plans; and take remedial actions to address delays or other problems.
• Make recommendations to the KPMP sites about informatics and data and/or information management processes.
• Awardee members of KPMP will be required to accept and implement policies approved by the SC.
• The SC may make recommendations to the CH to establish working groups, or assign responsibility to key staff for other KPMP-related activities.

Data Sharing

• The data sharing plan will be referenced as a term and condition of award. Applicant organizations must comply with the Public Health Service (PHS) policies relating to distribution of unique research resources produced with PHS funding and sharing of all research protocols, data, samples and other research resources, as well as the grantee’s data sharing plan subject to decisions of the SC. For further information, see the NIH Data Sharing Policy at https://grants.nih.gov/grants/policy/data_sharing/.
• The NIH intends for the resource sharing plans for the data and samples generated under the KPMP to follow the policy and objectives stated in the FOA. Specifically, consistent with achieving the objectives of the KPMP, all protocols (clinical and research), data (including processed/analyzed data) and samples (including research kidney biopsies and other biosamples) generated are expected to be deposited in a SC-specified repository as soon as quality control procedures have been completed and on a timeline defined by the SC for use by the broad biomedical community, and for these data to remain available to all qualified investigators, consistent with applicable laws, regulations, and policies and unencumbered by any intellectual property claims. The NIH, in consultation with the SC for this project, will make all final decisions concerning data and sample deposition 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.
• Applicant organizations will comply with and implement the recommendations and decisions of the SC with respect to the sharing of information, data, biosamples, protocols, resources, and methods developed by the KPMP investigators under the KPMP.
• This plan should also address methods for continuing to make the KPMP data available to the NIH and the research community upon completion or termination of the site so that accumulated data remain accessible, for example, through the NIDDK Central Repositories.

Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual 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.

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 progress report, 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.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

For general questions or specific questions regarding the DCC:

Tracy Rankin, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4748
Email: [email protected]

For general questions or specific questions regarding the DVC,

Deborah Hoshizaki, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7712
Email: [email protected]

Jason Hoffert, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-496-9010
Email: [email protected]

Carolyn Kofa-Sullivan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7687
Email: [email protected]

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.