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 Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) 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

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for George M. O Brien Kidney Research Centers to support both basic and clinical research on kidney disease. O'Brien Centers should provide shared institutional and national resources to facilitate basic and clinical research on kidney disease and improve the effectiveness of translating insights from basic biology to clinical practice. The Centers will also support pilot and feasibility studies to develop and test innovative approaches to therapy

Much progress has been made since the initial solicitation for O Brien Kidney Research Centers in 1987. This program not only allows for, but encourages regional, national and even international collaboration. While there is still no cure for chronic kidney disease (CKD), the number of patients progressing to kidney failure now appears to be stabilizing, and possibly even decreasing. Despite this trend in the overall population, however, the same decrease in disease incidence has not been realized in minority populations. Additionally, while there are new genetic findings that explain some of the increased risk for disease, many challenges remain in determining the pathophysiologic mechanisms of kidney disease that could potentially be targeted for therapeutic interventions. Acute kidney injury (AKI) remains an important clinical problem as well. In addition, interest has increased in evaluating the bidirectional links between AKI and CKD. Although important advances have been made in understanding AKI in animals, translating that knowledge from experimental models to humans is complicated by its heterogeneity, and has fallen short of expected goals of diminishing the morbidity and mortality of AKI, and developing therapeutics that engage appropriate targets. Finally, the treatment of inflammatory kidney diseases has improved, but definitive treatments as well as cure remain elusive.

The NIDDK currently supports through the Division of Kidney, Urologic and Hematologic Diseases (DKUHD), seven George M. O Brien Kidney Research Centers, two Centers of Excellence in Pediatric Nephrology, and four Polycystic Kidney Disease (PKD) Research and Translation Core Centers. These Centers are part of an integrated program of kidney-related research support within the NIDDK. Centers have provided a focus for increasing the efficiency and collaborative effort among groups of successful investigators at institutions with established comprehensive kidney research bases.

The NIDDK encourages interaction between the O'Brien, PKD and Pediatric Centers, and provides a structure for such interactions by scheduling meetings in the Bethesda MD area so leadership of the centers can communicate with each other and with the NIDDK. Funded Centers will cooperate with the NIDDK to facilitate research collaborations and interactions within and among Centers and with the larger research community.

The emphases of this program are fourfold: (1) To attract new scientific expertise to and develop new tools for the study of human kidney physiology and disorders in humans and in animal and other appropriate models; (2) To encourage multidisciplinary research in these areas; 3) To explore new areas with translational potential; and 4) To generate Developmental Research (DR)/Pilot and Feasibility (P and F) studies which should lead to new and innovative approaches to the study of kidney disease.

The Institute has recently focused on the importance of evaluation of normal and diseased human tissue, as an opportunity to test the validity of animal models, to evaluate the pathways involved in pathologic and reparative processes at the tissue and cellular levels, and to identify targets for drug development for kidney diseases.

Progressive kidney disease involves failure to effectively repair injury, ineffective regeneration of critical tissues, and unchecked continuation of pathophysiologic processes. Hence, the Institute has focused on development of potential alternative therapies for AKI and progressive kidney disease. The development and employment of strategies to enhance renal repair and promote the generation of new nephrons in the postnatal organ could have a significant impact on the prevalence, progression and outcomes of kidney disease. The de novo repair of nephrons, the regeneration of nephrons, and the in-vitro engineering of a kidney, which can be translated to human disease states, are all research and therapeutic strategies worthy of development.

The goal of the O Brien Centers is to provide unique resources for communication and collaboration between basic and clinical researchers in the field of kidney disease. Research with clear translational potential, as described above, is strongly encouraged, as is clinical research. O'Brien Centers will provide shared resources to enhance the efficiency of research and foster collaborations within and among institutions with strong existing bases of kidney disease research. O'Brien Centers may be located in a single institution or in multiple institutions with complementary research bases.

Institution and Research Base

An O'Brien Center must be an identifiable unit within a single institution such as a university medical center, or within a consortium of cooperating institutions. In either case, O'Brien Center applications must be associated with an existing program of excellence in biomedical research in kidney disease. Program excellence is measured through a consistent and outstanding record of productivity and peer-reviewed research funding in kidney disease and related research areas. A high level of integration and close collaboration among Center personnel from diverse scientific disciplines is an important feature of a successful O'Brien Center. The Center should be focused on one or more central themes or focus areas that link Center investigators and their research programs, and enhance synergy.

Kidney research often requires the use of specialized technologies and resources to support a cohesive research effort. The O'Brien Center program should make state-of-the art technologies and resources readily accessible to a broad spectrum of investigators who are pursuing studies in relevant topic areas.

Biomedical Research Cores

A biomedical research core is defined as a shared resource that provides essential services, techniques, or instrumentation to Center participants, enabling them to conduct their funded individual research projects more efficiently and/or more effectively. Cores provide specialized technologies and expertise needed to accomplish the stated goals of the Center. Each core should provide services to multiple funded research projects. Centers may propose either Institutional, Regional, National or International Cores. Whereas Institutional Cores support research at a single institution or a set of cooperating institutions, Regional/National/International Shared Resources serve specific scientific communities on a regional, national, or international level. A category of research base for Cores that are used as a regional, national, or international resource should be considered the "extended research base". The extended research base for a regional, national or international core could include all investigators who might be expected to use the Core in some way. The list could include investigators who use the Core services but otherwise have no collaborative interactions with other Center investigators. The extended research base should be defined as an entity separate from the institutional research base. For review purposes, the extended research base will be evaluated as part of the Core, in order to distinguish it from the local institutional research base.

Examples of types of Biomedical Core resources that would be considered responsive to this Funding Opportunity Announcement include, but are not limited to:

• Collection, analysis, storage and distribution of data and samples;
• Provision of specialized tools and technologies or access to specialized expertise;
• Development, standardization and distribution of reagents and/or protocols;
• Provision of technical assistance, training, and enrichment programs;
• Recruitment of patients and coordination of patient studies;
• Development, beta-testing and dissemination of specialty assays, methods, and services on an institutional level;
• Increasing interdisciplinary interactions at the institution through cross-project/laboratory exchange;
• Sharing of specialized tools, technologies and expertise between collaborating investigators.

Administrative Core

In addition to Biomedical Cores, Centers must include an Administrative Core which will be responsible for allocation of resources within the Center and distribution of resources to Center participants. Although funds are not provided directly for training purposes, the Core laboratories and Educational Program enrichment activities should provide educational opportunities for Center members as well as students. In addition, all O'Brien Kidney Research Core Centers are required to maintain a Center website, with the Administrative Core taking primary responsibility for its curation and oversight.

Pilot and Feasibility (P and F) Program

A Pilot and Feasibility project is intended to provide modest support that will allow an investigator the opportunity to develop sufficient preliminary data as a basis for an application for independent research support. Pilot and Feasibility projects are not intended to support or supplement ongoing research of an established investigator. This Program should be integrated into the overall research goals of the Center and make use of the resources provided by the Cores. Pilot and Feasibility projects could include clinical projects to investigate basic research findings in a clinical setting. Each application must include a minimum of three up to a maximum of four Pilot projects. Each Pilot project may request a maximum of $60,000 direct costs per year (excluding Facility and Administrative costs) for up to two years.

Enrichment Program

An Enrichment Program may provide support for visiting scientists, seminars, and research forums. Students, fellows, and junior faculty are encouraged to participate in Center-sponsored seminars, courses, workshops, and symposia. Enrichment Program-sponsored mini-sabbaticals, or other instructional opportunities also are supported under such programs.

Additional Features

Applicants from institutions with an NIH Clinical and Translational Science Award program (http://www.ncats.nih.gov/ctsa) are strongly encouraged to use the CTSA as a resource for enhancing clinical research programs within the O'Brien Kidney Research Center.

See Section VIII. Other Informationfor 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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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.

Applicant organizations (normally identified by having a unique DUNS number or NIH IPF number) may submit only one application. 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 Multi-Project (M) Instructions in 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 should be sent by email to:

John Connaughton PhD
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bethesda MD 20892
Telephone: 301-594-7797
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall(Use for Center Overview)	12
Admin Core (use for Administrative Core)	6
Core (Use for each Biomedical Core)	12
P and F Program (use for Pilot and Feasibility Program)	12
Enrichment Program	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:

• Center Overview: required
• Administrative Core: required
• Biomedical Research Cores: required, minimum of 3
• Pilot and feasibility Program: required, minimum of 3 projects, maximum of 4
• Enrichment Program: 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.

Project Summary/Abstract: Describe the scientific theme(s) of the O'Brien Center and the need for a Center to support the investigators in the research base. Include the number of Center members and the overall direct costs present in the research base. Provide a brief overview of the research base as it relates to the theme(s) of the Center, as well as an overview of the Biomedical Research Cores, and the Pilot and Feasibility and Enrichment Programs.

Project Narrative: In 1-3 sentences describe the relevance of the research to be supported and facilitated by Center activities (Core services; Pilot and Feasibility, and Enrichment Programs) for public health.

Facilities and Other Resources: Describe the existing environment and facilities briefly in the context of how the Center will use or change existing access, space, and use. Include space maps as needed. Scientific personnel and institutional resources capable of supporting the research base must be available. Applicants should address how the institution and pertinent departments will commit to supporting the Center, such as through dedicated space, staff recruitment, salary-support for investigators, Pilot and Feasibility Program funding, dedicated or shared equipment, or other financial support for the proposed Center.

Equipment: A general listing of major, shared pieces of equipment to be used by Center members should be provided. Note: Specific Research Core facilities, equipment, and special resources should be listed in each proposed Biomedical Research Core component.

Other Attachments: The following attachments should be included with the Center Overview Component in order to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image. All attachments need to be in .pdf format.

Grant Support: Please title this attachment "Grant Support" and list all Federal and non-federal grant support for the O'Brien Research Base investigators. List support related to Basic Kidney Research first, followed by Translational and Clinical Kidney Research and then non-Center-related research support. Include Supporting Organization/Grant Numbers, Complete Grant Title, Project Period, Annual Direct Costs, and identify any other NIDDK Centers used. The 'Current Grant Support' table should include research project grants relevant to the proposed O'Brien Center which are considered to be potential or likely users of the core services. 'Other Grant Support' should include infrastructure/services grants (other Centers or CTSA awards), training (such as T- or F-awards) grants, and other such grants that support nephrology research but would not be direct users of the Core services.

Biographical Sketches of O'Brien Research Base Investigators: Please title this attachment "O'Brien Research Base Biographical Sketches." Provide biographical sketches for all O'Brien Center members, as defined within the application and organize them alphabetically by the last name of the Research Base Investigator. Provide biosketches for all Research Base investigators. Do not include duplicate biosketches for Senior/Key personnel identified in application.

Description of O'Brien Research Base Investigators: Please title this attachment Description of O'Brien Research Base Investigators and organize alphabetically by investigator's last name. Provide a narrative description of no more than one page per Research Base investigator. Try to limit each to less than one page. These narratives should include the active grant number(s), title(s), and a few descriptive sentences regarding the investigator’s research projects, as well as a brief description regarding what aspect of the investigator’s research justifies the use of O'Brien Core facilities. In the description of the Research Base, include ONLY those grants awarded, or subcontracted, to investigators at the applicant institution or consortium, not to investigators at other locations. It is particularly important to provide a few sentences indicating the relatedness of a cited grant to research in basic or clinical nephrology and/or related conditions when this is not readily apparent from the project title of the grant.

Core Use by Center Members: Please title this attachment "Core Use by O'Brien Center Members" and organize alphabetically by Research Base investigator (last name). List all O'Brien Center investigators including Membership Category (only if more than one category of Membership is designated by the O'Brien Center), and for each O'Brien Center research base investigator indicate those O'Brien Center Core Facilities that will be used.

O'Brien Center Collaborations: Please title this attachment O'Brien Center Collaborations and organize alphabetically by O'Brien Center Member (last name, first name). List all O'Brien Center Members. Provide primary Department Affiliation, key words for research interests, names of other O'Brien Center members who are collaborators (through publications, grants or research projects), and the number of collaborative publications (only those relevant to the O'Brien Center).

Optional: Please title this attachment "Relation to Overall O'Brien Center". Provide Charts and Tables such as an organizational chart(s) to illustrate the structure, interactions, and leaders of the institution and the O'Brien Center.

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.

Each applicant institution will specify a Center Director to be responsible for the organization and operation of the Center. It would be highly desirable that the Center Director, as well as the applicant institution, has a commitment to the investigation of basic science, translational or clinical topics relevant to the kidney and kidney disease and disorders. The Center Director should be an experienced and respected individual who can provide scientific and administrative leadership for the overall program. This individual must be able to coordinate, integrate, and provide guidance in establishing new programs in kidney physiology and disease research. This commitment will require significant effort from the Center Director.

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.

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

Specific Aims: Describe the theme and goals of the Center, and how these will advance kidney physiology and disease research. Describe how the specific aims of the Center will achieve these goals.

Research Strategy: Provide an overview describing the central theme, purpose and objectives of the entire Center project. The overview should include the philosophy and general plan for the proposed grant period, and an explanation regarding how the Center will achieve its major objectives. The reason a Center approach is needed for this work should be articulated. The unique contribution of the Center and each Core should be fully described. Describe the significance of the overall research goal and research theme, and the importance and relevance of these to the mission of the Center's program. The overview should also provide a discussion on the capabilities of the Center Leadership, and how this team will work together to achieve the specific goals of the proposed Center.

This section must describe the scientific and administrative integration of the proposed program, coordination, interrelationships, and synergy among the individual research projects and Cores. The overview should also include a description of the thematic cohesion between the Biomedical Research Cores and individual research projects. A justification for the proposed administrative and organizational structure, including plans for internal quality control of ongoing research and for fair and effective communication and cooperation among Center members, including resolution of disputes and allocation of resources must be provided.

Summarize the special features in the environment and/or resources that make this application strong or unique. If the application is a Renewal, the Center Program Overview section should also highlight past performance and the major accomplishments from the prior funding period. For Renewals, changes from the original Center design should be highlighted.

Progress Report Publication List: Renewal applications only: In this attachment, list the titles and complete references of all appropriate publications and manuscripts accepted for publication, that have resulted from the project since it was last reviewed competitively. Identify the Core(s) used in association with the publication. List publications only once. Within individual Biomedical Research Core descriptions, refer to publications associated with the Core by number as listed in the table of publications.

Letters of Support: Letters of support should be provided, where appropriate, to demonstrate collaboration, access to resources, and institutional commitment. Letters of support for the Center overall should be included with the Overall Component. For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional official, must be submitted with the application. Appropriate letters of support from the CTSA program director or Program Director/Principal Investigator (PD/PI) should be included with the application detailing plans for appropriate integration and synergy of the O'Brien Kidney Research Center and CTSA activities. In addition, applicants should address the potential for integration, harmonization, and enhancement of O'Brien Kidney Research Center activities through cooperation with other NIH-supported Core facilities at the applicant institution. Other NIH-supported Centers and associated Cores at the institution should be identified, and assurances provided that overlap or redundancy in Core services will be avoided unless expressly required to fulfill the mission of the O'Brien Kidney Research Core Center.

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.

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 Admin Core.

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 Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

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

Personnel: The Center Director must devote a minimum of 2.4 person months to the Center, and at least 1.2 of those months must be within the Administrative Core to ensure adequate oversight of the Center. If a multiple-PD/PI application, the combined effort of the PD(s)/PI(s) must be at least 2.4 person months. Most Centers find that the size and complexity of an O'Brien Center warrant inclusion of a program administrator, so salary support for this individual should be included in the Administrative Core. Where possible and applicable, O'Brien Centers are encouraged to leverage administrative resources in other NIH funded centers to maximize efficiency of resources.

Equipment: If pieces of specialized equipment, or computers, costing more than $5,000 are requested, the application must identify similar equipment already available within the institution and provide a clear justification for purchase based on Core services provided to O'Brien Center investigators. Requests for general-purpose equipment should be included only after ascertaining the availability of such items within the institution. Justify the request based on this availability. Equipment may only be requested in the initial budget period.

Travel: Include the costs of domestic and foreign travel only if the travel is directly related to the activities of the O'Brien Center. The proposed budget should include travel for the Center Director and Associate Center Director, or other key personnel, to attend an annual O'Brien Kidney Research Core Centers meeting in the Bethesda MD area. Include a statement of willingness to attend this annual meeting. Additionally, the proposed budget may include travel for the Center Director and Center-associated students to attend the annual KUH Summer Undergraduate Research Symposium.

Supplies: Consumable supplies directly related to the operational aspects of the Administrative Core facilities are an allowable expense.

Consultants: Include costs associated with consultants (consultant fees, per diem, teleconferences and travel) when their services are required by the O'Brien Center, such as the members of the External Advisory Board.

Other Expenses: Funds for supporting the institutional O'Brien Center website may be requested.

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.

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the aims of the Administrative Core, and how these will advance kidney physiology and disease research in the Center.

Research Strategy: The Administrative Core will have the responsibility of coordinating the various functions of the Center. It is expected that the administrative organization of the Center will include a supportive structure, such as an internal Executive Committee to ensure (1) Coordinating and integrating the Center components and activities; (2) Reviewing the use of funds for Pilot and Feasibility studies; (3) Providing advice to the Director about the productivity and effectiveness of the activities of the Center; and (4) Interacting with the NIDDK and other appropriate individuals or groups, including the scientific and lay communities, in order to help develop relevant goals.

The final administrative structure of the Center will be left largely to the discretion of the applicant institution (subject to review by NIH peer review mechanisms). However, NIH's experience has demonstrated that the effective development of Center programs requires close interaction between the Center Director, the Core Directors and Project Leads, appropriate institutional administrative personnel, the staff of the awarding agency, and members of the research and lay communities in which the Center is located. Therefore, each Center applicant should establish an administrative structure that will permit the development of such interactions. The structure must include an External Advisory Board. New applications should NOT list members of the External Advisory Board but should describe what expertise is needed and the process by which members will be selected, and should budget accordingly. Renewal applications should provide information on membership of the External Advisory Board and must document the functions and effectiveness of the Board.

Letters of Support: Include letters of support specific to the Administrative Core.

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.

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.

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

A Biomedical Research Core is a shared facility that provides a needed service to Center investigators, enabling them to conduct their funded individual research projects more efficiently and/or more effectively. Cores should be designed to furnish a group of investigators with materials, techniques, determinations, instrumentations, and/or quality control to enhance research and contribute to cost effectiveness.

Cores may be proposed to support any research activity of the Center, but usually fall into one of the following categories:

• Collection, storage and distribution of data and samples;
• Provision of specialized tools and technologies or access to specialized expertise;
• Development, standardization, and distribution of reagents and/or protocols;
• Provision of technical assistance, training, and enrichment programs;
• Recruitment of patients and coordination of patient studies;
• Beta-testing and dissemination of specialty assays, methods, and services on an institutional level;
• Increasing interdisciplinary interactions at the institution through cross-project/ laboratory exchange; and
• Sharing of specialized tools, technologies and expertise between collaborating investigators.
• Clinical and translational research Cores could provide biostatistical expertise for study design and data management and analysis; bioinformatics support; infrastructure for recruiting and managing clinical research subjects and/or tracking and analyzing clinical samples; technologies useful for phenotyping and characterizing subjects or exploring clinical pathophysiology; and expertise for behavioral assessment or intervention.

Regional/National/International Cores: Centers are encouraged to propose Cores that provide unique resources to a community outside the Institution. These could be on a regional level, a national level, or an international level.

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

SF424 (R&R) Cover (Biomedical Research 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 (Biomedical Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Biomedical Research 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.

Facilities and Other Resources: The description of the physical arrangements and instrumentation for the cores should be given special attention. Arrangements for sufficient space for Core activities or for access to appropriate established facilities must be made.

Other Attachments: The following attachment should be included in order to aid in the review of applications. The filename provided for the attachment will be the name used for the bookmark in the application image. The attachment should be in .pdf format.

Core Facility Use: Please title this attachment "Core Facility Use" and, indicate the Core User, Funded Project that supports the Core use, Period of Core Use, services used, and estimated use and comments.

Project /Performance Site Location(s) (Biomedical Research Cores)

List all performance sites that apply to the specific component.

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

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director and provide a valid eRA Commons ID in the Credential field. A director must be named for each core.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Biomedical Research Core)

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

Personnel: This category should include salary support for key personnel, including the Core Director, Co-Director, and other professional and technical personnel. The Core Director must devote a minimum of one person month to the Core to ensure adequate oversight. The salary amount charged to the O'Brien Center grant must be commensurate with the time spent on Core activities, and is subject to institutional and NIH salary policies. A Core Director with requisite expertise may devote greater effort to the Core, and with exceptionally strong justification could devote up to 12 person months. Salary support for technicians and other Core personnel are allowable in accordance with the volume and type of work in the Core. Stipends (and tuition) for research trainees (e.g. graduate students, postdoctoral fellows) are not available through the Center.

Equipment: If specialized equipment costing more than $5,000 per piece is requested, the application must identify similar equipment already available within the institution and provide a clear justification for purchase based on core service provided to O'Brien Center investigators. Requests for general-purpose equipment should be included only after determining the availability of such items within the institution and unmet needs. Justify the request based on this availability. Equipment may be requested only in the initial year of the proposed project period.

Travel: If well-justified and related directly to Core activities/functions, limited travel funds for Core professional staff may be requested to support travel to national scientific meetings/workshops.

Supplies: Consumable supplies directly related to the operational aspects of the O'Brien Center Core facilities are an allowable expense. This includes office materials as well as laboratory supplies. The supply budgets of separately funded individual research projects must be appropriately reduced to reflect such support, thus eliminating duplication.

Research Patient Care Costs: Research patient care costs (both inpatient and out-patient) are an allowable expense. Attempts should be made to use existing clinical facilities, such as those supported by Clinical and Translational Science Awards (CTSAs) and individually supported beds. Costs already budgeted in individual projects should be appropriately reduced if such costs are to be transferred to the Center. The O'Brien Center is not intended to be a facility for health care delivery. Thus, only those patient costs directly related to research activities may be charged to the Center.

Other Expenses: Funds for equipment maintenance/service contracts may be requested, but should reflect only an equivalent percentage of the service contract based on the overall use of the specified equipment by Center investigators versus other users. The budget justification for any maintenance/service contracts should document use of the equipment by Center members. Only in very rare cases should full support for a maintenance/service contract be requested, and strong justification must be provided in such cases.

Consultants: Include costs associated with consultants (e.g. consultant fees, per diem, teleconferences, and travel) when their services are required by the Core.

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

PHS 398 Research Plan (Biomedical Research Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component

Specific Aims: Describe the specific aims of the Biomedical Research Core and how these relate to the overall theme and goals of the Center.

Research Strategy: It is acceptable to develop a cost recovery system to help defray costs to the Center. This system would charge a fee to Center participants for services provided by the Core, but at a reduced rate. If such a cost recovery system is developed, a detailed charge justification must be presented. Participating Center members must also be informed to include such costs with their full budget justifications in their applications for individual grant support.

Justification for proposing a Core: The establishment of and continued support for a Biomedical Research Core within a Center must be justified on the basis of use by Center investigators. The minimum requirement is significant use by two or more PDs/PIs, each with a Center project. While investigators holding awards from the Center’s Pilot and Feasibility Program are appropriate users of the Core facilities, their use does not contribute to justification for establishment or continued support of a Core. Additionally, the minimum of two independently funded users does not in itself provide sufficient justification, and will receive close scrutiny in review. The organization and proposed mode of operation of each Core should be described, with a plan for prioritizing investigator use of the Core, and criteria for determining Core users or potential users.

Core Access and Cost Recovery: Core resources must precisely define issues regarding access to Core services, including investigator eligibility requirements for services, and policies and procedures for prioritization of services when demand exceeds capacity. Financial considerations such as calculations that justify investment of funds in Core services (e.g., comparative costs of other sources of proposed Core services) and policies for cost recovery from investigators for use of services should also be included.

The Core must have in place a procedure to evaluate efficiency and to maintain appropriate quality control. Limited developmental research is an additional appropriate function of a Core facility, as long as the research is related directly to enhancing the function or utility of the Core and is not an undertaking that should be funded through other mechanisms. The Core should develop policies and procedures for ensuring continuing evolution of Core services in response to changing needs. New technologies or services might appear that should be supported, existing technologies might become less important, or economic changes might obviate the need for Core services, such as the availability of cost-effective commercial services or Core services provided by the research institution. Cores should address the issue of allocation of resources to development of new technologies versus provision of services with existing technologies. The Core must also have well-defined policies to ensure that intellectual property is identified and appropriately protected, but these issues should not impede the sharing of resources. Teaching the investigators and/or their staff members' new techniques and methodologies is also an important function of the Core. The Core is not intended to supplant investigator capabilities; rather, it is intended to enhance the opportunities of investigators to learn and become proficient in the technologies available through the Core.

Letters of Support: Include letters of support specific to the Biomedical Research Core.

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.

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 (Biomedical Research Core)

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 P and F Program .

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

SF424 (R&R) Cover (Pilot and Feasibility Program)

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 (Pilot and Feasibility Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot and Feasibility Program)

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.

Facilities and Other Resources: A description of the resources and working arrangements required to implement and conduct the proposed research should be fully elaborated with particular attention to a description of necessary resources, participants, clinical populations, tissue resources, biological models, existing data sets, etc., which will be involved in the proposed studies.

Other Attachments: The following attachments should be included in order to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image. All attachments should be in .pdf format.

Pilot Project Outcomes (renewal applications only): Please title this attachment "Pilot Project Outcomes" and list all Pilot Projects supported in full, or in part, by the O'Brien Center. Provide information on the most recent 5 or, if applicable, 10-year period. Include the years funded, awardee, dates and amount of Pilot and Feasibility funding, pilot project title and brief description, Pilot and Feasibility award type (i.e. new investigator; established investigator), numbers of abstracts and publications derived from pilot support, resulting grants funded or pending applications (including grant number/funding agency and project period), and whether the Pilot and Feasibility awardee is still involved in nephrology research.

Pilot Project Summary/Abstract: Please title this attachment "Pilot Project Information" and provide a Project Summary/Abstract for each proposed Pilot and Feasibility project (including any proposed Core use), as well as the biographical sketch of the investigator for each of the proposed Pilot and Feasibility projects.

Project /Performance Site Location(s) (Pilot and Feasibility Program)

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 (Pilot and Feasibility Program)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field. The program must have a director who is an established investigator in nephrology research.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. The Project Lead should be a qualified investigator and is responsible for the scientific direction and conduct of the individual research component

Budget (Pilot and Feasibility Program)

Budget forms appropriate for the specific component will be included in the application package. Each pilot/feasibility study is limited to direct costs of $60,000 per year and a two-year duration of support. Smaller budgets are allowed.

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 (Pilot and Feasibility Program)

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component

Specific Aims: Describe the specific aims of the Pilot and Feasibility Program.

Research Strategy: Describe the management of the Pilot and Feasibility program. Applicants must describe the process for soliciting, reviewing, and selecting projects to be funded. There must be a committee representing all aspects of the Center that will assist the Director in the management of the Pilot and feasibility Program. Committee members should be listed as key personnel for the Pilot and Feasibility Program.

Letters of Support: Letters of support for the specific Pilot and Feasibility Program only should be included.

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.

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.

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

PHS Inclusion Enrollment Report (Pilot and Feasibility Program)

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

The Enrichment Program may provide support for visiting scientists, seminars, and research forums. Students, fellows, and junior faculty should be encouraged to take full advantage of all Center-sponsored seminars, courses, workshops, and symposia. If appropriate, Centers may waive fees for attendance at such events for interested students, fellows, and junior faculty members. Enrichment Program-sponsored mini-sabbaticals, or other instructional opportunities, also may be appropriate for postdoctoral fellows.

When preparing your application in ASSIST, use Component Type Enrichment Program

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

SF424 (R&R) Cover (Enrichment Program)

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 (Enrichment Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Enrichment Program)

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.

Facilities and Other Resources: A description of the resources and working arrangements required to implement and conduct the proposed research should be fully elaborated with particular attention to a description of necessary resources, subjects, clinical populations, tissue resources, biological models, existing data sets, etc., which will be involved in the proposed studies.

Other Attachments (renewal applications only; optional): If not already described, additional critical documentation of Center-supported Enrichment Program activities, such as agendas/flyers for O'Brien retreats, symposia, workshops, meetings, specialized courses, seminar series, etc., illustrating the interactions among Center members and other investigators, as well as other educational opportunities may be included in the application. This should be loaded as a file in .pdf format titled "Enrichment Program".

Project /Performance Site Location(s) (Enrichment Program)

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 (Enrichment Program)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. The Project Lead should be a qualified investigator and is responsible for the scientific direction and conduct of the individual research component.

Budget (Enrichment Program)

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

Stipends for fellows are never an allowable Center expense, but travel, per diem, and registration expenses may be paid from Enrichment Program funds. Limited travel support is allowable for the Center investigators to travel to present scientific findings, learn new laboratory techniques, develop new collaborations, or engage in scientific information exchange. In all cases, the Enrichment Program should further the overall aims and objectives of the O'Brien Center as well as of the scientific Cores

Personnel: This category should include salary support for key personnel, including the Project Lead and any other professional and administrative personnel. The Enrichment Program Director must devote a minimum of 1 person month to ensure adequate oversight of the Program. Salary support charged to the O'Brien grant must be commensurate with the time spent on Program activities and is subject to institutional and NIH salary policies.

Other Expenses: Include funds to support Enrichment Program activities such as workshops, research fora, symposia, Center retreats and seminar series. Funds for Enrichment Program-associated activities such as the printing and distribution/mailing of brochures, programs, and meeting materials, as well as posters and other advertisement materials, may be requested.

Consultants: Include costs associated with consultants (e.g. consultant fees/honoraria, per diem, and teleconferences) when their services are required by the Enrichment Program.

Travel: Travel funds to support visiting scientists under the auspices of the Enrichment Program may be requested.

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 (Enrichment Program)

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component

Specific Aims: Describe the specific aims of the Enrichment Program.

Research Strategy: Describe plans for the Enrichment Program and indicate the Program’s value to Center members.

Renewal applications: Indicate how the program has grown or been adapted to better serve Center members' needs during the past funding period; Future directions and plans to ensure continuing evolution and relevance of the enrichment program; Other considerations (include plans to enhance interactions with relevant NIDDK supported T32 training programs)

Letters of Support: Letters of support for the specific Enrichment Program only should be included. Letters of acknowledgment and support from T32 PD/PIs should also be provided.

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.

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

Not Applicable.

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: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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

For assistance with your electronic application or for more information on the electronic submission process, visit 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.

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

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

Does the Center 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 Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: What is the relevance of the separate research projects to the Center objectives, and what is the likelihood for meaningful collaboration among Center investigators? What is the potential of the Cores for contribution to ongoing research, including their appropriateness, benefit, relevance, uniqueness, modes of operation, and suitability of facilities, at local and national levels? Do renewal applications document the use, impact, quality control, and cost effectiveness of each Core, and demonstrate progress of any developmental research in the cores? Are a minimum of two users (exclusive of Pilot and Feasibility projects) documented for each Core?

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

Specific to this FOA: Are the Center investigators responsible for the individual research projects willing to interact with each other and contribute to the overall objectives of the O Brien Center? What are the scientific and administrative leadership abilities of the proposed Center Director and Associate Director and their commitment and ability to devote adequate time to the effective management of the program? Will the investigative team enhance synergy throughout the Center?

Is appropriate administrative organization proposed for the following: (a) Coordination of ongoing research between the separately funded projects and the Center, including mechanisms for internal monitoring; (b) Establishment and maintenance of internal communication and cooperation among the Center investigators; (c) Establishing a mechanism for selecting and replacing professional or technical personnel within the Center, including the Cores; (d) Establishing a mechanism for reviewing the use of and administering funds for the Pilot and Feasibility program; (e) Managing capabilities that include fiscal administration, procurement, property and personnel management, planning, budgeting, and other appropriate capabilities? Will the administrative structure enhance synergy throughout the Center? Will the Investigator and key staff attend the Annual meeting?

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

Specific to this FOA: Do the Cores provide unique and important regional, national or international resources? Do the Cores provide opportunities for enhancement of synergy?

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

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

Specific to this FOA: Is there institutional commitment to the Center, including lines of accountability regarding management of the Center grant and the institution's contribution to the management capabilities of the Center? Is there clear potential for interaction with scientists from other departments and institutions? Is there efficient and effective use and/or planned use of the limited Enrichment funds, including the contribution of these activities in enhancing the objectives of the Center? Does the environment enhance synergy?

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

Research Base Productivity

Foremost, does the research base to be supported by the Center show evidence of a strong and consistent record of productivity and peer-reviewed funding in Center-related research areas?

Core Functions

Do the proposed Cores fill a need present in the kidney research community, and will they provide services that would otherwise be unavailable, or be more cost-effective to conduct centrally? Is the necessary technical and analytical expertise available? Does the application demonstrate ability to monitor use and utility of the Cores, and provide approaches to ensure continuing development and evolution of services as needs of the community change? Does the existing Center show clear evidence of successful implementation of a cost structure to support expanded and/or evolving Center activities? Do the new applications document a clear intent to implement a cost structure to support expanded and/or evolving Center activities?

Synergy

Does the Center function as a unit in which the whole is greater than the sum of its parts?

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 project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of 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.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

For Renewals, the committee will consider the progress made in the last funding period.

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.

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NIDDK in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• 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 on the basis of established PHS referral guidelines 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 appropriate national Advisory Council or Board. 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.

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.

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.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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: http://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

Paul L. Kimmel MD
National Institute of Diabetes and Digestive and Kidney Disease (NIDDK)
Telephone: 301-594-7717
Email: [email protected]

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

Norma DeGuzman
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-480-1810
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.