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; 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.

Required Application Instructions

It is critical that applicants follow the 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

Kidney disease is a major cause of illness and death in infants, children and adolescents. The incidence of end-stage renal disease (ESRD) in patients age 0 21 years in the United States is about 15 per million population, and has been stable for the past two decades, according to the 2015 USRDS Annual Data Report. The primary etiologies vary with age, but structural anomalies predominate. Data in the most recent report from the Chronic Kidney Disease arm of the North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS) indicate that overall, more than 50% of the patients in the registry had some type of structural anomaly. This diagnosis approaches 75% in infants. Approximately one third of adolescents in the study have some type of glomerular disease; >50% of African-American adolescents and 35% of Hispanic adolescents. These figures are consistent with the distribution of diagnoses seen in the NIDDK funded Chronic Kidney Disease in Children (CKiD) Study.

There are also several causes of acute kidney injury (AKI) particularly pertinent to the pediatric population, which are in need of translational research. These include hemolytic uremic syndrome (HUS), post infectious glomerulonephritis, and post cardiac surgery AKI.

Progress is being made in molecular and genetic analyses to link specific gene products to normal or abnormal kidney growth and development, and some human kidney diseases. For example, many genetic mutations have been identified as causative in some forms of familial focal segmental glomerulosclerosis (FSGS), as well as in some sporadic cases. However, the basic cellular and molecular mechanisms of the majority of pediatric kidney disorders remain poorly understood. Several diseases that lead to chronic kidney disease and end-stage renal disease (ESRD) in adults likely have their origin in childhood; notable examples are diabetes and hypertension. Up to one third of children who develop Type 1 diabetes will develop ESRD in their twenties or thirties. Therefore, strategies to prevent kidney disease should begin in childhood, ideally. A great need exists to better understand the pathogenesis of these conditions, and the child’s special growth and developmental needs present particular challenges.

The NIDDK 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.

Currently funded NIDDK pediatric multicenter studies include the Prospective Study of Chronic Kidney Disease in Children (CKiD) and the Recombinant Erythropoietin for Protection of Infant Renal Disease (REPAIReD). Additionally, there are pediatric cohorts in the Nephrotic Syndrome Study Network (NEPTUNE), the Cure Glomerulonephropathy (CureGN) Network, the Rare Kidney Stone Consortium, and the Assessment, Serial Evaluation, and Subsequent Sequelae of Acute Kidney Injury (ASSESS-AKI) study. Preliminary findings from these studies will inform the designs of future clinical trials in pediatric kidney disease patients.

The NIDDK currently supports through the Division of Kidney, Urologic and Hematologic Diseases (DKUHD) seven George M. O Brien Kidney Research Centers, three Pediatric Centers of Excellence in Nephrology (PCEN), and four Centers for Polycystic Kidney Disease Research. 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 purpose of the PCEN is to attract a partnership of interdisciplinary research among investigators with scientific expertise who will use complementary and integrated approaches to study kidney diseases endemic to the pediatric population. In approaching the study of these disease processes it is anticipated that extensive collaboration will be required among individuals in the clinical and basic sciences, including cell biology, molecular biology, immunology, virology, genetics, epidemiology, biochemistry, physiology and pathology. Studies designed to foster and extend the development of new approaches into the causes, early diagnoses, improved treatment, and where possible, prevention of these diseases and disorders are appropriate.

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 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 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.

Administrative Core

In addition to biomedical cores, an Administrative Core must be described 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 program enrichment activities should provide educational opportunities for Center members. In addition, the Pediatric Centers of Excellence in Nephrology should maintain a Center website, with the Administrative Core taking primary responsibility for its curation and oversight.

Pilot and Feasibility (P and F) Program

Each Center must develop a cohesive Pilot and Feasibility Program to develop new research directions or provide an opportunity for new investigators or established investigators to enter the field of kidney research. 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 two up to a maximum of four pilot projects. Each pilot project may request a maximum of $50,000 direct costs per year (excluding Facility and Administrative costs) for up to two years.

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 Pediatric Centers of Excellence in Nephrology.

Representative, but not all-inclusive areas of research appropriate for investigation include:

(1) Studies of renal disorders of genetic and congenital origin that may lead to progressive loss of renal function or cause severe metabolic imbalances in children;

(2) Further identification and study of genes and gene mutations and molecular events involved in renal and urogenital morphogenesis and differentiation;

(3) Studies of events involved in cellular signaling in renal morphogenesis in health and disease, including the definition of events involved in cellular communication and mechanisms by which growing cells influence and are influenced by extracellular matrix;

(4) Immune-mediated disorders, including such diseases as post-infectious glomerulonephritis, human immunodeficiency virus (HIV), immunoglobulin A (IgA) nephropathy, and Wegner’s granulomatosis;

(5) Studies to understand the molecular mechanisms underlying the renal hypertension in infants and children;

(6) Studies addressing the short and long-term effects of anti-hypertensive agents in infants and children;

(7) Identification of risk factors and predisposing factors contributing to renal disease progression in infants and children;

(8) Studies addressing the etiology, pathophysiology, and treatment strategies for end-stage renal disease in infants and young children, including determinants of abnormal growth and development, the development of animal models to quantitate the contribution of selective variables in growth retardation in chronic renal failure, the effects of exogenous recombinant hormones, and the role of uremia in protein synthesis in young growing infants; and

9) Cellular and molecular studies underlying the development and progression of glomerulonephritis in children, including the molecular changes affecting the glomeruli, alterations of the basement membrane, mechanisms leading to proteinuria, and the biochemistry of the nephron during pathological states.

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

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

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

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

Only one application per institution is allowed.

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

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

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

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

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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

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

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

The letter of intent, preferably electronically, should be sent to:

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

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

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

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

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Biomedical Research Cores: required, minimum of 2
• Research Projects: required; minimum of 2; maximum of 4
• Pilot and Feasibility Program: required, maximum of 1
• Enrichment Program: required

Center Overview 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 Pediatric Center of Excellence in Nephrology (PCEN) 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, reserch projects, and the pilot & 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, Research Projects, Pilot and Feasibility and Enrichment programs) on 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 usage; 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 PCEN 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 utilized (if the grant listed is also included in the other Center(s) research base). The 'Current Grant Support' table should include research project grants relevant to pediatric nephrology research 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 pediatric nephrology research but would not be direct users of the core services.

Biographical Sketches of PCEN Research Base Investigators: Please title this attachment "PCEN Research Base Biographical Sketches." Provide biographical sketches for all PCEN members, as defined by the PCEN 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 the application.

Description of PCEN Research Base Investigators: Please title this attachment Description of PCEN 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 of the investigator’s research projects, as well as a brief description regarding what aspect of the investigator s research justifies the use of PCEN 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 pediatric 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 PCEN Members" and organize alphabetically by research base investigator (last name). List all PCEN investigators including Membership Category (only if more than one category of Membership is designated by the PCEN), and for each PCEN research base investigator indicate those PCEN Core Facilities that will be used.

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

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

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 PCEN. 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. The Center Director should be an experienced and respected individual who can provide scientific and administrative leadership for the total program. This individual must be able to coordinate, integrate, and provide guidance in establishing new programs in pediatric kidney disease research. This commitment will require significant effort from the Center Director. Each Center Director is expected to commit 2.4 person months (calendar year) overall effort to the Center.

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

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

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

Specific Aims: Describe the theme and goals of the Center and how they will advance pediatric kidney 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 how the Center will achieve its major objectives. The reason a Center approach is needed for this work should be well-articulated. The unique contribution for 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 research cores and individual research projects. A justification for the proposed administrative and organization 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.

In addition, applicants should address the potential for integration, harmonization, and enhancement of Pediatric Centers of Excellence in Nephrology 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 Pediatric Centers of Excellence in Nephrology.

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 to all appropriate publications and manuscripts accepted for publication, that have resulted from the project since it was last reviewed competitively. Identify the core(s) utilized in association with the publication. List publications only once. Within individual biomedical research core descriptions, refer to publications associated within 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 overall Center should be included with the Center Overview. When collaborating with an institutional CTSA, appropriate letters of support from the CTSA PD/PI should be included with the application detailing plans for appropriate integration and synergy of the Pediatric Centers of Excellence in Nephrology and CTSA activities. 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.

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

All applications, regardless of the amount of direct costs requested for any one year, should address a 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 Core 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 2.4 person months. Most Centers find that the size and complexity of a PCEN warrant inclusion of a program administrator, so salary support for this individual should be included in the Administrative Core. Where possible and applicable, PCENs 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 service provided to PCEN 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 PCEN. The applicant should budget travel funds for the Center Director(s), Core and Project leads to travel to an annual 1-day meeting in Bethesda, MD.

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 PCEN, such as the members of the External Advisory Board.

Other Expenses: Funds for supporting the institutional PCEN 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.

Specific Aims: Describe the aims of the Administrative Core and how these will advance pediatric nephrology research in the Center.

Research Strategy: The administration of the PCEN will include the responsibility of coordinating the various functions of the Center. It is expected that the administrative organization of the PCEN will include a supportive structure, such as an internal executive committee to ensure accomplishment of (1) Coordinating and integrating the Center components and activities; (2) Review the use of funds for pilot and feasibility studies; (3) Provide advice to the Director about the productivity and effectiveness of the activities of the Center; and (4) Interact 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 the Center programs requires close interaction between the Center Director, the Core Directors, Project Leads, appropriate institutional administrative personnel, the staff of the awarding agency, and the members of the community in which the Center is located. Therefore, each Center applicant should establish an administrative structure that will permit the development of such interaction. The administrative 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. 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 Core)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Biomedical 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.

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.

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 1 person month to the Core to ensure adequate oversight. The salary amount charged to the PCEN 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 PCEN 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 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. The applicant should budget travel funds for the Center Director(s), Core and Project leads to travel to an annual 1-day meeting in Bethesda, MD.

Supplies: Consumable supplies directly related to the operational aspects of the PCEN 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 in-patient 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 PCEN 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 usage 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.

PHS 398 Research Plan (Biomedical Research Core)

Specific Aims: Describe the specific aims of the Biomedical Research Core.

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 biomedical research cores within a PCEN must be justified on the basis of use by Center investigators. The minimum requirement is significant usage by two or more principal investigators 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.

Each 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, so 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. The Core 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, they are 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 Project.

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

SF424 (R&R) Cover (Research Project)

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 (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

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.

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

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 (Research Project

• 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 (Research Project)

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

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.

Personnel: This category should include salary support for key personnel, including the project director, co-director, and other professional and technical personnel. The Project Director must devote a minimum of 1.2 person months to the project to ensure adequate oversight. The salary amount charged to the PCEN grant must be commensurate with the time spent on project activities and is subject to institutional and NIH salary policies. 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. 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 be requested only in the initial year of the proposed project period.

Travel: Funds for Center investigators/faculty to attend national or international scientific meetings or workshops may be requested, if well-justified and related directly to Core activities/functions.

Supplies: Consumable supplies directly related to the operational aspects of the PCEN project 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 coming from biomedical research cores, thus eliminating duplication.

Research Patient Care Costs: Research patient care costs (both in-patient 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. Request costs relating to the clinical research efforts of PCEN investigators ONLY if there is no overlap with other funding. The PCEN 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.

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

PHS 398 Research Plan (Research Project)

Specific Aims: Describe the specific aims of the Research Project.

Research Strategy: The Research Project must be integrated with, and contribute to, the overall goals of the Center program. The Research Strategy should include a clear description of the major goals and objectives, and how they integrate with the other research components in relation to the overall Center program. The hypotheses to be tested should be focused and fully detailed. The design and procedures should describe the strategies proposed to accomplish the specific aims. Innovative aspects of the approach should be highlighted. If resource core services are used, information on their use should be provided. If trainees are included in the research project, describe their roles in carrying out the aims of the project.

Letters of Support: Letters of support for the specific Research Project 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.

PHS Inclusion Enrollment Report (Research Project)

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, subjects, 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 PCEN. Provide information on the most recent 5 or, if applicable, 10-year period. Include the years funded, awardee, dates and amount of P and F funding, pilot project title and brief description, P and F 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 P and F awardee is still involved in pediatric 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 pediatric nephrology research.
• Committee members should be listed as key personnel for the Pilot and Feasibility Program.
• 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 $50,000 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)

Specific Aims: Describe the specific aims of the Pilot and Feasibility Program, which should support a minimum of two and maximum of four pilot projects.

Research Strategy: Describe the management of the pilot and feasibility program. Applicants should describe the process for soliciting, reviewing and selecting projects to be funded. There must be a committee representing all the aspects of the Center that will assist the director in the management of the 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.

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.

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 PCEN 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.

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.

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 0.6 calendar months to ensure adequate oversight of the Program. Salary support charged to the PCEN 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.

PHS 398 Research Plan (Enrichment Program)

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 PDs/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.

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 (Enrichment Program)

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

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

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

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the 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 project 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? 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? 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 Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are the Center investigators responsible for the individual research projects willing to interrelate with each other and contribute to the overall objectives of the 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? Is appropriate administrative organization proposed for the following:(a) Coordination of ongoing research between the separately projects, including mechanisms for internal monitoring;(b) Establishment and maintenance of internal communication and cooperation among the Center investigators;(c) Mechanism for selecting and replacing professional or technical personnel within the Center;(d) Mechanism for reviewing the use of and administering funds for the P&F program;(e) Management capabilities that include fiscal administration, procurement, property and personnel management, planning, budgeting, and other appropriate capabilities?

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?

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? Is there institutional commitment to the program, 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?

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

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

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

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

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

Not Applicable

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

Not Applicable

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

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

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.

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.

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.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Marva Moxey-Mims, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7717
Email: moxeymimsm@mail.nih.gov

Michele Barnard, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8898
Email: barnardm@mail.nih.gov

Amanda Linehan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4749
Email: linehana@mail.nih.gov

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.