Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Funding Opportunity Title	Pediatric Centers of Excellence in Nephrology (P50)
Activity Code	P50 Specialized Center
Announcement Type	Reissue of RFA-DK-06-011
Related Notices	July 11, 2016 - This RFA has been reissued as RFA-DK-16-032.
Funding Opportunity Announcement (FOA) Number	RFA-DK-11-009
Companion FOA	None
Number of Applications	Only one application per institution is allowed as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.847
FOA Purpose	This Funding Opportunity Announcement (FOA) invites new and renewal applications for the Pediatric Centers of Excellence in Nephrology to support both basic and clinical research on pediatric kidney disease. The emphases for this program are several-fold: (1) to continue to attract new scientific expertise into the study of the basic mechanisms of kidney diseases and disorders among infants, children, and adolescents; (2) to encourage multidisciplinary research focused on the causes of these diseases; 3) to explore new basic areas that may have clinical research application and 4) to design Developmental Research (DR)/Pilot and Feasibility (P&F) studies which should lead to new and innovative approaches to study kidney disease in the pediatric population, and the eventual submission of competitive investigator-initiated R01 research grant applications. These Centers complement the O Brien Kidney and Urological Research Centers. Information about the current NIDDK supported Centers may be found at the following URL: http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/.

Posted Date	July 21, 2011
Letter of Intent Due Date	October 6, 2011
Application Due Date(s)	November 3, 2011
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	February / March, 2012
Advisory Council Review	May 2012
Earliest Start Date(s)	July 2012
Expiration Date	November 4, 2011
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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 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

Research Objectives

Background

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 19 years in the United States is about 15 per million population, according to the 2010 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.

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), postinfectious 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 the nephrin mutation in congenital nephrotic syndrome, a glomerular disease characterized by massive amounts of proteinuria and progressive renal failure in infants. Similarly specific podocin mutations have been linked to some forms of familial FSGS. However, the basic cellular and molecular mechanisms of the majority of pediatric kidney disorders are poorly understood. Progression often occurs even when the primary disease process has been thought to be adequately treated and the disorder appears to have become inactive. 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. In addition, the child’s special growth and developmental needs present particular challenges.

The NIDDK has funded three pediatric multicenter studies in recent years: (1) Clinical trial in children and young adults with FSGS (FSGS-CT); (2) Prospective Study of Chronic Kidney Disease in Children (CKiD); (3) Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR). Preliminary findings from these studies will inform the designs of additional clinical trials in pediatric kidney disease patients in the future.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) currently supports through the Division of Kidney, Urologic and Hematologic Diseases (DKUHD) eight George M. O Brien Kidney Research Centers, two Centers of Excellence in Pediatric Nephrology, 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.

Research Goals and Scope

The purpose of the Pediatric Centers of Excellence in Nephrology 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.

Project Organization

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. The Administrative Core will also be responsible for planning an Educational Enrichment program and for implementing a process for solicitation, review and selection of projects for the Pilot and Feasibility Program within the Center. Although funds are not provided directly for training purposes, the core laboratories and program enrichment activities should provide training 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 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 Core Center 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) (NOT-OD-04-040) for up to two years. A comprehensive description of the Pilot and Feasibility Program can be found in the Administrative Guidelines (http://www2.niddk.nih.gov/NR/rdonlyres/6C7FDEDE-62ED-4196-8CBA-935B79252CED/17891/P50guidelinesPedsCenters.pdf ).

Additional Features

Applicants from institutions with an NIH Clinical and Translational Science Award program (http://www.ctsaweb.org/) are strongly encouraged to utilize the CTSA as a resource for enhancing clinical research programs within the Pediatric Centers of Excellence in Nephrology. In such cases, appropriate letters of support from the CTSA program director or principal investigator should be included with the application detailing plans for appropriate integration and synergy of the Pediatric Centers of Excellence in Nephrology and CTSA activities. 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.

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.

Center Evolution: Centers must document policies and procedures for ensuring continuing evolution of core services in response to changing needs. New technologies or services might appear that should be supported, existing technologies might become less important, or economic changes might obviate the need for core services, such as the availability of cost-effective commercial services or core services provided by the research institution. Cores should address the issue of allocation of resources to development of new technologies versus provision of services with existing technologies. In addition, cores must have well-defined policies to insure that intellectual property is identified and appropriately protected, but that intellectual property issues do not impede sharing of resources.

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;

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.

Funding Instrument	Grant
Application Types Allowed	New Renewal The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The NIDDK intends to commit approximately $2.4 million dollars in FY 2012 for 2 awards.
Award Budget	Application budgets are limited to $750,000 in direct costs per year. These budget limits are exclusive of F&A costs on consortium and subcontract arrangements.
Award Project Period	The project period for an application submitted in response to this funding opportunity may not exceed five years.

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

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 must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) 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 PHS398 Application Guide.

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

Only one application per institution is allowed.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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 research
• Name, address, and telephone number of the PD(s)/PI(s)
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

The letter of intent should be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: 301-594-8897
Email: fc15y@nih.gov

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: 301-594-8897
Email: fc15y@nih.gov

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following additional requirements:

• Research Strategy for the Center Overview is limited to 12 pages.
• Research Strategy for the Administrative Component is limited to 6 pages.
• Research Strategy for each Project is limited to 12 pages.
• Research Strategy for each Research Core is limited to 12 pages.
• Research Strategy for each Pilot and Feasibility Program is limited to 12 pages.,
• Research Strategy for the Enrichment Program is limited to 6 pages.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Supplemental Instructions for the Preparation of Pediatric Centers of Excellence in Nephrology Applications

Content and order of information to be provided should be presented in the form and format as described in the Pediatric Centers of Excellence in Nephrology administrative guidelines (http://www2.niddk.nih.gov/NR/rdonlyres/6C7FDEDE-62ED-4196-8CBA-935B79252CED/17891/P50guidelinesPedsCenters.pdf ) with adjustments as indicated in this FOA. An overview of the structure of a responsive Center application is provided below. Every effort should be made to provide information in tabular or chart form where indicated in the guidelines to facilitate application preparation and review. Failure to comply with these instructions may result in return of the application without review.

SECTION 1: CENTER OVERVIEW

Face Page, Descriptive Abstract, Key Personnel and Table of Contents should be prepared as per standard instructions.

Budgets

1. Detailed Budget for Initial Budget Period (398- Form Page 4)

2. Budget for Entire Proposed Project Period (398- Form Page 5);

3. Consolidated budget for first year of requested support (See Guidelines Illustration I; budgets for each individual Core should immediately precede the narrative for each Core)

4. Distribution of Professional Effort (see Guidelines Illustration II)

Biographical Sketches (in alphabetical order): for all Center investigators (key personnel, consultants and collaborators (PHS 398- Form Pages)

Biographical sketches for principal investigators on proposed P&F projects should be included within the P&F program section.

Resources Format Page:

Facilities and Major Equipment: general overall description of research facilities (space, equipment, collaborations, etc.) and the major, shared pieces of equipment to be used by Center members should be provided.

Specific core facilities, equipment, and special resources should also be listed in each core component.

Specific Aims (limited to 1 page): Provide the broad, long-range objectives and goals of the proposed Pediatric Center of Excellence in Nephrology.

Research Strategy (limited to 12 pages): This narrative section summarizes the overall plan for the proposed or established multi-component Center. The multi-component application should be viewed as a confederation of interrelated research resources that are complementary to one another. This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall Center by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems. As the strategy develops, each individual research component/core should be cited briefly as to its place in the overall scheme. 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 as described in the PHS 398 Instructions. For Renewals: Changes from the original Center design should be highlighted.

SECTION 2: ADMINISTRATIVE COMPONENT (Research Strategy is limited to 6 pages)

Description (PHS 398- Form Page 2)

Key personnel (PHS 398- Form Page 2 cont d)

Budget with comprehensive budgetary justifications (PHS 398- Form Page 4); funds requested for the P&F and enrichment programs should be included in the "other expenses" category of the budget for the Administrative Core.

Biographical Sketches: Director and Associate Director(s) (PHS 398 Form page)

Specific Aims (limited to 1 page): Describe the broad, long-range objectives and goals of the Administrative structure within the context of the proposed Center.

Research Strategy (limited to 6 pages): Presentation of the administrative structure; Relationship and lines of authority and sanction by appropriate institutional officials; Description of the process that would be used to recommend a successor to the Director, if needed; Committee structure (include External and Internal advisory boards and the pilot and feasibility program oversight committee; Description of plans for website development, maintenance and curation; General overall description of facilities and institutional commitment; Other Considerations (include listing of other relevant Centers and cores at the institution and affiliated hospitals, and plans to integrate, harmonize and reduce redundancies in activities)

SECTION 3: BIOMEDICAL RESEARCH COMPONENT

Biomedical research cores (present each core separately; Research Strategy limited to 12 pages per core)

1. Description (PHS 398- Form Page 2)

2. Key Personnel (PHS 398- Form Page 2-cont d)

3. Budget with justifications (PHS 398- Form Page 4)

4. Biographical sketches: Core Director and key personnel (PHS 398- Form Page)

5. Specific Aims (limited to 1 page): List in priority order, the broad, long-range objectives and goals of the proposed core. In addition, state the core’s relationship to the Center goals and how it relates to the other cores at the applicant institution and in the application.

6. Research Strategy, including: Objectives of the core; Core function, including quality control; Benefits from core; Proposed developmental research or training; Future directions and plans to ensure continuing evolution & relevance of the core; For renewals: Core progress and productivity (include 2-3 examples of literature citations, grant awards, and 2-3 key advances supported by core activity); to assist reviewers, for each core also refer to the page numbers of the individual core-specific research publications in Guidelines Illustration VII; if applicable, describe any recharge system that may be in place to allow investigators to utilize a core, including information on any proposed F&A charges to outside users of the core.

7. New applications: investigators who will use the core and proposed extent of use (see Guidelines Illustration III). For Renewals: Core Use during the last grant period (see Guidelines Illustration III)

Individual Research Projects (present each separately; Research Strategy limited to 12 pages per project

1. Description (PHS 398- Form Page 2)

2. Key Personnel (PHS 398- Form Page 2-cont d)

3. Budget with justifications (PHS 398- Form Page 4)

4. Biographical sketches: Project Director and key personnel (PHS 398- Form Page)

5. Specific Aims (limited to 1 page): List in priority order, the broad, long-range objectives and goals of the proposed core. In addition, state the core’s relationship to the Center goals and how it relates to the other cores at the applicant institution and in the application.

6. Research Strategy

Pilot and Feasibility Program

1. Description (PHS 398- Form Page 2)

2. Key Personnel (PHS 398- Form Page 2-cont d)

3. Budget with justifications (to be included in the Administrative Component budget; justify any changes for future years)

4. Biographical sketches: Program Director and Committee (PHS 398- Form Page)

5. Specific Aims (limited to 1 page):

6. Research Strategy (limited to 12 pages): Management of the pilot and feasibility program; Program progress and productivity (include key publications supported by the P&F program, grant awards resulting directly from P&F awards, and 2-3 key advances supported by the P&F program); Future directions and plans; For initial applications include: eligibility requirements, selection process, abstracts of proposed P&F awards, and justification for core usage by P&F awards; For competing renewal applications include: Total number of all P&F submissions received each year during the prior project period, selection process and funding success rates, single paragraph synopses of Pilot & Feasibility studies awarded during the last project period.

7. For Renewals: Pilot and Feasibility Project Outcomes (see Guidelines Illustration IV)

Enrichment Program (limited to 6 pages, exclusive of form pages)

1. Description (PHS 398- Form Page 2)

2. Key Personnel (PHS 398- Form Page 2-contd)

3. Budget with justifications (to be included in Administrative Component budget)

4. Biographical sketches: Program director and key personnel (PHS 398- Form Page)

5. Specific Aims (limited to 1 page)

6. Research Strategy (limited to 6 pages): New applications: Describe plans for the enrichment program; Renewal applications: Describe the enrichment program and indicate the program’s value to Center members. 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 acknowledgment and support from T32 PIs should be provided separately)

SECTION 4: CENTER-RELATED INFORMATION (suggested Illustrations only)

Suggested Illustration for Renewal Applications: Publications Citing Support from this Center during the past project period. List only those publications that clearly used Center resources (e.g. core or P&F support); do not list all publications from Center members (see Guidelines Illustration VII; include PMCID numbers).

Checklist (PHS 398- Form Page)

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the PHS398 Application Guide.,

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NIDDK, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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/priority 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.

Significance

Does the Center address an important problem or a critical barrier to progress in the field? 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, added value, relevance, uniqueness, modes of operation, and suitability of facilities? Do renewal applications document the use, added value, 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?

Investigator(s)

Are the PD/PIs, 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?

Innovation

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

Approach

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

If the Center involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 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/priority score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

When the proposed Center involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Revisions

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/priority score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDDK, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments 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/priority score.
• Will receive a written critique.

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.

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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.

Not Applicable.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) 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.

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Marva Moxey-Mims, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-7717
Email: mm726k@nih.gov

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8897
Email: fc15y@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 Parts 74 and 92.