Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

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

Funding Opportunity Title

George M. O’Brien Kidney Research Core Centers (P30)

Activity Code

P30 Center Core Grants

Announcement Type

Reissue of RFA-DK-07-002

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-DK-11-008

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 George M. O’Brien Kidney Research Core Centers to support both basic and clinical research on kidney disease.  The goal of the O'Brien Kidney Research Core Center program is to make state-of-the art technologies and resources readily accessible to a broad spectrum of investigators who are pursuing studies in relevant topic areas.  The emphases for this program are fourfold: (1) To attract new scientific expertise into the study of the basic mechanisms of kidney diseases and disorders; (2) To encourage multidisciplinary research focused on the causes of these diseases; 3) To explore new basic areas with translational potential; and 4) To generate Developmental Research (DR)/Pilot and Feasibility (P&F) studies which should lead to new and innovative approaches to study kidney disease.  Information about the current George M. O'Brien Kidney Research Core Centers may be found at the following URL: http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/.   

Key Dates
Posted Date

June 22, 2011

Letter of Intent Due Date

October 15, 2011

Application Due Date(s)

November 15, 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 16, 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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Background

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

Much progress has been made since the initial solicitation for O’Brien Kidney Research Centers in 1987. This program not only allows for, but encourages regional, national and even international collaboration. While there is still no cure for chronic kidney disease, the number of patients progressing to kidney failure now appears to be stabilizing, (possibly even decreasing). Despite this trend in the overall population, however, the same down turn in disease incidence has not been realized in minority populations. Additionally, while there are new genetic findings that explain some of the increased risk for disease,  many challenges remain in determining the pathophysiologic mechanisms of kidney disease that could potentially be targeted for therapeutic interventions. Similarly, acute kidney injury (AKI) remains an important clinical problem.  Although important advances have been made in understanding AKI in animals, translating that knowledge from experimental models to humans is complicated by its heterogeneity, and has fallen short of expected goals of impacting on the morbidity and mortality of this disease. 

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 Polycystic Kidney Disease (PKD) Research and Translation Core Centers.  These Centers are part of an integrated program of kidney-related research support within the NIDDK.  Centers have provided a focus for increasing the efficiency and collaborative effort among groups of successful investigators at institutions with established comprehensive kidney research bases. 

Research Goals and Scope

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

Project Organization

Institution and Research Base

A Kidney Research Core Center must be an identifiable unit within a single institution such as a university medical center, or within a consortium of cooperating institutions. In either case, Kidney Research Core Center applications must be associated with an existing program of excellence in biomedical research in kidney disease.  Program excellence is measured through a consistent and outstanding record of productivity and peer-reviewed research funding in kidney disease and related research areas.  A high level of integration and close collaboration among Center personnel from diverse scientific disciplines is an important feature of a successful Kidney Disease Core Research Center. Accordingly, the applicant should clearly state considerations for Center membership with specific reference to the potential of members to form interactive, collaborative and synergistic relationships. Center applicants should identify one or more central themes or focus areas that link Center investigators and their research programs.

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

Biomedical Resource Cores

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

Examples of types of biomedical core resources that would be considered responsive to this Request for Applications include, but are not limited to:

Collection, analysis, storage and distribution of data and samples;

Provision of specialized tools and technologies or access to specialized expertise;

Development, standardization and distribution of reagents and/or protocols;

Provision of technical assistance, training, and enrichment programs;

Recruitment of patients and coordination of patient studies;

Development, beta-testing and dissemination of specialty assays, methods, and services on an institutional level;

Increase interdisciplinary interactions at the institution through cross-project/laboratory exchange;

Sharing of specialized tools, technologies and expertise between collaborating investigators

Administrative Core

In addition to biomedical cores, 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, all O'Brien Kidney Research Core Centers will be required to maintain a Center website, with the Administrative Core taking primary responsibility for its curation and oversight.

Pilot and Feasibility Program

Each Core 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 $60,000 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/C109078B-2886-42CA-A050-49508AC812DC/0/RFADK11008P30guidelines.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 O'Brien Kidney Research Core Center. 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 O'Brien Kidney Research Core Center and CTSA activities. In addition, applicants should address the potential for integration, harmonization, and enhancement of O'Brien Kidney Research Core Center activities through cooperation with other NIH-supported core facilities at the applicant institution.  Other NIH-supported Centers and associated cores at the institution should be identified, and assurances provided that overlap or redundancy in core services will be avoided unless expressly required to fulfill the mission of the O'Brien Kidney Research Core Center.

The proposed budget should include travel for the Program Director/Principal Investigator (PD/PI) and Associate Center Director, or other key personnel, to attend an annual O'Brien Kidney Research Core Centers meeting.  The application should include a statement of willingness to attend this annual meeting.  

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.

Section II. Award Information
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 $3.6M for three awards in FY 2012.

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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Common Fund/Roadmap text, Collaborative Research, or Projects Greater than 5 years Duration:  See instructional documents in the NIH Guide Publishing System for the text to insert.

Foreign Institutions

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

Required Registrations

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.

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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

Research Base: Successful O'Brien Kidney Research Core Center applications require an existing program of excellence in biomedical research in kidney disease and  its complications. To justify Center support, the O'Brien Kidney Research Core Center must serve a large research base of NIDDK-funded investigators pursuing research activities in Center topic areas, as well as kidney disease investigators with other sources of peer-reviewed support.  Suggestions for describing and presenting this research base in the application are included in the Administrative Guidelines for NIDDK O'Brien Kidney Research Core Centers  (http://www2.niddk.nih.gov/NR/rdonlyres/C109078B-2886-42CA-A050-49508AC812DC/0/RFADK11008P30guidelines.pdf 

Section IV. Application and Submission Information

1. Address to Request Application Package

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

2. Content and Form of Application Submission

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.

Letter of Intent

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

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

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 (NIDDK)  
6707 Democracy Boulevard, Room 752
Bethesda, MD  20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: 301-594-8897
Email: fc15y@nih.gov

Application Submission

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 (NIDDK)
6707 Democracy Boulevard, Room 752
Bethesda, MD  20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: 301-594-8897
Email: fc15y@nih.gov

Page Limitations

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

Research Plan

All instructions in the PHS398 Application Guide must be followed.

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.

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

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 the NIDDK, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Supplemental Instructions for the Preparation of O'Brien Kidney Research Core Center Applications

Content and order of information to be provided should be presented in the form and format as described in the O'Brien Kidney Research Core Center administrative guidelines (http://www2.niddk.nih.gov/NR/rdonlyres/C109078B-2886-42CA-A050-49508AC812DC/0/RFADK11008P30guidelines.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 O'Brien Kidney Research Core Center investigators (key personnel, research base investigators, consultants and collaborators (PHS 398- Form Pages)

Biographical sketches for PD/PI on proposed P&F projects should be included within the P&F program section.

Summary of total current and pending support of all Center participants, including levels of professional effort.  Some institutions may have multiple NIDDK-funded center grants.  In those cases, investigators who participate in multiple centers should identify their primary center affiliation to aid NIDDK in matching center resources to the research base being served.  Research grant support that is listed as 'primary' for the Diabetes Research Center, should not be reported as part of the primary research base for any other NIDDK Center grants (i.e. each research grant should be reported as part of the primary Research Base on only one NIDDK Center grant application).  List 'primary' support related to diabetes first, followed by other related research support (see Guidelines Illustration III).

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 O'Brien Kidney Disease Research Core Center.

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 base (Research Strategy is limited to 6 pages): Provide an overview of ongoing research and the impact of the Center on this research. Include an overview of the current research in kidney disease and its complications at the institution(s). An appropriate and clear presentation of the ongoing research base is critical since it will show the research focus of the O'Brien Kidney Research Core Center and the interrelationships and potential for collaborations among investigators.  Since the research base projects will already have been peer- reviewed, the quality of the individual funded projects will have been established and will not be re-evaluated. Provide sufficient detail to assist reviewers in judging the extent and the interrelatedness of ongoing research. Grouping the research base into areas of emphasis for the Center is advised. Significant research accomplishments should be cited, and it may be helpful to include a few reprints as examples of the research conducted by Center participants as an appendix to the application, if not publically available.

New applications: Emphasize the anticipated impact of the establishment of an O'Brien Kidney Research Core Center on the research base. Include an indication of how the establishment of a O'Brien Kidney Research Core Center will provide added dimensions and new opportunities for kidney research, along with increased cooperation, communication, and collaboration among investigators.

For Renewals: Progress including description of significant findings and new participants. 

Description of biomedical research base investigators: Organize the  presentation of the research base to emphasize the focus of the research and the interrelationships of the Diabetes Research Center investigators. 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: (1) the grant number, title, and a few descriptive sentences, and (2) a list of the core(s) used with a brief sentence indicating what aspect of the research justifies the use of each core. Include ONLY those grants awarded to investigators at the applicant institution or consortium, not to investigators at other locations, in the description of the research base. It is particularly important to provide a few sentences indicating the relatedness of a cited grant to research in kidney diseases when this is not readily apparent from the title of the grant.

Document collaborative efforts using a format such as Guidelines Illustration IV to aid in the review process.

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

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 for the program (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 VI)

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)    

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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.

Overall Impact - Overall

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).

Scored Review Criteria - Overall

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

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?   

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 O’Brien Core 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 funded projects and the Center, 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 Core 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?  Are the cores providing unique regional, national or international resources? 

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?      

Additional Review Criteria - Overall

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.

The following additional review criteria apply to all new and renewal  O'Brien Kidney Research Core Center applications.  Foremost, does the research base to be supported by the Center show evidence of a strong and consistent record of productivity and peer-reviewed funding in Center-related research areas? Do the proposed cores fill a need present in the kidney research community, and will they provide services that would otherwise be unavailable, or be more cost-effective to conduct centrally?  Is the necessary technical and analytical expertise available?  Does the application demonstrate ability to monitor use and utility of the cores, and provide approaches to ensure continuing development and evolution of services as needs of the community change?  Do the existing Centers show clear evidence of successful implementation of a recharge structure to support expanded and/or evolving Center activities?  Do the new proposals document a clear intent to implement a recharge structure to support expanded and/or evolving Center activities? 

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. 

Research Base:

Does the Center show evidence of a stable or growing research base with strong and consistent record of scientific excellence and achievement reflected in an outstanding level of productivity and continuing success in securing peer-reviewed research funding?

Does the Center show evidence of fostering multi-disciplinary collaborations among Center investigators?

Biomedical Cores:

Are the number and impact of papers that acknowledge the Center sufficient to justify each core?

Is there a significant fraction of papers that acknowledge the Center but do not have core personnel as co-authors?

Are the number and listing of Center investigators who have used the core and resultant key advances consistent with the level of core investment?

Are there sufficient numbers of users who are not core personnel or their collaborators?

Are the number and listing of users who are not Center personnel or members consistent with the best utilization of the core by the community?

Are the numbers of tests completed for each core indicative of a growing need and sufficient to justify continued support?

Is the capacity of each core with current resources sufficient to serve the needs of the Center community?

Does the Center provide evidence of ability to evolve cores to meet changing needs of the research community?

Does the Center provide evidence of Program Income and sufficient institutional support?

Does the Center website show evidence of continuing maintenance and a high level of quality and usability?

Pilot & Feasibility Program:

Are the numbers and types of P&F awards well justified?

Are papers generated under these awards, projects successfully funded with independent grants, and key advances linked to these awards well documented and consistent with the level of support provided?

Revisions

Not Applicable.

Additional Review Considerations - Overall

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. Is the requested budget directly correlated to the breadth, quality and relevance to kidney disease areas of the research base being served by the Center?   

2. Review and Selection Process

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:

Applications will be assigned to the appropriate NIH Institute or Center and 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:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

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

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

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

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. 

Section VII. Agency Contacts

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

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
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

Scientific/Research Contact(s)

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

Peer Review Contact(s)

 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

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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