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

Diabetes Research Centers (P30)

Activity Code

P30 Center Core Grants

Announcement Type

Reissue of RFA-DK-11-015

Related Notices
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number

RFA-DK-13-004

Companion Funding Opportunity

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

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications for Diabetes Research Centers, formerly named Diabetes Endocrinology Research Centers (DERCs) and Diabetes Research and Training Centers (DRTCs).  Diabetes Research Centers are designed to support and enhance the national research effort in diabetes, its complications, and related endocrine and metabolic diseases.  Diabetes Research Centers support three primary research-related activities:  Research Core services, a Pilot and Feasibility (P&F) program, and an Enrichment program.  All activities pursued by Diabetes Research Centers are designed to enhance the efficiency, productivity, effectiveness and multidisciplinary nature of research in Diabetes Research Center topic areas.  The NIDDK Diabetes Research Centers program in 2013 consists of 16 Centers each located at outstanding research institutions with documented programs of excellence in diabetes-related research.  General information about the NIDDK Diabetes Research Centers program may be found at www.diabetescenters.org

Key Dates
Posted Date

July 17, 2013

Open Date (Earliest Submission Date)

May 17, 2014

Letter of Intent Due Date(s)

May 17, 2014

Application Due Date(s)

June 17, 2014, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October/November, 2014

Advisory Council Review

January, 2015

Earliest Start Date

April, 2015

Expiration Date

June 18, 2014

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

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

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Program Objectives

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Diabetes Research Center grants to support research in diabetes mellitus and its complications, and in related areas of endocrinology and metabolism.

The prevalence of diabetes mellitus in the United States is reaching epidemic proportions and accounts for a huge national burden of morbidity, mortality, and health care expenditures.  The mission of the Diabetes Research Centers is to serve as a key component of the NIDDK-supported research effort to develop new therapies and improve the health of Americans with, or at risk for, diabetes and related endocrine and metabolic disorders.  The Centers promote new discoveries and enhance scientific progress through support of cutting-edge basic and clinical research related to the etiology and complications of diabetes, with the goal of rapidly translating research findings into novel strategies for the prevention, treatment and cure of diabetes and related conditions.

To accomplish this mission, the Diabetes Research Centers:

Institution and Research Base

One of the primary objectives of the Centers is to bring together investigators from a variety of scientific disciplines in a manner that will enhance and extend the effectiveness of their research.  In addition to collaborations between scientists within an institution, Centers may also foster interactions and collaborations between investigators at multiple institutions to promote a multifaceted approach to a common goal.  A Diabetes Research 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, Diabetes Research Center applications must be associated with an existing program of excellence in biomedical and/or behavioral research in diabetes as well as related areas of metabolism and endocrinology.  Program excellence is measured through a consistent and outstanding record of productivity and peer-reviewed research funding in diabetes and related research areas.  This research should be in the form of NIH-funded research projects (R01), program projects (P01), or other peer-reviewed research, such as that supported by the American Diabetes Association and the Juvenile Diabetes Research Foundation.  Research programs outside the primary institution where the Center is based may utilize the core resources and participate in Center activities; Centers are encouraged to explore such opportunities. 

The base of research projects to be served by the cores must be clearly defined and justified in the application.  The research base for the Center must consist of at least $3,000,000 of peer-reviewed research projects. The research base for a Center is made up of investigators with individually-funded research projects who can benefit from shared resources.  Center funding will provide support for core facilities (shared resources), pilot and feasibility studies (new initiatives), and program enrichment activities.  Except for pilot and feasibility studies, Center funds are not intended to support individual biomedical or behavioral research projects other than through core usage.  The major source of support for biomedical research projects associated with the Center should be derived from separately-funded projects of the participating investigators.  Similarly, professional trainee stipends are not to be supported through Center funding.

At the time of initial submission, the applicant institution, or consortium of institutions, must have an active program of excellence in basic and clinical biomedical and behavioral research in the area of diabetes and related areas of endocrinology and metabolism.  The biomedical research base will be given emphasis in the peer review process.  There should be a focus on diabetes; however, related endocrinology and metabolism research relevant to diabetes may also be included in the research base.  Focus, relevance, interrelationships, quality, and to some extent quantity, are all considerations in judging the adequacy of the research base.

Center Structure and Activities

The organization and structure of the Diabetes Research Center should reflect the goals of the Center, encourage collaboration, develop and implement Diabetes Research Center-wide initiatives, and promote the use of shared resources and Pilot & Feasibility Program funds. The structure can change as needed based on new scientific opportunities and partnerships. This major underpinning of the Diabetes Research Center allows for modifications of programmatic and scientific activities and areas of support to fully capitalize on the most exciting research opportunities in diabetes-related research areas.

Administrative Core

Diabetes Research Center applications must include an Administrative Core that will be responsible for allocation and oversight of Center resources.  The Administrative Core is expected to ensure the coordination and integration of Diabetes Research Center components and activities.  The Administrative Core should have a process to a) assess the productivity, effectiveness, and appropriateness of Center activities; b) determine criteria and selection process for Center membership; and, c) foster collaborations and scientific opportunities among its members..  In addition, all Diabetes Research Centers will be required to maintain an institutional Center website, with the Administrative Core taking primary responsibility for its curation and oversight, as well as for ensuring proper and seamless integration of the Center website with the NIDDK Diabetes Research Center program website (http://www.diabetescenters.org/).

Biomedical Research Cores

Diabetes Research Centers are designed around Research Cores that provide shared, specialized technical resources and/or expertise that enhance the efficiency, productivity, and multidisciplinary nature of research performed by Center-affiliated investigators.  The goal of the Diabetes Research 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.  Moreover, cores are intended to facilitate basic, clinical and translational research in diabetes, endocrinology and metabolic diseases in order to accomplish the stated goals of the individual Center and of the NIDDK Centers program.

Each Research Core should provide state-of-the art services to multiple, funded research projects.  A Center may support research at a single or set of cooperating institutions through an Institutional Core.  In addition, Diabetes Research Center applicants may propose to share core services or functions with other Centers in the Diabetes Center program in order to expand, enhance, or increase the cost-effectiveness of research activities at the Center institution.  Examples of biomedical research cores that would be considered responsive to this FOA include, but are not limited to:

These cores are not listed in any particular order, nor do they represent a comprehensive list of possibilities.  In responding to this FOA, applicants are encouraged to propose cores that address specific objectives based on the unique requirements of investigators at the applicant institution(s).  Particular emphasis should be placed on services that support and foster interdisciplinary, integrated and translational approaches to research in Diabetes Center topic areas.  Preference will be given to core support services that are not readily available or cost-effective when supplied from commercial sources, and techniques or technologies that may be technically challenging or require specialized expertise, equipment or infrastructure.  Proposed Diabetes Center research cores may be an institutional shared research core.  In such cases, the research core support provided by the Diabetes Center should be proportional to the use of the institutional research core by Diabetes Research Center members.  Moreover, applicants should demonstrate that support for the existing resource through the Diabetes Research Center provides added value to the resource beyond that which would be provided by paying for the use of the resource through a fee for service.  As with other research cores, details about access and prioritization of Center members to the shared research core(s) should be provided.  Moreover, the applicant should document that the Diabetes Center will be in a position to have some input to, and oversight of, the shared institutional core with respect to its management, planning for future changes and improvements, etc.  

The need for core support from the Diabetes Research Center must be well justified, with clear documentation of a broad user base of NIDDK-funded investigators pursuing research activities in Center topic areas, as well as diabetes investigators with other sources of peer-reviewed support.  Participants in the Diabetes Center program are encouraged to become fully integrated into, and synergistic with, other NIDDK- and NIH-funded Centers within their institutional setting. This includes the clinical research homes being established by the Clinical and Translational Science Awards (CTSAs) supported by the NIH (https://www.ctsacentral.org/), other related NIH Common Fund activities (http://commonfund.nih.gov/), and any related NIDDK-funded Center programs such as the Nutrition Obesity Research Center (NORC) Program (http://www.norccentral.org/) and the Centers for Diabetes Translation Research (CDTR; http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-10-009.html).  Applicants should provide information on other programs supporting related resources at their institution and describe the nature of synergy and integration between the Diabetes Research Center and these other activities.  Applicants must also clearly describe how duplication or redundancies of effort, services and resources will be avoided.  Leveraging of existing resources that provide a range of services or efficiency that would not otherwise be available is also encouraged.

Pilot and Feasibility Program

The Diabetes Research Center Pilot and Feasibility (P&F) program provides seed support for new and innovative research projects directed at basic biomedical, clinical, behavioral and translational research questions relevant to diabetes and its complications.  Typically, at least 20-25% of the overall Center direct costs, exclusive of equipment and consortium Facilities and Administrative (F&A) costs, should be devoted for support of P&F projects.

Funding and Duration of Support: It is anticipated that up to $50,000 in direct costs per year for up to two years will be provided for the majority of approved P&F projects. However, a limited number of P&F applications may be selected for support as enhanced P&F awards with prior NIDDK approval. Enhanced P&F awards require prior approval from NIDDK and will be selected from worthy proposals in the following three project categories: clinical and translational research awards, clinical and basic research innovative partnership awards, or technology research and development awards. These enhanced awards may be funded at up to $100,000 direct costs per year and for up to two years. Efforts to increase the number of P&F awards and availability of funds for the program through the use of program income or alternative funding sources are particularly encouraged.

The P&F program is particularly directed at new investigators and established investigators new to diabetes research. Established diabetes investigators pursuing high impact/high risk projects or projects that are a significant departure from their usual work are also eligible for support under the Diabetes Research Center P&F program. P&F programs may also be structured to provide support for establishing interdisciplinary collaborations and to help forge new partnerships between basic scientists and clinical researchers. While the distribution of P&F funds to be used in each award category is ultimately at the discretion of the Center P&F committee, it is expected that the Center P&F program will, where possible, place particular emphasis on funding innovative clinical and translational research projects.

Named New Investigator (optional): Each Diabetes Research Center may provide salary support for a P&F project recipient whom they designate a Named New Investigator.  Salary support for this individual is generally for up to 2 years, and cannot exceed $90,000 per year, not including the appropriate fringe benefits; the level of effort for the Named New Investigator must be 9.0 to 12.0 calendar months.  These funds are included within the budget for the Pilot & Feasibility Program component, if requested, and the initial Named New Investigator should be clearly identified in the application.  The individual selected should be a New Investigator who meets the P&F project eligibility criteria and is a permanent resident or U.S. citizen. Individuals are eligible only once for this support.  Subsequent candidates for this position are nominated by the Center and reviewed by its External Advisory Board.  Appointment of the Named New Investigator is contingent upon the concurrence of the External Advisory Board and the NIDDK program director.

Enrichment Program

The Diabetes Research Center must provide support for enrichment activities to foster multidisciplinary approaches to diabetes research and to attract new investigators or investigators with relevant expertise to diabetes research.  While many of these activities occur at the grantee institution, applicants are encouraged to suggest coordinated efforts, such as educational activities, that might operate on a regional or national level and involve multiple Diabetes Research Centers.  

Limited support for an Enrichment Program under the auspices of the Diabetes Research Center may be requested.  Support for visiting scientists, seminars, and research fora are appropriate items for inclusion in an enrichment program as well as any appropriate, innovative means to support the goals of the Center, e.g. short-courses, etc.  Also, limited travel support may be requested to allow Diabetes Research Center investigators to learn new laboratory techniques, to develop new collaborations, or to engage in scientific information exchange.  In all cases, the enrichment program should further the overall aims and objectives of the Diabetes Research Center as well as its cores.  Creative new programs, not precluded by NIH or NIDDK policies, are encouraged. While Diabetes Research Centers may not support stipends for postdoctoral fellows, the environment fostered by the existence of the Center with its core facilities in conjunction with the enrichment program educational opportunities should serve to foster the careers of postdoctoral fellows and junior faculty, including K-awardees.

Additional Opportunities for Resource Cores (optional; opportunities to exceed the $1M direct costs cap, but not to exceed $1.25M in direct costs)

The principal goal of the opportunities listed below is to provide NIDDK Diabetes Center research core services (and pilot and feasibility grant opportunities) to diabetes researchers at institutions that are not currently served by an NIDDK Diabetes Research Center.

1) To broaden the scope and reach of the Diabetes Research Center P&F program, a Center may propose to serve a wider scientific community by expanding the Diabetes Center P&F program to a different institution(s). Expansion of the P&F program to an affiliated institution/hospital is encouraged, but is not sufficient to be considered a Regional/National program for purposes of expanding the allowable requested funds. In general, NIDDK currently expects Diabetes Research Centers to allow investigators at affiliated hospitals or institutions to participate in the Center P&F program. Applicants may request funds to expand their P&F program to researchers at non-Diabetes Research Center institutions, and the applicant should provide details on how F&A costs for P&F grants will be handled with the partnering institution(s).

2) To broaden the scope and reach of current research core services, a Center may propose to serve a wider scientific community on a geographic or national level through the establishment of a Regional/National Shared Resource Core that is located at a different institution. Such a Regional/National Core may not be established with an affiliated hospital of the applicant organization; such an arrangement would be considered an institutional, rather than a regional/national, core for the purposes of this FOA. If the Center is primarily located at an affiliated hospital, core(s) based at another affiliated hospital of the same academic institution will not be considered Regional/National Shared Resource Cores. With a regional or national core located at a different institution, the Center will service a specific research base that is expanded beyond investigators at the academic institution and/or affiliated hospitals where the Center is primarily located. Support for the expansion of the Center P&F program to investigators at the institution where the Regional/National Shared Resource Core is located may also be requested (see optional opportunity above).  

3) A Diabetes Research Center may serve a wider scientific community on a geographic or national level through the establishment of a Regional/National Shared Resource Core that is located at the applicant institution or an affiliated hospital. Such a Regional/National Shared Resource Core should provide a plan for expanding core services to investigators outside of the parent academic institution and its affiliated hospitals. Applicants should document that there is sufficient demand by the wider scientific community for the expansion (or establishment) of the proposed core services. The research base in diabetes at the institution(s) that would use the regional core(s) should also be documented. Plans for prioritization of research core services, as well as training to the broader research community, should be provided.  Funds requested for this opportunity must be carefully documented and justified, and should be dedicated solely to expanding core services to investigators outside of the parent institution or an affiliated hospital.  Support for the expansion of the Center P&F program to the partnering institution(s) may also be requested (see optional opportunity above).

Subcontracts to Support Underserved or Health Disparity Populations (optional; subcontracts for this funding opportunity have no direct costs cap)

Diabetes Research Centers may propose partnerships that establish research cores and/or P&F programs at institutions of higher education (i.e., rural institutions, historically black colleges and universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs) and Hispanic-serving Institutions (HSIs) and Alaska Native and Native Hawaiian Serving Institutions), or other agencies that focus on underserved or health disparity populations. The primary goal of such partnerships is to foster scientific collaborations and to provide access to the Diabetes Research Center infrastructure to investigators at these institutions or organizations in order to foster health disparities research in populations disproportionately affected by diabetes. All funds exceeding the cap proposed for this purpose must be awarded to the institution that serves underserved or health disparity populations. Funding for activities supporting the collaboration at the Diabetes Research Center institution must be included within the Diabetes Research Center cap.

Additional Features

Cooperation, Coordination and Integration:  applicants from institutions with an NIH Clinical and Translational Science Award (CTSA) program (https://www.ctsacentral.org/) are strongly encouraged to utilize the CTSA as a resource for enhancing clinical research programs within the Diabetes Research 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 Diabetes Research Center and CTSA activities. In addition, applicants should address the potential for integration, harmonization, and enhancement of Diabetes Research Center activities through cooperation with other NIH-supported core facilities at the applicant institution. Other NIH-supported Centers and associated cores at the institution should be identified, and assurances provided that overlap or redundancy in core services will be avoided unless expressly required to fulfill the mission of the Diabetes Research Center.

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. 

Applicants are encouraged to consult with NIDDK staff concerning plans for the development of the Diabetes Research Center and the organization of the application.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

Renewal, including active Diabetes Research and Training Center (DRTC) grants that currently use the P60 activity code

 Resubmissions from RFA-DK-11-015.

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIDDK intends to commit approximately $4.5M in FY 2015.

Award Budget

Application budgets are limited to $1.0M per year in direct costs unless the applicant organization proposes to provide regional or national core services as described in the Funding Opportunity Description section of the FOA. Applications proposing a Regional/National Shared Research Resource Core are limited to $1.25M per year in direct costs. These budget limits are exclusive of: (a) first year equipment costs, (b) direct costs on subcontracts to health departments, community health centers or other institutions/agencies that focus on underserved or health disparity populations for the purpose of establishing collaborations and providing access to the research infrastructure to investigators at these institutions to foster health disparities research in populations disproportionately affected by diabetes, and (c) F&A costs on consortium and subcontract arrangements.  It is anticipated that the award budget will be directly correlated to the breadth, quality and relevance to diabetes and related areas of the research base being served by the Center.

Award Project Period

The project period 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

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 SF424 (R&R) 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(s)/PI(s)) and component  Core/Program Leads who are not yet registered in eRA Commons must work with their institutional officials to register. Also, institutional officials at the applicant organization should ensure that the eRA Commons account for the contact PD/PI is affiliated with their organization.

eRA Commons accounts are necessary to use ASSIST to prepare and submit applications.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 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(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

Because a Diabetes Research Center has a large and complex administrative structure, the Project Director/Principal Investigator (PD/PI) must have strong leadership abilities and demonstrated proficiency in managing large, multi-component programs.  The Diabetes Research Center PD(s)/PI(s) must also be willing to participate in annual meetings of the Center Directors.

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 (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Research Base: Successful Diabetes Research Center applications require an existing program of excellence in biomedical research in the area of diabetes, its complications, and in related research in endocrine and metabolic diseases. To justify Center support, the Diabetes Research Center must serve a large research base of NIDDK-funded investigators pursuing research activities in Center topic areas, as well as diabetes investigators with other sources of peer-reviewed support.  The research base for the Center must consist of at least $3,000,000 of peer-reviewed research projects.

Section IV. Application and Submission Information


1. Requesting an Application Package

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

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

2. Content and Form of Application Submission

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

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

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

Page Limitations


Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall (use for Center Overview)

12

Admin Core

6

Core (use for Biomedical Research Cores)

12

P&F Program (use for Pilot & Feasibility Program)

12

Enrichment Program

6


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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF 424 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

http://nih-extramural-intranet.od.nih.gov/ElectronicSubmission/files/multi-project_app_pkgs.pdf

Overall Component (Center Overview)

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

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

SF424 (R&R) Cover (Center Overview)

Complete entire form.

PHS 398 Cover Page Supplement  (Center Overview)

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

Research & Related Other Project Information (Center Overview)

Follow standard instructions.

Project Summary/Abstract:  Describe the scientific theme(s) of the Diabetes Research Center and the need for a Center to support the investigators in the research base.  Include the number of Center members and the overall direct costs present in the research base.  Provide a brief overview of the research base as it relates to the theme(s) of the Center, as well as an overview of the biomedical research cores, and the pilot & feasibility and enrichment programs.

Project Narrative:  In 1-3 sentences describe the relevance of the research to be supported and facilitated by Center activities (Core services; P&F and Enrichment programs) on public health.

Facilities and Other Resources:  Describe the existing environment and facilities briefly in the context of how the Center will use or change existing access, space, and usage; include space maps as needed (see "Other Attachments") and letters of institutional commitment (see 'Letters of Support'). Scientific personnel and institutional resources capable of supporting the research base must be available.

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

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

Project/Performance Site Location(s) (Center Overview)

Enter primary site only.

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

Research & Related Senior/Key Person Profile (Center Overview)

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

Budget (Center Overview)

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

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

PHS 398 Research Plan (Center Overview)

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

Specific Aims:  Describe the broad long-term objectives of the proposed Diabetes Research Center.  A strategic vision, theme, and set of goals must be developed and described in the application. Provide a written strategy for how the Diabetes Research Center will implement this vision and which future directions will likely be followed during the project period. The plan should outline the existing skills, technologies and scientific research base and other resources at the institution. This plan should delineate how the Center will enhance ongoing projects, assist in the introduction of outstanding new projects, respond to future challenges and opportunities, and promote collaborations, advances in technology, and progress in diabetes research. Detail expected scientific outcomes including a description of anticipated impact on human disease and public health. 

Research Strategy: 

Research Base:

The Center Core grant provides a mechanism for fostering interdisciplinary cooperation within a group of established investigators conducting high quality research on diabetes and related areas of endocrinology and metabolism.  Therefore, existence of a strong, substantial research base in this area is a fundamental requirement for, and the most important aspect of, the establishment of a Center. 

Applicants should include an overview of current research in diabetes, its complications, and related areas being conducted at their institution in sufficient detail to allow reviewers to judge its extent and the interrelationship of ongoing research.  The relevance to diabetes of all research included in the research base should be described.  Applicants should indicate how the establishment of a Center will provide added dimensions, such as greater focus and increased cooperation, communication and collaboration that would not likely occur without Center resources.   

A high level of integration and close collaboration among Center personnel from diverse scientific disciplines is an important feature of a successful Diabetes 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.  Criteria for becoming a Diabetes Research Center ‘member’ should be clearly defined.  Each Center, however, is expected to formulate these definitions based on its own situation.  Center membership and affiliation are often open to those individuals who would like to promote the mission of the Center.  Specific membership criteria, and any affiliation categories (if applicable), should be clearly defined in order to better organize and facilitate the focus of the Center’s mission.  Subsets of members based on their degree of participation or other quantitative measures are acceptable.  Applicants should provide clear guidelines for a) how Center membership(s) is (are) defined; b) the application and selection processes for Center membership; and c) the obligations of Center membership.  Suitable criteria include, but are not limited to, peer-reviewed independent funding, participation in diabetes-related research, and the need for the use of core facilities.  All research base investigators should be Center members.  Designation as a Center member without the need for the use of core facilities must be well-justified. 

Presentation of the research base in the application should be done in two ways:  (1) by completing a Table (see "Other Attachments," like the one shown in "Grant Support"; Table A:  http://www2.niddk.nih.gov/Funding/FundingOpportunities/NIDDKDiabetesResearchCenters), and (2) by a full narrative description of the diabetes and related research activities at the applicant institution and any collaborating institutions.  This presentation should be organized into several areas of emphasis that demonstrate the research focus of the Center.  The research of each Center participant should be discussed and interrelationships of research being conducted by Center participants should be highlighted.  Since most, if not all, of the research base will have undergone separate peer review, the quality of the individual funded projects is already established.  The more important aspects are:  (a) interactions and interrelationships of the research efforts; (b) uses and benefits of core services; and (c) plans to develop productive collaborations among Center investigators.

Document collaborations and interrelationships of the Center members use by using a format such as a Table to aid in the review process (see "Other Attachments," like the one shown in "Center Collaborations" Table C: (http://www2.niddk.nih.gov/Funding/FundingOpportunities/NIDDKDiabetesResearchCenters).  

Strategic Vision:

Theme – Provide the central theme(s) of the Diabetes Research Center and the likely supported research, resources, and relevance to diabetes. The theme may be broad or focused, depending upon the goals of the Center.  For clearer presentation, it is recommended that Center applicants subdivide the research base into areas of research emphasis or central research themes that link Center members and their research programs.  Appropriate presentation of the research base is very important since its assessment is a primary emphasis in the evaluation of an application. 

Goals and Directions – Describe the current and future directions for the Diabetes Research Center in the forthcoming project period. Indicate how the research supported by the Center will impact the understanding of diabetes, its complications and, ultimately, public health.  Describe the short, mid- and long-term goals and measures of success.  Describe the likely advances expected in the field of diabetes and how these advances can be applied to human disease and public health.  Describe any basic science work that has successfully been translated to the bedside or community or plans to enhance that translation in the next project period.  Describe the expected, widely-applicable research tools and scientific advances that will emerge from the Center’s emphasis. Document how the Center will organize and lead the team towards these advances. Identify levels of risk for these goals, potential roadblocks to achieving them, and how the Center might respond to these challenges. Renewal applications must also describe the accomplishments of the Center in the preceding project period and how it intends to build upon its successes. These accomplishments should be presented, as appropriate in the areas of basic science, clinical research, public health, and prevention. The impact of Center-based science should be discussed in detail.

Biomedical Research Cores are to be discussed within the Strategic Vision. Brief examples of ongoing or planned research should be discussed as appropriate with reference to the supporting Core.  Do not provide an exhaustive list of ongoing incremental research.  Weave significant findings and advances throughout the narrative of this section to demonstrate the leadership and impact of the Center on building its diabetes-related research program.

Document the overall need for the proposed cores by the Center members by using a format such as a Table to aid in the review process (see "Other Attachments," like the one shown in "Core Use by Center Members" Table B: http://www2.niddk.nih.gov/Funding/FundingOpportunities/NIDDKDiabetesResearchCenters).   

Integration of investigators of multiple skills and talents – Outline steps the Diabetes Research Center will take to promote interdisciplinary studies and collaborations, especially among basic scientists and clinical researchers. Describe the types of initiatives that will stimulate the teams and attract high-caliber professionals. Indicate to what degree the high-risk/high-payoff research that may require long-term support will be implemented.  Document collaborative efforts using a format such as a Table (see "Other Attachments," like the one shown in "Center Collaborations" Table C: http://www2.niddk.nih.gov/Funding/FundingOpportunities/NIDDKDiabetesResearchCenters) to aid in the review process.   

Building research capacity – Provide details on the special talents and resources that will be drawn to and built upon at the Diabetes Research Center. Indicate how  these talents will be harnessed and used to promote new collaborations and produce multidimensional teams to address more complex questions. Include a plan for bringing investigators into the Center from within and outside the area of diabetes research. Describe the expertise that these individuals will share with the Center.  Describe academic and research partnerships that will be pursued by the Diabetes Research Center to advance its goals and missions.

Provide a plan to determine the need for services and instrumentation of the Center.  Address the steps that will ensure that the Diabetes Research Center proceeds at the cutting edge of technology and concepts. It is expected that biomedical research cores needs may change with time.  Include information on the process of re-evaluation of needs and implementation of changes.

Within this section, describe the research capacity and clearly identifiable major scientific focus in diabetes research. The Diabetes Research Center grant mechanism fosters interdisciplinary cooperation among established investigators conducting high-quality research related to diabetes. Therefore, existence of a strong research capability in diabetes is fundamental to establishment of a new, or continuation of an existing, Diabetes Research Center.

Innovation:

Address how the Diabetes Research Center will not only evolve with the science conducted by the Center Investigators, but also challenge and seek to advance or change current research or clinical practice paradigms by using novel theoretical concepts, approaches or methodologies, instrumentation, or interventions.  Explain how the synergy of the Center with the research base will lead to novel services and resources in the cores and their application to important questions in musculoskeletal biology and medicine. Describe the potential for interdisciplinary collaborations among Center Investigators.  For a Biomedical Research Core that by its nature is not innovative, describe how it is essential to advance the field.

Summarize the services and resources provided by the Center, and how they are managed and coordinated.  Describe how the Center will address the scientific needs of the research base. Indicate if any of the proposed cores will utilize or expand cores already existing at the institution. Describe how the proposed Center will leverage existing resources and fill gaps in the services available. Also describe how the Center will enhance the research base through enrichment activities.  

Leveraging of existing resources is encouraged, particularly when this provides a range of services or efficiency that would not otherwise be available.  Furthermore, applicants should demonstrate that support for the existing resource through the Diabetes Research Center provides added value to the resource beyond that which would be provided by paying for use of the resource through a fee for service.  Applicants from institutions that have a Clinical Translational Science Award (CTSA) funded by the NIH may wish to identify the CTSA as a resource for conducting the proposed research, if appropriate.

For renewal applications:  Consideration will be given to progress and accomplishments in the research base, to development of multidisciplinary, collaborative, and cooperative interrelationships, and to alteration in the original Center design in order to meet the evolving needs of the research base.  This should be described in a narrative fashion accompanied by a Table (see "Other Attachments," like the one shown in "Consolidated Publications List"; Table G: http://www2.niddk.nih.gov/Funding/FundingOpportunities/NIDDKDiabetesResearchCenters) that documents the contribution of individual cores to the peer-reviewed publications by the research base.  Since one of the objectives of the Center is to extend research relevant to diabetes, new areas of research and acquisition of new funding should be highlighted in the overview.    

For new applications: Emphasize the anticipated impact of the establishment of a Diabetes Research Center on the research base. Include an indication of how the establishment of a Diabetes Research Center will provide added dimensions and new opportunities for diabetes and related research, along with increased cooperation, communication, and collaboration among investigators.

Letters of Support: Include any letters of support for the proposed Center by appropriate institutional officials.  Letters should address the commitment of the parent organization, or any of its partners, to the Diabetes Research Center and its goals. The parent institution is expected to recognize the Diabetes Research Center as a formal organizational component and provide documented evidence of space dedicated to the needs of the Center, protected time to devote to Center activities, staff recruitment, dedicated equipment, or other financial support for the proposed Center. The parent institution should provide assurance of its commitment to continuing support of the Diabetes Research Center in the event of a change in directorship and a well-defined plan for this eventuality should be in place. In addition, it is expected that the Institution will support the goal of providing to Center members priority access to Institution’s and Center’s facilities and services at minimal or reduced cost.  Both the institution and pertinent departments must show a strong commitment to supporting the Center.  

If collaborative linkages are being developed between the Diabetes Research Center and the local CTSA staff and/or research personnel, a letter of agreement from the CTSA PD(s)/PI(s) should be included.   For any collaborative linkages between the CTSA and a specific Biomedical Research Core, the letter of support should be included within the specific Biomedical Research Core component of the application.

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 SF424 (R&R) Application Guide, with the following modification:

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

Administrative Core

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

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

SF424 (R&R) Cover Administrative Core

Complete only the following fields:

PHS 398 Cover Page Supplement Administrative Core

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information Administrative Core

Follow standard instructions.

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) Administrative Core

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile Administrative Core

In this component, also provide biographical sketches for any consultants; for renewal applications only, provide biographical sketches for the members of the External Advisory committee.  In the additional Senior/Key Profiles section, list these Senior/Key persons in the Project Role of 'Other' with Category of 'Consultant,' or 'Advisory Committee.' 

Budget Administrative Core

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

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

Personnel:  Most Centers find that the size and complexity of a Diabetes Research Center warrant inclusion of a program administrator, so salary support for this individual should be included in the Administrative Core.  The Center Director must devote a minimum of 2.4 person months to the Center, and at least 1.2 of those months must be within the Administrative Core to ensure adequate oversight of the Center.  If a multiple-PD/PI application, the combined effort of the PDs/PIs must be 2.4 person months.

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

Travel:  Include the costs of domestic and foreign travel only if the travel is directly related to the activities of the Diabetes Research Center.  Include travel costs for the Center Director, Associate Director, and others as appropriate (i.e. Core Directors) to attend the annual Diabetes Research Center Directors' meeting.

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

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

Alterations and Renovations:  Funds for the alteration and renovation of an existing structure to provide suitable space for core facilities may be requested.  ‘Cosmetic’ renovations are not appropriate.

Other Expenses:  Funds for supporting the institutional Diabetes Research Center website may be requested.    

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

PHS 398 Research Plan Administrative Core

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

Specific Aims:  Clearly state how the Administrative Core will contribute to the goals of the Center and outline interactions of the Administrative Core with each of the other Cores and Programs (P&F and Enrichment). Provide an overview of how the Administrative Core will set the overall direction of the Center and ensure optimal utilization of Center resources.

Research Strategy:  The Diabetes Research Center must be an identifiable organizational unit within a university medical center or a consortium of cooperating institutions including the university-affiliated Center.  Such a Center will involve the interaction of broad and diverse elements; thus, lines of authority and approval by the appropriate institutional officials must be clearly specified.  The Administrative Core plays a key role in the coordination and functioning of the Center.

Within the Research Strategy, the applicant should describe how the Administrative Core will take a leadership role in ensuring the synthesis of findings and activities from research projects and cores towards solving the central problem proposed by the Center.  In addition, direct lines of communication between the Administrative Core and Biomedical Research Cores (as well as with the P&F and Enrichment Programs) should be delineated, as all of these cores/programs serve critical roles for Center integration.

Each applicant institution specifies a Center Director(s) (PD(s)/PI(s)) to be responsible for the scientific and administrative leadership of the Center.  The Director should be an experienced and respected scientist with a proven track record for obtaining NIH funding.  She/he must be able to coordinate, integrate, and provide guidance in the establishment of new programs in diabetes and related research.  One or more Associate Directors should be named who will be involved in the administrative, scientific, or training efforts of the Center and will serve as Acting Center Director in the absence of the Director.  A process must be in place that would be used to recommend a successor to the Director, if needed.  An administrative assistant may also be proposed. 

It is expected that the organization of the Administrative Core should encompass a supportive structure sufficient to ensure accomplishment of the following:  coordinating and integrating the Center components and activities; reviewing the utilization and quality of core resources; interacting with the scientific and lay communities and the NIDDK in order to develop relevant goals for the Center; and interacting with the administrative and scientific leadership at the applicant institution(s) to enhance the visibility and effectiveness of the Center as a focus for diabetes research.  The application should include a statement of willingness of the PD/PI, Associate Center Director, or other key personnel to attend this annual meeting of Diabetes Research Center Directors.

It is expected that organization of the Administrative Core will provide a supportive structure sufficient to ensure accomplishment of the following:

The administrative structure must include an Internal Advisory Committee (IAC) and an External Advisory Committee (EAC). Renewal applications must document the functions and effectiveness of the External and Internal Advisory Committees.

The final administrative structure of the Center will be left largely to the discretion of the applicant institution.  However, past experience has demonstrated that the effective development of the Center programs requires close interaction between the Center director, Core/Program Leaders, appropriate institutional administrative personnel, the staff of the awarding agency, and the members of the community in which the Center is located.  Therefore, each Center applicant should establish an administrative structure that will permit the development of such interactions.  Within this structure, each applicant institution must also establish a mechanism to oversee the use of funds for the proposed pilot and feasibility program.  This mechanism must include the use of appropriate consultants for review from the scientific community outside the Center institution.  Consultants who will serve on advisory committees should not be specifically identified in the application but the process by which they will be selected should be described.  These same consultants may be utilized, if desired, for review of other activities of the Center.

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 SF424 (R&R) Application Guide, with the following modification:

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

Planned Enrollment Report  (Core or Project Name)

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

PHS 398 Cumulative Inclusion Enrollment Report (Core or Project Name)

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

Biomedical Research Core

When preparing your application in ASSIST, use Component Type ‘Core.’  Separate core components should be created for each individual Biomedical Research Core proposed, including optional Regional/National Shared Resource Cores or optional Biomedical Research Cores to support underserved or health disparity populations.

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

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

Complete only the following fields:

PHS 398 Cover Page Supplement (Biomedical Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Biomedical Research Core)

Follow standard instructions.

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Facilities and Other Resources:  Particularly in initial applications, the description of the physical arrangements and instrumentation for the cores should be given special attention.  Arrangements for sufficient space for core activities or for access to appropriate established facilities must be made. Centers are strongly encouraged to enter into cooperative arrangements with cores already established within their institution, or with other Centers in close proximity, when the existing cores offer the services needed.  These arrangements are important whenever greater efficiency or cost savings can be realized by such an agreement.   However, it should be clear that the Diabetes Research Center cores can function independently.  It may be advantageous for a Diabetes Center to provide support for appropriate personnel to work specifically for Diabetes Center members in an existing facility/core (e.g., transgenic animal core) at the institution. In this case, the designated Diabetes Center Core Director must work closely with the parent facility core Director to coordinate services, unless the same individual assumes both roles.

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

Core Facility Use: Please title this attachment "Core Facility Use" and for each Biomedical Research Core indicate the Core User, Funded Project that supports the Core use, Period of Core Use, services used, and estimated use and comments. Table E is provided for applicant assistance with this requirement:

(http://www2.niddk.nih.gov/Funding/FundingOpportunities/NIDDKDiabetesResearchCenters).

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

List all performance sites that apply to the specific component.

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

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

Budget (Biomedical Research Core)

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

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

Personnel: This category should include salary support for key personnel, including the core director, co-director, and other professional and technical personnel. The Core Director must devote a minimum of 0.6 person months to the Core to ensure adequate oversight.  The salary amount charged to the Diabetes Research Center grant must be commensurate with the time spent on Core activities and is subject to institutional and NIH salary policies.  A Core Director with requisite expertise may devote a greater effort to the core, and with exceptionally strong justification could devote up to 12 person months.  Salary support for technicians and other core personnel are allowable in accordance with the volume and type of work in the core.    Stipends for research trainees are not available through the Center.  Such funding must be sought through other grant mechanisms.

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

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

Research Patient Care Costs: Research patient care costs (both in-patient and out-patient) are an allowable expense. Attempts should be made to utilize existing clinical facilities, such as those supported by Clinical and Translational Science Awards (CTSAs) and individually supported beds. If the CTSA is to be used, include a letter of agreement from the PD/PI of the CTSA; such a letter (in .pdf format) may be attached as a 'Letter of support' for the appropriate Biomedical Research Core(s). 

Request costs relating to the clinical research efforts of Diabetes Research Center investigators ONLY if there is no overlap with other funding. Costs already budgeted in individual projects should be appropriately reduced if such costs are to be transferred to the Center. The Diabetes Research Center is not intended to be a facility for health care delivery.  Thus, only those patient costs directly related to research activities may be charged to the Center.

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

Alterations and Renovations: Funds for the alteration and renovation of an existing structure to provide suitable space for core facilities may be requested.  ‘Cosmetic’ renovations are not appropriate.

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

PHS 398 Research Plan (Biomedical Research Core)

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

Specific Aims:  Clearly state the aims of the Biomedical Research Core.

Research Strategy:   Cores may be based solely at the applicant institution or at multiple institutions through subcontracts.  If subcontracts are to be utilized the applicant must clearly demonstrate how a cohesive and integrated operation will be ensured and describe the advantages of this approach to the performance of core functions.  The Center may also provide resources for funded projects at collaborating institutions without a subcontractual arrangement with the parent institution. 

Definition:  A biomedical research core is a shared facility that provides a needed service to Center investigators enabling them to conduct their funded individual research projects more efficiently and/or more effectively.  Cores should be designed to furnish a group of investigators with materials, techniques, determinations, instrumentations, and/or quality control to enhance research and contribute to cost effectiveness.  A recharge mechanism is acceptable to help defray costs to the Center.  If such a cost recovery system is developed, a detailed charge justification must be presented.  Participating Center members must also be informed to include such costs with their full budget justifications in their applications for individual grant support.  Cores may be proposed to support any research activity of the Center, but usually fall into one of five categories:  (1) provision of a technology that lends itself to automation or preparation in large batches; (2) complex instrumentation; (3) animal preparation, care and characterization; (4) clinical resources; and (5) service and training.  Limited developmental research is also an appropriate function of a core facility.  Such activities, however, must be directly related to enhancing the function or utility of the Core.   

Justification for proposing a core:  The establishment and continued support of biomedical research cores within a Center are justified on the basis of use by independently-funded Center investigators.  The minimum requirement for establishing a core is significant usage by two or more investigators with independently-funded, peer-reviewed projects.  While investigators holding awards from the Center pilot and feasibility program are appropriate users of the core facilities, their use does not contribute to justification for establishment or continued support of a core.  Additionally, the minimum of two independently-funded users does not in itself provide sufficient justification and will receive close scrutiny in peer review.  Document Core use by using a format such as a Table to aid in the review process (see "Other Attachments," like the one shown in "Core Facility Use" Table E: (http://www2.niddk.nih.gov/Funding/FundingOpportunities/NIDDKDiabetesResearchCenters).

Recharge System:  A recharge system may be developed to allow investigators to utilize any core. Recharge fees are allowable budgetary items in the investigators' individual research project grants.  A system of payment management/accounting must be established such that it is clear to the individual users, the institutional business office, and the NIDDK what the recharge system covers and how funds recovered are being used. This will enable Center investigators to appropriately adjust the budgets on their own grants and ensure accountability. 

Management of the core and operational plan:  The organization and proposed mode of operation of each core should be presented.  Included should be a plan for prioritizing investigator use of the core as well as a definition of qualified users.  If use by investigators outside the parent institution is proposed, the mechanism by which such investigators will apply and be evaluated and selected should be detailed.  The definition of qualified users should not be too narrow.  Some minor core use could serve to entice established investigators in other scientific disciplines into the field of diabetes research.  Any proposed, ongoing or completed developmental efforts should be described.  If the core is used to train investigators in special techniques, the mechanism for this training should be included. 

Renewal applications:  Information relative to cores in renewal applications should generally cover all of the same points as initial applications.  In addition, past performance and accomplishments should be described and highlighted.  The effect of the service provided by a core on investigator productivity and cost effectiveness should also be addressed.  In renewal applications, any changes should be carefully documented.  Core productivity and accomplishments as demonstrated by peer-reviewed research publications supported by the core should be documented; refer to the page numbers of 'primary' publications supported by the core by using a format such as a Table to aid in the review process (see "Other Attachments," like the one shown in "Consolidated Publication List"; Table G: (http://www2.niddk.nih.gov/Funding/FundingOpportunities/NIDDKDiabetesResearchCenters). 

Letters of Support:  For Shared/National Research Cores/Resources, include any letters of support from partnering institutions.  For any collaborative linkages between the CTSA and a specific Biomedical Research Core, a letter of support should be included within the specific Biomedical Research Core component of the application.

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 SF424 (R&R) Application Guide, with the following modification:

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

Planned Enrollment Report  (Core or Project Name)

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

PHS 398 Cumulative Inclusion Enrollment Report (Core or Project Name)

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

Pilot and Feasibility Program

When preparing your application in ASSIST, use Component Type ‘P&F Program.’  Applicants who also propose an optional, expanded Diabetes Center P&F program to a different institution(s) should create a second, separate 'P&F Program' component.

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

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

Complete only the following fields:

PHS 398 Cover Page Supplement (Pilot and Feasibility Program)

Enter Human Embryonic Stem Cells in each relevant component.

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

Follow standard instructions.

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

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

Pilot Project Outcomes (renewal applications only): Please title this attachment "Pilot Project Outcomes" and list all Pilot Projects supported in full, or in part, by the Diabetes Research Center. Provide information on the most recent 5 or, if applicable, 10-year period.  Include the years funded, awardee, dates and amount of P&F funding, pilot project title, P&F award type (i.e. new investigator; established investigator), abstract and publications derived from pilot support, resulting grants funded or pending applications (including grant number/funding agency and project period), and whether the P&F awardee is still involved in diabetes research. Table F is provided for applicant assistance with this requirement (see: http://www2.niddk.nih.gov/Funding/FundingOpportunities/NIDDKDiabetesResearchCenters).

Pilot Project Summary/Abstract (new applications only): Please title this attachment "Pilot Project Information" and provide a Project Summary/Abstract for each proposed pilot and feasibility project, as well as the biographical sketch of the investigator for each of the proposed pilot and feasibility projects.  Include the biographical sketch and Project Summary/Abstract for the Named New Investigator, only if applicable.

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

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Pilot and Feasibility Program)

Budget (Pilot and Feasibility Program)

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

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

Personnel: This category should include salary support for key personnel, including the P&F Program Director, and other professional and administrative personnel. The P&F Program Director must devote a minimum of 0.6 person months to the Program to ensure adequate oversight.  The salary amount charged to the Diabetes Research Center grant must be commensurate with the time spent on P&F Program activities and is subject to institutional and NIH salary policies.  If requested, include the salary for the Named New Investigator.  Support for this individual is limited to 2 years and cannot exceed $90,000 per year, additional appropriate fringe benefits, and 9.0 calendar months effort.  The Pilot and Feasibility project summary/abstract of the Named New Investigator must be included in the P&F Program component (see "Other Attachments" for the P&F Program).

Other Expenses:  Include funds to support individual Pilot & Feasibility projects. Typically at least 20-25% of the overall Center direct costs, exclusive of equipment, should be for support of P&F projects.

Consultants:  Include costs associated with consultants (e.g. consultant fees/honoraria, per diem, and teleconferences) when their services are required by the Pilot and Feasibility Program, such as any external reviewers for P&F applications.

PHS 398 Research Plan  (Pilot and Feasibility Program)

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

Specific Aims:  Clearly state the aims of the Pilot and Feasibility Program.

Research Strategy:  The Pilot and Feasibility Program provides modest research support for a limited time (usually one to two years) to enable eligible investigators to explore the feasibility of a concept related to the mission of the Center and generate sufficient data to pursue it through other funding mechanisms. The pilot and feasibility studies are intended to: (1) provide initial support for new investigators; (2) allow exploration of possible innovative new leads or new directions for established investigators in diabetes and (3) stimulate investigators from other areas to lend their expertise to research in this area.  Pilot and feasibility study support is not intended for large projects by established investigators that would otherwise be submitted as separate research grant applications, nor is it intended to provide bridging support.  Pilot and feasibility funds are also not intended to support or supplement ongoing funded research of an investigator.

Requirements:  Each Center must propose a minimum of 2 pilot and feasibility studies to be supported from NIDDK funds each year. 

P&F award eligibility and related guidelines:  Investigators eligible for pilot and feasibility funding generally fall into three categories: (1) new investigators without current or past NIH research support as a program director/principal investigator (current or past support from other sources should have been modest); (2) established investigators with no previous work in diabetes who wish to apply their expertise to a problem in this area; and (3) established investigators in diabetes who propose testing innovative ideas that represent clear departure from ongoing research interests.  It is expected that the majority of the investigators will fall into the first category.  All eligible investigators, however, must have faculty appointments and be independent investigators.  Postdoctoral fellows or their equivalent are not eligible.  Each pilot and feasibility study proposal should state clearly the justification for eligibility of the investigator under one of the above three criteria. 

A proposed pilot and feasibility study should present a testable hypothesis and clearly delineate the question being asked, detail the procedures and approaches to be followed, and discuss how the data will be analyzed.  It must be on a topic related to the objectives of the Center. Projects should be focused, since funding for these studies is modest (typically $50,000 or less in direct costs per year per project) and is usually limited to two years or less.  Any one investigator is eligible only once for this P&F support, unless the additional proposed pilot and feasibility study constitutes a real departure from his/her ongoing research.

The application should clearly describe and justify the pool from which potential pilot and feasibility applications will be selected.  This can be limited to investigators at the parent institution or expanded to include investigators at institutions with a well-defined affiliation with the Center.  Such an affiliation can occur either through a sub-contractual relationship for support of core resources, or through inclusion of funded projects at a collaborating institution in the research base utilizing the shared resources of the Center.  The mechanisms by which information on the availability of pilot and feasibility awards will be disseminated and by which applicants will apply and be selected for these awards must be described and will be an important element in the review of the pilot and feasibility component of the Center.

Initial review and management of the pilot and feasibility program:  By the very nature of this program, a significant responsibility for its management will be left to the Center administration during the project periods.

Since pilot and feasibility studies can be awarded for varying periods of time, these studies may end at various times.  In addition, the studies may also be terminated by the Center administration before their approved time limit for various reasons:  e.g., (1) the investigator may receive outside funding for the project; (2) the project was found not to be feasible; (3) the investigator may leave the Center institution; etc.  When this occurs, the Center may make new awards for pilot and feasibility studies with the remaining funds. 

While a Center's administrative framework for management of the pilot and feasibility program is basically left up to each Center (subject to NIH peer review), certain minimal requirements must be met.  The P&F program must have a Director who is an established investigator in diabetes research.  There must also be a committee representing all the aspects of the Center to assist the P&F Director in the management of the program.  The major responsibilities of the P&F Program Director and the committee will be to:

(1)  Maintain oversight and review of progress for ongoing pilot and feasibility studies;

(2)  Make recommendations regarding termination or other actions to the Center Executive Committee (or equivalent);

(3)  Prepare and ensure appropriate distribution of announcements of the availability of pilot and feasibility funding;

(4)  Arrange and preside over the scientific merit review of proposals.  At least one reviewer from outside the parent institution must be used for each proposal.  All reviewers should assign  impact scores in accordance with the NIH system.  Copies of all of the proposals with written documentation of their reviews, impact scores, and final action must be retained by the Center. These records must be made available to reviewers if requested at the time of a renewal application;

(5)  Maintain, insofar as is possible, a record of subsequent career events of each pilot and feasibility study recipient.  This record must also be made available to reviewers at the time of the renewal application;

(6)  Make recommendations to the Center Executive Committee (or equivalent) for final decisions.  A record of actions by this committee must be documented.    

All applicants should describe how these requirements will be met and have been met in the case of renewal applications.  Also included should be an assessment of the relevancy of the proposed individual pilot and feasibility studies and of the program as a whole to research on diabetes and related areas of research and to the specific goals and objectives of the individual Center and of the Center program generally.

Pilot and feasibility program in new applications:  Applicants should provide (see 'Other Attachments") an abstract for each proposed pilot and feasibility project, and the biographical sketch of the investigator of the proposed pilot and feasibility project; these pilot and feasibility proposals are reviewed for scientific merit and eligibility by the initial review group.  These initial pilot and feasibility studies must have been reviewed by the Center in the manner proposed for review of future studies so that only those considered to be the highest quality are included in the grant application.  The amount of pilot and feasibility funds provided for the first year will be based on the review of the proposed studies.  The budget for future years is recommended by the initial review group based on the quality of the proposed pilot and feasibility studies, and the proposed method for management and review (as evidenced by this set of projects).  Also considered will be the review group's evaluation of the future justification for continued pilot and feasibility support.

Pilot and feasibility program in renewal applications:  After the initial review of pilot and feasibility proposals as described above, all responsibility for review and funding during the remainder of the project period will reside within the Center itself.  This approach provides each Center with the needed flexibility for effective and efficient management of the program.  In renewal applications, the review of this program will be based on the past track record, the management of the program, and an assessment of overall potential needs and opportunities.

In general, a renewal application will include:  (1) an historical overview; (2) a description of Center management of the program; (3) a description of the method for solicitation for pilot and feasibility projects and the number of respondents received for each solicitation; (4) a listing of all previous, ongoing and approved proposed pilot and feasibility studies with reports on those which were supported by the Center during the last project period; and (5) a statement of the benefits of the program to the Center, as well as the contribution of the uniqueness of the Center environment to the program.  Some of these points are detailed in the following paragraphs.

The historical overview will cover the pilot and feasibility program since the inception of the Center.  This should include, in summary format only, all pilot and feasibility projects ever awarded.  The pilot and feasibility program director may wish to highlight certain studies or particular aspects of the past studies such as research advances, collaborations which resulted in lasting relationships, acquisition of new skills by the study recipient, or other significant outcomes. The relationship of the scope of the various studies to that of the Center should be emphasized. 

The historical review of all pilot and feasibility studies ever awarded should include a report on each pilot and feasibility study conducted during the last project period.  These narrative reports should be brief and contain (1) the name of the investigator, degree(s), professional career status at the time awarded, and current professional career status (if known); (2) an overview of the project including its significance and salient results; (3) a list of resulting publications; and (4) peer-reviewed subsequent funding in the same or related area. 

The description of center management of the program will present in detail the current system used to manage the pilot and feasibility program, including its integration with and relationship to the rest of the administrative structure.  The use of outside consultants for review should be included in the discussion.  Important features of the solicitation process should be provided including the distribution and the number of respondents.

Document Pilot & Feasibility Project Outcomes over the past 5-10 years by using a format such as a Table to aid in the review process (see "Other Attachments," like the one shown in "Pilot Project Outcomes" Table F: (http://www2.niddk.nih.gov/Funding/FundingOpportunities/NIDDKDiabetesResearchCenters).

For renewal applications, the recommendation of the initial review group will be based on the overall performance of the Center's pilot and feasibility program as documented in the application.  This recommendation will be based on:  (1) the extent to which awarded funds were fully utilized during the previous project period; (2) awards were made to investigators who fully met the eligibility criteria for pilot and feasibility support as outlined above; (3) Center-relatedness; and (4) success of previously supported pilot and feasibility studies (e.g., publications, subsequent independent R01 or other peer-reviewed support, and/or attraction of new investigators into Center-related research).

Letters of Support:  Include any letters of support for the Pilot & Feasibility Program by appropriate institutional officials at partnering organizations (other than the parent institution), if applicable.

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 SF424 (R&R) Application Guide, with the following modification:

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

Planned Enrollment Report  (Core or Project Name)

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

PHS 398 Cumulative Inclusion Enrollment Report (Core or Project Name)

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

Enrichment Program

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

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

SF424 (R&R) Cover (Enrichment Program)

Complete only the following fields:

PHS 398 Cover Page Supplement (Enrichment Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Enrichment Program)

Follow standard instructions.

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Other Attachments (renewal applications only; optional):   Information related to the Center-supported Enrichment Program activities, such as Diabetes Research Center retreats, symposia, workshops, meetings, specialized courses, seminar series, etc., illustrating the interactions among Center members and other investigators, as well as other training and educational opportunities may be included in the application.  This should be loaded as a file in .pdf format titled "Enrichment Program" in Other Attachments.

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

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Enrichment Program)

Budget (Enrichment Program)

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

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

Personnel: This category should include salary support for key personnel, including the Enrichment Program Director and any other professional and administrative personnel. The Enrichment Program Director must devote a minimum of 0.6 calendar months to ensure adequate oversight of the Program.  The salary amount charged to the Diabetes Research Center grant must be commensurate with the time spent on Program activities and is subject to institutional and NIH salary policies.  

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

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

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

PHS 398 Research Plan (Enrichment Program)

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

Specific Aims:  Clearly state the aims of the Enrichment Program.

Research Strategy:  The Diabetes Research Center enrichment program should be designed to advance translational research in diabetes, endocrinology and metabolism and promote scientific exchange among investigators with research interests in these topic areas, and to enhance interactions between diabetes researchers and investigators from other fields with relevant expertise.  The enrichment program can support activities such as seminars, guest speakers, visiting scientists, consultants, and workshops.  Applicants should describe any training opportunities afforded by the Diabetes Center for Center participants, and document ways the Center may facilitate, enhance or foster the institutional training environment.  Specifically, Center applicants should provide information on related NIDDK T32 programs at the Center institution(s), and describe how the Diabetes Center will help to integrate, facilitate and enhance activities of T32-supported trainees Applicants should indicate if they plan to participate in the medical student summer research program that is currently organized through the Diabetes Research Centers program (http://medicalstudentdiabetesresearch.org/).  For those Centers that have participated in this program in the past, a brief report should be provided in the application.  

Training postdoctoral fellows to conduct research in diabetes is an associated activity of a Center.  While stipends for fellows cannot be funded from the Center, the establishment of a Center should provide an enhanced environment for research training.  Just as in the case of funding for individual research projects, funding for fellowships should be sought from NIH NRSA institutional training grants (e.g. T32, T35) and individual fellowships (e.g. F30, F32), and other sources such as private foundations, and commercial companies.

Letters of Support:  A letter(s) from the PD/PI of any related NIDDK-funded T32 and/or T35 institutional training grant(s) at the Center institution should be included that acknowledges and details how the PD/PI of the T32 training grant intends to promote cohesive interactions between the two programs.  Such letters should also briefly describe how any short-term (e.g. summer) medical student research programs, supported by NIDDK-funded T32 or T35 training grants, coordinate with Center activities related to the Enrichment Program.

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 SF424 (R&R) Application Guide, with the following modification:

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

Planned Enrollment Report  (Core or Project Name)

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

PHS 398 Cumulative Inclusion Enrollment Report (Core or Project Name)

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

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 submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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

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

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH.  Applications that are incomplete and/or nonresponsive will not be reviewed.  

Responsiveness Criteria

To be responsive to this FOA, the applicant institution must already have an existing, substantial base of ongoing, independently supported, peer-reviewed research projects in diabetes, its complications, and related endocrine and metabolic diseases. Applications with relevant research bases of less than $3 million are considered non-responsive.  Although collaborations with investigators outside the applicant institution/consortium are encouraged, the research base includes ONLY support for the investigators at the applicant institution/consortium.

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115 and NOT-OD-13-030, with the following modifications: 

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.

For these P30 Center applications, reviewers will be asked to evaluate the following individual sections, and the Scientific Review Officer will record these scores. The overall impact score is not the average of the scores for all these components.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Center proposed).

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?  What are the strengths of the Center's research base (its breadth and depth) and the relevance and interrelation of the separately funded research projects to the focus/theme(s) of the Center?  Is there a strong, scientifically excellent research base in diabetes, its complications, and related endocrinology and metabolic diseases at the Center that would benefit by the services/programs supported through the Diabetes Research Center?  What is the likelihood that the Diabetes Research Center will increase efficiency; promote new research directions and meaningful collaborations among Center investigators; facilitate interactions and collaborations among the investigators; and prove cost-effective?  

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  Are the Center investigators responsible for the individual research projects willing to interact with each other and contribute to the overall objectives of the Diabetes Research Center?  What are the scientific and administrative leadership abilities of the proposed Center Director and Associate Director(s) and their commitment and ability to devote adequate time to the effective management of the Center program?  Are the Core Directors well-qualified and appropriate?  If requested, does the Named New Investigator appear well qualified and appropriate for support?  

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 Pilot & Feasibility (P&F) applicants eligible and does the selection process by which the individual studies were selected appear appropriate?  Does the Center appear to encourage ‘high-risk’, innovative ideas through their P&F program?  Do the Cores provide new methods, techniques, and/or resources and demonstrate the ability to adapt when needed to support investigators in emerging areas of diabetes and its complications, and related areas of endocrinology and metabolism research, as appropriate to the purpose of the Core and the research supported by the Center?   

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?  How appropriate and relevant are the proposed cores and the modes of operation (such as potential utilization, prioritization of requests for services, cost-recovery, and quality control monitoring)?  Will the cores provide opportunities not otherwise available to the investigators through other available federally funded and/or institutional resources; represent appropriate cost savings/cost sharing advantage; and stimulate the development of new approaches?  Are criteria for membership in the Diabetes Research Center clear and appropriate?  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 cores;(d) mechanism for reviewing the use of, and administering funds for, the P&F program;(e) management capabilities, including fiscal administration, procurement, property and personnel management, planning, budgeting, and other appropriate capabilities?  Is there efficient and effective use and/or planned use of the limited enrichment funds, including the contribution of these activities to the stated goals of the Center?   

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 evidence of institutional commitment to the Center 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?       

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 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

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

Renewals

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

Research Base:

Biomedical Research Cores:

Administrative Core:

Pilot & Feasibility Program:

Enrichment Program:

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 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.

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. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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

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, SAM 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 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

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

Application Submission Contacts

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

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)

James F. Hyde, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7692
Email: hydej@mail.nih.gov

Peer Review Contact(s)

Francisco O. Calvo, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8897
Email: calvof@mail.nih.gov

Financial/Grants Management Contact(s)

Christina Coriz
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8848
Email: corizc@mail.nih.gov

Or

Todd Le
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7794
Email: toddle@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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NIH Funding Opportunities and Notices



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