RFA-DK-27-119-Full-Announcement.html

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

Silvio O. Conte Digestive Diseases Research Core Centers (P30-Clinical Trial Optional)

Activity Code

P30 Center Core Grants

Announcement Type

Reissue of

RFA-DK-25-003

Related Notices

Funding Opportunity Number (FON)

RFA-DK-27-119

Companion Notice of Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.847

Notice of Funding Opportunity Purpose

This Notice of Funding Opportunity (NOFO) invites applications for Silvio O. Conte Digestive Diseases Research Core Centers (DDRCCs). The DDRCCs are part of an integrated program of digestive and liver diseases research support provided by the NIDDK. The purpose of this Centers program is to bring together basic and clinical investigators to enhance communication, collaboration, and effectiveness of ongoing research related to digestive and/or liver diseases within the NIDDK's mission. DDRCCs are based on the core concept, whereby shared resources aimed at fostering productivity, synergy, and new research ideas among the funded investigators are supported in a cost-effective manner. Each proposed DDRCC must be organized around a central theme that reflects the focus of the digestive or liver diseases research of the Center members. The central theme must be within the primary mission of the NIDDK, and not thematic areas for which other NIH Institutes or Centers are considered the primary source of NIH funding.

Funding Opportunity Goal(s)

To promote extramural basic and clinical biomedical research that improves the understanding of the mechanisms underlying disease and leads to improved preventions, diagnosis, and treatment of digestive and/or liver diseases.

Key Dates

Posted Date

June 16, 2026

Open Date (Earliest Submission Date)

August 29, 2026

September 29, 2026

September 29, 2026

Not Applicable

July 2027

February 10, 2027

February 10, 2027

Not Applicable

December 2027

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date

February 11, 2027

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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 Key Dates Part 2. Full Text of Announcement Section I. Notice of 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. Notice of Funding Opportunity Description

Program Objective This Notice of Funding Opportunity (NOFO) invites applications for Silvio O. Conte Digestive Diseases Research Core Centers (DDRCCs) to support research related to digestive and/or liver diseases and their complications. The purpose of a DDRCC is to serve as a key component of the NIDDK-supported research effort to advance digestive and/or liver diseases research.

Overall Institution and Research Base A DDRCC must be an identifiable unit within a single university medical center or a consortium of cooperating institutions, including an affiliated university. An existing program of excellence as evidenced by productivity and peer-reviewed research funding in the area of digestive and/or liver diseases within NIDDK's mission is a prerequisite before applying. The currently funded research base provides the major support for the investigators, i.e. Center members, who would benefit from a Center's shared resources. The research base includes only currently funded, peer-reviewed research grants awarded to the applicant institution/consortium. These may be a mix of Federal and privately funded research awards or research career development awards. Moreover, there must be sufficient Federal support within the base to fulfill the requirement for a minimum of two federally funded Center members utilizing each Biomedical Research Core. Training grants, education grants, and fellowship awards are not considered part of the research base funding. Focus, relevance, interrelationships, quality, productivity, and, to some extent, quantity are all considerations in judging the adequacy of the research base. Importantly, quantity at the expense of other considerations should be avoided. A research base that has diminished focus because of inflation with the inclusion of grants with tangential relevance to digestive or liver diseases within the NIDDK's mission or the Center's theme should be avoided.

The absolute level of research base support must be sufficient to warrant the addition of a Center, typically at least $3 million per year in direct costs. At least 30 percent of the total funding contributing to the research base must be secured from the NIDDK. Since indirect costs vary considerably between institutions, these should not be included in the calculation of the research base. Although collaborations are encouraged, the research base includes ONLY support for the investigators at the applicant institution/consortium. Collaborations with investigators outside of the applicant institution/consortium or between DDRCCs are encouraged; however, they are optional. While optional, these collaborations often benefit the DDRCC's research base.

A DDRCC must have a central research focus or theme. The central focus must be a gastrointestinal/liver disease, group of diseases, or functional studies relating to digestive and/or liver diseases within the mission of the NIDDK. The theme should be cohesive and well-articulated to ensure a DDRCC with components that will substantially advance a defined area of NIDDK-related science. Existing, competing Centers are encouraged to focus their efforts. The direct cost cap for DDRCCs has not been increased in recent years and thus more focused DDRCCs might be necessary to avoid diluting the effectiveness of the limited Center support available. Therefore, it is not necessary for each competing Center to show growth in their research base when they have made the strategic decision to focus their research base (i.e., Center membership) rather than continuously expand. A flat or even slightly reduced research base in a renewal application is acceptable. When a reduction results in a more thematically focused DDRCC, with added benefit to Center members, this is appropriate and viewed as a positive development as long as the funds requested are well justified.

Overlaps in the research base among NIDDK-funded Centers should not inappropriately inflate the research base of any Center. Non-research base investigators at the applicant institution or elsewhere may be encouraged to make use of the core facilities, collaborate with Center members, and participate in scientific exchange activities when space, time, and funds permit.

Administrative Core (with a required Scientific Catalyst Program and an optional Clinical Component) Each Center must include an Administrative Core responsible for allocation and oversight of Center resources. The Administrative Core is expected to ensure the coordination and integration of the Center's components and activities. Administrative Core personnel provide support for the required External Advisory Committee and the internal committee structure of the Center. The Administrative Core should have a process to (a) assess the productivity, effectiveness, and appropriateness of Center activities; (b) determine criteria and the selection process for Center membership; (c) foster collaborations and scientific opportunities among its members; and (d) foster community engagement and participation of community partners. In addition, all DDRCCs 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.

Required Scientific Catalyst Program: As part of the Administrative Core, DDRCCs are expected to support activities such as visiting scientists, seminars, and research forums as well as other appropriate, innovative means to support the goals of the Center, e.g., short courses, mini-sabbaticals, or joint activities with other DDRCCs, via a Scientific Catalyst Program. Limited travel support may be requested to allow DDRCC investigators to present scientific findings, learn new laboratory techniques, develop new collaborations, or engage in scientific exchange. In all cases, the Scientific Catalyst Program should further the overall aims and objectives of the DDRCC as well as its Cores. While DDRCCs cannot support stipends for postdoctoral fellows, the environment fostered by the existence of the Center, with its core facilities in conjunction with the Scientific Catalyst Program educational opportunities, should serve to foster the careers of postdoctoral fellows and junior faculty, including K awardees.

Optional Clinical Component: The optional Clinical Component can serve as a resource, a focal point, and a facilitator for translating work supported by the DDRCC into practical therapies for digestive and liver diseases. Investigators, therefore, need not be funded directly for clinical studies to justify the inclusion of this unit. Likewise, individual researchers do not need to be funded directly for clinical studies to use the service or expertise of the Clinical Component. Providing the capability for translating basic research findings into a clinical setting is the goal of the Clinical Component for those Centers wishing to build this part of their research base. Besides leading to a better understanding of the etiology and natural history of disease, a Clinical Component might provide biostatistics support; help with clinical study design; foster collaboration among researchers; aid in recruitment of subjects for clinical studies; support epidemiological studies in areas of digestive and/or liver diseases; or provide modest funding for tissue, DNA, serum storage, or other human specimen storage. In addition, a Clinical Component may help Center members to effectively address NIH policies concerning inclusion of women, minorities, and people across the lifespan in clinical studies.

Biomedical Research Cores The DDRCCs are based on the core concept. Cores are defined as shared resources that foster productivity and benefit a group of investigators working to accomplish the stated goals of the Center. Cores should provide specialized technical resources, services, and/or other expertise that enhance the efficiency and productivity of Center members. The proposed Core services should be ones that are not readily available or are not cost-effective when supplied from commercial sources, or which are technically challenging or require specialized expertise, equipment, or infrastructure. Each proposed Core must be utilized by a minimum of two federally funded investigators (with projects other than training grants, education grants, or fellowship awards) who are Center members.

When appropriate, Core staff should provide instruction for investigators, laboratory personnel, and/or fellows to learn, and then become proficient in, technologies that will become part of the repertoire of the user's laboratory. Teaching new or complex techniques and methodologies is an important function of a Core.

When proposed core services are already available through the research institution (e.g., via an institutional core), there must be compelling justification for their support through the DDRCC. Strategies for preventing duplication of services between centers at the applicant institution or for collaboration between DDRCCs to maximize use of Core resources at each DDRCC are encouraged.

In addition to providing products or services, a Core must ensure appropriate quality control and maintain a record of use. Limited developmental research is also an appropriate function of a Core facility as long as it is directly related to enhancing the function or usefulness of the Core and is not an undertaking that should more appropriately be funded through other mechanisms. Plans for responding to the changing needs of the Center members should also be a part of each Core.

Two to six biomedical research Cores are usually included in a Center. Examples of Core services/resources include, but are not limited to, imaging facilities; transgenic or gnotobiotic animal units; microbiome and metagenomics services; and membrane, cell or tissue preparation, and/or storage facilities. If a Human Core, Clinical Core, or Translational Core is submitted (rather than a Clinical Component), such Cores must be utilized by two federally funded projects.

Pilot and Feasibility Program The Pilot and Feasibility Program (P and F Program) provides modest support (typically up to $50,000 per year) for new initiatives or feasibility research studies. P and F Programs are intended to provide support for investigators to collect preliminary data sufficient to support a grant application for independent research support and/or to test a novel, even high-risk, hypothesis. P and F studies may (1) provide support for new investigators, (2) provide support for established investigators who will have no independent R01 or R01-equivalent grant support if they do not secure a substantial grant award in the near future, or (3) encourage investigators from other areas of biomedical research to apply their expertise to an area of need in digestive disease research. P and F awards may elect to support post-doctoral fellows who have an interest in pursuing an academic research career and may be issued to investigators with research appointments outside the applicant institution/consortium.

P and F projects are expected to support research that primarily aligns with NIDDK's scientific mission rather than digestive or liver disease research that is better aligned with the mission of another NIH Institute or Center.

P and F support is not intended for large projects by established investigators that should be submitted as separate research grant applications, nor is it intended to provide bridging support for established investigators who are PIs of one or more R01 or R01-equivalent grants that will be active for at least two years. P and F funds are also not intended to support or supplement ongoing funded research of an investigator.

Named Supported Investigator (Optional): Each DDRCC may request salary support for a P and F Project recipient whom they designate as a Named Supported Investigator (NSI). The individual selected must be named in the application and be a junior investigator and a permanent resident or US 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 Committee. Appointment of the NSI is contingent upon the concurrence of the External Advisory Committee and the NIDDK DDRCC program director.

Center Evaluation It is anticipated that research advances, development of new research technologies/methods, and the changes in composition of the research base will require existing DDRCCs to evolve over time. DDRCCs are encouraged to develop a plan to continuously evaluate and respond to the changing needs of their research base members by adding, eliminating, or expanding Cores/core services during the course of the DDRCC.

DDRCC Directors' Meeting Every 12–18 months, all DDRCC Directors and Center administrators are expected to attend a meeting at one of the DDRCCs to exchange information, highlight the host Center, and interact with NIDDK senior staff.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed

New

Renewal

Resubmission

The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIDDK intends to commit $4.8 million in FY 2027 to fund 4 awards and $2.4 million in FY2028 to fund 2 awards.

Award Budget

Application budgets are limited to $750,000 in direct costs per year and need to reflect the actual needs of the proposed Center.

Award Project Period

The maximum project period is five years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Federal Governments

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other

Independent School Districts

Public Housing Authorities/Indian Housing Authorities

Native American Tribal Organizations (other than Federally recognized tribal governments)

Faith-based or Community-based Organizations

Regional Organizations

Only institutions at which there is a strong ongoing base of digestive and/or liver diseases-relevant research that relates to the proposed theme of the Center are eligible. The already funded research base must have at least $3 million per year in direct costs of supported research within a proposed theme area that is of primary interest to the NIDDK. These may be a mix of Federal and privately funded research awards or research career development awards. However, at least 30 percent of the total funding contributing to the research base must be secured from the NIDDK. Moreover, enough awards within the research base must be Federal to fulfill the requirement that each Biomedical Research Core must be utilized by a minimum of two federally funded Center members. Training grants, education grants, and fellowship awards are not considered part of the research base funding. Since "Facilities and Administration" costs vary considerably between institutions, these must not be included in the calculation of the research base.

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organization) 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 Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

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

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

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.

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 How to Apply - Application Guide.

2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Required

Required

Required

Required

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

Overall Component When preparing the application, use Component Type 'Overall'.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall) Complete entire form.

PHS 398 Cover Page Supplement (Overall) Follow standard instructions.

Research & Related Other Project Information (Overall) Follow standard instructions.

Project Summary/Abstract: Describe the scientific theme of the DDRCC and the need for a Cores Center to support the investigators in the research base. Include the number of Center members and the overall total direct costs present in the digestive and/or liver research base. Specify the total direct costs of NIDDK awards contributing to the research base. Provide a brief overview of the research base as it relates to the theme of the Center as well as an overview of the Biomedical Research Cores, the P and F Program, and the Scientific Catalyst Program.

Project Narrative: In 1–3 sentences describe the relevance of the research to be supported and facilitated by Center Activities (Biomedical Research Cores, P and F Program, and Scientific Catalyst Program) to public health.

Facilities and Other Resources: Describe the existing environment and facilities briefly in the context of how the Center will use or change existing access, space, and usage; include space maps as needed. Scientific personnel and institutional resources capable of supporting the research must be available.

Equipment: A general listing of major, shared pieces of equipment used by the 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" must be included with the Overall Component 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 must be in PDF format.

Table of DDRCC Research Base Investigators (Required): Please title this attachment "DDRCC Research Base Investigators" and include all Federal or non-federal grant support for Center members and organize alphabetically by the last name. The table must include PI name, the active grant number(s), title(s), amount of funding (Direct Costs only) in the current year, a few descriptive sentences of the investigator's research projects, the cores that the members use, and if not readily apparent, the relevance to digestive and/or liver disease research. The table of grant support should include R-series, individual K-series, U01s, DP-series, P01s, and other similarly peer-reviewed grants funded through other Federal Agencies or non-federal groups.

For renewal applications only, Progress Report Publication List (Required, not to exceed 5 pages): In this attachment, list the titles and complete references for representative examples of publications attributed to core usage and manuscripts accepted for publication that have resulted from the DDRCC since it was last reviewed competitively. Identify the core(s) utilized in association with the publication.

Project/Performance Site Locations (Overall) 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 and Related Senior/Key Person Profile (Overall) Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

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

Specific Aims: Describe the broad long-term objectives of the proposed DDRCC. Provide the central theme(s) of the DDRCC. The theme may be broad or focused, depending upon the goals of the Center. However, it should also be cohesive and well-articulated to ensure a DDRCC with components that will substantially advance a defined area of NIDDK-related science. Outline the existing skills and technologies available in the research base as well as other resources at the institution(s) and summarize how the Center will enhance ongoing projects, assist in the development of new projects, respond to future opportunities, and promote collaborations leading to advances in digestive and/or liver diseases research.

Research Strategy: The Research Strategy should include the following sections.

Research Base: Applicants should include an overview of current research in digestive and/or liver diseases related areas being conducted at their institution in sufficient detail to allow reviewers to judge the extent and the interrelationship of ongoing research. It is recommended that the DDRCC research base be subdivided into areas of research emphasis or research themes that link Center members and their research programs.

Presentation of the research base in the application should be done by completing a Table itemizing grant funding as described in Other Attachments above. The research of each DDRCC member should be discussed and interrelationships of research being conducted by the members 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 as well as relevance to the theme of the DDRCC; (b) uses and benefits of core services; (c) plans to develop productive collaborations among Center investigators; and (d) willingness of Center investigators to contribute to the overall objectives of the DDRCC. Collaborative activities with individuals outside the applicant institution/consortium or between DDRCCs is encouraged but optional. How collaboration will benefit the research base can be described.

Membership: A high level of integration and close collaboration among DDRCC members with varying perspectives and from different scientific disciplines is an important feature of a successful Center. Accordingly, the applicant should state considerations for DDRCC membership with specific reference to the potential of members to form interactive, collaborative, and synergistic relationships. Applicants should provide clear guidelines for how Center membership is defined (including, if applicable, how subsets of membership are defined), the application and selection processes for Center membership, the obligations of Center membership, and the criteria for termination of membership. Suitable criteria for membership include, but are not limited to, peer-reviewed independent funding, participation in digestive diseases research, and the need for the use of core facilities. All research base investigators must be Center members. Designation as a Center member without the need for the use of core facilities must be well justified.

Center Organization: Summarize the services, resources, and expertise provided by the proposed Biomedical Research Cores, emphasizing the support they will provide for the thematic areas of the research base. Point out novel services and resources available in the cores and describe the potential for interdisciplinary collaborations among Center Investigators.

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. Leveraging existing resources is encouraged, particularly when this provides a range of services or efficiency that would not otherwise be available.

Provide a plan to determine the need for new services or instrumentation of the DDRCC members. Discuss how the Center will ensure that Center members can take advantage of cutting-edge technology and how services no longer required, or no longer cost-effective, will be phased out. Include information on the process of re-evaluating the needs of Center members and how evolving needs will be met.

Also, describe how the Center will enhance the research base and foster the careers of its junior investigators through scientific exchange activities and the use of Core services/expertise.

Institutional commitment: Applicant institutions/consortia are expected to have demonstrable commitment to the Center's success. Examples of ways institutional commitment might be evidenced include, but are not limited to, financial support for Cores or other Center functions, salary support for Center staff, dedicated space, or availability of equipment. New applications should briefly describe plans for institutional commitment should the Center receive NIDDK support. Renewal applications should briefly describe both previous and ongoing instances of institutional commitment. These should be accompanied by letters of support from institutional officials verifying the commitment with specific details.

For renewal applications: Briefly discuss the progress and accomplishments of the research base as influenced by the DDRCC; the development of multidisciplinary, collaborative, and cooperative interrelationships among Center members; and indicate any alteration in the original Center design that was instigated to meet the evolving needs of the research base. Discuss changes to the research base over the past five years to either facilitate growth or to enhance its focus, instead of emphasizing growth. This should be described in a narrative fashion.

Letters of Support: Include any letters of support for the proposed DDRCC from appropriate institutional officials.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

The following modifications also apply:

Generally, Resource Sharing Plans are expected, but they are not applicable for this component.

Other Plan(s):

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

PHS Assignment Request Form (Overall) All instructions in the How to Apply- Application Guide must be followed.

Administrative Core When preparing your application, use Component Type 'Admin Core'.

All instructions in the How to Apply- 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) Follow standard instructions.

Research & Related Other Project Information (Administrative Core) Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

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)

Budget (Administrative Core) Budget forms appropriate for the specific component will be included in the application package.

Personnel: The Center Director must devote a minimum of 2.4 person months to the Center and at least 1.2 of the person months must be within the Administrative Core to ensure adequate oversight of the Center. If a multiple PD/PI application, the combined effort of the PD(s)/PI(s) must be 2.4 person months. Most Centers find that the size and complexity of a DDRCC warrant inclusion of a full-time program administrator, so salary support for this individual should be included in the Administrative Core. This category should also include salary support for any additional key personnel, including the Scientific Catalyst Program Director and any other professional and administrative personnel. The Scientific Catalyst Program Director must devote a minimum of 0.6 person months to ensure adequate oversight of the Program.

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 DDRCC 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. This includes all equipment in future budget years as well as the initial budget period.

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

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 (consultant fees, per diem, and travel) when their services are required by the DDRCC, such as the members of the External Advisory Committee. Include costs associated with consultants (e.g., consultant fees/honoraria, per diem, and teleconferences) when their services are required by the Scientific Catalyst Program.

Travel: Include the costs of domestic and foreign travel only if the travel is directly related to the activities of the DDRCC. Include travel costs for the DDRCC Director, Center administrator, and others as appropriate (i.e., co-Director, core Directors) to attend the DDRCC Directors' meeting. Travel funds to support visiting scientists under the auspices of the Scientific Catalyst Program may be requested.

Other Expenses: Support for development/maintenance of the Center's website may be requested as well as funds for supporting regional Center meetings, if appropriate. Include funds to support Scientific Catalyst Program activities such as workshops, research forums, symposia, Center retreats and seminar series. Funds for Scientific Catalyst 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.

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 DDRCC and outline interactions of the Administrative Core with each of the other Cores, Clinical Component (if proposed) and Programs (P and F and Scientific Catalyst). Provide an overview of how the Administrative Cores will set the overall direction of the Center and ensure optimal utilization of the Center resources. Provide a description of the objectives and operation of the Scientific Catalyst Program.

Research Strategy: The Administrative Core is key to the coordination and functioning of the Center. Therefore, describe the administrative structure of the DDRCC, including chain-of-command; committee structures (e.g., Internal Advisory Committee, P and F review committee, other oversight or management committees, and the required External Advisory Committee); and Core, Scientific Catalyst Program, and Clinical Component (if included) management.

The Director, who is the PD(s)/PI(s) of the application, should be assisted by one or more Associate Directors who will be involved in the administrative, scientific, or collaborative efforts of the Center and who will serve as Acting Center Director in the absence of the Director. Include a brief narrative describing the qualifications of the Director and Associate Director(s). A process must be in place to recommend a successor to the Director, if a successor becomes necessary.

The relationship of the DDRCC to the institution and the reporting lines of the DDRCC Director to appropriate institutional officials may be presented in diagrammatic form, but also provide a brief explanation in narrative form.

Include a description of the mechanism for monitoring budgetary overlap between the research projects included in the research base and the funds for the core facilities of the DDRCC, describing a mechanism to monitor the budgetary adjustments made necessary by the use of Core services. This will ensure that DDRCC investigators using Cores are able to provide a satisfactory explanation of their relationship to the DDRCC and their inclusion of charge-back fees for Core use in their individual grant budgets.

It is expected that the organization of the Administrative Core will provide a supportive structure sufficient to ensure the success of the Center and its activities.

Center Evolution: Applicants must document policies and procedures for ensuring continuing evolution of Center activities, such as core services, in response to changing needs of the research base. 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.