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)

Activity Code

P30 Center Core Grants

Announcement Type

Reissue of RFA-DK-11-022

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DK-12-023

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) issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 as a means to enhance communication, collaboration, and effectiveness of ongoing research related to digestive and/or liver diseases.  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 digestive or liver diseases research focus of the center members.

Key Dates
Posted Date

January 4, 2013

Letter of Intent Due Date(s)

June 14, 2013 and October 15, 2013

Application Due Date(s)

July 15, 2013 and November 15, 2013

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October/November, 2013 and February/March, 2014

Advisory Council Review

January, 2014 and May, 2014

Earliest Start Date

July, 2014 and December, 2014

Expiration Date

November 16, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Program Objective

The objective of the Silvio O. Conte Digestive Diseases Research Core Centers (DDRCCs) is to bring together, on a cooperative basis, basic science and clinical investigators to enhance the effectiveness of their research related to digestive and/or liver diseases and their complications.  DDRCCs are meant to improve communication among investigators and to integrate, coordinate, and foster interdisciplinary research involving the etiology, treatment, and prevention of digestive and/or liver diseases.  To accomplish this, the DDRCC supports a group of established investigators actively conducting programs of important, high-quality research that relates to a common theme in digestive diseases (DD) or liver diseases research.  Thus, the purpose of a DDRCC is to provide the capability for accomplishments greater than those that would be possible by individual research project grant support alone.

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 in biomedical research in the area of digestive and/or liver diseases is a prerequisite for applying.  This research must be in the form of NIH research projects, program projects, or other peer-reviewed research that is already funded at the time of submission of a center grant application.  This currently funded research base provides the major support for the investigators, i.e. center members, who would benefit from shared resources. The research base includes only currently funded, peer reviewed research grants awarded to the applicant institution/consortium. These may be Federally or privately funded research awards or Research Career Development Awards.  Training grants, education grants,  and fellowship awards are not considered part of the research base.  Focus, relevance, interrelationships, quality, productivity, and, to some extent, quantity, are all considerations in judging the adequacy of the research base.  

The absolute level of research base support must be sufficient to warrant the addition of a Center, typically at least $3 million a year. Since ‘Facilities and Administration’ costs vary considerably between institutions, these should not be included in the calculation of the research base.   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.

To revitalize the DDRCC program, NIDDK is encouraging our existing, competing centers to focus their efforts. NIDDK has not increased the direct cost cap for DDRCCs in recent years and thus more focused DDRCCs are necessary so as not to dilute the effectiveness of the limited Center support. 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 the research base (i.e. center membership) rather than continuously expand. 

NIDDK has instituted a policy that overlap in the research base among DK-funded centers should not inappropriately inflate the research base of any center.  Non-center members (i.e. those not included as research base investigators) are encouraged to make use of the core facilities, collaborate with center members, and participate in enrichment activities when space, time, and funds permit.  Due to NIDDK’s policies, therefore, 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 a positive as long as the funds requested are well-justified. 

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 or liver diseases.  At least one-half of the research must relate to this central focus in new applications.  Examples of a gastrointestinal disease-related central focus include, but are not restricted to, inflammatory bowel disease, functional bowel disorders, pancreatic disease, liver disease, pediatric gastrointestinal disease, and AIDS-related gastrointestinal disease. Examples of functional studies appropriate for a central focus include, but are not restricted to, gastrointestinal motility, actions of gastrointestinal hormones, role of the gastrointestinal tract in obesity, gastrointestinal physiology, or gene therapy for digestive or liver diseases. 

Criteria for becoming a DDRCC ‘member’ should be clearly defined. Subsets of members based on their degree of participation or other quantitative measures are acceptable.  Suitable criteria include peer-reviewed independent funding, participation in DD-related research, and 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.

Center Structure and Activities

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 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 Center members.   Criteria for use and for prioritization must be included in the application. 

Financial justification such as comparative costs of other sources of proposed core services as well as plans for cost recovery from users should be detailed. 

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

Proposed cores may be part of institutional shared research cores, such as a centralized animal facility.  In such cases, the support provided by the DDRCC should be proportional to the use of the institutional core by DDRCC members.  When proposing the use of a shared facility, details about access, fee-schedules, and prioritization of Center members' use of  the shared facility must be described. 

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 five 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; and membrane, cell, or tissue preparation and/or storage facilities.

Administrative Core

Each Center must include an Administrative Core responsible for allocation and oversight of Center resources.  The Administrative Core personnel provide support for the required External Advisory Committee and internal committee structure of the Center.  Maintaining a Center website, providing editorial services, and housing the optional Clinical Component as well as overseeing the Pilot and Feasibility (P/F) Program, Named New Investigator (if requested), and Enrichment Program are all functions of the Administrative Core.  The DDRCC Director, who is the PD(s)/PI(s) of the application, 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-PI application, the combined effort of the PDs/PIs must be 2.4  person months.  A full-time administrator for each center, or several part-time positions, are usually required for successful management of the DDRCC.  One or more Associate Directors should be named who will be involved in the administrative, scientific, or training efforts of the Center and who will serve as Acting Center Director in the absence of the Director.  A process must be in place to recommend a successor to the Director, if a successor becomes necessary. 

Clinical Component (optional)

Since the NIDDK is interested in translating work supported by the DDRCCs into practical therapies for digestive and liver diseases, the optional Clinical Component can serve as a resource, a focal point, and a facilitator for this function. For a Clinical Component, Investigators, therefore, need not be funded directly for clinical studies to use the services or expertise provided by the Clinical Component nor to justify the existence of this component. Providing the capability for translating basic research findings into a clinical setting is the ultimate goal of the Clinical Component.  

This Clinical Component may exist as a part of a Core, usually the Administrative Core.  Besides leading to a better understanding of the etiology and natural history of disease, clinical components might provide biostatistics support; enhance 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, or serum storage.  In addition, a Clinical Component may help Center members to effectively address NIH policies concerning women, children, and ethnic minority population participation in clinical studies. 

Alternatively, a full-fledged Clinical Core is also an option, if the requirements for a Core, and not just a component, apply. 

Pilot and Feasibility Program

The P/F program provides modest support (typically $10,000 to $50,000 per year) for new initiatives or feasibility research studies.  P/F projects 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/F studies may (1) provide support for new investigators; (2) encourage investigators from other areas of biomedical research to use their expertise for DD research; and (3) allow established DD-investigators to explore innovative new ideas that represent a significant departure from their ongoing, funded projects. 

Named New Investigator (optional)

Each DDRCC may request, in the budget for the Administrative core, salary support for a P/F project recipient whom they designate a Named New Investigator (NNI).  Support for this individual is limited to 3 years and cannot exceed $90,000 per year, additional appropriate fringe benefits, and  9.6 person months.  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 Board. Appointment of the NNI is contingent upon the concurrence of the External Advisory Board and the NIDDK DDRCC program director.

Enrichment Program

The DDRCC may request limited support for an enrichment program under the auspices of the Administrative Core. 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, mini-sabbaticals, etc.   Also, limited travel support may be requested to allow DDRCC investigators to present scientific findings, 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 DDRCC as well as its cores.  Creative new programs, not precluded by NIH or NIDDK policies, are encouraged.  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 enrichment program educational opportunities should serve to foster the careers of postdoctoral fellows and junior faculty, including K-awardees.

Applicants should consult with NIDDK staff concerning plans for the development of the DDRCC 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
Resubmission

The OER Glossary and the PHS 398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The NIDDK intends to commit $3.6 million for three awards in FY2014 and $4.8 million for four awards in FY 2015.

Award Budget

Application budgets are limited to $750,000 in direct costs per year.  This budget limit is exclusive of F&A costs for consortium and subcontract arrangements.

Award Project Period

The project period for an application submitted in response to this funding opportunity may not exceed five years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

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 PHS 398 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)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 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 PHS 398 Application Guide.

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

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:

Only institutions at which there is a strong ongoing base of digestive and/or liver diseases-related research are eligible.  At least 50 percent of the already funded research base in a new application must be supported by the NIDDK.  In renewal applications, the NIDDK-supported research base may be less than 50 percent due, typically, to a growing number of investigators entering digestive or liver disease research from other fields.

Applications for DDRCC grants must propose a theme for the Center that is relevant to digestive and/or liver diseases, is within the mission of the NIDDK, and is supported by the research base projects. 

Section IV. Application and Submission Information

1. Address to Request Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS 398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

The letter of intent should be sent to:

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

Application Submission

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

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

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

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

Page Limitations

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, as summarized here with the following exceptions or additional requirements:

Supplemental Instruction for the Preparation of Multi-Component Applications

The following section supplements the instructions found in Form PHS 398 for preparing a multi-component grant application. Additional instructions are required because the Form PHS 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for multi-component applications.  All applications must be submitted on Form PHS 398.  The multi-component grant application should contain the following components:

Face Page for the Entire Application

Submit only one PHS 398 Face Page for the entire application unless a consortium arrangement exists, and then include a Face Page for each site. 

Table of Contents

Do not use the Table of Contents form page from the PHS 398.  Instead, create a Table of Contents once the application is assembled, using the major headings in the application:  Center Overview, Research Base, Biomedical Research Core A, Biomedical Research Core B, etc.; Administrative Core; Pilot and Feasibility Program, and Clinical Component, if requested.  Include subheadings as appropriate.

Center Overview (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Face Page (Overall)

Do not use the Face Page of the 398.  Instead, use the PHS 398 continuation page to create a cover page labeled 'Center Overview'.   

Description, Project/Performance sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (Overall)

Follow all instructions in the PHS 398 Application Guide, but note the following additional instructions.

Description:  In the Project Summary, describe the theme of the DDRCC and the need for a core center to support the investigators in the research base.  Include the number of Center members and the overall total direct costs present in the research base.  Provide a brief overview of this research base as it relates to the theme of the Center as well as an overview of the biomedical cores, and enrichment, P/F, and, if requested, clinical component.  In the Relevance section of the Description, and all other sections, follow the instructions in the PHS 398.

Detailed Budget for Initial Budget Period, and Budget for Entire Proposed Period of Support (Overall)

Use form pages for the Center Overview initial year of support and overall 5-year plan.  Include here budget lines for each Biomedical Research Core, the Administrative Core, and, if requested, the Clinical Component.  Do not provide detailed budget justification here..  Future year budget requests must not exceed cost escalations specified by the NIH.  If a consortium arrangement exists, then include the initial year of support and overall 5-year plan for all sites in addition to the summary budget for the entire Center. 

For ease of review, provide a consolidated budget for the first year of requested support using s a format such as that in suggested Illustration 1 in the Suggested Illustrations for Silvio O. Conte Digestive Diseases Research Core Centers (http://www2.niddk.nih.gov/NR/rdonlyres/ECCA0A6D-1507-4C53-BD71-CDB7E9CA4C29/0/2013SampleIllustrations.pdf ). 

Personnel:  This category should include salary support for key personnel within the DDRCC who contribute to the allowable activities of the Center.  Salary support for a full time administrator for the Center is encouraged. Salaries of professional personnel engaged in research activities supported by P/F funds are an allowable budgetary item, as are salaries of professional and technical personnel in core facilities. The salary amount charged to the DDRCC grant must be commensurate with the time spent on DDRCC activities and is subject to institutional and NIH salary policies.  Stipends for research trainees are not available through the DDRCC.  Such funding must be sought through other grant mechanisms.

The Center application should include salaries for individual principal investigators/center members only to the extent that they provide an essential Center function. No overlap of time or effort between the Center and separately-funded projects is permitted.

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 DDRCC investigators.   Requests for general-purpose equipment should be included only after ascertaining the availability of such items within the institution.  Include all equipment in future budget years as well as the initial budget period.

Supplies:  Consumable supplies directly related to the operational aspects of the DDRCC 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 in 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 principal investigator of the CTSA.

Request costs relating to the clinical research efforts of DDRCC 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 DDRCC clinical component or clinical Core.  The DDRCC 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.

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 Board.

Travel:  Include the costs of domestic and foreign travel for core or clinical component personnel in the budgets for the individual cores, or the clinical component, 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 annual DDRCC Director's meeting in the budget of the Administrative Core.

Total Requested Amount:  Total direct costs requested should not exceed $750,000 per year except for those applications with contractual arrangements.

Biographical Sketches (Overall)   

Provide biographical sketches for all Center members, associate (or other types of) members, the Named New Investigator (if included), and named Core personnel as well as members of External Advisory committee (only for renewal applications) and any consultants.  The biographical sketches should be in alphabetical order.  Biographical sketches for the P/F applicants should be included in the P/F project component, not here.

Resources (Overall)

Describe 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 and letters of institutional commitment.  Such commitment may be provided as dedicated space, staff recruitment, salary support for investigators, dedicated or shared equipment, or other financial support for the proposed Center. Scientific personnel and institutional resources capable of supporting the research base must be available.  Both the institution and pertinent departments must show a strong commitment to supporting the Center.

Research Plan (Overall)

Research strategy: The Center Overview for a P30 DDRCC must include the following information:

Research Base

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Face Page (Research Base)

Do not use the PHS 398 face page. Instead, use the PHS 398 continuation page to create a cover page labeled ‘Research Base’.

Description, Project/Performance sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (Research Base)

Do not use this form.

Detailed Budget for Initial Budget Period, and Budget for Entire Proposed Period of Support (Research Base)

Do not use this form.

Biographical sketches (Research Base) 

Do not include Biographical Sketches here. 

Resources (Research Base)

Do not use this form.

Research Plan (Research Base)

Research strategy:  Include an overview of the current DD-research activities at the institution. A clear presentation of the ongoing research base is critical since it will highlight the research focus of the DDRCC and the interrelationships and potential for collaborations among investigators.  Since the research base projects will already have been peer-reviewed, the quality of the individual funded projects will have been established and will not be re-evaluated.

Provide sufficient detail to assist reviewers in judging the extent and the interrelatedness of ongoing research.  Emphasize the anticipated impact of the establishment of a DDRCC on the research base.  Include an indication of how the establishment of a DDRCC will provide added dimensions and new opportunities for DD-related research, along with increased cooperation, communication, and collaboration among investigators.

Group DD-related research projects into aggregates of thematically related studies with similar overall goals and objectives.  A majority of the research base should have a central focus or theme that is a digestive disease or related disorder, group of diseases, or functional studies relating to digestive diseases.  Overly detailed descriptions of the research base projects are not possible. 

Biomedical Research Cores (present each core separately)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Face Page (Biomedical Research Core)

Do not use the PHS 398 face page. Instead, use the PHS 398 continuation page to create a cover page labeled with the name of the Core.

Description, Project/Performance sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (Biomedical Research Core)

Follow all instructions in the PHS 398 Application Guide, but note the following additional instructions:

Description:  In the Project Summary, briefly describe the services and expertise provided by the core and the extent to which these are needed to support the research base investigators.  In the Relevance section of the Description, and all other sections, follow the instructions in the PHS 398.

Detailed Budget for Initial Budget Period, and Budget for Entire Proposed Period of Support (Biomedical Research Core)

For each core, include a budget with detailed justifications for:  (1) the initial budget period, and (2) entire project period. 

Personnel:  This category should include salary support for key personnel, including the core director, co-director, and other professional and technical personnel.  The salary amount charged to the DDRCC grant must be commensurate with the time spent on DDRCC activities and is subject to institutional and NIH salary policies.  Stipends for research trainees are not available through the DDRCC.  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 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 DDRCC 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 in 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 principal investigator of the CTSA.

Request costs relating to the clinical research efforts of DDRCC 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 DDRCC Core.  The DDRCC 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.

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 core.

Travel:  Include the costs of domestic and foreign travel for core personnel only if the travel is directly related to the activities of the DDRCC.

Resources  (Biomedical Research Core)

Give special attention to the description of the physical arrangements and instrumentation for the core.  Facilities must be available for the primary needs of the DDRCC because funds for new construction are not available from the P30 grant.

Arrangements for sufficient space for core activities or for access to established institutional facilities must be made. 

Research Plan (Biomedical Research Core)

Research strategy: Provide the rationale for establishing or continuing the core, the facilities to be used, and the activities of the core.  Include short descriptions of the services provided and the projects of the investigators who will use the core.  The description of each Core should indicate how it will support the Center’s research effort in a cost-effective manner.  A well-qualified Core Director must be named for each Core.  Core Directors should be acknowledged experts with independently funded research programs who will themselves use the core services.  Therefore, the percent effort for the Director requested from the DDRCC will be relatively low, typically 1.2 to 2.4 person months of effort.  While it is expected that all core Directors and co-Directors will be Center members, occasionally experts in the specialty area required by the core who are not part of the research base may be appropriate.  Sufficient and compelling reasons must be given for appointing any Core Director/co-Director who is not a Center member.

In instances where a junior scientist (who may or may not be a part of the research base) with appropriate expertise will devote a significant effort to the core and a more senior, established expert assumes the role of core Director, a title of ‘core manager’ or ‘core technical director’ might be appropriate for the junior scientist.  The career potential of, and institutional commitment to, junior scientists who serve as core managers/technical directors should be clearly outlined.

Include a definition of qualified users and provide a list of research base investigators who will use the core, including the expected extent of their proposed use.  Each proposed Core must be utilized by a minimum of two federally funded investigators who are Center members.  Emphasize the anticipated benefits that investigators will derive from using core facilities.

Present the organization and proposed mode of operation of each core. 

As appropriate to the core, a charge-back system should be developed to allow investigators to utilize any core.  Charge-back 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 charge-back 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.

Each core must have an operational plan which must include methods to:

Limited use of cores by investigators in other fields who are not center members is encouraged, as is use by trainees, students, and junior faculty, but rules to regulate this use should be defined.  If the core is used for training, the approach to and extent of training being performed in each core should be detailed.  Training is an appropriate and worthwhile activity of a core and is encouraged. 

Any core with a minimum number of users must develop plans to broaden the number of core users.  Such plans are particularly important for any core that is not extensively used, but is considered essential by the DDRCC administration.

Describe any plans to use the core for limited developmental research, including the relevance of this research to core services, effectiveness, and adaptability.

Since DDRCCs are strongly encouraged to enter into cooperative arrangements with established cores at the applicant institution or at other DDRCCs offering a similar type of service, describe the nature of any cooperative arrangements, access, fee-schedules,  the prioritization plan, and the methods to monitor use under these circumstances.  It may be advantageous for a DDRCC to provide support for appropriate personnel to work specifically for DDRCC members in an existing facility/core (e.g. transgenic animal core) at the institution.  In this case, the designated DDRCC core Director must work closely with the parent facility core Director to coordinate services, unless the same individual assumes both roles. These arrangements are important whenever greater efficiency or cost savings can be realized by such an agreement. Therefore, financial justification such as comparative costs of other sources of proposed core services as well as plans for cost recovery from users should be detailed. 

For renewal applications, indicate publications made possible by use of the core by referring to the appropriate pages of the publication list included in the Appendix  Tally the number of publications, regardless of primary or secondary category, for the core from that consolidated list.  The DDRCC should have been credited as a resource in all publications. This acknowledgement provides evidence to the study section, and the NIDDK, of core use. 

Also, for renewals, include information on past use of the core services for which further funding is not being requested, as well as a brief explanation of the reasons for deleting the services, combining facilities, or creating new cores. 

Protection of Human Subjects:  If the core uses human subjects, follow the instructions in the PHS 398.

Vertebrate Animals:  If the core uses animals, follow the instructions in the PHS 398.

Administrative Core

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Face Page (Administrative Core)

Do not use the PHS 398 face page. Instead, use the PHS 398 continuation page to create a cover page labeled ‘Administrative Core.’

Description, Project/Performance sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (Administrative Core)

Follow all instructions in the PHS 398 Application Guide, but note the following additional instructions:

Description:  In the Project Summary, briefly describe the structure of the Administrative Core and the services it provides to the DDRCC members.  Include pertinent information about unique aspects of the Enrichment Programs. In the Relevance section of the Description, and all other sections, follow the instructions in the PHS 398.

Detailed Budget for Initial Budget Period, and Budget for Entire Proposed Period of Support (Administrative Core)

Include a budget with detailed justifications for:  (1) the initial budget period, and (2) entire project period for the Administrative Core. 

Personnel:  Most Centers find that the size and complexity of a DDRCC warrants inclusion of a full-time 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-PI application, the combined effort of the PD(s)/PIs must be 2.4 person months.   If requested, include the salary for the Named New Investigator.  Support for this individual is limited to 3 years and cannot exceed $90,000 per year, additional appropriate fringe benefits, and 9.6 person months effort.  The P/F project of the Named New Investigator must be included in the P/F 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.

Other Expenses:  The P/F and enrichment programs budget requests should be included in the “other expenses" category in the budget for the Administrative Core.  DDRCC P/F programs are limited to $150,000 per year.

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 Board.

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 annual DDRCC Directors' meeting.

Biographical Sketches (Administrative Core) 

Do not include any Biographical Sketches here.

Resources (Administrative Core)

Describe the physical location of space specifically allocated for Administrative Core personnel and the equipment available for their use.

Research Plan (Administrative Core)

Research strategy:  Each Center must include an Administrative Core responsible for allocation and oversight of Center resources.  The research strategy for the Administrative Core for a P30 DDRCC must include a description of the administrative structure of the DDRCC, including:  chain-of-command, committee structures (e.g. Internal Advisory Committee; P/F review; other oversight or management committees and the required External Advisory Committee); and core, enrichment program, and clinical component (if included) oversight.

The DDRCC Director, who is the PD(s)/PI(s) of the application, 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-PI application, the combined effort of the PD(s)/PIs must be 2.4 person months.  One or more Associate Directors should be named who will be involved in the administrative, scientific, or training 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.   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.  Describe 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.

For new applications, list the areas of expertise necessary for inclusion on the External Advisory Board, not the names of the individuals whom you plan to recruit to serve in this capacity.  For renewals, list the current External Advisory Board members, and include their Biosketches in the application.

Enrichment Program

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Face Page (Enrichment Program)

Do not use the PHS 398 face page.  Instead, use the PHS 398 continuation page to create a cover page labeled ‘Enrichment Program.’

Description, Project/Performance sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (Enrichment Program)

Do not use for the Enrichment Program.

Detailed Budget for Initial Budget Period, and Budget for Entire Proposed Period of Support (Enrichment Program)

Do not use for the Enrichment Program.  The budget for this program should be included in the budget for the Administrative Core.

Biographical Sketches (Enrichment Program) 

Do not include any Biographical Sketches here. 

Resources (Enrichment Program)

Do not use this form.

Research Plan (Enrichment Program)

Research Strategy: Within the page limit for the Enrichment Program’s research strategy, describe plans for the enrichment program in as much detail as possible, including anticipated benefits to Center members and how the program will assist investigators, trainees, and junior faculty to accomplish the goals of the DDRCC.

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, mini-sabbaticals, etc.  Also, limited travel support may be requested to allow DDRCC investigators to present scientific findings, to learn new laboratory techniques, to develop new collaborations, or to engage in scientific information exchange.  Creative new programs, not precluded by NIH or NIDDK policies, are encouraged.  

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 Enrichment Program educational opportunities should serve to foster the careers of postdoctoral fellows and junior faculty, including K-awardees.

In renewals, describe the existing Enrichment Program, including its value to the DDRCC members and how the program has been adapted to the needs of the members.  Describe future plans for the Enrichment Program.

Clinical Component

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Face Page (Clinical Component)

Do not use the PHS 398 face page.  Instead, use the PHS 398 continuation page to create a cover page labeled ‘Clinical Component.’

Description, Project/Performance sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (Clinical Component)

Follow all instructions in the PHS 398 Application Guide, but note the following additional instructions:

Description:  In the Project Summary briefly describe the services and expertise provided by the clinical component and the need for these to support the investigators in the research base.  In the Relevance section of the Description, and all other sections, follow the instructions in the PHS 398.

Detailed Budget for Initial Budget Period, and Budget for Entire Proposed Period of Support (Clinical Component)

Include a budget with detailed justifications for:  (1) the initial budget period, and (2) entire project period for the Clinical Component. 

Personnel:  This category should include salary support for key personnel, including statistical support, patient coordinators, database managers, and other staff necessary for the functioning of the clinical component. 

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 the 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 clinical component 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 in 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 principal investigator of the CTSA.

Request costs relating to the clinical research efforts of DDRCC 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 DDRCC clinical component.  The DDRCC 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.

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 clinical component.

Travel:  Include the costs of domestic and foreign travel for clinical component personnel only if the travel is directly related to the activities of the DDRCC. 

Biographical Sketches (Clinical Component) 

Do not include any Biographical Sketches here. 

Resources (Clinical Component)

Describe existing environment and facilities briefly in the context of what is available for use by investigators taking advantage of the expertise and/or services of the Clinical Component.

Research Plan (Clinical Component)

Research Strategy: Within the page limit for the Clinical Component’s research strategy, include the rationale for establishing this component and how it will be used to translate the work of the DDRCC into practical therapies for digestive diseases.  Indicate how the staff of the component will assist investigators, trainees, and junior faculty to accomplish the goals of the DDRCC and what the services of the component will be.

Protection of Human Subjects:  If the Clinical Component uses human subjects, follow the instructions in the PHS 398.

Pilot and Feasibility (P/F) Program

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Face Page (P/F Program)

Do not use the PHS 398 face page.  Instead, use the PHS 398 continuation page to create a cover page labeled ‘P/F Program.’

Description, Project/Performance sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (P/F Program)

Do not use for the P/F Program.

Detailed Budget for Initial Budget Period, and Budget for Entire Proposed Period of Support (P/F Program)

Do not use for the P/F program.  The budget for this program should be included in the budget for the Administrative Core.  The P/F program is limited to no more than $150,000 direct costs per year.  

Biographical Sketches (P/F Program)

Include Biographical sketches, following the PHS 398 instructions, for the four P/F applicants whose project summaries are included in the application.  .

Resources (P/F Program)

Do not use for the P/F Program.

Research Plan (P/F Program)

Research strategy: Describe the management plans for the P/F program, including both internal and external review mechanisms along with an outline of the plans for future years of the P/F program.  While the management of the P/F program is left to the discretion of the DDRCC, it must include the elements listed below.

Each DDRCC is strongly encouraged to involve the External Advisory Board in the management of the P/F program.  P/F grant recipients are encouraged to collaborate or consult with any biostatistics component supported by the DDRCC or otherwise available at the applicant institution and to utilize the core facilities or the clinical component of the DDRCC.

Also indicate the number of applications submitted and evaluated by the DDRCC.

Clearly indicate the Named New Investigator, if such a position is being requested, and how he/she was selected.  Each DDRCC may request salary support for a P/F project recipient whom they designate a Named New Investigator (NNI). 

Within the page limit, Include a 1 page synopsis for each of four P/F project applications.  For new applications, these should be the best applications received by the proposed DDRCC and reviewed in the manner proposed for review of all future P/F applications, should the Center be funded.  For renewals, these should be from the most recent group of funded projects.Each synopsis should include:

In renewals, also indicate any lasting collaborations that have resulted from an historical look at the P/F Program.

Appendix for Entire Application

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide, with the following modifications:

For each component of the application where additional information is provided as indicated below, use a PHS 398 continuation page to create a cover sheet with the name of the component (i.e. Center Overview, Administrative Core, etc.) and the Illustration number.

Document collaborative efforts by using a format such as Illustration IV in the Suggested Illustrations for Silvio O. Conte Digestive Diseases Research Core Centers (http://www2.niddk.nih.gov/NR/rdonlyres/ECCA0A6D-1507-4C53-BD71 DB7E9CA4C29/0/2013SampleIllustrations.pdf).  For new applications, pre-existing extensive collaborations are not a prerequisite.  For renewals, the list of peer-reviewed publications resulting from research supported by the DDRCC, indicating the authors who are center members, serves to validate the information in Illustration IV.  A format such as Illustration VII in the Suggested Illustrations for Silvio O. Conte Digestive Diseases Research Core Centers

(http://www2.niddk.nih.gov/NR/rdonlyres/ECCA0A6D-1507-4C53-BD71-CDB7E9CA4C29/0/2013SampleIllustrations.pdf), sorted by core, should be used to present the publication list in renewals.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 Application Guide.

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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

Responsiveness to FOA

To be responsive to this FOA,  the applicant institution must already have a substantial base of ongoing, independently supported, peer-reviewed research projects related to digestive and/or liver diseases which exist at the time of submission.  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.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115, with the following modifications:Updated other support pages may be submitted prior to the review to better evaluate the research base.  This may be in the format of an updated Illustration III from the Suggested Illustrations for Silvio O. Conte Digestive Diseases Research Core Centers  available on the internet at  http://www2.niddk.nih.gov/NR/rdonlyres/ECCA0A6D-1507-4C53-BD71-CDB7E9CA4C29/0/2013SampleIllustrations.pdf

Section V. Application Review Information

1. Criteria

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

Overall Impact - Overall

Reviewers will provide an overall impact 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)?  Do the focus, relevance, interrelationships, quality, productivity, and, to some extent, quantity of the research base support the stated theme of the Center?  What is the likelihood that the DDRDC 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 DDRCC? 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 DDRCC?  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 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 digestive and/or liver diseases 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 their modes of operation (such as prioritization of requests for services)?  Will at least two funded investigators who are Center members use each Core? Will the Cores provide opportunities not otherwise available to the investigators; represent appropriate cost savings/cost sharing advantage; and stimulate the development of new approaches?  Are the criteria for membership in the DDRCC clear and appropriate?  Is appropriate administrative organization proposed for the following:(a) coordination of ongoing research between the separately funded projects and the DDRCC, 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 DDRCC?  

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 Center benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there institutional commitment to the DDRCC, including lines of accountability 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 project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period. Have the benefits of the Center been documented in the forms of increased collaboration, new research directions, and cost savings to its members and the institution? Is the focus of the DDRCC reflected in the research base?  Have the Cores provided appropriate methods, techniques, and/or resources and developed ways to support investigators in new areas of digestive and/or liver diseases research, as appropriate to the purpose of the Core and the research supported by the Center?  Have the Cores adapted to the changing needs of the investigators?  Are the use, utility, quality control, and cost effectiveness of each Core requested to continue as part of the Center documented?  Are Cores no longer needed appropriately being discontinued in response to the changing needs of Center investigators?  Is there a significant list of publications arising from each Core?  Has the administrative structure proven effective?  Are data provided to document the outcome of all completed P/F projects, including those that failed to lead to further funding? Has the enrichment program been effective?

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.

Scored Sections of Application

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.

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 response to this FOA.

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, 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

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)

Judith Podskalny, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases,(NIDDK)
Telephone: 301-594-8876
Email: podskalnyj@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)

Gene McGeehan
National Institutes of Diabetes, Digestive, and Kidney Diseases (NIDDK)
Telephone: 301-594-0417
Email: Gene.McGeehan@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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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