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-11-003
Related Notices	January 4, 2013 - This RFA has been reissued as RFA-DK-12-023.
Funding Opportunity Announcement (FOA) Number	RFA-DK-11-022
Companion FOA	None
Number of Applications	Only one application per institution is allowed as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.847
FOA Purpose	This 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.

Posted Date	September 8, 2011
Letter of Intent Due Date	March 2, 2012
Application Due Date(s)	March 30, 2012
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June-July, 2012
Advisory Council Review	October, 2012
Earliest Start Date(s)	December, 2012
Expiration Date	March 31, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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 integrate, coordinate, and foster interdisciplinary research involving the etiology, treatment, and prevention of digestive and/or liver diseases and related disorders by a group of established investigators actively conducting programs of important, high-quality research that relates to a common DD-relevant theme. 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 who would benefit from shared resources. The body of research described as the research base includes only currently funded, peer reviewed research grants awarded to the applicant institution. These may be Federally or privately funded awards; training 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 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.

A DDRCC must have a central focus of research investigation. The central focus must be a gastrointestinal 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. Examples of a gastrointestinal disease-related central focus of research investigation include, but are not limited to, inflammatory bowel disease, functional bowel disorders, pancreatic disease, liver disease, pediatric gastrointestinal disease, and AIDS in gastrointestinal disease. Examples of functional studies as the central focus include, but are not limited to, gastrointestinal motility, gastrointestinal hormones, role of the gastrointestinal tract in obesity, gastrointestinal physiology, or gene therapy for digestive or liver diseases.

Criteria for designating an investigator as 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.

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, and instruction, 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 federally funded investigators.

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 laboratory. Teaching new or complex techniques and methodologies is an important function of a core.

Proposed cores may be part of an institutional shared research core, such as a centralized animal facility. In such cases, the support provided by the DDRCC should be proportional to the use of the institutional research core by DDRCC members. When proposing the use of a shared facility, details about access, fee-schedules, and prioritization of Center members to 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 and ES-cell animal units, and membrane, cell, or tissue preparation laboratories.

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, and the PD(s)/PI(s) of the application, must devote a minimum of 2.4 calendar 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. 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 that would be used to recommend a successor to the Director, if a successor becomes necessary.

Clinical Component

Since the NIDDK is interested in translating the 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. 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, such as 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.

Pilot and Feasibility Program

The P/F program provides modest support (typically $10,000 to $50,000) 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. 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 80% effort. 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 forum are appropriate items for inclusion in an enrichment program. 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. Mini-sabbaticals to allow Center investigators to enhance their scientific and technical expertise are allowable expenses. 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 guidelines, are encouraged. While DDRCCs cannot support postdoctoral fellows, the environment fostered by the existence of the Center with its core facilitities in conjunction with the enrichment program educational opportunties should serve to foster the careers of postdoctoal fellows and junior faculty.

Applicants should consult with NIDDK staff concerning plans for the development of the DDRCC and the organization of the application.

Funding Instrument	Grant
Application Types Allowed	New Renewal Resubmission The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. The NIDDK intends to commit $2.5 million for two awards in FY 2013.
Award Budget	Application budgets are limited to $750,000 direct costs per year..
Award Project Period	The project period for an application submitted in response to this funding opportunity may not exceed five years.

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• 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

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.

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

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

All Program Director(s)/Principal Investigator(s) (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 four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 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.

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

Only one application per institution is allowed.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

Only institutions at which there is an ongoing, strong 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 or liver diseases and is supported by the research projects which comprise the research base for the DDRCC. The research base grants should be summarized in accordance with the DDRCC guidelines found at http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/DDRCCGuideTOC.htm in sample Exhibit III.

Scientific personnel and institutional resources capable of supporting the research base must be available. In addition, the institution and pertinent departments must show a strong commitment to supporting the Center. 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.

Each proposed Core must be utilized by a minimum of two federally funded investigators. A detailed description of each Core proposed must be provided, including a detailed budget and budget justification. A well-qualified Core Director must be named for each Core. The description of each Core should include a rationale indicating how it will support the Center s research effort in a cost-effective manner. Facilities must be available for the primary needs of the DDRCC because funds for new construction are not available from the P30 grant.

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

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

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

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

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

The letter of intent should be sent to:

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

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: [email protected]

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

• Introduction to a Resubmission Application is limited to 1 page.
• Research Strategy for the Center Overview is limited to 12 pages.
• Research Strategy for the Center Research Base is limited to 6 pages
• Research Base Investigator Project Description is limited to 1 page for each Center investigator to describe funded research, collaborations, and use of DDRCC resources
• Research Strategy for each Core is limited to 12 pages.
• Research Strategy for the Administrative Core is limited to 12 pages.
• Research Strategy for the Clinical Component, if requested, is limited to 6 pages when this component is part of the Administrative Core (in addition to the 12 pages for the Administrative Core). If a stand-along Core, rather than a component, the 12 page limit applies.
• Research Strategy for the Pilot & Feasibility Program is limited to 6 pages for the program overview. In addition, all applications must include four currently funded or approved P/F project descriptions, each no more than 1 page. Renewal applications must also include a 1 page summary for each P/F project funded in the past 5-year project period. A summary such as in sample Exhibit VI in the Adminstrative Guidelines for Digestive Diseases Research Core Centers (http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/DDRCCGuideTOC.htm ) should also be included.
• Research Strategy for the Enrichment Program is limited to 6 pages.

Sufficient pages to list publications in each core resulting from the use of that core in the past 5 years for renewal applications and, for all applications, sufficient pages for the suggested Exhibits as described in the Adminstrative Guidelines for Digestive Diseases Research Core Centers (http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/DDRCCGuideTOC.htm ).

Biographical sketches, following the instructions in the PHS 398, must be provided for all Center members, associate members, P/F applicants, the Named New Investigator (if included), and named Core personnel as well as members of External Advisory committees (only for renewal applications) and any consultants. The biographical sketches should be in alphabetical order except that those for the P/F applicants should be included with the P/F project.

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

• Each section's page limits are exclusive of the 1 page allowed for the Specific Aims.

The research strategy for the Center Overview for a P30 DDRCC must include the following information, within the 12 page limit:

• For all applications, the rationale and need for the Center, its overarching 'theme', the strengths of its membership, how the DDRCC will interact with other relevant Centers and core facilities at the institution, special resources that make the Center unique, and any other information that will convey the need for a DDRCC and the resources it provides.

For renewal applications, a short progress report on the previous funding period for the DDRCC, including changes in the membership, research base, and cores as well as major accomplishments.

The research strategy for the Research Base must include the following information, within the 6 page limit:

• an overview of the current DD-research activities at the institution. 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.

The presentation of the research base in the application is best done in two ways: (1) by providing information in a format such as that shown in Sample Exhibit III of the Adminstrative Guidelines for Digestive Diseases Research Core Centers (http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/DDRCCGuideTOC.htm ), and (2) by providing narrative description of no more than 1 page per research base investigator. These narratives should include:

• grant numbers, titles, and a few descriptive sentences, and
• a list of the core(s) which will be used with a brief sentence indicating what aspect of the research justifies the use of each Core.

ONLY those grants awarded to investigators at the applicant institution or the applicant consortium, not to collaborators at other locations, should be included in the research base. It is particularly important to provide a few sentences indicating the relatedness of a cited grant to digestive diseases research when this is not readily apparent from the title of the grant.

Document collaborative efforts by using a format such as Sample Exhibit IV of the Adminstrative Guidelines for Digestive Diseases Research Core Centers (http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/DDRCCGuideTOC.htm ), although pre-existing extensive collaborations are not a prerequisite for new applications.

The research strategy for each Biomedical Research core must include the following information, within the 6 page limit:

• the rationale for establishing the Core, the facilities to be used, and the activities of the Core;
• short descriptions of the services provided and the projects of the investigators who will use the Core. Give special attention to the description of the physical arrangements and instrumentation for the Core.
• a definition of qualified users. Provide a list of funded Center investigators who will use the core and the expected extent of their proposed use. Sample Exhibit V in the Adminstrative Guidelines for Digestive Diseases Research Core Centers (http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/DDRCCGuideTOC.htm ), is given as an example of how this may be accomplished. Emphasize the anticipated benefits that investigators will derive from using core facilities
• the Core Director's qualifications, including experience in running a Core facility, as well as his/her ability to devote sufficient time to oversee the activities of the Core and the Core personnel.
• the organization and proposed mode of operation of each Core, including plans for assuring quality control, prioritization of investigator use, monitoring Core use, and adapting to new technology and to the needs of the DDRCC members.

Limited use of the Core by established investigators in other fields is encouraged, but rules to regulate this use should be defined. If the core is used for training, detail the approach to and extent of the training. Use of the Core for training Center members is encouraged.

Describe any plans to use the Core for limited developmental research, including the relevance of this research to DDRCC member needs and to existing 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, the prioritization plan, and the methods to monitor use under these circumstances.

The research strategy for the Adminstrative Core must include the following information, within the 6 page limit:

• 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 Core and Clinical Component oversight.
• a brief narrative describing the qualifications of the Director and Associate Director(s);
• a plan for replacing the Director should this become necessary.
• an outline of the relationship of the DDRCC to the institution and the reporting lines of the DDRCC Director to appropriate institutional officials. If this is presented in diagrammatic form, also provide a brief explanation in narrative form.
• 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 and
• the mechanism for making budgetary adjustments necessitated 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 to the Cores in their individual grant budgets.

While facilities (space, equipment, library, etc.) must be clearly described for each element of the application, include a more global description of the overall facilities and a statement regarding institutional commitment to the DDRCC in the description of the Administration Core.

In 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. In renewal applications, list the current members and provide their Biographical sketches.

The research strategy for the Pilot and Feasibility Program must include the following information, within the 6 page limit:

• a justification for amount of P/F funds requested. The actual budget request is contained in the "other expenses" category in the budget for the Administrative Core.
• a description of the management plans for the P/F program, which should include eligibility criteria for applicants, how applications will be solicited, reviewed (including both internal and external committees), awarded, and, if required, terminated, along with an outline of the plans for future years of the P/F program. Also indicate the number of applications received and evaluated.
• a 1 page synposis for each of four P/F project 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. Each synopsis should include:
  • budget and number of years requested,
  • eligibility of the P/F project (how it fits with the DDRCC's goals)
  • name, department affiliation, and eligibility of the P/F investigator
  • proposed Core use
  • abstract of the project.

Clearly indicate the Named New Investigator , if such a position is being requested, and how he/she was selected. Include salary support for this position in the Administrative Core personnel section.

The research strategy for the Enrichment program must include the following information, within the 6 page limit:

• details on proposed enrichment activities, including the benefits to the Center members
• for renewals, indicate how the program has been modified or has adapted to the needs of the Center members.

Include the budget for the Enrichment Program in the Administrative Core.

Resource Sharing Plan

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

• Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

Appendix

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

Part I. Overview Information contains information about Key Dates.

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

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

This initiative is not subject to intergovernmental review.

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

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

Applications must be received on or before the due dates in Part I. Overview Information.

If an application is received after that date, it will not be reviewed.

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

A DDRCC must be an identifiable organizational unit within a single university medical center or within a consortium of cooperating institutions with a university affiliation. 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.

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

• 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 Exhibit III from the Administrative Guidelines for for Silvio O. Conte Digestive Diseases Centers (DDRCC) available on the internet at http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/DDRCCGuideTOC.htm

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

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

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a 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 Centeris collaborative or multi-PD(s)/PI(s), 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 no more than four Pilot & Feasibility (P&F) studies submitted for evaluation as part of the review of the P&F program? 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 the modes of operation (such as prioritization of requests for services)? Will at least two funded investigators 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 evidence of institutional support? 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?

As applicable for the Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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 Center .

Renewals

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

As applicable for the Centert proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Not applicable.

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

For these P30 Center applications, reviewers will be asked to evaluate the following individual sections, and the Scientific Review Officer will record these scores:

• Overall Research base, including the focus, quality of research, collaborations among members, relavence to the the Center's stated research focus, and, for renewal applications, the growth or evolution of the research base.
• Each scientific Core, as regards need for proposed services; number of users; qualifications of personnel; management, including prioritization and responsiveness to the needs of the users; quality control management; and any appropriate developmental work
• The Administrative Core, including committee structure, Center membership criteria, and lines of communication. The enrichment program and Named New Investigator, if requested, will also enter into this evaluation.
• Pilot and Feasibility program, including the quality and appropriateness of the four submitted P/F applications as well as the organization of the P/F overall process of solicitation, review, and monitoring of projects.
• Center Director (PD/PI) as regards leadership and commitment to the stated goals fo the DDRCC.

The overall impact score is not the average of the scores for all these components.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDDK , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• Will receive a written critique.

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Geographical distribution.

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

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

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

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

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

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

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

Not Applicable.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

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: [email protected]

Judith Podskalny, PhD.
National Institute of Diabetes and Digestive and Kidney Diseases,(NIDDK)
6707 Democracy Blvd., Room 667
Bethesda, MD 20892-5450)
Telephone: 301-584-8876
Email:[email protected]

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: [email protected]

Ms. Sharon Bourque
Senior Grants Management Specialist
National Institutes of Diabetes, Digestive, and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 707
Bethesda, Maryland 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: 301-594-8846
Email:[email protected]

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

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