National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
P30 Center Core Grants
See Section III. 3. Additional Information on Eligibility.
This Notice of Funding Opportunity (NOFO) invites applications for Silvio O. Conte Digestive Diseases Research Core Centers (DDRCCs). The DDRCCs are part of an integrated program of digestive and liver diseases research support provided by the NIDDK. The purpose of this Centers program is to bring together basic and clinical investigators to enhance communication, collaboration, and effectiveness of ongoing research related to digestive and/or liver diseases within the NIDDK's mission. DDRCCs are based on the core concept, whereby shared resources aimed at fostering productivity, synergy, and new research ideas among the funded investigators are supported in a cost-effective manner. Each proposed DDRCC must be organized around a central theme that reflects the focus of the digestive or liver diseases research of the Center members. The central theme must be within the primary mission of the NIDDK, and not thematic areas for which other NIH Institutes or Centers are considered the primary source of NIH funding.
To promote extramural basic and clinical biomedical research that improves the understanding of the mechanisms underlying disease and leads to improved preventions, diagnosis, and treatment of digestive and/or liver diseases.
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| September 29, 2026 | September 29, 2026 | Not Applicable | March 2027 | May 2027 | July 2027 |
| February 10, 2027 | February 10, 2027 | Not Applicable | July 2027 | October 2027 | December 2027 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
Program Objective
This Notice of Funding Opportunity (NOFO) invites applications for Silvio O. Conte Digestive Diseases Research Core Centers (DDRCCs) to support research related to digestive and/or liver diseases and their complications. The purpose of a DDRCC is to serve as a key component of the NIDDK-supported research effort to advance digestive and/or liver diseases research.
Overall Institution and Research Base
A DDRCC must be an identifiable unit within a single university medical center or a consortium of cooperating institutions, including an affiliated university. An existing program of excellence as evidenced by productivity and peer-reviewed research funding in the area of digestive and/or liver diseases within NIDDK's mission is a prerequisite before applying. The currently funded research base provides the major support for the investigators, i.e. Center members, who would benefit from a Center's shared resources. The research base includes only currently funded, peer-reviewed research grants awarded to the applicant institution/consortium. These may be a mix of Federal and privately funded research awards or research career development awards. Moreover, there must be sufficient Federal support within the base to fulfill the requirement for a minimum of two federally funded Center members utilizing each Biomedical Research Core. Training grants, education grants, and fellowship awards are not considered part of the research base funding. Focus, relevance, interrelationships, quality, productivity, and, to some extent, quantity are all considerations in judging the adequacy of the research base. Importantly, quantity at the expense of other considerations should be avoided. A research base that has diminished focus because of inflation with the inclusion of grants with tangential relevance to digestive or liver diseases within the NIDDK's mission or the Center's theme should be avoided.
The absolute level of research base support must be sufficient to warrant the addition of a Center, typically at least $3 million per year in direct costs. At least 30 percent of the total funding contributing to the research base must be secured from the NIDDK. Since indirect costs vary considerably between institutions, these should not be included in the calculation of the research base. Although collaborations are encouraged, the research base includes ONLY support for the investigators at the applicant institution/consortium. Collaborations with investigators outside of the applicant institution/consortium or between DDRCCs are encouraged; however, they are optional. While optional, these collaborations often benefit the DDRCC's research base.
A DDRCC must have a central research focus or theme. The central focus must be a gastrointestinal/liver disease, group of diseases, or functional studies relating to digestive and/or liver diseases within the mission of the NIDDK. The theme should be cohesive and well-articulated to ensure a DDRCC with components that will substantially advance a defined area of NIDDK-related science. Existing, competing Centers are encouraged to focus their efforts. The direct cost cap for DDRCCs has not been increased in recent years and thus more focused DDRCCs might be necessary to avoid diluting the effectiveness of the limited Center support available. Therefore, it is not necessary for each competing Center to show growth in their research base when they have made the strategic decision to focus their research base (i.e., Center membership) rather than continuously expand. A flat or even slightly reduced research base in a renewal application is acceptable. When a reduction results in a more thematically focused DDRCC, with added benefit to Center members, this is appropriate and viewed as a positive development as long as the funds requested are well justified.
Overlaps in the research base among NIDDK-funded Centers should not inappropriately inflate the research base of any Center. Non-research base investigators at the applicant institution or elsewhere may be encouraged to make use of the core facilities, collaborate with Center members, and participate in scientific exchange activities when space, time, and funds permit.
Administrative Core (with a required Scientific Catalyst Program and an optional Clinical Component)
Each Center must include an Administrative Core responsible for allocation and oversight of Center resources. The Administrative Core is expected to ensure the coordination and integration of the Center's components and activities. Administrative Core personnel provide support for the required External Advisory Committee and the internal committee structure of the Center. The Administrative Core should have a process to (a) assess the productivity, effectiveness, and appropriateness of Center activities; (b) determine criteria and the selection process for Center membership; (c) foster collaborations and scientific opportunities among its members; and (d) foster community engagement and participation of community partners. In addition, all DDRCCs will be required to maintain an institutional Center website, with the Administrative Core taking primary responsibility for its curation and oversight, as well as for ensuring proper and seamless integration of the Center website.
Required Scientific Catalyst Program: As part of the Administrative Core, DDRCCs are expected to support activities such as visiting scientists, seminars, and research forums as well as other appropriate, innovative means to support the goals of the Center, e.g., short courses, mini-sabbaticals, or joint activities with other DDRCCs, via a Scientific Catalyst Program. Limited travel support may be requested to allow DDRCC investigators to present scientific findings, learn new laboratory techniques, develop new collaborations, or engage in scientific exchange. In all cases, the Scientific Catalyst Program should further the overall aims and objectives of the DDRCC as well as its Cores. While DDRCCs cannot support stipends for postdoctoral fellows, the environment fostered by the existence of the Center, with its core facilities in conjunction with the Scientific Catalyst Program educational opportunities, should serve to foster the careers of postdoctoral fellows and junior faculty, including K awardees.
Optional Clinical Component: The optional Clinical Component can serve as a resource, a focal point, and a facilitator for translating work supported by the DDRCC into practical therapies for digestive and liver diseases. Investigators, therefore, need not be funded directly for clinical studies to justify the inclusion of this unit. Likewise, individual researchers do not need to be funded directly for clinical studies to use the service or expertise of the Clinical Component. Providing the capability for translating basic research findings into a clinical setting is the goal of the Clinical Component for those Centers wishing to build this part of their research base. Besides leading to a better understanding of the etiology and natural history of disease, a Clinical Component might provide biostatistics support; help with clinical study design; foster collaboration among researchers; aid in recruitment of subjects for clinical studies; support epidemiological studies in areas of digestive and/or liver diseases; or provide modest funding for tissue, DNA, serum storage, or other human specimen storage. In addition, a Clinical Component may help Center members to effectively address NIH policies concerning inclusion of women, minorities, and people across the lifespan in clinical studies.
Biomedical Research Cores
The DDRCCs are based on the core concept. Cores are defined as shared resources that foster productivity and benefit a group of investigators working to accomplish the stated goals of the Center. Cores should provide specialized technical resources, services, and/or other expertise that enhance the efficiency and productivity of Center members. The proposed Core services should be ones that are not readily available or are not cost-effective when supplied from commercial sources, or which are technically challenging or require specialized expertise, equipment, or infrastructure. Each proposed Core must be utilized by a minimum of two federally funded investigators (with projects other than training grants, education grants, or fellowship awards) who are Center members.
When appropriate, Core staff should provide instruction for investigators, laboratory personnel, and/or fellows to learn, and then become proficient in, technologies that will become part of the repertoire of the user's laboratory. Teaching new or complex techniques and methodologies is an important function of a Core.
When proposed core services are already available through the research institution (e.g., via an institutional core), there must be compelling justification for their support through the DDRCC. Strategies for preventing duplication of services between centers at the applicant institution or for collaboration between DDRCCs to maximize use of Core resources at each DDRCC are encouraged.
In addition to providing products or services, a Core must ensure appropriate quality control and maintain a record of use. Limited developmental research is also an appropriate function of a Core facility as long as it is directly related to enhancing the function or usefulness of the Core and is not an undertaking that should more appropriately be funded through other mechanisms. Plans for responding to the changing needs of the Center members should also be a part of each Core.
Two to six biomedical research Cores are usually included in a Center. Examples of Core services/resources include, but are not limited to, imaging facilities; transgenic or gnotobiotic animal units; microbiome and metagenomics services; and membrane, cell or tissue preparation, and/or storage facilities. If a Human Core, Clinical Core, or Translational Core is submitted (rather than a Clinical Component), such Cores must be utilized by two federally funded projects.
Pilot and Feasibility Program
The Pilot and Feasibility Program (P and F Program) provides modest support (typically up to $50,000 per year) for new initiatives or feasibility research studies. P and F Programs are intended to provide support for investigators to collect preliminary data sufficient to support a grant application for independent research support and/or to test a novel, even high-risk, hypothesis. P and F studies may (1) provide support for new investigators, (2) provide support for established investigators who will have no independent R01 or R01-equivalent grant support if they do not secure a substantial grant award in the near future, or (3) encourage investigators from other areas of biomedical research to apply their expertise to an area of need in digestive disease research. P and F awards may elect to support post-doctoral fellows who have an interest in pursuing an academic research career and may be issued to investigators with research appointments outside the applicant institution/consortium.
P and F projects are expected to support research that primarily aligns with NIDDK's scientific mission rather than digestive or liver disease research that is better aligned with the mission of another NIH Institute or Center.
P and F support is not intended for large projects by established investigators that should be submitted as separate research grant applications, nor is it intended to provide bridging support for established investigators who are PIs of one or more R01 or R01-equivalent grants that will be active for at least two years. P and F funds are also not intended to support or supplement ongoing funded research of an investigator.
Named Supported Investigator (Optional): Each DDRCC may request salary support for a P and F Project recipient whom they designate as a Named Supported Investigator (NSI). The individual selected must be named in the application and be a junior investigator and a permanent resident or US citizen. Individuals are eligible only once for this support. Subsequent candidates for this position are nominated by the Center and reviewed by its External Advisory Committee. Appointment of the NSI is contingent upon the concurrence of the External Advisory Committee and the NIDDK DDRCC program director.
Center Evaluation
It is anticipated that research advances, development of new research technologies/methods, and the changes in composition of the research base will require existing DDRCCs to evolve over time. DDRCCs are encouraged to develop a plan to continuously evaluate and respond to the changing needs of their research base members by adding, eliminating, or expanding Cores/core services during the course of the DDRCC.
DDRCC Directors' Meeting
Every 12–18 months, all DDRCC Directors and Center administrators are expected to attend a meeting at one of the DDRCCs to exchange information, highlight the host Center, and interact with NIDDK senior staff.
Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.
See Section VIII. Other Information for award authorities and regulations.
Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
NIDDK intends to commit $4.8 million in FY 2027 to fund 4 awards and $2.4 million in FY2028 to fund 2 awards.
Application budgets are limited to $750,000 in direct costs per year and need to reflect the actual needs of the proposed Center.
The maximum project period is five years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Higher Education Institutions - Includes all types
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Only institutions at which there is a strong ongoing base of digestive and/or liver diseases-relevant research that relates to the proposed theme of the Center are eligible. The already funded research base must have at least $3 million per year in direct costs of supported research within a proposed theme area that is of primary interest to the NIDDK. These may be a mix of Federal and privately funded research awards or research career development awards. However, at least 30 percent of the total funding contributing to the research base must be secured from the NIDDK. Moreover, enough awards within the research base must be Federal to fulfill the requirement that each Biomedical Research Core must be utilized by a minimum of two federally funded Center members. Training grants, education grants, and fellowship awards are not considered part of the research base funding. Since "Facilities and Administration" costs vary considerably between institutions, these must not be included in the calculation of the research base.
Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.
It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.
| Component | Component Type for Submission | Page Limit | Required/Optional | Minimum | Maximum |
|---|---|---|---|---|---|
| Overall | Overall | 12 | Required | 1 | 1 |
| Admin Core | Admin Core | 12 | Required | 1 | 1 |
| Biomedical Research Core | Core | 6 | Required | 2 | 6 |
| NOFO Specific | P and F Program | 6 | Required | 1 | 1 |
The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.
The application should consist of the following components:
When preparing the application, use Component Type 'Overall'.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.
Complete entire form.
Follow standard instructions.
Follow standard instructions.
Project Summary/Abstract: Describe the scientific theme of the DDRCC and the need for a Cores Center to support the investigators in the research base. Include the number of Center members and the overall total direct costs present in the digestive and/or liver research base. Specify the total direct costs of NIDDK awards contributing to the research base. Provide a brief overview of the research base as it relates to the theme of the Center as well as an overview of the Biomedical Research Cores, the P and F Program, and the Scientific Catalyst Program.
Project Narrative: In 1–3 sentences describe the relevance of the research to be supported and facilitated by Center Activities (Biomedical Research Cores, P and F Program, and Scientific Catalyst Program) to public health.
Facilities and Other Resources: Describe the existing environment and facilities briefly in the context of how the Center will use or change existing access, space, and usage; include space maps as needed. Scientific personnel and institutional resources capable of supporting the research must be available.
Equipment: A general listing of major, shared pieces of equipment used by the Center members should be provided. Note: Specific research core facilities, equipment and special resources should be listed in each proposed biomedical research core component.
Other Attachments: The following "Other Attachments" must be included with the Overall Component to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image. All attachments must be in PDF format.
Table of DDRCC Research Base Investigators (Required): Please title this attachment "DDRCC Research Base Investigators" and include all Federal or non-federal grant support for Center members and organize alphabetically by the last name. The table must include PI name, the active grant number(s), title(s), amount of funding (Direct Costs only) in the current year, a few descriptive sentences of the investigator's research projects, the cores that the members use, and if not readily apparent, the relevance to digestive and/or liver disease research. The table of grant support should include R-series, individual K-series, U01s, DP-series, P01s, and other similarly peer-reviewed grants funded through other Federal Agencies or non-federal groups.
For renewal applications only, Progress Report Publication List (Required, not to exceed 5 pages): In this attachment, list the titles and complete references for representative examples of publications attributed to core usage and manuscripts accepted for publication that have resulted from the DDRCC since it was last reviewed competitively. Identify the core(s) utilized in association with the publication.
Enter primary site only.
A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.
Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.
A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.
The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.
A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.
Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.
Specific Aims: Describe the broad long-term objectives of the proposed DDRCC. Provide the central theme(s) of the DDRCC. The theme may be broad or focused, depending upon the goals of the Center. However, it should also be cohesive and well-articulated to ensure a DDRCC with components that will substantially advance a defined area of NIDDK-related science. Outline the existing skills and technologies available in the research base as well as other resources at the institution(s) and summarize how the Center will enhance ongoing projects, assist in the development of new projects, respond to future opportunities, and promote collaborations leading to advances in digestive and/or liver diseases research.
Research Strategy: The Research Strategy should include the following sections.
Research Base: Applicants should include an overview of current research in digestive and/or liver diseases related areas being conducted at their institution in sufficient detail to allow reviewers to judge the extent and the interrelationship of ongoing research. It is recommended that the DDRCC research base be subdivided into areas of research emphasis or research themes that link Center members and their research programs.
Presentation of the research base in the application should be done by completing a Table itemizing grant funding as described in Other Attachments above. The research of each DDRCC member should be discussed and interrelationships of research being conducted by the members should be highlighted. Since most, if not all, of the research base will have undergone separate peer review, the quality of the individual funded projects is already established. The more important aspects are: (a) interactions and interrelationships of the research efforts as well as relevance to the theme of the DDRCC; (b) uses and benefits of core services; (c) plans to develop productive collaborations among Center investigators; and (d) willingness of Center investigators to contribute to the overall objectives of the DDRCC. Collaborative activities with individuals outside the applicant institution/consortium or between DDRCCs is encouraged but optional. How collaboration will benefit the research base can be described.
Membership: A high level of integration and close collaboration among DDRCC members with varying perspectives and from different scientific disciplines is an important feature of a successful Center. Accordingly, the applicant should state considerations for DDRCC membership with specific reference to the potential of members to form interactive, collaborative, and synergistic relationships. Applicants should provide clear guidelines for how Center membership is defined (including, if applicable, how subsets of membership are defined), the application and selection processes for Center membership, the obligations of Center membership, and the criteria for termination of membership. Suitable criteria for membership include, but are not limited to, peer-reviewed independent funding, participation in digestive diseases research, and the need for the use of core facilities. All research base investigators must be Center members. Designation as a Center member without the need for the use of core facilities must be well justified.
Center Organization: Summarize the services, resources, and expertise provided by the proposed Biomedical Research Cores, emphasizing the support they will provide for the thematic areas of the research base. Point out novel services and resources available in the cores and describe the potential for interdisciplinary collaborations among Center Investigators.
Indicate if any of the proposed Cores will utilize or expand Cores already existing at the institution. Describe how the proposed Center will leverage existing resources and fill gaps in the services available. Leveraging existing resources is encouraged, particularly when this provides a range of services or efficiency that would not otherwise be available.
Provide a plan to determine the need for new services or instrumentation of the DDRCC members. Discuss how the Center will ensure that Center members can take advantage of cutting-edge technology and how services no longer required, or no longer cost-effective, will be phased out. Include information on the process of re-evaluating the needs of Center members and how evolving needs will be met.
Also, describe how the Center will enhance the research base and foster the careers of its junior investigators through scientific exchange activities and the use of Core services/expertise.
Institutional commitment: Applicant institutions/consortia are expected to have demonstrable commitment to the Center's success. Examples of ways institutional commitment might be evidenced include, but are not limited to, financial support for Cores or other Center functions, salary support for Center staff, dedicated space, or availability of equipment. New applications should briefly describe plans for institutional commitment should the Center receive NIDDK support. Renewal applications should briefly describe both previous and ongoing instances of institutional commitment. These should be accompanied by letters of support from institutional officials verifying the commitment with specific details.
For renewal applications: Briefly discuss the progress and accomplishments of the research base as influenced by the DDRCC; the development of multidisciplinary, collaborative, and cooperative interrelationships among Center members; and indicate any alteration in the original Center design that was instigated to meet the evolving needs of the research base. Discuss changes to the research base over the past five years to either facilitate growth or to enhance its focus, instead of emphasizing growth. This should be described in a narrative fashion.
Letters of Support: Include any letters of support for the proposed DDRCC from appropriate institutional officials.
Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.
The following modifications also apply:
Generally, Resource Sharing Plans are expected, but they are not applicable for this component.
Other Plan(s):
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:
If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply - Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
When preparing your application, use Component Type 'Admin Core'.
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Follow standard instructions.
Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.
Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Budget forms appropriate for the specific component will be included in the application package.
Personnel: The Center Director must devote a minimum of 2.4 person months to the Center and at least 1.2 of the person months must be within the Administrative Core to ensure adequate oversight of the Center. If a multiple PD/PI application, the combined effort of the PD(s)/PI(s) must be 2.4 person months. Most Centers find that the size and complexity of a DDRCC warrant inclusion of a full-time program administrator, so salary support for this individual should be included in the Administrative Core. This category should also include salary support for any additional key personnel, including the Scientific Catalyst Program Director and any other professional and administrative personnel. The Scientific Catalyst Program Director must devote a minimum of 0.6 person months to ensure adequate oversight of the Program.
Equipment: If pieces of specialized equipment, or computers, costing more than $5,000 are requested, the application must identify similar equipment already available within the institution and provide a clear justification for purchase based on core service provided to DDRCC investigators. Requests for general-purpose equipment should be included only after ascertaining the availability of such items within the institution. Justify the request based on this availability. This includes all equipment in future budget years as well as the initial budget period.
Supplies: Consumable supplies directly related to the operational aspects of the Administrative Core facilities are an allowable expense.
Alterations and Renovations: Funds for the alteration and renovation of an existing structure to provide suitable space for core facilities may be requested. Cosmetic renovations are not appropriate.
Consultants: Include costs associated with consultants (consultant fees, per diem, and travel) when their services are required by the DDRCC, such as the members of the External Advisory Committee. Include costs associated with consultants (e.g., consultant fees/honoraria, per diem, and teleconferences) when their services are required by the Scientific Catalyst Program.
Travel: Include the costs of domestic and foreign travel only if the travel is directly related to the activities of the DDRCC. Include travel costs for the DDRCC Director, Center administrator, and others as appropriate (i.e., co-Director, core Directors) to attend the DDRCC Directors' meeting. Travel funds to support visiting scientists under the auspices of the Scientific Catalyst Program may be requested.
Other Expenses: Support for development/maintenance of the Center's website may be requested as well as funds for supporting regional Center meetings, if appropriate. Include funds to support Scientific Catalyst Program activities such as workshops, research forums, symposia, Center retreats and seminar series. Funds for Scientific Catalyst Program-associated activities such as the printing and distribution/mailing of brochures, programs, and meeting materials, as well as posters and other advertisement materials, may be requested.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: Clearly state how the Administrative Core will contribute to the goals of the DDRCC and outline interactions of the Administrative Core with each of the other Cores, Clinical Component (if proposed) and Programs (P and F and Scientific Catalyst). Provide an overview of how the Administrative Cores will set the overall direction of the Center and ensure optimal utilization of the Center resources. Provide a description of the objectives and operation of the Scientific Catalyst Program.
Research Strategy: The Administrative Core is key to the coordination and functioning of the Center. Therefore, describe the administrative structure of the DDRCC, including chain-of-command; committee structures (e.g., Internal Advisory Committee, P and F review committee, other oversight or management committees, and the required External Advisory Committee); and Core, Scientific Catalyst Program, and Clinical Component (if included) management.
The Director, who is the PD(s)/PI(s) of the application, should be assisted by one or more Associate Directors who will be involved in the administrative, scientific, or collaborative efforts of the Center and who will serve as Acting Center Director in the absence of the Director. Include a brief narrative describing the qualifications of the Director and Associate Director(s). A process must be in place to recommend a successor to the Director, if a successor becomes necessary.
The relationship of the DDRCC to the institution and the reporting lines of the DDRCC Director to appropriate institutional officials may be presented in diagrammatic form, but also provide a brief explanation in narrative form.
Include a description of the mechanism for monitoring budgetary overlap between the research projects included in the research base and the funds for the core facilities of the DDRCC, describing a mechanism to monitor the budgetary adjustments made necessary by the use of Core services. This will ensure that DDRCC investigators using Cores are able to provide a satisfactory explanation of their relationship to the DDRCC and their inclusion of charge-back fees for Core use in their individual grant budgets.
It is expected that the organization of the Administrative Core will provide a supportive structure sufficient to ensure the success of the Center and its activities.
Center Evolution: Applicants must document policies and procedures for ensuring continuing evolution of Center activities, such as core services, in response to changing needs of the research base. New technologies or services might appear that should be supported, existing technologies might become less important, or economic changes might obviate the need for core services, such as the availability of cost-effective commercial services or core services provided by the research institution. Centers should address the issue of allocation of resources toward development of new technologies versus provision of services with existing technologies.
The administrative structure must include an Internal Advisory Committee (IAC) and an External Advisory Committee (EAC). New applications should neither contact potential EAC members nor list members of the EAC, but they should describe what expertise is needed and the process by which they will be selected. Renewal applications should list the current EAC members (and include their biosketches on the Senior/Key Person form) in addition to documenting the functions and effectiveness of the External and Internal Advisory Committees. The structure must also include community partners who will provide perspectives on living with digestive and liver diseases and input to the Center. This can be achieved through either participation on the IAC or establishment of a community advisory board (CAB). Additional complementary strategies for community engagement may also be included.
The final administrative structure of the Center will be left largely to the discretion of the applicant institution. However, past experience has demonstrated that the effective development of the Center programs requires close interaction between the Center director, Core/Program Leaders, appropriate institutional administrative personnel, and the members of the community in which the Center is located. Therefore, each Center applicant should establish an administrative structure that will permit the development of such interactions. Within this structure, each applicant institution must also establish a mechanism to oversee the use of funds for the proposed pilot and feasibility program. This mechanism must include the use of appropriate consultants for review from the scientific community outside the Center institution. These same consultants may be utilized, if desired, for review of other activities of the Center.
Letters of Support: Include any letters of support for the proposed Administrative Core, as appropriate. Include any letters of support from community members who serve on the IAC or CAB. Letters from members of CABs dedicated to specific Cores (e.g., a CAB associated with a biorepository) should be included in that Core's Letters of Support.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:
Generally, Resource Sharing Plans are expected, but they are not applicable for this component.
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:
If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
When preparing your application, use Component Type 'Core'.
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Follow standard instructions.
Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.
Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Facilities and Other Resources: The description of the physical arrangements and instrumentation for the cores should be given special attention. Arrangements for sufficient space for core activities or for access to appropriate established facilities must be made. Centers are strongly encouraged to enter into cooperative arrangements with cores already established within their institution, or with other Centers in close proximity, when the existing cores offer the services needed. These arrangements are important whenever greater efficiency or cost savings can be realized by such an agreement. 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. It may be advantageous for a DDRCC to provide support for appropriate personnel to work specifically for Center members in an existing facility/core (e.g., transgenic animal core) at the institution. In that 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.
Other Attachments (Required): The following attachment must be included in PDF format. The filename provided will be the bookmark in the application image.
Core Facility Use (Required, up to 3 pages per Biomedical Research Core): For all applications, please title this attachment "Core Facility Use" and indicate the Core User, Funded Project that supports the Core use, Period of Core Use, Services to be used, and Estimated Use and comments. Identify in bold core users who are research base members. Renewal applications may describe productivity within a biomedical core that was discontinued during the prior project period. The prior use of the discontinued core may be presented in a Table(s).
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Budget forms appropriate for the specific component will be included in the application package.
Personnel: This category should include salary support for key personnel, including the Core Director, co-Director, and other professional and technical personnel. The Core Director must devote a minimum of 0.6 person months to the Core to ensure adequate oversight. The salary amount charged to the DDRCC grant must be commensurate with the time spent on Core activities and is subject to institutional and NIH salary policies. A Core Director with the requisite expertise may devote a greater effort to the core, and with exceptionally strong justification could devote up to 12 person months. 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. 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. Salary support for technicians and other core personnel is allowable in accordance with the volume and type of work in the core. Stipends for research trainees are not available through the Center. Such funding must be sought through other grant mechanisms.
Equipment: If pieces of specialized equipment costing more than $5,000 are requested, the application must identify similar equipment already available within the institution and provide a clear justification for purchase based on core services 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, when possible, all equipment in future budget years, in addition to the initial budget period.
Supplies: Consumable supplies directly related to the operational aspects of the core facilities are an allowable expense. This includes office materials as well as laboratory supplies. The supply budgets of separately funded individual research projects must be appropriately reduced to reflect such support, thus eliminating duplication.
Research Patient Care Costs: Research patient care costs (both in-patient and out-patient) are an allowable expense. Attempts should be made to utilize existing clinical facilities, such as those supported by Clinical and Translational Science Awards (CTSAs) and individually supported beds.
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 Center. 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 (e.g. consultant fees, per diem, teleconferences, 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.
Other Expenses: Funds for equipment maintenance/service contracts may be requested, but should reflect only an equivalent percentage of the service contract based on the overall use of the specified equipment by Center investigators versus other users. The budget justification for any maintenance/service contracts should document use of the equipment by Center members. Only in very rare cases should full support for a maintenance/service contract be requested, and strong justification must be provided in such cases.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: Clearly state the aims of the Biomedical Research Core.
Research Strategy: Provide the rationale for establishing or continuing the Core and the activities of the Core. Cores may be proposed to support any research activity of the Center. The description of each Core should indicate how it will support the Center's research base in a cost-effective manner.
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. Criteria for use and for prioritization must be included in the application.
Present the organization and proposed mode of operation of each core. As appropriate to the core, a charge-back system may be developed to allow investigators to utilize its services. Financial justification such as comparative costs of other sources of proposed core services as well as plans for cost recovery (i.e., charge-back fees) from users should be detailed.
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: 1) assure quality control, 2) prioritize investigator use, 3) monitor core use, and 4) adapt to new technology and to the needs of the DDRCC members.
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 the 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, while not extensively used, 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.
Because cooperation between DDRCCs is also encouraged, but not required, any plans to work with one or more other established DDRCCs may be provided and documented along with a description of the benefit(s) to the Center being proposed. Benefits might include, but are not limited to, cost savings, the ability to provide additional or improved services, or enhanced productivity by Center members. Likewise, collaborations with other Core Centers supported by other NIDDK Center Programs are also encouraged and may also be documented and described.
Proposed DDRCC cores may be an institutional-shared research core. In those cases, applicants must provide a rationale for using institutional cores, such as:
Program Income: Centers may, where appropriate, develop a program income (re-charge/fee-for-service) system for use of Core services. Such a program income system would constitute a method of charging Core users for their usage of expertise and research resources. Program income must be re-invested into direct support of Center-related activities and/or expenses and may not generate a profit for the Center.
For renewal applications: Information relative to cores in renewal applications should generally cover all the same points as initial applications. In addition, past performance and accomplishments should be described and highlighted. The effect of the service provided by a core on investigator productivity and cost-effectiveness should also be addressed. Any changes in services provided should be documented. Any Core usage by (1) Members of other DDRCCs; (2) Members of other NIDDK-funded Centers; and (3) Non-Center members, both locally and nationally, should be documented.
Also, for renewal applications, 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.
Letters of Support: For any collaborative links between the CTSA and a specific Biomedical Research Core, a letter of support should be included within the relevant Core. Also, provide letters to address the career potential of, and institutional commitment to, junior scientists who serve as core managers/technical directors. Letters of support from members of CABs that are specifically focused on a particular Core should be included within the relevant Core. In addition, other letters of support for the proposed Core may be included, as appropriate.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:
If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
When preparing your application, use Component Type 'P and F Program'.
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Follow standard instructions.
Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations' questions.
Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Other Attachments (Required): The following attachments must be included in PDF format.
For renewal applications only, Pilot Project Outcomes (Required, not to exceed 6 pages): Please title this attachment "Pilot Project Outcomes" and list all P and F Projects supported in the most recent 5 or, if applicable, 10-year period. Include the awardee, years funded, dates and amount of P and F funding, pilot project title and brief description of the project, P and F awardee type (i.e., new investigator; established investigator), numbers of abstracts and publications derived from pilot support, grants funded or pending applications (including grant number/funding agency and project period), and whether the recipient is still involved in GI and/or liver research.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Budget forms appropriate for the specific component will be included in the application package.
Personnel: Include salary support for the P and F Program director, who must devote sufficient effort to manage and provide oversight, typically 0.6 to 1 person month. If requested, include the salary for the Named Supported 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.
Other Expenses: Include funds to support the number of P and F projects requested. These funds are capped at $150,000 direct costs per year for the program.
Consultants: Include costs associated with consultants (e.g., consultant fees/honoraria, per diem, and teleconferences) when their services are required by the Pilot and Feasibility Program, such as any external reviewers for P and F applications.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: Clearly state the goals of the Pilot and Feasibility Program.
Research Strategy: Describe the overall goals and structure of the Pilot and Feasibility Program. Describe its management plans, including both internal and external review mechanisms, along with an outline of the plans for future years of the P and F Program. While the management of the P and F Program is left to the discretion of the DDRCC, the following must be described in the application:
Each DDRCC is strongly encouraged to involve the External Advisory Committee in the management of the P and F Program. P and 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 Biomedical Research Core facilities or the Clinical Component of the DDRCC.
Clearly indicate the Named Supported Investigator, if such a position is being requested, and how and why he/she was selected. Each DDRCC may request salary support for a P and F project recipient whom they designate a Named Supported Investigator (NSI).
All applicants should provide an assessment of the relevance of proposed P and F projects to the specific goals of the DDRCC as well as the P and F program's ability to encourage innovative research. Moreover, the P and F program is intended to primarily support digestive and liver research aligned with NIDDK's mission as opposed to digestive and liver disease research that is primarily aligned with another NIH Institute or Center. In this context, the research strategy should also include a brief, no more than one-page synopsis for 4 representative P and F project applications that have been vetted by the Center.
Each synopsis should include:
Requirements: Each Center must propose to support a minimum of 2 pilot and feasibility studies from DDRCC funds each year.
For new applications: These should be the best applications received by the DDRCC and reviewed in the manner proposed for all future P and F applications. If the P and F awards have been made through this process, that information may be provided.
For renewal applications: These should be from the most recent group of funded P and F projects.
Renewal applications should describe the success of their ongoing program. Indicators of a successful program include the number of P and F projects leading to successful career development awards, research project grants, or equivalent foundation grants and how they have benefited the recipients' career trajectories and the Center's scientific environment. The direct costs awarded to these grants is less important, because it conveys the budget required to accomplish the Aims and not the project's scientific merit. Other important outcomes associated with a successful program include publications, professional opportunities, and the development of new technologies or resources. New applications that have had demonstration P and F Programs may also describe their success.
Letters of Support: Include any letters of support for the Pilot & Feasibility Program by appropriate institutional officials at partnering organizations (other than the parent institution), if applicable.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:
If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in How to Apply- Application Guide.
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 Section 7.9.1 Selected Items of Cost.
Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.
For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply - Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in How to Apply - Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g., genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.
Applicants are required to follow the instructions for post-submission materials, as described in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular Notice of Funding Opportunity (NOFO), note the following:
Reviewers will be asked to evaluate the following individual sections. The overall impact score is not the average for these components.
Center Pilot and Feasibility Programs have the option to support Clinical Trials.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project 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 project 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 project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project 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?
Specific to this NOFO: What are the strengths of the Center's research base (its breadth and depth)? How appropriately do the focus, relevance, interrelationships, quality, productivity, and, to some extent, quantity of the research base support the stated theme of the Center? How effectively does the size of the research base strike a balance between having an appropriate number of investigators to justify a Center and maintaining a cohesive focus on digestive and/or liver diseases research aligned with the mission of NIDDK? To what extent will the Center members benefit from the services/programs supported by the DDRCC? What is the likelihood that the DDRCC will increase efficiency; promote new research directions and meaningful collaborations among center investigators; facilitate interactions and collaborations among the investigators; and prove cost-effective? If collaborations with other DDRCCs or individuals outside of the research base are described, how do they benefit the Center? For example, do they enhance the productivity or quality of the research base; enhance the services offered by the DDRCC; expand the varying perspectives within the Center; strengthen the Center's activities (e.g. P and F and Scientific Catalyst Programs); allow for a more efficient use of the DDRCC's available resources; or otherwise benefit the research base?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?
Specific to this NOFO: How effectively do the Center investigators responsible for the individual research projects interact with each other and contribute to the overall objectives of the DDRCC? How appropriate are the Center Director's and Associate Director(s)' administrative abilities and scientific expertise for effective management of the DDRCC? How strong is their commitment and their ability to devote adequate time for the effective management of the DDRCC? How well qualified are the Core Directors and how appropriate are their scientific expertise and administrative abilities? How well are the P and F applicants prepared to lead their proposed P and F Projects effectively? Do they have the appropriate conceptual and technical expertise for executing the proposed research? If requested, how well qualified and appropriate for support is the Named Supported Investigator? Is there an existing funded research base of relevance to digestive and/or liver disease, and has the research base demonstrated a strong contribution to the advancement of digestive and/or liver disease research? Are the research base members appropriate users for each of the proposed Cores and Programs? Do they demonstrate existing or the potential for future collaborations?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
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?
Specific to this NOFO: How innovative is the research conducted by the research base/Center members and how likely is the DDRCC to enhance and advance digestive and/or liver disease research? To what extent will the research base benefit from the overall resources, technical support, and new methods that will advance the Center members' research? How successfully does the DDRCC demonstrate the ability or have a plan to adapt to support the research base members in emerging areas of digestive and/or liver disease research, as appropriate to the purpose of the Core and the research supported by the Center? How successfully does the Center appear to encourage innovative ideas through their P and F Program? To what extent 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?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
For example, innovative designs such as platform trials, adaptive, including real-time adaptive methods, seamless Phase I/II designs, and Bayesian designs are encouraged as applicable.
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:
1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this NOFO: To what extent will the research base/users benefit from opportunities and services provided by the DDRCC that are not otherwise available at the institution/consortium, i.e., institutional cores and other Centers? To what extent will the Cores benefit the investigators by providing opportunities not otherwise available to the investigators; providing cost savings/cost sharing advantage; and stimulating the development of new approaches? How appropriate and relevant are the proposed Cores and their modes of operation (such as prioritization of requests for services)? How clear and appropriate are the criteria for membership in the DDRCC? How efficient and effective is the use and/or planned use of the limited Scientific Catalyst funds, including the contribution of these activities to the stated goals of the DDRCC? How appropriate is the administrative organization proposed for the following? How well does the vision or mission statement, including the P and F Program's, reflect the overall Center's goals and inform the Program's processes?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, sex, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Specific to this NOFO: How supportive is the institutional commitment to the Center program's management and scientific impact? How strong is the potential for scientific interactions?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
As applicable for the project 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.
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of the 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 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 Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medicine Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
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.
For Resubmissions (as applicable), 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.
For Renewals (as applicable), the committee will consider the progress made in the last funding period.
For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
As applicable for the project 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.
Not Applicable
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).
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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 project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project 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?
Specific to this NOFO: How appropriate is the structure and organization of the Administrative Core for the oversight and management of the DDRCC and its components? Are the proposed services appropriate and likely to be used, and how likely will they advance digestive and/or liver disease research? Will the Internal and External Advisory Board contribute to the oversight and strength of the DDRCC? Will the Scientific Catalyst Program further the overall aims and objectives of the DDRCC program as well as its cores?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?
Specific to this NOFO: Are the members of the Internal Advisory Board and the External Advisory Board (if identified) well-suited for the overall oversight and management of the Center? For Centers that do not name members of the External Advisory Board (i.e., new Centers), are the proposed areas of expertise for future members well-justified?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
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?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:
1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this NOFO: How appropriate is the 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) selecting and replacing professional or technical personnel within the Cores; and (d) managing resources, including fiscal administration, procurement, property and personnel management, planning, budgeting, and other appropriate capabilities? How well does the Center describe the participation of community partners (either through a Community Advisory Board or membership on the Internal Advisory Committee) and/or strategies for community engagement? If there is a Clinical Component, are the research services provided as described appropriate for the research base and likely to advance clinical research? How strong is the potential for scientific interactions as part of the Scientific Catalyst Program amongst the Center members, early career investigators, and trainees?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, sex, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
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 project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project 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?
Specific to this NOFO: What are the strengths of the proposed Research Cores? Are the individual Research Core's services appropriate for the Center's research base? What is the likelihood that the proposed research cores will increase efficiency, quality, and productivity? Are the research cores likely to facilitate interactions and collaborations among the investigators? If a research core leverages or resides within an institutional core, will the DDRCC members benefit beyond what is already available through fee-for-service or other access models within other Centers or other cores/service centers?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?
Specific to this NOFO: Are the identified core users likely to use all of the proposed core services? Is the Core Director(s) able to devote adequate time to provide effective management of the Center program?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
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?
Specific to this NOFO: To what extent do the proposed Research Cores provide the latest or state-of-the-art resources, technical support, and new methods that will advance the Center members' research? How successfully does the DDRCC demonstrate the ability or have a plan to adapt to support investigators in emerging areas of digestive and/or liver disease research, as appropriate to the purpose of the Core and the research supported by the Center?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:
1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this NOFO: To what extent will the Cores benefit the research base/users by providing opportunities not otherwise available to the members of the DDRCC? Are the professional or technical expertise for specific cores/services appropriate for the DDRCC? How appropriate are the modes of operation and oversight for the Research Cores, including the funding model, quality control, prioritization of requests for services, and interaction with other institutional cores or Centers, etc.? If a research core leverages or resides within an institutional core, is there a plan for prioritization of access for DDRCC members, and does/do the DDRCC Core Director(s) play a leadership role in the institutional core?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, sex, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
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 project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project 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?
Specific to this NOFO: Is the pool from which potential pilot and feasibility applications reasonable and well-justified? Are the metrics for assessing the productivity and success of the P and F program appropriate and reasonable? Are all aspects of the Center involved and able to assist the P and F Director in the management of the program? Will the P and F program invite and support projects across the full research spectrum from basic science and pre-clinical to translational research?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?
Specific to this NOFO: Is the P and F Program Director able to devote adequate time to provide effective management of the P and F Program? How well are the P and F applicants prepared to lead their proposed P and F Projects effectively? Do they have the appropriate conceptual and technical expertise for executing the proposed research? The qualifications and potential for each candidate should be evaluated in the context of the candidate's career stage. For a P and F applicant who is a New Investigator, evaluate their training and experience to date as well as their potential for a successful career in digestive and/or liver diseases research. For a P and F applicant who is an established investigator, evaluate their expertise and their past contributions to science as well as their potential to make future contributions to digestive and/or liver diseases research.
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
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?
Specific to this NOFO: Does the P and F Program leadership demonstrate the ability or have a plan to adapt to support investigators in emerging areas of digestive and/or liver research? How likely is the P and F program to support new investigators and encourage new research directions?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:
1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects?
Specific to this NOFO: How well does the P and F Program's vision or mission statement reflect the overall Center's goals and inform the Program's processes? How appropriate and transparent are the processes for soliciting, evaluating, and selecting the P and F projects? Is the solicitation process likely to reach the appropriate pool of potential candidates who have the potential to advance digestive and/or liver disease research? Are the evaluation and selection processes free of bias and likely to lead to awards for strong applications? How appropriate is the administrative organization proposed for internal oversight, communication, management, and tracking/evaluation of the P and F program? Is there a plan for involving community partners in the P and F Program's structure? Is the potential available funding for individual P and F projects well-justified and appropriate for the type of projects that the DDRCC is likely to fund?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, sex, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Specific to this NOFO: How supportive is the leadership of the institution to the DDRCC P and F program?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by CSR, in accordance with NIH peer review policies and practices, 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 will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Requests for reconsideration of initial peer review will not be accepted for applications submitted in response to this NOFO.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKAC). The following will be considered in making funding decisions:
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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.
Prior to making an award, NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant's integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 "Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.
After the peer review of the application is completed, the PD/PI will be able to access their Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.
A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient's business official.
In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient organizations must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
Recipient -selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.
Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy."
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).
Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.
Successful recipients under this NOFO agree that:
When recipients, subrecipients, or third-party entities have:
Cybersecurity plans and procedures must at minimum include the following:
All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings. Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety. If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.
For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.
For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on MAT/MOUD.
As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.
Not Applicable
A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.
Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.
A final RPPR, 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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk - Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues.
Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Email:NIDDK_DDN@nih.gov
Center for Scientific Review (CSR)
Email: NOFOReviewContact@csr.nih.gov
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Email:NIDDKGMBManagementTeam@niddk.nih.gov
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 2 CFR Part 200.