National Institutes of Health (NIH)
NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK)
Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements. Applicants should carefully note which ICOs participate in this announcement and view their respective areas of research interest at the ICO-Specific Scientific Interests website. ICOs that do not participate in this announcement will not consider applications for funding.
U54 Specialized Center- Cooperative Agreements
Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
The purpose of this Notice of Funding Opportunity (NOFO) is to invite applications for Centers within the NIDDK Cooperative Centers of Experimental in Hematology (CCEH) Program. Each Center will support one to three Biomedical Research Cores and an Administrative Core, including an Enrichment Program. Each Center is expected to work collaboratively with NIDDK, the Hematology Coordinating Center (HCC), and the other CCEH Centers. The CCEH Program is designed to increase access to critical research resources and expertise unique to nonmalignant hematology research. By providing innovative technology, resources, and expertise to the greater hematology research community, the program will serve as a national hub, aimed at recruiting and retaining both junior scientists just beginning their careers in the field as well as established investigators from other domains.
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 hematologic diseases. Programmatic areas within the National Institute of Diabetes and Digestive and Kidney Diseases include diabetes, digestive, endocrine, hematologic, liver, metabolic, nephrologic, nutrition, obesity, and urologic diseases. Specific programs areas of interest include the following: Research on hematopoietic stem cell quiescence, proliferation, and differentiation; metabolism of iron overload and deficiency; structure, biosynthesis and genetic regulation of hemoglobin as well as research on the etiology, pathogenesis, and therapeutic targets for nonmalignant blood 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 30, 2026 | September 30, 2026 | Not Applicable | March 2027 | May 2027 | July 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.
No late applications will be accepted for this Notice of Funding Opportunity (NOFO).
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.
Background
The NIDDK Cooperative Centers for Experimental Hematology (CCEHs) Program was created in 2014 to increase access to critical research resources by enhancing collaboration in the national multidisciplinary research effort to study normal hematopoiesis and combat nonmalignant hematologic diseases. The CCEH Program aims to foster broad, meritorious basic and translational research on significant questions in nonmalignant hematology; provide national access to innovative, state-of-the-art technologies, knowledge, and expertise uniquely needed by the larger hematology community; engage and attract new and established investigators to research on hematopoiesis and nonmalignant hematologic disorders; and promote the development of junior scientists beginning their careers in the hematology field. The CCEH Program consists of around five Centers and a Hematology Coordinating Center (HCC). The synergy created through these interactions is expected to advance the science and build the greater hematology community of investigators well beyond the capacity of any individual center. Each Center could be an identifiable unit within a single university medical center or a consortium of cooperating institutions.
Research areas addressed by each CCEH Center must fall within the NIDDK Hematology Program mission (see https://www.niddk.nih.gov/about-niddk/research-areas/hematologic-diseases). The individual components of a Center (the Biomedical Research Cores and Administrative Core) are described below in more detail.
Multi-institutional domestic applications are encouraged. Key Personnel of the Centers should include hematology expertise at the leadership level, have a history of funded peer-reviewed research, and demonstrate prior collaboration among team members. Applicants planning to apply to this NOFO are strongly encouraged to consult with the NIDDK Scientific/Research Contacts listed below.
NIDDK Hematology Centers Program Organization
The NIDDK CCEH Program will consist of about five Centers and the HCC, working together with the NIDDK under a cooperative agreement. Applications for HCC are invited through a separate, companion NOFO (RFA-DK-25-023). The overall goal of the HCC is to organize and facilitate the activities of the NIDDK CCEH Program, including development, support, and execution of an Opportunity Pool, including a Pilot and Feasibility Program. Sites with appropriate expertise may participate on both Centers and HCC teams.
The coordinated efforts of the Centers and the HCC will be overseen by the NIDDK CCEH Steering Committee composed of Center Directors, the HCC Director, and NIDDK Program staff.
The NIDDK CCEH Program will meet at minimum once yearly for a face-to-face meeting in the Bethesda, MD area (or another appropriate location) that will be coordinated by the HCC. The first meeting will be held in the Spring/Summer of 2027 and all Center Directors, Biomedical Research Core Directors, and the HCC Director are required to attend.
Center Structure and Activities
Components of each Center should reflect the overall goal of the NIDDK CCEH Program, encourage collaboration, and promote the use of shared resources among the Centers and the national nonmalignant hematology research community.
Administrative Core
The Administrative Core of a Center will be responsible for coordinating and integrating the various components. This Core should: a) track, manage, evaluate, and support continuous improvement of use of Center resources (including biomedical core and enrichment program) including subsequent outcomes (e.g., publications, successful grant applications using data generated by core services), challenges to service delivery, and opportunities to enhance core functions; b) provide oversight of the Biomedical Resource Cores and Enrichment Program, including fiscal management; c) coordinate the Center's research activities to synergize with other Centers; d) foster collaborations and scientific opportunities by promoting the CCEH; e) recruit and retain a robust user base of hematology researchers through outreach to the broader nonmalignant hematology community, supported by an enrichment program; and f) maintain a seamless working relationship with the administration of the awarded institution.
The enrichment program will foster collaborations, mentoring and/or career development to grow the nonmalignant hematology research community. Support for trainee exchange programs between Centers, hands on skill building sessions in core tools/techniques, and interactive conferences are appropriate enrichment program activities; seminars are not. Travel support may be requested to support such activities.
CCEH resources should complement existing regional career development experiences, including NIH institutional training grants or other awarded training programs.
Each Center will be required to create and maintain a Center-specific website, take responsibility for its curation and oversight, as well as ensure proper and seamless integration of their website with the HCC and/or NIDDK-managed CCEH Program websites.
Biomedical Research Cores
A Center is designed around Biomedical Research Cores that share technical resources and specialized expertise to uniquely enhance the productivity of national nonmalignant hematology research. Each Biomedical Research Core should provide state-of-the-art services that can support multiple research projects at once. Cores should be equipped to respond to the evolving needs of the research community, possessing the technical expertise (e.g., molecular biology, genetics, chemistry, or engineering) to discover and develop newly needed tools. Cores may be located at different institutions within the Center, but the technology supported by the CCEH should be well-defined and developed specifically for nonmalignant hematology research. Cores are also meant to enhance hematology researcher capabilities and provide opportunities for researchers and their staff to gain knowledge relevant to the technologies available through the core. Quality control of techniques and protocols should be incorporated into the Core processes, and standard operating procedures, other protocols, and quality control metrics should be made available to the research community through published literature and the CCEH website.
All Centers will be required to deliver national use of their cores, providing services beyond the awardee institution(s). Applicants should consider this requirement and how they can creatively make core resources available nationally when planning their Center.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.
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.
Not Allowed: Only accepting applications that do not propose clinical trials.
NIDDK intends to commit $3.745M in FY 2027 to fund around 5 awards in FY2027.
Application budgets are anticipated at approximately $650,000 in direct costs per year.
The maximum project period is 5 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
Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.
Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.
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. 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.
Multi-institutional domestic applications are also encouraged. Such applications should have a history of collaborations among investigators.
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 only one application.
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 | 6 | Required | 1 | 1 |
| Administrative Core including Enrichment Program | Admin Core | 6 | Required | 1 | 1 |
| Core- Use for each Biomedical Resource Core | Core | 6 | Required | 1 | 3 |
The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.
The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.
The application must consist of the following components:
NOTE: Cores will be listed in the final application in the order they were entered into ASSIST.
Revision applications may include an Introduction to Application for each component. For Revisions, 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.
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.
Please include additional information for the fields described below:
Project Summary/Abstract: Describe the scientific goals and objectives of the Center and how these objectives contribute to accomplishing the overall goals of the NIDDK CCEH. Explain the overall strategy for achieving the goals of the Center, including strategies for making resources available to the wider nonmalignant hematology research community outside of the CCEH institutions. Include a brief description of: 1) how the expertise available within your Center Institution(s) and networks will support the function of your Cores and enhance the CCEH mission, and 2) potential core users from across the nonmalignant hematology research community without naming anyone specifically.
Facilities and Other Resources: Briefly describe the existing environment and facilities available to the Center and the facility access process, including fee structure and usage prioritization offered to internal and external users (via the Biomedical Research Cores).
Equipment: A general listing of major pieces of equipment to be used by the Center should be provided.
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 scientific theme of the Center and state its overall goals, including both short-term and long-term objectives. Describe the strategy by which the long-term objectives will be reached. This plan should delineate how the Center will enhance ongoing projects, introduce synergistic new workflows at the CCEH, and respond to future challenges and opportunities including how it could become sustainable after the funding period. It should also describe how the Center will help to foster the wider nonmalignant hematology research community by recruiting and retaining new users and by promoting new collaborations, advances in technology, and progress in nonmalignant hematology research.
Research Strategy: Explain the overall strategy for achieving the goals for the Center as defined in the Specific Aims. Explain how the Administrative Core (including enrichment program) and Biomedical Research Cores will implement that strategy. Explain how the different components of the organization will interact, why they are essential to accomplishing the overall goals of the NIDDK CCEH Program, and how the combined resources create a Center that is worth more than the sum of its parts. Describe plans to work with NIDDK staff, other Centers, and the HCC toward overall CCEH Program goals.
Describe how this Center will seek to transform current nonmalignant hematology research paradigms or barriers to progress. In addition, describe how each Biomedical Research Core will provide national access to innovative, state-of-the-art technologies, knowledge, and expertise uniquely needed by the larger hematology community. Describe the interactions of the research efforts, and how the recruitment of new users will be capitalized to develop a broader and more interactive national nonmalignant hematology research community. Describe plans to overcome roadblocks that might exist in developing such collaborations; leveraging existing resources is encouraged. Different plans should be described to recruit and retain investigators already in the field and for those to be drawn into nonmalignant hematology through interaction with the Center.
Describe the organizational framework, including any advisory or user committees, without naming individuals. Also discuss the research of various prospective new user groups along with synergy of research being conducted by other collaborators, without naming individuals. Innovation - Explain how synergy of the Center with the research user base will lead to novel resources in the Biomedical Research Cores and how this synergy could not happen without the CCEH. Give an assessment of the potential for multidisciplinary collaborations among CCEH members. Describe plans to overcome roadblocks that might exist in developing such collaborations. Leveraging existing resources is encouraged. Describe how the CCEH will respond to the evolving needs of the research community, both in identifying these needs and developing new state-of-the-art tools.
Progress Report (for Renewal Applications only): Summarize the accomplishments and progress during the current funding period for specific Center components (Administrative, Biomedical Research, and Enrichment Cores). Applicants may explain how the resources they developed and deployed in response to evolving community needs have contributed to the research activities of the wider nonmalignant hematology research community. Mention major challenges and administrative changes that took place and how the Center then adapted to meet its overall objectives. Describe the activities and any outcomes of the Enrichment Program and how this program helped to build and support the national nonmalignant hematology community, including new junior investigators who established their own research programs as a result. Finally, describe how the Center iteratively evaluated and improved its performance. Applicants should use no more than two pages of the Research Strategy to address the Progress Report.
Progress Report Publication List (for Renewal Applications only): Include here only the publications that resulted directly from projects using Core resources or expertise during the current funding period. Copies of these publications must not be included as Appendix material.
Letters of Support: Letters from appropriate institutional officials should document the commitment of the parent institution, or any of its partners, to the Center, including: 1) dedication of space and equipment for the needs of the Center, 2) protected time to devote to Center activities, 3) staff recruitment, 4) other financial support for the proposed Center, 5) continuing support of the Center in the event of a change in leadership and provide a well-defined plan for this, and 6) providing national CCEH users priority access to Center facilities and services at a reduced cost.
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 modifications:
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.
Administrative Core
When preparing your application, use Component Type Admin Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Administrative Core)
Complete only the following fields:
PHS 398 Cover Page Supplement (Administrative Core)
Follow standard instructions.
Research & Related Other Project Information (Administrative Core)
Human Subjects: Answer only the "Are Human Subjects Involved?" and "Is the Project Exempt from Federal regulations?" questions.
Vertebrate Animals: Answer only the "Are Vertebrate Animals Used?" question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Project /Performance Site Location(s) (Administrative Core)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Administrative Core)
Budget (Administrative Core)
Budget forms appropriate for the specific component will be included in the application package.
Personnel: The CCEH Director(s) must devote at least 1.2 person months within the Administrative Core to ensure adequate oversight of the CCEH. In a multiple PD/PI application, the combined effort of the PDs/PIs must be 2.4 person months. One or more Associate Directors may be named as well, but the combined efforts of the CCEH Director(s) and named Associate Directors should not exceed 6 person months effort (equivalent to 50% full-time professional effort). The Enrichment Program Director must devote a minimum of 0.6 person months to ensure adequate oversight of the Program. The salary amount charged to the Center award must be commensurate with the time spent on the Program activities and is subject to institutional and NIH salary policies.
Enrichment Program expenses: Funds may be requested to support interactive workshops, career development symposia, Center retreats, or other meetings to disseminate results from relevant research activities. Funds for advertising these activities, such as designing and distributing electronic flyers, printing meeting materials, as well as posters and other advertisement materials, may be requested. All efforts to reduce paper printing should be made.
Consultants: Include costs associated with consultants (consultant fees, per diem, teleconferences and travel) when their services are required by the Center.
Travel: Include the costs of domestic and foreign travel only if the travel is directly related to the activities of the CCEH. Include travel costs for the Center Director, Associate Director (if employed), Core Directors, and others as appropriate to attend the annual CCEH Directors meeting once per year.
Travel expenses for visiting professors/scientists to enrichment activities may be requested, especially for junior investigators and trainees.
Other expenses: Funds for supporting the Center website may be requested.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Administrative Core)
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: Describe the specific aims of the Administrative Core.
Research Strategy: Describe the organization of the Administrative Core, including the strategy for achieving the goals for the CCEH as outlined in the Funding Opportunity Description. Describe the plan for overseeing the Resource Sharing plan for all Center components.
Describe the strategy by which the Administrative Core will effectively:
Letters of Support: As applicable, a letter from the PD/PI of a NIH training grant at the Center institution should be included that acknowledges and details how the PIs of the two awards intend to promote cohesive interactions between the two programs. Include any letters of support from appropriate institutional officials or partnering institutions.
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 Resource Sharing Plan in the Overall Center Overview applies to the entire application.
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 the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
PHS Human Subjects and Clinical Trials Information (Administrative Core)
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.
Biomedical Research Core
When preparing your application, use Component Type Core. Separate 'Core' components should be created for each individual Biomedical Research Core proposed.
A proposed Biomedical Research Core must be a shared facility that provides specialized technical resources (e.g., techniques, reagents, assays, or instrumentation) and/or expertise to the wider nonmalignant hematology research community. Cores designed to serve a single lab or research project will not be considered for funding. Biomedical Research Cores may be based solely at the applicant institution or at multiple institutions through subcontracts.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Biomedical Research Core)
Complete only the following fields:
PHS 398 Cover Page Supplement (Biomedical Research Core)
Follow standard instructions.
Research & Related Other Project Information (Biomedical Research Core)
Human Subjects: Answer only the "Are Human Subjects Involved?" and "Is the Project Exempt from Federal regulations?" questions.
Vertebrate Animals: Answer only the "Are Vertebrate Animals Used?" question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Project /Performance Site Location(s) (Biomedical Research Core)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Biomedical Research Core)
Budget (Biomedical Research Core)
Budget forms appropriate for the specific component will be included in the application package.
Personnel: Biomedical Research Core Director(s) must devote at least 0.6 person months (5% effort) as a Core Director to ensure adequate oversight. The amount of salary charged to the CCEH must be commensurate with the time spent on CCEH activities and is subject to institutional and NIH salary policies. A Biomedical Research Core Director with requisite expertise may devote a greater effort to the Core, and with strong justification could devote up to 12 person months. Salary support for technicians and other Core personnel are allowable in accordance with the volume and type of work in the Core.
Occasionally, Core direction may involve two individuals. In this case, the combined effort of the Biomedical Research Core Directors must be at minimum 0.6 person months. Salary for individuals with less than 2.5% effort may not be requested. Such individuals are considered Other Significant Contributors. Also, stipends for research trainees are not available through the CCEH. Such funding must be sought through other grant mechanisms.
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.
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 the wider nonmalignant hematology research community. Requests for general-purpose equipment should be included only after ascertaining the availability of such items within the institution. Justify the request based on this availability. Equipment may only be requested in the initial budget period.
PHS 398 Research Plan (Biomedical Research Core(s))
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: Describe the specific aims of each Biomedical Research Core.
Research Strategy: Describe the purpose and objectives of the Biomedical Research Core and its administration, organization, and operation. Include a description of resources and expertise provided and their role in enhancing productivity, provision of uniform quality control, imparting economy of scale, and efficiency. Describe creative ways these state-of-the art resources, tools, technologies, services, and expertise that are unique to nonmalignant hematology research will be accessible nationally.
Describe the strategy by which the Biomedical Research Core will effectively:
Outline the strategy for deciding how access to the Biomedical Research Core will be advertised and prioritized to users (including ensuring U54 funds are allocated only for projects within the NIDDK Hematology mission). If the Core already exists, include a description of past services provided, new technologies developed, changes in protocols or Core administration, and other significant developments.
Recharge system: A recharge system (fee for service) should be developed and described. Recharge fees are allowable budgetary items in an NIH research grant. A system of payment management/accounting must be established such that it is clear to the individual users, the institutional business office, and the NIDDK what the recharge system covers and how funds recovered are being used. This system will enable Center investigators to appropriately adjust budgets on their individual grant and ensure accountability. This information should be transparent and applied uniformly to users of the same category of usage of the cores.
Provide a description of how each Biomedical Research Core contributes to the goals of the CCEH. Describe how students, trainees, and other junior investigators are recruited to use the Biomedical Research Core.
In addition, provide the following information:
Letters of Support: Include any letters of support from appropriate institutional officials or partnering institutions.
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 Resource Sharing Plan in the Overall Center Overview applies to the entire application.
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 the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
PHS Human Subjects and Clinical Trials Information (Biomedical Research Core)
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.
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.
Use of Common Data Elements in NIH-funded Research
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 4.1.36.
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.
Any instructions provided here are in addition to the instructions 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.
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:
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:
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:
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:
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:
For Renewals:
Additional Scored Review Criteria
Reviewers will provide an overall impact score to reflect their assessment of each component. The overall impact scores of the components will be factored into the Overall Score for the Center application, but it is not an average of these scores.
Administrative Core
Reviewers will provide an overall impact score to reflect their assessment of this component, using the following:
Biomedical Research Core
Reviewers will provide an overall impact score to reflect their assessment of each Biomedical Research Core, using the following:
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.
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.
This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.
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.
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 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 Disease Advisory Council. 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.
Institutional Review Board or Independent Ethics Committee Approval: Recipient organizations must ensure that 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.
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.
In administering programs under this and all funding announcements, NIH prioritizes:
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.
The Program Director(s)/Principal Investigator(s) will have the primary responsibility for:
1. Developing the research design and study protocol, including definition of objectives and approaches, planning, conducting, sample size and power calculations, and establishing procedures for participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis, interpretation, conclusions of studies, and publication of results under the terms and conditions of the cooperative agreement award.
2. Recipient(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.
3. Recipients are responsible for their staff in maintaining confidentiality of the information as developed by the network/consortium, including, without limitation, study protocols, data analysis, conclusions, etc. per policies approved by the participating Program Directors/Principal Investigators and the NIH, and/or Steering Committee (SC) as well as any confidential information received by third party collaborators.
4. Recipient(s) will be required to participate in a cooperative and interactive manner with members of the network/consortium including designated NIH staff (e.g., Program Official, Project Scientist, Project Coordinator).
5. Recipient(s) agree to establish agreements amongst themselves that address the following issues: (1) procedures for data sharing amongst network/consortium members and data sharing with industry partners; (2) procedures for safeguarding confidential information, including without limitation, any data generated by the network/consortium as well as information and/or data received from external collaborators; (3) procedures for addressing ownership of intellectual property that result from aggregate multi-party data; (4) procedures for sharing bio-specimens under an overarching Material Transfer Agreement (MTA) amongst network/consortium members that operationalizes material transfer in an efficient and expeditious manner; (5) procedures for reviewing publications, determining authorship, and industry access to publications.
6. The Program Directors/Principal Investigators (for any multi-Center studies involving multiple protocols) shall designate a single Protocol Chairperson (if the Program Director/Principal Investigator does not assume this role) for each protocol to be carried out by the study group or collaborating Centers. The Protocol Chairperson shall function as the scientific coordinator for the common protocol and shall assume responsibility for obtaining approval to implement the common protocol from the participating Program Directors/Principal Investigators or Steering Committee and for developing and monitoring the protocol. Significant modifications to the approved protocols must be approved by the participating Program Directors/Principal Investigators or Steering Committee.
7. Implementing generation and collection of data specified by a common study protocol and ensuring that data will be submitted expeditiously to the Data Coordinating Center or Centers Interactions Core (U24).
8. Establishing and following procedures for data quality, completeness, and security. Recipients are responsible for ensuring accurate and timely assessment of the progress of each study, including development of procedures to ensure that data collection and management are: (1) adequate for quality control and analysis; and (2) sufficiently staffed across the participating institutions. For research involving multiple sites, a plan for analysis of pooled data will be developed by the participating Program Directors/Principal Investigators in consultation with NIDDK Staff or with the Steering Committee if applicable.
9. Any third-party collaboration (including but not limited to interactions with organizations from industry, academia, and nonprofit institutions) should be governed by a research collaboration agreement (e.g., Clinical Trial Agreement, Research Collaborative Agreement, etc.) or any third-party contract mechanism(s) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH/NIDDK policies and procedures, and network/consortium policies, and with written approval from NIDDK Program staff. Any relevant proposed third-party agreements related to the network/consortium studies between the grantee and a third-party will be provided to the NIDDK Program staff and NIDDK Technology Advancement Office for review, comment, and approval to assure compliance with NIH/NIDDK policies and network/consortium policies. Further, at the request of the NIDDK Program staff, any other network/consortium-relevant third-party agreements must be shared with NIDDK. Failure to comply with this term may prompt action in accordance with NIH Grants Policy Statement, Section 8.5 titled: "Special Award Conditions and Remedies for Noncompliance (Special Award Conditions and Enforcement Actions)", and Section 8.5.2, titled: "Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding Support", noncompliance with the terms and conditions of award will be considered by the funding IC for future funding and support decisions and may result in termination of the award."
10. Any involvement of a third-party (including but not limited to industry, academia, and nonprofit institutions) in the study and network/consortium activities that include access to any network/consortium generated resources (i.e., data and bio-samples), or study results that are not publicly available, or using the name of the network/consortium or study or the name of the NIH or NIDDK, is permitted only after written permission by the NIDDK Program staff who will consult with others at NIH and NIDDK Technology Advancement Office.
11. Recipients must agree to comply with the processes and goals as delineated within the NOFO.
12. Recipients must share data, materials, models, methods, information and unique research resources that are generated by the projects in concordance with Network/Consortium policies, in order to facilitate progress. When appropriate, and in accordance with NIH policies, as well as NIDDK policies, recipients will be expected to collaborate; share novel reagents, biomaterials, methods and models and resources; and share both positive and negative results that would help guide the research activities of other members.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The NIDDK will designate program staff, including a Program Official and a Grants Management Specialist to provide normal program stewardship and administrative oversight of the cooperative agreement. The Program Official and Grants Management Specialist will be named in the Notice of Grant Award (NOA).
An NIDDK Project Scientist/Project Coordinator with substantial involvement above and beyond the normal stewardship of an NIH IC Program Official will:
1. Serve as the contact point for all facets of the scientific interaction with the recipient (s). As required for the coordination of activities and to expedite progress, NIDDK may designate additional NIDDK staff to provide advice to the recipient on specific scientific and/or analytic issues.
2. Work with participating Program Directors/Principal Investigators to:serve as a resource, to study investigators with respect to other ongoing NIDDK activities that may be relevant to the study, to facilitate compatibility with the NIDDK missions and avoid unnecessary duplication of effort.
3. Have substantial involvement assisting in the design and coordination of research activities for recipients as elaborated below:
a. Assisting by providing advice in the management and technical performance of the investigations, coordinating required regulatory clearances for investigational agents used in the study, which are held by NIDDK. The NIDDK may reserve the right to cross file or independently file an Investigational New Drug Application or an Investigational Device Exemption form with the FDA.
b. Coordinating activities among recipients by assisting in the design, development, and coordination of a common research or clinical protocol and statistical evaluation of data; in the preparation of questionnaires and other data recording forms; and in the publication of results.
c. Review procedures for assessing data quality and study performance monitoring.
d. The NIDDK Project Scientist or Project Coordinator may be co-authors on study publications. In general, to warrant co-authorship, NIDDK staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; (c) participation in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.
The NIDDK Program Official(s) identified in the Notice of Award will:
Areas of Joint Responsibility include:
The Recipient, participating Program Directors/Principal Investigators or Steering Committee, and NIH staff, will cooperatively develop and implement processes to submit information and data to the Centers Interactions Core (U24), determine criteria and processes for quality control of information and data to be posted for the research community, refine scientific objectives, and implement research advances to facilitate the goals of the study, consistent with NIH policies and achieving the goals of the program as described in the NOFO.
Executive Committee (EC)
Steering Committee
External Consultants
Dispute Resolution
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.
Data Management and Sharing Plan: In accordance with the NIH Policy for Data Management and Sharing (NIH NOT-OD-21-013), the NIDDK approved plan will become a term and condition of award, be routinely monitored during the award period, and compliance may factor into future funding decisions. By the end of the funding or proprietary period, a recipient or study group may not continue to use or share study generated resources until those resources are available to the public via a NIDDK approved repository per the NIDDK approved plan. The NIDDK has established a Central Repository to support the receipt, storage, and distribution of data, bio-samples, and other resources generated in clinical studies funded by the NIH/NIDDK. When the NIDDK Central Repository is to be utilized, prior to enrolling participants, the PI or his/her designee will coordinate with the NIDDK Program and Central Repository staff to prepare for eventual archiving and distribution of the study generated resources that are to be maintained in the Central Repository. These resources will be available to the wider scientific community in accordance with the NIH Data Management and Sharing policy (http://grants.nih.gov/grants/policy/data_sharing/ and, https://grants.nih.gov/policy/sharing.htm, and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm), per the NIDDK approved data management and sharing plan.
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 Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Email: NIDDK_KUH@nih.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
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.