RFA-DK-27-127-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK)

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.

Funding Opportunity Title

Cooperative Centers for Experimental Hematology (CCEHs) (U54- Clinical Trial Not Allowed)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

Reissue of

RFA-DK-19-005

Related Notices

Funding Opportunity Number (FON)

RFA-DK-27-127

Companion Notice of Funding Opportunity

RFA-DK-25-023

, U24 Resource-Related Research Project (Cooperative Agreements)

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.847

Notice of Funding Opportunity Purpose

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.

Funding Opportunity Goal(s)

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

Key Dates

Posted Date

August 31, 2026

Open Date (Earliest Submission Date)

August 31, 2026

September 30, 2026

September 30, 2026

Not Applicable

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).

Expiration Date

October 01, 2026

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

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.

Section II. Award Information

Funding Instrument

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.

Application Types Allowed

New

Renewal

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

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIDDK intends to commit $3.745M in FY 2027 to fund around 5 awards in FY2027.

Award Budget

Application budgets are anticipated at approximately $650,000 in direct costs per year.

Award Project Period

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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Federal Governments

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other

Independent School Districts

Public Housing Authorities/Indian Housing Authorities

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

Faith-based or Community-based Organizations

Regional Organizations

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are 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.

Required Registrations

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

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

Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. Obtaining an eRA Commons account can take up to 2 weeks.

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

Multi-institutional domestic applications are also encouraged. Such applications should have a history of collaborations among investigators.

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

3. Additional Information on Eligibility Number of Applications

Applicant organizations may submit 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:

Section IV. Application and Submission Information

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

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

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

Required

Required

Required

Instructions for the Submission of Multi-Component Applications

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

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.

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

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

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

PHS 398 Cover Page Supplement (Overall)

Follow standard instructions.

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

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.

Project/Performance Site Locations (Overall) Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

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

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall) The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Describe the 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.

Other Plan(s):

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

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

Appendix:

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

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

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

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

Delayed Onset Study

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

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

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

All instructions in the 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:

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

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.