Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Opportunity Title

NIDDK Cooperative Centers of Excellence in Hematology (U54 Clinical Trial Not Allowed)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

Reissue of RFA-DK-14-001

Related Notices

NOT-OD-19-128, Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research.

NOT-OD-19-137, Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research.

Funding Opportunity Announcement (FOA) Number

RFA-DK-19-005

Companion Funding Opportunity

RFA-DK-19-013, U24 Resource-Related Research Projects – Cooperative Agreements

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.847  

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement is to invite U54 cooperative agreement applications for Cooperative Centers of Excellence in Hematology (CCEH). The NIDDK Hematology Centers Program is designed to increase access to critical research resources and collaboration in the national multidisciplinary research effort to combat nonmalignant hematologic diseases and to study normal hematopoiesis. In addition, it aims to improve cost-effectiveness of preparing critical reagents, maintaining state-of-the-art resources, and running multi-step molecular biologic assays. Each CCEH will support a minimum of three Biomedical Research Cores, an Administrative Core, and an Enrichment Program. The CCEH are expected to work collaboratively with the NIDDK Hematology Central Coordinating Center -- together comprising the NIDDK Hematology Centers Program. By providing state-of-the-art equipment, resources, and expertise to the greater nonmalignant hematology research community, the program will serve as a national hub for nonmalignant hematology research, supporting career development of scientists just beginning their careers in the field and attracting established investigators from other domains. Funded Centers will cooperate with the NIDDK to facilitate research collaborations and interactions within and among Centers and with the wider research community.  

Key Dates
Posted Date

September 12, 2019

Open Date (Earliest Submission Date)

October 21, 2019

Letter of Intent Due Date(s)

October 21, 2019 and May 30, 2020

Application Due Date(s)

November 21, 2019 and June 30, 2020  

All applicants are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). Applicants are encouraged to allow adequate time to make any apply corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February/March 2020 and October/November 2020

Advisory Council Review

May 2020 and January 2021  

Earliest Start Date

July 2020 and April 2021

Expiration Date

July 1, 2020

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information

    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    Purpose

    The objective of the NIDDK Hematology Centers Program is to increase access to critical research resources and collaboration in the national multidisciplinary research effort to combat nonmalignant hematologic diseases and to study normal hematopoiesis. It aims to provide state-of-the-art equipment, resources and expertise, and serve as a national resource for nonmalignant hematology research, including enhancing the research of scientists just beginning their careers in the field and attracting established investigators from other domains. A Cooperative Center of Excellence in Hematology (CCEH) could be an identifiable unit within a single university medical center or a consortium of cooperating institutions, including an affiliated university.  The overall goal of the NIDDK CCEHs, supported using the U54 cooperative agreement mechanism, is to bring together centers of excellence, including clinical and basic science investigators, in a manner that will enrich the effectiveness of nonmalignant hematologic diseases research or to gain a better understanding of normal hematopoiesis.

    Research areas addressed by a NIDDK CCEH must be in line with the research mission of the NIDDK Hematology program (see https://www.niddk.nih.gov/about-niddk/research-areas/hematologic-diseases) and should align with a defined theme, such as hematopoiesis, erythropoiesis, or iron and heme. Some examples of these research areas are:

    • Molecular and cellular biology of hematopoiesis and hematopoietic stem cell (HSC) biology, including ex vivo expansion of HSCs, definition of the niche in which HSCs thrive and relationships (cross-talk) between components of the niche and HSCs
    • Hematopoietic growth factors and erythropoietin
    • Use of primitive and/or definitive stem cells, including induced pluripotent stem cells (iPSCs) as a resource to study cell therapy tools for hematopoietic disorders, or to use hematopoietic stem cells as cell therapy tools for other disorders (non-hematopoietic)
    • Use of NIH-approved human embryonic stem cell (hESC) lines to explore development into primitive and/or definitive (adult) HSCs and their use for cell therapy
    • Expressed erythroid molecular biological components and creation of reagents useful for study of the erythroid cell lineages
    • Blood cell receptor biology and signaling
    • Computational biology approaches to accurately predict effects of distortion in a biochemical network
    • Blood cell metabolism; membrane biology and ion transport; heme metabolism; responses to environmental fluxes
    • Globin biosynthesis, including its genetic regulation and its control for therapeutic purposes
    • Iron absorption, storage and metabolism; pathophysiology of iron overload, and strategies for therapeutic intervention
    • Development of approaches and techniques for gene therapy using hematopoietic cells

    An existing biomedical research program of excellence in an area of nonmalignant hematologic diseases and disorders is required. This research base must be in the form of NIH-funded research projects, program projects, or other peer-reviewed research that is already funded at the time of submission of a CCEH cooperative agreement application. Key Personnel in the research base should have a history of close cooperation, communication, and collaboration.

    Furthermore, the research base should provide a foundation and nucleus for enhancing and expanding CCEH activities. It should provide a backbone of support for the development of early stage investigators who are just beginning a research career in nonmalignant hematology. Members of the research base are expected to be role models for the next generation of NIDDK Hematology researchers and to provide mentorship, career development guidance, and scientifically sound advice on new ideas proposed within the CCEH environment. The ultimate goal of research applications stimulated by NIDDK Hematology Centers Program activities (e.g., F-, K-, or R-series grant applications submitted by researchers using CCEH resources) should be the development of preventive, curative, or interventional strategies for addressing nonmalignant hematologic diseases.

    Applicants should consult with the NIDDK Scientific/Research staff listed below concerning plans for the development of a CCEH, on the organization of the application, and regarding the NIDDK Hematology mission.

    NIDDK Hematology Centers Program Organization

    The NIDDK Hematology Centers Program will consist of up to four CCEHs and a Hematology Central Coordinating Center (HCCC). Applications for HCCC are invited through a separate, companion FOA (RFA-DK-19-013). Investigators with appropriate expertise may apply to both RFA-DK-19-005 and RFA-DK-19-013.

    The NIDDK CCEHs are comprised of cores. A minimum of three Biomedical Research Cores are included in a CCEH. Biomedical Research Cores are defined as shared resources (e.g., core facilities) that enhance productivity, provide uniform quality control, impart an economy of scale, or in other ways benefit a group of investigators working to accomplish the stated goals of the CCEH. The reagents, resources or expertise from all Biomedical Research Cores should be made available nationally. Examples of such resources include functional genomics, bioinformatics, generation of transgenic animals, and cell preparation facilities.

    Multi-institutional domestic applications are encouraged. Such applications should have a history of collaborations among investigators. All applications will be required to encourage national use of cores. Applicants should consider this requirement and how they can make core resources available nationally when planning their Center. National use will also be encouraged through coordinated outreach and a Pilot and Feasibility Program, described below.

    The CCEH Structure and Activities, including the Administrative Core, the Biomedical Research Cores, and the Enrichment Program, are defined in more detail below. The NIDDK Hematology Centers Program will consist of Centers that will work together with the NIDDK under a cooperative agreement. Center Directors are expected to work with NIDDK staff to achieve program goals and to facilitate research collaborations within and between the Centers and with the wider nonmalignant hematology research community.

    The overall goal of the HCCC is to organize and facilitate the activities of the NIDDK Hematology Centers Program, including development, support, and execution of a Pilot and Feasibility Program.

    The coordinated efforts of the CCEHs and the HCCC will be overseen by the NIDDK Hematology Centers Program Steering Committee composed of CCEH Directors, the HCCC Director, and NIDDK Program staff, along with an External Evaluation Panel (EEP). The NIDDK Hematology Centers Program will meet at minimum once yearly for a face-to-face meeting in the Bethesda, MD area that will be coordinated by the HCCC. The first meeting will be held in the Fall of 2020 and all CCEH Directors, Biomedical Research Core Directors, and the HCCC Director are required to attend. The NIDDK will utilize an EEP to monitor research efforts and advise the Institute on the progress of the NIDDK Hematology Centers Program.

    CCEH Structure and Activities

    Components of each CCEH should reflect the overall goal of the NIDDK Hematology Centers Program and the theme of the individual CCEH, encourage collaboration, and promote the use of shared resources within and between the Centers and with the wider nonmalignant hematology research community.

    Administrative Core

    The Administrative Core of a CCEH will be responsible for coordinating and integrating the various components. This Core should: a) track and manage usage of CCEH resources (including fiscal management) and track subsequent outcomes; b) provide oversight of the Biomedical Resource Cores and Enrichment Program, ensuring resources are deployed for research that falls within the mission of the NIDDK Hematology Program; c) coordinate the CCEH’s research activities with other CCEHs and with the wider nonmalignant hematology research community; d) determine criteria and selection process for Center membership; e) foster collaborations and scientific opportunities among its members; and f) maintain a seamless working relationship with the administration of the institution.

    Each CCEH will be required to create and maintain a CCEH-specific website, take responsibility for its curation and oversight as well as ensure proper and seamless integration of the Center website with any centralized NIDDK CCEH website.

    Biomedical Research Cores

    A CCEH is designed around Biomedical Research Cores that provide robustly shared, specialized technical resources and/or expertise to enhance the efficiency, productivity, and multidisciplinary nature of research performed by the research base and by nonmalignant hematology researchers distributed nationally. Biomedical Research Cores may be a core facility and should be designed to furnish a group of investigators with some technique, assay, expertise, or instrumentation that will enhance the depth of science, reproducibility, efficiency, and cost effectiveness.

    Each Biomedical Research Core should provide state-of-the-art services to support multiple research projects. 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 develop newly needed tools. Cores may be located at different institutions and, if so, should focus on the overarching theme and purpose and theme of the CCEH. If Cores are extensions of existing infrastructure at an institution, the added value supported by the CCEH should be well-defined (e.g., specialized reagents, model systems, protocols, etc. developed specifically for nonmalignant hematology research). Cores are not meant to supplant investigator capabilities, but rather to enhance them and provide opportunities for investigators and their staff to learn and then become proficient in the technologies available through the core. Teaching investigators and/or their staff is an important function of a core. There should be quality control 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 or the CCEH website.

    Enrichment Program

    A CCEH will provide support for enrichment activities to foster collaborations and grow the nonmalignant hematology research community. Support for visiting scientists, exchange programs between Centers for postdoctoral fellows, hands on training sessions, seminars and research fora are appropriate items for inclusion in an enrichment program. In addition, travel support may be requested to allow CCEH investigators to travel to present scientific findings, to learn new laboratory techniques, to conduct outreach on behalf of the NIDDK Hematology Centers Program, to develop new collaborations, or to engage in scientific information exchanges.

    The presence of a CCEH, with the resources it provides, should enrich ongoing training experiences and should be a positive factor when recruiting postdoctoral fellows and junior faculty. Under this Cooperative Agreement mechanism, enrichment of individuals in training to become researchers in nonmalignant hematology may be included through the Enrichment Program. Training in the use of instrumentation, resources and reagents for early-stage investigators so they may generate preliminary data with which to apply for NIDDK Hematology grants is permitted. Either Ruth L. Kirschstein Individual Fellowships (F30 for MD/PhD candidates, F31 to Promote Diversity in Health-Related Research or F32 for postdoctoral fellows), KUH/NIDDK Predoctoral to Postdoctoral Fellow Transition Awards (F99/R00), Mentored Career Development awards (K01 or K08), Pathway to Independence awards (K99/R00) or research project grants, R01 may be sought. Other career development activities may be included, such as training on how to manage a laboratory, how to publish a paper in a peer-reviewed journal, how to negotiate a faculty position, etc. Leveraging of NIH institutional training grants or other awarded training programs is encouraged.

    See Section VIII. Other Information for award authorities and regulations.

    Section II. Award Information
    Funding Instrument

    Cooperative Agreement: A support 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 FOA.  

    Application Types Allowed

    New
    Renewal
    Resubmission

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    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 2020 to fund up to 2 awards in FY2020 and 2-3 awards in FY2021, so the final Hematology Centers Program will consist of four CCEHs and one HCCC.

    Award Budget

    Application budgets are limited to $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 FOA.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

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

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

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

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

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

    Governments

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

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
    Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

    Required Registrations

    Applicant Organizations

    Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • 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.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

    Program Directors/Principal Investigators (PD(s)/PI(s))

    All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

    For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

    Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

    The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
    • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
    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 FOA. See your administrative office for instructions if you plan 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 SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    Letter of Intent

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

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

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

    The letter of intent should be sent to:

    John F. Connaughton, Ph.D.
    Chief, Scientific Review Branch
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-594-7797
     Email: NIDDKletterofintent@mail.nih.gov  

    Page Limitations

    Available Component Types

    Research Strategy/Program Plan Page Limits

    Overall

    12

    Admin Core

    6

    Core (use for Biomedical Research Core)

    6 (for each Biomedical Research Core)

    Enrichment Program

    6

    Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

    Instructions for the Submission of Multi-Component Applications

    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 should consist of the following components:

    • Overall: Required (Minimum: 1; Maximum: 1)
    • Administrative Core: Required (Minimum:1; Maximum: 1)
    • Biomedical Research Cores: Required (Minimum:  3; No maximum)  NOTE: Cores will be listed in the final application in the order they were entered into ASSIST.
    • Enrichment Program: Required (Minimum:1; Maximum: 1)
    Overall Component

    When preparing your application, use Component Type ‘Overall’.

    All instructions in the SF424 (R&R) 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)

    Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

    Research & Related Other Project Information (Overall)

    Follow standard instructions. Please include additional information for the fields described below:

    Project Summary/Abstract: Describe the scientific theme, goals, and objectives of the CCEH and how these contribute to accomplishing the overall goals of the NIDDK Hematology Centers Program. Describe the need for a CCEH to support the investigators in the research base. Explain the overall strategy for achieving the goals of the CCEH, including strategies for making resources available to the wider nonmalignant hematology research community. Include the number and a brief description of the prospective CCEH members and the overall direct costs present in this research base. Provide a brief overview of the research base as it relates to the theme of the CCEH, as well as an overview of the Biomedical Research Cores and the Enrichment Program.

    Facilities and Other Resources: Briefly describe the existing environment and facilities available to the CCEH and the process, including fee structure offered to users (via the Biomedical Research Cores), to access the facilities.

    Equipment: A general listing of major, shared pieces of equipment to be used by the CCEH should be provided and the process, including fee structure offered to users (via the Biomedical Research Cores), to access shared equipment should be described.

    Other Attachments: The following "Other Attachments" should be included with the Overall Component in order to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image. All attachments should be in pdf format. Samples of Table formats that applicants may choose to use may be found at: https://www.niddk.nih.gov/research-funding/process/apply/funding-mechanisms/cooperative-centers-excellence-hematology, where Table A refers to the Center's Research Base.

    Grant Support of Research Base - Please give this attachment the title, "Grant Support of Research Base", and include all federal and non-federal grant support related to nonmalignant hematology for current/prospective CCEH members who are not Senior/Key Personnel on this U54 application (grant support where Senior/Key Personnel on this U54 application are not the contact PD/PI may be included). Organize the list alphabetically, first by the supporting organization (e.g., NIH, Department of Defense, American Society of Hematology), then by the grant mechanism (e.g., research projects, training and career development, etc.), then by the last name of the investigator who is listed as the PD/PI on the grant application. Include Supporting Organization, Grant Numbers, Complete Grant Title, Project Period, Annual Direct Costs. Table A is provided as a sample format to help applicants assemble this required information. The purpose of this Other Attachment is to demonstrate an adequately funded research base who can effectively use the cores.

    Project/Performance Site Location(s) (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 & Related Senior/Key Person Profile (Overall)

    Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) 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 applications, an Introduction to Application is required in the Overall component.

    Specific Aims: State the overall goals of the CCEH with both short-term and long-term objectives. Describe the strategy by which the long-term objectives will be reached. Describe the scientific theme of the CCEH. The plan should delineate how the Center will enhance ongoing projects, assist in the introduction of outstanding new projects (both at the CCEH and in the wider nonmalignant hematology research community), respond to future challenges and opportunities, and promote collaborations, advances in technology and progress in nonmalignant hematology research. Describe the scientific theme of the CCEH.   

    Research Strategy: Explain the overall strategy for achieving the goals for the Center as defined in the Specific Aims and explain how the Administrative Core, Biomedical Research Cores, and Enrichment Program relate to that strategy. Explain how the different aspects of the organization, including key personnel will interact, why they are essential to accomplishing the overall goals of the CCEH Program, and how combined resources create a Center that is worth more than the sum of its parts. Describe how this CCEH will seek to shift current research paradigms. In addition, describe how the reagents, resources, and expertise of each Biomedical Research Core will be made accessible to nonmalignant hematology researchers distributed over a large geographical area and well beyond the institution's boundaries. Describe plans to work with NIDDK staff, other CCEHs, and the HCCC toward overall Hematology Centers Program goals.

    Research Base

    Existence of a strong, substantial research base in nonmalignant hematology research, that is within the NIDDK Hematology program mission (see https://www.niddk.nih.gov/about-niddk/research-areas/hematologic-diseases) is a fundamental requirement for the establishment of a CCEH. Applicants should include an overview of current research in nonmalignant hematology that will form the base of the CCEH. This may be limited in size due to the focused area of research that is within the NIDDK Hematology program mission, but it may include research activities from other institutions (multi-institutional research base). Nevertheless, applicants should describe how the establishment of a CCEH will provide added dimensions, such as greater focus and increased cooperation, communication and collaboration that would not likely occur without CCEH resources. Justify why the CCEH is needed for this purpose and the deficiencies that would occur without the CCEH.

    As part of the Research Strategy, provide a full narrative description of the nonmalignant hematology research activities at the applicant institution and any collaborating institutions. The research of each prospective CCEH participant should be discussed along with interrelationships of research being conducted by other prospective CCEH participants. The quality of the research base is already vetted through the peer-review process, so there should be a focus on the interactions and interrelationships of the research efforts, uses and benefits of Core services, plans to develop productive collaborations among CCEH investigators, and how the research base will provide a springboard for the launching of talented postdoctoral fellows or other early-stage investigators.

    Criteria for becoming a CCEH member should be clearly defined. Specific membership criteria, and any affiliation categories (if applicable), should be clearly defined by the applicant in order to better organize and facilitate the focus of the CCEH mission. The application should state clearly: a) how CCEH membership(s) are defined; b) the application and selection processes for membership; and c) the obligations of membership. Suitable criteria include, but are not limited to, peer-reviewed independent funding, participation in nonmalignant hematology research, and the need for the use of Core facilities or contribution to the overall goals of the CCEH. A plan to arbitrate failures to meet stated obligations should also be provided.

    Administration, Organization, and Operation of the CCEH

    Describe the organizational framework. Include information on the use of an Executive Committee and any advisory or user committees. Do not name individuals who will serve on advisory or user committees. Additional instructions can be found under "Administrative Core".

    Building research capacity - Provide details on the special talents and resources that will be drawn to and built upon at the CCEH. How will these talents be harnessed and used to promote new collaborations and develop productive multidisciplinary teams to address more complex research questions? Different plans should be described for investigators already in the field and for those to be drawn into nonmalignant hematology.

    Integration of investigators with multiple skills and talents - Outline steps the CCEH will take to promote multidisciplinary studies and collaborations. Briefly describe the scientific need and rationale for fostering such integration.

    Innovation - Explain how synergy of the CCEH with the research base will lead to novel services and 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, 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. Address progress accomplished for specific Center components (Administrative Core, Biomedical Research Cores, and Enrichment Core). For example, applicants may present a description of the resources developed and deployed and how they have contributed to the research activities of the research base and wider nonmalignant hematology research community. Mention major administrative changes that took place and describe the activities and any outcomes of the Enrichment Program. Discuss how recommendations of any leadership or advisory bodies have influenced the initiation, modification, or discontinuation of any resource or activity. The use of tabular format to summarize all grants and publications resulting from resources or expertise provided is strongly recommended and must be included within page limitations. 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 and accepted manuscripts that resulted directly from activities of the Cores or 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: Include any letters of support for the proposed CCEH by appropriate institutional officials. Letters should address the commitment of the parent institution, or any of its partners, to the CCEH. The parent institution is expected to recognize the CCEH as a formal organizational component and provide documented evidence of space dedicated to the needs of the CCEH, protected time to devote to CCEH activities, staff recruitment, dedicated equipment, or other financial support for the proposed CCEH. The parent institution should provide assurance of its commitment to continuing support of the CCEH in the event of a change in leadership and provide a well-defined plan for this. In addition, it is expected that the institution will support the goal of providing CCEH members priority access to institutional facilities and services at a minimal or reduced cost. Both the institution and pertinent departments must show a strong commitment to supporting the CCEH.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
    • The application is expected to describe a plan for oversight of the Resource Sharing Plan for the entire Center, including a statement that it applies to the entire application (i.e., the Administrative Core, each Biomedical Research Core, and the Enrichment Program).
    • The Resource Sharing Plan should include plans to make standard operating procedures, other protocols, and quality control metrics available to the research community through published literature or the CCEH website.

    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 (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 SF424 (R&R) 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 SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed

    PHS Assignment Request Form (Overall)

    All instructions in the SF424 (R&R) 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:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates
    PHS 398 Cover Page Supplement (Administrative Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    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)
    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Administrative Director’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. One of the PDs/PIs is required to be the Administrative Core Director.  
    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 a total of 2.4 person months to the CCEH. At least 1.2 person months must be 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).

    Consultants: Include costs associated with consultants (consultant fees, per diem, teleconferences and travel) when their services are required by the CCEH, for example, as members of the External Advisory Committee.

    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 CCEH Director, Associate Director (if employed) and others as appropriate (e.g., Core Directors) to attend the annual CCEH Directors meeting once per year.

    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 CCEH members and 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.

    Other expenses: Funds for supporting the CCEH 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 CCEH components.

    Describe the strategy by which the Administrative Core will effectively a) track and manage usage of CCEH resources (including fiscal management) and track subsequent outcomes; b) provide oversight of the Biomedical Resource Cores and Enrichment Program, ensuring resources are deployed for research that falls within the mission of the NIDDK Hematology Program; c) coordinate the CCEH’s research activities with other CCEHs and with the wider nonmalignant hematology research community; d) determine criteria and selection process for Center membership; e) foster collaborations and scientific opportunities among its members, and f) maintain a seamless working relationship with the administration of the institution.

    Outline the approaches to be utilized for internal monitoring, including review of productivity and effectiveness of the activities of the CCEH and mitigation strategies for replacing CCEH personnel or ineffective Cores.

    Use of an External Advisory Committee is strongly encouraged. The members of this Committee should not be named in the application ; however, the process by which members are selected must be described in detail. The External Advisory Committee, consisting of 3-5 prominent members of the hematology research community, may advise the CCEH Director(s) and the CCEH's Executive Committee in the areas of scientific direction, budget, policy, collaborations, or other areas.

    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 SF424 (R&R) Application Guide, with the following modification:

    The Resource Sharing Plan in the Overall Center Overview applies to the entire application.

    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 SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) 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 SF424 (R&R) 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 CCEH members and the wider nonmalignant hematology research community. Depending on the nature of the specialized technical resources and/or expertise, the number of research projects that can be served may range from several to thousands. A Biomedical Research Core must be used by two or more research projects and no one project should utilize greater than 50% of the Core services. 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:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates

    PHS 398 Cover Page Supplement (Biomedical Research Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    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)

    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Biomedical Research Core Director’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

    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 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.

    PHS 398 Research Plan (Biomedical Research Core)

    Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

    Specific Aims: Describe the specific aims of the Biomedical Research Core.

    Research Strategy: Describe the purpose and objectives of the Biomedical Research Core and the administration, organization, and operation of the Biomedical Research Core. 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 techniques, reagents, assays, instrumentation, and/or expertise will fulfill the requirement of being made accessible nationally.

    The need for the Core must be well justified with clear documentation of the research base and the wider nonmalignant hematology research community. Applicants should provide information on other programs supporting related resources at their institution and describe the nature of synergy and integration between the CCEH and these other activities. Applicants must also clearly describe how duplication or redundancies of effort, services and resources will be avoided. The added value supported by the CCEH must be well-defined (e.g., specialized reagents, model systems, protocols, etc. developed specifically for nonmalignant hematology research). Leveraging of existing resources that provide a range of services or efficiency that would not otherwise be available is also encouraged. Explain any development of instrumentation, methodologies, etc., to be developed and the advantages over existing technologies.

    Outline the strategy for deciding how access to the Biomedical Research Core will be prioritized (including ensuring U54 funds are allocated only for projects within the NIDDK Hematology mission) and advertised, as well as fee structures for various categories of membership to the CCEH (including non-members). If a Core (e.g., core facility) 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 will enable CCEH investigators to appropriately adjust budgets on their individual grant and ensure accountability. This information should be transparent and applied uniformly to users in the same category of membership.

    Provide a description of how each Biomedical Research Core contributes to the goals of the CCEH. Describe how students, trainees, and other early stage investigators are recruited to use the Biomedical Research Core.

    In addition, provide the following information:

    • Brief description of the scientific, technical, and support staff functions;
    • When the Core is not being used for CCEH activities, is it idle? Or is it being used for other institutional activities? If so, describe these other activities.
    • Provide a description of the anticipated number of research projects and how the Core will be used by at least two research projects, with no one project utilizing greater than 50% of the Core services.

    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 SF424 (R&R) Application Guide, with the following modification:

    • The Resource Sharing Plan in the Overall Center Overview applies to the entire application.

    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 NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed

    Enrichment Program

    When preparing your application, use Component Type ‘Enrichment Program.’

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

    SF424 (R&R) Cover (Enrichment Program)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates

    PHS 398 Cover Page Supplement (Enrichment Program)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Enrichment Program)

    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) (Enrichment Program)

    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 (Enrichment Program)

    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Enrichment Program Director’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

    Budget (Enrichment Program)

    Budget forms appropriate for the specific component will be included in the application package.

    Personnel: This category should include salary support for key personnel, including the Enrichment Program Director and any other professional and administrative personnel. 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 CCEH must be commensurate with the time spent on the Program activities and is subject to institutional and NIH salary policies.

    Other expenses: Funds may be requested to support Enrichment Program activities, such as workshops, career development symposia, Center retreats, seminar series or other meetings to disseminate results from relevant research activities. Funds for Enrichment Program-associated 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.

    Travel expenses for visiting professors/scientists may be requested, especially for junior investigators and trainees.

    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 (Enrichment Program)

    Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

    Specific Aims: Describe the specific aims of the Enrichment Program.

    Research Strategy: A CCEH Enrichment Program should be designed to promote scientific exchange among investigators involved in NIDDK Hematology Program-relevant research. It should also be designed to recruit new investigators into relevant areas of the NIDDK Hematology mission. Describe any enrichment opportunities that will be offered by the CCEH, and document ways the CCEH will enhance the institutional training environment.

    Specifically, if there is a related NIDDK T32 program at the institution (or other relevant training program), describe how the CCEH will help to integrate, facilitate and enhance activities of T32-supported trainees. Likewise, coordinating an exchange program for students and fellows at one institution to allow short visits to another institution in order to expand their knowledge and skills is an acceptable activity of the Enrichment Program.

    While stipends for fellows cannot be funded from the CCEH budget, the establishment of a CCEH should provide an enhanced environment for research enrichment.

    Letters of Support: As applicable, a letter from the PD/PI of a T32 at the CCEH institution should be included that acknowledges and details how the PD/PI of the T32 intends 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 SF424 (R&R) Application Guide, with the following modification:

    • The Resource Sharing Plan in the Overall Center Overview applies to the entire application.

    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 (Enrichment Program)

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed

    3. Unique Entity Identifier and System for Award Management (SAM)

    See Part 1. 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.

    4. Submission Dates and Times

    Part I. Overview Information 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 Policy on Late Application Submission.

    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 the SF424 (R&R) Application Guide.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

    7. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

    For information on how your application will be automatically assembled for review and funding consideration after submission go 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 Component of the SF424(R&R) Application Package. 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 DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) 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. 

    Post Submission Materials

    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.

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

    Overall Impact - Overall

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

    Scored Review Criteria - Overall

    Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a CCEH that by its nature is not innovative may be essential to advance a field.

    Significance

    Does the CCEH 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 CCEH 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 FOA:

    • Is there a strong research base (characterized by breadth and depth) in nonmalignant hematology, with relevant and interrelated funded research projects aligned to the focus/theme of the CCEH?
    • Is it likely that the CCEH will increase efficiency; promote new research directions and meaningful collaborations among CCEH investigators and the wider nonmalignant hematology research community; facilitate interactions and collaborations among the investigators; and improve cost effectiveness?
    • Is the CCEH as a whole scientifically compelling, providing state-of-the-art research resources that will advance the field and the capacity to create new tools to respond to evolving community needs?
    • Are the overall goals significant and focused on a specific theme in nonmalignant hematology?
    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the CCEH? 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 FOA:

    • Are the PD/PIs committed to achieving the stated goals of the CCEH?
    • Are the PD/PIs committed to collaborating with other NIDDK Hematology Centers Program PD/PIs and NIDDK staff in order to achieve the overall objectives of the NIDDK Hematology Centers program?
    • Does the proposed CCEH Director (and Associate Director, if named) have strong scientific and administrative leadership abilities?
    • Do the PD(s)/PI(s) commit adequate time and effort to the program?
    • Are the Core/Program Directors well-qualified and appropriate?
    • For applications designating multiple PD(s)/PI(s), is there a reasonable plan that describes appropriate coordination, communication and conflict resolution among the PD(s)/PI(s)?
    Innovation

    Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the CCEH? Have 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 CCEH 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/gender, 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 FOA:

    • Are there plans to make research resources and expertise from all Biomedical Research Cores available at a national level?
    • What is the likelihood that the strategy for achieving the goals of the CCEH Program will be successful?
    • For renewals, does the CCEH show evidence of fostering nonmalignant hematology research among member investigators and the wider nonmalignant hematology research community?
    • For renewals, does the CCEH show evidence of being responsive to changing needs?
    • For renewals, are there coordination and synergy of the Administrative Core, Biomedical Research Cores, and Enrichment Program toward achievement of the central scientific theme and goals of the CCEH?
    Environment

    Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

    Specific to this FOA:

    • Does the CCEH show evidence of a stable or growing research base with strong and consistent record of scientific excellence and achievement reflected in an outstanding level of productivity and continuing success in securing peer-reviewed research funding?
    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:

    • What is the likelihood for the Administrative Core to exert a sustained and coordinating influence on the function of the CCEH?
    • Is the administrative and organizational structure appropriate and adequate to the attainment of the objective(s) of the proposed CCEH?
    • Is there an appropriate plan to a) track and manage usage of CCEH resources (including fiscal management) and track subsequent outcomes; b) provide oversight of the Biomedical Resource Cores and Enrichment Program, ensuring resources are deployed for research that falls within the mission of the NIDDK Hematology Program; c) coordinate the CCEH’s research activities with other CCEHs and with the wider nonmalignant hematology research community; d) determine criteria and selection process for Center membership; e) foster collaborations and scientific opportunities among its members, and f) maintain a seamless working relationship with the administration of the institution.
    • Are the plans for coordination, problem identification and resolution, and the establishment of a strong collaborative environment for the CCEH appropriate?
    Biomedical Research Core

    Reviewers will provide an overall impact score to reflect their assessment of each Biomedical Research Core, using the following:

    • What is the likelihood for the Biomedical Research Core to exert a sustained, powerful influence on the research field(s) involved?
    • Is provision of resources and expertise for the research base and the wider nonmalignant hematology research community critical and justified, and if the Biomedical Research Core leverages existing infrastructure, is there clear added-value for nonmalignant hematology research?
    • Is the management plan well-described, including a prioritization plan for responding to the needs of the community and ensuring resources are being deployed for projects within the NIDDK Hematology Program mission?
    • Is there evidence that the Biomedical Research Core has expertise and plans to develop new state-of-the-art tools, assays, or reagents?
    • Is the relationship of the Biomedical Research Core to the central theme/focus of the overall CCEH strong?
    • Are creative strategies being employed by the Biomedical Research Core to ensure access to techniques, reagents, assays, instrumentation, and/or expertise nationally by the wider nonmalignant hematology research community?
    • Is the quality of the relevant facilities or services provided state-of-the-art and criteria for prioritization and usage appropriate?
    • Are the qualifications, competence and commitment of the Biomedical Research Core leader(s) and key personnel appropriate?
    • Is there adequate quality control management?
    • Does the CCEH provide strategies to effectively use any Program Income generated by the CCEH, for example, to expand the capacity of CCEH?
    Enrichment Program

    Reviewers will provide an overall impact score to reflect their assessment of this component, using the following:

    • Are plans adequately described for the Enrichment Program to promote scientific exchange among investigators involved in NIDDK Hematology Program-relevant research?
    • Are plans adequately described for the Enrichment Program to recruit new investigators into the field(s) described in the central theme of CCEH?
    • Does the Enrichment Program describe efforts to coordinate an exchange program for students and fellows at one institution to visit another institution in order to expand their knowledge and skills?
    • What is the likelihood the Enrichment Program will promote new scientific collaborations, help to advance novel hypotheses and mentor early stage investigators?
    • If there is a NIDDK T32 program or other relevant program at the institution, are there adequate plans to promote cohesive interactions between the two programs?
    Additional Review Criteria - Overall

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

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the 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.

    Inclusion of Women, Minorities, and Individuals Across the Lifespan  

    When the proposed CCEH involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed.  For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    Biohazards

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

    Resubmissions

    For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

    Renewals

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

    Revisions

    Not Applicable

    Additional Review Considerations - Overall

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

    Applications from Foreign Organizations

    Not Applicable

    Select Agent Research

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

    Resource Sharing Plans

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

    Reviewers should comment on whether the Resource Sharing Plan includes adequate plans to make standard operating procedures, other protocols, and quality control metrics available to the research community through published literature or the CCEH website.

    Authentication of Key Biological and/or Chemical Resources

    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.

    Budget and Period of Support

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

    2. Review and Selection Process

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

    As part of the scientific peer review, all applications:

    • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
    • Will receive a written critique.

    Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

    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 FOA. 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:

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.
    • Achievement of a breadth of themes (e.g., hematopoiesis, erythropoiesis, and iron and heme) and Biomedical Research Core resources and expertise.
    3. Anticipated Announcement and Award Dates

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

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

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

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

    Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

    2. Administrative and National Policy Requirements

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

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    Cooperative Agreement Terms and Conditions of Award

    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 45 CFR Part 75, 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 awardees 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

    The PD(s)/PI(s) will have the primary responsibility for:

    • Pursuing research objectives consistent with the research scope of this FOA and favorably recommended by peer review; collecting, analyzing and disseminating the resulting data;
    • Accountability towards the applicant organization officials and to the NIDDK for the performance and proper conduct of the research supported by the project in accordance with the terms and conditions of the award;
    • Tracking the usage of CCEH and HCCC resources, providing usage data to the Steering Committee, and making efforts to expand CCEH and HCCC outreach and resource usage nationwide;
    • Sharing all standard operating procedures, other protocols, and quality control metrics with research community, to support the conduct of research at no charge other than the costs of reproduction and distribution, consistent with achieving the goals of this program.
    • Serving as voting members of the Steering Committee, and attending annual (in-person) and bi-weekly (virtual) meetings of the Steering Committee;
    • Sharing research results and CCEH and HCCC plans with the Steering Committee, the NIDDK and the External Evaluation Panel (EEP) as required for approved activities;
    • Submitting progress reports as needed to the NIDDK and the EEP for distribution to members of the NIDDK Hematology Centers Program. Such reports are in addition to the required annual noncompeting continuation progress report;
    • The PD(s)/PI(s) will agree to: 1) accept the coordinating roles of the Steering Committee, which includes evaluating objectives and research goals of the NIDDK Hematology Centers Program, and recommending modification, deletion or addition of projects within a CCEH or HCCC; 2) follow any common protocols in which they participate for multicenter projects that are approved by the Steering Committee; and 3) accept the cooperative nature of the group process, including the establishment, where appropriate, of smaller collaborative subcommittees comprised of interacting subprojects and/or Cores.
    • Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
    • Any third-party (including industry, academia, and foundations) collaboration 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 with written approval from NIDDK Program staff. Any relevant proposed third-party agreements related to the network studies between grantee and 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 policies. Further, at the request of the NIDDK Program staff, any other network-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.”
    • Any involvement of a third-party (including industry, academia, and foundations) in the study and network activities that includes access to any network study data and biosamples, or study results that are not publicly available, or using the name of the network 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.

    NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

    • NIDDK will form an External Evaluation Panel (EEP), comprised of the outside advisors with relevant expertise to the goals of the NIDDK Hematology Centers Program, and selected by the NIDDK. The EEP will convene annually to review and assess the program and to advise NIDDK Project Staff of scientific developments and opportunities that may enhance the achievement of the NIDDK Hematology Centers Program goals.
    • The NIDDK Project Scientist(s) will participate in the overall coordination of the NIDDK Hematology Centers Program and serve as a voting member(s) of the Steering Committee. This includes efforts to improve and strengthen intra- and inter-Center cooperation amongst the CCEH and HCCC, and among other funded NIDDK programs as it pertains to cross-fertilization of basic research disciplines. As a means of improving collaboration, the Project Scientist(s) will directly participate in the activities of the collaborative subcommittees as established by the Steering Committee. These may include activities of the Pilot & Feasibility Program administered by the HCCC, access to Biomedical Research Cores, and outreach to the greater hematology research community.
    • The Project Scientist(s) will, as required, help reprogram biomedical research efforts, including options to modify or terminate them, by mutual consent between the NIDDK Hematology Centers Program PD(s)/PI(s) and NIDDK. In the event of disagreements among Program participants, the Project Scientist will assist in forming an arbitration panel as discussed below.
    • NIDDK Project Scientist(s) will interact with each individual CCEH and HCCC awardee towards evaluating objectives and research goals of that particular Center, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted. The Project Scientist(s) will assist and facilitate this process and not direct it. The Project Scientist(s) will also assist in reviewing and commenting on all major transitional changes of an individual center’s activities prior to implementation to assure consistency with required goals of the NIDDK Hematology Centers Program.
    • NIDDK retains the option to recommend the withholding of support from a CCEH Core or other component of a CCEH or HCCC materially failing to meet the technical performance requirements established by this NIDDK Hematology Centers Program. This includes identifying jointly with participants of the Steering Committee the need to add additional service/reagent preparation/equipment Cores to CCEH or to phase out a service/reagent preparation/equipment Core when performance standards have not been met; and
    • To participate, where warranted, in data analyses, interpretations, and the dissemination of study findings to the greater research community and health care recipients including, co-authorship of the publications arising from results generated in research conducted by the CCEH.

    In addition, a separate NIDDK Program Official identified in the Notice of Award will be responsible for the normal stewardship and monitoring of the award including review and approval of all progress reports and all budgetary decisions. Additional responsibilities include:

    • Interacting with the Program Director(s)/Principal Investigator(s) on a regular basis to monitor progress. Monitoring may include: regular communications with the PD(s)/PI(s) and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at the Steering Committee and related meetings.
    • The NIDDK Program Official will monitor progress of the CCEH and HCCC and may request that a component be closed for reasons including: a) poor progress; b) patient safety and regulatory concerns (if applicable); c) emergence of new information that diminishes the scientific importance of that component.
    • Making recommendations for continued funding based on: a) overall project progress; b) cooperation in carrying out the research and evidence of collaboration (e.g., attendance at the Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high-quality research product that has potential to fill a national need.

    Areas of Joint Responsibility include:

    • The Steering Committee will consist of the PD(s)/PI(s) from each of the participating CCEH funded through RFA-DK-19-005 and the HCCC funded through RFA-DK-19-013, as well as and the NIDDK Project Scientist(s). A Chairperson of the Steering Committee, other than a NIDDK Project Scientist, will be selected by the NIDDK. Each full member of the Steering Committee will have one vote. The Steering Committee will be the main, governing body of the NIDDK Hematology Centers Program and voting members will be required to attend annual (in-person) meetings in Bethesda, MD. In addition, the steering committee will convene bi-weekly via teleconference.
    • The Steering Committee will document progress in written reports to the NIDDK Program Official and will provide periodic supplementary reports upon request.
    • The purpose of the Steering Committee will be to discuss and evaluate concerns and cooperative activities of the NIDDK Hematology Centers Program, including (but not limited to) the Pilot & Feasibility Program, Biomedical Research Cores, and the Enrichment programs. The Steering Committee will establish working subcommittees as necessary and provide feedback to the subcommittee leaders at least bi-annually. The Steering Committee reserves the right to implement changes in subcommittee membership or direction if needed. Awardees will be required to accept and implement policies approved by the Steering Committee.
    • The annual, in-person meeting will include the External Evaluation Panel. These meetings are separate from any regular conference calls. The purpose of these meetings is to share scientific information, assess scientific progress, identify new opportunities and potential avenues of collaborations such as with industry, private foundations, non-NIDDK Hematology Centers Program members of the research community and/or NIH intramural scientists, establish priorities that will accelerate achievement of the goals of the NIDDK Hematology Centers Program, and reallocate resources.
    • As needed, the Steering Committee will develop a publication policy regarding joint authorship of research reports derived from such collaborative efforts.

    Dispute Resolution

    Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

    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.

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

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    Section VII. Agency Contacts

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

    Application Submission Contacts

    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)

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Terry Rogers Bishop, Ph.D.
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-594-7726
    Email: terry.bishop@nih.gov

    Cindy N. Roy, Ph.D.
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-594-8805
    Email: cindy.roy@nih.gov

    Peer Review Contact(s)

    Ann A. Jerkins, Ph.D.
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-594-2242
    Email: ann.jerkins@nih.gov

    Financial/Grants Management Contact(s)

    Norma DeGuzman
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-480-1810
    Email: mailto:norma.deguzman@nih.gov

    Section VIII. Other Information

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

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.    

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