Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

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. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

The NIDDK CCEH Program aims to increase access to critical research resources and enhance collaboration in the national multidisciplinary research effort to study normal hematopoiesis and combat non-malignant hematologic diseases. The Program aims to foster broad, highly meritorious basic and translational research on questions of critical importance; provide innovative, state-of-the-art technologies, knowledge, and expertise to support the larger hematology community; engage and attract new and established investigators to research on hematopoiesis and nonmalignant hematological disorders; and promote the development of junior scientists beginning their careers in the hematology field. The Program consists of up to five Cooperative Centers of Excellence in Hematology (CCEHs) and a Hematology Coordinating Center (HCC). The synergy created through these interactions is expected to advance both the science and build the greater hematology community of investigators well beyond the capacity of any individual center.

The overall goal of the HCC is to 1) promote coordination and sharing of novel research strategies among the Centers; 2) enhance interaction and communication between the CCEH Program and the community, and 3) facilitate the activities of the greater NIDDK CCEH Program. All activities of the NIDDK CCEH Program, including the research projects awarded through the P&F Program, 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).

Research Objectives

In support of the broader mission of the CCEH Program and under the direction of the NIDDK CCEH Program Steering Committee (SC), the Hematology Coordinating Center (HCC) will: 

Administration:

• Provide central administrative support to the CCEH Program:
• Convene monthly virtual meetings of the CCEH Program Steering Committee and twice monthly meetings of the Executive Committee (EC), including development and distribution of meeting agendas, summaries and action items.
• Develop and implement standard operating procedures for CCEH Program activities including a rigorous Consortium-wide QA/QC (Quality Assurance/Quality Control) management plan for all CCEH resources.
• Establish and coordinate CCEH-wide efforts to monitor QA/QC plans and metrics, including dynamic measurements that can be quantified and compared to a threshold metric or benchmark. Discuss the inclusion of fit-for-purpose internal and external controls. Name an overall Quality Control Coordinator with appropriate laboratory expertise who will be ultimately responsible for QA/QC evaluation of all CCEH data, metadata, workflows, and biosamples. 
• Facilitate subcommittees as needed to conduct CCEH consortium activities.
• Plan, organize and support at least one annual face-to-face meeting for the NIDDK CCEH Program, including Steering Committee (SC) members, core directors and users from each CCEH, investigators supported by the P&F Program, and others as appropriate.
• Coordinate relevant agreements (e.g., data use, material transfer, etc.) across the Program.
• Coordinate evaluation of Hematology Center Core Resource activities, including collecting user and usage tables from each CCEH site twice yearly as well as monitoring and reporting program objectives/targets, outcomes (publications, etc.), challenges and proposed solutions. Findings from these evaluations should be used to promote the continuous improvement of current hematology resources, based on user engagement and in anticipation of future needs of hematology researchers, ensuring validation of new resources, or establishing a dynamic space that promotes innovative new resources.
• Develop and manage a user-friendly CCEH website for internal and external communication, including information on CCEH funding opportunities and a portal for accessing resources available at all CCEH cores, protocols, data, tools and other program deliverables.
• Identify and leverage communication channels (e.g., social media, professional conferences) that are most likely to engage the wider nonmalignant hematology research community.
• Schedule and facilitate virtual CCEH Program seminar series, scientific meetings, and office hours.
• Facilitate sharing of resources and data within the NIDDK CCEH Program and with the wider nonmalignant hematology research community.
• Design and implement enrichment program(s) for junior and early stage investigators to join and collaborate with the CCEH programs, including mentoring, virtual office hours, seminar series, virtual workshops, etc.
• Support travel of early-stage investigators to attend educational enrichment scientific meetings held by CCEHs including the annual in-person meeting.
• Support short term sabbaticals for investigators to travel to U54 Centers to learn new methods that will enhance nonmalignant hematological research and the widespread usage of new technologies.
• Coordinate and support implementation of novel enrichment programs proposed by individual CCEHs, including scaling up existing successful CCEH enrichment activities nationally via the Opportunity Pool.

Communication:

• Develop and execute a strategic communication plan to both raise awareness of and enable access to the resources offered through the CCEH Program to the wider nonmalignant hematology research community.

Enrichment:

• Develop and implement a multipronged professional development program for junior researchers and students interested in conducting NIDDK mission-relevant hematology research including travel awards and educational opportunities.

Final policies and criteria for the Travel and Professional Development awards will be developed in consultation with the Steering Committee and based on scientific priorities and available funds.

Opportunity Pool:

• Create, establish, and administer a national Opportunity Pool program to address gaps or form new partnerships including pilot and feasibility grants, enrichment programs, and emerging approaches and opportunities that may be unknown at the time of application. Applicants should outline a plan to adapt to evolving objectives and approaches that will address the changing needs of investigators in Hematology. The organization of the Opportunity Pool Program should be flexible as the size and use of the pool may change, but at a minimum, it should:
  • Develop and administer the Pilot and Feasibility (P&F) Program to encourage junior and early stage investigators in the nonmalignant hematology field and attract established investigators to bring in new concepts, technologies, and approaches. Basic and translational research projects are encouraged. The P&F Program is not intended to support or supplement ongoing research of an established nonmalignant hematology investigator. It is expected that P&F projects will generate preliminary data and collaborations to support future significant research grant applications, such as NIDDK investigator-initiated R01s.
  • Develop and/or support enrichment programs that promote innovative development activities at each CCEH while making them available to junior investigators and students nationwide.
  • Support the CCEH Program in its yearly assessment of infrastructure and resource needs. Promote and adapt emerging approaches and establishing strategic partnerships or opportunities that may address the changing needs of investigators in Hematology.
  • Help develop and publicly announce requests for applications, advertise solicitations, manage acceptance, and organize unbiased external expert peer-review.
  • Provide constructive comments on unsuccessful P&F applications to be shared with the applicants for future applications.
  • Establish an administrative structure to disburse and track awards.
  • Establish procedures, formats, and timelines for integrating awardees into the community and monitoring and reporting progress and outcomes of awards (e.g., publications, NIH awards)

Program Organization

Steering Committee

The coordinated efforts of the CCEHs and the HCC will be overseen by the NIDDK CCEH Program Steering Committee (SC), composed of CCEH Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)), the HCC PD(s)/PI(s), and NIDDK Program staff. The SC will designate subgroups and working groups and all PDs/PIs are expected to participate actively in these groups. The SC will serve as the governing body of the Consortium and decisions will be determined by majority vote, including actions pertaining to the governance, design and implementation of matters pertaining to the Program and the successful achievement of the goals of the NOFO (see section VI, #2, Cooperative Agreement Terms and Conditions of Award Areas of Joint responsibility). The NIDDK may select a chair of the SC [Steering Committee Chair (SCC)] either from the PDs/PIs of the Sites, or outside the study group. The NIDDK CCEH Program SC will meet virtually at least once per month and at minimum once yearly for a face-to-face meeting that will be coordinated by the HCC. The first face-to-face meeting will be held in the Fall of 2025 and all CCEH Directors, Biomedical Research Core Directors, and the HCC Director(s) are required to attend.

Executive Committee (EC)

An EC will be comprised of the SCC, HCC PDs/PIs, and NIH Program Staff. Additional Project site investigators and other support personnel may participate in the EC as needed. The EC will make operational decisions for the Consortium between SC meetings by means of at least twice monthly conference calls.

Plan for Enhancing Diverse Perspectives (PEDP)

The NIH recognizes that teams comprised of investigators with diverse perspectives working together and capitalizing on innovative ideas and distinct viewpoints outperform homogeneous teams. There are many benefits that flow from a scientific workforce rich with diverse perspectives, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

To support the best science, the NIH encourages inclusivity in research guided by the consideration of diverse perspectives. Broadly, diverse perspectives can include but are not limited to the educational background and scientific expertise of the people who perform the research; the populations who participate as human subjects in research studies; and the places where research is done.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation.  Assessment of applications containing a PEDP are based on the scientific and technical merit of the proposed project. Consistent with federal law, the race, ethnicity, or sex (including gender identify, sexual orientation, or transgender status) of a researcher, award participant, or trainee will not be considered during the application review process or when making funding decisions.  Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

The PEDP will be submitted as Other Project Information as an attachment (see Section IV).  Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP Guidance materials.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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)

Local 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)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Applicant Organizations

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

• 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.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; 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 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.

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 their organization to develop an application for support. Individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019, and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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

The HCC Director is required to have an established record of external funding and research accomplishment and at least one of the Directors should also have a significant background in nonmalignant hematology research. Applications should include a multidisciplinary research team with diverse perspectives and with relevant complementary and integrated experience. Other relevant areas of expertise may include biostatistics, bioinformatics, dissemination/communication, and project management.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

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, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. 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 instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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: [email protected]

Page Limitations

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

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

Other Attachments:

Statement of Willingness: Please title this attachment "Willingness to Participate". Applicants should provide a statement indicating a willingness to: 

• Work with the NIDDK and NIDDK Hematology Centers Program to participate in the initial and annual meetings thereafter during the course of the grant award;
• Cooperatively interact with the NIDDK and NIDDK Hematology Centers Program in support of the projects and activities;
• Work collaboratively with the CCEHs to develop and execute any relevant agreements to permit sharing of resources, biological specimens and de-identified patient data;
• Actively seek input from the NIDDK and NIDDK Hematology Centers Program regarding resource or expertise needs that may arise during the performance of the project; and
• Participate in monthly conference calls.

Plan for Enhancing Diverse Perspectives (PEDP)

• In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of actionable strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity.
• Applicants should align their proposed strategies for PEDP with the research strategy section, providing a holistic and integrated view of how enhancing diverse perspectives and inclusivity are buoyed throughout the application.
• The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured.
• The PEDP may be no more than 2 pages in length and should include:
  • Actionable strategies using defined approaches for the inclusion of diverse perspectives in the project;
  • Description of how the PEDP will advance the scientific and technical merit of the proposed project;
  • Anticipated timeline of proposed PEDP activities;
  • Evaluation methods for assessing the progress and success of PEDP activities.

Examples of items that advance inclusivity in research and may be appropriate for a PEDP can include, but are not limited to:

• Partnerships with different types of institutions and organizations (e.g., research-intensive; undergraduate-focused; HBCUs; emerging research institutions; community-based organizations).
• Project frameworks that enable communities and researchers to work collaboratively as equal partners in all phases of the research process.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as human subjects in clinical trials, including those from underrepresented backgrounds.
• Description of planned partnerships that may enhance geographic and regional diversity.
• Outreach and recruiting activities intended to diversify the pool of applicants for research training programs, such as outreach to prospective applicants from groups underrepresented in the biomedical sciences, for example, individuals from underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Plans to utilize the project infrastructure (i.e., research and structure) to enhance the research environment and support career-advancing opportunities for junior, early- and mid-career researchers.
• Transdisciplinary research projects and collaborations among researchers from fields beyond the biological sciences, such as physics, engineering, mathematics, computational biology, computer and data sciences, as well as bioethics.

Examples of items that are not appropriate in a PEDP include, but are not limited to:

• Selection or hiring of personnel for a research team based on their race, ethnicity, or sex (including gender identify, sexual orientation, or transgender status).
• A training or mentorship program limited to certain researchers based on their race, ethnicity, or sex (including gender identify, sexual orientation, or transgender status).

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see PEDP Guidance materials.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

The HCC Director is required to have an established record of external funding and research accomplishment and at least one of the Directors should also have a significant background in nonmalignant hematology research. Applications should include a multidisciplinary research team with diverse perspectives and with relevant complementary and integrated experience. Other relevant areas of expertise may include biostatistics, bioinformatics, dissemination/communication, and project management.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

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

The minimum level of effort for the HCC Director is 1.2 person months (10% effort). Associate Director(s) may be named as well, but the total, combined Directorship efforts may not exceed 2.4 person months. The HCC should also include a project manager, and other specialized support personnel (e.g., administrative assistants, communication specialist, website developer) may be proposed and must be fully justified.

The budget must include at least $700,000 direct costs per year to fund the Opportunity Pool, including approximately 500,000 for P&F projects, about 4-8 projects per year, administered as subcontracted awards. The budget to support the HCC, including personnel, travel awards, consortium meeting expenses and supplies, is expected to be approximately $200,000 direct costs per year. Additionally, the budget must include funds to support travel of the HCC Director to attend the face-to-face meeting, as outlined in Section VI.

Budget Justification: Describe the specific functions of all key personnel, consultants, collaborators, and support staff. For years 2-5 of support requested, justify any significant increase or decrease in any category over the initial budget period. Identify such changes with asterisks against the appropriate amounts.

PEDP implementation costs:

Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7): https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

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

Specific Aims: The specific aims should reflect the integrated approach that clearly presents a pathway to reach the goals of the NIDDK CCEH Program.

Research Strategy:

1. Provide leadership, administrative support, and project management to the entire CCEH Program by planning, organizing, and supporting meetings, education, and outreach activities to meet Consortium objectives. This should include:
   • An overview of the HCC, its objectives, and how they are aligned with the objectives of the Consortium.
   • An organizational chart of the HCC, identifying the proposed PD(s)/PI(s) and key personnel.
   • A description of relevant expertise, experience, and accomplishments of the proposed key personnel in the successful planning, direction, coordination, and management of a complex multi-institution Consortium. It is expected that diverse scientific expertise will be included at every level of HCC leadership. 
   • Strategies to maintain regular communication amongst CCEH Program members and facilitate working groups.
   • Plans to organize and support at least one annual, face-to-face meeting of the Consortium.
   • Plans to negotiate, establish, execute, and manage third-party and consortium agreements (e.g., Material Transfer Agreements) between all CCEHs and investigators and other external collaborators.
2. Develop, deploy, and curate a central "one-stop-shop” web-based portal to organize and facilitate sharing of all Consortium resources widely. Lead a Consortium-wide effort to develop metrics to evaluate their national distribution, usage, and impact.
3. Establish and implement a multifaceted communication and education strategy to ensure that the CCEH resources and all other aspects of the Consortium are widely publicized. This strategy should include:
   • Plans to use all appropriate modes of communication (including social media platforms) to ensure that researchers are aware of and encouraged to use Consortium resources.
   • Plans to execute and manage a national outreach program that will help promote a diverse biomedical research workforce and assist investigators in training of techniques and procedures developed by the CCEHs. Outreach may consist of a variety of activities and strategies like social media, seminar series, guest lectures, symposia, workshops, data hack-a-thons, etc. Outreach specifically to students, fellows, and junior faculty is always encouraged.
   • Plans to develop and administer an educational enrichment program, including an opportunity pool for individual CCEHs to design innovative novel programs to help mentor and train new (investigators who have not yet received independent NIH funding) and early-stage investigators, trainees and researchers who are new to hematology research. This program may involve travel support for these investigators, researchers and trainees to attend appropriate Consortium meetings or to the CCEHs to learn new skills or methodologies.
4. Plans to develop, establish, and administer a national Opportunity Pool program to address gaps or form new partnerships including pilot and feasibility grants, enrichment programs, and emerging approaches and opportunities that may be unknown at the time of application. Applicants should outline a plan to adapt to evolving objectives and approaches that will address the changing needs of investigators in Hematology. The organization of the Opportunity Pool Program should be flexible as the size and use of the pool may change, but at a minimum, it should:
   • Support the Hematology CCEH Program in a yearly assessment of infrastructure and resource needs. Work with the CCEHs to identify technological and scientific gaps in kidney research and seek applicants who can develop resources that are not present in the Consortium, but if offered could benefit the national hematology research community.
   • Help develop and publicly announce requests for applications, advertise solicitations, and manage acceptance.
   • Conduct outreach to prospective investigators from diverse scientific and demographic backgrounds, such as those from underrepresented racial and ethnic groups, rural areas, and under-resourced educational settings to encourage applications.
   • Describe specific guidelines for applicant eligibility and any additional review criteria that may help address any bias and select meritorious individuals. The P&F Grant Program is expected to have an emphasis on early-stage investigators and investigators new to hematology research. It is expected that P&F projects will generate preliminary data and collaborations to support future significant research grant applications, such as NIDDK investigator-initiated R01s. As such, this program is not intended to support or supplement ongoing research of an established investigator.
   • Establish an administrative process, with appropriate oversight and rigorous and unbiased external expert peer review, to prioritize, fund, and track awards.
   • Establish procedures, formats, and timelines for integrating awardees and monitoring and reporting progress and outcomes (e.g., publications, subsequent awards). Include plans to integrate and harmonize the activities of supported projects with ongoing Consortium activities.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

All applications are expected to provide plans that address sharing and demonstrate commitment to making resources, models, reagents, tools and methods available to the NIDDK Hematology Centers Program and the broader nonmalignant hematology research community. The terms and timelines for sharing within the NIDDK Hematology Centers Program, validation of models and methods and sharing with the broader research community will be established by the Steering Committee in a manner consistent with achieving the goals of the program and NIH policies. All participants are expected to adhere to these terms as a condition of award.

Other Plan(s): 

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
•  

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

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

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

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

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply – 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

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) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected]. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described 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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).As part of the overall impact score, reviewers should consider and indicate how the Plan for Enhancing Diverse Perspectives affects the scientific merit of the project.

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

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

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group, convened by the National Institute of Diabetes and Digestive and Kidney Diseases (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 will receive a written critique.

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

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

Please note that the reviewers will not consider race, ethnicity, age, or gender (including gender identity, sexual orientation or transgender status) of a researcher, award participant, or trainee, even in part, in providing critiques, scores, or funding recommendations. NIH will not consider such factors in making funding decisions.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Institutional Review Board or Independent Ethics Committee Approval: Recipient 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 recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 
  • HHS recognizes that NIH 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 NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

TERMS AND CONDITIONS OF COOPERATIVE AGREEMENT AWARDS RESEARCH PROJECT APPLICATIONS FOR NON-CLINICAL STUDIES

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 (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The NIDDK Hematology Centers Program will consist of up to four Cooperative Centers of Excellence in Hematology (CCEHs) and a Hematology Central Coordinating Center (HCC). 

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

• Recipient(s) will be primarily responsible for defining the objectives and approaches, planning, conduct, analysis, and publication of results, interpretations, and conclusions of studies conducted under the terms and conditions of the cooperative agreement award.
• The Program Director/Principal Investigator (PD/PI) will assume responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the research supported under this Funding Opportunity Announcement (NOFO) in accordance with the terms and conditions of award, as well as all pertinent laws, regulations and policies.
• Recipient(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.
• Recipients are responsible for their staff in maintaining confidentiality of the information as developed by the CCEH, including, without limitation, study protocols, data analysis, conclusions, etc. per policies approved by the Steering Committee (SC) as well as any confidential information received by third party collaborators.
• Recipients must analyze, publish and/or publicly release and disseminate results, data and other products of the study in a timely manner, concordant with the approved plan for making quality-assured data and materials available to the scientific community and the NIH, consistent with NIH policies and achieving the goals of the NOFO.
• Data Management and Sharing Plan: In accordance with the NIH Policy for Data Management and Sharing (NIH NOT-OD-21-013), the NIDDK approved plan will become a term and condition of award, be routinely monitored during the award period, and compliance may factor into future funding decisions. By the end of the funding or proprietary period, a recipient or study group may not continue to exclusively use or share study generated data until those data are available to the public via a NIDDK approved repository per the NIDDK approved plan.
• Recipient(s) will be required to participate in a cooperative and interactive manner with members of the CCEH including designated NIH staff (e.g., Program Official, Project Scientist, Project Coordinator).
• Recipient(s) agree to establish agreements amongst themselves that address the following issues: (1) procedures for data sharing among CCEH members and data sharing with industry partners; (2) procedures for safeguarding confidential information, including without limitation, any data generated by the CCEH as well as information and/or data received from external collaborators; (3) procedures for addressing ownership of intellectual property that result from aggregate multi-party data; (4) procedures for sharing bio-specimens under an overarching Material Transfer Agreement (MTA) amongst CCEH members that operationalizes material transfer in an efficient and expeditious manner; (5) procedures for reviewing publications, determining authorship, and industry access to publications.
• Any third-party collaboration (including but not limited to interactions with organizations from industry, academia, and nonprofit institutions) should be governed by a research collaboration agreement (e.g., Clinical Trial Agreement, Research Collaborative Agreement, etc.) or any third-party contract mechanism(s) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH/NIDDK policies and procedures, applicable CCEH policies, and with written approval from NIDDK Program staff. Any relevant proposed third-party agreements related to the CCEH activities 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 CCEH policies. Further, at the request of the NIDDK Program staff, any other CCEH-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 but not limited to industry, academia, and nonprofit institutions) in the study and CCEH activities that include access to any CCEH generated resources (i.e., data and biosamples), or study results that are not publicly available, or using the name of the CCEH 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.
• Recipients must agree to comply with the processes and goals as delineated within the NOFO.
• Recipient(s) agree to the governance of the study through a Steering Committee:
  • The PD/PI, or contact PD/PI in the case of multi-PD/PI awards, will serve as a voting member of the Steering Committee and will attend all meetings of the Steering Committee.
  • Each full member will have one vote.
  • The Recipient will be responsible for accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the Steering Committee and subcommittees.
  • Recipients must serve on Subcommittees as needed. Subcommittees will report progress at Steering Committee Meetings and/or lead discussions at the Annual Investigator’s Retreat.
• Recipients must share data, materials, models, methods, information and unique research resources that are generated by the projects in concordance with CCEH policies in order to facilitate progress. When appropriate, and in accordance with NIH policies, as well as NIDDK policies, Recipients will be expected to collaborate; share novel reagents, biomaterials, methods and models and resources; and share both positive and negative results that would help guide the research activities of other members.
• Upon completion or termination of the research project(s), the Recipients are responsible for making all study materials and procedures broadly available (e.g., putting them into the public domain) or making them accessible to the research community according to the NIH-approved plan submitted for each project, for making all study materials and procedures available to the scientific community and the NIH for the conduct of research. The Data Management and Sharing Plan should include a plan to accomplish aforementioned at the end of the study.
• Recipients may be asked to scientifically review applications for special opportunity pool funds, as deemed appropriate.

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

The NIDDK will designate program staff, including a Project Scientist, Program Official and a Grants Management Specialist to provide normal program stewardship and administrative oversight of the cooperative agreement. The Program Official and Grants Management Specialist will be named in the Notice of Grant Award (NOA).

The NIDDK may invite External Consultants/experts with relevant scientific expertise for the sole purpose of consultative advice on scientific developments and opportunities that may enhance the achievement of the study goals.

The NIDDK Project Scientist and Program Official will review and approve applications of the Special Opportunity Funds to ensure that they are within the scope of network/consortium research as described in the NOFO and NIH guidelines.

An NIH IC Project Scientist will be substantially involved in this project above and beyond the normal stewardship of an NIH IC Program Official as follows:

1. Serve as the contact point for all facets of the scientific interaction with the recipient(s). As required for the coordination of activities and to expedite progress, NIDDK may designate additional NIDDK staff to provide advice to the recipient on specific scientific and/or analytic issues.
2. Participate in the Steering Committee that oversees study conduct. The NIDDK Project Scientist will be a full participant and voting member of the Steering Committee and, if applicable, subcommittees.
3. Serve as a resource to study investigators with respect to other ongoing NIDDK activities that may be relevant to the study to facilitate compatibility with the NIDDK missions and avoid unnecessary duplication of effort.
4. Have substantial involvement assisting in the design and coordination of research activities for Recipients as elaborated below:
   1. Assisting by providing advice in the management and technical performance of the investigations, coordinating required regulatory clearances for investigational agents used in the study, which are held by NIDDK. The NIDDK may reserve the right to cross file or independently file an Investigational New Drug Application or an Investigational Device Exemption form with the FDA.
   2. The NIDDK Project Scientist may coordinate activities among recipients by assisting in the design, development, and coordination of a common research or clinical protocol and statistical evaluations of data; in the preparation of questionnaires and other data recording forms; and in the publication of results.
   3. Reviewing procedures for assessing data quality and study performance monitoring.
   4. The NIDDK Project Scientist may be co-authors on study publications. In general, to warrant co-authorship, NIDDK staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; (c) participation in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.

The NIDDK Program Official identified in the Notice of Award will:

1. Interact with the Program Director(s)/Principal Investigator(s) on a regular basis to monitor study progress. Monitoring may include regular communications with the Program Director/Principal Investigator 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 Steering Committee, data safety and monitoring board, and related meetings. The NIDDK retains, as an option, periodic review of progress by researchers not involved with the study.
2. Review and approve protocols prior to implementation to ensure they are within the scope of peer review, for safety considerations, as required by federal regulations.
3. Make recommendations for continued funding based on: a) overall  progress,; b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality of research, which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements.
4. Appoint an independent Data and Safety Monitoring Board (DSMB) as appropriate for Phase III clinical trials or other high-risk studies, or an Observational Study Monitoring Board (OSMB) for observational/epidemiologic studies; these Boards will review study progress, safety data, and interim results, as appropriate, and provide guidance to the NIDDK. The NIDDK Program Official or their Project Coordinator will serve as the Executive Secretary and/or NIDDK program representative on the DSMB/OSMB.

Areas of Joint Responsibility include:

• Through the Recipient, Steering Committee and NIH staff, the study members will cooperatively develop and implement processes to determine criteria and processes for quality control of information, resources, tools and data to be posted for the research community, refine scientific objectives, and implement research advances to facilitate the goals of the CCEH, consistent with NIH policies and achieving the goals of the program as described in the NOFO.
• Executive Committee (EC): The EC will consist of: The Director of the Hematology Central Coordinating Center (HCC), the NIDDK Project Scientist, and representative Principal Investigator(s) chosen among the Recipients; the EC is not a governing body and does not cast votes.
  • The EC will review the progress of all NIH-funded special funding opportunity programs and make recommendations for improvement. Annual reports will be prepared for each special funding opportunity to coincide with one of the annual SC meetings.
  • The EC will be responsible for organizing the yearly Scientific Retreat.
  • The EC will have meetings that will be organized by the Director of the Coordinating Center. Any EC member may place items on the agenda. These should be communicated in advance of the meeting to the Project Scientist, who will distribute these to all members. The designated NIDDK Program Official may be asked to participate in order to provide additional information and to summarize actions that are taken.
• Steering Committee (SC)
  • A Steering Committee organized by the study investigator(s) will be the main governing body of the study.
  • The Steering Committee has primary responsibility to design research activities, establish priorities, develop common processes, protocols and manuals, establish and maintain quality control among recipients, review progress, coordinate and standardize data management, and cooperate on the promotion of CCEH activities and resources. Major scientific/programmatic decisions will be determined by the Steering Committee. The Steering Committee will document progress in written reports to the NIDDK Program Official and will provide periodic supplementary reports upon request.
  • The Steering Committee will be composed of all Program Director(s)/Principal Investigator(s), (including those of the HCC) and co-investigator(s) as deemed necessary, and the NIDDK Project Scientist. The final structure of the Steering Committee and voting procedures will be established at the first meeting. The NIDDK Project Scientist will have voting membership on the Steering Committee, and as appropriate, its subcommittees. The frequency of Steering Committee meetings will be dictated by a vote of the members of the Steering Committee. The NIDDK Program Official may serve as a non-voting member on the Steering Committee.
  • A Chairperson of the Steering Committee will be selected and voted on by the Steering Committee members. The Chairperson provides leadership to the Committee by conducting the Steering Committee meetings and by interacting closely with the recipients during protocol development and implementation. The NIDDK Project Scientist may not serve as Chairperson. The NIDDK program official will review the Committee’s selection for potential bias, conflicts of interest, or lack of required expertise. If the Program Official has concerns regarding selection of the Chairperson which are not satisfactorily resolved, the Program Official may withhold concurrence if approved by the Director, Division of Extramural Activities, NIDDK based on written justification. In cases where Program Official concurrence is withheld, the Steering Committee will be required to make another selection.

External Consultants

An independent panel of External Consultants may be established by the Steering Committee. The External Consultants may periodically review interim progress of the project(s) and provide reports to the Steering Committee. Members of the panel of External Consultants may be asked, on an ad hoc basis, to participate in the peer review of applications for new research initiatives that utilize special “opportunity pool” funds. The NIDDK Program Official will review the Committee’s selections for potential bias, conflicts of interest, or lack of required expertise. If the NIDDK Program Official has concerns regarding selection of one or more External Consultants which are not satisfactorily resolved, the NIDDK Program Official may withhold concurrence if approved by the Director of NIDDK Division of Extramural Activities based on written justification. In cases where NIDDK Program Official concurrence is withheld, the Steering Committee will be required to make another selection.

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: 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 recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

• Recipients will provide updates at least annually on implementation of the PEDP.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Shilpa Hattangadi, MD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-7442
Email: [email protected]

Jenna Norton, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-928-5509
Email: [email protected]

Ann A. Jerkins, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-2242
Email: [email protected]

Lesley Whipp
National Institute of Diabetes and Digestive, and Kidney Diseases (NIDDK)
Telephone: 301-443-9360
Email: [email protected]

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.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.