Part 1. Overview Information

Key Dates

No late applications will be accepted for this Funding Opportunity Announcement.

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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this FOA is to invite applications from eligible organizations for an Integration and Coordination Center (ICC) for the Common Fund Data Ecosystem (CFDE) that will help build internal cohesion within the program. Award(s) made through this FOA will support CFDE by integrating relevant Common Fund (CF) programs within CFDE, coordinating across other CFDE centers, helping CF programs develop data sustainability plans, and ensuring continuous improvement through an annual evaluation program. The awardee(s) will work collaboratively with each other and other participating components of CFDE to integrate and coordinate activities across the ecosystem. The product of CFDE will be a thriving ecosystem that enables the research community to reuse CF data and resources for new discoveries and purposes.

This initiative is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have an exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.

Applicants responding to this FOA are expected to familiarize themselves with the other components of CFDE listed below, as the ICC will be expected to communicate, coordinate, and collaborate with these components. 

The NIH recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. To support the best science, the NIH encourages inclusivity in research. This initiative is responsive to NIH’s commitment to inclusivity. 

Background 

The NIH Common Fund (CF) supports bold scientific programs that catalyze discovery across all biomedical and behavioral research. CF programs create a space where investigators and multiple NIH Institutes and Centers (ICs) collaborate on innovative research addressing high-priority challenges for the NIH as a whole and make a broader impact in the scientific community. 

Approximately two-thirds of CF programs generate large-scale data resources and digital tools that are intended to be used by researchers across the entire spectrum of biomedical research. These resources provide unprecedented opportunities to understand biological mechanisms, interrogate complex biological systems, deliver new types of discoveries, and rapidly advance novel treatments and cures for many diseases. However, as a federated collection of CF programs, these resources reside in different locations and are made accessible via different locations, platforms, formats, and mechanisms. This federated setup creates unique challenges in working with CF resources in an easily accessible, integrated, and user-friendly manner. Multiple challenges in data collection, curation, storage, management, and sharing must be addressed to realize the full potential of the “big data” revolution in biomedical research. NIH is taking steps to modernize the NIH-funded biomedical data-resource ecosystem, as described in the NIH Strategic Plan for Data Science. In alignment with this plan, the CF addresses data science opportunities and challenges related to CF programs. 

The Common Fund Data Ecosystem (CFDE) is an infrastructure investment made by the CF to address the growing challenges facing scientific programs that leverage data-intensive strategies. To support these programs and downstream data users, CFDE is helping to ensure that all CF data sets are Findable, Accessible, Interoperable, and Reusable (FAIR), providing training for users to operate on the data in a cloud environment, and ensuring that CF data continue to be available after individual programs are completed. CFDE will amplify the impact of many CF programs by enabling researchers to interrogate disparate data sets, thereby making new kinds of scientific discoveries that are otherwise unattainable. CFDE is also being designed in parallel with NIH IC data platforms to enable crosstalk between CF and IC data sets and address NIH-wide data management objectives described in the NIH Strategic Plan for Data Science.

CFDE’s driving focus is to foster scientific discovery through the (re)use of data generated by CF programs. This will be achieved through three aims: 1) Enable users to query across and use multiple CF data sets; 2) Provide training and outreach to bring people to CF data and train them to work in the cloud; and 3) Coordinate and integrate infrastructure and activities into a cohesive ecosystem. Unlocking the full potential of CF resources through reuse will require expertise from multiple scientific domains, including biomedicine, data science, data management, and cloud workspace training.

Additional information on the program and FAQs are available on the program website at https://commonfund.nih.gov/dataecosystem/faqs.

Structure of the CFDE

Currently CFDE is in the third and final year of its pilot phase. During the pilot phase, a Common Fund Data Ecosystem Coordination Center (CFDE-CC) was established to provide technical and logistical coordination of the CFDE consortium activities. Tasks of the CFDE-CC during the current phase included engaging the Data Coordination Centers (DCCs) of CF programs as partners to establish an ecosystem of data sets and other resources generated by the DCCs that is FAIR. Further information about CFDE and its accomplishments in the first phase as well as the resources made available through the CFDE portal and other platforms can be found at https://nih-cfde.github.io/2022-CoC-Videos/appendix/. 

Building on the successful first phase, CFDE will be expanding its scope to increase the reuse of CF generated data, knowledge, and tools, and significantly ramp up the skills development and training efforts. CFDE will establish data resource and knowledge portal(s) and cloud workspaces that will enable users to query across and use multiple CF resources and will increase use by expanding outreach and training efforts that bring biomedical researchers to CF resources to work in the cloud. To accommodate these changes in the scope and better address the needs, CFDE will be structured as five tightly integrated Centers:

Data Resource Center (DRC): This center will be responsible for creating and maintaining the CFDE portal that enables users to query and use data sets from across CF programs. The portal will include a landing page for CFDE that integrates information and products from the other CFDE centers.

Knowledge Center (KC): This center will be responsible for establishing a Knowledge portal, a knowledge management platform that: aggregates and integrates the knowledge generated by different CF programs to amplify their impact, makes the knowledge accessible to a wide user community in a user-friendly manner, and enables various ways to query and access the available knowledge.

Cloud Workspace Implementation Center (CWIC): This center will be responsible for creating a cloud workspace that enables users to import their data and co-analyze them with other CF data sets and/or utilize CFDE-constructed analysis pipelines, workflows, and other analytical or visualization resources. The cloud workspace will meet the needs of both novice and expert users.

Center for Training (CT): This center will be responsible for performing a landscape analysis to identify the training opportunities and needs of the CFDE community. It will also develop and help other CFDE Centers develop and administer targeted training to address gaps in the training landscape.

Integration and Coordination Center (ICC): This center will focus on ensuring internal cohesion within CFDE and implementing a structured evaluation process to ensure a continuous improvement cycle. It will have three major responsibilities: (1) Integration and coordination across the CFDE Centers and CFDE-related activities among participating CF programs; (2) Sustainability services; and (3) Leading an annual program evaluation.

In addition to the CFDE Centers, CF Program DCCs will be critical components of CFDE. Participating CF programs will work closely with the DRC and KC to ensure their resources are available through the CFDE portal(s). They will also collaborate with the CWIC to make their resources available to the broader user community, and will coordinate their training and outreach activities with the CT. The participating CF program DCCs will also be required to perform regular FAIRness assessments to monitor changes in the FAIRness over time and collect regular usage statistics and metrics for their data sets and resources in coordination with the ICC as part of an annual program-wide evaluation. All CF DCCs will also be eligible to participate in CFDE partnership projects aimed to integrate data sets and resources across multiple CF programs. 

Research Objectives and Requirements of the FOA

Applicants responding to the ICC FOA are expected to familiarize themselves with the structure and other components of CFDE as described above. NIH's key expectations for the CFDE ICC are:

• The ICC will work under the management and oversight of the Office of Strategic Coordination in partnership with NIDCR, with technical and strategic guidance from the NIH CFDE Technical Working Group composed of NIH staff from OSC and participating CF programs.
• The ICC must effectively and productively collaborate with investigators representing CF programs, CFDE centers, and CFDE initiatives. This level of collaboration is essential for the success of both the ICC and CFDE during the performance of their activities.
• The ICC is expected to provide administrative, coordination, and project management support for the three primary cores outlined below.

The ICC responsibilities will include, but are not limited to, the following tasks, aligned to three cores: an Administrative Core, an Evaluation Core, and a Sustainability Core.

The Administrative Core will be responsible for ensuring internal cohesion of the CFDE ecosystem. For CFDE to succeed, many different teams and organizations need to work collaboratively across distinct but interrelated tasks. For example, the DRC and KC will be responsible for creating portals that will ultimately need to integrate seamlessly with the planned CFDE cloud workspaces. Similarly, CFDE approaches training and outreach holistically necessitating close coordination between the CFDE CT and the other centers developing product-related training materials. To help integrate interrelated tasks being performed by different members of the CFDE ecosystem, the Administrative Core will be responsible for developing and maintaining a comprehensive project management plan to ensure coordination of activities, timelines, and major milestones across CFDE-participating DCCs, Centers, and initiatives. They will also be responsible for organizing, managing, and administering CFDE meetings, including two in-person meetings annually. In support of its role in driving internal cohesion of the CFDE program, the Administrative Core will be responsible for liaising with nascent and existing CF programs that are not formally engaged with CFDE to help them understand the program and the benefits of participating in relevant activities.

The Evaluation Core will be responsible for performing an annual evaluation of CFDE that assess the program’s progress against the programmatic goals. With guidance and input from NIH, the evaluation core will be responsible for establishing evaluation metrics that can be used to monitor the progress of the program. Once an evaluation plan is in place, the Evaluation Core will need to work with participating CFDE DCCs, Centers and initiatives to gather the necessary metrics and produce an annual report that aggregates the metrics, interprets the findings, and issues recommendations. The Evaluation Core will also be responsible for providing advice and guidance to CFDE-participating DCCs, Centers, and initiatives based on the findings and recommendations of the annual evaluation process.

The Sustainability Core will be responsible for working with CF programs as needed to develop sustainability plans for program data and resources upon program sunsetting. The Sustainability Core will work with individual CF programs as needed to help them identify the most appropriate existing repositories for archiving programmatic data and resources based on the unique data types, use limitations and sample sharing considerations for each program. In addition to working with CF programs individually, the Sustainability Core will also create resources that all CF programs can leverage for sustainability planning, including a catalog of available public repositories as well as best practices and policies for managing, storing, and sharing data.

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 FOA.

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 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.

• 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 registration; 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 his/her organization to develop an application for support. Individuals from diverse backgrounds, including 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. 

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.

Due to the evaluation aspect of the ICC for the entire CFDE, the PI of the ICC cannot simultaneously be the PI of another CFDE Center including the Data Resource Center, Knowledge Center, Center for Training, and Cloud Workspace Implementation Center.

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, per 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 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 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:

Email: [email protected]

Page Limitations

All page limitations 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
• Administrative Core: required
• Evaluation Core: required
• Sustainability Core: required

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.

Project/Performance Site Locations (Overall)

Enter primary site only.

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

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this 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)

Specific Aims: Applicants must provide Specific Aims for the Overall ICC describing the objectives and goals of the ICC as they relate to the overarching goals of CFDE. The application should clearly state how the Cores of the ICC will interact and the role of each Core in meeting the objectives and responsibilities of the ICC. In addition, each specific aim should be supported by a brief description of how that aim will be accomplished through the interactions of the Cores.

Research Strategy: The Research Strategy section for the Overall ICC should explain in greater depth the significance of the ICCs overall goals relative to the CFDE program goals, the group expertise of the team to accomplish the goals (without duplicating information in the biosketches), the innovation and strengths of the approach and the work environment. The applicant should describe the integration between Cores, with a focus on how the overall ICC will achieve the goals by the Cores working synergistically rather than asynchronously.   

• Describe how the Center will be structured and governed, having well-delineated roles and responsibilities. Clearly indicate the roles of participating institutions, key personnel, as well as conflict resolution.
• Describe how the Center will operate. Provide a narrative description of how the Cores will work together to support the objectives of the ICC.
• Applicants should provide examples of past success relevant to the goals of this FOA without duplicating information in the biosketch.

Applications must include milestones for success that describe the anticipated performance of the ICC. Milestones proposed should include a timeline (e.g., by 6 month) and be quantitative (e.g., “Define 3 key performance measures for each CFDE Center by 6 months) rather than qualitative (e.g., “We will define key performance measures for each CFDE Center.”)

Letters of Support:: Applicants should include a letter of support from the appropriate senior institutional or organizational official that:

• Commits the institution(s) to the ICC goals
• Defines the institutional officials’ positions and authority to commit the institution
• Provides evidence and/or assurances that adequate arrangements are in place between participating 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.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component. 

All instructions in the SF424 (R&R) 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.

Plan for Enhancing Diverse Perspectives (PEDP)

In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate.

The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).

• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups historically under-represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage the participation of students, postdoctoral researchers, and co-investigators from diverse backgrounds, .
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants, including those from under-represented groups.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp

Additional information and FAQs about the PEDP are available on the program website at https://commonfund.nih.gov/dataecosystem/faqs. 

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. 

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

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 ‘Project Lead’ 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 (Administrative Core)

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

Appropriate travel funds must be included in the proposed budget to support travel for 2-3 personnel to an Annual CFDE Steering Committee meeting and 5-7 personnel to attend an Annual CFDE Program Meeting. The budget request should also include the funding needed to cover the costs of hosting two in-person meetings annually, one for approximately 30-50 attendees (CFDE Steering Committee meeting) and a second for 75-125 attendees (Annual CFDE Program Meeting). In-person meetings must be held within the contiguous US, with a preference for the Washington DC metro area.

Applicants must be committed to the success of the ICC. For a single-PI application, a minimum of 20% or 2.4 person months of effort per year to the program activities is expected for the PD/PI, with a maximum of three person months of effort per year. For a multi-PI application, at least one PI must commit to a minimum of 10%, and the total PI salary costs supported by this award cannot exceed 25%.

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)

Specific Aims: State concisely the goals of the Administration Core. Include a succinct summary of the core and its relevant experience to the stated objectives of this solicitation.

Research Strategy: This section should provide a clear description of the plan, timeline, and milestones to implement the proposed Administrative Core activities, including but not limited to:

• Develop and maintain a comprehensive project management plan to track activities, timelines, and milestones across CFDE-participating DCCs, Centers, and initiatives. Generate progress reports on a regular basis or as needed and facilitate identifying and managing risks and dependencies.
• Provide a synthesis of DCC, Center, and initiative progress reports, timeline and milestone updates and other information to the POs regularly and as needed. This information will be used by NIH staff when making decisions regarding the approval, continuation, and termination of efforts within CFDE.
• Liaise with relevant nascent and existing CF programs that are not formally engaged with CFDE to help them understand the program, relevant standards, as well as opportunities to engage in CFDE activities and resulting synergistic advancements.
• Onboard new CFDE partners and participants. This includes developing and maintaining the relevant documentation.
• Organize CFDE meetings (e.g., annual program meetings, steering committee meetings, working groups, cross pollination events). Responsibilities will include logistical coordination (e.g., securing a venue, distributing meeting invitations), implementing and managing a hybrid meeting platform (for in-person meetings), defining the meeting agendas, identifying and extending invitations to attendees, coordinating with speakers/presenters, documenting meeting minutes, action items and decisions, and ensuring follow-up. This will include two (2) in-person meetings annually, one in the Fall for the CFDE Steering Committee that will consist of approximately 30-50 individuals and an annual CFDE Program Meeting in the Spring that will include approximately 75-125 individuals. The in-person meetings must be held within the contiguous US, preferably within the Washington DC metro area.
• Develop and maintain CFDE documentation, including recordings, videos, agendas, and meeting minutes, and maintain a permission-based access system.
• Review outreach activities across CFDE to ensure coordination.
• Facilitate the logistics of training and outreach events in coordination with other CFDE Centers, partners and initiatives.
• Provide administrative support for community outreach events such as hack-a-thons, code-a-thons etc.

Letters of Support: Applicants should include a letter of support from the appropriate institutional or organizational official to substantiate the organizations' commitment the administrative and financial arrangements needed to host large (30–125 attendees) in-person program meetings at least twice annually and support other in-person community-building events (e.g., hackathons) and trainings as needed.

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:

Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

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 nbsp;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.

Evaluation Core

When preparing your application, use Component Type ‘Evaluation Core.’

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

SF424 (R&R) Cover (Evaluation 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 (Evaluation Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Evaluation 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) (Evaluation 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 (Evaluation Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ 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 (Evaluation Core)

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

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 (Evaluation Core)

Specific Aims: State concisely the goals of the Evaluation Core. Include a succinct summary of the core and its relevant experience to the stated objectives of this solicitation.

Research Strategy: This section should provide a clear description of the plan, timeline, and milestones to implement the proposed Evaluation Core activities, including but not limited to:

• Establish evaluation metrics that can be used to monitor progress against CFDE programmatic goals 
• Work with participating CFDE DCCs, Centers, and Initiatives to establish automated methods for collecting metrics, including FAIRness assessments. While the DCC, Center or initiative will be responsible for implementing the automated (where feasible) system(s) to gather the metrics, the ICC should provide advice and guidance on the metrics that need to be gathered and the frequency.
• Produce an annual evaluation report that aggregates metrics data, interprets the findings, and issues recommendations that capitalizes on strengths and addresses weaknesses, with a focus on return on investment for the changes proposed
• Ensure the findings from the annual evaluation report are incorporated into the relevant workplans that the other CFDE centers and participating DCCs will be required to prepare annually.
• Perform a final assessment in collaboration with the CT on CFDE training programs

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:

Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

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 (Evaluation 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.

Sustainability Core

When preparing your application, use Component Type ‘Sustainability Core.’

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

SF424 (R&R) Cover (Sustainability 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 (Sustainability Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Sustainability 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) (Sustainability 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 (Sustainability Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ 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 (Sustainability Core)

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

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 (Sustainability Core)

Specific Aims: State concisely the goals of the Sustainability Core. Include a succinct summary of the core and its relevant experience to the stated objectives of this solicitation.

Research Strategy: This section should provide a clear description of the plan, timeline, and milestones to implement the proposed Sustainability Core activities, including but not limited to:

• Create a prioritized shortlist of IC-specific, specialized, and public repositories that are appropriate for archiving CF program data and resources
• Create a catalog of CF programs that are within 3 years of close out, the location of their data, data owner/steward and/or sustainability plan
• Work with individual CF programs as needed to help them identify the most appropriate repositories based on their unique data use limitations or sample sharing considerations
• Develop best practices and policies for managing, storing, and sharing data for CF programs
• Assist CF DCCs as needed with the transfer of data and resources to long-term repositories
• Work with CT to address transition plans for training materials produced by Centers, DCCs, and Training Awards, including online deposition of materials and resources, hand-off to other NIH training programs, or transfer upon re-issuance of awards.

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:

Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

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 (Sustainability 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.

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 form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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. 

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.

For this announcement, each application will be evaluated on the basis of the overall impact of the application as a whole and the overall impact of each of the individual components. The overall application will receive an overall impact score reflecting the reviewers' assessment of the ICC’s Significance, Investigator(s), Innovation, Approach, and Environment, as well as the likelihood the ICC Center will be successful in accomplishing its goals.

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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).

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific for this FOA: To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific for this FOA: To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?

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?

Specific for this FOA: To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation? To what extent are the organizational concepts or management strategies proposed by the applicant in the coordination or execution of the planned activities novel? To what extent are the applications of organizational concepts or management strategies proposed a refinement or improvement of existing strategies?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/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 for this FOA: Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible? To what extent do the planned activities address how the ICC will achieve the goals of each core, working synergistically rather than asynchronously? Have the investigators aligned the milestones to the goals and objectives of the core with sufficient detail to assess progress against the goals and objectives of the ICC?

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 for this FOA: To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project? To what extent will the administrative support enable the effective execution and monitoring of any subcontracts or vendor agreements needed to successfully complete the project? 

Not Applicable

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 project 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 Animals 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

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Not Applicable

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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

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 Center for Scientific Review, 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 FOA

1. 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 appropriate national Advisory Council or Board. 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 including the PEDP.

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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 recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Prior Approval of Pilot Projects

Recipient-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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, Recipients, and Activities, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

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 and 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.”

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, 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 recipientss is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The Program Officer (PO) and Project Scientist (PS) roles are held by NIH staff members. The PS is part of the CFDE Technical Working Group (TWG). The PO role will be held by a member of the Office of Strategic Coordination, the office responsible for overseeing the Common Fund and this individual will have substantial programmatic involvement during the conduct of this award through facilitating technical assistance, advice, and coordination. Multiple program staff may be designated as Project Scientists as needed to manage CFDE program objectives and will work closely with the PO. The role of NIH PO/PS team will be to facilitate and not to direct the activities. The PO will be named in the Notice of Award.

The ecosystem will be governed by a Steering Committee (SC), composed of one representative from CFDE Center and each CF program participating in CFDE, either through base engagement support or a CFDE partnership. Each PD/PI will serve as the representative. Multi-PI grants will select one PI as representative. Co-chairs of the CFDE Steering Committee will be selected on an annual basis. The SC will have the responsibility to provide strategic guidance and recommendations. While the SC can form working groups and subcommittees as needed, there will only be one CFDE SC. The SC will provide guidance and recommendations and NIH will review and approve policies developed by the SC. NIH staff will maintain authority on all matters regarding funding or expenditure of funds. 

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

• Determining project approaches, designing protocols, setting project milestones and timelines, and conducting research
• Planning and directing the coordinating activities of the ICC in accordance with the goals of the CFDE program to meet the timeline stated in their application.
• Adhering to policies regarding sharing of genomic and other types of data, data access, and standardized formats; timely publication; and intellectual property established by the NIH, NIDCR and the Steering Committee (SC)
• Collaborating with other CFDE Centers, DCCs, initiatives, and partnerships to prepare abstracts, presentations, and publications to ensure timely dissemination of CFDE tools and resources.
• Working with the SC to codify and implement policies consortium-wide
• Accepting and implementing priorities, procedures and policies agreed upon by the SC to the extent of corresponding grant regulations.
• Not disclosing confidential information.
• Interacting with other relevant NIH programs and activities, as needed, to promote synergy and consistency among similar or related projects.
• Communicating across CFDE Centers, DCCs, initiatives, and partnerships, and cooperating with participating NIH staff to facilitate collaborative efforts.
• Fully participating in a cooperative, interactive, and collaborative manner with NIH staff, CFDE-funded investigators and other CFDE Center PIs.
• Submitting periodic progress reports to the CFDE TWG or an external scientific panel, as agreed by the SC or the NIH PO/PS
• Submitting regular progress reports and milestone updates to the NIH, at least annually in the RPPR, or in more frequent reporting that may be requested by the NIH PO.
• Cooperating with the other CFDE PDs/PIs, and with federal staff members in various joint activities; examples include partnerships and working groups
• Cooperate with the NIH staff members and/or external evaluators to conduct a site visit during the first three months of the award and additional site visit(s) or other evaluation process as needed as determined by the NIH PO/PS 
• Informing the NIH PO of plans to change or modify any project’s specific aims or strategy, and obtaining receipt of NIH approval prior to the implementation of changes and expenditure of funds
• recipients 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.

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

The PO/PS team will have the following substantial involvement:

• Serving as a liaison, helping to coordinate activities among and for the multiple CFDE recipients, including acting as a liaison between the CFDE SC and NIH, and as an information resource for the recipients about data science, interoperability, and data reuse efforts at NIH. The PO/PS team will serve as a liaison to help coordinate with other groups performing related sets of activities (e.g., the NIH Cloud Platform Interoperability [NCPI] effort)
• Reporting periodically on the progress of the recipients to the NIDCR and Common Fund Leadership and to the NIH Council of Councils
• Assisting the CFDE SC in developing and drafting operating policies and other policies for dealing with recurring situations that require coordinated action
• Providing advice, technical assistance and coordination for the management and technical performance of the award
• Assisting in promoting the availability of the data and related resources developed during the award to the scientific community
• The PO will be responsible for the normal scientific and programmatic stewardship of the award, including assessments of how well the recipient has met any milestones required for each year of funding.
• The PO may propose curtailing, withholding, or reducing support for any recipient that fails to make satisfactory progress toward the approved scope of work, has ethical or conflict of interest issues, or fails to comply with the Terms and Conditions of Award.
• Involving NIH staff who may assist the recipient(s) as designated by the PS/PO.
• Where warranted and consistent with authorship and conflict of interest requirements of journals in which the Consortium/Network decides to publish, co-authoring manuscripts through their role in scientific program management.

The Government, via the NIH PO/PS team, will have access to data generated under this Cooperative Agreement through recipient meetings and progress reports. Federal staff may use information obtained from the data for the preparation of internal reports on the activities of the study.

Consistent with 45 C.F.R. 75.322, the recipient will own the data and software developed under this award and be able to continue to use these data and software upon expiration or termination of the award. NIH will have unrestricted access to and use of the data and software, including the right to transfer them to other resource projects for their use, distribution, and integration with other data. NIH expects that the recipient will grant other resources the ability to use and redistribute the data, including integrating the data with other data sets, without restriction, unless otherwise limited by consent requirements.

External Program Consultants (EPCs): The NIH PO/PS team may engage external scientists with relevant scientific and consortium experience, who are not funded as part of the project and who agree to a confidentiality policy, to provide input and advice to the NIH PO/PS team about the project. The PO/PS team along with other CFDE program staff will engage external scientists and will determine the durations of service. Activities of the consultants could include:

• Participating, as appropriate, in CFDE SC calls, and the annual recipients’ meetings; EPCs may also meet remotely with NIH staff and recipients at other times during the project period, as needed.
• Reviewing and evaluating the progress of recipients in achieving the goals of the project.
• Recommending changes in priorities based on scientific advances within and outside the CFDE activities
• Providing individual recommendations regarding any changes in the project or grant(s) as necessary.The PO/PS team will use these recommendations to make project changes, as appropriate.

Areas of Joint Responsibility include: Close interaction between the participatingrecipient(s) and the PO/PS team will be required, to manage, assess, and implement the activities towards the common goals of the ecosystem. This is accomplished by:

• Before the initial award is made, NIH and the presumptive recipient(s) will negotiate a more detailed set of milestones and timeline. During these negotiations, NIH and the presumptive recipient may discuss clarifications, changes, or additions to the plans and commitments in the application. NIH and the PD(s)/PI(s) will also agree on the reporting structure and on performance elements prior to award. The milestones, timelines, changes to the plans described in the application, reporting structure and performance elements will be documented in a Letter of Agreement (LOA). They may be adjusted by NIH or the PD(s)/PI(s) later by mutual agreement.
• Meeting in person twice each year at locations selected by the recipient in consultation with NIH for program meetings to engage in strategic planning and disseminate information about accomplishments. In addition, the CFDE SC will meet regularly by or web-based/video call.
• Establishing best practices for collaboration as appropriate.
• Generating responses to EPC recommendations.
• The PO/PS will assist and facilitate the group process and not direct it.
• In addition to the PD(s)/PI(s), key co-investigators and pre- and postdoctoral trainees, especially those from different but related disciplines, are eligible to attend the annual in-person CFDE Program Meeting.
• The CFDE SC and PO/PS may invite additional, non-voting scientific advisors to the meetings.
• The CFDE SC, in partnership with NIH members, will monitor the progress of the ICC award, facilitate common data sharing and group publications and identify common resources to support such efforts.
• The ICC PDs/PIs will also work closely with each CFDE Center, the NIH PO/PS team and other CFDE program staff to develop and implement governance and oversight of the CFDE program objectives.
• The SC may establish subcommittees or working groups to provide input on specific matters as needed, and to oversee the development and implementation of ecosystem policies including data and software releases, publications, and standards, etc. Subcommittees may be either permanent or time limited, may include additional experts, depending on the needs of the research.
• The PD(s)/PI(s) will be expected to play an active role in these working groups, as appropriate.
• The NIH PO/PS team for CFDE awards will serve on subcommittees, as appropriate. Subcommittees or task forces may also include other representatives from NIH or other government agencies as non-voting members.
• It is expected that most of the decisions on the activities of the SC will be reached by consensus. If a vote is needed, at least 60% of the voting members most vote in favor of the proposal.
• NIH staff will review and approve policies developed by the SC. NIH staff will maintain authority on all matters regarding funding or expenditure of funds.
• recipients will be required to accept and implement relevant policies approved by the SC and NIH.

Minimal PD(s)/PI(s) Commitments. Applicants must be committed to the success of the ICC. For a single-PI application, a minimum of 20% or 2.4 person months of effort per year to the program activities is expected for the PD/PI, with a maximum of three-person months of effort per year. For a multi-PI application, at least one PI must commit to a minimum of 10%, and the total PI salary costs supported by this award cannot exceed 25%. 

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 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 DHHS regulation 45 CFR Part 16. 

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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. If additional Data Management and Sharing requirements need to be added, please insert what requirements are desired.

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.

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. NIH FOAs 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 75and 2 CFR Part 200 – Award Term and Condition 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.

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]

Christy Kano. Ph.D.
Office of the Director (OD)
Email: [email protected]

Center for Scientific Review (CSR)
Email: [email protected] 

Gabriel Hidalgo
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-827-4630
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 45 CFR Part 75 and 2 CFR Part 200.