1. What is the Common Fund Data Ecosystem (CFDE)?

The Common Fund Data Ecosystem (CFDE) is intended to provide the infrastructure needed to help solve key challenges facing Common Fund Data Coordinating Centers. CFDE will include a portal or central access point for Common Fund data sets, tools, and other digital objects, through which users can access and compute on data in a cloud environment. This CFDE portal is not designed as a data repository or platform, but will instead link multiple data platforms that have been established through Common Fund programs and create cloud workspaces for users to access and compute on data across the different platforms. While users may continue to access an individual data set via the platform created for that data set, the CFDE will foster new discoveries and support different types of analyses by enabling queries of multiple data sets simultaneously. The CFDE will provide user support through automated help tools, online courses, webinars, and in-person training events. By providing infrastructure, advice, resources, best practices, common components, and services to fit the needs of Common Fund programs, the CFDE will increase the utility of Common Fund digital objects by making them more findable, accessible, interoperable, and reusable, also known as FAIR. The CFDE will require a collaborative effort, involving Common Fund Data Coordinating Centers who represent the data generators for each program, and a central coordinating component. During the pilot phase (FY 2019 – 2022) the central coordinating body was known as the CFDE Coordinating Center (CFDE-CC). As CFDE begins Phase 2 (FY2023 – 2028) the coordination will be managed by five Centers: the Data Resource Center, Knowledge Center, Integration and Coordination Center, Center for Training, and Cloud Workspace and Integration Center.

See an overview presentation of the progress made during the pilot phase and plans for phase 2 from the September 2022 Council of Councils meeting, and watch the animated Overview of the Common Fund Data Ecosystem video to learn more.

2. Why is the CFDE focused on Common Fund (CF) data sets? Isn’t there a need for NIH to tackle this issue as a whole?

The NIH recognizes a need to modernize the NIH-funded biomedical data science ecosystem. The NIH Office of Data Science Strategy (ODSS), located within the Office of the Director, provides leadership and coordination on a broad range of NIH-wide data science activities to realize NIH’s vision for a modernized and integrated biomedical data ecosystem. ODSS is working across NIH to share information, adopt best practices, and leverage lessons learned from similar efforts, including the CFDE. As ODSS is responsible for NIH-wide data science efforts, the CFDE is focused on making Common Fund data more usable and useful to maximize the impact of Common Fund-supported programs. This focus aligns with the concept approved by the NIH Council of Councils to establish the CFDE as an infrastructure investment for Common Fund data sets. However, Common Fund programs are intended to create data sets that are useful to a very broad community. Common Fund data sets are usually related to other data sets supported by NIH Institutes/Centers or other entities. They may share data types or user communities such that a given user may want to access Common Fund data and non-Common Fund data together. The CFDE is working to create technology to prepare for a future of data sharing with other data ecosystems internal or external to the NIH. Participating Common Fund Data Coordinating Centers are invited to include collaborations with related data sets/platforms as they engage with the CFDE.

For more details on NIH-wide efforts, please see the NIH Strategic Plan for Data Science.

3. How is the Common Fund coordinating with ODSS or other NIH entities on these efforts?

NIH Office of Data Science Strategy (ODSS) located within the Office of the Director, provides leadership and coordination on a broad range of NIH-wide data science activities to realize NIH’s vision for a modernized and integrated biomedical data ecosystem. ODSS is working across NIH to share information, adopt best practices, and leverage lessons learned from similar efforts, including the CFDE. As ODSS develops solutions for trans-NIH data challenges, such as the need for single sign-on to access multiple data sets, the CFDE will pilot the solutions, provide feedback, and ultimately adopt standard approaches.

The Common Fund participates in the ODSS Technical Implementation Working Group and is also working with ICs to develop and demonstrate interoperability across data platforms. The Common Fund recognizes the importance of coordination across NIH to achieve long-term goals and will continue to align with these other efforts.

4. What types of data will be accessible via the CFDE?

Common Fund programs produce a wide variety of data types, including but not limited to genomic, epigenomic, transcriptomic, proteomic, metabolomic, imaging, and clinical data. The data and tools for each program are stored, managed, and made available through that program’s Data Coordinating Center or equivalent. The data include both raw and processed data, along with associated metadata and tools. The CFDE will not replicate or otherwise serve as a repository for these data sets; it will instead work with the individual program Data Coordinating Centers to provide access to the data through the CFDE portal as a way for users to gain access to multiple data sets simultaneously.

Since individual Common Fund programs are supported for a maximum of ten years, the CFDE will support ongoing data storage and maintenance costs so that data from programs that have ended continue to be accessible.

5. What about CF data/tools once a Common Fund program ends?

The Common Fund is committed to ensuring that data and resources developed by Common Fund programs are useful to the broad biomedical research community, and the CFDE is a key component for ensuring data resource sustainability. Through the CFDE, the Common Fund will explore ways to make existing tools and data sustainable and accessible. As support for individual Common Fund programs are designed to be time-limited investments, the Common Fund cannot commit to ongoing expansion of data sets or enhancement of tools once a program ends. However, the CFDE and Data Coordinating Centers will work collaboratively to facilitate sustainability and accessibility of program tools and data over the long-term.

6. Will the CFDE establish standards for the Data Coordinating Centers (DCCs) to follow and generate tools to share within the whole Common Fund community?

Efforts to harmonize across the CF DCCs will be a collaborative activity between the CFDE and DCCs. These activities will take the form of direct input from the DCCs; participation in workshops, site-visits, interviews; and standards development and testing. These efforts were led by the CFDE Coordinating Center during the pilot phase and will be led by the Data Resource Center during phase 2.

7. Is participation in CFDE required for Common Fund programs?

The CFDE is a key component in the Common Fund’s long-term strategy for the sustainability, availability, and utility of its data. While Common Fund programs are not required to be part of the CFDE, they are encouraged to work with the CFDE and utilize best practices and resources from the CFDE.

8. Could a non-Common Fund DCC participate in the CFDE?

The CFDE is designed to enhance utility of Common Fund programs. The Common Fund recognizes that there are significant opportunities for interoperability across the NIH and is actively working with several NIH Institutes and Centers to explore these opportunities. That said, many Common Fund datasets are highly related to non-Common Fund datasets. While the CFDE DCC Engagement Awards are available only to Common Fund DCCs, each Common Fund DCC may bring related datasets into the CFDE as collaborators. As new programs are created by the Common Fund, these programs may also be eligible to participate in the CFDE in the future. Common Fund Data Ecosystem (CFDE) General Questions.

1. What are the main goals of the CFDE Research Education Program?

The overarching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs. To accomplish this goal, this NOFO will support educational activities with a primary focus on:

• Courses for Skills Development
• Mentoring Activities

Programs will promote the use of two or more Common Fund datasets in rigorous biomedical research through short training courses and support the inclusion and retention of a diverse community of Common Fund data users through professional mentoring.

2. What are key dates in the timeline for planning our application?

Posted Date	November 28, 2023
Open Date (Earliest Submission)	January 14, 2024
Letter of Intent Due	January 16, 2024
Application Due Date	February 14, 2024
Scientific Merit Review	July 2024
Advisory Council Review	August 2024
Earliest Start Date	December 2024

3. Do I need to include a Data Management and Sharing Plan in my application?

No, a Data Management and Sharing Plan is not applicable for this notice of funding opportunity (NOFO).

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:

When relevant, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

• Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
• The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

4. If an applicant wants to form an Advisory Committee, are letters of support required from external advisory board members?

No, letters of support are not required from members of a proposed external advisory committee.

1. What organizations are eligible?

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Federal Governments

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

Other

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

Institutional Development Award (IDeA) eligible institutions are encouraged to apply for NIH support as Public or Private Institutions of Higher Education (https://www.nigms.nih.gov/capacity-building/division-for-research-capacity-building/institutional-development-award-(idea)).  

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving federal support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.
 

2. Are foreign institutions eligible?

No, foreign institutions are not eligible to apply for this announcement.

• 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 not are allowed.

3. Is there a limit to the number of applications that can be submitted by an institution? 

No, there is no limit to the number of applications an institution can submit.

1. When may I submit an application?

The application due date is February 14, 2024. All applications are due by 5:00 PM local time of the applicant organization. The earliest submission date is January 14, 2024.

2. Who may I contact if I have questions about my application?

If you have questions prior to submission or after summary statement release, please contact the Scientific Contact: 
Sahana N. Kukke, PhD
Office of Strategic Coordination (OSC)
sahana.kukke@nih.gov.

 
For questions about the review process after submission and before summary statement release, please contact the Peer Review Contact:
Center for Scientific Review
FOAReviewContact@csr.nih.gov.

3. How do I submit my application?

For instructions on how to submit an NIH grant application, please visit the NIH Office of Extramural Research "How to Apply-Application Guide” at How to Submit, Track and View Your Application.

4. Is a letter of intent required for submission?

The letter of intent (LOI) is optional. The LOI is due on January 16, 2024, and should be submitted to sahana.kukke@nih.gov. A letter of intent (LOI) is not required, is not binding, and does not enter into the review of a subsequent application. The information that it contains allows NIH staff to estimate the potential review workload and plan the review.

5. Do I use FORMS-G or FORMS-H to submit my application?

FORMS-H is required for grant application due dates on or after January 25, 2023. See NOT-OD-22-195: New NIH "FORMS-H" Grant Application Forms and Instructions for additional detail.

1. Are the standard project review criteria for “Significance,” “Investigator(s),” “Innovation,” “Approach,” and “Environment” applicable? Are there superseding RFA-specific criteria?

Please refer to the details that are provided in Section V of the funding opportunity. The standard review criteria still apply, including specific review criteria listed in the section.

2. How will applications be reviewed?

Applications will be reviewed by NIH staff for completeness and responsiveness. All applications determined to be complete and responsive will be reviewed by scientific experts convened by the Center for Scientific Review (CSR) in accordance with NIH peer review procedures and using review criteria outlined in the funding opportunity announcement. All applications received in response to the funding opportunity announcement will be reviewed in a special emphasis panel. Applications may undergo a 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.

3. When will my application be reviewed and by whom?

The Scientific Merit Review for this funding opportunity will convene in Summer 2024. Following initial peer review, applications will receive a second level of review by the National Advisory Dental and Craniofacial Research (NIDCR) Council. The Advisory Council Review will convene in September 2024. Questions about the review should be directed to the Center for Scientific Review at https://public.csr.nih.gov/.

4. How will awards be selected for funding?

Applications will compete for available funds with all other applications submitted in response to this funding opportunity. 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 the program priorities

5. How many total awards will be made?

Approximately 3-6 awards are anticipated, contingent upon availability of funds and receipt of a sufficient number of meritorious applications.

1. How many days should we budget for the PI to attend the Spring CFDE annual meeting?

A reasonable estimate would be to plan for up to three days for the PI to attend the Spring CFDE annual meeting.

2. What budget and project period should I request?

Application budgets should reflect the actual needs of the proposed project and are limited to $350,000 per year in direct costs. The scope of the proposed project should determine the project period. The maximum project period is three years.

1. Are there annual meetings I am required to attend?

The PI will be expected to attend one (1) in-person meetings annually, the annual Spring CFDE Program Meeting. The in-person meetings will be held within the contiguous US, ideally within the Washington DC metro area.

2. Do I need to submit an annual progress report?

Yes, a progress report is due annually.

Beginning in 2023, CFDE will include a new component in most Notice of Funding Opportunities (NOFO) requiring that applications include a Plan for Enhancing Diverse Perspectives (PEDP) in the proposed research. Evaluation of the applicant’s PEDP will be made during the review stages as part of the scorable criteria and during programmatic reviews, and will be used to inform funding decisions.

For more information on the PEDP, please see the Key Elements and Examples below. You can also email CFDE@od.nih.gov or the Program Official listed in the NOFO.

Additional, related resources for information about diversity and inclusion efforts around the NIH include:

• Ending Structural Racism: The NIH UNITE Initiative
• NIH Office of Scientific Workforce Diversity
• IDeA States
• Diversity in NIH Extramural Programs

1. What is a PEDP?

PEDP or “Plan for Enhancing Diverse Perspectives” strategies and relevant milestones should be integrated into the Research Plan section of the application. PEDP strategies aim to advance the scientific and technical merit of the proposed project through inclusivity. The PEDP strategies should also be summarized and submitted as a 1-page “Other Attachment” to be included in applications submitted in response to specified Research or Funding Opportunity Announcements. Please see the PEDP Overview and the Key Elements and Examples.

2. What does “diverse perspectives” mean for a research project?

Broadly, diverse perspectives refer to the people WHO* do the research and the places WHERE** research is done, as well as WHO PARTICIPATES *** in the research as part of the study population.

*WHO: The inclusion and empowerment of investigators and trainees from a variety of backgrounds, including those historically underrepresented in the biomedical research workforce (see NOT-OD-20-031), and investigators from different scientific disciplines, at varying career stages, and with varied skills, experience, and expertise.

**WHERE: Participation of researchers from all relevant sectors, including diverse organizations and institutions (e.g., research intensive and research active, undergraduate, minority-serving, community-based etc.).

***WHO PARTICIPATES: To realize the broadest benefits to human health impacting all segments of the population, CFDE is committed to promoting equity in research participation. To that end, maximum effort is encouraged to engage and recruit diverse participants for human studies.

3. Why is the PEDP included in CFDE funding opportunities?

It is widely accepted that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Accordingly, the NIH’s commitment to diversity is well documented (NOT-OD-20-031). The inclusion of a PEDP represents explicit alignment of research activities, peer review, and research funding considerations with the CFDE’s commitment to advance the scientific and technical merit of CFDE-related activities through expanded inclusivity.

4. What should be included in a PEDP?

Within the 1-page PEDP summary, applicant(s) are expected to show how enhancing diverse perspectives is supported throughout the application and how this strengthens the scientific and technical merit of the project (in terms of significance, investigator(s), innovation, approach, and environment), as appropriate. The PEDP will depend on the content and structure of the scientific aims, the expertise required, the environment, and the performance site(s). The PEDP strategies should include a timeline and milestones for relevant components that will be evaluated as part of the review. Within the research strategy, applicant(s) are expected to align their description with the strategies summarized in the PEDP. Please see the PEDP Key Elements and Examples below.

5. What guidance on the PEDP is available for applicants?

For guidance and other materials please see the FAQs and the Key Elements and Examples, below. Questions not covered in these FAQs can be directed to CFDE@od.nih.gov.

1. Where in the applications should the PEDP information be addressed?

The PEDP information should be included in the "Plan for Enhancing Diverse Perspectives" under “Other attachments” (1-page limit) and where appropriate, within the research strategy section. The 1-page PEDP attachment should:

• include a summary of strategies of expanded inclusivity to advance the scientific and technical merit of the proposed project.
• outline how enhancing diverse perspectives is viewed and supported throughout the application.
• incorporate strategies relevant to each of the review criteria (significance, investigator(s), innovation, approach, and environment), as appropriate.
• include a timeline and milestones for relevant components that will be considered as part of the review.

Within the Research Strategy, applicant(s) should align their description with the PEDP strategies and milestones and are encouraged to refer to information included in the PEDP attachment. The content of the PEDP will depend on the content and structure of the scientific aims, the required expertise, the environment, and the performance site(s). Please see the PEDP Key Elements and Examples below.

2. Are there examples of the types of strategies that might be part of a PEDP?

CFDE anticipates that every PEDP will be unique and will depend on the content and structure of the scientific aims, the required expertise, the environment, and the performance site(s). Examples of strategies that advance inclusivity in research and may be part of a PEDP can include but are not limited to the list provided in PEDP Key Elements and Examples, below.

3. Is there a PEDP template or example available?

No. A PEDP template or example is not available because the PEDP will depend on the content and structure of the scientific aims, required expertise, the environment, and performance site(s). Please see the PEDP Key Elements and Examples below.

4. Does a grant application need to include every strategy listed in the PEDP Key Elements and Examples?

No. The details of the PEDP will depend on the content and structure of the scientific aims, the required expertise, the environment, and the performance site(s). Applicants are asked to explain how the proposed research project will benefit from the diverse perspectives described in the application. They are expected to provide a rationale for the inclusion of different PEDP strategies and how these strategies strengthen the research project.

5. Are there specific type(s) of diversity that are preferred?

No. CFDE encourages innovative approaches that support scientific excellence by fostering inclusivity and promoting culture change. CFDE has always placed strong emphasis on the inclusion of investigators representing diverse disciplines of science. The PEDP seeks to broaden this approach beyond scientific disciplines to include career stage, investigator background, partnerships, collaborations, etc. that advance the goals of the project. Please see the PEDP Key Elements and Examples below.

6. What makes a strong PEDP?

Reviewers will evaluate the PEDP based on the review criteria specified in the NOFO. Briefly, the PEDP should reflect careful consideration of how to maximize diverse perspectives within the research project and outline the benefits. It should also provide rationale for the selected types of PEDP strategies and include a timeline and milestones for relevant PEDP components.

7. Are foreign collaborations considered to enhance diverse perspectives?

While an emphasis on U.S.-based geographic diversity is encouraged, foreign collaborations may be considered to enhance geographic and regional diversity, if justified. Consistent with NIH policy, foreign components will be subject to additional review requirements (Please see NIH Grants Policy Statement Section 16).

8. If costs increase as a result of the PEDP, can funds be requested to support the PEDP?

Applicants may include a request for allowable costs associated with PEDP implementation (please see NIH Grants Policy Statement Section 7).

1. How will reviewers be instructed to evaluate the PEDP?

PEDP considerations will be included in each of the scored review criteria (Significance, Innovation, Investigators, Approach, and Environment). Reviewers are asked to consider the strengths and weaknesses associated with each of the review criteria and weigh them appropriately. Thus, the PEDP evaluation will contribute to the criterion scores and overall impact score of each application. It is expected that a PEDP judged by reviewers as insufficient, would result in poorer criterion score(s) and overall impact score.

2. What will happen to an application with its PEDP judged by reviewers as insufficient?

A PEDP judged by reviewers as insufficient may result in poorer criterion scores and overall impact score. The reviewers are instructed to evaluate all components of the application as reflected in application review or objective review section of the FOA or ROA. As such, peer reviewers will evaluate the PEDP as part of each of the scored review criteria, and in the overall impact score.

3. Is training on the PEDP available for reviewers?

Reviewers will be directed to the guidance materials available to applicants.

1. Is a PEDP required?

Yes, a PEDP is required.

2. Will the PEDP be considered in programmatic funding decisions?

Yes. As a whole, the following will be considered in making programmatic 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. What post-award oversight of the PEDP will be expected?

As part of their required progress report, investigators will be asked for updates on the implementation of the PEDP in their annual NIH Research Performance Progress Report (RPPR) or Other Transaction reports. Investigators should describe progress in the PEDP based on the goals, timelines, and milestones outlined in the application and/or in response to the reviewers’ comments as well as on any additional elements recommended by the study section and/or program staff. If sufficient information is not provided in the progress report, program officials may request the additional information needed to assess satisfactory progress.

4. What administrative actions can be taken if a research project does not meet its PEDP objectives?

In cases where an investigator encounters challenges in meeting their PEDP objectives, Program Officers (POs) can request an interim progress report with clear explanation of the difficulties, as well as the actions taken to overcome them. In response, POs may suggest alternative approaches, request an interim progress report, or issue a no-cost extension, to delay the noncompeting renewal until the difficulties are resolved. Broadly speaking, failure to meet expectations agreed upon by the Recipient and the NIH/IC may result in Enforcement Actions as described in NIH Grants Policy Statement Section 8.5.2.

General Information about RFA-RM-23-002

1. What are the main goals of the Integration and Coordination Center (ICC)?

The ICC will focus on ensuring internal cohesion within the Common Fund Data Ecosystem (CFDE) and implementing a structured evaluation process to ensure continuous improvement cycle for the program. It will have three main 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.

2. What are key dates in the timeline for planning our application?

Posted Date	March 27, 2023
Open Date (Earliest Submission)	May 28, 2023
Letter of Intent Due	May 30, 2023
Application Due Date	June 28, 2023
Scientific Merit Review	November 2023
Advisory Council Review	January 2024
Earliest Start Date	April 2024

3. What is the composition of the Common Fund Data Ecosystem (CFDE)?

CFDE is composed of five Centers, including the Integration and Coordination Center, and approximately ten participating Common Fund (CF) programs represented by their Data Coordination Centers (DCCs). Collectively, the five Centers and engaged DCCs are responsible for building the infrastructure needed to facilitate broad reuse of Common Fund data, providing training to a diverse end user community, and ensuring the internal integration and cohesion of the program. The five centers are:

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 Data Coordinating Centers (DCC) are a critical part 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.

4. How does the role of the Integration and Coordination Center (ICC) relate to the other Centers in CFDE?

The ICC is responsible for driving integration and cohesion among the other Centers, participating Common Fund (CF) programs, CFDE partnerships and other CFDE initiatives. They must effectively and productively collaborate with the investigators of the CFDE Centers, participating CF programs, and CFDE initiatives. This level of collaboration is essential for both the success of the ICC and CFDE.

The ICC will be responsible for developing and maintaining a comprehensive project management plan to track activities, timelines, and milestones across CFDE-participating DCCs, Centers, and initiatives. They will also work with the other Centers to facilitate the logistics of training and outreach events as well as provide administrative support for community outreach events involving the other CFDE centers and programs, such as jamborees and hack-a-thons.

The ICC will also need to work with participating CFDE DCCs, Centers and initiatives to collect metrics as part of the annual evaluation process and integrate findings from the annual evaluation process into subsequent year workplans. The ICC will also be responsible for working with CF programs to ensure there is a long-term sustainability plan in place and assist with the transfer of data and resources to long-term repositories as needed.

5. Will the ICC be responsible for collecting evaluation data?

The ICC will work closely with participating DCCs, Centers, and Initiatives to gather the performance data needed for the annual evaluation process. The ICC will establish the metrics that are used to monitor progress against CFDE programmatic goals. The participating DCCs, Centers, and Initiatives will be responsible for gathering the data needed for the evaluation process. The ICC should offer advice and guidance to participating groups about the evaluation data that needs to be gathered, the frequency and potential methods.

6. What are milestones?

Milestones are objective measures of progress toward research goals and should represent the completion of specific tasks that are projected to have a significant impact on the completion of the project. Milestones must provide objective and quantitative outcomes by which to justify advancing the project, and must be measurable, have appropriate endpoints, and have specific due dates. An example of a poorly defined milestone is "establish a monthly liaise with CF programs not formally engaged with CFDE" whereas a well-defined milestone would be "by the end of the second quarter, meet with at least two CF programs not formally engaged with CFDE to provide them with information on the program, relevant standards and opportunities to engage with CFDE". Another example of a well-defined milestone is “The Integration and Coordinating Center will create summaries of the program, relevant standards, and opportunities to engage with CFDE for new CF programs by end of the first quarter.”

7. Where might I find a sample milestone document?

A sample milestone document can be found here.

8. How many letters of support can I include in my application?

Letters of support are not restricted to a number. Include letters of support from partnering institutions or outside collaborators/subcontractors with clear statements of roles/responsibilities. Submitted letters should directly demonstrate the ability of the proposed Integration and Coordination Center to fulfill the roles and responsibilities specified in this funding opportunity announcement.

9. Do I need to include a Data Management and Sharing Plan in my application?

In accordance with NIH Policy for Data Management and Sharing all applications, regardless of the amount of direct costs requested for any one year, must include a Data Management and Sharing Plan. The plan should include components related to public access; data security; and Findable, Accessible, Interoperable, Reusable (FAIRness). The Data Management and Sharing Plan will be evaluated as part of the Approach criterion. For elements to include in the Data Management and Sharing Plan, please see Writing a Data Management & Sharing Plan | Data Sharing (nih.gov) and NOT-OD-21-014: Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan.

10. Can a/the principal investigator(s) on the Integration and Coordination Center (ICC) also serve as a/the principal investigator for one of the other CFDE Centers?

No. 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.

11. Can a principal investigator from a Common Fund (CF) Data Coordinating Center (DCC) serve as a/the principal investigator for the Integration and Coordination Center (ICC)?

Yes, principal investigators from CF DCCs are eligible to serve as a/the principal investigator for the ICC.

12. If an applicant wants to form an advisory board, are letters of support required from external advisory board members?

No, letters of support are not required from members of an external advisory board.

 

General Information about the U54 Mechanism

1. What is a cooperative agreement?

A cooperative agreement is a support mechanism used when there will be substantial Federal scientific or programmatic involvement. It requires a level of involvement from NIH staff that is higher than for a typical research project (R) grant. After the award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. In many cases these are milestone-driven and to receive subsequent years of funding, milestones in the notice of award must be met which demonstrates the resource continues to have clear value to the CFDE program.

2. What are the main features of this U54 mechanism?

This U54 is a milestone-driven cooperative agreement. Investigators are required to propose quantitative milestones for each year of requested support in their applications. When an application is suggested for funding, the NIH staff and investigators negotiate milestones prior to award. Milestones will then be included in the notice of award and will be used to assess the success of the project. Investigators are required to meet all milestones and provide a milestone completion report in their annual progress report submitted to the NIH.

 

Eligibility

1. What organizations are eligible?

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

2. Are foreign institutions eligible?

• 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 are allowed.

3. Is there a limit to the number of applications that can be submitted by an institution? 

No, there is no limit to the number of applications an institution can submit.

4. With respect to OTA-23-004 and RFA-RM-23-002, can the same individual be listed as MPIs for both proposals?
If the same individual applies as an MPI for both opportunities, can they only receive one award, either the KC/DRC or the ICC but not both?

An individual can apply for both opportunities (OTA-23-004 and RFA-RM-23-002) as the contact PI or an MPI. However, they cannot serve as the PI or MPI on both awards. We anticipate that OTA-23-004 will be awarded first. The PI(s), including MPIs, under OTA-23-004 will be ineligible to receive an award under RFA-RM-23-002.

 

Application and Submission

1. When may I submit an application?

The application due date is June 28, 2023. All applications are due by 5:00 PM local time of the applicant organization. The earliest submission date is May 28, 2023.

2. Who may I contact if I have questions about my application?

If you have questions prior to submission or after summary statement release, please contact CFDE@od.nih.gov. 
For questions about the review process after submission and before summary statement release, please contact the Center for Scientific Review at FOAReviewContact@csr.nih.gov.

3. How do I submit my application?

For instructions on how to submit an NIH grant application, please visit the NIH Office of Extramural Research How to apply-Application Guide” at How to Submit, Track and View Your Application | grants.nih.gov.

4. Is a letter of intent required for submission?

The letter of intent (LOI) is optional. The LOI is due on May 30, 2023, and should be submitted to CFDE@od.nih.gov. A letter of intent (LOI) is not required, is not binding, and does not enter into the review of a subsequent application. The information that it contains allows NIH staff to estimate the potential review workload and plan the review.

5. Do I use FORMS-G or FORMS-H to submit my application?

FORMS-H is required for grant application due dates on or after January 25, 2023. See NOT-OD-22-195: New NIH "FORMS-H" Grant Application Forms and Instructions for additional detail.

 

Review & Selection

1. Are the standard project review criteria for “Significance,” “Investigator(s),” “Innovation,” “Approach,” and “Environment” applicable? Are there superseding RFA-specific criteria?

Please refer to the details that are provided in Section V of the funding opportunity. The standard review criteria still apply, including specific review criteria listed in the section.

2. How will applications be reviewed?

Applications will be reviewed by NIH staff for completeness and responsiveness. All applications determined to be complete and responsive will be reviewed by scientific experts convened by the Center for Scientific Review (CSR) in accordance with NIH peer review procedures and using review criteria outlined in the funding opportunity announcement. All applications received in response to the funding opportunity announcement will be reviewed in a special emphasis panel. Applications may undergo a 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.

3. When will my application be reviewed and by whom?

The Scientific Merit Review for this funding opportunity will convene in Fall 2023. Following initial peer review, applications will receive a second level of review by the National Institute of Dental and Craniofacial Research (NIDCR) Advisory Council. The Advisory Council Review will convene in January 2024. Questions about the review should be directed to the Center for Scientific Review at https://public.csr.nih.gov/.

4. How will awards be selected for funding?

Applications will compete for available funds with all other applications submitted in response to this funding opportunity. 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 the program priorities

5. How many total awards will be made?

This funding opportunity seeks to fund a single Integration and Coordination Center as an integral part of the CFDE program, subject to NIH appropriations and the submission of a sufficient number of meritorious applications.

 

Budget

1. Who should attend the bi-annual CFDE program meetings and how many days should we budget for this annual meeting?

Applicants should budget for the Principal Investigator(s), project manager, and any key staff needed for the planning and execution of the meeting. For budgeting purposes, planning for at least four attendees for up to three days would be a reasonable estimate.

2. What budget and project period should I request?

The budget should reflect the needs of the Center to perform the duties as outlined in the funding opportunity, up to $1,500,000 in FY 2024 and up to $2,000,000 per year for years FY2025 through FY2028.

 

Award Administration

1. Are there annual meetings I am required to attend?

The awardee will be expected to attend two (2) in-person meetings annually, one in the Fall for the CFDE Planning Workshop and an annual CFDE Program Meeting in the Spring. The in-person meetings will be held within the contiguous US, ideally within the Washington DC metro area.

2. Do I need to submit an annual progress report?

Yes, a progress report is due annually.

General Information about OTA-23-004

1. What are Other Transaction awards?

Other Transactions (OTs) are funding mechanisms, which are not grants, cooperative agreements, or contracts, authorized under the Other Transaction Authority (OTA) as authorized by the 21st Century Cures Act

OTs are used by components within the NIH, including the Common Fund, which have been authorized by Congress to use them. They allow the NIH to:

• Seek participation by non-traditional research partners
• Foster innovation and nimbleness to quickly develop and engage in programmatic activities
• Alter the course of the project in real-time to meet the overarching goal
• Conduct objective review
• Expand, modify, partner, not support, or discontinue awarded activities based on performance and programmatic need.

2. What are the key dates in the timeline for planning our application?

Research Opportunity Announcement Released	March 28, 2023
Applicants Register in eRA Commons*	April 18, 2023
Letter of Intent Due (optional but strongly recommended)	April 28, 2023
Application Submission Date	May 30, 2023

*Note that all applicants must be registered in eRA Commons, which make take up to six (6) weeks or more to complete. Applicants should therefore begin the registration process as soon as possible.

3. What makes a good application for a Common Fund Program?

Common Fund Programs are designed to support actively managed, milestone-driven projects that are different from mainstream studies. These projects are expected to work together to address key roadblocks in emerging fields that will transform the way biomedical research is conducted. Applicants must explicitly address how the proposed research will have an impact that cuts across the interests of individual NIH Institutes and Centers and the reviewers will evaluate whether the project proposes an incremental improvement or a significant advancement that will transform the field. Applicants must also provide compelling justification for Common Fund support rather than from an individual NIH Institute or Center.

4. Do applicants have to submit applications for both opportunities, the Data Resource Center and the Knowledge Center?

No, applicants can submit an application for a single center, the Data Resource Center or Knowledge Center, or both centers. The page limits vary depending on whether the application is for a single center or both centers. For more information, please review the ROA and the Full Application and Submission FAQs.

5. Which Common Fund Programs participate in CFDE?

A list of the Common Fund programs participating in CFDE can be found on the website at https://commonfund.nih.gov/dataecosystem. They include 4D Nucleome, Bridge 2AI, exRNA, Glycosciences, GTEx, HuBMAP, Human Microbiome Project, Kids First, LINCS, IDG, Metabolomics Workbench, MoTrPAC, SenNet, and SPARC. However, the number of participating Common Fund programs is expected to grow. A list of established Common Fund data sets that are well-poised for increased community use can be found in NOT-RM-23-006.

6. What is the rough size in terabytes or petabytes of participating Common Fund DCC datasets?

The existing CFDE portal provides information about the number and types of datasets that CFDE currently includes. The number of datasets and diversity of data types included in CFDE will continue to grow. Please note that, as stated in Section 1 of the ROA “Data Resource Portal will not be required to store data from Common Fund programs.” The Data Resource and Knowledge Centers will only deal with a fraction of the overall data, as they will incorporate metadata and unique identifiers or assertions, not the raw files themselves.

7. How often in general are Common Fund Program datasets updated?

The frequency with which Common Fund Program datasets are updated depends on many factors, including the age of the program with those programs that are at the beginning or end of their 10 year lifecycle having fewer updates. Currently participating Common Fund programs submit updated metadata to the CFDE portal once per quarter, as applicable. However, as the ROA states, "[i]deally, the DRC will employ a federated pull approach to extract the information from the DCCs that is as automated as possible without significant human involvement instead of a push model…” so the frequency of updates to the portal is not pre-determined and both push and pull models will be considered.

8. Are most of these DCC data on premise, or already in the cloud?

Most of the participating Common Fund Programs use a hybrid approach, with data stored both on-premise and in the cloud. Cloud usage includes on-premise resources or commercial providers.

9. Can the Government confirm if the contractor can provide alternative graph databases?

Yes, the applicant can provide alternative graph databases/schemas/methods for the Knowledge Center.

10. Can the Government confirm if the level of effort required for the PI and PM/PD (pgs. 15-16) is for each center? If an applicant proposes to do both centers, can the Government confirm if the level of effort be combined to meet the requirement?

The required level of effort for the PI and PM/PD is for each center. If an applicant proposes to address both centers, the level cannot be combined to meet the requirement.

11. Will the awardee need to obtain an Authority to Operate (ATO) at the Moderate level? Will NIH be providing support to ensure that the awardee will receive an ATO in time?

Presently, applicants should not anticipate collecting, storing, processing, transmitting, or using information on behalf of HHS in the context of this award. The Government does not anticipate issuing an ATO for information systems generated under this award. The Recipient will be responsible for information security of information systems used and developed for this award. Recipient-hosted information systems should maintain security controls in a way that is FISMA-equivalent.

12. Can the Government clarify what is meant by "FISMA-Equivalent" in the context of pg. 7, Requirements-CFDE Data Resource Center?

The Government expects the Recipient to implement Information Security for information systems used and developed for this award. While the Government will not assume a regulatory or compliance-enforcement role, the Government expects that the Recipient’s Information Security resembles Information Security under FISMA. For example, a FISMA Moderate system requires an external audit of the information system. Analogously, an information system developed under this award with moderate risk in confidentiality, integrity, or availability should have an external auditor review security controls.

13. Can the Government clarify if there is a preferred location for Common Fund DCC data files, retrieved via the GA4GH DRS API, to be placed by the Data Resource Center/Knowledge Center prior to cloud workspaces becoming available?

The CFDE DRC will not house the datasets of the Common Fund programs. Datasets will continue to be handled by the DCCs. DCCs will provide the information about the file locations to DRC via DRS-like microservices. This will be part of the information that the DCCs will provide to the DRC about their data sets (i.e., included as part of the metadata for the data sets).

14. Does this work have an I-ATO or a D-ATO?

The government does not currently plan to issue an ATO for this project.

15. Will the addition of this functionality change the FISMA watermark?

The added functionality should not change the FISMA watermark.

16. Will the program confirm if there is a Data Rights Assertion table that should be used?

We do not plan to include a Data Rights Assertion table because the OT is clear about the rights granted to the US Government. The OT states, 

“The Recipient grants to the Government a nonexclusive, irrevocable, sublicensable, worldwide, royalty-free, license to use, disclose, reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, the Data in any manner for any non-commercial purpose.” And “Data” is defined as: “Recorded information, regardless of form or method of recording, which includes but is not limited to, technical data, software, mask works, trade secrets, text, sound, images, metadata, video files, drawings, designs, forms, diagrams, data files, statistical records, and other research data.”

17. Where will the in-person CFDE meetings take place? Where are working group and other consortium activities usually held?

To date, all in-person meetings have taken place in the greater Washington DC metropolitan area and it is very likely this will continue. We advise budgets should be based on travel into the Washington DC metropolitan area.

Consortium and working group activities typically take place virtually or in conjunction with in-person meetings in the Washington DC metropolitan area.

 

Eligibility

1. What organizations are eligible?

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)
• Faith-based or Community-based Organizations
• Regional Organizations

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

Other

• Independent School Districts
• Native American Tribal Organizations (other than Federally recognized tribal governments)

2. Are foreign institutions eligible?

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

Non-domestic components of domestic organizations are not eligible.

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

3. Are there any other eligibility restrictions?

Since the CFDE Data Resource Center (DRC) and Knowledge Center (KC) teams will be directly interacting with the Integration and Coordination Center (ICC) for CFDE, a PI/MPI will not be eligible to serve as the PI/MPI for both i) the DRC and/or KC and ii) the ICC awards. If an application to this ROA is selected for award, the PI/MPIs for that application will be ineligible to serve as PI/MPI of the ICC award (RFA-RM-23-002). PIs/MPIs who have questions concerning their eligibility must contact the CFDE NIH team to clarify their eligibility before applying at CFDE@od.nih.gov.

4. With respect to OTA-23-004 and RFA-RM-23-002, can the same individual be listed as MPIs for both proposals? If the same individual applies as an MPI for both opportunities, can they only receive one award, either the KC/DRC or the ICC but not both?

An individual can apply for both opportunities (OTA-23-004 and RFA-RM-23-002) as the contact PI or an MPI. However, they cannot serve as the PI or MPI on both awards. We anticipate that OTA-23-004 will be awarded first. The PI(s), including MPIs, under OTA-23-004 will be ineligible to receive an award under RFA-RM-23-002.

5. We did not submit a letter of intent. Can we will apply for this opportunity?

A letter of intent is not required. NIH will consider all applications received by the application due date.

 

Budget

1. What is the budget for this opportunity?

The Common Fund may allocate up to $3,000,000 for the first-year total (direct + F&A) costs for these two centers. The level of funding for awards made under this solicitation and how funds may be split between the Data Resource Center (DRC) and Knowledge Center (KC) has not been predetermined. The funding split will depend on (1) the objectives for the centers proposed by the applicants and how well they fit with the goals of CFDE, (2) the quality of the applications received, (3) availability of funds and (4) programmatic priorities. First-year funding for either the DRC or the KC individually is not expected to exceed $1,750,000 total costs, with no more than $3,000,000 total for both awards.

2. Can you provide guidance on indirect costs? Are there any restrictions?

Indirect/F&A (Facilities and Administrative) costs that are suitable under the regular NIH policies are allowed to be included in the total budget and in the total award amount as specified in the Research Opportunity Announcement (ROA) OTA-23-004.

Institutions with an established Facilities and Administrative (F&A) rate should use up to their Federally approved indirect rate to calculate indirect costs for non-compute expenses.

Indirect costs for compute expenses in any application funded under this OT mechanism will be capped at a rate of ten (10) percent.

F&A costs on foreign components will be reimbursed at a rate of eight (8) percent of modified total direct costs, exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000.

3. What guidance can you provide about funding in years 2-5 for the Data Resource and Knowledge Centers?

Although budgets in subsequent years are not guaranteed and will be negotiated based on program needs, progress, and availability of funds, the CFDE Program intends to commit a combined total of $3,500,000 for the Data Resource and Knowledge Center in years 2-5, pending appropriations and availability of funds. The application budget should reflect the proposed activities and personnel of the applied center.

4. Can the Government confirm if the applicant is required to fill out the Research & Related Budget PDF form individually for DRC and KC?

Yes, the applicant is required to fill out the Research & Related Budget PDF form individually for the DRC and KC

5. Will the Government clarify if the "cloud computing expenses" referenced in section 10.4 are specific to ODCs/materials and not the services/labor?

The cloud computing expenses that are to be capped at a rate of ten (10) percent are specific to the ODCs/materials, not services/labor.

6. Is a sealed bid submission required?

For the purposes of submission for this ROA, a cost breakdown and budget justification of proposed subawardee cost is required.

7. Should subrecipients submit separate a budget form via the ASSIST portal?

The prime applicant is responsible for submitting the subrecipient’s budget form and budget justification. NIH’s relationship is with the prime applicant. Therefore, all required information from the subrecipient is to be provided to NIH through the prime applicant via the ASSIST portal.

 

Budget Form

1. I am having an issue accessing the budget forms. Can you please advise?

Please visit the Common Fund Other Transactions Forms page and click on the links to the budget forms to automatically download the PDFs. Select the 5-year forms. After you have downloaded it to your computer, you should be able to open it. If the file is still opening in your browser automatically and not displaying correctly, right click on the file in your “Downloads” folder and click “Open with Adobe Reader.”

2. The budget form has a place for the attachment of a justification. Should I attach the budget justification there?

No – when the budget form is flattened, it will be lost. Include it as a separate attachment to the application form with the name “Budget Justification.”

3. For the budget, in the "total funds requested" should this be for 5 years?

In ASSIST, the “Total Funds Requested” section, enter the total federal funds estimated to fund the project, including Direct Costs and Indirect (F&A) Costs requested for the project period of 5 years. The project period for this opportunity is 5 years.

4. Is the budget summary table required? What budget categories should the budget summary table include?

One, 5-year budget is required. Including a budget justification is required. A budget summary is strongly recommended. The 5-year budget should provide the overall expected cost for each of the following categories: personnel, equipment, travel, funds for third parties (i.e., subrecipients), if applicable, other direct costs, and total cost (with indirect costs included). Provide a budget justification for all budget items for all 5 years of the project. Subrecipients are required to provide details of cost breakdown. Prime recipient should follow their internal policies and procedures to calculate subrecipient’s budget. In addition, provide a budget summary. Annual budgets are expected to align with the total costs described in OTA-23-004.

If applying to both centers, the budgets for the Data Resource and Knowledge Centers should be clearly delineated and budget for each center should be provided, described, and justified separately.

5. In the R&R Budget Form, there is a box titled “Subaward/Consortium”, do our subaward partners have to complete this form and check that box?

Yes. Subrecipients should check the box title, “Subaward/Consortium” and complete the budget form for all 5 years of the project and provide a budget justification for all budget items for all 5 years of the project. Subrecipients need to provide details of cost breakdown for the categories described above. Further details can be found in Section 10.4 of the ROA.

6. For the budget, I’ve seen something about “flattening” a PDF for uploading to eRA Commons. What does that mean and how do I do it?

A PDF that has fillable fields, electronic signatures, text boxes or images inserted, becomes layered with each of these elements representing a layer. Flattening a PDF merges these separate elements into one flat layer. There are a number of methods to flatten a PDF, the easiest of which is to print it as a PDF. 

To do this, go to File>Print, select the printer option from the menu that has says PDF, such as "Adobe PDF.”.” Depending on the software available to you, the specific option may vary but should contain "PDF." Click the Print button and name the file. This will "print to a PDF" and the file will be flattened. 

Please note that when the budget form is flattened, its attachments will be lost. Therefore, the budget justification should not be included as an attachment to the budget form and instead submitted as a separate Budget Justification document as attachment to the application form.

 

Application and Submission

1. What are the important dates for the full application?

Applications must be submitted via Application Submission System & Interface for Submission Tracking (ASSIST) by May 30, 2023 at 5:00 pm (based on the local time of the applicant organization).

2. What must be done before I submit an application to the eRA Commons ASSIST system?

To submit an application via ASSIST, the applicant organization must be registered in eRA Commons (See Submission Instructions). You must be registered in eRA Commons, which may take up to six (6) weeks or more to complete, applicants should therefore begin the registration process as soon as possible. See “Resources only for Other Transactions Authority (OTA) Users of ASSIST for the Instruction Guide for OTA Submissions via ASSIST (version 11/03/2022) at this website: https://www.era.nih.gov/help-tutorials/assist/era-training-assist.htm.

3. Will late applications be accepted?

No, as stated in the Research Opportunity Announcement, late applications will not be accepted.

4. What are Other Transactions (OT) and where can I find more information about the funding mechanism for this initiative?

The Other Transaction (OT) is a unique type of legal instrument other than a contract, grant, or cooperative agreement that NIH uses to fund awards. For more information, click here.

5. How should full application documents be formatted? What is the page limit for the Application Project Plan?

Full applications must be in text-recognizable PDF (Adobe) format, use an 11-point font with 1” margins, be single-spaced. Use of graphics and images is allowed. For tables and images, the font size can be less than 11-point and should be legible by reviewers. Proposals deemed to be using images to bypass the font and margin requirements may be administratively withdrawn. We generally recommend one of the following fonts: Arial, Georgia, Helvetica, Palatino Linotype, or Times New Roman. The use of hyperlinks is strictly prohibited. The full application consists of the items listed in the Full Application section of the Research Opportunity Announcement.

The Application Project Plan should be no more than 8 pages if applying to establish one of the Centers or 12 pages if applying to establish both Centers, including any charts and figures. The page limits of the remaining items are stated in the Research Opportunity Announcement. The sections of the application should be loaded as separate attachments and titled as specified in the Research Opportunity Announcement.

6. How does the administration of the OT2 mechanism differ from the R01 mechanism?

A R01 application is a research grant application. The administrative and funding instrument used for this program will be the Other Transactions, OT2 mechanism, in which active oversight and management by the NIH are expected during the performance of the activities. The format used for an NIH grant application is acceptable, but not a required format, as Other Transactions are not grants. For more information, click here.

7. Does the Project Summary Page need to be included in the Letter of Intent (LOI)?

The LOI should include the items noted in the Project Summary Page, including a proposed budget and percent effort of key personnel. The content provided in the LOI should be as accurate as possible but it is not binding and can be adjusted in the full proposal.

8. Can the Government please provide instructions on how to access the 5 attachments mentioned on page 38 of the solicitation regarding OTA-23-004R?

Those attachments are not yet available and not needed for a responsive submission. The first four attachments will be added to the Terms and Conditions from the awardee’s proposal. The fifth attachment, Reporting Requirements, is still being finalized.

9. Given the restrictions on page count, may the offeror submit the MPI Leadership Plan as a separate document from the Leadership Plan, or alternatively, can the page limitation be adjusted if inclusion of an MPI Leadership Plan is required?

No, it cannot be submitted as a separate document, and the page limit cannot be adjusted if a MPI leadership plan is required.

10. For bidders applying to establish both Centers, can the page limit of the Milestone and Deliverables be expanded to 15 pages, similar to how the project plan page limit is 12 for bidders applying to establish both centers, and 8 if applying to establish one center?

The page limit for the Milestone and Deliverables is 10 pages, regardless of whether the applicant is applying for one or both centers.

11. Do collaborating institutions submit coordinated applications or does the lead institution submit a single application on behalf of the project?

The institution for the contact PI should submit a single proposal for the project. The collaborating institutions do not need to submit a copy of the application separately.

12. Can we include current CFDE project PIs as consultants in our application?

Yes, current CFDE project PIs may be included as consultants.

13. Can applicants include letters of support from CFDE project/DCC PIs in their application?

The only letter of support permitted is an institutional letter of support from the applicant’s organization indicating institutional commitment for the project and preparations to enter into a negotiated Other Transaction agreement. A description of the institutional letter of support can be found on page 19 of the ROA. As stated on page 20 of the ROA, additional letters of support will not be considered during the review process. Therefore, please do not include letters of support beyond the required institutional letter of support.

14. Are there additional resources on the Resource Sharing Plan or a standardized format for the submission of this section?

The SF424 (R&R) Application Guide provides the application submission guide that includes information about how to prepare Resource Sharing Plan:

1. Select the link
2. Scroll down to “Application Form Instructions”
3. Select the appropriate “Application Instructions,” in this case “G”.
4. Search for “Resource Sharing Plan.” It should take you to section 10.

Use the information as applicable. Additional information on a data sharing resource plan can be found at https://sharing.nih.gov/data-management-and-sharing-policy.

15. With reference to OTA-23-004, and the language requested of offerors on Page 17 that states: ‘Agreement that any and all parts of the application maybe shared among other applicants’: if an applicant has concerns about sharing part or all of their application with other applicants due to concerns about proprietary information, is there anything they can do?

Please add a statement to the project information summary indicating that the offeror reserves the right to sharing of information with other applicants and sharing of information will require written notice and agreement upon from Offeror.

16. Is a Resource Sharing Plan required?

See https://grants.nih.gov/grants/how-to-apply-application-guide/forms-h/re…, Section 10, page R-89 and https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-189.html, first bullet under Implementation Update for the instruction to discontinue using a Resource Sharing Plan except for Research Tools and Sharing Model Organisms.

As described in the ROA, DRC/KC will be coordinating the development and availability of the data/knowledge analysis tools that may be developed by the CFDE consortium and make those available through respective portals as needed. Additionally, if the KC proposes to house the various databases generated by DCCs in the constructed knowledge ecosystem, the KC will need to provide the sharing plans for those resources. These details can be provided in the Resource Sharing Plan.

17. Is the Facilities & Resources document per subaward site? Or just the main site?

The Facilities and Resources document should describe the facilities and resources that will be available for the project as a whole across the entire project team, including sub-awardees facilities and resources.

18. Are we required to have an institutional commitment letter for every subaward site?

Applicants are not required to have letters of support from every subaward site.

19. Would the government consider an extension of the due date?

We are not extending the due date stated in the Research Opportunity Announcement: May 30, 2023.

20. Are there extensions for Principal Investigators serving on review panels?

There are no extensions for individuals serving on review panels.

21. Can you clarify if the biosketches should be uploaded individually or combined as one PDF?

The ASSIST system allows applicants to upload less than or equal to 100 attachments that will then be converted into a single PDF upon submission.

eRA Commons and ASSIST

Frequently asked questions about using eRA Commons and ASSIST to submit applications is under development and will be posted soon.