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. Whom can I reach out to with questions about the CFDE R03 program?

All questions are welcome. Please reach out to Dr. George Papanicolaou at [email protected] or Dr Anthony Kirilusha, Ph.D. at [email protected] if you have questions about this opportunity.

2. What is unique about this CFDE R03 opportunity compared to the Parent R03 (PA20-200)?

This Notice of Funding Opportunity (NOFO) aims to promote innovative research to enhance the utility and usability of selected Common Fund (CF) data sets. The submission of small research (R03) applications is encouraged from institutions and organizations proposing projects that lead to enhanced use of selected Common Fund (https://commonfund.nih.gov/ data sets by the wider scientific community.

Please find Common Fund-specific information on this opportunity at: https://grants.nih.gov/grants/guide/rfa-files/RFA-RM-24-006.html. Information on the Common Fund Data Ecosystem (CFDE) can be found here.

Some key features include:

• To be eligible for consideration through this NOFO, the proposed research plan must substantially leverage data from at least TWO eligible Common Fund programs (see the complete list in the Objectives and Scope section). “Substantial leverage” is defined as the use and citation of the relevant dataset(s) in the envisioned research products of the proposed work (e.g., manuscripts, presentations, book chapters, portals, etc.) Data from other publicly available datasets, including Common Fund programs not listed above, can be included as needed.
• Common Fund support will be limited to 1 year and application budgets are limited to $200,000 in direct costs per year. If experimental approaches are proposed, they should be limited to 20% of the requested budget.
• Award recipients are asked to provide feedback on the utility of the Common Fund data resources.
• Applicants are expected to attend one two-day CFDE Consortium meeting in the Spring to be held in Bethesda, MD, to present their work and are also given an opportunity to present their work at a scientific meeting, as well as one additional external scientific meeting/symposium to present and discuss their findings.
• Grants funded by this NOFO require deposition of products (e.g., computational, annotation, derived, aggregated, summary, etc.) created under this NOFO into a relevant CF Data Coordinating Center, CFDE-affiliated resource, or to another public data repository, to be shared with the wider scientific community. Where applicable, the applicants must share any tools, pipelines, or workflows through open access channels (e.g., public GitHub links). Functionally, deposition would enable other researchers to replicate and incorporate findings and products into future research efforts.
• For applications that aim to co-analyze Common Fund data with other genomic data sets that are currently accessible through an NIH approved repository (e.g., dbGaP) or some other public controlled access database (e.g., European Genome-phenome Archive), applicants must describe the database through which the proposed data are accessible to the research community and the details of the data sets including any data use limitations based on the associated consent form and discuss the applicability of the data sets to diverse human populations.
• For applications that aim to co-analyze Common Fund data with genomic data sets that are not currently accessible through an NIH approved repository (e.g., dbGaP) or some other public controlled access database (e.g., European Genome-phenome Archive), applicants must describe in the Data Management Sharing Plan their ability and willingness to submit the individual-level sequence data to an NIH-approved repository (e.g., dbGaP) and provide an associated Institutional Certification using the current NIH template (https://osp.od.nih.gov/-sharing/institutional-certifications/) during the funded period of this award. If the Institutional Certification is not available, provide a Provisional Certification and describe the anticipated data use limitations and associated modifiers separately. If submitting a Provisional Certification with the application, please note that a completed Institutional Certification may be required prior to award.

3. What are key dates in the timeline for planning an application?

NOT-RM-24-006 Release Date	April 04, 2024
Application Due Date	June 27, 2024
Scientific Merit Review	November 2024
Earliest Start Date	January 2025

4. Which Common Fund programs have data sets that can be included in an application?

Since its inception as the NIH Roadmap for Biomedical Research, the NIH Office of Strategic Coordination (Common Fund - commonfund.nih.gov) has supported multiple transformative research programs that generate new technologies, methods, and data. Many of these programs produced rich public data sets containing multi-dimensional molecular and phenotypic data from humans and model organisms. The established Common Fund data sets listed below are well-poised for increased community use. If the applicant is part of a Common Fund program with early access to a particular data set, it may be advantageous to indicate this membership or a letter of support from the corresponding Common Fund program indicating they have been given early access. Applicants must propose using TWO or more Common Fund program data sets from the following list, and they can propose using other data sets (including additional NIH Common Fund data sets not listed, other NIH data sets, and non-NIH data sets that are publicly available):

• 4D Nucleome (4DN) (4dnucleome.org): Reference nucleomics and imaging data sets, including an expanding tool set for open data processing and visualization
• Acute to Chronic Pain Signatures (A2CPS) (org): Imaging, high-throughput omics, sensory testing, and psychosocial assessment data from patients who either transition to or are resilient to chronic pain.
• Bridge to Artificial Intelligence (Bridge2AI) (org): Ethically sourced, trustworthy, and well-defined flagship biomedical and behavioral datasets on salutogenesis, clinical care, functional genomics, and voice as a biomarker. This program is in its early phase and data generation is ongoing.
• Cellular Senescence Network (SenNet) (nih.gov/senescence): Atlases and datasets of senescent cells and their secretomes. This program is in its early phase and data generation is ongoing.
• Extracellular RNA Communication (exRNA) (org): Catalog of exRNA molecules found in human biofluids like plasma, saliva, and urine; and potential exRNA biomarkers for diseases.
• Gabriella Miller Kids First (KF) (org): Data from whole-genome sequencing of cohorts with structural birth defects and/or susceptibility to childhood cancer, with associated phenotypic and clinical data.
• Genotype-Tissue Expression (GTEx) (gtexportal.org/home): Whole genome and RNA sequence data from multiple human tissues to study tissue-specific gene expression and regulation, including tissue samples.
• Glycoscience (GL) (org): A data integration and dissemination project for carbohydrate and glycoconjugate related data.
• H3Africa (h3abionet.org/resources/h3africa-archive): Genomic and phenotypic research data generated by the Human Heredity and Health in Africa program, consisting of 51 projects across 30 countries. Includes population-based genomic studies of common, non-communicable disorders (e.g., heart and renal disease), as well as communicable diseases (e.g., tuberculosis).
• Human BioMolecular Atlas Program (HuBMAP) (org): An open and global platform to map healthy cells in the human body to determine how the relationships between cells can affect the health of an individual.
• Human Microbiome Project (hmpdacc.org): Characterization of the microbiomes from healthy human participants at five major body sites using 16S metagenomic shotgun sequencing; and characterization of microbiome and human host from three cohorts of microbiome-associated conditions.
• Illuminating the Druggable Genome (IDG) (net): Data on understudied druggable proteins, including mRNA and protein expression data, phenotype associations, bioactivity data, drug target interactions, disease links, and functional information.
• Integrated Human Microbiome Project (iHMP) (org/ihmp): Microbiome, epigenomic, metabolomic, and phenotypic data for three cohorts.
• Knockout Mouse Phenotyping Program (KOMP2) (mousephenotype.org): Data from broad, standardized phenotyping of a genome-wide collection of mouse knockouts.
• Library of Integrated Network-based Cellular Signatures (LINCS) (org): Molecular signatures that describe how different types of cells respond to a variety of agents that disrupt normal cellular function.
• Metabolomics Workbench (metabolomicsworkbench.org): Metabolomics data and metadata from studies on cells, tissues, and organisms.
• Molecular Transducers of Physical Activity in Humans (MoTrPAC) (motrpac-data.org/data-access): Data contain assay-specific results, associated metadata, quality control reports, and animal phenotype data related to molecular transducers that underlie the effects of physical activity.
• Somatic Mosaicism Across Human Tissues (SmaHT) (nih.gov/smaht): Data on DNA sequence variants within personal genomes in tissues from human donors. This program is in its early phase and data generation is ongoing.
• Stimulating Peripheral Activity to Relieve Conditions (SPARC) (science): Maps and tools to identify and influence therapeutic targets within the neural circuitry of a wide range of organs and tissues.
• Undiagnosed Diseases Network (UDN) (nih.gov/Diseases): A network of clinical and research centers helping individual patients and families living with the burden of undiagnosed disease and using advanced technologies to solve the most challenging clinical mysteries.

Additional information on some of these datasets can be found via the CFDE portal (functional through April 30^th) or the newly established CFDE Workbench Portal.

Please see Section III. Eligibility Information in RFA-RM-24-006 for Eligibility information.

1. Are foreign institutions eligible to apply?

No, 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, but foreign components, as defined in the NIH Grants Policy Statement, are allowed.

2. Are PIs and other personnel supported by this grant required to be U.S. citizens?

No, PIs and other personnel supported by this grant are not required to be U.S. citizens.

Generally, PIs and other personnel supported by NIH research grants are not required to be U.S. citizens; Any citizenship requirement will be stated in the program announcement (PA) or request for applications (RFA).

3. Are there any stipulations regarding PDs/PIs currently involved in CFDE?

Program Directors/Principal Investigators (PDs/PIs) and key personnel of the Data Coordinating Centers (DCCs) of the Common Fund programs, PDs/PIs of funded CFDE Centers, and researchers who are involved in the DCC activities as senior/key investigators are not eligible to respond to this announcement. Applicants who are not sure about their eligibility are strongly recommended to contact the Program Officers listed below to discuss their situation prior to submission.

4. Does accepting an R03 impact Early Stage Investigator status?

No. An investigator will retain their Early Stage Investigator status if they receive any of the smaller research grants, training, infrastructure, and career awards that appear on this list.

1. When may I submit an application?

The application due date is June 27, 2024. All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. Letters of intent (LOI) are not required or applicable. Submission of a letter of intent is not binding and the letter is not part of the application review.

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 Contacts:

George J. Papanicolaou, PhD
Email: [email protected] 

Dr Anthony Kirilusha, Ph.D.
Email: [email protected] 

 

1. What are the review criteria for this CFDE R03 opportunity?

Please refer to the details that are provided in Section V, Application Review Information, of the funding opportunity RFA-RM-24-006.

2. How will awards be selected for funding?

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.

1. How many years of support may I request and what is the direct cost cap?

Common Fund support will be limited to 1 year, and application budgets are limited to $200,000 in direct costs per year. If experimental approaches are proposed, they should be limited to 20% of the requested budget.

2. What travel costs should I budget for?

Travel and related expenses to attend a CFDE meeting and attend a secondary meeting as a presenter should not exceed $5,000 in total costs.

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 [email protected] 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 [email protected].

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

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 key dates in the timeline for planning our application?

Research Opportunity Announcement Released	February 20, 2024
Applicants Register in eRA Commons*	March 10, 2024
Letter of Intent Due (optional but strongly recommended)	March 21, 2024
Application Due Date	April 22, 2024

*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. 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, Acute to Chronic Pain Signatures (A2CPS), Bridge 2AI, Cellular Senescence Network, Extracellular RNA Communications, Gabriella Miller Kids First (KF), Genotype-Tissue Expression (GTEx), Glycoscience, Human BioMolecular Atlas (HuBMAP), Human Microbiome Project, Illuminating the Druggable Genome, Knockout Mouse Phenotyping Program, Library of Integrated Network-based Cellular Signatures (LINCS), Metabolomics Workbench, Molecular Transducers of Physical Activity in Humans (MoTrPAC), Nutrition for Precision Health, Somatic Mosaicism Across Human Tissues, Simulating Peripheral Activity to Relieve Conditions (SPARC), and the Undiagnosed Diseases Network (UDN). 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 RFA-RM-23-014.

4. 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. 

5. 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, the frequency of updates to the portal is not pre-determined and both push and pull models will be considered.

6. Do most of these DCC host the data on premise or 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.

7. 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. It is likely that 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.

8. Do you have any additional insight as to when the start of this award would occur? It says as early as July 1, 2024. Is this still anticipated as the start date?

This is an estimated start date. The award may start as early as July 1, 2024 or as late as September 25, 2024. Based on the projected review and negotiations timeline, and subject to availability of funds, the goal is for this award to begin in July of 2024.

9. Is FISMA certification required or is it enough to meet those FISMA requirements?

FISMA will be a process once an award is in place. For the application, applicants should submit a plan on how those requirements will be met and maintained because ongoing assessments and vigilance will be required to remaining FISMA compliant. If the applicant plans to use a particular resource that already meets security requirements, that is something that is important to note in the application.

If a new resource is proposed, then Authority to Operate (ATO) will need to be obtained in collaboration with the NIH INFOSEC.

10. What is the expected timeline for full deployment of the workspace?

By the end of the first year, the cloud workspace should meet the minimum-security requirements and allow users to import data sets from at least three (3) different Common Fund Programs, as well as provide access to at least one (1) tool or pipeline developed by CFDE for analyzing data from multiple programs.

Additionally, by the end of the first year the cloud workspace needs to have enough documentation to enable new users to begin leveraging the resource and a help desk in place to address user requests about features or usability.

The duration of the project is up to 5 years. Please see the full Research Opportunity Announcement for additional details.

11. The ROA says that CWIC would need to work with the Training Center to provide training on all the tools/techs in the environment. Is the CWIC group expected to provide training on these?

The application should address approaches to training.

12. Is the CWIC expected to include a data repository component that allows browsing/searching data?

The cloud workspace is not expected to include a data repository. It does need to accommodate some amount of data import by the user into the workspace. The Data Resource Center (DRC) and the Knowledge Center (KC) will be implementing search across Common Fund DCCs and data sets. The workspace will need to be able to leverage those search functions and allow users to locate the data sets that they are trying to work with. The cloud workspace must also enable the user to import the data that were found through the search function.

13. What is the overlap in outreach functionality for CWIC and the Training Center (TC)?

It is expected that the CWIC and TC will collaborate on outreach. The TC has a broader mandate for all CFDE. To have documentation developed by the cloud workspace implementation center and then work with the TC to make sure that that documentation can be disseminated to a wider audience. The responsibility for documenting the workspace rests with the CWIC. Wider promotion and dissemination activities will need to be coordinated with the TC.

14. Will this be in the NIH Strides environment?

No, the NIH Common Fund currently does not provide in kind contributions through the NIH Strides program.

15. Is any/every researcher eligible to use the CWIC? Can they be from any institution?

Yes, we want a broad a community of users as possible.

16. Do all users need RAS (single sign-on authentication) identities to access the CWIC?

It will be up to the applicants to provide proposals for sign-on authentication as part of a larger implementation plan. 

17. Should the CWIC group be prepared to develop workflows and analysis tools?

Yes, the CWIC should have workflows and analysis tools but the extent of this is up to the applicant. This fits into the help desk portion which requires that the help desk support users in their scientific use cases Tool development will not be the main goal of CWIC, but enabling support for existing tools that users request is a priority. The goal will be ensuring that the platform is accessible and delivers value to the users.

18. Is there a specialized data access committee (DAC) involved for granting access to controlled data?

There are multiple programs that participate in CFDE, some have controlled data. It depends on the specific program in which the data are being requested.

19. Is the CWIC responsible for enforcing the access to controlled access data resources?

The minim requirement is that each user must have the ability to create their own secure workspace to work in. This is not a core requirement of the announcement, but applicants are encouraged to provide solutions on how to navigate access control.

20. Is the CWIC expected provide a search interface for datasets, or will it be expected to pull in data from different stores that have their own search interfaces?

The CWIC will be expected to leverage the search functions that the Knowledge Center (KC) and DRC (Data Resource Center) have implemented.

21. Are the search commands a user-interface (UI) or a command line functionality?

It will be up to the applicant to determine a solution for this in the proposal.

22. Are there any security implications or preferred cloud environments for CWIC? Besides the three main cloud provider options (eg. Azure, AWS, GCP), there are protocols such as FedRAMP or hosted environments such as STRIDES related to cloud computing. Are any providers or hosted environments preferred?

Per Section 1 of the CWIC ROA (Goal 1), the cloud workspace will be expected to address and maintain security controls that are at least equivalent to NIST.800-171 (FISMA-low). It is possible that, as development work progresses and different scientific use cases arise, this requirement will be increased to NIST. 800-53 (FISMA-moderate). There are no preferred cloud providers, so long as the host environment can comply with these security requirements. Regarding STRIDES, the NIH Common Fund does not provide in-kind contributions through the NIH STRIDES initiative.

23. Are applicants able to use the NIH STRIDES program to fulfill the requirements for a cloud credits program with controls to prevent overspending?

While the NIH Common Fund no longer provides in-kind contributions through the NIH STRIDES program, applicants are encouraged to consider registering with STRIDES if they have not done so already and if doing so will enable them to obtain a better discount on cloud compute services than the one currently available to them

24. Regarding CFDE branding, landing page, and other identifying materials that will be required to distinguish the CWIC from existing computational environments – when a prototype is developed in the first year, who would the CWIC work with to rebrand/redesign the existing workspace look and feel and provide UI for CFDE?

The awarded CWIC will work with NIH and relevant CFDE Centers such as the CFDE Integration and Coordination Center, the CFDE Knowledge Center, and the CFDE Data Resource Center to coordinate the branding.

25. Is there a complete list of tools that are of interest and used by CFDE, preferably broken down by Python, R, JAVA, and OWL?

Applicants are welcome to propose the tools they envision in providing for the analysis and visualization tools and workflows they propose. The awarded CWIC will work with the CFDE Data Resource and Knowledge Centers, as well as with the individual participating DCCs, to identify relevant tools.

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?

The CFDE Cloud Workspace Implementation Center (CWIC) will be directly interacting with the Data Resource Center (DRC), Knowledge Center (KC), Integration and Coordination Center (ICC), and Training Center (TC) for CFDE. A PI/MPI for the CWIC may not serve as a PI/MPI for either the DRC, the KC, the ICC, or the TC. PIs/MPIs holding an award (active or in a no-cost extension) for the DRC, the KC, the ICC, or the TC are ineligible.

4. Can we apply for this opportunity without submitting a letter of intent?

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

5. Are postdoctoral researchers eligible to apply?

Postdoctoral researchers are eligible to apply if their institution determines that postdoctoral researchers are eligible to serve as a PI.

Budget

1. What is the budget for this opportunity?

The Common Fund may allocate up to $750,000 for the first-year total (direct + indirect) costs for this Center, and up to $1,500,000 total costs per year for years 2 – 5. This award is contingent upon NIH appropriations and the submission of a sufficient number of responsive and rigorous applications. Future year amounts will depend on annual appropriations.

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 (OTA-24-005).

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 on cloud computation, cloud storage, and cloud hosting are capped at ten (10) percent. This supersedes the institutionally established indirect costs rate.

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. 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.

4. Will cloud credits be provided as a part of CWIC? If so, is there an amount?

The CWIC is expected to budget for providing cloud credit to users as part of the application. The amount will be determined during negotiations.

5. Is it expected that researchers will not pay for compute / storage, and it will be provided though this grant or another mechanism?

Users will support their own compute and storage. However, the CWIC needs to have a mechanism where NIH can provide resources to users based on certain criteria that will be determined after the award.

6. Do user accounts and associated cloud costs/credits need to be integrated with any existing database or billing software already in use by the Common Fund or NIH? If not, is there a requirement to implement and manage billing, including accepting payments from individuals or ICs?

There is no expectation of integrating user accounts with existing Common Fund billing software. The cloud workspace users must have the ability to pay for their use of cloud resources directly, and the payment must not be higher than what they would have paid had they been working directly with the provider (e.g., Azure, AWS, GCP).

7. There are certain time and overall cost considerations associated with hosting large and frequently used datasets from individual DCCs within CWIC as read-only datasets for use by multiple users. This may introduce a level of complexity to storage costs estimates for users and overall CWIC operational costs. Are these types of functionality and considerations required or useful to include in the Full Application?

These types of functionality and considerations may be included in the full application.

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-24-005.

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 8.4 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 April 22, 2024 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. 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.

5. 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.

6. 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.

7. 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. The three page limit provided for the Leadership Plan component of the application takes into account the possibility that an MPI leadership plan may be required.

8. 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.

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

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

10. 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 in Section 8.3 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.

11. 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.

12. Is a Resource Sharing Plan required?

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

13. 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.

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

No. Applicants are not required to have letters of support from every subaward site.

15. Are Principal Investigators serving on review panels eligible for delayed application submission?

No. Late applications to this ROA will not be accepted. There are no extensions for individuals serving on review panels.

16. 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.

General

1. Whom can I reach out to with questions about the CFDE F32 program?

All questions are welcome. Please reach out to Dr. Sahana N. Kukke at [email protected] and Dr. George Papanicolaou at [email protected] if you have questions about this opportunity.

2. What is unique about this CFDE F32 opportunity compared to the Parent F32?

Please find Common Fund-specific information on this opportunity at: https://grants.nih.gov/grants/guide/contacts/parent-F32.html. Search for the entry in the table related to the Common Fund. Some key features include:

• Training should be directly relevant to the goals of the CFDE.
• Training should substantially leverage data from at least one Common Fund program to address novel research questions and encourage careers in bioinformatics research.
• Common Fund support will be limited to 2 years.

3. What are key dates in the timeline for planning an application?

NOT-RM-24-006 Release Date	February 14, 2024
Application Due Date	April 8, 2024
Scientific Merit Review	July 2024
Earliest Start Date	December 2024

4. Which Common Fund programs have data sets that can be included in an application?

Since its inception as the NIH Roadmap for Biomedical Research, the NIH Office of Strategic Coordination (Common Fund - commonfund.nih.gov ) has supported multiple transformative research programs that generate new technologies, methods, and data.  Many of these programs produced rich public data sets containing multi-dimensional molecular and phenotypic data from humans and model organisms.  The established Common Fund data sets listed below are well-poised for increased community use:

• 4D Nucleome (4DN) (data.4dnucleome.org): Reference nucleomics and imaging data sets, including an expanding tool set for open data processing and visualization
• Acute to Chronic Pain Signatures (A2CPS) (a2cps.org): Imaging, high-throughput omics, sensory testing, and psychosocial assessment data from patients who either transition to or are resilient to chronic pain.
• Bridge to Artificial Intelligence (Bridge2AI) (bridge2ai.org): Ethically sourced, trustworthy, and well-defined flagship biomedical and behavioral datasets on salutogenesis, clinical care, functional genomics, and voice as a biomarker. This program is in its early phase and data generation is ongoing.
• Cellular Senescence Network (SenNet) (commonfund.nih.gov/senescence): Atlases and datasets of senescent cells and their secretomes. This program is in its early phase and data generation is ongoing.
• Extracellular RNA Communication (exRNA) (exrna.org): Catalog of exRNA molecules found in human biofluids like plasma, saliva, and urine; and potential exRNA biomarkers for diseases.
• Gabriella Miller Kids First (KF) (kidsfirstdrc.org): Data from whole-genome sequencing of cohorts with structural birth defects and/or susceptibility to childhood cancer, with associated phenotypic and clinical data.
• Genotype-Tissue Expression (GTEx) (www.gtexportal.org/home): Whole genome and RNA sequence data from multiple human tissues to study tissue-specific gene expression and regulation, including tissue samples.
• Glycoscience (GL) (glygen.org): A data integration and dissemination project for carbohydrate and glycoconjugate related data.
• H3Africa (www.h3abionet.org/resources/h3africa-archive): Genomic and phenotypic research data generated by the Human Heredity and Health in Africa program. Includes population-based genomic studies of common, non-communicable disorders (e.g., heart and renal disease), and communicable diseases (e.g., tuberculosis).
• Human BioMolecular Atlas Program (HuBMAP) (hubmapconsortium.org): An open and global platform to map healthy cells in the human body to determine how the relationships between cells can affect the health of an individual.
• Human Microbiome Project (www.hmpdacc.org): Characterization of the microbiomes from healthy human participants at five major body sites using 16S metagenomic shotgun sequencing; and characterization of microbiome and human host from three cohorts of microbiome-associated conditions.
• Illuminating the Druggable Genome (IDG) (druggablegenome.net): Data on understudied druggable proteins, including mRNA and protein expression data, phenotype associations, bioactivity data, drug target interactions, disease links, and functional information.
• Integrated Human Microbiome Project (iHMP) (hmpdacc.org/ihmp): Microbiome, epigenomic, metabolomic, and phenotypic data for three cohorts.
• Knockout Mouse Phenotyping Program (KOMP2) (www.mousephenotype.org): Data from broad, standardized phenotyping of a genome-wide collection of mouse knockouts.
• Library of Integrated Network-based Cellular Signatures (LINCS) (lincsproject.org): Molecular signatures that describe how different types of cells respond to a variety of agents that disrupt normal cellular function.
• Metabolomics Workbench (www.metabolomicsworkbench.org): Metabolomics data and metadata from studies on cells, tissues, and organisms.
• Molecular Transducers of Physical Activity in Humans (MoTrPAC) (motrpac-data.org/data-access): Data contain assay-specific results, associated metadata, quality control reports, and animal phenotype data related to molecular transducers that underlie the effects of physical activity.
• Nutrition for Precision Health (NPH) (commonfund.nih.gov/nutritionforprecisionhealth): The goal of the NPH program is to predict individual responses to food and dietary patterns. Data being collected include metabolomics, clinical assays, microbiome, and dietary assessments. This program is in its early phase and data generation is ongoing.
• Somatic Mosaicism Across Human Tissues (SmaHT) (commonfund.nih.gov/smaht): Data on DNA sequence variants within personal genomes in tissues from human donors. This program is in its early phase and data generation is ongoing.
• Stimulating Peripheral Activity to Relieve Conditions (SPARC) (sparc.science): Maps and tools to identify and influence therapeutic targets within the neural circuitry of a wide range of organs and tissues.
• Undiagnosed Diseases Network (UDN) (commonfund.nih.gov/Diseases): A network of clinical and research centers helping individual patients and families living with the burden of undiagnosed disease and using advanced technologies to solve the most challenging clinical mysteries.

Additional information on some of these datasets can be found via the CFDE portal.

Eligibility

Please see Section III. Eligibility Information in PA-23-262 for Eligibility information.

1. Are foreign institutions eligible to apply?

Yes, non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply, non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply, and foreign components, as defined in the NIH Grants Policy Statement, are allowed.

2. Are there requirements on citizenship for the Program Director/Principal Investigator?

By the time of award, the individual applying as Program Director/Principal Investigator must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

3. Are only recent graduates eligible to apply? 

NIH encourages applications from individuals sufficiently early in their postdoctoral training period that they can benefit from the mentored research and training opportunities of an individual fellowship award, but there is no limit on the number of years since the PhD degree.

Application and Submission

1. When may I submit an application?

The application due date is April 8, 2024. All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

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 Contacts: 

Sahana N. Kukke, PhD 
Email: [email protected] 

George J. Papanicolaou, PhD 
Email: [email protected]

Review and Selection

1. What are the review criteria for this F32 opportunity?

Please refer to the details that are provided in Section V, Application Review Information, of the funding opportunity PA-23-262.

2. How will awards be selected for funding?

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.

Budget

1. Are there any CFDE meetings to include in the budget?

Recipients are expected to attend one two-day CFDE Consortium meeting in the Spring to be held in Bethesda, Maryland, for scientific and professional interactions with the CFDE community.

2. What is the award budget composed of?

Award budgets are composed of stipends, tuition and fees, and institutional allowance, as described in the funding opportunity PA-23-262.

3. May I request funding for training abroad? 

You may request support for training abroad. But please note that in such cases, you are required to provide detailed justification for the foreign training, including the reasons why the facilities, the sponsor, or other aspects of the proposed experience are more appropriate than training in a domestic setting. The justification is evaluated in terms of the scientific advantages of the foreign training as compared to the training available domestically. Foreign training will be considered for funding only when the scientific advantages are clear.

General

1. Who can I reach out to with questions about the CFDE Research Supplements to promote workforce diversity and enhance utility and use of Common Fund data sets (NOT-RM-24-003)?

All questions are welcome. Please reach out to Dr. Sahana N. Kukke at [email protected] and Dr. George Papanicolaou at [email protected] if you have questions about this opportunity.

2. What is unique about this CFDE Research Supplement opportunity compared to the Parent Announcement (PA-23-189)?

• Activities proposed in the administrative supplement should be directly relevant to the goals of the CFDE and be within the scope of the parent project.
• The Research Plan should substantially leverage data from at least one Common Fund program listed in NOT-RM-24-003. “Substantial leverage” is defined as the use and citation of the relevant dataset(s) in the envisioned research products of the proposed work (e.g., manuscripts, presentations, book chapters, portals, etc.). As one of the core goals of CFDE is to facilitate the integration of data across a range of Common Fund programs, candidates, especially those working with applicant organizations to ask for two years of support, are strongly encouraged to integrate data sets from multiple Common Fund programs in their proposed research activities.
• Common Fund support will be limited to 2 years.
• Applicants are expected to budget for attendance at one two-day CFDE Consortium meeting in the Spring to be held in Bethesda, Maryland, for scientific and professional interactions with the CFDE community.

3. What are key dates in the timeline for planning an application?

Application Due Date	April 8, 2024
Administrative Review	May 2024

Eligibility

Please see Section III. Eligibility Information in PA-23-189 for Eligibility information.

1. Are foreign institutions eligible to apply?

No, non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply, and non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed.

2. What parent awards are eligible to request a supplement?

A list of activity codes is provided in PA-23-189.

3. If the parent award is working with a particular Common Fund data set, is it allowable for the Research Supplement application to incorporate the same data set?

Yes, your Research Supplement application may focus on using a data set, even if the parent award is also focused on using that data set. Note that the data set should be substantially leveraged, which is defined by the use and citation of the data set in the envisioned training and research products of the proposed work. Applicants proposing two years of support are strongly encouraged to incorporate data from at least two Common Fund programs. Irrespective of which data set(s) are used, keep in mind the criteria listed in the Application Review Information, which is how your application will be assessed.

4. Can an investigator involved in the parent award be the supplement candidate in a Research Supplement application?

Yes, as long as the individual is not a PI or MPI on the parent award and has sufficient effort to dedicate to the proposed supplemental activity, they may apply as a candidate for this opportunity.

5. Are only principal investigators (PIs) associated with active Common Fund programs eligible to apply?

The supplement application is dependent upon the existence of an active parent award that the supplemental funds can be applied to. The active parent award can be any one of the numerous activity codes listed in PA-23-189. The supplement request must be within the scope and timeline of the parent award. The active parent award does not need to be a Common Fund award – it can be any active award of the eligible activity codes that serves the purpose described in NOT-RM-24-003. So, the PI applying does not need to be a PI already associated with a Common Fund program.

If you or your colleagues (re-)consider applying for a supplement on an active award, please check with PO of the parent award to make sure they are amenable to a supplement. Each NIH Institute/Center may have their own practices to follow relative to supplement applications. Applicants must check with the PO of the parent award to discuss viability of a supplement application. Each NIH Institute/Center may have their own practices to follow relative to supplement applications.

6. Are there any eligibility requirements for candidates in the supplement program?

The candidate should meet the following criteria: “Supplemental awards under this announcement are limited to citizens or non-citizen nationals of the United States or to individuals who have been lawfully admitted for permanent residence in the United States (i.e., in possession of a Permanent Resident Card, Form I-551). This program may not be used to provide technical support to NIH-supported investigators.”

7. Are predoctoral students and postdoctoral fellows eligible to apply?

The NOSI does not specify training stages for this opportunity, please follow the eligibility guidelines in the Parent Announcement. Predocs and Postdocs are both included.

Application and Submission

1. When may I submit an application?

The application due date is April 8, 2024. All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

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

If you have questions, please contact the Scientific Contacts:

Sahana N. Kukke, PhD
Email: [email protected]

George J. Papanicolaou, PhD
Email: [email protected]

Review and Selection

1. What are the review criteria for this Research Supplement opportunity?

Please refer to the details that are provided in Section V, Application Review Information, of the funding opportunity PA-23-189.

2. How will awards be selected for funding?

Administrative supplement requests will undergo an administrative evaluation by NIH staff, but not a full peer review. Applications submitted for this funding opportunity will be assigned to the awarding component for the parent award and will be administratively evaluated using the criteria listed in the funding opportunity PA-23-189, consistent with applicable law.

Budget

Are there any CFDE meetings to include in the budget?

Recipients are expected to attend one two-day CFDE Consortium meeting in the Spring to be held in Bethesda, Maryland, for scientific and professional interactions with the CFDE community.

General Information about OTA-24-004: NIH Common Fund Data Ecosystem (CFDE) Training Center (OT2)

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	February 1, 2024
Applicants Register in eRA Commons*	February 19, 2023
Letter of Intent Due (optional but strongly recommended)	March 1, 2024
Application Submission Date	April 1, 2024

*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. 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-23-014.

5. 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. 

6. 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, the frequency of updates to the portal is not pre-determined and both push and pull models will be considered.

7. 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.

8. 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.

9. Is there a certain format of training materials? Is there something that is required as for the structure of this training program as far as training materials, classroom format, teaching format?

All the training materials must be accessible, and it could be beneficial to be able to share the trainings that are developed in case certain individuals cannot attend in person or for future trainings down the line. The recipient will be conducting a landscape analysis to identify the community that the Training Center (TC) will want to reach. All materials should be made available on the CFDE portal.

10. Are training materials restricted in format to a particular Learning Management System (LMS)?

No, there is no LMS restriction.

11. What are the requirements for in-person training and events?

These must fulfill the aims and goals of the center. The TC should prioritize flexibility and inclusivity, but the other items are open to the applicant and related to the program plan. This is not pre-defined.

12. Is there any guidance for quantity of different kinds of materials (for example X number of workshops, courses, or events) per year?

No. This is based on the applicant’s program plan and justification. The justification should match the budget and resources being requested in the award.

13. Do you have any additional insight as to when the start of this award would occur? It says as early as July 2024. Is this still anticipated as the start date?

This is an estimated start date based on the due date and review process. Summer 2024 is the target.

14. Are exempt human subjects studies allowable for the purpose of program evaluation, presentation of program evaluation, or publication of program evaluation?

Yes, applicants may include exempt human subjects research for these purposes. Non-exempt human subjects research is not allowed. You can find more information about human subjects research at NIH here: https://grants.nih.gov/policy/humansubjects.htm. Please see the following infographic for more information on exempt human subjects research: https://grants.nih.gov/sites/default/files/exemption_infographic_v8_508c_1-15-2020.pdf. Applicants must answer ‘yes’ or ‘no’ to the question regarding involvement of human subjects when submitting an application through eRA’s Application Submission System & Interface for Submission Tracking (ASSIST). If the answer is ‘yes,’ indicate whether the studies are exempt from Federal Regulations, and indicate the appropriate exemption number. You will have to complete the Human Subjects and Clinical Trials (HSCT) Information (https://grants.nih.gov/policy/clinical-trials/new-human-subject-clinical-trial-info-form.htm) for exempt human subjects research. Please note, non-exempt human subjects research is not allowed.

15. Does the annual evaluation report of the Training Center’s (TC) activities meet the requirements of the Annual Report, or are these separate reporting requirements (Requirements – CFDE Training Center, Task 4e)?

The annual evaluation reports of TC activities to be provided to the ICC by the TC (Requirements – CFDE Training Center, Task 4e) is separate from the Annual Report (Special Award Terms and Information, Annual Reporting). The evaluation report of TC activities is specific to how the TC performed relative to the planned evaluation criteria. The Annual Report covers major accomplishments of the TC over the previous year more generally. However, there may be some common content.

16. Typically, how long are site visits (e.g., a single date or multiple)? 

If the Other Transactions Program Official (OTPO) deems a site visit necessary, it will most likely be a single day.

17. How frequent are the consortium-wide working group and committee activities, including the CFDE Steering Committee?

The CFDE Steering Committee meets monthly. Consortium wide working groups typically meet monthly though additional activities may occur on an ad-hoc basis.

18. Is there opportunity to provide live, recorded online trainings or does this ROA require only online, on-demand trainings?

Live recorded trainings are allowable in addition to online trainings.

19. Is there a length requirement for the monthly training seminar? Anywhere from 1 hour to 8 hours?

The length of these seminars may vary depending on the topics decided by the Training Center. A 1-hour seminar is acceptable.

20. Can we assume that the materials developed (Training Center produced trainings) can be made available in other public repositories with NIH permission?

Yes.

21. Can a 3rd party software platform be used to create the learning environment so long as it is accessed from the CFDE Landing Page?

Yes.

22. Does the CFDE Virtual Community need to be hosted on the CDFE site or can it be hosted in a 3rd party vendor?

It can be hosted in a 3rd party vendor that is linked on the CFDE site.

23. Can the Program Manager/Program Director also serve as the Contact PI?

No, the Program Manager/Program Director should be different from the Contact PI and any MPIs.

24. Can Program Manager/Program Director be split between multiple people?

There should be one Program Manager/Program Director.

25. Is the CFDE Consortium-Wide meeting different travel dates than the Fall/Spring CFDE Meetings?

The CFDE Consortium-Wide meetings are the same as the Fall/Spring CFDE Meetings and the travel dates will be the same.

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 Training Center (TC) will be directly interacting with the Data Resource Center (DRC), Knowledge Center (KC), and Integration and Coordination Center (ICC) for CFDE, a PI/MPI will not be eligible to serve as the PI/MPI for both i) the TC and ii) the DRC, KC, or ICC awards. In addition, as the TC will be directly interacting with the R25 awards funded by CFDE, a PI/MPI will not be eligible to serve as the PI/MPI for both i) the TC and ii) the R25 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) and R25 awards (RFA-RM-23-014), which are being planned for competition. PIs/MPIs who have questions concerning their eligibility must contact the CFDE NIH team to clarify their eligibility before applying.

4. With respect to OTA-24-004 and RFA-RM-23-014 (R25), 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 TC or the R25, but not both?

An individual can apply for both opportunities (OTA-24-004 and RFA-RM-23-014) as the contact PI or an MPI. However, they cannot serve as the PI or MPI on both awards. We anticipate that OTA-24-004 will be awarded first. The PI(s), including MPIs, under OTA-24-004 will be ineligible to receive an R25 award under RFA-RM-23-014.

5. Can we apply for this opportunity without submitting a letter of intent?

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

6. Do trainers in the Training Center have to be US citizens or will foreign nationals of distinction be acceptable as part of the training network?

Non-domestic entities are not eligible to apply, and non-domestic components of US organizations are not eligible to apply. However, foreign components are allowed. The application can include a component that goes to a foreign institution and there is no restriction placed on individuals.

7. You explicitly mentioned RFA-RM-23-014 as incompatible with this ROA. We didn’t apply for that RFA but did apply for another Research Education program (R25) award issued by a different NIH program. Would application to that R25 also preclude applying for this CFDE ROA?

No. You may apply to both.

8. Can a subrecipient be the Contact PI?

The contact Principal Investigator must be employed by or affiliated with the applicant organization, not a subrecipient.

9. NIH PHS 398 Research Training Program Plan has a requirement that is not in the OTA. Please confirm whether we follow the Training Program Section guidelines. For example, following is a section that is not in the OTA, but is a requirement for all training proposals. “Plan for Instruction in Methods for Enhancing Reproducibility” (T-94). A “Plan for Instruction in Methods for Enhancing Reproducibility” attachment is required for all training grant activity codes except D71, unless otherwise noted in the FOA. Applications lacking a Plan for Instruction in Methods for Enhancing Reproducibility will not be reviewed."

The Plan for Instruction in Methods for Enhancing Reproducibility is not a requirement for this OTA.

Budget

1. What is the budget for this opportunity?

The Common Fund may allocate up to $1,200,000 for the first-year total (direct + indirect costs for this center, up to $1,200,000 for year two, and up to $1,000,000 per year for years 3-5. This award is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations.

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 (OTA-24-004).

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. 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.

4. Typically, how many does should applicants estimate to be on site for annual Spring and Fall CFDE meetings?

The Spring and Fall meetings are each typically 2 days long but is subject to change based on the planned meeting agendas.

5. Many organizations that allow OT authority allow a wide variety of budget presentations. Please confirm that Time and Materials, Fixed Price, and Cost Reimbursable plus Fee are acceptable budget presentations under this OT.

OTA-24-004 falls under the funding instrument of the Other Transaction (OT) award mechanism. OT awards are not grants, cooperative agreements, or contracts. Because of this, Other Transactions are not bound by 2 CFR 200 or the FAR unless otherwise specified. NIH is willing to accept the components specified in Section 8.3 Full Application of the ROA.

6. For budgeting purposes, will all materials that go on the CFDE site need to be 508 compliant (training videos and documentation)?

Since one of the priorities of the Training Center is inclusivity, we recommend that the related materials on the website are 508 Compliant.

7. For the cloud computing expenses that have an indirect cost cap of 10%, would storage or project files on cloud services such as Azure, a license owned by the Respondent be included? Or does this only include third-party vendors that the Respondent does not have a license with?

All cloud costs are included.

8. Will trainees be given access to cloud resources through the TC (grant funded), their institutions or through the CFDE?

No, procurement of hardware, data, cloud computing, and the development of software capabilities to support the proposed activities are allowable costs that should be included in the budget and budget justification. Indirect costs for cloud expenses (e.g., computing and storage) in any application funded under this OT mechanism will be capped at a rate of ten (10) percent.

9. What percentage of time may applicants want to reserve for that collaboration and if that will be a consistent expectation across the Centers? Is 20% appropriate?

Based on the purview of each CFDE Center, expected collaborations with other CFDE Centers will likely differ. For the Training Center (TC), we expect collaborations with the ICC, especially regarding analysis, evaluation, and sustainability planning for the TC. We also expect collaborations with the Data Coordinating Centers (DCCs) of active Common Fund programs related to any trainings developed by the TC. Monthly Steering Committee meetings, regular (typically monthly) Consortium-wide working groups, and additional ad-hoc activities will allow for collaboration across the program. There is no pre-specified percentage effort to assign for collaboration. We expect it to be justified based on how it addresses the aims of the TC.

10. Is any of the anticipated collaboration with the ICCs (such as in ICC meeting) to be at cost recovery from the Training and Other Centers?

Meeting support will be directly provided by the ICC and will not need to be included in the Training Center budget.

11. For the Annual Spring/Fall Meetings, there is a charge to ROA applicants to allocate appropriate funding for up to five individuals to travel. Will all these meetings be at a specific location? Is it anticipated that this will rotate through the Centers and should ROA applicants be allocating hosting funding for at least two of those meetings?

The annual Spring and Fall CFDE meetings are hosted by the Integration and Coordination Center and the other CFDE Centers will not be required to host these events. Typically, they are held in or near Bethesda, MD but the location may vary.

12. In addition to the mandatory meetings, is it anticipated that there will be regular reciprocal hosting where Training Center would travel to Boston to meet with the Data Center and vice versa?

Any additional meetings not described in the ROA will be optional and up to the applicant to propose and justify.

13. Normally, it is not permitted to budget for food or beverages in NIH funding; is that true for this funding mechanism as well?

Awardees are not allowed to use NIH funding to budget for food or beverages.

14. In the Research Opportunity Announcement, it states that "travel costs for up to five individuals must be included in the proposed budget."  Can you confirm if it is acceptable to budget for less than five individuals - three for instance?

It is acceptable to budget for less than five individuals to attend the CFDE meetings. The upper limit is 5 individuals. Please note that the CFDE meetings are important for collaboration across the program, and we expect the Training Center to participate in it.

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-24-004.

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 8.4 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.

7. Are we allowed to set aside money in the budget for Common Fund experts to be instructors in the Training Center?

Yes.

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 April 1, 2024 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 10 pages. 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. 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.

9. 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.

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

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

11. 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 in Section 8.3 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.

12. 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.

13. Is a Resource Sharing Plan required?

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide . Include how resources developed in the Training Center will be disseminated.

14. 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.

15. 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.

16. Are Principal Investigators serving on review panels eligible for delayed application submission?

No, there are no extensions for individuals serving on review panels.

17. 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.

18. Besides having links to data sets and data resources on the CFDE Landing Page on the CFDE Portal, can applicants plan to include links out to other resources, including cloud-based collaboration software or blended learning platforms?

Yes.

19. Is the Training Center required to consider sustainability of resources not developed by the Training Center?

The application should consider sustainability as broadly as possible, and explain what any limitations may be.

20. If a Multiple Principal Investigator (MPI) Leadership Plan is applicable, is it excluded from the Leadership Plan page count (up to 3 pages total)?

The Leadership Plan, which is up to 3 pages in total, should include the Multiple Principal Investigator (MPI) Leadership plan.

21. Section 2b, under the Overview of Planned Products, requires the TC to develop a Recruitment Plan, but the Recruitment Plan is required with the proposal submission.  Does NIH anticipate that the proposed Recruitment Plan will meet this requirement, therefore making this task completed prior to award? Or is the Recruitment Plan submitted with the proposal considered a draft to be shaped and revised in collaboration with NIH post award?

The Recruitment Plan to Enhance Diversity, which is a requirement for application, is a draft which the Training Center may update after the award is made and the proposed activities begin. Recruitment processes may evolve over time.

22. Is the Milestones and Deliverables template for all years (1-5) considered a stand-alone submittal document or should this be included in the budget justification? Assume there is no page limit for this proposal deliverable.

The Milestones and Deliverables document has a 10-page limit separate from the budget justification.

23. Is a resource sharing plan required if we are not generating research tools?

Applicants are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, including how resources developed in the Training Center will be disseminated.

24. What type of “data” should the data management plan include – data collected from training participants or data and metadata about the trainings?

The data management plan should cover all types of data generated through the award, including data collected from training participants themselves and data/metadata about the trainings. Additional guidance on the 2023 NIH Data Management and Sharing Policy can be found at https://oir.nih.gov/sourcebook/intramural-program-oversight/intramural-data-sharing/2023-nih-data-management-sharing-policy.

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 [email protected].

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.

General Information about RFA-RM-23-014

1. Whom can I reach out to with questions about the CFDE R25 program?

All questions are welcome. Please reach out to Dr. Sahana N. Kukke at [email protected] and [email protected] if you have questions about this NOFO. 

2. 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.

3. 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

4. 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.

5. 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.

6. Is it allowable to develop a course about a data analysis tool, like a knowledge graph, that incorporates data from multiple CFDE programs? If we include an analytical tool, like a knowledge graph, in our course, should we budget for an expert from all the CF data sets represented in the knowledge graph to attend the course?

The goal of the R25 is to educate participants on how to use specific CF data sets rather than focusing on teaching how to use tools, like a knowledge graph. The data sets should be integrated in some kind of analysis, and if you want to use a knowledge graph to assist with an analysis, that would be fine. But the focus should be on primary data sets in specific areas of biomedical science. The participants should be able to interact with an expert from each data set they are learning about. If the project cannot accommodate that, you would have to adjust the plan accordingly. For example, if you plan to use a knowledge graph in an analysis of 3 CF data sets, you will only need experts from the 3 relevant DCCs to be included in the course (and not from any other DCCs associated with that tool).   

7. What strategies does NIH support to broaden recruitment and support trainee retention?

Please see https://extramural-diversity.nih.gov/building-participation/recruitment-retention and https://www.nigms.nih.gov/training/diversity for additional information.

 

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)

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.

4. Can the application have multiple PIs?

Multiple principal investigators (MPIs) are welcome on the R25 application. Please refer to the NIH policy on MPIs as you plan your application: https://grants.nih.gov/grants/multi_pi/. As with all parts of the application, a justification should be provided for how the planned MPI collaboration will address the goals of the R25. Single PI and MPI applications are both allowed, and neither will be given a priority; all proposals will be reviewed according to how the proposed leadership structure supports the goals of the program.

 

Application and Submission

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)
[email protected].

 
For questions about the review process after submission and before summary statement release, please contact the Peer Review Contact:
Center for Scientific Review
[email protected].

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 [email protected]. 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. Who should provide the letter of support? Do I need letters of support from related Common Fund programs?

The letter of support can come from any Senior/Key Personnel in any award made within a Common Fund program that has a data set to be used in the proposed R25. Senior/Key Personnel is defined as the program director/principal investigator (PD/PI) and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they request salaries or compensation (https://grants.nih.gov/faqs#/senior-key-personnel.htm?anchor=51334).

Yes, we would like to see letters of support from related Common Fund programs because we are aware that each program and data set has unique considerations and context that may need to be considered when teaching how to use it. Experts in those data sets and programs will have important insights and be able to add value to whatever courses are developed through the R25. There is no template for the letter, but it should include what kind of support that individual will provide. That will depend on the proposal and the individual, and might include consultation, teaching, mentoring, or other types of support. Please note that the R25 program budgets must accommodate funds for the travel and lodging of one expert from each Common Fund program whose data sets are being used as course material to attend the course (if the experts are not from the applicant institution).

6. 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 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.

 

Budget

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.

3. Do I need to budget for all the CFDE experts to travel?

Program budgets must accommodate funds for the travel and lodging of one expert from each Common Fund program whose data sets are being used as course material to attend the course (if the experts are not from the applicant institution). 

4. According to the RFA, indirect costs (also known as Facilities & Administrative [F&A] costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, expenditures for equipment and consortium costs in excess of $25,000), rather than on the basis of a negotiated rate agreement. Does this 8% cap also apply to indirect costs on a subaward?

Yes, all indirect costs will be capped at 8%, including those for subawards.

 

Award Administration

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.

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 [email protected]. 
For questions about the review process after submission and before summary statement release, please contact the Center for Scientific Review at [email protected].

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 [email protected]. 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.