Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
Office of Strategic Coordination (Common Fund)
This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative through the NIH Office of the NIH Director, Office of Strategic Coordination. All NIH Institutes and Centers participate in Common Fund initiatives. The FOA will be administered by the National Cancer Institute (NCI) on behalf of the NIH.
Reissue of RFA-RM-14-011
August 23, 2019- Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137
RFA-RM-20-007, U01 Research Project – Cooperative Agreements
93.310
This Limited Competition Funding Opportunity Announcement (FOA) invites an application from the currently funded NIH Common Fund-supported Four-Dimensional Nucleome (4DN) Data Coordination and Integration Center (DCIC) to support Phase 2 of the 4DN program. The 4DN DCIC will have two major areas of responsibility: (1) Data Standards, Storage, Analysis, and Dissemination; and, (2) Consortium Interactions and Outreach. The 4DN DCIC will collect, store, curate, and disseminate all 4DN-generated data, metadata, analysis and visualization tools, computational models, and navigable reference maps. The DCIC will also lead the development of data and metadata standards, implementation of processing pipelines and analysis and visualization tools, and facilitate the broader use of 4DN data by experts and non-experts through outreach activities.
December 20, 2019
February 17, 2020
March 17, 2020
No late applications will be accepted for this Funding Opportunity Announcement
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
June-July 2020
August 2020
September 2020
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Background
The 4D Nucleome (4DN) NIH Common Fund Program was launched in 2015 with the goal of developing the tools and resources that would enable the characterization of the three-dimensional structure and dynamics of human and mouse genomes and provide deeper mechanistic insights into how the nucleus is functionally organized. The impetus for its selection as a Common Fund program was the growing awareness that understanding the architecture of the cell nucleus may have widespread and profound implications for human health and disease, but our ability to study nuclear organization was hindered by technological and conceptual challenges.
Key deliverables from the initial 5 years of support include: 1) next-generation genome analysis, imaging and computational tools to explore nuclear organization and its relationship with the regulation of gene expression programs, including in single cells; 2) pilot reference maps of the 3D architecture of the interphase nucleus for a select set of eukaryotic cells; 3) validated predictive models of genome conformation/function relationships; 4) first-generation tools to explore nuclear dynamics through controlled disruption of nuclear architecture and imaging of reporter loci in live cells and tissue; and 5) first-generation community data and metadata standards for the most commonly used 4DN technologies and protocols (https://www.4dnucleome.org/).
A number of outstanding questions and technological challenges remain. These include: 1) better means of studying chromatin dynamics in live cells and in complex tissues, which will likely imply a heavier reliance on high-content imaging-based approaches and methods to distill massive amounts of imaging data; 2) better tools for the controlled disruption of nuclear features to better understand structure/function relationships in dynamic experimental systems; 3) tools to explore molecular components of the functional nuclear architecture that are still undefined, including protein complexes, non-coding RNAs, and the composition and organization of nuclear bodies, compartments and microenvironments; and 4) development of next-generation analytical, visualization and modeling tools that would be accessible and usable by the broader scientific community and could lead to reliable 4D models of genome organization.
These outstanding scientific and technology challenges can be met through the creation of a research environment that promotes multidisciplinary approaches, team science and data integration. The ultimate goal for this endeavor is to deliver data and tools to be used by the broader community to address the role of nuclear organization in health and disease and in lifespan. The proposed Phase 2 is designed to achieve these goals through the following six initiatives, of which this FOA is one:
RFA-RM-20-003 Real-Time Chromatin Dynamics and Function (U01 Clinical Trial Not Allowed)
RFA-RM-20-004 4DN Centers for Data Integration, Modeling and Visualization (UM1 Clinical Trial Not Allowed)
RFA-RM-20-005 4DN Organization and Function in Human Health and Disease (U01 Clinical Trial Not Allowed)
RFA-RM-20-006 New Investigator Projects on 4DN Organization and Function in Human Health and Disease (U01 Clinical Trial Not Allowed)
RFA-RM-20-007 Limited Competition: 4DN Organizational Hub (U01 Clinical Trial Not Allowed)
RFA-RM-20-008 Limited Competition 4DN Data Coordination & Integration Center (U01 Clinical Trial Not Allowed)
Awards funded under these FOAs are anticipated to pursue research activities conducted by multidisciplinary teams of investigators. Awardees from all 6 initiatives will form the 4DN Network, with the overarching goal of addressing the role of nuclear organization in health and disease and in lifespan. Validation and comparisons across studies will be essential to achieve this goal so investigators must be willing to work collaboratively as part of the Network.
Research Objectives and Scope
The overarching mission of the 4DN DCIC will be to collect, store, curate, and disseminate all 4DN-generated data, metadata, analysis and visualization tools, computational models, and navigable reference maps. Additionally, the DCIC will lead the development of data formats and standards, assay and biospecimen metadata standards, and data processing pipelines. The DCIC will also facilitate the integrative analysis and visualization of 4DN datasets. Finally, the 4DN DCIC will promote collaboration and communication among 4DN investigators and the broader research community and coordinate outreach and training activities to facilitate the broader use of 4DN data by expert and non-expert users. The 4DN DCIC, all 4DN investigators, and NIH staff will need to work closely together to accomplish the goals of the 4DN DCIC in a manner that will best benefit all 4DN investigators as well as the broader scientific community.
DCIC Activities – Development of the 4DN DCIC will require the DCIC team to work closely with all components of the 4DN program, including funded investigators and NIH staff. The DCIC will be required to abide by all data sharing and governance policies of the 4DN Program. Specific activities and roles of the 4DN DCIC will include, but are not limited to:
Data Standards, Storage, Analysis, and Dissemination
Consortium Interactions and Outreach
4DN Data Types – We anticipate that most of datasets handled by the DCIC will be next-generation sequencing data and advanced imaging data. However, it is difficult to predict the exact volume and types of data that will be submitted over the lifetime of the 4DN Program. Increasing efficiencies in generating data along with potential changes in technology platforms may dramatically alter the types and volume of data to be stored, curated, and analyzed by the 4DN DCIC. Furthermore, the integration of datasets generated outside of the 4DN Network to 4DN databases is likely to add data volume and complexity. Additionally, 4DN DCIC applicants need to keep in mind that 4DN data will likely be generated across many different model organisms and a variety of cell and tissue types, adding another layer of complexity to the curation and mining of the data. 4DN DCIC applicants will have to demonstrate that their team and project will have the expertise and flexibility to accommodate increasing data volume and evolving data types.
Open and Controlled 4DN Data Access – The NIH promotes broad and responsible sharing of genomic research data and respects the privacy and intentions of research participants. Some data generated by the 4DN will be open access, which means that no authentication or authorization is necessary to access it. Other data will be controlled access, which means that data access will be governed by the NIH Genomic Data Sharing Policy (https://grants.nih.gov/grants/guide/notice-files/not-od-14-124.html). Open access data generally includes high level genomic data that is not individually identifiable, such as verified somatic variants, biospecimen data elements, most clinical data elements, and most imaging data. Controlled data generally includes individually identifiable data such as low-level genomic sequencing data (BAM, FASTQ files), germline variants, and certain potentially identifiable clinical data elements. The DCIC will be responsible for coordinating the sharing of all data generated by 4DN investigators. The DCIC will accession all 4DN datasets and curate all metadata. 4DN DCIC will directly host and share open access data, including derived and processed data from raw data that is controlled access. For controlled access data, the DCIC will be responsible for coordinating data submission to the appropriate NIH repository (e.g., dbGaP) for distribution to the public.
The 4DN DCIC is expected to evolve, adapt, and improve throughout the project in response to the needs of the 4DN Network community. The DCIC team should solicit user feedback and otherwise evaluate all aspects of the usability of the DCIC to best serve the needs of the 4DN Research Network and the broader research community. As the data storage, analysis, and dissemination needs of the 4DN program evolve over time, the DCIC may be asked to implement modifications to its workflows as agreed upon by the 4DN investigators and NIH staff. The DCIC should be flexible in their implementation of data coordination, analysis, and outreach efforts.
Consortium Responsibilities
This FOA uses the U01 Cooperative Agreement mechanism. Successful applicants will become members of the larger 4D Nucleome Consortium composed of investigators who have been funded in response to at least one of the six related 4DN Network FOAs. In addition to completing the research goals outlined in their applications, successful applicants will be expected to work collaboratively with all members of the 4D Nucleome Network, including the 4DN Network Organizational Hub (RFA-RM-20-007) and the 4DN Network Data Coordination & Integration Center (RFA-RM-20-008), to help develop common standards, metrics for data generation and storage, and data analysis and visualization tools that can be used by the broader scientific community. The 4DN Network will encourage the initiation of new collaborative research projects across the entire network.
A key aspect of this program is the formation of a consortium-type partnership amongst all 4DN Network awardees. Shared responsibilities derived from the use of the cooperative agreement mechanism are described later in this FOA and will be further articulated during the kickoff meeting of the 4DN Network that will take place a few months after awards are made. All 4DN Network investigators will be required to attend this initial 4DN Kickoff meeting, as well as annual 4DN investigator meetings and regular teleconferences with Network members and NIH Staff for the duration of the funding cycle.
All applicants are strongly encouraged to contact NIH Staff to discuss the alignment of their proposed work with the goals of this FOA, and the 4DN Program. A Technical Assistance teleconference will be held for potential applicants. NIH staff will be available to answer questions related to this FOA. Time, date, and dial in information for the call will be announced in an NIH Guide Notice and will be posted on the 4DN website: http://commonfund.nih.gov/4Dnucleome/index.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Need help determining whether you are doing a clinical trial?
The Office of Strategic Coordination (Common Fund) intends to commit $2.5M in FY 2020 to fund 1 award. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The total project period requested for this FOA may not exceed five years.
Eligibility is limited to the currently funded 4DN Data Coordination and Integration Center (DCIC) supported through RFA-RM-14-011.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Sean E. Hanlon, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-781-3310
Email: [email protected]
In addition, applicants should:
All instructions in the SF424 (R&R) Application Guide must be followed.
In addition:
Leadership Effort Commitment: The effective management of a data coordinating center requires a significant commitment by the Program Director(s)/Principal Investigator(s). For single PD/PI applications, the PD/PI must commit and maintain through the life of the award a minimum of 2.0 person-months of effort. For applications with multiple PDs/PIs, each PD/PI is expected to commit sufficient time to serve their role, with a minimum aggregate PD/PI effort of 2.0 person-months through the life of the award. The appropriateness of the effort of key personnel must be justified in the budget justification.
4DN DCIC Administrator: Based on the complexity of the 4DN DCIC, the DCIC PD(s)/PI(s) are strongly encouraged to propose and budget for an 4DN DCIC Administrator to manage day-to-day operations and work with the DCIC PD(s)/PI(s), NCI staff, and 4DN investigators to manage and coordinate the DCIC activities.
Travel Funds: The budget should include funds to support travel for 4DN activities, including but not limited to supporting the travel and participation of PD(s)/PI(s) and other 4DN DCIC members at the annual 4DN Network Investigator's meetings.Specific Aims: Specific Aims should address the three subsections described below (DCIC Vision and Management; Data Standards, Storage, Analysis, and Dissemination; and Consortium Interactions and Outreach).
Research Strategy: In lieu of the standard sub-sections listed in the SF424 (R&R) Application Guide, the Research Strategy must consist of the following modified sub-sections.
Sub-Section A: DCIC Vision and Management
Overview and Goals – Applicants should describe the ultimate goals/deliverables of the 4DN DCIC. Deliverables should be quantitative whenever possible and would include items such as:
As mentioned above, it will be difficult to predict the exact volume and types of data that will be submitted over the lifetime of the 4DN Program. As the data production, storage, analysis, and dissemination needs of the 4DN Network change with time, the 4DN DCIC may be asked to implement modifications to their workflow and deliverables and applicants must demonstrate their willingness and aptitude to be flexible in their implementation of 4DN Network data coordination.
Milestones and Progress – Applicants should define a clear set of annual milestones with metrics that will document progress towards the achievement of the ultimate goals. Quantitative milestones are required to provide clear indicators of a project's continued success or emergent difficulties and will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years. Examples include, but are not limited to, milestones that track time to develop data standards and formats, turn-around time to analyze and/or release submitted data, or progress on analysis and visualization software implementation activities. Applicants should include plans for critically evaluating and revising these milestones on a regular basis. Applicants should describe how they will prioritize their activities to ensure that the main goals of the DCIC will be achieved. Milestones may be revised at the time of the award. Applicants should also describe plans to solicit user feedback, monitor metrics of DCIC usage, and otherwise evaluate all aspects of the usability of the 4DN DCIC. This plan should describe the frequency of these evaluations and how this information will be used to improve the utility of the DCIC.
Management and Communication Plan – Applicants should describe the plans for management and integration of the 4DN DCIC activities. Applicants should describe how they will manage the proposed project, who will oversee the day-to-day activities (e.g., a DCIC Administrator if not the PD/PI) and how the management structure will support achievement of the proposed goals and milestones. Useful elements of this description include: the organization of the proposed project; its management structure; key personnel and leadership structure; and oversight mechanisms for evaluating progress towards milestones. Applicants should describe how the team provides the appropriate expertise in the relevant areas, including, but not limited to: consortium management, information technology and bioinformatics, genomics and imaging-based nuclear architecture data, and data analysis and visualization. Applicants should describe plans for ongoing communication within the 4DN DCIC and between the DCIC and other components of the 4DN network. Plans for addressing some of the anticipated challenges of the 4DN DCIC should also be included. The plan should also describe how the various elements of the proposed production effort will be integrated, and how collaborations or subcontracts, if proposed, will be managed.
Sub-Section B: Data Standards, Storage, Analysis, and Dissemination
Data Portal Development – Applicants should describe plans for continuous development and maintenance of the 4DN Data Portal. The 4DN Data Portal must provide user-friendly submission of and access to genomics-based and imaging-based 4DN data, metadata, and analysis and visualization tools. The web-interface should provide controlled-access to both 4DN investigators and the broader scientific community. Each submitted dataset must be assigned a unique identifier that enables subsequent tracking for submitted data of all types. This pipeline must include quality assurance steps to monitor the quality of the submitted data and metadata, along with steps to release these data and metadata through the public data portal in a timely fashion. As the identity of the actual funded projects will not be known at the time that the applications in response to this FOA are due, applicants should provide a general submission plan. It is anticipated that most datasets generated by the 4DN network will be genomics-based data or advanced imaging-based data. In some cases, there will also be associated clinical and/or epidemiological data. The plan should describe how the DCIC will handle a range of data types from a variety of organisms and how the DCIC will provide the flexibility to accommodate increasing data volume and evolving data types. The plan should describe the capacity to scale activities as data volumes or complexity change over the course of the project. At the end of the project, the DCIC must be able to transfer the 4DN Network data to any other informatics resource, as designated by the NIH.
Data Storage and Access – Applicants should describe a plan for where and how all data, metadata, analysis and visualization tools, and computational models generated by the 4DN network will be stored. The DCIC team will need to work with the NIH STRIDES Initiative (https://datascience.nih.gov/strides) to facilitate use of STRIDES resources for cloud-based storage of 4DN data and resources. The DCIC will be responsible for coordinating the sharing of all data generated by the 4DN Network. The DCIC will accession all 4DN datasets and curate all metadata. 4DN DCIC will directly host and share open access data, including derived and processed data from raw data that is controlled access. For controlled access data, the DCIC will be responsible for coordinating data submission to the appropriate NIH repository (e.g., dbGaP) for distribution to the public. The data storage plan should describe a system that can distinguish between and segregate controlled-access and open-access data.
Information Technology and Technology Development – Applicants should discuss all pertinent informatics issues involved in providing the basic IT infrastructure/system administration for the proposed project. The plan should describe a framework to facilitate complex data loading including detailed experimental descriptions and metadata. The database infrastructure should be flexible and extensible to facilitate storage, management, and sharing of multiple types of data that may be generated by 4DN investigators, including genomics, proteomics, and advanced imaging. Incremental technology improvements may play an important role in increasing the efficiency and decreasing costs for the DCIC. Applicants are encouraged to include plans for such technology development activities in their applications, such as supporting new software tools to improve data management, increasing the efficiency of existing software, or developing an Application Programming Interface (API) to facilitate interactions with other resources. The plans for technology improvement should be well described and the cost of the proposed technology development should be justified in terms of reducing the overall operating costs for the DCIC.
Implementation and Development of Analysis and Visualization Tools – Applicants should describe plans for implementing analysis and visualization tools developed by 4DN investigators at the DCIC. Plans should include approaches for engineering and standardizing tools to function in the DCIC environment as needed. Applicants may also describe plans for developing user-friendly analysis and visualization tools. Priority should be given to tools and software that are modular, open-source, include appropriate documentation, use standard formats for data input and output, provide novel or enhanced functionalities, and are considered likely to be broadly useful to 4DN investigators and the broader research community including biomedical researchers and bioinformatics experts. Applicants should also describe plans for facilitating analysis interactions amongst 4DN investigators and between 4DN investigators and the broader scientific community. These plans may include, but are not limited to, implementing regular Data Analysis Working Group conference calls and organizing data analysis and visualization workshops
Centralized Access of Nuclear Architecture Data and Navigable Reference Maps – The DCIC will provide centralized access to all completed reference nuclear architecture datasets and models developed by 4DN investigators. In addition, the DCIC must work in close coordination with the 4DN Centers for Data Integration, Modeling and Visualization (RFA-RM-20-004) to develop or implement a system for visualizing and interacting with navigable reference maps. Applicants should describe their visions and plans to implement these capabilities.
Data Export and Dissemination – Applicants should include plans for exporting data to ensure the long-term archiving and distribution of 4DN datasets and tools. Repositories may include, but are not limited to, the Gene Expression Omnibus (GEO) at the National Center for Biotechnology Information (NCBI), the database of Genotypes and Phenotypes (dbGAP) at the NCBI (for controlled access datasets), the Common Fund Data Ecosystem (CFDE), or other resources deemed suitable by the 4DN consortium and NIH staff. Applicants should describe plans for developing an export process and pipeline to permit timely transfer of 4DN data to appropriate public repositories and community databases. Applicants should describe plans for seeking input from 4DN investigators and the broader research community about the best approaches for long-term storage of 4DN datasets. Regardless of where datasets are deposited, the 4DN DCIC will provide user-friendly access to the open access 4DN-generated data and metadata for the duration of the Program. Data and metadata must be available in standard formats and adhere to the FAIR (findable, accessible, interoperable, and reusable) principles to ensure the data and results are maximally useful to members of the 4DN Network and the broader scientific community.
Sub-Section C: Consortium Interactions and Outreach
Interactions with 4DN Data Producers – Development of the 4DN DCIC will require the DCIC team to work closely with 4DN investigators and NIH staff. Applicants should describe plans and strategies for facilitating interactions that allow the efficient development of the DCIC. DCIC tasks that will require significant interaction with members of the 4DN Network include, but are not limited to:
Data Wrangling – The DCIC must provide mechanisms and staff to interact with the data production groups to facilitate the timely and efficient transfer of data and metadata to the DCIC. Applicants should describe plans for working closely with 4DN investigators and NIH staff to ensure that all data and metadata, protocols, biospecimen and reagent information, analysis and visualization tools, and navigable reference maps generated or developed by 4DN investigators are deposited in a timely manner and made accessible through the 4DN DCIC consistent with the sharing policies of the 4DN.
Outreach, Training, and User Support – Applicants should describe a plan and allocate sufficient resources to provide training and outreach to the user communities to educate the community about the 4DN Network and its data, analysis and visualization tools, and navigable reference maps. This plan should include training and resources for both specialists and non-specialists to make the best use of the 4DN data and tools. Applicants should describe plans to develop and update 4DN DCIC user documentation such as user manuals and training guides that describe features of the 4DN Data Portal, web-based tutorials, and troubleshooting tips to assist 4DN DCIC data submitters and data consumers. Applicants should describe user support activities to be performed by the 4DN DCIC staff including, but not limited to, receiving and addressing user inquires, providing email support, and providing summary reports of questions and responses as appropriate. Plans should also describe outreach approaches to expand the awareness and use of 4DN data and tools including publications, presentations, short courses, hands-on workshops, and symposia offered independently or in conjunction with scientific meetings attended by the user community.The following modifications also apply:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific to this FOA: What is the likelihood that DCIC, as proposed, will meet all the data management, coordination, processing, analysis, and visualization needs of the 4DN Network? How well will the proposed plans facilitate the coordination with 4DN investigators and promote broader outreach and sharing of 4DN data and resources?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this FOA: How well do the PD(s)/PI(s) demonstrate evidence of experience working productively in collaborative environments and in large, distributed scientific projects? How well do the PD(s)/PI(s) and/or key personnel demonstrate scientific expertise and knowledge in the areas relevant to the 4DN Network including management and analysis of both genomics data and advanced molecular imaging data?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Specific to this FOA: How well do the proposed data management, coordination, processing, analysis, integration, and visualization approaches address current scientific or technical challenges in creative ways?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Specific to this FOA: How reasonable and appropriate are the milestones and goals proposed for the 4DN DCIC? How reasonable and appropriate are the plans to ingest, process, store, and disseminate the relevant 4DN datasets? How reasonable and appropriate are the plans to work with other 4DN Network members to define data and metadata requirements, develop processing pipelines, and facilitate data submission? How reasonable and appropriate are the plans for training and providing support and outreach to users of the 4DN DCIC with different levels of bioinformatics skills?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Specific to this FOA: Is the computational infrastructure adequate to meet the needs of the project? How well does the environment promote collaborations and transdisciplinary approaches to solving the technical and scientific problems of the proposed 4DN DCIC?
For research that involves human subjects but does not involve one of thecategories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not Applicable
For Renewals, the committee will consider the progress made in the last funding period.
Not Applicable
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
Applications will be assigned
to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.htmlor call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 75, and other HHS PHS, and NIH grant administration policies.
The administrative and funding instrument used for all awards in the 4DN program will be the cooperative agreement (U01 or UM1 grants), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. A Memorandum of Understanding (MOU) developed by the NIH Common Fund should serve as a guidance document to provide a framework under which relationships between investigators and NIH Program Staff are established. Templates for Confidential Disclosure Agreements (CDAs) and Collaborative Research Agreements (CRAs) have been developed by the NIH Office of Technology Transfer. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
Responsibilities of PD(s)/PI(s):
Sharing:
Involvement of NIH Program Staff
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of joint responsibilities:
4DN Consortium Steering Committee
The awardee agrees to the role and authority of the 4DN-SC that is responsible for joint governance of 4DN Consortium activities. The main characteristics and functions of the 4DN-SC are as follows:
4DN Data Release and Use, Software Sharing and Publication Policies
The PD/PI agrees to follow the 4DN Data Release and Use, Software Sharing and Publication Policies as currently stated (see https://www.4dnucleome.org/policies.html), and to follow any updates to these policies that may be approved by the 4DN-SC in the future.
4DN External Program Consultants (4DN-EPCs)
An independent panel of 4-8 External Experts will be appointed on an ad hoc basis by NIH and meet by teleconference or in person with the 4DN Program Staff at least once a year. The 4DN-EPCs will be updated on progress and provide feedback to NIH on adjustments and future directions for the 4DN Network activities. NIH staff will appoint a 4DN-EPC Chair who will attend the annual 4DN Network Investigator Annual Meeting and be invited to participate ex officio in 4DN-SC meetings. All 4DN-EPCs will be given the opportunity to listen to 4DN-SC meetings and to attend the annual 4DN Network Investigator Annual Meeting. The 4DN-OH will support costs for 4DN-EPCs who wish to participate in the 4DN Network Investigator Annual Meeting.
Dispute Resolution
Disagreements that may arise in scientific/technical matters, publication/authorship matters or programmatic matters (within the scope of the award) between award recipients, or between award recipients and the NIH, may be brought to arbitration after first attempting to resolve the issue through the 4DN-SC or its subcommittees, as appropriate. An Arbitration Panel composed of three members will be convened. The Panel will be composed of: a designee of the 4DN-SC chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two members; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure in no way affects the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreementsare required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings.Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
Finding Help Online:http://grants.nih.gov/support/(preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email:[email protected](preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support(Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email:[email protected]
Sean E. Hanlon, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-781-3310
Email: [email protected]
David Balasundaram, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1022
Email: [email protected]
Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]