Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
Office of Strategic Coordination (Common Fund)
This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (https://commonfund.nih.gov/) through the NIH Office of the NIH Director, Office of Strategic Coordination (https://commonfund.nih.gov/). All NIH Institutes and Centers participate in Common Fund initiatives. This FOA will be administered by the National Cancer Institute (NCI), (https://www.cancer.gov) on behalf of the Common Fund.
U24 Resource-Related Research Projects Cooperative Agreements
New
RFA-RM-21-008 - Cellular Senescence Network: Tissue Mapping Centers (U54 Clinical Trial Not Allowed)
RFA-RM-21-009 - Cellular Senescence Network: Technology Development and Application (UG3/UH3 Clinical Trial Not Allowed)
93.310
This funding opportunity announcement (FOA) invites applications for the Consortium Organization and Data Coordinating Center (CODCC) of the Cellular Senescence Network (SenNet) consortium. The goal of SenNet is to identify and functionally characterize the heterogeneity of senescent cells across multiple tissues in human health, and lifespan at single-cell resolution. The CODCC will serve as the organizational hub for SenNet collecting, storing, curating, and disseminating all data, metadata, analysis and visualization tools, computational models, and aggregate data across the Network into a searchable Atlas of Cellular Senescence; ensure the utility of the database; and promote collaboration through Network engagement with the research community.
New Date February 22, 2021
New Date March 22, 2021
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
July 2021
August 2021
December 2021
New Date March 23, 2021 per issuance of NOT-RM-21-015. (Original Expiration Date: March 9, 2021)
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to identify and support a Cellular Senescence Network (SenNet) Consortium Organization and Data Coordinating Center (CODCC). The goal of the SenNet consortium is to identify and functionally characterize the heterogeneity of senescent cells across multiple tissues in human health and lifespan at single-cell resolution. The CODCC will collect, store, curate, and disseminate all data, metadata, analysis and visualization tools, computational models, and completed tissue maps generated by the SenNet, and will do so in alignment with existing single cell data platforms such as those developed for the Human Tumor Atlas Network (HTAN), Human Biomolecular Atlas Program (HuBMAP), and Human Cell Atlas (HCA). Additionally, the CODCC will ensure that SenNet reuses applicable common data elements, data and metadata standards, clinical and epidemiological data requirements, and data processing pipelines established for HTAN, HuBMAP, and HCA and integrate SenNet into the Common Fund Data Ecosystem (CFDE). The CODCC will also coordinate SenNet activities including in-person and virtual Network Steering Committee meetings and working groups. Finally, the CODCC will promote collaboration and communication among SenNet Investigators and the broader research community in coordination with the Common Fund Data Ecosystem (CFDE). The CODCC will have two major areas of responsibility: (1) Data Analysis and Integration: including developing standard operating procedures for storage, analysis, dissemination, and deposition of all SenNet-generated data and (2) Administrative Core: including consortium coordination and outreach. The CODCC will be part of the SenNet which will also include SenNet Tissue Mapping Centers (solicited under RFA-RM-21-008) and SenNet Technology Development Projects (solicited under RFA-RM-21-009).
The Cellular Senescence Network (SenNet)
The purpose for the Cellular Senescence Network (SenNet) is to catalyze the development of a framework for mapping cellular senescence and its associated secretory phenotype at high resolution, to provide atlases of cellular senescence in multiple tissues and under diverse conditions, including early development, and across the lifespan. In addition, it is expected that the SenNet will provide comprehensive sets of biomarkers describing heterogenous senescent cell states.
The proposed Cellular Senescence Network will be funded by the NIH Common Fund as a goal-driven strategic investment, with deliverables intended to catalyze research across multiple biomedical research disciplines. The deliverables will provide a sound platform to develop approaches for the betterment of human health. This will be achieved by:
While the current SenNet components are focused on human tissues, accommodating murine studies will be a future consideration.
There are three research initiatives that comprise the program:
Successful applicants to this funding opportunity announcement will become members of the larger SenNet, composed of investigators who have been funded in response to at least one of the three SenNet FOAs. All projects within the SenNet will be funded as Cooperative Agreements, so that NIH staff will have a significant role in shaping the scientific aspects of the project. During the first year of the award, each TMC will establish an Administrative Core which will collaborate closely with its own Data Analysis Core and the SenNet Data Coordination Center (CODCC) to develop harmonious Standard Operating Practices, to generate data packages suitable for the development of the desired atlases, to evaluate novel approaches (especially as developed by the Technology Development Projects) and to coordinate activities with other TMCs. More specifically, the Administrative Core will ensure that, in addition to completing the research goals outlined in their own applications, each team works collaboratively with all members of the Network to contribute to developing data and metadata standards, develop metrics for data generation, participate in cross-site studies, engage in cross-training, and guide development of data analysis and visualization tools that can be used by the broader scientific community.
Background and Objectives of the Cellular Senescence Network (SenNet) consortium:
Cellular senescence was initially described by Hayflick and Morehead in 1961, but remained relatively understudied for the next 3 decades, as senescence was originally thought to be an in vitro phenomenon. However, starting in 2001, work by multiple groups showed that senescent cells can negatively affect their local tissue environments through multiple pathways including the Senescence-Associated Secretory Phenotype, or SASP. The subsequent finding that these cells are found in vivo and are more abundant than previously thought led to the development of genetic and pharmacologic methods to manipulate or remove senescent cells. Importantly, removal of SC in adult mice led to significant improvements in both healthspan and lifespan.
These advancements have resulted in significant interest in the development of senolytics, drugs that can preferentially eliminate senescent cells. However, several issues need resolution before interventions to remove senescent cells are tested in humans. For example, while excessive accumulation of senescent cells is associated with deleterious late-life effects including accelerated aging and increased susceptibility to chronic diseases such as atherosclerosis, cancer, cardiac dysfunction, kidney dysfunction, neurodegeneration, pulmonary fibrosis and many others, senescent cells also serve beneficial roles during tissue remodeling in embryogenesis, as well as during parturition and wound healing. In addition, their role as a tumor protection mechanism is also well established.
Progress in the past few years has also indicated a large heterogeneity in senescent cells characteristics depending on the inducing agent or pathway, the cell type and tissue, and life stage. Similarly, the SASP appears as heterogeneous as the cells from which it is derived. Therefore, understanding the mechanisms that distinguish beneficial from deleterious senescence and the heterogeneity underlying senescent cell states are critical knowledge gaps. As the science progresses, it is clear that a one size fits all for the development of senolytics that only remove deleterious without touching beneficial senescent cells is not realistic, and a detailed characterization of senescent cell states and their associated SASP is an urgent need.
To address the knowledge gaps noted above, the NIH intends to support a Cellular Senescence Network (SenNet) which will identify biomarkers and construct tissue atlases that describe multidimensional parameters of senescence across diverse tissue environments at molecular, cellular, and morphological levels and over longitudinal time frames. The SenNet effort builds upon and extends existing single cell tissue mapping efforts including the Human Tumor Atlas Network, Human Biomolecular Atlas Program, and Human Cell Atlas. Together with the SenNet program, these efforts will continue to generate important resources for the scientific community that will inform future research and, ultimately, clinical decision-making. While the current RFA is focused only on human tissues, the goal of the SenNet is to construct atlases of cellular senescence across multiple tissues, in response to multiple inducers and modifiers in both mice and humans. The SenNet will be comprised of Tissue Mapping Centers (this RFA), solicited under RFA-RM-21-008) and Technology Development Projects (solicited under RFA-RM-21-009), and a Consortium Organization and Data Coordination Center (CODCC, solicited under RFA-RM-21-010).
Consortium Organization and Data Coordination Center (CODCC):
Research Objectives
The overarching mission of the CODCC is to collect, store, curate, and disseminate all data, metadata, analyses and visualization tools, computational models, and completed tissue atlases generated by the SenNet consortium and to do so in a manner that ensures interoperability with data from other single cell atlasing efforts including HuBMAP, HTAN, and or HCA. Compile tissue atlases are expected to be assembled into a searchable Atlas of Cellular Senescence. Additionally, the CODCC will ensure that SenNet reuses applicable common data elements, data and metadata standards, clinical and epidemiological data requirements, and data processing pipelines established for HTAN, HuBMAP, and HCA and integrate SenNet into the Common Fund Data Ecosystem (CFDE). The CODCC will also coordinate SenNet activities including in-person and virtual Network Steering Committee meetings and cross-consortium working groups and integration into the larger Common Fund Data Ecosystem (CFDE). Finally, the CODCC will promote collaboration and communication among SenNet investigators and the broader research community in coordination with the Common Fund Data Ecosystem (CFDE).
Open and Controlled SenNet Data Access - To the extent that information considered for inclusion in SenNet, either as separate datasets or in combination with other data, triggers human subjects, privacy, or other laws or regulations, the CODCC must establish appropriate data sharing policies and data access procedures consistent with the provision of data to the public with a minimal embargo period, taking all steps needed to protect the information, and take other steps to protect the information of research participants. In addition, if the CODCC will store and permit controlled access to genomic data, included datasets must be consistent with the NIH Genomic Data Sharing Policy (NOT-OD-14-124) and the NIH Notice for Use of Cloud Computing Services for Storage and Analysis of Controlled-Access Data Subject to the NIH Genomic Data Sharing Policy (NOT-OD-15-086), as applicable. Finally, the CODCC will be primarily responsible for developing, getting approval, and implementing any Consortium-level data sharing policies.
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 SenNet will be open access, which means that no authentication or authorization is necessary to access it. Other data generated will be controlled access, which means that the database of Genotypes and Phenotypes (dbGaP) authorization and eRA Commons authentication are necessary for access to this data when the data is made publicly available. Whether a dataset is open or controlled is determined according to NIH Data Access Policies in a process that is driven by informed consent of research participants. SenNet is expected to use a process that provides consent for general research purposes. Decisions on which data generated by the SenNet are open or controlled access will be made in conjunction with the SenNet investigators, the Program Officer, and the NIH Office of Science Policy.
The SenNet CODCC will be responsible for establishing a cloud-based platform to house all data generated by the SenNet; cloud costs will provided through in-kind costs available through the STRIDES initiative. However, while the CODCC will host and share all SenNet data within the network (both controlled and open access data), the CODCC will only distribute open access data to the public. The CODCC will be responsible for ensuring any controlled access data generated by SenNet is submitted to the appropriate repository (e.g., the Genomic Data Commons, dbGaP) for distribution to the public. Consequently, the CODCC will be responsible for the creation of a system that can distinguish between and segregate controlled-access and open-access data. Because the SenNet CODCC will only distribute open access data to the public and will rely on other NIH repositories for distribution of controlled access data; the SenNet CODCC will not become an NIH Trusted Partner.
Activities directed by the CODCC include but are not limited to the following two components: Data Analysis and Integration: Including Data Standards, Storage, and Dissemination, and an Administrative Core: Including Consortium Coordination and Outreach:
Data Analysis and Integration: Including Data Standards, Storage, and Dissemination
Administrative Core: Including Consortium Coordination and Outreach
Other CODCC Application Considerations
There are a number of additional issues that applicants should consider when crafting their applications. These include:
CODCC applicants are encouraged to read the Tissue Mapping Centers (RFA-RM-21-008) and Technology Development Projects (RFA-RM-21-009) RFAs for more information regarding data generation and atlas construction.
Governance of the SenNet: The awards funded under this FOA will be cooperative agreements (see Section VI. 2. Cooperative Agreement Terms and Conditions of Award). Close interactions among the awardees and NIH will be required to maintain this complex program. All components will be governed by the SenNet Steering Committee (see Section VI: Terms and Conditions of Cooperative Agreement).
Performance Requirements: Meet yearly milestones as defined by investigators and NIH Program Official at the time of award. Work with, cooperatively interact with, and actively seek input from NIH.
Evaluation of the Program: As the efficiency of the funded research is an important priority for NIH, representatives from all award projects will be expected to participate in an external evaluation process of the SenNet coordinated by NIH Program Staff (see Section VI: Terms and Conditions of Cooperative Agreement.)
Leveraging STRIDES for Cloud Computing Activities
The NIH Science and Technology Research Infrastructure for Discovery, Experimentation, and Sustainability (STRIDES) initiative has established partnerships with commercial cloud service providers (CSPs) Google and Amazon Web Services (AWS) to provide favorable pricing for cloud-based costs. The NIH Common Fund, managed by the Office of Strategic Coordination, is using the STRIDES partnerships to provide in-kind support for CSP costs. For more details, please see NOT-RM-20-009.
Incomplete Applications
The following types of applications are incomplete and will not be reviewed.
Applications that do not address all sub-sections described in the Research Strategy instructions (see Section IV.2: Content and Form of Application Submission - PHS 398 Research Plan).
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
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.
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The NIH Common Fund (Office of Strategic Coordination) intends to commit $3.5M Total Costs per year in FY2021 to fund up to 1 award. The award is contingent upon NIH appropriations and the submission of a sufficiently meritorious applications.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are 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.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
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.
An investigator designated as the Contact PD/PI or MPI of an application under this FOA must not be the designated Contact PD/PI of another application under the companion SenNet FOAs RFA-RM-21-008 and RFA-RM-21-009
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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.
Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
T. Kevin Howcroft, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6229
Email: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Demonstrate strong scientific expertise in the areas that are critical to the success of the application.
Describe any experience in successfully leading the coordination of data intensive activities and management and analysis of high-throughput datasets such as those to be generated by the SenNet.
All instructions in the SF424 (R&R) Application Guide must be followed.
With the following addition:
Leadership Effort Commitment: The CODCC contact PD/PI must commit and maintain through the life of the award a minimum of 2.4 person-months of effort. For applications with multiple PDs/PIs, a minimum effort of 1.8 person-months is required for the Contact PD/PI and 1.2 person-months of effort per additional PD/PI is required.
CODCC Program Manager: Based on the complex roles the CODCC will play in organizing the SenNet, the CODCC PD(s)/PI(s) are strongly encouraged to propose and budget for an CODCC Program Manager to manage day-to-day operations and work with the CODCC PD(s)/PI(s), NIH staff, and SenNet Investigators to manage and coordinate the CODCC activities.
Travel Funds: The budget should include sufficient funds to support travel for SenNet activities, including but not limited to supporting the travel and participation of PD(s)/PI(s) and other CODCC members at twice yearly SenNet Steering Committee meetings.
The CODCC is responsible for arranging for and supporting travel expenses for up to six external program consultants to in-person Steering Committee meetings.
The CODCC is responsible for arranging for a meeting space(s) to accommodate 50-100 investigators for twice yearly in-person Steering Committee meetings at a non-federal facility in the Bethesda, MD area.
The CODCC is responsible for arranging for and supporting travel costs of approximately six NIH appointed External Program Consultants to the twice-yearly consortium-wide grantees meeting.
Equipment: If pieces of specialized equipment or computers exceeding $5,000 are requested, the application must provide a clear justification for the purchase in Budget Justification.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: Specific Aims should address the three subsections described below (Overall CODCC Vision and Management; Data Analysis and Integration: Including Data Standards, Storage, Analysis, and Dissemination; and Administrative Core: Including Consortium Coordination 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: Overall CODCC Vision and Management
Overview and Goals Applicants should describe the ultimate goals/deliverables of the CODCC. Deliverables should be quantitative whenever possible; expressed using a Gannt chart; and should address critical items such as:
It will be difficult to predict the exact volume and types of data that will be submitted over the lifetime of the SenNet Program. Thus, as the data production, storage, analysis, and dissemination needs of the SenNet change with time, the CODCC 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 SenNet coordination.
Leadership Plan: Describe the leadership team and how components of the CODCC, including key personnel, will interact within the CODCC itself, with the broader SenNet, the Common Fund Data Ecosystem, other single-cell atlasing efforts, and NIH program staff. Describe prior experience in working as part of a research network or other large-scale collaborative activities to meet individual and group goals, including examples of such prior work. Describe how decisions will be made by the leadership team and carried out. Describe mechanisms to ensure effective internal management of ongoing research activities across the CODCC.
Milestones and Progress Applicants should define a clear set of semi-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 release submitted data and the completed Atlas, or 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 CODCC 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 data usage, and otherwise evaluate all aspects of the usability of the CODCC. This plan should describe the frequency of these evaluations and how this information will be used to improve the utility of the CODCC.
Management and Communication Plan Applicants should describe the plans for management and integration of the CODCC activities. Applicants should describe how it will manage the proposed project, who will oversee the day-to-day activities (e.g., a CODCC 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 plans for ongoing communication within the CODCC and between the CODCC and other components of the SenNet. Plans for addressing some of the anticipated challenges of the CODCC 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 Analysis and Integration: Including Data Standards, Storage, and Dissemination
Data Portal Development Applicants should describe plans for developing a data portal that can be accessible through the main SenNet Web Portal. The SenNet Data Portal will provide user-friendly submission of and access to SenNet data (both raw data and derived datasets), metadata, analysis and visualization tools, computational models, and completed atlases generated by the SenNet. The web-interface should provide access to both SenNet members and the broader scientific community and should integrate with other single-cell atlasing efforts such as the Human Tumor Atlas Network, Human Biomolecular Atlas Program, and Human Cell Atlas. Applicants should describe a submission pipeline for both raw and derived datasets generated by SenNet Investigators. 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 to 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 handled by the CODCC will be next-generation sequencing data, proteomics data, and molecular and clinical imaging data. There will also be a spatial and temporal component to the data and associated clinical and epidemiological data. The plan should describe how the CODCC will handle a range of data types and how the CODCC 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 CODCC must be able and willing to transfer the SenNet data and computational tools to any other informatics resource, as designated by the NIH.
Data Security -- Applicants should provide a plan for satisfying federal data security regulations. The SenNet CODCC will be considered a federal electronic information system and as such, must meet the relevant federal regulations. This includes adopting and implementing the policies, procedures, controls, and standards of the HHS Information Security Program to ensure the integrity, confidentiality, and availability of Federal Information and the Federal Information system. The HHS Information Security Program is outlined in the HHS Information Security Program Policy, which is available on the HHS Office of the Chief Information Officer's (OCIO) Website, http://www.hhs.gov/ocio/index.html. This policy is in accordance with the Federal Information Security Management Act (FISMA).
The core data sets defined for the SenNet are categorized as Federal Information Management Security (FISMA) Law. The security requirements for this CODCC implementation include, but are not limited to, preparation of an IT Security Plan, IT Risk Assessment, FIPS 199 Assessment, and performance of security control testing and evaluation. The awardees will be responsible for attaining the Authority To Operate (ATO) from the NIH Program Officer. Additionally, any proposed solutions using a commercial cloud must demonstrate an understanding of FedRAMP requirements (http://www.fedramp.gov) and describe an approach for achieving compliance if FedRAMP has not yet been achieved.
Data Storage and Access Applicants should describe a plan for where and how all data, metadata, analysis and visualization tools, computational models, and completed atlases generated by the SenNet will be stored. The data, tools, models, and atlases are expected to be stored on a commercial cloud; costs for these services will be covered through provision of in-kind services via STRIDES.
Applicants who anticipate requiring >$10,000 direct costs in commercial cloud services from either Google or AWS in any one year of the anticipated award are expected to request in-kind support via the Common Fund STRIDES partnerships rather than requesting direct cost support for these services. To request in-kind support for cloud services via STRIDES, applicants must outline the anticipated costs of commercial cloud services in the Budget Justification section, including, but not limited to, data storage, analysis, data movement/egress, professional services, training, and related activities. Please review NOT-RM-20-009 for important details about how to provide this information in your application.
However, local private servers, existing public data repositories, or a combination of these solutions can also be proposed. The plan should include a description of why specific solutions are being implemented and how those advance the overall goals of the CODCC and the SenNet.
The SenNet CODCC will be responsible for ensuring all data generated by the SenNet is archived and retrievable. However, while the SenNet CODCC will host and share all SenNet data within the network (both controlled and open access data), the SenNet CODCC will only distribute open access data to the public. The SenNet CODCC will be responsible for submitting any controlled access data generated by SenNet to the appropriate repository (e.g., the Genomic Data Commons, 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 and how existing data platforms may be reused for this project. The plan should describe a framework to facilitate complex data loading including detailed experimental descriptions and metadata, especially for experimental results generated using high throughput or data-intensive approaches. The database infrastructure should be flexible and extensible to manage and integrate multiple types of data that may be generated by SenNet investigators, including genomics, proteomics, molecular and cellular imaging, clinical imaging, clinical and epidemiological data, as well as spatial and temporal information. All efforts to reuse existing infrastructure and to interoperate with existing single cell atlas platforms must be described. Incremental technology improvements may play an important role in increasing the efficiency and decreasing costs for the CODCC. Applicants are encouraged to include plans for such technology development activities in their applications, such as supporting new software tools to improve data management or making existing software more efficient (e.g., improving sequence read alignment software or data processing pipelines). 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 CODCC. Additionally, applicants should describe a plan to develop an Application Programming Interface (API) to facilitate interactions with other Common Fund data coordinating centers and components of the Common Fund Data Ecosystem.
Interactions with SenNet Data Producers Development of the SenNet CODCC will require the CODCC team to work closely with SenNet Investigators and NIH staff. Applicants should describe plans and strategies for facilitating interactions between CODCC team and the SenNet investigators and NIH staff to:
Note that these challenges have previously been addressed by other single-cell atlasing efforts, such as the Human Tumor Atlas Network, Human Biomolecular Atlas Program, and Human Cell Atlas. Applicants must address how they will reuse existing formats, common data elements, data types, pipelines, and describe where senescent cell-specific issues will require new efforts.
Data Wrangling The CODCC must provide mechanisms and staff to interact with the data production groups to facilitate the timely and efficient transfer of data, metadata, and atlases (provided by TMC groups) to the CODCC. Applicants should describe plans for working closely with SenNet Investigators and NIH staff to ensure that all data and metadata, protocols, biospecimen and reagent information, analysis and visualization tools, and completed atlases generated or developed by SenNet Investigators are deposited in a timely manner and made accessible through the SenNet Web Portal and/or SenNet Data Portal consistent with the NIH Data Sharing policy.
Implementation of Analysis and Visualization Tools Applicants should describe plans to implement analysis and visualization tools developed by SenNet Investigators or CODCC investigators at the SenNet Data Portal. Priority should be given to tools and software that are modular, open-source, include appropriate documentation, use standard formats for data input and output, and are considered likely to be broadly useful to SenNet Investigators and the research community at large. In addition, plans for implementing single-cell visualization tools developed by existing single-cell atlasing programs such as the Human Tumor Atlas Network, Human Biomolecular Atlas Program, and Human Cell Atlas should be described.
Centralized Access and Comparative Analysis of Atlases The CODCC will provide centralized access to all completed atlases generated by the Tissue Mapping Centers. In addition, the Data Portal should develop a unified platform that will integrate all atlases to enable comparative viewing and analysis. Applicants should describe their visions and plans to implement these capabilities.
Data Export and Dissemination Applicants should describe plans for developing an export process and pipeline to permit timely transfer of SenNet data from consortium data freezes or publications to appropriate public repositories and community databases to ensure the long-term availability of SenNet generated data. These repositories may include, but are not limited to, the database of Genotypes and Phenotypes (dbGAP) at the National Center for Biotechnology Information (NCBI), Biostudies at the European Bioinformatics Institute (EBI), Ensembl at the EBI and the Wellcome Trust Sanger Institute, or a Network-wide instance of OMERO from the University of Dundee and Open Microscopy Environment. Regardless of where datasets are deposited, the SenNet-CODCC will facilitate user-friendly access to the open access SenNet-generated data and metadata for the duration of the Program. Data and metadata must be available in standard formats and adhere to the FAIR principles(findable, accessible, interoperable, and reusable) to ensure the data and results are maximally useful to members of SenNet and the broader scientific community.
Sustainability - As described above, NIH's vision for the CODCC is that it will become a long-term resource of high value to the larger biomedical community. It is therefore likely that the CODCC will participate and contribute to the establishment of a federated ecosystem with similar programs, such as the Common Fund Data Ecosystem. The FAIR principles will be important to adopt, follow, and contribute towards their evolution. During the lifetime of the SenNet new scientific and technological advances are likely to happen in storing, access, and computing on data. The CODCC should aim to identify, evaluate and incorporate new data science approaches and information technologies that improve the usage, quality, and quality, cost effectiveness and sustainability of the resources. Examples include, but are not limited to, the optimization of analysis tools and workflows for cloud platforms, the adoption of new data compression methods to reduce storage costs, advances in mapping and spatial statistics approaches, tools to improve data security and protection of research participant data, and the development of tools for the parallel deployment of analysis workflows in a federated ecosystem.
Sub-Section C: Administrative Core: Including Consortium Coordination and Outreach
Web Portal Development Applicants should describe a plan for developing and maintaining the main SenNet Web Portal that will constitute the main entry point for the sharing of resources and information related to SenNet activities. The SenNet Web Portal should provide user-friendly access and navigation to resources generated by the SenNet, including protocols, data standards, biospecimen and reagent information, tutorials, analysis and visualization tools, and completed atlases. SenNet Web Portal should also include access to the SenNet Data Portal. The SenNet Web Portal should allow for multiple levels of access, based on the level of confidentiality of the data, resource, or information being requested, such as "NIH Staff", "SenNet Investigator" and "Public" access levels. How the CODCC will integrate with other single-cell atlasing platforms such as the Human Tumor Atlas Network, Human Biomolecular Atlas Program, and Human Cell Atlas should be described.
SenNet Activity Coordination Applicants should describe an approach to provide the administrative infrastructure necessary to facilitate and coordinate all common activities of the SenNet. SenNet activities that will be coordinated by the SenNet-CODCC will include: semi-annual 2-3 day SenNet in-person Steering Committee Meetings and focused workshops, monthly SenNet virtual Steering Committee and subcommittees, virtual SenNet working groups, and external scientific panels. The plan should describe approaches for managing these activities through in-person or web-based meetings, developing minutes, and drafting reports for the various committees and working groups. Additionally, the plan should describe an approach to develop, maintain, and make accessible all significant SenNet-related documents, including policies, reports, standard operating procedures, and a secure site for storing manuscripts from SenNet investigators submitted for publication. The plan should also include approaches to facilitate interactions and collaborations with outside groups other Common Fund-supported research efforts, other NIH supported efforts, and/or non-NIH partners.
Outreach, Documentation and User Support Applicants should describe a plan and allocate sufficient resources to provide outreach to the user communities to educate the community about the SenNet and its data, resources, tools, and completed atlases. This plan should include resources for both specialists and non-specialists to make the best use of the SenNet data, protocols, SOPs, computational models, tools, and completed atlases. Examples include presentations, short courses, or symposia offered independently or in conjunction with scientific meetings attended by the user community and social media. Provide plans to develop and update SenNet CODCC user documentation on the Web Portal such as User's guides, FAQs, Troubleshooting Tips, web-based tutorials and other content to assist SenNet CODCC data consumers, data providers, and general users.
Describe typical user support activities to be performed by the SenNet CODCC staff including, but not limited to, receiving and addressing user inquires, providing email support, maintaining publicly accessible website for helpdesk operations, providing news and announcements, hosting application use reports, frequently asked questions and troubleshooting tips, and providing summary reports of questions and responses, including frequency of inquiries and duration between inquiry and resolution as appropriate.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
Applicants should indicate their willingness to abide by all data deposition, quality control metrics, standardization, metadata requirements, data and software release, and public copyright license policies developed by the SenNet and approved by NIH staff.
A primary goal of the SenNet is to lay the foundation for a widely accessible atlas of cellular senescence and this will require data and resources to be shared quickly and openly once validated. Restrictive licensing and sharing practices for SenNet-generated data, tools, and resources could substantially diminish their value and public benefit. Accordingly, awardees should manage data, resources, protocols, tools, and software in a way that achieves this goal. Sharing practices that would prevent or block access to or use of SenNet data, tools, and resources for research purposes will be considered as hindering the goals of the SenNet and will be considered non-responsive.
The development of policies, methods, and standards for such sharing is critically important. The NIH expects that the awardees, through the CODCC, will develop such policies, methods, and standards in concert with the NIH. These policies, methods, and standards will remain consistent with NIH-wide policies on data and resource sharing. Prior to funding, NIH Program Staff may negotiate modifications to the Sharing Plan with the applicant.Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or 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.
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.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Specific to this FOA: Will the CODCC, as proposed, including data management, consortium coordination, and outreach needs of the SenNet while avoiding duplicative development of standards, common data elements, formats, if they exist in other single-cell data platforms? Will the proposed CODCC be able to meaningfully contribute to SenNet, e.g., by resolving major challenges in data management, consortium coordination, and outreach?
Investigator(s)
Specific to this FOA: Do the CODCC PD(s)/PI(s) and their administrative team demonstrate evidence of working productively in collaborative environments and in large, distributed scientific projects?
Innovation
Specific to this FOA: Do the CODCC PD(s)/PI(s) propose innovative solutions to interoperate with other single cell atlas platforms, reusing data management strategies and methods when possible while innovating specifically on challenges related to senescent cell data? Do the CODCC PD(s)/PI(s) propose innovative solutions to meet and manage consortium coordination and outreach?
Specific to this FOA: Are the PD(s)/PI(s) overall vision of CODCC activities, and milestones to track progress sufficiently detailed? How well does the research plan address the SenNet CODCC's two major areas of responsibilities (1) Data Analysis and Integration: Including Data Standards, Storage, Analysis, and Dissemination; and (2) Administrative Core: Including Consortium Coordination and Outreach? Are plans for handling data traditionally challenging to capture in databases (for instance cellular and clinical imaging) adequately addressed? Are the approaches flexible and adaptable to the changing needs of the senescence community as the field matures? Have effective management and leadership plans been proposed to achieve the goals of the Administrative Core? Have they described effective strategies for working with other components of the Consortium? Are plans and infrastructure in place to assure data back-up, integrity, and uninterrupted service to the data repository? Does the application contain acceptable plans for addressing the NIH Data Sharing Policy?
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?
Environment
Specific to this FOA: Is the computational infrastructure adequate to meet the needs of the project? How well does the environment promote the collaborations, transdisciplinary approaches, and flexibility required to solve the technical and scientific problems of the proposed CODCC? Does it have the capacity to meet changing needs over time; is it nimble to changing data and policy requirements/demands?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Sharing Model Organisms; and (2) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
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.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) 2 CFR Part 200 Administrative Regulations, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, NIH Grants Policy Statement (which implements the aforementioned HHS Regulations (45 CFR Part 75), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or play 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.
The PD(s)/PI(s) will have the primary responsibility for:
Awardees will retain ownership of the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies and must be prepared to deliver them to an NIH-designated recipient at the conclusion of the program. Participating SenNet Research Center members are also encouraged to organize and participate in other SenNet meetings and workshops, organize collaborative activities, and promote Trans-Network collaborations, and organize and participate in scientific and programmatic working groups.
NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
One or more designated NIH Program staff members will have substantial involvement as Project Scientist(s) for the SenNet. Additionally, an NIH Program Director (serving as the NIH Program Official) will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
Progress Reviews. The annual evaluation by the Program Officer will be based on the non-competing application and progress report, CODCC records, and assessments by the Project Scientist(s). The NIH staff will review the management, performance, and utilization of the project. If concerns are identified by the Program Officer, the Project Scientist(s) will work with the PD(s)/PI(s) to develop plans to address them in the next year of support. In addition, NIH staff may conduct interim reviews of scientific progress beyond the normal yearly non-competing progress review to determine progress and may use information from progress reviews to inform future funding for the project.
Special Reviews. Funds may be restricted pending completion of key award or consortium milestones independently of prior performance concerns. However, if concerns are identified about the performance or the management of the project, the Program Officer may conduct special reviews of the project as he/she deems necessary. NIH may engage outside experts to assist in these reviews. If concerns about the project arise and are not resolved, NIH may reduce or restrict the budget or reduce the term of support to phase out the project. In the event of long-term incapacitation of resource facilities, NIH may reduce the budget or term of support to phase out the project. Before any modifications are made, NIH staff will engage with the awardees in a positive manner and as allowed by the Cooperative Agreement mechanism to resolve performance issues in a timely manner where possible.
Areas of Joint Responsibility include:
Steering Committee: The Steering Committee will be the main governing body for the SenNet. The Steering Committee will be composed of one representative (contact PD/PI or other senior level investigator) from each SenNet awardee, i.e., from SenNet Tissue Mapping Centers (TMCs), Technology Development Projects, and the SenNet CODCC who will have one vote each.
NIH Project Scientists and Program Officers will participate in SenNet Steering Committee meetings as non-voting members, but Steering Committee decisions will be subject to final review and approval by the NIH.
If needed, other government staff members may also participate in SenNet Steering Committee meetings as non-voting members.
Two PD(s)/PI(s), representing two different SenNet awards, will be selected to serve as chairpersons of the Steering Committee starting at the first meeting of the Steering Committee following award issuance. All SenNet Steering Committee decisions and recommendations that require voting will be based on a majority vote.
The SenNet Steering Committee will meet monthly by videoconference and in-person at the SenNet semi-annual Steering Committee Meeting and as needed.
The SenNet Steering Committee will:
In order for awardees to fully comply with NIH and consortium data sharing policies as detailed above, all awardees will be expected to agree to a Confidentiality Disclosure Agreement (CDA) containing the following Statement of Confidentiality: The parties fully understand the potential confidential nature of discussions and presentations, and acknowledge that materials provided and discussions held prior to and during meetings may reveal confidential information. The Parties agree to respect and maintain confidentiality of any non-public information that is received or become aware of through participation in workshops, meetings, and teleconferences associated with the NIH Common Fund sponsored grants in this program: Cellular Senescence Network Program. Public information is classified as (a) is within the public domain prior to the time of the disclosure by the Disclosing Party/ies to the Receiving Party/ies or thereafter becomes within the public domain other than as a result of disclosure by the Receiving Party/ies or any of its representatives in violation of this Agreement; (b) was, on or before the date of disclosure in the possession of the Receiving Party/ies; (c) is acquired by the Receiving Party/ies from a third party not under an obligation of confidentially; or (d) is hereafter independently developed by the Receiving Party/ies, without reference to the information received from the Disclosing Party/ies. The Parties will maintain this confidentiality for a period of 7 years from the disclosure date or until the Confidential Information is classified as Public information based on a-d listed herein, whichever is earlier. The parties will not use such information for their personal benefit or for the benefit of their family, or associates of organizations to which they are connected or with which they have a financial involvement. Any breach of this agreement may be referred to the HHS Office of General Counsel. As to the parties participation in the development and conduct of these programs, the parties opinions and decisions will be based on their scientific judgment and medical or specialty expertise and will not knowingly be related to any other interest in organizations that may provide equipment, products or services to the studies.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
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 agreements are 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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: 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]
T. Kevin Howcroft, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6229
Email: [email protected]
Maqsood Wani, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-2270
Email: [email protected]
Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.