National Institutes of Health (NIH)
Office of Strategic Coordination (Common Fund)
This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/) through the NIH Office of the NIH Director, Office of Strategic Coordination (https://dpcpsi.nih.gov/). All NIH Institutes and Centers participate in Common Fund initiatives. The FOA will be administered by the National Cancer Institute (NCI), (https://www.cancer.gov) on behalf of the NIH.
The purpose of this FOA is to solicit applications for the development of novel, untested analytics and technologies to identify and map senescent cells in human tissues at high resolution. This FOA supports the accelerated proof-of-principle demonstration and validation of promising tools, techniques and methods that can be integrated, scaled and applied to multiple human tissues. The initial two-year UG3 phase will support the development and demonstration of feasibility of these emerging technologies in the identification and mapping of senescent cells in mammalian tissues. The subsequent UH3 phase is to support initial validation in human tissues, optimization and scale-up, and generation of production level data. Investigators responding to this FOA must submit both UG3 and UH3 projects as part of a single application. UG3 projects that have met their quantifiable milestones will be administratively considered by NIH staff and prioritized for transition to the UH3 phase, depending on the availability of funds.
December 18, 2021
|Application Due Dates||Review and Award Cycles|
|New||Renewal / Resubmission / Revision (as allowed)||AIDS||Scientific Merit Review||Advisory Council Review||Earliest Start Date|
|January 18, 2022||Not Applicable||Not Applicable||March 2022||May 2022||August 2022|
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.
No late applications will be accepted for this Funding Opportunity Announcement.
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.
The Cellular Senescence Network (SenNet)
The Cellular Senescence Network (SenNet) was recently launched by the NIH Common Fund in September 2021 with the goal of facilitating the construction of a molecularly defined, dynamic atlas of human cellular senescence and associated secretory phenotype at single-cell resolution across the entire human lifespan. It is anticipated that SenNet will produce spatially resolved atlases that are defined at the molecular and cellular level and provide a comprehensive set of biomarkers describing the heterogeneity of senescent cells in human tissues in the context of their microenvironments.
SenNet was conceived as a goal-driven strategic investment, with deliverables intended to catalyze research across multiple biomedical research disciplines. The deliverables will provide a sound platform on which to develop approaches for the betterment of human health. This will be achieved by:
While SenNet is currently focused on human tissues, efforts are now underway to incorporate murine Tissue Mapping Centers and murine Technology Development Projects into SenNet with a framework and goals consistent with those currently in place for the human. These efforts related to murine cellular senescence will be funded with the companion FOAs: RFA-RM-22-003 and RFA-RM-22-005.
SenNet consists of the following three major components:
Successful applicants to this FOA will become members of the larger SenNet consortium, composed of investigators who have been funded in response to at least one of the SenNet FOAs. All projects within SenNet will be funded as Cooperative Agreements with NIH staff playing a significant role in shaping the scientific aspects of the project.
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. 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 senescent cells 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. Thus, understanding the mechanisms that distinguish beneficial from deleterious senescence and the heterogeneity underlying senescent cell states are critical knowledge gaps. Thus, as the science progresses, a “one size fits all” for the development of senolytics that only remove deleterious senescent cells without touching those that are beneficial is not realistic and a detailed characterization of senescent cell states and their associated SASP is an urgent need.
Research Objectives and Main Requirements
Goal of the Cellular Senescence Network
To address the knowledge gaps noted above, the NIH intends to support SenNet to construct tissue maps describing multidimensional parameters of senescence across diverse tissue environments at molecular, cellular, and morphological levels and over longitudinal time frames. This SenNet effort builds upon, and extends, existing NIH single-cell tissue mapping efforts, including the Human Tumor Atlas Network (HTAN), Human Biomolecular Atlas Program (HuBMAP), and Human Cell Atlas (HCA) that are generating important resources for the scientific community and promoting advances in associated technologies and bioinformatic approaches that will inform future research and, ultimately, clinical decision-making. The goal of SenNet is to construct an atlas of human cellular senescence across multiple tissues, in response to multiple inducers and modifiers in health. SenNet is currently comprised of eight Tissue Mapping Centers (TMCs), solicited under RFA-RM-21-008 and seven Technology Development and Application Projects (TDAs), solicited under RFA-RM-21-009. The TMCs will construct tissue atlases describing the appearance, persistence, and dynamic role of senescence in health. The TDAs will promote the development of novel technologies to study cellular senescence in model systems and/or human tissues. These initiatives are supported by a Consortium Organization and Data Coordinating Center (CODCC), funded in 2021 through RFA-RM-21-010.
Objectives and Scope
This Technology Application and Development (TDA) FOA seeks to establish the next generation of tools, technologies, techniques and methods that will be foundational for mapping senescent cells in the human body with single-cell resolution, while a parallel effort to fund a similar effort in mouse tissues will be funded through a separate, companion RFA (RFA-RM-22-003). Successful projects will develop, demonstrate and validate technologies that can generate extensive biomolecular data on senescent cells and their context in multiple human tissues to comprehensively identify senescent cells. Applications are expected to be high impact with a milestone-driven engineering approach(es) that considers design, testing and evaluation and bring together multi-disciplinary teams that will result in technologies that can be easily disseminated to, and used by, other laboratories. By the end of the UG3 phase, the goal is to have successful proof-of-principle demonstrations of innovative technologies that can identify and quantitatively map DNA, RNA and protein distribution of senescent cells in mammalian tissues, and by the end of the UH3 phase optimized, scaled, benchmarked and successfully validated technologies that have been used to generate publication-quality data from multiple non-diseased human tissues.
As a component of the SenNet program, TDA projects will run in parallel and are expected to synergize with all projects supported in the TMCs and the CODCC.
Applications submitted in response to this FOA should focus on the development of in situ imaging and sequencing approaches, single-cell epigenomics, single cell proteomics and phosphoproteomics, methylomics, metabolomics as well as analysis of the extracellular environment that will functionally identify and characterize senescent cells and their associated secretome. This FOA encourages, but is not limited to, technologies that can address the following challenges:
Development and/or modification of microfluidic technologies (e.g., Drop-seq) that leverage the unique features of senescent cells to facilitate their identification, high resolution capture and analysis
Mapping RNA and protein expression of at least one hundred biomolecules of interest, that will be a determined by the consortium, across whole organs at a single cell resolution for the purpose of functionally identifying senescent cells;
Developing robust, comprehensive and unbiased descriptors including, but not limited to, biomarkers and signatures of senescent cell types and states present in a tissue (for example, different cell types such as tissue-resident immune cells and pluripotent cells) and inferring their functional states through analysis of modifications;
Studying both intracellular and extracellular biomolecular features (e.g., Senescence Associated Secretory Phenotype, SASP) within tissues to help understand cellular communication and contextual function;
Advancing methods for understanding the degree of organizational variability in senescent cells in the same tissue between different individuals and multiple tissues from the same individual;
Developing methodologies to affect and deliver an intervention to specific senescent cell types or tissue types; Optimizing techniques that can robustly identify senescent cell lineages, differential allelic expression, niche environments, viral infection or other microenvironment-defining biomolecular patterns in tissues
Given the focus of the SenNet program (https://commonfund.nih.gov/senescence), proposed technologies must be capable of defining senescence at high resolution, provide comprehensive insight into the distribution of multiple biomolecules, and be compatible with other assays and multiple human tissues. Although the focus of these projects should be on in-situ analysis of cells, it is expected that unbiased, dissociative techniques will be used in combination to inform the in-situ analysis in an iterative fashion. Likewise, although the focus is on building quantitative biomolecular tissue maps of human senescent cells, projects can propose integrating approaches such as MRI, micro-CT, photoacoustic, Raman spectroscopy, histology, morphology and mechanical imaging or analysis of mitochondria, exogeneous chemicals, extracellular space or viral signatures that will significantly enhance the ability to map human tissues rigorously and with high fidelity.
The TDA projects will be strongly encouraged to work closely with the other components of SenNet early on and the developed technologies will be integrated and scaled for production of senescence tissue maps and atlases across the human body. Thus, the TDAs are expected to work closely together with the TMCs to develop consortium-wide best practices for emerging approaches to data generation and compatibility, manage quality control, cleaning and harmonization of data received, conduct cross-site comparisons and test and validate technologies on multiple tissues. They are also expected to work closely with the CODCC to develop new and retrofit existing data and metadata standards for emerging technologies, to build calibration and validation datasets and engage in cross-site collaborations. Thus, it is strongly recommended that the TDAs plan for and budget for collaboration activities as part of their applications.
The NIH Common Fund (CF) supported programs are intended to provide resources that accelerate discovery across many different biomedical research fields. These resources include large data sets and associated digital tools needed to mine and analyze the data. To maximize their impact, data sets and tools generated by the CF programs must be usable together. Towards achieving this goal, the CF created the Common Fund Data Ecosystem (CFDE), a data management infrastructure where the interconnected ecosystem facilitates scientific advances by making CF data and digital objects usable and useful both within a program and in combination with data from other programs.
The SenNet Program is structured to facilitate engagement in the CFDE through the CODCC. This will be achieved by designing program components that: i) use the cloud platforms for data storage and management for easy access to data, ii) construct a data infrastructure which follows FAIR (Findable, Accessible, Interoperable, Reusable) Principles for usage of the data, iii) adapt the appropriate data and metadata standards to enable interoperability of the generated data with other data sets, and iv) adapt visualization tools for accessing data with various end-users in mind. Applicants are expected to discuss their plans for engagement in the CFDE through the CODCC in their application.
NIH intends that the products of the TDAs be broadly available to provide the foundations for human cellular senescence atlases that other programs and the community could build upon, including methods, tools, reagents, biospecimens, datasets, analysis algorithms and software. Approved projects are expected to agree to Consortium policies to rapidly share their products within the Consortium and with the external research community through the program Portal when established. The robustness, reproducibility and rapid dissemination of experimental results are critical to the success of the SenNet. It is anticipated that in some cases, conducting additional critical experiments will be important for assessing progress. Therefore, NIH Program staff, in consultation with the PD/PI, may modify or add experiments to be conducted during the award.
To be responsive to this FOA, investigators must propose the development of a novel, untested technology or the innovative modification or optimization of existing technology, that will considerably increase the repertoire of innovative technologies or methods currently used to identify, locate and functionally characterize senescent cells in human tissues. Applications should include evidence of expertise in cellular senescence research and the proposed technologies must be capable of defining location at cellular resolution, provide comprehensive insight into the distribution of multiple biomolecules, and be compatible with other assays and the analysis of human tissues. The goal of SenNet is not to develop a cell catalog but to produce molecularly defined, spatially resolved, single-cell atlases of cellular senescence in context of the human tissue. Therefore, applications that propose to focus primarily on using dissociative techniques that do not preserve spatial information, do not include techniques for studying the extracellular context of the cells, or propose to primarily study fluids will be considered nonresponsive. While the use of model systems is acceptable during the UG3 phase, the proposed technology should be implemented in human tissue by the UH3 phase.
Applications addressing the following topics will be deemed non-responsive and will not be reviewed:
Projects exclusively focused on the pursuit of a biological mechanism through basic research that do not result in the development of an innovative technology to significantly improve our capabilities of identifying and characterizing senescent cells in human tissues;
Projects proposing technologies that cannot be scaled for comprehensive analysis of multiple human tissues or that cannot be multiplexed with other assays.
Projects proposing to exclusively study fluids or dissociated cells;
This FOA uses the UG3/UH3 cooperative agreement mechanism to support the phased development of new technologies for the Cellular Senescence Program. Initial UG3 cooperative agreement awards for up to 2 years will be granted for demonstrating the proof-of-principle of these technologies. The subsequent UH3 phase will fund awards for up to 3 years (total of not more than 4 years for UG3+UH3) on the scaling, optimization and validation of the technologies for mapping human tissues. Because technology development that would be transformative is an inherently high-risk process, it is anticipated that the attrition rate could be significant as projects move through refinement and validation. Successful UG3 projects will be administratively reviewed by NIH, with priority projects proceeding to the UH3 phase pending availability of funds. Investigators responding to this FOA must address plans for both UG3 and UH3 phases in this initial application and will be asked for an updated description and scope prior to the UH3 administrative review.
As a cooperative agreement as part of the Consortium, all applicants are expected to describe how their proposed project meets the goals of the program, significantly improves upon the state-of-the-art, can be integrated with other technologies, and ultimately capable of being scaled to map multiple human tissues in a high-throughput fashion. Applicants are also expected to discuss performance, dynamic range, sensitivity and specificity of their technologies; calibration and control processes; testing, evaluation and improvement; and interoperability and usability. Projects are expected to have ambitious goals and annual milestones. Milestones are goals that are quantifiable for measuring success that can be used for go/no-go decision-making for the project and should have quantitative criteria associated with them. Prior to funding an application, NIH Program staff will contact the applicant to discuss the proposed milestones and any changes suggested by the review panel or NIH Program staff. A final set of milestones will be specified each year in the Notice of Award. Progress towards achievement of the annual milestones and the overall goals will be regularly evaluated by NIH Program staff and they may consult as necessary with independent consultants with relevant expertise. If justified, future year milestones may be revised based on data and information obtained during the previous project period. If, based on the progress report, a funded project does not meet the milestones, support recommended for future years may be adjusted, withheld or discontinued. In addition to milestones, the decision regarding continued funding will also be based on the overall robustness of the entire data package that adequately allows an interpretation of the results (regardless of whether they have been captured in the milestones), overall progress, SenNet portfolio balance and program priorities, competitive landscape, and availability of funds.
Objectives of the UG3 Phase
During the UG3 phase, the NIH is interested in developing and demonstrating:(1) novel, untested technologies or (2) the innovative modification, or use of, existing technologies, not previously described, that considerably expand the number and diversity of innovative tools capable of identifying, and functionally characterizing, individual senescent cells and their context in tissue. Expected outcomes include but are not limited to:
Milestones and Transition from UG3 to UH3:
Applications must include well-defined quantitative 6-month and 12-month milestones for the UG3 phase and annual milestones for the UH3 phase. Prior to a pending award, the PD/PI and NIH will negotiate a final list of milestones and go /no-go criteria for each year of support. The proposed milestones for the UH3 phase may be revised during the award period in coordination with the SenNet Research Program committee and NIH staff as activities in the UG3 phase progress.
At the completion of the UG3 funding period, the applicant will submit a transition request for the UH3 phase. The request should include:
Details on the successful completion of the quantitative scientific milestones of the UG3 phase.
Demonstration of the feasibility of the technologies in the identification and mapping of senescent cells in mammalian tissues;
A detailed research plan describing the goals, objectives, approaches, milestones and deliverables of the proposed UH3 implementation phase, approved by the SenNet.
A description of how the technologies will work collaboratively with other components of the SenNet Consortium and contribute to advancing the goals of the Consortium.
A demonstration that all the regulatory and other requirements have been met.
An intellectual property plan, if applicable.
A demonstration of compliance with the SenNet Data Sharing and Resource Sharing Plans.
An administrative review will be conducted by NIH Program Staff to decide whether a project will be considered for transition from the UG3 phase to the UH3 phase. It is anticipated that not all funded UG3 projects will transition to the UH3 stage. Prospective applicants should note that funding of the UG3 stage of the UG3/UH3 Phase cooperative agreement does not guarantee support of the UH3 project. Final UH3 funding levels will depend on availability of funds. UH3 eligible projects must have a compelling and innovative technology that has the potential to transform data collection for the SenNet program and has shown strong results to support validation in human tissues.
Criteria for evaluation of the UG3 transition to UH3 will include the following:
Successful completion of the UG3 milestones.
Feasibility to apply the technologies broadly to identify and/or characterize senescent cells, and the scaling, optimization and validation of the technologies for mapping senescent cells in human tissues at high resolution.
Potential for meeting the overall goals of SenNet, including contributions to collaborative activities.
Prior to transitioning, NIH Program staff will contact the applicant to discuss any proposed updates to the goals and milestones of the UH3 period and they may consult as necessary with independent consultants with relevant expertise.
Objectives of the UH3 Phase
During the UH3 phase, the NIH is interested in scaling-up, optimizing and validating the proposed technology for high throughput data generation from multiple human tissues. Expected outcomes include, but are not limited to:
Establishing collaborations between TDA and TMC investigators and the TMCs to integrate their technologies into the TMCs
Optimization and characterization of the technology for collecting data from at least one human tissue type
Generation of production level data from human tissues and submission of that data to the CODCC
Demonstration that the production level approaches contribute to the phenotypic comparisons of a single senescent cell and its positional coordinates in the host tissue
Development of a regulatory or intellectual property (IP) strategy, either through the applicant's organization or through appropriate arrangement with external regulatory consultants (see SF42 (R&R) Other Project Information for detail).
This initiative is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.
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.
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.
Not Allowed: Only accepting applications that do not propose clinical trials.
The NIH Common Fund (Office of Strategic Coordination) intends to commit $3.5M Total Costs in FY 2022 to fund up to 6 awards. The awards are contingent upon NIH appropriations and the submission of sufficiently meritorious applications.
Applications should not exceed $400,000 in direct costs per year during the UG3 phase and $550,000 in direct costs per year during the UH3 phase.
The proposed project period for the UG3 phase may not exceed 2 years and the UH3 phase may not exceed 3 years. The total duration of UG3 and the UH3 phases may not exceed 4 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
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
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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 any currently funded RFA-RM-21-008; RFA-RM-21-009, RFA-RM-21-010 or any of the companion SenNet FOAs RFA-RM-22-003 and RFA-RM-22-005.
2. Cost Sharing
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, per 22.214.171.124 Submission of Resubmission Application. This means that the NIH will not accept:
1. Requesting an Application Package
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.
2. Content and Form of Application SubmissionIt is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Chamelli Jhappan Ph.D.
National Cancer Institute (NCI)
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.
Applications must include an Intellectual Property (IP) Strategy. Applicants are encouraged to prepare this attachment section in consultation with their institution's technology transfer officials. The section should be labeled "Intellectual Property Strategy. pdf" and may not exceed 3 pages. This attachment should be included even if IP issues are not a consideration for the project. Indicate: IP issues are not applicable and explain why.
This section should describe a dissemination plan that involves patent protection and commercialization:
Describe the IP landscape surrounding their model system. Applicants should describe any known constraints that could impede sharing of their technology (e.g., certain restrictions under transfer or sharing agreements, applicants' previous or present IP filings and publications, similar model systems that are under patent protection and/or on the market, etc.) and how these issues could be addressed with achieving the goals of this program;
Include a letter from any entity who has ownership of the IP indicating whether they will provide the technology, if there are any limitations on the studies that can be performed with that technology, agreement about public disclosure of results (including negative results), and whether there is an agreement already in place;
If patents pertinent to the technology being developed under this application have been filed, the applicant should indicate the details of filing dates, what type of patents are filed, and application status, and associated US Patent and Trademark Office links, if applicable;
Describe future IP filing plans. For a multiple-PD/PI, multiple-institution application, applicants should describe the infrastructure of each institution for bringing the technologies to practical application and for coordinating these efforts (e.g., licensing, managing IP) among the institutions;
State how IP will be shared or otherwise managed if multiple PD/PIs and institutions are involved, consistent with achieving the goals of the SenNet.
All instructions in the SF424 (R&R) Application Guide must be followed.
Applicant must 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. Budget forms provided for each activity code are listed in the application package at https://grants.nih.gov/grants/how-to-apply-application-guide.html
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, with the following additional instructions:
Applicants should address the scientific questions to be answered, provide the overall goal for the entire application, and indicate separately Specific Aims to be accomplished in the UG3 phase and those in the UH3 Phase. Specific aims should be scientifically appropriate for the distinct research phases of the project.
Within the single Research Strategy attachment, separate the information into the sections identified below. Applications will be assigned a single impact score. Organize the Research Strategy as described below.
1. Background and Significance:
Define the problem to be solved and the specific gaps in technology the project will address.
Outline the main characteristics and applicability of the proposed tools, technologies and methods (TTM). Projects should be justified on the basis of a strong potential, if successful, to identify and functionally characterize the heterogeneity of senescent cells across multiple tissues in human health, and lifespan at single cell resolution. Explain and justify how the proposed TTM may contribute to an integrated model of atlas of cellular senescence. Explain whether the proposed TTM will be sufficiently used by the TMCs or relevant research communities.
If proposing a project involving a currently available TTM that was originally approved for other conditions, provide an explanation of how adopting the TTM would substantially facilitate the identification and functional characterization of the heterogeneity of senescent cells.
Describe how the proposed TTM addresses the challenge in a new and creative way. Describe how the proposed TTM offers clear and significant improvement over what is currently available. If the proposed TTM is optimized or adopted from an established technology area, describe how it overcomes a significant/longstanding technical challenge.
3. Preliminary data
Applicants should summarize preliminary data, if available, that document the technology’s potential to achieve both analytical and clinical sensitivity and specificity comparable to currently used technology. Do not include links to websites.
The Approach section should be sub-divided in two sections, describing activities to be completed during the UG3 Phase and the UH3 Phase. It is recognized that applications in response to this FOA may propose a project from different technology development phases, therefore, the research plan and approaches should be consistent with the technology development phase and stated program goals. All applications, regardless of stage category, should address plans for assessing potential utility and feasibility in identifying and functional characterizing senescent cells in human health, and lifespan at single cell resolution.
The UG3 section should address the following areas, if applicable:
Plans to develop new or adapt/improve existing TTM for identifications and functional characterization of senescent cells.
Plans to evaluate the specificity, sensitivity, selectivity, and other key functional parameters for the intended use and how will the TTM lead to a more rigorous distinction between potentially subtle parameters to establish analytical validity.
Plan to evaluate the feasibility and utility of the TTM for human tissue/cell types and to tissue/cell types identified by the consortium
Plans for replication/small scale validation studies to ensure quality of data and consistency of the experimental techniques for scale up for high throughput data generation.
Strategies, pitfalls and alternative approaches
Specific performance milestones to be achieved during the UG3 phase, e.g., analytical specificity, selectivity, and sensitivity.
Applications focused on the discovery of novel TTM should focus on the early and conceptual stages of project development, and proof-of-concept tests
The UH3 section should address the following areas, if applicable:
Plans for optimizing the TTM for operability in a scaled-up experimental setting for high throughput generation.
Plans to assess the validity of TTM with more than one human tissue, and willingness to collaborate with the TMCs to select high priority tissues —the choice of tissues could be in collaboration with the TMCs.
Statistical justification for study design and approach
Modifying approaches to accommodate the larger number of cell and tissue samples and data to be managed. Developing data generation pipeline optimization strategies for single cells to be ramped up to generate production level data, and this data be integrated into other emerging data from the Consortium
Specific performance specifications and milestones to be achieved during the UH3 phase.
5. Integration with Tissue Mapping Center and Future Directions Statement
Applicants should discuss a plan to interface with the Tissue Mapping Centers (TMCs). Describe how the TTM proposed can be used by the TMCs and specifically which core in the TMC will be the focus of the collaboration. Describe how the collaboration will be implemented and how the research data generated by the proposed TTM will be shared with the TMCs and the CODCC. Even though applicants will not know exactly who they will be collaborating with, they are expected to make reasonable assumptions as to the types of collaborations that will be available and build flexibility into their research plans. Applicants should also prepare a future directions statement to address the potential of the proposed tools, technologies and methods for senescence research beyond the UH3 phase.
6. Milestones and Timeline
A timeline (Gantt chart) including milestones is required. Milestones are goals that create go/no-go decision points in the project and must include clear and quantitative objective criteria for success. Yearly quantitative milestones are required to provide clear indicators of a project's continued progress 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. The application must include well-defined milestones: e.g., appropriate objective performance targets, quantitative for go/no go decision points such as an appropriate level of detection and coefficient of variation, or sensitivity and specificity; and timelines for assessing progress in both the UG3 and UH3 phases, including specific milestones for progressing from the UG3 phase to the UH3 phase. Milestones and timelines for each stage must be provided in a separate heading at the end of the Approach section for each UG3 and UH3 subsection, and should:
Provide appropriately detailed (quantitative) criteria by which milestone achievement will be assessed.
Provide a detailed timeline for the anticipated attainment of each milestone and the overall goal.
Identify any impediments that could require an addendum to the research plan, milestones, or timeline with a discussion of alternative approaches.
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:
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.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
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.
5. Intergovernmental Review (E.O. 12372)
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.
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.
Applications Involving the NIH Intramural Research Program
Should intramural scientists submit an application through this FOA, or should an extramural application include a collaboration with NIH intramural scientists, the requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.
If selected, appropriate funding will be provided by the Common Fund through the NIH Intramural Program. NIH intramural scientists will participate in this program as PD/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.
Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above and as described in the NIH Intramural Source Book.
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.
For this particular announcement, note the following:
The UG3/UH3 Phase Innovation Awards Cooperative Agreement supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. Accordingly, reviewers will focus their evaluation on the development, integration, validation and dissemination of single cell analysis tools and systems that significantly expand throughput, multiplexing and discrimination of biomolecules in human tissues at single-cell resolution to further identify cell types and tissue organization. Breakthrough in conceptual framework and/or the potential to significantly advance our knowledge or understanding of characteristics of senescent cells in mammalian tissues will be factored in.
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).
Scored Review Criteria
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.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific for this FOA: Do the proposed tools, technologies and methods development have the potential to address a significant unmet need in identification and mapping of senescent cells in human tissues? Regardless of the inherent risk of the project, if continued development of the tools, technologies and methods is successful, would its availability improve the overreaching goal of SenNet consortium? What are the potential and feasibility of the proposed tools, technologies and methods to be sufficiently used by SenNet consortium or relevant research communities?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific for this FOA: Is the team expertise appropriate and sufficiently diverse to effectively manage the steps necessary to develop and test the technology? For example: Does the team include appropriate expertise for identification and mapping of senescent cells in human tissues at single-cell resolution? What is the likelihood that all the collaborators and partners will work together effectively and complete the proposed technology translation from UG3 to UH3?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Specific for this FOA: How does developing the tool(s)/practices provide a major change in approaches from current technologies? To what extent do the tool(s)/technologies and practices provide first-in-class, cross-cutting or significantly advanced capacity for high throughput generation and scale up? Have the proposed tools, technologies and methods been used before in identification and mapping senescent cells in human tissues? Do the proposed tools, technologies and methods offer potential for clear and significant improvements over what is currently available? Do the proposed tools, technologies and methods overcome a significant/longstanding technical challenge if optimized or adopted from an established technology area?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific for this FOA: For the UG3 phase: Evaluate how the tools, technologies and methods will be made sufficiently sensitive, selective or appropriate for the intended use and how will the methodologies lead to a more rigorous distinction between potentially subtle parameters to establish analytical validity? How well has a described benchmark technology been used to assess the relative utility of the new tool(s)? How rigorous is the proof-of-concept test of the tool(s) when applied to human tissue/cell types and to tissue/cell types identified by the consortium? How rigorous is the demonstration of the feasibility for scale up of the proposed technology for high throughput data generation? Are risks clearly addressed described?
For the UH3 phase: How robust are the technologies developed in the UG3 phase so that they may be scaled up for high throughput generation? Are the number of subjects/samples needed statistically justified? Is there a clear scientific rationale for the range and types of subjects/samples to be used? How robust are the data generation pipeline optimization strategies for single cells to be ramped up to generate production level data, and this data be integrated into other emerging data from the Consortium?
Does the application provide a plan to interface with the Tissue Mapping Centers. What is the likelihood that the described technology will interface with the SenNet consortium? Evaluate the future directions statement provided in the application to appropriately address the potential of the proposed technology for senescence research beyond the UH3 project?
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?
Additional Review Criteria
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.
Transition Milestones to the UH3 Phase
Is the overall plan for the progression from UG3 to the UH3 funding periods well thought out? Are milestones provided for the UG3 stage properly objective and quantitative whenever appropriate? Are these milestones well aligned with the specific aims of the Research Phases? How realistic are these milestones and associated timelines? Do the proposed milestones and timelines clearly identify benchmarks for successful completion of the UG3 stage? Are other critical go/no go decision points and timelines well defined and appropriate?
Do the projects propose a feasible strategy to analyze mammalian tissue during the UG3 phase and non-diseased human tissue during the UH3 phase?
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.
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.
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.
If applicable, is the IP Strategy adequate? Does it include descriptions of the IP landscaping surrounding the proposed technologies, letters from IP owners, information about patents filed or to be filed? Does it address issues that may affect sharing of the technologies? Is the dissemination plan that involves patent protection and commercialization acceptable? If not applicable, does applicant provide an acceptable justification?
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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) Data Sharing Plan; (2) Sharing Model Organisms; and (3) 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.
2. Review and Selection Process
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.
3. Anticipated Announcement and Award Dates
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.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: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
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 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) 2 CFR Part 200 Administrative Regulations, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, NIH's Grants Policy Statement (which implements the aforementioned HHS Regulations (45 CFR Part 75), 2 CFR Part 200 and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients 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 reside with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
Recipients will retain ownership of the data and software developed under these awards, subject to Government rights of access consistent with current HHS, 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:
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 recipients 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 recipient, 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:
Identify scientific and policy issues that need to be, or can benefit by being, addressed at the Network level and develop recommendations to NIH Program Officials for addressing such issues.
Review progress of the SenNet toward meeting the overall Network goals.
Ensure that all SenNet members utilize the resources developed by the SenNet OC-CODCC, TMCs and Technology Development Projects.
Coordinate dissemination of Network output to the broader senescence research community.
Ensure that the Network takes advantage of existing NIH resources and programs.
Establish, as necessary, subcommittees to ensure the progress of the individual Centers and the Network.
In order for recipients to fully comply with NIH and consortium data sharing policies as detailed above, all recipients 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 the 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/Parties to the Receiving Party/Parties or thereafter becomes within the public domain other than as a result of disclosure by the Receiving Party/Parties 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/Parties; (c) is acquired by the Receiving Party/Parties from a third party not under an obligation of confidentially; or (d) is hereafter independently developed by the Receiving Party/Parties, without reference to the information received from the Disclosing Party/Parties. 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 party's participation in the development and conduct of these programs, the party's 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.
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $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: GrantsInfo@nih.gov (preferred method of contact)
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Chamelli Jhappan, Ph.D.
National Cancer Institute (NCI)
Center for Scientific Review (CSR)
National Cancer Institute (NCI)
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 2 CFR Part 200, 42 CFR Part 52 and 45 CFR Part 75.
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