Department of Health
and Human Services (HHS)
and Human Services (HHS)
National Institutes of Health (NIH)
National Institute on Aging (NIA)
U24 Resource-Related Research Projects – Cooperative Agreements
None
The National Institute on Aging (NIA) currently supports a group of multisite projects, using different and complementary approaches, for the discovery of factors (genetic and other) that influence exceptional longevity (EL) in humans and their translation into possible therapeutic targets to promote healthy aging. The purpose of this Funding Opportunity Announcement (FOA) is to solicit a cooperative agreement (U24) application for a Data Management and Coordinating Center (DMCC) which will support the integration of research activities across a group of ongoing human longevity translational projects and assume responsibilities for the management and expansion of the existing NIA Exceptional Longevity Portal (EL Portal). Specifically, the DMCC will facilitate and support collaborative research activities across the human longevity translational projects, manage the deposition and distribution of data and resources generated by these projects, as well as oversee outreach to and engagement of the broader scientific community to analyze the resources hosted by the EL Portal. The DMCC will also create a collaborative research workspace by leveraging the existing infrastructure of the NIA EL portal—an interoperable resource, a scalable data commons which will combine multidimensional data, cloud computing, and software tools in a secure environment to allow investigators to access, deposit, and analyze different data types from multiple sources to accelerate the translation of molecular factors contributing to exceptional health and life span.
Applicants must provide details on how the proposed DMCC will effectively interact with the investigators from the human longevity translational projects in the coordination of trans-project collaborations and describe a plan (with a timeline and benchmarks) for an expansion of the existing EL Portal infrastructure to a limited data commons.
Applicants are urged to consult with NIA staff early in the pre-submission process to ensure that applications are responsive to the programmatic goals of this FOA.
September 28, 2021
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| October 28, 2021 | Not Applicable | Not Applicable | March 2022 | May 2022 | July 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.
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.
Background
Exceptional longevity (EL) represents an extreme phenotype, and the ability to achieve exceptional health span is likely to be influenced by differing protective factors which contribute to the preservation of individual physiologic systems (e.g., cardiovascular, immune, CNS) or functional domains (e.g., mobility, cognition). Gaining a deeper understanding of the functional effects of protective human genetic variants and cellular factors associated with exceptional survival could lead to the identification of novel therapeutic targets to mimic their favorable effects and thereby promote healthy aging. Through a series of initiatives and across several years, the National Institute on Aging (NIA) has established a group of human longevity translational projects, including the Longevity Consortium (LC), Long-Life Family Study (LLFS), Longevity Genomics (LG) and Integrative Longevity Omics (ILO). Using different and complementary approaches, these multisite studies focus on the discovery of factors (genetic and other) influencing EL and their translation into possible therapeutic targets. For instance, the focus of the LLFS is the identification and functional characterization of rare gene variants linked to longevity endophenotypes through a family-based design, whereas the LC and ILO projects leverage resources from existing human cohorts, centenarian populations, and incorporate comparative biology approaches to identify possible molecular factors and omics profiles associated with exceptional health and life span. The LG uses publicly available data sets (e.g., the UK Biobank, GWAS studies obtained from dbGAP, etc.) to identify longevity-associated variant (LAV) effects of genes by eQTL/PrediXcan analysis. The longevity-associated genes (LAGs) from such analysis serve as the basis for subsequent functional characterization using in vitro and animal models. In a parallel approach, the LG project makes comprehensive use of chemoinformatic tools on the LAGs for the discovery of potential longevity-associated drugs. The combination of complex, multi-dimensional biological data and other research resources (e.g., data, biospecimens from long-lived individuals and from cross-species comparisons, analytical tools, drug screening databases/tools, cutting-edge algorithms) being generated by these studies raise new opportunities to extend research findings on protective factors (e.g., genomic and cellular) contributing to exceptional health and life span and accelerate the pace of their translation into putative therapeutic targets.
To achieve the above scientific synergisms, a Data Management and Coordinating Center (DMCC) is needed to: 1) facilitate and support the efficient exchange of knowledge and integration of research activities across the human longevity translational projects, 2) enable open access to interested research communities to the data/resources generated by these studies, and 3) create a collaborative workspace that will allow investigators to use cutting edge computational approaches across vast amounts of data to identify novel connections, profiles, and patterns that are not feasible when data are siloed. This also requires the co-location of different data types (e.g., phenotypic data, clinical variables, omics) on exceptional longevity with cloud computing infrastructure and commonly used software services, tools/apps for managing, analyzing, and sharing data to create an interoperable resource. As an initial step, the NIA Exceptional Longevity Portal (EL Portal) has been established to organize and make broadly available the research resources (e.g., biospecimens, organoids, analytical tools/apps, annotated databases) that have been created to date and to consolidate the storage of large volumes of omics data (e.g., transcriptomics, methylomics, proteomics, metabolomics) that will be generated by the human longevity translational projects in upcoming years.
NIA established the EL Portal on the same informatics platform as the NIA Alzheimer's Disease (AD) Knowledge Portal in order to facilitate interactions and open sharing of data/resources between investigators involved in studies of exceptional longevity and AD/ADRD research communities. Both portals are hosted on the Sage Bionetworks informatics platform, "Synapse", an Institutional Review Board (IRB)-approved environment where data can be stored/accessed and collaboratively analyzed. Moreover, data governance policies and procedures for the EL Portal are consistent with that of the AD Knowledge Portal where data are made available via multi-tiered, open (Tier 0) or controlled access (Tier 1-3) depending on the data type and data source and as determined by the informed consent documents (as applicable) for each study guided by the local IRB. A particularly noteworthy feature of the EL Portal data governance is that the highest data (Tier 3) enables secure, controlled, and time-limited access to approved users for age-specific data (i.e., individual data, minimally processed) from long-lived individuals (95+ years), including centenarians. Under all circumstances, there is no publication embargo imposed on the use of data after they have been made available through these portals.
Research Objectives
The purpose of this Funding Opportunity Announcement (FOA) is to solicit a cooperative agreement (U24) application for a Data Management and Coordinating Center (DMCC) which will support the integration of research activities across a group of ongoing human longevity translational projects and assume responsibilities for the management and expansion of the existing NIA Exceptional Longevity Portal (EL Portal). Specifically, the DMCC will facilitate and support collaborative research activities across the human longevity translational projects, manage the deposition and distribution of data and resources generated by these projects, as well as oversee outreach to and engagement of the broader scientific community to analyze the resources hosted by the EL Portal. Once the DMCC for the group of human longevity translational projects is established, it will assume responsibilities for the oversight and maintenance of the existing EL Portal, while concurrently planning for its expansion into a functional limited data commons. The DMCC will also create a collaborative research workspace by leveraging the existing infrastructure of the NIA EL portal—an interoperable resource, a scalable data commons which will combine multidimensional data, cloud computing, and software tools in a secure environment to allow investigators to access, deposit, and analyze different data types from multiple sources to accelerate the translation of molecular factors contributing to exceptional health and life span. A limited competition FOA is warranted so that these infrastructure improvements can be made in a manner which is cost-efficient, maximizes NIA’s investments in the EL and AD Portals, ensures continuity in the operations of the EL Portal, and enables the sharing of invaluable data resources for translational research on dementia and healthy aging on a common platform with common meta-data schema and streamlined data governance.
Applicants must provide details on how the proposed DMCC will effectively interact with the investigators from the human longevity translational projects in the coordination of trans-project collaborations and describe a plan (with a timeline and benchmarks) for expansion of the existing EL Portal infrastructure to a limited data commons. The DMCC will need to initiate, early in the project period, the needs assessment and strategic planning for the limited data commons to ensure that a scalable computing resource is an integral component of the overall collaborative research space to be achieved through this NIA initiative.
Applicants are encouraged to explore additional approaches and technologies that would enhance the EL Portal functionalities (e.g., graphical databases, genome browsers, visual tools to work with the data within the workspace).
The DMCC will lead the mission to integrate the efforts of the individual human longevity translational projects and to provide administrative and logistical support to develop and maintain a limited data commons to connect available resources generated by these projects with other relevant resources, including those hosted by the AD Knowledge Portal platform. The DMCC must consist of a team with the appropriate range of expertise to envision, create, and coordinate an interoperable resource for the current NIA awardees of exceptional longevity projects and the broader scientific community. Areas of domain expertise which must be included in the multidisciplinary DMCC research team include the following:
Responsibilities of the DMCC include, but are not limited to, the following domains:
Applicants are urged to consult with NIA staff early in the pre-submission process to ensure that applications are responsive to the programmatic goals of this FOA.
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.
Need help determining whether you are doing a clinical trial?
NIA intends to commit $2,000,000 in FY 2022 to fund one award.
Application budgets are limited to $1,330,000 in direct costs per year, exclusive of F&A costs for subcontract arrangements.
The maximum project period is five years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Federal Governments
Only those Institutions who have previously received a sub-award/award to develop the EL and AD portal infrastructure and the AD Portal data coordinating processes are eligible to submit an application in response to this FOA.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
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.
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:
Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.
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:
Chhanda Dutta, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-4161
Email: duttac@mail.nih.gov
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.
Facilities & Other Resources: Describe the scientific environment that supports the electronic information handling.
All instructions in the SF424 (R&R) Application Guide must be followed.
The DMCC must consist of a team with the appropriate range of expertise to envision, create, and coordinate an interoperable resource for the current NIA awardees of exceptional longevity projects and the broader scientific community. Areas of domain expertise which must be included in the multidisciplinary DMCC research team include:
R&R Budget
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:
Research Strategy: In addition to the strategy for achieving the scientific goals of the DMCC, please address the following:
Applicants are required to form a multidisciplinary research team that includes expertise in project management of collaborative research activities across complex multisite projects, computer science and cloud-based multiuser infrastructure, computational biology and large data visualization, bioinformatics and biostatistics, aging/gerontology and comparative biology and phylogenic analysis. Applicants should describe their previous experiences in the creation and management of cloud computing resources without duplicating information in the biosketches. In addition, describe whether members of the proposed research team, including consultants, have a history of conducting collaborative research and the nature of these collaborations.
A team management plan which describes in detail the management structure and how the research team will work together over the course of the currently proposed project (e.g., recurring team meetings, review and report of data usage, decision-making, participation in meetings with NIA, communication, etc.) must also be provided.
Plans for interactions with the investigators from the ongoing human longevity translational projects and for facilitating and enhancing trans-study research activities must be included.
Proposed strategies to raise the visibility of the research resources available through the EL Portal and describe how the proposed services and resources of the DMCC will facilitate outreach to and engagement of the broader scientific community to advance and extend translational research on exceptional longevity and related areas must be included.
Applicants must describe a plan (with a timeline and benchmarks) for expansion of the existing EL Portal infrastructure to a limited data commons.
Applicants must describe how the proposed services and resources of the proposed DMCC will support the coordination of trans-project collaborations and ensure continuity in the integrated approach to data collection, storage, and management of the EL Portal. Describe the logistical and administrative assistance as well as operational support, including, but not limited to, website maintenance, meeting support, maintenance of documents and email listservs, etc.
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.
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. Applications which do not leverage the infrastructure of the EL Portal to create the limited data commons/collaborative research space will be considered nonresponsive to this FOA.
In order to expedite review, applicants are requested to notify the NIA Referral Office by email at ramesh.vemuri@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
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.
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?
Does the proposed DMCC address the needs for coordination of research activities across the human longevity translational projects and infrastructure improvements to the EL Portal to foster open science? Is the scope of activities proposed for the DMCC appropriate to meet those needs?
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?
Does the multidisciplinary DMCC research team include the specified areas of domain expertise and are they well suited to their proposed roles in the DMCC? Has the applicant adequately described their previous experience with the creation and management of cloud computing resources? In addition, has the applicant described the DMCC research team's (including consultants) history of conducting collaborative research and the nature of these collaborations in sufficient detail?
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?
As it relates to coordination of research activities across the human longevity translational projects, does the DMCC application propose novel organizational concepts or management strategies?
Does the proposed plan for expansion of the EL Portal incorporate novel approaches and technologies that would enhance the EL Portal functionalities (e.g., graphical databases, genome browsers, visual tools to work with the data within the workspace)?
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?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of this initiative? Is there a DMCC plan for work-flow and a well-established timeline proposed? Is the proposed team management plan feasible? Is their leadership approach, governance and organizational structure appropriate for the project? Is the scope of activities proposed for the DMCC appropriate to meet those needs?
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?
Are adequate resources available within the scientific environment to support the expansion of the EL portal to a limited data commons/collaborative research workspace?
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) 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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIA, 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 National Advisory Council on Aging. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
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.
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: 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 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, Recipients, 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) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 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 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:
The Program Director(s)/Principal Investigator(s) will have the primary responsibility for defining the details for the projects within the guidelines of this FOA. The PD/PI will agree to accept the close coordination, cooperation, and participation of the NIH staff (Project Scientists) in those aspects of scientific and technical management of the projects as described below. Specifically, the PD/PI(s) supported by this NIA Data Management Coordinating Center (DMCC) will:
NIH staff 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, acting as Project Scientists, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The role of the Project Scientist(s) will be to facilitate and not to direct. This includes facilitating the partnership relationship between NIH, the group of ongoing human longevity translational projects and the DMCC. The Project Scientist(s)' role includes helping to maintain the overall balance in the program commensurate with the functions and scope of the DMCC activities, facilitating communication and coordination between the DMCC and the data science training and workforce development community, and ensuring that the activities of the awardees are consistent with the mission of the NIA. Specifically, the NIH Project Scientist will:
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
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: GrantsInfo@nih.gov (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: support@grants.gov
Chhanda Dutta, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496- 4161
Email: duttac@mail.nih.gov
Suzana Petanceska, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496- 9350
Email: petanceskas@nia.nih.gov
Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301- 402-7700
Email: Ramesh.Vemuri@nih.gov
Jeni Smits
National Institute on Aging (NIA)
Telephone: 301-827-4020
Email: Jeni.Smits@nih.gov
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.
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