Department of Health
and Human Services (HHS)
and Human Services (HHS)
National Institutes of Health (NIH)
National Institute on Aging (NIA)
None
The overarching objective of this funding opportunity announcement (FOA) is to develop and strengthen animal models for behavioral and social research in the interest of furthering the mechanistic understanding of how social and physical environmental factors contribute to aging processes and the etiology and progression of age-related conditions and diseases. With the explicit two-fold goal of identifying socio-environmental sources of aging processes and advancing the integration of behavioral, social, and environmental measures into biological hallmarks of aging, this FOA invites R61/R33 phased innovation applications that propose to develop and test behavioral and social methods, tools, and measures in: (1) research on the natural history of aging in populations of wild animals to increase the understanding of the complex interplay of social and environmental factors which affect individual differences in aging trajectories and health outcomes; and (2) basic and applied research in captive animals that can improve the validity and value of animal models for basic and translational research.
Funded projects will receive up to two years of R61 support for initial developmental, proof-of-concept activities, and up to three years of R33 research to support implementation. Projects may involve primary or secondary analysis of data collected in animals from well-characterized wild populations, captive populations, or both.
September 20, 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 20, 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.
Purpose
The overarching objective of this funding opportunity announcement (FOA) is to develop and strengthen animal models for behavioral and social research in the interest of furthering the mechanistic understanding of how social and physical environmental factors contribute to aging processes and the etiology and progression of age-related conditions and diseases. With the explicit two-fold goal of identifying socio-environmental sources of aging processes and advancing the integration of behavioral, social, and environmental measures into biological hallmarks of aging, this FOA invites R61/R33 phased innovation applications that propose to develop and test behavioral and social methods, tools, and measures in: (1) research on the natural history of aging in populations of wild animals to increase the understanding of the complex interplay of social and environmental factors which affect individual differences in aging trajectories and health outcomes; and (2) basic and applied research in captive animals that can improve the validity and value of animal models for basic and translational research.
Funded projects will receive up to two years of R61 support for initial developmental, proof-of-concept activities, and up to three years of R33 research to support implementation. Projects may involve primary or secondary analysis of data collected in animals from well-characterized wild populations, captive populations, or both.
Background
Understanding the natural history of aging and age-related diseases and conditions requires the ability to distinguish between pathology and a natural or inevitable consequence of aging and knowledge of how environmental factors influence the course of aging and contribute to pathogenesis. Mounting evidence suggests that early life adversity increases the risk of developing many age-related diseases and chronic conditions, and that health outcomes may not manifest in full until far later in life. Nevertheless, exposure to adverse conditions in the physical and social environment, and individual differences in the effects of these exposures—topics commonly addressed in social and behavioral sciences—are rarely measured or incorporated into aging-related animal research. Developing animal models of aging without consideration of effects of the social and physical environment can only provide a partial picture of age-related disease etiology, and this may limit applicability to human aging and lead to translational failure.
Although prior studies of animals have led to valuable insights about how social and environmental conditions influence behavioral and biological processes, many questions remain about how biobehavioral processes interact with social and physical environmental factors to influence aging. Without a rigorous methodology, the field will not be able to reliably identify and fully understand the developmental and environmental exposures that may help to explain individual differences in biological, cognitive, and functional aging; the risks for aging-related pathology, disease progression, and death; or the factors that contribute to resilience and adaptation. To fill in these missing pieces, and to improve the return on investment from animal models of aging, methodological limitations in behavioral and social research with animals must be overcome.
Project Characteristics and Scope of Research
This funding opportunity welcomes primary and secondary research focused on the role of behavioral, social, and/or environmental factors in aging and health conditions in wild animals in their natural habitat and/or animals in captive or laboratory settings. For the purpose of this FOA, examples of secondary data sources can include, but are not limited to the following: shared data resources, such as open-access data repositories, databases, and registries; animal welfare records, including those from behavioral management programs, social housing records, and veterinary health records; and datasets from ongoing studies and publications.
For research supported under this FOA, investigators can propose to focus on any non-human animal species and can source data from naturalistic or experimental studies. In all cases, applicants are required to provide an explicit rationale for the study approach, including the selection of animal species and environment, as well as its relevance to aging processes, and/or diseases or conditions associated with aging, and the National Institute on Aging’s Strategic Directions for Research, 2020-2025. For this FOA, NIA will prioritize behavioral and social research that aligns with Goals A, B, and/or C.
NIA encourages applications from multidisciplinary teams. Expertise on social and behavioral phenomena and/or aging processes in humans may increase the applicability or translatability of these studies of non-human animals. NIA is particularly interested in supporting research from investigative teams that cultivate a culture of inclusion and that are in alignment with NIH's Interest in Diversity.
The proposed budget should include travel costs to attend and participate in one annual RFA grantee network meeting for each project year.
NIA Research Interests
Methods, tools, and measures for aging research with animals in wild populations
NIA is especially interested in supporting research that builds on existing population-based studies that include longitudinal and intergenerational data. Researchers are encouraged to conduct event history analysis in life course studies to answer new questions about aging, and about sex differences in aging processes across different environmental and ecological conditions.
NIA is also interested in supporting research that uses a life-course approach to examine the impact of early life exposures in the social and physical environment on health in old age and aging processes, and that exploits 'natural experiments' to improve causal inference.
Specific areas of interest include, but are not limited to, the following:
Methods, tools, and measures for aging research with animals in captive populations
Specific areas of interest include, but are not limited to, the following:
Phased Award Activities and Specific Requirements
Development and/or refinement of methods, tools, and measures for aging research in animals is inherently a multi-stage process, which, at minimum, requires characterization and validation. Therefore, this FOA uses a bi-phasic, R61/R33 approach to support five-year exploratory and/or developmental studies.
The application must propose a well-defined set of study aims and milestones for both the planning (R61) and implementation phases (R33). For the purpose of this FOA, milestones are defined as scheduled, performance-based events that signify the successful completion of a significant stage in the project. Milestones should be specific, quantifiable, and scientifically justified, with well-defined criteria for success or go/no-go decisions within the R61 phase and for transitioning from the R61 to the R33 phase of the award.
Responsive applications must include specific project milestones to be achieved by the end of the R61 phase and on an annual basis for the R33 phase. Investigators and NIA will review and mutually agree upon final revised milestones that will be included in the Terms and Conditions of the grant, if awarded.
Funding of the R61 planning phase grant does not guarantee support of the R33 implementation phase grant. Prior to the end of the R61 phase, awardees will submit a package that requests transition to the R33 phase. This package will include a progress report that describes accomplishments toward each of the R61 milestones as proposed in the application and plans for studies during the R33 phase.
The transition from the R61 to the R33 phase of the award will be administratively reviewed for successful completion of the go/no-go criteria specified in the R61 phase. Materials will be reviewed by NIA grants management and program staff and, if approved, the grant will be transitioned to an R33 award without the need to submit a new grant application. Investigators and NIA program staff will review and mutually agree upon final revised milestones that will be included in the Terms and Conditions of the R33 grant, if awarded.
The transition from the R61 to the R33 phase will be contingent upon: (1) assessment of the R61 phase progress report and determination that core milestones were successfully achieved; (2) review and approval of other documents necessary for continuation; (3) NIA program priorities; and (4) availability of funds.
The R61 Planning Phase
The preliminary R61 planning phase will support exploratory, initial development, or proof-of-concept studies for up to two years in duration. The R61 phase can consist of basic research or infrastructure development.
Goals: The specific activities and milestones appropriate for the R61 phase will depend on the type of research project proposed and its stage of development. Together, by the completion of the R61 phase, preliminary evidence or initial proof of concept will support the feasibility, viability, or the functionality of the new or refined infrastructure, or will demonstrate that a behaviorally, socially, biologically, functionally, or clinically meaningful, or aging-relevant signal can be detected and implemented in primary research studies with captive and/or wild animal populations or secondary analysis, as appropriate.
Milestones: At minimum, R61 phase milestones must include, but are not limited to, the following:
The R33 Implementation Phase
The R33 phase will fund up to three years of research to support in-depth longitudinal characterization and/or the full realization and validation of the R61 concept in a primary or secondary study of aging in captive and/or wild animals, as applicable. Milestones and timelines for the R33 phase may be revised and finalized at the time of the R61/R33 transition.
Responsiveness Criteria
Non-responsive applications will be administratively withdrawn and not reviewed for this FOA.
Additional Considerations
Applicants are strongly encouraged to consult with NIA staff when developing plans for an application (see Section VII, Agency Contacts). This early contact will provide an opportunity to clarify NIA policies and guidelines and identify whether the proposed project is consistent with NIA program priorities
Frequently Asked Questions
Responses to Frequently Asked Questions about RFA-AG-22-015 will be posted here: https://www.nia.nih.gov/research/dbsr/behavioral-and-social-research-funding-opportunities-and-applicant-resources.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
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?
For the R61 phase, and pending annual appropriations, NIA intends to commit $2 million in FY 2022 to fund 5-7 awards.
For the R61 planning phase, the combined budget for direct costs for the two-year project period may not exceed $400,000, with no more than $200,000 requested in any single year.
For the three-year R33 implementation phase, applicants' combined budget for direct costs may not exceed $1,350,000. Applicant's budgets need to reflect the actual needs of the proposed project.
Applicant's budgets need to reflect the actual needs of the proposed project.
The scope of the proposed project should determine the project period. The maximum project period is five years.
The maximum project period for the R61 planning phase is two years.
The maximum project period for the R33 phase is three years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Melissa S. Gerald, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: melissa.gerald@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.
All instructions in the SF424 (R&R) Application Guide must be followed.
The investigative team should include senior/key personnel and/or consultants with expertise in social and behavioral phenomena and/or aging processes in humans, who will contribute to the scientific development or execution of the project in a substantive, meaningful way. The application should include person(s) in the "Profile - Senior/Key Person" section and a Biosketch that documents relevant expertise and experience.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
The proposed budget should include travel costs to attend and participate in one annual RFA grantee network meeting for each project year. The meetings will be held at the NIH in Bethesda, MD, or at another site agreed to by the PD/PIs and the NIA. The purpose of the meetings is to have investigators working in the same general area share information about research methods and findings. Applicants should include a statement in the application indicating a willingness to participate in such meetings and to cooperate with other researchers in the exchange of data, materials, and ideas.
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:
In the Research Plan, applicants should briefly describe the following in their respective sections:
Specific Aims: Describe specific aims for each of the two phases (R61 and R33) on the single Specific Aims attachment.
Describe specific aims focused on behavioral and social processes, and that address aging-relevant questions that align with Goals A, B, and/or C of the National Institute on Aging’s Strategic Directions for Research, 2020-2025.
Significance: Describe how the proposed research will advance: 1) the identification of socio-environmental sources of aging processes and/or the etiology and progression of age-related conditions and diseases, and 2) the integration of behavioral, social, and environmental measures into biological hallmarks of aging.
Research Strategy: The Research Strategy must contain separate sections that describe the R61 and R33 phases, as well as a sub-section that is devoted to describing milestones to be achieved during the R61 phase, to qualify for the transition to the R33 phase, and for the R33 phase.
Approach: Describe the rationale for the selection of the animal species and its relevance to aging research.
Vertebrate Animals Section: In addition to addressing the four required components, for applications that propose primary data analysis in captive and/or laboratory animals, the Vertebrate Animals Section must: 1) describe the Essential 10 items, at minimum, in the ARRIVE Guidelines 2.0 (Animal Research: Reporting of In Vivo Experiments); and 2) discuss the 3R principles of Replacement, Reduction and Refinement and how the proposed study can accelerate progress toward meeting these goals in aging research more broadly.
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.
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.
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.
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.
In order to expedite review, applicants are requested to notify the NIA Referral Office by email at ramesh.vemuri@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.
Specific to this RFA: Evaluation of the application's merit should emphasizethe rationale, likely feasibility, and the potential for making a lasting impact in advancing the understanding of how social and physical environmental factors contribute to aging processes and the etiology and progression of age-related conditions and diseases.
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?
Specific to this FOA: Evaluate the extent to which the proposed research, if successful in meeting the study aims, will advance: 1) the identification of socio-environmental sources of aging processes and/or the etiology and progression of age-related conditions and diseases, and 2) the integration of behavioral, social, and environmental measures into biological hallmarks of aging.
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 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?
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 to this FOA: Evaluate whether the R61 milestones are adequately specified, developed, feasible, and quantifiable, with regard to the specific aims, and the adequacy of the success or go/no-go criteria with respect to outcomes, for advancing from the R61 to the R33 phase, and for the R33 phase. Specifically, are clear metrics of success defined for the investigators and NIA Program Officials to determine if the project succeeded in (a) demonstrating initial proof of concept in the R61 phase, and (b) providing preliminary evidence that the new or refined infrastructure can be implemented in primary research studies or secondary analysis with data collection in captive and/or wild animal populations?
Does the application provide clear rationale for the appropriateness of the study species for aging research, more generally?
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).
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?
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.
Specific to this FOA: In addition, evaluate the adequacy of the application’s discussion of: 1) the Essential 10 items in the ARRIVE Guidelines 2.0 (Animal Research: Reporting of In Vivo Experiments); and 2) the 3R principles of Replacement, Reduction and Refinement and how the proposed study can accelerate progress toward meeting these goals in aging research more broadly, if appropriate.
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
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).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute on Aging, 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.
Not Applicable
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
Melissa S. Gerald, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: melissa.gerald@nih.gov
Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: ramesh.vemuri@nih.gov
John Bladen
National Institute on Aging (NIA)
Telephone: 301-402-7730
Email: bladenj@nia.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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