Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Funding Opportunity Announcement.

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to invite R61/R33 applications proposing to establish and conduct a networking and infrastructure project to enhance the development of comparative research on determinants of differences among human and nonhuman primate life spans, life histories, and other aging-related outcomes, and prospects for translating findings from this research into development of human interventions. NIA intends to fund a single award in response to this FOA.

This FOA is a companion to RFA-AG-24-019, Comparative Research on Determinants of Differences Among Human and Nonhuman Primate Species in Life Spans, Life Histories, and Other Aging-Related Outcomes, and Prospects for Translation, which invites R01 research projects in this topic area and describes specific topics of interest. Applicants for the R01 awards may also be included as personnel in applications for this networking/infrastructure project award.

The networking and infrastructure project selected for funding will address key needs for activities and infrastructure to promote development of this new research field. It will foster interactions and collaborations among researchers on topics including human longevity, aging biology, comparative biology, evolutionary genetics and biology, biological anthropology, neuroscience, and primatology. Interactions among several of these fields have been limited. To amplify synergy among projects funded through the companion R01 RFA, the project will support infrastructure to enhance the sharing of ideas and data, opportunities for pooling data, and interdisciplinary analyses. It will also provide a venue and support for researchers from relevant fields (including, but not limited to, researchers supported by the R01 projects) to develop concepts for additional research on determinants of species differences in human and nonhuman primate life spans and age-related outcomes through research planning, including data analyses and pilot studies needed for designing new projects. In addition, the networking/infrastructure project will enhance the quality and availability of data sources needed to design and implement research in this field through activities such as harmonizing data, creating new databases, increasing interoperability of existing data sources, and establishing public websites and other information architecture.

This FOA solicits applications that include expertise from multiple research disciplines such as human longevity, aging biology, comparative biology, evolutionary genetics and biology, biological anthropology, neuroscience, and primatology, in conjunction with expertise in coordinating diverse research projects, database management, statistics, and informatics. Applicants are encouraged to consider a multi-principal investigator project to ensure that investigators with expertise spanning the above topics have significant project involvement.

Project Objectives and Activities

The proposed networking/infrastructure project must have three main objectives:

1) To enhance the quality and synergy of projects supported through R01 research projects funded in response to RFA-AG-24-019, and to enhance the public accessibility of their results.

2) To identify promising directions for future research on determinants of species differences in human and nonhuman primate life spans and age-related outcomes through planning activities that engage researchers from pertinent fields (including, but not limited to, researchers supported by the R01 projects).

3) To enhance the quality, public availability, and interoperability of data sources needed to design and implement research on determinants of species differences in human and nonhuman primate life spans and age-related outcomes.

Each of the three above objectives must be addressed in the study aims and through activities proposed in the application.

Examples of activities related to these objectives include, but are not limited to:

• Organizing, participating in, and maintaining documentation on periodic meetings with R01 awardees supported through RFA-AG-24-019 and other researchers to exchange information, discuss needs and opportunities for data harmonization and/or pooled analyses, and assess needs for infrastructure for data sharing and new project development.
• Facilitating and supporting data harmonization, pooled analyses, or comparisons combining data from the associated R01 projects and other projects as appropriate.
• Facilitating collaborations beyond the group of R01 awardees by identifying needed expertise and interactions with relevant scientific communities(e.g., symposia and/or other presentations at meetings of pertinent professional societies) to stimulate interest in this field.
• Compiling information on ongoing research projects, databases, and animal specimen resources to facilitate development of new studies.
• Organizing and convening research workshops or webinars on topics for potential future research.
• Establishing working groups on topics and strategies for future research and identifying data sources and preliminary analyses needed for designing new studies.
• Conducting analyses of existing datasets and conducting de novo pilot studies to assess feasibility and inform design of specific future research projects in this field, and identifying feasible studies.
• Conducting analyses of genetic, biological, chemoinformatics, and other databases to identify potential targets for future intervention studies, based on relationships of primate species genomic or phenotypic differences to life span or age-related conditions.
• Developing specific plans for maintenance and public accessibility of data from the R01 projects and related projects.
• Developing or enhancing integrated, annotated databases incorporating information about primate species genomic, epigenomic, and other omic characteristics.
• Developing publicly available informatics tools and approaches to improve interoperability, comparability, and ease of use of relevant databases across multiple disciplines pertinent to comparative human and nonhuman primate studies.
• Developing best practices on methodologic topics (e.g., data collection methods and phenotypic characterization) and topics related to regulatory and policy issues (e.g., data sharing and ethical considerations).
• Identifying crucial gaps in primate resources needed for comparisons of species of differing life span (e.g., specific species, specific types of specimens, data, or informatics) and strategies by which they might be addressed.
• Identifying options for long-term sustainability of informational resources provided by the project after it ends.
• Maintaining documentation on materials related to the above activities.

In addition, applications must include plans to design and maintain a user-friendly website and/or other information architecture with:

1) Internal features to facilitate sharing of data and other collaborative activities among investigators supported by the R61/R33 and companion R01 awards, including sharing of schedules and documentation on meetings, and shared access to data where appropriate.

2) Public features to share information about ongoing studies, data and specimen resources, and best practices.

The project application must define the structure and operational procedures it will use to integrate the project team’s expertise in human longevity research and nonhuman primate research with its expertise in project coordination, data management, statistics, and informatics, to address its objectives.

It is expected that R61/R33 activities will be developed in collaboration with R01 awardees funded under the companion FOA. Applications must describe proposed steps for establishing and implementing collaborative activities.

Phased Award Activities and Project Milestones

This FOA uses the phased R61/R33 mechanism, in which initial activities toward the three main objectives described above are conducted during the R61 phase, followed by an extension of these activities in the R33 phase. The project selected for funding will receive up to two years of support for the R61 phase, followed by up to three years of support for the R33 phase, contingent on reaching project milestones for the R61 phase.

The application must provide separate Specific Aims for each of the R61 and the R33 phases. For each Specific Aim, the application must define milestones for the R61 phase and milestones for the R33 phase, and timelines for reaching them. Milestones should be defined as deliverables (e.g., plans, resources, research activities).

Applicants proposed milestones for both the R61 and R33 phases will be evaluated in peer review and by NIA program staff prior to award. In response to peer and program review, milestones may be modified or added and will be included in the terms of the award. Milestones may also be modified at the time of transition to the R33 award. NIA will appoint an independent Monitoring Board including experts from pertinent fields to assist in assessing study progress in reaching milestones during the R61 and R33 phases and assessing proposed new activities in the R33 phase.

Prior to the end of the R61 phase, grantees will be expected to submit a package requesting transition to the R33 phase. This transition package will be reviewed by NIA program staff and must include: a progress report describing the achievements of the R61 phase, including success in reaching R61 milestones, and plans for the R33 phase, including updated milestones if appropriate. If the transition package is approved, the R33 will be awarded for the remainder of the project period without the need to submit a new grant application.

R61 and R33 foci

While selection of specific activities and milestones for each of the R61 and R33 phases will depend on the project team’s resources, priorities, and specific aims, appropriate general foci for the R61 phase include, but are not limited to:

• Establishing infrastructure for information sharing and collaborations among awardees of R01 projects submitted in response to RFA-AG-24-019 sufficiently early in these projects to facilitate consideration and implementation of adjustments to study protocols that could enhance projects synergy and productivity (e.g., data harmonization, analyses spanning more than one project).
• Creating informational resources and conducting activities for exploration by R01 awardees and other researchers of further needs and opportunities for research on determinants of differences in primate species life spans, health spans, and age-related conditions.
• Establishing best practices on methodologic and regulatory issues pertinent to future studies.

In the R33 phase, operational and administrative coordination should be well established for the research network. R33 phase foci should be on extending activities developed during the R61 phase. Appropriate general foci for the R33 phase include, but are not limited to:

• Providing infrastructure and coordination for collaborative analyses of data from the associated R01 projects.
• Conducting preliminary research needed for assessing feasibility, design, and implementation methods of key future studies, and identifying feasible studies.
• Creating or enhancing public information resources to enable more and better interdisciplinary studies in this field, including resources for interoperability of data from primate longevity-related species comparisons with existing NIA databases and research portals related to longevity.
• Identifying further needs for pertinent informational, biospecimen, and animal population resources and organizational options for creating them.

Appropriate selection of specific activities in the R33 phase (e.g., of pilot studies, database construction) will depend in part on results in the R61 phase and on findings from the R01 projects and other studies during the time period of the R61 phase. In such cases, applicants for the R61/R33 award are not required to identify specific topic areas for projects in their competing applications. However, the R61/R33 application must describe proposed processes in the R33 for identifying potential activities, assessing their quality and priority by internal and/or external review, selecting them, and assessing and reporting their progress. Greater detail on proposed R33 activities will be required in the package submitted for NIA approval to transition from the R61 phase. NIA’s independent Monitoring Board will assist NIA in evaluating proposed new specific activities in the R33 phase.

Non-Responsiveness Criteria

The following types of applications will be considered non-responsive and will be withdrawn prior to review:

• Applications in which each of the three main objectives listed in the Project Objectives and Activities is not explicitly addressed by at least one Specific Aim of the proposed project.
• Applications whose Specific Aims are not all directed towards the three main objectives.
• Applications that do not describe Specific Aims for each of the R61 and R33 phases.
• Applications that do not describe milestones and timelines for meeting them for both the R61 and R33 phases of the project.
• Applications that do not define the project's organizational structure and operational procedures, including its plans for integrating expertise in human longevity research and nonhuman primate research expertise with its expertise in project coordination, data management, statistics, and informatics, to address its objectives.
• Applications that do not describe proposed steps for establishing and implementing collaborative activities with R01 awardees funded in response to RFA-AG-24-019.
• Applications that do not include plans for creation and maintenance of a website and/or other information architecture to address needs of R61/R33 participants and provide public information on research and scientific resources.
• Applications that do not describe processes in the R33 phase to identify potential activities (e.g. pilot studies, database construction), assess their quality and priority by internal and/or external review, select them, and assess and report their progress.

Additional Background Information and Pre-application Webinar

Additional information related to research on determinants of primate species life span differences (including animal, specimen, imaging, and data resources) is available in a report based on a recent NIA workshop on this topic. In addition, frequently asked questions and answers about the R61/R33 FOA will be posted here.

Prospective applicants for this award are encouraged to join a planned NIA webinar with representation from NIA’s Division of Geriatrics and Clinical Gerontology, Division of Aging Biology, Division of Behavioral and Social Research, and Division of Neuroscience. This webinar will include an overview of the initiative and address potential applicants questions related to the scope, R61/R33 phased activity, and other aspects of the project. The date of the webinar and access information will be posted here.

It is recommended that potential applicants consult with NIA program staff early in their process of considering or planning an application. Inquiries will be directed to appropriate NIA staff and should be sent to the NIA Scientific/Research Contact listed in Section VII of this FOA.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Carol Nguyen
National Institute on Aging (NIA)
Telephone: 202-450-9536
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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:

Applications must describe the project team's expertise in human longevity research, nonhuman primate research, project coordination, data management, statistics, and informatics, to address the project's objectives.

Applications must define how the project’s structure and operational procedures integrate its diverse types of expertise in order to address the FOA's objectives.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

The project should budget for costs associated with periodic meetings with awardees funded through the companion RFA (RFA-AG-24-019). At a minimum, the project budget should include costs for R61/R33 staff to organize and travel to annual two-day meetings with the R01 awardees in Bethesda, Maryland. (R01 awardees travel expenses will be paid from their project budgets.)

R&R Subaward 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, with the following additional instructions:

Specific Aims:

• Each of the following three main objectives must be explicitly addressed by at least one Specific Aim of the proposed project. All Specific Aims must be directed towards these main objectives.

1. To enhance the quality and synergy of projects supported through R01 research projects funded in response to RFA-AG-24-019, and to enhance the public accessibility of their results.
2. To identify promising directions for future research on determinants of species differences in human and nonhuman primate life spans and age-related outcomes, through planning activities that engage researchers from pertinent fields (including, but not limited to, researchers supported by the R01 projects).
3. To enhance the quality, public availability, and interoperability of data sources needed to design and implement research on determinants of species differences in human and nonhuman primate life spans and age-related outcomes.

• Applications must include separate sets of Specific Aims for the R61 and R33 phases.
• Milestones and timelines for meeting them must be described for both the R61 and R33 phases of the project.

Research Strategy:

• The project application must define its structure and operational procedures, including its plans for integrating expertise in human longevity research and nonhuman primate research with expertise in project coordination, data management, statistics, and informatics, to address its objectives.
• Applications must describe proposed steps for establishing and implementing collaborative activities with R01 awardees funded in response to RFA-AG-24-019.
• Applications must include plans for creation and maintenance of a website and/or other information architecture to address the needs of R61/R33 participants and provide public information on research and scientific resources.
• The R61/R33 competing application must describe processes in the R33 phase to identify potential activities (e.g. pilot studies, database construction), assess their quality and priority by internal and/or external review, select them, and assess and report their progress.

Vertebrate Animals:

• For applications that propose primary data analysis in captive and/or laboratory animals, the Vertebrate Animals Section will be required to: 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.

The following modifications also apply:

It is strongly encouraged that in the development of resources and tools, applicants should consider the interoperability of data from primate longevity-related species comparisons with existing NIA databases and research portals related to longevity.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. 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 unique entity identifier provided on the application is the same identifier 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 NIA, 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 [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Consultation with Scientific/Research Staff:

It is strongly encouraged that all applicants consult with NIA program staff early in their planning process and not later than the Letter of Intent due date. This consultation is considered separate from the Letter of Intent.

Inquiries should be sent to the NIA Scientific/Research Contact listed in Section VII of this FOA. Inquiries will be directed to the appropriate NIA Division staff who can then advise whether proposed project activities would be considered responsive to the objectives and goals of this FOA.

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

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.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

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?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

Specific to this FOA:

Does the project team have adequate expertise in human longevity research, nonhuman primate research, project coordination, data management, statistics, and informatics, to address its objectives?

Do the project’s structure and operational procedures adequately integrate its diverse types of expertise to address its objectives?

Innovation

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?

Approach

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:

Are the project’s proposed steps for establishing and implementing collaborative activities with the R01 awardees funded in response to the companion RFA-AG-24-019 adequate?

Are the application’s proposed R61 and R33 milestones adequate indicators of progress and success in addressing the objective to enhance the quality and synergy of projects supported through R01 research projects funded in response to RFA-AG-24-019, and to enhance public accessibility of their results?

Are the application’s proposed R61 and R33 milestones adequate indicators of progress and success in addressing the objective to identify promising directions for future research on determinants of species differences in human and nonhuman primate life spans and age-related outcomes, through activities that engage researchers from pertinent fields?

Are the application’s proposed R61 and R33 milestones adequate indicators of progress and success in addressing the objective to enhance quality, public availability, and interoperability of data sources needed to design and implement research on determinants of species differences in human and nonhuman primate life spans and age-related outcomes?

Is the proposed timeline for reaching milestones appropriate?

Are the project's proposed structure and operational procedures, including its plans for integrating expertise in human longevity research and nonhuman primate research expertise with its expertise in project coordination, data management, statistics, and informatics, adequate to address its objectives?

Are plans for creation and maintenance of a website and/or other information architecture well developed to address the needs of R61/R33 participants and provide public information on research and scientific resources?

Does the R61/R33 application describe satisfactory processes in the R33 phase to identify potential activities (e.g. pilot studies, database construction), assess their quality and priority by internal and/or external review, select them, and assess and report their progress?

Are plans for developing public data and information resources satisfactory for providing potential users from multiple research fields with pertinent data and analytic tools related to research on determinants of differences in primate species life spans and potential translational studies for human interventions?

For applications that propose primary data analysis in captive and/or laboratory animals, does the Vertebrate Animals Section satisfactorily describe the Essential 10 items, in the ARRIVE Guidelines 2.0 (Animal Research: Reporting of In Vivo Experiments) and discuss the 3R principles of Replacement, Reduction, and Refinement and adequately describe how the proposed study can accelerate progress toward meeting these goals in aging research more broadly?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

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 Animals 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

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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 Coucil on Aging. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Carol Nguyen
National Institute on Aging (NIA)
Telephone: 202-450-9536
Email: [email protected]

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: [email protected]

Laura Pone
National Institute on Aging (NIA)
Telephone: 301-451-9956
Email: [email protected]

Section VIII. Other Information

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 and 2 CFR Part 200.