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 Notice of Funding Opportunity (NOFO).

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

Conformance to all requirements (both in the Application Guide and the NOFO) 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. Notice of Funding Opportunity Description

Background

NIA’s Division of Behavioral and Social Research (BSR) supports a number of nationally representative, population-based, longitudinal studies, such as the Health and Retirement Study (HRS) and its international partners, the Mid-Life in the United States (MIDUS) study, and the National Health and Aging Trends Study (NHATS), which share key features that allow maximal utility for investigators and return on investment. NIA has successfully invested in research infrastructure that encourages coordination and collaboration among these population-based studies.

Meanwhile, NIA also supports many deeply phenotyped, psychologically rich, small- to mid-size longitudinal studies that, collectively, span the full life course and are designed to investigate the direct factors and mediators affecting health and well-being in later life. These studies have amassed rich and wide-ranging data on behavioral and psychological processes related to personality, stress, emotion, social relationships, self-regulation, decision-making, and health behaviors. Many of these studies also include detailed cognitive assessments. They often incorporate real-time experience sampling or daily diary protocols, and frequently include biomarker and neuroimaging assessments. These approaches allow the collection of precise and detailed data for hypothesis generation and provide opportunities for fine-grained mapping of individual differences in health and lifespan trajectories of aging.

These deeply phenotyped longitudinal studies have been developed by independent investigators, utilize unique designs, and have been funded as stand-alone research programs. The wealth of psychosocial, behavioral, and biomarker data available from these generally more modest-sized studies has yet to be fully exploited. Together, they represent an under-utilized resource. Establishing links across individual studies could address replication questions, allow findings to be extended to new contexts, and offer a greater potential to identify important factors that moderate healthspan and lifespan. This potential and recommendations for additional infrastructure needs were outlined in reports from 2019 and 2021 workshops.

Purpose

This Notice of Funding Opportunity (NOFO) invites applications to establish a Resource Development Network (RDN). The aim of the RDN will be to create the infrastructure needed to promote and support coordination, collaboration, and innovation across deeply phenotyped longitudinal behavioral and social studies of aging. This NOFO calls for investigator teams to design an innovative network that will serve the field at large and advance collaboration and coordination among studies.

Scope of Research Development Network Activities

This NOFO aims to develop resources to substantially impact the progress and quality of longitudinal behavioral and social research on aging and the life course. Proposed networks should promote productive collaborations across multiple NIA-funded small- to- mid-size longitudinal studies that have the potential to contribute to this agenda and create the infrastructure that will allow incorporation of other national and international datasets in the future. The meta-data catalog platform and network resources developed should achieve the following:  

• Facilitate investigator-initiated, coordinated, and/or parallel analyses of deeply phenotyped longitudinal datasets; 
• Foster innovation in data-analytic approaches and the implementation of advanced statistical models across studies; 
• Allow tests of the generalizability and replicability of findings across various populations, historical periods, and experimental designs; and 
• Be user-friendly, discoverable by the research community, and easy to access by analysts at all career stages.

Potential applicants must include concrete milestones for RDN deliverables. 

The proposed network structure can be flexible, but must adequately incorporate the activities described within the following four components: 

1. The creation of a publicly-available meta-data catalog on a web-based platform that will identify and describe existing small- to mid-size deeply phenotyped longitudinal studies that are designed to investigate factors affecting health and well-being in later life and are characterized by rich psychological, social, behavioral, and biobehavioral content.

• The proposed meta-data catalog must initially incorporate information from NIA-funded, relevant, small- to- mid-size longitudinal studies (an inexhaustive list of studies can be found in Appendix D of the 2021 workshop report). At least one of these must allow for the study of minority health and/or the health of NIH-designated populations that experience health disparities . 
• The meta-data catalog is expected to be flexible and interoperable enough to incorporate meta-data from additional studies in the future. The meta-data catalog should utilize a relational database with an accessible, web-based platform allowing user-friendly access to the following:  
  • A complete list and description of the construct clusters, specific variables/operationalizations, and items that exist in the cataloged studies; 
  • The experimental design, methodological details, and technical specifications associated with each study and the data collected, so as to allow meaningful replication studies; and 
  • Search features for available variables and/or methodological details across multiple studies for use in potential coordinated analyses across studies. 
• Applications must provide a detailed description of the organization, function, and interface of the online platform. 

The meta-data might include, for example: data collection period, number of participants, sociodemographic makeup of participants, constructs and variables measured, details on measurement methods, and/or the time-course of longitudinal follow-ups. Proposed meta-data catalogs are not required to allow for upload or storage of raw data or entire datasets.  

Designs that will allow investigators to more easily comply with the NIH Data Management and Sharing Policy  and design features that increase potential inter-operability with existing (or potential future) data archives are encouraged. To the extent possible, the proposed catalog and platform should leverage existing NIH-supported resources and support the access of data using open-source software. The (meta-) database and catalog must adhere to FAIR (Findable, Accessible, Interoperable, Reusable) principles.  

2. Outreach to, and engagement of, investigators that will stimulate innovation, collaboration, dissemination, and utilization of the meta-data catalog and associated datasets, such as the following: 

• Websites and newsletters for the dissemination of information regarding RDN resources; 
• Meetings to stimulate innovation in cross-study projects, designs, and analytical approaches; and 
• Educational activities for users, such as intensive workshops, pre-conferences, summer institutes, or visiting-scholar programs.  

Network meetings may include the support for collaborative teams to leverage a set of existing relevant deeply phenotyped longitudinal studies to: answer new questions of relevance to aging and the adult lifespan, including the influence of social and behavioral factors on healthspan and biological aging; address replication and generalizability issues; and provide educational opportunities for future  investigators. This may include planning and development activities necessary to add or modify measures to future waves of ongoing studies in order to extend the field’s capacity to explore important biological, psychological, and social factors. Outreach activities must include strategies to foster workforce diversity (see the Office of the Chief Officer for Scientific Workforce Diversity (COSWD) ). 

3. Methodological consultation services for investigators interested in data harmonization projects and/or coordinated data analysis with deeply phenotyped longitudinal studies.  

Methodological support may include, but is not limited to, individual consultation services for investigators; development of online 'how-to' webinars; or advanced seminars on methodology. 

4. Financial support for future  trainees and early-career investigators (e.g., graduate students, post-docs, assistant professors) to initiate new data harmonization, coordinated, and/or integrated data-analysis projects utilizing deeply phenotyped longitudinal studies to answer new questions relevant to aging and the adult lifespan. Projects may be either network-generated and/or solicited from outside investigators. 

The scope of these proposed projects should be realistically designed for completion within three years. These projects are expected to be large enough (~$100K each) to result in a cross-study coordinated data analysis publication or to generate sufficient pilot data to support a future collaborative data collection effort that will enable the replication and/or tests of generalizability of results across studies.  

Applications must articulate plans for the solicitation and review of   project applications.  

Together, these activities must be designed to grow the field substantially through the recruitment of new investigators rather than sustaining only the original team. Activities must serve and involve investigators across a wide range of institutions. 

Research Development Network Structure  

This NOFO is designed to address the need for resources that will create opportunities to shape the direction of an emerging field (coordinated analyses across deeply phenotyped longitudinal studies). Other than the consultation and  activities outlined above, RDN applications are not required to propose hypothesis testing or exploratory research projects during the U24 funding period. 

RDN organization and components should be designed to extend the capacity for future investigators from multiple fields to explore the influence of important biological, psychological, behavioral, and social factors on processes of aging across the full lifespan. Resources and infrastructure developed are expected to facilitate future studies on topics including, but not limited to, the following: 

• Impact of lifecourse adversity and other social determinants of health on trajectories of biological, psychological, and functional aging and later life health. 
• Examination of within-family, inter-generational experiences and their effects on adult health and well-being and aging trajectories. 
• Causal insights from historical 'natural' experiments and instrumental variables. 
• Increased rigor and reproducibility to strengthen evidence for causality, explore test-retest reliability and methodology, determine bounds of generalizability, identify sources of heterogeneity, and/or improve out-of-sample predictions. 
• Differentiation of age, period, and cohort effects. 
• Comparisons of data from prospective and retrospective designs. 
• Studies of interactions among psychological, cognitive, behavioral, social, and environmental factors and biological aging. 
• Research to elucidate how environmental, social, behavioral, and psychological mechanisms interact with one another and with biological processes to impact minority health and the health of NIH-designated populations that experience health disparities . 
• Identification of sensitive or optimal periods and targets for interventions to prevent adverse exposures, compensate or remediate their impacts on health and aging, and/or promote positive health and resilience. 

RDN teams must include individuals with the technical (‘back-end’) expertise to create and manage a user-friendly, web-based meta-data catalog. The team must have expertise in longitudinal study designs, state-of-the-art statistical and analytical approaches, and psychological, behavioral, social, or biological factors that impact health and well-being across the lifecourse.  

Applicants must secure and include letters of support from at least five of the investigators holding the data and meta-data of the deeply phenotyped longitudinal studies proposed for the initial meta-data catalog. These letters must specify that the investigators holding the data and meta-data will share all the meta-data requested by the RDN, will begin doing so within one year of the U24 award, and will continue to provide support, information, and consultation about their meta-data across the U24 funding period. Letters of support are not required to agree to share raw data or full datasets through the proposed platform. Applicants are encouraged to propose the inclusion of meta-data from additional studies, but formal letters of support are only required from a minimum of five collaborators. If the PIs for included studies are also key personnel for the RDN, a separate letter of support is not needed. 

Key personnel on network applications should be limited to personnel involved in the creation and maintenance of the network infrastructure. Potential participants involved in network activities (e.g., faculty for proposed summer institutes or workshops) should not be named in key personnel. Instead, their area of expertise should be described elsewhere in the application..  

NIA expects network applicants to support outreach activities with strategies to   foster diversity in the scientific workforce. Applications should include plans that articulate outreach to underrepresented groups including  individuals from underrepresented racial and ethnic groups as well as individuals with disabilities, to potentially participate in the project (see: NOT-OD-20-031 and NOT-OD-22-019 and  the Office of the Chief Officer for Scientific Workforce Diversity (COSWD) ). 

For network activities that span multiple institutions, applicants must propose how those activities will be coordinated across institutions, and how the proposed activities will effectively engage with other relevant activities at participating institutions. 

Non-Responsiveness Criteria

Applications that do not include all of the following elements will be considered non-responsive and will be withdrawn prior to review:

• Include a plan for each of these four components: creation of a meta-data catalog on a web-based platform; outreach; methodological support; and financial support for future  scientists. 
• Include letters of support from the investigators holding the data and meta-data of at least five of the deeply phenotyped longitudinal studies proposed for the initial meta-data catalog. 
• Include in the application a plan to recruit new investigators to the field.
• Include a plan for outreach to scientists from diverse backgrounds, including individuals from underrepresented groups. 
• Include a plan to include meta-data from at least one data set that will allow for the study of minority health and the health of NIH-designated populations that experience health disparities . 
• Include a Resource Sharing Plan for disseminating network resources. 
• Adhere to FAIR principles. 
• Include milestones for RDN deliverables.

Frequently Asked Questions

Responses to Frequently Asked Questions about this RFA will be posted here: Behavioral and Social Research Funding Opportunities and Applicant Resources. Potential applicants are strongly encouraged to contact Scientific/Research staff listed in Section VII to discuss potential network development programs prior to submission of an application. 

Resources for Applicants

• NIH Diversity in Extramural Programs 
• Expert Meeting on the Harmonization and Coordinated Analysis of Behavioral and Psychological Phenotypes 
• Deeply Phenotyped Longitudinal Studies of Aging: Opportunities for Coordination and Collaboration
• NIH Strategic Plan for Data Science
• ?NIA Guidance on Sharing Data and Other Resources
• NIH Office of the Chief Officer for Scientific Workforce Diversity (COSWD)
•  
• NIA Health Disparities Framework

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 NOFO.

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 Governments

• 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 Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• 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 registrations; 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 their organization to develop an application for support. Individuals from diverse backgrounds, including individuals from 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 NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

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 NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity 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:

Janine Simmons, M.D., Ph.D.
National Institute on Aging (NIA)
Telephone: 301-529-7254
Email: janine.simmons@nih.gov

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. The additional instructions apply:

The PD(s)/PI(s) must  have appropriate experience and training, with demonstrated experience and an ongoing record of accomplishments in managing transdisciplinary behavioral and social research projects and coordinating collaborative research. 

The team must have expertise in longitudinal study designs, state-of-the-art statistical and analytical approaches, and psychological, behavioral, social, or biological factors that impact health and well-being across the lifecourse. 

The team should include both established and emerging leaders in the scientific area of focus, expertise in the development, interoperability, and maintenance of relational databases and meta-data catalogs, and experience in resource sharing through web-based platforms or other means. 

R&R Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy:  

The application must  adequately describe how proposed activities will advance collaboration and coordination among deeply phenotyped longitudinal studies, as well as how well the resulting network infrastructure and outreach promote productive collaborations across multiple, NIA-funded, relevant small- to- mid-size longitudinal studies and allow for future incorporation of other meta-data nationally and internationally . The application must  address how the proposed RDN will have a substantial impact on the progress and quality of behavioral and social research of relevance to health, well-being, aging, and lifespan trajectories. Applicants must  adequately describe how the RDN will serve the broader community of behavioral and social researchers engaged in NIA-relevant research and should propose appropriate procedures for coordination and engagement with other relevant activities at participating institutions and across the field at large. The application must thoroughly detail the extent to which network activities advance interdisciplinary research or develop innovative research resources for the defined high priority scientific area the network will serve. RDN teams must have expertise in longitudinal study designs, state-of-the-art statistical and analytical approaches, and psychological, behavioral, social, or biological factors that impact health and well-being across the lifecourse.

 The application must  also include outreach plans designed to reach a broad swath of psychologically rich datasets, completed or ongoing, collected over a range of years, age groups, and priority populations, as defined by the NIA Health Disparities Framework. The required outreach plan must include adequate dissemination of network products and opportunities, which are appropriately targeted for the highest impact to potential participants, beneficiaries, and the field at large. The plan for dissemination must  ensure that the network and its products will be appropriately targeted for the highest impact to potential participants and beneficiaries. Outreach activities must include strategies to foster workforce diversity (see https://diversity.nih.gov/ ). Applicants must thoroughly detail how the proposed activities will have the potential to grow the field substantially through recruitment of new investigators rather than sustaining only the original team.

The application’s planned web-based meta-data catalog must  be designed to allow users to access information on experimental designs, constructs assessed, and variables available for possible coordinated analyses. It should initially incorporate meta-data from NIA-funded relevant studies and be flexible and interoperable enough to incorporate additional variables and studies in the future. Applicants must include a detailed description of the organization, functionality, and interface of the platform . Applicants should describe how the proposed catalog and database design depends, where possible, on software with an open-source license. Applications must describe the nature of the resources available within the participating scientific environment to sufficiently support electronic information handling and development of web resources for dissemination of network products. Teams must include sufficient expertise in quantitative fields necessary for conducting advanced statistical analyses and providing consultation services to outside investigators on advanced statistical analyses. Likewise, RDN teams must include individuals with sufficient technical (‘back-end’) expertise to create and manage a user-friendly, web-based meta-data catalog (e.g., the development, interoperability, and maintenance of relational databases and meta-data catalogs and experience in resource sharing through web-based platforms or other means). 

Applicants must ensure that methodological and statistical consultation services are comprehensive.  Applications must articulate plans for solicitation and review of  project applications. Applicants must  describe how their approach for soliciting and reviewing projects from future  scientists will be aligned with the network’s goals, appropriately impartial and rigorous, and likely to advance progress in the field at large. Plans for engaging and providing financial support for future  scientists must describe how they will reach and recruit prospective   investigators from diverse fields, backgrounds, and career stages.

Applications must detail concrete milestones with clear outcome measures as well as demonstrate milestone feasibility.

Letters of Support:

 The letters of support  should  specify that the investigators holding the data and meta-data will share all the meta-data requested by the RDN, will begin doing so within one year of the U24 award, and will continue to provide support, information, and consultation about their meta-data across the U24 funding period. Letters of support are not required to agree to share raw data or full datasets through the proposed platform. If the PIs for included studies are also key personnel for the RDN, a separate letter of support is not needed. 

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.

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. 

Appendix: 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.

PHS Human Subjects and Clinical Trials Information

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.

PHS Assignment Request Form

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

4. Submission Dates and Times

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

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 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 NOFO 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 ramesh.vemuri@nih.gov when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

Post Submission Materials

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.

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.

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.

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.

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 NOFO.

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 NOFO. 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:

• 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 2.4.4 Disposition of Applications.

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.6. 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 NOFO 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:

• Federalwide Standard Terms and Conditions for Research Grants
• 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.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website.

HHS recognizes that NIH 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 NOFO.

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 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at  2 CFR 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients  and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Developing objectives, approaches, and goals for network infrastructure development, including all four required components.
• Designating investigators to serve as members on a Network Steering Committee and other subcommittees with NIH staff, as appropriate.
• Complying with Federal regulatory requirements, including, but not limited to, those relating to human subjects protections.
• Attending quarterly (or as needed) virtual Network Steering Committee meetings.
• Accepting the participatory and cooperative nature of the collaborative research process and complying with policies and practices of NIH. Agreeing to accept close coordination, cooperation, and management of the project with NIA Staff. The PD/PI(s) will be expected to maintain close communications with the NIA Project Scientist(s) and, where appropriate, the Program Officer. The Project Scientist(s) will have substantial scientific involvement that is above and beyond the normal stewardship role in awards.
• Cooperating in the reporting of the study progress and findings. Where warranted by appropriate participation, plans for joint publication with NIA of the results and conclusions are to be developed by the Principal Investigator or Steering Committee, as applicable. NIH policies governing possible co-authorship of publications with NIH staff will apply in all cases. In general, to warrant co-authorship, NIH staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; and (c) preparation and authorship of pertinent manuscripts.
• Overseeing the overall budget, activities, and performance of the cooperative agreement.
• Sharing data, resources, and software as appropriate and consistent with achieving the goals of the program and the approved sharing policies for NIH.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NIA Project Scientist

• The NIA Project Scientist will participate as a member of the resource development network and assist the PD/PI(s) in the identification of relevant NIA/NIH-funded researchers and longitudinal studies for potential involvement in Network activities. The NIA Project Scientist will serve as liaison to other NIA components to promote collaborations. The NIA project scientist will also facilitate the involvement of representatives from other NIH institutes, as appropriate, in Network activities.
• The NIA Project Scientist(s) will work with the PD(s)/Pl(s) and participate in the Network Steering Committee to ensure the objectives of the program are being met. The primary responsibility for the program resides with the recipient, although specific tasks and activities will be shared among the recipient  and the NIH Project Scientist(s).
• NIA will assign a Program Officer(s) who will be responsible for retaining overall programmatic responsibility for the award and will clearly specify to the recipient the name(s) and role(s) of any additional individuals with substantial involvement in the project and the lines of reporting authority.
• NIA may designate additional staff to provide advice to the recipient on specific scientific and/or administrative issues to optimize the conduct of network activities.
• NIA will serve as a resource with respect to other ongoing NIH activities that may be relevant to the protocol to facilitate compatibility and avoid unnecessary duplication of effort.
• NIA staff will interact with the PD(s)/Pl(s) on a regular basis to monitor progress. Monitoring may include regular communication with the PD(s)/Pl(s) and his/her staff.
• NIA staff (Project Scientist(s)) will provide input, expert advice, and suggestions in the design, development, and coordination, and implementation of the network objectives.

NIA Program Official

• An NIA program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIA Program Officer will make recommendations for continued funding based on: a) overall networks progress; b) cooperation in carrying out the research; and/or c) maintenance of high quality of research in alignment with the goals of this RFA.

Areas of joint responsibility include:

• The primary responsibility for the program resides with the recipient, although specific tasks and activities will be shared among the recipient and the NIH Project Scientist(s).

Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 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 NOFOs 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 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), 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 the threshold.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, 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 2 CFR Part 200 – Award Term and Condition 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: GrantsInfo@nih.gov (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: support@grants.gov

Janine Simmons, M.D., Ph.D.
National Institute on Aging (NIA)
Telephone: 301-529-7254
Email: janine.simmons@nih.gov

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: ramesh.vemuri@nih.gov

Ryan Blakeney
National Institute on Aging (NIA)
Telephone: 301-451-9802 
Email: blakeneyr@mail.nih.gov

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 2 CFR Part 200.