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 SF424 (R&R) 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

Purpose

The purpose of this Notice of Funding Opportunity (NOFO) is to invite basic observational or experimental behavioral and/or social science R01 applications that test how intrapersonal and interpersonal mechanisms of behavior change interact with, influence, or are influenced by characteristics of social networks, with implications for health. Research supported through this NOFO will examine at least two levels of analysis: interpersonal processes and social network characteristics. Projects will identify targets for future social network health behavior change interventions across the lifespan, especially in populations in which they are currently largely underdeveloped and untested (e.g.,  populations in mid- to- late life). Basic research to develop, refine, or optimize measures (i.e., assays) of putative targets (e.g., interpersonal mechanisms of behavior change and/or social network characteristics) is  also supported by this NOFO. 

Background

Key Definitions for this NOFO:

• Interpersonal processes of behavior change: Malleable processes that play a role in initiating or maintaining behavior change and that involve, precede, or result from interactions or behaviors involving more than one individual (e.g., dyads, families, peer groups), whether that involvement is perceived and/or actual. Examples include, but are not limited to,  social support; social control and social norms; social exclusion; interpersonal emotion regulation; behavioral modeling and/or social observational learning; stigmatization/shame; positive reinforcement; and interpersonal expectations. 
• Social network characteristics: Features of a social structure (e.g., network) within which an individual is embedded. The social network is typically comprised of people who are connected to each other through meaningful social relationships or patterns of social interaction (e.g., social ties), which may manifest face-to-face or virtually. For the purposes of this announcement, only social networks comprising more than two  individuals are of interest. Examples of social network characteristics include, but are not limited to,  the density, centralization, or modularity of the network; the centrality or social bridging potential of target individuals within the network; the presence or absence of strong, weak, and Simmelian ties; and the degree of homophily/heterogeneity within the network. 
• Social network intervention: An intervention that targets specific, malleable interpersonal processes and/or characteristics of a social network to cause widespread individual behavior change. Social network interventions for health use social network data or social network characteristics to promote the uptake of positive health behaviors (or curtailment of negative health behaviors) among individuals, communities, organizations, or populations. These interventions typically (a) change the behavior of individual(s) within a network who are identified to be most likely to influence the behaviors of others and promote interpersonal processes between those individuals and others  to achieve the ultimate goal of maximizing widescale uptake of behavior change across the network (including among those who did not themselves directly receive the intervention), or (b) manipulate social network characteristics in ways that are likely to modify social ties and/or interpersonal processes that influence behavior  with the ultimate goal of changing, at scale, the behaviors of individual network members. 

Nearly 40% of all deaths in the United States are due to diseases or injuries that could have been prevented by changing health behaviors. Instigating behavior change, however, is challenging, indicating a need for novel approaches. Though research suggests that the health behaviors of our spouses, friends, family members, and peers impact our own health behaviors, there are surprisingly few interventions that leverage interpersonal processes to promote healthy behavior. A growing body of literature demonstrates further that characteristics of the social networks within which individuals are embedded are also associated with individual health behaviors and health outcomes, yet even fewer interventions leverage the properties of broader social networks to promote healthy behavior at scale. Despite the promising potential of social network interventions, they currently remain largely underdeveloped and untested, especially among populations in mid- and late-life. Further development of social network interventions requires understanding the mechanisms by which network characteristics interact with, influence, or are influenced by the interpersonal mechanisms of behavior change.  

NOTE: Applicants seeking to develop a new or adapt an existing social network intervention for which a target has already been identified should apply to the companion announcement RFA-AG-24-026, which supports planning activities necessary to develop social network interventions to promote health behavior change across the lifespan. Investigators funded through these two announcements will be expected to share research methods and findings with one another at an annual meeting.  

Research Objectives

This NOFO will support use-inspired basic observational or experimental behavioral and/or social science research that tests hypotheses about how interpersonal mechanisms of health behavior change interact with, influence, or are influenced by characteristics of social networks. This basic research should be designed to inform the identification of targets for future social network interventions. At least two levels of analysis must be examined: processes at the level of interpersonal relationships and characteristics of the social network.  

Projects must examine interpersonal processes of health behavior change as defined above. Projects must also examine characteristics of social networks and assess the extent to which they modulate,  or are modulated by,  interpersonal processes of health behavior change. Though not required, projects may also choose to also examine intrapersonal processes of health behavior change, assuming they also examine both interpersonal processes of health behavior change and social network characteristics. Projects should be designed to test hypotheses about whether interpersonal processes and/or social network characteristics are potentially malleable, such that they could be targets for future social network interventions.  

This NOFO also supports the development, refinement, optimization, and validation of appropriate assays (measures) of putative interpersonal or social network targets, including,  but not limited to,  the identification of the most appropriate means of mapping the social network (e.g., ‘name generators’) and operationalization of social network characteristics.  A ssays that consider the characteristics of  individuals who comprise the social network (such as their sociodemographic and sociocultural characteristics, likelihood of life transitions, etc.) and that account for features of the health behavior outcome of interest (such as the behaviors’ visibility to other network members and how difficult the behavior is to enact) are of high priority. 

Both experimental studies that meet the federal definition of basic research (e.g., basic experimental studies in humans) and observational studies  in humans will be considered  responsive to this NOFO: 

• Experimental studies in which a purported interpersonal process is manipulated to test impacts on network characteristics relevant to behavior change (or vice versa), as well as experimental studies in which an interpersonal process of behavior change or social network characteristic is experimentally manipulated to test impacts on individual health behavior throughout the social network, will be considered  responsive to this NOFO, as long as the studies are designed to understand fundamental aspects of phenomena and/or to identify a potential malleable target for future intervention development (for examples of case studies that meet this criteria, see Basic Experimental Studies Involving Humans Case Studies).  
• Observational studies that identify interpersonal processes by which health behavior changes over time, measure the impact of social network characteristics, and use causal inference approaches (such as, but not limited to, quasi-experimental designs, propensity score matching, and predictive modeling) to determine the potential malleability of those processes will  be considered responsive to this NOFO. Observational studies may leverage secondary data from nationally-representative studies (e.g., see d ata r esources available from the NIA, such as the Health and Retirement Study (HRS), and its international sister studies;  National Health and Aging Trends Study (NHATS);  National Survey of Caregiving (NSOC);  Panel Study of Income Dynamics (PSID);  Add Health Parents Study;  National Longitudinal Study of Adolescent to Adult Health (Add Health);  Understanding America Study;  and Midlife Development in the United States (MIDUS) survey). However, use of existing infrastructure or measures is not a requirement for consideration under this NOFO.  

Research supported by this RFA must fall within Stage 0 of the NIH Stage Model – that is, it should be use-inspired basic science research on mechanisms of behavior change that is relevant and ultimately translatable to social network intervention development. This research should test hypotheses about the malleability of interpersonal processes or social network characteristics relevant to behavior change that can ultimately support social network intervention development. For example, projects might seek to identify why an experimental manipulation (that can be leveraged in a behavioral intervention) might produce an effect (that is, the intervention’s mechanism of action), the extent to which a target interpersonal process or social network characteristic is malleable, the extent to which the target process or characteristic is valid for changing a health behavior outcome of interest, and/or for whom and under what circumstances modifying that target interpersonal process or network characteristic will be most likely to produce health behavior change. Stage 0 projects do not include later Stage activities related to the development, testing, and/or implementation of interventions.  nbsp;

NIH is committed to supporting a sustainable and diverse biomedical research workforce. Individuals from a wide variety of backgrounds, including those from groups identified as underrepresented  in the biomedical, clinical, behavioral, and social sciences (collectively termed "biomedical") research workforce (see NOT-OD-20-031) are encouraged to apply (see also NOT-OD-22-019). 

Specific Areas of Interest

National Institute on Aging (NIA) 

NIA supports research on the broad impacts of interpersonal processes and social network characteristics on health behavior, health outcomes, quality of life, and utilization of healthcare services in aging. NIA is interested in basic behavioral and social science research that will help catalyze the development of future social network health behavior change interventions in mid-to-late life. Such future social network health behavior change interventions have the potential to impact physical, cognitive, sensory, or emotional health and/or risk of disease and disability as people age, improve the quality of life of older adults, and/or change the behaviors of institutions and systems that influence those outcomes.  

Projects submitted to NIA should identify potentially malleable interpersonal processes and social network characteristics that influence health behavior change in mid-to-late life. NIA is particularly interested in research that accounts for mid-to-late life changes in interpersonal relationships and social network composition (e.g., age-based changes in social network size, the perceived quality and function of interpersonal relationships, the preponderance of kin- and non-kin- based ties), as well as projects that consider sociodemographic trends in aging (e.g., increasing prevalence of aging in place, living alone, kinlessness) and the impact of major later-life transitions (e.g., retirement, bereavement, divorce, re-partnering, caregiving, children exiting/reentering the home, residential change) on interpersonal processes, social network characteristics, and health outcomes. NIA also encourages projects that consider how social network analysis techniques (e.g., egocentric and sociocentric network analyses) can account for changes in social network characteristics over time. Projects that focus on people who themselves would benefit from health behavior change as well as those that focus on changing the behavior of people who are critical for promoting or helping maintain good health in others (e.g., formal or informal care providers, health systems leaders, allied health professionals, and other community leaders or organizations) are both of interest.   

Applicants are encouraged to refer to the NIA Health Disparities Research Framework to learn about NIA priority populations, the integration of multi-level factors, and the incorporation of a life course perspective. Populations of interest include, but are not limited to, individuals at increased risk for development of aging-related chronic diseases, as well as NIH-designated populations that experience health disparities in the United States, including African American/Black, Latino/Hispanic, American Indian and Alaska Native, Asian American, and Native Hawaiian and Pacific Islander persons, less privileged socioeconomic groups, underserved rural populations, and individuals from sexual and gender minority (SGM) groups.  

National Cancer Institute (NCI) 
NCI is interested in observational, experimental, and intervention research to understand mechanisms through which social networks influence health behaviors for cancer prevention and control. This includes the broad effects that social networks have on health outcomes, quality of life, decision making, utilization of healthcare services, and engagement of health behaviors through biobehavioral processes, social influence, norms, the perception of social support, and the flow of information and resources. NCI is interested in research that identifies how social networks and specific linkages within them can serve as targets for cancer risk behavior and survivorship interventions, and research that incorporates social network methods and measures (e.g., egocentric and sociocentric network analyses) to measure survivorship or care networks, and the influence on health behaviors and outcomes for cancer survivors, caregivers, and families.  

Research areas of interest include etiology, prevention, detection, diagnosis, treatment, survivorship, and end-of-life support among health disparity populations (i.e., racial and ethnic minority groups (see OMB Directive 15), people with lower socioeconomic status (SES), underserved rural communities, and sexual and gender minority (SGM) groups ). Research  that identifies the ways in which social network-level factors and other factors that affect social network dynamics (e.g., social structures and processes, culture, adverse conditions, racism and discrimination, stressors, coping, resilience, among others) may interact with individual- and systems-level (e.g., structural racism/bias) factors to influence cancer prevention and control outcomes in recognized health disparity populations is especially encouraged. 

Non-Responsiveness Criteria

The following research activities will be considered  non-responsive to this NOFO, and such applications will be administratively withdrawn prior to scientific peer review: 

• Clinical trials that do not meet the federal definition of basic research (CFR 272.3)  
• Projects that do not examine how interpersonal mechanisms of health behavior change interact with, influence, or are influenced by characteristics of social networks (where the social network comprises more than two individuals) – including examination of both levels of analysis 
• Projects that do not clearly articulate how proposed processes relate to health behavior or behavior change in populations of interest 
• Non-human animal studies 
• For applications submitted to NIA: Projects that do not focus on mid-to-late life health or health behavior change 

Resources for Applicants

• This NOFO utilizes the NIH Stage Model as its conceptual framework. It encourages Stage 0 activities (i.e., basic science) associated with the identification of putative targets for future social network health behavior change interventions across the lifespan, especially in populations in which they are currently largely underdeveloped and untested (such as populations in mid- to- late life), as well as basic science activities associated with development, refinement, or optimization of measures (i.e., assays) of those targets. Target identification is a critical step in the ultimate development of social network interventions that are consistent with the experimental medicine approach that is central to the NIH Stage Model and the NIH Science of Behavior Change Program. 
  • The NIH Stage Model for Behavioral Intervention Development: The NIH Stage Model has the goal of creating efficacious, ultimately implementable interventions defined by their principles. A central tenant of this model is that understanding mechanisms of change is critical for developing the most effective and scalable interventions. Further, understanding mechanisms of action can help identify essential components of an intervention. By offering a framework for describing where an intervention is in the developmental pipeline and appropriate research activities within different Stages of intervention development, the NIH Stage Model facilitates discussion of intervention development research by applicants, reviewers, and funders with a common language.  
  • The NIH Common Fund's Science of Behavior Change (SOBC) Program/Experimental Medicine Approach: The SOBC mechanism-focused, experimental medicine approach is a methodology that is compatible with the NIH Stage Model. It encourages clear a priori specification of the intended mechanistic target(s) of an intervention, methods that test causal hypotheses about the degree to which an experimental manipulation or intervention engages those targets, and validation that engaging those targets produces the desired behavior change. Within the experimental medicine approach to behavior change, intervention targets may include mechanisms or processes at any level of analysis (e.g., environmental, social, contextual, interpersonal, behavioral, psychological, and/or neurobiological). The SOBC program established the expectation that behavior change interventions are designed to explicitly test hypotheses about mechanisms of action, and that they incorporate appropriate measures to enable such tests. This includes testing hypotheses about which components of an intervention are responsible for change in a target mechanism or process (i.e., which components of an intervention are essential to ‘engage’ a target), as well as hypotheses about whether changes in that mechanism result in a change in the relevant outcome (i.e., the extent to which the target is ‘valid’ for the health behavior outcome of interest). 
• Social Network Diffusion of Individual Behavior Change Interventions Virtual Workshop Report 
• NIA Health Disparities Framework 
• Data Resources for Behavioral and Social Research on Aging 
• Responses to Frequently Asked Questions about this NOFO will be posted here: https://www.nia.nih.gov/research/dbsr/behavioral-and-social-research-funding-opportunities-and-applicant-resources. 

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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 Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

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

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

Applicant Organizations

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

• 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 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.

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 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 SF424 (R&R) 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:

Elizabeth Necka, Ph.D. 
National Institute on Aging (NIA) 
Telephone: 301-480-6947 
Email: Liz.Necka@nih.gov   

Page Limitations

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 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.

R&R or Modular Budget

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

Application budgets must include funds each year for travel to an annual meeting of grantees on or near the NIH Campus in Bethesda to share research methods and findings. 

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:

Applications should describe how successful completion of the aims will lead to the project’s ability to identify interpersonal processes and/or social network characteristics that can be targets for future social network interventions for health. 

Applications must propose basic observational or experimental behavioral and/or social science research that falls within Stage 0 of the NIH Stage Model. This basic research should be designed to inform identification of targets for future social network interventions.  

Applications must propose to examine the interaction between interpersonal processes of behavior change and social network characteristics (that is, whether and to what extent characteristics of the social network modulate or are modulated by processes of behavior change at the interpersonal level). 

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.

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.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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

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

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 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.

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.

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 FOA 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.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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 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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all 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.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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 NOFO.

• 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.html and https://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 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 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 the threshold.  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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 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 45 CFR Part 75 and 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

Elizabeth Necka, Ph.D. 
National Institute on Aging (NIA) 
Telephone: 301-480-6947 
Email: Liz.Necka@nih.gov 

Emerald Nguyen, Ph.D. 
National Institute on Aging (NIA) 
Telephone: 301-402-7571 
Email: emerald.nguyen@nih.gov  

Laura Major, DrPH 
National Institute on Aging (NIA) 
Telephone: 301-827-4464 
Email: laura.major@nih.gov  

Jennifer Guida
National Cancer Institute (NCI)
Telephone: 240-276-7634
Email: jennifer.guida@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: ryan.blakeney@nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: crystal.wolfrey@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 45 CFR Part 75 and 2 CFR Part 200.