Part 1. Overview Information

Key Dates

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

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

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

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

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

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Key Definitions for This Funding Opportunity Announcement (FOA)

• Environmental contextual data General exposome factors that capture environmental (e.g., physical, chemical, political, social, psychological, and economic) exposures. Environments include a variety of geographic and political units (e.g., countries, regions, states, counties, neighborhoods, Census tracts), as well as other institutions such as schools, workplaces, nursing homes and assisted living facilities, and informal units such as families and peer social networks.
• Individual exposure data Specific exposome factors experienced at the individual level, such as early life adversity, social relationships, family structure, occupational history, educational experiences, lifestyle (health behaviors including diet, sleep, physical activity, substance use, etc.), psychosocial stress exposures (includes traumatic stressors such as exposure to disasters, combat exposure, etc.), and other aspects of life histories.

Background

A variety of exposures in the environments where people live, work, pray, and play shape health, including one’s risk profile for Alzheimer’s Disease (AD) and AD-Related Dementias (ADRD). Together, this comprehensive set of exposures across domains (e.g., physical, chemical, social, psychological, economic) constitute the exposome. The exposome impacts individuals health and development from before they are born and continues throughout their lives. Aspects of the exposome salient for AD/ADRD range from the microscopic (e.g., microbiome, particulate matter, SARS-CoV-2) to the individual (e.g., early life adversity, occupational history, lifestyle) to the macro level (e.g., structural racism, climate change). Moreover, exposures vary by place and individual life history and change over time. This underscores the need for longitudinal studies to examine the timing, dose, and duration of unique or combined exposures that may account for individual differences and group disparities in dementia-related outcomes and help us identify potential targets for prevention. Central to this research agenda is the recognition that exposures are inequitably distributed in our society. Social and environmental contexts are key social determinants of health but often tend to cluster. For example, individuals with less education or members of marginalized populations are more likely to live in communities with fewer resources and be exposed to more environmental hazards. Behavioral and social research on the exposome seeks to understand how contextual features of social, economic, cultural, and built environments and individual-level behavioral and social factors interact with biological processes to get under the skin to affect health. A recent NIA workshop, Understanding the Role of the Exposome in Brain Aging, Alzheimer’s Disease (AD) and AD-Related Dementias (ADRD), highlighted the need for further investigation into how social environmental and behavioral factors impact disparities in, and the etiology of, AD/ADRD.

Exposome measures include environmental contextual data and individual exposure data. Environmental contextual exposure information can be linked to, and data from questions about individual exposures can be incorporated in, longitudinal population-representative surveys or deeply phenotyped studies. In addition to information collected from individual survey items, exposome data can be gathered from personally worn sensors or from administrative data linkages. Together, these data can allow us to answer rich questions about the impact of various environmental and personal exposures on the social and behavioral life course processes that influence health outcomes, including cognitive aging and AD/ADRD.

Purpose

In response to Congressional report language recogniz[ing] the importance of mechanistic research to address ADRD disparities, including the social and contextual factors that contribute to increased risk for disease, this FOA invites applications that propose to establish a national AD/ADRD Exposome Coordinating Center, which henceforth will be referred to as "the CC." The CC will serve as a centralized hub for accessing, harmonizing, linking, and sharing environmental contextual data and individual exposure data with NIA/NIH-funded projects that hold potential for advancing the understanding of links between life course exposures and AD/ADRD risk and resilience, as well as disparities in AD/ADRD across populations.

The objectives of this FOA are the following:

1. To develop an organizational and governance structure to support the administration, innovation, and dissemination functions of the CC.
2. To propose activities to establish guidance and practices for the use and harmonization of exposure data across NIA-supported infrastructure projects, as well as other longitudinal studies of aging. Additionally, to propose and support activities for the development of innovative and novel exposure measures and data.
3. To disseminate resources and products developed by the CC to the broader AD/ADRD research community to expand the use of social and behavioral data and harmonized measures in a wide range of studies.

Current Initiatives

NIA already supports numerous population-based longitudinal studies that capture variation in the social, healthcare, and policy environment and have worked to harmonize data to facilitate cross-national comparative research on aging. For example, NIA supports a set of nationally representative international studies harmonized with the Health and Retirement Study (HRS) in the U.S. A number of these studies, including the HRS, incorporates the Harmonized Cognitive Assessment Protocol (HCAP) to allow for the study of environmental and behavioral factors linked to dementia risk. Resources such as Gateway to Global Aging Data and National Archive of Computerized Data on Aging (NACDA) support these efforts by providing researchers with information about variables shared across studies. In addition, the HRS has, and continues to develop, contextual data linkages allowing researchers (via the MiCDA Enclave Virtual Desktop Infrastructure) to examine HRS data in combination with geographically-linked data on health care and long-term care access, air quality, land use, crime, food access, COVID-19 policies, etc. Additional sources of contextual data on topics ranging from community resilience to disasters (such as the Census Community Resilience Estimates) to economic vulnerability (e.g., housing eviction) are available from federal and private sources and offer opportunities for expansion of these NIA-funded resources.

Additional NIA-funded longitudinal studies of aging and AD/ADRD that focus on the role of social, behavioral, psychological, and economic exposures in shaping health outcomes hold potential for advancing this work (see, for example, data resources for behavioral and social research on aging). Similarly, other AD/ADRD studies/projects may benefit from the addition of resources developed under this initiative as they seek to incorporate a wider array of risk and protective factors into their analyses to better understand AD/ADRD etiology and disparities. Alongside the population-based longitudinal studies, NIA also supports educational cohort studies seeking to elucidate how education and other social and economic factors (e.g., social relationships, occupation) operate as risk and protective factors for AD/ADRD risk across the life course, and social inequities therein. A recent funding initiative aims to enhance measures of educational exposures and cognitive assessments in existing studies to support this line of AD/ADRD research. NIA also has investments in longitudinal deeply-phenotyped biosocial surveys collectively spanning the full life course that are rich in psychological, social, behavioral, and biological content. These surveys often bring participants into clinics or neuroscience labs for health, performance, and imaging protocols, allowing the study of integrative pathways linking social environments, psychological processes, behaviors, cognition, and physical health.

In addition, a number of NIA-supported Centers that support centralized infrastructure for aging and AD/ADRD science may contribute to, or leverage, resources from this initiative to support the harmonization of exposure measures and enable comparability across studies. Finally, NIA supports Behavioral and Social Research Networks that develop and share resources for contextual and individual exposure assessment in social, behavioral, psychological, and economic domains, including psychosocial stress, early life adversity, education, criminal justice involvement, state and local policy, rurality, and other social determinants of health.

Alongside these studies, centers, and networks, there exist multiple federal and private sources of administrative and contextual data, a variety of NIA-funded efforts to forge links between some of these sources and specific NIA studies, and a widely dispersed set of efforts to create tools to address the needs of various groups working in exposome science. Common data elements (CDEs) and databases of vetted measures may be helpful for investigators and could advance research on the role of the exposome in health. In addition to selecting appropriate measures, a significant hurdle for researchers is combining and harmonizing datasets to create larger data resources, with challenges that may be specific to some forms of social and behavioral data. The federal statistical system, including the Census Bureau and the National Center for Health Statistics, as well as private sources, have extensive sets of validated measures that investigators may be able to use, which can then facilitate comparisons of non-representative samples to larger populations. However, investigators currently spend considerable time selecting measures specifically tailored to their own protocol. As concerns grow about the role of social and behavioral determinants of health, obtaining and assembling contextual data and individual level exposure data requires common solutions that would benefit multiple investigators and accelerate the study of the role of the exposome in AD/ADRD risk.

While these valuable and disparate projects are all actively contributing to exposome research on the social and behavioral determinants of aging and AD/ADRD, there is value in greater coordination among them to accelerate progress on understanding the role of the exposome in AD/ADRD risk. To date, the rich resources and infrastructure described above are not centrally organized, which reduces the potential impact of existing investments. The resources developed through this initiative, if widely shared and disseminated to the broad range of NIA-supported programs examining AD/ADRD risk and resilience factors, may support efforts to understand whether and how exposures operate differently in different contexts to shape AD/ADRD etiology and disparities.

Research Objectives

The CC will facilitate and advance research on the role of social, behavioral, psychological, and economic exposures in the etiology of, and disparities in, AD/ADRD risk and resilience through research development and sharing activities intended to support the field. It will offer researchers across the many disciplines addressing AD/ADRD science an authoritative source of guidance and tools for the study and measurement of environmental contextual and individual exposures in their work. Applicants are strongly encouraged to consider types of exposures operating at multiple levels of influence across the life course, with attention to timing, dose, and duration. Each application must propose five to seven social, behavioral, psychological, and economic exposome domains relevant to AD/ADRD, justify that relevance, and articulate strategies to develop or link measures within these domains to NIA infrastructure projects and disseminate tools for their wider use by the research community. Examples of socially- and behaviorally-driven exposure domains that fall within the scope of this FOA include, but are not limited to, the following:

• Education, work, and occupations
• Economic and financial conditions
• Insurance, healthcare access, and healthcare utilization
• Residential, neighborhood, and environmental characteristics
• Interpersonal relationships and social networks
• Psychosocial stress exposures, including acute or chronic stress, trauma, and early life adversity
• Health behaviors and lifestyle factors
• Organizational, social, and economic policies
• Structural racism and discrimination
• Human behavior-driven or socially disruptive climatological conditions, air pollution, and natural disasters

Examples of types of exposure data that fall within the scope of this FOA include, but are not limited to, the following:

• Self-report instruments
• Administrative data from federal sources
• Programmatic/administrative data from private sources
• Contextual data from federal and non-federal sources
• Wearable sensors
• Indoor and outdoor monitors

The CC will facilitate the development and dissemination of exposome measures and data via proposed collaborations with NIA-supported infrastructure projects (e.g., population-representative and educational cohort longitudinal studies, small deeply phenotyped longitudinal studies), Center and Network programs, and data sharing/discovery projects to support innovative research on AD/ADRD through administration, innovation, and dissemination activities. Specific functions in these activity areas are described below:

Administration Administration activities are intended to accomplish the following:

• Enable effective governance of the CC to complete the goals of developing and disseminating tools and resources in five to seven exposure domains.

Innovation Innovation activities are intended to accomplish the following:

• Support the coordinated development, linkage, sharing, and discoverability of exposome data with NIA-supported studies (see Collaboration in Section IV of this FOA)
• Produce guidance for the collection/production/sharing of exposome data among studies to support comparability, reduce redundancy, and support broad research access (see Guidance in Section IV of this FOA)
• Gather experts to identify priority areas of exposome data for production to support AD/ADRD research using NIA-supported studies (see Guidance in Section IV of this FOA)
• Facilitate new research conducted by new/earlystage investigators from different backgrounds (see Pilot Program in Section IV)

Dissemination The applicant must propose activities to disseminate the CC's products to the research community. Dissemination activities are intended to accomplish the following:

• Share all output from Administration and Innovation activities, including discovery of data, guidance and practices developed via the CC, as well as plans to share and facilitate sharing of exposome measures and data produced by NIA-supported studies and other relevant sources, as appropriate

For Innovation and Dissemination activities throughout the course of this initiative, applicants must engage with a wide range of NIA-supported AD/ADRD infrastructure projects, such as the centers in the NIA Research Centers Collaborative Network (RCCN), and with other NIA-funded programs and centers, such as the following:

• Claude D. Pepper Older Americans Independence Centers (OAICs)
• Centers on the Demography and Economics of Aging
• Resource Centers for Minority Aging Research (RCMARs)
• Edward R. Roybal Centers for Translational Research in the Behavioral and Social Sciences of Aging
• Behavioral and Social Research Networks
• Alzheimer's Disease Research Centers (ADRCs)
• Nathan Shock Centers of Excellence in the Basic Biology of Aging

Additional Activities

Additional activities or functions must be proposed that seek to accomplish the following:

• Promote collaboration across NIA-funded AD/ADRD Exposome projects
• Encourage interactions between Exposome programs and other NIH-supported contextual data resources
• Enhance the value, innovativeness, and visibility of research on the role of the social, behavioral, psychological, and economic exposome in aging and AD/ADRD

Specific required components of the application, including milestones,are described in Section IV of this FOA. Characteristics of applications that will be considered non-responsive to this FOA are described below under the "Non-Responsiveness Criteria".

Resources for Applicants

• Data Resources for Behavioral and Social Research on Aging
• AD+ADRD Research Implementation Milestone Database
• NIA-supported Behavioral and Social Research Centers
• NIA-supported Behavioral and Social Research Networks
• NIH Scientific Data Sharing
• NIA Data Sharing Resources for Researchers
• Notice of NIH's Interest in Diversity
• NASEM's Decadal Survey of Behavioral and Social Science Research on AD/ADRD -The committee conducted a decadal survey focusing on developing a research agenda for the next decade in the behavioral and social sciences as it relates to AD/ADRD. Drawing on extensive input from the scientific community and other stakeholders, the committee assessed the role of the social and behavioral sciences, including data sources and other resources, in reducing the burden of AD/ADRD

Non-Responsiveness Criteria (Applications Not Responsive to this FOA)

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

• Applications that propose less than a minimum of 65% of the direct cost budget devoted to innovation activities, as described in Section IV of this FOA
• Applications that exclusively propose exposure data collection or the development of an exposome data repository
• Applications that exclusively propose data harmonization or linkage activities
• Applications that do not articulate plans to develop five to seven broad social, behavioral, psychological, and environmental exposome domains with justification of relevance to AD/ADRD to achieve the objectives of this FOA
• Applications that do not include administration, innovation, and dissemination activities
• Applications that do not propose a well-defined set of milestones and a timeline for accomplishing the administration, innovation, and dissemination activities
• Applications that do not include a detailed data management and sharing plan for rapid and broad sharing of all guidance, practices, measures, and data developed by the CC. For more information, visit NIH's webpage and NIA's webpage on the topic

Frequently Asked Questions

Responses to frequently asked questions about this FOA will be posted here.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Government

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

Other

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

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

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

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

Applicant Organizations

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

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

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIA 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:

Emerald T. Nguyen, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

For this specific FOA, the Research Strategy section is limited to 20 pages.

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

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

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

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

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

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

The applicant must propose PD(s)/PI(s) and other personnel well suited to implement the activities of the CC. Specifically, the PD(s)/PI(s) must have the following experience:

• Demonstrated experience, and an ongoing record of accomplishments, in managing social, behavioral, psychological, and economic research and research resources
• Experience coordinating collaborative research
• Expertise appropriate to support the development and implementation of relevant comparable data constructs for secondary data collections or CDEs for primary data collections

Key personnel must include individuals with the following experience:

• Demonstrated expertise in the fields of social, behavioral, psychological, and economic exposures relevant to AD/ADRD
• Demonstrated expertise in resource sharing through web-based platforms or other means
• Demonstrated experience overseeing the selection and management of subawards

If the application is multi-PD/PI, the investigators must have complementary and integrated expertise, as well as clear governance plans, for the administration of the proposed CC.

NOTE: Applicants are strongly encouraged to limit the number of key personnel with substantial roles in the CC to avoid establishing conflicts of interest throughout the field. Participation in CC activities, including attending meetings to offer scientific consultation, receiving pilot funding, or collaborating on measure or data development activities will not constitute formal collaboration from the perspective of NIH, with the exception of those key personnel listed on the application.

Applicants should NOT name proposed members of the Coordinating Center Advisory Committee (CCAC) referenced below in the Research Strategy instructions. The panel will be established post award in collaboration with NIA staff.

R&R Budget

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

A minimum of 65% of the direct cost budget must be devoted to innovation activities, as described in the Innovation section of the Research Strategy instructions. This includes large scale collaborative studies with existing infrastructure projects to develop novel measures in the five to seven prioritized domains, which may require resources to support measurement development, linkage, data collection, data documentation, and archiving. Applicants must include a statement as part of the Budget Justification describing the fraction of direct costs in each year supporting these innovation activities. Applicants should budget for up to 7 collaborative studies (as defined in the Collaboration section of the Research Strategy instructions below) per year, some of which may span more than one year. Collaborative studies are expected to be initiated in each year of the award. Innovation activities also include pilot projects for new and early-stage investigators. Pilot opportunities are expected to be offered in each year of the award. NIA recommends budgets up to $75K for one-year awards and recommends funding up to 10 awards in each year. Pilot funds may support salary, research expenses, travel, equipment, and supplies, as appropriate to the project. The CC is permitted to leverage support from other sources to increase the amount of pilot funds available for a single project. Funds for the proposed pilot projects should be included under the other expenses. Future-year pilots must be submitted with the annual non-competing renewal applications.

Inflationary Increases for Future Years: Inflationary salary increases for future year commitments are not allowed for applications submitted to this FOA. However, necessary increases for other costs (e.g., supplies, equipment, etc.) are allowable as long as the out-year increase for a specific cost is well justified in the Budget Justification. For additional information, click here.

Additionally, all applications must include costs to attend an in-person annual meeting. The meeting will be held in the Bethesda, Maryland area. Meetings are expected to last for two days. Non-CC participants should support their own travel costs. Applicants may request funds to cover limited amounts of third-party travel to support broader participation from attendees . Requested costs should reflect the proposed activities for this meeting.

Requested costs should reflect the proposed dissemination activities, including the website and plans to make it sustainable beyond the award period, as well as other forms of outreach.

R&R Subaward Budget

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

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

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

Specific Aims:

The specific aims page must directly address the core functions of the CC, including administration, innovation, and dissemination.

Research Strategy:

The application must explain how the five to seven proposed domains will lead to scientific advances in characterizing environmental contextual and individual exposures in the etiology of, and disparities in, AD/ADRD risk and resilience. The application must explain how the proposed activities will enable the CC to lead, coordinate, and manage the establishment of guidance and practices for the use and harmonization of exposure data across NIA-supported infrastructure projects, as well as other longitudinal studies of AD/ADRD. The application must explain how the proposed activities will enable the CC to lead, coordinate, and manage the development of innovative and novel exposure measures across NIA-supported infrastructure projects, as well as other longitudinal studies of AD/ADRD. The application must explain how the proposed activities will lead to innovation across the broad spectrum of scientists seeking to advance research on social, behavioral, psychological, and economic exposures that influence AD/ADRD etiology and disparities.

The research strategy must justify selection of, and describe planned activities related to, five to seven social, behavioral, psychological, and economic exposome domains relevant to AD/ADRD that will be developed over the five-year award period. Additionally, the strategy must describe the approaches that will be taken to identify, develop, or link measures in these domains to NIA infrastructure projects, and disseminate guidance for researchers as articulated below.

To meet the objectives of this FOA, the CC must effectively interact with experts in exposome-relevant research, including, but not limited to, the following six groups:

1. NIH Program Staff:
   • NIH Program Official(s) will be responsible for standard grant program management
   • NIH Project Scientist(s) will have substantial involvement providing recommendations/guidance on the conduct of aims (e.g., recommendations on dissemination, collaboration, and CDE development/implementation)
2. PIs of NIA-funded nationally representative and deeply phenotyped longitudinal data studies
3. PIs of NIA-funded environmental contextual and individual-level exposure data infrastructure projects
4. The CCAC: A panel comprised of independent scientific experts in areas appropriate to the multidisciplinary content areas of the CC, including areas of social, behavioral, psychological, and economic exposures relevant to AD/ADRD
5. The broader research community: Potential users of resources developed and disseminated by the CC
6. Other relevant experts and studies: Other experts and study investigators of relevance to support the research and data objectives of this FOA that are not in the four groups above, including the following:
   • Researchers from various disciplines that can help advance methods and measures to enhance research
   • Representatives from federal statistical agencies
   • Developers of private sources of administrative and contextual data and other data sources to support ADRD-relevant research
   • Representatives from relevant public and private entities that develop tools to facilitate research, including the conceptualization and production of comparable data, and the development of tools for dissemination of findings/outcomes

Working in collaboration with these groups, and others as appropriate, the CC must propose approaches to support the following activities:

Administration Applicants must propose an innovative organizational governance structure to support proposed administration, innovation, and dissemination activities. Describe how interactions with the six groups listed above will take place to achieve the objectives of this FOA.

Describe how the activities will lead to the following:

• Advancement of the field by fostering communication, development, and collaborative activities with NIA-funded investigators conducting large, as well as deeply-phenotyped, longitudinal studies
• Researchers engaged in exposome measure creation
• Early career scholars
• Pilot project awardees
• Engagement of other relevant experts, as appropriate, to achieve the administration, innovation, and dissemination activities specified in this FOA

When developing the CC, it is important to consider whether the proposed activities will have the potential to substantially stimulate progress in research on social, behavioral, psychological, and economic exposures related to AD/ADRD through broad engagement with the research community and the recruitment of prospective new/early-stage investigators from various backgrounds.

Activities shall include arranging and hosting virtual calls/meetings around specific research or administrative topics, as needed, to accomplish the following:

• Facilitate AD/ADRD Exposome CC objectives (e.g., interactions with NIA-supported studies on exposome data production, etc.)
• Respond to queries by the NIH staff regarding CC activities and respond to information requests generated by the NIH, the scientific community, and the public
• Plan and administer project aims with NIH staff
• Organize and maintain the CCAC to provide insights regarding the activities and priorities of the CC to NIH staff and the CC investigative team

Applicants must describe how they will work with NIA-supported infrastructure project investigators to accomplish the following:

• Negotiate access to relevant closed-source data resources (e.g., CMS claims data, death records, etc.) to reduce overlap in effort across infrastructure projects to access the same data source
• Create economies of scale in purchasing by concentrating the coordination center’s resources
• Create efficiencies with regards to broader use, common data constructs, and other factors that can promote use, comparability, and discoverability

Administrative duties should include serving as the point of contact for the activities of the CC for NIH staff and the broader scientific community. Applicants must describe how the institutional environment is appropriate for leading, coordinating, and managing a highly collaborative research coordinating center.

Applicants must propose a series of specific, quantifiable, and scientifically justified milestones, and a timeline for milestone completion, during the five-year award period to assess progress towards achieving the proposed administration, innovation, and dissemination activities as described in this section. Describe the process for how the CC will work with NIA and the CCAC to further develop milestones relevant to the activities and refine the milestones as necessary. Examples of such milestones must include, but are not limited to, the following:

• Initiating and carrying out activities associated with each of the five to seven identified exposome domains
• Establishing the CCAC
• Conducting and supporting innovation and data development activities in collaboration with NIA supported infrastructure projects
• Awarding pilot projects to new/early-stage investigators, including investigators from diverse backgrounds, such as those from groups underrepresented in aging, behavioral and social science, and/or AD/ADRD research.
• Developing the CC’s website and other dissemination activities
• Developing a process for accepting and vetting submissions of resources related to non-CC supported exposome domains from the broader exposome science community and making the information widely discoverable and available alongside CC-supported exposome domains (see Exposome Database in the Dissemination section below)

Innovation Applicants must propose five to seven exposome domains and provide a justification for each selection. The justification must describe each domain's relevance to AD/ADRD, how each domain is substantive in its own right, and the extent to which there are synergies between domains. Describe the approach for the selection of data and development of measures to capture each domain. Descriptions of each domain should be limited to one page in the Research Plan.

Applicants must propose activities intended to support the development and use of exposome measures and data within NIA-supported infrastructure projects (such as center grants, research networks, and large-scale primary data collection (e.g., surveys)), focused on social, behavioral, psychological, and economic exposures related to aging and AD/ADRD, and for future adoption by other NIA-supported studies. These activities must include, but not be limited to, the following:

Collaboration Activities Applications must propose five to seven initial domains for exposome data development with ongoing development of these domains, and any alternate/additional domains, enhanced via interactions with NIA and the CCAC. This will involve supporting collaborative data collection or linkage of new exposome data to NIA-supported infrastructure studies/projects. Collaborative studies supported through this program should develop a plan for long-term support required to maintain and continuously update data elements. Describe approaches to develop and validate new data elements and constructs to facilitate harmonization and cross-study examination of the exposome. Constructs include both primary and secondary data elements to promote comparability. Describe the proposed approach for bringing together PIs of NIA-funded studies and new/early-stage investigators of CC-funded pilots to foster collaborative studies, including the development of novel measures/data. Describe how the CC will actively engage NIA-supported longitudinal studies to help identify and coordinate development and sharing of existing and new social, behavioral, psychological, and economic exposome data that is, or can be, linked to NIA-supported studies.

Guidance Activities Applicants must describe plans to accomplish the following:

• Host and convene expert workshops to develop guidance for identification, development, harmonization, and sharing of exposome data with NIA-funded studies
• Identify and develop technical and policy guidelines and best practices for effectively and ethically sharing data
• Develop new guidelines and best practices as needed for AD/ADRD exposome researchers

Describe how the CC will support the work of the CCAC and provide consultative services to the AD/ADRD research community to facilitate use of the resources developed by the CC. Provide information on how the CC will share NIH guidance and practices on common data constructs as they become available.

Pilot Program Activities Applicants must describe how the CC will administer and manage the pilot study program to support 12-month pilot research projects for new and early-stage investigators, including investigators from diverse backgrounds, such as those from underrepresented groups (see Notice of NIH's Interest in Diversity, NOT-OD-20-031), to conduct behavioral and social exposome research on AD/ADRD or work with NIA-funded studies/projects on developing exposome data. Describe how pilot projects will be solicited, reviewed, and selected prior to their submission to NIH for approval. Describe approaches to engage prospective researchers from diverse backgrounds, including those from underrepresented groups identified in NOT-OD-20-031. Describe how pilot project grantees will be supported through all phases of their projects, including the implementation and close out phase, to assure all resources, materials, protocols, data, best practices, and lessons learned, as well as software or sets of code, are disseminated broadly through the AD/ADRD and aging research community. NIA's Program and Grants Management staff must review pilot projects selected by the CC prior to initiating work to ensure that the pilot projects are within scope, consistent with the goals of the initiative, and have appropriate human subjects protections in place.

Dissemination Applicants must describe the innovative strategies that the CC will take to ensure wide dissemination of all products and resources developed by the CC to the broader AD/ADRD research community. Applicants must describe approaches for disseminating scientific and methodological advances, activities, and resources produced by the CC to the research community, policymakers, and other relevant stakeholders.

Sharing Activities Applicants must describe how the CC will engage in activities to share any guidance, practices, measures, and data resources developed by the CC, and make them discoverable by the exposome research community, to promote data sharing, broad use, and replication, including in NIA-supported studies. Specifically, CC activities that directly develop new data sources should include planning and implementation of sharing data as broadly as possible to the research community while providing reasonable protections against inappropriate or illegal disclosure of data. NIA recommends sharing newly developed data in the NIA-supported Medicare & Medicaid Resource Information Center (MedRIC), the Health & Aging Data (HaAD) Enclave, and/or the National Archive of Computerized Data on Aging (NACDA) based on data security and cost considerations.

Though the CC will not directly share data produced by pilots and other NIA-supported infrastructure projects, the CC will facilitate the use of shared data resources by: (1) promoting data assets via the CC website and (2) sharing protocols and programs used to obtain and use third-party data. In instances where captured/re-used data is not directly shareable by the CC, the CC must support the development and sharing of plans for providing access protocols and programs to allow third-party researchers to replicate proposed research data files. Specifically, the CC is required to provide the following:

• Information describing the data source and how any investigator can apply for data access
• Computer code used to convert data from the capture source into research data files
• Explanations of any constructed variables
• Other relevant information required to assist the use of data from the source for replication studies

The CC will provide expertise to support these activities and share them on the CC's website. NIH requires researchers and publishers to make their AD/ADRD exposome publications immediately accessible in PubMed Central. The CC should seek out awardees from the Research Infrastructure on Exposome Studies in AD/ADRD (NOT-AG-22-022), and other studies with similar data sharing needs, for inclusion in CC discoverability and sharing activities.

Website Activities Applicants must describe their approach to development and maintenance of an active website that provides information about the CC, including all activities and products supported by the center, such as guidance, workshop summaries, etc. Additionally, information about supported pilot projects and data-related resources relevant to NIA-supported studies must be provided. The website must include an Exposome Database featuring information on exposome domains developed by the CC along with domains developed by the broader exposome science community to promote data discoverability of both existing and newly developed social, behavioral, psychological, and economic exposome resources. Describe plans to produce and maintain the Exposome Database that categorizes exposome characteristics by data source and includes key information to support research use (e.g., information on populations studied, item concordance, timing of measures, etc.). Describe plans for environmental scans, updates, curation, and expansion of the Exposome Database to a self-sustaining, publicly available resource beyond the five-year project period and/or to transition support to a new awardee should this program be renewed.

Annual Meeting Activities Applicants must describe how the CC will implement annual in-person meetings at NIH, planned in coordination with relevant NIH program staff. The purpose of the meeting is to accomplish the following:

• Share updates and scientific advances
• Discuss and plan collaborative activities with NIA-funded studies, including the development/sharing of CDEs
• Host expert sessions on measurement advancement
• Present results from the pilot program, discuss and plan activities to develop new research activities to advance the field relevant to NIH research priorities, etc.

The meeting will be attended by PD/PIs of AD/ADRD exposome-related projects and members of the CCAC. The CC will create the agenda and chair the meeting, with guidance from NIH program staff. The annual meeting should feature a combination of CC investigators, PD/PIs of NIA-supported projects focused on population-based longitudinal studies, pilot awardees, and other relevant experts as appropriate to provide updates on, and inform, future activities to achieve the innovation and dissemination functions of the CC. Proceedings of each annual meeting should be recorded and subsequently made available through the CC website to promote dissemination of presentations and foster discussion within the research community.

Additional Dissemination Activities Applicants must propose a plan for other types of dissemination activities (e.g., research briefs, blogs, webinars, or other means to highlight and disseminate advances, activities, and resources) via the website and other platforms geared towards the broader AD/ADRD research community, policymakers, and other relevant stakeholders. Applicants should describe how the CC will facilitate access to secondary data relevant to this initiative by NIA-supported infrastructure project Investigators.

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.

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

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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

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

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIA, NIH. Applications that are incomplete, non-compliant, and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIA Scientific Review Office, by email at [email protected], when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the proposed AD/ADRD Exposome CC address the needs of the research projects that it will coordinate? Is the scope of activities proposed for the AD/ADRD Exposome CC appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research projects?

Questions Specific to this FOA:

To what extent will the five to seven proposed domains lead to scientific advances in characterizing environmental contextual and individual exposures in the etiology of, and disparities in, AD/ADRD risk and resilience?

To what extent will the proposed activities enable the CC to lead, coordinate, and manage the establishment of guidance and practices for the use and harmonization of exposure data across NIA-supported infrastructure projects, as well as other longitudinal studies of AD/ADRD?

To what extent will the proposed activities enable the CC to lead, coordinate, and manage the development of innovative and novel exposure measures across NIA-supported infrastructure projects, as well as other longitudinal studies of AD/ADRD?

To what extent will the proposed activities lead to innovation across the broad spectrum of scientists seeking to advance research on social, behavioral, psychological, and economic exposures that influence AD/ADRD etiology and disparities?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the AD/ADRD Exposome CC? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing exposome research? Do the investigators demonstrate significant experience with coordinating collaborative social and behavioral research? If the AD/ADRD Exposome CC is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the AD/ADRD Exposome CC? Does the applicant have experience overseeing selection and management of subawards? Does the applicant have expertise in resource sharing through web-based platforms or other means?

Questions Specific to this FOA:

To what extent does the PD(s)/PI(s) have demonstrated experience and an ongoing record of accomplishments in managing social, behavioral, psychological, and economic research and research resources; experience with coordinating collaborative research; and expertise appropriate to support the development and implementation of relevant comparable data constructs for secondary data collections or CDEs for primary data collections?

To what extent do the key personnel have demonstrated expertise in resource sharing and experience overseeing the selection and management of subawards?

If the application is multi-PD/PI, to what extent do the investigators have complementary and integrated expertise as well as clear governance plans for the administration of the proposed CC?

Innovation

Does the application propose novel strategies for developing guidelines and practices for exposure measurement development, data linkages, and data harmonization in the research projects the AD/ADRD Exposome CC will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies, or instrumentation proposed?

Questions Specific to this FOA:

How innovative are the strategies for administration, innovation (i.e., developing novel exposure measures and data and fostering collaboration), and for establishing and disseminating guidance and practices for the use and harmonization of exposure data?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research projects the AD/ADRD Exposome CC will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the projects, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the projects are in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the projects? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Questions Specific to this FOA:

To what extent will the implementation of the proposed activities address the objectives of this FOA?

How well justified is the selection of the five to seven exposome domains in relation to AD/ADRD?

To what extent does the application justify the substantiveness of each domain in its own right and the synergies between domains?

How well justified are the plans for carrying out the proposed organizational governance structure to support the proposed administration, innovation, and dissemination activities as part of the administrative function of the CC?

To what extent does the application adequately describe plans for identifying and engaging relevant experts (i.e., NIH program staff, PIs of NIA-funded longitudinal data studies and infrastructure projects, the CCAC, the broader research community, and other relevant experts and studies) for the activities associated with the proposed exposome domains?

To what extent will the proposed interactions and collaborations with NIA-supported infrastructure projects support the administration, innovation, and dissemination activities of the CC?

How well justified are the plans for carrying out the proposed collaboration activities as part of the innovation function of the CC, including collaborative studies with NIA-supported infrastructure projects/studies?

How well justified are the plans for carrying out the proposed guidance activities as part of the innovation function of the CC?

How well justified are the plans for carrying out the proposed pilot program activities as part of the innovation function of the CC, including the recruitment of prospective new/early-stage investigators from diverse backgrounds, including those from underrepresented groups(see Notice of NIH's Interest in Diversity, NOT-OD-20-031)?

How well justified are the plans for carrying out the proposed sharing activities as part of the dissemination function of the CC?

How well justified are the plans for carrying out the proposed website activities as part of the dissemination function of the CC, including the development, maintenance, and sustainability of the Exposome Database?

How well justified are the plans for carrying out the proposed annual meeting activities as part of the dissemination function of the CC?

How well justified are the plans for carrying out the proposed other activities as part of the dissemination function of the CC?

To what extent are the milestones for the accomplishment of the administration, innovation, and dissemination activities specific, quantifiable, and scientifically justified?

To what extent is the timeline for the completion of the milestones appropriate and feasible?

How well justified are the proposed plans for the sustainability of the resources developed by the CC beyond the award period?

Environment

Will the institutional environment in which the AD/ADRD Exposome CC will operate contribute to the probability of success in facilitating the research projects it serves? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the AD/ADRD Exposome CC proposed? Will the AD/ADRD Exposome CC benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Questions Specific to this FOA:

How appropriate is the institutional environment for leading, coordinating, and managing a highly collaborative research coordinating center?

Additional Review Criteria

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

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

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIA, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory 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.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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

2. Administrative and National Policy Requirements

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

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

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

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

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

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

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

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

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

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

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75 and 2 CFR Part 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", 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 purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the 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 prime responsibility of conducting study aims 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:

• Designing the details of the project funded by this FOA and retaining primary responsibility for performance of the activities.
• Accepting assistance from the designated NIH Program Official and Project Scientist in aspects of the scientific and technical management of the study/studies and in coordinating with other Federal agencies.
• Accepting and participating in the cooperative nature of the CC.
• Participating with NIH staff and the CCAC in determining the process of setting CC priorities, deciding optimal administrative and governance approaches, and contributing to the adjustment of approaches as warranted.
• Developing the CC's initial website and making it discoverable within the first year of the award.
• Establishing metrics and timelines for accomplishing the activities and achieving the objectives of the CC.
• Fully disclosing all database schema, algorithms, software source code, and methods to NIH program staff and the broader scientific community for purposes of scientific evaluation.
• Planning and participating in outreach and dissemination activities, including developing, hosting, and maintaining a public website for the CC; hosting and attending meetings to discuss the project's progress; coordinating the publication of research results; and other coordination, outreach, and dissemination activities.
• Responding promptly and cooperatively to requests for information or input from NIH.
• Participating in ongoing conference calls with Project Scientist(s) and/or other NIH program staff, as scheduled and agreed upon.
• Convening the first meeting of the CC and NIH program staff within 4 months of the award.
• Retaining custody of, and having 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 will assign a Project Scientist and a Program Official to assist recipients.
• An NIH Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIH Program Official will approve all major stages of the project and all new major additions/changes to planned activities, including approval of all collaborative studies and pilot awards for compliance with NIA/NIH requirements prior to funding. In addition, this individual will assist in initiating and maintaining collaborative relationships with relevant federal agencies. Prior approval is required by the NIH Program Official for any replacements of key personnel or other changes in subawards. The NIH Program Official is an ex officio member of the CCAC and will be consulted as to the membership and agendas of the CCAC.
• An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The NIH Project Scientist will assist in refining study objectives and activities.

A reas of Joint Responsibility include:

• Organizing and coordinating scientific and annual meetings for the CC, as required.
• Coordinating and facilitating the interactions between participants under this cooperative agreement and other NIA awardees.
• Considering the working group and the CCAC's recommendations for modifying the CC's focus to accommodate new scientific opportunities and directions.
• Sharing and reviewing annual progress among components of the CC, and with external stakeholders.
• Meeting at least once per month by teleconference.

Coordinating Center Advisory Committee

• In order to ensure that the CC achieves its objectives under the cooperative agreement, the CCAC will be comprised of independent scientific experts in areas appropriate to the multidisciplinary content areas of the CC. Experts, including, but not limited to, the Principal Investigator, Co-Investigators, NIA staff, and invited independent experts, will make presentations to the CCAC on scientific and administrative issues regarding the development and implementation of CC aims. The CCAC will do the following:
  • Report to NIA and will communicate specific recommendations to NIA regarding priorities via executive sessions of CCAC meetings.
  • Review and comment on the conduct of the CC aims and discuss progress in meeting the innovation and dissemination goals of the initiative, as well as activity milestones of the CC.
  • Where appropriate, provide recommendations to the Principal Investigator on procedures and policies necessary to successfully accomplish the initiative; this is not binding on the Principal Investigator who retains primary responsibility for scientific direction and implementation.
  • Recommend activities to improve coordination approaches to achieve the CC's goals, and advance relevant scientific approaches to exposome research.
  • Make recommendations for redirecting the CC’s focus to accommodate new scientific opportunities and directions within the scope of the award.
  • Other guidelines for the CCAC, such as a quorum and frequency and type of meetings (in-person, remote), will be determined at its initial meeting. It is anticipated that the CCAC will meet at least annually, with intermittent conference calls as needed.
  • The CCAC may establish subcommittees as needed to advance the CC’s goals.

The NIA Program Official and the PIs may request the CCAC’s assistance on specific issues. The NIA Program Official and the investigators will consider the recommendations of the CCAC regarding implementation of CC aims, as well as additions or changes to content and methods, during the execution of the cooperative agreement. Any new CCAC Chair and members will be appointed by NIA when necessary. NIA will provide a charter for the CCAC that describes the selection, composition, tenure, and responsibilities of the CCAC membership.

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: a designee of the CCAC chosen by majority vote of the CCAC, one NIH designee chosen by the NIA Program Official, and a third designee with expertise in the relevant area who is chosen by the other two members. 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

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.

This program requires sharing of research resources to facilitate collaboration across multiple projects/programs. The goal of this requirement is to facilitate innovative, replicable, and comparable social, behavioral, psychological, and economic research on the AD/ADRD exposome. The NIH requires awardees to implement a Data Management and Sharing Plan. Applicants are required to provide an overarching data and resource sharing plan consistent with achieving the program's goals of sharing project information/findings, and common data construct/CDE guidance.

4. Reporting

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

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

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

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

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

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

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

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

Emerald T. Nguyen, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]

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

Ryan Blakeney
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.