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

Background

Initiated in 1992, the Health and Retirement Study (HRS) is a longitudinal study that surveys a representative sample of approximately 20,000 people, aged 50 and older, in the United States via mixed-mode data collection. The objective of the HRS is to produce infrastructure to support multidisciplinary research on life course health and aging. To achieve this objective, the HRS collects survey data related, but not limited, to the following topics:

• Demographics
• Life histories
• Health status and care
• Dimensions of economic status (e.g., income sources, wealth sources, housing, insurance, etc.)
• Work and occupation
• Family
• Cognitive and psycho-social factors on participants

The HRS collects core data in two-year intervals supplemented with off-year sub-studies using mixed modes of data collection. The HRS supplements core and supplemental survey collection with linkages to administrative records from Medicare and Social Security; contextual data on participant living environments; and biomarker data generated from saliva, dried blood spots, and, more recently, venous blood. Approximately 23,000 HRS participants have been genotyped to date, with the most recent data released on the NIA Genetics of Alzheimer’s Disease Storage Site (NIAGADS). HRS is currently collaborating with the Alzheimer’s Disease Sequencing Project (ADSP) to conduct the Follow-Up Study 3.0 to enhance the heterogeneity of AD/ADRD case and control sequences. A wide range of biomarkers were assayed from dried blood spots (e.g., HDL/LDL, CRP, HBA1c) and an even wider range of biomarkers were assayed in the HRS venous blood study from over 9,000 samples collected in 2016, with a repeat collection in 2022. Recently, HRS assayed a range of AD biomarkers (e.g., ABeta42, Abeta40, pTau181, NfL, GFAP) in a sample of 4,200 participants, including all who received the enriched Harmonized Cognitive Assessment Protocol battery (described below), and participated in the Venous Blood Study. To support analyses of health disparities, HRS oversamples Black/African American and Hispanic/Latino populations.

A relatively new companion study initially fielded in 2016, the Harmonized Cognitive Assessment Protocol (HCAP), provides additional research opportunities to use HRS to study AD/ADRD. HCAP seeks to measure and understand dementia risk by using a selected set of established cognitive and neuropsychological assessments, as well as informant reports, to better characterize cognitive function among older people and establish similar protocols in the HRS comparator studies in countries around the world to facilitate AD/ADRD research in different social, cultural, environmental, and economic contexts. Users can employ HRS and data from the HCAP sub-sample to model dementia status to the entire HRS sample and conduct comparative studies of factors driving prevalence cross-nationally. HCAP, together with additional core HRS panel data and continued support of targeted oversamples of Black/African American and Hispanic/Latino respondents, can support innovative AD/ADRD research. The combination of individual longitudinal data on cognition, coupled with rich life history data and information on economic factors and health care, has made the HRS/HCAP ideal studies to examine AD/ADRD prevalence, costs, risk, and protective factors, and care with over 300 journal articles on dementia to date.

HRS and HCAP data, collected longitudinally on a large representative sample to capture change over time, provides an invaluable and growing body of multidisciplinary data that researchers can use to address important questions about the challenges and opportunities of aging in the context of an ever-changing world (e.g., pandemics, economic and social change). While most grant proposals that collect data do so to support analysis of a specific hypothesis, the HRS/HCAP data is collected and shared to facilitate exploration of numerous hypotheses by the research community, not just the study investigators. Continuing the HRS will allow the continued collection of data to answer important longitudinal questions, including longer term implications of the COVID-19 pandemic and the influence of economic trends (e.g., the rapidly changing labor market), on health. Publicly shared via the HRS website and associated enclaves for sensitive data, the HRS boasts over 6,500 current registered users and over 4,000 journal publications since inception. Currently, over 150 active NIA grant awards use HRS data. Additionally, the study has served as a model for international comparator studies (see Gateway to Global Aging Data for information and links to individual studies).

The HRS Data Monitoring Committee, a multidisciplinary group of experts that provides comment regarding the conduct of the study, engaged the investigative team and third-party experts via presentations and papers on potential avenues for the study moving forward. This process produced insights on a collection of activities for HRS to prioritize to continue the study. Specifically, recommendations included the following:

• Add larger samples of Black/African American and Hispanic/Latino populations in HCAP to support research on health disparities in AD/ADRD prevalence, incidence, and risk
• Link and collect new data elements to capture social, contextual, and environmental exposures, ranging from microscopic to macro-level exposures, to support the study of how the exposome influences AD/ADRD risk
• Add activities to manage and improve overall response/retention rates to maintain representativeness
• Enhance data on occupational/employment exposures/characteristics
• Expand/enhance blood-based biomarkers, including clinical reference markers, neurological assays, immune function assays, and assays considered to contribute to the aging process (i.e., hallmarks of aging)
• Add content on social factors to study racial disparities and minority health via life histories, as well as the medium and long-term social impacts of the COVID-19 pandemic

The continuation of the HRS and HCAP, along with the described enhancements, should be proposed in a unified single application to facilitate enhanced AD/ADRD research opportunities addressing NIA AD Research Implementation Milestones (including, but not limited to, Milestone 1.B; Milestone 2.J; and Milestone 13.D), to allow for a more comprehensive and efficient application development, scientific review, and project management.

Purpose

The purpose of this limited competition FOA is to continue data collection, development, and dissemination of the HRS and HCAP. Continuation of the study requires both knowledge of, and access to, the HRS sample frame. Therefore, this FOA is limited to investigators and institutions with access to the HRS sample frame, as the frame will be used to contact and collect new data from participants. This FOA aims to provide additional research opportunities to use HRS to formally study AD/ADRD. This single integrated award combining HRS and HCAP seeks to implement the recommendations of the HRS Data Monitoring Committee.

Applicants are required to submit a Letter of Support from their institution confirming that they have access to personally identifiable information about Health and Retirement Study panel members and the ability to contact study participants for longitudinal follow-up, dementia assessment, blood collection, and administrative/program data linkage.

Research Objectives

The primary research objective of this FOA is to combine and continue the HRS and HCAP studies for a new 6-year period (i.e., renewal) to support the study of aging with specific enhancements intended to support novel and generalizable AD/ADRD research. A fundamental activity of this FOA is to continue core study aims of the HRS. Therefore, applications must outline plans to conduct Core Activities, including the following:

Sustain the steady state longitudinal design and periodicity by doing the following:

• Employ the HRS multidisciplinary core survey to re-interview all panel members in 2024, 2026, and 2028 with 50-50 sample rotation between in-person and phone/internet interviews
• Continue venous blood and physical performance measures as part of in-person interviews
• Re-administer off-wave surveys in 2025, 2027, and 2029
• Refresh sample in 2028 via implementation of innovative, cost-effective approaches to recruit new participants from the1972-1977 birth cohort to maintain age representation of study
• Maintain and update geographic, employer, and economic contextual data resources

Maintain and expand administrative/program data linkages by doing the following:

• Continue to obtain consent of participants for linkage to Centers for Medicare and Medicaid Services (CMS) and Social Security Administration (SSA) program data to maximize coverage over time among study participants
• Continue linkage to the National Death Index data
• Produce, document, maintain, update, and share linked administrative/program records in accordance with established Data Use Agreements and Memorandums of Understandings with federal data provider

Continue distribution, dissemination, and user support for all study data by doing the following:

• Maintain protocols for rapidly sharing survey, performance measure, genetic, and assay data, as well as the production of user-friendly longitudinal survey files
• Maintain a biospecimen repository along with rules for sharing these data with researchers
• Administer and expand HRS website for data distribution, documentation, and bibliographic information as necessary to make the HRS discoverable and accessible to the public
• Continue online user support services
• Maintain and develop training courses (in-person and on-line accessible video recordings) on use of complex and/or high priority data elements (e.g., genetics, HCAP, contextual data, etc.)
• Advertise data at academic conferences, professional associations, and relevant social media channels
• Share all study data in accordance with NIH Data Sharing Policies

Collaborate with other studies to promote harmonization and innovation by doing the following:

• Engage in harmonization efforts both with the international family of HRS studies around the world as well as other aging studies to promote comparable and innovative measures to support aging research
• Promote and implement harmonization activities with relevant studies to support research on the prevalence and future trends of cognitive functioning, including AD/ADRD
• Continue collaborations with genetics consortia

Provide a multidisciplinary and collaborative organizational and management structure by doing the following:

• Maintain a multifaceted and multidisciplinary study team to administer the study
• Outline and adhere to a study governance plan that includes contingencies for losses of key personnel
• Continue engagement with NIA program staff and the HRS Data Monitoring Committee on the conduct of study aims (see Section VI, Cooperative Agreement Terms and Conditions of Award)

In addition to the Core Activities, the application must include rationales and plans to add the following Enhancement Activities to the HRS:

HCAP

• Outline plans to implement 4-year periodicity of HCAP sub-study data collection, conducting follow-up in 2026
• Expand samples of Black/African American and Hispanic/Latino participants
• Lower age-eligibility of new participants to include those aged 60-64

Participant Response Rates

• Propose innovative and cost-effective activities intended to address key issues/challenges in the field by maximizing participant response rates, including adaptive survey methods and modified incentives and investments in the survey workforce
• Experiment with employing different screener/interview modes
• Propose experiments to improve response and protocol consent rates (e.g., blood collection, administrative/program consents, etc.)

Blood-based Biomarkers

• Describe plans to expand assays (both new assays and longitudinal measurement of existing assays) for well-characterized AD/ADRD and aging phenotypes and share data, including the following:
  • Clinical reference markers that serve as indicators of metabolic or organ function
  • Neurological assays including ATN biomarkers of AD and heavy metals exposure
  • Hallmarks of aging biomarkers considered to contribute to the aging process (e.g., DNA methylation)
  • Immune function, infection and inflammation markers, including those that could clarify COVID-19 exposure
• Explain how the plans are innovative within the frame of a large scale nationally representative study to support research on aging and AD/ADRD

COVID-19

• Propose plans to build on existing HRS investments to study the COVID-19 pandemic (i.e., COVID surveys, policy/contextual data resources, and antibody data), including the development of new resources, to support research on the short and long-term impact of COVID-19 and the pandemic on health, welfare, and aging

Exposome Studies in AD/ADRD

• Propose activities to enhance measurement of exposures across domains (e.g., residential, occupational or educational histories) to support longitudinal research on the impacts of the exposome on AD/ADRD risk and resilience
• Explain how the proposed activities are novel or how the activities will produce unique opportunities for new research or expanded exposure linkages

Specific details and application instructions for each activity are provided sequentially in Section IV.2 of this FOA.

Applicants are encouraged to balance longitudinal continuity of design and methods, scientific innovation, the stated FOA budget, and other constraints in designing a response to this FOA.

Resources for Applicants

• NIA Data Sharing Resources for Researchers provides guidance on repositories and other data sharing resources as well as specific data sharing guidance.

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 do not include a Letter of Support from the applicant's institution confirming that the applicant has access to personally identifiable information about HRS panel members and the ability to contact study participants for longitudinal follow-up, dementia assessment, blood collection, and administrative/program data linkage
• Applications that do not include a study governance plan, as described in Section IV of this FOA
• Applications that do not include a detailed Data Management and Sharing Plan that describes how all study data will be shared, documented, and disseminated. For more information, see NIH Data Sharing Policies

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

Only recipients previously funded under RFA-AG-18-005 are eligible to apply.

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 not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not 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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

This 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:

John W.R. Phillips, 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. For this specific FOA, the Research Strategy section is limited to 30 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.

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 proposed key personnel must have expertise and experience required to successfully implement the aims and study governance plan (see Study Governance Plan requirements below).

R&R or Modular Budget

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

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.

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 application must include specific aims summarizing proposed plans to continue the following Core Activities and rationales and plans to add Enhancement Activities to the HRS. Below are the specific elements that Core Activities and Enhancement Activities must address:

Core Activities

Sustain the steady state longitudinal design and periodicity by doing the following:

• Employ the HRS multidisciplinary core survey to re-interview all panel members in 2024, 2026, and 2028 with 50-50 sample rotation between in-person and phone/internet interviews
• Continue venous blood and physical performance measures as part of in-person interviews
• Re-administer off-wave surveys in 2025, 2027, and 2029
• Refresh sample in 2028 via implementation of innovative, cost-effective approaches to recruit new participants from the1972-1977 birth cohort to maintain age representation of study
• Maintain and update geographic, employer, and economic, contextual data resources

Maintain and expand administrative/program data linkages by doing the following:

• Continue to obtain consent of participants for linkage to CMS and SSA program data to maximize coverage over time among study participants
• Continue linkage to the National Death Index data
• Produce, document, maintain, update, and share linked administrative/program records in accordance with established Data Use Agreements and Memorandums of Understandings with federal data provider

Continue distribution, dissemination, and user support for all study data by doing the following:

• Maintain protocols for rapidly sharing survey, performance measure, genetic, and assay data, as well as the production of user-friendly longitudinal survey files
• Maintain a biospecimen repository along with rules for sharing these data with researchers
• Administer and expand HRS website for data distribution, documentation, and bibliographic information as necessary to make the HRS discoverable and accessible to the public
• Continue online user support services
• Maintain and develop training courses (in-person and on-line accessible video recordings) on use of complex and/or high priority data elements (e.g., genetics, HCAP, contextual data, etc.)
• Advertise data at academic conferences, professional associations, and relevant social media channels
• Share all study data in accordance with NIH Data Sharing Policies

Collaborate with other studies to promote harmonization and innovation by doing the following:

• Engage in harmonization efforts both with the international family of HRS studies around the world as well as other aging studies to promote comparable and innovative measures to support aging research
• Promote and implement harmonization activities with relevant studies to support research on the prevalence and future trends of cognitive functioning, including AD/ADRD
• Continue collaborations with genetics consortia

Provide a multidisciplinary and collaborative organizational and management structure by doing the following:

• Maintain a multifaceted and multidisciplinary study team to administer the study
• Outline and adhere to a study governance plan that includes contingencies for losses of key personnel
• Continue engagement with NIA program staff and the HRS Data Monitoring Committee on the conduct of study aims (see Section VI, Cooperative Agreement Terms and Conditions of Award)

Enhancement Activities

The application must include plans to enhance the HRS by adding the following:

HCAP

• Outline plans to implement 4-year periodicity of HCAP sub-study data collection, conducting follow-up in 2026
• Expand samples of Black/African American and Hispanic/Latino participants
• Lower age-eligibility of new participants to include those aged 60-64

Participant Response Rates

• Propose innovative and cost-effective activities intended to address key issues/challenges in the field by maximizing participant response rates, including adaptive survey methods and modified incentives and investments in the survey workforce
• Experiment with employing different screener/interview modes
• Propose experiments to improve response and protocol consent rates (e.g., blood collection, administrative/program consents, etc.)

Blood-based Biomarkers

• Describe plans to expand assays (both new assays and longitudinal measurement of existing assays) for well-characterized AD/ADRD and aging phenotypes and share data, including the following:
  • Clinical reference markers that serve as indicators of metabolic or organ function
  • Neurological assays including ATN biomarkers of AD and heavy metals exposure
  • Hallmarks of aging biomarkers considered to contribute to the aging process (e.g., DNA methylation)
  • Immune function, infection and inflammation markers, including those that could clarify COVID-19 exposure
• Explain how the plans are innovative within the frame of a large scale nationally representative study to support research on aging and AD/ADRD

COVID-19

• Propose plans to build on existing HRS investments to study the COVID-19 pandemic (i.e., COVID surveys, policy/contextual data resources, and antibody data), including the development of new resources, to support research on the short and long-term impact of COVID-19 and the pandemic on health, welfare and aging

Exposome Studies in AD/ADRD

• Propose activities to enhance measurement of exposures across domains (e.g., residential, occupational or educational histories) to support longitudinal research on the impacts of the exposome on AD/ADRD risk and resilience
• Explain how the proposed activities are novel or how the activities will produce unique opportunities for new research or expanded exposure linkages?

Research Strategy: The research strategy must include descriptions of the significance, innovativeness, and approaches the investigative team will employ to conduct Core Activities and Enhancement Activities. The descriptions must include information on key aspects of the study and proposed plans, including the following:

• Significance of extending the study
• Survey response rates, attrition, weights, and consent rates for administrative data and blood collection
• Significance of selected assays
• Plans for collection and storage of blood specimens
• Measures and methods of the study
• Confidentiality protections for public and restricted/sensitive data
• Collaboration with other studies

Further, the descriptions must include plans to incorporate the following:

• Additions of larger samples of Black/African American and Hispanic/Latin populations in HCAP to support enhanced research on health disparities in AD/ADRD prevalence, incidence, and risk
  • The application must explain how the approach is novel or produces opportunities for path breaking research on health disparities in AD/ADRD prevalence, incidence, and risk
• Linkage/collection of new data elements to capture social, contextual, and environmental exposures ranging from microscopic to macro-level exposures to support study of how the exposome influences AD/ADRD risk
• Activities to manage and improve overall response/retention rates to maintain representativeness
  • The application must explain how the approach is novel
• Enhanced data on occupational/employment exposures/characteristics to support advances relating life course employment to health
  • The application must explain how the approach is novel or produces unique opportunities to support advances relating life course employment to health
• Expanded/enhanced blood-based biomarkers, including clinical reference markers, neurological assays, immune function assays, and assays considered to contribute to the aging process (i.e., hallmarks of aging)
• Additional content on social factors to study racial disparities and minority health via life histories, as well as the medium and long-term social impacts of the COVID-19 pandemic, to provide opportunities to advance knowledge regarding health disparities and their causes
  • The application must explain how the approach is innovative or will provide unique opportunities to advance knowledge regarding health disparities and their causes

Activities should be summarized with a timeline and milestones for key achievements (e.g., field period initiation and end points, data product release, etc.).

Study Governance Plan: Applications must include a study governance plan that describes the following:

• Organization and roles of the study team
• Contingency plans for loss of key study personnel
• General processes for interactions/collaboration among team members and study leadership, NIA Program Staff, and the Data Monitoring Committee (see Section VI, Cooperative Agreement Terms and Conditions of Award)

Letters of Support

• Applicants must submit a Letter of Support from their institution confirming that they have access to personally identifiable information about HRS panel members, and the ability to contact study participants for longitudinal follow-up, dementia assessment, blood collection, and administrative/program data linkage.
• All key personnel should provide a letter of support confirming their intention to provide effort as described in the application and agreement with the governance plan.?
• If the application includes subawards to other institutions, the applicant should include a Letter of Support from each proposed subaward institution describing their agreement to conduct any activities covered under the subaward.

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 Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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 project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA:

• If the proposed Core Activities and Enhancement Activities (see Section IV. Application and Submission Information) succeed, how adequately will the resulting data products support research that advances knowledge of aging, life course health, and AD/ADRD? How impactful is the gain to science from continuing the longitudinal study?
• If achieved, how effective will proposed collaborations with other studies to promote harmonization and innovation be in enhancing opportunities for cross-national or cross-study research on aging and AD/ADRD?
• How well suited are the proposed Blood-based Biomarkers, in a nationally representative longitudinal study, to advance research in aging, life course health, and AD/ADRD? Specifically, how impactful will the proposed clinical reference markers, neurological assays, immune function assays, and assays considered to contribute to the aging process (i.e., hallmarks of aging) in improving scientific knowledge?
• If successful, how effective can the proposed plans to build on existing HRS investments to study the COVID-19 pandemic be to advance research on the short and long-term impact of COVID-19 and the pandemic on health, welfare, and aging?
• How well suited are the proposed activities to enhance measurement of exposures across domains (e.g., residential, occupational, or educational histories) to support significant advances in research on the impacts of the exposome on AD/ADRD risk and resilience via a nationally representative longitudinal study?
• How adequately will proposed additions of larger samples of Black/African American and Hispanic/Latino populations in HCAP enhance research on health disparities in AD/ADRD prevalence, incidence, and risk?
• How effectively do the proposed activities to manage and improve overall response/retention rates to maintain representativeness address key issues/challenges in the field?
• How appropriate are the proposed enhanced data on occupational/employment exposures/characteristics to support advances relating life course employment to health?
• How suitable are the proposed content on social factors to study racial disparities and minority health via life histories, as well as the medium and long-term social impacts of the COVID-19 pandemic, to provide opportunities to advance knowledge regarding health disparities and their causes?

Investigator(s)

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

Specific to this FOA:

• How ample is the requisite expertise and experience of the proposed key to successfully implement the aims and study governance plan?
• How much confidence does the team composition and organization provide regarding the success of the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this FOA:

• How appropriate and efficient are proposed activities to improve response and protocol consent rates (e.g., blood collection, administrative/program consents, etc.)?
• How sufficient are the proposed expanded clinical reference markers that serve as indicators of metabolic or organ function; neurological assays including ATN biomarkers of Alzheimer's Disease and heavy metals exposure; hallmarks of aging biomarkers considered to contribute to the aging process (e.g., DNA methylation); and immune function, infection and inflammation markers, including COVID-19 innovative within the frame of a large scale nationally representative field study to support research on aging and AD/ADRD?
• How likely are proposed cross-study collaborations likely to produce innovations in measurement, methods, or aging research within the HRS or other aging studies?
• How novel are the proposed activities to enhance measurement of exposures across domains (e.g., residential, occupational, or educational histories)? Are they likely to produce unique opportunities for new research or expanded exposure linkages?
• How innovative is the proposed approach to produce larger samples of Black/African American and Hispanic/Latino populations in HCAP? What is the likelihood it will produce opportunities for path breaking research on health disparities in AD/ADRD prevalence, incidence, and risk?
• How novel are the proposed activities to manage, test, and improve overall response/retention rates to maintain representativeness?
• How novel is the proposed approach to collect enhanced data on occupational/employment exposures/characteristics? What is the likelihood it will produce unique opportunities to support advances relating life course employment to health?
• How innovative is the proposed content on social factors to study racial disparities and minority health via life histories, as well as the medium and long-term social impacts of the COVID-19 pandemic? What is the likelihood it will provide unique opportunities to advance knowledge regarding health disparities and their causes?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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

Specific to this FOA:

• How appropriate and feasible is the proposed approach to sustain the steady state longitudinal design and periodicity?
• How appropriate and feasible is the proposed approach to maintain and expand administrative/program data linkages?
• How appropriate and feasible is the proposed approach to continue distribution, dissemination and user support for all study data?
• How appropriate and feasible is the proposed approach to collaborate with other studies to promote harmonization and innovation?
• How appropriate and feasible is the proposed approach to implement 4-year periodicity of HCAP sub-study data collection, conduct follow-up in 2026, expand samples of Black/African American and Hispanic/Latino participants and lower age-eligibility of new participants to include those aged 60-64?
• How appropriate and feasible is the proposed approach to implement innovative and cost-effective activities intended to maximize participant response rates?
• How appropriate and feasible is the proposed approach to expand assays for blood-based biomarkers (both new assays and longitudinal measurement of existing assays) for well-characterized AD/ADRD and aging phenotypes and share data?
• How appropriate and feasible is the proposed approach to build on existing HRS investments to study the COVID-19 pandemic?
• How appropriate and feasible is the proposed approach to enhance measurement of exposures across domains to capture social, contextual, and environmental exposures ranging from microscopic to macro-level exposures to support research on the impacts of the exposome on AD/ADRD risk and resilience?

Study Governance Plan

• How suitable is the required study governance plan description of study organization and roles of the study team, contingency plans for loss of key study personnel, and general processes for interactions/collaboration among team members and study leadership, NIA Program Staff and the Data Monitoring Committee for oversight and management of the project (see Section VI, Cooperative Agreement Terms and Conditions of Award)?
• How much confidence does the plan provide regarding the success of the project?

Data Management and Sharing Plan

• How appropriate is the comprehensiveness of the plan?
• How adequately does the plan describe how all study data will be shared, documented, and disseminated?
• How adequately does the plan provide assurance that collected data will be effectively shared with sufficient protections from inappropriate disclosures?

Environment

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

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

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

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" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH 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 dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The Program Directors/Principal Investigators (PD(s)/PI(s)) will have the primary responsibility for:

The PI will have the primary responsibility for the design and details of the study/studies funded from this FOA and will retain primary responsibility for performance of the activities, including collecting, producing, and sharing resultant data/results; negotiating required Restricted Use Agreements with administrative data, as required; and maintaining ownership over data collected. The recipient agrees to accept assistance from the designated NIH/NIA Program Official in aspects of the scientific and technical management of the study and in coordinating with other Federal agencies. Further, the recipient agrees to accept recommendations on scientific activities under the award from the NIA Project Scientist as described below.?Finally, a committee of experts in areas of relevance to the study aims will provide guidance on the conduct of study aims.?The PI and/or designated member of the investigative team will provide a Study Update on the implementation of study aims to the Data Monitoring Committee (DMC) (see below) at meetings scheduled by the NIA Program Official. The Study Update should include information on established study targets, timelines, and milestones as described in the application (e.g., survey response rates, attrition, consent rates for administrative data and blood collection; release of data products, initiation/completion of field periods, etc.) that convey progress toward completion of study aims.

Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

Project Scientist: An NIA Project Scientist from the NIA Division of Behavioral and Social Research, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The NIA Project Scientist will assist in activities including refining study objectives, methodologies, and aims; setting priorities in the content of data collection; exploring the use of alternative strategies for incorporating new measurement approaches and instruments; facilitating cross-project coordination and cross-project analyses; analyzing and publishing results of the study. Given the function of the HRS and the HCAP as resources for the larger aging research community, the NIH/NIA Project Scientist will facilitate coordinating the study with other surveys (nationally and internationally) of the older adult population in order to enhance the capacity for comparative and integrative analyses. This will include facilitating efforts to harmonize data with other NIH and NIA-supported projects, engaging study investigators in formal harmonization activities supported by the NIA, promoting efforts to enhance the accessibility of study data to a wider range of scientists, and offering advice on how to enhance the value of the study for addressing scientific questions of priority to the NIH/NIA.??

Program Official: An IC/Agency Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIA Program Official will approve all major stages of the study and all new major additions/changes to content and methods. In addition, this individual will assist in initiating and maintaining collaborative relationships with relevant federal agencies. Prior approval is required by the NIA Program Official for any replacements of key personnel or other changes in subcontracts. Co-funding NIH institutes may appoint representatives/liaisons to monitor award progress, but all programmatic decisions for this award are made by the NIA Program Official. The NIA Program Official is responsible for final approval of DMC members and agendas.

Data Monitoring Committee (DMC): In order to ensure that the HRS and the HCAPl achieve NIA assistance objectives under the cooperative agreement, NIA shall establish and appoint members to a DMC comprised of independent scientific experts in areas appropriate to the multidisciplinary content areas of the HRS and the HCAP. Experts, including but not limited to the PI, co-Investigators, NIA staff, and invited independent experts, will make presentations to the DMC on scientific and administrative issues regarding the development and implementation of study aims, including the Study Update (see PD(s)/PI(s) responsibilities above).

The NIA Program Official and the PIs may request the DMC’s guidance on specific issues associated with the conduct of study aims or future study directions. NIA Program Official and the investigators will consider the guidance of the DMC regarding implementation of study aims as well as additions or changes to content and methods during the execution of the cooperative agreement. The DMC will report to the NIA and it will communicate specific guidance to the NIA regarding priorities via executive sessions of DMC meetings. The DMC will also, where appropriate, provide guidance to the PI; this advice is not binding on the PI who retains primary responsibility for scientific direction and implementation.

New DMC Chair and members will be appointed by NIA when necessary. The NIA will provide a charter for the DMC that describes the selection, composition, tenure, and responsibilities of the DMC membership.?

?Agendas for DMC meetings are developed through consultations between NIA Program Staff and the PI, informed by the DMC, and approved by the NIA Program Official. The DMC shall meet at least once a year, and may include additional short, focused discussions as needed over the course of a year to address time-sensitive issues. The NIA Program Official will organize support via a NIA-supported contractor to schedule and organize virtual, hybrid or in-person meetings as appropriate. This support will include scheduling, organizing travel for DMC members and invited third-party experts, and running logistical aspects of meetings. If a DMC meeting occurs as part of a site visit at the study institution, the PD/PI will arrange site-specific support.

NIA will consider the following Conflict of Interest factors in appointing individuals to the DMC:???

• DMC members should have no direct involvement with the study other than serving on the DMC or using the publicly available (including restricted) data.?
• DMC members may not be employed by the PD/PI institution(s).?
• DMC members may not have significant financial interests in the study proposed.?
• DMC members should not have published or collaborated with the PD/PI(s) or key personnel of the study within the last three years.??
• Relationships which may give the appearance of conflict, such as longstanding scientific or personal disagreement and mentor-mentee relationships, should be avoided.?
• Individuals may serve on the DMC if they are employed by institutions that are sub-awardees of the study’s NIA grant if they meet the above guidelines.????

The NIA Director of the Division of Extramural Activities, or a designee, will be appointed to serve as the Conflict Manager of the DMC. If, during the course of the DMC member’s term of appointment, there is a change in any of the above, the NIA Program Official and the NIA Conflict Manager should be notified in order to handle DMC member conflicts of interest.??

Areas of Joint Responsibility:

• The NIA Program Official, Project Scientist, and the PI(s) will be jointly responsible for the following:
  • Collaborating on the development of a roster of experts for the DMC and DMC agendas
  • Coordinating and facilitating the interactions between the study and other NIA recipients or federal partners
  • Considering DMC guidance for modifying or initiating study activities or directions

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 DMC chosen by majority vote of the DMC, 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.

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]

John W.R. Phillips, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9666
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.