Part 1. Overview Information

Key Dates

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

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

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

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

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

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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background  

Initiated in 2011 with 10 rounds of data available for public use, NHATS is a nationally representative sample of Medicare beneficiaries ages 65 and older. NHATS participants are interviewed in-person, annually to collect detailed information on the disablement process and its consequences to support the study of national-level disability trends, as well as individual-level trajectories. To support studies of racial/ethnic disparities in disability, additional data from Black/African American and Hispanic/Latino American participants is collected.  

The study content focuses on physical and cognitive capacity distinct from the environment in which activities take place to capture both function and the potential for accommodation. Foundational items include measures of the following: 

• The physical, social, technological, and service environment 
• Tests and self-reports of physical and cognitive capacity 
• Use of assistive devices and rehabilitation services 
• Help received with daily activities (self-care, household, and medical) 
• Participation in valued activities 
• Chronic conditions 
• Sensory impairments 
• Subjective and economic wellbeing 
• Demographic factors 

Additionally, informant interviews provide data on quality of end-of-life care, and administrative linkages to Medicare records are also available. Additional health data is provided via biomarkers from dried blood spots (i.e., high-sensitivity Creactive protein [hsCRP], glycosylated hemoglobin [HbA1c], Cytomegalovirus [CMV], and Interleukin [IL-6]), wrist-based accelerometry to capture physical activity and sedentary behaviors, and linkage to data from the 1940 Census. To better understand informal caregiving, NHATS' companion study, NSOC, collects data from a sample of up to five caregivers that provided care to NHATS participants in 2011, 2015, and 2017. The 2017 collection provides both longitudinal follow-up to the two cross-sectional samples from 2011 and 2015 and includes a time diary measuring what the caregivers did, how long it took, and, for some activities, follow-up questions about where they were, who they were with, and how they felt during that activity.  The NHATS and NSOC data combine to provide a rich understanding of disability trends, the disablement process, and its influence on wellbeing. The studies are effectively shared and well utilized for aging research, boasting a user base of over 5,500 scientists and over 500 journal publications by researchers across the country. The combination of individual data on cognition and function coupled with formal and informal care data have made the NHATS/NSOC ideal studies to examine dementia and related care (115 journal articles to date). NIA grantees frequently make use of NHATS in their supported research on disability and care including dementia care.  The NHATS/NSOC investigative team, in concert with NIA program staff, organized working meetings with subject-matter experts to consider enhancements to NHATS/NSOC in the following 11 subject areas: 

• Early signs of physical disability
• Wearable technology 
• Residential care measures 
• Sensory measures 
• Strengthening cognition/dementia measurement
• Resiliency
• Biomarkers of aging 
• Racial/ethnic disparities in disablement 
• Capturing rural older adults in NHATS 
• Enhancing end-of-life measures
• Paid caregiving

The NHATS Data Monitoring Committee (DMC), a group of third-party experts charged with providing expert guidance on the conduct of study aims, engaged the investigators based on their learnings from these expert sessions to provide comment on potential future directions for NHATS/NSOC that were considered in a project renewal. The result of the engagement was the conclusion that unifying the individual applications supporting elements of the study (i.e., core NHATS, NSOC, supplements for add-on samples, etc.) that have been funded under separate awards would both bring the various scientific elements into a single project that would provide a better basis for scientific review assessment of the complete study, as well as allow the investigators to focus on the conduct of aims as opposed to producing multiple applications over the grant period. A single application that continued the core elements of NHATS/NSOC and expanded content to include new data elements such as enhanced cognitive/dementia measures, new sensory measures, richer dementia care measures, life course measures to capture sources of health disparities, improved residential care data, and an expanded accelerometry sample can facilitate AD/ADRD research that could enhance research targeting related NIA Dementia Care Milestones. Renewing the project via a cooperative award would allow for substantial programmatic involvement including the continued use of a project scientist to represent the NIA perspective to the investigative team on the conduct of aims and a DMC to provide comment on the conduct of aims and new study content. 

Purpose

The purpose of this limited competition NOFO is to continue data collection, development, and dissemination of NHATS and NSOC. Continuation of the studies requires both knowledge of, and access to, the NHATS and NSOC sample frames. Therefore, this NOFO is limited to investigators and institutions with access to the NHATS and NSOC sample frames, as the frames will be used to contact and collect new data from participants. This NOFO aims to provide additional research opportunities to use NHATS to formally study disability and AD/ADRD. This single integrated award combining NHATS and NSOC seeks to implement the comments of the NHATS Data Monitoring Committee, to include continue the core elements of NHATS/NSOC and expand content related to the following:  cognitive/dementia measures, new sensory measures, richer dementia care measures, life course measures to capture sources of health disparities, improved residential care data, and the  accelerometry sample to facilitate AD/ADRD research that could enhance research related to the NIA Dementia Care Milestones. Applicants are required to submit a Letter of Support from their institution confirming that they have access to personally identifiable information about NHATS and NSOC panel members and the ability to contact study participants for longitudinal follow-up and administrative/program data linkage. 

Research Objectives 

The primary research objective of this NOFO is to combine and continue the NHATS and NSOC studies for a new 5-year period (i.e., renewal) to support the study of disability at older ages with specific enhancements intended to support novel and generalizable dementia care research.  A fundamental activity of this NOFO is to continue “Core” study aims of the NHATS and NSOC (the combined study hereafter referred to as NHATS). Therefore, applications must outline plans to conduct Core Activities, including the following:  

• Sustain longitudinal design and periodicity 
• Maintain and expand administrative/program data linkages 
• Continue distribution, dissemination, and user support for all study data 
• Provide a multidisciplinary and collaborative organizational and management structure 

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

• Expand Accelerometry 
• Enhance Data to Support Health Disparities Research 
• Participant Response Rates 
• Sensory Measurement 
• Enhance Residential Care Data 
• End of Life Measures  
• Cognition Measures 

 Specific details and application instructions for each activity are provided sequentially in Section IV.2 of this NOFO.  Applicants are encouraged to balance longitudinal continuity of design and methods, scientific innovation, the stated NOFO budget, and other constraints in designing a response to this NOFO.  

Non-Responsiveness Criteria 

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 NHATS panel members and the ability to contact study participants for longitudinal follow-up and administrative/program data linkage
• Applications that do not include a study governance plan, as described in Section IV of this NOFO
• 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 

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
• Responses to frequently asked questions about this NOFO 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 NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

The purpose of this limited competition, NOFO is to continue data collection, development, and dissemination of the National Health and Aging Trends Study (NHATS) and the National Study of Caregiving (NSOC). Continuation of the studies requires both knowledge of, and access to, the NHATS and NSOC sample frames. Therefore, this NOFO is limited to investigators and institutions with access to the NHATS and NSOC sample frames, as the frames will be used to contact and collect new data from participants.

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

Page Limitations

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 NOFO, the Research Strategy section is limited to 15 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 NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

The proposed key personnel must have 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.

Inflationary Increases for Future Years: Inflationary salary increases for future year commitments are not allowed for applications submitted to this NOFO. 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.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

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 NHATS.  Below are the specific elements that Core Activities and Enhancement Activities must address:

Core Activities

• Sustain longitudinal design and periodicity by doing the following:
  • Employ the NHATS study protocols (e.g., Sample Person Interview, Last Month of Life Interview, etc.) to re-interview all panel members annually in 2024, 2025, 2026, 2027 and 2028
  • Employ the NSOC study protocols to interview all existing panel members and new caregivers annually in 2024, 2025, 2026, 2027 and 2028
  • Refresh NHATS sample in 2026 to recruit new participants to maintain age representation of study and established oversamples/add-on samples
• Maintain and expand administrative/program data linkages by doing the following:
  • Continue to support linkage to Centers for Medicare and Medicaid Services (CMS) program data
  • Continue to support and improve linkages to 1940 and other historic Census records
  • Produce, document, maintain, update, and share linked administrative/program records in accordance with established Data Use Agreements and Memorandums of Understandings with data provider
• Continue distribution, dissemination, and user support for all study data by doing the following:
  • Maintain protocols for rapidly sharing all study data
  • Maintain a biospecimen repository, along with rules for sharing these data with researchers
  • Administer and expand NHATS website for data distribution, documentation, and bibliographic information as necessary to make the NHATS discoverable and accessible to the public
  • Continue user support services
  • Maintain and develop training courses (e.g., in-person and on-line accessible video recordings) on use of complex and/or high priority data elements (e.g., accelerometry, Census linkage, etc.)
  • Advertise data at academic conferences, professional associations, and on relevant social media channels
  • Share all study data in accordance with NIH Data Sharing Policies
• 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 NHATS DMC 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 NHATS by adding and/or enhancing the following:

• Expand Accelerometry
  • Propose plans to increase the accelerometry sample to at least 5,000 participants to better assess movement, sedentary, and sleep patterns as precursors to disability
• Enhance Data to Support Health Disparities Research
  • Link historical residence to external data on topics such as exposures, housing discrimination, and school quality to support life course studies of health disparities
  • Describe plans to recruit and maintain samples of Black/African American and Hispanic/Latino participants
• Participant Response Rates
  • Propose activities intended to address key issues/challenges in the field to improve response rates and limit attrition
  • Experiment with employing different strategies to improve field/survey operations
• Sensory Measurement
  • Add olfaction threshold testing to complement other sensory measures
• Enhance Residential Care Data
  • Expand facility questionnaire to capture information about the physical environment and service provision
• End of Life Measures
  • Expand Last Month of Life questionnaire to consider new items, including the following: communications with medical providers; receiving desired help for pain; whether family was kept informed about care; use of bereavement support; and off hour access to care
• Cognition Measures
  • Evaluate protocols (i.e., CogState and MAT) to assess the classification of individuals with probable, possible and no dementia
  • Co-calibrate the NHATS protocol with Health and Retirement Study/Harmonized Cognitive Assessment Protocol (HRS/HCAP)
  • Explore additional cognitive assessments (e.g., Digit Symbol Substitution Test or the Animal Naming Test) to capture earlier cognitive declines

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, and weights
• Measures and methods of the study
• Confidentiality protections for public and restricted/sensitive data
• Collaboration with other studies, as appropriate (e.g., the Harmonized Cognitive Assessment Protocol (HCAP))

Further, the descriptions must include the following:

• Plans to refresh sample of NHATS Sample Persons to maintain representativeness of Medicare population 65 and older, including oversamples/add-ons of age 90+ population, Black/African American and Hispanic/Latino populations to support enhanced research on health disparities in disability and dementia/dementia care
• Descriptions of plans to recruit and maintain sample of caregivers in NSOC
• Plans to link and share Medicare data
• Activities to manage and improve overall response/retention rates to maintain representativeness
• Additional content on social factors to study racial disparities and minority health via Census data linkage and other contextual measures
• Protocols to expand accelerometry to at least 5,000 Sample Persons and share data/measures

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 DMC (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 NHATS/NSOC panel members, and the ability to contact study participants for longitudinal follow-up 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.

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

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

Post Submission Materials

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

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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

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

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

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

2. Review and Selection Process

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

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

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

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging. The following will be considered in making funding decisions: 

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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

2. Administrative and National Policy Requirements

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

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

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

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

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

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

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

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

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

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

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

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 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 NOFO 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; and analyzing and publishing results of the study. Given the function of the NHATS as a resource for the aging research community, the NIH/NIA Project Scientist will facilitate coordinating the study with other surveys of the older adult population in order to enhance the capacity for comparative and integrative analyses, as necessary/appropriate. 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: A NIA/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 NHATS achieves 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 NHATS. 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-recipients 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 include:

• 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. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Data Management and Sharing

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

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

4. Reporting

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

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

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [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.