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 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

Key Definitions for This NOFO

• AD/ADRD - Debilitating conditions that impair memory, thought processes, and functioning, primarily among older adults.
• Cost of illness - The value of the resources that are expended or forgone as a result of a health problem. It includes health sector costs (direct costs), the value of decreased or lost productivity by the patient or caregiver(s) (indirect costs), and the cost of pain and suffering (intangible costs).
• Simulation modeling - A set of mathematical or computational techniques, including Monte Carlo simulation, agent-based modeling, and discrete event simulation, that can be used to simulate the transition of human individuals from a particular health/disease state to a different health or disease state.
• Stakeholder engagement - The meaningful involvement of patients, caregivers, clinicians, experts, and other healthcare stakeholders throughout the research process from planning the study, to conducting the study, and disseminating study results.

Background

The mission of the National Institute on Aging (NIA) is to support and conduct...clinical, behavioral, social, and economic research on aging and to foster the development of research and clinician scientists in aging. As part of its efforts, NIA provides research resources by supporting data collection. These data are made available to approved research and relevant scientific communities to analyze. Many of the data resources needed to conduct this study may be available through the Medicare & Medicaid Resource Information Center (MedRIC).

NIA's Division of Behavioral and Social Research (BSR) coordinates, implements, and supports initiatives related to aging research data and resources in the social and behavioral sciences, and actively supports the development of research-accessible study datasets linked to administrative data on health care. Linkages of administrative and other datasets enhance value and utility of data by facilitating research on health care utilization, health outcomes, and health expenditures, all of which can inform policy and encourage the development of more effective programs and provide insight on older adults health.

The population of people living with AD/ADRD continues to grow, and is projected to reach 16 million Americans by the year 2050. Significant concerns exist over the cost of treatment and care for persons living with dementia. To support the development of a national estimate of the cost of illness specific to AD/ADRD, NIA seeks a study team to develop and present cost estimates on an annual basis.

Purpose

The purpose of this NOFO is to develop a transparent and reproducible model to estimate the direct and indirect costs of treatment and care for PLWD. The project will aim to develop initial estimates of the cost of AD/ADRD and must share access to the dataset with the research community to permit additional analyses.

This NOFO will also support pilot studies to conduct simulations of changes in policy or treatment. The purpose of the pilot studies is to facilitate efforts to democratize widespread access to data resources for researchers working in aging in support of AD+ADRD Research Implementation Milestones 13.M and 13.P.

It should be noted that there are significant health inequities in AD/ADRD disease burden. African Americans/Blacks and Hispanics/Latinos bear a disproportionate number of cases, are diagnosed later in the disease trajectory, are underrepresented in clinical trials, and experience higher rates of medication discontinuation compared with Non-Hispanic Whites. Therefore, research conducted under this NOFO is intended to facilitate scientific understanding of disparities in the cost of illness, including differences in cost of illness by race and ethnicity. In order to understand lived experiences of unequal cost, quality, and access, a PLWD engagement panel will be established (See Research Objective 1.a.).

Research Goals

The primary goal of this NOFO is to develop a publicly available and shareable research and data infrastructure that will generate cost of illness estimates for AD/ADRD in the United States from a societal perspective. The cost of illness estimates must be updatable with the input of additional data years and data sources. A secondary goal is to share the analytic code used to develop the cost estimates and foment the use of economic simulation models to assess payment policy changes and the health gains of treatment advances.

Research Objectives

This NOFO utilizes the U01 Research Project Cooperative Agreements activity code. Under the Cooperative Agreement, the investigative team will:

1. Convene two engagement panels. The first panel, a family and people living with dementia (FPLWD) engagement panel, hereafter FPLWD Engagement Panel, will include a multifarious group of people, families, and caregivers with various perspectives on living with, and supporting those living with, AD/ADRD. The second panel, which will be called a Technical Monitoring Committee, will be comprised of economists, data scientists, and modeling experts to provide guidance to the study team on developing estimates of the cost of illness. It is not anticipated that there will be significant overlap between the activities of the FPLWD Engagement Panel and the Technical Monitoring Committee.
   • FPLWD Engagement Panel: The goal of engaging FPLWD is to ensure that the challenges of finding, paying for, and maintaining treatment and care for AD/ADRD are adequately captured. Through the FPLWD Engagement Panel, FPLWD provide input on the services, treatments, and processes that cost them time and money to navigate, regardless of whether the care and treatment is paid for out of pocket or by other payers. FPLWD will have the opportunity to ground the study in lived experience. This Patient-Centered Outcomes Research Institute's webpage is a possible source of patient and family engagement information.
   • Technical Monitoring Committee: The goal of the Technical Monitoring Committee is to provide critical feedback to the study team on data sources, data access, data analysis, development of analytic models, and content of scientific manuscripts. The Technical Monitoring Committee supports the scientific rigor of the project. Potential Technical Monitoring Committee members must not be named or contacted during the application period, rather applicants are invited to describe their approach to establishing and engaging with the Technical Monitoring Committee.
2. Identify appropriate nationally representative longitudinal studies of older adults with data that can be linked to other datasets to create a dynamic linked dataset. These datasets will be used to calculate the cost of dementia care and treatment in the United States. This data source must be updated with additional data years no less than annually.
3. Obtain access to the data needed to conduct the study. The dataset(s) shall be housed in MedRIC.info or a similar NIA funded repository. The project shall complete all the necessary activities needed to obtain access to datasets.
4. Maintain an updated dataset suitable for modeling and simulations studies, which is updated no less than annually. The hosting for the dataset shall be provided by an NIA-funded contractor.
5. Using the selected data source(s), calculate the costs associated with care and treatment for PLWD. This analysis may include self-reported out-of-pocket spending and the utilization of nursing home care; Medicare claims data; Medicaid claims data; the value of hours of informal (unpaid) care; and/or value of the cost of equivalent formal (paid) care; and the estimated wages forgone by informal caregivers.
6. Post the analytic code used to produce the estimates in a publicly accessibly repository (hosted on, e.g., GitHub).
7. Prepare data briefs and other products with appropriate text to communicate the background, data, method, results, and implications of the study.
8. Prepare a scientific manuscript for publication in a scientific journal. This scientific manuscript shall be authored by the Principal Investigator (PI) and may include co-investigators and other researchers who meet the International Committee of Medical Journal Editors qualifications for authorship as co-authors.
9. Submit the manuscript, revise and resubmit if needed, and publish the results of the study in a scientific journal.
10. Conduct project management activities essential to study performance. Develop a milestone schedule to guide project execution. Specifically, the project shall ensure that the necessary project management activities required to implement the Cooperative Agreement, such as conception and initiation, project planning, project execution, performance/monitoring, and project completion are conducted. A study timeline and milestones must be submitted in the initial application to guide the study.
11. Conduct nationwide outreach to invite pilot project applications. The Cooperative Agreement must support pilot studies to conduct policy simulations and model enhancements. The study shall ensure that the tasks needed to invite, select, and mentor pilot investigators are undertaken. Any proposed approach must include the involvement of the NIA Program Official in the review and selection of pilot projects.

Applications Not Responsive to this NOFO

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

• Applications that do not clearly articulate a plan to calculate the monetary cost of AD/ADRD in the United States from a societal perspective.
• Applications that do not include a FPLWD Engagement Panel component.
• Applications that do not include a proposed approach to establishing a Technical Monitoring Committee.
• Applications that do not clearly articulate a plan to make the resources developed through this project available to others.
• Applications that do not clearly articulate a plan to transfer data, simulation model, code, and other resources to a new institution/investigative team in the event an award is not continued by NIH.
• Applications that do not clearly articulate a plan for inviting, reviewing, and prioritizing pilots.
• Applications that do not contain a study timeline with key milestones based on accomplishment of project specific aims.
• Applications that do not specify the approach to sharing restricted data within the MedRIC Health and Aging Data enclave.
• Applications that do not include a detailed Data Management and Sharing Plan that describes how all study data will be shared, documented, and disseminated. See NIH Data Sharing Policies for recommended guidance.
• Applications that propose non-human research studies.

Resources for Applicants

• A pre-application technical assistance webinar for this NOFO will be held within 30 days of the publication of this announcement. Information regarding the webinar will be posted here
• Responses to frequently asked questions about this NOFO will be posted here
• NIA Guidance on Sharing Data and Other Resources
• Medicare & Medicaid Resource Information Center (MedRIC)

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)

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

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

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

Applicant Organizations

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

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

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

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

Priscilla Novak, Ph.D., MPH
Telephone: 301-496-3136
Email: Priscilla.Novak@nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

The investigative team must have experience with PLWD stakeholder engagement.

The investigative team must have expertise in modeling costs of health and medical care.

R&R or Modular Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: The application must address plans to increase understanding of the monetary cost of AD/ADRD in the US.

Innovation: The application must specify an innovative approach to modeling that would make the model replicable/updatable as new data become available.

Research Strategy:

The applicant must describe:

1. The approach to convening two engagement panels, one FPLWD Engagement Panel, and one with Technical Experts on data sources, data access, data analysis, development of analytic models (Technical Monitoring Committee). Members of the Technical Monitoring Committee must not be named or contacted during the application period; however, the approach to establishing (including member expertise) and engaging with the Technical Monitoring Committee should be described.
2. The approach to identifying appropriate nationally representative longitudinal studies of older adults with data that can linked to other datasets to create a dynamic linked dataset.
3. The approach to obtaining access to the data needed to conduct the study.
4. The approach to updating a dataset suitable for modeling and simulations studies, which is updated no less than annually.
5. The approach to calculating the costs associated with care and treatment for persons with dementia.
6. The approach to sharing the data, analytic code, and models used to produce the estimates in a publicly accessibly repository (hosted on, e.g., GitHub).
7. The approach to data briefs and other products with appropriate text to communicate the background, data, method, results, and implications of the study.
8. The approach to writing and submitting scientific manuscripts.
9. The timeline and milestones for the study. Develop a milestone schedule to guide project execution. Specifically, the project shall ensure that the necessary project management activities required to implement the Cooperative Agreement, such as conception and initiation, project planning, project execution, performance/monitoring, and project completion are conducted.
10. The approach to conducting project management activities essential to study performance.
11. The approach to conducting nationwide outreach to invite pilot project applications as well as how pilot recipients will be selected and engaged. Applicants must present a plan for inviting, reviewing, and prioritizing pilot projects.
12. The approach to transfer data, simulation model, code, and other resources to a new institution/investigative team in the event an award is not continued by NIH.

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. The plan must specify the approach to sharing restricted data within the MedRIC Health and Aging Data enclave.

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.

Foreign Institutions

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

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

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

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

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

2. Review and Selection Process

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

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

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

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

• 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.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 other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be a 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, NIH will support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

• The Principal Investigator(s) will have the primary responsibility for the design and details of the project funded from this NOFO and will retain primary responsibility for performance of the activities. The recipient(s) agree(s) to accept assistance from the designated NIH Program Official and Project Scientists in aspects of the scientific and technical management of the study/studies and in coordinating with other Federal agencies. Specifically, the PD(s)/PI(s) will have the primary responsibility to:
  • Convene the FPLWD Engagement Panel and the Technical Monitoring Committee.
  • Identify appropriate nationally representative longitudinal studies of older adults with data that can linked to other datasets to create dynamic linked dataset.
  • Obtain access to the data needed to conduct the study (e.g., obtain IRB clearance, complete DUA forms, remit fees for data access).
  • Update and maintain a dataset suitable for modeling and simulations studies.
  • Using the selected data source(s), calculate the costs associated with care and treatment for persons with dementia.
  • Post the analytic code used to produce the estimates in a publicly accessibly repository (hosted on, e.g., GitHub).
  • Prepare data briefs and other products with appropriate text to communicate the background, data, method, results, and implications of the study.
  • Prepare and submit a scientific manuscript on the findings of the project for publication in a scientific journal.
  • Create the study timeline and milestones. Conduct project management activities essential to study performance.
  • Conduct nationwide outreach to solicit pilot project applications and support pilot studies to conduct policy simulations.

The PD/PI(s) will provide details to the Technical Monitoring Committee for what data and modeling resources will be shared, how resources will be organized to enhance the user experience, and any limitations/restrictions on access to resources and data produced by the project. Research products should be discoverable and shared in a user-friendly fashion. The Data Management and Sharing Plan must be in accordance with the NIH Data Management and Sharing Policy.

The recipient(s) will retain custody of and have primary rights to any data and software developed under this award, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

The FPLWD Engagement Panel will ground the project in the daily lived experiences of people experiencing the challenges of paying for care and services required to cope with AD/ADRD.

To the extent possible, the PD/PI will use the NIA sponsored contractor environment (https://www.medric.info/data-enclave/enclave-pages/enclave) to house the data needed to execute the project.

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

• NIH Project Scientist(s) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The NIH Project Scientist will assist in refining study objectives and activities, including pilot projects, representing the scientific objectives of the project as they relate to the aims (e.g., recommendations on workshop topics, areas for collaboration, products for dissemination, etc.).
• An NIH Program Official will be responsible for the normal scientific and programmatic stewardship of the award, including approving pilot projects. The NIH Program Official will approve all major stages of the project and all new major additions/changes to planned activities. In addition, this individual will assist in initiating and maintaining collaborative relationships with relevant federal agencies. Prior approval is required by the NIH Program Official for any replacements of key personnel or other changes in subawards. The NIH Program Official will serve as the primary programmatic/administrative liaison to the project. The Program Official is responsible for final approval of FPLWD Engagement Panel and Technical Monitoring Committee panel rosters, meeting agendas, and other work products of strategic importance to successful execution of the project. The Program Official is responsible for the final approval of pilot projects.

The government’s involvement in the project will include the following: 1) the NIH Project Scientist; 2) engagement with the Technical Monitoring Committee; 3) engagement with the FPLWD Engagement Panel; and the 4) the provision of the Health and Aging Data enclave. After the award is made, the PD/PI(s) should work with the study’s co-Investigators group plus the Technical Monitoring Committee to advise the PD/PI(s) on the overall scientific management of the project and on the recruitment of new investigators to the project as necessary.

Areas of Joint Responsibility include:

• Establishing the Technical Monitoring Committee and FPLWD Engagement Panel.
• Participating in organizing and coordinating scientific and annual meetings as required.
• Coordinating and facilitating the interactions between this cooperative agreement and other NIA funding recipients.
• Considering Technical Monitoring Committee recommendations for modifying the simulation model to accommodate new scientific opportunities and directions.
• Sharing and reviewing annual progress among the components of the U01 and with the public.
• It is anticipated that the PD/PIs and the NIA PO/PS will meet no less than once per month by teleconference. It is anticipated that meetings begin within one month of award.

Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and 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.

The plan must specify the approach to sharing restricted data. 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. This plan must specify the approach to sharing restricted data within a FedRAMP compliant GovCloud space such as the MedRIC Health and Aging Data enclave.?

4. Reporting

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

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

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

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

Section VII. Agency Contacts

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Priscilla Novak, PhD, MPH
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: Priscilla.Novak@nih.gov

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

Jeni Smits
National Institute on Aging (NIA)
E-mail: Jeni.smits@nih.gov

Section VIII. Other Information

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

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