Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)

Funding Opportunity Title
Consortium for Economic Research on AD/ADRD Prevention, Treatment, and Care (R01 Clinical Trial Optional)
Activity Code

R01 Research Project Grant

Announcement Type
New
Related Notices
  • October 27, 2023 - Adjustments to NIH Grant Application Due Dates on or Between October 28, 2023 and October 31, 2023. See Notice NOT-OD-24-020.
  • September 21, 2023 - Notice of Pre-Application Webinar for Funding Opportunities RFA-AG-24-030 and RFA-AG-24-031. See Notice NOT-AG-23-053
  • August 31, 2022- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 5, 2022- Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
Notice of Funding Opportunity (NOFO) Number
RFA-AG-24-031
Companion Funding Opportunity
RFA-AG-24-030 , U54 Specialized Center (Cooperative Agreements)
Assistance Listing Number(s)
93.866
Funding Opportunity Purpose

This notice of funding opportunity (NOFO) invites applications proposing research projects that aim to advance economic research on Alzheimer’s disease (AD) and AD-related dementias (ADRD) by examining the development and diffusion of treatment/care innovations, payment and treatment models for care and care access for people living with dementia (PLWD) and their caregivers, and?economic factors influencing disease progression to address AD/ADRD research implementation milestones?1.P,?13.P,?13.M, and?13.N.

This NOFO, in conjunction with its companion NOFO, RFA-AG-24-030, aims to establish a consortium. The consortium's goal will be to establish a collaborative research network that unites a coordinating center with 4 to 5 research projects, all working towards the following: (1) creating evidence-based research for enhancing AD/ADRD prevention, treatment, and care, and (2) disseminating results to stakeholders. RFA-AG-24-030 invites applications to establish the coordinating center, and this NOFO invites applications proposing the research projects.

Key Dates

Posted Date
August 28, 2023
Open Date (Earliest Submission Date)
September 29, 2023
Letter of Intent Due Date(s)

September 29, 2023

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
October 30, 2023 Not Applicable Not Applicable March 2024 May 2024 July 2024

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).

Expiration Date
October 31, 2023
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - 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.

Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Key Definitions for this Notice of Funding Opportunity (NOFO)

  • Alzheimer’s disease (AD) and Alzheimer’s disease-related dementias (ADRD): ADRD include, but are not limited to, Frontotemporal dementia (FTD), Vascular Contributions to Cognitive Impairment and Dementia (VCID), Lewy Body Dementias (LBD), and Multiple Etiology Dementias (MED).
  • Underserved populations: Groups identified as Priority Populations in the National Institute on Aging’s (NIA's) Health Disparities Framework and/or other groups known to experience barriers to accessing needed health care services or to have inadequate health care coverage.
  • Medically and/or socially vulnerable populations: Residents of nursing homes and assisted living facilities, and individuals who access care from adult day care centers or other professional care settings that serve individuals living with AD/ADRD.

Background????

Dementia is a growing concern worldwide. According to the Alzheimer's Association, AD is responsible for 60-80% of all dementia cases, and the prevalence of this condition is expected to rise in the coming years. However, current treatments for AD have limited effectiveness, which highlights the need for exploring new health policies and interventions to accelerate innovation in AD/ADRD prevention, treatment, and care.

Further, as the population ages and the number of people living with AD/ADRD continues to increase, it is important to also measure the economic burden of dementia on patients and caregivers/care partners to develop policies that efficiently enhance access to, and quality of, care. It is projected that the economic cost of AD/ADRD will rise to over $350 billion by 2040, with most of the burden of formal costs falling on government programs such as Medicare and Medicaid. However, a significant fraction of AD/ADRD care is provided by informal caregivers. These caregivers substitute their time, sometimes at the expense of pursuing paid work, to provide care to a relative due to preference, cost barriers, or both. Therefore, it is essential to improve our understanding of how health policy and interventions that support care provision influence access to care and the labor force, both formal and informal, that provide care to individuals living with AD/ADRD. As noted in a recent workshop organized by the National Academies of Sciences, Engineering, and Medicine Board on Health Care Services, utilizing an economics framework can provide important insights into means of improving care for AD/ADRD patients and their care providers, both formal and informal.

Economic factors may also influence AD/ADRD risk factors. For example, some occupations may expose individuals to activities (e.g., cognitively challenging tasks) or environments (e.g., high risk of concussions) that may mitigate or exacerbate AD/ADRD risk. Further, economic circumstances may limit access to various types of healthcare services to prevent or treat conditions associated with AD/ADRD risk or serve as a direct risk factor (e.g., stress associated with economic uncertainty). Limited access to health services may also increase the likelihood that a person experiences symptoms of cognitive decline that may impair their ability to manage their work and financial lives. Economical methods and insights can serve as a useful tool to address these myriad questions regarding AD/ADRD prevention, treatment, and care.

Given that questions about these economic topics are often linked (e.g., features of the AD/ADRD care workforce are related to payment policies and access to services, etc.), establishing a consortium of research projects examining economics research on AD/ADRD prevention, treatment, and care has the potential to create synergies to better generate innovative projects and collaborations, as well as share findings, more rapidly. A consortium organized around a coordinating center could also serve as an incubator for new research that builds on consortium findings as well as bring new investigators to the topic to expand the network of experts studying the economics of AD/ADRD to provide an evidence base for policy-making and address NIA AD/ADRD research implementation milestones 1.P, 13.P, 13.M, and 13.N.

Purpose

This NOFO invites applications proposing research projects that aim to advance economic research on AD/ADRD by examining the development and diffusion of treatment/care innovations, payment and treatment models for care and care access for PLWD and their caregivers, and?economic factors influencing disease progression to address AD/ADRD research implementation milestones?1.P,?13.P,?13.M, and?13.N.

Specific Research Objectives????

This NOFO, in conjunction with its companion NOFO, RFA-AG-24-030, aims to establish a consortium. The consortium's goal will be to establish a collaborative research network that unites a coordinating center with 4-5 research projects, all working towards the following: (1) creating evidence-based research for enhancing AD/ADRD prevention, treatment, and care, and (2) disseminating results to stakeholders. RFA-AG-24-030 invites applications to establish the coordinating center, and this NOFO invites applications proposing research projects that aim to advance economic research on AD/ADRD.

Economics research on AD/ADRD is critical for informing evidence-based policy decisions and improving the quality of life and health for PLWD and their families. Research under this NOFO can cover a range of economic research topics, such as examining the cost of AD/ADRD prevention, treatment, and care. Through exploring these issues, researchers can provide policymakers and healthcare providers with effective and equitable strategies for addressing the economic challenges of dementia. Potential areas of research include the following topics:

  • Cost of dementia care: This research area includes investigations of the economic impact of dementia on families, healthcare systems, and society as a whole. It can examine direct costs such as medical care and support services, as well as indirect costs such as lost productivity and wages of caregivers. Additionally, this research may explore the impact of health insurance access on health and wellbeing outcomes for PLWD, the cost of drug development, and the role of policies and payment models in shaping access to care.
  • Health systems research: This research area includes investigations of how institutional factors, such as the organization of care, payment for care (e.g., Accountable Care Organizations, augmenting service coverage, etc.), and care coordination influence access, utilization, and outcomes (e.g., quality of life, morbidity, mortality, and health disparities) for PLWD and their families. This research may also explore how systemic or institutional incentive structures can improve care for persons with dementia and cost-effectiveness research utilizing data from the Long-Term Care Data Cooperative.
  • Prevention and management of dementia: This research area includes investigations of the economic impact of prevention and management strategies for dementia, as well as the use of economic incentives, to modify individual or institutional actions. For example, researchers may investigate interventions such as lifestyle changes, medications, and non-pharmacological therapies. This research may also explore how policies of governments and other institutions influence access, use, and quality of health care, as well as how payment models impact what care is provided to whom.
  • Long-term care: This research area includes investigations of the economic impact of long-term care for PLWD, including institutional care and home care, and compare different models of care and transition from long-term care facilities to home or hospital. This research may also investigate the impact of how care is financed on access, long-term care outcomes as well as how policies and payment models shape access to long-term care services.
  • Impact of labor force participation/occupation on AD/ADRD risk: This research area includes investigations of the relationship between labor force participation, occupation, tenure, voluntary or involuntary interruption (e.g., unemployment, retirement, etc.), gig employment, job features/rules (e.g., shift work rules, etc.), and other aspects of employment over time on dementia risk and health outcomes. For example, researchers may investigate how the interaction between employment options and familial caregiving responsibilities impact related economic and health outcomes.
  • Economic research on the dementia care workforce: This research area includes examinations of the economic and labor market factors that impact the recruitment, training, and retention of healthcare workers in the dementia care workforce. It includes investigations of the costs and benefits of different training and education programs on care worker retention and productivity, as well as the effectiveness of different incentive structures in promoting the recruitment and retention of skilled care workers. This research may also explore how changes in reimbursement rates and payment models impact the availability and quality of dementia care services. By better understanding the economic and labor market factors that influence the size and composition of the dementia care workforce, policymakers and healthcare providers can work together to develop more effective and sustainable strategies for ensuring high-quality care for PLWD.
  • Economics of dementia drug development: This research area includes examinations of the economic aspects of drug development for dementia treatments, including the costs, incentives, and barriers associated with discovering and bringing new drugs to market, including issues of resultant access and coverage for patients. This research may also explore the impact of intellectual property rights, regulatory frameworks, and public-private partnerships on the economic viability and accessibility of dementia drugs, as well as the potential for international collaborations to promote more effective and equitable approaches to drug development for PLWD.
  • Cross-national comparative studies of AD/ADRD risk factors and dementia care: This research area includes examinations of cross-national comparative studies of AD/ADRD risk factors and dementia care. By comparing and contrasting the economic and healthcare factors that impact dementia care across different countries, researchers can identify best practices and policy approaches that can be adapted in different contexts to improve care for PLWD. This research can also explore the similarities and differences in care delivery and healthcare utilization patterns by exploiting national policy differences.
  • Demonstration projects and behavioral economics interventions in AD/ADRD care: This research area includes examinations of the economic and behavioral factors that influence healthcare utilization patterns of PLWD and can improve care for them. Interventions can include financial incentives, nudges such as the development of personalized feedback, and social support, which can promote healthy behaviors and improve health outcomes for PLWD by providing guideline concordant care to physicians, nurses, caregivers, or older adults. This research may also investigate the impact of modifications to insurance and payment models on healthcare utilization, as well as the role of statewide demonstration projects for improving care for PLWD. Please note that only Stage IV or Stage V clinical trials as defined by the NIH Stage Model, are allowed.
  • Economic modeling of future costs of AD/ADRD: This research area includes developing economic models to predict the future economic impact of AD/ADRD on individuals and society, considering demographic trends, development of potential drugs/interventions, changes in multiple comorbidities across cohorts, and the changes in the prevalence of AD/ADRD. The models may also incorporate the impact of policies and payment models on the future burden of dementia and the provision of care, and account for drivers of disparities.
  • Artificial Intelligence (AI) and big data for economic research on AD/ADRD: This research area includes utilizing advanced AI methods and big data analytics to gain deeper insights into the economics of dementia care. By implementing AI approaches, such as machine learning, natural language processing, and predictive modeling, researchers can detect patterns, trends, and potential policy interventions within large and multifaceted datasets related to dementia care and how to improve care for PLWD. This research might concentrate on areas such as healthcare utilization, cost-effectiveness, tailored care interventions, and refining incentive structures for enhanced care and outcomes for PLWD and their families. Moreover, AI-driven techniques can facilitate more efficient analysis of data from various sources, including electronic health records, administrative data, and longitudinal studies, leading to more comprehensive and actionable findings.

Regardless of their specific focus, all applications must include aims that address health disparities among underserved populations. For example, researchers can explore the efficacy and cost-effectiveness of various interventions alongside strategies for enhancing access, equity, and dementia care outcomes for medically and/or socially vulnerable groups experiencing health disparities. Further researchers may investigate the effectiveness and cost-effectiveness of various interventions, and other strategies to improve access, equity, and outcomes in dementia care for populations experiencing health disparities and/or that are medically and/or socially vulnerable.

As detailed in NOT-OD-16-025, NIH accepts applications involving health economics research in which health outcomes and health-related behaviors are the primary focus, and the connection between the subject(s) of the study and improved understanding of health are clear and explicit. NIH may also fund health economics research that meets the mission-based priorities of individual NIH Institutes and Centers, exemplified by those outlined in NIA AD/ADRD research implementation milestones 1.S, 1.P, 13.F, 13.J, 13.M, 13.N, and 13.P. Potential applicants are encouraged to consult with the NIA scientific/research contact listed in Section VII of this NOFO if they have questions about the alignment of their proposal with NIA’s priorities.

Coordination requirement: The Coordinating Center will serve as a central hub for research dissemination, collaboration, and coordination across all consortium projects. Therefore, research projects resulting from applications funded under this NOFO will be required to coordinate activities with the Coordinating Center. The aim of this requirement is to facilitate synergies, streamline research efforts, and maximize the impact of funded projects on our understanding of the economic aspects of AD/ADRD prevention, treatment, and care. To support these efforts, all applications must?include plans to collaborate with the Coordinating Center and the consortium as a whole. A full list of required activities can be found in Section IV of this NOFO.

Milestone Requirements: To ensure transparency, accountability, and the effective management of research projects, applicants must outline specific research milestones for each year of the award, which must be shared with the Coordinating Center. These milestones will serve as benchmarks to track the progress of the research project and assess its overall success. A full list of requirements for defining milestones can be found in Section IV of this NOFO.

By clearly defining and adhering to research milestones throughout the course of the award, applicants can ensure that their projects remain on track and contribute effectively to the consortium's overall objectives. Regular reporting of progress reports to the Center and close coordination with the Center is required and will be essential in tracking the achievement of these milestones and ensuring the successful completion of the research project.

Non-Responsiveness Criteria????

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

  1. Applications without aim(s) describing how research will address health disparities in the subject area.
  2. Applications that do not provide a plan for how the research will explore economic aspects of AD/ADRD prevention, treatment, or care.
  3. Applications that do not provide plans to coordinate with the Coordinating Center
  4. Applications that focus solely on the biological or clinical aspects of AD/ADRD, without addressing the economic implications of the disease.
  5. Applications that do not address Stage IV and Stage V of the NIH Stage Model when pursuing clinical trials.
  6. Clinical trial applications that do not provide a plan for how the research will facilitate the recruitment of health disparities populations.
  7. Applications that do not provide the required Milestone schedule for all years of the project with a clear timeline for achieving these milestones.

Clinical Research Operations Management System

?NIA utilizes a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. NIA Clinical Research Operations & Management System (CROMS) is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects. NIA investigators of grants, contracts, and cooperative agreements that are active as of July 1, 2021 and support human subjects research as defined by the DHS HHS OHRP regulations at 45 CFR 46 will be required to interact with and use existing and future components of CROMS as required by NIA throughout the lifecycle of the grant, as described in NOT-AG-23-017. Data to be submitted to NIA CROMS includes those elements reported in the standard NIH requirement annual progress report (GPS 4.1.15.7). Details regarding the standard operating procedures for CROMS can be found on the NIA CROMS website.

When applicable, all NIA grantees must ensure:

1. The study’s Informed Consent Document (ICD) lists The National Institutes of Health (NIH) and its authorized representatives as one of the organizations that may look at or receive copies of information in participants study records. According to DHS HHS OHRP 45 CFR 46 46.116, all ICDs must contain A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained. If using the NIA informed consent template please see Section 6: Statement of Confidentiality.

2. An assigned NIH ClinicalTrials.gov identifier (NCT number) is reported in its respective CROMS study record within three months after assignment, and the reporting of final enrollment data to CROMS is consistent with final enrollment data reported in ClinicalTrials.gov.

Resources for Applicants????

Applicants may benefit from the following research resources when developing their applications:

  • Gateway to Global Aging - A platform for population survey data on aging around the world.
  • Health and Retirement Study (HRS) - a longitudinal panel study that surveys a representative sample of approximately 20,000 people in America. HRS provides an invaluable body of multidisciplinary data to address important questions about the challenges and opportunities of aging.
  • National Health and Aging Trends Study (NHATS) and the National Study of Caregiving (NSOC) - NHATS conducts annual in-person interviews with a nationally representative sample of Medicare beneficiaries ages 65 or older designed to study late-life disability trends and trajectories. The supplemental NSOC provides the perspective of family and friends who help NHATS respondents experiencing limitations in daily life.
  • MedRIC Health & Aging Data Enclave - is a secure computing desktop for studies on aging, healthcare, and health outcomes. The desktop provides access to sensitive Centers for Medicare & Medicaid Services (CMS) datasets linked to NIA-sponsored study or survey datasets.
  • IMPACT Collaboratory Long-Term Care Data Cooperative - is the largest integrated database of detailed, normalized, electronic health record data from nursing homes in the United States.
  • Responses to frequently asked questions about this NOFO will be posted here.

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

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

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Funds Available and Anticipated Number of Awards

NIA intends to commit $3,000,000 in fiscal year 2024 to fund 4-5 awards.

Award Budget

Application budgets are limited to $400,000 per year in direct costs and need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

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

Eligible Organizations

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
Foreign Institutions

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 allowed.

Required Registrations

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted 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.

Eligible Individuals (Program Director/Principal Investigator)

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 NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Partha Bhattacharyya, Ph.D.
Telephone: 301-496-3136
Email: bhattacharyyap@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

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.

Investigative teams must possess the experience in economic research and aspects of AD/ADRD relevant to their proposed research on AD/ADRD prevention, treatment and care to effectively conduct the proposed project (e.g., studies of AD/ADRD care should include expertise in health systems and related care practices). If proposing an artificial intelligence (AI) and/or big data research project, the team must have appropriate experience in AI methodology.

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:

Applications must?describe?how they will address?the economic aspects of dementia care and its impact on individuals and society.

Research Strategy:

Applications must propose plans for economics research on AD/ADRD prevention, treatment, and care that include aim(s) must address health disparities Applications should describe how the proposed research will build on the current evidence base for policies addressing the economics of AD/ADRD research, and how these findings will be used to inform future policy decisions.

Regardless of specific focus, all applications must include aims that address health disparities among underserved populations; for example, researchers can explore the efficacy and cost-effectiveness of diverse interventions alongside strategies for enhancing access, equity, and dementia care outcomes for medically and/or socially vulnerable groups experiencing health disparities. For projects proposing clinical trials, applications must provide a plan describing how the research will facilitate recruitment of health disparities populations. Additionally, for projects proposing clinical trials, the application must address Stage IV and Stage V of the NIH Stage Model.

For projects proposing primary data collection, applications must outline strategies for collection (if applicable) and acquisition of data related to the economic aspects of AD/ADRD prevention, treatment, and care. Applications must include plans to handle the data acquisition, development, and analysis required for the application, particularly with a focus on addressing health disparities in the selected research areas. The plans must address the NOFO requirements for sharing data, specifically in relation to the proposed best practices in data sharing, adherence to findable, accessible, interoperable, and reusable (FAIR) principles, access protocols and programs, and clinical trial best practices.

Applications must describe how they will introduce novel data resources, innovative methodologies, or groundbreaking approaches in the field of economic research related to AD/ADRD prevention, treatment, and care. Applications must describe how the proposed project will present new insights or challenge existing paradigms in addressing health disparities for people living with dementia, their caregivers or the system providing care.

Coordination requirement: The Coordinating Center serve as a central hub for research dissemination, collaboration, and coordination across all consortium projects. Therefore, research projects resulting from applications funded under this NOFO will be required to coordinate activities with the Coordinating Center. The aim of this requirement is to facilitate synergies, streamline research efforts, and maximize the impact of funded projects on our understanding of the economic aspects of AD/ADRD prevention, treatment, and care. To support these efforts, all applications must?include plans to:

Collaborate with the Coordinating Center to:

  • Coordinate meetings and workshops;
  • Participate in stakeholder engagements activities;
  • Disseminate research findings; and
  • Meet the data, collaboration, and dissemination objectives of the consortium.

Contribute to the collective knowledge generated by the consortium by:

  • Sharing data generated by the project, in accordance with NIH' Data Management and Sharing Policy;
  • Sharing codes, study protocols, and documentation with consortium members and the broader research community;
  • Leading training and mentoring activities to develop the next generation of dementia researchers;
  • Participating in annual conferences in Bethesda and/or other relevant national conferences to present research findings, network with fellow consortium members, and foster collaborations;
  • Closely coordinating with the Coordinating Center to report progress associated with each project milestone to ensure transparency and accountability throughout the research process.
  • Supporting junior investigator networks

Milestone Requirements: To ensure transparency, accountability, and the effective management of research projects, applicants must outline specific research milestones for each year of the award, which must be shared with the Coordinating Center. These milestones will serve as benchmarks to track the progress of the research project and assess its overall success.

Applicants must do the following when defining their research milestones:

  • Research objectives: Clearly state the research objectives for each year, outlining specific goals and targets that the project aims to achieve during that period.
  • Methodology and data collection (if applicable): For projects proposing primary data collection, describe the research methods and data collection strategies to be employed during each year of the project, along with any relevant timelines for these activities and when data will be shared.
  • Data analysis and interpretation: Detail plans for data analysis and interpretation for each year of the award, including any statistical techniques to be employed and expected outcomes to be derived from the data and sharing of analytical codes for replication.
  • Dissemination and collaboration: Outline plans for disseminating research findings, participating in consortium meetings and conferences, and engaging with the Coordinating Center and other consortium members.
  • Training and mentoring: Specify any planned training and mentoring activities for each year of the award, aimed at developing the next generation of dementia researchers.
  • Any other PD/PI defined milestones:?PD/PIs can prepare additional milestones deemed appropriate to complete proposed aims beyond those described above.

By clearly defining and adhering to research milestones throughout the course of the award, applicants can ensure that their projects remain on track and contribute effectively to the Consortium's overall objectives. Regular reporting of progress on milestones/outcomes to the Coordinating Center is essential to ensuring the successful and timely completion of the research project.

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.

This NOFO REQUIRES the sharing of ALL resources with a broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication, as appropriate and consistent with achieving the goals of the program, unless prohibited under Bayh-Dole Regulations.

It is imperative that the data collection and permission/consents are set up in such a manner with respondents and institutions that will allow broad use of resource sharing.

This NOFO encourages sharing software and codes that are developed or modified to accomplish the aims of this program, unless prohibited under Bayh-Dole Regulations.

This NOFO requires adoption of Findable, Accessible, Interoperable, and Re-usable (FAIR) data principles when addressing each application component and encourages PD/PIs to store data in repositories that hold a Core Trust Seal.

Applications must address the following items:

  • Indicate the repository/consortium/enclave where they will place the resource or have a clear plan and capacity to share from their own site(s). Working with an external repository or through a consortium can be advantageous for many investigators.
  • Describe and justify the timetable to release the resource. Generally, the referenced resource from a publication should be made available by the on-line publication date unless NIH policy specifies an earlier date. Investigators should justify exceptions to that timing.
  • Identify any restrictions on sharing and justify them. Restrictions might include, for example, no commercial use of the resource, only qualified users may access the material, or, no attempt to reveal personal or private information may be made. Investigators may also set different levels of access, for example, for expert users and novice users.
  • Describe how all materials will be transferred to a new entity at the end of the project period to enable long-term follow up with survey respondents and institutional representatives.
  • To ensure that qualified users will have easy access to the resource, describe either (1) how the investigators will curate the resource, what documentation they will provide about the resource and the format in which it will be provided, and whether any resource will be held back, and (2) if/how the investigators will work with the identified repository/consortium/enclave to prepare the resource and documentation.
  • Address considerations of privacy-preserving linkages and how such keys will be transferred to various parties (e.g., consortium members, researchers) preserving PII for future follow-up.
  • Address timely (i.e., within 30 days of NIA notice) execution of the material transfer agreement within and across the Consortium, and with third parties if directed by NIA. The material transfer agreement includes, but is not limited to, transfer of sampling frame and all resources generated by the grant.

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify the NIA Referral Office by email at ramesh.vemuri@nih.gov when the application has been submitted. Please include the 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.

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

Overall Impact

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

Scored Review Criteria

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


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

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Specific to this NOFO:

To what extent does the proposed project for the consortium address important economic questions/issues in AD/ADRD prevention, treatment, and care?

How comprehensively does the proposed research plan consider health disparities in the selected research areas??How will the proposed research build on the current evidence base for policies addressing the economics aspects of AD/ADRD prevention, treatment or care and how will these findings be used to inform future policy decisions?


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

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Specific to this NOFO:

To what extent does the investigative team possess the expertise and experience required in economic research and relevant aspects of AD/ADRD to effectively conduct the proposed project??If an AI and/or big data research project was proposed, how adequate is the team’s experience in artificial intelligence methodology?


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

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Specific to this NOFO:

To what extent does the proposed project introduce novel data resources, innovative methodologies, or groundbreaking approaches in the field of economic research related to AD/ADRD prevention, treatment, and care? How does the project present new insights or challenge existing paradigms in addressing health disparities for people living with dementia, their caregivers or the system providing care??


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

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

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Specific to this NOFO:

To what extent does the application outline strategies for collection (if applicable) and acquisition of data related to the AD/ADRD prevention, treatment, and care? For applications proposing clinical trials, how adequate is the plan describing how the research will facilitate recruitment of health disparities populations?


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

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria

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


Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?


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

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


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


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


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


Not Applicable.


Not Applicable.


Not Applicable.

Additional Review Considerations

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.


Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Not Applicable.


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


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


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


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

2. Review and Selection Process

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

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

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

Appeals of initial peer review will not be accepted for applications submitted in response to this 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 FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging. The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

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

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

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

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

2. Administrative and National Policy Requirements

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

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.

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Data Management and Sharing

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

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

This NOFO REQUIRES the sharing of ALL resources with a broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication, as appropriate and consistent with achieving the goals of the program, unless prohibited under Bayh-Dole Regulations.

It is imperative that the data collection and permission/consents are set up in such a manner with respondents and institutions that will allow broad use of resource sharing.

This NOFO encourages sharing software and codes that are developed or modified to accomplish the aims of this program, unless prohibited under Bayh-Dole Regulations.

This NOFO requires adoption of Findable, Accessible, Interoperable, and Re-usable (FAIR) data principles when addressing each application component and encourages PD/PIs to store data in repositories that hold a Core Trust Seal.

Applications must address the following items:

  • Indicate the repository/consortium/enclave where they will place the resource or have a clear plan and capacity to share from their own site(s). Working with an external repository or through a consortium can be advantageous for many investigators.
  • Describe and justify the timetable to release the resource. Generally, the referenced resource from a publication should be made available by the on-line publication date unless NIH policy specifies an earlier date. Investigators should justify exceptions to that timing.
  • Identify any restrictions on sharing and justify them. Restrictions might include, for example, no commercial use of the resource, only qualified users may access the material, or, no attempt to reveal personal or private information may be made. Investigators may also set different levels of access, for example, for expert users and novice users.
  • Describe how all materials will be transferred to a new entity at the end of the project period to enable long-term follow up with survey respondents and institutional representatives.
  • To ensure that qualified users will have easy access to the resource, describe either (1) how the investigators will curate the resource, what documentation they will provide about the resource and the format in which it will be provided, and whether any resource will be held back, and (2) if/how the investigators will work with the identified repository/consortium/enclave to prepare the resource and documentation.
  • Address considerations of privacy-preserving linkages and how such keys will be transferred to various parties (e.g., consortium members, researchers) preserving PII for future follow-up.
  • Address timely (i.e., within 30 days of NIA notice) execution of the material transfer agreement within and across the Consortium, and with third parties if directed by NIA. The material transfer agreement includes, but is not limited to, transfer of sampling frame and all resources generated by the grant.

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.

Application Submission Contacts

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: 301-637-3015

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

Scientific/Research Contact(s)

Partha Bhattacharyya, Ph.D.
Division of Behavioral and Social Research (DBSR)
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: bhattacharyyap@mail.nih.gov

Peer Review Contact(s)

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: ramesh.vemuri@nih.gov

Financial/Grants Management Contact(s)

Ryan Blakeney
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: ryan.blakeney@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.

Authority and Regulations

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.

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