Part 1. Overview Information

Key Dates

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

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

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

It is critical that applicants follow the instructions in the Research (R) Instructions in the 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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

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

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

The rationale for pursuing global AD/ADRD research in LMICs is compelling. Approximately 60% of all people living with AD/ADRD live in LMICs, and this percentage is expected to increase to 71% by 2050. Moreover, the number of people living with AD/ADRD in LMICs is expected to experience a greater increase compared to the number of people with AD/ADRD in high-income countries by 2050 due to increases in life expectancy alongside a greater burden of risk factors. Furthermore, these projections might be confounded by temporal changes due to shorter survival after dementia, lack of education and awareness, inadequate diagnostic assessment, and variability in costs of care for the elderly with AD/ADRD, all of which could lead to under-accounting of the AD/ADRD burden. Although most people living with AD/ADRD live in LMICs, research on AD/ADRD in these regions is limited and under-resourced. Most research data on AD/ADRD and evidence for AD/ADRD risk factors come from high-income countries (HICs) and research and data on the impact of risk factors on AD/ADRD in LMICs are lacking. AD/ADRD risk and protective factors in HICs might be different from those in LMICs, and modification in interventions might be required for people from different regions and cultures. Diversity in AD/ADRD research participants and global research are crucial in ensuring research findings are generalizable. Moreover, global AD/ADRD research and cross-country comparisons may assist in improving our understanding of the multifactorial and complex nature of AD/ADRD. The wide variety of dietary, lifestyle, and environmental exposures, as well as genetic variation of respective populations, can provide valuable insights on factors that contribute to, or protect against, developing AD/ADRD in different populations.  

A dearth of AD/ADRD research in LMICs has created limitations in knowledge of AD/ADRD epidemiology, which warrants the need for sustainable AD/ADRD research programs in LMICs. Supporting AD/ADRD research, research infrastructure, and AD/ADRD scientists in LMICs will provide the opportunity to study populations that are currently underrepresented in AD/ADRD research and ultimately lead to more evidence-based prevention, detection, intervention, and treatment strategies for those populations. Evidence-based AD/ADRD prevention, detection, and intervention strategies that are practical for populations living in LMICs could contribute greatly to reducing the global burden of the disease due to the higher prevalence of modifiable risk factors in LMICs compared to HICs, and the subsequent higher potential for AD/ADRD prevention in LMIC regions.

Purpose 

 Through this NOFO, the National Institute on Aging (NIA) seeks to support Cooperative Agreement (U01) projects that propose to achieve the following objectives:

1. Enable the formation of transformative collaborations between institutions/scientists in the U.S. and LMICs.
2. Support experienced LMIC scientists to perform innovative and sustainable AD/ADRD neuroscience research within their LMIC environment.

These research programs are expected to contribute to the long-term goals of building sustainable AD/ADRD neuroscience research capacity and research, ultimately leading to prevention and mitigation strategies for AD/ADRD in LMICs. To achieve this goal, the proposed projects are expected to include the following types of activities:

• The formation and/or solidification of collaborations/partnerships between scientists/institutions in the U.S. and LMICs using a Multiple Principal Investigators(MPI) approach. MPIs should consist of at least one scientist working in an institution based in an LMIC and at least one U.S. scientist. Scientist(s) from LMIC institutions must have prior experience conducting neuroscience AD/ADRD research and may demonstrate experience either through proof of leading a scientific endeavor or through receipt of funding from a local funding agency. The U.S.-based scientist(s) must have documented experience conducting research within LMIC settings, as well as experience conducting NIH-supported research. To enable succession planning, LMIC institutions are encouraged to include at least one early-stage investigator in the research team and to include them in the development and planning aspects of the research award. Applicants must present an MPI plan that clearly delineates roles and responsibilities. Applicants are encouraged to involve multiple U.S. and LMIC partner institutions in the proposed research project, as scientifically appropriate and justified. Partnerships with appropriate LMIC governmental organizations, non-governmental organizations (NGOs), and academic institutions are encouraged. Initial inclusion of more than three LMICs in the overall partnership structure for new applications is likely to be very challenging and should only be undertaken if there is strong justification, including how the partnership will be managed and how the support and responsibilities will be distributed.
• The formation of an External Advisory Board with subject matter expertise in order to supplement or complement the areas of expertise of the research team members.  The proposed External Advisory Board is required to provide guidance and feedback on conducting the research project and develop a sustainability plan. The composition of this committee depends on the nature and scope of the project, and the committee may include, as appropriate to the project, individuals employed by the Program Director/Principal Investigator's (PD/PI) institution. The application should identify the types of expertise appropriate for the External Advisory Board, the number of members, and the operations and frequency of meetings, but it must NOT recommend individuals by name nor provide biographical sketches of proposed members. Membership can be negotiated with program staff at the time of award.
• Conducting AD/ADRD neuroscience research within LMICs, that addresses significant issues unique to LMICs and that are also relevant to the U.S.. Applicants must demonstrate relevance to their LMIC as well as how their proposed research can inform preventative or therapeutic strategies for the U.S.

Specific Areas of Interest

Investigators should propose studies that advance understanding of AD/ADRD neuroscience in LMICs. Although study designs will depend upon the specific goals of the project, all applications must clearly define the population(s) or sub-population(s) of interest and describe how investigators will ensure representation appropriate for future research goals. All studies must have a neuroscience focus. Research areas include, but are not limited to, the following:

• Descriptive epidemiology and trends (i.e., incidence, prevalence, morbidity, mortality) in diverse populations.
• Longitudinal cohort and other epidemiological studies that investigate risk and preventive factors associated with mild cognitive impairment (MCI),AD/ADRD, and/or neuropathological outcomes in diverse populations. Risk factors include those that are genetic, environmental, modifiable, and co-morbidities.
• Novel genetic variants that may have a strong genetic contribution to AD/ADRD biology.
• Examination of the association between highly prevalent co-morbidities (e.g., cardiovascular risk factors, diabetes, dyslipidemia, peripheral arterial disease), cognitive impairment and AD/ADRD phenotypes.
• The role of early life co-morbidities, such as childhood infections and diseases prevalent in LMICs.
• The impact of the exposome (e.g., environmental exposures including environmental toxicants, air pollution, and diet) on brain health, AD/ADRD risk, and cognitive reserve/resilience.
• The role of infectious agents, including COVID-19, in cognitive impairment and AD/ADRD.
• Etiology of age-related AD/ADRD subtypes.
• Genetic and other -omics data (e.g., APOE status, genome-wide association study or whole sequencing, epigenetics, transcriptomics, metabolomics, and proteomics).
• Neurobiological and Neuropathological neuroimaging endpoints, including, but not limited to, the use of novel positron emission tomography (PET) ligands; cerebrospinal fluid, or blood-based biomarkers such as beta-amyloid, tau, and neurofilament; and autopsy tissue when possible.
• Physiology and other co-morbidities including, but not limited to, obesity, diabetes, hypertension, and other vascular contributions to cognitive impairment (VCID); brain stress measures (e.g., autonomic, cortisol, EEG, fNIRS); role of inflammation or immune systems; and mental health history.
• Identification of underlying mechanisms of cognitive reserve/resilience (e.g., protective genotypes of cognitive reserve).
• Development of accessible, low-cost tools for the diagnosis of AD/ADRD.
• Population-based research for the discovery or expansion of predictive pre-clinical biomarkers (e.g., blood, fluid, neuroimaging, language) associated with vascular or neurological changes in different populations.

Annual Investigator Meeting

Investigators are expected to participate in an annual (virtual or in-person) PD/PI meeting. The first meeting will be held after the first Notice of Awards are issued. The meeting is expected to last up to two days. The annual meeting will provide a forum for investigators to discuss research updates, identify opportunities for synergy and collaboration across projects (e.g., data harmonization, protocol optimization), and identify pertinent research challenges and solutions. The consortium coordinating center will organize annual meetings in coordination with NIA Program Officials and Project Scientists and investigators and develop the agenda with input from the funded research teams. Applicants should include funds to support travel to the meeting in their yearly budget.

Non-responsiveness Criteria

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

• Applications that include non-human animals.
• Applications that include populations not from LMICs.
• Applications that do not propose research related to AD/ADRD neuroscience.
• Applications from high-income countries, as defined by the World Bank.
• Applications not from an established LMIC investigator.
• Applications which do not include a U.S. collaborator.
• Applications that do not include a U.S.-LMIC collaborative MPI plan.

Frequently Asked Questions

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

Resources for Applicants

Applicants are encouraged to leverage existing NIH and NIA-supported infrastructure, such as the following:

• Human, Health and Hereditary in Africa (H3Africa)
• Harnessing Data Science of Health Discovery and Innovation in Africa (DSI-Africa)
• Global Environmental and Occupational Health program (GEOHealth)
• Health and Retirement Study: International Family of Studies
• Harmonized Cognitive Assessment Protocol (HCAP) Network
• Gateway to Global Aging
• Alzheimer’s Disease Research Centers
• Alzheimer’s Disease Sequencing Project
• NIA’s Genetics of Alzheimer's Disease Data

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 Organizations)

Non-domestic (non-U.S.) Entities (Foreign Organizations) are 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. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• 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 How to Apply - Application Guide.

The PDs/PIs must be established, experienced investigators in the scientific area on which the application is focused and capable of providing both administrative and scientific leadership on the development and implementation of the proposed program. The U.S. PDs/PIs should have experience conducting research in LMICs.

Non-U.S.-based high-income countries (HIC) investigators are NOT eligible as PD/PIs but may be included as consultants, especially if they present special opportunities for furthering research programs, present special opportunities and/or unusual talent for furthering research programs, or provide resources relevant to the proposed project that either are not readily available in the eligible LMIC or the U.S. institution or which augment existing resources.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

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 How to Apply - 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:

Maryam Ghaleh, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-529-7468
Email:[email protected]

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

The PDs/PIs should be established investigators in the scientific area on which the application is focused and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The U.S. PDs/PIs should have experience conducting research in the LMICs.

R&R or Modular Budget

All instructions in the How to Apply - Application Guide must be followed.

The budget should include costs for PDs/PIs and selected key personnel to travel to attend meetings of their research group at least once annually.

The budget should also include costs for the PDs/PIs and selected key personnel to travel to attend the annual network meeting of all funded awards.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy: Applicants must organize the research strategy into subsections as indicated below. Applicants may include other sections as needed.

Sub-section A. Background and Significance

• Provide an overview of relevant scientific literature.
• Identify the scientific gap(s) fulfilled by the proposed projects, its relevance to the LMIC and how the proposed research will address the scientific gap.
• Describe how the design and data collected will advance the understanding of AD/ADRD in LMIC(s).
• Explain how the findings of the project will inform future AD/ADRD preventative, therapeutic or intervention strategies, or public health guidelines to decrease the burden of AD/ADRD in LMIC(s).
• Describe how the research could inform AD/ADRD preventative, therapeutic, or intervention strategies in the U.S. or globally.
• Justify and explain the rationale for selection of the study population/geographic regions.

Sub-section B. Multi-disciplinary Team

• Applicants must present an MPI plan that clearly delineates roles and responsibilities. MPIs must consist of at least one U.S. scientist and at least one scientist working in an institution based in an LMIC. The U.S. scientist(s) must have documented experience conducting research activities within LMIC settings. Describe the scientific expertise of the members of the U.S.-LMIC MPI team. Provide a rationale and a justification for choosing the scientific team. In the justification, outline the individual team members' areas of expertise and ways in which team members complement each other for the benefit of the project.
• Describe the experience/expertise of the lead U.S. investigator(s) in performing research in a LMIC setting. Describe how this experience will be used to successfully implement the proposed aims of the project.
• Explain how the expertise of the research team is appropriate for the types of data to be collected/included and/or the tools/techniques needed to establish or expand the infrastructure proposed (e.g., genetic or environmental, epidemiology, exposure assessment, cell/molecular sciences, engineering/database management). If the project focuses on a particular population, explain how the expertise and experience of the research team is appropriate to support engaging with those populations and relevant community partners. 
• Provide an overview of the governance and organizational structure of the team, including the process for making decisions on scientific direction and allocating funds and resources.
• Provide a summary of prior or new collaboration(s) with community partners, including, but not limited to, the following:
  • Patient advocacy groups
  • Healthcare organizations
  • Community-based organizations
  • Health systems
  • Clinics
  • Health departments
  • Professional organizations
• Describe how the team will engage with relevant stakeholders, how the relationship will draw upon the respective strengths of the team and the stakeholders over the course of the study, and how this relationship will be sustained.

Sub-section C. Innovation and Preliminary Data

• Describe how the project is innovative, and how data collected, or new research infrastructure created, will allow for novel and/or expanded investigations of AD/ADRD in LMICs.
• Summarize preliminary data that demonstrates the feasibility of the proposed research, methods to recruit the selected population of interest, collection and use of high-quality data, collaboration within a multidisciplinary team, and productive interactions with community stakeholders.
• Summarize preliminary data on the proposed assessments as valid and reproducible.

Sub-section D. Approach

• Provide an overview of the study population selected.
• If new recruitment is planned, provide a description of how the participants of the study will be recruited and retained in the study. Describe any potential challenges in recruitment, retention, and how these challenges will be addressed.
• Describe methods that will be used to accomplish specific aims.
• Describe the information or types of data to be collected in the study and how the activities and research proposed will advance AD/ADRD research for the study population.
• Describe the development and/or testing of new measures, tools and/or methods for recruitment, retention, and data collection from well-defined populations.
• Describe the analytic plan, including calculations for expected effect sizes, sample size, and power analyses for all aims.
• Include a description of community engagement activities and explain how these activities will be sustained over the period of the study and/or beyond.
• Describe how the infrastructure created and/or data collected will support a precision medicine approach for future preventative or therapeutic intervention strategies development.
• Describe plans for sustainability and future research.
• Propose an External Advisory Board. The application should identify the types of expertise appropriate for the External Advisory Board, the number of members, and operations and frequency of meetings but must NOT recommend individuals by name nor provide biographical sketches of proposed members. 

 Letters of Support: Applicants should include letters of support from collaborating entities that are essential to the mission of the work proposed.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s): 

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.  

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - 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 How to Apply - 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 How to Apply - 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 How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

Foreign Organizations

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply Application Guide.

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

See Part 2. 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. 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 How to Apply – 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - 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 How to Apply - 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 National Institute on Aging Referral Office by email at [email protected] when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected]. 

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 policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

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

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

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

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

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

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 
  • HHS recognizes that NIH 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.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

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 (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

• Developing objectives, approaches, and measures to be included in the U01 project.
• Designing protocols, proposing milestones, and overseeing conduct of analyses and experiments.
• Overseeing and coordinating the effort of the multidisciplinary team and participating institutions and ensuring their optimal interactions and integration in the conduct of research activities.
• Complying with Federal regulatory requirements, including but not limited to those relating to human subject protections, informed consent, and reporting of adverse events.
• Agreeing to accept close coordination, cooperation, and management of the project with NIH, including those outlined below in the "NIH Staff" section. The PD/PI(s) will be expected to maintain close communications with the NIH Project Scientist(s) and, where appropriate, the Program Officer(s). The Project Scientist(s) will have substantial scientific involvement that is above and beyond the normal stewardship role in awards.
• Cooperating in the reporting of the study progress and findings. Where warranted by appropriate participation, plans for joint publication with NIH of the results and conclusions are to be developed by the Principal Investigator or Steering Committee, as applicable. NIH policies governing possible co-authorship of publications with NIH staff will apply in all cases. In general, to warrant co-authorship, NIH staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; and (c) preparation and authorship of pertinent manuscripts.
• Overseeing the overall budget, activities, and performance of the cooperative agreement.
• Accepting the participatory and cooperative nature of the collaborative research process and complying with the policies and practices of NIH.
• Participating in teleconferences with NIH program staff, as needed; and in an annual Program Director/Principal Investigator (PD/PI) meeting.
• Sharing data, resources, and software as appropriate and consistent with achieving the goals of the program and the approved DMS Plan for this award and NIH sharing policies.
• Designating investigators to serve as members of an External Advisory Committee. Organizing and attending annual (or as needed) External Advisory Committee meetings.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

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

• NIA will assign a Project Scientist(s) as the point of contact to work with the PD(s)/Pl(s).
• The NIA/NIH Project Scientist will interact scientifically with the research team and provide input, expert advice, and suggestions on the design, development, coordination, and implementation of the study objectives. They may present experimental findings to the research team from published sources or from other relevant sources, participate in the analysis of results, and advise on management and technical performance.
• The NIA/NIH Project Scientist will facilitate interaction with other NIH-supported activities or programs to allow exchange of relevant tools and data, to facilitate resource compatibility, and to avoid unnecessary duplication of effort.
• NIH will assign a Program Officer(s) who will be responsible for retaining overall programmatic stewardship of the award. The PO will interact with the PD(s)/Pl(s) on a regular basis to monitor progress and facilitate cooperation. Monitoring may include regular communication with the PD(s)/Pl(s) and his/her staff.
• NIH may designate additional staff to provide advice to the recipient on specific scientific and/or analytic issues. Such staff may include another Project Scientist(s) or Analyst, who will provide direct technical assistance to the recipients to optimize the conduct and/or analysis of the study; or who may assist in the coordination of activities across multiple sites. NIH will clearly specify to the recipient the name(s) and role(s) of any additional individuals with substantial involvement in the project and the lines of reporting authority.
• NIH staff will make recommendations for the future years of funding based on: a) overall study progress, including sufficient patient and/or data accrual; b) cooperation in carrying out the research; and/or c) maintenance of a high quality of research, which will allow improvements in future studies of minority health and health disparities.
• NIH reserves the right to terminate or curtail the award (or an individual component of the award) in the event of inadequate progress or data reporting.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Agreeing upon and formalizing project-specific milestones.
• Ensuring that sites and investigators as well as NIH and other research partners fully comply with Federal regulatory requirements. This includes, but is not limited to, those relating to human subjects protections, informed consent, and reporting of adverse events.
• Establishment of a Research Governing Body:
  • The Steering Committee will serve as the research governing body for the U01 project, consisting of the leadership of the U01 project and NIA staff.  The Project Scientist will have one vote and other Program Officials may serve in a non-voting capacity. .
  • The Steering Committee will be chaired by one of the U01 PDs/PIs.
  • The Steering Committee members will meet regularly to review and monitor progress, plan and design research activities, and establish priorities. Meetings may occur as regularly scheduled teleconferences and include at least one in-person meeting each year over the course of the U01 project period.
  • The PI(s)/PD(s) will be responsible for scheduling the teleconferences and in-person meetings, as well as for preparing concise minutes from teleconferences and in-person meetings. The meeting minutes will be distributed to the NIA Program Officer(s) and to research team members within one week of the meeting. 

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: 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 HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. 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 2 CFR Part 200.301.

In carrying out its stewardship of this NOFO, the NIH or its Institutes and Centers may request information essential to an assessment of the effectiveness of this program from the participants (LMIC investigators, U.S. collaborators and others as determined). Participants may be contacted during and after the completion of this award for periodic updates on publications, new collaborations, support from research grants or contracts, and other information helpful in evaluating the impact of the program. NIH and its ICs will use this information to determine overall success in building sustainable, independently resourced AD and/or ADRD neuroscience research programs at the LMIC institution. 

Section VII. Agency Contacts

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

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

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

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

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

Maryam Ghaleh, Ph.D.
Division of Neuroscience
National Institute on Aging (NIA)
Email: [email protected]   

Damali Martin, Ph.D., MPH
Division of Neuroscience
National Institute on Aging (NIA)
Email: [email protected] 

Dallas Anderson, Ph.D.
Division of Neuroscience
National Institute on Aging (NIA)
Email: [email protected]   
   

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

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

Jeni Smits
National Institute on Aging (NIA)
Telephone: 301-827-4020
E-mail: [email protected] 
 

Section VIII. Other Information

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

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