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
Building Neuroscience Research Infrastructure for Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) in Africa (UG3/UH3 Clinical Trial Not Allowed)
Activity Code

UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement

Announcement Type
New
Related Notices
  • October 6, 2023 - Notice of Change to Key Dates Listed in RFA-AG-24-027. See Notice NOT-AG-23-056.
  • 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-24-027
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.866
Funding Opportunity Purpose

This notice of funding opportunity (NOFO) promotes collaborative research programs to support the development/enhancement of infrastructure (e.g., tools, surveys, biospecimens, data) for Alzheimer's disease (AD) and AD-related dementias (ADRD) neuroscience research in low- and middle-income countries (LMICs) in Africa, as defined by the World Bank. Specifically, the National Institute on Aging (NIA) seeks to support UG3/UH3 Exploratory/Developmental Phase Innovation Awards Cooperative Agreement projects to enable the following:

(1) The formation of transformative collaborations between institutions/scientists in the US and LMICs in Africa;
(2) The development, or enhancement, of research infrastructure and resources for studies of AD/ADRD neuroscience relevant to Africa, as well as to examine how social or behavioral factors influence AD/ADRD in Africa; and
(3) The initiation of pilot or exploratory studies that may inform future research for AD/ADRD neuroscience in Africa.

The research infrastructure programs are expected to contribute to the long-term goals of building sustainable AD/ADRD neuroscience research capacity and research, with the aim of ultimately leading to prevention and mitigation strategies for AD/ADRD in Africa.

Key Dates

Posted Date
August 25, 2023
Open Date (Earliest Submission Date)
January 12, 2024
Letter of Intent Due Date(s)

January 12, 2024

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
February 14, 2024 Not Applicable Not Applicable June 2024 October 2024 November 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
February 15, 2024
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.

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.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Relevant Term

Low- and middle-income countries in Africa: refers to African countries with low-, lower middle-, and upper middle-income economies as defined by the World Bank.

Background

Alzheimer's disease (AD) and AD-related dementias (ADRD) represent a substantial global health issue, especially for low- and middle-income countries (LMICs). Researchers estimate that the greatest increases for AD/ADRD will occur in LMICs, where approximately 71% of the global cases will reside. While not currently experiencing the largest AD/ADRD burden of all LMIC regions, Africa is expected to undergo a significant increase in the number of new cases. Aging of the population, successes in primary healthcare, and economic development have led to a demographic transition and population growth in Africa. According to the report Africa Aging: 2020 (US Census Bureau), the number of Africans age 60 years and older is projected to triple from 74.4 million to 235.1 million between 2020 and 2050, with at least two-thirds of African countries counting at least 1 million in their population. Africa's growth for this age group is projected to outpace that of any other region of the world.

The rationale for pursuing global AD/ADRD research in Africa is compelling.? Older people in Sub-Saharan Africa are more likely to live in rural areas, spend more time in multigenerational households, and play an active role as caregivers of younger people. In addition, older Africans tend to stay in the labor force longer compared to their peers in other parts of the world. African older adults, particularly those living in rural areas, may face challenges accessing health care due to shortages of health workers, insufficient financial resources, inadequate health insurance coverage, and high out-of-pocket payments. These factors may affect the trajectory of cognitive aging and AD/ADRD and the experience of living with or managing AD/ADRD. Nationally or regionally representative studies based on probability-based sampling, such as?HRS?International Family of Studies ?and?Harmonized Cognitive Assessment Protocol , allow for studies which produce findings that are generalizable to an entire country or region. These studies, along with community-based epidemiological studies, can help us better address these issues.

Studies of AD/ADRD in Africa have the potential to present significant research opportunities that may increase knowledge about the etiology of this family of diseases and accelerate the pace of scientific discovery. Longitudinal?and well-phenotype population-based studies are needed to identify trends of mild cognitive impairment and AD/ADRD and may contribute to our understanding of clinicopathological features for subtypes of dementia. The prevalence of co-morbidities, such as cerebrovascular diseases and other vascular factors (e.g., hypertension, dyslipidemia, hyperinsulinemia, type 2 diabetes, obesity, subclinical atherosclerosis), within the region may contribute to increased risks of cognitive impairment and different AD/ADRD neuropathologies. The genetic variation within African populations, along with the diversity of dietary, lifestyle, cultural, and environmental exposures can provide valuable insights on factors that contribute to, or protect against, AD/ADRD. ?For example, genetic studies, along with comprehensive investigations of the exposome, may increase knowledge of gene-environment interactions and subsequent influence on AD/ADRD risks. ?Thus, identifying the underlying mechanisms of these protective and risk effects could lead to greater understanding of the etiology of AD/ADRD and more personalized therapeutic or prevention interventions in Africa and globally.

Purpose??

This NOFO promotes collaborative research programs to support the development/enhancement of infrastructure (e.g., tools, surveys, biospecimens, data) for AD/ADRD neuroscience research in LMICs in Africa, as defined by the World Bank. Specifically, NIA seeks to support projects to enable the following:

(1) The formation of transformative collaborations between institutions/scientists in the US and LMICs in Africa;
(2) The development, or enhancement, of research infrastructure and resources for studies of AD/ADRD neuroscience relevant to Africa as well as to examine how social or behavioral factors influence AD/ADRD in Africa; and
(3) The initiation of pilot or exploratory studies that will inform future research for AD/ADRD neuroscience in Africa.

These research infrastructure programs are expected to contribute to the long-term goals of building sustainable AD/ADRD neuroscience research capacity and research, with the aim of ultimately leading to prevention and mitigation strategies for AD/ADRD in Africa.

Specific Areas of Interest

Investigators should propose studies that advance the understanding of AD/ADRD in Africa across well-characterized populations.

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 to both immediate research goals and future generalization. Research areas include, but are not limited to, the following:

  • Studies of novel genetic variants that may have a strong genetic contribution to AD biology.
  • Studies that examine the association of highly prevalent co-morbidities (e.g., cardiovascular risk factors, diabetes, dyslipidemia, peripheral arterial disease), cognitive impairment and AD/ADRD phenotypes.
  • Environmental exposures, including environmental toxicants, air pollution, and diet.
  • The role of infectious agents, including COVID-19 in cognitive impairment and age-related dementia.
  • Etiology of age-related dementia subtypes.
  • Genetic and other -omics data: 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: Obesity, diabetes, hypertension, and other vascular contributions to cognitive impairment (VCID); stress measures (e.g., autonomic, cortisol); role of inflammation or immune systems; and mental health history.
  • Identification of underlying mechanisms of resilience (e.g., protective genotypes of cognitive reserve).
  • Social determinants of health and exposome: poverty, discrimination, early or mid-life adversity, neighborhood, occupation and education, cultural and familial contexts, pollution and toxicants, and healthcare access.
  • Psychological: personality, cognitive ability, emotional function (e.g., stress reactivity and resilience, self-regulation), social connection, and loneliness.
  • Behavioral and functional: health behaviors (e.g., physical activity, smoking, diet, sleep, etc.), financial decision-making, physical function, sensory function, and social relationships.
  • Data collection at regional or state-level, particularly in large, populous countries, or on a probability-based sample with the long-term goal is to conduct a nationally representative study.
  • Conducting a multi-disciplinary nationally representative study that is harmonized with the HRS International Family of Studies and Harmonized Cognitive Assessment Protocol.

UG3/UH3 Exploratory/Developmental Phased Award

This NOFO utilizes the UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement activity code. All projects must have a UG3 Exploratory/Developmental Phase and a UH3 Implementation Phase. Applications that only propose UG3 or UH3 activities will be considered incomplete and will not be accepted.

The UG3 phase provides 2-3 years of support for exploratory/developmental activities. The proposed project period for the UG3 phase must not exceed 3 years. The UH3 phase provides 3-4 years of support for implementation activities. The total project period (including both the UG3 and UH3 phases) must not exceed 6 years.

An UG3/UH3 award is not renewable.

Prior to submission, applicants are strongly advised to contact the Scientific/Research contact(s) listed in Section VI of this NOFO to discuss the alignment of their proposed work with the goals of this NOFO.

The UG3 Exploratory/Developmental Phase

The following are the aims of the UG3 Phase:

  1. The formation and/or solidification of collaborations/partnerships between scientists/institutions in the US and LMICs in Africa using a Multiple Principal Investigator (MPI) approach. ?MPIs must consist of at least one US scientist and at least one scientist from the African LMIC. The US scientist(s) must have documented experience conducting research and training activities within LMIC settings. To enable succession planning, African 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 African LMICs in the overall partnership hub 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.
  2. The formation of an External Advisory Board with subject matter expertise to supplement or complement the areas of expertise of the research team members. The application should identify the types of expertise appropriate for the External Advisory Board and the number of members, but NOT recommend individuals by name nor provide biographical sketches of proposed members.
  3. The development or scaling up of research infrastructure, expertise, and resources for AD/ADRD neuroscience research in Africa. The resulting infrastructure or resources must ensure sufficient variation in relevant demographic and life history characteristics as appropriate to the scientific focus of the application. Approaches may include, but are not limited to, the following:
    • The development, translation and/or pilot testing of new measures, tools (e.g., surveys, software, technologies),?and/or methods for recruitment, retention, and data collection (e.g., demographic or clinical data) from well-defined populations.
    • The development and/or testing of methods for bio-sample or environmental-sample collection.?
    • The collation, integration, or harmonization of existing, complementary datasets into a single data-base or linked data-bases.
    • The addition of AD-related data to existing non-aging or non-AD/ADRD population-representative studies.
    • The development of a sampling frame or adapting an existing sampling frame, and/or development of skills in probability-based sampling for new population-representative studies for subsequent implementation in full-scale research on AD/ADRD.
    • The development of computational infrastructure and training in causal inference to support secondary data analysis using advanced programming skills and statistical methods and developing familiarity with relevant datasets.
  4. The facilitation of meaningful engagement of relevant local stakeholders. The partnership between the research scientists and other local relevant stakeholders is expected to draw upon each of their respective strengths, allowing for the integration of their unique perspectives and expertise in informing research priorities and leading to overall sustainability. The relationship should also facilitate bi-directional communication between the researchers and the engaged stakeholders over the course of the research study. Types of relevant stakeholders include, but are not limited to the following:
    • Those with appropriate background(s) for the types of subjects to be recruited, data to be collected, and/or scientific topics to be explored.
    • Representatives of community organizations, i.e., non-Federal, non-academic organizations that provide goods, services, support, resources, or advocacy to members of a defined community. Examples include community or faith-based organizations; local businesses; neighborhood associations; labor unions; patient or consumer advocacy groups; public health departments; healthcare systems; school systems; law enforcement or criminal justice agencies; social service agencies; or departments of commerce, labor, transportation, housing, and recreation. Governmental organizations at the local, regional, tribal, or state level fall within this definition.
    • Those skilled in outreach, education, social work, or public health.
  5. The creation of a comprehensive Data Management and Sharing Plan.
  6. The leveraging of existing NIH and NIA-supported infrastructure, such as the following:

The UH3 Implementation Phase

UH3 phase will support adequately powered pilot projects to investigate AD/ADRD research in Africa, and to lay the foundation for future, larger scale projects.

During the UH3 phase, investigators should do the following:

  1. Utilize data collected or collated during the UG3 phase;
  2. Further develop analytic approaches and/or data sharing platforms;
  3. Develop mechanistic hypotheses and design rigorous studies to test those hypotheses; and
  4. Demonstrate feasibility and collect preliminary data to support future, larger scale research projects for AD/ADRD research in Africa.

The UG3/UH3 Transition Process

At the completion of the UG3 planning phase, the applicant will be required to submit a detailed transition request for the UH3 research implementation phase. The UH3 transition request will undergo an administrative review to determine whether the study will be awarded the implementation phase (UH3). Only those UG3 phase projects that have met the specific criteria below will be eligible to transition to the UH3 phase after the NIH administrative review.

To initiate the transition from the UG3 phase to the UH3 implementation phase, the applicant will submit a detailed transition request to proceed. UH3 transition requests will undergo administrative review by NIA staff to determine whether the study will be awarded the UH3 phase. In addition, transition decisions will be based on readiness to conduct the UH3 study, the feasibility of completing the UH3 study, availability of funds, and program priorities. Prospective applicants should note that initial UG3 funding for the UG3/UH3 cooperative agreement does not guarantee support of the UH3 phase. UH3 funding is dependent on NIA program priorities and availability of funds. In addition, applicants should understand that transition to the UH3 phase of the project will occur only if an administrative review process determines that the UG3 planning milestones have been successfully met.

Milestones and Timelines

The application must include well-defined quantitative milestones and timelines for assessing progress in both the UG3 and UH3 phases, including specific milestones for progressing from the UG3 phase to the UH3 phase. Each milestone must be included in a project timeline for completion.

The milestone plan will require NIA review and approval before the UH3 grant is awarded, and will be included in the terms and conditions of the UG3 Notice of Award (NoA). Successful completion of UG3 milestones is required to transition to the UH3 award. For information on how to write a research milestone, please visit the Create Bio Examples:Milestones webpage.

Annual Investigator Meeting

Investigators are expected to participate in an annual (virtual or in-person) Program Director/Principal Investigator (PD/PI) meeting. In-person meetings will be held in the Bethesda, Maryland area. The first meeting will be held after the first NoAs are issued. The meeting is expected to last for 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. NIA Program Officials and Project Scientists will organize annual meetings in coordination with 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.

Frequently Asked Questions

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

Non-responsiveness Criteria

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

  • Applications that only propose UG3 or UH3 activities
  • Applications that include non-human animals
  • Applications that include populations not from Africa
  • Applications from high-income countries, as defined by the World Bank, including high-income African countries
  • Applications that do not include all the following components:
    • A U.S-Africa collaborative MPI plan
    • A description of the scientific area to be addressed and a description of how the proposed infrastructure and resources will help address the scientific area.
    • A plan for appropriate and meaningful community engagement
    • A description of milestones, performance metrics, and a timeline for completion of milestones

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

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?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

NIA intends to commit $3M in FY 2024 to fund 4 awards.

Award Budget

Application budgets are limited to $400,000 in direct costs per year during the UG3 phase, and $800,000 in direct costs per year during the UH3 phase.

Awards will be made to the US institution and at least 60% of the awarded funds must be used to support research activities within the African LMIC institution.

Award Project Period

The proposed project period for the UG3 phase must not exceed 3 years. The total duration of the UG3/UH3 phases combined must not exceed 6 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.

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 PDs/PIs should have experience conducting research in the LMICs.

MPIs must consist of at least one US scientist and at least one scientist from the African LMIC. The U.S scientist(s) must have documented experience conducting research and training activities within LMIC settings.

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 and/or have an 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.

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:

Damali Martin, Ph.D., MPH
Telephone: 301-802-4310
Email: martinda@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.

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 PDs/PIs should have experience conducting research in the LMICs.

MPIs must consist of at least one US scientist and at least one scientist from the African LMIC. The U.S scientist(s) must have documented experience conducting research and training activities within LMIC settings.

The senior PI must have an ongoing record of effectively leading multi-disciplinary teams in LMIC settings.

R&R Budget

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

At least 60% of the Award Budget in direct costs per year must be allocated to support activities in an African LMIC Institution

The budget should include costs for PDs/PIs and selected key personnel to travel to attend meetings of their research group at least 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 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: In the single Specific Aims attachment, provide the overall goal for the entire proposal and indicate separately the Specific Aims to be accomplished in the UG3 Exploratory/Developmental phase and the UH3 Implementation Phase.

Research Strategy: Applicants must organize the research strategy into subsections as indicated below. The applicant must complete the task outlined in each bullet point. 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 African LMIC and how the proposed research infrastructure and resources will address the scientific gap.
    Describe how achieving the aims of the proposed project will lead to the development of new research resources for AD/ADRD neuroscience research in Africa.
  • Describe how the design and data collected will advance the understanding of AD/ADRD in Africa, and expand or improve research for AD/ADRD in Africa.
  • Describe how the proposed plans will enhance the ability of the African institution to perform AD/ADRD research in the future.
  • 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 Africa.
    Explain how resources created will serve to improve or expand research on AD/ADRD neuroscience research in Africa.
  • Describe how the research could inform AD/ADRD preventative, therapeutic, or intervention strategies in the US 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 US scientist and at least one scientist from the African LMIC. The U.S scientist(s) must have documented experience conducting research and training activities within LMIC settings. Describe the scientific expertise of the members of the US-African 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 research 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 Africa.
  • Describe (if any) previous scientific or public health needs assessments that were performed that will help inform the work proposed in the application. If no previous needs assessment was performed, describe plans for current needs assessment and how this will be used to inform research and resource infrastructure needs.
  • Summarize preliminary data that demonstrates the feasibility of the development and/or testing of new tools or methods to recruit the selected population of interest, collect and use high-quality data, work collaboratively in a multidisciplinary team, and interact productively with community stakeholders.
  • Summarize preliminary data on the proposed assessments as valid and reproducible.

Sub-section D. Approach (maybe divided into the UG3 Phase and the UH3 Phase)

  • 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.
  • The application must include a plan for appropriate and meaningful community engagement. 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 plans for sustainability of research resources within the African LMIC institution.
  • Describe plans for sustainability of research infrastructure, research resources, and future research for AD/ADRD in Africa.

Sub-section E. Milestones and Timelines

At the completion of the UG3 planning phase, the applicant will be required to submit a detailed transition request for the UH3 research implementation phase. The UH3 transition request will undergo an administrative review to determine whether the study will be awarded the implementation phase (UH3). Successful completion of UG3 milestones is required to transition to the UH3 award.

The application must include well-defined quantitative milestones and timelines for assessing progress in both the UG3 and UH3 phases, including specific milestones for progressing from the UG3 phase to the UH3 phase. A timeline, with milestones incorporated, is required for the UG3 Exploratory/Developmental Phase and the UH3 Implementation Phase. The timeline and milestones should reflect the overall objectives of each phase. Milestones should be well-defined and include objective criteria for success. Annual milestones should function as indicators of a project's progress. The annual milestones will be used to evaluate the application in peer review and in consideration of funding for the project in non-competing award years.

Milestones and timelines for each UG3 and UH3 stage must be provided in a separate heading at the end of the Approach section and must:

  • Provide appropriately detailed criteria by which milestone achievement will be assessed;
  • Provide a detailed timeline for the anticipated attainment of each milestone and the overall goal;
  • Identify any impediments that could require an addendum to the research plan, milestones, and/or timeline with a discussion of alternative approaches;
  • Provide detailed timelines that are aligned with the overall objectives of each phase: the UG3 Exploratory/Developmental phase (including specific milestones that will serve as criteria for progressing to the UH3 Implementation Phase), and the UH3 Implementation Phase focused on completing the research agenda; and
  • Identify performance metrics to be achieved during the UH3 phase.

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 SF424 (R&R) Application Guide.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

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

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

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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?

Specific to this NOFO:

How adequately did the investigators describe the relevance of the proposed work in the African LMIC? How likely is it that achieving the aims of the proposed project will lead to the development of new research resources for AD/ADRD neuroscience research in Africa? To what extent will resources created serve to improve or expand research on AD/ADRD neuroscience research in Africa? How well will the research infrastructure created and/or data collected support research that could inform future preventative or therapeutic intervention strategies for Africa, the US, and globally?


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

Specific to this NOFO:

How adequately does the senior PI demonstrate an ongoing record of effectively leading multi-disciplinary teams in LMIC settings? How appropriate is the expertise of the research team 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, how appropriate is the expertise and experience of the research team in engaging with those populations and relevant community partners?


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?


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?


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?

Specific to this NOFO:

How likely is it that the proposed project will enhance the ability of the African institution to perform AD/ADRD research in the future? How adequate are the plans for sustainability of research resources within the African LMIC institution?

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.



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.


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 NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging. . The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

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

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

2. Administrative and National Policy Requirements

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

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 2 CFR 200 and other DHHS, 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 award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipient’s for the project as a whole, although specific tasks and activities may be shared among the recipient’s and the 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 UG3/UH3 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 coauthorship 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 Data Management and Sharing Plan for NIH.
  • 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 DHHS, PHS, and NIH policies.

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

  • 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 the normal scientific programmatic stewardship of the award and will be named in the notice of 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 transition from UG3 to UH3 and funding of UH3 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.

Areas of joint responsibility include:

  • Agreeing upon and formalizing project-specific milestones to be met prior to consideration of the transition from UH2 to UH3 phases.
  • Ensuring that sites, investigators, 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 UH2/UH3 project, consisting of the leadership of the UH2/UH3 project and NIA staff. The Project Scientist(s) will have one collective vote. Other NIA staff will participate in a non-voting capacity. The PI/PD will have one vote.
    • The Steering Committee will be chaired by one of the UH2/UH3 PDs/PIs. The Steering Committee will select the chair by vote.
    • 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 1 in-person meeting each year in Bethesda, MD over the course of the UH2/UH3 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 Office and to research team members within one week of the meeting.

Dispute Resolution:

Any disagreements that may arise on scientific or programmatic matters (within the scope of the award) between award recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient.This special dispute resolution procedure does not alter the recipient 's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Data Management and Sharing

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

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

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)

Damali Martin, Ph.D., MPH
Division of Neuroscience (DN)
National Institute on Aging
Email: martinda@mail.nih.gov

Maryam Ghaleh, Ph.D.
Division of Neuroscience (DN)
National Institute on Aging
Email: maryam.ghaleh@nih.gov

Minki Chatterji, Ph.D.
Division of Behavioral and Social Research (DBSR)
National Institute on Aging
Email: minki.chatterji@nih.gov

Peer Review Contact(s)

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)
Phone: 301-402-7700
Email: Ramesh.Vemuri@nih.gov

Financial/Grants Management Contact(s)

Jeni Smits
National Institute on Aging (NIA)
Phone: 301-827-4020
Email: Jeni.smits@nih.gov

Section VIII. Other Information

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

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.

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.